MIR Spirotel User manual

Spirotel®
Rev.1.6
Page 1 of 37
User Guide
Spirotel®
User manual
Rev. 1.6
Date issued 19.10.2020
Date of approval 19.10.2020

Spirotel®
Rev.1.6
Page 2 of 37
User Guide
TABLE OF CONTENTS
1. INTRODUCTION ..................................................................................................................................................................................................4
1.1 Intended use...................................................................................................................................................................................................4
1.1.1 User type....................................................................................................................................................................................................4
1.1.2 Ability and experience required .............................................................................................................................................................4
1.1.3 Where the device is used.........................................................................................................................................................................4
1.1.4 Use at home ..............................................................................................................................................................................................4
1.1.5 Individual patient factors that can affect use of the product ...........................................................................................................4
1.1.6 Limitations of use –Contraindications ................................................................................................................................................4
1.2 Important safety warnings ...........................................................................................................................................................................5
1.2.1 Risk of cross contamination...................................................................................................................................................................5
1.2.2 Turbine.......................................................................................................................................................................................................5
1.2.3 Mouthpiece................................................................................................................................................................................................6
1.2.4 Sensor for oximetry .................................................................................................................................................................................6
1.2.5 USB connection cable .............................................................................................................................................................................7
1.2.6 The Spirotel®unit ....................................................................................................................................................................................7
1.2.7 Warnings for use in electromagnetic environments ..........................................................................................................................7
1.3 Warnings regarding use of the lithium ion battery..................................................................................................................................7
1.4 Warnings regarding the GSM module.......................................................................................................................................................9
1.5 Labels and symbols .......................................................................................................................................................................................9
1.5.1 ID label ......................................................................................................................................................................................................9
1.5.2 FCC certification label...........................................................................................................................................................................10
1.5.3 Electrostatic discharge symbol ............................................................................................................................................................10
1.6 Product description.....................................................................................................................................................................................11
1.7 Technical specifications .............................................................................................................................................................................11
1.7.1 Spirometer specifications......................................................................................................................................................................12
1.7.2 Oximeter specifications.........................................................................................................................................................................12
1.7.3 Oximetry alarms description ................................................................................................................................................................13
1.7.4 Other features.........................................................................................................................................................................................14
2. USING THE Spirotel®..........................................................................................................................................................................................15
2.1 Display...........................................................................................................................................................................................................15
2.2 Turning the Spirotel®ON and OFF .......................................................................................................................................................16
2.3 Saving energy ...............................................................................................................................................................................................16
2.4 Main screen ..................................................................................................................................................................................................16
2.5 Symbols and icons.......................................................................................................................................................................................16
2.6 Service menu................................................................................................................................................................................................17
2.6.1 Configuration menu...............................................................................................................................................................................19
2.6.2 Turbine calibration.................................................................................................................................................................................25
2.7 Showing the current patient's last session...............................................................................................................................................27
2.8 On-line mode (connected to a PC)..........................................................................................................................................................27
2.9 Performing spirometry ...............................................................................................................................................................................27
2.9.1 FVC test...................................................................................................................................................................................................27
2.10 The display and reading of spirometry results .......................................................................................................................................28
2.10.1 Interpreting spirometry results ............................................................................................................................................................28
2.11 Performing oximetry...................................................................................................................................................................................28
2.11.1 Oximetry test classification ..................................................................................................................................................................30
2.11.2 Instructions for using the sensor on adult patients..........................................................................................................................31
3. DATA TRANSMISSION.....................................................................................................................................................................................32
3.1 Data transmission via Bluetooth to a mobile phone ............................................................................................................................32
3.2 Connecting with a PC via USB port ........................................................................................................................................................32
3.2.1 Up-dating internal software..................................................................................................................................................................32
3.2.2 Configuration for data transfer via GSM...........................................................................................................................................32
3.3 Data transfer via GSM ...............................................................................................................................................................................33
3.3.1 Errors that might occur during the GSM connection .....................................................................................................................33
4. MAINTENANCE..................................................................................................................................................................................................34
4.1 Cleaning and disinfection of the turbines ...............................................................................................................................................34
4.2 Cleaning and disinfection of the oximetry sensor .................................................................................................................................35
4.3 Cleaning of the device ................................................................................................................................................................................35
4.4 Recharging the battery................................................................................................................................................................................35
5. TROUBLE SHOOTING AND SOLUTIONS ...............................................................................................................................................36
Guarantee conditions......................................................................................................................................................................................................37

Spirotel®
Rev.1.6
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User Guide
Thank you for having chosen a MIR product
MEDICAL INTERNATIONAL RESEARCH
The following table describes the contents of the package and the accessories that can be used:
•Carrying case
•Plastic nose clip
•USB cable
•Mouthpiece
•User manual - winspiroPRO CD
•Reusable turbine
•Oximetry sensor
WARNING
The nose clip and mouthpiece that come supplied with the device are to be treated as single-use disposable items.
Spirotel® products are available in two versions:
•spirometer only
•spirometer with oximeter function
This manual is for the dual function device. Before reading this manual, check which version you have. The present document is available
for 15 years after the device discontinuing.
Before using your Spirotel®…
•Carefully read the user manual, the labels and all the information supplied with the device
•Configure the device (date, time, assigned values, language etc.) as described in section 2.6
WARNING
Before connecting the Spirotel® to a PC, install the winspiroPRO software supplied with the device.
Once the software has been correctly installed, connect the device to the PC and a message will appear that confirms the
recognition of a new peripheral device.
Keep the original packaging!
In the event of a problem with the product, use the original packaging to send it to your local distributor or to the manufacturer.
If the device is being sent for repair, the following rules apply:
•Goods must be sent in their original packaging;
•Costs involved in sending the product are at the sender's expense.
Manufacturer's address
MIR SRL
VIA DEL MAGGIOLINO, 125
00155 ROMA (ITALY)
Tel + 39 0622754777 Fax + 39 0622754785
Sito web: www.spirometry.com Email: [email protected]
MIR USA, Inc.
5462 S. Westridge Drive
New Berlin, WI 53151 - USA
Tel + 1 (262) 565 –6797 Fax + 1 (262) 364 –2030
Website: www.spirometry.com Email: [email protected]m
MIR implements a policy of constant product improvement and the technology we use is in a state of continuous evolution.
For this reason, the company reserves the right to up-date these instructions if necessary. If you have any suggestions that
you consider useful, please send an e-mail to the following address: [email protected]. Thank you.
MIR does not accept any responsibility for any harm or damage caused by users failing to follow the instructions or failing to
heed the warnings in this manual.
Total or partial copying of this manual is forbidden.

