Siaretron4000 960501 UE Rev1

Siaretron 4000 - 15”
ICU Lung Ventilator

Touch-screen
User’s 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 Siaretron 4000 15” lung ventilator must be
entrusted to qualified technical personnel only. The responsibility of SIARE
Engineering International Group s.r.l. concerning the Siaretron 4000 15” 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 Siaretron
4000 15” lung ventilator produced or updated after January 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 DU3501101

Revision 1 - 10.01.2019
Siaretron4000e - 15 III
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 lung ventilator.
NOTE
This indicates information worthy of note, making the
operation of the Siaretron 4000 15” lung ventilator more
efficient or practical.
IV User manual, DU3501101

Warnings, cautions and notes
You are advised to carefully read the information given alongside the three
symbols shown on the previous page, since it contains considerations on
the safety, the special requirements for the use Siaretron 4000 15” lung
ventilator (hereinafter called lung ventilator) and the relative safety
regulations.
 In order to understand how the lung 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 the patient and
operator’s safety, the lung 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 lung ventilator must only be used for the purposes specified herein
and the safety of the lung ventilator is therefore only guaranteed if it is
used in accordance with the instructions given in this manual.
 The lung ventilator must only be used by qualified personnel and only in
equipped and dedicated rooms, according to the regulations in force in
the country where the lung ventilator is installed. Furthermore, during all
the operation of lung 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 lung ventilator or
authorised modifications to the lung 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 of 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 lung ventilator (due to malfunctioning, defects or
failures), the user must contact SIARE or the authorised local Technical
Service Centre; it is advisable to specify the data on the identification
label (model, serial number, ……) when requesting intervention.
Siaretron4000e - 15 V
 SIARE recommends establishing a maintenance and service contract
with SIARE or the local authorised service dealer in order to guarantee
the scheduled maintenance required to operate the lung ventilator in a
safe and correct manner.
 To prevent the risk of fire, keep the lung 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 lung ventilator to the patient by flexible connectors,
and antistatic or conductive tubes to prevent patient burnings during the
use of high frequency surgical equipment, especially dangerous with
antistatic tubes. The use of flexible connectors, antistatic or conductive
tube is never permitted with lung 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 easily 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
lung ventilator should immediately be disconnected from the electrical
power supply and from the battery (if fitted).
 When coming into contact with any component of the lung 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 structure 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 lung ventilator is installed be
taken into consideration.
 The lung ventilator was not designed as a total monitoring device: some
conditions of danger for the patients treated with vital support
equipment will not trigger any alarm.
 Before using the lung ventilator or any connected component, carefully
check that the lung 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.
VI User manual, DU3501101

 Check the lung ventilator periodically as described in the relative
“Maintenance” 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 authorized
by SIARE to the lung 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 lung 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 lung ventilator is used
and periodically maintained 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 lung 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.
Siaretron4000e - 15 VII
WARNING !!
 The lung ventilator is not approved for operation in places
where there is any risk of explosion.
 Do not use the lung ventilator in the presence of flammable
gases.
 The lung ventilator cannot be used in the presence of
explosive gases.
WARNING !!
 The lung ventilator shall not be used in a hyperbaric
chamber.
 The lung ventilator shall not be used with nitric oxide.
 The lung ventilator shall not be used with helium or mixtures
with helium.
WARNING !!
Before starting the lung ventilator use, you have to carry out the
preliminary checks.
WARNING !!
Before connecting the lung 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 !!
Do not block the gas intake port or emergency intake port,
thereby interfering with PATIENT ventilation.
WARNING !!
Means for independent ventilation system shall be available (i.e.
manual resuscitation bag with mask) whenever the lung
ventilator is in use.
VIII User manual, DU3501101

SIARE declines all civil and penal responsibility in the
following cases:
 If the lung ventilator is used in conditions and for
purposes not stated or described in this manual.
 If the lung 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 lung 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 lung ventilator not in accordance with the
instructions contained in the users and maintenance
manual.
Year of manufacture
Check the identification data label of the Siaretron 4000 15” 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 Siaretron 4000
15” is 10 years.
Manufacturer
SIARE Engineering International Group s.r.l.
Via Giulio Pastore, 18 - 40056
Località Crespellano, 40053 Valsamoggia (BO), ITALY
Tel.: +39 051 969802 - Fax: +39 051 969366
E-mail: [email protected] - Web: www.siare.it
Siaretron4000e - 15 IX
Electromagnetic Compatibility
The Siaretron 4000 15” lung ventilator is designed to operate in the
specified electromagnetic environment (see warning below).
The customer or the user of Siaretron 4000 15” lung ventilator should
ensure that it is used in such an electromagnetic environment.
The lung 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 lung ventilator adjacent to high-powered
equipment or to units, which emit strong electro-magnetic
fields. Mobile phones, cordless phones or other radio
transmitters used in the vicinity of the lung ventilator could
influence its operation. Whenever the lung 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 RF equipment and the device”, always refer to
what is described in the lung ventilator manual.
Requirements applicable to cables, transducers and other

accessories that could affect compliance with the
requirements of 6.1 and 6.2
X User manual, DU3501101

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 Presentation.......................................................................................................... 1-1
1.1.1 Main technical characteristics ................................................................................ 1-2
1.1.2 Foreseen use ......................................................................................................... 1-2
1.2 Correct operation .................................................................................................. 1-3
1.3 Norms and standards regulations ......................................................................... 1-5
2 DESCRIPTION .............................................................................................................. 2-1

2.1 Overall view .......................................................................................................... 2-2
2.2 Front view ............................................................................................................. 2-3
2.3 Lung ventilator front view ...................................................................................... 2-4
2.3.1 Electric connections side ....................................................................................... 2-6
2.3.2 Gas supply side ..................................................................................................... 2-8
2.4 15’’ LED display – Touch screen .......................................................................... 2-9
2.4.1 Touch screen ....................................................................................................... 2-10
2.4.2 Keyboard with soft key and encoder knob ........................................................... 2-14
2.4.3 Operative mode ................................................................................................... 2-16
2.4.4 Patient Data ......................................................................................................... 2-18
2.4.5 PRP - Respiratory Parameters: visualization and modification ........................... 2-19
2.4.6 PRP list ................................................................................................................ 2-20
2.4.7 Monitoring of respiratory parameters ................................................................... 2-22
2.4.8 Additional respiratory parameters ........................................................................ 2-24
2.4.9 Alarm visualization ............................................................................................... 2-27
2.4.10 Measures, charts and loops ................................................................................. 2-28
2.4.11 Loops area: lung status ....................................................................................... 2-29
2.4.12 Graphic setting, operative functions and general informations ........................... 2-30
2.5 Rear view ............................................................................................................ 2-32
2.6 Product identification label .................................................................................. 2-33
Siaretron4000e - 15 XI
3 PREPARATION TO USE .............................................................................................. 3-1
3.1 Notes .................................................................................................................... 3-2
3.2 Before the use ...................................................................................................... 3-4
3.2.1 Assembling of O2 cell ............................................................................................ 3-4
3.2.2 Battery charger ...................................................................................................... 3-5
3.3 Preparation to use ................................................................................................ 3-7
3.3.1 Medical gas connection ......................................................................................... 3-7
3.3.2 Connection of medical gas supply from cylinder ................................................... 3-8
3.3.3 Mains power supply ............................................................................................... 3-9
3.3.4 External 12Vdc power supply .............................................................................. 3-12
3.3.5 Protection fuses ................................................................................................... 3-13
3.3.6 Patient circuit supporting arm .............................................................................. 3-14
3.3.7 Patient circuit connections ................................................................................... 3-14
3.3.8 Use of antibacterial filter ...................................................................................... 3-15
3.3.9 Gas analyzer connection ( Gas Sensor ) ............................................................. 3-16
3.3.10 Data connection (Trend and Events downloading )............................................. 3-17
3.3.11 Nebulizer connection ........................................................................................... 3-18
3.3.12 Humidifier connection .......................................................................................... 3-18
3.3.13 Connection to other equipments .......................................................................... 3-20
3.4 List of predisposition sequence for use .............................................................. 3-21
3.5 Use ..................................................................................................................... 3-22
3.5.1 Preliminary tests .................................................................................................. 3-22
3.5.2 Ventilator switch ON / Self Test phase ................................................................ 3-24
3.5.3 Turn the lung ventilator OFF ................................................................................ 3-28
3.6 Preliminary checks - Introduction........................................................................ 3-29
3.7 Preliminary checks - Supplementary Tests ........................................................ 3-30
3.7.1 Leak Test ............................................................................................................. 3-31
3.7.2 Respiratory Flow Sensors Calibration ................................................................. 3-34
3.7.3 O2 Sensor calibration .......................................................................................... 3-35
3.7.4 Exit from Supplementary Tests............................................................................ 3-38
3.8 Preliminary checks - Lung Ventilator .................................................................. 3-39
3.8.1 Preliminary checks – MONITORING PARAMETERS ......................................... 3-41
3.8.2 Preliminary checks – ALARMS ............................................................................ 3-43
3.8.3 Alarm limits check ................................................................................................ 3-44
3.8.4 Conclusions ......................................................................................................... 3-48
3.9 Preliminary checks sequence list........................................................................ 3-49
XII User manual, DU3501101

4 LUNG VENTILATOR USE ............................................................................................ 4-1
4.1 General notes ....................................................................................................... 4-3
4.2 Stand-by mode ..................................................................................................... 4-4
4.3 PATIENT DATA / SETUP parameters .................................................................. 4-6
4.3.1 PATIENT DATA ..................................................................................................... 4-6
4.3.2 SETUP parameters ................................................................................................ 4-9
4.4 Setting up the UGI language .............................................................................. 4-13
4.4.1 Mode 1 ................................................................................................................. 4-13
4.4.2 Mode 2 ................................................................................................................. 4-15
4.5 Setting the PATIENT DATA ................................................................................ 4-17
4.5.1 Mode 2 ................................................................................................................. 4-17
4.5.2 Erasing the PATIENT DATA ................................................................................ 4-19
4.6 Setting up the ALARMS ...................................................................................... 4-21
4.7 Operative modes ................................................................................................ 4-22
4.7.1 Operative Modes setting procedure..................................................................... 4-22
4.7.2 APCV ( NIV APCV ) ............................................................................................. 4-26
4.7.3 APCV-TV ............................................................................................................. 4-28
4.7.4 PSV ( NIV PSV ) .................................................................................................. 4-30
4.7.5 PSV-TV ................................................................................................................ 4-32
4.7.6 VC-VAC ............................................................................................................... 4-34
4.7.7 VC-VAC BABY ..................................................................................................... 4-36
4.7.8 V-SIMV ................................................................................................................. 4-38
4.7.9 P-SIMV ................................................................................................................. 4-40
4.7.10 CPAP ................................................................................................................... 4-42
4.7.11 APRV (Airway Pressure Release Ventilation) ..................................................... 4-43
4.7.12 MAN operative mode ........................................................................................... 4-44
4.7.13 APNOEA BACK-UP ............................................................................................. 4-44
4.8 PRP parameters ................................................................................................. 4-45
4.8.1 PRP parameters setting procedure ..................................................................... 4-45
4.8.2 Monitoring of additional respiratory parameters .................................................. 4-48
4.9 Ventilation phase ................................................................................................ 4-49
4.9.1 Ventilation interruption ......................................................................................... 4-50
4.10 Operative functions and Graphic settings ........................................................... 4-51
Siaretron4000e - 15 XIII
4.11 GRAPHICs visualization ..................................................................................... 4-57
4.11.1 Combinations of the graphics displayed .............................................................. 4-57
4.11.2 Modification Charts combination.......................................................................... 4-59
4.11.3 Loops combination modification .......................................................................... 4-61
4.11.4 TRENDS visualization.......................................................................................... 4-64
4.11.5 EVENTS visualization .......................................................................................... 4-65
4.12 Default parameters ............................................................................................. 4-66
4.13 Alarms SETUP.................................................................................................... 4-67
4.14 Patient data SETUP............................................................................................ 4-67
4.15 List of functions ................................................................................................... 4-67
4.16 List of default parameters ................................................................................... 4-70
4.17 Calibration Programs .......................................................................................... 4-71
4.17.1 Preliminary ........................................................................................................... 4-71
4.17.2 Calibration Programs displaying .......................................................................... 4-72
4.17.3 Respiratory Flow Sensors Calibration ................................................................. 4-73
4.17.4 High Altitude usage ( On - Off ) ........................................................................... 4-76
4.17.5 CAN module Test................................................................................................. 4-77
4.17.6 VTEc ( On - Off ) .................................................................................................. 4-78
4.17.7 ScreenShot Enable ( On - Off )........................................................................... 4-79
4.17.8 Self Test ............................................................................................................... 4-80
4.18 Power Off ............................................................................................................ 4-82
4.19 Other functions ................................................................................................... 4-83
4.19.1 Reset to ZERO the “Partial operating hours “ ...................................................... 4-83
4.19.2 Data Connection (Trend and Events downloading) ............................................. 4-84
4.19.3 Default parameters set ........................................................................................ 4-86
4.19.4 Touch Screen set ................................................................................................. 4-86
5 ALARMS ........................................................................................................................ 5-1

5.1 Introduction ........................................................................................................... 5-2
5.2 Displaying and used symbols ............................................................................... 5-3
5.2.1 Alarms display area ............................................................................................... 5-3
5.2.2 A1 - Alarm area ...................................................................................................... 5-4
5.2.3 A2 - ALARMS parameter ....................................................................................... 5-6
5.2.4 A3 - General information area ............................................................................... 5-7
5.2.5 A4 - Acoustic alarm silencing ................................................................................. 5-8
XIV User manual, DU3501101

5.3 Alarms setting ....................................................................................................... 5-9
5.3.1 Setting of ALARMS limits values ........................................................................... 5-9
5.3.2 Setting of ALARMS volume ................................................................................. 5-12
5.3.3 Setting of DEFAULT parameters ......................................................................... 5-14
5.3.4 Alarms DEFAULT parameters values.................................................................. 5-16
5.4 Summary table of alarm characteristics .............................................................. 5-17
5.4.1 Alarms configurable by user ................................................................................ 5-17
5.4.2 System alarms ..................................................................................................... 5-18
5.4.3 Gas Sensor Alarms .............................................................................................. 5-19
5.5 Troubleshooting .................................................................................................. 5-17
5.5.1 Troubleshooting list .............................................................................................. 5-17
6 MAINTENANCE ............................................................................................................ 6-1

6.1 Notes .................................................................................................................... 6-2
6.2 Cleaning, disinfection and sterilization .................................................................. 6-3
6.3 General indications ............................................................................................... 6-4
6.3.1 Cleaning ................................................................................................................. 6-4
6.3.2 Disinfection and sterilization .................................................................................. 6-4
6.3.3 Disinfection by immersion (chemical) .................................................................... 6-5
6.4 Cleaning, disinfection and sterilization table ......................................................... 6-6
6.4.1 Sterilization of EXP V. Monoblock ( exhalation block with flow sensor ) ............... 6-8
6.4.2 Disposable bacteria filter ..................................................................................... 6-10
6.5 Periodic maintenance ......................................................................................... 6-11
6.5.1 Maintenance operations ...................................................................................... 6-11
6.5.2 Cleaning, disinfection and sterilization before use with another patient .............. 6-13
6.6 Repairs and spare parts ..................................................................................... 6-13
6.6.1 Spare parts kit for lung ventilator ......................................................................... 6-13
6.7 Miscellaneous ..................................................................................................... 6-14
6.7.1 Storage ................................................................................................................ 6-14
6.7.2 Repackaging and shipment ................................................................................. 6-14
6.7.3 Disposal ............................................................................................................... 6-14
Siaretron4000e - 15 XV
A ANNEX ......................................................................................................................... A-1
A.1 Technical sheet..................................................................................................... A-2
A.1.1 Ventilator for Intensive Care - code 960502 .......................................................... A-2
A.2 Preliminary checks.............................................................................................. A-11

A.3 Table for Identification of medical gas hose colours ........................................... A-13
A.4 IP classification ................................................................................................... A-14
A.4.1 First digit: solid particle protection ....................................................................... A-14
A.4.2 Second digit: liquid ingress protection ................................................................. A-15
A.4.3 Additional letters .................................................................................................. A-17
A.5 Pneumatic diagram ............................................................................................. A-18

A.5.1 Pneumatic diagram description ........................................................................... A-19
A.6 Glossary.............................................................................................................. A-21

A.7 Electromagnetic compatibility tables ................................................................... A-26
A.7.1 Annex A: Table 1 ................................................................................................. A-26
A.7.2 Annex B: Table 2 ................................................................................................. A-27
A.7.3 Annex C: Table 3 ................................................................................................. A-28
A.7.4 Annex E: Table 5 ................................................................................................. A-29
XVI User manual, DU3501101

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.
Even the maintenance procedures have been simplified and the parts subject to wear or
deterioration have substantially decreased.
The new Siaretron 4000 intensive care lung ventilator is equipped with a 15” TFT display
touch screen and is considerably different from all other previously manufactured versions
of Siare intensive care lung ventilators.
1.1 Presentation
The Siaretron 4000 15” (hereinafter called lung ventilator) is a new generation equipment,
designed for the treatment of acute and sub acute diseases and can be used on Adults,
Children or New Born patients.
The lung ventilator provides new advanced features for operative modes management; it is
equipped with different ventilation functions and thanks to its keyboard and decoder knob
the user’s selection of most suitable settings is simplified.
For those having a basic knowledge on how lung ventilators for intensive care work, the use
of this equipment is intuitive and a brief training course on regard would be enough.
The user’s interface (GUI) includes the keyboard, the decoder knob and the screen; the last
one displays the lung ventilators settings and measured data, as well as various functions,
allowing the operator an immediate evaluation of the patient conditions; moreover, it is
possible to select and display the temporal trends of the pressure, flow, volume, the loops
of flow/volume, pressure/volume.
An immediate information management system, allows the User to set the alarms, collect
data concerning the trend of the operating parameters (TREND) and the lung ventilator
EVENTS log using the MENU.
The same system allows the operator to set the PATIENT TYPE (Adult, Child or New Born),
load or erase the PATIENT DATA and in case of needs, load automatically the DEFAULT
PARAMETERS of the lung ventilator.
Siaretron4000e - 15 1-1
1.1.1 Main technical characteristics
The Siaretron 4000 15” lung ventilator is composed of two main blocks: the trolley and the
lung ventilator block. The trolley, if required, can be equipped with a built-in medical air
compressor.
In turn, the lung ventilator block is divided in two parts: the upper part that includes a 15”
TFT colour monitor touch screen, the board for the elaboration of all data and information
(CPU) that supervises the operation and display of patient parameters. To manage the
pneumatic part, the CPU board uses serial transmission system by bus, type Controller
Area Network (also known as CAN-BUS) that allows it to check and communicate with the
electronic boards peripherals.
The CAN communication system was expressly designed to operate without any problem
also in environments highly disturbed by the presence of electromagnetic waves. The EMC
immunity level is further increased by using twisted pair type connection cables.
The lower part of the lung ventilator block includes the pneumatic control and all the fittings
or connections, both electrical and pneumatic, to the outside. In this area are also mounted
the back-up batteries for use in case of power supply absence and the board for battery
charge management.
The Siaretron 4000 15” foresees the possibility to upgrade the software for implementing
advanced ventilation modalities and functionalities. The ventilator block can be used as a
stand-alone part being separable from the trolley, by positioning it on a flat surface.
Obviously, this operation can be done only in case the medical air compressor is not
provided within the trolley.
1.1.2 Foreseen use
The Siaretron 4000 system delivers controlled or spontaneous ventilations with a re-
adjustable level of end expiration positive pressure (PEEP), of the trigger sensitivity and
oxygen concentration.
Adult, Child or New Born ventilation are available, thanks to an adjustable minimum Tidal
Volume from 2 ml to 3000 ml.
After the switching-on of the lung ventilator it is possible to choice the patient type (Adult,
Child or New Born) setting the relevant default parameters.
The lung ventilator is equipped with a flow and pressure trigger, also it includes the most
modern ventilation modes: volume controlled ventilation modalities VC/VAC, VC/VAC-
BABY, pressure controlled ventilation modalities APCV (BILEVEL ST), APCV-TV, SIMV by
Volume and by Pressure, Pressure supported modalities PSV (BILEVEL S), PSV-TV,
CPAP, APRV, SIGH, Non Invasive Ventilation (NIV APCV - NIV PSV), Drug Nebulizer
(NEB.) and Manual Ventilation (MAN).
In spontaneous ventilation mode, it ensures inspiratory flow up to 240 l/min, both with
control and support pressure.
The medical air compressor (optional) supplies compressed air to the ventilator block and it
can be used in spite of medical air distribution system or from cylinder.
1-2 User manual, DU3501101

The battery, in perfect conditions and fully charged, allows the lung ventilator to operate for
at least 90 minutes (without compressor and/or humidifier), allowing to power the lung
ventilator in case of transport within hospital facilities. It is possible to reach an autonomy of
about 3 hours by the aid of an auxiliary external battery (or battery pack).
The present manual explains how to use the Siaretron 4000 15” unit and
how performing some simple maintenance procedures.
SIARE recommends to read carefully the present manual and its relevant
instructions before using the lung ventilator or proceeding to maintenance.
Please read the recommendations and the instructions herein in order to

ensure a correct and safe use of Siaretron 4000 15” both for the User and
for the patient.
Siaretron 4000 15” must be used only for the purposes mentioned below
and, in the manner, described herein, therefore the User must thoroughly
follow these instructions for use.
1.2 Correct operation

For correct and complete operation, the lung ventilator must be:
 connected to the oxygen outlets of the medical gas distribution system or of the
cylinders; the air can also be supplied by a medical air compressor (optional);
 correctly connected to the patient circuit;
 connected to a mains power supply with the same voltage as specified on the
identification plate;
 correctly connected to all accessories and equipment necessary for the operation of the
lung ventilator.
The connection with main power supply, as well as connections with

medical gas distribution system, must be effected according to the
indications contained in the present user’s manual (see chapter 2).
The lung ventilator incorporates a series of sensors for continuous patient monitoring, the
most important of which are:
 the flow sensors on the expiratory (external) / inspiratory lines (internal), are used to
measure the expiratory / inspiratory volumes of the patient;
 the pressure sensors (internal), used to control the pressure of the airways or of the
medical gases;
 the oxygen sensor (external), used to measure the concentration of oxygen in the gas
inspired by the patient.
The output signals (from the, pressure, flow and oxygen sensors) are
filtered by an R-C circuit from the input circuits. This particular electronic
filtering is used to eliminate disturbances before the signals themselves
are processed by the microprocessor.
Before using the lung ventilator, the User 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 Siaretron 4000 15” lung ventilator 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.
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
International Group s.r.l.
SIARE Engineering International Group s.r.l. recommends careful

reading of this manual and the relative labels before operating the lung
ventilator or carrying out any maintenance.

1.3 Norms and standards regulations
The Siaretron 4000 15” ICU lung ventilator (equipped with a turbine and with a 15” TFT display
touch screen), is made in compliance with the following norms (and following updates) and it is
manufactured according to UNI EN ISO 13485:2016 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 - Part 1-2: General requirements for
safety - Collateral standard: Safety requirements for medical electrical
systems.
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 equipment - Recurrent test and test after repair of
medical electrical equipment
IEC 601-2-12:2007 Medical electrical equipment - Part 2-12: Particular requirements for
basic safety and essential performance of critical care ventilators
ISO 80601-2-12:2011 Medical electrical equipment - Part 2-12: Particular requirements for
basic safety and essential performance of critical care ventilators
ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1: General
requirements
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 (Implementation of the 2012/19/UE Directive on

waste electrical and electronic equipment)
EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
EN ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary
DIR. 93/42/EEC (2007) Medical devices directive
This page has been added to make front / back copy easier.

2 DESCRIPTION
This chapter describes the Siaretron 4000 lung ventilator, equipped with a 15” TFT display
touch screen; the main parts and modules of which it is composed are specially considered.
This chapter describes the following items.
2.1 Overall view

2.2 Front view
2.3 Lung ventilator front view
2.3.1 Electric connections side
2.3.2 Gas supply side
2.4 15’’ LED display - Touch screen
2.4.1 Touch screen
2.4.2 Keyboard with soft key and encoder knob
2.4.3 Operative mode
2.4.4 Patient Data
2.4.5 PRP - Respiratory Parameters: visualization and modification
2.4.6 PRP list
2.4.7 Monitoring of respiratory parameters
2.4.8 Additional respiratory parameters
2.4.9 Alarm visualization
2.4.10 Measures, charts and loops
2.4.11 Loops area: lung status
2.4.12 Graphic setting, operative functions and general information’s
2.5 Rear view
2.6 Product identification label
2.1 Overall view
Concerning the assembling, the interfacing and maintenance make reference

to relevant chapters or contact the SIARE Service Centre.
WARNING!!
All the pictures and the examples shown in the present chapter have the sole
purpose of being an example and they do not make any reference to real
clinical cases.
Siaretron 4000 15” lung ventilator, equipped with a 15” TFT display touch screen;
available models:
 code 960501 medical gas-driven: Adults, Children and New Born patients
 code 960502 turbine-driven: Adults, Children and New Born patients
The picture is exclusively an example and shows a possible configuration of

the Siaretron 4000 15” lung ventilator (hereinafter called lung ventilator).

2.2 Front view
cfr. 2.4 15” LED monitor - Touch screen
cfr. 3.3.6 Support for patient circuit supporting arm
cfr. 3.3.12 Support for humidifier
cfr. 3.1 Wheels diameter 10 cm (2 wheels with brakes)
cfr. 2.4.1 Keyboard with soft key and encoder knob
cfr. 3.1 Transport handle
cfr. 2.3 Attachments for patient circuit connection
For the description of above listed parts make reference to the paragraphs
beside highlighted.
2.3 Lung ventilator front view
Instruction label
Refer to instruction manual/booklet
O2 SENSOR Oxygen cell (see cfr. 3.2.1)
O2 SENSOR INLET Cable end RJ connector for O2 cell connection (see cfr. 3.2.1)
EXP. VALVE Expiratory Valve
EXP. FLOW
SENSOR INLET RJ connector for flow sensor connection
NEBULIZER Nebulizer circuit outlet (6 l/min) (see cfr. 3.3.11)

AIR SAFETY
VALVE Safety air valve
Specific inlet allowing inspiration of ambient air by the

patient when the volume of fresh gas and/or gas for
inspiration is insufficient.
INSP. TO PATIENT Inspiration connector for patient circuit (see cfr. 3.3.7)
EXP. FROM
PATIENT Expiration connector for patient circuit (see cfr. 3.3.7)
EXP. FLOW
SENSOR Expiratory flow sensor
COVER UNIT Protection for flow sensor and oxygen cell
2.3.1 Electric connections side
Instruction label for connections
General warning sign
Instruction label: refer to instruction manual/booklet
ON-OFF I / O switch for ventilator powering
FUSE 2x1 AT Protection fuses for main power supply circuit at 220 Vac
(2 x 1AT - 250V)
100 - 240 VAC Plug for main power supply connection at 100 - 240 VAC
(50 - 60 Hz / 50 VA) Power consumption 50 VA.

