806 00535 I Ix5 4th Edition Op Manual en Rev01

iX5™ Ventilator
Operator’s Manual
ii
The iX5 ventilator must be handled and operated only by qualified professionals.
Read this manual thoroughly before using the iX5 ventilator on patients.
After the initial reading, always keep this manual at an accessible location, for future consulting.
This equipment and its documents may be modified without any further notice to the user.
This Operator’s manual refers to the iX5 ventilator, software version 6.nn.
Trade Name: iX5 Ventilator

Technical Name: Pressure and Volume Ventilator
ANVISA Registration no. 10243240052
Technician in Charge: Eng. Julio Cesar Zambon – CREA 0681886376
This document is protected by United States and International Copyright laws.

This document may not be copied, reproduced, translated, stored in a retrieval system, transmitted in any form, or
reduced to any electronic medium or machine-readable form, in whole or in part, without the written permission of
Vyaire. Information in this document is subject to change without notice.
This document is for informational purposes only and should not be considered as replacing or supplementing the
terms and conditions of the License Agreement.
© 2019 Vyaire Corporation or one of its affiliates. All rights reserved. iX5, Vyaire, and the Vyaire logo are
trademarks or registered trademarks of Vyaire Corporation or one of its affiliates. All other trademarks are the
property of their respective owners. Intermed Equipamento Médico Hospitalar Ltda is one of Vyaire affiliates.
Authorized Representative in
Manufacturer
the European Community
Intermed Equipamento Médico OBELIS S. A
Hospitalar Ltda Bd General Wahis, 53
CNPJ: 49.520.521/0001-69 1030, Brussels
I.E.: 278.082.665-115 BELGIUM
Rua Santa Mônica, 980
Parque Industrial San José
06715-856, Cotia/SP, BRAZIL
+55 11 4615-9300 tel +32 2 732-59-54 tel
+55 11 4615-9310 fax +32 2 732-60-03 fax
www.vyaire.com
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Contents
Chapter 1 Intended Use ............................................................................................................... 1-1

Standards ..................................................................................................................................... 1-1
Equipment Classification .............................................................................................................. 1-1
Operating Principles ..................................................................................................................... 1-2
Supply Sources............................................................................................................................. 1-4
Physical Features ......................................................................................................................... 1-5
Chapter 2 Safety Warnings ......................................................................................................... 2-1

Introduction ................................................................................................................................... 2-1
Warnings ....................................................................................................................................... 2-1
Cautions ........................................................................................................................................ 2-6
Chapter 3 Equipment Setup ........................................................................................................ 3-1

Introduction ................................................................................................................................... 3-1
Environment Specifications .......................................................................................................... 3-3
Connection to the Power Source .................................................................................................. 3-3
Connection to the Gas Pipeline .................................................................................................... 3-7
Breathing circuit assembly ............................................................................................................ 3-8
Chapter 4 Operation .................................................................................................................... 4-1

Turning the equipment On ............................................................................................................ 4-1
Turning the equipment Off ............................................................................................................ 4-6
Ventilation Modes ......................................................................................................................... 4-7
Breath Types .............................................................................................................................. 4-13
VC – Volume Control .................................................................................................................. 4-13
Circuit Compliance Compensation ............................................................................................. 4-14
VC + PS – Volume Controlled Ventilation + Pressure Support .................................................. 4-14
PC – Pressure Controlled ........................................................................................................... 4-15
PC + PS – Pressure Controlled Ventilation + Pressure Support ................................................ 4-16
TCPL – Time Cycled Pressure Limited ...................................................................................... 4-16
TCPL+PS – Time Cycled and Pressure Limited + Pressure Support ........................................ 4-17
PRVC – Pressure Regulated Volume Controlled ....................................................................... 4-18
PRVC + PS – Pressure Regulated Volume Controlled + Pressure Support .............................. 4-19
VG – Volume Guarantee ............................................................................................................ 4-19
VG + PS – Volume Guarantee + Pressure Support ................................................................... 4-22
PS + Backup ............................................................................................................................... 4-23
CPAP + Backup .......................................................................................................................... 4-23
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nCPAP......................................................................................................................................... 4-24
nTCPL ......................................................................................................................................... 4-24
nCPAP LP ................................................................................................................................... 4-25
Biphasic LP ................................................................................................................................. 4-27
Airway Pressure Release Ventilation (APRV/Biphasic) .............................................................. 4-29
Bilevel / PC .................................................................................................................................. 4-31
Chapter 5 Ventilation Features ................................................................................................... 5-1

Buttons and LEDs ......................................................................................................................... 5-1
Front Panel Buttons and LEDs...................................................................................................... 5-2
Basic Controls ............................................................................................................................... 5-4
Advanced Settings Characteristics and Ranges ......................................................................... 5-12
Chapter 6 Alarms and Messages ................................................................................................ 6-1

Alarms ........................................................................................................................................... 6-1
Visual Indicators .......................................................................................................................... 6-23
Messages .................................................................................................................................... 6-24
Chapter 7 Monitoring Features ................................................................................................... 7-1

Introduction.................................................................................................................................... 7-1
Numerical Monitoring .................................................................................................................... 7-2
Graphic Monitoring ........................................................................................................................ 7-5
Trend Screen ................................................................................................................................ 7-8
Chapter 8 Troubleshooting.......................................................................................................... 8-1
Chapter 9 Cleaning, Disinfection, and Sterilization .................................................................. 9-1

ISO 17664 Compliance ................................................................................................................. 9-1
Indicated Processes ...................................................................................................................... 9-1
Description of the Indicated Processes ......................................................................................... 9-3
Chapter 10 Preventive Maintenance ........................................................................................... 10-1

Introduction.................................................................................................................................. 10-1
IVT – Initial Verification Test ....................................................................................................... 10-2
RI – Routine Inspection ............................................................................................................... 10-4
FVT – Functional Verification Test .............................................................................................. 10-5
BPT – Battery Performance Test .............................................................................................. 10-10
APM – Annual Preventive Maintenance ................................................................................... 10-12
Chapter 11 Accessories, Parts, and Pieces ............................................................................... 11-1

Introduction.................................................................................................................................. 11-1
Warnings and Cautions ............................................................................................................... 11-1
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Parts and A11-2ccessories ......................................................................................................... 11-2
Chapter 12 Terminology, Symbols, and Definitions ................................................................. 12-1

Terminology ................................................................................................................................ 12-1
Symbology .................................................................................................................................. 12-1
Chapter 13 Technical Specifications ......................................................................................... 13-1

Controls and Monitors Accuracy................................................................................................. 13-1
Measurement Uncertainty .......................................................................................................... 13-2
Controls ...................................................................................................................................... 13-2
Ventilation Alarms ..................................................................................................................... 13-10
Monitors .................................................................................................................................... 13-17
Filter Specifications .................................................................................................................. 13-18
Ventilation System .................................................................................................................... 13-20
Pneumatic Diagram .................................................................................................................. 13-25
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Chapter 1 Intended Use

The iX5™ ventilator is intended to provide continuous respiratory support in an professional
health care environment (e.g. hospitals). It may be used on neonatal through adult patients,
invasively or noninvasively. It should only be operated by properly trained clinical personnel,
under the direction of a physician.
The ventilator is suitable for use in institutional and intra-hospital transport settings. It is not
intended for use as an emergency medical transport ventilator or homecare applications.
Standards
The iX5 ventilator was developed, tested and certified in accordance with the following safety
standards for electromedical equipment:
 IEC 60601-1:2005 + Amendment 1:2012: Medical Electrical Equipment – Part 1
General Requirements for Basic Safety and Essential Performance
 IEC 60601-1-2:2014: Medical Electrical Equipment – Part 1-2
Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
 IEC 60601-1-6:2010 + Amendment 1:2013: Medical Electrical Equipment – Part 1-6
Collateral Standard: Usability
 IEC 60601-1-8:2006 + Amendment 1:2012: Medical Electrical Equipment – Part 1-8
Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems
 ISO 80601-2-12:2011: Medical Electrical Equipment – Part 2-12
Particular Requirements for Basic Safety and Essential Performance of Critical Care
Ventilators
 ISO 80601-2-55:2011: Medical Electrical Equipment – Part 2-55
Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas
Monitors
Additionally, the design and manufacture of the iX5 ventilator complies with all the Brazilian and
European legislation applicable to its product class.
Equipment Classification
This section features the classifications that can be applied to this product, in accordance with
the safety standards listed on the previous item.
Each of these classifications is followed by a brief explanation about it. The exact definitions for
each of the terms mentioned in this section can be found in Section 12, Terminology, Symbols,
and Definitions of this manual.
Classification
Classification according to Directive 93/42/EEC, as amended by Directive 2007/47/EC
 Class IIb
Electrical Safety
Classification according to Standard IEC 60601-1:2005 + AMD1:2012
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 Class I Equipment
Equipment with electrically insulated metallic parts and a grounding terminal (plug with
ground pin).
 Internally energized equipment
Electric equipment capable of working by means of an internal battery.
 Type B applied part
20 cm of the breathing circuit in contact with the patient providing protection against electric
shock.
Protection against Liquid and Particle Ingress

 IP21 equipment
Sterilization Methods
 Autoclave
 Ethylene Oxide Sterilization
Safety
 Equipment not suitable for use in oxygen-rich environments
Equipment not suitable for use in environments featuring an oxygen concentration higher
than 25%. In case of pressurized environments, the equipment is not suitable for use if, in
such environment, the partial oxygen pressure is higher than 27.5kPa.
 Equipment not suitable for use in the presence of an anesthetic mixture flammable
with air, oxygen or nitrous oxide.
Operation Mode
 Equipment for continuous operation
Equipment capable of operating for unlimited time without overheating.
Operating Principles
The iX5 ventilator features a modular design, focusing on safety and operational reliability, as
well as easy maintenance. Additionally, it was designed to be an upgradable platform as new
technologies become available.
The main modules are:
 Front Panel Module
 Electronic Actuation Module
 Electric Power Supply Module
 Pneumatic Control Module
 Rear Panel Module
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Front Panel Module

The Front Panel Module is responsible for the user interface and the ventilator’s main control. It
consists of a liquid crystal display screen (LCD TFT), electronic boards, and control/quick
access buttons.
The 12-inch colored liquid crystal display screen features high resolution (XGA 1024x768), high
brightness and contrast, as well as anti-reflex and abrasion (scratches) resistant touch screen
surface. The screen can be activated through finger touch, also working with gloves. Control
actuation is done by touching the screen and/or using the main button for adjusting and
confirming parameters. Some special functions also have quick access buttons.
The ventilator control is independent of the interface control; each of them is performed and
supported by separate electronic boards and software. A monitoring routine independent from
central processing supervises the entire system in order to prevent communication and/or
control failures.
Electronics Module
The Electronics Module consists of electronic boards and transducers and it is responsible for
actuating valves, monitoring of sensors, controlling the battery system, and activating alarms.
Electric Power Supply Module

The Electric Power Supply Module is responsible for powering the equipment and it consists of
an AC stabilized power source and an internal rechargeable battery. An External Battery not
recheargeable can be used optionaly. Both the internal and external batteries are sealed lead-
acid.
Pneumatic Control Module

The Pneumatic Control Module is responsible for:
 Air and oxygen flow valves
 Exhalation valve
 Safety valve
 Nebulizer/Tracheal Gas Insufflation (TGI) actuation valve
 Paramagnetic oxygen sensor
 Pneumotachograph circuit
 Intake filters
The ventilator controls the air and oxygen flows by means of separate solenoid-actuated valves.
Each gas flow rate is measured by independent heated film sensors, calibrated for air and
oxygen. Based on the measured flow rate values, the values continuously feed back in order to
meet the set flow rate, volume and mixture composition (FiO2) parameters. The mixture
resulting from the composition of air and oxygen flow rates is continuously measured by means
of a paramagnetic oxygen sensor located inside the equipment, which data sample rate is 5 Hz.
During the installation, a Vyaire Authorized Technician must configure the equipment according
to the altitude of the installation location, thus enabling the equipment, based on the barometric
pressure, to properly compensate the controlled and monitored gas volume and oxygen
concentration parameters.
The exhalation valve consists of a flexible diaphragm that actuates over a nozzle connected to
the expiratory limb. The diaphragm actuation is done by means of a solenoid-actuated pilot
valve. Based on the pressure values measured in the inspiratory and proximal route, the pilot
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valve continuously feeds back, in order to keep the airway pressure at the desired value both on
the inspiratory phase and on the expiratory phase.
The system also has two solenoid valves – one for compressed air and another for oxygen –
their purpose is to keep constant the control pressure of the nebulization, TGI and safety valve
valve systems. To control these systems, compressed air is preferably used; oxygen is only
used in case of lack of compressed air or if the FiO2 used is too high.
When nebulization is used, the system enables the compensation of the tidal volume and of the
oxygen concentration of the mixture supplied to the patient.
In specific cases, when it is impossible to keep the ventilation at safe levels, an safety valve is
opened; this opens the ventilator circuit to enable the patient’s spontaneous respiration.
To measure the flow rate and the volume on the external portion of the ventilator, flow sensors
are used; they can be either proximal (mounted on the wye piece, close to the patient
connection) or distal (mounted on the exhalation valve) type. An optical coupling located on the
Pneumatic Control Module identifies the type of sensor in use.
The compressed air and oxygen pipelines are directly connected to the intake of the Pneumatic
Control Module. In order to protect against the entry of water coming from the gas pipelines, trap
filters are used and, in case of compressed air, two filters are used to provide additional safety.
Rear Panel Module

The Rear Panel Module is formed by electrical supply connections (AC/External Battery), the
outlet of the fan from the supply source, and the communication ports, which, along the intake of
the Pneumatic Control Module, constitutes the rear panel. In addition, the Rear Panel features
an Equipotential Pin, according to the DIN 42801 standard. This Equipotential Pin is intended to
the connection of a potential equalization conductor, which connects the equipment to the
potential equalization conductor bus of the electrical installation (when available). The
equipotential pin is provided along the iX5 ventilator in anticipation of potential applications
comprising the use of other devices connected to one of the communication interfaces located
on the Rear Panel.
Supply Sources
Power Supply
The iX5 ventilator is capable of working by means of three different types of power supply
sources:
 AC Mains Power Supply
 Internal Battery
 External Battery
AC Mains Power Supply

Voltage: 100 – 240V (Full Range power supply – automatic switching)
Frequency: 50 / 60 Hz
Consumption: less than 130VA
Fuse: Time Lag T, L, 250VAC, 2.0A, IEC 60127-2/3
Internal Battery
PN: UP1290
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Battery type: Valve Regulated Sealed Lead Acid Rechargeable Battery (leak proof)
Voltage: 12V
Charge capacity: 9.0 Ah
Autonomy: up to 3 hours (see Chapter 3, section Connection to Power Source)
External Battery
PN: UP12120 (or similar)
Battery Type: Valve Regulated Sealed Lead Acid Rechargeable Battery (leak proof)
Voltage: 12V
Charge Capacity: 12.0 Ah
Autonomy: Up to 5 hours
Fuse (PCB Mother-F3): Time Lag T, 125VAC/VDC, 4.0A, UL 248-14
Internal Fuses
Board Fuse ID Specification
Mother F1 Time Lag T, 125VAC/VDC, 2.0A, UL 248-14
Mother F2, F3, F4, F5 Time Lag T, 125VAC/VDC, 4.0A, UL 248-14
Transducer F2 Time Lag T, 125VAC/VDC, 250mA, UL 248-14
Transducer F3 Time Lag T, 125VAC/VDC, 375mA, UL 248-14
Pneumatic Supply
Intake gases: oxygen and compressed air (in accordance with ISO 7396-1)
Connection standard: NIST or DISS (gas input connector for Brazil is in accordance with NBR
12188 / NBR 11906)
Pressure range: 250 – 600 kPa (2.5 – 6.0 kg/cm2)
Input flow(10s average) for each gas: 60 lpm at 280 kPa
Transient: less than 200 lpm for ≥ 3 (three) s
Intrinsic gas consumption: = 4 lpm (on standby mode)
NOTE
The volumes and flows of the intake gases are expressed at STPD (Standard Pressure
Temperature Dry). The volume and flow supplied to the patient is corrected to
compensate the fixed compliance of the respiratory circuit, the gas composition (FiO2
and humidity), and the body temperature (BTPS).
Physical Features
Weight
Ventilator: 12 kg
Ventilator including Patient Circuit: 13 kg
Stand: 12 kg
Circuit Support Arm: 1 kg
Dimensions
Height: 300 mm
Width: 290 mm
Depth: 400 mm
Stand Height: 1110 mm
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Stand
Finishing: Anti-corrosive epoxy paintwork
Casters: Four casters, four of them with locks
Weight: 12 kg
Height: 1110 mm
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Chapter 2 Safety Warnings
Introduction
Please review the following safety information prior to operating the ventilator. Attempting to
operate the ventilator without fully understanding its features and functions may result in unsafe
operating conditions.
Be sure to read the Warning and Caution statements that appear throughout this document.
These statements are defined in the following examples. In addition to the warnings and
cautions, Note statements are provided where appropriate.
WARNING
Warnings identify conditions or practices that could result in serious adverse reactions
or potential safety hazards.
CAUTION
Cautions identify conditions or practices that could result in damage to the ventilator or
other equipment.
NOTE
Notes provide additional information to clarify an explanation or instruction.
Warnings
WARNING
The following information indicates conditions that may result in safety risks to the
patient and/or operator.
Operator’s Responsibilities
 Before using the iX5 ventilator with patients, it is essential to fully read and understand this
manual. Using this equipment before fully understanding its features and functions may
result in risk condition both for patient and operator, and for the equipment itself.
 After the initial reading, keep this manual in an accessible location for future consultation.
 The equipment should be used in accordance to this manual. For additional information,
please contact Vyaire Customer Service.
 This equipment must be handled and operated only by qualified professionals.
 A qualified professional must be readily available whenever this equipment is being used in
order to take the necessary actions should there be an alarm or any other event.
 Never operate this equipment before setting up its alarms. An alarm indicates the
occurrence of a situation that requires the operator’s attention and should never be ignored.
 Always keep an alternative means of ventilation (e.g. manual resuscitator) when this
equipment is being used. In case of ventilator failure the lack of immediate access to
appropriate alternative means of ventilation can result in PATIENT death.
 Before using the equipment, always perform the IVT – Initial Verification Test, as described
under Section 10, Preventive Maintenance of this manual.
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 Never use this equipment in the presence of flammable anesthetic gases. This situation
poses a risk of explosion.
 Do not use the ventilator in a hyperbaric chamber.
 Ensure the compatibility of the ventilator and all of the parts used to connect to the patient
before use.
 The gas inlet of the ventilator must be used with Air and Oxygen only. Do not use xenon,
helium, nitric oxide and anesthetic agents or other mixtures with the ventilator. Examples of
anesthetic gases are: Nitrous oxide, Halothane, Enflurane, Isoflurane, Sevoflurane, and
Desflurane nitric oxide.
 The ventilator accuracy can be affected by the gas added by use of a nebulizer.
 The patient’s actual exhaled volume may differ from the exhaled volume reported by the
ventilator when using non-invasive ventilation (NIV) due to leaks around the mask.
 Do not modify this ventilator without Vyaire’s authorization. If this ventilator is modified,
appropriate inspection and testing must be conducted to ensure its continued safe use.
 The assembly of the ventilator system and modifications during its service life require
evaluation to ensure the requirements of IEC 60601-1:2005 + AMD1:2012 are met.
Maintenance
 This ventilator is life support equipment. Do not entrust its maintenance to unauthorized
personnel. In case of problems or difficulties, please contact Vyaire or a Vyaire Authorized
Technician.
 Do not use the equipment if it is not working within the specifications contained in this
manual. In this case, interrupt its use and contact Vyaire or a Vyaire Authorized Technician.
 In order to ensure electrical protection and avoid the risk of fire, never replace the power
cord or internal components (e.g. batteries or fuses) of this equipment. The improper
replacement of the fuse voids the warranty and poses a risk to the operation of the
equipment and to the safety of the operator and the patient.
 Lack of maintenance or maintenance performed by a non-accredited company will grant the
product the status of tampered product, and this will subject those responsible to the
sanctions provided by law. The change of basic equipment components will constitute the
non-observance of the guidelines contained in this Operator’s manual and it may affect the
basic safety and essential performance of the equipment, including in relation to
electromagnetic disturbances.
 The equipment shall not receive maintenance during operation. Performing maintenance
during operation, including cleaning, may result in patient injury.
 Circuit diagrams, component part lists, descriptions and calibration instructions used to
assist qualified personnel to repair the ventilator are in the iX5 Service Manual. Contact a
Vyaire Authorized Technician for service assistance.
Accessories
 The complete list of parts, pieces and the recommended accessories are defined in
chapter 11.
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 Always use original Vyaire parts, pieces and the recommended accessories, in order to
ensure the correct performance of this equipment and the validity of the warranty. In
addition, this measure is also intended for the patient’s and operator’s safety.
 The use of non-original parts, pieces and the recommended accessories poses risk to the
users, and does not meet the provisions of ANVISA and other local regulations, and the
instructions contained in this Operator’s manual. Incompatible parts, pieces and
accessories can result in degraded performance.
 When using other equipment along this ventilator (e.g. heated humidifier), check the
instructions provided with them.
 When accessories or other components are added to the breathing circuit, system
inspiratory resistance and expiratory resistance will be increased. The operator must ensure
that they do not exceed the following values (measurements performed at the patient
connection during spontaneous respiration and normal equipment operation):
Tidal Volume ≤ 50 ml (neonatal use) 6 cmH2O for 2,5 lpm
50 ml ≤ Tidal Volume ≤ 300 ml (pediatric use) 6 cmH2O for 15 lpm
Tidal Volume ≥ 300 ml (adult use) 6 cmH2O for 30 lpm
 All components of this ventilator and proprietary accessories are totally latex-free and
comply with the biocompatibility standards, meeting the cytotoxicity, irritation and sensitivity
requirements. The information of non proprietary accessories, are under responsibility of
each corresponding manufacturer.
 Do not reuse single-use accessories. Reuse of single use accessories may cause
inaccurate monitoring, alarms, and infection risk to the patient. Risks associated with reuse
of single-patient use items include but are not limited to microbial cross-contamination,
leaks, loss of part integrity, and increased pressure drop.
 Use of accessories, transducers and cables other than those specified or provided by
Vyaire could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
Cleaning, Disinfection and Sterilization

 Disinfection is a process capable of destroying pathogenic microorganisms, but it is not
capable of destroying spores. Spores are only destroyed by means of the sterilization
process.Before the first use, clean and sterilize the components of the breathing circuit,
following the instructions shown under the Section 9, Cleaning, Disinfection and Sterilization
of this manual. The frequency of exchange and sterilization of these circuits is defined by
the protocols observed in each hospital.
 For sterile single use recommended accessories, verify the integrity of the package. In case
of damage, follow the manufacturer’s instructions for re-sterilization or discard.
 After sterilizing, rinse and dry properly the components of the breathing circuit in order to
remove any chemical residue from them. Especially after the ethylene oxide sterilization,
wait 24 to 48 hours before using the material again in order to ensure the aeration and the
total removal of any residue this gas.
 Ensure the proper cleaning of the flow sensors, eliminating eventual solid residues
deposited in its measurement ducts. The presence of such residues may affect the
accuracy of such sensors.
 Do not reuse any component that is damaged or that is showing signs of wear.
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Pneumatic Supply
 Use only medical grade gases (dry and contaminant-free) in order to avoid internal
damages to the equipment and risks to the patient.
 Intake gases – compressed air and oxygen – must be in accordance with the standards ISO
7396-1:2007.
 This ventilator is a high flow device and should only be connected to a pipeline installation
that allows for the indicated flow at the terminal outlets, in order to avoid exceeding the
pipeline design flow, thereby minimising the risk that the ventilator interferes with the
operation of adjacent equipment
Batteries
 In case the Low Internal Battery alarm is activated, immediately connect the equipment to
the power mains or to an external battery.
Discard
 All replaced parts and pieces must be discarded as set forth by the local legislation where
the equipment is installed at the end of their expected service life.
 Discard all damaged parts removed from the ventilator during the maintenance procedures
according to your institution's protocol.
 Sterilize contaminated parts before non-destructive disposal.
 Special attention should be given when discarding the internal lead-acid type battery, which
must follow its manufacturer’s instructions, described on the component’s body.
 The same attention should be given when discarding the printed circuit boards and other
electronic components, which must not be discarded as normal waste, since they can be
hazardous to the environment.
Electric Safety
 To avoid the risk of electric shock, this equipment must only be connected to an AC Mains
Power Supply with protective earth.
 In case of doubts about the mains grounding system integrity, run the equipment using its
internal battery or an external battery.
 Never cut the ground pin in the equipment plug.
 Never use adaptors when connecting the equipment to the AC Mains Power Supply, always
plug it directly into the mains outlet.
 Never use anti-static or electrically conductive hoses or tubes in the patient circuit.
 Never disassemble the ventilator cabinet. This situation poses a risk of electric shock.
 Never touch at same time the patient and either the rear panel (data communication ports
and external battery connector) or non-medical electrical equipment and the patient. This
may cause an unsafe electrical shock to the patient.
Electromagnetic Compatibility
 The use of this equipment requires special precautions regarding its electromagnetic
compatibility.
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 This equipment, when exposed to situations that are adverse to its specification, can
generate or suffer electromagnetic interference.
 In the situation where essential performance is lost or degraded due to EM disturbances,
the ventilator will activate the appropriate protection mechanisms (i.e. audible alarm, visual
alarm, safety valve opening) going to a safe state and thus protecting the patient's integrity.
 In order to prevent harmful interferences, it is necessary:
 To observe the distances between this equipment and other possible EMI
(Electromagnetic Interference) emitters.
 Only connect this equipment to a power outlet with protective grounding.
 Never cut the grounding pin from the equipment’s power cord plug.
 Use restrictions:
 Radiofrequency equipment – mobile or portable – can interfere in the operation and
performance of this ventilator.
 Do not use this equipment in a magnetic resonance environment or close to high
frequency surgical equipment or short wave therapy equipment.
 The unauthorized modification of any element or component whose operation can be
affected by electromagnetic fields voids the warranty of this product and may produce
adverse results to its operation.
 Use of other electrical equipment adjacent to or stacked with the ventilator may cause
interference. If adjacent or stacked use is necessary, the ventilator should be observed to
verify normal operation in the configuration in which it will be used.
 The emissions characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 Class A). The ventilator is suitable for use in institutional and
intra-hospital transport settings. It is not intended for use as an emergency medical
transport ventilator or homecare applications.
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Cautions
CAUTION
The following information indicates conditions that may affect or damage the
equipment and/or its accessories.
Installation
 The initial assembly of this equipment must be done only by Vyaire or by a Vyaire
Authorized Technician. When in operation, never cover or position this equipment in such a
way that its cooling air intake or outlet is blocked. This intake is located on the frontal lower
portion of the equipment and remains unblocked when the equipment is properly mounted
on its Stand. The outlet is located on the rear panel of the equipment, where there is a
warning: – Do not obstruct.

 Never operate this equipment when it is directly exposed to heat and sunlight.
 After positioning the equipment for operation, lock the Stand casters, in order to prevent it
from moving inadvertently.
 The transportation of the ventilator can be done when it is mounted on the Stand.
Maintenance
 This equipment features safety seals on the closing bolts. If these seals are broken by
unauthorized personnel, warranty will be voided.
 The use of non-original parts, pieces and recommended accessories poses a risk to the
users, and does not meet the provisions of ANVISA and other local regulations and the
instructions contained in this Operator’s manual.
 In order to prevent premature wear of the equipment and to ensure the safe performance
and within the required specifications, the following must be performed:
IVT – Initial Verification Test
This test checks the general condition of the equipment, as well as the aspects of
cleanliness, assembly, and connections to the power and gas supply sources.
It is recommended that it be performed daily or before each use, according to the
instructions mentioned under Section 10, Preventive Maintenance.
RI – Routine Inspection
This inspection performs routine verification of the ventilation system during its use.
It is recommended that it be performed several times a day or as required by your
institution’s policy, according to the instructions mentioned under Section 10, Preventive
Mintenance.
FVT – Functional Verification Test
This test verifies the equipment’s operation, including alarm and monitoring features. It is
performed by simulating failure situations, using a lung simulator.
It is recommended that it be performed before using the equipment with a patient or when
there are doubts about the equipment’s operation, according to the instructions mentioned
under Section 10, Preventive Maintenance.
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BPT – Battery Performance Test
It performs the verification of the status of the internal battery and the external battery
(optional).
It is recommended that it be performed every 6 months to make sure batteries capacity is at
least at the minimum level recommended, according to the instructions mentioned under
Section 10, Preventive Mintenance.
APM – Annual Preventive Maintenance
It consists of the verification and eventual adjustment of the ventilator functions, as well as
the replacement of parts that are worn or deteriorated due to their use, in order to extend
the durability of the equipment and ensure its safe operation within the original
specifications and the applicable normative requirements.
The yearly performance of APM is recommended, and it must be performed only by Vyaire
or by a Vyaire Authorized Technician.
Cleaning, Disinfection and Sterilization

 Do not sterilize the equipment. Its internal components are not compatible with sterilization
techniques.
 Do not submerge the equipment into liquid solution or allow liquids to enter into its internal
part.
 Do not use abrasive materials on the ventilator’s surface, especially on its screen. It is
recommended to clean the screen with a 70% Isopropyl Alcohol-moist gauze.
 Do not use the following solutions for cleaning and/or disinfecting the components of the iX5
ventilator original breathing circuit; they can accelerate the degradation of the materials,
causing the plastic components to crack or disintegrating the silicone tubes.
 Phenol (> 5%)
 Chlorinated Hydrocarbons
 Ketones
 Aromatic Hydrocarbons
 Formaldehyde
 Inorganic Acids
 Hypochlorite
 Quaternary Ammonium Compounds
 Components subjected to sterilization experience a natural degradation due to the
characteristics of the processes employed. Vyaire define a maximum of 50
cleaning/sterilization cycles for the parts subjected to sterilization (see table 9-1).
 The accessory lifetime will depend on the care given while using and handling it.
Pneumatic Supply
 At each gas intake there is a coalescent filter capable of retaining solid particles up to 0.3
µm and liquid aerosols up to 0.75 µm that are suspended in the gaseous mixture. These
filters must be periodically inspected. Whenever required, drain the water condensed in the
collection cup in order to prevent it from entering into the equipment, compromising its
operation. At the compressed air intake, apart the coalescent filter, there is a pre-filter,
which can be seen on the ventilator’s left-hand side. Should accumulated liquid be noticed
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in the collection cup, perform the drainage by opening the pin located at the bottom of the
cup.
 Pneumatic supply sources (oxygen and compressed air) must always be at a pressure
between 250 and 600 kPa, and they must be capable of providing a flow of 60 lpm at 280
kPa. The transient will not exceed 200 lpm for ≥ 3 (three) s.
 Gas cross flow from one high pressure input port of one type of gas to another high
pressure input port of a different gas will not exceed 100 mL/h under normal or single fault
conditions.
Batteries
 Always use an External Battery in accordance with the specifications mentioned under
Section 1, General Specifications, of this manual.
 For maximum battery autonomy, connect the equipment to the AC Mains Power Supply at
least for 15 ininterrupted hours and up to 48 hours prior to use. After this period (48 hours),
it is possible that a drop in the battery power level occurs depending on the battery’s status
of use.
 The battery service life depends on the ventilator’s use conditions (frequency and duration
of ventilator and/or internal battery use, environmental conditions of temperature and
humidity, etc.); therefore its condition must be periodically checked.
 The storage the ventilator without recharging the battery for periods longer than two months
may reduce the battery service life.
CAUTION
All parts and pieces replaced must be discarded as set forth by the local legislation
where the equipment is installed.
Special attention must be given to the disposal of the internal lead-acid type
battery, which must follow its manufacturer’s guidelines, described on the
component’s body.
CAUTION
The iX5 ventilator does not charge its internal battery when connected to an
External Battery.
For maximum battery autonomy, connect the equipment to the AC Mains Power
Supply at least for 15 ininterrupted hours and up to 48 hours prior to use. After this
period (48 hours), it is possible that a drop in the battery power level occurs
depending on the battery’s status of use.
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Chapter 3 Equipment Setup

The iX5 ventilator is a servo-controlled, software-driven ventilator. It has a dynamic range of
breathing gas delivery that provides for neonatal through adult patients. Its revolutionary user
interface provides maximum flexibility with simple operator interaction. It has a flat panel color
LCD with real-time graphic displays and digital monitoring capabilities, a touch screen for easy
interaction, front panel buttons, and a dial for changing settings and operating parameters.
The iX5 ventilator is easy to clean and its design does not allow liquids to pool on the casing,
reducing the likelihood of fluid leakage into the body of the ventilator.
Introduction
Setting Up the Rear of the Ventilator
Figure 3-1. Rear Panel
A AC Mains Power Supply H External Battery connector

connector
B Power ON/OFF switch I Oxygen hose connection
C IT Network/Ethernet connector J Air hose connection
D Equipotential pin K Oxygen primary intake filter
E USB connector L Air primary intake filter
F RS232 connector M Air secondary intake filter
G Fan inlet
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WARNING
Do not connect any device different than those specified in the Chapter 13 Data
Communication Ports.
Installation
The initial assembly of the equipment must be performed only by Vyaire or by Vyaire Authorized
Technicians.
Positioning
Do not operate this equipment when it is directly exposed to heat and sunlight.
When in operation, do not cover or position this equipment in such a way that its cooling air
intake or outlet is blocked. This intake is located on the frontal lower portion of the equipment
and remains unblocked when the equipment is properly mounted on its Stand. The outlet is
located on the equipment’s rear panel, where there is the warning: – Do not obstruct.
Figure 3-2. Rear panel detail—Ventilation Output

To ensure proper operation, ensure that the power outlet used for the ventilator is easily
accessible; disconnecting the power cord from the outlet is the only way to completely isolate
the equipment from the supply mains. Do not position the ventilator in a way that makes it
difficult to access the AC power cord.
After positioning the equipment for operation, lock the Stand casters, in order to prevent it from
moving inadvertently.
To move the equipment make sure that it is in transport position: the circuit support arm is totally
retracted and the Stand casters are unlocked.
NOTE
When using the circuit support arm make sure it only supports the pacient circuit. It shall
not be used to support other accessories or devices.
During transport never pull the ventilator by the circuit support arm.
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When using the pacient circuit with water traps, properly position it in the circuit support
arm in order to have the water traps in the lowest level.
Do not stretch the arm more than 80 cm from its assembling point.
NOTE
For optimal awareness of an alarm state, the ideal operator position is one meter in
front of the iX5 screen at an angle subtended by 30 degrees from the screen midpoint
horizontal and normal to the screen plane.
NOTE
When using the compressor, position the compressor so that none of the air vents are
blocked. Good air ventilation prevents overheating.
Accessories
When using other equipment with this ventilator (e.g. heated humidifier and CO2 monitoring
equipment), ensure they comply with applicable standards and follow the instructions provided
with them.
NOTE
All parts of the ventilator are suitable for use within the patient environment.
Environment Specifications
Room Temperature
Operation: +5 to +40°C
Transportation and Storage: -20 to +70°C
CAUTION
The storage the ventilator without recharging the battery for periods longer than two
months may reduce the battery service life.
Relative Humidity
Operation: 15 to 95% – without condensation
Transportation and Storage: 10 to 95% – without condensation
Atmospheric Pressure
Operation: 70 to 106 kPa (0.7 to 1.0 atm)
Transportation and Storage: 50 to 106 kPa (0.5 to 1.0 atm)
Connection to the Power Source

