MIR Spirobank II Bluetooth Low Energy User Manual
- June 2, 2024
- MIR
Table of Contents
MIR Spirobank II Bluetooth Low Energy
Product Information
Specifications
- Product Name: Spirobank II Bluetooth low energy
- Model: Spirobank II
- User Manual Revision: 2.4
- Issue Date: 23.06.2023
- Approval Date: 23.06.2023
Product Usage Instructions
Introduction
The Spirobank II is designed for specific purposes as outlined below:
Intended Use
The Spirobank II is intended for:
- User Category: Individuals requiring respiratory function testing
- Ability and Experience Required: Users should be trained in spirometry testing
- Operating Environment: Use in a clean and well-ventilated area
- Patient Effect on Device Use: Ensure patients follow instructions for accurate results
- Limitations of Use – Contraindications: Certain medical conditions may restrict use, consult a healthcare professional
Important Safety Warnings
Ensure the following safety precautions are observed:
- Danger of Cross-Contamination: Clean and disinfect the device between uses
- Turbine: Handle with care to prevent damage
- Mouthpiece: Use a new, clean mouthpiece for each test
- Oximetry Sensors: Check sensors for proper functioning before each use
- USB Connection Cable: Use only the provided cable for connectivity
FAQ (Frequently Asked Questions)
Q: How often should the device be calibrated?
A: Calibration frequency may vary based on usage, but it is recommended to
calibrate the Spirobank II annually or as per manufacturer’s guidelines.
Q: Can the Spirobank II be used on pediatric patients?
A: The Spirobank II can be used on pediatric patients with appropriate
supervision and guidance from healthcare professionals experienced in
pediatric spirometry.
Q: What is the battery life of the Spirobank II?
A: The battery life of the Spirobank II depends on usage but typically
lasts for several hours of continuous operation before requiring recharging.
Spirobank II Bluetooth low energy
Spirobank II
User manual
User manual rev. 2.4
Issue date Approval date
ENGLISH (EN)
23.06.2023 23.06.2023
Rev.2.4
Page 1 of 35
Spirobank II
User manual
Thank you for choosing a MIR product MEDICAL INTERNATIONAL RESEARCH
Spirobank II
User manual
The following table describes the contents of the package e the accessories which can be used with spirobank II:
REF
Description
672679
Carrying case
532367
USB cable
Software MIR Spiro
910002
Reusable turbine
910004
Disposable turbine
919024_INV Oximetry sensor
included
optional
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
MIR Spiro must be installed correctly in the device. The device may be
connected to the PC only after the MIR Spiro software has been installed. Once
the new hardware is “recognized” by the PC the device may now be used with the
MIR Spiro 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.
Rev.2.4
Page 3 of 35
Manufacturer’s address:
MIR S.p.A. – Medical International Research
Viale Luigi Schiavonetti 270
00173 ROME (ITALY)
Tel + 39 0622754777
Fax + 39 0622754785
Web site: www.spirometry.com Email: mir@spirometry.com
MIR USA, Inc. 5462 S. Westridge Drive New Berlin, WI 53151 – USA Tel + 1 (262) 565 6797 Web site: www.spirometry.com
Fax + 1 (262) 364 2030 Email: mirusa@spirometry.com
Spirobank II
User manual
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: mir@spirometry.com. 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
Rev.2.4
Page 4 of 35
INTRODUCTION
Spirobank II
User manual
1.1 Intended use
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 the
doctor’s office, in a 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.
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”.
Rev.2.4
Page 5 of 35
Spirobank II
User manual
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.
Spirometry has relative contraindications, as reported in the 2019 update of
the ATS/ERS guideline: Due to increased myocardial demand or changes in blood
pressure
– Acute myocardial infarction within 1 week – Systemic hypotension or severe
hypertension – Significant atrial/ventricular arrhythmia – Uncompensated heart
failure – Uncontrolled pulmonary hypertension – Acute pulmonary heart –
Clinically unstable pulmonary embolism – History of syncope related to forced
expiration/cough Due to increased intracranial/intraocular pressure – Cerebral
aneurysm – Brain surgery within 4 weeks – Recent concussion with persistent
symptoms – Eye surgery within 1 week Due to increased sinus and middle ear
pressure – Sinus or middle ear surgery or infection within 1 week Due to
increased intrathoracic and intraabdominal pressure – Presence of pneumothorax
– Thoracic surgery within 4 weeks – Abdominal surgery within 4 weeks –
Pregnancy beyond term Due to infection control problems – Active or suspected
transmissible respiratory or systemic infection, including tuberculosis –
Physical conditions predisposing to transmission of infection, such as
haemoptysis, significant secretions or oral lesions or oral bleeding.
WARNING
When the Spirobank II is used as oximeter with limited alarms setting, the
SpO2 and Pulse Rate values shown on the display needs to be checked frequently
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 606011-2. Spirobank II is continuously checked during
manufacturing and therefore the product complies with the established security
levels and quality standards laid down by Regulation (EU) 2017/745 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 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.
Notice You must report any serious incidents occurring in relation to the
device to the manufacturer and the competent authority of the Member State
where the user and/or patient is established, in accordance with Regulation
2017/745.
Rev.2.4
Page 6 of 35
1.2.1 Danger of cross-contamination
Spirobank II
User manual
To avoid the danger of cross-contamination, a disposable mouthpiece must be used for each patient. The disposable turbine sensor must be replaced with each patient change. The instrument can use two types of turbine sensors: a reusable type and a disposable type. The reusable turbine sensor must be cleaned before using it on a new patient. The use of a viral antibacterial filter is left to the physician’s discretion.
1.2.2 Turbine
Disposable turbine
WARNING
If you decide to perform spirometry with the “disposable” turbine, it is
essential to use a new turbine for each patient. The accuracy and hygiene
characteristics and correct functioning of the disposable turbine are only
guaranteed if it is kept intact in its original unopened packaging. The
disposable turbine is made of plastic, and local regulations must be followed
when disposing of it.
Reusable turbine
WARNING Proper functioning of the ‘reusable’ turbine is only guaranteed if it
is ‘clean’ and free of foreign bodies that alter its movement. Insufficient
cleaning of the reusable turbine can lead to cross-infection of the patient.
Only and exclusively when the instrument is used for personal use, being used
by the same patient, is periodic cleaning sufficient. For cleaning, please
refer to the appropriate section in this user 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
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
Envitec Envitec Envitec BCI
Code RS-3222-12 RM-3222-12 R-3222-12 3044
Description Reusable small soft sensor (paediatric) Reusable medium soft sensor (adults ) Reusable large soft sensor (adults) Reusable hard finger sensor (adults)
MIR code 939006 939007 939008 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 · Cod. 919210_INV
Rev.2.4
length 1.5 m length 0.5 m
Page 7 of 35
Spirobank II
User manual
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.
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, which will show very inaccurate values of the patient’s
condition. Carefully inspect each cable before use. Do not use cables that
appear to be or are damaged. If a new cable is required, contact your local
distributor. Use only cables supplied by MIR, specifically designed to be used
with 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. If the
device is connected to other instruments, to satisfy the safety requirements
of the system required by the standard 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
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.
