Siare Morpheus ND User manual

Anaesthesia Unit
User's Manual

Morpheus_ND III
GENERAL INFORMATION
The information contained in this manual are the exclusive property of SIARE
ENGINEERING INTERNATIONAL GROUP s.r.l. and may not be reproduced in any
way without authorisation. SIARE ENGINEERING INTERNATIONAL GROUP s.r.l.
reserves the right to modify or replace this manual at any time without prior notice.
It is however recommended that you make sure you have the most recent version of
the manual. In the event of doubt, contact SIARE ENGINEERING INTERNATIONAL
GROUP s.r.l. (see the address on page IX). The information contained herein can be
considered correct, but do not exclude
professional knowledge by the user of the
equipment.
The operation and maintenance must be entrusted to qualified technical personnel
only. The responsibility of SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. as
regards the anaesthesia unit and its use is limited to what is indicated in the guarantee
supplied with the equipment.
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 MORPHEUS
anaesthesia unit ( _ND ) produced or updated after January 2018. 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 DU33ND101
Revision - 13.05.2019.

IV User manual, DU33ND101
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 User.
CAUTION
This indicates the possibility of danger to the anaesthesia unit.
NOTE
This indicates information worthy of note, making the operation of the
anaesthesia unit more efficient or practical.

Morpheus_ND V
Warnings, cautions and notes
You are advised to carefully read the information given a
longside the three symbols
shown on the previous page, since it contains considerations on the
safety, the special
requirements for the use of anaesthesia unit and the relative safety regulations.
•In order to understand how the anaesthesia unit works and h
ow 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 User
’s safety,
the anaesthesi
a unit 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 anaesthesia unit must only be us
ed for the purposes specified herein and the
safety of the anaesthesia unit is therefore only guaranteed if it is used in
accordance with the instructions given in this manual.
•
The anaesthesia unit must only be used by qualified personnel and only in
equip
ped and dedicated rooms, according to the regulations in force in the country
where the anaesthesia unit is installed. Furthermore, during all the operation of
anaesthesia unit, it is required the presence of qualified personnel.
•Regarding the general safe
ty 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 anaesthesia unit or authorised m
odifications to the anaesthesia unit. The user
of this product is solely responsible for any operating defect caused by improper
use or interventions carried out by third parties other than specialised SIARE
personnel.
•The maintenance and the replacement o
f any part have to be performed by
authorized service personnel and only original SIARE spare parts or components
checked by SIARE should be used.
•Regarding the general safety of the electro-
medical equipment, it is important to
follow all rules about the interaction between the machine and the patient, the User
and the nearby environment.
•
For any repairs to anaesthesia unit (due to malfunctioning, defects or failures), the
user must contact SIARE or the authorised local Technical Service Centre; it is
advi
sable to specify the data on the identification label (model, serial number, ……)
when requesting intervention.
•
SIARE recommends establishing a maintenance and service contract with SIARE
or the local authorised service dealer in order to guarantee the sche
duled
maintenance required to operate the anaesthesia unit in a safe and correct manner.
•
To prevent the risk of fire, keep the anaesthesia unit and/or the oxygen tubes away
from matches, lit cigarettes and inflammable material, such as anaesthetic gases
and/or sources of heat.

VI User manual, DU33ND101
•
Do not connect the anaesthesia unit 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 tub
es. The use
of flexible connectors, antistatic or conductive tube is never permitted with
anaesthesia unit.
•
Do not use worn and consumed tubes or tubes contaminated by flammable
substances like grease or oil to deliver oxygen; (fabrics, oil and other fuels
can
easy ignite and they intensively burn in air with high concentration of oxygen.
•
In the event of fire or an unpleasant smell (e.g. a smell of burning), the anaesthesia
unit should immediately be disconnected from the electrical power supply and from
the battery (if fitted).
•
When coming into contact with any component of the anaesthesia unit, the hospital
procedures for the handling of infected material should always be respected.
•SIARE is aware that cleaning, sterilisation and disinfection procedures v
ary
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,
sterili
sation and disinfection of the product components, it is therefore
recommended that the regulations currently in force in the country where the
anaesthesia unit is installed be taken into consideration.
•The anaesthesia unit was not designed as a total moni
toring device: some
conditions of danger for the patients treated with vital support equipment will not
trigger any alarm.
•
Before using the anaesthesia unit or any connected component, carefully check
that the anaesthesia unit is functioning correctly; whe
n 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.
•Check the anae
sthesia unit 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 anaesthesia unit (example
: scavenging systems, patient simulators, etc…..),
and not described in the present user’s manual: in case of need contact SIARE.
•The correct functi
oning of the anaesthesia unit 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.

