Respironics 1127941 User Manual

Instructions for Use | Introduction
Trilogy Evo Universal Instructions for Use
For Technical Support and Customer Service, contact Philips Customer Service:
USA
Respironics Inc.
1001 Murry Ridge Lane Murrysville, PA 15668
Email: service@philips.com, clinical@philips.com
Web: www.philips.com\healthcare
Authorized European Representative:
Respironics Deutschland GmbH & Co. KG
Gewerbestrasse 17
D-82211 Herrsching Germany
+49 8152 93060
Copyright © 2018 Koninklijke Philips N.V. All rights reserved.
This work is protected under Title 17 of the United States copyright code and is the sole property of Philips Respironics. No part of this document may be copied or otherwise reproduced, or stored in any electronic information retrieval system, except as specifically permitted under United States copyright law, without the prior written consent of Philips Respironics.
Trilogy Evo Universal is the registered trademark of Respironics Inc.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Philips Respironics is under license.
Dawn Ultra is a registered trademark of Procter & Gamble.
Other trademarks and trade names are those of their respective owners.
Illustrations and screen images in this document are representative depictions.
Instructions for Use | Introduction
Contents
1. Introduction ................................................................ 4
Intended Use................................................................... 4
Environments of Use ....................................................... 4
Contraindications ............................................................ 4
Package Contents............................................................ 5
Warnings ......................................................................... 5
Symbols Glossary ............................................................ 9
How to Contact Philips Respironics .............................. 11
2. About Trilogy Evo Universal ...................................... 12
Parts of Trilogy Evo Universal ........................................... 12
Parts of the User Interface ............................................ 14
Monitoring Window ...................................................... 15
3. Therapy Modes and Controls .................................... 17
Overview ....................................................................... 17
Control Modes .............................................................. 19
Spontaneous Modes ..................................................... 21
Mixed Modes ................................................................ 23
Therapy Features .......................................................... 25
Therapy Actions ............................................................ 27
Therapy Control Settings .............................................. 27
Dynamic Therapy Parameters ....................................... 29
4. Device Setup ............................................................. 31
Setup Overview ............................................................. 31
Placement ..................................................................... 31
Connecting AC Power ................................................... 31
Installing Filters ............................................................. 31
Connecting a Circuit ...................................................... 33
Adding Oxygen .............................................................. 35
Starting Trilogy Evo Universal ....................................... 36
5. Device Operation ...................................................... 37
Clinical Assessment ....................................................... 37
Entering New Patient Information ................................ 37
About Prescriptions ...................................................... 37
Starting and Stopping Ventilation ................................. 39
Actions during Ventilation ............................................ 39
6. Alarms and System Messages .................................. 41
Overview ...................................................................... 41
About Alarms ................................................................ 41
The Alarm List ............................................................... 42
Setting and Changing Alarms........................................ 42
Setting the Alarm Volume ............................................ 43
Responding to an Alarm ............................................... 43
Resetting Alarms .......................................................... 43
Alarms and System Messages ...................................... 44
Prescription Alarm Availability by Therapy Mode ........ 60
Testing Alarms .............................................................. 60
Alarm and Event Log .................................................... 63
7. Device Options ......................................................... 65
Device Settings ............................................................. 65
Calibration .................................................................... 66
Data Transfer ................................................................ 68
Information .................................................................. 70
8. Cleaning and Disinfection ......................................... 71
Exterior Cleaning and Disinfection ............................... 71
Cleaning the Detachable Battery .................................. 72
Rinsing the Air-Inlet Foam Filter ................................... 72
External Active Exhalation Valve Cleaning and
Disinfection .................................................................. 73
9. Service and Maintenance ......................................... 75
Service .......................................................................... 75
Disposal ........................................................................ 75
Routine Maintenance ................................................... 75
Replacing the Air-Inlet Foam Filter ............................... 75
Replacing the Particulate Filter .................................... 76
Preparing the Device for a Use by a Different Patient.. 76
10. Trilogy Evo Universal Accessories ......................... 77
Power Accessories ........................................................ 77
Patient Monitors .......................................................... 77
Filters ............................................................................ 80
Patient Circuits ............................................................. 81
Circuit Accessories ........................................................ 81
Dual Limb Active Exhalation Valve ............................... 82
Oxygen ......................................................................... 82
Portability and Travel Accessories ................................ 83
Instructions for Use | Introduction
11. Power Management ............................................. 84
Power Sources .............................................................. 84
Battery Power Indicator ................................................ 84
Battery Status Indicator ................................................ 84
AC Power ........................................................................ 84
External Battery ............................................................ 85
Detachable Battery ....................................................... 85
Internal Battery ............................................................. 86
Power Loss .................................................................... 86
Power Indicator Icons ................................................... 86
12. Technical Specifications ........................................ 88
Specifications ............................................................... 88
Standards Compliance .................................................. 91
Pneumatic Diagram ...................................................... 92
EMC Information .......................................................... 92
13. Wireless Connectivity ........................................... 96
Bluetooth Actions ......................................................... 96
NFC Actions .................................................................. 97
Troubleshooting ........................................................... 97
14. Glossary ................................................................ 98
15. Warranty ............................................................ 100
Intended Use 3
Instructions for Use | Introduction

1. Introduction

The Trilogy Evo Universal ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician according to its technical specifications.

Intended Use

The Trilogy Evo Universal ventilator provides invasive and non-invasive positive pressure ventilation for the care of patients ≥2.5 kg through adults. The ventilator can measure, display, record, and alarm SpO data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair, personal vehicle, or ambulance.
, FiO2, CO2, respiratory rate, and pulse rate
2

Environments of Use

The Trilogy Evo Universal ventilator is intended to be used:
In institutional environments.
While attached to a wheelchair, bedrail, gurney, roll stand, or sitting on a flat surface such as a table or nightstand.
While transporting patients within and between facilities such as automobile or commercial aircraft.

