MIR Spirobank II User manual

Spirobank II
Page 1 of 34
Rev.1.1
User manual
Spirobank II
Bluetooth low energy
User manual rev. 1.1
Issue date 20.11.2014
Approval date 20.11.2014

Spirobank II
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User manual
INDEX
1. INTRODUCTION .............................................................................................................................................................................................. 4
1.1 Intended use ............................................................................................................................................................................................ 4
1.1.1 User category ........................................................................................................................................................................................... 4
1.1.2 Ability and experience required.................................................................................................................................................................... 4
1.1.3 Operating Environment ............................................................................................................................................................................. 4
1.1.4 Homecare usage........................................................................................................................................................................................ 4
1.1.5 Patient effect on the use of the device........................................................................................................................................................... 5
1.1.6 Limitations of use - Contraindications .......................................................................................................................................................... 5
1.2 Important safety warnings .......................................................................................................................................................................... 5
1.2.1 Danger of cross-contamination.................................................................................................................................................................... 5
1.2.2 Turbine ................................................................................................................................................................................................... 6
1.2.3 Mouthpiece.............................................................................................................................................................................................. 6
1.2.4 Oximetry sensors ...................................................................................................................................................................................... 6
1.2.5 Device..................................................................................................................................................................................................... 7
1.3 Lithium-ion battery pack warning................................................................................................................................................................. 7
1.4 Labels and symbols ................................................................................................................................................................................... 9
1.4.1 Identification label..................................................................................................................................................................................... 9
1.4.2 CE mark for medical devices....................................................................................................................................................................... 9
1.4.3 Electrical safety symbol............................................................................................................................................................................ 10
1.4.4 Warning symbol for the USB .................................................................................................................................................................... 10
1.4.5 Warning symbol for the SpO2 port for oximetry .......................................................................................................................................... 10
1.4.6 Warning symbol for the WEEE................................................................................................................................................................. 10
1.4.7 FDA and FCC Warnings .......................................................................................................................................................................... 10
1.4.8 (ESD) Electrostatic discharge sensitivity symbol........................................................................................................................................... 10
1.4.9 Information regarding the protection against the ingress of liquids................................................................................................................... 11
1.4.10 Symbol for devices that include RF transmitter........................................................................................................................................ 11
1.5 Product description ................................................................................................................................................................................. 11
1.6 Technical specification............................................................................................................................................................................. 12
1.6.1 Features of the spirometer ........................................................................................................................................................................ 13
1.6.2 Oximeter features.................................................................................................................................................................................... 13
1.6.3 Other features ........................................................................................................................................................................................ 14
2. FUNCTIONING OF THE SPIROBANK II ......................................................................................................................................................... 14
2.1 switch on and switch off the device............................................................................................................................................................ 14
2.2 Energy saving......................................................................................................................................................................................... 15
2.3 Main screen............................................................................................................................................................................................ 15
2.4 Symbols and Icons .................................................................................................................................................................................. 15
2.5 Service menu.......................................................................................................................................................................................... 16
2.5.1 Turbine calibration .................................................................................................................................................................................. 18
2.6 Patient Data ........................................................................................................................................................................................... 19
2.6.1 Inserting data of a new patient................................................................................................................................................................... 20
2.6.2 Patient data modification.......................................................................................................................................................................... 20
2.7 Visualization of memory data .................................................................................................................................................................... 20
2.7.1 Database research modality....................................................................................................................................................................... 20
2.7.2 Visualization of database info.................................................................................................................................................................... 21
2.8 On line mode ......................................................................................................................................................................................... 21
2.9 Spirometry testing ................................................................................................................................................................................... 21
2.9.1 FVC test................................................................................................................................................................................................ 22
2.9.2 POST test, after drug administration .......................................................................................................................................................... 22
2.10 Viewing the spirometric results.................................................................................................................................................................. 23
2.10.1 Spirometry test interpretation ............................................................................................................................................................... 23
2.11 Oximetry Testing .................................................................................................................................................................................... 24
2.11.5 Instructions for Adult Single Patient Sensor............................................................................................................................................ 26
3. DATA TRANSMISSION.................................................................................................................................................................................... 27
3.1 PC connection via USB port ..................................................................................................................................................................... 27
3.2 Internal software upgrade ......................................................................................................................................................................... 27
4. MAINTENANCE ............................................................................................................................................................................................. 27
4.1 Oximetry sensor cleaning ......................................................................................................................................................................... 27
4.2 Changing the adhesive wrap sensor ............................................................................................................................................................ 28
4.3 Battery charging...................................................................................................................................................................................... 28
5. PROBLEM SOLVING....................................................................................................................................................................................... 28
LIMITED WARRANTY CONDITIONS ..................................................................................................................................................................... 31
ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT..................................................................... 32