Equipotential node
This is used for connection to the equipotential node of

the electrical system.
EXT. ALARM Connection for external remote alarm
Connector for external power supply at 12 Vdc - 4,2 A.

12 VDC IN (4,2 A)
The external supply voltage can be through a battery

or a continuous energy source with above mentioned
features.
FUSE 6,35 AT Protection fuse for 12 Vdc power supply circuit
LAN RJ 45 connector for network connection (optional)
Optional connection for:

RS-232  sidestream or mainstream gas analyzer device
 data download
FAN FILTER Cooling fan for lung ventilator
2.3.2 Gas supply side
Instruction label for connections
Instruction label: refer to instruction manual/booklet.
Air INLET Connector for Air hose connection from compressor/trolley.
O2 INLET Connector for O2 hose connection from gas distribution system.
The pressure of the medical gases should be between

280 kPa and 600 kPa (2,8 - 6 bar / 40 - 86 psi).
280 - 600 kPa

2.4 15’’ LED display – Touch screen
On the upper side of the lung ventilator is a 15” LED display that will show all information
necessary for patient ventilation. Operating mode selection, respiratory parameters setup
and display, visual and acoustic alarm warnings are the main featured information
visualized.
By the use of the, touch screen system or the control keyboard and the encoder knob on
the side of the ventilator to interact directly with the display: this system is defined as GUI
(graphical user interface). The GUI is very easy to use by those who are already
familiarised with lung ventilation: you can find in this paragraph all available functionalities.
The picture shows how the ventilator graphical interface is divided in different area:
 operative mode, START and patient data
 alarm signal and visualization
 respiratory parameters
 measures, charts and loops display area
 monitoring of all respiratory parameters
 setting menu, graphic setting and operative functions
This paragraph describes the functionalities available on graphical user interface.
2.4.1 Touch screen
In electronics a “ touch screen “ is a particular device resulting from the merge of a

display/screen and a digital display, allowing user interaction with a graphic interface by
fingers or particular objects.
Therefore, a touch screen is a inlet and outlet device at the same time.
The touch screen, thanks to its features, can replace the functions of the keyboard with soft
key and encoder knob, and can have, contemporarily, a larger display in the same space
and a direct interactivity between user and device.
Here below some examples on how to use the “touch screen“.
Operative command
 Select icon to START ventilation in the selected operative

mode.
 Select icon to STOP ventilation; lung ventilator goes to Stand-

by mode.
Operative mode set
 Select the area indicating Operative Mode
 All available operative modes are shown

 Select the new operative mode
 The new operative mode is available

Respiratory parameters set
 Select the area indicating the respiratory

parameters to be modified
 The modification bar is displayed
 Select the new parameter’s value on the

bar:
o Drag the cursor
o Select the icon + or -
 Confirm the selection
 Cancel
Respiratory parameters visualization
 Select the area to display other respiratory parameters
 Other respiratory parameters related to VC/VAC operative

mode are displayed.
 To return to previous displaying, re-select
This displaying modality can be applied to patient’s monitoring parameters.

Graphic visualization
 User can display different types of

detections: Loops / Charts / Measures.
 Select the area indicating for example the
graphic to be modified for a few seconds.
 The selected area (purple marked box)
becomes green.
 Release and the drop-down menu and the
list with available options appears.
 Select Loops: the drop-down menu and the

list with available options appears.
 Select P / F.
 The PAW / FLOW Loop appears in place of
PAW / Tidal Volume Loop
The procedure described is applicable in all Loops / Charts / Measures

areas and hence in the different available visualisations.
2.4.2 Keyboard with soft key and encoder knob
 A control keyboard and an encoder knob are available on the upper side of the lung
ventilator.
 These components allow a rapid interaction between the User and the lung ventilator.
Main power supply indication by presence led.
ON/OFF soft key.
Soft key to START ventilation.
ESC soft key for rapid escape from MENÙ - SETUP

visualization.
Soft key to silence an active alarm

(ALARM RESET).
Multifunction encoder knob.
Control keyboard description
When an alarm condition is active, the activated acoustic alarm can

be silenced by pressing the ALARM RESET soft key.
Whenever the condition that activated the alarm is no more present,

by a second pressure of the key, it is possible to cancel the visual
indication on the screen.
By pressing ESC soft key, it is possible to escape from “current”

screen to return to “previous” one.

The multifunction encoder knob is used to select, modify and
confirm all the functions shown on display.
The encoder knob is used to access the MENU function and then
to function modes, parameters, alarms, parameters’ values and all
is concerned to the normal operation of ventilator.
Use of encoder knob.
 Press the encoder to access the modification (enabling) of the
parameter (function); turn clockwise or counter-clockwise to
select the box.
 Turn clockwise (counter-clockwise) to increase (decrease);
press the knob to confirm.
If the encoder knob is not pressed within 10 seconds to

confirm a value after modifying it, the ventilator will
restore the value prior to the modification.
By pressing START soft key it is possible to start ventilation in the

selected operative mode and with parameters set by operator.
The functional switch ON or OFF of ventilator is possible by the

ON/OFF key. To switch ON the lung ventilator, press the ON/OFF
key. After a few seconds a series of messages appears on the
screen, indicating that the system is entered in the SELF TEST
phase; this phase takes some minutes.
At the end of this procedure the equipment is ready to ventilate the
patient. Keep pressed the ON/OFF soft key for a few seconds to
switch off the ventilator (this function has been introduced to avoid
accidental shutdowns of the same).
ON
When the led is light on (green colour) it indicates that the

ventilator is supplied by the main power supply.
2.4.3 Operative mode
You can select one of these ventilation modes using the touch screen
(please see 2.4 .1 or 2.4.2).
Assisted pressure controlled ventilation, synchronised with patient's

respiratory with leak compensation.
(Volume Targeted) Assisted pressure controlled ventilation,

synchronised with patient's respiratory and with assured current
volume.
Assisted pressure support ventilation with assured respiratory rate

set by the User (Apnea Back Up) with leak compensation.
(Volume Targeted) Pressure support ventilation with assured

current volume and assured safety respiratory rate set by the User
(Apnea Back Up).
Volume targeted controlled ventilation synchronised with the patient

if the inspiratory trigger is activated.
Volume targeted controlled ventilation synchronised with the patient

if the inspiratory trigger for paediatric and neonatal patients is
activated.
The VC/VAC-BABY Operative Mode is not active when the PATIENT TYPE
selected is: Adult

Volume-targeted synchronised intermittent mandatory ventilation.
Pressure-targeted synchronised intermittent mandatory ventilation.
Continuous Positive Airway Pressure applied on the airways with

granted respiratory rate set by the User (Apnea Back Up) with leak
compensation.
Airway pressure release ventilation: this type of ventilation features

two positive pressure levels.
After selecting the most suitable operative mode for patient ventilation, the
system will automatically display the physiological respiratory parameters for
the new setup.
 Alongside the Operative Mode acronym, the patient type set is specified
(Adult, Child, New Born). In this way the default respiratory parameters
are set automatically (respiratory parameters and alarms levels).
 Default Parameters: please refer to cfr. 4 Use of Lung Ventilator and cfr.
5 Alarm.
2.4.4 Patient Data
 Select the icon for see Patient

Data parameters.
PATIENT DATA displaying allows

setting / modification of the
following data.
 Adult, Child, New Born
 Male / Female
 Name / Surname
 Physical date
 Birthday
 Note
 The new set data will be

displayed on GUI.
For more information about PATIENT DATA set, please see on chapter 4.5.

2.4.5 PRP - Respiratory Parameters: visualization and modification
Visualization of a PRP parameter.
Operative mode: VC/VAC
 Select the icon for see all PRP

parameters.
 Selecting the PRP parameters icon (see on previous image) the

parameters related to the set Operative Mode are displayed.
 For more information about PRP respiratory parameters, please see on

chapter 4.7 and 4.8.13.
Modification of a PRP parameter.
 Select a parameter (e.g. RR:

Respiratory Rate)
 Select the RR icon.
 The bar for parameters setting is
displayed.
Decreases the parameter value
Increases the parameter values
Confirms the set value
Cancels the setting bar
2.4.6 PRP list
The parameters marked with BK are referred to the BACK-UP operative

mode.
RR BK (bpm): Back-up respiratory rate, used when an Apnoea condition
arises to enable a controlled ventilation mode.
CPAP/PEEP (cmH2O)
Continuous positive airway pressure during respiration phase in
CPAP operative mode.
I:E
Ratio between inspiration and expiration phases.
Flow (L/min)
Flow value during inspiration phases
O2
Concentration percentage delivered to the patient can be set
from 21% to 100%.
Pause (%)
Inspiratory pause time. The “inspiratory pause time” is displayed
on the screen in % (% of the inspiratory time). It is also used to
calculate the lung mechanics parameters (resistance and static
compliance).
PEEP (cmH2O)
Positive airway pressure value during expiratory phase.
Pinsp (cmH2O)
Maximum airway pressure limit value. The parameter is used in
pressure controlled modes to fix an operating limit for the airway
pressure that shall not be exceeded.
Pressure Low (cmH2O) - Pressure High (cmH2O)

Pressure levels to be set in APRV mode.
PMax (cmH2O)
Maximum airway pressure limit.

Pmin (cmH2O)
Minimum airway pressure limit.
PS (cmH2O)
Positive airway support pressure value during inspiratory phase.
RR (bpm)
Lung ventilator respiratory rate.
RRsimv (bpm)
Value of forced respiratory rate in SIMV mode.
Sigh. Ampl. (%)

Sigh. Percentage increase of the set Vti.
Sigh. Int. (b)

Sigh. Activation frequency.
Ti (s)
Time that defines the lung ventilator inspiration duration. The
values can be set based on the set RR.
Ti max (s)
Time that defines the maximum duration of an inspiration. If the
duration of the inspiratory phase is lower than the set value, the
patient will be forced to exhale.
Time Low (s) - Time High (s)

Duration of the two pressure levels set in APRV mode.
Tr. E (%)
Percentage of the inhaled flow with regard to the maximum
peak where the inspiratory phase ends and the expiratory
phase begins.
Tr. I (L/min) (cmH2O)
Flow level (pressure) for detecting the patient spontaneous
breathing.
Vte (ml)
Expired tidal volume guaranteed for the patient.
Vti (ml)
Inspired tidal volume guaranteed for each breath.
2.4.7 Monitoring of respiratory parameters
 Based on the ventilator parameters set by the User and on the patient's
characteristics, the lung ventilator is able to monitor and measure a
series of values necessary for the patient's clinical evaluation.
 At the top of the screen, there is a bar led indicator that displays the
pressure inside the airways in real time. The measured and monitored
values (right side of the screen) are updated after each breath of the
patient.
E.g. Here below the data in the images below refer to VC/VAC operating
mode with standard PRP.
The light bar indicator (with scale from -0 to 80 cmH2O), displays

the pressure inside the airways during the respiratory phase, in real
time.
The value displayed is the maximum measured pressure inside the

airways (cmH2O).
The displayed value shows the positive pressure at the end of the
expiration: the measurement unit is cmH2O.
The User can control if the ventilator is able to reach and keep the
PEEP pressure level set, using this value.

The displayed value shows the real respiratory rate (number of
breaths per time unit) taking into consideration for the calculation
any spontaneous activity.
It shows the ratio between the inspiration time and the expiration
time.
It shows the oxygen concentration value (as percentage) inhaled by

the patient.
The inhaled oxygen concentration value is read by the system by
means of the oxygen cell installed on the inspiratory line.
It shows the current volume value during patient's expiratory phase:

the unit of measurement is ml.
The value is detected by the flow sensor installed on the expiratory
line.
It shows the volume value expired by the patient per minute: the unit
of measurement is L/min.
You can also calculate this value using the formula: current volume
(Vte) x respiratory rate (RR).
It shows the value of end expiration CO2 (end-tidal CO2).

The value is detected by the gas sensor analyzer installed on the
expiratory line.
Description
 Vte: respiratory parameter

 ml: unit of measurement
 503: value set by the User
 1000 - 100: alarm limits
2.4.8 Additional respiratory parameters
 The measured and monitored values (right side of the screen) are
updated after each breath of the patient.
E.g. Here below the data in the images below refer to VC/VAC operating
mode with additional PRP.
Static compliance
It is one of the parameters of the lung mechanics: measured in
ml/cmH2O, represents the lung compliance when the patient does
not breathe.
You can use it to assess the lung elasticity: the higher the
compliance, the more elastic the “lung”; the lower the compliance,
the more “rigid” the lung.
The static compliance can be calculated using the formula below:
Cs = current inspired volume / pause pressure.
Dynamic compliance
It is one of the parameters of the lung mechanics: measured in
ml/cmH2O, represents the lung compliance either during the
inspiration or during the expiration.
You can use it to assess the lung elasticity: the higher the
compliance, the more elastic the “lung”; the lower the compliance,
the more “rigid” the lung. The dynamic compliance can be
calculated using the formula below:
Cd = current inspired volume / peak pressure
Expiratory peak flow

Use the flow sensor installed on the expiratory line to measure the
exhaled flow peak. At the beginning of the expiration, a flow peak
arises in correspondence with the expiratory valve opening and it
depends on the lung resistance and compliance
This measure, just like the previous one, is not related to specific
alarms thresholds, it only provides information on the ventilation
status.

Inspiratory peak flow
Use the flow sensors installed on the inspiratory line to measure that
maximum inhaled flow value (measured in l/min) and to view it on
the screen.
For this value there are no alarm limits but it can be used to gather
information on the ventilation status.
Leak
Shows the ‘Leak’ value measured that must be adequate to the
ventilation mode enabled (volumetric or pressometric) and within the
range in compliance with the local regulations.
The unit of measurement is %.
Mean airways pressure

It shows the average calculated pressure for the airways: the unit of
measurement is cmH2O.
Oxygen consumption calculation
The oxygen consumption value in L/min is displayed after one

minute and in case of oxygen set value higher than 21%.
Pause pressure
It shows the pause pressure: the unit of measurement is cmH2O.
When the inspiratory pause enables, the lung ventilator maintains
the airway pressure constant (it maintains a pause pressure) for a
certain amount of time of the inspiratory time, defined by the User
(INSP PAUSE %). The static conditions allow the lung ventilator to
calculate the breathing mechanics parameters.
Inspiratory resistance
It is the parameter of the lung mechanics that describes the
resistance to the opposite flow of the airways: measured in
cmH2O/(l/s). The greater the patient resistance, the higher the
airway pressure you need to apply to obtain the same volume.
The formula used by the ventilator to calculate the inspiratory
resistance is as follows:
Ri = (peak pressure – pause pressure) / inspired flow.
Expiratory time
It shows the duration of the patient's expiratory phase: the unit of
measurement is the second. This parameter defines the expiration
duration. This value depends on the respiratory rate and I:E ratio
parameters.
Example: if RATE = 15 and I:E=1:1 you will have an expiratory
phase of 2 seconds.
Inspiratory time
It shows the duration of the patient's inspiratory phase: the unit of
measurement is the second. This value represents the total
inspiratory time, and also includes the inspiratory pause period. This
value depends on the respiratory rate and I:E ratio parameters.
For example: if RATE = 15 and I:E=1:1 you will have an inspiratory
phase of 2 seconds.
Inspiratory pause
It shows the duration of the patient's inspiratory standby phase: the
unit of measurement is the second. This parameter represents the
inspiratory time during which the lung ventilator keeps the airway
pressure constant.
Example: if RATE=15, I:E=1:1, Ppause=50% you will have an
inspiratory pause period of 1 second.

2.4.9 Alarm visualization
 The ventilator features automatic means for detecting and identifying any
conditions that might put the patient at risk (based on the level of urgency
and seriousness), using acoustic or visual alarm signals.
 The role of the alarm signal is to draw the attention of the User to the
event as well as to inform him on the requested response speed.
 For more information, please see on chapter 5 Alarms.
In case of alarm, the system displays the information below.

 “Alarm bell” symbol indicating the alarm priority and status.
 Text string referring to the active alarm.
The User can display the alarm set limits, selecting the dedicated
Alarms icon. After editing the alarm settings, the relative signal will
remain active and the status icon will blink for a pre-set time.
ALARM SILENCING
 Select the bell icon (or press the RESET key) to interrupt the
acoustic signal for a pre-set period of time.
 During the silencing period, the text of the alarm will still be
displayed.
 Select the bell icon (or press the RESET key) once again to delete
the alarm text, only if the alarm activation condition is no longer
present.
 If during the silencing period, a new alarm (of high priority) occurs,
the alarms silencing command is automatically cancelled and the
acoustic and visual signals are reactivated.
WARNING!! Patient injury hazard

The User should not interrupt patient control during alarms silencing period.
2.4.10 Measures, charts and loops
The lung ventilator is equipped with tools for charts and loops display so as
to quickly and accurately notify the User on the patient's condition.
The User selecting the icon (GRAPHICs) can choose “which“ and
“how” to display in time the following detections:
 Charts: PAW , Flow , Tidal Volume, O2, CO2
 Loops: Tidal Volume / Flow , PAW / Tidal Volume , PAW / Flow
 Measures: respiratory parameters
 Lung status icon
 To change the combination of curves displayed, the lung ventilator must

be started.
 Select “GRAPHICs” icon to quit the function.
 For more information, please see on chapter 4.10.

2.4.11 Loops area: lung status
 The lung status icon simulates the patient's lungs, graphically displaying
the respiratory cycle by alternatively switching the lungs color.
 In fact, in case of patient's spontaneous activity (Trigger), the lung status
icon turns to yellow and if the “Low Pressure of Airways” alarm value
set has not been exceeded the icon turns red.
 For more information, please see on chapter 4.10.
During inspiration the lungs icon turns green.
The lungs turn green during inspiration only if the PAW exceeds the “Low
Pressure of Airways alarm value set.
During expiration the lungs icon turns light grey.
At trigger activation the lungs icon is yellow.
If the airways pressure does not reach the value of “Low

Pressure of Airways” alarm parameter. the lungs icon turns
red.
WARNING!! Patient injury hazard

If the airways pressure does not reach the value of “Low Pressure” alarm
parameter, the lungs icon turns red and after about 15 seconds, the system
activates the Low Pressure of Airways alarm.
2.4.12 Graphic setting, operative functions and general informations
In the lower side of GUI there are a series of controls and functions that are fundamental for
use of Siaretron 4000 lung ventilator.
Select the icon to access the lung ventilator's SETTING MENU.

 Select the icon to Turn OFF the lung ventilator.
 Select the icon to improve the lung ventilator Supplementary
Tests.
 When the lung ventilator is in Stand-by mode, selecting this icon it is

possible to enter the PATIENT DATA setting (for more information, please
see on chapter 4.3.1).
 The choice of the Patient Data (Adult, Child, New Born) set automatically
the default physiologic respiratory parameters (PRP) of the lung ventilator
(respiratory parameters and alarms levels).
Select the icon to access the lung ventilator's ALARM LIMITS.
Select the icon to access the lung ventilator's GRAPHICs set.
Leds: if Led is lit: indicate that the relevant function is enabled (or if it has been
enabled); if the led is off or in case it does not switch on, it means the relevant
function is not enabled.
INSP HOLD function

EXP HOLD function
100% oxygen concentration function
NEBULIZER function
The “NEB” function is active only when the lung ventilator is supplied by
oxygen.
MAN operative mode (lit green led: MAN function has been enabled)
About “ MAN operative mode “, please see on chapter 4.7.12.
 Date & Time visualization
 (USB): Indication of flash drive (USB) inserted on USB socket

(see on cfr. 2.5) for downloading Screen Shoot
General information
 Battery level (if the symbol is steadily lit and green, the battery is
full).
 Presence of mains power supply, (the “green plug” symbol means
that the device is powered from mains).
 About “General information”, please see on chapter 5.2.4.
 For more information about “Graphic setting, operative functions”,

please see on chapter 4.10.
2.5 Rear view
cfr. 2.4 15” LED monitor - Touch screen
USB sockets for CPU programming
One USB socket for CPU programming (near the reset button) and one USB
socket for Screen Shoot (for more details see on Service Manual).
cfr. 3.3 Medical gas supply connection.
Electric power supply block
ON-OFF I / O switch for ventilator power supply
FUSE Protection fuses for 220 Vac power supply circuit (2 x 3,15
AT - 250V without air compressor).
100 - 240 VAC Connection of main power supply cable 100 - 240 VAC.
100 - 240 VAC Plug for “Electronic Heated Humidifier” power supply.
Medical air compressor: see on enclosed User and Service manual.

2.6 Product identification label
The product identification label mentions the
following information.
 Manufacturer
 Model name
 Main power supply
 Battery’s features
 Fuses features
 Weight
 Regulation (CE mark)
 Serial number
 Symbols (see description)
The mark identifies the protection level against electric shock (category of
protection type B).
CE mark, complying with European Regulation 93/42/CEE pertaining to

medical devices.
0476
RAEE marc, indicates the waste of electronic or electric equipments.
2019
The number indicates the year of production of the equipment.
The symbol indicates ‘refer to the instructions for use’ of the equipment.
Hazard of: instability from horizontal forces.

The symbol stands for “ it is forbidden not to lean or push “ the
equipment.
This precaution must be taken into consideration in order to maintain
sufficient stability of the equipment.

3 PREPARATION TO USE
This chapter explains the main installation phases of Siaretron 4000 15” lung ventilator
equipped with TFT display touch screen. In the first section of this chapter is illustrated how
to install the equipment. In the second section it is illustrated how to perform the preliminary
tests before using the Siaretron 4000 15” lung ventilator (hereinafter called lung ventilator).
3.1 Notes
3.2 Before the use
3.2.1 Assembling of O2 cell
3.2.2 Battery charger
3.3 Preparation to use
3.3.1 Medical gas connection
3.3.2 Connection of medical gas supply from cylinder
3.3.3 Mains power supply
3.3.4 External 12Vdc power supply
3.3.5 Protection fuses
3.3.6 Patient circuit supporting arm
3.3.7 Patient circuit connections
3.3.8 Use of antibacterial filter
3.3.9 Gas analyzer connection (Gas Sensor)
3.3.10 Data connection (Trend and Events downloading)
3.3.11 Nebulizer connection
3.3.12 Humidifier connection
3.3.13 Connection to other equipment’s
3.4 List of predisposition sequence for use
3.5 Use
3.5.1 Preliminary tests
3.5.2 Ventilator switch ON / Self Test phase
3.5.3 Turn the lung ventilator OFF
3.6 Preliminary checks - Introduction
3.7 Preliminary checks - Supplementary Tests
3.7.1 Leak Test
3.5.1 Respiratory Flow Sensors Calibration
3.7.2 O2 Sensor calibration
3.7.3 Exit from Supplementary Tests
3.8 Preliminary checks - Lung Ventilator
3.8.1 Preliminary checks – MONITORING PARAMETERS
3.8.2 Preliminary checks – ALARMS
3.8.3 Alarm limits check
3.8.4 Conclusions
3.9 Preliminary checks sequence list
3.1 Notes
UNPACK THE EQUIPMENT

Unpack carefully.
It is suggested to keep the original package, to avoid damages to the
equipment in case of it should be returned to the factory.
TRANSPORT – equipment moving

 Move the trolley/lung ventilator using the handles positioned laterally to
the work shelf which allow to grab and move easily the unit.
The lung ventilator must be moved possibly by two persons in good
physical condition; this condition facilitates the manoeuvrability of the unit.
 During this transport phase, be careful not to bump or hit the unit with
foreign bodies (e.g., tables, doors, elevator, etc….).
 Do not try to drag the unit over obstacles in general (hoses, cables or
other obstacles on the floor).
WARNING !! Risk of personal-physical injuries

 If handled incorrectly, the unit may tip over causing personal-physical
injuries to the patients and/or users.
 Remove the eventual devices positioned on the shelves or fixed
laterally.
 Ensure that the front panels are closed.
 Pay much warning to eventual obstacles in the path during moving and
positioning phases.
WARNING !! Collision danger

Pay much warning during moving, positioning and use phases.
The devices or accessories applied can collide with other objects or
persons present in the path and/or in the operating room.

WARNING !! Accidental moving danger
If the unit is not correctly positioned, it could accidentally move during
operation.
 Position correctly the trolley/lung ventilator on a flat surface.
 Apply the unit brakes to ensure that it could not accidentally move
during operation.
WARNING !! Risk of injury for the user / patient

 The assembly and connection of all the accessories must be carried out
by highly qualified technical personnel, trained and formally authorised
by SIARE.
 This type of lung ventilator not suitable for and therefore cannot be used
in a hyperbaric chamber.
 To avoid an increase in the concentration of oxygen in the surrounding
air, the lung ventilator should only be used in appropriately ventilated
rooms.
 Do not connect or disconnect parts or components when the lung
ventilator is on or connected to the mains power supply.
 Before using the lung ventilator, carry out all the necessary preliminary
tests.
CAUTION
 If this is the first time you install the lung ventilator, it is suggested to
consult thoroughly this user manual.
 Before using the unit, clean the external surfaces and sterilize the
components.
 Use the maintenance instructions provided in this user manual and
respecting the regulations in force in the country where the unit is sold.
WARNING !! Risk of injury for the patient.

All the pictures and the examples shown in the present chapter have the
mere purpose of being an example and they do not make any reference to
real clinical cases.
3.2 Before the use
3.2.1 Assembling of O2 cell
 Open the left front panel of the trolley.
 Disassemble the cover of valves group.
 Screw the O2 sensor inside its location taking

care not to damage the thread.
 Insert the spin in the apposite O2 sensor
connector.

Verify to have correctly inserted the spin and the RJ connector on the
apposite outlet inside the lung ventilator.

 Mount the cover of valves group.
 Close the left front panel of the trolley.
WARNING !! Risk of injury for the patient

 Check of electric connection of O2 sensor.
 At lung ventilator start-up, the system checks the presence of the
electric connection to the O2 cell (Self Test phase).
3.2.2 Battery charger
In case of electric power failure, the lung ventilator is equipped with a internal batteries that
guarantees (if perfectly efficient) at least 90 minutes operation (with default physiological
respiratory parameters).
The switching to battery operation is made automatically: on the lung ventilator screen
appears the relevant message “ON BATTERY”.
The lung ventilator battery can be recharged by connecting the equipment to main power
supply (using power cable supplied with the unit) and placing the main switch in " I "
position.
Carry a battery charge at least 8 hours, before using the lung ventilator the
first time.
The operating time of lung ventilator guaranteed by the battery, can vary in
the following cases:
 old battery or not perfectly efficient;
 not standard ventilatory parameters.
Follow the instructions.
 Connect the outlet of the power cable to the

plug on the unit.
 Insert the plug of the power cable in the
mains supply wall socket.
The electric main power supply must correspond

to that indicated in the identification label of the
lung ventilator.
 Place the main switch (located in the back

side of the trolley) in position “I”.
 Place the power supply switch of the lung
ventilator (located in the left side of the
trolley) in position “I”.
 Verify on the upper side of the lung ventilator, if the green led is on (it indicates the
presence of main power supply).
To ensure maximum autonomy of operation, it is necessary to guarantee sufficient

recharging time.
To bring the charge level from 0 to 90% takes approximately 8 hours recharging through
the mains power supply.
It is not necessary to start-up the lung ventilator.

