Siare Falco 101 User Manual
Falco 101
Lung ventilator
turbine-driven ventilation
User manual
GENERAL INFORMATION
The information contained in this manual are the exclusive property of SIARE
Engineering International Group s.r.l. and may not be reproduced in any way
without authorisation. SIARE Engineering International Group s.r.l. reserves
the right to modify or replace this manual at any time without prior notice.
It is however recommended that you make sure you have the most recent
version of the manual. In the event of doubt, contact SIARE Engineering
International Group s.r.l. (see the address on page IX). The information
contained in the present User’s Manual can be considered correct, but do not
exclude professional knowledge by the user.
The operation and maintenance of Falco 101 lung ventilator must be
entrusted to qualified technical personnel only. The responsibility of SIARE
Engineering International Group s.r.l. concerning the Falco 101 lung
ventilator and its use is limited to what is indicated in the guarantee supplied.
The contents of this manual do not in any way limit the right of SIARE
Engineering International Group s.r.l. to revise, change or modify without
prior notice the equipment (including the relative software) described herein.
Unless otherwise specifically agreed in writing, SIARE Engineering
International Group s.r.l. is not obliged to supply such revisions, changes or
modifications to the owner or user of the equipment (including the relative
software) described herein.
The information contained in this manual refers to the versions of Falco
101 lung ventilator produced or updated after May 2019. It is possible that
some information may not apply to previous versions. Contact SIARE
Engineering International Group s.r.l. if you have any doubts.
User’s Manual, version DU3111103
Revision 3 - 20.05.2019
Fal
co 101
III
Observations
SIARE Engineering International Group s.r.l. wishes to thank you for
Any comment on the accuracy and usefulness of this User’s Manual would be
of the high
quality level of our manuals. We would be grateful if you would send us your
The SIARE trademark is used throughout this manual as an abbreviation for
Three symbols are used in this User’s Manual to indicate particularly important
This indicates a condition of danger for the patient or for the
This indicates information worthy of note, making the
operation of the Falco 101 lung ventilator more efficient or
purchasing one of its products.
very helpful in allowing us to guarantee current and future users
comments (see address at page IX).
the manufacturer: SIARE Engineering International Group s.r.l.
Directive 93/42 EEC
Definitions
information.
WARNING !!
operator.
CAUTION
This indicates the possibility of danger to the ventilator.
NOTE
practical.
IV User Manual, DU3111103
tion given alongside the three
symbols shown on the previous page, since it contains considerations on
safety, the special requirements for the use Falco 101 lung ventilator
to understand how the ventilator works and how to use it
correctly to ensure patient and user safety, the recommendations and
instructions contained in this manual must be read with care and
he patient and
operator’s safety, the ventilator was designed and manufactured
following warranty standards of quality of the product and its
components. Any part of circuit must therefore only be replaced with
The ventilator must only be used for the purposes specified herein and
the safety of the ventilator is therefore only guaranteed if it is used in
sonnel and only in
equipped and dedicated rooms, according to the regulations in force in
the country where the ventilator is installed. Furthermore, during all the
general safety and to ensure correct technical assistance
and avoid possible physical damage to the patient, the maintenance
schedule foreseen in this manual must be respected; qualified
personnel must only carry out maintenance of the ventilator or
ised modifications to the ventilator. The user of this product is
solely responsible for any operating defect caused by improper use or
interventions carried out by third parties other than specialised SIARE
f any part have to be
performed by authorized service personnel and only original SIARE
medical equipment, it is
interaction between the machine
For any repairs to ventilator (due to malfunctioning, defects or failures),
the user must contact SIARE or the authorised local Technical Service
ble to specify the data on the identification label
Warnings, cautions and note s
You are advised to carefully read the informa
the
(hereinafter called ventilator) and the relative safety regulations.
In order
understood.
In order to grant maximum reliability and to ensure t
original spare parts supplied or checked by SIARE.
accordance with the instructions given in this manual.
The ventilator must only be used by qualified per
operation of ventilator, it is required the presence of qualified personnel.
Regarding the
author
personnel.
The maintenance and the replacement o
spare parts or components checked by SIARE should be used.
Regarding the general safety of the electro-
important to follow all rules about the
and the patient, the operator and the nearby environment.