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Thank you for choosing a MIR product
MEDICAL INTERNATIONAL RESEARCH
Spirobank II is sold in three different configurations; the following table describes these three configuration and the relevant
functions:
Spirobank II ®
Basic
Advanced
Advanced Plus
Additional parameters
POST Bronchodilator
test
Bluetooth 2.1
Oximeter
Battery charger
Standard Optional Not Available
WARNING
The paper mouthpiece, the nose clip and the disposable turbine with mouthpiece in the equipment should be considered
disposable products.
Before using your SPIROBANK II
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 2.5
WARNING
Before connecting the SPIROBANK II to another device, the application must be installed correctly in the device. 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: [email protected]
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.

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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 SPIROBANK II 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
SPIROBANK II 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.
WARNING
When used as a pulse-oximeter, the SPIROBANK II is intended for spot-checking, overnight sleep screening and/or
continuous monitoring when used by a trained healthcare professional.
1.1.3 Operating Environment
SPIROBANK II 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).
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 1.6.3 below.
WARNING
Exposure to unsuitable environmental conditions may cause the device to malfunction, and to provide incorrect results.
1.1.4 Homecare usage
The device requires installation by qualified personnel. The doctor will configure the device before handing it over to the patient for
homecare use.

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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 SPIROBANK II has limited alarms, therefore the device requires frequent display
observation of SpO2 and pulse rate.
1.2 Important safety warnings
SPIROBANK II 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.
SPIROBANK II 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.
1.2.1 Danger of cross-contamination
In order to avoid exposing the patient to the critical danger of cross-contamination use a single-patient disposable turbine , then a new
one must be used for each patient.

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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.
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 SPIROBANK II:
Manufacturer
Code
Description
BCI
1300
adult disposable sensor
BCI
3026
wrap-around reusable sensor for infants
BCI
3043
Universal reusable Y sensor
BCI
3078
Reusable 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 SPIROBANK II. Two cable
lengths are available:
Cod. 919200_INV 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.
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 SPIROBANK II. Use of oximetry
sensors not intended for use with the SPIROBANK II 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.

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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 SPIROBANK II 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.
Do not modify this equipment without authorization of the manufacturer.
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.
Technical description indicates, manufacturer will provide circuit diagrams, component part lists, descriptions, calibration
instructions to assist to service personnel in parts repair.
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.
SPIROBANK II should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary,
SPIROBANK II 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 SPIROBANK II is connected must be compliant to the standard CEI EN 60601-1.
To dispose of the SPIROBANK II, 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

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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.
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 who comply with the characteristics defined in point 1.6.3 of this manual 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.

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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.
NOTE
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.
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 Labels and symbols
1.4.1 Identification label
The label shows:
Serial number of the device (SN)
Product name (REF)
Antenna symbol for devices whom include RF transmission
Name and address of the manufacturer
Electrical safety symbol
CE mark in compliance with the Directive 93/42 EEC.
WEEE symbol
FCC ID identification according to FCC standard
Symbol for FDA regulation (Rx ONLY)
Index protection against the penetration of external agents (IPX1)
1.4.2 CE mark for medical devices
0476
This product is certified to conform to the Class II requirements of the 93/42/EEC medical device directive.

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1.4.3 Electrical safety symbol
In accordance with the IEC 60601-1 Standard, this product and its component parts are of type BF and therefore protected against
the dangers of direct and indirect contact with electricity.
1.4.4 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.
1.4.5 Warning symbol for the SpO2 port for oximetry
SpO2
1.4.6 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.
1.4.7 FDA and FCC Warnings
SPIROBANK II complies with Part 15 of the FCC Rules. The correct operation is subject to the following conditions:
(1) this device must not cause harmful interference
(2) this device must accept any interference received, including interference that may cause undesired operation.
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:
SpO2
1.4.8 (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.

