PHILIPS Respironics Trilogy 100 Instructions for use

CLINICAL MANUAL
CLINICAL MANUAL
REF 1066819
1072847 R01
JJB 03/10/2011

Table of Contents
i
FOR CLINICIAN’S USE ONLY Accessing Prescription Setting Screens .................................................. i
Chapter 1. Introduction....................................................................................................................................... 1
Package Contents.................................................................................................................1
Intended Use..........................................................................................................................2
Warnings and Cautions ......................................................................................................3
Warnings.........................................................................................................................3
Cautions ..........................................................................................................................8
Notes ..............................................................................................................................10
Contraindications...............................................................................................................11
System Overview................................................................................................................11
Symbols..................................................................................................................................12
Front Panel ...................................................................................................................12
Rear and Side Panels.................................................................................................12
How to Contact Philips Respironics.............................................................................13
Chapter 2. System Description........................................................................................................................15
Front Panel Features..........................................................................................................15
Buttons ..........................................................................................................................15
Visual Indicators .........................................................................................................16
Display Screen.............................................................................................................16
Side and Rear Panel Features .........................................................................................17
Trilogy100
clinical manual
Table of Contents

Trilogy100 clinical manual
ii
Chapter 3. Modes, Features, and Alarms......................................................................................................19
Therapy Modes....................................................................................................................19
Breath Types.................................................................................................................20
Therapy Mode Table .................................................................................................21
Pressure Control Ventilation Therapy Modes...................................................22
Volume Control Ventilation Therapy Modes....................................................27
Therapy Mode Features...................................................................................................30
Flex Comfort Feature................................................................................................30
Ramp ..............................................................................................................................31
Rise Time .......................................................................................................................32
AVAPS Feature.............................................................................................................32
Flow Pattern Types ....................................................................................................33
Sigh Feature.................................................................................................................35
Dual Prescription Feature .......................................................................................35
Triggering ....................................................................................................................36
BTPS Compensation..................................................................................................36
Ventilator Alarms ................................................................................................................37
Loss of Power Alarm..................................................................................................37
Ventilator Inoperative Alarm .................................................................................37
Ventilator Service Required Alarm.......................................................................37
Check Circuit Alarm ..................................................................................................37
Low Circuit Leak Alarm ...........................................................................................38
High Expiratory Pressure Alarm ...........................................................................38
Low Expiratory Pressure Alarm ............................................................................38
High Internal Oxygen Alarm..................................................................................38
Circuit Disconnect Alarm ........................................................................................38

Table of Contents
iii
Apnea Alarm ...............................................................................................................39
High Vte Alarm............................................................................................................39
Low Vte Alarm ............................................................................................................39
High Vti Alarm.............................................................................................................39
Low Vti Alarm .............................................................................................................40
High Respiratory Rate Alarm .................................................................................40
Low Respiratory Rate Alarm ..................................................................................40
High Inspiratory Pressure Alarm ..........................................................................40
Low Inspiratory Pressure Alarm ...........................................................................41
High Minute Ventilation Alarm ............................................................................41
Low Minute Ventilation Alarm ..............................................................................41
Low Battery Alarm .....................................................................................................42
High Temperature Alarm .......................................................................................42
Replace Detachable Battery Alarm......................................................................42
AC Power Disconnected Alarm.............................................................................43
Keypad Stuck Alarm .................................................................................................43
Battery Discharging Stopped due to Temperature Info Message............43
Battery Not Charging due to Temperature Info Message ..........................43
Battery Not Charging Info Message....................................................................43
Check External Battery Info Message .................................................................44
Battery Depleted Info Message ...........................................................................44
External Battery Disconnected Info Message..................................................44
Detachable Battery Disconnected Info Message...........................................44
Start On Battery Info Message ..............................................................................44
Card Error Info Message .........................................................................................44