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1. INTRODUCTION
1.1 Intended use
The Spirotel® spirometer and pulse oximeter is intended to be used by a physician, by a licensed healthcare professional or by a patient
under the instruction of a physician or of a licensed healthcare professional.
The device is intended to test lung function and can make:
•spirometry testing in adult and pediatric patients, excluding infants and neonates ;
•oximetry testing in people of all ages.
It is also intended to be used as a single-patient device and it can be used at home, hospital setting, physician's office, factory, pharmacy.
1.1.1 User type
The Spirotel® spirometer + oximeter provides information about a series of parameters relating to human respiratory function.
Use of the device is usually "prescribed" by a doctor who is responsible for analysing and checking the results and the data gathered
during the test period.
1.1.2 Ability and experience required
The technique for using and maintaining the device along with the ability to interpret the results provided calls for a qualified health
worker. Before a patient is allowed to operate the device, he or she must be taught how to use it by a qualified health worker.
WARNING
MIR will not be held responsible for any harm or damage of any kind caused by mistakes made by users failing to heed the
warnings in this manual.
If Spirotel® user is a person who is incapable of looking after him or herself, the device must be used under the supervision
and responsibility of the person who is legally in charge of that person.
When Spirotel® device is used as an oximeter, it is intended for spot checks, bedside sleep oximetry checks during the night
and/or monitoring in the presence of a specialist doctor.
1.1.3 Where the device is used
Spirotel® device was designed for use in doctors' surgeries, in hospital wards or by the patient during daily activities to monitor physical
conditions.
When used at home, at work, in school or during sporting activities, the device records data and respiratory function parameters every
day for a period of weeks or months thus helping the patient better assess his/her physical condition.
The instructions for operating the device at home are given in detail for the type of test that has to be performed; the display provides
step-by-step instructions (messages, recommendations etc.) that allow the patient to perform tests properly and to obtain reliable,
trustworthy results for the doctor to analyse.
The product is not suitable for use in operating theatres or in the presence of flammable liquids or detergents or where there are
anaesthetic gas mixtures that become flammable in the presence of air, oxygen or nitrous oxide.
The product is not suitable for use where it may be exposed to air currents (e.g. the wind), sources of heat or cold, direct sunlight or
other sources of light or energy, dust, grit or chemical substances.
It is the responsibility of the user to ensure that the product is used and stored under the proper environmental conditions; for further
information, refer to the instructions in section 1.7.3.
WARNING
If the device is subjected to climatic conditions different from those shown in section 1.7.3, it is possible that malfunctions
may occur and/or that incorrect results may be displayed.
1.1.4 Use at home
If the device is used for carrying out tests at home, it must be configured for such use beforehand by a qualified person. It is the doctor's
responsibility to ensure that the device is configured before giving it to the patient for use at home.
1.1.5 Individual patient factors that can affect use of the product
The spirometer can only be used when the patient is resting and is in good health or at least in a state of health that is compatible with
the test being carried out. Performing the test actually calls for collaboration from the patient who must exhale forcefully to ensure that
the parameters measured provide reliable results.
1.1.6 Limitations of use –Contraindications
An analysis of the results of spirometry alone is not sufficient to provide a diagnosis of a patient's clinical condition. A diagnosis can
only be made in conjunction with an examination that takes the patient's case history into account as well as the results of other tests
recommended by the doctor.

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Comments, diagnosis and appropriate therapeutic treatments are made by the doctor.
Any symptoms must be evaluated before spirometry is carried out. The doctor who prescribes use of the device must first ascertain the
physical/psychological capacity of the patient to assess his or her suitability for performing tests. The same doctor must subsequently
evaluate the data gathered by the device to estimate the degree of collaboration for each test carried out.
A correct spirometry test calls for a patient's complete collaboration. The results obtained depend on the patient's ability to inhale and
exhale as quickly as possible. If these key conditions cannot be met, the spirometry results will not be reliable or as doctors say, will be
"unacceptable".
The acceptability of a test is the doctor's responsibility. Extra care must be taken when dealing with elderly patients, children or
differently-able persons.
The product must not be used if malfunctions or faults are detected or suspected as these may compromise results.
WARNING
When the Spirotel®device is used as an oximeter with limited alarms setting, the SpO2and Pulse Rate shown on the display
needs to be checked frequently.
1.2 Important safety warnings
Spirotel®devices have been examined by an independent laboratory that certified their conformity with EN 60601-1 safety standards
and guarantee that their electromagnetic compatibility is within the limits laid out in EN60601-1-2.
Spirotel® devices are subject to continuously checks during production and therefore comply with the safety and quality standards laid
down in Council Directive 93/42/EEC for Medical Devices.
Once the device has been removed from its packaging, examine it carefully to make sure there are no signs of damage. If any damage is
found do not use the device but return it immediately to the manufacturer for possible replacement.
WARNING
Patient safety and device performance are only guaranteed if warnings and current safety standards are complied with.
The manufacturers declines all responsibility for harm or damage caused by failure to follow the instructions for using the
product.
The product must be used as described in the User Manual especially as regards § Intended Use and only original accessories
as specified by the manufacturer are to be used. The use or turbine sensors, oximetry sensors or other non-original accessories
might cause erroneous readings or compromise the correct functioning of the device. For this reason, the use of such items
is not permitted.
In particular, the use of cables other than those specified by the manufacturer could cause increased emissions or lower
electromagnetic immunity from the device and result in improper operation.
Do not use the product if it has passed its lifetime. Standard duration of the device is estimated at about 10 years under normal
conditions of use.
The battery charge level is constantly monitored by the device itself. The device will display a message warning the user if the
battery is flat.
In the event of any incident arising from use of the advise, we strongly advise the user to inform his or her doctor who will
then complete the procedure laid down by Article 9 of Legislative Decree N° 46/1997 implementing EC Directive N° 93/42.
1.2.1 Risk of cross contamination
So as to avoid any risk of cross contamination, it is imperative to use a single-use mouthpiece for each individual patient.
Reusable turbine sensors must be cleaned before being used by a new patient. The use of an anti-bacterial viral filter is left to the doctor's
discretion.
1.2.2 Turbine
Reusable turbine
WARNING
The correct use of a “reusable” turbine is guaranteed only and exclusively if it is “clean”
and free from foreign bodies that alter the motion of the blades. If a reusable turbine can is
not properly cleaned, it can cause cross infection between patients. Periodical cleaning of
the device is sufficient only if that device is used exclusively by the same patient. For further
details about cleaning, refer to the appropriate section in this User Manual.
Never expose turbine sensors to jets of water or air or allow contact with hot liquids.
To avoid malfunctions or damage, do not introduce dust or foreign bodies into the turbine sensor. The presence of foreign bodies (such
as bodily hair, hair, saliva etc.) inside the turbine flow meter can compromise the accuracy of readings.

