MIR Spirobank II User manual

Spirobank II
Rev.1.6
Page 1 of 35
User manual
Spirobank II
User manual rev. 1.6
Issue date 20.01.2021
Approval date 20.01.2021

Spirobank II
Rev.1.6
Page 2 of 35
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 Patient effect on the use of the device............................................................................................................................................... 5
1.1.5 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 USB connection cable ....................................................................................................................................................................... 7
1.2.6 Device............................................................................................................................................................................................... 7
1.2.7 Warnings for use in electromagnetic environments ........................................................................................................................... 8
1.3 Lithium-ion battery pack warning............................................................................................................................................................ 8
1.4 Labels and symbols ............................................................................................................................................................................. 10
1.4.1 Identification label ........................................................................................................................................................................... 10
1.4.2 FDA and FCC Warnings ................................................................................................................................................................. 10
1.4.3 (ESD) Electrostatic discharge sensitivity symbol ............................................................................................................................. 11
1.5 Product description .............................................................................................................................................................................. 11
1.6 Technical specification ......................................................................................................................................................................... 13
1.6.1 Features of the spirometer .............................................................................................................................................................. 13
1.6.2 Oximeter features ........................................................................................................................................................................... 14
1.6.3 Oximetry alarms description ............................................................................................................................................................ 15
1.6.4 Other features ................................................................................................................................................................................. 16
2FUNCTIONING OF THE Spirobank II ............................................................................................................................................................... 17
2.1 Switch on and switch off the device ..................................................................................................................................................... 17
2.2 Energy saving ...................................................................................................................................................................................... 18
2.3 Main screen ......................................................................................................................................................................................... 18
2.4 Symbols and Icons .............................................................................................................................................................................. 18
2.5 Service menu ....................................................................................................................................................................................... 19
2.5.1 Reusable turbine calibration ............................................................................................................................................................ 22
2.6 Patient Data ......................................................................................................................................................................................... 23
2.6.1 Inserting data of a new patient ........................................................................................................................................................ 23
2.6.2 Patient data modification ................................................................................................................................................................. 24
2.7 Visualization of memory data ............................................................................................................................................................... 24
2.7.1 Database research modality ............................................................................................................................................................ 24
2.7.2 Visualization of database info .......................................................................................................................................................... 24
2.8 PC On line mode (connected to a PC) ................................................................................................................................................. 25
2.9 Spirometry testing ................................................................................................................................................................................ 25
2.9.1 FVC test .......................................................................................................................................................................................... 26
2.9.2 Test VC ........................................................................................................................................................................................... 26
2.9.3 MVV Test ........................................................................................................................................................................................ 26
2.9.4 POST test, after drug administration ............................................................................................................................................... 27
2.10 Viewing the spirometric results ............................................................................................................................................................ 27
2.10.1 Spirometry test interpretation .......................................................................................................................................................... 27
2.11 Oximetry Testing.................................................................................................................................................................................. 28
2.11.1 Instructions for Adult Patient Sensor ............................................................................................................................................... 30
3DATA TRANSMISSION .................................................................................................................................................................................... 30
3.1 Data Transmission via Bluetooth.......................................................................................................................................................... 31
3.2 PC connection via USB port ................................................................................................................................................................. 31
3.3 Internal software upgrade .................................................................................................................................................................... 31
4MAINTENANCE ............................................................................................................................................................................................. 31
4.1 Cleaning and checking the reusable turbine ......................................................................................................................................... 32
4.1.1 Proper turbine operation check ....................................................................................................................................................... 32
4.2 Cleaning of the device ......................................................................................................................................................................... 33
4.3 Oximetry sensor cleaning .................................................................................................................................................................... 33
4.4 Battery charging................................................................................................................................................................................... 33
5PROBLEM SOLVING ....................................................................................................................................................................................... 34
LIMITED WARRANTY CONDITIONS ..................................................................................................................................................................... 35

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Thank you for choosing a MIR product
MEDICAL INTERNATIONAL RESEARCH
The following table describes the contents of the package e the accessories which can be used with spirobank II:
REF
Description
672679
Carrying case
✓
910320
Plastic noseclip
✓
532367
USB cable
✓
910300
Cardboard mouthpiece
✓
\
User manual - winspiroPRO CD
✓
910002
Reusable turbine

919024_INV
Oximetry sensor

✓included optional
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 the PC, the winspiroPRO PC software supplied with the device must be installed
correctly in the PC. The device may be connected to the PC only after the winspiroPRO software has been installed. Once the
new hardware is "recognized" by the PC the device may now be used with the winspiroPRO software.
Keep the original packaging!
In the unlikely event that you have a problem with your device please use the original packaging and return it to the distributor or
manufacturer.
Should this be the case, please follow these guidelines:
• Return the complete device in the original packaging.
• Shipping costs and any customs duties must be paid by the sender.
Manufacturer’s address:
MIR Srl
via del Maggiolino, 125
00155 Rome (ITALY)
Tel + 39 0622754777 Fax + 39 0622754785
Web site: www.spirometry.com Email: [email protected]
MIR USA, Inc.
5462 S. Westridge Drive
New Berlin, WI 53151 - USA
Tel + 1 (262) 565 –6797 Fax + 1 (262) 364 –2030
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.
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

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1. INTRODUCTION
Configuration
Spirobank II BASIC
Spirobank II
Spirobank II Advanced
Oximetry


✓spot
Spirometry
FVC-VC
FVC-VC-MVV
FVC-VC-MVV
Rechargeable via USB
✓
✓
✓
Bluetooth

✓
✓
winspiroPRO
✓
✓
✓
✓yes optional no
1.1 Intended use
The Spirobank II 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 can be used in hospital setting, physician's office, factory, pharmacy.
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 hospital setting, physician's office, factory, pharmacy.
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.