Rev.2.4
Page 8 of 35
Spirobank II
User manual
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. 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.
Rev.2.4
Page 9 of 35
Spirobank II
User manual
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 and stored within a temperature range between -20°C
and approximately 60°C.
1.4 Labels and symbols
1.4.1 Identification label and symbols
The symbols are described in the table below:
SYMBOL Model
DESCRIPTION Product name
SN
Device serial number
0476 Rev.2.4
Manufacturer’s name and address
CE mark for medical devices: this product is a Class IIa medical device that
is certified and in compliance with the requirements of Regulation (EU)
2017/745 for medical devices
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.
Page 10 of 35
SYMBOL IPX1
Spirobank II
User manual
DESCRIPTION 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
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
SpO2
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 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
The symbol indicates that the product is a medical device
The symbol indicates the Unique Device Identification
The symbol indicates that the device must not be exposed to direct sunlight
The symbol indicates that the device must be kept dry
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. 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.
1.4.3 (ESD) Electrostatic discharge sensitivity symbol WARNING
Rev.2.4
Page 11 of 35
Spirobank II
User manual
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 Walking over untreated vinyl floor Vinyl envelope used for work instructions Worker at a bench
1.500 35.000 volts 250 12.000 volts 600 7.000 volts 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
1.5 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.
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)
Rev.2.4
Page 12 of 35
· Not affected by relative humidity and air density · Shockproof and
unbreakable · Inexpensive to replace.
The turbine flow measurement sensor is available both in reusable and in
single-patient disposable versions.
Spirobank II
User manual
Reusable turbine
Disposable turbine
The following precautions must be observed to ensure that the characteristics of the turbine remain unaltered over time:
· for the disposable turbine: must always be substituted from one patient to
the other. · for the reusable turbine: always disinfect the turbine for
testing from one patient to the next, to ensure the maximum level of hygiene
and safety.
For a correct interpretation of a spirometry test, the measured values must be compared either to the so-called normal or predicted values which are calculated from the anthropometric details of the patient or, alternatively, to the personal best values from the clinical history of the subject. The personal best values can vary considerably from the predicted values, which are taken from “healthy” subjects.
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 MIR Spiro 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. Automatic functional interpretation involves the levels defined by the 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:
1.6.1 Features of the spirometer
This device meets the requirements of the following standard: · ATS
Standardization of Spirometry 2005, 2019 update · ISO 23747: 2015 · ISO 26782:
2009
Measured parameters:
Rev.2.4
Symbol FVC FEV1 *PEF FVC FEV1 FEV1/FVC
Description Best FVC Best FEV1 Best PEF Forced Vital Capacity Volume expired in the 1st second of the test FEV1/FVC x 100
Units L L L/s L L %
Page 13 of 35
Symbol FEV1/VC PEF T-PEF FEF2575 FEF7585 FEF25 FEF50 FEF75 FEV05 FEV05% FEV075 FEV075% FEV2 FEV2% FEV3 FEV3/FVC FEV6 FEV6% FET EVol FIVC FIV1 FIV1/FIVC PIF FIF25 FIF50 FIF75 R50 MVVcal VC EVC IVC IC ERV TV VE RR tI tE TV/tI tI/tTot MVV ELA
Description FEV1 / best between EVC and IVC x 100 Peak expiratory flow Time to perform the 90% of PEF Average flow between 25% and 75% of the FVC Average flow between 75% and 85% of the FVC Forced Expiratory Flow at 25% of FVC Forced Expiratory Flow at 50% of FVC Forced Expiratory Flow at 75% of FVC Volume expired after 0.5 seconds FEV05/FVC x 100 Volume expired after 0.75 seconds FEV075/FVC x 100 Volume expired in the first 2 seconds of the test FEV2/FVC x 100 Volume expired in the initial 3 seconds of the test FEV3/FVC x 100 Volume expired in the initial 6 seconds of the test FEV1/FEV6 x 100 Forced expiratory time Extrapolated volume Forced inspiratory volume Volume inspired in the 1st second of the test FIV 1 % Peak inspiratory flow Maximum flow at 25% of FIVC Maximum flow at 50% of FIVC Maximum flow at 75% of FIVC FEF50/FIF50 x 100 Maximum voluntary ventilation calculated on FEV1 Slow vital capacity (expiratory) Slow espiratory vital capacity Slow inspiratory vital capacity Inspiratory capacity (max between EVC and IVC) – ERV Expiratory reserve volume Current volume Ventilation per minute, at rest Respiratory frequency Average time of inspiration, at rest Average time of expiration, at rest Average flow of inspiration, at rest tI/(tI+tE) Maximum voluntary ventilation Estimated lung age
Units % L/s s L/s L/s L/s L/s L/s L % L % L % L % L % s mL L L % L/s L/s L/s L/s % L/s L L L L L L L/min Breath/min s s L/min L/min year
Spirobank II
User manual
*= best values
Flow/volume measurement system Temperature sensor Measurement principle Volume
range Flow range
Volume accuracy (ATS 2019)
Flow accuracy Dynamic resistance at 12 L/s
Bi-directional digital turbine semiconductor (0-45°C) Infrared interruption 10 L 16 L/s 2.5% or 50 mL 5% or 200 mL/s <0.5 cmH2O/L/s
1.6.2 Oximeter features
For oximetry measurements, the device complies with the requirements of the
following standard: ISO 80601-2-61:2017 Medical electrical equipment –
particular requirements for basic safety and essential performance of pulse
oximeter equipment
Rev.2.4
Page 14 of 35
Reusable hard sensor for adults
Range (SpO2)
Arms (%)
70-100 %
1.19
70-80 %
0.554
80-90 %
1.32
90-100 %
1.45
Reusable soft sensor for adults
Range (SpO2) 70-100 %
Arms (%) ± 1.470
70-80 %
± 1.626
80-90 %
± 1.667
90-100 %
± 0.941
Spirobank II
User manual
Reusable paediatric soft sensor
Range (SpO2) 70-100 %
Arms (%) ± 1.390
70-80 %
± 1.851
80-90 %
± 1.397
90-100 %
± 0.652
The Arms (Accuracy Root Mean Square), as recalled in the above mentioned standard, represents the accuracy of the device in terms of the mean square error of each SpO2 measurement, obtained by pulse oximetry, in relation to the respective SaO2 reference value, obtained by co-oximetry. The ranges listed show the different oxygen saturation ranges for which the accuracy has been calculated. Any SpO2 simulators should not be used to validate the accuracy of the Oximeter, they can only be used as functional testers to verify its precision and the alarm system (when it is necessary).
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 Pulse rate rise 10 BPM in limited period of 8-40 sec and successive fall 8 BPM during a total period
Variation
of 150 sec.