Contraindications

If the patient has any of the following conditions, consult the patient’s health care professional before using noninvasive ventilation:
An inability to maintain a patent airway or adequately clear secretions
At risk to aspirate gastric contents
Acute sinusitis or otitis media
Epistaxis, causing pulmonary aspiration of blood
Hypotension

Package Contents

Instructions for Use | Introduction

Warnings

Environmental

You should not operate Trilogy Evo Universal in the presence of flammable gasses.
Do not cover the ventilator or place in a position that affects proper operation.
Do not block the cooling and intake air vents.
Do not operate Trilogy Evo Universal in an environment that is outside the specified ranges. Using the ventilator outside
of this temperature range or above this altitude can affect the ventilator performance.
The blower warms the temperature of the airflow. Use of the device at room temperatures warmer than 40˚C may cause thermal irritation.
Do not expose the device or detachable battery to temperatures above 60˚ C (140˚ F) during use or above 70˚ C (158˚ F) during storage. This will reduce battery life and may increase the risk of fire or damage the battery.
The Trilogy Evo Universal is not intended for MRI or anesthesia applications, and is not intended to be permanently mounted in EMS vehicles.
When disposing of this device or any accessories, ensure you comply with your local regulations. Dispose of any potentially biohazardous waste according to your local regulations.
Warnings 5
Instructions for Use | Introduction
This device is intended for use in the electromagnetic environment specified in the “EMC Information” chapter. Ensure the environment is compatible. Portable and mobile RF communications equipment, including cables, should be no closer to any part of the device than the recommended separation distance indicated in the “EMC Information” chapter.
This device is not made with natural rubber latex.
Do not use the ventilator in a hyperbaric chamber.
Do not use the ventilator in the presence of nitric or nitrous oxide.
Do not use the ventilator with helium or in the presence of mixtures in combination with helium.
Route all cables in a manner to prevent injury, such as tripping or strangulation, to the patient and caregiver.

Clinical

Before placing a patient on the ventilator, perform a clinical assessment. Considerations should include:
- Choosing alarm settings
- Whether alternative ventilation equipment is required
- Whether alternative monitors are required, such as Vte monitoring for Active PAP circuit, pulse oximeter or respiratory monitor with alarm
Trilogy Evo Universal is a restricted medical device. It is designed for use by respiratory therapists or other trained and qualified caregivers under the supervision of a physician. Only the supervising physician’s orders authorize changes to the prescription and other device settings. Before using Trilogy Evo Universal, you must read and understand this manual.
When using the ActivePAP circuit, CO
80601-2-55.
U
nintentional leaks cause exhaled volume and expired CO2 values to differ from actual patient values.
The caregiver or health care professional is responsible for verifying any changes to the device, prescription, or other settings before applying changes. The caregiver or health care professional is responsible for ensuring settings are correct and compatible with the patient. Using the wrong prescription for a patient may result in improper therapy, lack of appropriate safety monitoring, or risk of death or injury to the patient.
monitoring is required to measure exhaled carbon dioxide, in accordance with ISO
2

Alternate Ventilation

To avoid patient death or serious injury, ventilator-dependent patients require immediate access to alternate ventilation equipment, such as a back-up ventilator or manual resuscitator.
Qualified personnel should monitor ventilator-dependent patients continuously. Personnel should be prepared to provide alternate therapy in the event of ventilator failure or inoperative equipment.

Alarms

Do not rely on any single alarm to detect a disconnected circuit.
Respond immediately to any high priority alarm. It may indicate a potentially life-threatening condition.
Visually monitor the patient and ventilator at all times during an Alarm Silence period. Allowing alarms to continue
without intervention may result in harm to the patient.
If the high-priority Low Battery alarm occurs, immediately connect the ventilator to an alternate power source. If no alternate power source is available, immediately place the patient on an alternate source of ventilation.
When using a remote alarm, make sure you fully test the remote alarm connector and cable by verifying that:
- You can hear the ventilator’s audible alarms on the remote alarm.
- The remote alarm signals when you disconnect the remote alarm cable from the ventilator or from the remote alarm
Test the operation of the circuit disconnect function daily and whenever the patient circuit is changed. An increase in circuit resistance can prevent proper operation of some alarms.
Warnings 6
Instructions for Use | Introduction
Speaking valves, heat moisture exchangers (HMEs), humidifiers, and filters create additional circuit resistance and may affect the performance of alarms chosen for circuit disconnect protection.
Do not set the Low Peak Inspiratory Pressure alarm too low, or the system may not detect large circuit leaks or a patient disconnect.

Accessories

Use Trilogy Evo Universal only with accessories intended for use with this device. Otherwise, adverse performance including increased electromagnetic emissions or decreased electromagnetic immunity of this equipment can occur. For a list of accessories, such as patient interfaces, circuits, exhalation ports, and cables, see the Trilogy Evo Universal accessories guide. Ensure accessories and parts are compatible before you connect a patient to the device. Consult the accessory’s instructions before use.
The air-inlet foam filter is required to protect the ventilator from dirt and dust. See the “Service and Maintenance” chapter for maintenance instructions.
Be certain that any breathing system filter used with this device complies with ISO 23328-1 and ISO 23328-2. · To prevent patient or ventilator contamination, we recommend you use a Respironics-approved main flow bacteria filter (Part
Number 342077) on the patient gas outlet port. Filters not approved by Respironics may degrade system performance.
When adding any components (such as humidifiers, speaking valves, heat moisture exchangers, and filters) to the breathing system, consider the flow resistance and dead space in relation to the potential for adverse effects on the patient’s ventilator management and device alarms.
Nebulization or humidification can increase the resistance of breathing system filters. Monitor the breathing system frequently for increased resistance and blockage.
Gas added by the use of a pneumatic nebulizer can adversely affect ventilator accuracy.
When using a passive circuit an exhalation port is required. At low expiratory pressures, the flow through the exhalation
port may be inadequate to clear all exhaled gas from the tubing – some rebreathing may occur.
Do not use antistatic or conductive hoses or conductive patient tubing with the device.
The ventilator system (used with patient circuit accessories, such as patient interface devices, humidifiers, water traps, and
circuit tubing) may contain small parts that could result in a choking hazard.
Be certain that any humidifier in use, including any heated breathing tube, complies with ISO 8185.