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1.2.3 Mouthpiece
The single use mouthpiece that comes supplied with the device is provided as a sample to demonstrate the correct type and size. It must
be considered clean but not sterile. We recommend that you contact the local distributor where you bought your spirometer to obtain
additional mouthpieces. These are usually made of cardboard or plastic and are always for single use only.
WARNING
Use biocompatible mouthpieces to avoid problems for the patient; unsuitable materials might cause the device to malfunction
and compromise the accuracy of readings.
It is the responsibility of the user to provide suitable mouthpieces. These items generally have a standard 30 mm external diameter and
are commonly used by health workers. They are widely available.
WARNING
To avoid contamination of the environment caused by the disposal of used mouthpieces, the user must comply with all the
local regulations in force.
1.2.4 Sensor for oximetry
In addition to the sensor code number 919024_INV supplied with the device, the following specific sensors can also be used for different
types of patients:
Manufacturer
Code
Description
MIR code
Envitec
RS-3222-12
Reusable small soft sensor (paediatric)
939006
Envitec
RM-3222-12
Reusable medium soft sensor (adults )
939007
Envitec
R-3222-12
Reusable large soft sensor (adults)
939008
BCI
3044
Reusable hard finger sensor (adults)
919020
These sensors, with the exception of the sensor MIR code 919020 which has the MIR connector with orange arrow, require the use of
an extension cable for connection with the Spirotel®. Two lengths of extension cable are available:
item code 919200_INV 1.5 m in length
item code 919210_INV 0.5 m in length
The prolonged use of a sensor or a patient's condition may mean that the location of the sensor has to be changed periodically. Change
the position of sensors every 4 hours and check the condition of the skin, blood flow and that the sensor is properly aligned.
WARNING
The incorrect use of a sensor or faulty sensor cable may compromise the accuracy of readings that could affect the patient's
condition. Check every sensor carefully before use.
Do not use sensors that appear to be or are damaged. If you do not have any more working sensors, contact your local
distributor who supplied the device.
Only use MIR sensors that have been specifically designed to work with Spirotel®. The use of other sensors may provide faulty
readings. Oximetry results may be faulty if the test is performed under very bright conditions. If necessary, cover the sensor
(e.g. with a clean cloth).
WARNING
Any colouring agent present in the blood (e.g. for performing diagnostic tests), such as methylene blue, indocyanine green,
indigo carmine, patent blue-V (PBV), can compromise the accuracy of oximetry readings.
Any condition that restricts the flow of blood, e.g. the use of a cuff to measure blood pressure, can compromise the accuracy
of readings for SpO2and pulse rate.
False nails and nail varnish must be removed before using the sensor as they can compromise the accuracy of oximetry
readings. Significant levels of dysfunctional haemoglobin such as carboxyhemoglobin or methemoglobin affect the accuracy
of oxygen readings.
If two or more oximetry sensors are positioned near each other, optical interference may occur. Such interference can
compromise the accuracy of oxygen readings. To eliminate any such interference, cover the sensors with an opaque material.
Dirt or obstructions that block the red light on the sensor or the detector may provide inaccurate readings or sensor
malfunctions. Always make sure that the sensor is clean and free of obstructions.
Never place the sensor in an autoclave. Do not sterilise the sensor.
Before cleaning the sensor, first disconnect it from the Spirotel®unit to prevent damage to the sensor and device and to avoid
compromising user safety.

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1.2.5 USB connection cable
Incorrect use or application of the USB cable may produce inaccurate measurements, which will show very inaccurate values of the
patient’s condition. Carefully inspect each cable before use.
Do not use cables that appear to be or are damaged. If a new cable is required, contact your local distributor.
Use only cables supplied by MIR, specifically designed to be used with Spirotel®. The use of other types of cables can lead to inaccurate
measurements.
1.2.6 The Spirotel®unit
WARNING
All the maintenance operations described in the User Manual must be carried out with great care. Failure to follow these
instructions may lead to incorrect readings or the incorrect interpretation of readings that have been taken.
All modifications, adjustments, repairs and reconfigurations must be performed by the manufacturer or by personnel
authorised by the manufacturer. In the event of problems, do not attempt to make repairs. The setting of configurable
parameters must be performed by qualified staff. The incorrect setting of parameters however will not compromise a patient's
state of health.
If the device is used in conjunction with other items of equipment, only equipment that complies with current safety
regulations can be used so as meet the safety standards laid down by EN 60601-1.
As regards the disposal of Spirotel®devices, accessories, plastic consumables (mouthpieces), removable components and
items that are subject to ageing (e.g. the battery) only use suitable containers or better, send the materials to the device retailer
or an approved disposal centre. Local current legal requirements must be complied with in all cases.
Failure to comply with the above mentioned regulations will relieve MIR of all responsibility from any direct or indirect claim
for damages.
The device can also be powered using a USB cable connected to a computer thus also allowing on-line operation.
Keep the device out of the reach of children and differently able persons.
1.2.7 Warnings for use in electromagnetic environments
Due to the increasing number of electronic devices (computers, cordless phones, cell phones, etc.) medical devices may be
subject to electromagnetic interference caused by other equipment.
Such electromagnetic interference could cause the medical device to malfunction, such as a lower measurement accuracy
than stated, and create a potentially dangerous situation.
Spirotel®complies with the EN 60601-1-2:2015 standard on electromagnetic compatibility (EMC for electromedical devices)
both in terms of immunity and emissions.
For the correct operation of the device, however, it is necessary not to use Spirotel®near other devices (computers, cordless
phones, cell phones, etc.) that generate strong magnetic fields. Keep these devices at a minimum distance of 30 centimeters.
If it is necessary to use it at shorter distances, Spirotel®and the other devices must be kept under observation to verify that
they work normally.
Do not use the instrument in the presence of MRI equipment, which can generate an induced current in the sensor to measure
oximetry, causing injury to the patient.
1.3 Warnings regarding use of the lithium ion battery
The device is powered by a rechargeable lithium ion battery. The power supply is 3.7 V.
For correct use of the device, read the following instructions carefully.
WARNING
Only use batteries supplied by MIR.
Improper use of a battery could lead to an acid leak, the emission of heat and fumes or even explosion or fire.
This could lead to deteriorated performance or damage to the battery or protective device installed in the pack. It could also
damage equipment or harm the user.
Pay close attention to the following instructions.
DANGER
Do not open or modify the battery. The pack is fitted with an internal protective device; if the unit is mishandled an acid leak,
the emission of fumes or even explosion or fire could follow.
Do not short the positive (+) and negative (-) terminals with metal objects.
Do not place the battery in a pocket or in a bag along with metal objects such as items of jewellery, hairpins, coins or keys.
Do not keep the device near such items.
Do not heat the battery or throw it into the fire.