Morpheus_ND VII
•SIARE assumes
all foreseen legal liability if the anaesthesia unit 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 anaesthesia unit is equipped with a safety valve which allows
to the patient to breathe spontaneously the ambient air even in case of gas supply
failure, the auxiliary ventilation system must be always
promptly available; such a
component is part of SIARE Engineering International Group s.r.l. products range.

VIII User manual, DU33ND101
WARNING !!
•The anaesthesia unit
is not approved for operation in places
where there is any risk of explosion.
•The anaesthesia unit cannot be
used in the presence of
explosive gases.
•Do not use the anaesthesia unit
in the presence of flammable
gases.
WARNING !!
•The anesthesia unit shall not be used in a hyperbaric chamber.
•The anesthesia unit shall not be used with nitric oxide.
•The anesthesia unit shall
not be used with helium or mixtures
with helium.
WARNING !!
•Before starting the anesthesia unit use, you have to carry out the
preliminary checks.
•Qualified staff must
make the regulation of ventilation
parameters.
•Do not block the
gas intake port or emergency intake port
(valves group), thereby interfering with PATIENT ventilation.
WARNING !!
Before connecting the anaesthesia unit
to other electrical equipment
not described in this manual, a request for authorisation shou
ld be
sent to Siare.
WARNING !!
An auxiliary ventilation system is suggested for the patients for which
the anaesthesia unit represents a life support.
WARNING !!
Means for independent ventilation shall be available (i.e. manual
resuscitation bag with mask) whenever the anaesthesia unit
is in
use.

Morpheus_ND IX
SIARE declines all civil and penal responsibility in the
following cases:
•If the anaesthesia unit is used in conditions and for purposes not
stated or described in this manual.
•If the anaesthesia unit 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 spar
e parts or components not checked by
SIARE have been used.
•If the anaesthesia unit
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 int
ervention or by improper use of the
anaesthesia unit
not in accordance with the instructions
contained in the User’s manual.
Year of manufacture
Check the identification data label of the MORPHEUS anaesthesia unit
in the relative
chapter.
Shelf life of medical device
The Directive 93/42/EEC 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 MORPHEUS anaesthesia unit is 10 years.
Manufacturer
SIARE Engineering International Group s.r.l.
Via Giulio Pastore, 18 - 40056
Località Crespellano, 40053 Valsamoggia (BO), ITALY
Tel.: [phone] - Fax: [phone]
E-mail: [e-mail] - web: www.siare.it

X User manual, DU33ND101
Electromagnetic Compatibility
The MORPHEUS anaesthesia unit is designed to operate in the specified
electromagnetic environment (see warning below).
The customer or the user of MORPHEUS anaesthesia unit should ensure that it is used
in such an electromagnetic environment.
The MORPHEUS anaesthesia unit 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
Anaesthesia unit adjacent to high-powere
d equipment or to units,
which emit strong electro-
magnetic fields. Mobile phones, cordless
phones or other radio transmitters used in the vicinity of the
equipment could influence its operation. Whenever the anaesthesia
unit should be necessarily used nea
rby 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
MORPHEUS anaesthesia unit user’s manual.
Requirements applicable to cables, transducers and other
accessories
that could affect compliance with the requirements of
6.1 and 6.2