Oxygen

This device is equipped with an oxygen blender that can deliver oxygen to the patient within a range of 21-100% concentration.
To ensure accuracy of oxygen administration when using the oxygen blender, use the internal FiO2 accessory or an external oxygen monitor that complies with ISO 80601-2-55 to verify the oxygen concentration in the delivered gas.
Substantial leaks may reduce the inspired oxygen concentration to less than the expected value. Use appropriate patient monitoring, as medically indicated, such as an alarming pulse oximeter.
Do not connect the device to an unregulated oxygen source.
Do not use oxygen while smoking or in the presence of an open flame.
Turn off the oxygen flow when the device is not in use.

Cleaning and Maintenance

To avoid electric shock, do not remove the enclosure cover. Only service personnel should remove the enclosure.
Do not immerse the device or allow liquids into any of the controls or the interior of the enclosure as the device may be
damaged. If this occurs, contact your equipment provider for assistance. Use only the agents and methods described in
Warnings 7
Instructions for Use | Introduction
this manual to clean and disinfect the device. After cleaning and disinfecting, ensure the device is completely dry before reattaching accessories and connectors and before reconnecting it to a power source. Do not use solvents, polishes, or any oily substances on the device, as they are flammable.
If the device has been exposed to rain or dampness, dry the device including the area around the power cord connection
with the power cord disconnected from the device before applying AC power.
Repairs and adjustments must be performed by service personnel only. Unauthorized service could cause death or injury,
invalidate the warranty, or result in costly device damage.
If you notice any unexplained changes in the performance of the device, if it is making unusual sounds, if the device or
detachable battery is dropped, if water is spilled into the enclosure, or if the enclosure is cracked or broken, discontinue use and contact Philips Respironics.
To avoid electrical shock, always unplug the power cord from the wall outlet before cleaning the ventilator.
Periodically inspect electrical cords, cables, and the detachable battery pack for damage or signs of wear. Discontinue use
and replace if damaged.
No modification of this equipment is allowed. Any changes or modifications made to the device that are not expressly
approved by Respironics may void the user’s authority to operate the equipment.

Power

Do not connect the ventilator to the battery of a battery-powered wheelchair as this can affect the ventilator performance,
which can result in patient death.
An external battery should only be connected to the ventilator using the Philips Respironics approved External Battery
Cable. This cable is fused, pre-wired, and properly terminated to ensure safe connection
Warnings 8
Instructions for Use | Introduction
Symbol
Definition
Symbols on the Model and Warning Label
Refer to instruction manual
Prescription device
Not made with natural rubber latex
For airline use. Complies with RTCA D0160 section 21, category M
Bluetooth symbol
This equipment includes RF transmitters.
IP22: protection against finger-sized objects tilted up to 15 degrees.
Catalog number
Batch code
Serial number
Manufacturer
Date of manufacture
Class II equipment
BF applied part
LI-ion recycling
Waste electrical & electronic equipment
Humidity limit
Temperature limit
Symbols on the Device
On/Off (Standby) button
Alarm Silence button
USB connection Nurse call connection
DC power (direct current)
AC power (alternating current)
Symbol
Definition
Oxygen inlet
Low flow oxygen inlet Flow sensor cable connection
Proximal pressure out
AEV control line
Patient in
Patient out
Symbols on the Screen - General
Prescription settings
Home screen
Options
Help
Manual breath
Deliver 100% oxygen
Delete prescription
Patient type indicators Touch screen lock
Edit
Wi-Fi Symbols on the Screen - Alarms
Alarms tab
Alarm Silence
High priority alarm

Symbols Glossary

This glossary contains the symbols on the model label and on the device exterior. Software symbol explanations appear throughout this book. For a complete explanation of symbols appearing on the device and associated labels, go to the following web address:
http://www.symbols.philips.com
and protected against dripping water when
Symbols Glossary 9
Instructions for Use | Introduction
Medium or low priority alarm
System message
Alarm reset Symbols on the Screen – Monitoring Views
See chapter 2, “About Trilogy Evo.”
Symbols on the Screen - Power
See the Power Management chapter.
Symbols on the Screen –Connectivity
Bluetooth enabled
Bluetooth connected
USB is exporting data
Symbols Glossary 10
Instructions for Use | Introduction

How to Contact Philips Respironics

If you need help setting up, using or maintaining Trilogy Evo Universal, or if this device does not perform as expected, contact Philips Respironics. Call Philips Respironics Customer Service at:
1-724-387-4000
1-800-345-6443 (toll-free)
+49 8152 93060 (international)
How to Contact Philips Respironics 11
Instructions for Use | About Trilogy Evo Universal
1. On/off (standby) button
1. Carrying handle

2. About Trilogy Evo Universal

Parts of Trilogy Evo Universal

Front Panel

2. AC power indicator
3. Alarm indicator/alarm silence
4. Alarm bar
5. Touch screen
6. Ambient light sensor

Back Panel

Parts of Trilogy Evo Universal 12
2. FiO
3. Power cord retention clip
4. Air inlet
5. Oxygen blender
6. High pressure oxygen inlet
7. Air vents
sensor access panel
2
Instructions for Use | About Trilogy Evo Universal
1. Accessory USB port
1. AC power connector

Patient Panel

(pulse oximeter, CO2 monitor)
2. Inspiratory port (to patient)
3. Proximal pressure port
4. Active exhalation valve line connection for
ActivePAP and Active Flow circuits
5. Dual limb active exhalation valve connection (from
patient)
6. Flow sensor cable connector

Utility Panel

2. Air vents
3. Low flow oxygen inlet
4. Detachable battery access door
5. Micro USB Port for device service
6. Accessory USB Port (USB external storage
device, communication cables)
7. Remote alarm or nurse call connector (RJ9)
8. DC power connector
Parts of Trilogy Evo Universal 13
Instructions for Use | About Trilogy Evo Universal

Parts of the User Interface

Standard Screen Elements

1. Menu bar
2. Main window
3. Monitored parameters pane
4. Status bar

Menu Bar

Use the menu bar to navigate, manage alarms, and see the active prescription at a glance.
1. Home: view the main window
2. Prescriptions: manage patient prescriptions
3. Options:
- Device Settings
- Calibration
- Data Transfer
- Information
- Alarm & Event Log
4. Patient type indicator
Parts of the User Interface 14
Instructions for Use | About Trilogy Evo Universal
1
Manual breath
8
Wi-Fi
2
Deliver 100% Oxygen
9
Alarm silence
3
100% Oxygen timer
10
Power sources and their status
4
CMD
11
5
USB data transfer
12 6 Bluetooth
13
Device Actions Menu
7
Bluetooth data transfer
14
System time

Main Window

The main window contents vary depending on the action you are performing. The main window can show the standby window, prescription window, monitoring window, and others.