Trilogy100 clinical manual
iv
Chapter 4. Ventilator Setup...............................................................................................................................45
Position the Device............................................................................................................46
Install the Air Filter .............................................................................................................46
First Time Use.......................................................................................................................46
Supply Power to the Device............................................................................................47
Using AC Power ..........................................................................................................47
Using DC Power..........................................................................................................48
Device Power Source Indicators...........................................................................50
Battery Disposal..........................................................................................................52
Connect the Breathing Circuit to the Ventilator .....................................................53
Changing the Exhalation Porting Blocks ...................................................................55
Connect Supplemental Oxygen (Optional) ..............................................................57
Chapter 5. Viewing and Changing Settings................................................................................................59
Keypad Lock Feature.........................................................................................................59
Accessing the Startup and Monitor Screens ............................................................60
Monitor Screen Indicators ......................................................................................62
On-Screen Button Panel ..........................................................................................67
Navigating the Menu Screens........................................................................................67
Changing and Viewing Settings in Full Menu Access Mode...............................68
Changing the Device Settings and Alarms.......................................................69
Viewing and Changing Options Menu Items ..................................................79
Viewing the Alarm Log ............................................................................................82
Viewing the Event Log .............................................................................................83
Viewing Device Information..................................................................................83
Updating Prescriptions Using the SD Card ...............................................................84
Changing and Viewing Settings in Limited Menu Access Mode.......................87

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v
Activating Your Primary or Secondary Prescription ......................................88
Viewing and Changing My Settings Menu Items...........................................89
Connecting the Ventilator to the Patient...................................................................91
Chapter 6. Ventilator Alarms ............................................................................................................................93
Audible and Visual Alarm Indicators............................................................................94
Alarm LED Indicators ................................................................................................94
Audible Indicators .....................................................................................................95
Alarm Messages .........................................................................................................96
Remote Alarm .............................................................................................................98
Audio Pause and Alarm Reset Features......................................................................99
Audio Pause .................................................................................................................99
Alarm Reset..................................................................................................................99
Alarm Volume Control...........................................................................................100
What to Do When An Alarm Occurs.......................................................................... 100
Alarm Summary Table....................................................................................................101
Chapter 7. Cleaning and Maintenance.......................................................................................................115
Cleaning the Ventilator.................................................................................................. 115
Cleaning and Replacing the Air Inlet Filter.............................................................116
Replacing the Air Inlet Path Foam.............................................................................117
Cleaning the Patient Circuit......................................................................................... 118
Reusable Circuit Cleaning Instructions ..........................................................118
Cleaning the Reusable Exhalation Devices...........................................119
Replacing the Bacteria Filter (Optional).................................................119
Preventive Maintenance ...............................................................................................120
Chapter 8. Troubleshooting............................................................................................................................123

Trilogy100 clinical manual
vi
Chapter 9. Accessories......................................................................................................................................127
Adding a Humidier.......................................................................................................127
Adding Supplemental Oxygen to the Device....................................................... 127
Supplemental Oxygen Warnings...............................................................................128
Using a Remote Alarm Unit..........................................................................................128
Using a Nurse Call System............................................................................................129
Using a Secure Digital (SD) Card ................................................................................129
Using the Philips Respironics DirectView Software ............................................130
Using the Optional In-Use Bag ...................................................................................130
Connect a Water Trap.....................................................................................................130
Using an Oximetry Module (When Available)....................................................... 131
Traveling with the System............................................................................................131
Airline Travel...................................................................................................................... 131
Chapter 10. System Checkout Procedures................................................................................................133
Tools Required..................................................................................................................133
Visual Inspection..............................................................................................................133
Initial Setup........................................................................................................................134
Settings and Alarms Tests............................................................................................. 134
Battery Function Verication.......................................................................................142
Alarm and Event Log Clean-Up ..................................................................................143
Results .................................................................................................................................144
Chapter 11. Technical Specications...........................................................................................................145
Chapter 12. Glossary .........................................................................................................................................149
Chapter 13. EMC Information ........................................................................................................................155
Index ........................................................................................................................................................................159
Limited Warranty .................................................................................................................................................163