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Do not use or store the battery near a fire or in a car where the temperature can reach over 60°C.
Do not immerse the battery in water or seawater and do not leave it wet. In the event of the battery getting wet, the internal
protective device could be damaged leading to a recharge at very high voltages and currents. Chemical reactions might also
take place that lead to an acid leak, the emission of fumes or even explosion or fire.
Do not recharge the battery near a fire or in very hot surroundings. High temperatures can activate the internal protective
device preventing the battery from recharging or can damage the protective device itself causing a recharge at very high
voltages and currents. This could cause chemical reactions that could lead to an acid leak, the emission of fumes, rupture of
the device or even explosion and/or fire.
Recharge the battery with a charger that complies with the specifications given in section 1.7.3 A recharge carried out using
an unsuitable charger and under non-conforming charging conditions can cause the pack to over-charge or to a recharge at
very high voltages and currents. This could cause chemical reactions that could lead to an acid leak, the emission of fumes,
rupture of the device or even explosion and/or fire.
Do not pierce the battery with sharp objects e.g. a nail.
Do not hit the battery with a hammer, stand on it, throw it or subject it to knocks. A damaged or deformed battery may have
internal short circuits that can lead to an acid leak, the emission of fumes, rupture of the device or even explosion and/or fire.
Do not use a badly scratched or deformed battery as to an acid leak, the emission of fumes, rupture of the device or even
explosion and/or fire could occur.
Do not solder the battery.
Do not fit the battery to the device with the terminals inverted. If it is difficult to connect the battery to the device, do not use
force. Check that the terminals are the right way round. Inverting the terminals generates an inverse charge that could lead
to an acid leak, the emission of fumes, rupture of the device or even explosion and/or fire.
Do not connect the battery to an electrical socket, a car cigarette lighter etc. If the pack is subjected to a high voltage, over-
charging might occur that could lead to an acid leak, the emission of fumes, over-heating, rupture of the device or even
explosion and/or fire.
Do not use the battery for purposes other than specified as this may affect its functionality and compromise the life span of
the unit. Depending upon the device in which a battery is used, power surges can occur through the battery that can cause
an acid leak, the emission of fumes, over-heating, rupture of the device or even explosion and/or fire.
If the battery leaks acid that comes into contact with the eyes, do not rub them but rinse with clean running water and contact
a doctor immediately. Failure to do so may result in injury to the eyes.
WARNING
Refer to section “Recharging the battery”for instructions about battery charging cycles.
Do not place the battery in a microwave oven or a pressurised container. Rapid heating or a loss of water proofing can lead to
an acid leak, the emission of fumes, over-heating, rupture of the device or even explosion and/or fire.
If the battery leaks acid or gives off a bad smell, move it away from any naked flames. Failure to do so may result in the
electrolyte catching fire then emitting fumes, rupturing or bursting into flames.
If the battery gives off a smell, generates heat, becomes discoloured or deformed or displays any unusual behaviour during
use, recharging or storage, remove it from the device immediately or disconnect the charger and do not use the pack. The use
of a faulty battery could lead to an acid leak, the emission of fumes, over-heating, rupture of the device and/or fire.
WARNING
The battery has an in-built safety device. Do not use in an environment where static electricity may be present (in excess of
the level specified by the manufacturer). Failure to comply with this may cause damage to the safety device that could result
in an acid leak, the emission of fumes, over-heating, rupture of the device and/or fire.
If acid from the battery comes into contact with the skin or clothes, rinse immediately with running water to prevent
inflammation of the skin.
Keep batteries out of the reach of children to prevent accidental swallowing.
If a child is to use a battery, an adult must explain the rules governing such use.
Before using the battery, read the User Manual carefully paying particular attention to correct handling procedures.
For information about fitting and removing the battery, refer to the device User Manual.
Read the User Manual carefully before charging the battery.