Centre; it is advisa
(model, serial number, ……) when requesting intervention.
Falco 101
V
SIARE recommends establishing a maintenance and service contract
with SIARE or the local authorised service dealer in order to guarantee
heduled maintenance required to operate the ventilator in a safe
To prevent the risk of fire, keep the ventilator and/or the oxygen tubes
away from matches, lit cigarettes and inflammable material, such as
Do not connect the ventilator to the patient by flexible connectors, and
antistatic or conductive tubes to prevent patient burnings during the use
of high frequency surgical equipment, specially dangerous with
ble connectors, antistatic or conductive
Do not use worn and consumed tubes or tubes contaminated by
flammable substances like grease or oil to deliver oxygen; (fabrics, oil
intensively burn in air with high
In the event of fire or an unpleasant smell (e.g. a smell of burning), the
ventilator should immediately be disconnected from the electrical power
ing into contact with any component of the ventilator, the
hospital procedures for the handling of infected material should always
SIARE is aware that cleaning, sterilisation and disinfection procedures
ture to another. SIARE cannot
be held responsible for the efficacy of the cleaning and sterilisation
procedures, nor for the other procedures carried out while the patient is
being treated. As regards cleaning, sterilisation and disinfection of the
components, it is therefore recommended that the regulations
currently in force in the country where the ventilator is installed be taken
The ventilator was not designed as a total monitoring device: some
atients treated with vital support
Before using the ventilator or any connected component, carefully
check that the ventilator is functioning correctly; when needed, the
in the present
Do not use pointed instruments, such as pencils, screwdrivers or the
like to make selections or settings as they could damage the surface
the sc
and correct manner.
anaesthetic gases and/or sources of heat.
antistatic tubes. The use of flexi
tube is never permitted with ventilator.
and other fuels can easy ignite and they
concentration of oxygen.
supply and from the battery (if fitted).
When com
be respected.
vary considerably from one health struc
product
into consideration.
conditions of danger for the p
equipment will not trigger any alarm.
preliminary tests must be performed as described
manual.
of the LCD panel.
VI User Manual, DU3111103
Check the ventilator periodically as described in the relative
ance” chapter and do not use it if it is faulty or malfunctioning.
Replace any broken, missing, obviously worn, deformed or
zed
by SIARE to the ventilator (example: scavenging systems, patient
simulators, etc…..), and not described in the present user’s manual: in
The correct functioning of the ventilator can be impaired if original
and accessories are not used; the use of other
accessories is however allowed only if formally authorised by SIARE
SIARE assumes all foreseen legal liability if the ventilator is used and
ned according to the instructions contained in this
manual: the Technical Assistance Report, drawn up and signed by the
authorised SIARE technician, is proof of the completion of the
safety valve which
allows to the patient to breathe spontaneously the ambient air even in
case of gas supply failure, the auxiliary ventilation system must be
always promptly available; such a component is part of SIARE
“Mainten
contaminated parts immediately, with spare parts supplied by SIARE.
Do not connect external devices NOT manufactured or NOT authori
case of need contact SIARE.
SIARE spare parts
in accordance with current safety regulations.
periodically maintai
scheduled maintenance.
Notwithstanding the ventilator is equipped with a
Engineering International Group s.r.l. products range.
Falco 101
VII
The ventilator is not approved for operation in places
Do not use the ventilator in the presence of flammable
Before starting the ventilator use, you have to carry out the
Before connecting the ventilator to other electrical
equipment not described in this manual, a request for
Qualified staff must make the regulation of ventilation
An auxiliary ventilation system is suggested for the patients
vailable (i.e.
manual resuscitation bag with mask) whenever the
WARNING !!
where there is any risk of explosion.
gases.
WARNING !!
The ventilator cannot be used in the presence of explosive
gases.
WARNING !!
preliminary checks.
WARNING !!
authorisation should be sent to Siare.
WARNING !!
parameters.
WARNING !!
for which the ventilator represents a life support.
WARNING !!
Means for independent ventilation shall be a
ventilator is in use.