Monitored Parameters Pane

Use the monitored parameters pane to see measured and calculated values while delivering therapy. These values vary based on the circuit, therapy mode, and accessory type.
Depending on the accessories you use, values such as SpO2 appear during active ventilation and during standby. Parameters that may appear are:
- PIP: peak inspiratory pressure
- Vte: exhaled tidal volume
- RR: respiratory rate
- MinVent: minute ventilation
- SpO
- Pulse Rate
- etCO
: saturation of peripheral oxygen
2
: end tidal carbon dioxide
2

Status Bar

Use the status bar to monitor device status and the availability of manual therapeutic actions.

Monitoring Window

During ventilation, a monitoring window, or home screen, contains information such as measured parameters and battery status. You can select the type of information you want to see.

Selecting a Monitoring View

To select a monitoring view during ventilation:
1. In the Menu Bar, tap the Home button.
2. In the monitoring window, tap the Views button
3. In the Views menu, tap the type of view you want to use.
Monitoring Window 15
Instructions for Use | About Trilogy Evo Universal
Views menu icon
Monitoring window contents
- Manometer pressure indicator
- Set parameters
Modes.”
Large manometer
- Large manometer pressure indicator
- Customizable scalar waveform graphs
Button
Description
Select the waveforms to graph. On
graphs.
Pause graphing.
Automatically size the vertical scale
Tap to change the time scale, and
the list.

Types of monitoring windows

Monitoring windows may vary based on your model.
- Set parameters
Small manometer
Measured and
calculated
parameters
Waveform graphs
- Measured and calculated parameters
- Additional parameters based on the prescription (including
accessories)
- This is the default view.
An explanation of dynamic parameters is in chapter 3, “Therapy
- Six measured and calculated parameters
To customize the graphs, use the buttons in the window as follows:
the Select Waveforms dialog box, select data for the top and bottom
to fit the data.
then select a new time scale from
Monitoring Window 16
Instructions for Use | Therapy Modes and Controls

3. Therapy Modes and Controls

Overview

Trilogy Evo Universal therapy modes can be used for invasive and noninvasive ventilation with all circuit types, including mouthpiece ventilation.

Breath Types

Trilogy Evo Universal can deliver the following breath types:
o Mandatory: Ventilator-initiated, time-cycled o Assist-Control: Patient-initiated, time-cycled o Spontaneous: Patient-initiated, patient-cycled

Triggering and Cycling

Patient triggers
Auto-Trak is a flow trigger with rules that make patient-triggering and cycling more comfortable for the patient. The system uses multiple algorithms to detect the start and end of the breath. Also, it automatically adjusts the trigger and cycle sensitivity to optimize synchronization between the patient and the ventilator.
Sensitive Auto-Trak is a more sensitive version of Auto-Trak
Flow trigger initiates a breath when the patient’s inspiratory effort creates a flow equal to or greater than the flow trigger sensitivity setting. A
lower number is more sensitive. As inspiratory flow begins to decrease, the device cycles to expiration when the patient flow is less than the percentage of peak flow, based on the flow-cycle sensitivity setting.
Ventilator trigger
Time Trigger is time-based, defined by the Breath Rate setting.
Flow patterns
Ramp wave pattern: airflow starts high and decreases throughout inspiration of the breath.
Square wave pattern: airflow is generally constant throughout inspiration of the breath.

Therapy Modes Overview

Control Modes: breaths are assist-control or mandatory.
A/C-PC: Assist control – assist-control and mandatory breaths with pressure control
A/C-VC: Assist control – assist control and mandatory breaths with volume control
Spontaneous modes: the patient initiates all breaths.
CPAP: Continuous positive airway pressure
PSV: Pressure support ventilation
Overview 17
Instructions for Use | Therapy Modes and Controls
Mode
Breath Types
Trigger Source
Inspiration
Cycle
Exhalation
Control Modes
Assist-Control
Patient
Assist-Control
Patient
Spontaneous Modes
CPAP
Spontaneous
Patient
CPAP
Patient
CPAP
Mixed Modes
Spontaneous
Patient
Patient
Pressure Support + PEEP Assist-Control
Patient
Pressure Support + PEEP Assist-Control
Patient
Mixed modes: breaths are spontaneous, assist-control, or mandatory.
S/T: Spontaneous/timed ventilation – spontaneous breaths with pressure support and mandatory breaths with pressure control
SIMV-PC: Synchronized intermittent mandatory ventilation (pressure control) – spontaneous breaths with pressure support, assist—
control breaths and mandatory breaths with pressure control
SIMV-VC: Synchronized intermittent mandatory ventilation (volume control) – spontaneous breaths with pressure support, assist—
control breaths and mandatory breaths with volume control

Low Tidal Volume Therapy

For low tidal volume therapy, use the infant/pediatric external flow sensor. See the instructions included with the sensor.
When setting volumes greater than or equal to 50ml, use any circuit type.
When setting volumes greater than or equal to 35ml, use either the active flow or dual limb circuits.
The following pressure modes are available for patients who require a tidal volume less than 35ml:
A/C-PC
PSV
S/T
SIMV-PC