The iX5 ventilator is capable of working by means of three different types of power sources:
 AC Mains Power Supply
 Internal Battery
 External Battery
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AC Mains Power Supply

Connect the equipment plug to a power mains outlet according to the specifications mentioned
under Section 1, General Specifications, of this manual.
This equipment can be connected to AC Mains Power Supply ranging from 100V to 240V. The
operator does not have to activate any voltage switching button.
WARNING
Always use AC Mains Power Supply with grounding pin connections. In case of doubts
about the integrity of the power mains grounding system, run the equipment using its
internal battery or an external battery.
Never cut the grounding pin from the equipment plug, nor use adaptors when
connecting the equipment to the AC Mains Power Supply. Always plug it directly into
the power.
Internal Battery
The iX5 ventilator has an internal battery that enables its operation even when it is not
connected to an external power source.
If the external power source (AC or External Battery) connected to the ventilator disconnects or
fails, the ventilator will automatically switch to the internal battery, keeping all functionalities
active.
The iX5 ventilator automatically charges its internal battery whenever it is connected to an AC
Mains Power Supply.
External Battery
This alternative power supply is intended to provide an extended autonomy to the internal
battery of the ventilator. It must be connected to a battery pack in accordance with the specified
voltage and current.
In order to use the equipment connected to an external battery, use the battery and the optional
power cord listed under Section 11, Accessories, Parts, and Pieces.
One end of this cord shall be connected to the equipment rear panel, on the input port with the
indication , while the other end must be connected to the external battery according to the
specifications mentioned under Section 1, General Specifications, of this manual.
When the AC Mains Power Supply fails, the ventilator will activate the visual and audible alarm
“AC Line Fail” (Medium Priority) and the “Internal Battery” indicator lights up continuous yellow.
To avoid undesirable noise, press twice the “Audio Pause / Alarm Reset” button and the alarm
changes to visual and audible alarm “Battery in Use” (Low Priority).
An external battery can be connected to increase the operation autonomy up to 8 hours. If
connected, the “Ext Batt” indicator light up continuous green.
The Ventilator will consume charge from the both batteries, internal and external (if connected),
The “Low Internal Battery” alarm (Medium Priority) will be activated when battery is near
depletion, approximately 15 minutes of operation.
The Low Internal Battery alarm evolves to High Priority at least 5 min prior to the loss of all
power.
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Note: The Vent Inop alarm may be activated as the remaining power is not enough to sustain
ventilation.
Once the AC Mains Power Supply is restored, the ventilator will recharge the internal battery.
During the recharge time, the “Int Batt Level” indicator (LED) changes its color to inform the
current battery level:
 Flashing Red: Charge below 30% of total capacity
 Continuous Orange: Charge between 80% and 30% of total capacity
 Continuous Green: Charge above 80% of total capacity
The recharge time is 15 hours to make sure the internal battery is fully charged.
When the internal battery is fully charged, the “Int Batt” visual indicator (LED) turns off.
The iX5 Ventilator does not recharge the external battery.
The Ventilator can operate on battery power:
Up to 3 hours when the internal battery is new and fully charged.
A minimum 90 minutes when the battery is maintained in accordance to the battery performance
procedure. See “Testing Battery Performance”.
Whether both batteries are present (Internal and External) the operating time is up to 8 hours
when the batteries are new and fully charged.
Actual operating time on battery power depends on the ventilator settings, battery age, and level
of battery charge. The battery capacity time is approximate. To maximize battery life, maintain a
full charge and minimize the number of discharges. When the ventilator is on battery power, the
battery icon appears at the top right of the screen.
CAUTION
The iX5 ventilator does not charge its internal battery when connected to the External
Battery.
For maximum battery autonomy, connect the equipment to the AC Mains Power Supply
at least for 15 ininterrupted hours and up to 48 hours prior to use. After this period (48
hours), it is possible that a drop in the battery power level occurs depending on the
battery’s status of use.
WARNING
Do a battery test each 6 months to make sure battery capacity is at least 90 minutes.
Replace the battery when necessary.
WARNING
The iX5 ventilator does not charge the external battery. Always make sure to connect a
fully charged external battery prior to use.
As the batteries age with use, the time the ventilator will operate on battery power from
a fully charged battery will decrease. Perform the battery test each 6 months according
to Chapter 10 – “Battery Performance Test” section and provide the replacement if
battery operation time is insufficient for your usage..
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WARNING
In case the Low Internal Battery alarm is activated, immediately connect the equipment
to the AC Mains Power Supply or to an external battery. Otherwise, the ventilator will
generate a Vent Inop alarm and will be led to an inoperative condition.
Check Section 6, Alarms and Messages, in this manual for more information about the
internal battery charge status indications.
CAUTION
The battery service life depends on the ventilator’s use conditions (frequency and
duration of ventilator and/or internal battery use, temperature and humidity room
conditions, etc.).
The storage the ventilator without recharging the battery for periods longer than two
months may reduce the battery service life.
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Connection to the Gas Pipeline

Connect the compressed air and oxygen hoses supplied with the equipment to their
corresponding inputs, located on the ventilator’s rear panel. Connect the other end of each of
these hoses to the corresponding gas source output.
Figure 3-3. Connection of the air and oxygen hoses
WARNING
Use only medical grade gases (dry and contaminant-free) in order to avoid internal
The equipment features internal regulating valves that ensure its operation under pressures
ranging from 250 kPa (2.5 kg/cm2) and 600 kPa (6.0 kg/cm2). The optimum pressure range is
between 300 kPa (3.0 kg/cm2) and 500 kPa (5.0 kg/cm2). Confirm if the gas sources are kept
within this pressure range during the entire time the equipment is being used, and use external
pressure regulating valves when required.
If necessary, it is possible to use the iX5 ventilator with only one supply gas. In this case, it will
not be possible to adjust the oxygen concentration (FiO2). If the equipment is connected solely
to a compressed air source, the ventilation provided will only be 21% oxygen; if it is connected
to an oxygen-only source, then the ventilation provided will be 100% oxygen.
CAUTION
At each gas intake there is a coalescent filter capable of retaining solid particles up to
0.3 µm and liquid aerosols up to 0.75 µm that are suspended in the gaseous mixture.
These filters must be periodically inspected. Whenever required, drain the water
condensed in the collection cup in order to prevent it from entering into the equipment,
compromising its operation. At the compressed air intake, apart from the coalescent
filter, there is a pre-filter, which can be seen on the ventilator left-hand side. Should
accumulated liquid be noticed in the collection cup, perform the drainage by opening the
pin located on the bottom of the cup.
Upon turning the equipment off, disconnect it from the oxygen source in order to reduce
the risk of accumulating this gas inside it in case of eventual leaks.
Pneumatic supply sources (oxygen and compressed air) shall be capable of supplying a
flow up to 60 lpm at 280 kPa.
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Figure 3-4. Gas intake filters
Breathing circuit assembly

Always use original parts, pieces and recommended accessories, in order to ensure the correct
performance of this equipment and the validity of the warranty. In addition to that, this measure
is also intended for the patient’s and operator’s safety.
All components of this ventilator and its original accessories are latex-free and comply with the
biocompatibility standards, meeting the cytotoxicity, irritation and sensitivity requirements.
WARNING
Before the first use, clean and sterilize the components of the breathing circuit, following
the instructions shown in Section 9, Cleaning, Disinfection, and Sterilization, of this
manual. The frequency of exchange and sterilization of these circuits is defined by the
protocols observed in each hospital.
When accessories or other components are added to the breathing circuit, system
inspiratory resistance and expiratory resistance will be increased. The operator must
ensure that they do not exceed the following values (measurements performed at the
patient connection during spontaneous respiration and normal operation of the
equipment):
Tidal Volume ≤ 50 ml 6 cmH2O for 2.5 lpm
50 ml ≤ Tidal Volume ≤ 300 ml 6 cmH2O for 15 lpm
Tidal Volume ≥ 300 ml 6 cmH2O for 30 lpm
WARNING
All parts of the breathing circuit assembly are subjected to the patient’s gas. Therefore,
those parts shall be properly discarded, if single-use, or sterilized, according to Chapter
9, Cleaning, Disinfection and Sterilization or instructions for use of third-party
recommended accessories.
To avoid contamination of the ventilator's manifold with body fluids or expired gases,
always use an Inspiratory filter connected to the Gas Output port. In case of
contamination, internal components shall be replaced.
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Selection of the Patient Breathing Circuit and Flow Sensor

Select the breathing circuit and the flow sensor based on the patient’s weight.
Ideal Body Weight
(IBW) Patient Category Breathing Circuit Flow Sensor
From 300 g to 3000 g Neonatal Neonatal/Pediatric Neonatal Proximal
From 3.1 kg to 30 kg Pediatric Neonatal/Pediatric Pediatric Proximal
More than 30 kg Adult Pediatric/Adult Expiratory
CAUTION
In the case where humidification filter is used, it should be assembled between the
proximal flow sensor and the patient connection in order to protect the sensor against
exhalation-generated condensation.
NOTE
To avoid the risk of inacurate measures, always use the neonatal proximal flow sensor
for intended volumes equal or below 50 ml.
NOTE
If a flow sensor is not compatible with the selected patient weight (IBW), a medium
priority alarm (Wrong Flow Sensor) will be activated. In this case, the operator must
initially check whether the weight selected on the IBW control is correct; if it is, the
sensor must be replaced.
NOTE
Make sure that the flow sensors are properly cleaned; eliminate residues deposited in
the measurement ducts. The presence of residue may affect the accuracy of these
sensors.
NOTE
Upon acknowledging the flow sensor and periodically (every 5 minutes), the iX5
ventilator performs a flow sensor Autozero process. This process is meant to both
eliminate the condensation found on the two ways of the sensor measurement pipe and
reset the flow zero point, in order to ensure the monitoring accuracy.
NOTE
The volume and flow supplied to the patient is corrected to compensate the compliance
of the respiratory circuit (as calculated during accessory self-check function), the gas
composition (FiO2 and humidity), and the body temperature (BTPS). All other gas
volumes and flows measurements are expressed at STPD (Standard Pressure
Temperature Dry).
Exhalation Valve Connection

In order to ensure that the diaphragm and exhalation valve have been assembled correctly,
proceed according to the orientation label attached on the equipment’s side panel.
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 Turn the ventilator off or press the Standby Mode button.

 Carefully position the diaphragm on the exhalation port, located on the equipment’s side
panel. Check to ensure that the embossed part of the diaphragm is facing outwards.
 Insert the exhalation valve perpendicularly, following the fitting position. Turn it slightly to the
right, until locking it.
 To disassemble the exhalation valve, press the button with the instruction Push to Unlock
and turn the valve body to the left.
Figure 3-5. Exhalation valve assembling sequence.
WARNING
Handle the diaphragms carefully. Before assembling them, check whether they are
intact, without any tears or punctures.
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WARNING
Do not use the exhalation valve exhaust port for spirometry or to gauge the equipment.
Due to the bias flow of the ventilator, the gas exhaust volume is greater than the actual
tidal volume exhaled by the patient.
Patient Circuit Assembly

Assemble the selected patient breathing circuit and connectors according to the instructions
provided with them. Then connect each part to the ventilator.
Connect the Inspiratory filter to the Gas Output port, then connect the inspiratory limb of the
breathing circuit to the Inspiratory filter output.
Connect the expiratory limb of the breathing circuit to the exalation valve connector.
Connect the proximal pressure line of the breathing circuit to the Proximal Pressure port at the
ventilator.
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Figure 3-6. Side panel connections: inspiratory limb, expiratory limb and proximal pressure line
Connecting the Humidifier

The ventilator is designed to work with active humidification (refer to the humidifier instructions
for detailed information on humidifier connections and use).
Fit the humidifier heater on the front rail of the ventilator’s stand.
Connect the provided elbow to the Inspiratory filter attached to the Gas Output port.
Connect a tube between the elbow and the chamber’s input.
Connect the Inspiratory limb of the breathing circuit to the chamber’s output.
WARNING
To avoid contamination of the ventilator’s manifold with body fluids or expired gases,
always use an Inspiratory filter connected to the Gas Output port. In case of
contamination, internal components shall be replaced.
WARNING
Do not use anti-static or electrically conductive tubes along the pacient circuit of this
ventilator.
WARNING
When assembling the proximal pressure line, make sure that there is no type of
resistance or obstruction along its length.
WARNING
When assembling the circuit on the ventilator, make sure that there is no obstruction on
the opening of the side panel with the indication Warning: - Do not obstruct. This
is the safety valve intake, which opens when the equipment is not operating (Vent Inop
alarm), allowing the patient to breath spontaneously.
Figure 3-7. Side panel detail – safety valve intake.
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IF LP Generator Assembly
For assembling the IF LP generator breathing system, follow the steps below:
1. Gather the nCPAP supplies:

• Single-limb, heated breathing circuit
• IF LP Generator kit
• Fixation device
• Humidifier and chamber
• Sterile water supply (optional)
NOTE: Discard the extra bag of
adapters found in the circuit package.
2. Attach the water chamber to the

humidifier, and connect it to the water
feed system (if being used). Follow the
manufacturer instructions for the proper
set-up.
3. Connect the gas delivery tubing (A) to

the gas output port on the ventilator (I)
and the humidifier chamber port (II).
4. Connect the elbow connector on the

heated breathing circuit (B) to the
humidifier chamber. Insert the heater
wire plug into the wire socket. Securely
insert the temperature probe into the
port on the circuit elbow (III). Insert the
second temperature probe (IV) into the
airway port at the distal end of the
breathing circuit.
5. Connect the non-heated section (C)

to the drive line of the generator
assembly (D).
NOTE: When an isolette warmer is
being used, an extension tube may be
used to extend the generator assembly
(D). Connect the Infant Flow extension
tube to the end of the Infant Flow
generator exhaust tube.
6. Connect the proximal pressure line

(E) to the proximal pressure port on the
ventilator (V) and the pressure line on
the generator.
NOTE: The recommended temperature
for inspired gases is between 96.8ºF
(36ºC) and 98.6ºF (37ºC), but never
higher than 98.6ºF (37ºC).
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Flow Sensor Connection

Proximal Flow Sensors
Assemble the flow sensor body on the wye piece, taking care so that the pressure intakes are
always facing upward.
Connect the other end of the sensor to the equipment’s side panel, observing the assembly
sequence shown below:
Figure 3-8. Proximal flow sensors assembly
WARNING
When connecting the flow sensor, carefully observe the two pressure intake limbes.
Make sure that the limb identified by a colored line along the duct is facing the wye
piece. The other limb, with no identification along the duct, must be facing the patient
connection.
CAUTION
In the case where a humidification filter is used, it shall be assembled between the
proximal flow sensor and the patient connection in order to protect the sensor against
exhalation-generated humidity.
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Expiratory Flow Sensor

Assemble the Expiratory Flow sensor on the exhalation valve.
Connect the other sensor end to the equipment side panel, as shown.
Figure 3-9. Expiratory flow sensor assembly
HME, Nebulization and TGI Connection

HME
When using an expiratory flow sensor, install an HME filter between the wye piece and the
endotracheal tube.
When using a proximal flow sensor, install an HME filter between the flow sensor and the
endotracheal tube.
Nebulization
Install a standard nebulizer on the inspiratory limb of the patient breathing circuit, connecting its
end to the auxiliary output identified as Nebulizer/TGI, located on the equipment’s side panel.
TGI
Assemble the NIV/TGI connector between the wye piece and the patient connection. Insert a
catheter through the orifice of the connector plug into the ET tube. Place the catheter close to
the carina, following the protocols recommended by the hospital.
Connect the other end of this catheter to the auxiliary output identified as Nebulizer/TGI, located
on the equipment’s side panel.
WARNING
Do not use heated humidifier nor a nebulizer with HME. The combined use of one of
these items can increase the resistance of HME.
Always monitor the filters for increased resistance or blockage.
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WARNING
The use of expiratory filters may cause monitored tidal fluctuations. The volume and
pressure alarms should be set at appropriate levels for the patient.
Always monitor the filters for increased resistance or blockage.
CAUTION
When the NIV/TGI connector is being used to connect the breathing circuit to a non-
invasive interface (mask), make sure to use the blind plug in order to prevent leaks.
Connecting the Patient to the Ventilator

Ensure that the breathing circuit and the additional items (e.g. HME, flow sensor, humidifier,
etc.) are properly assembled. Using humidifier, check the water level.
Turn the equipment On according to the instructions in Chapter 4 Operation.
Verify the breathing circuit trhough the Accessory Self-Check function according to the
instructions in Chapter 4 Operation.
Set the ventilation parameters and alarms according to the instructions in Chapter 4 Operation.
Connect the breathing circuit to the patient’s airway interface.
Start ventilation.
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Chapter 4 Operation
Turning the equipment On

Make sure all the gas connections, power cord and breathing circuit are properly assembled as
indicated in the Chapter 3 Equipment Setup, also make sure that there is no patient connected
to the ventilator.
Turn the On/Off switch located on the equipment’s rear panel.
Autotest Routine
An autotest routine will be automatically initiated and if a failure is detected, the equipment will
not start operating. When a failure that prevents the equipment from operating safely is
detected, it will be indicated on the front panel, and the equipment will not start operating until
the failure is resolved.
Figure 4-1. Autotest Routine
NOTE
When only one of the gas sources is being used, the autotest routine will indicate a
failure to the inactive gas source, but it will not prevent the operation from starting. The
operator will evaluate whether the situation represents a safe operational condition.
Patient Category Selection

After the autotest routine, the ventilator will automatically switch to the patient selection screen.
Since the iX5 ventilator is capable of storing all set parameters into memory even when it is
turned off, it is possible to make the ventilator recover the last configuration by pressing the
Return to Last Patient button.In the case of a new patient, it is possible to choose between
Neonatal, Pediatric, and Adult.
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Figure 4-2. Patient Selection: Current or New
Neonatal patient 300 g ≤ IBW ≤ 3000 g

Scales Pediatric patient 3.1 kg ≤ IBW ≤ 30 kg
Adult patient IBW > 30 kg
The patient category is used by the ventilator to automatically adjust the control scale limits.
When a ventilation mode change occurs, the ventilator will automatically assume safe values for
critical parameters, based on the type of patient, waiting for readjustments and/or confirmation
by the operator.
When the parameters are set above the limits typically used (Safe Limits), the ventilator will
show an alert warning. However, if the operator so desires, they can accept the value outside
the recommended range.
Accessory self-check function

The accessory self-check function measures the patient circuit’s compliance and resistance, in
order to provide optimized conditions to the patient’s ventilation.
The user should start a “Patient Circuit and Flow Sensor Test” every time a New Patient is
selected or if the patient circuit is changed.
CAUTION
Make sure the breathing circuit and the additional items (e.g. HME, flow sensor,
humidifier, etc.) are properly assembled, as recommended in Chapter 3. Using
humidifier, check the water level.
WARNING
Before proceeding, make sure that NO PATIENT is connected to the ventilator.
When choosing the “Start Test Now” button, the equipment will start the Patient Circuit and Flow
Sensor Test function.
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Figure 4-3. Start Test Now
Select the type of humidifying system that will be used for the patient circuit configuration.
Figure 4-4. Type of Humidifying System Selection
Obstruct the circuit wye piece and press the Next button. Make sure there are no leaks through
the patient breathing circuit.
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Figure 4-5. Circuit Wye Piece Obstruction
Open circuit after the wye piece and press the Next button.
Figure 4-6. Open Circuit
Before running the test, the ventilator will show a message to indicate if the patient circuit and
the flow sensor are ready for use.
If it is ready, select the Proceed button.
If the ventilator shows a message indicating that the patient circuit and/or the flow sensor are
inappropriate for use or that the patient circuit can be usable with caution, the user can select
the Repeat Test button in order to start the verification all over again.
Every time these messages come to the user, the Help button can be selected in order to
provide additional information about Possible Cause and Solution.
WARNING
When the Accessory Self Check function shows the messages “inappropriate for
use” or “usable with caution”, the user must know that if the Proceed anyway
button is selected, patient ventilation may present inaccuracies.
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NOTE
If the flow sensor test does not successfully passed or not executed, the VG mode will
not be enabled.
Table 4-1. Ventilation System / Breathing Circuit Parameters

Parameter Value
Inspiratory and Expiratory Adult 0 to 6 cmH2O @ 30 lpm
Resistance Pediatric 0 to 6 cmH2O @ 15lpm
Neonatal 0 to 6 cmH2O @ 2.5lpm
Circuit Compliance Adult 0.5 to 7 mL/cmH2O
Pediatric 0.1 to 4 mL/cmH2O
Neonatal 0.1 to 4 mL/cmH2O
Table 4-2. Dead Space of the Flow Sensors

Flow Sensor Value Tolerance
Neonatal Proximal 0.8 mL 5%
Pediatric Proximal 0.8 mL 5%
Expiratory 17.5 mL 5%
WARNING
Always disconnect the patient from the ventilator prior to running the function.
When changing any accessories in the patient circuit, run the function to ensure the
circuit compliance and the resistance values are adequate.
A proper patient circuit is necessary to maintain the accuracy described in this manual.
Ventilation Mode Selection

After selecting the patient category, the ventilator switches to the ventilation mode selection
screen. Select the intended ventilation mode for the patient, see section Ventilation Modes.
Controls Selection
After selecting the ventilation mode, the ventilator automatically switches to the ventilation
controls selection screen. Set the intended vantilation parameters. See section Ventilation
Modes in this chapter and Basic Controls and Advanced Settings Characteristics and Ranges in
Chapter 5.
Alarm Selection
After selecting the control parameters, the ventilator automatically switches to the alarm limit
selection screen. Set the alarms according to the intended patient ventilation. See Adjustable
Alarms in Chapter 6.
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Making changes
If changes are needed during ventilation follow the steps below:
Ventilation mode – press the Ventilation Summary Button.
Controls – use either the Ventilation Summary Button or Quick Access buttons (may vary
according to the selected mode).
Alarms – press the Alarm button.
NOTE
To confirm the changes press Apply button. You can discard the changes by pressing
the Cancel button.
WARNING
Hospital institution is responsible for ensuring the compatibility of the ventilator and all
of the parts used to connect to the patient before use.
Always use original Vyaire parts, pieces and recommended accessories, in order to
addition, this measure is also intended for the patient's and operator's safety.
The use of non-original parts, pieces and recommended accessories poses risk to the
users. Incompatible parts can result in degraded performance.
The accessories are defined in chapter 11.
Turning the equipment Off

Make sure that the patient is not connected to the ventilator. Otherwise, select Standby Mode
and disconnect the patient from the breathing circuit.
Turn the On/Off switch located on the equipment’s rear panel. After the shutdown, the ventilator
will generate a continuous auditory signal to indicate that the ventilator is turned off. Press the
Audio Pause/Alarm Reset button to finish the procedure.
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Ventilation Modes
Introduction
The ventilation modes are organized into four groups: Assisted/Controlled, SIMV,
Spontaneous and Non-Invasive Modes.
The iX5 ventilator offers the following ventilation modes:
VC – Volume Control Adult / Pediatric

PC – Pressure Control Adult / Pediatric / Neonatal
Assisted-
TCPL – Time Cycled Pressure Limited Pediatric / Neonatal
Controlled
PRVC – Pressure Regulated Volume Control Adult / Pediatric
VG – Volume Guarantee Neonatal
VC – Volume Control Adult / Pediatric
PC – Pressure Control Adult / Pediatric / Neonatal
SIMV+PS TCPL – Time Cycled Pressure Limited Pediatric / Neonatal
PRVC – Pressure Regulated Volume Control Adult / Pediatric
VG – Volume Guarantee Neonatal
PS – Pressure Support + Backup Adult / Pediatric / Neonatal
Spontaneous
APRV/BiPhasic – Airway Pressure Release Ventilation Adult / Pediatric / Neonatal
Bilevel PC – Bi-level Positive Airway Pressure Adult / Pediatric
nTCPL – Non Invasive Time Cycled Pressure Limited Neonatal
NIV CPAP – CPAP + Backup Adult / Pediatric / Neonatal
(non-invasive) nCPAP – Nasal CPAP + Backup Neonatal
Biphasic LP – Biphasic for use with LP Generators Neonatal
nCPAP LP – Nasal CPAP for use with LP Generators Neonatal
Assist Control Ventilation (A/C)

In Assist Control ventilation mode, all breaths initiated and delivered are mandatory breaths. The
initiation of a breath is triggered by one of the following:
 Patient effort activates the inspiratory trigger mechanism,
 The breath interval, as set by the RATE control, times out,
 The operator presses the MANUAL BREATH button.
Initiation of a breath by any means resets the breath interval timing mechanism. It is possible for
the patient to initiate every breath if he/she is breathing faster than the preset breath rate. If the
patient is not actively breathing, the ventilator automatically delivers breaths at the preset
interval (set breath rate), initiating the inspiratory phase.
The end of the inspiratory phase is determined by a time cycle or a flow cycle. .
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Breath Breath
Interval Interval
PRESSURE
elapsed elapsed
TIME
① Mandatory Breath (Breath interval expired)

② Mandatory Breath (Patient triggered)
Figure 4-7, Assist Control Ventilation Waveform
Synchronized Intermittent Mandatory Ventilation (SIMV)

In SIMV mode, the ventilator can deliver both mandatory and demand breath types. Mandatory
breaths are delivered when the SIMV “time window” is open and one of the following occurs:
 A patient effort is detected;
 The breath interval has elapsed with no patient effort detected;
 The MANUAL BREATH button has been pressed.
For mandatory demand breaths, the end of the inspiratory phase is determined by a time cycle
or a flow cycle. For demand breaths, delivery and terminating of the inspiratory phase are
determined by the settings for Pressure Support (PS), PEEP, rise time %, and PS cycle value.
Pressure Support (PS) is active for demand breaths in SIMV mode.
Pressure
Time
Assist Window Open
Patient triggered Volume breath
Pressure supported breath
Figure 4-8. SIMV Waveform
The breath interval is established by the preset breath rate. It resets as soon as the interval time
determined by the set breath rate has elapsed, or when the MANUAL BREATH button is
pressed.
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Pressure Spontaneous Ventilation
Time
Demand Breath
Figure 4-9. CPAP Waveform
In this mode, all breaths are patient-initiated demand breaths unless the MANUAL BREATH
button is pressed or apnea backup ventilation is activated. When the MANUAL BREATH button
is pressed, a single breath is delivered at the currently selected apnea backup control settings.
The delivery and terminating of the inspiratory phase are determined by the settings for
Pressure Support (PS), PEEP, rise time %, and PS cycle value.
Pressure Support (PS) is active in this mode.
NOTE
If PS level is insufficient to meet patient demand, premature termination of the breath
may occur with auto-triggering.
In these cases the PS level should be increased slightly.
Figure 4-10. PS Waveform

In Figure 4-10, breath number 1 represents the pressure and flow tracing which occurs when the
PS level is adequate to meet the patient demand. Breath number 2 shows what happens when
the PS level is insufficient.
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Non-Invasive Ventilation:
WARNING
Exhaled volume of the PATIENT can differ from the measured exhaled volume due to
leaks around the mask.
The iX5 ventilator performs non-invasive ventilation with a standard dual limb circuit. For
pediatric/adult non-invasive modes (Bilevel PC and CPAP), it is required a mask with no bleed
holes. For neonatal non-invasive modes (nCPAP, nTCPL), it is required a nasal prong.
The initiation of a breath is triggered by one of the following, depending on the chosen mode:
 Patient effort activates the inspiratory trigger mechanism,
 The breath interval, as set by the RATE control, times out,
 The operator presses the MANUAL BREATH button.
For Bilevel PC and nTCPL the initiation of the inspiratory phase can be delivered by both
mandatory and demand breath types and cycled by time or flow.
For CPAP and nCPAP the initiation of the inspiratory phase is delivered by demand breaths and
cycled by flow, terminating the inspiratory phase.
NOTE
Excessive leaks around the mask or prong may result in false triggering of the ventilator
or assertion of disconnect alarms.
Leak Compensation
The ventilator incorporates a leak compensation system. This system compensates for baseline
leaks at the patient interface or around the patient’s endotracheal tube. It only provides baseline
leak compensation and is not active during breath delivery.
For non-invasive modes (Bilevel PC, CPAP, nCPAP and nTCPL), the maximum leak
compensation is 120 lpm for adults, 80 lpm for pediatrics and 30 lpm for neonatal patients.
For all the other modes, the maximum leak compensation is 60 lpm for adults, 40 lpm for
pediatrics and 20 lpm for neonatal patients.
Backup Ventilation
When an event of Anea occurs, the ventilator sends a mandatory cycle of backup ventilation,
started from the Apnea alarm independently of the ventilation mode selected (controlled,
assisted or spontaneous), according with the sction 6 Alarms. Especially in PS, CPAP, nCPAP
and APRV modes, there are extra controls available for backup ventilation. When any of those
modes is selected, you MUST:
 Set the primary and advanced settings for the selected mode.
 Set the primary controls appearing at the top-right of the touch screen, for the apnea breath
type.
For each selected mode, the respective Backup Ventilation is as follows:
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Selected Mode Apnea Backup Mode Backup Parameters

PS PC Backup Rate, Insp Time, Insp Pres
CPAP Bilevel PC Backup Rate, Insp Time, IPAP
nCPAP nTCPL Backup Rate, Insp Time, Pres Limit
APRV PC Backup Rate, Insp Time, Insp Pres
Apnea Backup ventilation is initiated when the patient’s spontaneous monitored rate is lower
than the adjusted backup rate.
Apnea Backup ventilation will terminate when one of the following criteria are met:
 The patient initiates a spontaneous breath
 A manual breath is delivered
Neonatal Ventilation
The ventilator provides 4 different Neonatal nasal non-invasive modes: nCPAP, nTCPL, nCPAP
LP and Biphasic LP.
The nCPAP LP and Biphasic LP modes are dedicated for use only with LP generators and
interfaces.
For use with other interfaces, you shall use the nCPAP or nTCPL modes.
For non-invasive ventilation, select the non-invasive option after selecting the neonatal patient
category.
Figure 4-11. Ventilation type selection for neonatal patient
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Select the appropriate interface by pressing Nasal Prong or LP Generator button. After selected
the interface, only the respective modes will be available
Figure 4-12. Neonatal interfaces choice
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Breath Types
This section contains a brief description of the breath types and ventilation mode combinations
available for adult, pediatric and neonatal patients.
There are two basic breath types:
 Mandatory breaths (delivered according to set ventilator parameters), and
 Demand breaths (triggered by the patient)
All breaths are defined by four variables:
 Trigger (initiates the breath),
 Control (controls the delivery),
 Cycle (primary breath termination), and
 Limit (secondary breath termination).
VC – Volume Control
Description
In this mode, the ventilator provides inspiratory flow set on control Insp Flow until the tidal
volume set on the control Tidal Vol is reached, cycling to volume.
The inspiratory pressure will depend on the set parameters (Insp Flow, Tidal Vol and PEEP)
and on the patient’s respiratory mechanics.
The iX5 ventilator provides three waveforms (Waveform) of the inspiratory flow controlled on
the VC mode:
 Constant Flow ( )
 Decreasing Flow ( )
 Sinusoidal Flow ( )
NOTE
In the case of decreasing flow, the value set on Insp Flow will be the mean inspiratory
flow of each cycle. The initial flow (peak) will be 50% greater than the set value, and the
end flow, 50% lower. Therefore, an inspiratory time and an I:E ratio equivalent to a
constant flow cycle will be maintained.
In case of sinusoidal flow, the value set on Insp Flow will be the mean inspiratory flow
of each cycle. The initial flow (peak) will be 56% greater than the set value. Therefore,
an inspiratory time and an I:E ratio equivalent to a constant flow cycle will be
maintained.
NOTE
The VC mode is not enabled for neonatal patients.
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The Intra-Breath Demand System in Volume Ventilation

The iX5 ventilator features an intra-breath demand system in Volume Controlled ventilation,
designed to provide additional flow to the patient during periods of demand.
It continuously measures the Peak Inspiratory Pressure (Ppeak) throughout the breath cycle
and compares the Ppeak measurement to its previous value. Should the Ppeak decrease by the
2 cmH2O, the ventilator will recognize the patient demand and automatically allows flow to
exceed the set Peak Flow, thereby meeting the patient’s demand.
The maximum demand flow is 180 lpm for adult patients and 100 lpm for pediatric patients.
Settings
Basic Settings
%O2 % Oxygen
Volume Tidal Volume
Rate Respiratory Rate
PEEP Positive End Expiratory Pressure
Flow Trig Flow Trigger
Insp Flow Inspiratory Flow
Insp Pause Inspiratory Pause
Advanced Settings / Maneuvers
Waveform Flow Pattern (Decelerating/Square/Sinusoidal)
Pres Trig Pressure Trigger
Sigh Sigh
Neb Nebulization
TGI Tracheal Gas Insufflation
Slow Flow Slow Flow Maneuver
Circuit Compliance Compensation

The volume of gas delivered during a VC mode is increased to include the set volume, plus the
volume lost due to the compliance effect of the circuit.
Preset Values:
Adult patients (IBW setting higher than 30 kg): 1.96 mL/cmH2O
Pediatric patients (IBW equal or lower than 30 kg): 1.08 mL/cmH2O
NOTE
As iX5 ventilator uses preset values for compliance compensation, it is important to use
breathing circuits with compatible values of compliance. Therefore Vyaire recommends
using Vyaire approved circuits.
VC + PS – Volume Controlled Ventilation + Pressure Support
Description
In VC+PS mode, spontaneous cycles are interspersed with mandatory cycles, which can be
assisted by pressure support (PS). Upon detecting the patient’s effort, the ventilator helps the
respiration of the patient, increasing the airway pressure until the set pressure support (PS) level
is reached. The resulting flow is decreasing and its amplitude depends on the patient’s
respiratory mechanics or the patient’s effort. Cycles are terminated when the inspiratory flow
falls to the set PS Cycle value. On spontaneous cycles with pressure support, the volume
delivered to the patient depends on the level of the pressure support, on the PS cycle, and on
the patient’s effort and respiratory mechanics.
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Settings
Basic Settings
%O2 % Oxygen
Volume Tidal Volume
PS Pressure Support
Insp Flow Inspiratory Flow
Insp Pause Inspiratory Pause
Waveform Flow Pattern
(Decelerating/Square/Sinusoidal)
Rise Pressure Rise
PS Cycle Flow Cycle % for spontaneous breaths
AAC Artificial Airway Compensation
Sigh Sigh
Neb Nebulization
TGI Tracheal Air Insufflation
Slow Flow Slow Flow Maneuver
PC – Pressure Controlled
Description
In this mode, the ventilator continuously controls the inspiratory flow in order to reach and
maintain the pressure on the patient’s airway on the value set by the operator on the Insp Pres
control. The time during which such pressure will be maintained is set by the operator on the
Insp Time control.
Settings
Basic Settings
%O2 % Oxygen
Insp Pres Inspiratory Pressure
Insp Time Inspiratory Time
Rise Pressure Rise
PC Cycle Flow Cycle % for mandatory breaths