VIII User Manual, DU3111103
SIARE declines all civil and penal responsibility in the
If the ventilator is used in conditions and for purposes
If periodic maintenance as foreseen by this manual has
If personnel not officially authorised by SIARE have
original SIARE spare parts or components not
If the ventilator has been connected to equipment not
Direct or indirect damage to persons or things caused
technical intervention or by improper
use of the ventilator not in accordance with the
instructions contained in the users and maintenance
Check the identification data label of the Falco 101 lung ventilator in the
The Directive 93/42EEC on medical devices foresees that the manufacturer
defines the shelf life of the device according to the intended purpose. The
1 is 10
following cases:
not stated or described in this manual.
If the ventilator is used by non-qualified personnel.
not been carried out correctly or has been skipped.
performed maintenance.
If non-
checked by SIARE have been used.
complying with the safety norms for the intended use.
by unauthorised
manual.
Year of manufacture
relative chapter.
Shelf life of medical device
shelf life foreseen by SIARE for the lung ventilator model Falco 10
years.
Manufacturer
SIARE Engineering International Group s.r.l.
Falco 101
IX
Via Giulio Pastore, 18 - 40056
Località Crespellano, 40053 Valsamoggia (BO), ITALY
Tel.: +39 051 969802 - Fax: +39 051 969366
E-mail: mail@siare.it
- web: www.siare.it
The Falco 101 lung ventilator is designed to operate in the specified
2 regulations
equipment. It is in any case highly recommended not to use
wered equipment or to
magnetic fields. Mobile
phones, cordless phones or other radio transmitters used in
the vicinity of the ventilator could influence its operation.
to such equipment, it will be required to supervise its
In general, as regards the regulations regarding
“electromagnetic emissions”, “electromagnetic immunity”
“recommended separation distances between portable
F equipment and the device”, always refer to
Requirements applicable to cables, transducers and other
accessories that could affect compliance with the
Electromagnetic Compatibility
electromagnetic environment (see warning below).
The customer or the user of Falco 101 lung ventilator should ensure that it
is used in such an electromagnetic environment.
The ventilator complies with the EN 60601-1on Electromagnetic Compatibility of electro-medical
the ventilator adjacent to high-po
units, which emit strong electro-
Whenever the ventilator should be necessarily used nearby
normal operation.
and
and mobile R
what is described in the ventilator manual.
requirements of 6.1 and 6.2
X User Manual, DU3111103
Table of contents
GENERAL INFORMATION .................................................................................................. III
Observations .................................................................................................................. IV
Definitions ...................................................................................................................... IV
Warnings, cautions and notes ......................................................................................... V
Year of manufacture ....................................................................................................... IX
Shelf life of medical device ............................................................................................. IX
Manufacturer .................................................................................................................. IX
Electromagnetic Comp a tibility ......................................................................................... X
Table of contents............................................................................................................ XI
1 INTRODUCTION ......................................................................................................... 1-1
1.1 Foreseen use ...................................................................................................... 1-1
1.2 Main innovations ................................................................................................. 1-2
1.2.1 Automatic compensation of all ventilation parameters ............................. 1-2
1.2.2 Falco 101: high performance home care ventilator .................................. 1-2
1.2.3 PEEP and leakages compensation .......................................................... 1-2
1.2.4 Display a LED a 5,6” e visualizzazioni grafiche ........................................ 1-2
1.2.5 Small and powerful .................................................................................. 1-2
1.2.6 Battery ..................................................................................................... 1-2
1.2.7 Turbine advantages ................................................................................. 1-2
1.3 Main technical characteristics ............................................................................. 1-3
1.3.1 Graphic user interface (GUI) .................................................................... 1-3
1.3.2 Electronics and driving ............................................................................. 1-3
1.3.3 Pneumatics .............................................................................................. 1-3
1.4 Correct operation ................................................................................................ 1-4
1.4.1 Use of Falco 101 ..................................................................................... 1-5
1.5 Norms and standards regulations........................................................................ 1-6
2 DESCRIPTION ............................................................................................................ 2-1
2.1 Side view ............................................................................................................ 2-3
2.2 Power supply area .............................................................................................. 2-4
2.3 Patient connections ............................................................................................. 2-5
Falco 101
XI
2.4 Keyboard with soft keys and encoder knob ......................................................... 2-6
2.4.1 Encoder knob : use .................................................................................. 2-6
2.4.2 Soft keys: use .......................................................................................... 2-7