3.3 Preparation to use
3.3.1 Medical gas connection
 Screw the AIR gas supply hose to relevant

connectors of the gas supply area on the
trolley.
 Screw the O2 gas supply hose to relevant

connectors of the gas supply area on the lung
ventilator.
 Screw the gas supply hoses to the relevant connectors of the hospital distribution
system. Be sure that the pneumatic hoses are well fixed and that the hospital medical
gas pipeline system is clean and without lubricants.
The pneumatic hoses are already supplied with screw connection DISS
type (Diameter Index Safety System) for connection to the lung ventilator
connectors.
The installation technician taking care of the hoses connection to the
outlets must ensure that they are compatible with the hospital medical gas
pipeline system.
To prevent inversions of gases that can be FATAL for the patient, assembly
of the connectors compatible with the hospital distribution system and all
the maintenance and/or replacement operations of the medical gas supply
hoses must be carried out by highly qualified technical personnel only.
The lung ventilator can also work with AIR medical gas supply only, but in
this case the FiO2 will be adjustable at 21% only. An alarm indicating “Low
Oxygen Pressure” condition will be activated.
WARNING !! Unit failure risk.
 In order that the lung ventilator operates as specified, the input medical
gas pressure must be between 280 kPa and 600 kPa (2,8 - 6 bar / 40 -
86 psi).
 Before using the lung ventilator, make sure that this requirement is met.
 After connecting the medical gas supply hoses, make sure that the
system works properly.
WARNING !! Risk of lung ventilator failure.

 The gas used must be of medical type, therefore oil free and filtered.
 The medical gas source shouldn’t contain water: if you suspect the
presence of water, connect a water trap to avoid damages on the lung
ventilator and its components.
WARNING !! Risk of gas supply failure.

 If the medical gas supply hoses are not correctly connected, the lung
ventilator will not be available in case of gas supply failure.
 Ensure that medical gas supply hoses are connected according with the
indication engraved on the gas inlet bloc and the illustrations in the side
of the equipment.
3.3.2 Connection of medical gas supply from cylinder
 Screw the pneumatic O2 supply hose on the relevant lung ventilator connector.
 Connect the pneumatic O2 supply hose on the relevant connector of the O2 cylinder
pressure reducer.
 Ensure that the medical gas supply hoses are connected and work correctly.
We suggest you to install on reducers the same inlets used on the

distribution system so as to make switching from one system to the other
safe and quick (at least for oxygen).
WARNING !! Risk of explosion.

If the pressure reducers for O2 are touched with fingers/hands soiled with
oil or grease, there is the risk of explosion.
Do not apply oil or grease on the O2 cylinders pressure reducer and never
touch with fingers soiled with oil or grease.

3.3.3 Mains power supply
The electrical connections are a very important part in the installation of the lung ventilator.
Incorrect connections or connections to unsuitable electrical systems can compromise the
safety of the patient and the User.
Mains power supply must comply with the prescriptions in CEI 64-8/7 standards concerning
the locations intended for type A medical use.
The power supplies foreseen on lung ventilator unit are of three types:
 by main power supply (100 - 240Vac / 50 - 60Hz)
 by internal battery (2 batteries Pb / 12Vdc - 1.3Ah)
 by external power supply (12Vdc / 4,2A).
Connection to the main power supply

The main electric power supply must correspond to that indicated on the identification
label (electric power supply, frequency and power consumption) located on the unit: 100 -
240Vac / 50 - 60Hz / 50 VA.
 Connect the power cable outlet to the plug on

the unit.
 Insert the plug of the power cable in the main
power supply outlet.
 Position the main switch (located in the back
side of the trolley) in position “I”.
 Place the power supply switch of the lung

ventilator (located in the left side of the lung
ventilator) in position “I”.
 Verify on the upper side of the lung ventilator, if the green led is on (it indicates the
presence of main power supply).
WARNING !! Risk of personal - physical injuries

In order to avoid any electric shock hazard, make sure that the supply cable
is connected to an electrical socket with the grounding cable connected.
CAUTION
 The Siaretron 4000 15” lung ventilator complies with the requirements
for electro-medical devices detailed on chapter 1.3 (Norms and
standards regulations).
 To ensure proper operation of the Siaretron 4000 15” lung ventilator,

please connect to it only additional devices that comply with the
standards specified above.
 The User should be always sure that the power supply electric plug is
accessible during the normal using and functioning of the Siaretron
4000 15” lung ventilator.

Battery power supply
WARNING !! Risk of failure.

 The batteries, inside the lung ventilator, must always be installed.
 If the batteries are not fitted, the lung ventilator is not protected against
fluctuations or failures of the power supply.
 The lung ventilator must not be used without batteries charged and in
perfect conditions.
 The use of the battery must be limited to short periods and is not
foreseen as an alternative to the mains power supply.
 Do not open the lung ventilator to replace the battery or to carry out
maintenance operations on the battery charger.
When the green led on the upper side of the lung ventilator is light on, it indicates that the
lung ventilator is correctly supplied.
To silence the acoustic alarm, push the ALARM RESET

“soft key; located on the lung ventilator front panel.
The operation time of the lung ventilator guaranteed by the battery can vary
in the following cases:
 old battery or not perfectly efficient;
 not standard ventilatory parameters.
Battery charger
The lung ventilator battery can be recharged by leaving the unit connected
to the main power supply (using power cable supplied with the unit) it is not
necessary that the unit is on.
For battery recharging follow what specified in technical data sheet (Battery
re-charging time).
WARNING !! Risk of failure.

In case of power supply failure, the optional devices connected to the
supplementary electric socket are not supplied by the battery.
Pay much warning to all power supply indicators of connected devices.
3.3.4 External 12Vdc power supply
The Siaretron 4000 15” lung ventilator can be

supplied by an apposite cable to an external
12Vdc power supply (4,2 Max.).
WARNING !! Warning to the polarities.

The red cable must be connected to the positive pole (+) of the battery.

3.3.5 Protection fuses
Protection fuses are foreseen in the following

circuit:
 Main power supply (protection fuses without
compressor: 2x3,15 AT).
 Lung ventilator power supply fuses

(2x1 AT).
 External 12Vdc power supply fuse

(6,35 AT).

The operations described here below must be carried out by highly qualified
technical personnel, trained and formally authorised by SIARE only.
In case of break of protection fuse:

 interrupt the main power supply;
 eliminate the malfunctioning or the cause which caused the fuse break,
 replace the protection fuse with one with the same value and technical characteristics.

Fuses with wrong values and technical characteristics can compromise
equipment integrity and lung ventilator safety.
3.3.6 Patient circuit supporting arm
 Insert the patient circuit supporting arm in the

apposite bracket
 Place the patient circuit supporting arm
 Lock the pivot with the hex screw and the
knob to avoid the patient circuit supporting
arm turns.
3.3.7 Patient circuit connections
Tidal Volume Set of hoses

< 50 ml Neonatal
Use a patient circuit suitable for
the patient to ventilate. From 50 to 200 ml Paediatric
> 210 ml Adult
 Connect the supplied patient circuit to the

apposite INS and EXP connectors on the
lung ventilator.
 Position the patient circuit on the patient

circuit supporting arm.

3.3.8 Use of antibacterial filter
Apply the antibacterial filters to the patient circuit.

To protect the patient from particles and dust, it is necessary to use a filter
between the inspiratory hose and the patient, i.e., the filter on the Y
connector or the filter on inspiratory hose.

Replace the antibacterial filters as indicated in the maintenance
instructions.

Please perform the “SELF TEST” phase (lung ventilator - switch ON) every
time you replace the patient circuit.
The system will check the patient circuit every time you switch ON the lung
ventilator.
WARNING !! Risk of strangling.

 Pay special warning when connecting the patient circuit to the lung
ventilator.
 If not carefully positioned, the hoses, the cables, the patient circuit and
other similar components to the lung ventilator, these can be dangerous
for the patient.
WARNING !! Risk of burns

Do not use conductive masks or conductive breathing hoses during surgery
with electrosurgical units because they can cause burns.
3.3.9 Gas analyzer connection (Gas Sensor)
For more details and information about the CO2 analyzer (Sidestream or
Mainstream model) please refer to the user manual supplied with the GAS
ANALYZER.
 Extract the gas analyzer and the cable +

interface module, from package.
 Switch OFF the lung ventilator power supply -
lung ventilator OFF -
 Connect the interface cable between the RS-
232 connector (positioned on the side of the
lung ventilator) and the interface module.
 Connect the GAS ANALYZER to the interface
module.
Mainstream GAS ANALYZER

 Apply the gas sensor to the patient circuit.
Sidestream GAS ANALYZER

 Connect the sampling line to the GAS
ANALYZER.
 Connect the sampling line to the patient
circuit.

Verify the functioning of the Mainstream GAS ANALYZER
 Switch ON the electric power supply.
 A green LED (on the gas analyzer) indicates that the IRMA analyzer is
ready for use.
Verify the functioning of the Sidestream GAS ANALYZER

 Switch ON the electric power supply.
 A green LED (on the gas analyzer - sampling line) indicates that the ISA
analyzer is ready for use.
CAUTION
GAS ANALYZER - Zeroing
 Mainstream IRMA sensor: after around one minute from the device is
turned on, it is necessary to perform the manual procedure of Zero
Calibration (please see 3.9 TESTS ON DEMAND).
 With sidestream ISA sensor: the zeroing of gas sensor measurement

is activated in automatic mode; anyway, it is possible to perform the
Zeroing calibration procedure when needed (the green led blinks when
turn-on the GAS ANALYZER).
3.3.10 Data connection (Trend and Events downloading)
 Connect a USB flash drive to the USB1 socket used for CPU
programming and data download (USB socket near the reset button).
 For more information see chapter 4.3.2 (SETUP - Other: Save to

USB).
 Request the guide with the relative instructions for data interpretation
(Procedure for downloading data).
3.3.11 Nebulizer connection
 To connect the Nebulizer it is necessary to

use the apposite connector provided on the
front side of lung ventilator.
Use the control provided on the Graphical Users Interface (NEB function)
to enable the Nebulizer functionality (see on cfr 4.10).

The lung ventilator accuracy can be affected by the gas added by the use of
a nebulizer.
3.3.12 Humidifier connection
 A support for Vapour 2 humidifier mounting is

provided on the front side of the trolley.
 The Vapour2 must be inserted on the INSP

line of patient circuit, using the hose provided
with humidifier (code A2000 or P2000).
For further doubts on which types of humidifiers should be used on

Siaretron 4000 lung ventilator, contact Siare.

 Connect the provided hose (code A2000
or P2000), from INSP connector of lung
ventilator to the external connector of
Monopack column.
 Connect the patient circuit to the EXP

connector of lung ventilator and the central
connector of the Monopack column.
 Connect the temperature probe to the

TEMP PROBE connector of Vapour2 and
introduce it in the hole for probe of the
straight connector provided to be mounted
on patient circuit.
 Connect the plug of the Vapour2 supply

cable to the electric outlet in the rear side
of the trolley.
WARNING !! Trouble risk

The Vapour 2 humidifier must be installed by qualified technical personnel,
trained and formally authorized by SIARE; for additional information,
consult the provided user’s manual.

A Nebulisation or Humidification system can increase the resistance of
breathing system filters and that the user needs to monitor the breathing
system filter frequently for increased resistance and blockage.
Please see relevant note on chapter Index.
3.3.13 Connection to other equipments
Connection to Siare equipment

If the equipment to be connected is a SIARE unit, all the instructions
necessary for the connection to lung ventilator can be found in the
documentation supplied.

Do not connect external devices NOT manufactured or NOT authorized by
SIARE to the lung ventilator (e.g., scavenging systems, patient simulators),
and not described in the present user’s manual.
In case contact SIARE or the Authorized local technical service.
WARNING !! Risk of injuries for the patient

When using additional components in the respiratory systems or
configurations not conform to those supplied with the lung ventilator, the
inspiratory and expiratory resistance can increase until overcome the
standard requirements.
When using configurations of this type, it is necessary to pay particular

warning to the measuring values.
WARNING !! Risk of electric shock.

 In case of malfunctioning of ground conductor, the connection of other
electric equipment to the supplementary outlet of the lung ventilator
could cause an increase in leakage current over the values allowed by
the law.
 In case of connection of other devices to the supplementary outlet, it is

necessary to verify the total leakage current.
 In case of overcoming of the values allowed for total leakage current, do

not connect other devices to the supplementary outlet of lung ventilator;
connect other devices to a separate electric outlet.
 All the system must satisfy the requirements for electromedical

equipment stated by the IEC/EN 60601-1-1 and IEC/EN 60601-1-2.
directives.

3.4 List of predisposition sequence for use
3.2 Before the use 3-4

3.2.1 Assembling of O2 cell 3-4
3.2.2 Battery charger 3-5
3.3 Preparation to use 3-7

3.3.1 Medical gas connection 3-7
3.3.2 Connection of medical gas supply from cylinder 3-8
3.3.3 Mains power supply 3-9
3.3.4 External 12Vdc power supply 3-12
3.3.5 Protection fuses 3-13
3.3.6 Patient circuit supporting arm 3-14
3.3.7 Patient circuit connections 3-14
3.3.8 Use of antibacterial filter 3-15
3.3.9 Gas analyzer connection (Gas Sensor) 3-16
3.3.10 Data connection (Trend and Events downloading) 3-17
3.3.11 Nebulizer connection 3-18
3.3.12 Humidifier connection 3-18
3.3.13 Connection to other equipments 3-20
3.4 List of predisposition sequence for use 3-21
3.5 Use
To obtain better performances, leave the lung ventilator working for at least
15 minutes, before patient connection or before executing preliminary
checks.
This operation will allow the system to reach the correct temperature for the
spirometry.
3.5.1 Preliminary tests
Before using the lung ventilator on a patient, it is necessary to perform some of preliminary
tests in order to check that the equipment is properly operating.
The preliminary checks have the aim to verify the correct connection and functionality of the
lung ventilator and all its components.
The list of preliminary tests is available at the end of the present chapter or in
APPENDIX chapter.
The preliminary test’s should be performed:

 each time the lung ventilator is turned ON and used
 or whenever a connection is made or an important component is
replaced (patient circuit, oxygen probe, flow sensor, etc…)
Before starting preliminary tests, the Siaretron 4000 lung ventilator must be:
 prepared for use (cfr. Maintenance, Cleaning, Disinfection and Sterilisation)

 correctly positioned
 all accessories and devices for correct operation must be predisposed
 electric power and gas supplies must be connected
 it is used a patient simulator fixed to the terminal of supplied patient circuit.
The patient simulator suggested for tests and checking’s is SIARE code
LS.AB.001 which is equipped with variable compliance and resistance.

Risk of explosion and/or fire
Do not use the lung ventilator if you detect any suspect oxygen leaks from
the lung ventilator or any other unit next to it.
Close all oxygen supply sources and contact the nearest Siare Support
Centre or any other support centres authorised by Siare.
Risk of accidental movement.

If the trolley/lung ventilator is not blocked in the proper way, it could
accidentally move during operation.
Apply the unit brakes to prevent accidentally movements (front side of the
trolley/lung ventilator).
Emergency conditions
 In emergency conditions, the preliminary checks can be skipped.
 You should carry out the preliminary checks once the emergency
condition stops, and at least once a week.
Preventive MAINTENANCE
The preliminary checks do not remove the necessity for periodical preventive
maintenance operations carried out by SIARE authorised staff, aimed at
replacing the worn parts and checking the overall lung ventilator condition
(please refer to Maintenance chapter).
For the periodical checks that you should carry out, please refer to
Maintenance chapter.
Patient/User injury hazard

All maintenance and/or repair interventions require full knowledge of the lung
ventilator, and therefore such operations must be carried out only by highly
qualified staff, specifically trained and authorised by SIARE.
Serious patient injuries

All figures and examples featured in this chapter are purely informative and
do not refer to real clinical cases.
Siaretron 4000e - 15 3-23

3.5.2 Ventilator switch ON / Self Test phase
 Set the main switch (placed on the back of the lung ventilator) to “I”.
 Make sure that on the lung ventilator keyboard

(commands area) the green led (that indicates the
presence of mains power supply) is on.
 Hold the ON-OFF key for few seconds; the lung ventilator turns ON and the automatic
Self Test phase starts.
During Self Test phase, the lung ventilator software carries out the self-
diagnostic tests and checks a series of devices necessary for safe operation
of the lung ventilator /patient.
Self Test phase. Please close the

patient circuit
 Turbine: Absent
 Oxygen Inlet: check the

oxygen input pressure
 Air Inlet: check the air input
pressure
 Insp. Flow Sensor: check the
operation of the Inspiratory
Flow sensor
 Exp. Flow Sensor: check the
operation of the Expiratory
Flow sensor
 Pressure Sensor: check the
operation of the Pressure
sensor

The Self Test phase in progress.
 Patient Circuit: check the

patient circuit connection and
the presence of pressure in the
circuit.
 Battery: check of the battery
voltage value.
 Oxygen sensor: check of the

electric connection and the
calibration of the O2 sensor
 Acoustic Alarm: check if the

system generates the acoustic
alarm signal
Note! “ If the acoustic alarm is
audible, please push the reset
key ”.
CAUTION. Acoustic Alarm test.
If you do not hear any acoustic alarm signal and/or you did not press the
Alarm Reset key, the red message “ Press OK to begin anyway ” will appear
on the screen.

The Self Test phase completed
successfully.
Note. For a more correct and

detailed analysis of the issues
arising during Self Test phase,
please consult the chapter 5.4 or
consult the Service Manual.
Select OK: the system will display the PATIENT

DATA page and later on, it will switch to Stand-by
mode.
Select Cancel: the system will display the

Supplementary Tests page.
The Self Test phase did not

complete successfully.
 However, the system allows

you to proceed “ Press
START to begin anyway “.
Patient/User injury hazard

The Self Test phase did not complete successfully. Please see chapter 5 and
contact the nearest Siare Support Centre or any other support centres
authorised by Siare.

The system will display the Supplementary Tests page.
By means of this page it is

possible to perform the:
 Leak Test
 Expiratory Flow Sensor
Calibration
 O2 Sensor calibration
 Switch to the Stand-by
visualization
For a correct and more detailed analysis of Supplementary Tests, see

chapter 3.7.
The system will display the PATIENT DATA page and later on it will
switch to the Stand-by visualization.
Through this page it is possible to

set the following PATIENT DATA:
 Patient type
 Male / Female
 Name / Surname
 Physical date
 Birthday
 Note
 PATIENT DATA set (see on 4.3.1).

 Select Cancel or OK for procedures and display Stand-by page.

Stand-by mode
 In Stand-by mode the User

can set and/or edit all lung
ventilator parameters and
alarms limit relative to the
operating mode that you will
use on the patient that you
want to treat.
3.5.3 Turn the lung ventilator OFF
 Stand-by mode. Hold the ON-OFF key for few

seconds to turn the lung ventilator off.
 The system will ask you if you

want to Turn-Off the lung
ventilator (switched off).
Press NO: cancel the

command (the lung ventilator
returns to Stand-by mode).
Press YES: the lung ventilator
will be switched OFF.
During the switching OFF the system performs a clean of the oxygen inside
the lung ventilator which grants a 21% concentration on the inspiratory line.
This procedure grants a longer O2 sensor life and a quicker Self Test phase
when the device is turned-on. The duration of this procedure depends by
the FiO2 present in the inspiratory line and can be of 60 seconds max.

3.6 Preliminary checks - Introduction
Patient injury hazard

The preliminary checks are divided in 4 phases.
- SUPPLEMENTARY TESTS
 Leak Test
 Respiratory Flow Sensor Calib. (see note at the beginning of chap. 3.7.2)
 O2 Sensor calibration
- LUNG VENTILATOR
 Respiratory parameters
 Spirometry
- LUNG VENTILATOR ALARMS
- OPTIONAL
Risk of ventilator failure and/or injuries for the patient.

Running or cancelling the preliminary checks might result in a malfunction
during ventilatory operation: pay utmost attention.
Always carry out all preliminary checks, unless there is an emergency
situation.
You should carry out the preliminary checks once the emergency condition
stops, and at least once a week.
CAUTION
The lung ventilator must be ready for use in order for you to proceed with
the preliminary checks.
 Connect the power supply, the medical gases and the patient circuit.
 Insert and connect the oxygen sensor.
 Connect a patient simulator to the patient circuit terminal.
 Lung ventilator ON: Stand-by mode.

3.7 Preliminary checks - Supplementary Tests
To carry out the Supplementary Tests you must know the keyboard
operating mode and the options available in the lung ventilator SETTING
MENU (please see chapter 2.4).
 Select the icon to

access the lung
ventilator's SETTING
MENU.
 Select Supplementary Tests.
 To go back to Stand-by displaying, select Cancel.
 The Supplementary
Tests screen
appears.

3.7.1 Leak Test
Risk of DM failure and/or injuries for the patient
 This test verifies that there are no leaks higher than 100 ml in the
anaesthesia unit pneumatic circuits.
 Perform the Leak Test weekly.
 Select Leak Test.
 The page for the

verification of the
leakage, Leak test is
displayed
 Before performing the

Leak Test (select
OK), ensure that the
patient circuit is
closed
The Leak Test procedure starts.
The system quit from Leak Test procedure and goes

back to the ‘Supplementary test” screen.

 The Leak Test
procedure is in
progress.
 The Leak Test

procedure was
completed successfully:
the measured value is
9 ml/min.
At the end of the

procedure, the system
automatically goes back to
the page Supplementary
Tests.
LEAK TEST
 Based on known and calculated data (flow, pressure and time), the
software calculates the parameters displayed at the end of test.
 The value of the compliance obtained during the Leak Test is used for
the “compensation of dead space” function (e.g. 0,3 x cmH2O
measured).
Range of values accepted by the Leakage Test Min. Max.
Patient Circuit Compliance 0,2 4

Leak (ml/min) 0 100

Leak Test not overcome
Risk of DM failure
 The Leak Test is not overcome when the pressure within the pneumatic
circuit does not arrive to 30 cmH2O.
 If the problem persists, contact the Siare Service Centre or a Centre
authorised by Siare.
The Leak Test procedure

was not completed
successfully.
CAUTION - Leak Test ERROR

Verify that:
 the ventilator module is in Stand-by operative mode;
 the patient circuit is correctly connected to the flow sensor and to the
INSP connector;
 Y of patient circuit is correctly closed / plugged;
 the ventilator module delivers a flow.
Repeat the Leak test
Leak Test ERROR

Please see chapter 5 (Alarms and/ Troubleshooting).

WARNING !! Ventilator malfunctions risk

The activation of this procedure is only necessary in the following cases.
 Noted differences are more than 15% (over 100ml) between the set
Volume value (VTi - Vte) and the expired Tidal Volume reading ( Vte ).
 In the case of maintenance intervention or replacement of components
 Select Respiratory
Flow Sensors
Calibration.
 The system will

activate the Flow
Sensors Calibration.
CAUTION
Not being a useful procedure for the purpose of "Preliminary Checks", see
chapter 4.17 for a more detailed description of the same.

3.7.3 O2 Sensor calibration
Risk of DM failure and/or injuries for the patient
 This procedure should be carried out to check the proper operation of the
oxygen sensor.
 Perform this procedure monthly.
 Select O2 Sensor
calibration.
 The system will enable

the O2 sensor
calibration.
 The system reads the

electrical value (mV)
generated by the
oxygen sensor when
immersed in a pure
oxygen flow provided
by the lung ventilator
during the test.
 The O2 sensor
calibration in progress.

At the end of the O2 sensor calibration a message is showed (if the O2
sensor is new and in perfect conditions): Test Completed (XXmV) which
show the value in Volts measured by the sensor with 100% Oxygen (Optimal
value = 60mV).
 The oxygen sensor

calibration procedure
was completed
successfully: the
measured voltage value
is 62mV.
 At the end of the

procedure, the system
automatically goes back
to the Supplementary
Tests
CAUTION - REPLACING THE OXYGEN CELL

 The oxygen cell must be replaced when, at the end of the calibration
phase, appears a detected voltage value that is not between 43 mV to 67
mV and/or if the system displays the relevant alarm message.
 To order the replace sensor and to dispose of the worn one, please see
chapter “ Maintenance “.
Conditions to be met for proper calibration

 The O2 sensor must be placed in its seat.
 The O2 sensor must be electrically connected through the suitable cable.
 The medical gases must be properly connected.
If any of these conditions is not met, the calibration cannot be successful.

O2 Sensor calibration not overcome
 The oxygen sensor

calibration procedure
was not completed
successfully.
 O2 Sensor Calibration
Failed.
Ventilator malfunctions risk

If the TEST result is negative check:
 if the O2 sensor is installed and electrically connected to the ventilator;
 if the O2 sensor is worn out (the oxygen detection cell is worn out;
replace the O2 sensor).
Repeat O2 Sensor Calibration.
CALIBRATION procedure Failed

If the system does not exceed the preliminary checks phase, please see
chapter 5 Alarms - Trouble Shooting or contact the nearest Siare Support
Centre or any other support centres authorised by Siare.

3.7.4 Exit from Supplementary Tests
 The system
automatically quits O2
sensor calibration after
a few seconds.
 Select Stand-by: the

system will leave the
Supplementary Tests.
CAUTION - Supplementary Tests

 In the previous paragraphs the tests to be performed before using the
lung ventilator have been shown.
 It’s recommended to perform the tests on schedule defined by this
manual or by the local norms in force.

3.8 Preliminary checks - Lung Ventilator
To carry out the preliminary checks you need to know how the system and
the Physiological Respiratory Parameters (PRP) work.
Preliminary checks to be carried out on the Lung Ventilator.

 Respiratory parameters setup.
 Spirometry proper operation check.
In order to carry out the preliminary checks, proceed as follows.
1. Lung Ventilator in STAND-BY.
2. Select VC-VAC operative

mode.
Modification of the PRP

 Select the parameter you want to change.
 For more information about PRP set, please see cfr. 2.4.1 and cfr. 2.4.5.
For tests and checks, please use the patient simulator SIARE cod.
LS.AB.001 that is equipped with variable resistance and compliance.

3. Set the physiological
respiratory parameters (PRP)
Vti 500
RR 15
I:E 1:2
Pause 0
PEEP OFF, 5, 10 cmH2O
O2 21%
Tr. I -2 cmH2O
1 L/min
4. Select / Press START: the

lung ventilator begins its cycle.

3.8.1 Preliminary checks – MONITORING PARAMETERS
 Based on the PRP set by the User and on the patient's [patient simulator]
 Before checking the value of the set parameters, leave the lung ventilator
on for at least 15 minutes. This way the system will be able to reach its
operating condition.
5. Check the compliance

between the parameters set
and those monitored.
 In the middle of the screen the
system displays the operating
curves.
 On the right side of the screen
you can see the monitored
parameters.
6. Change the PRP values.

 PEEP: 5, 10 cmH2O
 Tr. I: -2 cmH2O, 3 L/min
 O2: 60%
7. Check the correspondence

between the monitored
parameters and the displayed
curves.
8. Select the key to display all
the parameters.