Sigh Sigh
Neb Nebulization
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PC + PS – Pressure Controlled Ventilation + Pressure Support
Description
In the PC+PS mode, spontaneous cycles are interspersed with mandatory cycles, which can be
assisted by pressure support (PS). Upon detecting the patient’s effort, the ventilator helps the
respiration of the patient, increasing the airway pressure until the set pressure support (PS)
level. The resulting flow is decreasing and its amplitude depends on the patient’s respiratory
mechanics or the patient’s effort. Cycles are terminated, when the inspiratory flow falls to the set
PS Cycle value. On spontaneous cycles with pressure support, the volume delivered to the
patient depends on the level of the pressure support, on the PS cycle, and on the patient’s effort
and respiratory mechanics.
Settings
Basic Settings
%O2 % Oxygen
Rise Pressure Rise
Sigh Sigh
Neb Nebulization
TCPL – Time Cycled Pressure Limited
Description
This mode is indicated for the ventilation of neonatal and pediatric patients only.
In this mode, during the mandatory cycles, the ventilator maintains a constant flow in the airway,
and the exhalation valve controls the expiratory pressure (PEEP) and the inspiratory pressure
limit Pres Limit.
In this mode, during the mandatory cycles, the pressure in the airway is simply limited, and not
controlled. Depending on the values set to continuous flow (Cont Flow) and inspiratory time
Insp Time, and the patient’s respiratory mechanics, it is possible that the pressure in the airway
will not reach the intended inspiratory pressure value. The set flow Cont Flow must be enough
to meet the patient’s demand.
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Settings
Basic Settings
%O2 % Oxygen
Pres Limit Pressure Limit
Cont Flow Continuous Flow
Neb Nebulization
TCPL+PS – Time Cycled and Pressure Limited + Pressure Support
Description
When TCPL+PS mode is used, the spontaneous cycles can be assisted by the pressure support
PS. During the spontaneous cycles, the ventilator can increase the inspiratory flow beyond the
set Insp Flow, in order to maintain the pressure support and meet the patient’s demand.
Settings
Basic Settings
%O2 % Oxygen
PS Pressure Support
Rise Pressure Rise
Neb Nebulization
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PRVC – Pressure Regulated Volume Controlled

Pressure Regulated Volume Control (PRVC) breaths are pressure breaths where the pressure
level is modulated by the ventilator to achieve a preset volume. PRVC breaths are:
 Controlled by pressure (inspiratory + PEEP) and volume
 Limited by pressure (inspiratory + PEEP + margin)
 Cycled by time or flow
 PRVC breath operation is as follows:
 When PRVC is selected, a volume controlled test breath is delivered to the patient. This
test breath consists of a volume controlled cycle with the equal Vol Target set, with
inspiratory flow rate calculated using Vol Target and the adjusted inspiratory time (T
Insp). The test cycle always includes an inspiratory pause of 200 ms.
 The measured plateau pressure in this cycle is used as the initial control pressure for
the subsequent cycle.
 The next breath and all subsequent breaths are delivered as pressure control breaths.
 Inspiratory pressure is modulated by the ventilator to maintain the target volume. The
maximum step change between two consecutive breaths is 2 cmH2O.
The test breath sequence is initiated when any of the following occur:
 Entering the Mode (PRVC)
 Exiting Standby
 Changing the Target Volume
 Disconnecting and reconnecting (replacing) the flow sensor
 Deactivating any of the following alarms:
 Circuit Disconnection
 Circuit Occlusion
 Vent Inop
 High Ppeak
NOTE
Demand Flow is active for all mandatory breaths. The maximum peak inspiratory
pressure achievable by the ventilator is limited by the high peak pressure alarm
setting.
WARNING
In PRVC breaths, the pressure may be regulated between the PEEP and High
Ppeak alarm – 5 cmH2O in order to achieve the Vol Target setting. The PEEP and
High Ppeak alarm settings should be set at appropriate levels for the patient to
avoid over or under delivery of pressure.
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Settings
Basic Settings
%O2 % Oxygen
Vol Target Volume Target
T Insp Inspiratory Time
Pres Trigger Pressure Trigger
Rise Pressure Rise
PRVC + PS – Pressure Regulated Volume Controlled + Pressure Support
Description
When the PRVC+PS mode is used, the spontaneous cycles can be assisted by the pressure
support (PS).
Settings
Basic Settings
%O2 % Oxygen
PS Pressure Support
T Insp Inspiratory Time
Pres Trigger Pressure Trigger
Rise Pressure Rise
VG – Volume Guarantee
Description
Volume Guarantee breaths are pressure control breaths where the pressure level is modulated
by the ventilator to achieve a preset tidal volume (Vol Target).
VG breath operation is as follows:
 When VG is selected, pressure controlled test breath, to the set P Backup, is delivered to
the patient. Default is 15 cmH2O (P Backup).
 The next breath will deliver an inspiratory pressure based on the dynamic compliance of the
previous breath and the set tidal volume (Vol Target).
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 Inspiratory pressure is modulated by the ventilator to maintain Vol Target. The maximum
step change between two consecutive breaths is 2 cmH2O. The maximum tidal volume
delivered in a single breath is determined by Vol Limit.
NOTE
Breath to breath variation of delivered pressure will not be more than 4 cmH2O
between successive breaths of the same trigger type (time vs. patient triggered).
NOTE
Volume Guarantee is only available in the neonatal patient size and requires the
use of a proximal flow sensor.
WARNING
In VG breaths, the pressure may be modulated between Pres Min and Pres Max in
order to achieve the Vol Target setting. The Pres Min and Pres Max settings should
be set at appropriate levels for the patient to avoid over or under delivery of
pressure.
Settings
Basic Settings
%O2 % Oxygen
P Backup Backup Pressure
Insp Time Inspiratory Pause
Breath Av Breath Average
Pres Min Pressure Minimum
Pres Max Pressure Maximum
Vol Limit Volume Limit
Rise Pressure Rise
P Backup
Backup Pressure (cmH2O)
In VG, P Backup is used for test breaths and acts as a backup pressure setting during certain
alarm conditions.
Range: 5–40 cmH2O
Default: 15 cmH2O.
NOTE
The P Backup value is the absolute pressure value for the breath. Example: if the Pres
Limit is set to 15 cmH2O and PEEP is set to 5 cmH2O, the pressure will be limited to 15
cmH2O.
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WARNING
Disconnecting the proximal flow sensor or removing it from the circuit while VG Mode is
active will cause the ventilator to deliver pressure ventilation at the set P Backup.
WARNING
The P Backup setting should be set at an appropriate level for the patient to avoid under
or over delivery of tidal volume during test breaths or flow sensor disconnect.
Maximum and Minimum Pressure (Pres Max and Pres Min)
Pres Max and Pres Min settings determine the range wherein the ventilator will modulate the
inspiratory pressure during VG mode.
Breath Av
Breath Average (b/min)
The Breath Av setting in VG allows the clinician to set the number of breaths for which the
ventilator uses to calculate the average volume delivered. Using Breath Av can help with
irregular breathing patterns and help to provide a basis for a more consistent regulated pressure
delivery.
NOTE
When in SIMV mode, Breath Av does not take into consideration the spontaneous
triggered breaths. Breath Av will take the average of the previous mandatory breaths
for the target volume.
Mode Patient Minimum Maximum Default
VG
Neonatal 1 60 1
VG + PS
Vol Limit
This is the maximum tidal volume delivered to the patient during the maneuver. This setting has
no effect on the settings during normal ventilation and can be set to any tidal volume desired
independent of the current mode of ventilation.
Range: 10 to 120 mL
Default: 2 x IBW x mL/kg
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VG + PS – Volume Guarantee + Pressure Support
Description
When the VG+PS mode is used, the spontaneous cycles can be assisted by the pressure
support (PS).
Settings
Basic Settings
%O2 % Oxygen
PS Pressure Support
P Backup Backup Pressure
Insp Time Inspiratory Pause
Breath Av Breath Average
Pres Min Pressure Minimum
Pres Max Pressure Maximum
Vol Limit Volume Limit
Rise Pressure Rise
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PS + Backup
Description
The minimum pressure support level is PEEP + 5 cmH2O in adult and pediatric applications,
independent of the set PS pressure level. In neonatal applications the minimum pressure
support level is zero.
PS breaths are:
 Controlled by pressure (PS level + PEEP)
 Limited by pressure (PS level + PEEP)
 Cycled by flow (PS Cycle)
Settings
Basic Settings
%O2 % Oxygen
PS Pressure Support
Rise Pressure Rise
Neb Nebulization
Backup Settings
Backup Backup Rate
CPAP + Backup
Description
In this mode, the ventilator only maintains the continuous expiratory pressure and, if necessary,
guarantees backup cycles.
Settings
Basic Settings
%O2 % Oxygen
CPAP Positive End Expiratory Pressure
Neb Nebulization
Backup Settings
Backup Backup Rate
IPAP Inspiratory Positive Airway Pressure
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nCPAP
Description
This is a spontaneous, non-invasive mode, specific for neonates ventilated with nasal prongs. In
this mode, the ventilator maintains the continuous expiratory pressure and continuous flow
(Cont Flow).
Settings
Basic Settings
%O2 % Oxygen
Backup Settings
Backup Backup Rate
NOTE
The Insp Hold and Exp Hold buttons are not active in nCPAP mode.
NOTE
Volume monitoring is not available in this mode. It is recommended to remove flow
sensor from the breathing circuit.
nTCPL
Description
This is a controlled, non-invasive mode, specific for neonates ventilated with nasal prongs.
In this mode, during the mandatory cycles, the ventilator maintains a constant flow in the airway,
and the exhalation valve controls the expiratory pressure (PEEP) and the inspiratory pressure
limit Pres Limit.
In this mode, during the mandatory cycles, the pressure in the airway is limited, and not
controlled. Depending on the values set to continuous flow (Cont Flow) and inspiratory time
(Insp Time), and the patient’s respiratory mechanics, it is possible that the pressure in the
airway does not reach the intended inspiratory pressure value. The set flow Cont Flow must be
enough to meet the patient’s demand.
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Settings
Basic Settings
%O2 % Oxygen
Insp Time Inspiratory TIme
NOTE
The Insp Hold and Exp Hold buttons are not active in nTCPL mode.
NOTE
Volume monitoring is not available in this mode. It is recommended to remove the flow
nCPAP LP
Description
This is a spontaneous, non-invasive mode, specific for neonates ventilated with LP generators
and interfaces. In this mode, the ventilator maintains a continuous flow (Base Flow) to reach the
continuous CPAP pressure.
Settings
Basic Settings
%O2 % Oxygen
Flow
Base Flow Baseline Continuous Flow /
Backup Settings
Flow High Flow High
Time High Time with Flow High
pressure relationship
The Infant Flow LP driver is subject to a direct relationship between the controlled enriched gas
flow and airway pressure. A nomogram illustrating the relationship between constant airway
pressure and flow settings is shown in Figure 4-13. For example, 8 lpm gas flow provides
approximately 5 cmH2O.
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Flow Pressure Nomogram (for

reference only) is showing
typical flow pressure
relationships. This is not
meant to establish actual
product performance.
Figure 4-13. Flow pressure nomogram
NOTE
Individual devices have a tolerance of up to ±15 percent from that illustrated in the
nomogram, and in particular, at pressures below 2cmH2O.
NOTE
The Insp Hold and Exp Hold buttons are not active in nCPAP LP mode.
NOTE
Manual Insp function will use Flow High and Time High settings to generate a manual
inspiration.
NOTE
Volume monitoring is not available in this mode. Flow sensor should be removed from
the breathing circuit.
NOTE
To deliver manual breaths, the Pressure High flow meter must indicate a flow that is
above zero.
CAUTION
• The nCPAP LP mode has been designed and tested using only Vyaire accessories.
Only accessories approved for use by Vyaire should be used. If in doubt, please contact
your local sales representative.
• If the patient pressure is inconsistent with set flow, be aware of possible leaks,
connection faults or occlusion
• Monitor the breathing circuit for excessive condensation and drain and replace circuit
as necessary.
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WARNING
• Do not use the IF LP generators with dry unheated gas.
• Under certain conditions (minimum supply pressure and maximum gas demand,
including auxiliary output) output flow rates and therefore pressure delivered to the
generator may be reduced.
• Nasal CPAP therapy in general can cause nasal irritation, septal distortion, skin
irritation and pressure necrosis. Adherence to the recommended usage instructions for
the IF LP system may reduce the incidence of these complications.
Biphasic LP
Description
This is a bi-phasic, non-invasive mode, specific for neonates ventilated with LP generators and
interfaces. In this mode, the ventilator switches between two levels of pressure, achieved by
adjusting the Base Flow and High Flow. The Rate button defines how many times per minute
the ventilator switches between the Base Flow and the High Flow
Settings
Basic Settings
%O2 % Oxygen
Base Flow Baseline Flow
Flow High High Flow
Time High Time in High Flow
Flow / pressure relationship

The Infant Flow LP driver is subject to a direct relationship between the controlled enriched gas
flow and airway pressure. A nomogram illustrating the relationship between constant airway
pressure and flow settings is shown in Figure 4-13. For example, 8 lpm gas flow provides
approximately 5 cmH2O.
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Flow Pressure Nomogram (for

reference only) is showing
typical flow pressure
relationships. This is not
meant to establish actual
product performance.
Figure 4-14. Flow pressure nomogram
NOTE
Individual devices have a tolerance of up to ±15 percent from that illustrated in the
nomogram, and in particular, at pressures below 2cmH2O.
NOTE
The Insp Hold and Exp Hold buttons are not active in Biphasic LP mode.
NOTE
Volume monitoring is not available in this mode. It is recommended to remove flow
NOTE
To deliver manual breaths, the Pressure High flow meter must indicate a flow that is
above zero.
CAUTION
• The Biphasic LP mode has been designed and tested using only Vyaire accessories.
Only accessories approved for use by Vyaire should be used. If in doubt, please contact
your local sales representative.
• If the patient pressure is inconsistent with set flow, be aware of possible leaks,
connection faults or occlusion
• Monitor the breathing circuit for excessive condensation and drain and replace circuit
as necessary.
WARNING
• Do not use the IF LP generators with dry unheated gas.
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• Under certain conditions (minimum supply pressure and maximum gas demand,
including auxiliary output) output flow rates and therefore pressure delivered to the
generator may be reduced.
• The Pres High flow meter may be adjusted to zero when the BiPhasic mode is not
required for the patient.
• Nasal CPAP therapy in general can cause nasal irritation, septal distortion, skin
irritation and pressure necrosis. Adherence to the recommended usage instructions for
the IF LP system may reduce the incidence of these complications.
Airway Pressure Release Ventilation (APRV/Biphasic)
Description
APRV/BiPhasic is a time-cycled pressure mode, where the ventilator cycles between two
different baseline pressures based on time; this can be synchronized with patient effort.
Controlled ventilation can be maintained by time cycling the transitions between baseline
pressures. Additionally, pressure support can be added to improve comfort for the spontaneous
breathing patient.
In this mode, the patient is allowed to breathe spontaneously at two preset pressure levels.
These are set using the Pres High and Pres Low controls. The maximum duration at each
pressure during timed cycling is set with the Time High and Time Low controls.
The ventilator synchronizes the change from Pressure Low to Pressure High with the detection
of inspiratory flow or the first inspiratory effort detected within the T Delay window. Transition
from Pressure High to Pressure Low occurs with the first end of inspiration detected after the T
Delay window
Settings
Basic Settings
%O2 % Oxygen
Pres High Pressure High
Time High Time High
Pres Low Pressure Low
Time Low Time Low
T Delay Time Delay
PS High Pressure Support High
PS Low Pressure Support Low
Rise Pressure Rise
Neb Nebulization
Backup Settings
Backup Backup Rate
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WARNING
The PS High setting is measured above the P High setting. The PS High setting should
be set at an appropriate level for the patient to avoid over delivery of pressure in
support breaths during Pressure High. Also, High Ppeak alarm should be set above
Pres High + PS High in order to avoid improper alarm activation.
NOTE
Time High and Time Low are maximum time settings for a time-cycled transition. Actual
times may vary depending on the patient’s spontaneous breathing pattern and the T
Delay setting. Setting the T Delay as zero cycles the transition between pressure levels
on time only and will not provide synchronization with patient efforts.
NOTE
The Manual Breath, Insp Hold and Exp Hold buttons are not active in APRV / BiPhasic.
Pressure
Time High
Pressure High
Time Low
Pressure Low
Time
Demand Breath
Time
Spontaneous Breath triggers change to Pressure High
Spontaneous Breath triggers change to Pressure Low
Figure 4-15. Spontaneous breathing on APRV/BIPHASIC Mode

Pressure
Time High
Pressure High
Time Low
Pressure Low
Time
Backup Cycles above Pressure Low
Backup Cycles above Pressure High
Figura 4-16. Backup ventilation on APRV/BIPHASIC mode
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Bilevel / PC
Description
This is a controlled non-invasive mode, specific for pediatric and adult patients, ventilated with
masks.
The joint and simultaneous operation of the flow and exhalation valve allows the patient to
exhale during the inspiratory phase of the controlled pressure cycles. That means, in each
phase, if the patient exerts an inspiratory effort, the ventilator will increase the airway flow to
meet the inspiratory demand; if the patient exerts an expiratory effort, the ventilator will relief the
airway pressure, keeping it in its set level (PEEP or IPAP).
Settings
Basic Settings
%O2 % Oxygen
IPAP Inspiratory Positive Airway Pressure
EPAP Expiratory Positive Airway Pressure
Rise Pressure Rise
Neb Nebulization
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Chapter 5 Ventilation Features
Buttons and LEDs
Figure 5-1. User interface, showing buttons and LEDs
Button Letter Function

A Standby
B 100% O2
C Manual Insp
D Exp Hold
E Insp Hold
F Setup
G Panel Lock
H Audio Pause / Alarm Reset
I Main Knob
J Power
K AC Line
L Ext Batt
M Int Batt
N Int Batt Level
O Master Alarm
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Front Panel Buttons and LEDs
Standby Mode (Standby)

This button is located on the front panel and puts the ventilator on standby mode.
 The ventilator suspends operation, interrupting the ventilation functions, monitoring, and
alarms, with the exception of the trend curves.
 The operator can proceed to adjust all control and alarm parameters.
 The operator can access all information stored in the ventilator’s memory (trend curves).
 The operator can change any parts of the circuit assembly while in Standby Mode.
WARNING
Ensure that the breathing circuit and the additional items (e.g. HME, flow sensor,
humidifier, etc.) are properly assembled. Using humidifier, check the water level.
Verify the breathing circuit through the Accessory Self-Check function according to the
instructions in Chapter 4 Operation.
 To start the programmed ventilation, the operator must press the Standby Mode button
again, or the Start Ventilation button on the screen.
When the Standby Mode button is pressed after an oxygenation period, activated by the
100% O2 button, a suction sequence starts. This sequence is described under 100% O2
control.
The activation of this function is indicated by the corresponding LED signal.
NOTE
During Standby Mode, iX5 sends a constant flow of 4 lpm to avoid gas overheating in
the patient circuit when using a heated humidifier.
100% O2 – Oxygenation/Suction Maneuver

Pressing the 100% O2 button starts the oxygenation process, adjusting the oxygen
concentration to 100% for 3 minutes. If the button is pressed again within 1 minute, the
maneuver will be interrupted, immediately returning to the previously set oxygen concentration
value.
For opens suction and closed suction instructions, see Chapter 5 – Advanced Features -
Suction
Manual Insp – Manual Cycle

This button (located on the front panel) starts a controlled cycle on the selected mode. The
ventilator ignores this command, if the button is pressed during the inspiratory phase or during
the initial period of 300ms of the expiratory phase.
Exp Hold – Manual Expiratory Pause

This button (located on the front panel) enables a pause at the end of the expiratory phase of
the respiratory cycle. The button can be activated at any time, and will activate at the end of the
next exhalation.
In order to make the detection of the pause easier, the indicating LED remains flashing from the
time the button is depressed until the start of the pause, remaining lit during the entire time of
the pause.
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The pause can be activated either by c:

 One Touch: an automatic pause will be activated at the end of the next exhalation, with a
fixed duration of 2 seconds.
 Press and Hold: while the operator keeps the button pressed, the pause will be maintained
for a maximum time of 15s.
NOTE
The expiratory pause measures the Auto PEEP or the Occlusion Pressure P0.1
(measured 100ms after the pause start).
For further information about these parameters, see Section 7, Monitoring
Features, of this Manual.
Insp Hold – Manual Inspiratory Pause

This button (located on the front panel) initiates a pause at the end of the inspiratory phase of
the respiratory cycle. The button can be activated at any time, and the pause will only be
activated at the end of the next inspiration.
In order to make the detection of the pause easier, the LED indicator remains flashing from the
moment the button is pressed until the pause starts, remaining lit during the entire pause time.
The pause can be activated either by One Touch or by Press and Hold:
 One Touch: an automatic pause will be activated at the end of the next inhalation, with a
fixed duration of 2 seconds.
 Press and Hold: while the operator keeps the button pressed, the pause will be maintained
for a maximum time of 15s.
NOTE
During the inspiratory pause, in the absence of flow, the equalization between the
alveolar pressure and the airway pressure occurs, monitored on the manometer.
Therefore, it is possible, during the inspiratory pause, to directly check on the
ventilator manometer, or on the graphic or digital display, the Plateau Pressure
value (alveolar pressure at the end of inhalation, lung elastic pressure,
plateau pressure).
For more information about the monitoring of Plateau Pressure, check Section 7,
Monitoring Features, in this Manual.
Setup
This menu, accessed through the Setup button located on the front panel, grants access to the
system information and general configurations.
Screen Setup
The screen brightness control enables the adjustment of display’s luminosity, providing more
comfort to the operator/patient in rooms with less light.
The sleep mode option enables a secondary luminosity adjustment, always inferior to the main
adjustment, which becomes effective 20 seconds after the last action of the operator on the
equipment screen. The ventilator automatically assumes the brightest level, when any alarm
occurs or when the operator touches any control.
Sound Setup
The loudspeaker volume control makes the configuration of the volume level of the sound alarm
possible. This control does not allow the muting of the alarms.
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System Info
This submenu displays information about the hardware and software installed in the ventilator. It
also shows the ventilator cumulative hours of operation.
Panel Lock – Panel Lock

This button (located on the front panel) locks the control panel, avoiding the unintentional
pressing of equipment buttons. Only the Panel Lock button remains enabled – and this is the
only way of disabling this function.
Audio Pause/Alarm Reset – alarm silence and clearing of inactive alarms

This button (located on the front panel) inhibits the audible indication of active alarms for 120
seconds; it can be reactivated in case thebutton is pressed again within this period. This button
also works as an alarm system reset, clearing the visual alarm indicators whose generating
causes have already ceased.
The activation of this function is indicated by the corresponding LED.
NOTE
The Audio Pause/Alarm Reset button does not prevent the sound activation when a
new alarm generating condition occurs.
Basic Controls
NOTE
The volume and flow supplied to the patient is corrected to compensate the fixed
compliance of the respiratory circuit, the gas composition (FiO2 and humidity), and the
body temperature (BTPS). All other gas volumes and flows measurements are
expressed at STPD (Standard Pressure Temperature Dry).
% O2
Oxygen Concentration (%)
This control enables the adjustment of the percentage of oxygen in the air/oxygen mixture sent
to the patient on each cycle (FiO2). When changes are made to the %O2 setting, the iX5
automatically changes the FiO2 alarm setting by ± 5%. The set FiO2 alarm limit is indicated by
operator action when needed.
All Patients 21 to 100%
Scale
Default Value 21%
Volume
Volume (mL)
This control enables the adjustment of the tidal volume during the mandatory cycles (controlled
and assisted) on the VC modes.
Neonatal Patient (not enabled)
Pediatric Patient 10 to 500 mL
Scales Default Value IBW × mL/kg
Adult Patient 100 to 2000 mL
Default Value IBW × mL/kg
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NOTE
The tidal volume supplied on pressure-based ventilation modes depends both on the
applied inspiratory pressure and on the lung mechanics.
Insp Pres
Inspiratory Pressure (cmH2O)
This control enables the adjustment of the Inspiratory Pressure value over PEEP, applied to the
mandatory cycles in the PC modes.
For example: for a Insp Pres set to 20 cmH2O with a PEEP of 5 cmH2O, the final inspiratory
pressure value in the airway will be 25 cmH2O.
The Inspiratory Pressure is actively maintained by the simultaneous control of the flow valves
and the exhalation valve during the entire respiratory cycle. The flow is automatically set to meet
the patient’s demand and/or compensate leakages while the pressure is relieved whenever the
patient makes an expiratory effort.
The pressure’s rise time, from PEEP to (PEEP + Insp Pres) will depend on the Rise
adjustment.
All Patients 5 to 80 cmH2O
Scale
Default Value 15 cmH2O
NOTE
On the PC mode, the controlled pressure value Insp Pres is above to the PEEP value.
Insp Flow
Inspiratory Flow (lpm)
This control enables the adjustment of the inspiratory flow in VC mode.
Besides amplitude, the VC mode enables the selection of three different waveforms:
 Constant flow ( )
The value of the set flow is kept constant throughout the entire inspiratory time.
 Decreasing flow ( )
The initial flow (Insp Peak Flow) will be 50% greater than the set value, while the end of
cycle flow will be 50% lower than the value set on Insp Flow. Therefore, the inspiratory time
and the I:E ratio will be maintained equivalent to those of a constant flow cycle at a lower
airway pressure.
 Sinusoidal flow ( )
The initial flow (Insp Peak Flow) will be 56% greater than the set value, in order to maintain
the inspiratory time and the I:E ratio equivalent to those of a constant flow cycle.
Pediatric Patient 2 to 50 lpm

Default Value 20 lpm
Scales
Adult patient 2 to 120 lpm
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Insp Time
Inspiratory Time (s)
This control enables the adjustment of the inspiratory time on PC, TCPL , PRVC, VG, Bilevel
PC, and nTCPL modes.
0.10 to 15.0 s
Neonatal Patient
0.10 to 5.0 s on nTCPL and nCPAP modes
0.50 s
Default Value
0.30 s on VG, nTCPL and nCPAP modes
0.10 to 15.0 s
Pediatric Patient
0.50 to 5.0 s on CPAP and Bilevel PC modes
Scales
0.75 s
Default Value
0.50 s on PRVC mode
0.10 to 15.0 s
Adult Patient 0.50 to 15.0 s on PRVC modes
0.50 to 5.0 s on CPAP and Bilevel PC modes
Default Value 1.00 s
Time High
Time with high pressure or flow (s)
This control enables the adjustment of the time wherein the flow remains in the upper level
adjusted on nCPAP LP and Biphasic LP modes. For the APRV mode, this control enables the
adjustment of the time while the pressure remains in the upper level adjusted.
Neonatal Patient 0.10 to 5.0 s on nCPAP LP and Biphasic LP modes

Default Value 0.30 s on nCPAP LP and Biphasic LP modes
Scales Pediatric / Adult 0.2 to 30.0 s on APRV mode
Patient
Default Value 4.0 s on APRV mode
Time Low
Time with low pressure (s)
This control enables the adjustment of the time wherein the pressure remains in the lower level
adjusted on APRV mode.
Pediatric / Adult 0.2 to 30.0 s on APRV mode

Scales Patient
Default Value 0.5 s on APRV mode
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Rate
Respiratory Controlled Rate (/min)
This control enables adjustment of rate of the controlled cycles supplied by the ventilator.
1 to 180 bpm
Neonatal Patient 1 to 120 bpm on VG mode
1 to 60 bpm on nTCPL and Biphasic LP modes
30 bpm
Default Value
20 bpm on nTCPL and Biphasic LP modes
1 to 180 bpm
Scales Pediatric Patient 1 to 60 on PRVC mode
1 to 40 on Bilevel PC mode
Default Value 20 bpm
1 to 180 bpm
Adult Patient
1 to 40 bpm on PRVC and Bilevel PC modes
Default Value 12 bpm
PEEP
Positive End-Expiratory Pressure (cmH2O)
WARNING
If High Ppeak alarm is set too close to PEEP setting, Circuit Occlusion alarm may
be triggered.
This control enables the adjustment of the expiratory pressure level on all modes.
The PEEP expiratory pressure is actively maintained by simultaneously controlling the flow
valves and the exhalation valve. The flow is automatically set to meet the patient’s demand
and/or compensate leakages, maintaining the functional residual capacity while the pressure is
relieved whenever the patient makes an expiratory effort.
0 to 50 cmH2O
Neonatal Patient 0 to 25 cmH2O on VG mode
0 to 15 cmH2O on nCpap and nTCPL modes
Scales
Pediatric and Adult 0 to 50 cmH2O
Patients
Default Value 5 cmH2O
NOTE
On the PC mode, the controlled pressure value Insp Pres is above to the PEEP value.
NOTE
When changing the PEEP, check the set value on the High Ppeak alarm. If the PEEP
is set close to or above the set alarm value, there may be some limitation of ventilation,
since detection of the High Ppeak alarm causes the ventilator to cycle to exhalation.
Pres Limit
Pressure Limit (cmH2O)
This control enables the adjustment of the Pressure Limit value, where the Pres Limit value is
an absolute pressure value, applied to the mandatory cycles on the VG, TCPL, nTCPL and
nCPAP modes.
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For example: for a Pres Limit value set to 20 cmH2O with a PEEP of 5 cmH2O, the final
inspiratory pressure value in the airway will be 20 cmH2O.

TCPL Neonatal
TCPL + PS 5 80 20
Pediatric
PC
PC + PS All NA NA OFF (120)
PS + Backup
Bilevel PC Pediatric
NA NA OFF (40)
Adult
nTCPL
nCPAP + Backup Neonatal 5 30 10
NOTE
The minimum possible Pres Limit adjustment will be within 5 cmH2O above the set
expiratory pressure (PEEP) for TCPL mode, and 2 cmH2O above the set PEEP level
for nCPAP and nTCPL modes.
NOTE
The Pres Limit value is the absolute pressure value for the breath. Example: if the Pres
Limit is set to 15 cmH2O and PEEP is set to 5 cmH2O, the pressure will be limited to 15
cmH2O.
Cont Flow
Continuous Base Flow (lpm)
The Cont Flow control sets the continuous flow used in the breath delivery for VG, TCPL,
nTCPLand nCPAP modes.
2 to 30 lpm
Neonatal Patient
2 to 20 lpm on nTCPL and nCPAP modes
6 lpm
Scales Default
8 lpm on nTCPL and nCPAP modes
Default 20 lpm
Flow Base
Continuous Base Flow (lpm)
The Flow Base control sets the continuous flow used in the breath delivery for nCPAP LP and
Biphasic LP modes.
Neonatal Patient 2 to 15 lpm
Scales
Default 8 lpm
Flow High
High Flow to increase baseline CPAP (lpm)
The Flow High control sets the flow used in the breath delivery for Biphasic LP mode and in
backup breaths in nCPAP LP mode. Flow High is delivered above the Flow Base setting.
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NOTE
The resulting flow in breath delivery in Biphasic LP and nCPAP LP modes is the sum
of Base Flow and Flow High. Example: if the Flow Base is set to 8 lpm and Flow High
is set to 4 lpm, the resulting flow used in breath delivery will be 12 lpm. The resulting
flow is limited to 20 lpm.
Neonatal Patient 0 to 10 lpm

Scales
Default 2 lpm
Vol Target
Volume Target (ml)
The Vol Target control is active in VG and PRVC. The tidal volume target is based on the
previous exhaled measured tidal volume. Vol Target is based on previous mandatory breaths,
spontaneous breaths are excluded from the calculation.
NOTE
When Breath Av is active, the target volume will be based on the previous breath
average cycles. Example, if Breath Av is set to 1, then the volume target will be based
on the previous exhaled volume. If the Breath Av is set to 3, then the volume target will
be based on the average of the last 3 mandatory breaths.

PRVC Pediatric 20 500 IBW x mL/kg
PRVC + PS Adult 100 2000 IBW x mL/kg
VG
Neonatal 2 100 IBW x mL/kg
VG + PS
NOTE
Excessive leaks may reduce the ability to achieve the desired Volume Target.
NOTE
Delivered volume may be reduced if inspiratory time and/or flow are inadequate to
achieve the Volume Target. Volume guarantee will attempt to compensate by
increasing delivered pressure up to 4 cmH2O below the pressure limit. The Low Volume
alarm will be activated if the expiratory volume falls below the alarm threshold.
Back Up
Back Up Rate (b/min)
The Back Up control sets a Backup breath rate in PS, CPAP, nCPAP and APRV modes.
Neonatal OFF, 1 60
PS + Backup Pediatric OFF, 1 40
Adult OFF, 1 40
nCPAP Neonatal OFF, 1 40
OFF
Pediatric OFF, 1 40
CPAP
Adult OFF, 1 40
APRV Pediatric OFF, 1 40
Adult OFF, 1 40
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CPAP
Continuous Positive Airway Pressure (cmH2O)
This control enables the adjustment of the expiratory pressure level in CPAP modes.

Pediatric
CPAP + Backup 0 20 5
Adult
PS
Pressure support (cmH2O)
This control enables the adjustment of the pressure support to above the PEEP, on the
spontaneous cycles in the SIMV/CPAP mode.
When the patient’s effort is detected, the ventilator increases the inspiratory flow and pressure in
the airway, up to the resulting inspiratory pressure value (PEEP + PS).
For example: for a pressure support set to 20 cmH2O with a PEEP of 5 cmH2O, the final
inspiratory pressure value in the airway will be 25 cmH2O.
The ventilator will finish the cycle, when the inspiratory flow reaches the cycling flow value set
on the PS cycle control.
The pressure rise time, from PEEP to (PEEP + PS) will depend on the Rise adjustment.
Off, 5 to 80 cmH2O
Neonatal Patient
Off, 2 to 30 cmH2O on VG mode
Scales Pediatric and Adult Patients Off, 5 to 80 cmH2O
15 cmH2O
Default Value
5 cmH2O on VG mode
NOTE
On spontaneous cycles with pressure support, the PS value is added to the PEEP
value.
NOTE
During the respiratory cycles on PCV, NIV, and other modes using the programmed PS,
the ventilator supplies a demand flow (free flow) of up to 180 lpm for adult, 100 lpm for
pediatric, and 30 lpm for neonatal patients.
IPAP
Inspiratory Positive Airway Pressure (cmH2O)
This control enables the adjustment of the Inspiratory Pressure Limit in non-invasive Bilevel PC
mode. The IPAP value is an absolute pressure value, for example: when IPAP is set to 20
cmH2O with EPAP is set to 5 cmH2O, the final inspiratory pressure value in the airway will be
20 cmH2O.
The Inspiratory pressure rise time from EPAP to IPAP is controlled via the Rise control in
advanced settings.

Bilevel PC Pediatric 5 40 15
CPAP + Backup Adult
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EPAP
Expiratory Positive Airway Pressure (cmH2O)
This control adjusts the expiratory pressure level in Bilevel PC mode.

Pediatric
Bilevel PC 0 20 5
Adult
Pres Trig
Pressure Trigger (cmH2O)
Sets the level below PEEP at which the inspiratory trigger mechanism is activated. When the
pressure in the patient circuit falls below the set PEEP by the set pressure trigger level, the
ventilator will cycle to inspiration.