2.5 5,6” LCD Display ................................................................................................. 2-8
2.5.1 Respiratory parameters monitoring .......................................................... 2-9
2.5.2 Selezione modo operativo ..................................................................... 2-12
2.5.3 Alarm signals area ................................................................................. 2-13
2.5.4 Pressure graphic display ....................................................................... 2-15
2.5.5 General informations ............................................................................. 2-16
2.6 MAIN MENU ..................................................................................................... 2-17
2.7 Product identification label ................................................................................ 2-19
3 PREPARATION FOR USE .......................................................................................... 3-1
3.1 General warnings ................................................................................................ 3-1
3.2 Before use .......................................................................................................... 3-3
3.2.1 Mounting the O2 sensor (optional) ........................................................... 3-3
3.2.2 Battery recharge ...................................................................................... 3-4
3.3 Preparation for use ............................................................................................. 3-5
3.3.1 Connection to power supply ..................................................................... 3-5
3.3.2 Protection fuses ....................................................................................... 3-7
3.3.3 Patient circuit conenction ......................................................................... 3-8
3.3.4 Use of antibacterial filters......................................................................... 3-9
3.3.5 Data Connection (Trend and Events downloading ) ................................. 3-9
3.3.6 Five wheels support ............................................................................... 3-10
3.3.7 Connection of other devices .................................................................. 3-11
3.4 Lung ventilator use ............................................................................................ 3-12
3.4.1 Highlights ............................................................................................... 3-12
3.5 Turn the lung ventilator OFF ............................................................................. 3-14
3.5.1 Ventilator switch-on / “ SELF TEST “ phase ........................................... 3-14
3.6 Turn the lung ventilator OFF ............................................................................. 3-18
3.7 Preliminary checks – Introduction ..................................................................... 3-19
3.7.1 Preliminary checks - Lung Ventilator ...................................................... 3-20
3.7.2 Preliminary checks - Parameters monitoring .......................................... 3-22
3.7.3 Preliminary checks – Alarms .................................................................. 3-23
3.7.4 Alarms check ......................................................................................... 3-24
3.7.5 Conclusions ........................................................................................... 3-26
3.8 List of preliminary checks .................................................................................. 3-27
XII User Manual, DU3111103
4 LUNG VENTILATOR USE ........................................................................................... 4-1
4.1 General warnings ................................................................................................ 4-1
4.2 STAND-BY mode ................................................................................................ 4-2
4.2.1 “ SELF TEST “ phase .............................................................................. 4-2
4.2.2 Keyboard with soft key and encoder knob use ......................................... 4-4
4.3 Setting up the MENU language ........................................................................... 4-4
4.3.1 SETUP screen parameters editing procedure .......................................... 4-5
4.4 Setting the PATIENT DATA ................................................................................ 4-6
4.4.1 Procedure for setting the PATIENT DATA ............................................... 4-7
4.5 Erasing the PATIENT DATA ............................................................................... 4-9
4.6 Setting up the ALARMS .................................................................................... 4-10
4.7 Operating modes and PRP parameters............................................................. 4-11
4.7.1 Operating mode and PRP parameters editing procedure ....................... 4-11
4.7.2 Operative modes with expiratory valve enabled ..................................... 4-12
4.7.3 Operative modes with the whisper system (leak system) ....................... 4-23
4.7.4 Physiological respiratory parameters ( PRP )......................................... 4-25
4.8 Ventilation phase .............................................................................................. 4-27
4.8.1 Ventilation interruption ........................................................................... 4-29
4.9 Graphical settings and operating functions ........................................................ 4-30
4.9.1 MAIN MENU .......................................................................................... 4-32
4.9.2 MENU PRINCIPALE - SETUP ............................................................... 4-32
4.9.3 MENU PRINCIPALE - ALLARMI ............................................................ 4-32
4.9.4 MAIN MENU – TRENDS........................................................................ 4-33
4.9.5 MAIN MENU – EVENTS ........................................................................ 4-36
4.9.6 MAIN MENU - PATIENT DATA.............................................................. 4-38
4.9.7 MAIN MENU - PATIENT DATA ERASE ................................................. 4-38
4.9.8 MAIN MENU - DEFAULT PARAMETERS ............................................. 4-38
4.9.9 MAIN MENU – CLOSE .......................................................................... 4-39
