Siare Falco 101 User manual

Falco 101
Lung ventilator
turbine-driven ventilation
User manual

Falco 101 III
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

IV User Manual, DU3111103
Observations
SIARE Engineering International Group s.r.l. wishes to thank you for
purchasing one of its products.
Any comment on the accuracy and usefulness of this User’s Manual would be
very helpful in allowing us to guarantee current and future users
of the high
quality level of our manuals. We would be grateful if you would send us your
comments (see address at page IX).
The SIARE trademark is used throughout this manual as an abbreviation for
the manufacturer: SIARE Engineering International Group s.r.l.
Directive 93/42 EEC
Definitions
Three symbols are used in this User’s Manual to indicate particularly important
information.
WARNING !!
This indicates a condition of danger for the patient or for the
operator.
CAUTION
This indicates the possibility of danger to the ventilator.
NOTE
This indicates information worthy of note, making the
operation of the Falco 101 lung ventilator more efficient or
practical.

Falco 101 V
Warnings, cautions and notes
You are advised to carefully read the informa
tion given alongside the three
symbols shown on the previous page, since it contains considerations on
the
safety, the special requirements for the use Falco 101 lung ventilator
(hereinafter called ventilator) and the relative safety regulations.
In order
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
understood.
In order to grant maximum reliability and to ensure t
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
original spare parts supplied or checked by SIARE.

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
accordance with the instructions given in this manual.
The ventilator must only be used by qualified per
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
operation of ventilator, it is required the presence of qualified personnel.
Regarding 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
author
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
personnel.
The maintenance and the replacement o
f any part have to be
performed by authorized service personnel and only original SIARE
spare parts or components checked by SIARE should be used.
Regarding the general safety of the electro-
medical equipment, it is
important to follow all rules about the
interaction between the machine
and the patient, the operator and the nearby environment.

For any repairs to ventilator (due to malfunctioning, defects or failures),
the user must contact SIARE or the authorised local Technical Service
Centre; it is advisa
ble to specify the data on the identification label
(model, serial number, ……) when requesting intervention.

VI User Manual, DU3111103

SIARE recommends establishing a maintenance and service contract
with SIARE or the local authorised service dealer in order to guarantee
the sc
heduled maintenance required to operate the ventilator in a safe
and correct manner.

To prevent the risk of fire, keep the ventilator and/or the oxygen tubes
away from matches, lit cigarettes and inflammable material, such as
anaesthetic gases and/or sources of heat.

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
antistatic tubes. The use of flexi
ble connectors, antistatic or conductive
tube is never permitted with ventilator.

Do not use worn and consumed tubes or tubes contaminated by
flammable substances like grease or oil to deliver oxygen; (fabrics, oil
and other fuels can easy ignite and they
intensively burn in air with high
concentration of oxygen.

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
supply and from the battery (if fitted).
When com
ing into contact with any component of the ventilator, the
hospital procedures for the handling of infected material should always
be respected.

SIARE is aware that cleaning, sterilisation and disinfection procedures
vary considerably from one health struc
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
product
components, it is therefore recommended that the regulations
currently in force in the country where the ventilator is installed be taken
into consideration.

The ventilator was not designed as a total monitoring device: some
conditions of danger for the p
atients treated with vital support
equipment will not trigger any alarm.

Before using the ventilator or any connected component, carefully
check that the ventilator is functioning correctly; when needed, the
preliminary tests must be performed as described
in the present
manual.

Do not use pointed instruments, such as pencils, screwdrivers or the
like to make selections or settings as they could damage the surface
of the LCD panel.

Falco 101 VII

Check the ventilator periodically as described in the relative
“Mainten
ance” chapter and do not use it if it is faulty or malfunctioning.
Replace any broken, missing, obviously worn, deformed or
contaminated parts immediately, with spare parts supplied by SIARE.
Do not connect external devices NOT manufactured or NOT authori
zed
by SIARE to the ventilator (example: scavenging systems, patient
simulators, etc…..), and not described in the present user’s manual: in
case of need contact SIARE.