Morpheus_ND XI
Table of contents
GENERAL INFORMATION ...........................................................................................................III
Observations ..........................................................................................................................................IV
Definitions...............................................................................................................................................IV
Warnings, cautions and notes.................................................................................................................V
Year of manufacture...............................................................................................................................IX
Shelf life of medical device.....................................................................................................................IX
Manufacturer ..........................................................................................................................................IX
Electromagnetic Compatibility.................................................................................................................X
Table of contents....................................................................................................................................XI
1 PRESENTATION................................................................................................................1-1
1.1 Foreseen use ............................................................................................................................. 1-1
1.2 Main innovations ........................................................................................................................ 1-2
1.2.1 Strengths of the new Morpheus_ND HYBRID .............................................................. 1-2
1.3 Main characteristics : anaethesia unit structure......................................................................... 1-3
1.3.1 Valves group - Breathing System.................................................................................. 1-3
1.3.2 Lung ventilation module ................................................................................................ 1-4
1.3.3 Flowmeter...................................................................................................................... 1-4
1.3.4 Trolley (optional)............................................................................................................ 1-5
1.4 Proper operation ........................................................................................................................ 1-5
1.5 Norms and standards regulations.............................................................................................. 1-7
2 MORPHEUS_ND - DESCRIPTION.....................................................................................2-1
2.1 Front view................................................................................................................................... 2-1
2.1.1 Keyboard for manual ventilation.................................................................................... 2-2
2.1.2 Other commands........................................................................................................... 2-3
2.2 Side view – power supply connections ...................................................................................... 2-4
2.2.1 Gas supply connection.................................................................................................. 2-5
2.3 Back view................................................................................................................................... 2-6
2.3.1 Electric power supply area............................................................................................ 2-7
2.4 Side view.................................................................................................................................... 2-8
2.5 Product identification label......................................................................................................... 2-9
2.6 Valves group - Breathing system .............................................................................................2-10
2.6.1 Patient circuit view....................................................................................................... 2-11
2.6.2 Electric connexion view...............................................................................................2-11
2.6.3 Upper view .................................................................................................................. 2-11

XII User manual, DU33ND101
2.7 Breathing system use............................................................................................................... 2-12
2.7.1 CO2soda lime absorber canister................................................................................ 2-12
2.7.2 Assembling and disassembling of absorber canister (e.g. disposable model) ...........2-12
2.7.3 Dismount of the valves group......................................................................................2-13
2.8 Breathing system accessories ................................................................................................. 2-14
2.8.1 O2sensor ....................................................................................................................2-14
2.8.2 Patient circuit...............................................................................................................2-15
2.8.3 Manual ventilation kit...................................................................................................2-15
2.8.4 MAPLESON C Adult patient circuit .............................................................................2-16
3 USER INTERFACE MODULE............................................................................................3-1
3.1 Keyboard with soft key and encoder knob................................................................................. 3-2
3.2 Anaesthesia unit switching ON .................................................................................................. 3-5
3.2.1 Self Test phase ............................................................................................................. 3-6
3.2.2 Anaesthesia unit switching OFF.................................................................................... 3-8
3.3 15” touch screen monitor ........................................................................................................... 3-9
3.3.1 Touch screen...............................................................................................................3-10
3.3.2 Operative modes......................................................................................................... 3-10
3.3.3 Operative commands..................................................................................................3-15
3.3.4 PATIENT DATA...........................................................................................................3-17
3.3.5 SETUP......................................................................................................................... 3-20
3.4 Physiological respiratory parameters.......................................................................................3-24
3.4.1 Respiratory parameters display ..................................................................................3-24
3.4.2 Respiratory parameter modification ( Respiratory Rate )............................................ 3-25
3.4.3 List of available respiratory parameter........................................................................3-26
3.4.4 Monitoring of respiratory parameter............................................................................ 3-28
3.4.5 Monitoring of “ gas analysis parameters “...................................................................3-33
3.5 Alarms areas............................................................................................................................ 3-34
3.6 Measures, charts and loops.....................................................................................................3-37
3.6.1 Available graphics combinations.................................................................................3-37
3.6.2 How to edit a new Charts............................................................................................3-40
3.6.3 How to edit a new Loop............................................................................................... 3-42
3.6.4 How to edit a new Measures....................................................................................... 3-43
3.6.5 Meaning of lung status icon ........................................................................................3-45
3.6.6 TRENDs ...................................................................................................................... 3-46
3.6.7 EVENTs.......................................................................................................................3-49
3.7 Flowmeter................................................................................................................................. 3-52
3.8 MENU, Operative functions and general informations.............................................................3-56
3.9 List of default parameters.........................................................................................................3-60