Specification:
Measurement method: Range of measurement %SpO2: SpO2 Resolution %SpO2
accuracy: Average number of heart beats for the %SpO2 calculation: Range of
measurement of cardiac pulse: Cardiac pulse resolution
Accuracy of cardiac pulse:
Average interval for the calculation of cardiac pulse: Signal quality
indication: Wavelengths and maximum optical output power average of oximetry
sensors (919024, 919020) Wavelengths and optical output power of oximetry
sensors (Envitec sensors)
** This information may be useful to the doctor
Red and infrared absorption 0 99% (with 1% increments) 1%
2% between 70-99 % SpO2 8 beats 30 300 BPM (with 1 BPM increments) 1 BPM
2 BPM or 2% whichever is greater 8 seconds 0 – 8 segments on display Red
light: 660 nm, 2.0 mW () Infrared light: 905 nm, 2.4 mW () Red light: 660
nm, 3.5-4.5 mW () Infrared light: 905 nm, 3.5-4.5 mW ()
Parameters for the oximetry test:
Symbol %SPO2 min %SPO2 max BPM min BPM max %SPO2 mean BPM mean
Description Minimum SPO2 during the test Maximum SPO2 during the test Minimum BPM during the test Maximum BPM during the test Average SPO2 Average BPM
Units % % BPM BPM % BPM
1.6.3 Oximetry alarms description
Spirobank II is equipped with audio and visual alarm indicators to alert the
operator to provide prompt patient attention or to abnormal device conditions.
Spirobank II detects both patient and equipment alarms. Both, patient alarms
and equipment alarms are identified as medium priority as defined in IEC
60601-1-8 standard.
Medium Priority Alarms Medium priority alarms signal potential problems with the equipment or other non-life-threatening situations. Medium priority auditiry alarms are sounded as three beeps. The intended operator’s position for correctly perceiving a visual alarm signal is 1 meter.
Alarm Summary Spirobank II detects both patient and equipment alarms. Alarm indicators remain active for as long as the alarm condition is present.
WARNING Verify all alarm settings and limits before oximetry test starts to
ensure that they are set as intended. Setting ALARM LIMITS to extreme values
can render the ALARM SYSTEM useless. A hazard can exist if different presets
are used on multiple devices in one care area.
Rev.2.4
Page 15 of 35
Spirobank II
User manual
The alarm system provides medium priority alarm conditions for: – Low and high SpO2 level; – Low and high Pulse Rate level; – Sensor is unplugged; – Finger is not inserted – Low battery level.
Each alarm condition causes the generation of a visual alarm signal. The oximetry tests are intended not to be continuously attended by an operator in normal use, so additional auditory alarm signals are generated.
Patient (physiological) Alarms If patient SpO2 or pulse readings are equal to or above the upper alarm limit, or if they are equal to or below the lower alarm limit, the device will signal a medium priority alarm.
Patient Alarm Description SpO2 High Alarm Limit SpO2 Low Alarm Limit Pulse Rate High Alarm Limit Pulse Rate Low Alarm Limit
Factory default 99% 85%
120 bpm 60 bpm
Adjustment Options 85-99% 85-99%
30-240 bpm 30-235 bmp
Increment 1% 1%
1 bpm 1 bpm
Equipment (technical) Alarms – Sensor is unplugged – Finger is not inserted – Low battery level
Visual Alarm Indicator When the alarm is activated through over limitation of physiological alarm, corresponding data area will view in reverse (video) mode. When the alarm is activated by more than one physiological alarm condition, each parameter will be displayed in reverse mode. If the alarm is triggered by a technical condition, the relevant warning message is displayed, for example:
WARNING FINGER is not inserted
Auditory Alarm Indicator Audible alarms can be heard in a quiet environment. The medium priority audible alarm has a “du-du-du” tone that repeats every 5 seconds. The acoustic alarm signal can be temporarily disabled while an alarm condition is in progress. The duration of the paused audio, the time interval in which the alarm system or part of the alarm system does not generate an audible alarm signal, is a maximum of 2 minutes. The sound pressure level of the alarm tone is about 55 dB, in complies with the standard.
Other beeps (acoustic signals): · Pulse tone, beeps at frequency depending on Pulse Rate · Sounds the next time the device is turned following an interrupted test due to low battery
The specifications that apply to SpO2 and Pulse Rate are the same regardless of the sensor used as long as it is one of those mentioned beforehand.
1.6.4 Other features
Memory
keyboard Display Interface
Bluetooth interface
Duration of the 3,7V lithium battery Power supply
Battery charger
Dimensions Weight
Rev.2.4
Memory capacity for over 10000 spirometric tests The precise number depends on
the individual configuration, so it cannot be determined more closely membrane
keyboard with 6 keys Display LCD 160×80 monochromatic USB, Bluetooth operating
frequenzy range = 2.4 – 2.4835 GHz rated RF power output = 7.5 dBm maximum
trasmit power type of antenna = drawn on the board Antenna gain = 0 dBi Approx
500 charge cycles, under normal conditions of use Battery pack Li-ion 3.7 V
1100mAh Voltage = 5VDC Current = 500 mA or higher Connector = micro USB type B
160×55.2x25mm; Central unit 140g (including batteries)
Page 16 of 35
Type of electrical protection Degree of electrical protection Grade of
protection against water ingress Safety level in the presence of inflammable
anaesthetic gas, oxygen or nitrogen Conditions of use Storage conditions
Transport condition
Operating conditions
Applied norms
Essential performances (EN 60601-1:2005 + A1: 2012) Emission limits
Electrostatic discharge protection Magnetic field immunity Radio Frequency
Immunity
internally powered BF IPX1 device, protected against water drops
Spirobank II
User manual
Device not suitable
Device for continuous use Temperature: MIN -20 °C, MAX + 60 °C Humidity :MIN 10% RH; MAX 95%RH Athmospheric pressure: 50kPa, 106 kPa Temperature: MIN -20 °C, MAX + 60 °C Humidity :MIN 10% RH; MAX 95%RH Athmospheric pressure: 50kPa, 106 kPa Temperature: MIN + 10 °C, MAX + 40 °C; Humidity: MIN 10% RH; MAX 95%RH Athmospheric pressure: 50kPa, 106 kPa IEC 60601-1:2005 + A1: 2012 (Electrical Safety) IEC 60601-1-2:2015 (EMC) ATS/ERS Guidelines: 2005, 2019 update ISO 26782: 2009 ISO 23747: 2015 EN ISO 14971: 2019 ISO 10993-1: 2018 2011/65/UE Directive EN ISO 15223-1:2021 EN IEC 60601-1-6: 2010+Amd2013 ISO 80601-2-61: 2017 IEC 60601-1-8: 2006 Directive 2014-53-EU-RED Error of displayed numeric value: Flow measurement percentage error < ± 5% Measure of the oximetry parameters with accuracy defined in section Oximeter specifications CISPR 11 Group 1 Class B 8kV contact, 15kV air 30 A/m 3V/m @ 80-2700 MHz
MIR will make available on request wiring diagrams, parts lists, descriptions, calibration instructions or other information that will assist the service personnel in repairing those parts of the device which are designated by MIR as service able by the service personnel.
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.
Rev.2.4
Page 17 of 35
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.
Spirobank II
User manual
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
Rev.2.4
Page 18 of 35
ICON DESCRIPTION To access the database of the performed tests.