CAUTION. Lung Ventilator operation check
 Make sure that the airways pressure increases during the inspiratory
phase.
 Make sure that the airways limit pressure intervenes (pressometric
operating mode).
 Make sure that the variation in the set oxygen concentration value (O2 %)
corresponds.
 Make sure that the lung ventilator responds properly at parameters
variation.
 Make sure that that the trigger works properly.
 Make sure that the values set for respiratory frequency and volume are
properly displayed and the pressure, volume and flow curves match the
monitored parameters.
 Make sure that the alarms intervene properly.
CAUTION
 If the O2 measured value differs from the set value by more than +/- 10%,
please repeat the “O2 Sensor Calibration” procedure: Supplementary
Test.
 If the Vte measured value differs from the set value by more than +/- 20%
(Adult parameters), please go to the “CALIBRATION PROGRAMS”
visualization to perform the calibration of the expiratory flow sensor (see
chapter 4.16).

3.8.2 Preliminary checks – ALARMS
To carry out the preliminary checks relative to lung ventilator's alarms, you
need to know how the system and the alarms work: please see chapter 2.4.
9. Select the icon to access the

lung ventilator's ALARMS.
 The Alarm Limits screen

appears.
 Check the Alarms Limits and if necessary, change the values set, based
on the test you want to carry out.
 Select the Alarm parameter you want to change. For more information
about use of touch screen or key board, please see on chapter 2.4.
Exit the Alarm Limits screen
Select
 YES: to quit Alarm page; the alarm set will NOT be saved.
 NO: it remains in Alarm page.
Select
 YES: to quit Alarm page; the alarm set will be saved.
 NO: it remains in Alarm page
To set or modify the Alarm Limits make reference to chapter 5 (Alarms).

3.8.3 Alarm limits check
Severe patient injuries

The alarms must trigger at the proper time and in the correct manner.
 Check the proper activation of the visual and acoustic signals.
Before starting the alarm limits, check the alarms setup, and change the set
values whenever necessary (please see previous paragraph).
10. Select VC/VAC operative

mode.
11. Press START: the lung

ventilator begins its ventilation
cycle.
 Set the high pressure alarm limit to a value higher than the PAW
ventilation pressure by 5 cmH2O.
 Block the patient simulator (using your hands) during ventilation.
High Pressure
 The system activates the airways HIGH PRESSURE alarm: silence
the alarm.
 Unlock the patient simulator.
PAW
 Set the low pressure alarm limit to 5 cmH2O.

 Disconnect the patient circuit during ventilation.
Low Pressure  After about 20 seconds the system activates the airways LOW
PRESSURE alarm: silence the alarm.
 Reconnect the patient simulator.

 During ventilation please set PEEP = 10 cmH2O
 Set the high pressure limit to 5 cmH2O.
High
 The system activates the HIGH PEEP alarm: silence the alarm.
 Restore the default alarm value.
PEEP
 During ventilation please set PEEP = 3 cmH2O
 Set the low pressure limit to 8 cmH2O.
Low
 The system activates the LOW PEEP alarm: silence the alarm.
 During ventilation, set Vti to 500 ml.

 Set the high expired Vte alarm limit to 400 ml.
High EXP Vt
 The system activates the high expired Vte alarm: silence the alarm.
Vte
 During ventilation, set Vti to 200 ml.
 Set the low expired Vte alarm limit to 250 ml.
Low EXP Vt
 The system activates the low expired Vte alarm: silence the alarm.
 Set the high expired Vm alarm limit to 8 l.

 During ventilation, set Vti to 800 ml / 15 bpm.
High
 The system activates the high expired Vm alarm: silence the alarm.
Vm
 Set the low expired Vm alarm limit to 5 l.
 During ventilation, set Vti to 175 ml / 20 bpm.
Low
 The system activates the low expired Vm alarm: silence the alarm.

 Set a O2 concentration to 50% on the lung ventilator.
High oxygen  Set the high O2 concentration alarm limit to 30%.

concentration  The system activates the high O2 alarm: silence the alarm.
O2
 Set a O2 concentration to 30% on the lung ventilator.
Low oxygen  Set the low O2 concentration alarm limit to 50%.

concentration  The system activates the low O2 alarm: silence the alarm.
High / Low FiO2

If the lung ventilator is in Stand-by the alarms are not active.
 During ventilation please set RR = 20 bpm.
High respiratory  Set the high respiratory rate alarm limit to 15 bpm.
rate  The system activates the high RR alarm: silence the alarm.
RR
 During ventilation please set RR = 10 bpm.
Low respiratory  Set the low respiratory rate alarm limit to 15 bpm.
rate  The system activates the low RR alarm: silence the alarm.

 During ventilation, set the main power supply switch to OFF (0).
Power Supply  The system activates the main power failure alarm: silence the
Fault alarm.
 Restore the main switch and set it to ON (I).
 Close the medical gas supply during lung ventilator operation.

Low Gas  The system activates the gas supply failure alarm: silence the
Supply alarm.
 Restore the medical gas supply.

3.8.4 Conclusions
Carry out all preliminary checks and make sure that they were completed successfully
before connecting the patient to the Siaretron 4000 15” lung ventilator.
CAUTION
Preliminary checks phase failed.
Please see Alarms chapter and/or Trouble Shooting chapter.
Please contact the nearest Siare Support Centre or any other support
centres authorised by Siare.
Patient injury hazard

Check the alarm limits setup values before connecting a patient to the lung
ventilator.
Change the alarm limits setup based on the clinical situation.
User and patient injury hazard

The intensive care lung ventilator must be inspected and serviced once it
reaches 1000 hours of operation or, in case of limited use, at least once
every 6 months.
All maintenance and/or repair interventions require full knowledge of the lung
ventilator, and therefore such operations must be carried out only by highly
qualified staff, specifically trained and authorised by SIARE.
Any improper intervention or unauthorised modification may affect the

device's safety, putting the patient at risk.

3.9 Preliminary checks sequence list
3.6 Preliminary checks - Introduction 3-29

3.6.1 Supplementary Tests 3-30
3.6.2 Leak Test 3-31
3.6.3 O2 Sensor calibration 3-34
3.6.4 Exit from Supplementary Tests 3-37
3.7 Preliminary checks - Lung Ventilator 3-38

3.7.1 Preliminary checks - MONITORING PARAMETERS 3-40
3.7.2 Preliminary checks - ALARMS 3-42
3.7.3 Alarm limits check 3-43
3.7.4 Conclusions 3-47
3.8 Preliminary checks sequence list 3-48


4 LUNG VENTILATOR USE
This chapter shows you how to use the Siaretron 4000 15” lung ventilator for intensive care,
(hereinafter called lung ventilator).
Thoroughly read this chapter and the whole manual to make sure respiratory parameters
and alarm limits are set correctly and choose the most suitable ventilation mode. The User
must choose the Operative modes and the alarm limits best matching patient's
physiological state and pathologies.
4.1 General notes

4.2 Stand-by mode
4.3 PATIENT DATA / SETUP parameters
4.3.1 PATIENT DATA
4.3.2 SETUP parameters
4.4 Setting up the UGI language
4.4.1 Mode 1
4.4.2 Mode 2
4.5 Setting the PATIENT DATA
4.5.1 Mode 2
4.5.2 Erasing the PATIENT DATA
4.6 Setting up the ALARMS
4.7 Operative modes
4.7.1 Operative Modes setting procedure
4.7.2 APCV (NIV APCV)
4.7.3 APCV-TV
4.7.4 PSV (NIV PSV)
4.7.5 PSV-TV
4.7.6 VC-VAC
4.7.7 VC-VAC BABY
4.7.8 V-SIMV
4.7.9 P-SIMV
4.7.10 CPAP
4.7.11 APRV (Airway Pressure Release Ventilation)
4.7.12 MAN operative mode
4.7.13 APNOEA BACK-UP
4.8 PRP parameters
4.8.1 PRP parameters setting procedure
4.8.2 Monitoring of additional respiratory parameters
4.9 Ventilation phase
4.9.1 Ventilation interruption
4.10 Operative functions and Graphic settings
4.11 GRAPHICs visualization
4.11.1 Combinations of the graphics displayed
4.11.2 Modification Charts combination
4.11.3 Loops combination modification
4.11.4 TRENDS visualization
4.11.5 EVENTS visualization
4.12 Default parameters
4.13 Alarms SETUP
4.14 Patient data SETUP
4.15 List of functions
4.16 List of default parameters
4.17 Calibration Programs
4.17.1 Preliminary
4.17.2 Calibration Programs displaying
4.17.4 High Altitude usage ( On - Off )
4.17.5 CAN module Test
4.17.6 VTEc ( On - Off )
4.17.7 ScreenShot Enable ( On - Off )
4.17.8 Self Test
4.18 Power Off
4.19 Other functions
4.19.1 Reset to ZERO the “Partial operating hours “
4.19.2 Data Connection (Trend and Events downloading)
4.19.3 Default parameters set
4.19.4 Touch Screen set

4.1 General notes
WARNING !! Patient/User injury hazard

Before starting the lung ventilator you have to:
 carry out the preliminary checks (please see the previous chapter)
 set the language and the patient data (please see 4.4 and 4.3)
 set and check the alarms limits (please see 4.6)
 set the physiological respiratory parameters and the operative mode that
match the patient's clinical situation best (please see 4.7 and 4.8).
CAUTION
Before subjecting the patient to a lung ventilation treatment, please:
 set the airway pressure limit alarm to a value that does not exceed 20
cmH2O; this way you will prevent any problems that might arise due to
incorrect respiratory volume or frequency setup (you can increase the
pressure if the patient's pathology and conditions require such
modification).
 check the set oxygen concentration (FiO2) as high concentrations might
affect the patient's health.
 please consult this User Manual.
WARNING !! Collision danger

Graphics interface and control keyboard use

For methodology of the use of touch screen and/ or control keyboard and
encoder knob, see chapter 2.4.2.
4.2 Stand-by mode
 Set the main switch (placed on the back of trolley/lung ventilator) in position “I” (ON).
 Make sure that on the lung ventilator keyboard

(commands area), the green led (that indicates the
presence of mains power supply) is on.
 Hold the ON-OFF key for few seconds; the lung ventilator turns ON and the automatic
Self Test phase starts.
During Self Test phase, the lung ventilator software carries out the self-
diagnostic tests and checks a series of devices necessary for safe operation
of the lung ventilator /patient.
Self Test phase. Please close the

patient circuit
The Self Test phase in progress.
 For more information on the

Self Test please refer to
chapter 3.3.2.
The Self Test phase completed

successfully.
 Press OK to begin
 Press Cancel for other tests

The system will display the Supplementary Tests page.
Through of this page it is possible

to perform the Supplementary Test
(for further details see on 3.6).
The system will display the PATIENT DATA page.
PATIENT DATA
By means of this page it is

possible set the PATIENT DATA
(for more details see on 4.3).
 Select Cancel or OK for

procedures and to display the
Stand-by page.
Stand-by mode
 In Stand-by mode the User

can set and/or edit all lung
ventilator parameters and
alarms limit relative to the
operating mode that you will
use on the patient that you
want to treat.
4.3 PATIENT DATA / SETUP parameters
Actually, the lung ventilator software does not switch directly from Self Test
phase to Stand-by operative mode, but it previously displays a page which
allows the adjustment of the following types of information and machine
setup.
 PATIENT DATA (see on 4.3.1)
 SETUP parameters (see on 4.3.2)
4.3.1 PATIENT DATA
The PATIENT DATA displaying

allows to set the following data.
 Patient type
 Male / Female
 Name / Surname
 Physical date
 Birthday
 Note
The system displays the "Stand-by" page without saving the data
stored in the PATIENT DATA page.
The system displays the "Stand-by" page, saving the data stored in
the PATIENT DATA page.
CAUTION
During the normal operation of the lung ventilator, the
User can modify the PATIENT DATA selecting the
function: SETTING MENU / PATIENT DATA (cfr. 2.4) or
by touching the relative icon (PATIENT DATA).

PATIENT DATA page view.
 The choice of the Patient

Type (Adult, Child, New
Born), set automatically the
default functioning
parameters of the lung
ventilator (breathing
parameters and alarms
levels).
 Select and set the patient

type and the related physical
data.
 Select the desired data area:

the system displays a
keyboard for entering the
Patient Data.
 Once completed the entering

of patient data, save or
cancel what is typed in the
page.
 Select OK :
 Select Cancel :
Once completed the entering of
patient data, save or cancel what
is indicated in the page.
 Select
The PATIENT DATA setting will

NOT be saved.
 Select
The PATIENT DATA setting will

be saved.
 The system will display the

Stand-by screen (in the figure
on the side the PATIENT
DATA have been saved).

4.3.2 SETUP parameters
CAUTION
During the normal operation of the lung ventilator, the
User can modify the parameters SETUP selecting the
function: SETTING MENU.
 Select MENU - SETUP
Display
 BRIGHTNESS
 ENERGY SAVING
 SOUND VOLUME
 TOUCH AUDIO
Date & Time
 Date
 Time
Language
 Italian
 English
 German
 Turkey
 Polish
 French
 Russian
 Spanish
Units
 Weight (referred to the
patient)
 Height (referred to the
patient)
 CO2 (unit of measurement)
 Pressure (unit of
measurement)

Default
 Trends data Default
 Events data Default
 Patient data Default
 Setting & Ventilation rends
data Default
Other
 NIV Enable
 Power Failure
 APNOEA TIME
 CHANGE PASSWORD
 Save to USB
At the end, save or cancel what

is set in SETUP pages.
 Select
YES: to quit SETUP page
without saving.
NO: it remains in SETUP page.
 Select
YES: the set values will be
saved.
NO: it remains in SETUP page.
 The system will display the

Stand-by screen.
It is suggested to set the parameters: see the following chapters.

4.4 Setting up the UGI language
Two ways are available to set/modify the UGI (User Graphic Interface) language.
Mode 1: at ventilator start-up at the end of Self Test phase.
Mode 2: during normal operation of lung ventilator.
4.4.1 Mode 1
At the end of Self Test phase

the system displays the page:
PATIENT DATA.
 Select: SETUP
 Select: Language
A series of MENU languages are
available and identified by an
icon.
 Select the flag.
 Confirm the choice.
 Press YES: the setting will

be saved.
 Press NO: it remains to
language setting.
The UGI (User Graphic Interface) language is ENGLISH.

4.4.2 Mode 2
Lung ventilator in Stand-by

operative mode.
 Select: SETTING MENU
 Select: Language
At Language page the SETUP / PATIENT DATA screen is displayed.
A series of MENU languages are
available and identified by an
icon.
 Select the flag
 Confirm the choice
 Press YES: the setting will

be saved.
 Press NO: it remains to
Language setting.
The UGI (User Graphic Interface) language is ENGLISH.

4.5 Setting the PATIENT DATA
Two ways are available to set/modify the PATIENT DATA.
Mode 1: at ventilator start-up at the end of Self Test phase (see on 4.3.1).
Mode 2: during normal operation of lung ventilator (see on 4.5.1).
4.5.1 Mode 2

operative mode.
 Select: Display
 Select: PATIENT DATA
The displaying of PATIENT

DATA allows to set / modify the
following data.
 Patient type
 Male / Female
 Name / Surname
 Physical date
 Birthday
 Note
To set/modify the PATIENT DATA; see on 4.3.1.

4.5.2 Erasing the PATIENT DATA

operative mode.
 Select: Default
 Select: Patient data Default
Confirm the choice: select
Cancel the choice: select
 Press YES: to RUN the
selected DEFAULT.
 Press NO: to Cancel the
command.

 Select: Display
 Select: PATIENT DATA
The page of PATIENT DATA is

displayed in Default
configuration.
To enter the PATIENT DATA; see on 4.3.1.

4.6 Setting up the ALARMS

operative mode.
 Select: ALARMS
 Select
YES: to quit Alarm page; the
alarm set will NOT be saved.
NO: it remains in Alarm
page.
 Select
alarm set will be saved.
NO: it remains in Alarm
page.
For ALARMS parameters and limits setup, please see on 5.3.
4.7 Operative modes
In the following chapter you will find a description of available Operative Modes selectable
on Siaretron 4000 15” lung ventilator.
WARNING !! Patient injury hazard

The User must choose the Operative modes that match the patient's
physiological features and pathologies best.
4.7.1 Operative Modes setting procedure
CAUTION
 When the lung ventilator is turned ON, the system restores the operative
mode and the relevant parameter values set before the last shut-down.
 Just for our examples we refer to the Operative Modes available with
ADULT Patient Data (VC/VAC).
CAUTION
A new operative mode can be selected in two different operating conditions.
1. Lung ventilator in Stand-by mode.
2. During the normal operation of the lung ventilator.
1. Lung ventilator in Stand-by mode
 Select the icon, VC/VAC.

 All the operative modes
foreseen are displayed.
 Select a new operative mode.
 Operative mode selected:

APCV-TV.
CAUTION
If the lung ventilator is in Stand-by mode, the system does not require any
confirmation or enabling for setting a new operative mode.
 PRP parameters referred to

the APCV-TV operative mode
can be displayed.

parameters.
Lung ventilator in Stand-by, ready to be used in APCV-TV operative mode.
2. Lung ventilator in normal operation
 Operative mode: VC/VAC.
 All the operative modes

foreseen can be displayed.
 Select a new operative mode.
 APCV-TV operative mode

selected.
 A second column with the

PRP parameters referred to
can be displayed.
CAUTION
When the lung ventilator is working, the system requires a confirmation by
the user for the modification of the operative mode.

 YES: The Lung ventilator
directly switches to the new
selected operative mode
APCV-TV
 NO: to exit
 YES: The PRP parameters of

modified, are stored by the
system; the system is fitted
for a future APCV-TV
ventilation mode.
The lung ventilator continues
to ventilate in VC/VAC
operative mode.
 NO: to exit
 NO: The system remains in

the condition where the PRM
of the two operative modes
selected are displayed.
 YES: The system goes back
to the VC/VAC
Operative modes list
4.7.2 APCV (NIV APCV)
Assisted pressure controlled ventilation, synchronised

with patient's breathing with leak compensation.
 The system displays all PRP relative to the set
operative mode.
APCV is a pressure controlled ventilation, synchronised with the patient's breathing with
leak compensation.
With this parameters configuration, APCV is a pressure controlled ventilation,
synchronised with the patient's breathing, during which the system generates a patient
ventilation at a pre-set inspiratory pressure (Pinsp), a pre-set flow (Flow), a calculated I:E
ratio and a settable respiratory rate (RR).
In APCV the current volume depends on the inspiratory pressure (Pinsp) and on the
patient's lungs characteristics (compliance, lung capacity) therefore the tidal volume will
vary depending on changes in lung mechanics.
During the inspiratory phase, the lung ventilator generates a settable flow (Slope). When
the airway pressure reaches the control value (Pinsp), this pressure level is kept constant
by the lung ventilator until the end of the inspiration that you can set using (RR).

Use the settable parameters to define an inspiratory trigger (Tr. I) used to set a flow
expressed in litres per minute (or a pressure in cmH2O) that represents the limit for
detecting the patient's spontaneous breathing attempt.
The greater the value, the greater the patient's effort to breath.
If the pressure set is not reached, make sure that the patient circuit is perfectly sealed and
that the PRP parameters are properly set.
4.7.3 APCV-TV
(Volume Targeted) Pressure controlled ventilation,

synchronised with patient's breathing and with
guaranteed current volume.
operative mode.
APCV-TV is a pressure controlled ventilation, synchronised with the patient's breathing

(automatic Pinsp) with guaranteed current volume (Vte).
The system generates a ventilation at automatic inspiration pressure (automatic Pinsp), in

order for the expired volume to equal the volume set (Vte).
During the inspiratory phase, the lung ventilator generates an automatic flow. When the
pressure reaches the control value inside the airway (automatic Pinsp, at maximum
PMax), this pressure level is kept constant by the lung ventilator until the end of the
inspiration that you can set using the (RR) and the I:E ratio.
Use the settable parameters to define an inspiratory trigger (Tr. I) used to set a flow
expressed in litres per minute (or a pressure in cmH2O) that represents the limit for
detecting the patient's spontaneous breathing attempt.
The greater the value, the greater the patient's effort to breath.

4.7.4 PSV (NIV PSV)
Assisted pressure support ventilation with guaranteed

safety respiratory rate, set by the User (Apnoea Back
Up) with leak compensation.
operative mode.
PSV is an assisted type of ventilation with pre-set pressure support (PS) with guaranteed
safety respiratory rate set by the User in case of patient apnoea (RR bk) and with leak
compensation.
PSV can be used to sustain spontaneous ventilation for patients with

stabilised ventilation needs or who are in weaning phase.
Therefore, keep in mind that, in order to have the ventilator's support, when
using PSV mode, the patient must be able to inhale and so you can’t use
this operative mode to ventilate a patient who is sedated or paralysed.
Therefore, the Tr. I parameter can’t be set to OFF.
PSV is a ventilation technique during which, at the beginning of the patient's spontaneous
inspiratory effort, the lung ventilator provides a constant positive support pressure (PS)
pre-set by the User with high-speed flow supply, until the pressure inside the airway
reaches the desired support value.

When the set support pressure is reached, the expiration takes the place of the inspiration
(according to Tr. E - percentage of the inspiratory flow peak beyond which the expiration
can begin). This technique saves the patient from the work of breathing, as he only has to
reach the small quota necessary to enable the lung ventilator trigger (Tr. I).
This way, the respiratory rate depends on patient spontaneous activity and the current
volume depends on set parameter values and patient patophysiological conditions.
With optimal PSV, the breathing pattern can be standardised (by increasing the Vte and
reducing the respiratory rate) and the work of breathing can be reduced, improving the
respiratory exchange ratios.
In this mode the patient's work of breathing is assumed by the lung ventilator. Each breath
initiated by the patient (Tr. I enabled) is supported by the lung ventilator, that sends a gas
flow inside the airway, at a certain pre-set pressure, called support pressure (PS).
If the patient does not trigger (spontaneous breathing during the apnoea
time set in SETUP - Other), the system enables the APNOEA acoustic and
visual alarm.
The system will automatically provide an APCV ventilation with set safety
respiratory rate (RR bk) and I:E ratio (I:E bk).
4.7.5 PSV-TV
(Volume Targeted) Pressure support ventilation with

guaranteed current volume and guaranteed safety
respiratory rate set by the User (Apnoea Back Up).
operative mode.
PSV-TV is an assisted pressure support ventilation with guaranteed current volume and
guaranteed safety respiratory rate set by the User in case of patient apnoea (RR bk).
PSV-TV can be used to sustain spontaneous ventilation for patients with

stabilised ventilation needs or who are in weaning phase.
Therefore, keep in mind that, in order to have the ventilator's support, when
using PSV-TV mode, the patient must be able to inhale and so you can’t use
this operative mode to ventilate a patient who is sedated or paralysed.
Therefore, the Tr. I parameter can’t be set to OFF.
PSV-TV is a ventilation technique during which, at the beginning of the patient's

spontaneous inspiratory effort, the lung ventilator provides support at an guaranteed
volume (Vte) pre-set by the User.

When the Vte pre-set value is reached, the expiration takes the place of the inspiration
(according to Tr. E - percentage of the inspiratory flow peak beyond which the expiration
can begin).
This technique saves the patient from the work of breathing, as he only has to reach the
small quota necessary to enable the lung ventilator trigger (Tr. I). This way, the respiratory
rate depends on patient spontaneous activity and the PAW depends on set parameter
values and patient patophysiological conditions.
In this mode the patient's work of breathing is assumed by the lung ventilator. Each breath
initiated by the patient (Tr. I enabled) is supported by the lung ventilator, that sends inside
the airway an guaranteed tidal volume, pre-set by the User.
visual alarm.
The system will automatically provide an APCV-TV ventilation with set safety
4.7.6 VC-VAC
Volume targeted controlled ventilation synchronised

with the patient if the inspiratory trigger is active.
operative mode.
VC/VAC is a volume-targeted controlled ventilation (Vti), synchronised with the patient's

breaths if the inspiratory trigger (Tr. I) is active.
In this type of ventilation, the work of breathing is fully assumed by the lung ventilator, and
therefore it is used when the patient is unable to breath on his own, or in order to assure
an efficient pre-set current volume and therefore the mechanical ventilation must fully
replace the spontaneous breathing.
The inspired volume (Vti) is pre-set and generated in a pre-set time (RR and I:E) and
determines the characteristics and the pressure range necessary to reach the pre-set
amount of gas mixture that must be provided.
The patient's breathing attempt is detected by the system (Tr. I) and it automatically sends
inside the airway a gas flow at a pre-set volume (Vti).

To combine the assisted mode with the control mode, the User must adjust the trigger
sensitivity (Tr. I) at a value that suits the patient.
If during the expiratory phase, the patient generates a spontaneous breath that enables
the trigger, the lung ventilator will synchronise its activity to the patient's spontaneous
breath, recalculating the I:E cycle times starting from that event and displaying them on
the lung ventilator screen.
This way the lung ventilator provides a minimum number of breaths as indicated on the
RATE display of the integrated screen.
If the patient's spontaneous breathing respiratory rate is greater (than the respiratory rate
set on the lung ventilator) the machine will increase the number of breaths per minute
(with regard to the number set in the control panel) and displays the value.
4.7.7 VC-VAC BABY
Volume targeted controlled ventilation synchronised

with the patient if the inspiratory trigger for paediatric
and neonatal patients is active.
operative mode.
VC/VAC BABY is a volume-targeted controlled ventilation (Vte), synchronised with the

patient's breaths if the inspiratory trigger (Tr. I) is enabled.
The Operative Mode VC/VAC BABY is active only with patients: PAEDIATRIC and
NEONATAL.
The VC/VAC BABY operative mode also includes two additional parameters
identifying the maximum and the minimum pressure limit (PMax. - Pmin) that
can be reached during ventilation.
In this type of ventilation, the work of breathing is fully assumed by the lung ventilator, and
therefore it is used when the patient is unable to breath on his own, or in order to assure
an efficient pre-set current volume and therefore the mechanical ventilation must fully
replace the spontaneous breathing.

The volume (Vte) is pre-set and generated in a pre-set time (RR and I:E) and determines
the characteristics and the pressure range necessary to reach the pre-set amount of gas
mixture that must be provided.
The patient's breathing attempt is detected by the system (Tr. I) and it automatically sends
inside the airway a gas flow at a pre-set volume (Vte).
To combine the assisted mode with the control mode, the User must adjust the trigger
sensitivity (Tr. I) at a value that suits the patient. If during the expiratory phase, the patient
generates a spontaneous breath that enables the trigger, the lung ventilator will
synchronise its activity to the patient's spontaneous breath, recalculating the I:E cycle
times starting from that event and displaying them on the lung ventilator screen.
4.7.8 V-SIMV
Volume-targeted synchronised intermittent mandatory

ventilation.
operative mode.
V-SIMV is a synchronised intermittent mandatory ventilation, during which the lung

ventilator generates a certain number of breaths per minute (RRsimv) at a pre-set volume
(Vti).
SIMV allows the patient to breath spontaneously, between the forced breaths, with a pre-
set positive pressure support (PS) if the patient's breath is strong enough to enables the
flow trigger (Tr. I - this parameter can’t be set to OFF).
The spontaneous phase is characterised by the set inspiration time (Ti) that once the
pressure support value (PS) set by the User is reached, leaves its place to the expiration
phase (Tr. E).
Therefore, in SIMV mode, the lung ventilator can provide a combination of spontaneous
and controlled breathing.
SIMV mode is frequently used as a weaning ventilation mode from a fully controlled
ventilation (completely depending on the lung ventilator) to an assisted ventilation mode.