Morpheus_ND XIII
4 PREPARATION TO USE....................................................................................................4-1
4.1 General warnings....................................................................................................................... 4-1
4.2 Before the use............................................................................................................................ 4-3
4.2.1 O2cell assembling ........................................................................................................ 4-3
4.2.2 Assembling of absorber canister................................................................................... 4-3
4.2.3 Battery charger.............................................................................................................. 4-5
4.3 Preparation to use...................................................................................................................... 4-6
4.3.1 Medical gas connection................................................................................................. 4-6
4.3.2 Connection of medical gas supply to cylinders ( optional )...........................................4-7
4.3.3 Medical gas connection checks .................................................................................... 4-8
4.3.4 Connection of anaesthetic gases scavenging system .................................................. 4-9
4.3.5 Use of antibacterial filter................................................................................................ 4-9
4.3.6 Patient circuit connections........................................................................................... 4-10
4.3.7 Gas analyzer connection............................................................................................. 4-11
4.3.8 Data Connection (Trend and Events downloading ) ...................................................4-12
4.4 MAN ventilation........................................................................................................................ 4-13
4.4.1 Fresh gases exit - TO and FRO patient circuit............................................................4-13
4.4.2 Connection of circuit for manual ventilation ................................................................ 4-14
4.5 Connection to power supply..................................................................................................... 4-15
4.5.1 Main power supply ...................................................................................................... 4-15
4.5.2 Low voltage power supply........................................................................................... 4-16
4.5.3 Battery power supply...................................................................................................4-17
4.5.4 Protection fuses...........................................................................................................4-18
4.6 Connection to other equipments.............................................................................................. 4-19
4.7 Use - Preliminary tests............................................................................................................. 4-20
4.7.1 Introduction to preliminary tests .................................................................................. 4-20
4.8 Power-ON / Self Test phase .................................................................................................... 4-22
4.8.1 Self Test phase : Fail................................................................................................... 4-26
4.8.2 Self Test : list of self-diagnostic tests..........................................................................4-27
4.9 Preliminary checks................................................................................................................... 4-28
4.9.1 Introductions................................................................................................................ 4-28
4.9.2 Supplementary Test....................................................................................................4-29
4.9.3 Leak Test..................................................................................................................... 4-29
4.9.4 Leak Test not overcome..............................................................................................4-32
4.9.5 O2 Sensor calibration..................................................................................................4-33
4.9.6 O2 Sensor calibration not overcome...........................................................................4-35
4.9.7 Exit from SUPPLEMENTARY TESTS......................................................................... 4-36
4.10 Flowmeter module.................................................................................................................... 4-37
4.11 Ventilation module....................................................................................................................4-45
4.12 Conclusions.............................................................................................................................. 4-52