Spirobank II
User manual
To search a test with the date of birth of a patient
To search a test starting from a specific date onwards..(partial database)
To flick through a database from beginning to end and viceversa (complete database)
Male sex patient selection
Female sex patient selection
To access all oximetry test options / To perform an SpO2/BPM test
To access oximetry testing type
To access spirometry testing type
To perform a forced vital capacity test FVC/search FVC tests in memory
To carry out a VC-type spirometry test/search in the VC-type test archive
To perform a bronchodilator test (POST)
To check alarms and thresholds set during the oximetry test
To check alarms and thresholds set during the oximetry test when at least one
parameter is set to OFF
Alarm warning active during oximetry test Temporarily disable alarm Alarm
disabled during oximetry test Enable 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 shows the
main screen, pressing the key The service menu shows the following list of
voices:
and then the key .
· Change date/time · LCD settings · Bluetooth suspend · Select language · Delete memory · Standard setting · Select predicted · Select turbine · 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
. To return to the service menu press
.
e keys. It is possible to switch from a parameter to the other using and
Bluetooth suspend
Rev.2.4
Page 19 of 35
Spirobank II
User manual
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:
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 device returns to the Service Menu.
and , then press
, the setting takes effect and the
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 ERS Knudson USA ERS MC-Barcelona JRS Pereira
Pediatric Knudson Knudson Knudson Zapletal Zapletal Knudson Pereira
Select with and the pair to use and press . The Predicted values are set and the device returns to the Service Menu.
Turbine Type
Select the type of turbine you will use (reusable or disposable) and press
menu.
, the selection is set and the device returns to the service
Turbine calibration Select the Turbine Calibration item and choose from the following options:
· show current values · modify calibration · factory defaults
Rev.2.4
Page 20 of 35
Spirobank II
User manual
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
Alarms setting Access to these settings is password protected and allows the user to set the lower and upper threshold values for SpO2 and Pulse Rate; during the test, an acoustic alarm will warn the user if the SpO2 and/or Pulse Rate values fall below the minimum threshold or exceed the previously set maximum threshold. The configurable parameter are the lower/upper thresholds of the SpO2 and Pulse Rate parameters. For each parameter is possible to set the alarm ON or OFF and to change the Default threshold value.
Use and to switch from a parameter to the other, then
e are
useful to decrease/increase the value: the selected icon is the grey one. Press
to confirm and change screen. The table shows the lower and upper threshold values may be set:
Alarm Limit SpO2 min SpO2 max BPM min BPM max
Minimum 85 85 30 30
Maximum 99 99 235 240
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.
Spirometry configuration Configuring Spirometry The type of parameters
calculated during the spirometry test can be selected. The user can select
between the following two options:
· simplified · personal
The ‘simplified’ mode only allows the following parameters:
FVC FEV1 PEF FEF2575 FET VEXT ELA (for FVC test) VC IVC IC ERV EN (for VC test)
In ‘personal’ mode, the user can select which parameters will be displayed. The parameters highlighted in white will be displayed.
Select a parameter with and . Select a parameter to be displayed using and delete a parameter with
..
ATTENTION The ‘simplified’ mode parameters are always displayed regardless of the selected mode.
ATTENTION When the NHAHES III standard is selected, the spirometry parameter setting function will be automatically disabled.
UNIT format
The voice allows to choose one of the following option:
· Imperial
(in,lb)
· Metric
(cm kg)
Select the format by using or and confirm with
; the selection will be saved.
Rev.2.4
Page 21 of 35
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 Reusable turbine calibration
WARNING
The reusable turbine does not need calibration, but only requires periodic
cleaning. The reusable turbine is checked before being closed in the bag, so
it does not need calibration. However, if you really want to carry out a
calibration, bear the following in mind. The calibration operation can be
performed on the reusable turbine as well as on the disposable turbine.
Spirobank II
User manual
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:
Rev.2.4
Page 22 of 35
Spirobank II
User manual
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 *
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 Group Without correction Caucasian Oriental Hong Kong Chinese Giapanese polinesian North Indian South Indian Pakistani African descendant Aboriginal
% correction 100% 100% 100% 100% 89% 90% 90% 87% 90% 87% 85%
Standard NAHNES III
Caucasian Mexican-American Afro-American Other
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
Rev.2.4
Page 23 of 35
Spirobank II
User manual
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 Three methods of research are available:
icon (key ).
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 visualized concerns tests performed by patients whose date of birth corresponds to the inserted date of birth.
All data
Database by date of testing: requires the insertion of the date when the test was performed; once all the date information has been inserted press . The data returned by the device are all the test sessions performed during that specific day.
Complete database: shows data starting from the most recent session. The end of the database is signalled by a double beep. The database search is resumed from the last session.
2.7.2 Visualization of database info
The result of a search performed in one of the described methods in paragraph 2.7.1 can be viewed in the adjacent image. By selecting the desired session one may access the performed tests
Use the keys and to select the desired test. Once a testing session has been selected the database screen will show the adjacent image. The two icons on the lower part of the screen allow access to the following functions:
(key
) to make a new test on the current patient
(key ) to show the parameters of the selected test
The user may return to the previous screen by using
.
2.8 On line mode
In the on-line mode the Spirobank II becomes a fully functional laboratory device which works in real-time connected to a device us a tablet. The connection is wireless via Bluetooth. The Spirobank II becomes an intelligent transducer for the measurement of volume and flow while the tablet controls the device including the on and off function.
2.8.1 How to download app for iPad
The application to use is “MIR-Spiro”. On the apple store search the voice
“MIR-Spiro”. The icon which identifies the application is shown. Once
downloaded the application it is necessary to pair the tablet with the device.
For more information please refer to application user manual.
WARNING For a correct functioning of the device with the tablet it is necessary that this one has a Bluetooth version 4.0 or higher.
Opening the application automatically starts the Bluetooth connection with spirobank II and the connection remains active until the application is closed. Even if the Spirobank II is switched off, starting the application the Bluetooth will automatically turn on it again. This application enables complete control of the device.
Other than the usual spirometric parameters and the F/V in real-time the Spirobank II also plots the most refined indices such as the ventilatory profile and the extrapolated volume (Vext). The application on the tablet incorporates the most up to date bronchial provocation protocols displaying the dose-response and timeresponse of the FEV1
Rev.2.4
Page 24 of 35
For more details on the correct use of the application please refer to the relevant user manual.
Spirobank II
User manual
WARNING
When the device is connected to the table it can be only remotely controlled.
The default settings of the tablet software will be transferred to the device
and will remain in the device even when used in stand-alone mode, until the
device is restarted.
2.9 Spirometry testing
In order to perform proper spirometry testing the following instructions are
to be followed carefully.
· Insert the turbine in the appropriate housing until it reaches the mechanic
stop and successively rotate the turbine clockwise until it stops. Insert the
mouthpiece at least 0.5 cm inside the groove of the turbine.