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The battery has a predetermined life span. If the device appears to run for a shorter period of time than usual, replace the
battery with a new one.
Remove the battery if it is past its expiry date.
Once the battery has been removed from the device, make sure that the (+) and (-) terminals are isolated with insulating tape;
to dispose of the battery, comply with current legal requirements or place the pack in an approved recycling container or send
it to an official recycling centre.
If the battery is not going to be used for a long period, remove and store the pack in an environment where the temperature
and humidity levels meet specification.
If the battery terminals are dirty, clean them with a dry cloth before use.
The battery can be charged in an environment where the temperature ranges from 0°C to about 40°C.
The battery can be used in an environment where the temperature ranges from -20°C to about 60°C.
1.4 Warnings regarding the GSM module
The GSM module is based in the standard GSM system for mobile communication technology. The GSM standard is used all over the
world. This covers Europe, Asia and some parts of America and Asia, it is the most used telecommunication system.
The GSM module used is a low power transmitter and receiver that transmits and receives radio signals. With the GSM application, the
system manages calls, controls the radio frequency and power levels in the modem.
To reduce exposure to radio signals, limit the length of calls or use the device efficiently by complying with the following instructions.
Do not use the device if the aerial is damaged, if a damaged aerial comes into contact with the skin, it could cause a second degree burn.
A damaged aerial must be replaced immediately by a qualified technician with a unit approved by the manufacturer.
In healthcare environments, some devices are shielded from radio signals and these can have a negative effect on other shielded devices.
Consult the manufacturer of each medical device to see if they are suitably shielded against from radio interference.
Turn the device off in any healthcare settings where it is specifically requested to do so. Hospitals and other healthcare settings often
employ radio signal monitoring equipment.
Do not use the device on board planes to prevent possible interference with flight equipment.
Keep the device out of the reach of children. The device is not a toy.
Turn the device off in any area that is potentially explosive as it can generate sparks that could set off an explosion or fire.
1.5 Labels and symbols
1.5.1 ID label
The symbols are described in the table below:
SYMBOL
DESCRIPTION
Model
Product name
SN
Device serial number
Manufacturer's name and address
0476
CE mark for medical devices: this product is a Class IIa medical device that is certified and in compliance with the
requirements of Council Directive 93/42/EEC
Electrical safety symbol: as per IEC60601-1, the product and its component parts are type BF and therefore offer
protection against electrical shocks
WEEE symbol is mandatory to European Directive 2012/19/EEC on Waste Electrical and Electronic Equipment.
On completion of its useful life, this appliance must not be disposed of as urban waste but must be sent to an
authorised WEEE waste disposal centre. The device can also be sent back to the original supplier free of charge
when a new equivalent model is bought.
Due to the materials used in its manufacture, disposal of the device as urban waste could harm the environment
and/or health.
There are legal penalties in place for those who fail to observe the legal requirements mentioned here
IP22
Information on protection against ingress of liquids. Indicates the degree of resistance to liquids. The device is
protected against falling water drops if placed at an angle of up to 15 ° from the vertical position
Antenna symbol for devices that include RF transmitters
FCC ID
FCC Identification code indicating traceability to FCC compliance

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SYMBOL
DESCRIPTION
Rx ONLY
Reference to US FDA regulations: use the device on prescription
Instruction for use symbol. Refer to instruction manual. Read this manual carefully before using the medical device
Production date of the device
USB port warning label. For connecting the device to a PC. Only use cables supplied by the manufacturer and
observe the IEC 60601-1 safety standards
SpO2
SpO2oximetry port warning label
Electrostatic discharge symbol. This symbol is used near every connector that has been excluded from the
electrostatic discharge test. In this device the electrostatic discharge tests have been performed
Temperature limits: indicates the temperature limits to which the medical device can be safely exposed
Humidity limitation: indicates the range of humidity to which the medical device can be safely exposed
Pressure limitation: indicates the range of pressure to which the medical device can be safely exposed
1.5.2 FCC certification label
Spirotel®complies with part 15 of FCC standards. Operation of the device is subject to the following conditions:
(1) this device must not cause harmful interference
(2) this device can be subjected to all types of interference including those which may cause undesired effects
Any modifications made without the express approval of this company may compromise the use of the device by the user.
WARNING: This device has been subjected to tests that confirm it complies with the limits of a class B digital instrument as per part
15 of the FCC Standards. These limits have been set to provide appropriate protection against interference when the device is used in
the home. This device generates, uses and can emit radio signals and, if not installed and used as per instructions, can create interference
with radio communications.
The absence of interference cannot however be guaranteed for all installations.
If this device causes interference to radio or TV reception (that can be determined by turning the device on and off), we recommend
that the user corrects the interference by adopting one of more of the counter measures listed below:
•Change the angle or position of the aerial
•Increase the distance between the device and the appliance receiving the signal
•Connect the device to a different power socket than the appliance receiving the
signal.
•Contact the supplier or radio/TV technician for expert advice.
The symbols mentioned can be found as shown in the illustration shown.
1.5.3 Electrostatic discharge symbol
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 vales:
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

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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
Spirotel®is a pocket spirometer that can also features a pulse oximeter function (optional). The device can operate completely
autonomously or can be connected to a personal computer or printer by means of various types of connections: USB or Bluetooth.
Also, Spirotel® is connected to a PC via a micro USB port to recharge the battery.
Spirometry function
Spirotel®is intended for use by medical specialists and it provides them with a powerful but compact, portable tool that can process
about 30 functional spirometry parameters. The device carries out a control test on the quality of the readings taken and can save the
results of about 10.000 spirometry tests or a maximum of 300 hours of oximetry data.
A turbine measures volume and flow rate by the interruption of infra-red light as its operating principle ensuring accurate and
reproducible results without needing periodic recalibration.
The key features of this type of sensor are as follows:
•Accurate readings even with low air flow rates (end of exhalation)
•Not affected by humidity and gas density
•Unbreakable and shock resistant
•Inexpensive to replace
To keep the turbine working as it should, it must always be disinfected before use on a new patient to ensure the best possible hygiene
and safety standards
To properly interpret the results of a spirometry test, it is essential to compare them with the so-called normal values that are calculated
using standardised patient data or with personal reference values associated with that specific patient's clinical history.
An individual patient's clinical history values can vary significantly from normal values that always refer to a "healthy" subject.
Spirotel®can be connected to a computerised system for configuration. The data from every test are stored in the device and can be
transferred to a server and displayed (flow/volume curves, spirometry parameters, oximetry parameters optional).
Oximetry function (optional)
The oximetry sensor features two light emitting diodes (LED), one emits visible red light and the other infra-red. Both bands of light
pass through the finger to reach a light detector. During the passage through the finger, some of the light is absorbed by the blood and
soft tissue depending on the concentration of haemoglobin.
The amount of each light frequency absorbed depends on how oxygenated the blood is inside the tissue.
This operating principle ensures accurate and reproducible readings without the need to constantly calibrate the device.
1.7 Technical specifications