XIV User manual, DU33ND101
5 MORPHEUS_ND USE........................................................................................................5-1
5.1 Flowmeter................................................................................................................................... 5-2
5.1.1 Dosing and administration of fresh gas......................................................................... 5-2
5.1.2 Administration of fresh gas in the "TO and FRO" system............................................. 5-4
5.1.3 Flowmeter pre-setting.................................................................................................... 5-5
5.2 Anaesthesia Unit switching ON - Self Test phase ..................................................................... 5-7
5.3 PATIENT DATA / SETUP parameters.....................................................................................5-10
5.3.1 PATIENT DATA...........................................................................................................5-10
5.3.2 SETUP parameters..................................................................................................... 5-13
5.4 Setting up the UGI language.................................................................................................... 5-16
5.4.1 Mode 1......................................................................................................................... 5-16
5.4.2 Mode 2......................................................................................................................... 5-18
5.5 PATIENT DATA Setting ........................................................................................................... 5-20
5.5.1 Mode 2......................................................................................................................... 5-20
5.5.2 Erasing PATIENT DATA ............................................................................................. 5-22
5.6 Setting up the ALARMS........................................................................................................... 5-24
5.6.1 Mode 2......................................................................................................................... 5-24
5.7 Operative modes......................................................................................................................5-25
5.7.1 Operative Modes setting procedure............................................................................ 5-25
5.8 Operative modes list ................................................................................................................5-29
5.8.1 APCV ( NIV APCV ) ....................................................................................................5-29
5.8.2 APCV-TV.....................................................................................................................5-31
5.8.3 PSV ( NIV PSV )..........................................................................................................5-33
5.8.4 PSV-TV........................................................................................................................5-35
5.8.5 VC-VAC....................................................................................................................... 5-37
5.8.6 VC-VAC BABY............................................................................................................ 5-39
5.8.7 V-SIMV........................................................................................................................ 5-41
5.8.8 P-SIMV........................................................................................................................ 5-43
5.8.9 MAN operative mode...................................................................................................5-45
5.8.10 APNOEA BACK-UP ....................................................................................................5-48
5.9 Physiological Respiratory Parameters ( PRP )........................................................................ 5-49
5.10 Ventilation phase......................................................................................................................5-50
5.10.1 Ventilation interruption................................................................................................. 5-51
5.10.2 SETUP MENU............................................................................................................. 5-52
5.10.3 Alarm limits..................................................................................................................5-53
5.10.4 GRAPHICs visualization.............................................................................................. 5-54
5.10.5 INSP – EXP hold and Manual breath..........................................................................5-54
5.11 Functions list ............................................................................................................................ 5-55

Morpheus_ND XV
5.12 Calibration programs................................................................................................................5-58
5.12.1 Calibration Programs displaying .................................................................................5-59
5.12.2 Turbine Characterization.............................................................................................5-60
5.12.3 Respiratory Flow Sensors Calibration.........................................................................5-61
5.12.4 VTEc ( On - Off ) ......................................................................................................... 5-65
5.12.5 ScreenShot Enable ( Off - On )................................................................................... 5-66
5.12.6 Self Test ...................................................................................................................... 5-67
5.12.7 Power Off .................................................................................................................... 5-68
5.13 Further functions ...................................................................................................................... 5-69
5.13.1 Default parameters set................................................................................................ 5-69
5.13.2 Touch screen set.........................................................................................................5-70
5.13.3 Reset to ZERO the “ Partial operating hours “............................................................5-71
5.13.4 Data Connection (Trend and Events downloading ) FARE.........................................5-73
6 ALARMS ............................................................................................................................6-1
6.1 Displaying and used symbols..................................................................................................... 6-2
6.1.1 A1 - List of active alarms messages ............................................................................. 6-3
6.1.2 A2 - ALARMS Limits : respiratory parameters.............................................................. 6-7
6.1.3 A3 - ALARMS limits : gas sensor.................................................................................. 6-8
6.1.4 A4 - General information area....................................................................................... 6-9
6.1.5 A5 - Acoustic alarm silencing...................................................................................... 6-10
6.2 Alarms setting........................................................................................................................... 6-11
6.2.1 Setting of ALARMS limits values.................................................................................6-11
6.2.2 Setting of ALARMS volume......................................................................................... 6-14
6.2.3 Setting of DEFAULT parameters ................................................................................6-16
6.2.4 Alarms DEFAULT parameters values.........................................................................6-18
6.3 Tables of alarm characteristics ................................................................................................ 6-19
6.3.1 Alarms configurable by User....................................................................................... 6-19
6.3.2 System alarms............................................................................................................. 6-20
6.3.3 Gas Sensor alarms...................................................................................................... 6-21
7 MAINTENANCE .................................................................................................................7-1
7.1 Cleaning, disinfection and sterilisation....................................................................................... 7-2
7.2 General instructions ................................................................................................................... 7-3
7.2.1 Cleaning ........................................................................................................................ 7-3
7.2.2 Disinfection and sterilisation.......................................................................................... 7-3
7.2.3 Disinfection by immersion (chemical)............................................................................ 7-4
7.3 Cleaning, disinfection and sterilisation table.............................................................................. 7-5
7.3.1 Sterilization of “ EXP flow sensor “................................................................................ 7-7
7.3.2 Disposable bacterial filter.............................................................................................. 7-8