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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
1.4.9 Information regarding the protection against the ingress of liquids
The label
IPX1
The symbol describes the protection of the device against the ingress of liquids. The device is protected from the vertical fall of water
drop.
1.4.10 Symbol for devices that include RF transmitter
The symbol is required from the standard CEI EN 60601-1-2: 2007 point 5.1.1, for devices that include RF transmitters.
1.5 Product description
The SPIROBANK II 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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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 900 hours of oximetry monitoring.
SPIROBANK II 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.
To ensure that the characteristics of the turbine remain unaltered over time replace always it from one patient to the other.
For a correct interpretation of a spirometry test, the measured values must be compared either to the so-called normal or predicted
values which are calculated from the anthropometric details of the patient or, alternatively, to the personal best values from the
clinical history of the subject.
The personal best values can vary considerably from the predicted values, which are taken from “healthy” subjects.
SPIROBANK II 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.
SPIROBANK II can perform FVC, test, 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.
1.6 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:

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1.6.1 Features of the spirometer
Measured parameters:
Symbol
Description
Units
*FVC
Best FVC
L
*FEV1
Best FEV1
L
*PEF
Best PEF
L/s
FVC
Forced Vital Capacity
L
FEV1
Volume expired in the 1st second of the test
L
FEV1/FVC
FEV1/FVC x 100
%
PEF
Peak expiratory flow
L/s
FEF2575
Average flow between 25% and 75% of the FVC
L/s
*= 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
1.6.2 Oximeter features
Definitions:
Desaturation Event
Desaturation events SpO2 fall 4% in a limited period of 8-40 sec and successive rise 2% within a
total period of 150 sec.
Total Pulse rate
Variation
Pulse rate rise 10 BPM in limited period of 8-40 sec and successive fall 8 BPM during a total
period of 150 sec.
Parameters 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
=DELTA
Parameters requested for six minute walk test analysis
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 %SpO2calculation:
8 beats
Range of measurement of cardiac pulse:
18 –300 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

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The specifications for both the oximetry and for the cardiac pulse are the same regardless of which of the above mentioned oximetry
sensors is used.
1.6.3 Other features
Memory
Memory capacity for over 10000 spirometric tests
The precise number depends on the individual configuration, so it cannot be
determined more closely
keyboard
membrane keyboard with 6 keys
Display
Display LCD 160x80 monochromatic
Interface
USB, Bluetooth
Bluetooth interface
frequenzy range = 2402-2480 MHz
rated RF power output = 7.5 dBm maximum trasmit power
type of antenna = drawn on the board
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 or higher
Connector = micro USB type B
Dimensions
160x55.2x25mm;
Weight
Central unit 140g (including batteries)
Type of electrical protection
Class II device
Type of electrical protection
BF
Grade of protection against water ingress
IPX1 device, protected against water drops
Safety level in the presence of
inflammable anaesthetic gas, oxygen or
nitrogen
Device not suitable
Conditions of use
Device for continuous use
Storage conditions
Temperature: MIN -20 °C, MAX + 60 °C
Humidity :MIN 10% RH; MAX 95%RH
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 SPIROBANK II
2.1 switch on and switch off the device
To switch on the SPIROBANK II push
The first screen shows the manufacturer logo, information of date and hour
set on the device.If no key are touched, after a few seconds the device shows
the main screen.

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The second screen shows the information as in the image beside. He key
allows to visualize the service menu; with these voices it is possible to
configure the device in the correct way.
If any keys are touched, then the device goes to the main screen.
To switch off the device push .
WARNING
SPIROBANK II does not switch off completely but goes in stand by status with a very low power consumption. Some
functions are ready and the device updates date and hour or to switch on the device using other remote controllers when
required. For this the symbol in use is corresponding to the stand by status.
2.2 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.
2.3 Main screen
On the main screen, while in Doctor Mode the following areas can be
accessed :
patient data management area
spirometry area
oximetry area
archive area
This screen allows the patient to access more quickly the dedicated functions. For further information please view paragraph 3.6.1.
2.4 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 access the database of the performed tests.
To search a test with the date of birth of a patient