VC
VC + PS Neonatal -10 -0.3 OFF
PC
PC + PS
PS + Backup
TCPL
TCPL + PS
PRVC
Pediatric
PRVC + PS -10 -0.5 OFF
Adult
VG
VG + PS
APRV
Bilevel PC
CPAP + Backup
nTCPL
nCPAP
Neonatal -10 -0.1 OFF
Biphasic LP
nCPAP LP
Flow Trig
Flow Trigger (lpm)
The inspiratory flow trigger mechanism is activated when the Net Flow becomes greater than
the Flow Trig setting. Net Flow is defined as [Delivered Flow − Exhaled Flow] (or proximal
inspiratory flow when using a proximal flow sensor).
Neonatal Patient 0.2 to 2 lpm; OFF
Default Value 0.5 lpm
Pediatric Patient 0.5 to 5 lpm; OFF
Scales
Adult Patient 2 to 15 lpm; OFF
NOTE
During expiratory phase, iX5 ventilator provides a preset Bias Flow of 4 lpm.
NOTE
Whenever the patient’s effort reaches the set sensitivity level, the Patient Effort
indicator will be displayed on the ventilator screen.
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NOTE
The improper pressure sensitivity (Pres Trig) or flow sensitivity (Flow Trig) adjustment
may result in the autocycling of the equipment due to the occurrence of false-positive
alarms or due to not detecting the patient’s real efforts.
NOTE
The iX5 ventilator does not allow the simultaneous adjustment of the Pres Trig or
Flow Trig. The adjustment of a value in any of the trigger sensitivities (Flow Trig or
Pres Trig) will automatically turn the other off.
Insp Pause
Inspiratory Pause (s)
This control enables the activation of an inspiratory pause in the controlled and assisted cycles
on the VC mode, according to the set pause time (Insp Pause).
Pediatric and adult patients 0.0 to 2.0 s
Scale
Default Value 0.0 s
NOTE
During the inspiratory pause, in the absence of flow, the equalization between the
alveolar pressure and the airway pressure occurs, monitored on the manometer.
Therefore, it is possible, during the inspiratory pause, to directly check on the ventilator
manometer, or on the graphic or digital display, the Plateau Pressure value (alveolar
pressure at the end of inhalation, elastic pressure of the lung, plateau pressure).
Advanced Settings Characteristics and Ranges
Waveform Tab
This control enables the adjustment of the inspiratory flow in VC mode.
Besides amplitude, the VC mode enables the selection of three different waveforms:
 Decreasing flow ( )
The initial flow (Insp Peak Flow) will be 50% greater than the set value, while the end of
cycle flow will be 50% lower than the value set on Insp Flow. Therefore, the inspiratory time
and the I:E ratio will be maintained equivalent to those of a constant flow cycle at a lower
airway pressure.
 Sinusoidal flow ( )
The initial flow (Insp Peak Flow) will be 56% greater than the set value, in order to maintain
the inspiratory time and the I:E ratio equivalent to those of a constant flow cycle.
 Constant flow ( )
The value of the set flow is kept constant throughout the entire inspiratory time.
Scales
Adult patient 2 to 120 lpm
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Rise
Inspiratory Rise Slope (%)
The Inspiratory Rise setting controls the slope of the pressure rise during a mandatory breath,
whether it is in Insp Pres, P Backup, PS or IPAP. This control affects the inspiratory flow and
with a higher Rise% to pressure, there will be a higher flow required.
The Inspiratory Rise control is not active for TCPL breaths.
All Patients 25% (slow) to 100% (fast)
Scales
Default Value 50%
NOTE
All patient range 25-100%
A Rise % higher means a faster rise or pressure slope = 100%, conversely a slower
Rise % percentage equates to a slower rise or pressure slope = 25%.
PC Cycle
Pressure Control Flow Cycle for Mandatory Breaths in PC and PRVC
This control sets the ability to turn flow cycle on or off for mandatory pressure breaths in PC,
PRVC and Bilevel PC modes. When PC Cycle is active, the control sets the percentage of peak
inspiratory flow at which the inspiratory phase of a pressure breath is terminated..
Scales
Default Value OFF
NOTE
When PC Cycle is active, the mandatory pressure breaths will be terminated based on
either flow cycle or time cycle, whichever comes first.
A lower percentage of flow cycle such as 10% can mean a longer breath cycle, while a
higher flow cycle percentage such as 75% may mean a shorter breath cycle.
PS Cycle
Pressure Support Flow Cycle %
The PS Cycle control sets the percentage of peak inspiratory flow at which the inspiratory phase
of a pressure breath is terminated.
Scales Default Value 25%
Neonatal Patients 10%
NOTE
A lower percentage value of flow cycle such as 10% can mean a longer breath cycle,
where a higher flow cycle percentage such as 75% may mean a shorter breath cycle.
Sigh Tab
Sigh
Sigh Breath On/Off
This control determines whether a sigh breath will be active in either VC or PC breath types. The
control is can be set either on or off. The ventilator will deliver a sigh breath when this setting is
ON. The sigh breath configuration, duration and frequency delivered is determine by the Sigh
%, Sigh Breaths and Sigh Interval control settings.
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Range: On/Off
Default: Off
Sigh%
Sigh%
The Sigh% sets the configuration of the Sigh Breath by percentage. For example, if the
ventilator is in VC and the Sigh % is set to 50%, the Sigh breath will deliver a volume breath 1.5
times or 50% greater than the set Volume control. In PC, if the Sigh % is set to 25%, the
delivered Sigh breath will be 1.25 time higher or 25% greater than the set Insp Pres control.
Sigh breaths are active in both VC and PC.

VC
VC + PS Pediatric
25 50 25
PC Adult
PC + PS
Cycle Breath
Cycle Breath
This control sets the number of sigh breaths that can occur in one sequence.

VC
VC + PS Pediatric
1 3 1
PC Adult
PC + PS
Cycle Interval
Cycle Interval
This control sets the interval for when the Sigh breaths will occur. Example, if the Sigh Interval is
set to 20, the ventilator will deliver a number of Sigh Breaths based on the Sigh Cycle setting,
at the Sigh% size every 20 breaths as set by the Sigh interval.

VC
VC + PS Pediatric
20 100 20
PC Adult
PC + PS
Nebulizer Tab
Nebulizer On/Off
Nebulizer (lpm)
This feature enables the auxiliary flow for nebulization. The user should activate nebulization
after a standard nebulizer is connected and positioned on the inspiratory limb of the breathing
circuit. The nebulization flow is compensated in order to maintain the previously set oxygen
concentration in all breath types and volume compensates in VC only.
Nebulization Flow
Neonatal patient 3 lpm
Scales
Pediatric patient 6 lpm
Adult patient 6 lpm
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Mode
Sync: Nebulization is synchronized with the patient’s inspiratory flow only
Cont: Nebulization is delivered continuously throughout the breath cycle, both on inspiration and
expiration.
Neb time
Nebulization time (mins)
The user is able to select the nebulization time, when the time is reached the nebulization flow is
automatically terminated.
Range: 5–30 min.
Default: 15 min.
WARNING
The ventilator accuracy can be affected by the gas added by use of a external
nebulizer.
TGI Tab:
TGI on/off
This control enables the Tracheal Gas Insufflation maneuver.
Range: On/Off
TGI
Tracheal Gas Insufflation (lpm)
This feature promotes the “flushing” of CO2 retained in the airways during exhalation. Flow is
synchronized with the expiratory phase of the breath cycle.
A non-proprietary catheter designed for this maneuver is positioned at the patient’s carina.
NOTE
The delay in the activation of the TGI flow (TGI Delay) is intended to be in synchrony
with the patients exhaled gas, increasing the flushing efficiency and minimizing the risk of
auto-PEEP occurring.
TGI Flow
Neonatal Patient 3 lpm
Scale
Pediatric Patient 6 lpm
Adult Patient 6 lpm
AAC Tab
AAC On/Off
Artificial Airway Compensation On/Off
This control switch enables AAC in PC and PS breath types.
AAC%
Artificial Airway Compensation %
The AAC% control sets the percentage of resistance that is being applied to endotracheal tube
(ETT) for compensation. For example, a setting of 75% results in a 75% resistance
compensation of the ETT.
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NOTE
AAC is available only in Pediatric and Adult patient sizes.
Range: 10-75%
Default: 10%
ETT Size
Endotracheal Tube Size (mm)
This ETT Size setting is where the user identifies the size of the ETT being used. From this
setting the resistance of the tube is calculated and is used for resistance compensation set in
AAC%.
Range: 2.0–12.0 mm
Default: 8.0 mm
Advanced Setting Tab

APRV:
T Delay
Time Delay (secs)
Setting a time delay in APRV helps synchronize the transition from both Pressure High and
Pressure Low with the end of the patients expiratory cycle.
NOTE
In very high respiratory rates, if the T Delay is active, it may not allow the transition from
both Pressure High and Pressure Low.

Pediatric
OFF; 0,2 1.0 OFF
APRV Adult
Infant N/A N/A N/A
PS High
Pressure Support High (cmH2O)
This control allows the user to set Pressure Support during Time High in APRV / BiPhasic. If
PS High is activated, during Time High, the ventilator will deliver the set pressure support for
spontaneous triggered breaths.
WARNING
The PS High setting is measured above the P High setting. The PS High setting should
be set at an appropriate level for the patient to avoid over delivery of pressure in
support breaths during Pressure High.
NOTE
High Ppeak alarm should be set above Pres High + PS High in order to avoid improper
alarm activation.
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Pediatric
OFF; 5 80 OFF
APRV Adult
Infant N/A N/A N/A
PS Low
Pressure Support Low (cmH2O)
This control allows the user to set Pressure Support during Time Low in APRV / BiPhasic. If
PS Low is activated, during Time Low, the ventilator will deliver the set pressure support for
spontaneous triggered breaths.

Pediatric
OFF; 5 40 OFF
APRV Adult
Infant N/A N/A N/A
VG:
Breath Av
Breath Average (Breath)
The Breath Av setting in VG allows the clinician to set the number of breaths for which the
ventilator uses to calculate the average volume delivered. Using Breath Av can help with
irregular breathing patterns and help to provide a basis for a more consistent regulated pressure
delivery.
NOTE
When in SIMV mode, Breath Av does not take into consideration the spontaneous
triggered breaths. Breath Av will take the average of the previous mandatory breaths
for the target volume.

VG
Neonatal 1 60 1
VG + PS
Vol Limit
Volume Limit
The Vol Limit setting sets the volume limit for a Volume Guarantee breath. When the volume
delivered to the patient meets or exceeds the preset Vol Limit, the inspiratory phase of the
breath is terminated.

VG 2 x IBW x
Neonatal 10 120
VG + PS mL/kg
Pres Min
Pressure Minimum (cmH2O)
The Pres Min control works as a pressure minimum band and also as the inspiratory pressure
used for the test breath sequence in VG. The default for the test breath is 10cmH20 unless
otherwise changed by the user. The pressure minimum is displayed on the monitoring screen
with a colored line displaying where the Pres Min is set. When the Pres Min limit is reached an
alarm notification will be exerted.
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NOTE
In VG breaths, the pressure may be modulated between Pres Min and Pres Max in
order to achieve the Vol Target setting. The Pres Min setting should be set at an
appropriate level for the patient to avoid under delivery of pressure.

VG
Neonatal 5 30 10
VG + PS
Pres Max
Pressure Maximum (cmH2O)
The Pres Max control works as a pressure maximum band in VG. The pressure maximum is
displayed on the monitoring screen with a colored line displaying where the Pres Max is set.
When the Pressure Maximum limit is reached the breath will cycle to exhalation.
NOTE
In VG breaths the pressure may be modulated between Pres Min and Pres Max in order
to achieve the Vol Target setting. The Pres Max setting should be set at an appropriate
level for the patient to avoid over delivery of pressure.

VG
Neonatal 10 70 20
VG + PS
P Backup
Backup Pressure (cmH2O)
In VG, P Backup is used for test breaths and acts as a backup pressure setting during certain
alarm conditions.
CAUTION
If a proximal flow sensor is used it must be attached at both the patient wye and at the
ventilator connection to ensure proper function of the iX5 ventilator.
NOTE
Excessive inspiratory flow rates or highly compliant ventilator circuits may allow delivery
of a tidal volume that exceeds the volume limit setting. This is due to the ventilator
circuit recoiling and providing additional tidal volume to the patient. Delivered tidal
volumes should be closely monitored to ensure Volume Limit accuracy.
Slow Flow Maneuver

The Slow Flow maneuver allows the clinician to determine opening pressures of the lung during
a slow flow volume controlled breath. Because this maneuver is performed at a slow inspiratory
flow rate the effects of respiratory system resistance are minimized.
NOTE
Performance of the Slow Flow maneuver requires a passive patient. In the event that a
patient effort is detected the ventilator will abort the maneuver and returns to normal
ventilation at the current settings.
The Slow Flow maneuver screen allows the operator to set:
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Vol Max – This is the maximum tidal volume delivered to the patient during the maneuver. This
setting has no effect on the settings during normal ventilation and can be set to any tidal volume
desired independent of the current mode of ventilation.
Range: 300 to 2000 mL
Default: 500 mL
P Max – This is the maximum inspiratory pressure during the maneuver.
Range: 10 to 80 cmH2O
Default: 30 cmH2O
T Max – This is the maximum duration of the maneuver.
Range: 5 to 40s
Default: 20 s Flow – This is the inspiratory flow used to deliver the maneuver tidal
volume.
Range: 4 to 20 lpm
Default: 6 lpm
Mode
I (Inspiratory)
I+E (Inspiratory and Expiratory)
It defines whether the maneuver will perform during the inspiratory phase of the breath, or
during both inspiratory and expiratory phases. Default: I+E
Figure 5-2. Slow Flow Maneuver Screen

During this maneuver, only the P x V loop graph will be visible on the corresponding area of the
screen. After the maneuver is completed, the Freeze function will be automatically activated,
enabling the use of the cursor to determine the inflection point of the P x V loop.
NOTE
All maneuver control settings are independent of control settings in normal ventilation.
WARNING
Normal ventilation is suspended for the duration of the maneuver. The patient should be
evaluated for contraindications prior to executing the maneuver. The patient should be
directly monitored by trained medical personnel during the maneuver.
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Suction
There are two ways to do the suction procedure:
Open
Pressing the 100% O2 button starts the oxygenation process, adjusting the oxygen
maneuver will be interrupted, immediately returning to the previously set oxygen concentration
value.
Phase I – Pre-Oxygenation – 100% O2 (LEDs: 100% O2 lit, Standby Mode off):
 Pressing the 100% O2 button starts the oxygenation process, adjusting the oxygen
maneuver will be interrupted, immediately returning to the previously set oxygen
concentration value.
 After 3 minutes, if the Standby Mode button is not pressed, then Phase IV is started
with the oxygen concentration returning to the previously set value at a rate of 20% per
minute.
Phase II – Suction – Standby Mode (LEDs: 100% O2 lit, Standby Mode lit):
 After pressing the Standby Mode button during Phase I sequence, the operator can
disconnect the patient from the ventilator and start the suction procedure, while the
ventilator is in Standby Mode for up to 1 minute without alarms.
 The operator can reconnect the patient and resume ventilation at any time, by pressing
the Standby Mode button or the Start Ventilation button again. In case the Standby
Mode button or the Start Ventilation button has not been pressed after 1 minute, a
continous visual signal is activated followed by an audible alarm every 15 seconds,
warning the operator to reconnect the patient to the ventilator and resume ventilation.
Phase III – Post-Oxygenation – 100% O2 (LEDs: 100% O2 lit, Standby Mode off):
 After reconnecting the patient and pressing the Standby Mode button or the Start
Ventilation button, the ventilator will maintain the oxygen concentration at 100% for 3
more minutes, or until the 100% O2 button is pressed again, returning to the previously
set oxygen concentration value at the rate of 20% per minute (Phase IV).
Phase IV – Weaning (LEDs: 100% O2 flashing, Standby Mode off)
 The return from the 100% oxygen condition to the previously set concentration is
performed gradually, at a rate of approximately 20% of O2 per minute.
Closed
Closed-suction procedure
The following pressure ventilation modes may be used with a closed suction catheter:
 PC
 PC + PS
 PS
 APRV/BiPhasic
Use the proper patient settings and follow the hospital institution protocols for the closed-suction
procedure.
Alarms, such as, patient disconnected, low Vte, apnea, and other may occur during use of a
closed suction catheter. To perform suctioning without nuisance alarms, set alarms at minimum
sensitivity or perform an open suction procedure.
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Chapter 6 Alarms and Messages
Alarms
Introduction
The iX5 ventilator features low, medium, and high priority visual and audible alarms,
classified according to the urgency required for the action to be taken by the operator.
Low Priority Alarm
It requires a brief response from the operator. Its visual indication is in a continuous blue color
and it has an associated audible indication of a single pulse every 60 seconds..
Medium priority alarm
It requires a fast response from the operator. Its visual indication is in a flashing yellow color,
associated with an audible indication of 3 pulse every 25 seconds.
High priority alarm
It requires an immediate response from the operator. Its visual indication is in a flashing red
color, associated with an audible indication of 10 pulses (5 + 5) every 10 seconds.
Priority High Medium Low

Situation Warning Caution Advisory
Visual Indication Red Yellow Blue
Audible Indication Every 10s Every 25s Every 60s
Alarm status
An alarm is considered active when the condition that has generated it remains present in the
system. This alarm is indicated by an audible and visual signal (Master Alarm and flashing
message on the upper area of the screen). When the condition that has originated an alarm
ceases to exist, it goes to the persistent status, characterized by a visual sign only (non-
flashing message on the upper area of the screen).
NOTE
The messages with higher priority are displayed in an alternating way, according to the
following list:
 High priority active alarms
 Medium priority active alarms
 Low priority active alarms
 High priority persistent alarms
 Medium priority persistent alarms
 Low priority persistent alarms
 When there are no items from a higher order, the next order items will be alternated
until there are no messages.
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NOTE
A numerical indicator displaying the total number of existing alarms is shown on the
right-hand side of the message area whenever there is more than one simultaneous
occurrence. Upon touching the screen on the visible alarm message or on the message
counter, a list of active and persistent alarms will be displayed, which will be
automatically closed after 5 seconds or with a new touch on the list.
NOTE
For optimal awareness of an alarm state, the ideal operator position is one meter in
front of the iX5 screen at an angle subtended by 30 degrees from the screen midpoint
horizontal and normal to the screen plane.
NOTE
To ensure that the device is accurately calibrated, perform the Functional Verification
Test (FVT) outlined in Chapter 10. The FVT procedure must be performed prior to
connecting the patient to the device.
Audio Paused / Alarm Reset

(Alarm silenced and clearing of inactive alarms)
This button, located on the front panel, silences the active alarm for 120 seconds; it can be
reactivated, if the button is pressed again within this period. The lighting of the yellow-colored
LED indicates that the audio is temporarily silenced.
The alarm reset button clears visual indicators for alarms that are no longer active.
NOTE
The Audio Paused / Alarm Reset button does not prevent alarm activation when a new
alarm generating condition occurs.
Ventilation Alarms
NOTE
The adjustment ranges for each of the ventilator alarms may vary, depending on the
type of patient selected (neonatal, pediatric or adult) and the ventilation mode applied
(invasive or non-invasive ventilation).
NOTE
Unless it is specifically stated, the alarm signal generation delay is of one breath cycle.
NOTE
Do not adjust any of the Alarm Limit settings to an extreme value. Selecting an extreme
value can make the alarm system inadequate for the patient.
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Autoset
This feature suggests values for the alarm limits to make the adjustment easier.
The limits suggested by the ventilator depend on the type of patient selected, as well as on the
monitoring and control setting conditions during ventilation.
To adjust the alarms using this feature, the operator shall Press the Autoset button, check the
values suggested for each alarm and confirm them by pressing the “Apply” button. The alarm
limits are indicated by operator action when needed.
Note: This feature is not available on the initial setting. It is enabled only after ventilation has
already started.
Alarm and Event Log Screen
The iX5 ventilator stores the log of all alarms and events occurred during the last 72 hours or
the last 10.000 records, whichever happens first (older records are discarded after that limit is
reached). Each record contains its date, time, type and identification indication.
When iX5 ventilator experiences a total loss of power (mains and internal battery depleted), the
log is maintained by the system.
The list of events can be filtered to display alarms only, events only or both types of
occurrences.
Adjustable Alarms
Low Peak Pressure
Parameter: Low Ppeak (cmH2O)
High Priority
This alarm defines the minimum airway pressure limit that must be reached during the
inspiratory phase of the controlled and/or assisted and spontaneous cycles with pressure
support greater than 5 cmH2O.
Mode IBW Min Max Default Auto Set

VC
PC To a maximum
All 3 70 Ppeak – 5
TCPL of 25 cmH2O
PS+Backup
PEEP + PEEP +
VG Neo 3 70
Pres Min – 5 Pres Min – 5
Ped
PRVC 3 70 PEEP + 5 PPeak – 5
Adult
Ped Pres Low + Pres Low +
APRV 3 70
Adult PS Low – 5 PS Low – 5
nTCPL
Neo 2 30 7 Ppeak – 5
nCPAP+Backup
Biphasic LP
nCPAP LP
Bilevel PC Ped To a maximum
3 60 Ppeak – 5
CPAP+Backup Adult of 25 cmH2O
High Peak Pressure

Parameter: High Ppeak (cmH2O)
High Priority
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WARNING
If High Ppeak alarm is set too close to PEEP setting, Circuit Occlusion alarm may be
triggered.
This alarm defines the maximum airway pressure limit during the inspiratory phase of controlled,
assisted and spontaneous cycles.
If, during the inspiratory phase, the pressure limit established by the alarm is reached, the
ventilator will immediately interrupt the cycle and return to the set expiratory pressure (PEEP)
value.

VC
PC
All 10 120 30 Ppeak + 5
TCPL
PS+Backup
VG VG – Neo PEEP + PEEP +
10 120
PRVC PRVC – Ped/Adult Pres Max + 10 Pres Max + 10
Ped Pres High + Pres High +
APRV 10 120
Adult PS High + 10 PS High + 10
nTCPL
Neo 5 40 20 Ppeak + 5
nCPAP+Backup
Biphasic LP
Neo 5 20 15 Ppeak + 5
nCPAP LP
Bilevel PC Ped
5 40 30 Ppeak + 5
CPAP+Backup Adult
Low Minute Volume

Parameter: Low Min Vol (L)
Medium Priority
This alarm defines the minimum exhaled minute volume limit, considering mandatory and
spontaneous cycles.

Ped OFF; 0.10 20.0
VC (Volume x Rate) – 40% Min Vol – 40%
Adult OFF; 1.0 40.0
PC Neo OFF; 0.01 2.0
(IBW x mL/kg x Rate) – 40% Min Vol – 40%
TCPL Ped OFF; 0.10 20.0
PS+Backup Adult OFF; 1.0 40.0 OFF OFF
VG Neo OFF; 0.01 2.0 (Vol Target x Rate) – 40% Min Vol – 40%
Ped OFF; 0.10 20.0
PRVC (Vol Target x Rate) – 40% Min Vol – 40%
Adu OFF; 1.0 40.0
Ped OFF; 0.10 30.0
APRV OFF OFF
Adult OFF; 1.0 40.0
nTCPL
Neo – – OFF OFF
nCPAP+Backup
Bilevel PC Ped OFF; 0.10 20.0
OFF OFF
CPAP+Backup Adu OFF; 1.0 40.0
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High Minute Volume

Parameter: High Min Vol (L)
Medium Priority
This alarm defines the maximum exhaled minute volume limit, considering mandatory and
spontaneous cycles.

Ped 0.10 30.0; OFF
VC (Volume x Rate) + 40% Min Vol + 40%
Adult 1.0 60.0; OFF
PC Neo 0.01 3.0; OFF
(IBW x mL/kg x Rate) + 40% Min Vol + 40%
TCPL Ped 0.10 30.0; OFF
PS+Backup Adult 1.0 60.0; OFF OFF OFF
VG Neo 0.01 3.0; OFF (Vol Target x Rate) + 40% Min Vol + 40%
Ped 0.10 30.0; OFF
PRVC (Vol Target x Rate) + 40% Min Vol + 40%
Adult 1.0 60.0; OFF
APRV Ped 0.10 30.0; OFF OFF OFF
Bilevel PC Adult 1.0 60.0; OFF
OFF OFF
CPAP+Backup Ped 0.10 30.0; OFF
nTCPL
Neo – – OFF OFF
nCPAP+Backup
Low Volume
(Low Exhaled Tidal Volume)
Parameter: Low Vol (mL)
Medium Priority
This alarm defines the minimum exhaled tidal volume limit on mandatory cycles. It is activated
after three consecutive mandatory cycles whose monitored exhaled tidal volume is smaller
than the limit set on the alarm.

Ped OFF; 10 500
VC Volume – 50% Volume – 50%
Adult OFF; 100 2,000
PC Neo OFF; 1 50
TCPL Ped OFF; 10 500 (IBW x mL/kg) – 50% Vte – 50%
APRV
PS+Backup Adult OFF; 100 2,000
VG Neo OFF; 1 50 Vol Target – 50% Vol Target – 50%
Ped OFF; 10 500 Vol Target – 50% Vol Target – 50%
PRVC
Adult OFF; 100 2,000 Vol Target – 50% Vol Target – 50%
nTCPL
Neo – – OFF OFF
nCPAP+Backup
Bilevel PC Ped OFF; 10 500
(IBW x mL/kg) – 50% Vte – 50%
CPAP+Backup Adult OFF; 100 2,000
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High Volume
(High Exhaled Tidal Volume)
Parameter: High Vol (mL)
Medium Priority
This alarm defines the maximum exhaled tidal volume limit on mandatory and spontaneous
cycles.

Ped 10 500; OFF
VC 2,000; Volume + 50% Volume + 50%
Adult 100
OFF
PC Neo 1 50; OFF
TCPL Ped 10 500; OFF
(IBW x mL/kg) + 50% Vte + 50%
APRV 2,000;
PS+Backup Adult 100
OFF
VG Neo 1 50; OFF Vol Max + 5 Vol Max + 5
Ped 10 500; OFF Vol Target + 50% Vol Target + 50%
PRVC 2,000;
Adult 100 Vol Target + 50% Vol Target + 50%
OFF
nTCPL
Neo – – OFF OFF
nCPAP+Backup
Ped 10 500; OFF
Bilevel PC
2,000; (IBW x mL/kg) + 50% Vte + 50%
CPAP+Backup Adult 100
OFF
Apnea
Parameter: Apnea (s)
Medium / High Priority
This alarm is active on all ventilation modes and defines the maximum apnea limit (period
without patient’s inspiratory effort). In the event of apnea, the ventilator delivers a backup cycle
according to the parameters set by the user for mandatory cycles.
This alarm starts with Medium Priority and evolves to High Priority in the event of three
consecutive apnea periods.

VC
PC
TCPL All 3 60; OFF (60/Rate) + 5 Te + 5
VG
PRVC
APRV All 3 60; OFF OFF OFF
Neo 3 60; OFF 5
PS+Backup Ped 3 60; OFF 10 OFF
Adult 3 60; OFF 15
nTCPL
Neo 3 60; OFF OFF OFF
nCPAP+Backup
Biphasic LP
Neo 3 60; OFF OFF OFF
nCPAP LP
Bilevel PC Ped 3 60; OFF 10 Te + 5
CPAP+Backup Adult 3 60; OFF 15 Te + 5
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Low Respiratory Rate

Parameter: Low Rate (/min)
Medium Priority
This alarm defines the minimum respiratory rate limit, considering mandatory and spontaneous
respiratory cycles.
VC
PC Neo OFF; 4 120 25
TCPL
VG
Ped OFF; 4 120 15
PRVC Rate – 30%
APRV
PS+Backup
Bilevel PC Adult OFF; 4 120 5
CPAP+Backup
nTCPL
Neo OFF; 4 60 20 Rate – 30%
nCPAP+Backup
Biphasic LP 10 on Biphasic LP
Neo OFF; 4 60 Rate – 30%
nCPAP LP OFF on nCPAP LP
High Respiratory Rate

Parameter: High Rate (/min)
Medium Priority
This alarm defines the maximum respiratory rate limit, considering mandatory and
spontaneous respiratory cycles.

VC
PC Neo 4 180; OFF 50
TCPL
VG
Ped 4 180; OFF 30
PRVC Rate + 30%
APRV
PS+Backup
Bilevel PC Adult 4 180; OFF 20
CPAP+Backup
nTCPL
Neo 4 80; OFF 40 Rate + 30%
nCPAP+Backup
Biphasic LP 40 on Biphasic LP
Neo 4 80; OFF Rate + 30%
nCPAP LP OFF on nCPAP LP
Low FiO2
Parameter: Low FiO2 (%)
Medium Priority / High Priority
This alarm defines the minimum oxygen concentration (FiO2) limit measured in the gas mixture
supplied to the patient. It is activated whenever the measured concentration (FiO2) is below the
alarm set value.

All All OFF; 19 100 %O2 – 5 FiO2 – 5
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NOTE
The FiO2 Low alarm evolves to High Priority when the measured concentration value is
lower than or equal to 18%.
High FiO2
Parameter: High FiO2 (%)
Medium Priority
This alarm defines the maximum oxygen concentration (FiO2) limit measured in the air/oxygen
mixture supplied to the patient. It is activated whenever the measured concentration (FiO2) is
above the alarm set value.

All All 19 100; OFF %O2 + 5 FiO2 + 5
Low PEEP
Parameter: Low PEEP (cmH2O)
Medium Priority
This alarm defines the minimum expiratory pressure (PEEP) limit measured in the airways. It
is activated when the difference between the airway pressure value during the expiratory phase
and the PEEP value set is higher than the set value, observing the following conditions:
 For expiratory times shorter than 15 seconds and after 3 consecutive cycles.
 For expiratory times greater than 15 seconds, the alarm will activate immediately.
This alarm is defined 3 cmH2O below the set PEEP, with the exception for nTCPL,
nCPAP+Backup, Biphasic LP and nCPAP LP modes:

nTCPL
Neo 0 15 PEEP – 2 PEEP – 2
nCPAP+Backup
Biphasic LP
Neo 0 15 2 PEEP – 2
nCPAP LP
High PEEP
Parameter: High PEEP (cmH2O)
Medium Priority
This alarm defines the maximum expiratory pressure (PEEP) limit measured in the airways. It is
based on the PEEP setting and is activated whenever the pressure in the airway during the
expiratory phase is above the PEEP value on the current cycle, on the following conditions:
 For expiratory times shorter than 15 seconds and after 3 consecutive cycles.
 For expiratory times greater than 15 seconds, the alarm will activate immediately.
This alarm is defined 5 cmH2O above the set PEEP, with the exception for nTCPL,
nCPAP+Backup, Biphasic LP and nCPAP LP modes:

nTCPL
Neo 3 20 PEEP+2 PEEP + 2
nCPAP+Backup
Biphasic LP
Neo 3 20 7 PEEP + 2
nCPAPLP
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Non-adjustable Alarms
Auto PEEP
Low Priority
The Auto PEEP alarm is activated if the Expiratory Flow does not reach a minimum value at the
end of exhalation on three consecutive cycles. This minimum value is defined from the
Expiratory Peak Flow value.
Non-adjustable
All patients 50% of the Expiratory Peak Flow value
value
Auto Trigger
High Priority
The Auto trigger alarm is activated if, during three consecutive cycles, the start of an assisted
or spontaneous cycle with Expiratory Time smaller than half of the Inspiratory Time
(equivalent to a I:E ratio = 2:1) is detected.
Technical Alarms (non-adjustable)

Low O2 Pres
Low Oxygen Intake Pressure (kPa)
High Priority
The Low O2 Pressure alarm is activated if the oxygen intake pressure is lower than 250 kPa
(2.5 kg/cm2) and oxygen concentration (% O2) set on the ventilator is higher than 21%. If the
oxygen flow is insufficient to meet the programmed demand, the ventilator will automatically
compensate the flow with compressed air, eventually leading to the activation of the Low FiO2
alarm. If the oxygen intake pressure reaches levels below 120 kPa (1.2 kg/cm2), the ventilator
switches to air intake and continues operating on the Low O2 Pressure alarm condition.
NOTE
On the Low O2 Pressure condition, the ventilator checks the air pressure level, also
activating the Low Air Pressure alarm, in case it also features a value lower than
250kPa (2.5 kg/cm2).
Low Air Pres
Low Air Intake Pressure (kPa)
High Priority
The Low Air Pressure alarm is activated if the compressed air intake pressure is lower than
250kPa (2.5 kg/cm2) and if the oxygen concentration (% O2) set on the ventilator is lower than
100%. If the air flow is insufficient to meet the programmed demand, the ventilator will
automatically compensate the flow with oxygen, eventually activating the High FiO2 alarm. If the
oxygen intake pressure reaches levels below 120 kPa (1.2 kg/cm2), the ventilator switches to
the oxygen intake and continues operation on the Low Air Pressure alarm condition.
NOTE
In the Low Air Pressure condition, the ventilator checks the oxygen pressure level,
activating the Low O2 Pressure alarm, in case it also features a value lower than
250 kPa (2.5 kg/cm2).
WARNING
In the event that the ventilator cannot meet the required inlet pressure, the Gas Fail
alarm will be triggered and the ventilator will go into an inoperative state and activate
the Vent Inop alarm. Remove the patient from the device and provide an alternate
source of ventilation.
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High O2 Pres
High Oxygen Intake Pressure (kPa)
High Priority: Pressure > 600 kPa
The High O2 Pressure alarm is activated if the oxygen intake pressure exceeds 600 kPa (6.0
kg/cm2). In this situation, the operator must reduce the intake pressure, using, for example,
pressure reducing valves.
As a safety feature, the ventilator also integrates an intake pressure relief valve mechanism for
each gas, set to 650 kPa (6.5 kg/cm2). If the pressure exceeds this value, the valves will open to
the atmosphere, limiting the ventilator supply pressure.
Ext High O2 Pres
Oxygen Intake Overpressure (kPa)
In extreme situations, when the intake pressure exceeds the 660 kPa limit, the alarm displays
O2 Overpressure, with High Priority, enters a Vent Inop condition, and generates a Vent Inop
alarm.
High Air Pres
High Air Intake Pressure (kPa)
The High Air Pressure alarm is activated if the compressed air intake pressure exceeds
600 kPa (6.0 kg/cm2). In this situation, the operator must reduce the intake pressure, using, for
example, pressure reducing valves.
As a safety feature, the ventilator also integrates intake pressure relief valve mechanisms for
each gas, set to 650 kPa (6.5 kg/cm2). If the pressure exceeds this value, the valves will open to
the atmosphere, limiting the ventilator supply pressure.
Ext High Air Pres
Air Intake Overpressure (kPa)
On extreme situations, when the intake pressure exceeds the 660 kPa limit, the alarm also
starts displaying Air Overpressure, with High Priority, besides entering the inoperative
condition, also generating the Vent Inop alarm.
WARNING
Whenever the O2 Overpressure or the Air Overpressure condition occurs, the
ventilator enters an inoperative condition, generating the Vent Inop alarm.
Internal Fail
High Priority
This alarm is activated for internal device failures requiring the user to discontinue use and find
alternate methods of ventilation as soon as possible. Depending on the severity of the failure
detected by the safety circuits, the ventilator can go to the inoperative condition, generating the
Vent Inop alarm. In this situation, when both Vent Inop and Internal Fail alarms occur
simultaneously, immediately stop using the equipment.
NOTE
In the occurrence of the Internal Fail alarm, contact Vyaire or a Vyaire Authorized
Technician.
Vent Inop
High Priority
The Vent Inop alarm indicates that the ventilator is not operating and the electronic and
pneumatic controls are inactive.
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The inoperative condition can be generated by a power or intake gas supply failure, when the
following alarms are also generated:
 Power Fail
 Gas Fail
 O2 Overpressure
 Air Overpressure
NOTE
The return to adequate power and gas supply conditions eliminates the Vent Inop
condition.
The Vent Inop condition can also be generated by a technical failure, when the alarms
associated with the failures indicated below are generated:
 Internal Fail
 Gas Administration Fail
 Regulator Pressure Fail
 Exhalation Valve Fail
 Low Internal Battery
NOTE
In the event of a Vent Inop alarm associated with a technical failure, immediately stop
using the ventilator and contact Vyaire or a Vyaire Authorized Technician.
NOTE
The Vent Inop alarm is associated to a full-screen indication, highlighting the presence
of this alarm condition.
The full-screen can be minimized by touching any point of the highlighted region. In
case the alarm condition is not eliminated, the full-screen indication returns after 30
seconds.
Gas Fail (kPa)
High Priority
The Gas Fail alarm is activated when the ventilator cannot meet the minimum required demand,
even after switching to the remaining gas. This condition occurs when both the air and the
oxygen intake pressure is lower than 120 kPa (1.2 kg/cm2).
WARNING
Whenever the Gas Fail condition occurs, the ventilator enters an inoperative condition,
generating the Vent Inop alarm.
Power Fail
High Priority
The Power Fail alarm is activated when a failure in any internal voltage in the ventilator occurs.
WARNING
Whenever a Power Fail condition occurs, the ventilator enters an inoperative condition,
generating the Vent Inop alarm.
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Patient disconnected
High Priority
The Patient disconnected alarm is activated when a patient disconnection is detected, when
the difference between the volume supplied and the exhaled one is equal to or greater than
95%.
NOTE
The Patient disconnected alarm is associated to a full-screen indication, highlighting
the presence of this alarm condition.
The full-screen can be minimized by touching any point of the highlighted region. In
case the alarm condition is not eliminated, the full-screen indication returns after 30
seconds.
Circuit Occlusion
High Priority
WARNING
Circuit Occlusion alarm may be triggered if High Ppeak alarm is set too close to PEEP
setting.
During ventilation, iX5 continuously monitors the difference between the pressure measured at
the wye piece and the internal pressure of the manifold, measured at the gas output port. This
difference takes into consideration the pressure drop generated by the flow in the inspiratory
limb. The maximum acceptable value is:
Category Formula
Adult 13.0 cmH2O + (0.0038 * measured Flow2 - 0.0088 * measured Flow) cmH2O
Pediatric and
13.0 cmH2O + (0.01 * measured Flow2 - 0.0482 * measured Flow) cmH2O
Neonatal
If the maximum acceptable value is exceeded for more than 30 ms during inspiratory phase, or
60 ms during expiratory phase, then Circuit Occlusion alarm is activated.
Also, during exhalation phase, the pressure is verified against the maximum acceptable values
of:
Category Formula
Adult and Pediatric PEEP + MAXIMUM(0.15 * PEEP; 10) cmH2O
Neonatal PEEP + MAXIMUM(0.15 * PEEP; 10) cmH2O
If the maximum acceptable value is exceeded for more than 150 ms for neonatal category, 250
ms for pediatric category, or 400 ms for adult category, then Circuit Occlusion alarm is activated.
Also, if the airway pressure reaches the High Ppeak alarm before the the persistence time is
reached, then Circuit Occlusion alarm is activated.
After patient circuit is obstructed and the above conditions are met, the Circuit Occlusion alarm
is generated in no longer than two breath cycles or 5 s, whichever is greater.
When the Circuit Occlusion alarm is activated, the ventilator immediately opens the safety
valves for a 5 seconds period. After this period, the safety valve is closed and the ventilator
attempts to control a PEEP of 5 cmH2O during 3 seconds. If it succedes, the ventilator
understands that the cause of obstruction was cleared, therefore the alarm is changed from
active to the persistent status and normal operation of ventilation is resumed. If the ventilator
doesn't succeed to control a PEEP of 5 cmH2O during 3 seconds, the ventilator understands
that the cause of obstruction remains. Therefore it is started a new cycle of opening the safety
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valve for 5 seconds, closing the safety valve and attempt to control a PEEP of 5 cmH2O during
3 seconds.
Patient Circuit Leak
Low Priority
The Patient Circuit Leak alarm is activated if a leak in the breathing circuit is detected, when
the difference between the supplied volume and the exhaled one is equal to or greater than
50% and lower than 95%.
This alarm is not activated in the TCPL, nTCPL and nCPAP_Backup modes.
Wrong Flow Sensor
Medium Priority
This alarm is activated if the type of the flow sensor connected to the ventilator differs from the
patient category, as defined by the IBW. The sensor is identified by its connector through an
optical sensor.
Flow Sensor Disconnect
Low Priority
This alarm is activated if the presence of a Proximal Flow Sensor or an Expiratory Flow Sensor
is not detected. The flow sensors are identified by the connector through an optical sensor.
Gas Supply Fail
High Priority
This alarm is activated if the controlled flow differs from the supplied flow, measured by the
internal flow sensor. Depending on the severity of the failure detected by the safety circuits, the
ventilator can go to the inoperative condition, generating the Vent Inop alarm.
Standby Time Elapsed
High Priority
This alarm is activated if, after the maximum suction period (60 seconds), during the 100% O2
maneuver, ventilation has not been resumed through the activation of the Standby Mode button.
Low Internal Battery
Medium / High Priority
The Low Internal Battery alarm is activated when battery is near depletion, approximately 15
minutes of operation. The Low Internal Battery alarm evolves to High Priority at least 5 min prior
to the loss of all power.
Note: The Vent Inop alarm may be activated as the remaining power is not enough to sustain
ventilation.
NOTE
The estimated operating time after activating the Low Internal Battery alarm may vary
according to the battery service life and the ventilator use mode.
WARNING
When the Low Internal Battery alarm is activated, immediately connect the equipment
to the power mains or to an external battery.
If the ventilator is not connected to a power source, the ventilator will go into an
inoperative condition, generating the Vent Inop Alarm.
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Internal Battery Fail