· Place the noseclips on the nose so as not to let any air out of the
patient’s nostrils. · Hold the Spirobank II with both hands or grasp it like a
mobile phone. The display must always face the patient taking the test. ·
Place the upper part of the mouthpiece in the mouth making sure that no air
leaks from the sides of the mouth.
WARNING
Correct positioning of the mouthpiece extending under the dental arch in the
patient’s mouth is fundamental so as to avoid any turbulence which could
erroneously affect the spirometry results.
WARNING
If possible it is recommended to stand up while performing the test. During
expiration it is recommended to bend forward the upper part of the body so as
to release all the air out with the aid of the abdominal muscles.
By pressing
relative to icon, the user may access the spirometry testing area which includes the following tests:
FVC spirometry testing VC type spirometry test MVV type spirometry test test with broncodilator (POST)
Once a test is selected the screen will display information concerning the type of turbine in use including the necessary information to complete the test in the correct manner.
To end a test press
key
2.9.1 FVC test
Proper execution of a FVC test must take into account the phases as described
on the screen, more specifically:
INSPIRE all the air EXPIRE fully with force INSPIRE fully with force
It is possible (and may be helpful) to start the test by breathing at rest for
a few moments. When ready to start inspire slowly as much air as possible
(made easier by raising the arms wide apart) and then make a complete
expiration as fast as possible. Then with the mouthpiece always held firmly in
the mouth, complete the cycle by inspiring again as quickly as possible. This
final inspiration may be left out if the inspiratory parameters (FIVC, FIV1,
FIV1%, PIF) are not of interest. The optional initial inspiration phase can
also be performed before inserting the mouthpiece in the mouth. After
inspiring slowly and deeply, the following expiration must be made with the
maximum effort by expiring all the air in the lungs as fast as possible. After
6 seconds of expiration the device will emit a continuous beep, this helps the
user to understand whether the minimum expiry time has been reached, as
recommended by the main international respiratory institutions.
WARNING Accurate spirometry testing requires that the patient expire all the air in the lungs.
The test may be carried out several times by repeating the cycle without
taking the mouthpiece out of the mouth, in which case Spirobank II recognises
the best test (largest FVC+FEV1) and will automatically display the results of
the best test.
To end the test press .
Rev.2.4
Page 25 of 35
Spirobank II
User manual
During the test the Spirobank II emits “beeps”, the frequency of which are
directly proportional to the inspired and expired velocity of the air. This
helps the doctor understand when the velocity of the air is approaching zero,
and the patient has almost exhausted all of the inspired or expired volume. In
the maintenance section an explanation is given as to how this feature can
also function as a very simple checking system for the correct operation of
the mobile “rotor” of the turbine. For the FVC test to be judged as
acceptable, besides breathing as deep as possible, it is also required that
the forced expiratory time (FET) is sufficiently long to allow for the
complete expiration of all air contained in the lungs.
2.9.2 POST test, after drug administration
WARNING
To carry out a POST test it is necessary to have carried out at least one PRE
FVC test the same day; it is not possible to do a POST test on the PRE VC or
MVV tests; it is however possible to do a POST VC or MVV test if the database
already contains at least one PRE test carried out on the same day.
To carry out a POST test please access to the spirometry area pressing
and subsequently pressing .
A POST test is a spirometry test following the administration of a drug of some kind, usually a bronchodilator. The sign “POST Phase” is shown on the screen of the device (center) on the first screen of the spirometry area.. The following tests made by the patient show the following parameters:
· Those values related to the test performed · Those values related to the best PRE test performed by the same patient the same day.(that is in the same test session) · The percentage variation between the PRE and POST values (in the CHG column)
It is not possible to perform a POST test with a patient whose PRE testing was
not carried out on the same day. If during a POST session a new patient is
inserted or another is recalled from the archive the device will automatically
exit the current POST session.
2.10 Viewing the spirometric results
Following a FVC test, the spirometry test results are shown. The first screen
displays a Flow/Volume graph of the Forced Vital Capacity
pressing the parameters FVC, FEV1, FEV1%, PEF relative to the best acceptable
in the session are displayed with the percentage ratio in relation to the
theoretical values.
By scrolling with and it is possible to view all the parameters next to the chosen predicted values.
2.10.1 Acceptability, Repeatability and quality messages
Acceptability, usability, and repeatability of FVC and FEV1 parameters for
each single test are defined as summarized in Table 7 of the ATS/ERS 2019
guideline:
For FEV1 and FVC
Acceptability and Usability Criterion Must have EVOL (VEXT or BEV) <5% of FVC
or 0.100 L, whichever is greater Must have no cough in the first second of
expiration Must have no glottic closure in the first second of expiration
Must have no glottic closure after 1 second of expiration Must achieve one of
these three end of forced expiration (EOFE) indicators: Expiratory plateau
(<0.025 L in the last 1 second of expiration) Expiratory time >15 seconds FVC
is within the repeatability tolerance of or is greater than the largest prior
observed FVC Must have no evidence of obstructed mouthpiece or spirometer Must
have no evidence of a leak If the maximal inspiration after EOFE is greater
than FVC, then FIVC – FVC must be <0.100 L or 5% of FVC, whichever is greater
Required for Acceptability FEV1 FVC YES YES YES NO YES YES NO YES NO YES
YES YES YES YES YES YES
Required for Usability FEV1 FVC YES YES YES NO YES YES NO NO NO NO
NO NO NO NO NO NO
Repeatability criteria (applied to acceptable FVC and FEV1 values) Age > 6 years: The difference between the two largest FVC values must be <0.150 L, and the difference between the two largest FEV1 values must be <0.150 L
Rev.2.4
Page 26 of 35
Spirobank II
User manual
Age < 6 years: The difference between the two largest FVC values must be
<0.100 L or 10% of the highest value, whichever is greater, and the difference
between the two largest FEV1 values must be <0.100 L or 10% of the highest
value, whichever is greater
Abbreviations: EVOL (VEXT o BEV) = back-extrapolated volume; EOFE = end of
forced expiration; FEV075 = forced expiratory volume in the first 0.75
seconds. The grading system (above Table 10) will inform the interpreter if
values are reported from usable maneuvers not meeting all acceptability
criteria. *For children aged 6 years or younger, must have at least 0.75
seconds of expiration without glottic closure or cough for acceptable or
usable measurement of FEV0.75. Occurs when the patient cannot expire long
enough to achieve a plateau (e.g., children with high elastic recoil or
patients with restrictive lung disease) or when the patient inspires or comes
off the mouthpiece before a plateau. For withinmaneuver acceptability, the FVC
must be greater than or within the repeatability tolerance of the largest FVC
observed before this maneuver within the current prebronchodilator or the
current post-bronchodilator testing set. Although the performance of a maximal
forced inspiration is strongly recommended, its absence does not preclude a
maneuver from being judged acceptable, unless extrathoracic obstruction is
specifically being investigated. The design of MIR spirometers with turbine is
such that they are not subject to faulty zero-flow setting.
For VC test the acceptability criteria according to ATS/ERS 2019 guideline is defined as follows: the VC test is considered acceptable is there is less than a 0.025 L volume increase over 1 second; in this case the test is deemed as having a plateau.