Therapy Mode Comparison Table

For all modes, the breath type varies based on time of patient inspiration. The breath type is always ventilator-initiated and mandatory when the Trigger Type is set to Off.
A/C-PC
A/C-VC
PSV Spontaneous Patient Pressure Support + PEEP Patient PEEP
S/T
SIMV-PC
SIMV-VC
Mandatory
Mandatory
Mandatory
Spontaneous Patient
Mandatory
Spontaneous Patient
Mandatory
Ventilator (Breath Rate)
Ventilator (Breath Rate)
Ventilator (Breath Rate)
Ventilator (Breath Rate)
Ventilator (Breath Rate)
Pressure Control +PEEP Inspiratory
Tidal Volume
IPAP
Pressure Control + PEEP Inspiratory
Tidal Volume
Time
Inspiratory Time
Inspiratory Time
Patient PEEP
Time
Patient PEEP
Inspiratory Time
PEEP
PEEP
EPAP
PEEP
PEEP
Overview 18
Instructions for Use | Therapy Modes and Controls
Setting Name
Description
Pressure Control
Inspiratory pressure above PEEP
PEEP
Positive end expiratory pressure
Rise Time
Time required for the ventilator to change from the expiratory pressure setting to the inspiratory pressure setting when the breath is triggered.
Breath Rate
Minimum rate of breaths per minute
Inspiratory Time
Length of the inspiratory phase
Trigger Type
Auto-Trak (passive circuits only)
Off
Flow Trigger Sensitivity
This control is available when the trigger type is Flow Trigger. The flow trigger initiates when the patient’s inspiratory effort creates a flow equal to or greater than the flow trigger sensitivity setting.
Flow Cycle
This control is available when the trigger type is Flow Trigger.
device cycles to expiration.
FiO2 (optional)
Requires model with oxygen blender

Control Modes

A/C-PC: Assisted/Control-Pressure Control

DESCRIPTION:
The A/C-PC mode provides pressure-controlled mandatory or assist-control breaths. When the Trigger Type is set to Off, the ventilator triggers and cycles all breaths. When the Trigger Type is not set to Off, then the ventilator or the patient can trigger a breath, and the ventilator cycles all breaths.
SETTINGS:
Sensitive Auto-Trak (passive circuits only)
Flow Trigger (Passive, Active PAP, Active Flow, or Dual Limb circuits)
Sensitivity
SETTABLE ALARMS:
Circuit disconnect
High tidal volume
Low tidal volume
High minute ventilation
Low minute ventilation
High respiratory rate
Low respiratory rate
ILLUSTRATION
As flow begins to decrease during inspiration, if the patient flow is less than the flow cycle set point, the
1. EPAP
2. Pressure control
Control Modes 19
Instructions for Use | Therapy Modes and Controls
Setting Name
Description
Tidal Volume
Set inspiratory volume
PEEP
Positive end expiratory pressure
Inspiratory Time
Length of the inspiratory phase
Breath Rate
Minimum rate of mandatory breaths per minute
Flow Pattern
Sets the shape of the waveform as a ramp or square
Trigger Type
Auto-Trak
Off
Flow Trigger Sensitivity
This control is available when the trigger type is Flow Trigger. The flow trigger initiates when the patient’s inspiratory effort creates a flow equal to or greater than the flow trigger sensitivity setting.
Flow Cycle
This control is available when the trigger type is Flow Trigger.
device cycles to expiration.

A/C-VC: Assisted/Control-Volume Control

DESCRIPTION:
The A/C-VC mode provides volume-controlled mandatory and assist breaths. When the Trigger Type is set to Off, both triggering and cycling are performed by the ventilator. When the Trigger Type is not Off, then the trigger can be performed by the vent or patient and the cycle is always performed by the ventilator. To deliver the set volume in the set time, the ventilator alters the flow rate. The flow pattern setting defines the shape of the flow delivery pattern.
SETTINGS:
Sensitive Auto-Trak (passive circuits only)
Flow Trigger (Passive, Active PAP, Active Flow, or Dual Limb circuits)
Sensitivity
SETTABLE ALARMS:
Circuit disconnected
High tidal volume
Low tidal volume
High minute ventilation
Low minute ventilation
High respiratory rate
Low respiratory rate
High inspiratory pressure
Low inspiratory pressure
ILLUSTRATION
As flow begins to decrease during inspiration, if the patient flow is less than the flow cycle set point, the
Control Modes 20
Instructions for Use | Therapy Modes and Controls
Setting Name
Description
CPAP
Continuous positive airway pressure range
Trigger Type
Flow Trigger (Passive, Active PAP, Active Flow, or Dual Limb circuits)
Flow Trigger
This control is available when the trigger type is Flow Trigger. The flow trigger initiates when the
setting.
Flow Cycle
This control is available when the trigger type is Flow Trigger.
point, the device cycles to expiration.

Spontaneous Modes

CPAP: Continuous Positive Airway Pressure

DESCRIPTION:
In CPAP mode, the pressure delivered to the patient during both inhalation and exhalation is the CPAP pressure setting. All breaths in this mode are spontaneous breaths. The ventilator monitors inspiratory and expiratory tidal volume.
SETTINGS:
Auto-Trak
Sensitive Auto-Trak (passive circuits only)
Sensitivity
Sensitivity
SETTABLE ALARMS:
Circuit disconnected
High tidal volume
Low tidal volume
High minute ventilation
Low minute ventilation
High respiratory rate
Low respiratory rate
ILLUSTRATION
patient’s inspiratory effort creates a flow equal to or greater than the flow trigger sensitivity
As flow begins to decrease during inspiration, if the patient flow is less than the flow cycle set
Spontaneous Modes 21
Instructions for Use | Therapy Modes and Controls
Setting Name
Description
Pressure Support
Target pressure that the device delivers during the inspiratory phase of a spontaneous breath
PEEP
Positive end expiratory pressure
Rise Time
Time required for the ventilator to change from the expiratory pressure setting to the inspiratory pressure setting when the breath is triggered.
Trigger Type
Auto-Trak
Flow Trigger (Passive, Active PAP, Active Flow, or Dual Limb circuits)
Flow Trigger Sensitivity
This control is available when the trigger type is Flow Trigger. The flow trigger initiates when the patient’s inspiratory effort creates a flow equal to or greater than the flow trigger sensitivity setting.
Flow Cycle
This control is available when the trigger type is Flow Trigger
device cycles to expiration.