XVI User manual, DU33ND101
7.4 Periodic maintenance................................................................................................................. 7-9
7.4.1 Maintenance operations table....................................................................................... 7-9
7.4.2 Cleaning, disinfection and sterilization before use with another patient .....................7-12
7.4.3 Turbine ........................................................................................................................7-12
7.5 Repairs and spare parts...........................................................................................................7-13
7.5.1 Annual kit for Morpheus_ND anaesthesia unit............................................................7-13
7.6 Miscellaneous...........................................................................................................................7-13
7.6.1 Storage........................................................................................................................ 7-13
7.6.2 Repackaging and shipment.........................................................................................7-13
7.6.3 Disposal.......................................................................................................................7-14
8 APPENDIX .........................................................................................................................8-1
8.1 Technical sheet.......................................................................................................................... 8-2
8.1.1 Morpheus – code MND.SE-T........................................................................................ 8-2
8.2 Glossary...................................................................................................................................8-15
8.3 Electromagnetic compatibility tables........................................................................................8-19
8.3.1 Annex A: Table 1......................................................................................................... 8-19
8.3.2 ANNEX B: Table 2....................................................................................................... 8-20
8.3.3 ANNEX C: Table 3 ...................................................................................................... 8-21
8.3.4 ANNEX E: Table 5....................................................................................................... 8-22
8.4 Preliminary tests.......................................................................................................................8-23
8.4.1 List of preliminary tests - Morpheus anaesthesia unit.................................................8-24

Morpheus_ND
1 PRESENTATION
SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. is glad to introduce this new product, as the
result of 40 years of experience and investment in technological innovation that we are implementing
in recent years. Siare has heavily focused on the innovation of materials, ergonomics and ease of
use.
The outcome of this work is a new anaesthesia unit which incorporates all advanced modalities
required in modern gaseous anaesthesia, to meet all the expectations of end users.
The new anaesthesia unit, “MORPHEUS_ND HYBRID “, is considerably different from all the former
ones manufactured versions: in fact, it can be configurable in different ways to respond to the
numerous market demands and requirements.
The “MORPHEUS_ND HYBRID “, marks an epochal step, having solved all the critical points of an
anaesthesia machine. SIARE has always been an innovative company in anaesthesia and intensive
care, offering safe products realized with the suggestions and experience of the most exigent
anaesthetists and resuscitation therapy doctors.
1.1 Intended Use
The Morpheus anaesthesia unit equipped with a 15” colour Touch Screen display, is an equipment of
new generation, projected to be used in anaesthesia wards.
The lung ventilation module provides new advanced features for operative modes management; it is
equipped with different ventilation functions and thanks to its keyboard and encoder knob the user’s
selection of most suitable settings are simplified. Varying the breathing parameters, adjustable by
user’s interface, the Morpheus_ND HYBRID anaesthesia unit can be used on Adults, Children,
Neonatal patients.
The Morpheus_ND HYBRID anaesthesia unit is suitable for the administration of: Oxygen - Air -
Nitrous Oxide / Xenon - Halothane - Enfluorane - Isoflurane - Sevoflurane - Desflurane mixtures. The
fraction of inspired oxygen can vary from 21% to 99%.
For a correct comprehension of Morpheus_ND HYBRID anaesthesia unit operation
and for a correct and safe use both for the Patient and User, the knowledge of
recommendations an
d instructions indicated in the present User’s Manual is
required.
For anyone who already has basic knowledge of anaesthesia unit functioning and
of ventilation in general, the use of the “graphics user interface
“ is intuitive and it
will be sufficient t
o consult this user’s manual in order to use the anaesthesia unit
correctly.
WARNING !!
The Morpheus_ND HYBRID anaesthesia unit
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.
SIARE recommends to read carefully the present manual and its relevant
instructions before using the anaesthesia unit or proceeding to maintenance.