4.10 MAIN MENU – SETUP .......................................................................... 4-40
4.10.1 Impostazioni di SETUP in MENU PRINCIPALE ..................................... 4-41
4.11 CALIBRATRION PROGRAMS .......................................................................... 4-43
4.11.1 Preliminary ............................................................................................ 4-43
Falco 101
4.11.2 Turbine characterization ........................................................................ 4-44
4.11.3 Inspiration flow sensor calibration .......................................................... 4-45
XIII
5 ALARMS ..................................................................................................................... 5-1
5.1 Displaying and used symbols .............................................................................. 5-2
5.1.1 Alarms display area ................................................................................. 5-2
5.1.2 A1 - Alarm area ....................................................................................... 5-3
5.1.3 A2 - MAIN MENU / ALARMS parameters ................................................ 5-5
5.1.4 A3 - General information area .................................................................. 5-6
5.1.5 A4 - Acoustic alarm silencin g ................................................................... 5-7
5.2 Alarms setting ..................................................................................................... 5-8
5.2.1 Setting of ALARMS limits values .............................................................. 5-8
5.2.2 Setting of ALARMS volume ................................................................... 5-10
5.2.3 Setting of DEFAULT values ................................................................... 5-12
5.3 Troubleshooting ................................................................................................ 5-13
5.3.1 Troubleshooting list................................................................................ 5-13
6 MAINTENANCE .......................................................................................................... 6-1
6.1 Cleaning, disinfection and sterilization ................................................................ 6-2
6.2 General indications ............................................................................................. 6-3
6.2.1 Cleaning .................................................................................................. 6-3
6.2.2 Disinfection and sterilization .................................................................... 6-3
6.2.3 Disinfection by immers ion ( c h emic a l) ....................................................... 6-4
6.2.4 Cleaning, disinfection and sterilization table ............................................ 6-5
6.2.5 Periodic maintenance .............................................................................. 6-7
6.2.6 Maintenance operations .......................................................................... 6-7
6.2.7 Cleaning, disinfection and sterilization before use with another patient .... 6-9
6.3 Repairs and spare parts .................................................................................... 6-10
6.3.1 Spare parts kit for lung ventilator ........................................................... 6-10
6.4 Storage ............................................................................................................. 6-10
6.5 Repackaging and shipment ............................................................................... 6-10
6.6 Disposal ............................................................................................................ 6-11
XIV User Manual, DU3111103
A ANNEX ....................................................................................................................... A-1
A.1 Technical sheet ................................................................................................... A-1
A.2 Preliminary checks .............................................................................................. A-7
A.3 Glossary.............................................................................................................. A-9
A.4 EMC tables - Guidance and manufacturer’s declaration .................................... A-13
A.4.1 Table 1 .................................................................................................. A-13
A.4.2 Table 2 .................................................................................................. A-14
A.4.3 Table 3 .................................................................................................. A-15
A.4.4 Table 4 .................................................................................................. A-16
Falco 101
XV
This page has been left blank intentionally to make front / back copying easier.
XVI User Manual, DU3111103
1 INTRODUCTION
SIARE Engineering International Group s.r.l. is glad to introduce this new product, result of
40 years of experience and investment in technological innovation that we are
implementing in recent years.
SIARE Engineering International Group s.r.l. has focused heavily on innovation of
materials, ergonomics and ease of use of its equipment. All routine operat ions have been
simplified and the operational procedures are “foolproof”, in this way there is no margin for
the user to make incorrect or inadequate manoeuvres.
The new Falco 101 lung ventilator is very different from all the previous versions and it has
been conceived for the using in Intensive Care, Emergency and Transport. Even the
maintenance procedures have been simplified and the parts subject to wear or deterioration
have substantially decreased.
1.1 Foreseen use
The Falco 101 is a lung ventilator equipped with an innovative pneumatic system including
a turbine with differential cooler which grant a longer duration and a higher precision in the
delivery of gas mixture.
The Falco 101 can be used on Adult, Paediatric; it has been conceived for home care and
transport use.
The Falco 101 includes new advanced functionalities that help you manage the operating
modes and the various patient ventilation functions; the keyboard and the encoder knob
simplify the settings and the operations significantly.
The present manual explains how to use the Falco 101 lung ventilator
system and how performing some simple maintenance procedures.