The graphic shows how the SIMV operative mode works.
The spontaneous activity between one synchronised breath and the other is
70% managed in pressometric mode (PS) while the remaining 30%
represents the window for the activation of the forced synchronised
breathing.
4.7.9 P-SIMV
Pressure-targeted synchronised intermittent mandatory

ventilation.
operative mode.
P-SIMV is a synchronised intermittent mandatory ventilation, during which the lung

ventilator generates a certain number of breaths per minute (RRsimv) at a pre-set
inspiratory pressure (Pinsp) providing pressure support (PS) during the spontaneous
phase.
SIMV allows the patient to breath spontaneously, between the forced breaths, with a pre-
set positive pressure support (PS) if the patient's breath is strong enough to enable the
flow trigger (Tr. I - this parameter can’t be set to OFF).
The spontaneous phase is characterised by the set inspiration time (Ti) that once the
pressure support value (PS) set by the User is reached, leaves its place to the expiration
phase (Tr. E).
Therefore, in SIMV mode, the lung ventilator can provide a combination of spontaneous
and controlled breathing. SIMV mode is frequently used as a weaning ventilation mode
from a fully controlled ventilation (completely depending on the lung ventilator) to an
assisted ventilation mode.

The graphic shows how the SIMV operative mode works.
The spontaneous activity between one synchronised breath and the other is
70% managed in pressometric mode (PS) while the remaining 30%
represents the window for the activation of the forced synchronised
breathing.
4.7.10 CPAP
Positive continuous pressure applied on the airway.

operative mode.
CPAP is a spontaneous positive pressure ventilation at continuous flow.

In this operative mode the patient is free to breath spontaneously inside the circuit but at a
pressure greater than the atmospheric one, with increased residual functional capacity.
During spontaneous breathing the pressure value varies around the set value, it tends to
drop when the patient inhales and to rise when the patient exhales.

visual alarm.
The system will automatically provide an APCV ventilation with set safety

4.7.11 APRV (Airway Pressure Release Ventilation)
Airway ventilation and pressure release: this type of

ventilation features two positive pressure levels.
operative mode.
APRV is a spontaneous ventilation mode with constant positive pressure on 2 different

levels, during which the lung ventilator keeps the two pressure levels set constant.
In this mode the patient is free to breath spontaneously inside the circuit but at a pressure
greater than the atmospheric one, with increased residual functional capacity. The User
can set on the lung ventilator the pressure of the two levels and the relative times.
 LOW LEVEL pressure - LOW level TIME
 HIGH LEVEL pressure - HIGH level TIME
During spontaneous breathing the pressure value varies around the set value, it tends to
drop when the patient inhales and to rise when the patient exhales.
In APRV the patient breaths on two positive pressure levels not

synchronised with the patient's spontaneous breathing.

If the patient stops breathing, after 20 seconds the system enables the low
PAW acoustic and visual alarm (low airway low pressure).
4.7.12 MAN operative mode
MANUAL ventilation available in all operative modes.
 By selecting the MAN mode (at the bottom of the display) the system provides the
patient with a breath.
 The breath ventilation parameters depend on the set operative mode.
 The function activation is monitored by the screen and signalled by the green LED
inside the box, that turns on.
 This mode is active while the lung ventilator is running.
4.7.13 APNOEA BACK-UP
Apnoea BACK-UP is a safety function available in two of the Operative modes: PSV,
PSV-TV and CPAP. The Apnoea BACK-UP function enables if the patient, ventilated in
one of the modes above, stops breathing.
After a pre-set time (Apnoea Time) in the SETUP - Other, will appear the relative alarms
and the system automatically starts ventilating the patient.

When the lung ventilator switches to this safety mode automatically, the
User CANNOT edit the ventilation parameters.
The lung ventilator continues its activity and the User acknowledges the
emergency condition.
When the apnoea BACK-UP function enables, the ventilation parameters
used are those set based on the selected operative mode.

4.8 PRP parameters
In the following chapter you will find a description of available physiological respiratory
parameters (referred to from now on as PRP) selectable on Siaretron 4000 15” lung
ventilator.

Thoroughly read this chapter and the entire manual to make sure you set the
PRP correctly.
The User must choose the Operative modes that match the patient's
physiological features and pathologies best.
4.8.1 PRP parameters setting procedure
CAUTION
 When the lung ventilator is turned ON, the system restores the operative
mode and the relevant parameter values set before the last shut-down.
 Just for our examples we refer to the Operative Modes available with
ADULT Patient Data (VC/VAC).
 Select: VC/VAC operative

mode

parameters.
Selecting the PRP parameters icon (see the image on the next page) the
parameters relevant to the set Operative Mode are displayed
VC/VAC operative mode: available PRP parameters.
 Select the icon for  Reselect the icon

see the PRP for see all PRP
parameters. parameters.
Modifying a PRP parameter

(e.g. RR: Respiratory Rate).
 Select the RR icon.
Note. The bar for RR parameter is

displayed.
To decrease the parameter value
To increase the parameter value
To confirm set value
The system go back to Stand-by

page.

 The PRP must be set by the User in Stand-by mode before activating
the necessary operative mode.
 The system allows you to set default PRP (SETUP - Default) suited for
ventilating an adult patient.
 During the ventilation of the

patient, use the dedicated icon
(PRP parameters) to display
the parameters referred to the
Operative Mode set.

Depending on the chosen ventilation mode, the same PRP can be a
dependent variable (that varies depending on other parameters
modification) or an independent variable (a value that if modified, affects the
values of other parameters).
The PRP can also be adjusted while the lung ventilator runs, adapting them
to the patient's clinical situation.
Selecting PRP icon parameters (see the image above) the respiratory
parameters are displayed.
4.8.2 Monitoring of additional respiratory parameters
series of an additional values necessary for the patient's clinical
evaluation.
 The data in the images below refer to VC/VAC operative mode with
standard PRP, and they are only informative, they do not refer to real
clinical cases.
 Selecting PRP icon

parameters (see the image
above) the additional
respiratory parameters are
displayed.
For more details about the monitoring of respiratory parameters, please

see on chapter 2.4.7 and chapter 2.4.8.

4.9 Ventilation phase
Before starting the ventilation, you have to:

 carry out all lung ventilator connections (medical gases, power supply,
patient circuit, ……..)
 carry out the preliminary checks (please see chapter 3.5)
 set and check the patient data, language and alarm limits
 set the Physiological Respiratory Parameters and the operative mode
that match the patient's clinical situation best.
Based on the PRP set by the User according to the patient's characteristics,
the lung ventilator is able to display and measure a series of values
necessary for the patient's clinical evaluation.
 Press START to begin the

ventilation in the selected
mode with the most suitable
PRP for the clinical situation
of the patient.
 On the left side of the display you can find PRP parameters.
 In the main section you can see the Charts that show the trend of the
respiratory parameters.
 On the right side of the display you can find values that will help you
asses the patient's clinical condition.
 In the upper part the Operative Mode is displayed as well as both Start
and Stop controls for the ventilation and the message for active alarms.
 At the bottom, the functions to be activated by the user as well as time
and status of the power supply are available.
4.9.1 Ventilation interruption
 Press ON/OFF, to return in

Stand-by mode.
 The system will ask you if
you want to stop the
ventilation (switch to Stand-
by mode).
YES: stop ventilation.
NO: cancel the command.

mode.
 Press ON/OFF, to Turn-off

the lung ventilator.
 The system will ask you if
you want to Turn-off the lung
ventilator (switched off).
YES: lung ventilator will be
switched off.
NO: cancel the command
(the lung ventilator returns to
Stand-by mode).

4.10 Operative functions and Graphic settings
During the patient ventilation, the User can intervene using the graphical
user interface, by selecting the “Operative Functions” in the lower side on the
screen.

access the lung
ventilator's SETTING
MENU.
 Select Cancel, to go back to the Stand-by display.
Note! The functions that can be enabled from the SETTING

MENU are shown in Chapter 4.15.
access the lung
ventilator's ALARM
LIMITS.
 For ALARM LIMITS, please see on chapter 5 (Alarms).

 To go back to the Stand-by display, select Cancel or OK (follow the
instructions displayed).

 Select the GRAPHICs icon: six icons representing 6 types of graphic visualizations
are displayed are displayed (see the above picture)
The User can display four different graphic types (see list below) and the visualization
of Trends and Events.
1. Charts: PAW , Flow ,

Tidal Volume, O2, CO2
2. Loops: Tidal Volume /
Flow , PAW / Tidal
Volume , PAW / Flow
3. Lung status icon
4. Measures: respiratory
parameters.
 For GRAPHICs setting, please see on chapter 4.11.
 To quit the function, select again the icon GRAPHICs.
Select the INSP HOLD
mode: the system will
extend the inspiration
time to 20 seconds.
The function activation is
displayed by the screen
and signalled by the
yellow LED inside the
box, that turns on.
Select the EXP HOLD

mode: the system will
extend the expiration time
to 20 seconds.
The function activation is
displayed by the screen
and signalled by the
yellow LED inside the
box, that turns on.
The User can enable both modes in sequence; the lung ventilator will carry
out both modes, giving priority to the mode that was activated first.
INSP HOLD and EXP HOLD modes:

 are deactivated automatically,
 or by pressing the encoder knob.

O2 100% mode
 Select the function O2 100% , the system will provide
100% oxygen concentration for 5 minutes (pre-set time).
Select the icon to supply  After the pre-set time the systems automatically restores
an oxygen concentration the previously set O2 concentration value.
of 100% to the patient.  The function activation is monitored by the screen and
signalled by the yellow LED inside the box, that turns on.
The O2 100% mode is deactivated:

 automatically after 5 minutes
 or by select the icon O2 100%

The O2 100% mode is not available if the oxygen pressure supply is lower
than 1,5 bars.
NEB. operative mode

Select the NEB mode to enable the nebulizer use. The lung
ventilator provides a flow of 6 litres/min through the relative
connector for a period of time equal to the inspiratory time.
Select the icon to supply
to the patient a flow of 6 The function activation is signalled by the green LED inside
litres/min. the box, that turns on.
During nebulizer use the lung ventilator maintains the oxygen
concentration set. You can do this according to the current
settings.
 The NEB. function is enabled only when the lung ventilator is connected
to an oxygen source (connection: HIGH PRESSURE).
 The NEB. operative mode can be enabled and disabled manually using
the icon.
MAN operative mode
By selecting the MAN mode the system provides the patient
with a breath.
Select the icon to activate The breath ventilation parameters depend on the set operative
the manual ventilation to mode. The function activation is monitored by the screen and
the patient. signalled by the green LED inside the box, that turns on.
This mode is active while the lung ventilator is running.
The selection of the Time

icon , allows to update
time and date set.
Page: SETUP / Date &

Time is displayed.
 For Date & Time setting, please see chapter 4.3.1.
 To modify select + or - ; select OK to confirm.
 To quit SETUP / Date & Time , select Cancel.

4.11 GRAPHICs visualization
The icon GRAPHICs allows the user to combine the Loops, the Charts
and the Measured patient respiratory parameters in different ways
Moreover, it allows to display the Trends and Events.
4.11.1 Combinations of the graphics displayed

All figures and examples featured in this chapter are purely informative.
Charts: PAW , Flow ,

1.
Tidal Volume
Charts: PAW , Flow

Loop: PAW / Tidal
2. Volume
Lung status icon
Charts: PAW
Loop: Tidal Volume /
Flow , PAW / Tidal
Volume
3. Lung status icon
Measures: Vte
Loop: PAW / Flow , PAW

/ Tidal Volume
4. Lung status icon

Measures: Vti, Vte, PAW
5. Trends

6. Events
4.11.2 Modification Charts combination
 The user can display different kind of Charts detections.
 The selection of the box of one of the Charts displayed, enable the
visualization of a screen of a drop-down menu with the list of the options
available.
 Available charts: PAW , Flow , Tidal Volume, O2, CO2 .
 Keep selected the area

of the graphic some
seconds; the selected
area (the violet frame)
becomes green.
 Release; the drop-down
menu with the list of the
options available
appears.
 Select Charts: the drop-

down menu with the list
of the options available
appears.
 Select CO2.
The CO2 graphic is
displayed and it replaces
the Tidal Volume
graphic.
The procedure described is applicable to all the Charts areas and in the
different visualizations available.

4.11.3 Loops combination modification
 The user can display different kinds of Loops detections.
 The selection of the frame of one of the Loops displayed, enable the
visualization of a drop-down menu with the list of the options available.
 Available Loops: Tidal Volume / Flow , PAW / Tidal Volume , PAW / Flow.
 Keep selected the area

of the graphic some
seconds; the selected
area (the violet frame)
becomes green.
 Release; the drop-down

menu with the list of the
options available
appears.
 Select Loops: the drop-
down menu with the list
of the options available
appears.
 Select P / F.
The PAW / FLOW Loop
is displayed and it
replaces the PAW / Tidal
Volume Loop.
The procedure described is applicable to all the LOOPs areas and in all the
different visualizations available.

 Select Measures: a
drop-down menu with a
list of the respiratory
parameters available
appears.
 Select Vti.
The respiratory
parameter Vti is
displayed and it replaces
the PAW / Tidal Volume
Loop.
The procedure described is applicable to all the MEASURES areas and in all
the different visualizations available.
4.11.4 TRENDS visualization
Select the TRENDS visualization to monitor the most significant respiratory parameters on
medium - long term.
Monitored Respiratory
parameters:
 Rate
 P Insp
 PEEP
 Vm
 Vte
The storage capacity for

each parameter is 72 hours
with sampling at every 4
minutes.
 The vertical scrollbar allows to display the respiratory parameters

monitored.
 The horizontal scrollbar allows to check the parameters in the timeframe.
 The vertical dashed bar (in the graphic) indicates on the graphic the
movement of the values measured in the timeframe.
 On the left side of the Trends graphic are mentioned the data measured
and related to the parameter displayed and to the vertical dashed bar.

4.11.5 EVENTS visualization
Select the EVENTS function to monitor the information on the lung ventilator operation over
time. The monitored EVENT refer mainly to the alarms (active alarms) and the various
operating conditions of the lung ventilator (POWER ON, POWER OFF, STAND-BY,
VENTILATION START).
The system can register up

to 100 events, including the
alarms.
The vertical scrollbar allows to display all the events.
The Table of the Events provides the following indications:

 Alarm icon
 Event date and time indication
 Event description: green (lung ventilator operating conditions), red
(information on event's alarms)
4.12 Default parameters
The screen PATIENT DATA / Default allows the User to restore the
Default parameters (Factory set).
Restoring “Factory set “ means to set once again the Default parameters
of the lung ventilator (MENU, SETUP, PRP, ALARMS limits).
Lung ventilator in Stand-by mode.
Select: SETTING MENU /

Default
Select: Enable: Setting & Ventilation Default

YES: the default data
will be improved.
NO: the system cancels

the RUN command.
Select:
YES: exit without
perform any other
operation.
NO: the system

remains in Default
page.

4.13 Alarms SETUP
For ALARMS parameters and limits setup please see 5.3.4 ALARMS setup.
4.14 Patient data SETUP
For Patient Data parameters and setup please see 4.3.1 PATIENT DATA.
4.15 List of functions
Here below the list of the available functions and positioning inside the
Graphic User Interface.
Operative mode  See on chapter 4.7
Ventilation status  See on chapter 2.4
Patient data  See on chapter 4.3
Password  See on chapter 5.2
 Brightness
 Energy saving
Display
 Sound volume
 Touch audio
 Date
Date & Time
 Time
 Italian, English, German, Turkey,
Language
Polish, French, Russian, Spanish
 Weight (referred to the patient)
 Height (referred to the patient)
Units
 CO2 (unit of measurement)
 Pressure (unit of measurement)
 Events data Default
Default
 Setting & Ventilation Default
 NIV Enable
 Power Failure
Other
 APNEA TIME
 CHANGE PASSWORD
 Save to USB
IRMA/ISA  Gas Sensor (IRMA or ISA type)
 Enabling the Supplementary Tests
function.
 The system shows the test
available on the lung ventilator.
Supplementary Tests
 Before using the lung ventilator on
a patient, you have to carry out a
series of preliminary checks to
make sure that it works properly.
Turn Off  See on chapter 4.9.1
Cancel  See on chapter 4.3.2

Alarms Limits  See on chapter 5 Alarms
 Charts
 Loops
 Lung status icon
GRAPHICs visualization
 Measures
 Trends
 Events
INSP Hold  See on chapter 4.10
EXP Hold  See on chapter 4.10
100% Oxygen  See on chapter 4.10
Nebulizer function  See on chapter 4.10
Operative mode: MAN  See on chapter 4.7.12 - 4.10
Time / Data  See on chapter 4.10
Battery / Power supply  See on chapter 5 Alarms
4.16 List of default parameters
Parameters Adult Child New Born
Mode VC/VAC APCV-TV NIV APCV
VT (ml) 500 400 -
RR (bpm) 12 12 12
I:E 1:2 1:2 1:2
Trigger (cmH2O) OFF OFF OFF
PEEP (cmH2O) OFF OFF OFF
FiO2 (%) 21% 21% 21%
Pinsp (cmH2O) - - 20
Pmin (cmH2O) - 5 -
Pmax (cmH2O) - 25 -
Flow - 3 3

4.17 Calibration Programs
4.17.1 Preliminary
WARNING !! Patient / User injury hazard

 In order to start the Calibration Program is necessary the intervention of
SIARE personnel or qualified technical personnel authorized by SIARE.
 The information’s herein are exclusively intended for use by SIARE
specialised or qualified technical staff, formally authorised by SIARE.
 The procedures described are critical operations and must be carried out
only by authorised staff as they might affect the equipment's safety and
proper operation.
WARNING !! Patient / User injury hazard

CAUTION
 The specialist SIARE staff or qualified technical staff, formally authorized

by SIARE, must know the full content of this manual (and of the Service
manual), before carrying out the operations described below.
 The SIARE authorized technician avails of suitable tools and spare parts
and is trained to work in compliance with product safety.
 SIARE declines all liability for technical interventions carried out on the
equipment without formal authorisation from SIARE.
 In order to start the Calibration Program display the lung ventilator

should be operating and correctly connected.
 For tests and checks, please use the patient simulator SIARE cod.
LS.AB.001 that is equipped with variable resistance and compliance.
 For a more correct and detailed analysis of the Calibration Program,
please consult the SERVICE manual.
4.17.2 Calibration Programs displaying
 Set the main switch (placed on the back of the trolley/lung ventilator) in position ”I”.
 Make sure that on the lung

ventilator keyboard (User
commands area) the green
led (that indicates the
presence of mains power
supply) is on.
 In sequence, keep pressed

for a few seconds the
ALARM RESET and ON-
OFF soft keys to switch-up
the lung ventilator.
 The Calibration Programs

page is displayed.
 Select Self Test to switch to the normal operation of the lung ventilator
(see cfr 4.2)
 Select Power Off to switch-OFF the lung ventilator.

The Respiratory Flow Sensors Calibration is necessary in the following cases.

 Noted differences are more than 15% (over 100ml) between the set Volume value ( VTi
- Vte ) and the expired Tidal Volume reading ( Vte ).
 In case of first calibration of lung ventilator or replacement of flow sensors (INSP inside
the unit or EXP outside the unit), it is suggested to perform this calibration.
 Select the function (or

select and press by the
encoder knob).
 The Respiratory Flow

Sensors Calibration page
is displayed.
The Respiratory Flow Sensors Calibration program starts.
The User quit the Respiratory Flow Sensors Calibration and the
system goes back to the ‘Calibration Programs’ visualization.
The User can check the correct Respiratory Flow Sensors

Calibration through the displaying of the Exp - Insp flow parameters.
 Select

Sensors Calibration phase
starts.
 The system provides 11

constant flows at pre-set
intervals ( 0, 1.8,
3.75,…….. ….., 75, 90
litres/minutes) and
captures the values of the
flow sensors signal,
reconstituting the feature.
Select ESC to stop the Respiratory Flow Sensors Calibration phase.
Select Cancel to stop the Respiratory Flow Sensors Calibration.
 At the end of the Respiratory Flow Sensors Calibration phase the system
goes back to the Calibration Programs menu.
 In case of first calibration, we suggest to execute this procedure after
having checked the PEEP calibration and the Leak Test (see on 3.7 Test
on Demand)
 For more information please refer to the SERVICE manual.

 Select

Sensors Calibration check
phase starts.
 The aim of this procedure is

to display and check the
Inspiration Flow and
Expiration Flow measured
values (in l/min) stored
during the Respiratory Flow
Sensors Calibration phase.
 The two measured and
displayed values should
have a numerical value very
similar to each other.
Select ESC to stop the Respiratory Flow Sensors Calibration phase

check.
Select Cancel to stop the Respiratory Flow Sensors Calibration

check.
 At the end of the Respiratory Flow Sensors Calibration check the system
goes back to the Calibration Programs menu.
 For further information please refer to the SERVICE manual.
4.17.4 High Altitude usage ( On - Off )
The activation of the Usage at High Altitude (High Altitude: On) function, is useful to
optimize the calculation of oxygen concentration (FiO2) at heights higher than 2000 mt
on the sea level.

encoder knob).
 The Usage at High Altitude

function is enabled (On).
Nota. Select or press the

encoder knob again; the
Usage at High Altitude
function is disabled (Off).
Select Self Test to go to the Self Test phase and escape from Calibration
Programs window.

4.17.5 CAN module Test
Function not available.
4.17.6 VTEc ( On - Off )
The activation of VTEc ( VTEc On ) function is necessary to optimize the displaying of

calculation of the Vte parameter displayed during lung ventilator operation.

encoder knob).
 Press the encoder knob.
 VTEc function (On) is

enabled.
 Press again the encoder

knob; VTEc function is
disabled (Off)
Select Self Test to go to the SELF TEST phase and escape from
“Calibration Programs”window.

4.17.7 ScreenShot Enable ( On - Off )
This option, if enabled, allows the User to store on an USB key an instant image (image
saved in bmp format) during the operation of the lung ventilator, (for further details, see on
chapter 2).

encoder knob).
 ScreenShot function is
enabled (On).
 Press again the encoder

knob; ScreenShot function
is disabled (Off)
Select Self Test to go to the SELF TEST phase and escape from Calibration
Programs window.
4.17.8 Self Test
Once the Siaretron 4000 15” lung ventilator is switched ON, the system (SW) carries out
the self-diagnostic tests (Self Test) and checks a series of devices necessary for safe lung
ventilator operation.

encoder knob).
 The Self Test phase starts.
For further details, about the Self Test phase, see on chapter 3.5.2.

 The Self Test phase
completed successfully.
Select OK for displaying the Stand-by screen.
Select Cancel for displaying the Supplementary tests screen.
4.18 Power Off

encoder knob).

4.19 Other functions
4.19.1 Reset to ZERO the “Partial operating hours “
The zeroing of the partial operating hours can be performed both in the
page of turbine characterization, and in the expiratory flow sensors
calibration page. As an example, the Expiratory Flow Sensors Calibration
displaying is used.
 Select the function (or select

and press by the encoder
knob).
 The Expiratory Flow Sensors

Calibration page is displayed.
 To continue, see the note

(ATTENTION) below.
WARNING !! Risk of DM failure and/or injuries for the patient
 Refer directly to SERVICE Manual.

 Contact SIARE or a Centre authorized by SIARE.
4.19.2 Data Connection (Trend and Events downloading)
Lung Ventilator: OFF.
The system software permits the

download of the data stored in the
Siaretron 4000 15” memory.
Note! Ask Siare for the dedicated
program to transform the stored and
downloaded data (see procedure
below) into a file that can be read
and interpreted by the User.
 Connect a USB drive to a USB1
socket.
To perform the data download it is

necessary to switch ON the lung
ventilator to enter the "Calibration
Programs" and enable:
 ScreenShoot Enable - On
ScreenShoot enable:
 select Self Test
and follow the procedures indicated

during the power up phase of the
unit (see on chapter 3.3)
Lung Ventilator: Stand-by.
 Check that the USB drive is

connected and active: see
image below (USB).

 Select SETUP
A series of pages (displaying) are

available to determine the operation
SETUP of lung ventilator.
 Select Other
The system displays a page where

the command is enabled that
enables the saving on USB drive of:
Trend and Events.
 Select Save to USB
 Switching OFF the lung

ventilator.
 The Trend and Events data are saved on the USB drive in TXT format.
 Ask Siare for the dedicated program to transform the TXT file into a
readable and interpretable file of the User.
4.19.3 Default parameters set
By selecting the function: MENU SETUP / DEFAULT, the operator has the possibility to
restore the original factory parameters (default parameters).
With the term "Default Parameters" we refer to all the DM settings (MENU, SETUP,
ALARMS Limits, etc ...).
For more information on the default parameters setup, see chapter 4.11.
4.19.4 Touch Screen set
The Siaretron 4000 lung ventilator is equipped with a 15” colour Touch Screen display.
In case of Touch Screen system malfunctioning, it is possible to perform calibration of the
same system (see on Service Manual).
WARNING !! Risk of DM failure and/or injuries for the patient
 Refer directly to SERVICE Manual.

 If the problem persists, contact the Siare Service Centre or a Centre
authorized by Siare.

5 ALARMS
This chapter illustrates the part of the system relevant to the alarms operation of the
Siaretron 4000 15” lung ventilator (hereinafter called lung ventilator); also, the operating
logic and issues for alarms action are taken into consideration.
5.1 Introduction
5.2 Displaying and used symbols
5.2.1 Alarms display area
5.2.2 A1 - Alarm area
5.2.3 A2 - ALARMS parameter
5.2.4 A3 - General information area
5.2.5 A4 - Acoustic alarm silencing
5.3 Alarms setting
5.3.1 Setting of ALARMS limits values
5.3.2 Setting of ALARMS volume
5.3.3 Setting of DEFAULT parameters
5.3.4 Alarms DEFAULT parameters values
5.4 Summary table of alarm characteristics
5.4.1 Alarms configurable by user
5.4.2 System alarms
5.4.3 Gas Sensor Alarms
5.5 Troubleshooting
5.5.1 Troubleshooting list
5.1 Introduction

All the pictures and the examples shown in the present chapter have the
mere purpose of being an example and they do not make any reference to
real clinical cases.

Before using the lung ventilator, it is recommended to set the entries and the
parameters referred to the alarms.
The lung ventilator is equipped with automatic means for detection and identification of
serious and sudden events through alarm signals or information signals.
The aim of the alarm signal is to draw the attention of the user on the event, as well as to
indicate the required response speed.
Level or urgency
 Immediate, the event is potentially able to develop in a period of time which generally is
not enough to undertake a corrective manual action.
 Brief, the event is potentially able to develop in a period of time which generally is
enough to undertake a corrective manual action.
 Delayed, i.e. that the event is potentially able to develop in a not specified period of
time.
Level of severity
 Severe, i.e. leading to irreversible damage.