High Priority
The Internal Battery Fail alarm is activated when a failure on the internal battery or in the
charging circuit is detected.
AC Line Fail
Medium Priority
The AC Line Fail alarm is activated with Medium Priority when the ventilator is powered by its
internal battery, due to an AC Mains Power Supply failure.
After this alarm has been muted by the operator, by pushing the Audio Paused/Alarm Reset
button, it will be replaced by the Low Priority Battery in Use alarm (see below).
High External Battery Voltage

High Priority
The High External Battery Voltage alarm is activated when the external battery voltage
connected to Ext Batt port is above 14.5 V dc.
Internal Battery in Use
Low Priority
The Internal Battery in Use alarm is activated with Low Priority when the ventilator is powered
by its internal battery, always after the AC Line Fail alarm has been muted (see above).
This alarm is also indicated by the Internal Battery LED on the ventilator’s front panel.
Low Setup Battery
Low Priority
The Low Setup Battery alarm is activated if a failure is detected on the PCI Control RAM
battery, which ensures that the last setup set into the machine is kept in the memory when the
equipment is turned off. This alarm is only activated when the ventilator is turned on or as soon
as the failure is detected, being cancelled after the Audio Paused/Alarm Reset button has
been pressed. In this case, contact Vyaire or a Vyaire Authorized Technician, and arrange for
the battery to be replaced as soon as possible because the ventilator data storage feature will
be lost.
Fan Fail
Medium Priority
The Fan Fail alarm is activated when a failure on the internal cooling system of the ventilator is
detected. In this case, stop using the equipment as soon as possible, and contact Vyaire or
Vyaire Authorized Technician.
Exhalation Valve Fail
High Priority
The Exhalation Valve Fail alarm is activated when a failure on the exhalation valve control is
detected. Depending on the severity of the failure, the ventilator can go into an Internal Fail or
Vent Inop condition. In this case, stop using the equipment as soon as possible, and contact
Vyaire or Vyaire Authorized Technician
Autozero Error
Medium Priority
The Autozero Error alarm is activated when a failure during the autozero routine of the
transducer responsible for the measurement of the external flow (Proximal Flow Sensor or
Expiratory Flow Sensor) is detected. In this case, stop using the equipment as soon as possible,
and contact Vyaire or Vyaire Authorized Technician
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Regulator Pressure Fail

High Priority
The Pressure Regulator Fail alarm is activated when a failure on the Pressure Regulator
control is detected, which is responsible for the actuation of several ventilator systems.
This failure can be caused by lack of intake gas supply, when the Gas Fail alarm is also
activated. In this situation, restoring the intake gases will eliminate the failure condition.
The Pressure Regulator Fail can also be caused by a technical problem, where the Vent Inop
alarm will also be activated. In this case, stop using the ventilator immediately, and contact
Vyaire or Vyaire Authorized Technician
Keyboard Fail
Medium Priority
The Keyboard Fail alarm is activated when a failure in the communication between the quick
access buttons and the ventilator control circuits is detected. In this case, stop using the
ventilator as soon as possible, and contact Vyaire or Vyaire Authorized Technician
Motherboard Fail
High Priority
The Motherboard Fail alarm is activated when a failure in the communication between the
motherboard and the ventilator control circuits is detected. Stop using the ventilator as soon as
possible, and contact Vyaire or Vyaire Authorized Technician
Ventilator Off
Audible Beep
When the device is turned off with the On/Off switch, the ventilator generates a sound until the
operator presses the Audio Paused/Alarm Reset button.
Table 6-1. High Priority Alarms

Alarm Possible Causes Recommended Actions
Inspiratory sensitivity is too high. Check whether the inspiratory sensitivity is
properly set.
Apnea1
Apnea Alarm is incorrectly set. Check whether the ventilator alarm is correctly
set.
Detection of start of an assisted or Check whether the pressure and flow sensitivity
spontaneous cycle with expiratory time values set on the equipment are not too low.
shorter than half of the Inspiratory Time Check whether there is any leakage in the
Auto Trigger (equivalent to an I:E ratio = 2:1), during breathing circuit.
three consecutive cycles.
Equipment malfunction. Stop using the ventilator and contact Vyaire or
Vyaire Authorized Technician
Low Internal Battery near depletion (at least 5 min Urgently charge the internal battery by
Battery 3 since the High Priority alarm is activated). connecting to AC Mains Power Supply.
The breathing circuit is disconnected from Connect the patient back to the ventilator.
the patient.
Patient Breathing circuit leak Check for the presence of holes or tears on the
Disconnected breathing circuit, or whether the parts are
properly assembled.
Defective flow sensor. Replace the flow sensor.
Internal Failure on the internal battery or on the Stop using the ventilator and contact Vyaire or
Battery Fail battery charging circuit. Vyaire Authorized Technician
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Motherboard Failure in the communication between the Stop using the ventilator and contact Vyaire or
Fail motherboard and the ventilator control Vyaire Authorized Technician
circuits or failure on the equipment internal
power sources.
Power Fail Failure on one or more ventilator internal Stop using the ventilator and contact Vyaire or
power sources. Vyaire Authorized Technician
Gas Fail Cannot meet the intake gas demand, even Ensure the air or oxygen intake pressure above
after switching to alternate gas. 250 kPa (2.5 kg/cm2) at least.
Gas Supply Controlled flow differing from the supplied Stop using the ventilator and contact Vyaire or
Fail flow, as measured by the internal flow Vyaire Authorized Technician
sensor.
Internal technical failures detected by the Stop using the ventilator and contact Vyaire or
Internal Fail
ventilator safety circuits. Vyaire Authorized Technician
Failure in the Regulator Pressure control, Stop using the ventilator and contact Vyaire or
which is responsible for the actuation of Vyaire Authorized Technician
Pressure several ventilator systems.
Regulator Fail Compressed air and/or oxygen intake Feed the compressed air and/or oxygen intake
pressure below the specified limit. with a pressure greater than the lower specified
limit of 250 kPa (2.5 kg/cm 2).
Punctured or misplaced diaphragm. Check the diaphragm’s conditions and whether
it has been properly mounted.
If necessary, replace the diaphragm.
Exhalation Damaged or misplaced exhalation valve. Check the exhalation valve conditions and
Valve Fail whether it has been properly mounted.
If necessary, replace the exhalation valve.
Exhalation valve control failure. Stop using the ventilator and contact Vyaire or
Low oxygen intake pressure. Check whether the oxygen intake pressure is
within the specified range from 250 kPa (2.5
kg/cm2) to 600 kPa (6.0 kg/cm2).
Low FiO22 Value regarding the compensation for Contact Vyaire or Vyaire Authorized Technician
local altitude not properly set during the
installation of the equipment.
Uncalibrated oxygen sensor. Contact Vyaire or Vyaire Authorized Technician
High resistance due to saturated filter. Replace Filters.
High resistance between the inspiratory Check for the presence of foreign bodies or
and expiratory limbs, resulting in the occlusion on the breathing circuit.
increase of the pressure difference above
Circuit the acceptable limit.
Occlusion
Obstruction of the expiratory limb. Check for the presence of foreign bodies or
occlusion on the expiratory limb.
Compressed air intake pressure above the Feed the compressed air intake with a pressure
specified limit. lower than the specified upper limit of 600 kPa
High Air Pres (6.0 kg/cm2).
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Compressed air intake pressure below the Feed the compressed air intake with a pressure
specified limit. higher than the specified lower limit of 250 kPa
(2.5 kg/cm2).
Low Air Pres
Clogged coalescent filter. Replace the coalescent filter.
Oxygen intake pressure above the Feed the oxygen intake with a pressure lower
specified limit. than the specified upper limit of 600 kPa (6.0
High O2 Pres kg/cm2).
Oxygen intake pressure below the Feed the oxygen intake with a pressure higher
specified limit. than the specified lower limit of 250 kPa (2.5
kg/cm2).
Low O2 Pres
Clogged coalescent filter. Replace the coalescent filter.
The upper respiratory airway pressure Check patient’s condition, the ventilation
alarm limit was exceeded. The patient is waveforms, and the alarm limits..
fighting the ventilator, or coughing.
Blocked ETT Check the breathing circuit and ETT.
Secretion build-up in the breathing circuit. Unobstruct/suction the airway and/or ETT.
Water build-up in the water trap or the Drain the water traps and check whether there
circuit, if they are not correctly positioned. is water accumulated in the circuit.
High Ppeak
Alarm improperly set. Check whether the alarm set on the ventilator is
correct.
Change to the patient’s respiratory Reassess ventilation parameters (volume,
mechanics (increased resistance or inspiratory pressure, PEEP, etc.)
reduced compliance)
PEEP set above the alarm settings. Check whether the PEEP and alarm settings are
appropriate.
Leakage or disconnection Check whether the exhalation valve is properly
connected.
Check for leakage in the breathing circuit.
Leaking cuff. Insufflate the cuff, checking whether the system
is properly sealed.
Punctured or misplaced diaphragm. Check the diaphragms condition and if it was
correctly positioned.
Low Ppeak Alarm improperly set. Check whether the alarm is correctly set.
Change to the patient’s respiratory Reassess the ventilation parameters (volume,
mechanics (reduced resistance or inspiratory pressure, PEEP, etc.)
increased compliance)
On the volume controlled or time-cycled Increase the Inspiratory Flow.
modes, the Inspiratory Flow set is
insufficient to meet the patient’s inspiratory
effort.
Exhalation valve control system failure. Contact Vyaire or Vyaire Authorized Technician
806.00535 Version I
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Compressed air intake pressure well Feed the compressed air intake with a pressure
above the specified limit with risk of lower than the upper specified limit of 600 kPa
compromising the patient safety and (6.0 kg/cm2).
Ext High Air damaging the equipment internal
Pres components.
Oxygen intake pressure well above the Feed the oxygen intake with a pressure lower
specified limit with risk of compromising than the upper specified limit of 600 kPa
Ext High O2 the patient safety and damaging the (6.0 kg/cm2).
Pres equipment’s internal components.
Equipment malfunction. Stop using the equipment and contact Vyaire or
Not resuming the ventilation after the During the 100% O2 maneuver, make certain
Standby Time maximum period intended for suction (60 that the Standby Mode button is pressed within
Elapsed seconds), during the 100% O2 maneuver. the maximum 60-seconds period intended for
suction.
Detection of major failures that may Stop using the ventilator and contact Vyaire or
compromise the patient safety and/or the Vyaire Authorized Technician
operation of equipment’s internal
Vent Inop components.
Lack of minimum gas source requirements Supply at least one of the gas sources with a
to initiate ventilation. minimum pressure of 250 kPa (2.5 kg/cm2) to
establish the ventilation.
1. This alarm starts with medium priority, evolving to high priority after 3 consecutive apnea periods.
2. This alarm will assume the high priority condition if the concentration is lower than or equal to 18%. In other cases,
the alarm will be a medium priority one.
3. This alarm starts with medium priority, evolving to high priority at least 5 min prior to battery depletion.
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Table 6-2. Medium Priority Alarms

Check whether the trigger sensitivity is properly
The trigger sensitivity is too high.
set.
Apnea1
Check whether the ventilator alarm is correctly
Apnea Alarm is improperly set.
set.
Failure during the autozero routine of
the transducer responsible for the
Stop using the ventilator and contact Vyaire or
Autozero Error measurement of the external flow
(Proximal Flow Sensor or Expiratory
Flow Sensor)
Failure in the communication between
the keyboard and the ventilator control Stop using the ventilator and contact Vyaire or
Keyboard Fail
circuits or detection of any button Vyaire Authorized Technician
pressed for more than one minute.
Battery near depletion (approximately
Low Internal Urgently charge the internal battery by
15 min since the Medium Priority
Battery³ connecting to AC Mains Power Supply.
alarm is activated).
Internal ventilator cooling system Stop using the ventilator and contact Vyaire or
Fan Fail
failure. Vyaire Authorized Technician
Connect the equipment to AC Mains Power
Lack of AC Mains Power Supply. Supply as soon as possible in order to prevent
the internal battery from being fully discharged.
Remove the power cord’s fixation support, check
The power cord is not properly
whether the cable is properly connected and fix
connected.
the power cord’s support again.
AC Line Fail
The power cord is damaged. Replace the power cord.
The power outlet to which the power
cord is connected does not have Use a different power outlet.
power.
Contact Vyaire or Vyaire Authorized Technician
Blown power source fuse.
to provide the replacement of the fuses.
Check whether the air intake pressure is within
Low air intake pressure. the specified range from 250 kPa (2.5 kg/cm 2) to
600 kPa (6.0 kg/cm2).
High FiO2 Value regarding the compensation for
local altitude not properly set during Contact Vyaire or Vyaire Authorized Technician
the installation of the equipment.
Check whether the oxygen intake pressure is
Low oxygen intake pressure. within the specified range from 250 kPa
(2.5 kg/cm2) to 600 kPa (6.0 kg/cm 2).
Value regarding the compensation for
Low FiO22 local altitude not properly set during Contact Vyaire or Vyaire Authorized Technician
the installation of the equipment.
Improper pneumatic supply source
Provide a suitable pneumatic supply source.
with low O2 concentration.
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Ensure that the ventilator configurations are
Respiratory rate greater than the set
properly defined for the patient’s condition and
value.
that the alarm set value is correct.
High Rate
Occurrence of respiratory autocycles
Check whether the sensitivity value set in the
depending on the ventilator sensitivity
equipment is not too low.
adjustment.
Ensure that the ventilator configurations are
Respiratory rate lower than the set
properly defined for the patient’s condition and
value.
Low Rate that the alarm set value is correct.
Ventilator does not detect the patient’s Check whether the sensitivity value set in the
effort. equipment is too high.
Check the breathing circuit pipe system and the
Expiration valve locked.
exhalation valve.
Check whether there is any obstruction in the
Increased expiratory resistance.
expiratory limb.
Water build-up in the water trap or
Drain the water traps and check whether there is
High PEEP circuit, in case they are not correctly
no water accumulated on the circuit.
positioned.
Check on the graph whether the expiratory time
High respiratory rate
is shorter than the required for exhalation.
Defective equipment.
Check whether the exhalation valve is properly
Leakage or disconnection connected.
Check leakage in the breathing circuit.
Insufflate the cuff, checking whether the system
Low PEEP Leaking cuff.
is properly sealed.
Check the exhalation diaphragm’s condition and
Punctured or misplaced exhalation whether it was correctly positioned.
diaphragm.
Check whether the type of sensor connected
The flow sensor connected to the matches the IBW range set in the ventilator,
ventilator does not match the IBW according to the table under Sections 3 and 6,
WrongFlow range set in the equipment. Equipment Set-up or Alarms and Messages, of
Sensor this manual.
Defective optical sensor of the flow
sensor detection board.
The expiratory tidal volume alarm limit
Check the patient’s condition, ventilator
High Volume has been exceeded on 3 respiratory
waveforms and alarm limits..
cycles.
The inspiratory tidal volume alarm limit Check the patient’s condition, ventilator
has not been reached. waveforms and alarm limits.
Low Volume Check whether the exhalation valve is properly
Leakage or disconnection. connected.
Check for leaks in the patient airway or circuit.
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Insufflate the cuff, checking whether the system
Leaking cuff.
is properly sealed.
Check the exhalation diaphragm’s condition and
Punctured or misplaced diaphragm. whether it was correctly positioned. If necessary,
replace the diaphragm.
Improperly set alarm. Check whether the ventilator’s alarm is correct.
The upper minute volume alarm limit Check the patient’s condition, ventilator
has been exceeded. waveforms, and alarm limits.
Defective flow sensor. Replace the defective flow sensor.
High Min Vol Drain the humidity condensate.
Water in the flow sensor.
Dry the flow sensor.
Equipment malfunction.
The lower minute volume alarm limit Check the patient’s condition, ventilator
has not been reached. waveforms, and alarm limits.
Leakage in respiratory system. Establish a respiratory system without leakages.
Low Min Vol
Defective flow sensor. Replace the defective flow sensor.
Equipment malfunction.
1. This alarm starts with medium priority then evolving to high priority after three consecutive periods of apnea.
2. This alarm will assume the high priority condition if the concentration is lower than or equal to 18%. In other cases,
the alarm will be a medium priority one.
3. This alarm starts with medium priority, evolving to high priority at least 5 min prior to battery depletion.
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Table 6-3. Low Priority Alarms

Expiratory Flow is above the minimum Properly adjust the respiratory rate.
flow at the end of exhalation on three
consecutive cycles.
Auto PEEP
Occurrence of respiratory autocycles Check whether the sensitivity value set in the
due to the ventilator sensitivity equipment is not too low.
adjustment.
Connect the equipment to AC Mains Power
Lack of AC Mains Power Supply. Supply as soon as possible in order to prevent
the internal battery from being fully discharged.
Remove the power cord’s fixation support,
The power cord is not properly
check whether the cable is properly connected
connected.
and fix the power cord’s support again.
Battery in Use
The power cord is damaged. Replace the power cord.
The power outlet to which the power Use a different power outlet.
cord is connected does not have power.
Blown power source fuse.
to provide the replacement of the fuses.
Failure in the battery of the PCI Control Contact Vyaire or Vyaire Authorized Technician
Low Setup
RAM, which ensures that the last
Battery
machine setup remains in the memory.
The flow sensor is not connected to the Connect the flow sensor to the ventilator.
ventilator.
Flow Sensor
Defective flow sensor connector. Replace the flow sensor.
Disconnected
Defective optical sensor of the flow Contact Vyaire or Vyaire Authorized Technician
sensor detection board.
Low exhaled tidal volume. Check for leaks in the breathing circuit.
Patient Circuit Check the presence of impurities in the sensor
Clogged flow sensor (with water).
Leak or water build-up.
Defective flow sensor. Replace the flow sensor.
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Visual Indicators
Power
Continuous Green color
The Power On visual indicator (LED) is activated whenever the equipment is turned on by the
On/Off switch located on the rear panel.
AC Line
Continuous Green
The AC Line visual indicator (LED) is activated whenever the equipment is connected to AC
Mains Power Supply. This indication remains active even when the equipment is turned off.
Ext Batt
Continuous Green
The Ext Batt visual indicator (LED) is activated whenever the equipment is connected to an
External Battery by means of the existing external connection located on the rear panel. This
indication remains active even when the equipment is turned off.
Int Batt
Off / Continuous Yellow / Flashing Green
The Internal Battery visual indicator (LED) remains off when the battery is charged and the
equipment is connected to AC Mains Power Supply. In the absence of an AC Mains Power
Supply, the Internal Battery visual indicator (LED) changes to the continuous yellow state,
indicating that the internal battery is in use. When the AC Mains Power Supply is connected
again, the Internal Battery visual indicator (LED) starts flashing in green color to indicate that
the battery is being recharged, regardless if the equipment is turned on by the On/Off switch or
not.
 Off: Charged Internal Battery
 Continuous Yellow: Internal Battery in Use
 Flashing Green: Internal Battery being Recharged
Int Batt Level
Continuous Green / Continuous Orange / Flashing Red
The Battery Level visual indicator (LED) allows the identification the autonomy of the internal
battery through its different colors:
 Continuous Green: Charge above 80% of total capacity
 Continuous Orange: Charge between 80 and 30% of total capacity
 Flashing Red: Charge below 30% of total capacity
NOTE
The Battery Level visual indicator is activated whenever the equipment is turned on by
the On/Off switch or, when turned off, if it is connected to AC Mains Power Supply.
WARNING
When the battery charge reaches levels below 5% of the total capacity, the ventilator
will be led to an inoperative condition, generating the Vent Inop alarm.
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Messages
Table 6-4. Alarm Messages
Alarms Type Window Message
Warning!
Values below [set alarm] may hide an unsafe physiologic condition.
All Warning
Warning!
Values above [set alarm] may hide an unsafe physiologic condition.
Warning!
AutoSet Warning
Please check all suggested values before applying these changes.
Note!
High FiO2 cannot be set lower than Low FiO2.
FiO2 Note
Note!
Low FiO2 cannot be set higher than High FiO2.
Note!
High Min Vol cannot be set lower than Low Min Vol.
Min Vol Note
Note!
Low Min Vol cannot be set higher High Min Vol.
Note!
High PEEP cannot be set lower than Low PEEP.
PEEP Note
Note!
Low PEEP cannot be set higher than High PEEP.
Note!
High Ppeak cannot be set lower than Low Ppeak.
Ppeak Note
Note!
Low Ppeak cannot be set higher than High Ppeak.
Note!
High Rate cannot be set lower than Low Rate.
Rate Note
Note!
Low Rate cannot be set higher than High Rate.
Note!
High Volume cannot be set lower than Low Volume.
Volume Note
Note!
Low Volume cannot be set higher than High Volume.
Table 6-5. Control Messages

Controls Type Window Message
Warning!
Values below [set value] may be unsafe for the patient.
All Warning
Warning!
Values above [set value] may be unsafe for the patient.
Note!
Volume Note Values above [set value] cannot be reached. Check Flow and Rate settings.
Note!
Flow Note Values below [set value] cannot be reached. Check the Volume and Rate
settings.
Note!
Rate Note Values above [set value] cannot be reached. Check the Volume and Flow
settings.
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Note!
Values above [set value] cannot be reached. Check Insp Time setting.
Insp Note!
Note
Time Values above [set value] cannot be reached. Check the Rate setting.
Note!
Insp
Note Values above [set value] cannot be reached. Check Volume, Insp Flow and
Pause
Rate settings.
Note!
Insp Pres Note
Pressures cannot be set higher than 120 cmH2O. Also check PEEP setting.
Note!
Insp Pres Note
Pressures cannot be set higher than P Limit. Also check PEEP setting.
Note!
PEEP Note
Pressures cannot be set higher than 120 cmH2O. Also check Insp Pres setting.
Note!
PEEP Note
Pressures cannot be set higher than P Limit. Also check Insp Pres setting.
Note!
Note Pressures cannot be adjusted above 120 cmH2O. Also check the PEEP
adjustment.
Note!
P Supp Note Pressures cannot be adjusted above 40 cmH2O. Also check the PEEP
adjustment.
Note!
Note Pressures cannot be adjusted above P Limit. Also check the PEEP
adjustment.
Note!
P Insp Note
Pressures cannot be adjusted above 40 cmH2O.
Note!
Note
PEEP must be at least 5 cmH2O lower than Insp Pres.
Note!
Note
PEEP must be at least 5 cmH2O lower than P Limit.
PEEP Note!
Note Pressures cannot be adjusted above P Limit. Also check the P Supp
adjustment.
Warning!
Warning Prior to increasing PEEP, check whether the High Pressure alarm will not limit
or prevent ventilation.
Note!
P Limit Note
P Limit must be adjusted to at least 5 cmH2O above the PEEP adjustment.
High Note!
Note
Pressure The High Pressure alarm cannot be adjusted below the Low Pressure alarm.
Low Note!
Note
Pressure The Low Pressure alarm cannot be adjusted above the High Pressure alarm.
High Vol Note!
Note
Min The High Vol Min alarm cannot be adjusted below the Low Minute Vol alarm.
Low Note!
Minute Note The Low Minute Vol alarm cannot be adjusted above the High Vol Min alarm.
Vol
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High Note!
Note
Tidal Vol The High Tidal Vol alarm cannot be adjusted below the Low Tidal Vol alarm.
Low Tidal Note!
Note
Vol The Low Tidal Vol alarm cannot be adjusted above the High Tidal Vol alarm.
High Note!
Note
Rate The High Rate alarm cannot be adjusted below the Low Rate alarm.
Note!
Low Rate Note
The Low Rate alarm cannot be adjusted above the High Rate alarm.
Attention!
Autoset Caution
Please check all the suggested values before applying the changes.
NOTE
Notes: They restrict the value adjustment, but they indicate the cause to make it easier
to understand and/or overcome the limitation.
Warnings: They do not restrict the value adjustment, but notify a condition of risk to the
patient.
Actions: They only require attention to related events.
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Chapter 7 Monitoring Features
Introduction
The monitoring of patient ventilation occurs in real time, on a continuous basis, and based on
flow, pressure, time, and oxygen concentration signals.
Pressure monitoring is performed close to the patient (mouth pressure or proximal pressure),
through a proximal pressure line on the wye piece of the circuit.
On the iX5 ventilator, the flow monitoring can be performed both on the wye pieceof the circuit
(proximal position), through the Neonatal or Pediatric Proximal Flow Sensors, as well as on the
exhalation valve (distal position), through the Expiratory Flow Sensor.
The distal monitoring is performed when the Expiratory flow sensor is connected to the
exhalation valve. In this case, the ventilator monitors the Inspiratory Flow by means of the
internal flow sensors, and the exhaled flow by means of the flow sensor on the exhalation valve.
The proximal monitoring is performed when Proximal Flow Sensors, suitable for each type of
patient (Pediatric or Neonatal), are used. In this case, both inhaled and exhaled flows are
monitored at the same point, close to the patient. This configuration is particularly suitable for
monitoring neonatal and pediatric patients.
The flow sensor selection must follow the type of patient, identified in the ventilator through the
IBW.
NOTE
To avoid the risk of inacurate measures, always use the neonatal proximal flow sensor
for intended volumes equal or below 50 ml.
IBW Patient Category Breathing Circuit Flow Sensor

From 300 g to 3000 g Neonatal Neonatal/Pediatric Neonatal Proximal
From 3.1 kg to 30 kg Pediatric Neonatal/Pediatric Pediatric Proximal
More than 30 kg Adult Pediatric/Adult Expiratory
NOTE
If a flow sensor is not compatible with the selected patient weight (IBW), a medium
priority alarm (Wrong Flow Sensor) will be activated. In this case, the operator must
initially check whether the weight selected on the IBW control is correct; if it is, the
sensor must be replaced.
NOTE
Make certain that the flow sensors are properly cleaned; eliminate residues deposited in
the measurement ducts. The presence of residue may affect the accuracy of these
sensors.
NOTE
When using a humidification filter, to protect the sensor from the humidity generated
through the patient’s exhalation, the filter should be assembled between the proximal
flow sensor and the patient connection.
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NOTE
Upon acknowledging the flow sensor periodically (every 5 minutes), the iX5 ventilator
performs a flow sensor Autozero process. This process is meant to both eliminate the
condensation found on the two ways of the sensor measurement pipe and reset the
flow zero point, in order to ensure the monitoring accuracy.
NOTE
The volume and flow supplied to the patient is corrected to compensate the fixed
compliance of the respiratory circuit, the gas composition (FiO2 and humidity), and the
body temperature (BTPS). All other gas volumes and flows measurements are
expressed at STPD (Standard Pressure Temperature Dry).
Numerical Monitoring
Ppeak
Peak Pressure (cmH2O)
It indicates the pressure at the end of the inspiratory cycle.
Pplat
Plateau Pressure (cmH2O)
When an Inspiratory Pause (Insp Pause or Insp Hold) is programmed, it indicates the
inspiratory pressure at the end of the respiratory cycle (when the flow is zero). When there is no
Inspiratory Pause, it indicates the pressure during the transition from the inspiratory to the
expiratory phase, at the moment, when the flow is zero.
Pmean
Mean Airway Pressure (cmH2O)
It indicates the mean airway pressure of the last 40 seconds, being updated at every 10
seconds.
PEEP
Positive End Expiratory Pressure (cmH2O)
It indicates the expiratory pressure at the end of exhalation. During Bilevel PC mode, this
parameter is identified as EPAP. During CPAP+Backup and nCPAP LP modes, it is identified as
CPAP.
AutoPEEP
Auto PEEP Pressure
It indicates the Auto PEEP pressure, which is measured 200 ms before the start of a controlled
cycle. The measurement is done by momentarily pressing the Exp Hold button preceding a
controlled cycle (without patient’s effort). The Auto PEEP indication is shown on the same field
where PEEP is displayed, with the corresponding modified title and value; remaining active on
the screen for 1 minute – after this time, the field shows the PEEP value again.
PEEPpause
PEEP Pause Pressure
It indicates the PEEP pressure, which is measured during an expiratory hold maneuver. The
measurement is done by continuously pressing the Exp Hold button and waiting until the next
cycle is hold.
P 100
Occlusion Pressure at 100 ms
It indicates the P 0.1 value, occlusion pressure measured 100 ms after the start of an inspiratory
effort (assisted or spontaneous cycles). The measurement is done by momentarily pressing the
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Exp Hold button preceding a patient’s effort. The P 0.1 indication is shown on the same field
where PEEP is displayed, with the corresponding modified title and value; the screen remains
active for 1 minute – after this time, the field shows the PEEP value again.
Vte
Exhaled Tidal Volume (L)
It indicates the exhaled tidal volume (controlled, assisted and spontaneous) at each cycle.
Vti
Inspired Tidal Volume (L)
It indicates the inspired tidal volume (controlled, assisted and spontaneous) at each cycle.
Vte/kg
Volume / Weight Ratio (mL/kg)
It indicates the exhaled tidal volume adjusted for patient ratio. IBW should be properly set in
order to avoid incorrect monitoring of Vte/kg.
Min Vol
Total Exhaled Minute Volume (L)
It indicates the minute volume, including controlled, assisted and spontaneous cycles.
Leak
Circuit Leakage (%)
It indicates the difference between the inspired and exhaled tidal volumes in terms of %
difference.
It is avalilable only for non-invaisive modes in pediatric and adult patients (CPAP+Backup and
Bilevel PC modes) and for neonatal patients in invasive modes (TCPL, PC, VG, PS+Backup)
Rate
Total Respiratory Rate (/min)
It indicates the total respiratory rate, including controlled, assisted and spontaneous cycles.
Spon Rate
Spontaneous Respiratory Rate (/min)
It indicates the respiratory rate on spontaneous cycles only.
I:E
I:E Ratio
It shows the digital indication of the ratio between the inspiratory time and the expiratory time
values for each of the respiratory cycles.
FiO2
Fraction of Inspired Oxygen (%)
It indicates the oxygen concentration of the mixture inspired by the patient. The monitoring of the
oxygen concentration is performed on the inspiratory limb, inside the ventilator.
NOTE
Oxygen monitor time duration from start-up to providing accurate measurements in the
Gas Output Port is less than 20s.
The Oxygen monitor Response Time in the gas output port is less than 20s. To know
the delay between the gas output port and the patient’s wye piece, see the %O2 Delay
on Chapter 13.
The oxygen sensor has indirect contact with the patient via gas passing at Gas Output
Port.
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FiO2 measures are automatically corrected based on barometric pressure defined

during installation procedure.
PIFR
Peak Inspiratory Flow Rate
It indicates the maximum Inspiratory Flow of the respiratory cycle.
PEFR
Peak Expiratory Flow Rate
It indicates the maximum Expiratory Flow of the respiratory cycle.
Te
Expiratory Time (s)
It indicates the Expiratory Time of the respiratory cycle.
Ti
Inspiratory Time (s)
It indicates the Inspiratory Time of the respiratory cycle.
Rinsp
Airway Inspiratory Resistance (cmH2O/L/s)
It indicates the airway resistance, measured at the start of the inspiratory phase. It is calculated
from the airway pressure, PEEP, and the Inspiratory Flow.
 Rinsp = (Paw* – PEEP) / Flow*
Where Flow* and Paw* are the Inspiratory Flow and the airway pressure values measured
100ms after the start of the respiratory cycle, respectively.
Rexp
Airway Expiratory Resistance (cmH2O/L/s)
It indicates the airway resistance measured during the expiratory phase. It is calculated from the
Plateau Pressure, PEEP, and the Expiratory Peak Flow.
 Rexp = (Pplat – PEEP) / PEFR
Cstat
Respiratory System Static Compliance (mL/cmH2O)
It indicates the respiratory system static compliance. It is calculated from the Plateau Pressure,
the pressure at the end of the exhalation and the exhaled tidal volume.
 Cstat = Vte / (Pplat – PEEP)
Cdyn
Respiratory System Dynamic Compliance (mL/cmH2O)
It indicates the respiratory system dynamic compliance. It is calculated from the peak pressure,
the pressure at the end of exhalation, and the exhaled tidal volume.
 Cdyn = Vte / (Ppeak – PEEP)
RC exp
Expiratory Time Constant (s)
It indicates the respiratory system time constant value during the expiratory phase. It is
calculated from the Expiratory Resistance and the Static Compliance.
 RC exp = Rexp x Cstat
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WOBv
Ventilator Respiratory Work (J/L)
It indicates the respiratory work performed by the ventilator for overcoming the elastic and
resistive forces on the respiratory system and the patient circuit. It is calculated from the airway
pressure and the inhaled volume.
 WOBv = ∫P dV
RSBI
Rapid Shallow Breathing Index
It indicates the ratio between spontaneous respiratory rate and the exhaled tidal volume at the
same moment.
 RSBI = Spon Rate / Vte
NOTE
RSBI is a weaning measurement that is used to evaluate the patient’s readiness to be
weaned from the ventilator.
Graphic Monitoring
Graphic Screen
NOTE
The iX5 ventilator allows the operator to configure the screen and is capable of
displaying up to 5 curves simultaneously, in real time.
▌▌ – Freeze
This button allows momentarily freezing (stopping) graph plotting. While the function is active, a
cursor will be visible, and it can be moved by rotating the Main Button, showing instantaneous
values of graphic readings. Plotting will remain frozen until the button is pressed again or if there
is no activity with the cursor for 60 seconds.
Patient Effort
Patient’s Inspiratory Effort Indicator
It indicates the occurrence of a patient’s inspiratory effort, enough to reach the sensitivity level
set by the Trigger control.
The indication can be directly observed on the Pressure graphic or on the Flow graphic,
depending on the type of set sensitivity.
Bar Graph
Airway Pressure (cmH2O)
The airway pressure measurement, taken at the wye piece of the patient, is shown on a linear
display with a vertical bar whose height corresponds to the pressure measured at every
moment.
On this bar, the Peak Pressure, Mean Pressure, and PEEP values are indicated for each
cycle.
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Curves and Loops