SIARE recommends to read carefully the present manual and its relevant
instructions before using the ventilator or proceeding to maintenance.
WARNING !!
Please read the recommendations and the instructions herein in order to
ensure a correct and safe use of Falco 101 both for the clinician and for
the patient.
The Falco 101 must be used only for the purposes mentioned below and
in the manner described herein, therefore the clinician must thoroughly
follow these instructions for use.
Falco 101
1-1
1.2 Main innovations
The new 2nd generation of lung ventilators Falco 101 combines aesthetic and reliability in an
ergonomic structure which permit to the device to be easy to use and easy to understand.
1.2.1 Automatic compensation of all ventilation parameters
Automatic compensation of all measured and supplied ventilation parameters, with no
need of operator intervention.
The new design is based on a dedicated microprocessor only for flow compensation:
that guarantees an outstanding precision and response time, breath by breath.
1.2.2 Falco 101: high performance home care ventilator
The same functions necessary in IGU, now available in a portable ventilator.
It includes both pressure and flow trigger.
It includes the most modern ventilation modes: PCV, APCV, PSV, PSV-Tv, P-SIMV
(with expiratory valve) and CPAP, BILEVEL ST (whisper system with “leakage”).
Adult, paediatric ventilation.
1.2.3 PEEP and leak ag es c o mp en sati on
PEEP up to 50 cmH2O with high precision and stability.
Flow-by with automatic leaks compensation up to 60 l/min.
Ventilation “with leakage” with whisper together with facial mask.
1.2.4 5,6” LED Display and graphic visualization
High resolution display with user friendly graphic interface
Pressure graphic visualization
Leakage value in percentage (Leak: %).
1.2.5 Small and powerful
Dimensions, 290 x 245 x 215 mm (W x H x D) and light weight 5.5 Kg.
These special features permit to the Falco 101 to be handy and easy to use in small
spaces even during transport.
1.2.6 Battery
Thanks to Ni-Mh 12Vdc / 4.2Ah internal battery it has been possible to have a battery
autonomy of about 4 hours.
The battery is easily removable for service operations.
1.2.7 Turbine advantages
The air is generated by the internal turbine, so no external air sources are requested to
power the ventilator.
1-2 User Manual, DU3111103
1.3 Main technical characteristics
1.3.1 Graphic user interface (GUI)
The graphic user interface (GUI) includes: a led 9” display, a membrane keyboard and one
encoder. The display shows the measured ventilation parameters, pressure, flow, volume
curves, loops and trends; moreover it shows the ventilation parameters and the leak
percentage value (leak: %).
The user has the possibility to set all the functions available on the GUI using the keyboard
and the encoder present on the front panel of the device.
The graphic interface includes a screen divided in areas where it shows:
the operatives mode
the alarm messages and signals
the monitoring of physiological breathing parameters
Pressure graphic and leakages (%)
the function MENU for setting operation parameters
the special functions
the visualization of clock, date, time functions and software version.
1.3.2 Electronics and driving
The electronic of the lung ventilator is developed on a single main board; this board handles
all the information received by the connected devices (the graphic interface settings,
sensors, turbine and monitor interface) and consequently set the ventilation.
The lung ventilator is equipped with a battery charger board which handle the charging of
the internal Ni-Mh battery and with an internal power supply module (feeder) which takes
care of the alarms relevant to the main power supply absence and/or discharged battery.
1.3.3 Pneumatics
The pneumatic part of the lung ventilator consists of various internal pneumatic circuits as
well as actuators designed to control the flow and the pressure of the medical gases. The
lung ventilator does not need to be connected to any medical gas distribution sources or to
devices that supply compressed air since this is done independently by an internal turbine.
The lung ventilator is able to deliver Air/Oxygen mixtures as it could be connected to an
external Oxygen source (please, refer to chapter n. 2).
Falco 101
1-3
1.4 Correct operation
medical gas distribution system at low pressure must be effected
For correct and complete operation, the Falco 101 must be:
correctly connected to the patient circuit;
connected to a mains power supply with the same voltage as specified on the
identification plate (or supplied by internal battery);
correctly connected to all accessories and equipment necessary for the operation of the
lung ventilator;
if requested, connected O
2 inlet at low pressure.
The connections with main power supply, as well as connections with
according to the indications contained in the present user’s manual (see
on chapter 2).