PSV: Pressure Support Ventilation

DESCRIPTION:
PSV mode is patient-triggered, pressure-limited, and flow-cycled. With this strategy, breaths are assisted by a set inspiratory pressure that is delivered until inspiratory flow drops below a set threshold.
In the PSV mode, the ventilator delivers spontaneous, pressure-supported, breaths and user-initiated mandatory breaths. The ventilator functions as a demand flow system, with the patient triggering breaths and determining their timing and volume. The ventilator can support the breaths with the set pressure support.
The Pressure Control setting defines the applied pressure above PEEP. The patient determines the breath timing. As in other dual limb modes, you also set PEEP, inspiratory trigger, and O2. It is recommended that you set backup ventilation in PSV mode.
SETTINGS:
Sensitive Auto-Trak (passive circuits only)
Sensitivity
SETTABLE ALARMS:
Circuit disconnected
High tidal volume
Low tidal volume
High minute ventilation
Low minute ventilation
High respiratory rate
Low respiratory rate
ILLUSTRATION:
As flow begins to decrease during inspiration, if the patient flow is less than the flow cycle set point, the
Spontaneous Modes 22
Instructions for Use | Therapy Modes and Controls
Setting Name
Description
IPAP
Inspiratory positive airway pressure Must be greater than or equal to EPAP
EPAP
Expiratory positive airway pressure
Rise Time
Time required for the ventilator to change from the expiratory pressure setting to the inspiratory pressure setting when the breath is triggered.
Breath Rate
Minimum rate of breaths per minute. If the patient doesn’t trigger a breath within this time, the ventilator triggers the breath.
Inspiratory Time
For a mandatory breath, length of the inspiratory phase
Trigger Type
Auto-Trak
Flow Trigger (Passive, Active PAP, Active Flow, or Dual Limb circuits)
Flow Trigger Sensitivity
This control is available when the trigger type is Flow Trigger. The flow trigger initiates when the patient’s inspiratory effort creates a flow equal to or greater than the flow trigger sensitivity setting.
Flow Cycle
This control is available when the trigger type is Flow Trigger
device cycles to expiration.

Mixed Modes

S/T: Spontaneous/Timed

DESCRIPTION:
A bi-level therapy mode where each breath is patient-triggered and patient-cycled or ventilator-triggered and ventilator-cycled. In this mode, an IPAP is delivered during inhalation and a lower EPAP is delivered during exhalation. The duration of a spontaneous breath is determined by the patient effort. The duration of a mandatory breath is determined by the inspiratory time setting. Remember that the IPAP setting is the maximum pressure the ventilator will deliver; it is not in addition to the EPAP setting.
SETTINGS:
Sensitive Auto-Trak (passive circuits only)
Sensitivity
As flow begins to decrease during inspiration, if the patient flow is less than the flow cycle set point, the
SETTABLE ALARMS:
Circuit disconnect
High tidal volume
Low tidal volume
High minute ventilation
Low minute ventilation
High respiratory rate
Low respiratory rate
ILLUSTRATION:
Mixed Modes 23
Instructions for Use | Therapy Modes and Controls
Setting Name
Description
Pressure Control
Defines the applied pressure for all breaths
Pressure Support
Target pressure that the device delivers during the inspiratory phase of a spontaneous breath
PEEP
Positive end expiratory pressure
pressure setting.
Inspiratory Time
For a mandatory breath, length of the inspiratory phase
Rise Time
Time required for the ventilator to change from the expiratory pressure setting to the inspiratory pressure setting when the breath is triggered.
Breath Rate
Minimum rate of mandatory breaths per minute
Trigger Type
Auto-Trak
Flow Trigger (Passive, Active PAP, Active Flow, or Dual Limb circuits)
Flow Trigger Sensitivity
This control is available when the trigger type is Flow Trigger. The flow trigger initiates when the patient’s inspiratory effort creates a flow equal to or greater than the flow trigger sensitivity setting.
Flow Cycle
This control is available when the trigger type is Flow Trigger
device cycles to expiration.

SIMV-PC: Synchronous Intermittent Mandatory Ventilation- Pressure Control

DESCRIPTION:
SIMV-PC mode is a pressure control mode that provides a mixture of mandatory and spontaneous breaths. SIMV-PC mode guarantees one mandatory breath in each cycle. Spontaneous breaths can be delivered with pressure support. The breath rate determines the length of the cycle. The first phase of the cycle is reserved for synchronizing a mandatory breath with patient effort. If the patient triggers a breath during this phase of the cycle, the ventilator delivers a synchronized mandatory breath. If a patient does not trigger a breath during the mandatory phase of the cycle, then the ventilator delivers a mandatory breath. Breaths triggered by the patient after the mandatory breath in the cycle are spontaneous breaths. This process is repeated at the start of every cycle.
SETTINGS:
Sensitivity
SETTABLE ALARMS:
Circuit disconnect
High tidal volume
Low tidal volume
High minute ventilation
Low minute ventilation
High respiratory rate
Low respiratory rate
ILLUSTRATION
Positive pressure maintained in the patient circuit during exhalation: must be less than or equal to the
Sensitive Auto-Trak (passive circuits only)
As flow begins to decrease during inspiration, if the patient flow is less than the flow cycle set point, the
Mixed Modes 24
Instructions for Use | Therapy Modes and Controls
Setting Name
Description
Tidal Volume
Target gas volume that the device delivers during a spontaneous breath
Pressure Support
Target pressure that the device delivers during the inspiratory phase of a spontaneous breath
PEEP
Positive end expiratory pressure
pressure setting.
Inspiratory Time
For a mandatory breath, length of the inspiratory phase
Rise Time
Time required for the ventilator to change from the expiratory pressure setting to the inspiratory pressure setting when the breath is triggered.
Breath Rate
Minimum rate of mandatory breaths per minute
Flow Pattern
Sets the flow-pressure waveform
Trigger Type
Auto-Trak
Flow Trigger (Passive, Active PAP, Active Flow, or Dual Limb circuits)
Flow Trigger Sensitivity
This control is available when the trigger type is Flow Trigger. The flow trigger initiates when the patient’s inspiratory effort creates a flow equal to or greater than the flow trigger sensitivity setting.
Flow Cycle
This control is available when the trigger type is Flow Trigger
device cycles to expiration.