The iX5 ventilator allows the visualization of the following ventilation curves:
 Pressure x Time
 Flow x Time
 Volume x Time
 Pressure x Volume
 Volume x Flow
Figure 7-1. Curves and Loops

For the three first curves, there is a difference in curve colors in the inspiratory and expiratory
phases of the respiratory cycles.
It is possible to adjust the scale for each of the parameters, just touching on the corresponding
axis of the graphic.
The scales applied to each of the parameters of the loops (Pressure, Flow, and Volume) are the
ones chosen for the ventilation curves.
iX5 ClearView™ Screen
This screen displays the main ventilation parameters in a clean and visually clear fashion.
The iX5 ventilator ClearView Screen is an important surveillance feature, because it allows the
operator to immediately identify the patient’s conditions, even at distance.
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Figure 7-2. iX5 ClearView Screen

Lung Icon
A color-coded, lung-shaped icon is shown at the center of the screen, and it moves with the
respiratory cycle Rate in a synchronized way. The color of the lung denotes the trigger
mechanism for each breath.
 Red – Mandatory
 Yellow – Triggered
 Green – Spontaneous
 Orange – Apnea.
In addition to that, the amplitude of the icon’s movement is directly related to the Volume of
each respiratory cycle.
Numerical Parameters
The following parameters are shown on this screen:
 Volume: Exhaled Tidal Volume
 Rate: Total Respiratory Rate
 Ppeak: Peak Pressure (Positive Inspiratory Pressure)
 PEEP: Positive End Expiratory Pressure
 FiO2: Measure Oxygen Concentration
Minute Volume Bargraph

The Minute Volume is shown on a linear display with a vertical bar whose colors identify the
portion of the minute volume coming from Controlled, Assisted and Spontaneous cycles.
These portions of the Minute Volume Bargraph are also color coded Red, Yellow and Green,
similar to the Lung Icon.
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Trend Screen
The iX5 ventilator stores a series of ventilation parameters and displays them as trends.
The trend graphics store up to 72 hours of data, and they can be visualized on 15-minute, 1-, 2-
, 4-, 8-, and 12-hour scales.
 PEEP: Positive End Expiratory Pressure
 Ppeak: Peak Pressure (Positive Inspiratory Pressure)
 Rate: Total Respiratory Rate
 FiO2: Oxygen Concentration
 Volume: Exhaled Tidal Volume
 Min Vol: Minute Volume
 mL/kg: Volume / Weight Ratio
 Rinsp: Airway Inspiratory Resistance
 Cstat: Respiratory System Static Compliance
Figure 7-3. Trends
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Alarm and Event Log

The iX5 ventilator stores the log of all alarms and events occurred during the last 72 hours or
the last 10.000 records, whichever happens first (older records are discarded after that limit is
reached). Each record contains its date, time, type and identification indication.
When iX5 ventilator experiences a total loss of power (mains and internal battery depleted), the
log is maintained by the system.
The list of events can be filtered to display alarms only, events only, or both types of
occurrences.
Figure 7-4. Alarm and Event Log
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Chapter 8 Troubleshooting
Table 8-1. Troubleshooting Symptoms, Problems, and Solutions
Symptom Problem Solution
Contact Vyaire or Vyaire Authorized

LED is out. Technician to arrange for the repair of
The Power On light the ventilator.
indication is off and the
equipment is operating. Contact Vyaire or Vyaire Authorized
Failure in the communication with
Technician to arrange for the repair of
the side LED board.
the ventilator.
Remove the power cord’s fixation
The power cord is not properly support, check whether the cable is
connected. properly connected and fix the power
cord fixation support again.
The power cord is damaged. Technician to arrange for the repair of
the ventilator.
The power outlet to which the power Use a different power outlet.
cord is connected does not have
The AC Line light indicator power.
is off.
Blown power source fuse. Technician to provide the replacement of
the fuses.
the ventilator.
the side LED board.
the ventilator.
The power cord is not properly Check whether the cable is properly
connected. connected.
The power cord is damaged. Technician to arrange for the repair of
the ventilator.
The Ext Batt light indicator The External Battery is defective. Technician to arrange for the repair of
is off. the ventilator.
the ventilator.
the side LED board.
the ventilator.
806.00535 Version I
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the ventilator.
The Internal Battery light
indicator does not light up Contact Vyaire or Vyaire Authorized
when the ventilator is Battery charging system failure. Technician to arrange for the repair of
disconnected from an AC the ventilator.
Mains Power Supply.
the side LED board.
the ventilator.
The Battery Level light the ventilator.
indicator is off when the
equipment is operating. Contact Vyaire or Vyaire Authorized
the side LED board.
the ventilator.
The button light indicator LED is out. Technician to arrange for the repair of
and the Master Alarm light the ventilator.
indicator (in alarm Failure in the communication with Contact Vyaire or Vyaire Authorized
condition) are off. the button board and with the Master Technician to arrange for the repair of
Alarm LED board. the ventilator.
Both air and O2 inlet gases are not Failure during initialization of ventilator
connected. internal sensors or actuators.
Check if diaphragm and exhalation valve
Exhalation valve and diaphragm are
During ventilator start-up, are properly assembled, as indicated in
not properly assembled.
autotest routine shows chapter 3, Exhalation Valve Connection.
failure.
Press the button to restart verification. If
Failure during initialization of
the problem persists, contact Vyaire or
ventilator internal sensors or
Vyaire Authorized Technician to arrange
actuators.
for the repair of the ventilator.
Check leakages in the respiratory circuit.
Reduce the flow-triggered sensitivity or
Ventilator is auto Leakage in the breathing circuit is change from flow- to pressure-triggered
triggering. causing the ventilator to auto cycle. sensitivity.
Make certain the IBW has been properly
configured.
Patient cannot trigger Adjust the sensitivity to detect the
assisted/spontaneous Improperly adjusted sensitivity. patient’s efforts.
cycles.
Parameter and pressure Check whether the proximal line is in
graphic monitoring loss perfect condition and whether it is
Proximal pressure reading loss.
(Ppeak, Pplat, PEEP, properly connected to the equipment.
Pmean).
When configured without Insp Configure an Insp Pause or activate the
The Plateau Pressure
Pause or in the absence of the Insp Insp Hold command to obtain an
features the “---“
Hold command, the ventilator voids accurate Pplat value.
indication.
the Pplat field.
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There is no ventilation and Properly adjust the PEEP and High
PEEP adjustment is above the High
the High Pressure alarm Press parameters.
Press alarm adjustment.
is active.
The Insp Hold function is only Check whether there is a programmed
The Insp Hold function is
enabled in the presence of assisted respiratory rate.
not activated.
and/or controlled cycles.
Check whether the alarm is correctly set.
The High Press alarm prevents the
Aspirate the patient.
volume from being supplied on the
inspiratory period. Check whether the hygroscopic filter is
The ventilator does not
saturated.
supply the set volume
(Vte and Vti are smaller Provide the replacement of the proximal
than the set value). Defective proximal flow sensor.
flow sensor.
Check the integrity and the assembly of
Leaking breathing circuit.
the breathing circuit and its parts.
Replace the external battery by one
indicated in Chapter 1, section Supply
Sources.
The High External
Incorrect battery connected to Ext Perform the Functional Verification Test
Battery Voltage alarm is
Batt port. to check that the equipment is not
active.
damaged. If the equipment was
damaged, contact Vyaire or a Vyaire
authorized Technician.
The ventilator does not Disable this parameter.
supply the set volume
The Sigh parameter is active.
(Vte and Vti are greater
than the set value).
Exhaled tidal volume (Vte) Replace the Expiratory Flow sensor.
is smaller than the set one Defective Expiratory Flow Sensor.
or it is instable.
Defective Flow Sensor. Replace the Flow Sensor.
With a Flow Sensor
properly connected, there Replace by the Expiratory Flow Sensor.
is a message in the diplay Proximal Adult Flow Sensor The Adult Proximal Flow Sensor is not
“No sensor” and/or an attached.
compatible with this version.
alarm “Flow sensor
desconected” is activated. Defective optical sensor of the Flow Contact Vyaire or Vyaire Authorized
Sensor detection board. Technician
This parameter is a direct Check whether the total respiratory rate
Minute volume (Min Vol)
consequence of the total respiratory (Rate) and the exhaled tidal volume
shows a different value
rate (Rate) and the exhaled tidal (Vte) values are within expectations.
from the expected one.
volume (Vte).
Adjust both intake pressures within the
Low oxygen and/or compressed air
specified range from 250 kPa to 600 kPa
intake pressure.
(2.5 kg/cm2 to 6.0 kg/cm2).
Oxygen concentration
(FiO2) different from the Contact Vyaire or a Vyaire Authorized
Uncalibrated oxygen sensor.
set one. Technician.
Unsuitable pneumatic supply source Provide a suitable pneumatic supply
with low O2 concentration. source.
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Oxygen concentration Contact Vyaire or a Vyaire authorized
(FiO2) shows indication “-- Failure in oxygen sensor. Technician.
-“.
Disable the Inspiratory Pause (Insp
The Inspiratory Pause (Insp Pause)
Pause) or consider it when checking the
parameter is active.
calculation shown on the screen.
I:E ratio with a different The ratio depends on flow and Check whether the flow and respiratory
value from the one respiratory rate parameters. rate parameters are within expectations.
expected.
On time-cycled modes, reduce the
The I:E ratio has reached the limit
inspiratory time.
3:1 (on volume-cycled modes) or 4:1
On volume-cycled modes, increase the
(on time-cycled modes).
flow and/or reduce the volume.
Check the condition of the filters coupled
to the breathing circuit, if applicable.
Expiratory Peak Flow
Check the water or impurity build-up in
(PEFR) with different Obstruction in the breathing circuit.
the flow sensor.
value from the expected
one. Check whether the breathing circuit
tubes are not folded, interrupting the free
flow passage.
Check the condition of the filters coupled
to the breathing circuit, if applicable.
Check the water or impurity build-up in
Obstruction in the breathing circuit. the flow sensor.
Check whether the breathing circuit
tubes are not folded, interrupting the free
flow passage.
Inspiratory (Rinsp) and Check whether the proximal line is in
expiratory (Rexp) Loss of proximal pressure reading. perfect condition and properly connected
resistance with values to the equipment.
different from the
expected ones. The inspiratory resistance (Rinsp) Check whether the indicated parameters
depends on Ppeak, PEEP and Flow are within expectations.
parameters. In case of Rexp, configure an Insp
The expiratory resistance (Rexp) Pause or Pres Insp Hold to obtain a
depends on Pplat, PEEP and Flow valid Pplat value and, consequently, a
parameters. Rexp value.
The variation can be related to any
parameter composing the calculated
value.
When configured without Insp Configure an Insp Pause or activate the
Expiratory Resistance
Pause or in the absence of the Insp Insp Hold command to obtain an
features the “---“
Hold command, the ventilator voids accurate Rexp value.
indication.
the Rexp field.
Check the integrity and assembly of the
Static compliance (Cstat) breathing circuit and its parts.
with a different value from Check whether the proximal line is in
the expected one. Loss of proximal pressure reading. perfect condition and properly connected
to the equipment.
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The static compliance depends on Check whether the indicated parameters

Volume, Pplat and PEEP are within expectations.
parameters. The variation can be Configure an Insp Pause or Pres Insp
related to one of the parameters Hold to obtain a valid Pplat value and,
composing the calculated value. consequently, a Cstat value.
When configured without Insp Configure an Insp Pause or activate
Cstat features the “---“ Pause or in the absence of the Insp Insp Hold command to obtain an
indication. Hold command, the ventilator voids accurate and valid Cstat value.
the Cstat field.
Check the integrity and assembly of the
breathing circuit and its parts.
Check whether the proximal line is in
Dynamic compliance Loss of proximal pressure reading. perfect condition and properly connected
(Cdyn) with a different to the equipment.
value from the expected
Dynamic compliance depends on Check whether the indicated parameters
one.
Volume, Peak pressure and PEEP are within expectation.
parameters. The variation can be
related to any of the parameters
composing the calculated value.
Upper controlled volume To enable adjustments above the rule-

Violation of the 3/4 rule (I:E ratio limited value, increase the Inspiratory
(Volume) adjustment
must be smaller than 3:1 on volume- Flow (Flow), reduce the respiratory rate
limitation – dependant cycled modes). (Rate) or reduce the automatic
message. Inspiratory Pause (Insp Pause).
Lower controlled volume To enable adjustments below the rule-
Values lower than the limited value
(Volume) adjustment limited value, reduce the Inspiratory Flow
result in Inspiratory Time (Insp (Flow).
limitation – dependant Time) < 100 ms.
message.
To enable adjustments above the rule-
Upper Inspiratory Flow limited value, reduce the controlled
Violation of the 3/4 rule (I:E ratio
(Flow) adjustment
must be smaller than 3:1 on volume- volume (Volume), reduce the controlled
limitation – dependant
cycled modes). rate (Rate) or reduce the automatic
message.
Inspiratory Pause (Insp Pause).
Lower Inspiratory Flow To enable adjustments below the rule-
Values lower than the limited value
(Flow) adjustment limited value, increase the controlled
result in Inspiratory Time (Insp
limitation – dependant volume (Volume).
Time) < 100 ms.
message.
To enable adjustments above the rule-
limited value, reduce the controlled
Upper controlled rate Violation of the 3/4 or 4/5 rule (I:E volume (Volume), increase the
(Rate) adjustment ratio must be smaller than 3:1 on Inspiratory Flow (Flow) or reduce the
limitation – dependant pressure-cycled modes, or 4:1 on automatic Inspiratory Pause time (Insp
message. time-cycled modes). Pause) on volume-cycled modes, or
reduce the Inspiratory Time (Insp Time)
on time-cycled modes.
Upper Inspiratory Time To enable adjustments above the rule-
Violation of the 4/5 rule (I:E ratio
(Insp Time) adjustment limited value, reduce the controlled rate
must be smaller than 4:1 on time-
limitation – dependant (Rate).
cycled modes).
message.
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To enable automatic Inspiratory Pause
Upper automatic (Insp Pause) time adjustments above
Inspiratory Pause (Insp Violation of the 3/4 rule (I:E ratio the rule-limited value, reduce the
Pause) time adjustment must be smaller than 3:1 on volume-
controlled volume (Volume), reduce the
limitation – dependant cycled modes).
message. controlled rate (Rate) or increase the
Inspiratory Flow (Flow).
Inspiratory Pause Time Adjust a new Inspiratory Pause time
(Insp Pause) is Ventilation mode modification. (Insp Pause) every time the ventilation
automatically reset. mode is changed, if required.
Keep the Audio Pause/Alarm Reset
Ventilator cannot be Ventilator permanently connected to button pressed for 10 seconds.
turned off by the On/Off the AC Mains Power Supply, Contact Vyaire or Vyaire Authorized
switch. external battery or internal battery. Technician to arrange for the repair of
the ventilator.
NOTE
In case of a failure not foreseen in this manual, stop using the equipment and
immediately contact Vyaire or a Vyaire Authorized Technician.
806.00535 Version I
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806.00535 Version I
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Chapter 9 Cleaning, Disinfection, and Sterilization
ISO 17664 Compliance

According to ISO 17664, “It remains the responsibility of the processor to ensure that the
reprocessing as actually performed using equipment, materials, and personnel in the
reprocessing facility achieve the desired result. This requires validation and routine monitoring of
the process.”:
Autoclave and Ethylene Oxide Sterilization have been validated, and the instructions for these
methods have been written to be in compliance with ISO 17664:2004
Indicated Processes
NOTE
The components in the gas pathways that can become contaminated with body fluids or
expired gases during both normal and single fault conditions are: Inspiratory filter and
any other filters used in the patient circuit, Exhalation Valve, Exhalation Diaphragm,
Flow Sensors, Proximal Line, Nebulizer, Nebulizers Tees, Humidification Chamber,
Suction Systems and Patient Interfaces.
Ventilator Body
The cleaning of the exterior of the iX5 ventilator—except the main display—can be done using
a common germicide or antibacterial agent.
It is recommended to clean the main display with gauze moistened with 70% Isopropyl
Alcohol.
NOTE
Do not sterilize the equipment. Its internal components are not compatible with
sterilization techniques.
Do not submerge the equipment into a liquid solution or allow liquids to enter into the
internal parts of the ventilator.
Do not use abrasive materials on the ventilator’s surface, especially on its screen.
Cooling Air Intake Filter

The cleanliness of the Cooling Air Filter must be periodically checked, according to the Section
10, Preventive Maintenance, of this manual.
If necessary, this filter must be carefully washed with warm water and neutral detergent. After
washing, it must be thoroughly rinsed and completely dried.
Figure 9-1. Cooling air intake filter.
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Expiratory Flow Sensor
CAUTION
During or after cleaning / sterilizing:
Do not direct high pressure air / water streams to the internal part
Do not put any type of object in the internal part
Such actions can damage the metallic film inside the sensor, compromising the reading
of equipment flow.
Breathing Circuit and all parts declared in Table 9-1
WARNING
Before the first use, clean and sterilize the components of the breathing circuit, following
the instructions contained in this section. The frequency of exchange and sterilization of
these circuits is defined by the protocols observed in each hospital institution.
WARNING
After the sterilization, properly rinse and dry the components of the breathing circuit in
order to remove any chemical residues from them. Especially after the ethylene oxide
sterilization process, wait from 24 to 48 hours before using the material again in order to
ensure the aeration and the complete elimination of any gas residues.
Do not reuse any component that is damaged or shows signs of wear.
CAUTION
Never let oils, grease and petroleum jellies touch the silicone components since these
products can chemically attack them, affecting their physical properties.
Components subjected to sterilization experience a natural degradation due to the
cleaning/sterilization cycles for the supplied parts, even if they are performed in
accordance with the conditions explicitly mentioned in this manual (see table 9-1). For
the third parties accessories, see the recommendation of each manufacturer.
Do not use the following solutions for cleaning and/or disinfecting the components of the
breathing circuit because they can accelerate the degradation of the materials, causing
cracks on the plastic components or disintegration of the silicone tubes.
 Phenol (> 5%)
 Chlorinated Hydrocarbons
 Ketones
 Aromatic Hydrocarbons
 Formaldehyde
 Inorganic Acids
 Hypochlorite
 Quaternary Ammonium Compounds
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Description of the Indicated Processes
Table 9-1. Indicated Process Table

Part Part Number Indicated processes
L + ETO
Elbow 90° Adaptor 100.00116
L + AC
L + ETO
Exhalation Valve 177.00437
L + AC
L + ETO
Exhalation Diaphragm 132.01362A
L + AC
L + ETO
TGI/NIV Connector 100.00202
L + AC
L + ETO
Expiratory Flow Sensor 179.00734
L + AC
L + ETO
Pediatric Proximal Flow Sensor 136.00311
L + AC
L + ETO
Neonatal Proximal Flow Sensor 136.00347
L + AC
Caption
L: Washing
ETO: Ethylene Oxide Sterilization
AC: Autoclave
Washing (L)
Prior to any sterilization process, the components must be properly washed.
This process consists of immersion in a neutral solution with enzymatic detergent, at a
temperature between 35 and 65°C, for approximately 10 minutes.
Rinse thoroughly with distilled or filtered water and let it dry on a clean environment before
proceeding with the sterilization.
Ethylene Oxide (ETO)

The ethylene oxide (C2H4O) gas sterilization process must comply with standard ISO 11135-1 –
Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices.
The following procedure indicates the ETO sterilization process.
1. Manually clean the parts
2. Wrap the parts in a sterilization wrap.
3. Place the wraps into the machine’s chamber.
4. Preconditioning
 Temperature: 50°C – 55°C
 Relative humidity: 35% – 85%
 Time: 60 minutes
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5. Follow the machine’s instructions for use to program it with the following settings:
 Temperature: 50 – 55 °C
 Sterilization phase (Time): 4 hours
 Forced aeration: 9 pulses
 Relative humidity: 35 – 85 %
 ETO concentration: around 600 mg/L
6. After the finishing of the sterilization cycle, unload the parts.
7. Wait from 24 to 48 hours before using the material again in order to ensure the aeration
and the complete elimination of any gas residues.
8. Store the parts in the sterilization wrap until they are ready to use.
9. Prior to use, check the parts for deterioration and discard if damaged.
10. Install the component in the ventilator according to the instructions on Chapter 3.
11. Proceed with the Accesory Self-Check Function according to the instructions on Chapter
4.
Autoclave (AC)
The sterilization and autoclave process must comply with the standard ISO 17665-1 –
Sterilization of health care products – Requirements for validation and routine control – Industrial
moist heat sterilization.
The following procedure indicates the autoclave sterilization process.
12. Manually clean the parts
13. Wrap the parts in a sterilization wrap.
14. Place the wraps into the autoclave machine.
15. Follow the autoclave machine’s instructions for use to program it with the following
settings:
 Pressure of the chamber: 2,0 – 2,5 kgf/cm2
 Sterilization cycle at 134° C for 4 minutes.
 20-minute drying cycle.
16. After the finishing of the sterilization cycle, unload the parts.
17. Allow the parts to cool in room air inside the sterilization wrap.
18. Store the parts in the sterilization wrap until they are ready to use.
19. Prior to use, check the parts for deterioration and discard if damaged.
20. Install the component in the ventilator according to the instructions on Chapter 3.
21. Proceed with the Accesory Self-Check Function according to the instructions on Chapter
4.
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Chapter 10 Preventive Maintenance
Introduction
To prevent the premature equipment wear and achieve a safe performance within the required
specifications, Vyaire recommends that the following procedures be performed:
Procedure Frequency
IVT – Initial Verification Test Daily or before each use
RI – Routine Inspection Several times a day or as required by institution’s policy
Before each use or when there are doubts about the
operation of the equipment
BPT - Battery Performance Test Each six months
APM – Annual Preventive Maintenance Yearly
WARNING
This ventilator is life-support equipment. Do not entrust its maintenance to unauthorized
personnel. In case of problems or difficulties, contact Vyaire.
Do not disassemble the ventilator cabinet. This situation poses a risk of electric shock.
To ensure the electrical protection and avoid risk of fire, never replace the equipment
fuse. The improper fuse replacement voids warranty and poses a risk to the equipment
operation and to the operator’s and patient’s safety.
Lack of maintenance or maintenance performed by a non-accredited company will grant
the product the status of tampered product, and this will subject those responsible to the
sanctions provided by law. The change of basic equipment components will constitute
the non-observance of the guidelines contained in this Operator’s manual and it may
affect the basic safety and essential performance of the equipment, including in relation
to electromagnetic disturbances.
The procedures indicated above shall be performed only by trained personnel in the
operation of the equipment (for IVT, RI and FVT) or in the maintenance of the
equipment (for FVT and BPT). APM shall be perfomed only by Vyaire technician or
technician authorized by Vyaire.
The equipment shall not receive maintenance during operation. Performing
maintenance during operation, including cleaning, may result in patient injury.
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IVT – Initial Verification Test

This test performs the verification of the equipment general state, as well as cleanliness,
assembly, and connections to the power and gas supply sources aspects.
It is recommended that it be performed daily, or before each use, according to the instructions:
General State
 Check the general state of the equipment in order to ensure that it has not been dropped or
damaged in such a way that its safe operation can be compromised.
 Check the status of the cooling air intake filter and, if required, wash it according to the
instructions contained under Section 9, Cleaning, Disinfection, and Sterilization, of this
manual. This filter is located on the lower portion of the equipment’s front panel.
Power Source Connection
 If the equipment is connected to an AC Mains Power Supply, check the general state of its
power cord and plug. Make certain that it is directly connected to a grounded power mains
outlet.
 If the equipment is connected to an external battery, check whether it has the features
contained under Section 1, General Specifications, of this manual.
 Check the internal battery charge level. For maximum battery autonomy, connect the
equipment to the AC Mains Power Supply at least for 15 ininterrupted hours and up to 48
hours prior to use. After this period (48 hours), it is possible that a drop in the battery power
level occurs depending on the battery’s status of use.
Gas Pipeline Connection
 Check the integrity of the air and oxygen supply hoses. Confirm that they do not have
cracks and/or leaks.
 Only use medical grade (dry and contaminant-free) gases, in order to avoid internal
 Check the air and oxygen intake filters. If necessary, drain the condensed water from their
collection cups.
Automatic Self-Test
 The system runs an automatic self-test every time it is powered on. This process checks
flow and pressure functions and identifies if gases sources and internal valves are intact
and ready for use. In case of failure, the system will require a new cycle of verification. If the
failure persists, user must contact Vyaire or Vyaire-Authorized Technician.
Cleaning
 Check the general cleanliness of the equipment.
 Check the cleanliness of the breathing circuit. If necessary, assemble a sterilized circuit.
 Ensure the proper cleaning of the flow sensors, eliminating eventual solid residues
deposited on their measurement ducts. The presence of such residues may affect the
accuracy of these sensors.
 Check the state of the Cooling Air Intake filter. If necessary, wash it carefully with warm
water and neutral detergent. After washing, rinse it and dry it thoroughly.
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Assembling
 Check the operation of the support arm from the breathing circuit and the Stand caster
locks.
 Check the conservation status of the components of the breathing circuit. Do not reuse any
part that is damaged or worn.
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RI – Routine Inspection
This inspection performs routine verification of the ventilation system during its use. The
operator needs to perform the inspection as indicated by the table below:
Parts Inspection
Check for water build-up in the circuit and in the water traps and empty
Patient circuit as needed.
Check for secretion build-up in the circuit and replace as needed.
Humidifier Chambers Check the water level.
Check resistance across patient circuit filters. Perform the Accessory
Bacteria filters
Self-Check function as needed.
Air and Oxygen intake filters Check for water build-up and empty as needed.
It is recommended that it be performed several times a day or as required by your institution’s

policy.
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This test performs the functional verification of the equipment, as well as the operation of the
alarm and monitoring features by simulating failure situations, using a lung simulator.
Vyaire recommends performing the FVT – Functional Verification Test before each use, or when
there are doubts about the operation of the equipment, in order to check whether the ventilator
and its accessories are working according to their specifications.
Preferably, it is recommended to perform the FVT, setting the ventilator with the parameters that
will be applied to the patient. Using a calibrated lung simulator, simulate failure situations to
check the operation of alarm and monitoring features, according to the specifications contained
in this manual.
Below, there are some parameters that can be used as reference for performing the FVT on
adult, pediatric and neonatal patients.
NOTE
Do not use the equipment if it is not working within the specifications contained in this
manual. In this case, interrupt its use and immediately contact Vyaire or Vyaire-
Authorized Technician.
NOTE
For the performance of the FVT – Functional Verification Test Vyaire recommends a
LS2000 Lung Simulator or equivalent, duly calibrated.
Adult Standard
 Assemble the pediatric/adult breathing circuit and the expiratory flow sensor, according to
Section 3, Equipment Setup, of this manual.
 Connect the lung simulator into the circuit (after the flow sensor).
 Adjust the simulator according to the following parameters:
 Resistance: 20 cmH2O/L/s
 Compliance: 50 mL/cmH2O
 Set the ventilator to the following parameters:
Mode VC – A/C
IBW 40 kg
% O2 21 %
Volume 500 mL
Insp Flow 30 lpm
Waveform Square
Rate 15 /min
PEEP 5 cmH2O
Flow Trig off
Pres Trig off
Insp Pause 0.5 s
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 Check, on the equipment’s display to ensure the following monitored parameters match the
values shown below:*
Ppeak 25 ± 5 cmH2O
PEEP 5±1 cmH2O
Pplat 15 ± 5 cmH2O
Pmean 11 ± 2 cmH2O
Vte 500 ± 50 mL
Min Vol 7.50 ± 0.75 L
Rate 15 ± 1 /min
FiO2 21 ± 1 %
* The highlighted fields are directly influenced by the accuracy of the lung simulator used. The values shown on the
table are intended for reference purposes only and have been based on a simulator with the above-described features.
 Set % O2 to 100%. Wait for some breath cycles and check to ensure the equipment’s
display is monitoring this parameter and following any changes.
 Check and ensure that the pressure, flow, and volume curves are compatible with the
ventilation parameters and the ventilation mode in use.
 Set the alarm limits to values compatible with the parameters in use. Change the set
parameters in the ventilator to generate alarm conditions, checking their performance on the
monitor.
NOTE
FiO2 monitor is not calibrated by the operator before or during use. If it is detected error
related to FiO2 monitoring value, contact Vyaire or Vyaire Authorized Technician.
Pediatric Standard
 Assemble the neonatal/pediatric breathing circuit and the pediatric proximal flow sensor,
according to Section 3, Equipment Setup, of this manual.
 Set the ventilator to the following parameters :
Mode TCPL – A/C

IBW 20 kg
% O2 21 %
Cont Flow 15 lpm
Insp Time 1.00 s
Rate 20 /min
PEEP 5 cmH2O
Pres Limit 70 cmH2O
Flow Trig off
Pres Trig off
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 Check on the equipment’s display to ensure the following monitored parameters match the
Ppeak 30 ± 5 cmH2O
PEEP 5±1 cmH2O
Pmean 11 ± 2 cmH2O
Vte 250 ± 25 mL
Min Vol 5.00 ± 0.5 L
Rate 20 ± 1 /min
FiO2 21 ± 1 %
* The highlighted fields are directly influenced by the accuracy of the lung simulator
used. The values shown on the table are intended for reference purposes only and have
been based on a simulator with the above-described features.
Set % O2 to 100%. Wait for some breath cycles and check to ensure the equipment’s display is
monitoring this parameter and following any changes.
parameters in the ventilator to generate alarm conditions, checking their performance on the
monitor.
NOTE
Neonatal Standard
 Assemble the neonatal/pediatric breathing circuit and the neonatal proximal flow sensor,
according to Section 3, Equipment Setup, of this manual.
 Set the ventilator to the following parameters:
Mode TCPL – A/C

IBW 2 kg
% O2 21 %
Cont Flow 5 lpm
Insp Time 1.00 s
Rate 30 /min
PEEP 5 cmH2O
Pres Limit 70 cmH2O
Flow Trig off
Pres Trig off
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 Check on the equipment’s display to ensure the following monitored parameters match the
Ppeak 15 ± 2 cmH2O
PEEP 5±1 cmH2O
Pmean 10 ± 2 cmH2O
Vte 100 ± 10 mL
Min Vol 3.00 ± 0.3 L
Rate 30 ± 1 /min
FiO2 21 ± 1 %
* The highlighted fields are directly influenced by the accuracy of the lung simulator used. The values
shown on the table are intended for reference purposes only and have been based on a simulator with
the above-described features.
Set % O2 to 100%. Wait for some breath cycles and check to ensure the equipment’s display is
monitoring this parameter and following any changes.
parameters in the ventilator in order to generate alarm conditions, checking their
performance on the display.
NOTE
Alarm Testing
Once the ventilator is set according to the chosen patient, follow the procedures below in order
to check the alarm system. If the alarm does not activate as expected, verify the ventilator
settings and repeat the tests. If the failure persists, interrupt its use and contact Vyaire
authorized service assistance.
Adjustable Alarms
After 1 minute of ventilation, press button “Alarms” then press “Autoset”. The ventilator should
set the best limits according to the chosen patient.
Change the set parameters in the ventilator in order to generate alarm conditions for each of the
parameters below, checking their activation both visual and audible. Once the activation is
confirmed, return the parameter to the previous value.
 Low Ppeak
 High Ppeak
 Low Min Vol
 High Min Vol
 Low Vol
 High Vol
 Low Rate
 High Rate
 Apnea
 Low FiO2
 High FiO2
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Non-Adjustable and Technical Alarms

After the test above, return to the original alarm conditions by pressing the “Autoset” button and
follow the procedures below in order to check the remaining alarms.
Patient Disconnected
During ventilation, disconnect the inspiratory limb at the wye piece and verify if the alarm is
activated in no more than 3 breaths.
Reconnect the inspiratory limb. The alarm must be de-activated.
Circuit Occlusion
During ventilation, make a total occlusion of one of the limbs, inspiratory or expiratory. Verify if
the alarm is activated and the pressure in the circuit is reliefed. Release the patient circuit from
the occlusion and verify that the ventilation is resume in less than 15 s.
Gas fail
Make sure both gas supply (Air and O2) are properly connected to the pipeline and ventilator.
During ventilation, set FiO2 to 100%, wait 3 breaths and disconnect the O2 hose from the
pipeline. The ventilator will switch to the Air supply and the ventilation must remain. The Low O2
Press alarm is activated. Note that the FiO2 monitor will drop until 21%.
Reconnect the O2 hose. The alarm must be de-activated.
During ventilation, set FiO2 to 21%, wait 3 breaths and disconnect the Air hose from the pipeline.
The ventilator will switch to the O2 supply and the ventilation must remain. The Low Air Press
alarm is activated. Note that the FiO2 monitor will increase until 100%.
Reconnect the Air hose. The alarm must be de-activated.
During ventilation, disconnect both (Air and O2 hoses) from the pipeline. Verify that Vent Inop
alarm is activated.
Reconnect the hoses. The alarm must be de-activated.
AC Line fail
During ventilation, disconnect the power cord from the power mains. Verify that the alarm is
activated. The ventilator will switch to the internal battery and the ventilation must remain.
Reconnect the power cord. The alarm must be de-activated.
CAUTION
The alarm volume shall be set in a reasonable value according with the
environment noise level. Otherwise, alarm conditions may not be recognized.
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BPT – Battery Performance Test

It performs the verification of the status of the internal battery and the external battery (optional).
Testing Internal Battery Performance

Performance testing is recommended every 6 months to make sure battery capacity is at least
90 minutes.
Only use batteries recommended by Vyaire. See section “APM – Annual Preventive
Maintenace”. If the batteries need to be replaced, contact an authorized service to install them.
 Connect the ventilator to the AC Mains Power Supply for 15 hours to make sure the
internal battery is fully charged. When the AC external source is connect the “Internal
Battery” visual indicator (LED) starts flashing in green color to indicate that the battery is
recharging. When the internal battery is fully charged the visual indicator (LED) stops
flashing and turns off.
 Set the following parameters:
Parameters Adjustment
IBW 15 kg
Patient Pediatric
Resistance 50cmH2O/L/s
Compliance 5 ml/ cmH2O
Circuit Patient Infant
Flow Sensor Pediatric Proximal
Mode PCV / SIMV
Rate 20/min
Insp. Pressure 15 cmH2O
PEEP 5 cmH2O
Insp. Time 0,75s
Flow Trigger 1.0 lpm
FiO2 21%
Pressure suporte 15 cmH2O
Rise 50%
PS Cycle 25%
PC Cycle Off
Alarms Auto set
Sound Setup 60%
Screen brightness Setup 80%; Sleep Mode 20%
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 Start Ventilation
 Disconnect power cord from de mains power source.
o If the internal battery remains the ventilation for 90 minutes or longer, the battery
has the sufficient charge.
o If the internal battery do not remains the ventilation for 90 minutes, contact an
authorized technician to replace the battery.
NOTE
After this test is completed, connect the ventilator to the main power source for 15 hours
to make sure the internal battery is fully charged before it is used.
Testing External Battery Performance

Performance testing is recommended every 6 months to make sure battery capacity is at least 7
hours.
Only use batteries recommended by Vyaire. See section “APM – Annual Preventive
Maintenace”. If the batteries need to be replaced, contact an authorized service to install them.
To test an external battery follow the steps below.
 Make sure the external battery is fully charged.
 Make sure the “Internal Battery Performance Test” above was succesfuly performed.
 If the internal battery is not fully charged, connect the ventilator to the AC Mains Power
Supply for 15 hours to make sure the internal battery is fully charged. When the AC
external source is connect the “Internal Battery” visual indicator (LED) starts flashing in
green color to indicate that the battery is recharging. When the internal battery is fully
charged the visual indicator (LED) stops flashing and turns off.
 Set the following parameters:
Parameters Adjustment
IBW 15 kg
Patient Pediatric
Resistance 50cmH2O/L/s
Compliance 5 ml/ cmH2O
Circuit Patient Infant
Flow Sensor Pediatric Proximal
Mode PCV / SIMV
Rate 20/min
Insp. Pressure 15 cmH2O
PEEP 5 cmH2O
Insp. Time 0,75s
Flow Trigger 1.0 lpm
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FiO2 21%
Pressure suporte 15 cmH2O
Rise 50%
PS Cycle 25%
PC Cycle Off
Alarms Auto set
Sound Setup 60%
Screen brightness Setup 80%; Sleep Mode 20%
 Start Ventilation
 Disconnect power cord from de mains power source.
 The “AC Line” visual indicator turns off and “Internal Battery” lights up continuous yellow.
 Connect an external battery (See external battery specifications).
 The “Ext Batt” visual indicator (LED) lights up continuous green.
o If the ventilator remains operative for 8 hours or longer, the external battery is
appropriate for use.
o If the ventilator does not remain operative for at least 7 hours, contact an
authorized technician to replace the battery.
 Reconnect power cord to AC Mains Power Supply, the “AC Line” visual indicator lights
up and “Ext Batt” and “Internal Battery” visual indicators turns off.
NOTE
After this test is completed, provide the recharge of the external battery and make sure
it is ready for use.
APM – Annual Preventive Maintenance

The iX5 ventilator is composed of complex electronic, mechanical, and pneumatic components.
Because the iX5 ventilator is respiratory life-support equipment and its electronic components
and some of its pneumatic components, are, in their own nature, subject to deviations in their
settings from time to time, we suggest that an Annual Preventive Maintenance (APM) be
conducted, to check each function of the ventilator and return it to optimal performance and
safety conditions, whenever a deviation is detected.
The APM is a service requested by the customer and solely provided by a Vyaire technician or a
technician authorized by Vyaire. The replacement of parts subject to normal usage wear and
tear is also part of the APM service. The process to check and adjust the equipment is
conducted in accordance to the requirements of a certified Quality Management System, using
calibrated measuring equipment that are traceable to primary standards.
APM has the following characteristics:
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 APM is a service to be requested by the customer every 12 months.