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1.1.4 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.
1.1.5 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.
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.
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
Two different types of turbine sensors can be used with the device, one is reusable and the other is single-patient disposable. A disposable
mouthpiece is required in order to connect a patient to the spirometer. In order to avoid exposing the patient to the critical danger of
cross-contamination, the reusable flow sensor must always be cleaned before each spirometry test, and a new disposable mouthpiece
must always be used for each patient. The use of an anti-bacterial filter is at the discretion of the doctor. If a single-patient disposable
turbine is used, then a new one must be used for each patient.

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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.
Reusable turbine
WARNING
The correct functioning of the re-usable turbine can only be guaranteed if it has
been cleaned in the correct manner and is free from foreign bodies which could
alter its movement. If the turbine has not been cleaned sufficiently this could
cause cross-contamination from one patient to another. Periodic cleaning
should only be done when the device is for personal use and will only be used
by one patient. The cleaning of the turbine should be performed according to
the instructions contained in the User’s Manual.
The following information applies to both types of turbine.
The turbine must never be held under running water or direct air pressure and must never come into contact with hot fluids.
Do not allow dust or foreign matter to enter the turbine sensor which may alter the correct functioning and possibly cause damage.
The presence of any impurities such as hair, sputum, threads etc. within the body of the turbine sensor may seriously compromise
measurement accuracy.
1.2.3 Mouthpiece
Any disposable mouthpieces included with the spirometer are only to be used as a reference guide to purchase the correct size
mouthpiece required. These mouthpieces are clean but not sterile. To purchase appropriate mouthpieces, generally either paper or
plastic, single-use/disposable, we suggest that you contact your local distributor.
WARNING
Use a bio-compatible mouthpiece to avoid any problems to the patient; unsuitable materials could cause the device to
malfunction, consequently providing incorrect test results.
The user is responsible for obtaining the proper mouthpieces for the device. The required mouthpiece is a standard type with an outside
diameter of 30 mm, is of common use and in general easily procured.
WARNING
To avoid environmental contamination caused by the disposal of used mouthpieces, the user must follow all the relevant local
regulations.
1.2.4 Oximetry sensors
In addition to the sensor code 919024_INV supplied with the device, the following oximetry sensors can be used with Spirobank II:
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 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.

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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.
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 USB connection cable
Incorrect use or application of the USB cable may produce inaccurate measurements, wich 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 Spirobank II. The use of other types of cables can lead to
inaccurate measurements.
1.2.6 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.
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.
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.

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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.
1.2.7 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.
Spirobank II 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 Spirobank II 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, Spirobank II 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 Lithium-ion battery pack warning
The device is powered by a rechargeable lithium-ion battery pack with a supply voltage of 3.7 V.
For proper use of the battery pack please read carefully the warning below
WARNING
Use only battery packs supplied by MIR
Improper use of the battery pack may cause acid leakage, overheating, smoke, breakage an explosion and/or fire.
Consequently the battery pack may be damaged or suffer a drop in overall performance. The internal battery pack safety
sensor could also be damaged as well by any of the above events. Furthermore the user of the device could be harmed and
other nearby appliances could be damaged as well.
Please read the following instructions carefully.
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.

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A damaged or deformed battery pack may cause internal short-circuits thus creating the possibility for acid leakage,
overheating, smoke, breakage and/or fire.
Do not use a heavily scratched or deformed battery back as this may be cause for acid leakage, overheating, smoke, breakage
and/or fire.
Do not solder directly on the battery pack.
Do not mount the battery pack inside the device with the + and –poles inverted.
If the battery leads do not connect easily to the battery charger or to the device do not apply excessive force. Check to see
that the leads are properly aligned. If the leads are inverted, an inverse polarity connection may provoke acid leakage,
overheating, smoke, breakage and/or fire.
Do not connect the battery pack leads to a wall socket or to the car lighter Under high voltage the battery may leak acid,
overheat, emit smoke, explode and/or catch fire.
Do not use the battery pack for any other purpose other than those specified otherwise its features may be compromised, and
its useful life reduced
If the battery acid inadvertently enters the eyes do not rub the eyes, instead wash the eyes with clean running water and call
a doctor immediately.
WARNING
Do not leave the battery pack charging longer than the average charging length of time specified.
Do not place the battery in a micro-wave oven or in a pressurized container. Rapid overheating or loss of proofing may cause
acid leakage, overheating, smoke, breakage and/or fire.
If the battery pack gives off a bad smell, if it generates heat, if it fades/deformes or if anything abnormal happens during
storage, usage and recharging immediately remove the battery pack from the device or the battery charger and do not use it
any longer, as any of these events may cause acid leakage, overheating, smoke, breakage and/or fire.
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.

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1.4 Labels and symbols
1.4.1 Identification 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
IPX1
Information on protection against ingress of liquids. The label indicates the degree of protection against ingress of
liquids (IPX1). The device is protected against vertically falling drops of water
Antenna symbol for devices that include RF transmitters
FCC ID
FCC Identification code indicating traceability to FCC compliance
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
SpO2 oximetry 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
1.4.2 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.