Chapter 1 Introduction
1
This chapter provides an overview of the Trilogy100 device.
Package Contents
The Trilogy100 system may include the following components.
Clinical Manual
AC Power Cord
Flexible Tubing
Exhalation Porting Blocks
Reusable Gray Foam Filters
Secure Digital
(SD) Card
(pre-installed)
Detachable
Battery
O2Inlet
Quick Connects
(pre-installed)
Trilogy 100
Carrying Case
Whisper Swivel II
Clinical Manual
AC Power Cord
Flexible Tubing
Reusable Gray Foam Filters
Secure Digital
(SD) Card
(pre-installed)
O2Inlet
Quick Connects
Active Exhalation
Device (AED)
(pre-installed)
Exhalation Valve
Line (pre-assembled
to AED)
Trilogy200
Carrying Case
Proximal
Pressure Line
(pre-assembled
to AED)
Whisper Swivel II
Disposable Active Circuit, No Water Trap
Disposable Passive Circuit, NoWater Trap
Package Contents
Trilogy100
clinical manual
1. Introduction

Trilogy100 clinical manual
2
Intended Use
The Philips Respironics Trilogy100 system provides continuous
or intermittent ventilatory support for the care of individuals who
require mechanical ventilation. Trilogy100 is intended for pediatric
through adult patients weighing at least 5 kg (11 lbs.).
The device is intended to be used in home, institution/hospital, and
portable applications such as wheelchairs and gurneys, and may be
used for both invasive and non-invasive ventilation. It is not intended
to be used as a transport ventilator.
The system is recommended to be used only with various
combinations of Philips Respironics-approved patient circuit
accessories, such as patient interface devices, humidiers, water
traps, and circuit tubing.

Chapter 1 Introduction
3
Warnings and Cautions
Caution: U.S. federal law restricts this device to sale by or on the order of a physician.
Warnings
A warning indicates the possibility of injury to the user or operator.
Patient Monitoring Prior to placing a patient on the ventilator, a clinical assessment should
be performed to determine:
•The device alarm settings
•Needed alternative ventilation equipment
•If an alternative monitor (i.e. an alarming Pulse Oximeter or
Respiratory Monitor) should be used
Alternative
Ventilation
For ventilator dependent patients, always have alternate ventilation
equipment, such as a back-up ventilator, manual resuscitator, or similar
device, available.
Ventilator dependant patients should be continuously monitored by
qualied personnel. These personnel should be prepared to provide
alternate therapy in the event of ventilator failure or inoperative
equipment.
Patient Disconnect
Protection
For ventilator dependent patients, do not rely on any single alarm
to detect a circuit disconnect condition. The Low Tidal Volume, Low
Minute Ventilation, Low Respiratory Rate, and Apnea alarms should
be used in conjunction with the Circuit Disconnect and Low Peak
Inspiratory Pressure alarms.
Test the operation of the circuit disconnect function daily and
whenever a change is made to the patient circuit. An increase in circuit
resistance can prevent proper operation of some alarms.
Speaking valves, Heat Moisture Exchangers (HMEs), and lters create
additional circuit resistance and may aect 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.

Trilogy100 clinical manual
4
Personnel
Qualications
Trilogy100 is a restricted medical device designed for use by
Respiratory Therapists or other trained and qualied caregivers under
the supervision of a physician.
The prescription and other device settings should only be changed on
the order of the supervising physician.
The operator of the ventilator is responsible to read and understand
this manual before use.
Modes of
Ventilation
The device can provide therapies typically associated with both
ventilator dependant and non-dependant patients. The mode of
ventilation, circuit type, and alarm strategies should be chosen after a
clinical evaluation of each patient’s needs.
C-Flex, Bi-Flex, and AVAPS are intended for use by adult patients.
SD Card
Prescription
Changes
When you change the device prescription, alarms, and other settings
using the SD card, Trilogy100 requires that the caregiver review and
verify the changes prior to the changes being used by the device. The
caregiver or health care professional is responsible to ensure that the
prescription settings are correct and compatible with the patient after
using this feature. Installing the wrong prescription for a particular
patient may result in improper therapy, lack of appropriate safety
monitoring, and risk of death or injury to the patient.
Electrical
Interference
This device is intended for use in the electromagnetic environment
specied in Chapter 13 of this manual. The user of this device should
make sure it is used in a compatible environment.
Portable and mobile RF communications equipment should be
used no closer to any part of the device, including cables, than the
recommended separation distance calculated using the information
provided in Chapter 13 of this manual.
Battery Back-up
Power
The internal battery is NOT intended to serve as a primary power
source. It should only be used when other sources are not available or
briey when necessary; for example, when changing power sources.
The ventilator has a two-stage low battery alarm. The medium priority
alarm indicates that approximately 20 minutes of operation remain,
and the high priority alarm indicates that less than 10 minutes of
operation remain. Actual run time may be more or less than this and
varies with battery age, environmental conditions, and therapy.
Immediately seek an alternate power source when the“Low Battery”
alarm appears. Complete power failure and loss of therapy is imminent.