 Only a Vyaire technician or a Technician Authorized by Vyaire can conduct interventions
in Vyaire products preserving the conditions of the original equipment.
 APM is limited to equipment, and does not include the accessories.
The table below shows recommended parts to be replaced in the APM:
Acessories
Part # Description Interval
130.01362A Exhalation diaphragm 12 months
150.00562 Air inlet filter 12 months
179.A0740 Battery set 12 months
401.00028 Coalescent filter, green (X2) 12 months
401.00030 Sintered filter, white 12 months
136.00311 Pediatric Proximal Flow Sensor As needed*
136.00347 Neonatal Proximal Flow Sensor As needed*
179.00734 Expiratory Flow Sensor As needed*
177.00437 Exhalation Valve Body As needed*
100.00116 Elbow 90º Adaptor As needed*
100.00202 TGI/NIV Connector As needed*
* Inspect and look for cracks or deterioration to determine if replacement is needed.
NOTE
This equipment features safety seals on the closing screws. If these seals are
broken by unauthorized personnel, warranty will be voided.
CAUTION
The battery service life depends on the ventilator’s use conditions (ventilator and/or
internal battery use frequency and time, environmental conditions of temperature
and humidity, etc.). The storage the ventilator without recharging the battery for
periods longer than two months may reduce the battery service life.
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CAUTION
Vyaire recommends the use of original parts, pieces and recommended accessories.
The use of different parts other than those mentioned on the list of accessories is the
operator’s sole responsibility.
All parts and pieces that need to be repaired or replaced during the maintenance
process must be replaced by original components. The use of non-original components
may compromise the equipment safety, implying in product tampering and thus voiding
the warranty.
All parts and pieces replaced during the maintenance processes must be discarded in
compliance with the local legislation where the equipment is installed.
Special attention must be given to the internal lead-acid type battery, which must follow
its manufacturer’s guidelines, described on the side of the component.
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Chapter 11 Accessories, Parts, and Pieces
Introduction
This Chapter indicates parts and accessories that are validated for use with iX5.
Warnings and Cautions
CAUTION
Please contact Vyaire for the latest accessory, parts and piece lists for the iX5
ventilator. Always use original parts, pieces, and recommended accessories, in order to
Never use anti-static or electrically conductive hoses or tubes in the patient circuit.
All of the components of iX5 ventilator circuits (silicone tubes, plastic connections, and
plastic flow sensors) meet the cytotoxicity, irritation and sensitivity requirements.
The iX5 ventilator recommended circuits provides protection against electric shock
considering 20 cm of the breathing circuit in contact with the patient (TYPE B applied
part).
It is not expected that the applied part reach temperatures over 43 °C in worst case
conditions and using the recommended accessories. Always use recommended
humidifiers/heaters in order to prevent temperatures that may harm the patient.
CAUTION
Components subjected to sterilization experience a natural degradation due to the
cleaning/sterilization cycles for the parts of the original breathing circuit (see table 9-1).
WARNING
Use of accessories, transducers and cables other than those specified or provided by
Vyaire could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
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 Always use original Vyaire parts, pieces and the recommended accessories, in order to
 The use of non-original parts, pieces and the recommended accessories poses risk to the
users, and does not meet the provisions of ANVISA and other local regulations, and the
instructions contained in this Operator’s manual. Incompatible parts, pieces and
accessories can result in degraded performance.
Parts and Accessories
Part # Description
Intermed Equipamento Médico Hospitalar Ltda accessories with CE certification/ certified
with iX5 Ventilator
136.00311 Pediatric Proximal Flow Sensor
136.00347 Neonatal Proximal Flow Sensor
179.00734 Expiratory Flow Sensor
177.00437 Exhalation Valve Body
130.01362A Exhalation Diaphragm
179.01200 iX5 ventilator Stand
177.01000 iX5 ventilator Circuit Support Arm
100.00202 TGI / NIV Connector
031.00643 External Battery Power Cord
100.00116 Elbow 90o adapter
Intermed Equipamento Médico Hospitalar Ltda accessories without CE certification
100.19000 Neonatal/Pediatric Breathing Circuit with water trap **
100.21000 Pediatric/Adult Breathing Circuit with water trap **
100.20000 Neonatal/Pediatric Breathing Circuit **
100.22000 Pediatric/Adult Breathing Circuit **
408.00002 O2 Hose DISSF X DISSF 3m, Green **
408.00003 Air Hose DISSF X DISSF 3m, Yellow **
141.00000 LS2000 Lung Simulator **
158.00001 LS1000 Test Lung Neonatal **
159.00001 LS1500 Test Lung Pediatric / Adult **
014.11201B External Battery UNIPOWER UP12120 *
* Similar battery may be used provided that the specification of Chapter 1 (section Supply
Sources) is followed.
** Not for sale in countries that requires CE certification
Vyaire Corporation accessories with their own CE certification
26404-001 Infant Flow LP generator kit without nasal prongs, with
306.00126 Fisher & Paykel RT132 neonatal single-limb, heated circuit. Single
Patient Use. Box of 10
26405-001 Infant Flow LP generator kit without nasal prongs, with
306.00127 Fisher & Paykel RT132 neonatal single-limb, heated circuit. Single
Patient Use. Box of 20
7772000LP Infant Flow LP generator kit without nasal prongs.
306.00128 Included: Dual-jet, variable flow generator and sizing guide. Single
patient use, box of 10
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Part # Description
7772020LP Infant Flow LP generator kit with nasal prongs Included:
306.00129 Dual-jet, variable flow generator, sizing guide and small, medium and
large nasal prongs Single patient use, box of 10
7772010 Infant Flow LP starter kit. Included: 5 Infant Flow LP generator
kits with S, M, L prongs; 2 XS, S, SM, M, L and
306.00130
XL headgear sizes; 2 XS, S, SM, M, L and XL nasal masks sizes; 2 XL
nasal prongs; and 2 XS nasal prongs Single patient use
7772011 Infant Flow LP generator kit/Fisher & Paykel MR730 or MR850
breathing circuit Included: Infant Flow LP generator kit with prongs and
306.00131
neonatal, single-limb, heated breathing circuit Single patient use, box of
10
7772021 Infant Flow LP generator kit/Fisher & Paykel MR730 or MR850
breathing circuit Included: Infant Flow LP generator kit with nasal
306.00132
prongs and neonatal, single-limb, heated breathing circuit Single patient
use, box of 20
Nasal Masks For use with the Infant Flow LP generator Single patient use, pack of 10
306.00133 777002XS Green - Extra small
306.00134 777002S Pink – Small
306.00135 777002M Blue – Medium
306.00136 777002L Purple – Large
306.00137 777002XL Clear - Extra large
Nasal Prongs For use with the Infant Flow LP generator Single patient use, pack of 10
306.00138 777000XS Green - Extra small
306.00139 777000S Pink – Small
306.00140 777000M Blue – Medium
306.00141 777000L Purple – Large
306.00142 777000XL Clear - Extra large
For use with the Infant Flow LP generator assembly Single patient use,
Headgear
box of 10
306.00143 777040XS Extra small - 17–21 cm
306.00144 777040S Small - 21–26 cm
306.00145 777040SM Small-medium - 24–28 cm
306.00146 777040M Medium - 26–32 cm
306.00147 777040L Large - 32–37 cm
306.00148 777040XL Extra large - 37–42 cm
For use with the Infant Flow LP generator assembly Single patient use,
Bonnets
pack of 10
306.00149 777010 Size 000 – White - 18–20 cm
306.00150 777012 Size 00 – Gray - 20–22 cm
306.00151 777014 Size 0 - Pink - 22–24 cm
306.00152 777016 Size 1 - Lt. brown - 24–26 cm
306.00153 777018 Size 2 - Yellow - 26–28 cm
306.00154 777020 Size 3 - Lt. blue - 28–30 cm
306.00155 777022 Size 4 - Gold - 30–32 cm
306.00156 777024 Size 5 – Green - 32–34 cm
306.00157 777026 Size 6 - Lt. burgundy - 34–36 cm
306.00158 777028 Size 7 – Orange - 36–38 cm
806.00535 Version I
11-4
Accessories supplied by third parties with their own CE certification

305.00005 DHR280 Compressor for iX5 Ventilator
305.00006 DHR280 Stand
305.00009 DHR280 Water Trap Filter
408.00202 25534-001 O2 Hose NISTF X NISTF 3m, W, BayCorp
408.00203 25544-001 Air Hose NISTF X NISTF 3m, B/W, BayCorp
408.00204 25538-001 O2 Hose NISTF X AFNORF 3m, W, BayCorp
408.00205 25548-001 Air Hose NISTF X AFNORF 3m, B/W, BayCorp
408.00206 25539-001 O2 Hose NISTF X BSF 3m, W, BayCorp
408.00207 25549-001 Air Hose NISTF X BSF 3m, B/W, BayCorp
408.00208 25536-001 O2 Hose NISTF X DINF 3m, W, BayCorp
408.00209 25546-001 Air Hose NISTF X DINF 3m, B/W, BayCorp
408.00210 25532-001 O2 Hose DISSF X DISSF 3m, W, BayCorp
408.00211 25542-001 Air Hose DISSF X DISSF 3m, B/W, BayCorp
408.00212 25531-001 O2 Hose DISSF X DISSF 3m, G, BayCorp
408.00213 25541-001 Air Hose DISSF X DISSF 3m, Y, BayCorp
408.00214 25537-001 O2 Hose NISTF X UNIFORF 3m, W, BayCorp
408.00215 25547-001 Air Hose NISTF X UNIFORF 3m, B/W, BayCorp
100.15016 Humidification Chamber MR340S Fisher&Paykel – reusable
100.15017 Humidification Chamber MR370 Fisher&Paykel – reusable
Accessories supplied by third parties without CE certification
830.00043 Heated Humidifier GlobalTec GT2000 – 110V **
830.00046 Heated Humidifier GlobalTec GT2000 – 220V **
830.00066 Heated Humidifier GlobalTec GT5000 Plus – 110/220V **
830.00071 Temperature Sensor EQA200 for GT5000 Plus - GlobalTec **
830.00044 Humidification Chamber GT-250 **
138.01900 Pressure Regulating Valve Air, Moriya (P/N 100.149) **
138.02900 Pressure Regulating Valve O2, Moriya (P/N 100.147) **
** Not for sale in countries that requires CE certification
Table 11-1. Recommended Accessories with their own CE certification
Part # Description
RT206 Breathing Circuit, Adult, Disposable, w/ Expiratory Water-trap, Pressure
Line and MR290V autofeed humidification chamber, Fisher&Paykel (10)
RT106 Breathing Circuit, Adult, Disposable, w/ Expiratory Water-trap and
Pressure Line and w/o humidification chamber, Fisher&Paykel (10)
RT225 Breathing Circuit, Infant (flow > 4 lpm), Disposable, w/ Expiratory Water-
trap, Pressure Line and MR290V autofeed humidification chamber,
Fisher&Paykel (10)
RT125 Breathing Circuit, Infant (flow > 4 lpm), Disposable, w/ Expiratory Water-
trap and Pressure Line and w/o MR290V autofeed humidification
chamber, Fisher&Paykel (10)
RT019 Inspiratory/Expiratory Breathing Circuit Filter, Fisher&Paykel
RT020 Expiratory Breathing Circuit Filter, Fisher&Paykel (20)
HEPA (001852) HEPA Filter, AirLife
806.00535 Version I
11-5
Part # Description
28HEPA (70538) HEPA Filter, Hsiner
28FHMET (70531- HME Filter, Hsiner
FB)
Bacterial/Viral Bacterial/Viral Filter, AirLife
(001851)
04FBVG Bacterial/Viral Filter, Vital Signs
002438 Nebulizer, w/ Baffled Tee Adapter, Mouthpiece, 7” tubing and 6’
flexitube, Air Life, Misty Max 10
MR850 Heated Humidifier, w/ Heater Wire (900MR805), Temperature Probe
(900MR869), Fisher&Paykel
MR810 Heated Humidifier, w/ Evatherm (900MR810), Fisher&Paykel
MR290VX Auto-Fill Humidification Chamber, Disposable, Fisher&Paykel (10)
80MDI06 Closed Suction 72-hour System, w/MDI port, 6 Fr, Pacific Hospital
Supply (Free Trachea, Newmed)
RT041S Full Face Mask, Non-vented, Small size, Single Use, Fisher&Paykel
RT041M Full Face Mask, Non-vented, Medium size, Single Use, Fisher&Paykel
RT041L Full Face Mask, Non-vented, Large size, Single Use, Fisher&Paykel
04MAPF Clear, Flexible Dome, Air-Filled Cushion Face Mask w/ no Top Valve,
Disposable, Size #0, Vital Signs
04MANF Clear, Flexible Dome, Air-Filled Cushion Face Mask w/ no Top Valve,
04MAIF Clear, Flexible Dome, Air-Filled Cushion Face Mask w/ no Top Valve,
04MATF Clear, Flexible Dome, Air-Filled Cushion Face Mask w/ no Top Valve,
04MACAPF Clear, Flexible Dome, Air-Filled Cushion Face Mask w/ no Top Valve,
04MAAF Clear, Flexible Dome, Air-Filled Cushion Face Mask w/ no Top Valve,
04MAAG Clear, Flexible Dome, Air-Filled Cushion Face Mask w/ no Top Valve,
20160 Air Cushion Mask With Valve, Size #0, Extra Large Adult, Hsiner (30)
806.00535 Version I
11-6
Part # Description
10110 Silicone Mask, One Shape Design, Transparent, Autoclavable, Size #0,
Small Infant, Hsiner
10111 Silicon Mask, One Shape Design, Transparent, Autoclavable, Size #1,
Large Infant, Hsiner
Small Child, Hsiner
Child, Hsiner
Small Adult, Hsiner
Large Adult, Hsiner
806.00535 Version I
11-7
806.00535 Version I
12-1
Chapter 12 Terminology, Symbols, and Definitions
Terminology
The main terms used in this manual, defined by standard IEC 60601-1:2005 + AMD1:2012, are
presented hereinafter:
1 – ACCOMPANYING DOCUMENTS
Documents supplied along the equipment or accessory, containing all relevant information for
the equipment’s user, operator, and installer or assembler, especially regarding safety.
2 – CLASS I EQUIPMENT
Equipment in which the electric shock protection is not only based on the basic insulation, but it
has one additional safety precaution. This additional safety consists of a feature connecting the
equipment to the protective grounding conductor integrated to the facility fixed wiring in order to
prevent accessible metallic parts from being energized in case the basic insulation fails.
3 –TYPE B APPLIED PART
Part applied in compliance with the prescriptions specified in standard IEC 60601-1:2005
+AMD1:2012 for providing protection against electric shock.
4 – PROTECTIVE GROUNDING TERMINAL
Terminal connected to the conductive parts of a class I equipment for safety purposes, and
foreseen to be connected to an external protective grounding system by means of a protective
grounding conductor.
Symbology
The symbols used in this document and defined in the following table are intended to draw
attention to important information and special content. Pay particular attention to the content
identified with these symbols.
Table 12-1. The meaning of the symbols used in this document is presented in this table.
General warning
ISO 7010-W001
Caution
ISO 7000-0434A
Manufacturer
Indicates the medical device manufacturer
Authorized representative in the European Community
Indicates the authorized representative in the European Community
806.00535 Version I
12-2
Table 12-2. The meaning of the standardized symbols printed on the equipment is presented
in this table.
Symbol Reference Description
IEC 60417-5032 Alternating current
IEC 60417-5031 Direct current
IEC 60417-5016 Fuse
IEC 60417-5019 Protective grounding terminal
Equipment is protected against vertically dripping water and

IP21 IEC 60529 against the penetration of solid particles with diameters
greater than or equal to 12.5mm
ISO 7000-0434A Caution! Check ACCOMPANYING DOCUMENTS
IEC 60417-5265 Off, for only a part of the equipment
IEC 60417-5264 On, for only a part of the equipment
IEC 60417-5034 Input
IEC 60417-5035 Output
IEC 60417-5333 Equipment with Type B applied part
IEC 60417-5036 Dangerous electric voltage
Variant of
Pressure
ISO7000(2621)
ISO 7000-0233 Pressure measurement
Vyaire symbol Nebulizer
N/A RoHS Compliant
IEC 60417-5850 Serial interface
usb.org USB port
IEC 60417-5988 Computer network
Variation of
External Battery
ISO7000(0247)
806.00535 Version I
12-3
Table 12-2. The meaning of the standardized symbols printed on the equipment is presented
in this table.
Marking of electrical and electronic equipment in

EN 50419 accordance with article 11(2) of Directive 2002/96/EC
(WEEE)
ISO 7000-2493 Catalogue number
ISO 7000-2498 Serial number
IEC 60417-5021
Equipotential Pin
IEC 60878-01-24
IEC 60417-5570 Unlocking
ISO 7010-M002 Mandatory to follow instructions for use
ISO 7010-P023 Do not obstruct
Do Not Push (Do not push on the iX5 ventilator while it

ISO 7010-P017
is mounted on the cart.)
Vyaire variant of
Not User Serviceable
ISO7010(P001)
IEC 60417-1:5307 Alarm Indication
Manufacturer
EN 980-5.12 Indicates the medical device manufacturer
Authorized representative in the European Community
EN 980-5.13 Indicates the authorized representative in the European
Community
806.00535 Version I
12-4
Table 12-3. The meaning of the standardized symbols printed on the equipment packaging
is presented hereinafter:
Symbol Standard Description
ISO 780:1997(E) FRAGILE: The content of the packaging is fragile;

Symbol No. 1 therefore, it shall be handled with care.
ISO 780:1997(E) THIS SIDE UP: It indicates the position of the top
Symbol No. 3 of the packaging.
ISO 780:1997(E) PROTECT AGAINST SUNLIGHT: The packaging

Symbol No. 4 must be sheltered from sunlight.
ISO 780:1997(E) PROTECT AGAINST RAIN: The packaging must

Symbol No. 6 be sheltered from rain.
ISO 780:1997(E) MAXIMUM STACKING: It indicates the maximum

Symbol No. 14 number of identical packages that can be stacked.
TEMPERATURE LIMIT: It indicates the limit

ISO 780:1997(E)
temperature for storing and handling the packaging
Symbol No. 17
as cargo being transported.
ISO 7000:2004 (E/F)

Humidity limitation
Symbol No. 2620
ISO 7000:2004 (E/F)

Atmospheric pressure limitation
Symbol No. 2621
N/A RoHS Compliant
ISO 7000-2492 Batch code
Vyaire symbol Quantity of items inside the box
ISO 7000-2493 Catalogue number
ISO 7000-2498 Serial number
Authorized representative in the European

Community
EN 980-5.13
Indicates the authorized representative in the
European Community
ISO 7000-1135 General symbol for recovery/recyclable
806.00535 Version I
12-5
Table 12-3. The meaning of the standardized symbols printed on the equipment packaging
is presented hereinafter:
MANUFACTURING DATE: It indicates the

EN 980-5.6
manufacturing date of the equipment.
MANUFACTURER: It indicates the equipment’s

EN 980-5.12
manufacturer
CE COMPLIANCE: It indicates that the System

complies with the European Council Directive
CE COMPLIANCE 93/42/EEC, as amended by Directive 2007/47/EC.
MARK The “xxxx” stands for the certification number
issued by the Certifying Entity used by the
manufacturer’s Quality System.
806.00535 Version I
12-6
806.00535 Version I
13-1
Chapter 13 Technical Specifications
Controls and Monitors Accuracy

The accuracy of controls and monitors described in this chapter is maintained under de following
conditions:
 Using the ventilator according to the Intended Use described in Chapter 1.
 Assemblying the ventilation system according to the Equipment Setup described in
Chapter 3.
 Performing the Autotest Routine when the ventilator is turned on (automatically
performed as described in Chapter 4) and after a 30 minute warm-up period.
 Using patient circuit only with the recommended configurations and recommended
accessories according to the Chapter 3 and Chapter 11.
 Performing the Accessory Self-Check Function described in Chapter 4.
 Performing ventilator maintenance as described in Chapter 10.
Table 13-1. Delivery Accuracy

Inspiratory Pressure ± (2.5 cmH2O + 5% of the set pressure)
PEEP ± (2.0 cmH2O + 5% of the set PEEP)
Tidal Volume ± (5 ml + 10% of the set volume)
Delivered O2 concentration* For intended volumes above 50 ml: ± 3 % v/v
For intended volumes equal or below 50 ml:
± (Volume fraction of 2,5 % + 2,5 % of the set %O2)
Table 13-2. Monitors Accuracy

Monitors based on pressure measurement:
Ppeak
PEEP / CPAP
± (2.0 cmH2O + 5% of the actual value)
Pmean
Pplat
Paw
Monitors based on volume measurement:
Vte
Vti
± (4.0 ml + 15% of the actual value)
Vte/kg
Vol FRC
Min vol
Monitors based on time measurement:
Rate ± (1.0 bpm + 10% of the actual value)
Spon Rate
FiO2* ± (Volume fraction of 2.5 % + 2.5 % of the gas level)
*Note: Oxygen monitor time duration from start-up to providing accurate measurements in the Gas Output
Port is less than 20s. Drift: less than 0.4% over 24 h.
Ventilating a patient with cyclical pressure of up to 100 cmH2O may add tolerance errors up to 2% (V/V).
806.00535 Version I
13-2
Measurement Uncertainty
Accuracy of iX5 is verified against a test system which has the uncertainties indicated in the
table below:
Table 13-3. Measurement Uncertainty
Measured Parameter Uncertainty
Volume ± 2.3 %
Inspiratory Pressure ± 2.7 %
PEEP / CPAP ± 5.4 %
FiO2 ± 0.5 %
Time ± 5.0 %
Controls
Table 13-4. Adjustable Parameters

Lower Limit Upper Limit
Control
Parameters Mode IBW Min Safe Safe Max Resolution Default
% O2
All All 21 — — 100 1 21
(%)
Neo OFF; 1 10 — 60 1 OFF
PS+Backup
Ped OFF; 1 10 — 40 1 OFF
Backup CPAP +Backup
Backup Rate Adu OFF; 1 6 — 40 1 OFF
(/min)
nCPAP+Backup Neo OFF; 1 10 — 40 1 OFF
Breath Av
Breath Average VG Neo 1 — — 60 1 1
(cycles)
Neo 2 4 15 30 1 6
Cont Flow TCPL
Continuous Ped 2 10 30 50 1 20
Flow VG Neo 2 4 15 30 1 6
(lpm)
nTCPL
Neo 2 4 15 20 1 8
nCPAP
CPAP
Countinuous Ped 0 5 15 20 1 5
CPAP +
Positive Airway
Backup
Pressure Adu 0 5 15 20 1 5
(cmH2O)
EPAP
Ped 0 5 15 20 1 5
Expiratory
Bilevel PC
Pressure
Adu 0 5 15 20 1 5
(cmH2O)
PC, OFF;
PC Cycle Neo — — 75 5 OFF
PC+PS, 10
806.00535 Version I
13-3

Control
Expiratory PRVC,
OFF;
Trigger for PRVC+PS Ped — — 75 5 OFF
10
mandatory Bilevel PC
breaths
OFF;
(%) Adult — — 75 5 OFF
10
VC+PS,
PC+PS, Neo 10 — — 75 5 10
PS Cycle
Expiratory PRVC+PS,
Trigger for TCPL+PS,
Ped 10 — — 75 5 25
spontaneous APRV,
breaths PS+Backup,
(%) CPAP+Backup Adult 10 — — 75 5 25
VC,
2.0;
PC, Neo 0.2 — — 0.1 0.5
OFF
TCPL,
Flow Trig
PRVC,
Flow Inspiratory 5.0; 0.5 – 1.0: 0.1
VG, Ped 0.5 — 3.0 1.0
Trigger OFF 1.0 – 5.0: 0.5
APRV,
(lpm)
Bilevel PC,
15.0; 2.0 – 5.0: 0.5
PS+Backup, Adu 2.0 — 10.0 2.0
OFF 5.0 – 15.0: 1.0
CPAP+Backup
Biphasic LP
Flow Base Neo 2 — — 15 1 8
nCPAP LP
Biphasic LP
Flow High Neo 0 — — 10 1 2
nCPAP LP
0.3 – 1: 0.01
IBW Neo 0.3 — — 3 2
1 – 3: 0.05
Ideal Body
All 3.1 – 10: 0.1
Weight Ped 3.1 — — 30 15
11 – 30: 1
(kg)
Adu 31 — — 110 1 50
Insp Flow Ped 2 10 30 50 1 20
Inspiratory Flow VC
(lpm) Adu 2 30 80 120 1 30
Insp Pause
Ped 0.0 — — 2.0 0.1 0.0
Inspiratory
VC
Pause
Adu 0.0 — — 2.0 0.1 0.0
(s)
Insp Pres
Controlled 35-PEEP, min
PC All 5 10 80 1 15
Pressure 30
(cmH2O)
0.1 – 1.00: 0.05
Insp Time
PC, TCPL, 1.0 – 3.0: 0.1
Inspiratory Time Neo 0.10 0.25 1.00 15.0 0.50
PS+Backup 3.0 – 10.0: 0.5
(s)
10.0 – 15.0: 1.0
806.00535 Version I
13-4

Control
0.1 – 1.00: 0.05
1.0 – 3.0: 0.1
Ped 0.10 0.50 2.00 15.0 0.75
3.0 – 10.0: 0.5
10.0 – 15.0: 1.0
0.1 – 1.00: 0.05
1.0 – 3.0: 0.1
Adu 0.10 0.75 3.00 15.0 1.00
3.0 – 10.0: 0.5
10.0 – 15.0: 1.0
0.1 – 1.00: 0.05
1.0 – 3.0: 0.1
Ped 0.10 0.50 2.00 15.0 0.5
3.0 – 10.0: 0.5
10.0 – 15.0: 1.0
PRVC
0.5 – 1.00: 0.05
1.0 – 3.0: 0.1
Adu 0.50 0.75 3.00 15.0 1.00
3.0 – 10.0: 0.5
10.0 – 15.0: 1.0
0.1 – 1.00: 0.05
1.0 – 3.0: 0.1
VG Neo 0.10 0.25 1.00 15.0 0.30
3.0 – 10.0: 0.5
10.0 – 15.0: 1.0
0.1 – 1.00: 0.05
Ped 0.50 — 2.00 5.0 1.0 – 3.0: 0.1 0.75
Bilevel PC, 3.0 – 10.0: 5.0
CPAP +
Backup 0.1 – 1.00: 0.05
Adu 0.50 0.75 3.00 5.0 1.0 – 3.0: 0.1 1.00
3.0 – 10.0: 5.0
0.1 – 1.00: 0.05
nTCPL
Neo 0.10 — 2.00 5.0 1.0 – 3.0: 0.1 0.30
nCPAP
3.0 – 10.0: 5
IPAP
Ped 5 10 35 40 1 15
Inspiratory Bilevel PC and
Pressure CPAP+Backup
Adu 5 10 35 40 1 15
(cmH2O)
P Backup
Backup
VG Neo 5 – – 40 1 15
Pressure
(cmH2O)
VC,
PC,
PEEP TCPL, All 0 5 15 50 1 5
Positive End PRVC,
Expiratory PS+Backup
Pressure VG Neo 0 5 15 25 1 5
(cmH2O) nTCPL,
nCPAP+ Neo 0 5 10 15 1 5
Backup
806.00535 Version I
13-5

Control
35-PLow, Min
Pres High Ped 5 10 80 1 15
30
Pressure High APRV
35-PLow, Min
(cmH2O) Adu 5 10 80 1 15
30
VG Neo 5 — — — 1 15
Pres Limit
Neo 5 10 35 80 1 20
Pressure Limit TCPL
Ped 5 10 35 80 1 20
(cmH2O)
nCPAP, nTCPL Neo 5 10 20 30 1 10
Pres Low Ped 0 — 15 45 1 5

Pressure Low APRV
(cmH2O) Adu 0 — 15 45 1 5
Pres Max
Pressure
VG Neo 10 — — 70 1 20
Maximum
(cmH2O)
Pres Min
Pressure
VG Neo 5 — — 30 1 10
Minimum
(cmH2O)
VC, OFF; -10.0 – -1.0:0.5
Neo -5.0 — -0.3 OFF
PC, -10.0 -1.0 – -0.3:0.1
TCPL,
PRVC,
Pres Trig VG,
Ped OFF; -10.0 – -1.0:0.5
Pressure APRV, -5.0 — -0.5 OFF
Adu -10.0 -1.0 – -0.5:0.1
Inspiratory Bilevel PC,
Trigger PS+Backup,
(cmH2O) CPAP+Backup
nTCPL,
nCPAP, OFF; -10.0 – -1.0:0.5
Neo -5.0 — -0.1 0.5
Biphasic LP, -10.0 -1.0 – -0.1:0.1
nCPAP LP
VC+PS,
35-PEEP, (if
PC+PS, All OFF; 5 10 80 1 15
PEEP<5)
PS+Backup
35-PEEP, (if
Neo OFF; 5 10 80 1 15
PEEP<5)
PS TCPL +PS
Pressure 35-PEEP, (if
Ped OFF; 5 10 80 1 15
Support PEEP<5)
(cmH2O) 35-PEEP, (if
Ped OFF; 5 10 80 1 15
PEEP<5)
PRVC +PS
35-PEEP, (if
Adu OFF; 5 10 80 1 15
PEEP<5)
15-PEEP,(if
VG +PS Neo OFF; 2 5 30 1 5
PEEP<5)
806.00535 Version I
13-6

Control
PS High
25,(if P
Pressure Ped High>5)
Support during APRV OFF; 5 10 80 1 OFF
Adu 30-P High,(if
Pres High
P High<5)
(cmH2O)
PS Low 25 (if Pres
Pressure Low>5)
Ped
Support during APRV OFF; 5 10 30-Pres Low 40 1 OFF
Adu
Pres Low (if Pres
(cmH2O) Low<5)
VC, Neo 1 20 60 180 1 30
PV, Ped 1 10 40 180 1 20
TCPL Adu 1 6 30 180 1 12
Rate Ped 1 10 40 60 1 20
PRVC
Respiratory Adu 1 6 30 40 1 12
Rate VG Neo 1 10 40 120 1 30
(/min) Ped 1 10 — 40 1 20
Bilevel PC
Adu 1 6 30 40 1 12
nTCPL Neo 1 20 40 60 1 20
Biphasic LP Neo 1 — — 60 1 20
PC,
PRVC,
Rise
VG,
Pressure Rise
APRV, All 25 — — 100 5 50
Slope
Bilevel PC,
(%)
PS+Backup,
CPAP+Backup
T Delay
Ped OFF;
Time Delay APRV — — 1.0 0.1 OFF
Adu 0.2
(s)
0.2 – 1.00: 0.1
Ped 1.0 – 5.0: 0.2
APRV 0.2 — — 30 4.0
Time High Adu 5.0 – 10.0: 0.5
Time High 10.0 – 30.0: 1.0
(s) 0.10 – 1.00: 0.05
Biphasic LP,
Neo 0.10 — — 5.0 1.0 – 3.0: 0.1 0.30
nCPAP LP
3.0 – 5.0: 0.5
0.2 – 1.00: 0.1
Time Low
Ped 1.0 – 5.0: 0.2
Time Low APRV 0.2 — — 30 0.5
Adu 5.0 – 10.0: 0.5
(s)
10.0 – 30.0: 1.0
Vol Limit
10 – 20: 1 2 x IBW x
Volume Limit VG Neo 10 20 75 120
20 – 120: 5 mL/kg
(mL)
806.00535 Version I
13-7