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ICON
DESCRIPTION
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)
Male sex patient selection
Female sex patient selection
To access all oximetry test options / To perform an SpO2/BPM test
To access spirometry testing type
to perform a forced vital capacity test FVC/search FVC tests in memory
To perform a spirometry test with a broncodilator
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
2.5 Service menu
To enter the service menu press the key on the second screen corresponding to the icon
It is also possible to enter in the service menu when the device showa the main screen, pressing the key and then the key .
The service menu shows the following list of voices:
Change date/time
LCD settings
Bluetooth suspend
Select language
Delete memory
Select predicted
Turbine calibration
Oximetry setup
Date format
Unit format
Info firmware
To select the desired voice use the keys and , then enter using the key .
Change date/time
When setting the date and time, the cursor indicates the data item which is being modified. Use the keys and to modify
the data item of interest, move on to the next data item by pressing . Press 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 press .
LCD settings
Change and set brightness and contrast using e keys. It is possible to switch from a parameter to the other using and
. To return to the service menu press .
Bluetooth suspend
The Bluetooth function is automatically activated when the device switchs on.
With this menu voice it is possible to suspend the function, the Bluetooth will come active automatically at the next device switch on.
Select language
Select the desired item using the and keysand press , the language is now set and the device will return to the Service
Menu.
Delete Memory
To delete the memory of the device insert the following password by touching the numbers shown below:
If the password was not properly inserted the message below is shown:

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WARNIG
Password Error
Press OK to try again
If the user fails to enter the correct password three consecutive times the device will automatically turn off.
If instead the password was properly inserted the message below will be displayed:
WARNIG
Please wait
erasing memory
After approximately 30 seconds the following message will appear:
WARNIG
Memory deleted
Press to return to the service menu.
Select standard
Select the standard to be used (ATS/ERS, or NHANES III) with the keys and , then press , 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.
Select predicted
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
Pereira
Pereira
Select with and the pair to use and press . The Predicted values are set and the device returns to the Service Menu.
Turbine calibration
Select the Turbine Calibration item and choose from the following options:
show current values
modify calibration
factory defaults
Selection of the first item shows the percent correction applied in that moment.
The item “modify calibration” allows to insert new calculated values referred to a new test with a calibration sirynge. A password is
required to access this option;insert the following password starting from left to right:
The item “factory defaults” erases the previous calibration values and restores the two percentage corrections to zero percent
correction factor; in this case a password is required as explained above.
To perform this procedure correctly please refer to paragraph 2.5.1.
Oximetry setup
When entering the Oximetry Setting menu the following items are shown:
Alarms Setting
Default alarms

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Alarms setting
Access to this function allows to setup the parameters linked to the oximetry
First parameter is the alarm intensity: it can be possible to set the type and
volume. Use and to switch from a parameter to the other, then
e are useful to set the desired value: the select icon is the grey one. Press
to change screen. Step following steps allow to set the threshold value
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.
Use keys and to decrease/increase the values and select moving
the arrow with the keys and .
At the end press to return to the service menu.
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.
UNIT format
The voice allows to choose one of the following option:
Imperial (in,lb)
Metric (cm kg)
Select the desired format with or and press ; the selection will be saved automatically and the device will return to the
service menu.
Info firmware
In this menu the user may view information regarding the components version
presents in the device:
Bluetooth version
Bluetooth PIN
Oximeter
After approximately 10 seconds the device will automatically return to the
service menu, otherwise press .
Once all of the items in the service menu have been set it is possible to exit the
menu by pressing .
2.5.1 Turbine calibration
WARNING
The turbine flow sensor does not require calibration, however regular cleaning of the turbine is necessary . The disposable
turbine is check before the application of the external packaging, for this reason it doesn’t requires a periodic calibration. If
a calibration must be performed the following guidelines should be carefully noted.