 Moderate, i.e. leading to reversible damage.
 Minor, i.e. involving a distress or leading to a minor damage.
The combination of urgency level and severity level of the listed factors,
determines the assignment of priority condition of an alarm situation.
The parameters and the characteristics (activation time, presence or lack of
an acoustic and/or luminous indicator) and the possible user’s actions
respect to the alarm signals (silencing, suspend, inhibit) are described here
below.

5.2 Displaying and used symbols
5.2.1 Alarms display area
A1 - Alarm area: this area of the monitor provides the following indications.
 A string of text relevant to the type of active alarm.
 An “alarm bell symbol” which indicates the priority and the alarm state.
 A ‘lock icon’ to be used to inhibit the screen from possible accidental contacts “
A2 - ALARMS parameter
 Touching the icon, it is possible to entry in the ALARMS area and to access the Min and Max.
alarms value setting.
A3 - General information signal area: this area of the monitor provides the following indications.
 Battery charge level and main power presence (failure).
A4 - Soft key for acoustic alarm silencing
5.2.2 A1 - Alarm area
This area shows the text of the active/s alarm/s and the priority / status of the same and a
lock icon indicating whether the touch screen is enabled.
CAUTION
Three different alarms can be displayed at most and simultaneously; any
further alarm signals will be displayed in sequence at intervals of 3/5
seconds.
Priority / alarm status: “ alarm bell symbol “:

The “ alarm bell symbol “ assumes a colour based on the priority and status of the activated
alarm.
Suspended alarm
Media priority
 Yellow bell crossed
 Yellow bell
through
Suspended alarm
High priority
 Red bell crossed
 Red bell
through
"Padlock" icon used to inhibit the screen from accidental contacts
Lock icon (open) green color: touch screen enabled.
Lock icon (closed) red color: touch screen disabled.

Alarms configurable by User System alarms
 Low / High Pressure of Airways  Low Battery: 50% Remaining

 Low / High Respiratory Rate  Low Battery: 25% Remaining
 Low / High Expiratory Volume  Low Battery
 Low / High Volume Minute  Battery Disconnected
 Low / High PEEP  Battery Charger Disconnected
 Low / High O2 Concentration  Battery Overtemperature
 Gas Sensor: Low / High EtCO2  (Patient) Circuit Disconnected
 On Battery (Power Failure - MENU  Low O2 Supply
SETUP - Other)
 Low Air Supply
 Apnoea (MENU SETUP- Other)
 CAN Bus Failure
 MAINTENANCE 1000 hours (* a
symbol replace the alarm bell image).
WARNING !! ( * ) MAINTENANCE 1000 HOURS

Once reached 1000 hours operation this symbol appears.
Contact the Siare Service Centre or a Centre authorized by Siare
for preventive maintenance.
Gas Sensor alarms
 Sampling Line Clogged

 No Sampling Line
 Replace Adapter
 No Adapter
 Unspecified Accuracy (……)
 Error (......)
 No Breaths
 Low EtCO2
 High EtCO2
 Check the Flow Sensor (……)
Characters sequence (…..) has to be considered as an indicator to which the

equipment inserts a value in function.
5.2.3 A2 - ALARMS parameter
This monitor area, allows to display and set the Min and Max. alarms limit values.
 Select: ALARMS icon
The Alarm Limits screen appears.
 Select
NO: it remains in Alarm page.
 Select
 The lung ventilator used in the same health environments can have
different preset configurations of alarm limits.
 Verify that the preset alarm limits are appropriate for the new patient
and adjust the alarm limits on values suitable to the new condition of
use.
 The alarms setting to the range limit could make the alarm not
properly working.

5.2.4 A3 - General information area
This area shows the battery charge level and the power supply status (present/absent).
Green “BATTERY” symbol: battery completely charge:

 with fix symbol the battery is complete charge;
 with flashing symbol, the battery is in charging phase.
Green “PLUG” symbol: lung ventilator connected to the
main power supply.
The absence of Green “PLUG” symbol indicates that the

lung ventilator is not connected to the main power supply
Active alarm: On Battery.
The battery charge level is evidenced by the presence of coloured “notches”

within the symbol, where each notch represents the 25% charging level.
 ORANGE flashing symbol, 2 notches: it indicates that the charge level of

the battery is at 50%.
- The relevant alarm is active (Low Battery: 50% Remaining).
 ORANGE flashing symbol, 1 notch: it indicates that the charge level of the
battery is at 25%.
- The relevant alarm is active (Low Battery: 25% Remaining).
The colour of the last flashing “notch” is red (High priority alarm): this
extremely serious alarm condition indicates that the battery is almost
completely low (Low Battery)
The alarm remains always actives to indicate the occurred
malfunctioning.
5.2.5 A4 - Acoustic alarm silencing
 It’s possible to change the alarm settings even when the alarms are
activated.
 After changing an alarm setting, the relevant sign is lighted and the
status icon will flash for a defined time.
During the normal operating phase of lung ventilator, it is

possible to silence the active acoustic alarm.
 By pressing the Alarm Reset soft key
 By selecting the bell evidencing the active state of the

alarm.

The User should never stop checking the patient conditions during the alarm
silencing.
NOTE
 The acoustic alarm silencing is active and will stop the acoustic alarm for
a defined time.
 During the alarm silencing the alarm text is showed on the panel.
 A new alarm silencing will cancel the alarm text only if the alarm
conditions is disappeared.
 If during the alarm silencing a new high priority alarm occur, the alarm
silencing is cancelled and the acoustic signal and the visual texts are
activated again.

5.3 Alarms setting
5.3.1 Setting of ALARMS limits values

Using in the same area more than one medical device having different alarm
limits setting, the User could have a potential false misinterpretation.
 Before using the lung ventilator, it is suggested to adjust the parameters

necessary for the correct operation of the lung ventilator.
 During operation it is possible to adapt the ALARM limits values setting in
function of the patient clinical situation.
 Select: ALARMS icon
The Alarm Limits screen appears.
 Select
 Select
Available Alarm Limits.
 PAW
 PEEP
 Vte
 Vm
 O2
 RR
 EtCO2
The values set by the scrolling cursor are

displayed in the parameter monitoring box
( e.g. PAW ).
 Select the Alarm Limits to be

modified.
 The parameter bar is
highlighted and the
monitoring parameter box on
display is activated ( e.g.
PAW ).

 40: High Alarm Limits value set (it is
displayed in the PAW parameter box)
 Coloured bar: the bar is active to be
modified
 Scrolling cursor: to be used for setting
the parameter value
 PAW: PAW parameters
 cmH2O: unit of measurement
 White bar: the bar IS NOT active to be
modified
 Scrolling cursor: to be used for setting
the parameter value
 5: Low Alarm Limits value set (it is
displayed in the PAW parameter box)
 Arrows: it increases or decrease a factor
equal to 1 the value of the selected
alarm.
The selection of both the bar or the cursor of the alarm can be done by
using the encoder knob or the touch screen.
 Select
YES: to quit Alarm page; the alarm set
will NOT be saved.
After modification of Alarm limit ( PAW )
values:
 Select
YES: to quit Alarm page; the alarm set
will be saved.
5.3.2 Setting of ALARMS volume
The SOUND VOLUME parameter allows the adjustment of the volume of

acoustic alarms signals at any priority level. Acoustic intensity value at 1 mt
distance.
 Minimum level Acoustic Volume setting at 1 = 54dBA
 Maximum level Acoustic Volume setting at 20 = 70dBA

access the lung
ventilator’s SETTING
MENU.
 Select Display
 To go back to the Stand-by displaying, select Cancel
The Display page allows

to set:
 BRIGHTNESS
 ENERGY SAVING
 SOUND VOLUME
 TOUCH AUDIO

 Select the SOUND
VOLUME scrolling
cursor
 Set the SOUND

VOLUME
 Select
YES: to quit from Display page; the set
will NOT be saved.
NO: it remains in Display page.
After modification of SOUND VOLUME
value.
 Select
YES: to quit Display page; the set will be
saved.
NO: it remains in Display page.

When the alarm Sound Volume is set to the minimum value (Setting = 1), its
intelligibility can be lost.
5.3.3 Setting of DEFAULT parameters
The DEFAULT page allows setting the standard factory parameters.

access the lung
ventilator’s SETTING
MENU.
 Select Default
 To go back to Stand-by page, select Cancel
The Default page allows

to set:
 Setting & Ventilation
Default

 Select Setting &
Ventilation Default
 Select RUN
 The system requires

to confirm the
application of default
parameters.
 Select
YES: to quit Default page; the Default
Parameters will be saved.
NO: it remains in Default page.
Possible User’s options.
 Select
YES: to quit Default page; the Default
Parameters will NOT be saved.
NO: it remains in Default page.
5.3.4 Alarms DEFAULT parameters values
Alarm Settings Adult Paediatric Neonatal
Pressure (cmH2O) 5 - 40 5 - 35 5 - 35
Respiratory Rate
(bpm) 8 - 20 12 - 30 25 - 50
Tidal Volume (ml) 100 - 1000 50 - 30 10 - 30
Minute Volume (L) 2 - 12 1-8 1-4
PEEP (cmH2O) 0 - 15
FiO2 (%) 21 - 80
Gas sensor 1.0 - 5.0
Power Failure Enable
Apnea Time
(configurable in 20 sec.
SETUP – Other area)

5.4 Summary table of alarm characteristics
5.4.1 Alarms configurable by user
Delay Time Suspendable

Alarms Priority Suspendable Inhibition
(s) for (s)
Low Pressure of
HIGH 15 YES 15 NO
Airways
High Pressure of
HIGH 0 NO - NO
Airways
Low Respiratory 3 patient

HIGH YES 30 NO
Rate breaths
High Respiratory 3 patient

HIGH YES 30 NO
Rate breaths
Low Expiratory
HIGH 15 YES 30 NO
Volume
High Expiratory
HIGH 0 YES 30 NO
Volume
Low Volume
HIGH 60 YES 30 NO
Minute
High Volume
HIGH 60 YES 30 NO
Minute
Low PEEP HIGH 0 YES 30 NO
High PEEP HIGH 0 YES 30 NO
Low O₂
HIGH 30 YES 30 NO
Concentration
High O₂
HIGH 30 YES 30 NO
Concentration
Low EtCO2 HIGH 30 YES 30 NO
High EtCO2 HIGH 30 YES 30 NO
Apnoea HIGH 5 - 60 YES 30 NO
On Battery HIGH 15 YES 120 YES
5.4.2 System alarms

(s) for (s)
Low Battery 50%

HIGH 0 YES - YES
Rem.
Low Battery 25%

HIGH 0 YES - YES
Rem.
Low Battery HIGH 0 NO - NO
Battery
HIGH 0 NO - NO
Disconnected
Battery Charger
HIGH 0 NO - NO
Disconnected
Battery
HIGH 0 NO - NO
Overtemperature
(Patient) Circuit
HIGH 0 NO - NO
Disconnected
Low O2 Supply HIGH 0 YES 30 if FiO2=21%
Low Air Supply HIGH 0 YES 30 NO
CAN-Bus Failure HIGH 0 NO - NO
Maintenance 1000
HIGH 0 YES - NO
hours

5.4.3 Gas Sensor Alarms

(s) for (s)
Sampling Line
HIGH 0 YES 30 NO
Clogged
No Sampling Line HIGH 0 YES 30 NO
Replace Adapter HIGH 0 YES 30 NO
No Adapter HIGH 0 YES 30 NO
Unspecified
HIGH 0 YES 30 NO
Accuracy
Error HIGH 0 YES 30 NO
No Breaths HIGH 0 YES 30 NO
Low EtCO2 HIGH 0 YES 30 NO
High EtCO2 HIGH 0 YES 30 NO
Check the Flow

HIGH 0 YES 30 NO
Sensor
5.5 Troubleshooting
This chapter is an indicative but not exhaustive guide for the user and the technician,
providing indications for eliminating, as quickly as possible, most of the problems that may
have caused malfunctioning or alarm signals.
This chapter describes the possible causes of problems, indicated by alarms that are
activated during normal functioning.
WARNING !!
If the problem persists, carry out a complete check of the lung ventilator to
identify any irregularities.
If the problem cannot be resolved, contact the Siare Service Centre or a
Centre authorized by Siare.
5.5.1 Troubleshooting list
Switch ON failure The lung ventilator does not switch on.
 Check that it is connected to the main power supply.

 Check that the main switch is turned to the I position (ON).
 Check the main fuses.
 Check the display connection cable.
 Contact the Siare Service Centre or a Centre authorized by Siare.
Power Failure There is a power supply fault and the lung ventilator is operating on the
battery.
 Check if the LED power indicator is ON.
 Check that the main switch is turned to the I position (ON).
 Check the correct connections of the plug, the fuses and the
connector, and the condition of the cable (if necessary, restore the
connections and replace the cable if it is damaged).
 Check that power is present at the relative socket by plugging in
another electrical device. If there is no power, use another socket
or check the overload switch on the electrical panel of the room.
 Check the 12V voltage is properly supplied to the main board.

Initialization The initialization phase is not completed.
phase - Self Test
 Verify and intervene subject on the error messages detected during

the “SELF TEST” phase (see on following issue).
Turbine: Absent
Oxygen inlet: check that the oxygen is correctly connected to the lung
ventilator. Restore the connection or replace the tubes if damaged.
Check that there is sufficient pressure in the supply system or in the
cylinders. Adjust or repair the supply system (or replace the cylinders)
if the pressure is insufficient.
Air inlet: check that the air is correctly connected to the lung ventilator.
Restore the connection or replace the tubes if damaged. Check that
there is sufficient pressure in the supply system or in the cylinders.
Adjust or repair the supply system (or replace the cylinders) if the
pressure is insufficient.
Insp. flow sensor: if this step is not passed means that the inspiratory
flow is not measured correctly by the sensor so check the inspiratory
flow sensor cable if it is properly connected otherwise the inspiratory
flow sensor is broken so it must be changed.
Exp. flow sensor: if this step is not passed means that the expiratory
flow is not measured correctly by the sensor so check the expiratory
flow sensor cable if it is properly connected, if the problem is not solved
please perform the expiratory flow sensor calibration.
Pressure sensor: if this step is not passed means that the airway
pressure is not measured correctly by the sensor so check if the
inspiratory flow is generated by the ventilator; check if there are
leakages in the inspiratory and expiratory line of the ventilator or in the
patient circuit.
Patient circuit: if this step is not passed means that the measured
airway pressure is very low so check if there are leakages in the
inspiratory and expiratory line of the ventilator or in the patient circuit.
Battery: if this step is not passed means that the battery voltage is less
than 11Vdc so connect the ventilator to the main power supply for 10
hours with the main switch on the I position (ON) and check again. If
the problem is not solved replace the battery.
Oxygen sensor: if this step is not passed means that the oxygen is not
measured correctly by the sensor so check the oxygen sensor cable if
it is properly connected; perform the oxygen calibration in the test on
demand MENU and check the oxygen output if the voltage is under
43mV the oxygen sensor is exhausted and so it must be changed.
Acoustic alarm: at the end of the self test the activate the alarm
sound. If the sound is heard by the operator the alarm reset button
must be pressed, if it is not heard check that the speaker cable is well
connected otherwise the speaker is defective and must be replaced.
 Turn the lung ventilator OFF and ON and repeat “SELF TEST”
phase.
 If the problem persists, contact the Siare Service Centre or a
Soft keys and This condition occurs when the control keyboard or the Encoder are
encoder knob not working.
 Switch the lung ventilator OFF and then switch back ON.
 Continuity test of the keyboard and encoder cable.
CAN-BUS failure This alarm condition occurs in case of system failure (electronic
boards).
 Check if the CAN-BUS cable between the main board and the EV
board is properly connected.
(Patient) Circuit This alarm conditions occur in case of disconnection of the patient
disconnected circuit (missed Vte detection for three times).
 Vte volume limit for circuit disconnected condition: 50ml for ADULT,
20 ml for PAEDIATRIC, 0 ml for NEONATAL patient).
 Check that the mask, endotrachéal tube and patient circuit are not
in some way split, disconnected or connected wrongly. If this is the
case, eliminate the problem or replace them.
 Check the correct settings of the patient's respiratory parameters
(according to the operative mode selected: Volume/Flow, Rate, I/E,
Trigger).
 Check that the patient circuit is connected correctly to the lung
ventilator and to the patient.

Low O2 gas This alarm is enabled when the pressure is insufficient (< 2.7 bar) for
pressure the lung ventilator to operate correctly.
 Check that the oxygen is correctly connected to the lung ventilator.
Restore the connections or replace the tube if damaged.
 Check that there is sufficient pressure in the supply system or in
the cylinders. Adjust or repair the supply system (or replace the
cylinders) if the pressure is insufficient.
 Contact the Siare Service Centre or a Centre authorised by Siare.
Low Air gas This alarm is enabled when the pressure is insufficient (< 2.7 bar) for
pressure the lung ventilator to operate correctly.
 Check that the medical air is correctly connected to the lung
ventilator. Restore the connections or replace the tube if damaged.
 Check that there is sufficient pressure in the supply system or in
the cylinders. Adjust or repair the supply system (or replace the
cylinders) if the pressure is insufficient.
Low battery level This alarm is enabled when the charge level of the battery is at 25%
25% (50%) (50%) of the fully charged level.
 Recharge the battery.
 If the alarm is activated when the battery has not provided the time
autonomy indicated on the technical sheet, request the intervention
of a Service Centre.
It is possible to silence the LOW BATTERY LEVEL 50% e LOW BATTERY

LEVEL 25% alarms pressing the ALARM RESET button on the control
keyboard.
The LOW BATTERY LEVEL 50% alarm will sound again when the battery level
will join the following battery alarm level: LOW BATTERY LEVEL 25%.
The LOW BATTERY LEVEL 25% alarm will sound again when the battery level
will join the following battery alarm level: LOW BATTERY (10 mins).
Low battery (10 This alarm condition is present when the charge battery level is such to
minutes) be guaranteed a residual autonomy of about 10 minutes.
 Verify the power supply connection; recharge the battery.
 If the alarm is activated when the battery has not provided the time
autonomy indicated on the technical sheet, request the intervention
of a Service Centre.
Battery This alarm condition is present when the battery is not properly
disconnection connected to the device.
 Check the battery connection.
Centre authorised by Siare.
Battery charger The alarm condition is present when the battery does not charge
disconnected properly.
 Check the correct connection of the battery.

 Check the output voltage from the charging card to the battery
(12Vdc)
 If the problem persists, contact the Siare Service Centre or a
Battery This alarm condition is present when the battery pack internal
overtemperature temperature pass the 75°C.
Exhausted O2 The oxygen sensor is exhausted.

sensor
 See information on FiO2 % low alarm.
 Replace the oxygen sensor with a new one.
Disconnected O2 This alarm indicates the connection status of the oxygen sensor.
cell
 Check that the oxygen cell is correctly connected.
 Check the condition of the cable and the connector (if necessary,
restore the connection and replace the cable if damaged).
 Replace the oxygen sensor with a new one.

1000 working This alarm condition occurs at overcoming of 1000 working hours from
hours the last reset.
 When this alarm occurs, it is recommended to perform the
preventive maintenance procedure, check the ventilator operation
and finally reset the working hours.
 Contact the Siare Service Centre or a Centre authorised by Siare to
execute the periodic scheduled maintenance.
FiO2 % high This alarm is activated when the measured concentration of oxygen
exceeds the set limit.
 Check that the corresponding alarm limits are set correctly.
 Calibrate the oxygen cell: if the problem occurs again after a short
time, replace the oxygen cell.
FiO2 % low This alarm is activated when the measured concentration of oxygen is
below the set limit.
 Check that the oxygen cell is fitted correctly in its housing.
 Calibrate the oxygen cell: if the problem occurs again after a short
time, replace the oxygen cell.
 Check that the feeding pressure of the medical gases is correct: if it
is not, check the pressure of the distribution system and the correct
connection to the supply.
Min. Vte / VM This alarm condition occurs in case the Vte is lower than set value.

 Check that the mask, endotracheal tube and patient circuit are not
 Check that the mask, endotracheal tube and patient circuit are not
in some way clogged, bent or crushed. If this is the case, eliminate
the problem or replace them.
Trigger).
 Check if the lung ventilator works properly verifying the airways
pressure. If the lung ventilator works properly perform the
expiratory flow sensor calibration.
Max. Vte / VM This alarm condition occurs in case the Vte is higher than set value.

Trigger).
pressure. If the lung ventilator works properly perform the
expiratory flow sensor.
Low (High) PEEP This alarm condition occurs if the measured PEEP value is lower
(higher) than the value set.

 Check if the mask / endotracheal tube / patient circuit / expiratory
valve (membrane), are not damaged, if holes are present or if they
are connected in a bad way. If it’s the case, replace them or solve
the trouble.
pressure.
 In case of differences higher than 2 cmH2O (10%) between the
value set and the value read, a turbine calibration shall be
performed.
 Check the EV1/EV2 electrovalves.

PAW high In this condition, the patient circuit + patient system presents a higher
resistance than expected or a lower compliance. This causes an
increase in airways pressure that exceeds the set limit.
in some way clogged, bent or crushed. If this is the case, eliminate
the problem or replace them.
Trigger).
 Check that the luminous PAW bar on lung ventilator (the airways
pressure curve) correctly follows the inspiration / expiration cycle.
 Check that nothing is limiting the patient's respiratory capacity.
PAW low In this condition, the patient circuit + patient system presents a lower
resistance than expected or a higher compliance. This causes
insufficient ventilation pressure.
Trigger).
 Check that the luminous PAW bar on lung ventilator (the airways
pressure curve) correctly follows the inspiration / expiration cycle.
 Check that the low pressure level is higher than the PEEP level set.
If not, increase it above the PEEP level.
RR high This alarm is activated when the respiratory rate value is higher than
the set value.
 Check that the corresponding alarm limits and the patient's
respiratory parameters are set correctly.
 Check that the patient's respiratory parameters are set correctly.
 Check that the sensitivity of the Trigger is appropriate to the
patient's physiological conditions.
RR low This alarm is activated when the respiratory rate value is lower than the
set value.
 Check that the lung ventilator operates correctly, checking the
airways pressure trend. If the lung ventilator operates correctly,
check the flow sensor and the correct connection of its cable.
Apnea In this condition, no spontaneous respiratory activities is detected (RR

= 0).
 Check that the lung ventilator operates correctly, checking the
airways pressure trend. If the lung ventilator operates correctly,
check the flow sensor and the correct connection of its cable.

Flow sensor The user can note indirectly, by monitoring the flow graph, the value of
calibration failed the expired volume and the peak value of expired flow, if the self-
calibration of the flow sensor has been successful or not.
 Check the proper mounting of the sensor (patient circuit) and the
relevant connections to the lung ventilator and to the patient.
 Check if the patient circuit is properly closed during the calibration.
 Replace the sensor and repeat the expiratory flow sensor
calibration.
CO2 Analyzer Malfunctioning.

 Check the proper mounting of the sensor (patient circuit) and the
relevant connections to the lung ventilator and to the patient.
 Check the IRMA/ISA is enabled in the Calibration Program.
 Check the state indicator on the CO2 analyzer, is a fix green light.
For further information on operating logic and on gas sensor malfunctioning,

make reference to the CO2 Analyzer manual supplied with the device.

6 MAINTENANCE
To guarantee the regular ventilator operation of the Siaretron 4000 15” lung ventilator for
intensive care (hereinafter called ventilator), perform the following maintenance
interventions with the recommended frequency.
All interventions must be conformed to the practice and protocols in force in each facility.
This chapter describes the following operation.
6.1 Notes
6.2 Cleaning, disinfection and sterilization
6.3 General indications
6.3.1 Cleaning
6.3.2 Disinfection and sterilization
6.3.3 Disinfection by immersion (chemical)
6.4 Cleaning, disinfection and sterilization table
6.4.1 Sterilization of EXP V. Monoblock (exhalation block with flow sensor)
6.4.2 Disposable bacteria filter
6.5 Periodic maintenance
6.5.1 Maintenance operations
6.5.2 Cleaning, disinfection and sterilization before use with another patient
6.6 Repairs and spare parts
6.6.1 Spare parts kit for lung ventilator
6.7 Miscellaneous
6.7.1 Storage
6.7.2 Repackaging and shipment
6.7.3 Disposal
6.1 Notes
The instructions for carrying out more detailed tests, for trouble-shooting
and for other interventional procedures, information intended for qualified
technical personnel, are contained in the relative chapter.
On completion of the maintenance operations, all removed components

should be disposed of according to current waste disposal regulations:
components that cannot be destroyed should be sterilized before disposal.
Follow current regulations for the disposal or recycling of all removed

components.

To ensure the safety of the patient and the User, the ventilator must be
inspected and checked when the limit of 1000 working hours has been
reached or, in the event of limited use of the machine, at least every 6
months.
All maintenance and/or repair operations require perfect knowledge of the

ventilator and must therefore only be carried out by highly qualified
personnel, specifically trained and formally authorised by SIARE.
Inappropriate intervention or unauthorized modifications can compromise

safety and cause danger to the patient.
CAUTION
To avoid the danger of electric shock during maintenance and/or repair
operations, make sure that all power supplies have been disconnected,
disconnect the power supply source (positioning the special danger signs)
and disable the protection switch of the ventilator.
CAUTION
Before performing the maintenance or repairing works, also in case of
returning the ventilator for repairing to manufacturer, it is required to clean
and disinfect the ventilator.

6.2 Cleaning, disinfection and sterilization
The User is responsible for carrying out the ordinary maintenance as foreseen in this
chapter.
Cleaning, disinfecting, sterilizing and replacement of parts must be carried out as indicated
in this manual in order to avoid damage to the ventilator which could also endanger patient
and User safety.
WARNING !! Risk of personal injury

 Do not attempt to dismantle, clean or rinse parts or components, such
as the screen or knobs, with liquids or compressed air.
 To avoid exposing the patient to sterilizing substances, these parts

must be sterilized as described below. Remember that exposure to
sterilizing substances can reduce the working life of some components.
 Always use filters to protect circuits and ventilator: if foreseen, handle

the filters with care to reduce the risks of bacterial contamination or
material damage to a minimum.
 Always respect the hospital procedures regarding the control of

infections.
 The ventilator does not require particular maintenance and preventive

operations other than those indicated in this manual or in order to
respect standards applied in the specific country where the ventilator is
sold.
 Siare is aware that working procedures can differ considerably from one
health structure to another: it is therefore impossible to indicate specific
procedures that are suitable for all requirements.
 SIARE cannot be held responsible for the efficacy of the cleaning,

disinfection and sterilization procedures, nor for the other procedures
carried out while the patient is being treated.
 This manual can only provide general instructions for cleaning,

disinfection and sterilization. It is nevertheless the User’s responsibility
to ensure the validity and efficacy of the methods used.
6.3 General indications
6.3.1 Cleaning
Use a disposable cloth moistened with neutral detergent, a chemical substance or the
equivalent; use water to remove any traces of chemical.
 Do not clean or re-use disposable products.
 Do not use hard brushes to clean the components, or other instruments that could
damage their surface.
 Wash the components with hot water and a neutral detergent solution.
 Rinse the parts well with clean hot water (tap water can be used) and leave to dry.
 Siare recommends that the components should be checked every time they are cleaned
and any damaged parts should be replaced.
 Whenever a part or component is changed, check the functioning of the ventilator.
CAUTION
Follow the manufacturer’s instructions for the detergent substances used:
the use of detergents that are too strong could compromise the working life
of the components.
Deposits of detergent substances can cause damage or micro cracks,

especially on parts exposed to high temperatures during sterilization.
6.3.2 Disinfection and sterilization
To disinfect the components, dismantle them and place them in a steam disinfection
chamber at 93°C for 10 minutes.
After this first operation and before placing the components in an autoclave, wrap them in
muslin or in a similar material.
Effective sterilization is achieved in an autoclave at 121°C for approx. 15 minutes.