Control
IBW x
Ped 20 100 300 500 10
mL/kg
PRVC
Vol Target 100 – 1000: 10 IBW x
Adu 100 200 700 2000
Volume Target 1000 – 2000: 50 mL/kg
(mL)
2 – 20: 1 IBW x
VG Neo 2 10 50 100
20 – 100: 5 mL/kg
Volume IBW x
Ped 10 50 350 500 10
Controlled mL/kg
VC
Volume 10 – 1000: 10 IBW x
Adu 100 250 750 2000
(mL) 1000 – 2000: 50 mL/kg
4,
Volume /
6,
Weight Ratio All All — — — — 6
8,
(mL/kg)
10
Square
Ped — — — — Decelerating Square
Waveform Sine
VC
Flow Pattern Square
Adu — — — — Declining Square
Sine
Table 13-5. Maneuvers Settings

Control
VC,
PC,
Neb Time
TCPL,
Nebulization
APRV, All 5 — — 30 1 15
Time
Bilevel PC,
(min)
PS+Backup,
CPAP+Backup
VC, Neo — — — — — 3
PC, Ped — — — — — 6
Neb Flow
TCPL,
Nebulization
APRV,
Flow
Bilevel PC, Adu — — — — — 6
(lpm)
PS+Backup,
CPAP+Backup
VC,
PC,
Neb Mode
APRV, Continuous /
Nebulization All — — — — Syncronized
Bilevel PC, Syncronized
Mode
PS+Backup,
CPAP+Backup
806.00535 Version I
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Table 13-5. Maneuvers Settings

Control
Ped Continuous /
TCPL — — — — Continuous
Neo Syncronized
TGI Delay VC,
TGI Delay PC, All 0 — — 500 100 300
(ms) TCPL
TGI Flow VC, Neo — — — — — 3
TGI Flow PC, Ped — — — — — 6
(lpm) TCPL Adu — — — — — 6
% Sigh
VC, Ped
Sigh SIze 25 — — 50 5 25
PC Adu
(%)
Cycle Breath
Cycles with VC, Ped
1 — — 3 1 1
sigh PC Adu
(cycles)
Cycle Interval
Cycles without VC, Ped
20 — — 100 1 20
sigh PC Adu
(cycles)
AAC PC
Automatic
TCPL Ped
Airway 10 — — 75 5 10
APRV, Adu
Compensarion
(%) PS+Backup
ET Size PC
Endotracheal TCPL Ped
2.0 — — 12.0 0.5 8.0
Tube Diameter APRV, Adu
(mm) PS+Backup
Slow Flow VC, I
Adu — — — — I+E
Maneuver PC I+E
Slow Flow 300 – 1,000: 50
VC,
Vol Max Adu 300 — 750 2,000 1,000 – 2,000: 500
PC
(mL) 100
Slow Flow
VC,
P Max Adu 10 — 35 80 1 30
PC
(cmH2O)
Slow Flow
VC,
T Max Adu 5 — — 40 1 20
PC
(s)
Slow Flow
VC,
Insp Flow Adu 4 — — 20 1 6
PC
(lpm)
NOTE
The controlled flow and volume values are expressed in BTPS (Body Temperature and
Pressure, Saturated).
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Pressure Limits
Maximum Limited Pressure: 120 cmH2O ±5%. It is ensured by the safety valve.
Maximum Working Pressure: It is ensured by the High Peak Pressure alarm. See range of High
Peak Pressure alarm in Chapter 6, Alarms and Messages. If, during the inspiratory phase, the
pressure limit established by the alarm is reached, the ventilator will immediately interrupt the
cycle and return to the set expiratory pressure (PEEP) value. If the pressure remains high at the
expiratory phase, the ventilator will open the safety valve and activate the obstruction alarm.
NOTE
The ventilator does not generate subatmospheric airway pressures during exhalation.
Flow Limits
Maximum Inspiratory Flow (Demand): 180 lpm
%O2 Delay
The length of time required to achieve intended oxygen concentration in the patient connection
depends on the ventilation settings and the patient circuit. This time delay may be up to the
values described in the table below, considering worst case configuration.
Delivered volumes Time duration from 21% to 90% at patient connection port
500 ml Less than 76 s
806.00535 Version I
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Ventilation Alarms
Table 13-6. Adjustable Physiological Alarms
Alarms Priority Mode IBW Min Max Default Auto Set
VC
PEEP+10 (if
PC
All 3 70 PEEP<10) Ppeak – 5
TCPL
25 (if PEEP>10)
PS+Backup
Ped
PRVC 3 70 PEEP + 5 Ppeak – 5
Adu
Low Ppeak PEEP + PEEP +
VG Neo 3 70
Low Pres Min – 5 Pres Min – 5
Inspiratory High Ped Pres Low + Pres Low +
APRV 3 70
Pressure Adu PS Low – 5 PS Low – 5
(cmH2O) PEEP+10 (if
Bilevel PC Ped
3 40 PEEP<10) Ppeak – 5
CPAP+Backup Adu
25 (if PEEP>10)
nTCPL
nCPAP+Backup
Biphasic LP
nCPAP LP
VC
PC
All 10 120 30 Ppeak + 5
TCPL
PS+Backup
Ped
PRVC 10 120 PEEP + 30 Ppeak + 10
Adu
High Ppeak PEEP + PEEP +
High VG Neo 10 120
Pres Max + 10 Pres Max + 10
Inspiratory High
Ped Pres High + Pres High +
Pressure APRV 10 120
Adu PS High + 10 PS High + 10
(cmH2O)
Bilevel PC Ped
5 60 30 Ppeak + 5
CPAP+Backup Adu
nTCPL
Neo 5 40 20 Ppeak + 5
nCPAP+Backup
Biphasic LP
Neo 5 20 15 Ppeak + 5
nCPAP LP
Ped OFF; 0.10 20.0 (Volume x Rate) –
VC Min Vol – 40%
Adult OFF; 1.0 40.0 40%
PC Neo OFF; 0.01 2.0
(IBW x mL/kg x
TCPL Ped OFF; 0.10 20.0 Min Vol – 40%
Rate) – 40%
PS+Backup Adult OFF; 1.0 40.0
Low Min Vol
Ped OFF; 0.10 20.0 (Vol Target x Rate) –
Low Minute PRVC Min Vol – 40%
Medium Adu OFF; 1.0 40.0 40%
Volume
(L) (Vol Target x Rate) –
VG Neo OFF; 0.01 2.0 Min Vol – 40%
40%
Ped OFF; 0.10 20.0 (IBW x mL/kg x
APRV Min Vol – 40%
Adult OFF; 1.0 40.0 Rate) – 40%
Bilevel PC Ped OFF; 0.10 20.0
OFF OFF
CPAP+Backup Adu OFF; 1.0 40.0
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nTCPL
Neo – – OFF OFF
nCPAP+Backup
30.0;
Ped 0.10
OFF (Volume x Rate) +
VC Min Vol + 40%
60.0; 40%
Adult 1.0
OFF
3.0;
Neo 0.01
OFF
PC 30.0; (IBW x mL/kg x
Ped 0.10 Min Vol + 40%
TCPL OFF Rate) + 40%
60.0;
Adult 1.0
OFF
3.0;
Neo 0.01 OFF OFF
OFF
30.0;
PS+Backup Ped 0.10 OFF OFF
OFF
High Min Vol 60.0;
Adult 1.0 OFF OFF
High Minute OFF
Medium
Volume 30.0;
Ped 0.10
(L) OFF (Vol Target x Rate) +
PRVC Min Vol + 40%
60.0; 40%
Adu 1.0
OFF
3.0; (Vol Target x Rate) +
VG Neo 0.01 Min Vol + 40%
OFF 40%
30.0;
Ped 0.10
OFF
APRV OFF OFF
60.0;
Adult 1.0
OFF
30.0;
Ped 0.10
Bilevel PC OFF
OFF OFF
CPAP+Backup 60.0;
Adu 1.0
OFF
nTCPL
Neo – – OFF OFF
nCPAP+Backup
Ped OFF; 10 500
VC Volume – 50% Volume – 50%
Adult OFF; 100 2,000
PC Neo OFF; 1 50
TCPL Ped OFF; 10 500 (IBW x mL/kg) –
Vte – 50%
APRV 50%
PS+Backup Adult OFF; 100 2,000
Low Vol
Low Tidal Vol Target –
Medium Ped OFF; 10 500 Vol Target – 50%
Volume 50%
PRVC
(L) Vol Target –
Adult OFF; 100 2,000 Vol Target – 50%
50%
Vol Target –
VG Neo OFF; 1 50 Vol Target – 50%
50%
Bilevel PC Ped OFF; 10 500 (IBW x mL/kg) –
Vte – 50%
CPAP+Backup Adult OFF; 100 2,000 50%
806.00535 Version I
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nTCPL
Neo – – OFF OFF
nCPAP+Backup
500;
Ped 10
OFF
VC Volume + 50% Volume + 50%
2,000;
Adult 100
OFF
50;
Neo 1
PC OFF
TCPL 500; (IBW x mL/kg) +
Ped 10 Vte + 50%
APRV OFF 50%
PS+Backup 2,000;
Adult 100
High Vol OFF
High Tidal 500; Vol Target +
Medium Ped 10 Vol Target + 50%
Volume OFF 50%
PRVC
(L) 2,000; Vol Target +
Adult 100 Vol Target + 50%
OFF 50%
50;
VG Neo 1 Vol Max + 5 Vol Max + 5
OFF
500;
Ped 10
Bilevel PC OFF (IBW x mL/kg) +
Vte + 50%
CPAP+Backup 2,000; 50%
Adult 100
OFF
nTCPL
Neo – – OFF OFF
nCPAP+Backup
VC
PC
60;
TCPL All 3 (60/Rate) + 5 Te + 5
OFF
PRVC
VG
60;
APRV All 3 OFF OFF
OFF
60;
Neo 3 5 OFF
OFF
Apnea 60;
Medium / PS+Backup Ped 3 10 OFF
Apnea Time OFF
High
(s) 60;
Adult 3 15 OFF
OFF
60;
Ped 3 10 Te + 5
Bilevel PC OFF
CPAP+Backup 60;
Adult 3 15 Te + 5
OFF
nTCPL 60;
Neo 3 5 Te + 5
nCPAP+Backup OFF
Biphasic LP 60;
Neo 3 OFF OFF
nCPAP LP OFF
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VC Neo OFF; 4 120 25
PC Ped OFF; 4 120 15
TCPL
PRVC
VG Rate – 30%
APRV Adu OFF; 4 120 5
Low Rate PS+Backup
Medium
(1/min) Bilevel PC
CPAP+Backup
nTCPL
Neo OFF; 4 60 20 Rate – 30%
nCPAP+Backup
Biphasic LP Neo OFF; 4 60 10 Rate – 30%
nCPAP LP Neo OFF; 4 60 OFF Rate – 30%
VC 180;
Neo 4 50
PC OFF
TCPL 180;
Ped 4 30
PRVC OFF
VG 180; Rate + 30%
APRV OFF
PS+Backup Adu 4 20
High Rate
Medium Bilevel PC
(1/min)
CPAP+Backup
nTCPL 80;
Neo 4 40 Rate + 30%
nCPAP+Backup OFF
80;
Biphasic LP Neo 4 40 Rate + 30%
OFF
80;
nCPAP LP Neo 4 OFF Rate + 30%
OFF
Low FiO2
Medium All All OFF; 19 100 %O2 – 5 FiO2 – 5
(%)
High FiO2 100;
Medium All All 19 %O2 + 5 FiO2 + 5
(%) OFF
nTCPL
Low PEEP Neo 0 15 PEEP – 2 PEEP – 2
Medium nCPAP+Backup
(cmH2O)
Biphasic LP Neo 0 15 2 PEEP – 2
Low CPAP
Medium nCPAP LP Neo 0 15 2 CPAP – 2
(cmH2O)
nTCPL
High PEEP Neo 3 20 PEEP + 2 PEEP + 2
Medium nCPAP+Backup
(cmH2O)
Biphasic LP Neo 3 20 7 PEEP + 2
High CPAP
Medium nCPAP LP Neo 3 20 7 CPAP + 2
(cmH2O)
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Table 13-7. Non-adjustable Physiological Alarms

Alarms Prior. Mode IBW Auto Set
Low FiO2
High All All ≤ 18%
(%)
VC
PC
TCPL
PRVC
Low PEEP
Medium VG All 3
(cmH2O)
APRV
Bilevel PC
PS+Backup
CPAP+Backup
VC
PC
TCPL
PRVC
High PEEP
Medium VG All 5
(cmH2O)
APRV
Bilevel PC
PS+Backup
CPAP+Backup
Auto PEEP
Low All All End expiratory flow > 50% of Exp Peak Flow
(cmH2O)
3 consecutive assisted/spontaneous cycles
Auto Cycle High All All
with I:E > 2:1
Table 13-8. Technical Alarms

Alarms Prior. Mode IBW Limits
Patient Disconnected High All All NA
Except
nTCPL
Patient Circuit Leak Low All NA
and
nCPAP
See Circuit Occlusion alarm at
Circuit Occlusion High All All
Chapter 6
Sensor type incompatible with
Wrong Flow Sensor Medium All All
patient category
Flow Sensor Disconnected
Low All All Absence of flow signal
Disconnection of Flow Sensor
Standby Time Elapsed High All All > 60 seconds
Low Air Pres
Low Air Intake Pressure High All All < 250
(kPa)
High Air Pres
High Air Intake Pressure High All All > 600
(kPa)
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Table 13-8. Technical Alarms

Alarms Prior. Mode IBW Limits
Ext High Air Pres
Extremely High Intake Pressure High All All > 660
(kPa)
Low O2 Pres
Low Oxygen Intake Pressure High All All > 250
(kPa)
High O2 Pres
High Oxygen Intake Pressure High All All > 600
(kPa)
Ext High O2 Pres
Extremely High Oxygen Intake
High All All > 660
Pressure
(kPa)
Gas Fail
High All All < 120 (for both intakes)
(kPa)
Gas Administration Fail High All All NA
Power Fail High All All NA
AC Line Fail
AC Mains Power Supply Failure Medium All All NA
and Battery Input
Internal Battery in Use Low All All NA
High External Battery Voltage High All All > 14.5 Vdc
Battery near depletion:
Medium / - Approximately 15 min
Low Internal Battery All All
High (Medium Priority)
- At least 5 min (High Priority)
Internal Battery Fail High All All NA
Low Setup Battery Low All All NA
Autozero Error Medium All All NA
Fan Fail Medium All All NA
Exhalation Valve Fail
Exhalation Valve Control High All All NA
Failure/PIP-PEEP
Pressure Regulator Fail
Pressure Regulator Control High All All NA
Failure
Keyboard Fail Medium All All NA
Motherboard Fail High All All NA
Internal Fail High All All NA
Vent Inop
High All All NA
Ventilator Inoperative
Ventilator Off – All All NA
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Sound Pressure
Alarm volume: 72.5 ± 22.5 dBA @ 1 meter.
Ventilator without compressor: 52 dBA when measured in accordance with ISO 3744.
Ventilator with compressor: 57 dBA when measured in accordance with ISO 3744.
Sound Power
Ventilator without compressor: 63 dBA when calculated in accordance with ISO 3744.
Ventilator with compressor: 68 dBA when calculated in accordance with ISO 3744.
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Monitors
Table 13-9. Measured Parameters
Parameter Range Resolution
Ppeak
Inspiratory Pressure 0 – 120 0 – 120: 1
(cmH2O)
PEEP / CPAP
Positive End Expiratory Pressure 0 – 120 0 – 120: 1
(cmH2O)
Pmean
Mean Airway Pressure 0 – 120 0 – 120: 1
(cmH2O)
Pplat
Plateau Pressure 0 – 120 0 – 120: 1
(cmH2O)
Vte 0.000 – 0.999: 0.001
Expiratory Tidal Volume 0.000 – 3.00
1.00 – 3.00: 0.01
(L)
Vti 0.000 – 0.999: 0.001
Inspiratory Tidal Volume 0.000 – 3.00
1.00 – 3.00: 0.01
(L)
Vte/kg
0.000 – 0.999: 0.001
Volume / Weight Ratio 0.000 – 3.00
(mL/kg) 1.00 – 3.00: 0.01
Vol FRC (in APRV only) 0.000 – 0.999: 0.001

Functional Residual Capacity 0.000 – 3.00
1.00 – 3.00: 0.01
(mL)
Leak (only in adult and pediatric NIV
modes and neonatal IV modes)
0 – 100 1
Circuit Leakage
(%)
Min Vol 0.00 – 9.99: 0.01
Minute Volume 0.00 – 99.9
10.0 – 99.9: 0.1
(L)
Rate
Total Respiratory Rate 0 – 180 0 – 180: 1
(/min)
Spon Rate
Spontaneous Respiratory Rate 0 – 180 0 – 180: 1
(/min)
I:E
1:99 – 9.9:1 1:99 – 9.9:1: 1
I:E Ratio
PIFR
Peak Inspiratory Flow Rate 0 – 180 1
(lpm)
PEFR
Peak Expiratory Flow Rate 0 – 180 1
(lpm)
Paw
Airway Pressure (Manometer) -10 – 120 -10 – 120: 1
(cmH2O)
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Table 13-9. Measured Parameters

Parameter Range Resolution
FiO2
Inhaled Oxygen Fraction 0 – 100 0 – 100: 1
(%)
Filtering and Smoothing Techniques

The measured and calculated values displayed or used to control suffer from noise removal
processes in order to deliver a more significant result. This is performed by the inclusion of
signal filters. These filters are part of the accuracy described in the technical description and are
defined by:
 Pressure and flow readings: Low Pass Filter (median type) with time constant of 40 ms.
 FiO2 reading: Nonlinear Filtering (fashion type) with a maximum time of 2 s update.
Filter Specifications
Table 13-10. Filter Specifications

Part # Manufacturer Technical Specification
RT019 Fisher&Paykel Compliance 0.13mL/cmH2O
Deadspace: 38 ml
Flow resistance: 1.08 ± 0.18 cmH2O @ 45 lpm
Viral efficiency: > 99.99 %
Organism: ΨX174 Bacteriophage
Bacterial efficiency: > 99.9997 %
Organism: Bacillus subtillis
Mean particle size: 3μm
RT020 Fisher&Paykel Bacterial efficiency: > 99.9997 %
Viral efficiency: > 99.99 %
Flow resistance: 1.018 ± 0.18 cmH2O @ 45 lpm
Deadspace: 38 ml
Bacterial/Viral AirLife Bacterial filtration efficiency (BFE): 99.9%
(001851) Viral filtration efficiency (VFE): 99.7%
Flow resistance: 0.90 cmH2O at 1.0 l/s (after 48 h)
Deadspace: 43mL
HEPA (001852) AirLife Bacterial filtration efficiency (BFE): > 99.9999 %
Viral filtration efficiency (VFE): > 99.9999 %
Flow resistance: 1.7 cmH2O @ 1.0 l/s (after 48 h)
Deadspace: 84 ml
28HEPA (70538) Hsiner Bacterial filtration efficiency: 99.999 % (3.2 µ)
Viral filtration efficiency: 99.99 % (3.2 µ)
Flow resistance: 58.8 Pa @ 30 lpm
Deadspace: 135 ml
28FHMET (70531-FB) Hsiner Bacterial filtration efficiency: 99.999 % (3.2 µ)
Viral filtration efficiency: 99.99 % (3.2 µ)
Flow resistance: 2.02 cmH2O @ 30 lpm
Deadspace: 38 ml
04FBVG Vital Signs Bacterial filtration efficiency: 99.997 %
Viral filtration efficiency: 99.94 %
Flow resistance: 1.8 cmH2O @ 60 lpm
Deadspace: 27 ml
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Table 13-11. Calculated Parameters

Parameter Calculation / Description
Rinsp = (Paw* – PEEP) / Flow*
Rinsp
Where Flow* and Paw* are respectively the inspiratory flow
Airway Inspiratory Resistance
and airway pressure values measured 100ms after the start
(cmH2O/L/s)
of the respiratory cycle.
Rexp
Airway Expiratory Resistance Rexp = (Pplat – PEEP) / PEFR
(cmH2O/L/s)
Cstat
Static Compliance Cstat = Vte / (Pplat – PEEP)
(mL/cmH2O)
Cdyn
Dynamic Compliance Cdyn = Vte / (Ppeak – PEEP)
(mL/cmH2O)
RC exp
Expiratory Time Constant RC exp = Rexp x Cstat
(s)
Te
Expiratory Time It indicates the expiratory time of the respiratory cycle.
(s)
Ti
Inspiratory Time It indicates the inspiratory time of the respiratory cycle.
(s)
WOBv
Ventilator Respiratory Work WOBv = ∫P dV
(J/L)
RSBI
RSBI = Spont Rate / Vte
Rapid Shallow Breathing Index
P 100 It indicates the P 0.1 value – pressure measured 100 ms
Occlusion Pressure at 100 ms after the start of the inspiratory effort (assisted or
(cmH2O) spontaneous cycles).
PEEPpause It indicates the PEEP value – pressure measured during an
PEEP during Exp Hold Expiratory Hold maneuver.
AutoPEEP
It indicates the Auto PEEP value – pressure measured 200
Auto PEEP
ms before the start of a controlled cycle.
(cmH2O)
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Ventilation System
Essential Performance
The Essential Performance of the system consists of delivery of ventilation at the patient-
connection port within the alarm limits adjusted by the operator or the generation of an alarm, as
required by ISO 80601-2-12:2011: Medical Electrical Equipment – Part 2-12 Particular
Requirements for Basic Safety and Essential Performance of Critical Care Ventilators.
The verification of the Essential Performance will be conducted by Functional Verification Test-
FVT, as described in Chapter 10.
WARNING
In the situation where essential performance is lost or degraded due to EM
disturbances, the ventilator will activate the appropriate protection mechanisms (i.e.
audible alarm, visual alarm, safety valve opening) going to a safe state and thus
protecting the patient's integrity.
Data Communication Ports
WARNING
Connection of the ventilator to other equipment may result in previously unidentified
risks to patients, operators, or third parties. The institution should identify, analyze,
evaluate, and control these risks. Subsequent changes to data communication ports
may introduce new risks and require additional analysis.
Do not touch the patient and either data communication ports or non-medical electrical
equipment and the patient at the same time. This may cause an unsafe electrical shock
to the patient.
USB
Used for screen captures. External USB memory storage device (“flash drive”) is required to
extract the stored images.
CAUTION
Do not turn on the equipment with the external USB memory storage device connected.
Performing this operation will unable the equipment to start. If that happens, remove the
external USB memory storage device, turn off the equipment and turn it on again.
RS 232
The RS 232 port is intended only for maintenance and shall be accessed only by trained people
authorized by Vyaire.
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CAUTION
Do not connect any equipment in the RS 232 port during normal operation. The
presence of any voltage or current from other electrical equipment may result in
previously unidentified risks to patients, operators, or third parties.
IT Network/Ethernet
The IT Network port on the rear panel may be used to output data to other equipment. The
ventilator share information from measured data, including waveforms and alarms. The
ventilator doesn’t allow change of ventilation mode settings, start of maneuvers or change of
alarm settings through IT network port. The connection to other equipment, e.g. an IT network
server, is performed by Dynamic Host Configuration Protocol (DHCP). As this connection is
stablished and the ventilator receives an Internet Protocol (IP) address from the receiving
system, the ventilator may send data through the use of iX5 IT Network Protocol. The receiving
system must use the iX5 IT Network Protocol in order to request and receive data from the
ventilator. Information on iX5 IT Network Protocol is available by contacting Technical Support.
CAUTION
Failure to implement iX5 Network Protocol will result in failure in sending data by the
ventilator to the receiving system.
iX5 shall be only connected to IT system compliant with IEEE 802.3u.
Use a cable category CAT 5E or better to connect to the ventilator IT network port.
Note: Category CAT 5E is defined by standard ANSI/TIA/EIA-568 .
Connection of the ventilator to an IT network that includes other equipment could result in
previously unidentified risks to patients, operators, or third parties. The facility should identify,
analyze, evaluate and control these risks.
Note: IEC 80001-1:2010 provides guidance for the facility to address these risks. IEC 80001
1:2010 refers to “Application of risk management for IT-networks incorporating medical devices
Part 1: Roles, responsibilities and activities”.
CAUTION
Subsequent changes to the IT network could introduce new risks and require additional
analysis. Changes to the IT network include:
 Changes in the IT network configuration.
 Connection of additional items to the IT network.
 Disconnecting items from the IT network.
 Update of equipment connected to the IT network
 Upgrade of equipment connected to the IT network.
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The delay time from detection of an alarm condition to the signal leaving the ventilator IT
network port is up to two seconds. The facility is responsible for any additional delays introduced
by the equipment connected to the ventilator IT network port.
WARNING
Only the ventilator should be relied upon for alarm signal generation and information.
Do not rely on the IT network connection for distribution and receipt of alarm signals.
Therefore, a DISTRIBUTED ALARM SYSTEM should not be used as the only mean to
recognize alarm signal generation.
Eletromagnetic Compatibility
Table 13-12. Electromagnetic Emission Tests
Emission Test Standard Specifications
Group 1 /
Radiated Emission CISPR 11 Ed. 5.0 (2009) + A1 (2010)
Class A
Group 1 /
Conducted Emission CISPR 11 Ed. 5.0 (2009) + A1 (2010)
Class A
Harmonic Distortion IEC 61000-3-2 Ed. 3.0 (2005) + A1 (2008) + A2 (2009) Class A
Voltage Fluctuations
IEC 61000-3-3 Ed. 3.0 (2013) -
and Flicker
Table 13-13. Electromagnetic Immunity Tests

Immunity Test Standard Test Levels
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Electrostatic ± 8 kV - contact
Discharge IEC 61000-4-2 Ed. 2.0 (2008)
(ESD) ± 2, 4, 8, 15 kV - air
Radiated RF 3V/m, 80% AM at 1 KHz
IEC 61000-4-3 Ed. 3.0 (2006) + A1 (2007) +
electromagnetic
A2 (2010) 80 MHz – 2700 MHz
fields
27 V/m, 380 MHz – 390 MHz
28 V/m, 430 MHz – 470 MHz
Proximity fields 9 V/m, 704 MHz – 787 MHz
IEC 61000-4-3 Ed. 3.0 (2006) + A1 (2007) +
from RF 28 V/m, 800 MHz – 960 MHz
A2 (2010)
wireless 28 V/m, 1700 MHz – 1990 MHz
28 V/m, 2400 MHz – 2570 MHz
9 V/m, 5100 MHz – 5800 MHz
Electrical fast ± 2 kV, 100 KHz – AC Mains
transient and IEC 61000-4-4 Ed. 3.0 (2012)
burst (EFT&B) ± 1 kV, 100 KHz – I/O ports
± 0,5, 1, 2 kV - AC Mains (Line to
Ground)
Surges IEC 61000-4-5 Ed. 2.0 (2005)
± 0,5, 1 kV - AC Mains (Line to Line)
± 2 kV – I/O (Line to Ground)
Conducted
disturbances 3V with 6V ISM, 80% AM at 1 KHz
IEC 61000-4-6 4.0 (2013)
induced by RF 150 KHz – 80 MHz
fields
100% drop, 0,5 periods, 0°, 45°, 90°,
Voltage dips/ 135°, 180°, 225°, 270°, 315°
interruptions on
IEC 61000-4-11 Ed. 2.0 (2004)
power supply
100% drop, 1 period
input lines
30% drop, 25/30 periods
Power
frequency IEC 61000-4-8 Ed. 2.0 (2009) 30 A/m, 50 or 60 Hz
magnetic field
806.00535 Version I
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Table 13-14. Test specification for Enclosure Port Immunity to RF wireless communications equipment
The iX5 ventilator is intended for use on an electromagnetic environment where the RF perturbations are
controlled. The user can help preventing electromagnetic interference keeping a minimum distance
between mobile and portable RF communication equipment (transmitters) and the ventilator (as
recommended below), according to the maximum communication equipment output power.
Test Immunity
Band Maximum Distance
frequency Service Modulation Test Level
(MHz) power (W) (m)
(MHz) (V/m)
Pulse
385 380 - 390 TETRA 400 modulation 1,8 0,3 27
18 Hz
FM ± 5 KHz
GMRS 460,
450 430 - 470 desviation 2 0,3 28
FRS 460
1 KHz sine
710 Pulse
LTE Band 13, modulation
745 704 - 787 0,2 0,3 9
17
780 217 Hz
810 GSM 800/900
870 TETRA 800 Pulse
800 - 960 iDEN 820 modulation 2 0,3 28
930 CDMA 850 18Hz
LTE Band 5
1720 GSM 1800
1845 CDMA 1900
GSM 1900 Pulse
1700 - 1990 DECT modulation 2 0,3 28
1970 LTE Band 1, 3, 217 Hz
4, 25
UMTS
Bluetooth
WLAN Pulse
2450 2400 - 2570 802.11 b/g/n modulation 2 0,3 28
RFID 2450 217 Hz
LTE Band 7
5240 Pulse
WLAN 802.11
5500 5100 - 5800 modulation 2 0,3 9
a/n
5785 217 Hz
NOTE: If necessary to achieve the Immunity Test Level, the distance between the transmiting antenna and the ME Equiment or
ME System may be reduced to 1m. The 1m tet distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an Alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual
modulation, it would be worst case.
806.00535 Version I
13-25
Pneumatic Diagram
See Chapter 3 for correct assembly of the breathing circuit assembly
806.00535 Version I
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806.00535 Version I
A-1
Appendix A Warranty Term

The iX5 ventilator is warranted to be free from defects in material and workmanship and to meet
the published specifications for 24 (twenty four) months.
The liability of Vyaire (referred to as the Company) under this warranty is limited to replacing,
repairing or issuing credit, at the discretion of the Company, for parts that become defective or
fail to meet published specifications during the warranty period; the Company will not be liable
under this warranty unless (A) the Company is promptly notified in writing by Buyer upon
discovery of defects or failure to meet published specifications; (B) the defective unit or part is
returned to the Company, transportation charges prepaid by Buyer; (C) the defective unit or part
is received by the Company for adjustment no later than four weeks following the last day of the
warranty period; and (D) the Company’s examination of such unit or part shall disclose, to its
satisfaction, that such defects or failures have not been caused by misuse, neglect, improper
installation, unauthorized repair, alteration or accident.
Any authorization of the Company for repair or alteration by the Buyer must be in writing to
prevent voiding the warranty. The equipment features safety seals on the closing bolts. If these
seals are broken by unauthorized personnel, equipment warranty is voided.
In no event shall the Company be liable to the Buyer for loss of profits, loss of use,
consequential damage or damages of any kind based upon a claim for breach of warranty, other
than the purchase price of any defective product covered hereunder.
The Company warranties as herein and above set forth shall not be enlarged, diminished or
affected by, and no obligation or liability shall arise or grow out of the rendering of technical
advice or service by the Company or its agents in connection with the Buyer's order of the
products furnished hereunder.
Limitation of Liabilities
This warranty does not cover normal maintenance such as cleaning, adjustment or lubrication
and updating of equipment parts. This warranty shall be void and shall not apply if the
equipment is used with accessories or parts not manufactured by the Company or authorized for
use in writing by the Company or if the equipment is not maintained in accordance with the
prescribed schedule of maintenance.
The warranty stated above shall extend for a period of 24 (twenty four) months, with the
following exceptions:
1. Elastomeric components and other parts or components subject to deterioration, over which
the Company has no control, are warranted for 60 (sixty) days from date of receipt.
2. Internal batteries are warranted for 90 (ninety) days from the date of receipt.
The foregoing is in lieu of any warranty, expressed or implied, including, without limitation, any
warranty of merchantability, except as to title, and can be amended only in writing by a duly
authorized representative of the Company.
806.00535 Version I
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806.00535 Version I
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Appendix B Contact and Ordering Information

How to Call for Service with Vyaire Authorized Technicians
To get help on performing installation, any of the preventive maintenance routines or to request
service on your ventilator, to schedule training (for operation or maintenance) or to obtain iX5
ventilator parts, pieces, and accessories contact Vyaire at:
Hours: 7:30 AM to 4:30 PM (BRT) Monday through Friday
Phone: 55 (11) 4615-9380
e-mail: [email protected]
806.00535 Version I
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806.00535 Version I

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iX5™ Ventilator

Trade Name: iX5 Ventilator

This document is protected by United States and International Copyright laws.

Chapter 1 Intended Use ............................................................................................................... 1-1

Chapter 2 Safety Warnings ......................................................................................................... 2-1

Chapter 3 Equipment Setup ........................................................................................................ 3-1

Chapter 4 Operation .................................................................................................................... 4-1

Chapter 5 Ventilation Features ................................................................................................... 5-1

Chapter 6 Alarms and Messages ................................................................................................ 6-1

Chapter 7 Monitoring Features ................................................................................................... 7-1

Chapter 8 Troubleshooting.......................................................................................................... 8-1

Chapter 9 Cleaning, Disinfection, and Sterilization .................................................................. 9-1

Chapter 10 Preventive Maintenance ........................................................................................... 10-1

Chapter 11 Accessories, Parts, and Pieces ............................................................................... 11-1

Parts and A11-2ccessories ......................................................................................................... 11-2

Chapter 12 Terminology, Symbols, and Definitions ................................................................. 12-1

Chapter 13 Technical Specifications ......................................................................................... 13-1

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Chapter 1 Intended Use

Protection against Liquid and Particle Ingress

Front Panel Module

Electric Power Supply Module

Pneumatic Control Module

Rear Panel Module

AC Mains Power Supply

Chapter 2 Safety Warnings

Cleaning, Disinfection and Sterilization

warning: – Do not obstruct.

BPT – Battery Performance Test

Cleaning, Disinfection and Sterilization

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Chapter 3 Equipment Setup

Setting Up the Rear of the Ventilator

Figure 3-1. Rear Panel

A AC Mains Power Supply H External Battery connector

Figure 3-2. Rear panel detail—Ventilation Output

Connection to the Power Source

AC Mains Power Supply

Connection to the Gas Pipeline

Figure 3-3. Connection of the air and oxygen hoses

Figure 3-4. Gas intake filters

Breathing circuit assembly

Selection of the Patient Breathing Circuit and Flow Sensor

Exhalation Valve Connection

 Turn the ventilator off or press the Standby Mode button.

Figure 3-5. Exhalation valve assembling sequence.

Patient Circuit Assembly

Connecting the Humidifier

Figure 3-7. Side panel detail – safety valve intake.

1. Gather the nCPAP supplies:

2. Attach the water chamber to the

3. Connect the gas delivery tubing (A) to

4. Connect the elbow connector on the

5. Connect the non-heated section (C)

6. Connect the proximal pressure line

Flow Sensor Connection

Figure 3-8. Proximal flow sensors assembly

Expiratory Flow Sensor

Figure 3-9. Expiratory flow sensor assembly