Chapter 1 Introduction
5
Operating
and Storage
Temperatures
Do not use this device if the ambient temperature is warmer than
40˚ C (104˚ F). If the device is used at room temperatures warmer than
40˚ C, the temperature of the airow may exceed 43˚ C (109˚ F). This
could cause system alarms, thermal irritation, or injury to the patient’s
airway.
Bacteria Filter Philips Respironics recommends that a main line outlet bacteria lter
(Part Number 342077) be used whenever the device is used for invasive
therapy or if the ventilator may be used on multiple patients.
Patient Circuits
(General)
The ventilator should only be used with patient interfaces (e.g., masks,
circuits and exhalation ports) recommended by Philips Respironics.
Proper operation of the device, including alarms, with other circuits has
not been veried by Philips Respironics and is the responsibility of the
health care professional or respiratory therapist.
When adding any components to the breathing system, the ow
resistance and dead space of the added components such as
humidiers, speaking valves, Heat Moisture Exchangers (HMEs) and
lters should be carefully considered in relation to the potential for
adverse eects on the patient’s ventilatory management and device
alarms.
Passive Circuits An exhalation port is required when using a passive circuit.
For the passive circuit, at low expiratory pressures, the ow through
the exhalation port may be inadequate to clear all exhaled gas from
the tubing – some rebreathing may occur.Rebreathing of exhaled air
for longer than several minutes can in some circumstances lead to
suocation.
Active Circuits Only use the active exhalation device designed for Trilogy100. Philips
Respironics has not veried proper operation of other active exhalation
devices, and their use may result in improper or unsafe device
operation.
With the active patient circuit, the exhalation device must be operating
properly for the ventilator to deliver therapy. The exhalation device
should be inspected on a daily basis and replaced whenever necessary.

Trilogy100 clinical manual
6
System Checkout Do not use the ventilator on a patient until a system checkout has been
performed. See Chapter 10 of this manual.
To make sure the device is operating properly at start-up, always verify
that the audible tone sounds and the alarm LEDs light red and then
yellow momentarily. Contact Philips Respironics or an authorized
service center for service if these indications do not occur at start-up.
Remote Alarms When using a remote alarm, make sure you fully test the remote alarm
connector and cable by verifying that:
–Annunciated alarms on the ventilator are also
annunciated on the remote alarm.
–Disconnecting the remote alarm cable from the
ventilator or from the remote alarm results in an alarm
notication at the remote alarm.
The remote alarm should be tested daily.

Chapter 1 Introduction
7
Oxygen When administering xed-ow supplemental oxygen, the oxygen
concentration may not be constant. The inspired oxygen concentration
will vary, depending on the pressures, patient ows and circuit leak.
Substantial leaks may reduce the inspired oxygen concentration to less
than the expected value. Appropriate patient monitoring should be
used, as medically indicated, such as an alarming pulse oximeter.
This device DOES NOT alarm for loss of the low ow oxygen supply.
This device is intended to be connected to a low ow (0-15 l/min)
oxygen source such as an oxygen concentrator or other oxygen source
equipped with a pressure regulator (set to 50 PSI or less) and a ow
regulator/meter.
Do not connect the device to an unregulated or high pressure oxygen
source.
The device may result in incorrect ow and tidal volume measurements
and improper operation of related alarms if you add low ow oxygen
directly into the patient circuit or mask instead of using the oxygen
inlet on the back of the ventilator.
Oxygen supports combustion. Oxygen should not be used while
smoking or in the presence of an open ame.
If oxygen is used with the device, the oxygen ow must be turned
o when the device is not in use. Explanation of the Warning:
When the device is not in operation and the oxygen ow is left on,
oxygen delivered into the tubing may accumulate within the device’s
enclosure.
Fire or Explosion The ventilator should not be operated in the presence of ammable
gasses. This could cause a re or explosion.