Always refer to the instructions provided by the autoclave manufacturer
regarding temperature and time.

CAUTION
 Do not disinfect, sterilize or re-use disposable products.
 Disinfect and sterilize every time an infected patient is ventilated.
 In normal conditions, disinfect and sterilize according to how often the

ventilator is used and, in any case, at least once a month.
CAUTION
 That the components should be checked every time they are sterilized
and any damaged parts should be replaced.
 Carrying out a functioning test of the machine whenever parts or

components are replaced.
6.3.3 Disinfection by immersion (chemical)
If a steam disinfection chamber is not available, the dismantled parts can be chemically
disinfected by means of immersion.
Immerse the dismantled components in the solution with the disinfectant, following the
manufacturer’s instructions.
CAUTION
 Not using formaldehyde or phenol-based disinfectants as they can
cause cracking and reticulation of plastic parts;
 Not using too strong disinfectants as they can compromise the working
life of the immersed parts;
 Rinsing and carefully drying the components since marks and other
damage can occur when the components are exposed to high
temperatures.
When disinfection is complete, rinse with running, preferably decalcified, water; shake and
drain off any remaining water. Leave the components to dry completely.
After this first operation and before placing the components in an autoclave, wrap them in
muslin or in a similar material.
Effective sterilization is achieved in an autoclave at 121°C for approx. 15 minutes.
Always refer to the instructions provided by the autoclave manufacturer

regarding temperature and time.
6.4 Cleaning, disinfection and sterilization table
Component Procedure Notes

Use a moistened disposable cloth with
neutral detergent or a chemical substance or
the like. Use water to remove any remaining
traces of chemical.
The User may use disinfectants (e.g.
Buraton 10 F, diluted according to the
manufacturer’s instructions or VPRO 60C°)
to clean the components. Make sure that no sprays
Disinfectants based on the following or liquids penetrate inside
Outer casing
substances can cause damage: the equipment and the
connectors.
 halogen-releasing compounds;
 strong organic acids;
 oxygen-releasing compounds.
Remove any dust from the surfaces or in
openings using a vacuum cleaner or a soft
cloth.
Do not use cloths or

Screen See above. sponges that could scratch
the surface.
To avoid damaging the labels and outer surfaces of the

ventilator, use only the chemical substances listed.
Dismantle and clean: sterilize in an 121°C rubber cycle.

Patient circuit autoclave, disinfect with steam or Before using again, eliminate
(silicone chemically. any humidity inside the tubes
tubes) Check that there are no splits in the tubes by means of compressed air.
and replace them if they are damaged.
The patient circuit can be sterilized by means of steam but

this can lead to early wear of the tubes.
Yellowing and reduced flexibility are side effects caused by
sterilization using steam.

It is necessary to have at least one spare patient circuit in
stock for routine use and /or accidental breaks.
 Do not clean or re-use disposable circuit tubes.
Components that cannot be destroyed should be sterilized

and disinfected according to local standards.
Dismantle and clean with hot water and a Before mounting the filter
Compressor neutral detergent solution. again, eliminate any humidity
air filter
(optional) Check that there are no splits and replace inside the components by
them if they are damaged. means of compressed air.
Compressor air filter (optional)

For more details about the maintenance please refer to the
user manual supplied with the medical air compressor.
Dismantle and clean: sterilize in an Before using again, eliminate

Couplings and autoclave, disinfect with steam or any humidity inside the
connectors chemically. components by means of
compressed air.
Check that there are no splits and replace
them if they are damaged.
 Perform daily cleaning of the mask
following the instructions of the
responsible doctors or recommended
by the Manufacturer.
 Hang up the clean mask to provide

that it is completely dry before use.
Mask  Always clean the mask and the hoses See Manufacturer’s
or use a new mask in case the lung instructions.
ventilator must be used with a
different patient.
 If the lung ventilator is used with more

than one patient in the clinic, insert an
antibacterial filter between the patient
outlet and the hose.
Check the presence of

Water trap If reusable: clean, then sterilize in
fissures and replace in case of
filter autoclave or chemically disinfect.
damages.
Other Carefully follow the manufacturer’s Refer to the accompanying

accessories instructions. documentation.
Perform daily checking’s of

cable condition; any damage,
On the aim to guarantee patient and User also a minimum damage,
Electrical
safety it is necessary to keep the power must be promptly eliminated.
connections
supply cable in perfect conditions.
Eventually replacing the whole
cable.

6.4.1 Sterilization of EXP V. Monoblock (exhalation block with flow sensor)
Disinfect with steam ( 93° - 10 minutes )

or chemically.
It is possible to sterilize the
EXP V. When disinfection is complete, rinse with component with gamma rays
Monoblock running, preferably decalcified, water; or ethylene oxide (ETO).
shake and drain off any remaining water.
Leave the components to dry completely.
CAUTION
 The EXP V. monoblock includes the expiratory valve and the flow
sensor.
 Do not attempt to dismantle or clean with compressed air.
 The EXP. V. monoblock can be washed and disinfected by immersing it

in a bowl with 3 centimetres of liquid (chemical), keeping the connector
for the electrical connections facing upwards, following the
manufacturer’s instructions (see following note about recommended
chemical agents).
The following are chemical agents recommended for cold sterilization

of flow sensor.
 5.25% - 6.15% Sodium Hypochlorite solution
 Protex wipes (Didecyl Dimethyl Ammonium Chloride)
WARNING !! Risk of device failure

EXP valve and EXP flow sensor disinfection.
 Do not use formaldehyde or phenol-based disinfectants as they can
cause cracking and reticulation of plastic parts.
 Do not use too strong disinfectants as they can compromise the
working life of the immersed parts.
 Rinsing and carefully drying the components since marks and other
damage can occur when the components are exposed to high
temperatures.
6.4.2 Disposable bacteria filter
CAUTION
It is important to use a disposable bacteria filter at the
expiratory port of ventilator between the patient circuit’s
expiratory limb and the expiratory flow sensor.
Do not clean or re-use if the filters are the Components that cannot be
Disposable disposable type. destroyed should be sterilized
bacteria filter and disinfected according to
local standards.
WARNING !! Risk of device failure

Disposable bacteria filter.
 Do not attempt to sterilize and reuse a disposable bacterial /HEPA filter.
It is meant for single use.
 Do not use filters that aren’t in sealed pack.
 Do not try to dry the filter and reuse in the same patient in case of
increased resistance.
 Do not use it longer than the time-period recommended by
manufacturer.
 Do not use filters that had exceeded the expiry date.
Disposable bacteria filter.

 Replace the bacterial filter as per manufacturer’s advice (24 - 72 hours).
 If used with humidifier, change the filter more frequently (as and when
the resistance increases or patient’s “work of breathing” increases).
 Immediately replace the filter if it is stained with blood, secretions or
other human fluid
 Check the expiry date before using on patient.
 Change the filter early if nebulisation is done frequently.

6.5 Periodic maintenance
CAUTION
The lung ventilator does not require particular maintenance and preventive
operations other than those indicated in this manual or in order to respect
standards applied in the specific country where the ventilator is sold.
 Inspections and periodic maintenance are ensured by taking out a maintenance

contract with SIARE or an authorised dealer.
 Contact SIARE for information regarding authorised Service Centers in your area.
 When you require service, please indicate the serial number of the unit and the problem
to SIARE or to your authorised technicians.
 SIARE assumes responsibility for all provisions foreseen by the law, if the equipment is
used and maintained as per the instructions in this manual and the technical manual
 The Technical Assistance Report, signed by the authorised SIARE technician, is proof
of the completion of the scheduled maintenance.
6.5.1 Maintenance operations

Always refer to the instructions contained in the previous section: cleaning,
disinfection and sterilization of the components.
The table summarizes the preventive maintenance frequency and procedures to be carried
out on the lung ventilator.
Frequency Component Procedure / Action
Several times a day Patient circuit Check for any water collection, drain and clean the
/ according to local tubes when necessary.
practice and
standards Disposable bacteria Replace
filter
Condensation trap Check for any water collection, drain and clean
filter when necessary.
Frequency Component Procedure / Action
Every day / when Oxygen sensor Calibrate according to the procedures described in
necessary this manual.
Condensation trap Check for any water collection, drain and clean
filter when necessary.
Lung ventilator General cleaning and checks.
Sterilize / disinfect according to the procedure

EXP. V. Monoblock described in this manual and according to local
standards.
Every 6 months or Lung ventilator The lung ventilator must be inspected and
1000 working hours checked in general and any worn parts must be
(*) replaced.
Use the appropriate preventive maintenance kit.
Oxygen sensor Replace.
The working life of the cell depends on the working

environment. If the temperature or the O2 % is
high, the working life of the sensor will be lower.
O2 and Air filters Replace.
Patient circuit (silicone Sterilize according to the procedure described in

tubes) this manual and according to local standards.
Washers / O-Rings Components that cannot be destroyed should be

sterilized before disposal.
Every year ( * ) Lung ventilator Check the lung ventilator performance.
This includes an electrical safety test and

inspection of the ventilator for mechanical damage
and legibility of the labels.
The lung ventilator must also be inspected and

checked in general and worn parts must be
replaced, using the appropriate preventive
maintenance kit.
Use the appropriate preventive maintenance kit.
Every two years / Internal battery Replace.

when necessary
This operation must only be carried out by
qualified technical personnel, according to the
instructions contained in the relative service and
maintenance manual.
The working life of the battery depends on the

working conditions and environment.

WARNING !! Risk of injury for the patient ( * )
All maintenance and/or repair operations require perfect knowledge of the
ventilator and must therefore only be carried out by highly qualified
personnel, specifically trained and formally authorised by SIARE.
Inappropriate intervention or unauthorized modifications can compromise

safety and cause danger to the patient.
CAUTION
To avoid damage to components due to excessive wear, carry out

preventive maintenance and replace parts following the recommended
frequency.
6.5.2 Cleaning, disinfection and sterilization before use with another patient
We recommend the use of procedures for sterilization and disinfection referred to in the
preceding paragraphs when a new patient must use the lung ventilator.

It is recommended to sterilize / disinfect the lung ventilator every time is
used with another patient.
6.6 Repairs and spare parts
Use only original SIARE spare parts or spare parts checked and approved
by SIARE.
6.6.1 Spare parts kit for lung ventilator
Code: R501000A1
Spare parts kit for annual maintenance to be used with the Siaretron 4000
15”, code 960501.
6.7 Miscellaneous
6.7.1 Storage
If for any reason the lung ventilator is not used, we suggest leaving it in its
original packaging and storing it in a safe and dry place.
If it is believed that the lung ventilator will be left unused for at least 6
months, Siare recommends disconnecting the battery or recharging it every
3/6 months, depending on the storage temperature.
See the technical sheet in the Appendix A.
6.7.2 Repackaging and shipment
If it is necessary to return the equipment to SIARE for any reason, we

suggest using the original packaging to prevent damage to the equipment
during shipment.
If this is no longer available, order a repackaging kit.
6.7.3 Disposal
Batteries, accumulators, oxygen cells and electronic parts in general:

 do not put them in the fire, explosion risk
 do not open them, corrosion danger
 do not recharge batteries
 do not throw them away with normal waste.
The batteries and the accumulators are special waste materials and they
must be disposed of in appropriate containers in accordance with local
regulations for the disposal of such waste materials.
The components of the electronic boards can contain compounds, such as

arsenic, lead, cadmium, mutagenic and cancerogenous agents, that are a
health hazard if dispersed in the environment in an uncontrolled way.
For further information contact the relevant authorities for environmental and public health
monitoring.

A APPENDIX
This chapter includes all the information and data necessary to provide full knowledge and
interpretation of the Siaretron 4000 15” lung ventilator (hereinafter called lung ventilator)
manual.
This chapter describes the following operation.
A.1 Technical sheet

A.1.1 Ventilator for Intensive Care - code 960501
A.2 Preliminary checks
A.3 Table for Identification of medical gas hose colours
A.4 IP classification
A.4.1 First digit: solid particle protection
A.4.2 Second digit: liquid ingress protection
A.4.3 Additional letters
A.5 Pneumatic diagram
A.5.1 Pneumatic diagram description
A.6 Glossary
A.7 Electromagnetic compatibility tables
A.7.1 Annex A: Table 1
A.7.2 Annex B: Table 2
A.7.3 Annex C: Table 3
A.7.4 Annex E: Table 5
Siaretron4000e - 15 A-1
A.1 Technical sheet
A.1.1 Ventilator for Intensive Care - code 960501
GENERAL DATA
Siaretron 4000 15” electronic lung ventilator is equipped with a TFT LED 15”
touch screen - colour monitor displaying the curves of pressure, flow, volume,
the loops of breathing parameters, the trends and the ventilation parameters.
Siaretron 4000 15” lung ventilator is suitable for ventilation of adult, paediatric
and neonatal patients.
Siaretron 4000 15” is equipped with a flow and pressure trigger, it provides
the most advanced volume controlled ventilation modalities VC/VAC,
VC/VAC-BABY, pressure controlled ventilation modalities APCV (BILEVEL
ST), APCV-TV, SIMV by Volume and by Pressure, Pressure supported
modalities PSV (BILEVEL S), PSV-TV, CPAP, APRV, SIGH, Non Invasive
Ventilation (NIV APCV - NIV PSV), Drug Nebulizer (NEB) and Manual
Ventilation (MAN).
Siaretron 4000 15” is supplied with back up long lasting batteries and its
software can be updated for new modes and last generation ventilation
strategies.
Optional Medical air compressor for trolley mounting.
NORMS
The lung ventilator complies with the essential requirements and it is realized
0476 according to the references of the Annex II of 93/42/EEC Medical Devices
Directive.
Class and type according to Class I Type B

IEC 601-1
Class according to 93/42 Class IIb

EEC Directive
Electromagnetic Conform to the requirements of the EN 60601-1-2: 2015 and following

compatibility (EMC)
Norms DIR. 93/42/CEE (2007); EN 60601-1 :2006/A1 :2011/A1 :2013; EN 60601-1-2

:2015; IEC 601-1-6:2013; IEC 601-1-8:2012; EN 62304:2006/AC:2008; ISO
10993-1:2009; IEC 62353:2014; EN 60601-2-12:2007; ISO 80601-2-12:2011;
ISO 15223-1:2016; DIR. 2011/65/CE; D.Lgs 49/2014; ISO 14971:2012; EN
ISO 4135:2001
ENVIRONMENTAL CONDITIONS
Operating Relative humidity: 30 - 95% non-condensing
Temperature: from +10 to +40°C
Storage Relative humidity: < 95%

Temperature: from -25 to +70°C
A-2 User manual, DU3501101

TECHNICAL DATA
Dimensions (W x H x D) Ventilator unit and trolley 530 x 1400 x 460 mm
Weight 26 Kg
Electric power supply 100 - 240Vac / 50 - 60Hz
Power Max 50 VA
External power supply (low 12 Vdc / 4.2 A

tension)
Internal battery 2 batteries (Pb 12 Vdc - 1,3 Ah)
Internal battery operation 90 minutes max.
Battery re-charging time About 8 hours
External electric  RJ connector for O2 cell connection

connections
 RJ connector for Flow sensor connection
Electric external  RS232 for CO2 module

connections (optional)
 USB 1 (connector for CPU programming)
 USB 2 (connector for transfer patient data, events, trends)
Patient connections Male conic connectors 22 mm / Female of 15 mm (according to EN ISO

5356-1:2015 norm)
Supply pressure Oxygen - Air: 280 kPa - 600 kPa / 2.8 - 6 bar / 40 – 86 psi
Max flow requested 120 l/min (for each gas inlet)
IP degree of protection IP21
LUNG VENTILATOR FUNCTIONAL FEATURES

Use destination Ventilator for intensive care therapy; it is suitable for ventilation of Adult,
Paediatric and Neonatal patients.
Operation principle  Time cycled at constant volume

 Pressure cycled
 Microprocessor controlled flow
 Spontaneous breath with integrated valve
Pressure automatic Automatic compensation of atmospheric pressure on measured pressure:
compensation present (max. 5000 mt)
Dead space compensation Automatic compensation of mechanical and patient circuit dead space
Automatic leaks Present: with FLOW parameter set in AUTO, in NIV modalities (NIV APCV,
compensation NIV PSV): max 60 l/min
Leak % visualization Present
Visualization of the oxygen Present

consumption calculation
Altitude compensation for Present

oxygen sensor
Respiratory parameters Present (Neonatal, Paediatric, Adult)

default setting
Ventilation modalities  APCV (BILEVEL ST), APCV-TV, PSV (BILEVEL S), PSV-TV (Auto
Weaning), VC/VAC, VC/VAC BABY, V-SIMV+PS, P-SIMV+PS, CPAP,
APRV
 SIGH, NEB (Nebulizer), Apnoea BACK-UP (PSV, PSV-TV, CPAP),

MANUAL
Breathing rate VC/VAC From 4 to 150 rpm
 Ti min = 0.036sec (minimum inspiratory time)

Inspiratory and Expiratory  Ti max = 9.6sec (maximum inspiratory time)
Time (maximum, minimum)  Te min = 0.08sec (minimum expiratory time)
 Te max = 10.9sec (maximum expiratory time)
Breathing rate From 1 to 60 bpm
V-SIMV e P-SIMV
SIMV Inspiratory time From 0.2 to 5.0 sec.
Tidal volume (Vt)  From 100 to 3000 ml (Adult)
 From 50 to 400 ml (Paediatric)
 From 2 to 100 ml (Neonatal)
I:E ratio From 1:10 to 4:1
Inspiratory pause From 0 to 60 % of the inspiratory time
Inspiratory pressure limit Pinsp: from 2 to 80 cmH2O (in function of low and high pressure alarm set)
Inspiratory flow From Auto, 5 to 120 L/min
PEEP From OFF, 1 to 50 cmH2O
PEEP adjustment Microprocessor controlled valve
O2 concentration Adjustable from 21 to 100% with electronic integrated mixer
Trigger detective method Through sensor (Pressure or Flow)
Pressure trigger By adjustable pressure from OFF; -1 to -20 cmH2O under PEEP level (step of
1 cmH2O)

Flow trigger Flow adjustable from OFF; 0.3 to 15 L/min
 From 0.3 to 1 L/min: step of 0.1 L/min

 From 1 L/min to 2 L/min: step of 0,5 L/min
 From 2 L/min to 15 L/min: step of 1 L/min
Trigger E From 5 to 90 % of the inspiratory flow peak
Inspiratory flow max. 120 l/min per every gas (240 L/min max.)
Flow-by 0,6 l/min + Flow Trigger
PS (pressure support) From 2 to 80 cmH2O (PSV, V-SIMV+PS, P-SIMV+PS)
SIGH in VC/VAC modality  Interval: 40 ÷ 500 bpm (step 1 bpm)

 Amplitude: OFF, 10 ÷ 100% of set Tidal Volume (step 10%)
CPAP From 3 to 50 cmH2O
APRV  Time High and Time Low: from 1 to 200 sec.
 Pressure High and Pressure Low: from 3 to 50 cmH2O
Functions  MENU function (SETUP – PATIENT DATA)

 Alarms Limits
 Graphics visualization (Auto-Range)
 INSP Block - EXP Block (max 20 sec.)
 O2 100% control (O2 to 100% max. 5 min.)
 NEB control (6 l/min)
 MAN control (manual ventilation)
Miscellaneous Connector for “Remote Alarm”
NEB Drug nebulizer: selectable to 6 l/min with automatic compensation on forced

ventilation modes and dedicated output
Patient circuit  Double hose 150 cm. Adult/Paediatric patient circuit (expiratory valve on
the ventilator)
 Double hose 150 cm. Neonatal patient circuit (expiratory valve on the
ventilator)
Expandability Software upgradeable
USER INTERFACE
Touch screen monitor Module with TFT LED display with touch screen
Dimensions 15”
Displaying area 304 x 228 mm
Display keyboard Keyboard for rapid access of functions. Encoder knob for:
 selection, set up and confirmation of physiological breathing parameters
 selection and direct activation of function
Displaying and settings  Operative Mode setting
 Visualization of alarm messages and signals
 Setting and monitoring of physiological breathing parameters
 Visualization of additional graphs and breathing parameters
 MENU function for setting operation parameters
 Activation of special functions
 Visualization of operative mode, clock, date and time functions
 Visualization of software version
Calibration Programs  Self Test
 Turbine Characterization
 Expiratory Flow Sensor Calibration
 Usage at High Altitude
 VTEc
 Nebulizer Enable
 ScreenShoot Enable
MENU function - SETUP  Display (Brightness, Energy Saving, Sound Volume, Touch Audio)
 Date & Time
 Language
 Units (Weight, Height, CO2, Pressure)
 Default (Default parameters: Erase Trend data, Erase Patient data,

Setting & Ventilation Default)
 Other (NIV Enable, Power Failure, Apnoea Time, Change Password,

Save to USB)
 Gas Sensor (IRMA/ISA)
 Supplementary Tests (Expiratory Flow Sensor Calibration, O2 Sensor

Calibration)
 Turn Off?
MENU function - PATIENT The PATIENT DATA can be set or deleted

DATA

Alarm Limits PAW (cmH2O), PEEP (cmH2O), Vte (ml), VM (L/min), O2 (%), RR (bpm),
EtCO2 ( % )
Displayed graphics  CURVES: Pressure (PAW) - Flow - Volume (Vte) - O2 (CO2 optional)
 LOOPS: Pressure / Volume - Flow / Volume - Pressure/Flow
 Graphics: INSP-EXP cycle
 Events
 Trends
Events Memory storage up to 100 machine events including the alarms.
Trends Storage capacity (72 h) of all measured parameters.
Physiological breathing Vti (ml), RR (bpm), I:E, Pause (%),PEEP (cmH2O), O2 (%),Tr. I (L/min -
parameters setting cmH2O), SIGH (Sigh. Amp. (%), Sigh. Int. (b)), Vte (ml), PMax, Pmin, Pinsp
(cmH2O), Flow (L/min), BACK-UP parameters, PS (cmH2O), RRsimv (bpm),
Ti (s), Ti Max (s), Tr. E (%), CPAP (cmH2O), Pressure High - Low (cmH2O),
Time High - Low (s).
Range of measured  Rate (range: 0 ÷ 200 bpm)

parameters
 I:E ratio (range 1:99 ÷ 99:1)
 % of FiO2 (range: 0% ÷ 100%)
 Tidal Volume: Vte, Vti (range: 0 ÷ 3000 ml)
 Minute Volume (range: 0 ÷ 40 l/min)
 PAW: peak, mean, plateau, PEEP (range -20 ÷ 80 cmH2O)
 Inspiratory Peak Flow (range: 1 ÷ 240 l/min)
 Expiratory Peak Flow (range: 1 ÷ 150 l/min)
 Tinsp., Texp, Tpause (range 0.036 ÷ 10,9sec)
 Static and Dynamic compliance (range: 10 ÷ 150 ml/cmH2O)
 Resistance (range: 0 ÷ 400 cmH2O/l/s)
 EtCO2: with optional CO2 module (range: 0 ÷ 10%)
 Leak (%) (range: 0 ÷ 100%)
 O2 consumption (range: 0 ÷ 100l/min)
Displayed parameters PAW, PEEP, CPAP (cmH2O), RR (bpm), I:E, O2 (% - l/min), Vte (ml),
VM (L/min), EtCO2 ( % ), MAP (cmH2O), Pplateau (cmH2O), Fi , Fe (L/min),
Ti, Tpause, Te (sec.), Ri (cmH2O/l/s), Cs, Cd (ml/cmH2O), Leak ( % )
Flow sensor Magnetic disturbance (patented), multi-usage type
Calibration Automatic (started by the operator)
Maintenance By steam or chemical disinfection
Oxymeter Electronic (value displayed in breathing parameters)
Calibration Automatic (started by the operator)
CO2 analyzer Optional function (Sidestream or Mainstream module available)
ALARMS
Alarm types  By MENU: with limits set by the operator
 By default: the operator cannot set them up
Alarms default setting Present (Neonatal, Paediatric, Adult)
Alarm priority High - Mean - Standby
Alarms visualization Max 3 alarms simultaneously; additional alarms, scroll every 3-5 sec.
Alarms with limits set up by the operator
Pressure of Airways High – Low
Respiratory Rate High – Low
Expiratory Volume High – Low
Volume Minute High – Low
PEEP High – Low
O2 Concentration High – Low
EtCO2 High – Low (with optional CO2 gas analyser)
On Battery Alarm occurs in case of failure of external power supply
Apnoea Low Rate (function of Apnoea BACK-UP)
System alarms
Low Battery: 50% Remaining Battery at 50%
Low Battery: 25% Remaining Battery at 25%
Low Battery 10 Minutes
Battery Disconnected Yes / No

Battery Overtemperature Indication of exceeding the temperature limits inside the battery
Circuit Disconnected Indication of patient circuit disconnected
O2 Supply Low (< 2,7 bar)
Air Supply Low (< 2.7 bar)
Maintenance 1000 hours
CO2 Analyzer Sampling Line Clogged, No Sampling Line, Replace Adapter, No

Adapter, Unspecified Accuracy, Error, No Breaths, Low/High EtCO2.
SELF-TEST alarms
Turbine Verification of the presence
Gas supply Verification of the presence of Air and O2 supply pressure
INSP.- EXP. Flow sensor Verification of flow sensors operation
Pressure sensor Verification of pressure sensor operation through control of PAW reading
Patient circuit Verification of patient circuit
Battery Checking on battery power
Oxygen cell Cell condition
Acoustic alarm Verification by the user of acoustic signal emission, the confirmation of the
test is made by silencing of that alarm
ACCESSORIES
Supplied Accessories  User's Manual
 O2 supply hose
 AIR supply hose
 Nebulizer set
 Double hose patient circuit
 Antibacterial filter
 Power cable
 O2 cell
Optional Accessories Refer to price list.