The correct functioning of the ventilator can be impaired if original
SIARE spare parts
and accessories are not used; the use of other
accessories is however allowed only if formally authorised by SIARE
in accordance with current safety regulations.

SIARE assumes all foreseen legal liability if the ventilator is used and
periodically maintai
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
scheduled maintenance.
Notwithstanding the ventilator is equipped with a
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
Engineering International Group s.r.l. products range.

VIII User Manual, DU3111103
WARNING !!

The ventilator is not approved for operation in places
where there is any risk of explosion.

Do not use the ventilator in the presence of flammable
gases.
WARNING !!
The ventilator cannot be used in the presence of explosive
gases.
WARNING !!
Before starting the ventilator use, you have to carry out the
preliminary checks.
WARNING !!
Before connecting the ventilator to other electrical
equipment not described in this manual, a request for
authorisation should be sent to Siare.
WARNING !!
Qualified staff must make the regulation of ventilation
parameters.
WARNING !!
An auxiliary ventilation system is suggested for the patients
for which the ventilator represents a life support.
WARNING !!
Means for independent ventilation shall be a
vailable (i.e.
manual resuscitation bag with mask) whenever the
ventilator is in use.

Falco 101 IX
SIARE declines all civil and penal responsibility in the
following cases:

If the ventilator is used in conditions and for purposes
not stated or described in this manual.
If the ventilator is used by non-qualified personnel.

If periodic maintenance as foreseen by this manual has
not been carried out correctly or has been skipped.

If personnel not officially authorised by SIARE have
performed maintenance.
If non-
original SIARE spare parts or components not
checked by SIARE have been used.

If the ventilator has been connected to equipment not
complying with the safety norms for the intended use.

Direct or indirect damage to persons or things caused
by unauthorised
technical intervention or by improper
use of the ventilator not in accordance with the
instructions contained in the users and maintenance
manual.
Year of manufacture
Check the identification data label of the Falco 101 lung ventilator in the
relative chapter.
Shelf life of medical device
The Directive 93/42EEC on medical devices foresees that the manufacturer
defines the shelf life of the device according to the intended purpose. The
shelf life foreseen by SIARE for the lung ventilator model Falco 10
1 is 10
years.
Manufacturer
SIARE Engineering International Group s.r.l.
Via Giulio Pastore, 18 - 40056
Località Crespellano, 40053 Valsamoggia (BO), ITALY
Tel.: [phone] - Fax: [phone]
E-mail: [e-mail] - web: www.siare.it

X User Manual, DU3111103
Electromagnetic Compatibility
The Falco 101 lung ventilator is designed to operate in the specified
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 60601-1-
2 regulations
on Electromagnetic Compatibility of electro-medical
equipment. It is in any case highly recommended not to use
the ventilator adjacent to high-po
wered equipment or to
units, which emit strong electro-
magnetic fields. Mobile
phones, cordless phones or other radio transmitters used in
the vicinity of the ventilator could influence its operation.
Whenever the ventilator should be necessarily used nearby
to such equipment, it will be required to supervise its
normal operation.
In general, as regards the regulations regarding
“electromagnetic emissions”, “electromagnetic immunity”
and
“recommended separation distances between portable
and mobile R
F equipment and the device”, always refer to
what is described in the ventilator manual.
Requirements applicable to cables, transducers and other
accessories that could affect compliance with the
requirements of 6.1 and 6.2

Falco 101 XI
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 Compatibility.........................................................................................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

XII User Manual, DU3111103
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

Falco 101 XIII
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
4.11.2 Turbine characterization ........................................................................4-44
4.11.3 Inspiration flow sensor calibration..........................................................4-45

XIV User Manual, DU3111103
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 silencing...................................................................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 immersion (chemical).......................................................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

Falco 101 XV
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

XVI User Manual, DU3111103
This page has been left blank intentionally to make front / back copying easier.

Falco 101 1-1
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 operations 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.

1-2 User Manual, DU3111103
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 leakages compensation
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.

Falco 101 1-3
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).

1-4 User Manual, DU3111103
1.4 Correct operation
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 O2 inlet at low pressure.
The connections with main power supply, as well as connections with
medical gas distribution system at low pressure must be effected
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.