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Turbine calibration is performed with a calibration syringe to simulate a
FVC test for the expired parameters and a FIVC test for the inspired
parameters.
To enter the calibration function, select the “Turbine Calibration” option
from the Service Menu (as explained in paragraph 2.5). To enter the new
calibration values choose the item “Modify calibration” in the submenu,
enter the password and insert the new calibration values. Make three
manoeuvres with a sirynge as described by the screen on the device, then
SPIROBANK II calculates the FVC and FIVC values.
Press .
The screen requires to insert the volume of the syringe in use; SPIROBANK II so calculates the correction percentage between the
reference and the calculated value. It can be possible to change the syringe volume using and , then press . At this
point two new correction values are shown. Press to apply these correction, otherwise press to set the factory calibration
values (0%).
If the FVC and FIVC correction factors are > 10% the following message appears on the screen:
WARNING
The calibration
Is out of range
The FVC and FIVC values will not be accepted. This means that the device is not capable of correcting such a large calibration error
In this case:
- Check the correct functioning of the SPIROBANK II with a new turbine and/or
- Clean the turbine.
To erase the calibration in use and to reset the original factory calibration, use the item “Factory defaults” from the Calibration menu
WARNING
In line with the publication "Standardised Lung Function Testing" of the European Respiratory Society (Vol 6, Supplement
16, March 1993), the air expired from the mouth is at a temperature of circa 33/34 °C.
The expired flow and volume, to be converted to BTPS conditions (37 °C) must be increased by 2.6% - this is derived from
the BTPS factor of 1.026 at a temperature of 33°C, which represents a correction of 2.6%. In practice the BTPS factor for the
expired flow and volumes is therefore constant and equal to 1.026.
For the inspired volumes and flows, the BTPS factor depends upon the ambient temperature as the air inspired is at
ambient temperature.
For instance at an ambient temperature of 20°C with relative humidity at 50%, the BTPS factor is 1.102, a correction of
+10.2%.
The correction of the inspired volumes and flows is made automatically as the machine has an internal temperature sensor;
the BTPS values are thus calculated.
If a 3L syringe is used to make the calibration and if the SPIROBANK II is calibrated correctly then the FVC (syringe) value
will be:
3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS).
If the ambient temperature is 20°C, the FIVC (syringe) value will be:
3.00 (FIVC) x 1.102 (BTPS) = 3.31 L (FIVC at BTPS).
The user must be aware that the volume of the syringe shown by the machine is converted to BTPS conditions, so that the
"increase" of the results with respect to the expected values does not constitute an error.
For instance, if the calibration procedure is carried out with measured data:
FVC = 3.08 L and FIVC = 3.31 L at an ambient temperature of 20°C the resulting correction factor becomes:
EXPIRATION .00%
INSPIRATION .00%
This does not represent an error, but is a logical consequence of the above detailed explanation.
2.6 Patient Data
From the main screen the user can access the patient data management by using . By entering this menu it is possible to:
Insert a new patient
Modify current patient data *

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2.6.1 Inserting data of a new patient
Press and insert the patient information in the required sequence.
First screen (date of birth, weight, height and sex)
Use and to set the correct value; use instead and to switch from one to another parameter. Set the day, month, year
of birth, height and weight of the patient. The last data to insert is the sex of the patient, which can be chosen by selecting one of the
following icons:
Male
Female
Second screen (ethnic group)
Setting of the correction factor: these values allow to adjust the test data as a function of the ethnic group of the patient (it is possible
to opt for “without correction”);
Standard ATS/ERS
Standard NAHNES III
Group
% correction
Without correction
100%
Caucasian
Caucasian
100%
Mexican-American
Oriental
100%
Afro-American
Hong Kong Chinese
100%
Other
Giapanese
89%
polinesian
90%
North Indian
90%
South Indian
87%
Pakistani
90%
African descendant
87%
Aboriginal
85%
When using ATS/ERS standards, the correction is applied to the predicted values of the following parameters:
FVC, FEV1, FEV3, FEV6, FIVC, FIV1, EVC, IC, VC, ERV, TV, TV/ti
When using NAHNES III standards, the correction is based on several theoretical formulas (as per NAHNES III standards).
Once the ethnic group is set the device saves the data and automatically returns to the main screen.
To interrupt the data insertion, press and the device will automatically return to the main screen.
2.6.2 Patient data modification
The key allows to modify current patient data; by entering in this function the patient data is presented on the various screens;
modify the data by using the and key which are shown time and again.
Press icon to return to the main screen without modifying any data
WARNING
A new patient is not created from the previous patient when selecting this function. Patient info however can be modified.
Future tests will be associated to the patient always identified by the same ID code, unique to that specific patient.
2.7 Visualization of memory data
2.7.1 Database research modality
From the main screen it is possible to access the database of the device by using the icon (key ).
Three methods of research are available:
Reseach by patient date of birth.
Research by the date of testing.
Visual of all tests in the database starting form the most recent.
Research by patient date of birth: patient date of birth must be inserted; after all the data has been inserted press All data
visualized concerns tests performed by patients whose date of birth corresponds to the inserted date of birth.