A.2 Preliminary checks
See the table here below.
List of preliminary checks
REF. DESCRIPTION MEASURE RESULT NOTES
1. ON/OFF SWITCH  Pos.  Neg.
2. SELF TEST overcome  Pos.  Neg.
3. O2 sensor calibration (TEST) _____ %  Pos.  Neg.
4. O2 - FiO2 alarm check  Pos.  Neg.
5. Leak test (TEST) _____ Leak  Pos.  Neg.
OPERATIVE MODE : VC-VAC / PARAMETERS MONITORING
6. Vti check: 500mv  Pos.  Neg.
7. Rate check: 15  Pos.  Neg.
8. I:E ratio check: 1:2  Pos.  Neg.
9. PEEP check: (5 – 10 cmH2O)  Pos.  Neg.
10. PAUSE check: 50 %  Pos.  Neg.
11. FiO2 check: 21%  Pos.  Neg.
ALARM CHECKS
12. High / Low Pressure  Pos.  Neg.
13. High / Low Frequency  Pos.  Neg.
14. High / Low Expired Vte  Pos.  Neg.
15. High / Low Volume Minuto  Pos.  Neg.
16. High / Low airways PEEP  Pos.  Neg.
17. High / Low oxygen concentration  Pos.  Neg.
18. Main power failure  Pos.  Neg.
19. Gas supply failure  Pos.  Neg.
20. High / Low EtCO2  Pos.  Neg. (with optional

CO2 module)
RESPIRATORY PARAMETERS CHECKS
21. Pmax Check  Pos.  Neg.
22. Peep Check  Pos.  Neg.
23. Rate Check  Pos.  Neg.
24. I:E Check  Pos.  Neg.
25. O2 Check  Pos.  Neg.
26. Vte Check  Pos.  Neg.
27. VM Check  Pos.  Neg.

A.3 Table for Identification of medical gas hose colours
GAS SYMBOL ISO & UK USA GERMANY
OXYGEN O2 White Green Blue
NITROUS OXIDE N2O Blue Blue Grey
CARBON CO2 Grey Grey -

DIOXIDE
CYCLOPROPANE C3H6 Orange Orange -
MEDICAL AIR AIR White & Black Yellow Yellow
ENTONOX 50/50 N2O + O2 Blue & White - -

N2O/O2
EMPTY - Yellow - -
A.4 IP classification
The IP Code, International Protection Marking, IEC standard 60529, sometimes interpreted as
Ingress Protection Marking, classifies and rates the degree of protection provided against intrusion
(body parts such as hands and fingers), dust, accidental contact, and water by mechanical casings
and electrical enclosures. It is published by the International Electro technical Commission (IEC).
The equivalent European standard is EN 60529. This table shows what each digit or part of the IP
code represents.
First digit Second digit Third digit Additional letter

IP
indication Solid particle Liquid ingress Mechanical impact
Other protections
protection protection resistance
Single numeral: Single numeral: Single numeral:

IP Single letter
0–6 0–9 0–9
Mandatory Mandatory Mandatory No longer used Optional
A.4.1 First digit: solid particle protection

The first digit indicates the level of protection that the enclosure provides against access to
hazardous parts (e.g., electrical conductors, moving parts) and the ingress of solid foreign objects.
Level Effective
Description
sized against
0 — No protection against contact and ingress of objects
Any large surface of the body, such as the back of a hand, but no
1 >50 mm
protection against deliberate contact with a body part
2 >12.5 mm Fingers or similar objects
3 >2.5 mm Tools, thick wires, etc.
4 >1 mm Most wires, slender screws, large ants etc.
Ingress of dust is not entirely prevented, but it must not enter in

5 Dust protected sufficient quantity to interfere with the satisfactory operation of the
equipment.
No ingress of dust; complete protection against contact (dust tight). A

6 Dust tight vacuum must be applied. Test duration of up to 8 hours based on air
flow.

A.4.2 Second digit: liquid ingress protection
The second digit indicates the level of protection that the enclosure provides against harmful ingress
of water. The ratings for water ingress are not cumulative beyond IPX6.
A device which is compliant with IPX7, covering immersion in water, need not be compliant with IPX5
or IPX6, covering exposure to water jets. A device which meets both tests is indicated by listing both
tests separated by a slash, e.g. IPX5 / IPX7.
Protection
Level Effective against Details
against
0 None — —
Dripping water (vertically falling
drops) shall have no harmful Test duration: 10 minutes.
effect on the specimen when
1 Dripping water Water equivalent to 1 mm rainfall
mounted in an upright position
onto a turntable and rotated at 1 per minute.
RPM.
Vertically dripping water shall Test duration: 2.5 minutes for
have no harmful effect when the every direction of tilt (10 minutes
Dripping water enclosure is tilted at an angle of
2 when tilted at total).
15° from its normal position.
15° Water equivalent to 3 mm rainfall
A total of four positions are tested
within two axes. per minute.
For a spray nozzle:

Water falling as a spray at any
angle up to 60° from the vertical Test duration: 1 minute per
shall have no harmful effect, square meter for at least
utilizing either: a) An oscillating 5 minutes
fixture, or b) A spray nozzle with a
counterbalanced shield. Water volume: 10 litres per
3 Spraying water minute
Test a) is conducted for 5
minutes, then repeated with the Pressure: 50–150 kPa
specimen rotated horizontally by
90° for the second 5-minute test. For an oscillating tube:
Test b) is conducted (with shield Test duration: 10 minutes

in place) for 5 minutes minimum.
Water Volume: 0.07 l/min per hole
Water splashing against the
enclosure from any direction shall
have no harmful effect, utilizing Oscillating tube:
either: a) An oscillating fixture, or
Splashing of b) A spray nozzle with no shield. Test duration: 10 minutes, or
4 spray nozzle (same as IPX3
water
Test a) is conducted for 10 spray nozzle with the shield
minutes. removed).
Test b) is conducted (without
shield) for 5 minutes minimum.
Protection
against
Test duration: 1 minute per
square meter for at least
Water projected by a nozzle 15 minutes
(6.3 mm) against enclosure from
5 Water jets Water volume: 12.5 litres per
any direction shall have no
harmful effects. minute
Pressure: 30 kPa at distance of
3m
Test duration: 1 minute per
square meter for at least
Water projected in powerful jets 3 minutes
Powerful water (12.5 mm nozzle) against the
6 Water volume: 100 litres per
jets enclosure from any direction shall
have no harmful effects. minute
Pressure: 100 kPa at distance of
3m
Water projected in powerful jets
(6.3 mm nozzle) against the Test duration: at least 3 minutes
Powerful water enclosure from any direction,
jets with Water volume: 75 litres per
6K under elevated pressure, shall
increased minute
have no harmful effects.
pressure Pressure: 1000 kPa at distance of
Found in DIN 40050, and not IEC 3m
60529.
Test duration: 30 minutes - ref
Ingress of water in harmful IEC 60529, table 8.
quantity shall not be possible
Immersion, up when the enclosure is immersed Tested with the lowest point of the
7 enclosure 1000 mm below the
to 1 m depth in water under defined conditions
of pressure and time (up to 1 m of surface of the water, or the
submersion). highest point 150 mm below the
surface, whichever is deeper.
The equipment is suitable for
continuous immersion in water
under conditions which shall be
specified by the manufacturer.
However, with certain types of
equipment, it can mean that water Test duration: Agreement with
Immersion, can enter but only in such a Manufacturer.
8 1 m or more manner that it produces no
depth harmful effects. Depth specified by manufacturer,
generally up to 3 m .
The test depth and duration is
expected to be greater than the
requirements for IPx7, and other
environmental effects may be
added, such as temperature
cycling before immersion.

Protection
against
Protected against close-range
high pressure, high temperature
spray downs.
Smaller specimens rotate slowly Test duration: 30 seconds in each

on a turntable, from 4 specific of 4 angles (2 minutes total)
angles. Larger specimens are
Powerful high mounted upright, no turntable Water volume: 14–16 litres per
9K temperature required, and are tested freehand minute
water jets for at least 3 minutes at distance
Pressure: 8–10 MPa (80–100 bar)
of 0.15–0.2 m.
at distance of 0.10–0.15 m
There are specific requirements Water temperature: 80 °C
for the nozzle used for the testing.
This test is identified as IPx9 in

IEC 60529.
(All tests with the letter "K" are defined by ISO 20653 (replacing DIN 40050-
9) and are not found in IEC 60529, except for IPx9 which is the same as the
IP69K water test.)
A.4.3 Additional letters

Further letters can be appended to provide additional information related to the protection of the
device.
Letter Meaning
f Oil resistant
H High voltage device
M Device moving during water test
S Device standing still during water test
W Weather conditions
A.5 Pneumatic diagram

A.5.1 Pneumatic diagram description
The mechanical study and diagram of the pneumatic system for gas delivery and dosage is
given in the attached illustrations.
The system is designed to safely administer the correct amount of respiratory gas to the
patient, and is completely controlled by the electronic system.
The device can be configured to use either a single or dual limb patient circuit (see the two
pneumatic diagrams attached).
PR AIR Air pressure regulator. It reduces the infeed gas pressure at a stable
value of 2.6 bar.
PR O2 Oxygen pressure regulator It reduces the infeed gas pressure st a

stable value of 2.6 bar.
FILTER Medical gas infeed filter
GAS SUPPLY Medical gas supply pressure sensor. It signals when the gas pressure
TRANSDUCER is missing or is insufficient.
NEBULIZER Digital flow generation Block for nebulizer (6 litres).

D.F.G.
12 V pilot solenoid valve usually closed, controlled by a
microprocessor. Its function is to activate the nebulization flow.
AIR D.F.G. Air circuit digital flow generation block (120 l/min)
12 V pilot solenoid valve usually closed, controlled by ventilator

microprocessor. Once activated, each solenoid valve opens allowing
the passage of a pre-set flow regulated by the relative flow regulator.
In automatic mode - inspiratory phase, the microprocessor controls

the activation and therefore the opening of the solenoid valves
necessary to provide the required flow based on the set ventilator
parameters.
OXYGEN D.F.G. Oxygen circuit digital flow generation block (120 l/min)
12 V pilot solenoid valve usually closed, controlled by ventilator

the passage of a pre-set flow regulated by the relative flow regulator.
In automatic mode - inspiratory phase, the microprocessor controls

the activation and therefore the opening of the solenoid valves
necessary to provide the required flow based on the set ventilator
parameters.
V EXP D.C. 12 V pilot solenoid valve usually closed, controlled by ventilator
the distribution of a pre-set flow regulated by the relative flow
regulator.
In the inspiratory phase of the automatic mode, the microprocessor

controls the activation and then opening of all these solenoid valves
so that the provided flow fully closes the expiratory valve.
In expiratory phase are activated only the solenoid valves that allow
providing the flow necessary to partially close the expiratory valve so
as to obtain the desired PEEP.
NEBULIZER Output coupling for nebulizer circuit (6 litres).
INSP VALVE Inspiratory circuit valve
EXP VALVE Expiratory circuit valve
AIR SAFETY Environmental air infeed safety valve that allows ventilation even if the
VALVE. medical gas supplying the patient circuit is missing. It opens with
negative pressure of 2 mbar.
LIMIT VALVE The "pressure limit valve" is necessary to limit airway pressure
(80 cmH2O).
OXYGEN Polarographic oxygen transducer. It measures the real oxygen

SENSOR concentration administered to the patient.
INSP FLOW Semiconductor inhaled flow sensor.

SENSOR
EXP FLOW Semiconductor exhaled flow sensor.

SENSOR
PAW Semiconductor pressure sensor. It continuously measures the

TRANSDUCER pressure inside the respiratory circuit.
PEEP PEEP valve flow regulator

A.6 Glossary
A Ampere (current intensity measurement unit)
Alarm message A message which appears together with an alarm indication; this consists of a
basic message indicating the type of alarm.
Alarm silencing or Key that stops the acoustic alarm signal for a software value preset by the last
suspension key pressing of the key.
APCV Pressure controlled ventilation: type of controlled ventilation during which the
ventilator delivers an inspiratory pressure set by the user for an inspiratory
time also set by the user.
Apnoea End of ventilation. The ventilation system indicates apnea and starts the
corresponding ventilation when the interval between the two respiratory cycles
exceeds the set apnoea time.
Automatic alarm This occurs when an alarm is disabled, i.e. when the alarm conditions are no
resetting longer present, without pressing the alarm reset key. ALARM RESET
Basic flow Constant flow (depending on the sensitivity value set in the “trigger value”
parameter) circulating in the patient circuit with respect to which the ventilator
measures the Flow Trigger value.
CE A certificate of origin issued by the European Economic Community indicating

that the equipment conforms to the Medical Device Directive (MDD),
93/42/EEC.
Clinical alarm An alarm that can indicate an abnormal physiological condition
cm Centimetre (unit of length).
cmH2O Centimetres of water (unit of pressure = 0.98068 mbar = 1 hPa).
Compliance (Cs) This term defines the variation in volume of the respiratory tract determined by
a variation in pressure; it is measured in ml/cmH2O. It provides an indication of
the elastic properties of the respiratory system and its components (Inspiratory
Tidal Volume / Pause Pressure).
Compressor The Compressor (optional) provides the system with compressed air and can
be used instead of the mains or cylinder supply of compressed air.
CPU Central processing unit
DISS Diameter Index Safety Standard: a standard for high pressure gas input
connectors.
EMC Electromagnetic Compatibility
EN European norm referring to the European Economic Community
EPU Electric power supply unit: the battery powers the system with direct current if
the alternate current supply is not available. On the basis of the ventilator
settings, the battery can provide back-up power for at least 3 hours in rated
and perfect working conditions.
Error Category of conditions detected during functioning of the system implying an

open safety status. A fan FAILURE means that the fan cannot be clinically
used and must be repaired immediately.
EXP. PAUSE Expiratory pause, a manoeuvre started by the User which closes the
inspiratory and expiratory valves during the expiratory phase of a breath.
FiO2 Parameter set by the User and monitored. The % setting of FiO2 determines
the percentage of oxygen in the gas delivered to the patient. The monitored
data of the % of FiO2 indicate the percentage of oxygen delivered to the
patient, measured on the inspiratory line.
Flow Trigger Method of recognition of the inspiratory effort of the patient, during which the
ventilator controls the basic flow circulating in the patient circuit. An inspiratory
attempt by the patient is translated into a decrease of the basic flow, which the
ventilator recognizes as a spontaneous breath and delivers a synchronized
breath.
GUI Graphics user interface, the part of the ventilator which comprises the screen,
the keys and the knob. The GUI is equipped with an independent CPU which
monitors the data of the ventilator and the patient. The screen displays the
monitored information, including the alarms, the monitored parameters, the
graphs, the ventilator settings and the messages.
High priority alarm As defined by the international standards organizations, this is an alarm which
requires immediate intervention to ensure the safety of the patient. During a
high priority alarm, the corresponding red signal flashes rapidly, a high priority
acoustic alarm signal is emitted (a series of five tones repeated twice, followed
by a pause, then repeated again) and an alarm message is displayed in the
upper part of the screen.
hPa Hectopascal (unit of pressure, approximately equal to 1 cmH2O).
Hz Hertz (unit of measurement of frequency, indicating cycles per second).
I:E ratio The ratio between inspiratory time and expiratory time
IEC International Electro-technical Commission: international organisation for the

definition of standards.
INSP. PAUSE Inspiratory pause, a manoeuvre started by the User which closes the
inspiratory and expiratory valves during the inspiratory phase of a breath. This
manoeuvre can be used to determine the static compliance (C) and the
resistance (R).
IPPV Intermittent Positive Pressure Ventilation
IPPV - AST Assisted Intermittent Positive Pressure Ventilation: a ventilation mode that
makes it possible to deliver only controlled ventilation (started by the patient,
the ventilator or the User) on the basis of the current settings.

ISO International Standards Organization
kg Kilogramme (unit of weight).
L Litre (unit of volume).
L/min Litres per minute (unit of flow).
Loop Parameter-based curve with respect to time
Low priority alarms As defined by the international standards organizations, this is an alarm that
indicates a change in the patient-ventilator system. During a low priority alarm,
the corresponding yellow signal lights up and an alarm message is displayed
in the upper part of the screen.
m Metre (unit of length).
Maintenance All the operations necessary to maintain the equipment in working order or to
carry out cleaning, maintenance, repairs, modifications, revisions and
performance checks.
MAN If the MANUAL key is pressed in PSV mode, the system delivers pressure
controlled ventilation to the patient.
MAP Indication of the mean airways pressure
Medium priority As defined by the international standards organizations, this is an abnormal

alarm condition which requires immediate intervention to ensure the safety of the
patient. During a medium priority alarm, the corresponding yellow signal
flashes. A medium priority acoustic alarm signal is emitted (a repeated series
of three tones) and an alarm message is displayed in the upper part of the
screen.
min Minute (unit of time).
Minute volume Expired tidal volume normalized to the unit of time (L/min). The system
estimates the total minute volume on a 60 second basis or on previous
ventilations, whichever is the shorter. The value displayed includes the
compensation for compliance.
mL Millilitre (unit of volume).
Mode Ventilation mode; an algorithm which determines the type and sequence of
ventilation: the system offers a series of possible choices, including assisted,
spontaneous or synchronized ventilation.
ms Millisecond (unit of time).
NIST Non-interchangeable screw thread: standard for high pressure gas inlet
connectors.
Patient circuit All the inspiratory-expiratory conduits, including the tubes, the humidifier and
the filters (when foreseen).
PAW Measured airways pressure
PCV Pressure controlled ventilation: a type of controlled ventilation during which
the ventilator delivers an inspiratory pressure set by the User for an inspiratory
time also set by the User.
PEEP Positive end expiratory pressure: the minimum level of pressure maintained in
the patient circuit during ventilation. Parameter set by the User and monitored.
Pressure Trigger Method of recognition of the inspiratory effort of the patient, in which the
ventilator controls the pressure in the patient circuit. The ventilator enables
ventilation when the airways pressure decreases by an amount at least equal
to the selected threshold value in a defined period of time.
PSV Pressure support ventilation: a type of spontaneous ventilation in which the

ventilator delivers pressure set by the User during the inspiratory phase.
RAM Random access memory
Resistance (Ri) The drop in pressure caused by a flow passing through a conduit: measured
in cmH2O/(litres/sec) or hPa/(litres/sec).(peak pressure - pause pressure /
inspiratory flow).
sec Second (unit of time).
SIMV+PS Synchronized Intermitted Mandatory Volumetric ventilation with spontaneous

ventilation by pressure support.
SPONT In SPONT mode, the patient activates all ventilations delivered by ventilator
without any controlled respiratory rate set. The patient makes spontaneous
breaths by pressure support.
STANDBY Ventilation system in pause status: no ventilation is enabled when the

ventilator is in this status.
System error Definition used by the safety system of the ventilator. System errors include
faults of the hardware inside the ventilator and which affect its performance,
software errors which occur momentarily inside the ventilator and interfere
with its normal functioning, an inadequate supply of alternate current or gas
and the problems of integrity of the patient circuit (block or disconnection). In
general system errors are not corrected automatically
T Exp Expiratory time: duration of the expiratory interval of a breath.
T Insp Inspiratory time: duration of the inspiratory interval of a breath.
T pause Pause time: percentage of inspiratory time during which the ventilator
maintains a constant airways pressure. Used for calculation of the respiratory
mechanics parameters (compliance and resistance).
Tidal volume Inspired and expired tidal volume during each breath. The value delivered by
the system is a parameter set by the User which determines the volume
delivered to the patient during controlled volume ventilation. Tidal volume
includes the compensation for compliance and for pressure and body
temperature.
TREND Medium and long-term monitoring of the respiratory parameters.

VA Volt - Ampere (unit of power).
Vac Alternate current voltage
VC-VAC Intermitted ventilation by assisted positive pressure: a ventilation mode which

allows to deliver controlled ventilations only (started by the patient, by the
ventilator or by User) basing on current settings.
Vdc Direct current voltage
Ventilations per Respiratory rate unit (Resp/min).

minute (bpm)
A.7 Electromagnetic compatibility tables
A.7.1 Annex A: Table 1
Guidance and manufacturer’s declaration – electromagnetic emissions
The Siaretron 4000 is intended for use in the electromagnetic environment specified below. The customer
or the user of the Siaretron 4000 should assure that it is used in such an environment.
Emissions test Compliance Virdict Electromagnetic environment – guidance
The Siaretron 4000 uses RF energy only

for its internal function. Therefore, its RF
RF emissions emissions are very low and are not likely
Group 1 Compliance
CISPR 11 to cause any interference in nearby
electronic equipment.
The Siaretron 4000 is suitable for use in

RF emissions all establishments other than domestic,
Class A Compliance
CISPR 11 and may be used in domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes,
Harmonic emissions Class A, B, C, D, o provided the following warning is heeded:
Class A
IEC 61000-3-2 NOT APPLICABLE
Warning: This equipment/system is
intended for use by healthcare
professionals only. This equipment/
Voltage fluctuations/ system may cause radio interference or
flicker emissions may disrupt the operation of nearby
IEC 61000-3-3 Compliance Compliance equipment. It may be necessary to take
mitigation measures, such as re-orienting
or relocating the Siaretron 4000 or
shielding the location.

A.7.2 Annex B: Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity
Electromagnetic
IMMUNITY test IEC 60601 test level Compliance level / Virdict environment –
guidance
Electrostatic discharge  6 Kv contact  6 kV contact Residential –

(ESD) IEC 61000-4-2  8 kV air  8 kV air Hospital – Other
 2 kV for power supply  2 kV for power supply

Electrical fast
lines lines Residential –
transient/burst
Hospital – Other
IEC 61000-4-4
 1 kV for input/output lines  1 kV for input/output lines
1 kV line(s) to line(s) 1 kV line(s) to line(s)

Residential –
Surge IEC 61000-4-5
Hospital – Other
2 kV line(s) to earth 2 kV line(s) to earth
<5 % UT (>95 % dip in UT) <5 % UT (>95 % dip in UT)

for 0,5 cycle for 0,5 cycle
Voltage dips, short 40 % UT (60 % dip in UT) 40 % UT (60 % dip in UT)

interruptions and for 5 cycles for 5 cycles
Residential –
voltage variations on
Hospital – Other
power supply input
70 % UT (30 % dip in UT) 70 % UT (30 % dip in UT)
lines IEC 61000-4-11
for 25 cycles for 25 cycles
<5 % UT (>95 % dip in UT) <5 % UT (>95 % dip in UT)

for 5 s for 5 s
Power frequency
Residential –
(50/60 Hz) magnetic 3 A/m 3 A/m Hospital – Other
field IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
A.7.3 Annex C: Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
Electromagnetic environment –
IEC 60601 TEST Compliance Compliance guidance
IMMUNITY test
LEVEL level effective level Recommended separation
distances
3 Vrms 150 kHz to

80 MHz outside VRMS [V1] VRMS SEE ANNEX E
ISM bands
Conducted RF
IEC 61000-4-6
10 Vrms 150 kHz
to 80 MHz in ISM VRMS [V2] VRMS SEE ANNEX E
bands
80  800 MHz
Radiated RF SEE ANNEX E

10 V/m 80 MHz to
IEC 61000-4-3 V/m [E1] V/m
2,5 GHz
800  2500 MHz
SEE ANNEX E
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be
less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol:
Note:
1. At 80 MHz and 800 MHz, the higher frequency range applies.
2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

A.7.4 Annex E: Table 5
Recommended separation distances between portable and mobile RF communications

equipment and the Siaretron 4000.
The Siaretron 4000 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Siaretron 4000 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Siaretron 4000 as recommended below, according to
the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter m

Rated maximum
output power of 150 kHz  80 MHz 150 kHz  80 MHz
transmitter 80 MHz  800 MHz 800 MHz  2,5 GHz
outside ISM bands in ISM bands
12   12   23 
W  3,5  d   P d   P
d   P d   P
 V1   E1   E1 
V2 
0,01 0,12 0,12 0,12 0,23
0,1 0,37 0,38 0,38 0,73
1 1,17 1,20 1,20 2,30
10 3,69 3,79 3,79 7,27
100 11,67 12,00 12,00 23,00
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note :
1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
2. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to
6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70
MHz.
3. An additional factor of 10/3 has been incorporated into the formulae used in calculating the
recommended separation distance for transmitters in the ISM frequency bands between 150 kHz
and 80 MHz and in the frequency range 80 MHz to 2,5 GHz to decrease the likelihood that
mobile/portable communications equipment could cause interference if it is inadvertently brought
into patient areas.
Note: the values shown in the table refer to the standard levels of the norm, 3V for V1 and 10V for V2

Siaretron 4000 15”
ICU lung ventilator
Touch-screen
User’s Manual - 960501

User’s Manual, version DU3501101
Revision 1 - 10.01.2019
SIARE ENGINEERING INTERNATIONAL GROUP s.r.l.

Via Giulio Pastore, 18
Località Crespellano, 40053 Valsamoggia (BO), ITALY
Tel.: +39 051 969802 - Fax: +39 051 969809
E-mail: [email protected]
Web: www.siare.it

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Siaretron 4000 - 15”

ICU Lung Ventilator

User’s Manual, version DU3501101

Directive 93/42 EEC

IV User manual, DU3501101

VI User manual, DU3501101

VIII User manual, DU3501101

Shelf life of medical device

The lung ventilator complies with the EN 60601-1-2

In general, as regards the regulations regarding

Requirements applicable to cables, transducers and other

X User manual, DU3501101

1 INTRODUCTION ........................................................................................................... 1-1

2 DESCRIPTION .............................................................................................................. 2-1

XII User manual, DU3501101

5 ALARMS ........................................................................................................................ 5-1

XIV User manual, DU3501101

6 MAINTENANCE ............................................................................................................ 6-1

A.2 Preliminary checks.............................................................................................. A-11

A.5 Pneumatic diagram ............................................................................................. A-18

A.6 Glossary.............................................................................................................. A-21

XVI User manual, DU3501101

1.1.2 Foreseen use

1-2 User manual, DU3501101

Please read the recommendations and the instructions herein in order to

1.2 Correct operation

The connection with main power supply, as well as connections with

To ensure the best performance of the lung ventilator periodic

SIARE Engineering International Group s.r.l. recommends careful

1-4 User manual, DU3501101

EN 60601-1:2006/ A1:2011/ A1:2013

Medical electrical equipment - Part 1: General requirements for

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

D.Lgs 49/2014 RAEE Directive (Implementation of the 2012/19/UE Directive on

EN ISO 14971:2012 Medical devices. Application of risk management to medical devices

EN ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary

DIR. 93/42/EEC (2007) Medical devices directive

1-6 User manual, DU3501101

This chapter describes the following items.

2.1 Overall view

Concerning the assembling, the interfacing and maintenance make reference

The picture is exclusively an example and shows a possible configuration of

2-2 User manual, DU3501101

cfr. 2.4 15” LED monitor - Touch screen

cfr. 3.3.6 Support for patient circuit supporting arm

cfr. 3.3.12 Support for humidifier

cfr. 3.1 Wheels diameter 10 cm (2 wheels with brakes)

cfr. 2.4.1 Keyboard with soft key and encoder knob

cfr. 3.1 Transport handle

cfr. 2.3 Attachments for patient circuit connection

Refer to instruction manual/booklet

O2 SENSOR Oxygen cell (see cfr. 3.2.1)

EXP. VALVE Expiratory Valve

NEBULIZER Nebulizer circuit outlet (6 l/min) (see cfr. 3.3.11)

2-4 User manual, DU3501101

Specific inlet allowing inspiration of ambient air by the

COVER UNIT Protection for flow sensor and oxygen cell