The Falco 101 incorporates a series of sensors for continuous patient monitoring, the most
important of which are:
the inspiration line flow sensor (internal) measures the volumes set for the patient.
the pressure sensors (internal), used to control the pressure of the airways or of the
medical gases;
the oxygen sensor (external-optional), used to measure the concentration of oxygen in
the gas inspired by the patient.
1-4 User Manual, DU3111103
To ensure the best performance of the lung ventilator periodic
maintenance of the unit by qualified technical personnel is
recommended. For further information, contact SIARE Engineering
SIARE Engineering International Group s.r.l. recommends careful
Before using the lung ventilator, the clinician should check the operation
of all these sensors in order to avoid any incorrect assessments of
patient's condition
WARNING !!
Before using the lung ventilator on a patient it is necessary to perform a
series of preliminary checking to verify the correct operation of the
equipment.
The preliminary checking has the aim to verify the correct connections
and functionalities of the ventilator and all its parts.
For its employ the Falco 101 has been designed and made to guarantee
full quality of the product and its components, in order to ensure the
maximum reliability of the lung ventilator for the patient and user safety
International Group s.r.l.
reading of this manual and the relative labels before operating the lung
ventilator or carrying out any maintenance.
1.4.1 Use of Falco 101
The use of Falco 101 lung ventilator is simple and intuitive for the persons familiarised with
resuscitation ventilators, a short training course is in enough to learn how to use it.
A basic user interface: keyboard, encoder knob and a 9” display that simplifies the selection
of the most suitable settings.
The 9” screen displays the ventilator settings and the measured data, as well as several
functions, allowing the clinician to asses patient's condition immediately; you can also
select and view the trend of the pressure, flow, volume, flow/volume loops,
pressure/volume, pressure/flow, over time.
An immediate information management system, allows the clinician to set the alarms,
collect data concerning the trend of the operating parameters (TREND) and the ventilator
EVENTS log using the MENU.
The same system allows the operator to set the patient type (neonates, children, adults),
load or erase the PATIENT DATA and in case of needs, load automatically the DEFAULT
PARAMETERS of the lung ventilator.
For those who already have the basic knowledge on the functioni ng of lung ventilators, t he
use of the Falco 101 lung ventilator is simple and intuitive and for its learning a short
Falco 101
training course is sufficient.
1-5
1.5 Norms and standards regulations
The Falco 101 lung ventilator is made in accordance with the following norms (and following
updates) and it is manufactured according to UNI EN ISO 13485:2004 standards.
EN 60601-1:2006/ A1:2011/ A1:2013
Medical electrical equipment - Part 1: General requirements for
safety.
EN 60601-1-2:2015 Medical electrical equipment. General requirements for basic
safety and essential performance. Collateral Standard.
Electromagnetic disturbances. Requirements and tests.
IEC 601-1-6:2013 Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral
standard: Usability.
IEC 601-1-8:2012 Medical electrical equipment - Part 1-8: General requirements
for basic safety and essential performance - Collateral
Standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical
systems.
EN 62304:2006/AC:2008 Medical device software - Software life cycle processes.
ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation
and testing within a risk management process.
IEC 62353:2014 Medical electrical equipm ent – Recurrent test and test after
repair of medical electrical equipment.
ISO 15223-1:2016 Medical devices – Symbols to be used with medical device
labels, labelling and information to be supplied – Part 1:
General requirements
ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary
EN 60601-1-11:2015 Medical electrical equipment – Part 1-11: G eneral requirements
for basic safety and essential performance – Collateral
standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare
environment.
ISO 14971:2012 Medical devices. Application of risk management to medical
devices
DIR. 2011/65/CE RoHS Directive (on the restriction of the use of certain
hazardous substances in electrical and electronic equipment).
D.Lgs 49/2014 RAEE Directive ( I mplementation of the 2012/19/UE Directive on
waste electrical and electronic equipment).
1-6 User Manual, DU3111103
2 DESCRIPTION
This section of the user manual features the main parts and components of the Falco 101
lung ventilator for Intensive Care, Emergency and Transport (hereinafter called ventilator)
and some of its most used functionalities.
Falco 101: front view ( code 980111 )
With regard to the assembly, the interface and the servicing operations,
please refer to the relative chapter or contact Siare technical support
service.