1-2 Manuale Utente, DU33ND100
1.2 Main innovations
The Morpheus_ND HYBRID anaesthesia unit represents a true new revolution, engineered with the
help of anaesthetists of proven experience aiming to realize a safe device both for the doctor and for
the patient.
The anaesthesia unit is equipped by a Turbine (hence the name “Morpheus HYBRID”) and provides
a double functionality: the traditional gas supply system (Air and Oxygen) and the turbine functioning
(in this case it is not necessary a pneumatic Air supply for the movement of the breathing system
bellows). The system, during the switching on and the ‘Self-Test’ phase, detects the turbine
functionality and prepare the anaesthesia unit for the correct functionality. In case of turbine
operation, it is however and always necessary to foreseen an oxygen supply source, useful for
operation of internal pneumatic system of Morpheus anaesthesia unit.
This double functionality presents important advantages and among them. Use of the equipment in
environments where there is a lacking of medical air (this way, a considerable quantity of oxygen
necessary for the pneumatic system, can be saved); moreover, this double functionality, in case of
fault of one of the two systems the other is always available: it’s like to have an emergency
ventilation always at your disposal.
1.2.1 Strengths of the new Morpheus_ND HYBRID
•Extremely small dimensions and weight (25 Kg without accessories): it can be positioned in any
environment and situation, on a trolley, on a wall unit, on a shelf, etc.
•Can be equipped with a trolley (on request).
•It can be positioned both left and right of the patient thanks to the rotatable connections.
•Technologically advanced it is designed for a long life; requires low maintenance with low
management costs.
•Turbine drive: external compressed air sources are not required; ideal in environments characterized
by limited infrastructure or with the need for frequent travel and transport
•15 "touch screen display. High resolution with easy and intuitive graphic interface; visualization of the
ventilation graphs, loops, respiratory parameters, of the percentage value of the losses (Leak: %)
and of the value in Liters / minute of the oxygen consumption (L / min).
•Reduced, simple and ergonomic controls.
•Intelligent graphic interface: the doctor has all the parameters under control and can choose the
visual configuration he prefers.
•Double controls: in the event of a malfunction of the touch screen system it is possible to continue
with the manual controls: encoder knob and keys (or vice versa).
•Dedicated ventilation for: Adults, Children and Infants (up to 2 ml to 1500 ml); when switched on it
allows you to choose the type of patient (newborn, child, adult) by automatically setting the relative
default respiratory parameters.
•The lung ventilator can work even in the absence of compressed gas and mains voltage. A special
ultra-low noise compressor (29dB) guarantees the functionality of the fan even on battery power.
Furthermore, the patented HYBRID system allows operation with compressed gases in the event of
compressor failure. It is therefore also suitable for use in difficult and uncomfortable situations such
as field hospitals etc.
•The patient circuit is quickly disassembled without additional pipe connections