The Repeatability criteria in case of VC test is defined as follows:
Number of 3 acceptable tests are required
tests
VC
The difference in VC between the largest and next largest manoeuvre must be smaller of the following:
0.150 L or 10% VC, for patient older than 6 years of age
Or
0.100 L or 10% VC. For those aged 6 years or younger
Otherwise, additional trials should be performed.
After each maneuver, ATS/ERS 2019 guideline provides a quality messages based on acceptability criteria define in table 7 of ATS/ERS 2019 guideline, as follows:
Warning message No plateau Hesitant start Slow start Abrupt stop
Warning trigger no plateau and expiration < 15 s EVOL (VEXT o BEV) exceeds limit rise time > 150 ms suspected glottis closure
Cough
in
expiration
Hesitation at
maximum
volume
Slow filling
Low
final
inspiration
suspected cough in first second of expiration
hesitation time > 2 s
mean inspiratory flow of the breath just prior to forced expiration is less
than 2 L/s FIVC < 90% FVC
Incomplete inspiration
FIVC < FVC
Instruction to patient keep going until completely empty blast out immediately
when completely full blast out immediately when completely full if you feel
your throat closing, relax, but keep pushing try having a sip of water before
the next blow
blast out when completely full
breathe in faster before blasting out
after completely emptying your lungs, remember to breathe in – back to the top
fill your lungs completely before blasting out take the deepest breath
possible
WARNING
The best test with the criteria defined in the 2019 ATS guideline is not
considered the one with the best FVC+FEV1 sum, but is chosen among the tests
that meet the acceptability criteria set by the aforementioned guideline. Then
it is chosen among those tests that did not provide error messages The
following table of the ATS 2019 guideline defines the criteria for choosing
tests for acceptability and repeatability.
Rev.2.4
Page 27 of 35
Spirobank II
User manual
Further consideration and management of particular cases are detailed in the ATS/ERS 2019 guideline.
The quality grade of a test session is expressed with a letter, which separately refers to FVC and FEV1, as described in Table 10 of the ATS/ERS 2019 guideline:
Grade Number of Measurements
Repeatability: Age > 6 years
Repeatability: Age <6 years*
A
3 acceptable
Within0.150 L
Within0.100 L*
B
2 acceptable
Within0.150 L
Within0.100 L*
C
2 acceptable
Within0.200 L
Within0.150 L*
D
2 acceptable
Within0.250 L
entro 0.200 L*
E
2 acceptable
0.250 L
0.200 L*
or 1 acceptable
N/A
N/A
U
0 acceptable AND > 1 usable N/A
N/A
F
0 acceptable AND 0 usable
N/A
N/A
The repeatability grade is determined for the set of prebronchodilator maneuvers and the set of post-bronchodilator
maneuvers separately. The repeatability criteria are applied to the differences between the two largest FVC values and
the two largest FEV1 values. Grade U indicates that only usable but not acceptable measurements were obtained.
Although some maneuvers may be acceptable or usable at grading levels lower than A, the overriding goal must be
to always achieve the best possible testing quality for each patient. Adapted from Am. J. Respir. Crit. Care Med. 2017;196:14631472.
*Or 10% of the highest value, whichever is greater; applies for age 6 years or younger only
2.10.2 Interpreting spirometry results
The interpretation of spirometry refers to Forced Vital Capacity (FVC) and is
seen by means of indicator lighting. This interpretation is calculated on the
best manoeuvre according to the ATS /ERS 2019 guideline. The messages can
include the following:
Normal spirometry Light obstruction/restriction Moderate
obstruction/restriction Moderately severe obstruction/restriction Severe
obstruction/restriction Very severe obstruction/restriction
The final interpretation level is “restriction + obstruction”, where the indicator light indicates the worst parameter between restriction and obstruction.
2.11 Oximetry Testing
WARNING Check if the oximetry function is available in the device, this function is an option in some models.
WARNING
The oximetry sensor used in the manual is only one of the different types of
sensors which can be used listed in paragraph 2.2.4. MIR does not recommend
any particular sensor; the doctor will chose the sensor which she/he believes
to be more suitable.
Rev.2.4
Page 28 of 35
Spirobank II
User manual
During oximetry testing the Spirobank II cannot be turned off. To turn off the
device the oximetry test must be stopped first. This has been implemented so
as to avoid any unwanted interruptions which could compromise the accuracy of
the data.
For the non-invasive measurement of SpO2 oxygen saturation and blood pulse rate, utilize the re-usable finger sensor. This sensor is recommended for patients weighing more than 20 Kg while remaining still during testing. For the 6 minute walk test other types of sensors are recommended which are less influenced by the movement of the hand.
To carry out an oximetry test: · Connect the sensor to the device: insert the
connector with the arrow
(printed on the connector) face-up, as shown: · Choose a high perfusion site,
easily adaptable to the sensor. · Insert the finger into the sensor until the
finger touches the end of the
probe. Ensure that the bottom part of the finger completely covers the
detector. If the finger cannot be placed properly inside the sensor try
another finger. · Place the sensor so that the cable rests on the back of the
hand. This ensures that the light source rests. On the side of the nail and
the reader on the lower part of the hand. · Select one of the tests that can
be performed with Spirobank II.
To access the oximetry area press immediately.
on the main screen; the test starts
If the following message appears upon start-up:
WARNING OXIMETER NOT PRESENT This means that your device does not have this
function.
WARNING Before carrying out a test, if the power supply value is low the following message will appear:
Low battery level
Press the
key to exit the test, otherwise after a seconds will start the test.
In the event that a test is interrupted due to a complete battery discharge,
the next time the device is turned on the following message is displayed:
WARNING
Wrong interruption of last oximetry test
At the same time an intermittent beep is emitted for 4 seconds. Subsequently the Spirobank II returns to the main screen.
WARNING Avoid twisting the sensor’s cable as this may compromise measurement
accuracy and the integrity of the sensor itself, also do not apply excessive
force when using, connecting, disconnecting or storing the oximetry sensor.
The first few seconds are used to find the best signal possible; after which
the Spirobank II timer resets itself and the device starts recording data. For
any type of oximetry test if the sensor is not properly connected the
following message will be displayed on screen after a few seconds:
Sensor unplugged
At the same time Spirobank II emits an acoustic alarm (if previously set in
the service menu). If the sensor has been connected properly but the finger
has not been properly inserted in the sensor the following message will be
displayed on screen.
Finger Not inserted
At the same time Spirobank II emits an acoustic alarm (if previously set in
the service menu). If the signal reaches the sensor properly, after a few
seconds the device will emit an acoustic signal while also displaying the
values on screen. The alarms can be customized, the procedure is described in
paragraph 2.5.
Rev.2.4
Page 29 of 35
Spirobank II
User manual
If during oximetry the test the %SpO2 and/or BPM value goes above or below its
threshold, the Spirobank II will emit an acoustic alarm `(if previously set in
the service menu.)’ until such this anomaly continues. For sleep oximetry
testing the Pulse rate tone is always disabled.