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Below is a complete description of the specifications for the device, the volume and flow turbine and the oximetry sensor.
1.7.1 Spirometer specifications
This device meets the requirements of the following standard:
•ATS Standardization of Spirometry 2005, 2019 update
•ISO 23747: 2015
•ISO 26782: 2009
Measured parameters:
Symbol
Description
U.M.
FVC
Forced Expiratory Vital Capacity
L
FEV1
Forced Expiratory Volume after 1 sec
L
PEF
Peak Expiratory Flow
L/s
FEF2575
Value of parameter FEF2575
L/s
Flow/volume sensor
Bi-directional turbine
Temperature sensor
semiconductor (0-45°C)
Method of detection
Infra-red interruption
Maximum volume measured
10 L
Flow rate
16 L/s
Volume accuracy (ATS 2019)
2.5% or 50 mL
Flow accuracy
5% or 200 mL/s
Dynamic resistance at 12 L/s
<0.5 cmH2O/L/s
Time zero
At the point of peak expiratory flow (PEF), a tangent is drawn with a slope
equal to PEF and its intersection on the abscissa defines the TIME ZERO.
The back extrapolated volume is the volume of gas that has already been
exhaled at the point of TIME ZERO as defined by back extrapolation. The
method to determine the time elapsed by TIME ZERO, t0, is given by
equation:
Time zero = tPEF - (VPEF/PEF)
Where
PEF is the the peak expiratory flow;
tPEF is the the elapsed time at PEF;
VPEF is the the expired volume at PEF
1.7.2 Oximeter specifications
For oximetry measurements, the device complies with the requirements of the following standard:
ISO 80601-2-61:2017 Medical electrical equipment - particular requirements for basic safety and essential performance of pulse oximeter equipment
The Arms (Accuracy Root Mean Square), as recalled in the above mentioned standard, represents the accuracy of the device in terms of
the mean square error of each SpO2 measurement, obtained by pulse oximetry, in relation to the respective SaO2 reference value,
obtained by co-oximetry. The ranges listed show the different oxygen saturation ranges for which the accuracy has been calculated.
Any SpO2 simulators should not be used to validate the accuracy of the Oximeter, they can only be used as functional testers to verify
its precision and the alarm system (when it is necessary).
Specification:
Method of detection
Red and infra-red light absorption
Measuring range of %SpO2
0 –99% (with 1% increments)
Resolution of SpO2
1%
Accuracy of %SpO2
2% between 70-99% SpO2
Number of beats for calculating the median SpO2%
8 beats
Measuring range Pulse rate
30 –300 BPM
Resolution of Pulse rate
1 BPM
Reusable hard sensor for adults
Reusable soft sensor for adults
Reusable paediatric soft sensor
Range SpO2(%)
Arms (%)
Range SpO2 (%)
Arms (%)
Range SpO2(%)
Arms (%)
70-100
1.19
70-100
±1.470
70-100
±1.390
70-80
0.554
70-80
± 1.626
70-80
± 1.851
80-90
1.32
80-90
± 1.667
80-90
± 1.397
90-100
1.45
90-100
± 0.941
90-100
± 0.652

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Accuracy Pulse rate
2 BPM or 2% of highest value
Interval for calculating median pulse rate
8 seconds
Signal quality
0 - 8 display segments
Wavelengths and maximum optical output power
average of oximetry sensors (919024, 919020)
Red light: 660 nm, 2.0 mW (**)
Infrared light: 905 nm, 2.4 mW (**)
Wavelengths and optical output power of oximetry
sensors (Envitec sensors)
Red light: 660 nm, 3.5-4.5 mW (**)
Infrared light: 905 nm, 3.5-4.5 mW (**)
** This information may be useful to the doctor
Definitions:
Desaturation event
Drop in SpO2 >= 4% in a 8- 40 sec period limited and subsequent rise
>=2% inside an overall period of 150 sec.
Pulse variation event
Rise in Pulse >= 10 BPM in a 8- 40 sec limited period and subsequent
drop >=8 BPM inside an overall period of 150 sec.
Oximetry test parameters:
Symbol
Description
u. m.
Median %SPO2
Median SPO2
%
Median BPM
Median BPM
BPM
Analysis T
total measuring time (duration of test excluding zeroes)
hh:mm:ss
T<89%
time with SPO2 less than 89%
%-hh:mm:ss
steps
Estimate of number of steps took during test
/
ODI
Desaturation events per hour of analysis
1/h
m
Estimated distance covered during the test
m
1.7.3 Oximetry alarms description
Spirotel is equipped with audio and visual alarm indicators to alert the operator to provide prompt patient attention or to abnormal
device conditions. Spirotel detects both patient and equipment alarms. Both, patient alarms and equipment alarms are identified as
medium priority as defined in IEC 60601-1-8 standard.
Medium Priority Alarms
Medium priority alarms signal potential problems with the equipment or other non-life-threatening situations. Medium priority auditiry
alarms are sounded as three beeps.
The intended operator’s position for correctly perceiving a visual alarm signal is 1 meter.
Alarm Summary
Spirotel detects both patient and equipment alarms. Alarm indicators remain active for as long as the alarm condition is present.
WARNING
Verify all alarm settings and limits before oximetry test starts to ensure that they are set as intended.
Setting ALARM LIMITS to extreme values can render the ALARM SYSTEM useless.
A hazard can exist if different presets are used on multiple devices in one care area.
The alarm system provides medium priority alarm conditions for:
- Low and high SpO2level;
- Low and high Pulse Rate level;
- Sensor is unplugged;
- Finger inserted incorrectly;
- Battery level is insufficient.
Each alarm condition causes the generation of a visual alarm signal. The oximetry tests are intended not to be continuously attended
by an operator in normal use, so additional auditory alarm signals are generated.
Patient (physiological) Alarms
If patient SpO2or pulse readings are equal to or above the upper alarm limit, or if they are equal to or below the lower alarm limit, the
device will signal a medium priority alarm.
Equipment (technical) Alarms
- Sensor is unplugged
Patient Alarm Description
Factory default
Adjustment Options
Increment
High SpO2 Alarm Limit
99%
85-99%
1%
Low SpO2 Alarm Limit
85%
85-99%
1%
High Pulse Rate Alarm Limit
120 bpm
30-240 bpm
1 bpm
Low Pulse Rate Alarm Limit
60 bpm
30-235 bmp
1 bpm