Morpheus_ND
•Standard auxiliary fresh gas outlet
•The fresh gas dosing system guarantees maximum safety thanks to the redundant system with
double valve and double control. In this way, the supply of oxygen or overdoses of nitrous oxide in
the event of a failure will never be interrupted.
•Emergency back-lit oxygen flowmeter that can be used even when the machine is off.
•The incorporated PROTOLOCK system identifies any wrong connection of the incoming gases
during the initial test phase: this device avoids potentially deadly situations for the patient, as already
happened with traditional systems.
1.3 Main characteristics: anaethesia unit structure
The mechanic structure of the anaesthesia unit is made of light aluminium alloy and plastic moulds:
this ensures an excellent impact resistance thanks to its flexibility and excellent abrasion resistance.
The mechanic structure also includes:
•the housing for the valves group,
•the manual ventilation controls, a mechanical flow meter and three pressure gauges
•on the back side are provided the medical gas intakes, which are positioned in a rational and
easily visible way,
•two horizontal guide for vaporizer supports (a vaporizer in use and one in parking)
The dimensions and weight of the anaesthesia unit are very reduced and allow its installation also in
small rooms or small working areas or combined with pendant lifting systems. Two handles on the
lateral perimeter allow to easily grasp and move the anaesthesia unit.
On the rear side, a full-height steel rod is available to fix the patient monitoring.
1.3.1 Valves group - Breathing System
•Completely renewed and performing, it presents the following definite advantages.
•Extraction from above and perfect integration with the work shelf.
•Automatic connections with double seal gaskets against accidental leaks.
•Mono-bloc, fully stérilisable in autoclave.
•Calibration of flow and O2sensors can be performed in automatic mode by the User; The
access to flow sensor and O2sensor is simple and immediate.
•The CO2absorber canister is located in the upper side and it easy to disconnect by apposite
unlock lever. With canister inserted the system makes automatic configuration in rebreathing
modality; with taken off canister, the system makes automatic configuration in non rebreathing
modality (real open circuit). It is possible to put and take off the canister during intervention.
•The canister is available in version for reuse and disposable version including soda lime
granules.
•Low periodic and extraordinary maintenance operations; easy training of technical personnel
thanks to the extreme rationality of the system and to the drastic reduction of accidental leaks.

1-4 Manuale Utente, DU33ND100
1.3.2 Lung ventilation module
For those who have a basic knowledge on how medical devices for resuscitation
work, the use of this equipment is intuitive and a brief training course on regard
would be enough.
•The lung ventilation module equipped with a 15” colour Touch Screen display, delivers
controlled or spontaneous ventilations with a re-adjustable level of end expiration positive
pressure (PEEP), of the trigger sensitivity and oxygen concentration.
•It is characterized by a very simple and powerful user’s interface, with large graphic display of
respiratory parameters, allows to choose the curves to be shown simultaneously and an easy
interaction in the selection of MENUS. After the switching-on it is possible to choose the
PATIENT TYPE (Adult, Paediatric and Neonatal) and setting automatically the relevant default
parameters.
•The lung ventilation module 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, PSV, SIGH, non-
invasive ventilation NIV (NIV APCV – NIV PSV) and Manual Ventilation (MAN).
•Adjustable Tidal Volume from 2 ml to 1500 ml. In spontaneous ventilation mode, it ensures
inspiratory flow up to 190 l/min, both with control and support pressure.
•The graphics user’s interface includes the keyboard, the decoder knob and the touch screen;
the last one displays, the lung ventilation module settings and measured data, as well as various
functions, allowing the User 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.
•Through the selection of special and dedicated icons (MENU-SETUP, PATIENT, GRAPHIC
DATA, ALARMS) placed on the front of the monitor, the user can interact immediately with all
the operating parameters of the anesthesia unit. (see on chapter 3).
•In the same way allows, the User to set the PATIENT TYPE (adult, paediatric and neonatal),
load or erase the PATIENT DATA and in case of needs, load automatically the DEFAULT
PARAMETERS of the anaesthesia unit and also set the alarms, collect data concerning the
trend of the operating parameters (TREND) and the anaesthesia unit EVENTS.
1.3.3 Flowmeter
The flowmeter is electronic, completely integrated in the monitor, it presents all those advantages in
use, previously illustrated in the pulmonary ventilation module. In fact the user does not act on the
classic knobs, but selects the fresh gas flows and / or the oxygen concentration by exerting a slight
pressure on the screen of the pulmonary ventilation module (see on chapter 3).
To complete the flow meter there are: a back-lit mechanical flow meter for total flow control and three
pressure gauges for checking the inlet pressures of medical gases (O2, ARIA and N2O / XENO this
last optional gas).