If all alarms are enabled during a test, the following icon will be displayed
on the screen . By touching this icon you can view the alarm settings, as
shown in the adjacent image which allows you to check the thresholds and
alarms activated in the service menu; after few seconds, the screen returns to
the on-going test screen.
If
appears during the test, this means that at least one of the alarms is set to OFF in the service menu. It is always possible to
check the configuration by touching the icon itself.
When one of the activated alarm conditions occurs, Spirobank II will beep and the icon
is displayed on the screen. If you press it,
the acoustic alarm will be paused for 2 minutes; in such event, the icon will change to once the muted mode is over.
and then then return to the previous one
WARNING
A test is saved with the code of the last patient displayed. If a test refers
to a previously saved patient, then prior to performing a test the user must
recall that patient from the database as described in paragraph 2.7.2
WARNING During oximetry testing the display will always show the battery pack
level; thus providing an estimate of the actual charge level which can vary as
a function of whether the device is in energy saving mode or with the
backlight display at max level.
During a test the display will show the following information:
To end the oximetry test press
key.
2.11.1 Instructions for Adult Patient Sensor
WARNING
The oximetry sensor used in the manual is only one of the different types of
sensors which can be used with Spirobank II listed in paragraph 1.2.4. MIR
does not recommend any one particular sensor, the decision is left to the
doctor who will choose the sensor which she/he believes to be more suitable.
To perform a non-invasive continuous monitoring of arterial oxygen saturation it is recommended to use the reusable “soft” type sensor.
WARNING
The materials used for manufacturing the sensor are NATURAL LATEX PROTEIN
FREE, and are subject to biocompatibility tests.
· Choose an application site on the patient’s finger or toe where the light
source will be directly over and in-line with the detector. The preferred
sites are the forefinger or smaller thumb.
· Remove nail polish or artificial fingernails.
Rev.2.4
Page 30 of 35
Spirobank II
User manual
· Insert the patient’s digit in the sensor nail-side up, lining up the digit’s
pad over the detector. The sensor’s positioning line runs across the mid axis
of the fingertip
· Fold the sensor’s top over the digit, making sure the light source is
directly over and in-line with the detector. Route the cable along the palm or
the bottom of the foot, and secure with adhesive tape if necessary.
· Connect the sensor to the device: insert the connector with the arrow on the
connector face-up and check the proper functioning of the sensor according to
the previous instructions.
WARNING Do not twist the cable or use excessive force when using, connecting,
disconnecting, or storing the sensor. To reduce chances of entanglement it is
recommended to fasten the cable to the wrist with a bandage.
3. DATA TRANSMISSION
WARNING Please read carefully and make sure to have properly understood the
instructions before commencing the data trasmission.
3.1 PC connection via USB port WARNING
Before connecting the Spirobank II via USB to the PC, the MIR Spiro software
must be installed on the PC first to enable the software to interface with the
device. Before initiating the following procedure it is important to know the
operating system version installed on the PC used for the connection (from
control panel click on “System”, where the type of operating system installed
on the PC can be checked). If MIR Spiro is already installed on the PC then a
new installation is not required.
To make the connection, insert the mini USB connector supplied with Spirobank
II as shown in the picture and attach the other connector to the USB port of
the PC. When initially making a connection, depending on the version of the
operating system, the PC will either make an automatic driver installation
(for Windows 98, 2000, ME) or request some information (for Windows XP, Vista
and Seven). To avoid making any errors at this stage please read the Advanced
section of the MIR Spiro User Manual carefully.
3.2 Internal software upgrade
Spirobank II internal software can be upgraded from a PC via USB connection.
Upgrades can be downloaded by registering on www.spirometry.com. For further
information on software upgrading please read the “MIR Spiro” software manual.
4. MAINTENANCE
WARNING No part can be subjected to maintenance during use.
Spirobank II requires very little maintenance The operations to perform
periodically are:
· Cleaning and checking the reusable turbine. · Changing the disposable
turbine before each test · Cleaning of the device · Cleaning the oximetry
sensor · Recharging the internal battery pack
The maintenance operations described in the User’s Manual must be carried out
with extreme care. Failing to observe the instructions may cause errors in
measurement or the misinterpretation of the measured values. Modifications,
adjustments, repairs, and reconfigurations must be carried out by the
manufacturer or by qualified personnel. In the unlikely event of a problem do
not attempt to repair the unit. The parameter configuration setup must be
carried out by qualified personnel. In any case the risks pertaining to an
incorrect configuration setting in no way endangers the patient.
Rev.2.4
Page 31 of 35
4.1 Cleaning and checking the reusable turbine
Spirobank II
User manual
Two types of turbines can be used with Spirobank II. The disposable turbine or the reusable turbine. Both guarantee precise measurements and have the advantage of requiring no periodic calibration. In order to maintain the default characteristics of the reusable turbine a simple cleaning procedure is required before use. Cleaning of the disposable turbine is not required, as it is supplied clean in a sealed plastic bag. It must be disposed of after use.
WARNING
Periodically check the inside of the turbine to ensure that there are no
impurities, corpuscles, or any foreign matter like hairs which could
inadvertently block or even slow down the mobile equipment in the turbine and
as a consequence compromise spirometry measurement accuracy.
Before use perform the test described in paragraph 4.1.1 which allows to the
check the efficiency of the turbine. If the test result is negative perform
the following procedure. To clean the reusable turbine remove it from its
housing by rotating it counter-clockwise and apply slight pressure with a
finger from the bottom of the turbine to lift it out of its housing. Immerse
the turbine in a cold liquid solution and shake it so as to remove any
impurities. Leave the turbine immersed for the time specified in the
instruction of the solution.
WARNING To avoid irreparable damage to the reusable turbine please do not use
any alcoholic or oily detergent solutions, and do not immerge the turbine in
hot water or hot liquids. Do not place the turbine under a direct water jet or
other liquid. If no detergent solution is available, clean the turbine in
clean water. Do not use compressed air to clean the turbine.
Rinse the turbine by immerging it in clean water (not hot). Shake off the
excess water from the turbine and let it dry, position the turbine vertically
on a dry surface.
Before inserting the reusable turbine in the device it is good practice to
visually check that the rotor inside turns freely. Hold the turbine
horizontally and slowly move it left and right and vice versa. You should be
able to see the mobile equipment (blade) rotate freely. If this is not the
case then the measurement accuracy can no longer be guaranteed and as such the
turbine must be replaced.
Having completed the turbine cleaning procedure, insert the turbine in its
housing making sure to turn it clockwise as shown by the symbol of the lock
printed on Spirobank II.
The turbine is inserted properly by pushing it all the way in and subsequently
rotating it clockwise until it stops; this bayonet mechanism ensures that the
turbine is blocked inside the plastic casing.
To be absolutely certain that the turbine is functioning properly perform the
checklist in paragraph 4.1.1; if the turbine is still malfunctioning please
replace it with a new one.
WARNING Do not carry out any cleaning procedures when using disposable
turbines, a new disposable turbine must be used for every new patient.