SIMV-VC: Synchronous Intermittent Mandatory Ventilation- Volume Control

DESCRIPTION:
Similar to SIMV-PC, but with volume control.
SETTINGS:
Sensitivity
SETTABLE ALARMS:
Circuit disconnect
High tidal volume
Low tidal volume
High minute ventilation
Low minute ventilation
High respiratory rate
Low respiratory rate
High inspiratory pressure
Low inspiratory pressure
ILLUSTRATION
See SIMV-PC.
Positive pressure maintained in the patient circuit during exhalation: must be less than or equal to the
Sensitive Auto-Trak (passive circuits only)
As flow begins to decrease during inspiration, if the patient flow is less than the flow cycle set point, the

Therapy Features

The following features are available in addition to the therapy modes.

Backup Ventilation Enable

DESCRIPTION
Set the device to deliver ventilator-initiated breaths when patient-initiated breaths are not detected, based on the Apnea alarm interval. When you turn Backup Ventilation on, set an Apnea interval in the alarm settings tab. Within the apnea interval; if no breaths are triggered by the patient, the ventilator delivers breaths at the set pressure or volume based on the Backup Rate. When an Apnea alarm occurs, the ventilator automatically starts backup ventilation. When two consecutive patient-initiated breaths are detected, the ventilator automatically reverts to patient-initiated breaths.
Backup ventilation settings take precedence over standard therapy mode settings.
Therapy Features 25
Instructions for Use | Therapy Modes and Controls
SETTINGS:
Backup Ventilation (On/Off): when you turn this setting On, set an Apnea interval in the alarm settings tab.
Backup Rate: when in backup ventilation, the backup breath rate takes precedence over any breath rate set in the therapy mode. The rate cannot be less
than the Breath Rate set in the current therapy mode.
Backup Inspiration Time (CPAP and PSV modes only) when in backup ventilation the Back Up Tinsp controls the duration of inspiration.
Backup PS (CPAP mode only)
Backup Rise Time (CPAP mode only)
To access the Backup Ventilation feature, in the Prescription window, tap Advanced. When you turn the feature on, the additional settings appear in the prescription window.
If Trigger Type is Off, this feature is unavailable.
APPLICABLE THERAPY MODES
A/C-PC
A/C-VC
CPAP
PSV
S/T
SIMV-PC
SIMV-VC

Insp Time Min/Max Enable

DESCRIPTION
Set the minimum and maximum inspiratory time for pressure support breath types. This feature changes inspiration time from a constant to a variable value so you can select a range for the inspiration time.
The range allows the patient to have a chance to cycle. When the maximum time has passed with no patient-initiated breath, then the ventilator automatically cycles the breath.
To access this feature, in the Prescription window, tap Advanced. When you turn the feature on, the additional settings appear in the prescription window.
APPLICABLE THERAPY MODES
PSV
S/T
SIMV-PC
SIMV-VC

Sigh Enable

DESCRIPTION
Delivers a periodic, larger volume breath.
SETTINGS:
Sigh (On/Off)
Sigh Volume
Sigh Frequency (deliver a sigh after X number of patient- or ventilator- triggered breaths)
To access the Sigh feature, in the Prescription window, tap Advanced. When you turn the feature on, the additional settings appear in the prescription window.
APPLICABLE THERAPY MODE
A/C-VC
Therapy Features 26
Instructions for Use | Therapy Modes and Controls
To start an oxygen flush:
To deliver a manual breath:
Setting Name
Setting Range/Increment
Adult patient type:
Increments: 1 cmH
2
O
Pediatric patient type:
Increments: 1 cmH
2
O
Infant patient type:

Therapy Actions

Oxygen Flush

DESCRIPTION
This feature requires the oxygen blender. When active, the device delivers 100% oxygen for two minutes. This feature functions independent of any oxygen blending setting. During an oxygen flush, the High FiO2 alarm is disabled.
WORKING WITH OXYGEN FLUSH
Tap 100% O2 in the status bar and then tap Start. A timer appears that counts down the two minutes.
To stop an oxygen flush:
Tap 100% O2 in the status bar and then tap Stop.
APPLICABLE THERAPY MODES
All

Manual Breath

DESCRIPTION
Delivers a breath based on the current therapy mode settings.
Tap the Manual Breath button in the status bar and then tap Start.
APPLICABLE THERAPY MODES
A/C-PC
A/C-VC
PSV
S/T
SIMV-PC
SIMV-VC