All figures and examples featured in this chapter are purely informative and
do not refer to real clinical cases.
Falco 101
2-1
Falco 101 – rear view
see. 2.1 Side view
see. 2.2 Power supply area
see. 2.3 Patient connection
SEE. 2.4
Keyboard with soft keys and encoder knob
see. 2.5 5,7” LCD Display
see. 2.6 Main Menu
For more information please refer to the paragraphs highlighted on the
side.
2-2 User Manual, DU3111103
2.1 Side view
11
12
21
Electric power supply (please, refer to next paragraph)
AIR FILTER : turbine air filter
O2 connection (see next chapter)
Air intake
RS-232 connector ( ODU connector ) : Trend and Events downloading
Falco 101
2-3
2.2 Power supply area
22 FUSE 10 AT : safety fuse for battery power circuit (1 x 10 AT)
23
12 VDC IN (7 A) : connector for external 12 Vdc 7A power supply
The external supply voltage can be provided trough a battery or a
supply source having the characteristics specified above.
An external battery used as power source for the functioning of the
Falco 101 become integral part of this medical system.
I / O : ventilator supply switch
24
FUSE 2 x 1AT : safety fuses for 220 Vac power supply circuits
100-240VAC 50-60Hz 60VA : plug for mains power supply connection
12
Air intake
2.3 Patient connections
2-4 User Manual, DU3111103
32 O2 SENSOR : mechanical guard for O2 sensor electrical connection (optional)
33 V.EXP (OPTION) : EXP valve command connector (used with expiratory valve
built-in circuit)
28 O2 (LOW PRESSURE) : Gas inlet to connect low pressure medical oxygen
WARNING !!
LOW PRESSURE : medical oxygen low pressure connection, max.
flow 15 l/min.
35
Patient circuit connector: supplied with unidirectional valve for the using of a
circuit with expiratory valve, supplied without unidirectional valve for the using of a
whisper “leak” system.
36
Falco 101
2-5
Transport handle
2.4 Keyboard with soft keys and encoder knob
.
k and easy use of the Falco 101 lung ventilator (referred to
A control keyboard and an encoder knob are available on the upper side of the ventilator
These components allow quic
from now on as ventilator).
2.4.1 Encoder knob : use
ENCODER KNOB
The encoder knob is a multifunctional tool: it is used for selecting
and editing all ventilator functions.
Turn clockwise or anti-clockwise to select the desired box (item) :
e.g. MENU (changes color).
Press the knob to confirm (the box MENU changes color); you will
see the MAIN MENU page at SETUP option.
2-6 User Manual, DU3111103
SETUP function activated (box in
different color).
Press the knob; you will see the
SETUP parameters page at the
LANGUAGE item.
LANGUAGE function activated (box
in different color).
Turn clockwise or anti-clockwise to
select the desired box (item) : e.g.
SOUND VOLUME (the box changes
color).
After the choice of the parameter (or the value to modify), if you do not
push the knob within 10 sec., the ventilator set again the previous value (to
be modified).
To modify other parameters: turn the knob clockwise or anti-clockwise.
Press the ESC membrane button to go in the STAND-BY screen.
Falco 101
2-7
2.4.2 Soft keys: use
ALARM RESET
Press this key to silence the acoustic warning of an active alarm.
After removing the alarm cause, press this key once again to cancel the
visual warning displayed on the screen.
ESC
Press this key to exit the “current” screen and return to the “previous”
one.
START - ENTER
Press this key to start the ventilation in the pre-set mode, using the
physiological respiratory parameters set by the clinician.
ON/OFF
Press the ON/OFF key to start and stop the ventilator. To access the
ventilator, press the ON/OFF key. After a few seconds, on the screen
will appear a series of messages indicating that the system entered the
“SELF-TEST” mode ; this phase will take a few minutes.
At the end of this procedure, push START to begin, the system goes to
STAND-BY mode, ready to ventilate the patient. To turn the ventilator
off, hold the ON/OFF key for few seconds and then confirm the action.
The system features a turn off delay that helps you prevent
any accidental ventilator deactivation during operation.
Mains voltage presence indicator
If the led is on (green color), it means that the lung ventilator is powered
from the mains.
2-8 User Manual, DU3111103
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