4.1.1 Proper turbine operation check
· Turn on Spirobank II · setup the device to perform a spirometry test (for
example FVC). · Hold the Spirobank II with one hand and move it slowly
sideways, having the air pass through the turbine. · If the rotor spins
properly the device will emit a series of acoustic signals “beeps”. The
beeping frequency is a function of the air
flow passing through the turbine. · If no beeps are heard while moving the
device, proceed to clean the turbine
4.2 Cleaning of the device
Clean the device once a day or every time changes the patient. Use only the
substances and methods listed in this chapter to clean the device. Recommended
cleaning agents are:
· Mild soap (diluted) · Sodium hypochlorite bleach (10% diluted) · Hydrogen
peroxide (1.5%)
Rev.2.4
Page 32 of 35
· Alcoholic Solvents
Spirobank II
User manual
Moisten a soft cloth with a recommended solution, but not so much that the cloth drips, and lightly wipe the surface for 30 seconds. Let it air dry. Do not use ketonic solvents and aromatic solvents. Never put the device into water or other fluids.
4.3 Cleaning and disinfection of the oximetry sensor
The reusable finger sensor must be cleaned every patient change, so clean the
sensor before to use this on a new patient. Clean the sensor with a soft cloth
moistened with water or a mild soap solution. To disinfect the sensor, rub
with isopropylic alcohol. Allow the sensor to dry completely after cleaning.
Do not use any abrasive or caustic material to clean the sensor.
WARNING Do not sterilize by irradiation, steam or by using ethylene oxide.
Unplug the sensor from the device before cleaning or disinfecting it.
The sensor included with the Spirobank II is made with latex free material.
4.4 Battery charging
Turn on Spirobank II and the following icon will appear on the main screen
showing the charge level of the battery pack:
The maximum charge level is displayed with all 6 bars inside the battery. If
only one bar is shown or if the device will not even turn on the battery pack
must be recharged in the following manner:
· Plug the battery charger into a socket and the battery charger cable into
the micro USB connector of the device; the device in this phase is always
turned on
· When the charging is complete the battery icon will display all six bars.
· At this point disconnect the battery charger from the device.
SpO2 WARNING It is recommended not to use the device while the battery is
charging. Always disconnect the battery charger from the device when the
charge cycle has terminated.
WARNING Operator shall not touch simultaneously the patient and the parts of
non-medical equipment that are accessible to the operator during routine
maintenance after removal of covers without the use of a tool.
PROBLEM SOLVING
PROBLEM
Spirobank II does not turn on
MESSAGE
POSSIBLE CAUSES
REMEDY
The battery pack could be discharged
Connect the device to the battery charger.
The battery pack has not been properly
Contact a technical service center
inserted in the device
The device may have lost its internal software Connect the device to the PC with the
USB cable and update the internal software;
For more detailed information please
consult the MIR Spiro software user
manual available on line within the
software itself.
Rev.2.4
Page 33 of 35
PROBLEM
Problem when turning on the device
MESSAGE POSSIBLE CAUSES
Error in ram memory
Memory data within the device has been damaged
Recovering
data
Please wait
Spirobank II
User manual
REMEDY If the data has been restored correctly the standard turn-on process
will complete itself. If this process does not finalize contact an authorized
technical service center.
The device turns off and subsequently turns on again.
Spirometry test results are unreliable
Certain spirometry and/or oximetry parameters are not shown at the end of a
test. During an oximetry test values are returned at irregular intervals,
intermittent or simply wrong. During oximetry testing the screen is barely
readable Problem during battery pack recharging Unforseeable error of the
memory The device has frozen due to an unforseeable event
An internal error has occurred.
Check on the following website
www.spirometry.com for a more recent
internal software release of the device.
Update the internal software by
downloading the latest release by using the
MIR Spiro software For further
information consult the MIR Spiro manual
available on line within the software itself.
The turbine may contain dirt or foreign matter. Clean the turbine as explained in paragraph
4.1; if necessary replace the turbine with a
new one.
The test was not performed correctly.
Repeat the test and follow closely the
indications shown on the screen.
Personalized parameter setting in the service Check the parameter setting in the item
menu.
“PARAMETER setting” within the Service
Menu as explained in paragraph 2.5
The sensor is positioned incorrectly or the Riposition the oximetry sensor.
patient perfusion is insufficient.
The patient has moved.
To obtain accurate oximetry readings it is
important that the patient must not move
abruptly.
After a few minutes the screen backlight turns None
off automatically to save battery energy.
Damaged The battery pack could be damaged or simply Contact a technical service center
battery pack mispositioned.
Error in Data in archive is damaged.
Contact a technical service center
memory
Press the power key 3 times and wait
approximately four seconds after which the
device will reset itself and turn on again
WARNING
Before contacting a technical service center, please try downloading the
database from the device to the PC using the MIR Spiro software. This
procedure is necessary to save a backup in case all the data is accidentally
lost during device repair. Furthermore the database could be of confidential
nature and as such not accessible by authorized personnel and also subject to
privacy laws.
Rev.2.4
Page 34 of 35
Spirobank II
User manual
LIMITED WARRANTY CONDITIONS
Spirobank II, together with its standard accessories is guaranteed for a
period of: · 12 months if intended for professional use (doctors, hospitals,
etc.) · 24 months if the product has been purchased directly by the end user.
The warranty is effective from the date of purchase shown on the relevant
sales invoice or proof of purchase.
The warranty is effective from date of sale which must be shown on the
relevant sales invoice or proof of purchase.
The device must be checked at the time of purchase, or upon delivery, and any
claims must be made immediately in writing to the manufacturer.
This warranty covers the repair or the replacement (at the discretion of the
manufacturer) of the product or of the defective parts without charge for the
parts or for the labour.
All batteries and other consumable parts, reusable turbine included, are
specifically excluded from the terms of this guarantee.
This warranty is not valid, at the discretion of the manufacturer, in the
following cases:
· If the fault is due to an improper installation or operation of the machine,
or if the installation does not conform to the current safety norms in the
country of installation.
· If the product is utilised differently from the use described in the User’s
Manual. · If any alteration, adjustment, modification or repair has been
carried out by personnel not authorised by the manufacturer. · If the fault is
caused by lack of or incorrect routine maintenance of the machine. · If the
machine has been dropped, damaged or subjected to physical or electrical
stress. · If the fault is caused by the mains, or by a product to which the
device has been connected. · If the serial number of the device is missing,
tampered with and/or not clearly legible.
The repair or replacement described in this warranty is supplied for goods
returned at the customers’ expense to our certified service centers. For
details of these centers please contact your local supplier of the spirometer
or contact the manufacturer directly.
The customer is responsible for the transportation and for all transport and
customs charges as well as for delivery charges of the goods both to and from
the service center.
Any device or accessory returned must be accompanied by a clear and detailed
explanation of the defect or problem found. If units are to be returned to the
manufacturer then written or verbal permission must be received before any
devices are returned to MIR.
MIR S.p.A. Medical International Research reserves the right to modify the
device if required, and a description of any modification made will be sent
along with the returned goods.
Rev.2.4
Page 35 of 35