Therapy Control Settings

Therapy control settings can be interdependent. For guidance, see the previous therapy mode descriptions.
Backup Pressure Support
Therapy Control Settings 27
All circuits but passive: 0-60 cmH
Passive circuit: 0-57 cmH
All circuits: 0-30 cmH
O
2
O
2
O
2
Instructions for Use | Therapy Modes and Controls
Setting Name
Setting Range/Increment
All circuits: 0-20 cmH
O
Increments: 1 cmH
2
O
Adult patient type: 0-80 BPM, 1BPM increments
Infant patient type: 0-40 BPM, 1 BPM increments
Adult and pediatric patient types: 3-25 cmH2O, 1 cm H2O increments Infant patient type: 3-15 cmH2O, 1 cm H2O increments
Adult and pediatric patient types: 3-25 cmH2O, 1 cm H2O increments Infant patient type: 3-15 cmH2O, 1 cm H2O increments
21-100%, 1% increments (21% = ambient condition, no control)
Flow Cycle Sensitivity
10-90%, 1% increments
Square: airflow is constant Ramp: inspiration airflow starts high and decreases
Flow Trigger Sensitivity
0.5 (high sensitivity) to 9 L/min (low sensitivity)
Adult patient type: 0.5-5.0 seconds, 0.1 second increments
Pediatric patient type: 0.3-2.0 seconds, 0.1 second increments
Infant patient type: 0.3-1.0 seconds, 0.1 second increments
Adult patient type: 3-60 cmH2O, 1 cmH2O increments
Pediatric patient type: 3-45 cmH2O, 1 cmH2O increments
Infant patient type: 3-35 cmH2O, 1 cmH2O increments
Max Pressure
6-60 cmH
2
O, 1 cmH2O increments
Adult patient type:
Increments: 1 cmH
2
O
Pediatric patient type:
Increments: 1 cmH
2
O
Infant patient type:
Increments: 1 cmH
2
O
Adult patient type:
Increments: 1 cmH
2
O
Pediatric patient type:
Increments: 1 cmH
O
Infant patient type:
Increments: 1 cmH
O
Adult patient type:
Increments: 1 cmH
2
O
Pediatric patient type:
Increments: 1 cmH
2
O
Infant patient type:
Increments: 1 cmH
2
O
All circuits but passive: 0-60 cmH
O
Increments: 1 cmH
2
O
Rise Time
0 (faster) to 6 (slower)
Adult patient type:
Increment: 5 ml
2
Breath Rate
CPAP
EPAP Min/Max
FiO2
Flow Pattern
Inspiratory Time
IPAP
PEEP
Pediatric patient type: 0-60 BPM, 1BPM increments
Active circuit: 0-35 cmH
Passive circuit: 3-25 cmH
O
2
O
2
Active circuit: 0-25 cmH
Passive circuit: 3-25 cmH
O
2
O
2
Pressure Control
Pressure Support
PS Min/Max
Active circuit: 0-15 cmH
Passive circuit: 3-15 cmH
O
2
O
2
All circuits but passive: 0-60 cmH
Passive circuit: 0-57 cmH
All circuits: 0-30 cmH
All circuits: 0-20 cmH
O
2
O
2
2
O
2
2
All circuits but passive: 0-60 cmH
Passive circuit: 0-57 cmH
O
2
All circuits: 0-30 cmH
O
2
All circuits: 0-20 cmH
O
2
Passive circuit: 0-57 cmH
O
2
O
2
O
2
2
Tidal Volume
70-1200 ml
Therapy Control Settings 28
Instructions for Use | Therapy Modes and Controls
Setting Name
Setting Range/Increment
Auto-Trak (passive circuits only)
Off
Pediatric patient type: Dual limb or active flow: 35-400 ml Passive or Active PAP: 50-400 ml Increment: 5 ml
Trigger Type
Sensitive Auto-Trak (passive circuits only)
Flow Trigger (all circuits)

Dynamic Therapy Parameters

It is unnecessary to perform an inspiratory hold to assess the plateau pressure and other lung parameters. The advanced measurement system of Trilogy Evo estimates lung compliance, airway resistance, AutoPEEP and plateau pressure during normal mechanical ventilation without requiring a static maneuver.

Dyn R

Airway resistance is the opposition to the motion of gas within the airways. In the Measured and Calculated Parameters window, this value is Dyn R
(dynamic resistance), so named because it is estimated without requiring a static maneuver.
At the end of inhalation, Trilogy Evo estimates the airway resistance by computing the ratio between the driving pressure from within the lung to the air flow. The flow term is corrected to take into account the contributions of the following:
Intrinsic PEEP, by subtracting the expiratory flow at the end of exhalation
The elastic recoil of the lungs, by adding the tidal volume divided by the respiratory time constant, τ.
(Respiratory time constant is the airway resistance times the summed compliance of the lung and chest wall)
Trilogy Evo calculates Dyn R using the following formula:
  =
Where:
PIP is the peak inspiratory pressure (pressure at the end of inhalation)

is the extrinsic pressure (pressure applied by the ventilator) at the end of the breath
is the tidal volume
(
= ) is the patient flow at the end of the exhalation (EOE)
(
= ) is the patient flow at the end of inhalation(EOI)
To understand the calculations adopted to compute Dyn R, note that the above equation can be rewritten as the classic equation for airway resistance:
 −( +  + /  )=   ∗ 
That is to say, pressure across the resistance equal to resistance times flow, where:

 + 
= − ∗ () this value is the intrinsic PEEP or AutoPEEP (see the section, “AutoPEEP” below)
is the total pressure (extrinsic plus intrinsic) at the end of the breath
 − 
(
= )− 
(
= )+
()

Dyn C

Lung Compliance is the ratio between the tidal volume and the changes in pressure. In the Measured and Calculated Parameters window, this value is Dyn C (dynamic compliance), so named because it is estimated without requiring a static maneuver.
Trilogy Evo estimates the integrated compliance of the pulmonary system, (the summed compliance of the lung and chest wall). The compliance of the respiratory system can be derived from the measurement of plateau pressure, the difference between the Trilogy Evo calculates Dyn C using the following formula:
Dynamic Therapy Parameters 29
and PEEP.

, using the relationship between the tidal volume, , and

Instructions for Use | Therapy Modes and Controls
  =

− 
Where:
PEEP is the total pressure (intrinsic plus extrinsic) at the start of the breath ( = 
is the tidal volume
+ )
Note that the compliance is related to the airway resistance by the respiratory time constant, τ, by the relationship described above.
  =
 

Dyn Pplat

Plateau pressure is the pressure applied to small airways and alveoli during positive-pressure mechanical ventilation. In the Measured and Calculated Parameters window, this value is Dyn Pplat. Having already estimated the compliance (Dyn R and Dyn C above), Trilogy Evo calculates Dyn Pplat as follows:

=
+  + 
 
Where:
is the tidal volume
  is dynamic compliance
PEEP is the total pressure (intrinsic plus extrinsic) at the start of the breath ( = 

= − ∗ () this value is the intrinsic PEEP or AutoPEEP
+ 

AutoPEEP

Intrinsic PEEP, , is the resistive pressure at the end of exhalation (EOE), that occurs when a new breath is initiated before the previous breath is completed. In the Measured and Calculated Parameters window, this value is AutoPEEP. AutoPEEP can be used as a guide to detect the presence of dynamic hyperinflation. In most cases, this number represents the pressure in the small airways at the start of the breath in excess of the PEEP applied by the ventilator. In some cases, such as a ventilated, complex, COPD patient, the displayed pressure may not be accurate. However, in these complex cases, any non-zero pressure displayed (accurate or not) indicates the presence of AutoPEEP. When Auto PEEP is zero, this indicates that there is no intrinsic PEEP.
Trilogy Evo calculates AutoPEEP using the following formula:
(
= )
Where:
Dyn R is the dynamic resistance (explained in a previous section, “Dyn R” above)
= −  ∗ 
(
= ) is the patient flow at the end of the exhalation (EOE)
Dynamic Therapy Parameters 30
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