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- Finger inserted incorrectly
- Battery level is insufficient
Visual Alarm Indicator
When the alarm is activated through over limitation of physiological alarm, corresponding data area will view in reverse (video) mode.
When the alarm is activated by more than one physiological alarm condition, each parameter will be displayed in reverse mode.
If the alarm is triggered by a technical condition, the relevant warning message is displayed, for example:
WARNING
FINGER inserted incorrectly
Auditory Alarm Indicator
Audible alarms can be heard in a quiet environment. The medium priority audible alarm has a "du-du-du" tone that repeats every 5
seconds. The acoustic alarm signal can be temporarily disabled while an alarm condition is in progress. The duration of the paused audio,
the time interval in which the alarm system or part of the alarm system does not generate an audible alarm signal, is a maximum of 2
minutes.
The sound pressure level of the alarm tone is about 55 dB, in complies with the standard.
1.7.4 Other features
Memory
The memory can store the data from over 10000 spirometric tests. The exact number
cannot be established as it depends on the configuration set by the doctor
Display
LCD black and white touch screen with 160x80 resolution
Keypad
None - touch screen display
Interface
USB, Bluetooth
Duration of 3.7 V Lithium battery
About 500 charge cycles, under normal condition of use
Power supply
Li-ion 3.7 V 1100mAh battery
Battery charger
Voltage = 5VDC
Current = 500 mA or more
Connector = Type B micro USB
Dimensions
Main body 88x74x38 mm;
Weight
central unit 151 g (including battery)
Bluetooth function
Operating frequency range 2402 –2480 MHz
Spreading FHSS
Modulations GFSK, PI/4-DQPSK, 8-PSK
Number of channels 79 hopping channels at all
Channel spacing 1 MHz
Number of antennas 1
Antenna type Integrated ceramic chip antenna
Antenna gain 0 dBi
Output power 0.1 mW
FCC-ID TUK-MIR045
GSM function
Quad-Band 850/900/1800/1900 MHz.
EDGE (E-GPRS) multi-slot class 10.
GSM 850/900MHz power class 4 (33dBm).
GSM 1800/1900MHz power class 1 (30dBm).
Internal antenna (gain 2.42 dBi).
SMS MT, MO.
SMS CB.
SMS storage into SIM card.
Internet protocols: TCP/IP, SSMTP, FTP, HTTP, POP3.
Secure connection protocol: SSL.
Symmetric key encryption: DES, 3DES, RC2,RC4.
Asymmetric key encryption: RSA, DSS.
Certified R&TTE, FCC, PTCRB.
Type of electrical protection
Internally powered
Degree of electrical protection
BF
Degree of protection against water
penetration
IP22 device protected against falling water drops if placed at an angle of up to 15 ° from
the vertical position
Safety level in the presence of
flammable anaesthetic gases, oxygen
and nitrogen
Appliance 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
Athmospheric pressure: 50kPa, 106 kPa

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Transport condition
Temperature: MIN -20 °C, MAX + 60 °C
Humidity :MIN 10% RH; MAX 95%RH
Athmospheric pressure: 50kPa, 106 kPa
Operating conditions
Temperature: MIN + 10 °C, MAX + 40 °C;
Humidity: Humidity: MIN 10% RH; MAX 95%RH
Athmospheric pressure: 70kPa, 106 kPa
Applicable standards
IEC 60601-1:2005 + A1: 2012 (Electrical Safety)
IEC 60601-1-2:2015 (EMC)
ATS/ERS Guidelines: 2005, 2019 update
ISO 26782: 2009
ISO 23747: 2015
EN ISO 14971: 2019
ISO 10993-1: 2018
2011/65/UE Directive
EN ISO 15223:2016
EN IEC 60601-1-6: 2010+Amd2013
ISO 80601-2-61: 2017
IEC 60601-1-8: 2006 + Amd1:2012
IEC 60601-1-11:2015
Essential performances (according to
EN 60601-1: 2005 + A1: 2012)
Error of displayed numeric value: Flow measurement percentage error < ± 5%
Measure of the oximetry parameters with accuracy defined in section Oximeter specifications
Emission limits
CISPR 11 Group 1 Class B
Electrostatic discharge protection
8kV contact, 15kV air
Magnetic field immunity
30 A/m
Radio Frequency Immunity
3V/m @ 80-2700 MHz
Other beeps (acoustic signals):
•Pulse tone, beeps at frequency depending on Pulse Rate
•Sounds the next time the device is turned following an interrupted test due to low battery
The specifications that apply to SpO2and Pulse Rate are the same regardless of the sensor used as long as it is one of those mentioned
beforehand.
MIR will make available on request wiring diagrams, parts lists, descriptions, calibration instructions or other information
that will assist the service personnel in repairing those parts of the device which are designated by MIR as serviceable by the
service personnel.
2. USING THE Spirotel®
2.1 Display
The device does not have a keypad. Simply tapping the touchscreen provides access to all
functions.
The touchscreen controls change dynamically in line with the operations performed.
To access a function, press the relevant icon on the display.
To see the list of information, scroll down the right side of the screen.

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2.2 Turning the Spirotel®ON and OFF
To turn Spirotel®ON, press then release the key on the bottom of the unit
When the device is turned on, the screen shows the manufacturer's name as well as
the time and date.
If the screen is not touched, the display will automatically visualise the main menu
after a few seconds.
To turn Spirotel®OFF, press the key at the bottom of the device then the OK icon
at the bottom right of the screen. Keeping the key at the bottom of the device pressed
will also turn the unit OFF.
The message alongside, that appears after pressing the key, will guide you through the
correct procedure.
2.3 Saving energy
WARNING
When the device is turned on, the display will go into energy saving mode after about 1 minute of inactivity. This automatically
lowers the set level of contrast on the screen.
If the device remains inactive for about 5 minutes and is not connected to a PC or battery charger, it emits a beep and turns
itself OFF.
The battery charge is displayed when the device is turned on with the following symbol:
This configuration shows that the pack is charged (5 bars). A decreasing number of bars appears as the charge drops.
2.4 Main screen
The following areas can be accessed from the main screen:
diary area (not enabled in default configuration)
spirometry area
oximetry area
last test results area
send data area
2.5 Symbols and icons
The following table shows the icons displayed on the various screen and what they mean
ICON
DESCRIPTION
To go back

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ICON
DESCRIPTION
To access oximetry area
To access spirometry area
To access the diary area
To display the last test performed on current patient/display values from a test
To send data to a phone by e-mail
To select male patient
To select female patient
Change the current set value
To enter new patient data
To check the alarms and thresholds set during an oximetry test
To indicate that at least one alarm is disabled
Auditory alarm enabled during oximetry test. Press it to pause audio for 2 minutes
Auditory alarm is paused during oximetry test. Press it to turn the auditory alarm back on
To access the diary area
2.6 Service menu
To access the menu, touch the display on the bottom right and keep it pressed for several seconds.
The service menu will display the following headings
•Change date/time
•LCD settings
•Configuration
•Bluetooth settings
•Info firmware
When you access “Configuration”, you can set other options on the device.
To access this area, enter the following password:
1 2 2 3 3 3
The headings in this sub-menu are as follows:
•Turn ON mode
•Patient data
•Oximetry setup
•Set questions
•Set symptoms
•Personal best
•Select predicted
•Select standard
•Turbine calibration
•Select language
•Date format
•Unit format
•Delete memory
•Email/FTP
Scroll the various headings of the menu as defined in section 2.1; display the
heading you want by touching it on the display.

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Change date/time
Touch the display to select the heading.
When setting the time and date, the cursor _ indicates the data that will be modified. Use the numbers shown on the screen to modify
the date involved, go to the next date with OK. Finally, touch OK per confirm the settings and go back to the service menu; to go back
to the service menu without modifying the data, touch .
LCD settings
Through this menu you can:
•Set the display brightness and contrast
There are two ranges that range from 0 to 31 that let you set the display parameters and see the result in real time; once you have
found the best combination for your needs, touch OK at the bottom right of the display
•Touch screen function calibration
This function lets you control correct touchscreen response; when you select the function, a confirmation message appears, touch
OK to access calibration.
The procedure is in four stages:
- touch the spot at the top left three times in succession
- touch the spot at the top right three times in succession
- touch the spot at the bottom right three times in succession
- touch the spot at the bottom left three times in succession
The reference point is the one inside the flashing diagram.
This procedure calibrates the touchscreen to match the size of the screen itself.
The procedure must be performed using the tip of a touchscreen stylus from as vertical
a position as possible in relation to the screen.
If the calibration procedure is successful, the following message will appear:
The calibration is OK
If unsuccessful, you will be asked to repeat the procedure.
During calibration, it is not possible to stop the procedure. Carry out the procedure correctly then return to the service menu.
Configuration
This section deals with this menu heading. As mentioned previously, this menu heading allows you to access other function settings,
however, these have been set by the doctor who prescribed the device.
Bluetooth settings
The menu lets you choose how you want Bluetooth to be enabled.
Activation: it can be possible to choose between: “On request" and “Always on”; with the former, the function is only enabled when
you need it (e.g. to print a test) and otherwise remains off in energy saving mode; with “Always on”, the function is always enabled and
ready for use (e.g. for transferring data to a mobile phone).
Pairing: lets you automatically connect with a device in such a way that the spirometer acts as a “slave” device.
Search devices: to look for devices that are available for connection. The Spirotel®will start searching for nearby Bluetooth devices;
On completion, the names of any devices found will be displayed on the screen and simply touching these names will save them to the
device. These can include appliances such as a printer, phone or an on-line PC; select one item. If a device has previously been found
and connected, an icon will appear that identifies the previous connection (phone, printer or PC).
Option printer, Option phone, Option PC –On line: you can select a device as the default unit by opening the list, touching the
display and selecting that device (with which the Spirotel®will then automatically connect). Alternatively, you can remove a device from
the (in which case you will be asked to confirm the removal by pressing OK).
To exit the screen without making any changes, press at the bottom left of the screen.
Info Firmware
This function provides you with information about the revision status of the following components:

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To exit the service menu, press OK at the bottom right of the screen.
2.6.1 Configuration menu
On opening this menu, the following headings will appear:
•Turn ON mode
•Patient data
•Oximetry setup
•Set questions
•Set symptoms
•Personal best
•Select predicted
•Select standard
•Turbine calibration
•Select language
•Date format
•Unit format
•Delete memory
•Update GSM firmware
Tun ON mode
This function lets you set a certain hour at which the device will automatically turn itself on. The device will then start and perform an
automatic oximetry test while you are sleeping (this test can also monitor the patient throughout the whole day evaluating rates and
VMU).
The device will automatically switch itself off at the preset time.
WARNING
If the device is set to automatically switch on, it is impossible to turn it off
during the test. The closed padlock icon to the middle right advises the user
about the current setting.
Select the heading you want then choose between the following options:
•Manual: lets you choose when to turn on the device
•Automatic: lets you programme the frequency and duration of when the device
is turned on.
Confirm your preference pressing OK.

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If you select automatic mode, the following options will appear:
•Once time only
•Once a week
•Monday to Friday
•Saturday –Sunday
•Every day
a menu will appear for each option that lets you set the time and day parameters for
switching on/off
Patient data
Through this menu you can:
•change current patient data
•create a new patient
The icon lets you change the current patient's data; in this mode patient data are shown on different screens; to change the data,
use the alphabetic or numeric keypads that will appear as and when needed.
WARNING
Selecting this function does not create a new patient as described beforehand, but changes the data of the same patient and
associates future test data with that patient who is always identified with the same unique ID code.
To go back to the main screen without making any changes, press .
Press one of the two options; the steps needed to properly manage patient are as follows:
First screen (name)
Use the keypad to enter the patient's name. On completion, press OK to go to the next screen.
Second screen (surname)
Use the keypad to enter the patient's surname then press OK
Third screen (date of birth, weight, stature and gender)
Use the numbers shown at the bottom of the screen, set the day, month and year of the patient's birth followed by stature and weight;
the last item to set is the patient's gender that you can select from the following icons:
Male
Female
Press OK to move from parameter to the next.
Fourth screen (ethnic group)
Set a correction factor: this value allows adapting test data to the ethic group to which the patient belongs (you can also set “without
correction”):
ATS/ERS standards
NHANES III standards
Group
Correction %
Without correction
100
Caucasian
Caucasian
100
Afro-American
Oriental
100
Mexican-American
Hong Kong Chinese
100
Others
Japanese
89
Polynesian
90
North Indian
90
South Indian
87
Pakistani
90
Of African descent
87
Aborigine
85