Trilogy100 clinical manual
8
Alarms Respond immediately to any alarm. It may indicate a potentially
life-threatening condition. Refer to the Alarms and Troubleshooting
chapters for more information.
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 Internal Battery” message appears,
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.
If the “Ventilator Inoperable”alarm occurs, immediately place the
patient on an alternate source of ventilation.
You should not rely on any single alarm to detect a circuit disconnect
condition. The Low Tidal Volume, Low Minute Ventilation, Low
Respiratory Rate, and Apnea alarms should be used in conjunction with
the Circuit Disconnect alarm.
Make sure the alarm volume is set loud enough to be heard by the
caregiver. Consider the use of a remote alarm.
Trilogy100 oers the following circuit types:
•Passive
•Active PAP
The Passive circuit type provides an ESTIMATE of Vte.
The Active PAP circuit type DOES NOT measure Vte and only provides
for an indication of the delivered tidal volume (Vti).
Improperly
Functioning
Ventilator
If you notice any unexplained changes in the performance of the
device, if it is making unusual sounds, if the device or detachable
battery are dropped, if water is spilled into the enclosure, or if the
enclosure is cracked or broken, discontinue use and contact Philips
Respironics or an authorized service center for service.

Chapter 1 Introduction
9
Maintenance Follow the service recommendations provided in chapter 7 of this
manual.
Periodically inspect electrical cords, cables, and the detachable battery
pack for damage or signs of wear. Discontinue use and replace if
damaged.
Repairs and adjustments must be performed by Philips Respironics-
authorized service personnel only. Unauthorized service could cause
death or injury, invalidate the warranty, or result in costly device
damage.
Cleaning
(Refer to Chapter 7
for detailed cleaning
instructions.)
To avoid electrical shock, always unplug the power cord from the wall
outlet before cleaning the ventilator.
Do not immerse the device in any uids or spray the device with water
or cleaners. Clean the device with a cloth dampened with an approved
cleaner.
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.
Cautions
A caution indicates the possibility of damage to the device.
Storage The internal and detachable batteries will self-discharge in storage.
If it is desired to keep the batteries fully charged (for example, as
a back-up ventilator), plug the device into AC power for about
eight hours every 16 days. Alternatively, the ventilator may be left
continuously connected to AC power without battery degradation.
Allowing the batteries to fully discharge will not harm the batteries or
lose device settings, but may require a longer battery charge time prior
to use.

Trilogy100 clinical manual
10
Operating
and Storage
Temperatures
The device may only be operated at temperatures between 5˚ C and
40˚ C (41˚ F and 104˚ F).
Do not operate the device in direct sunlight or near a heating
appliance because these conditions can increase the temperature of
the airow delivered to the patient.
Prolonged operation or storage at elevated temperatures may reduce
the service life of the battery and other internal components of the
ventilator.
The ventilator has an internal and detachable Lithium-Ion Battery. Do
not expose the device or detachable battery to temperatures above
40˚ C (104˚ F) during use, or above 60˚ C (140˚ F) during storage. This
will reduce battery life and may increase the risk of re or damage the
battery.
Condensation Condensation may aect operation or accuracy of the device. If the
device has been exposed to either very hot or very cold temperatures
during storage, allow it to adjust to ambient temperature before
starting therapy.
Air Filter The reusable foam inlet lter is required to protect the ventilator from
dirt and dust. Wash periodically and replace when damaged for proper
operation.
Cooling Air Vents Do not block the cooling air vents located on the base and the rear
of the device. This may cause the device to overheat in high ambient
temperatures or at high therapy settings.
Battery Life The internal and detachable batteries wear out based on the amount
of use (hours or full charge-discharge cycles). The battery capacity and
life are also reduced by operation at higher temperatures.
Detachable Battery Only use the Philips Respironics Trilogy Detachable Battery with the
ventilator.

Chapter 1 Introduction
11
Cleaning Do not steam autoclave the ventilator. Doing so will destroy the
ventilator.
Do not immerse the device in liquid or allow any liquid to enter the
enclosure or inlet lter.
Do not spray water or any other solutions directly onto the ventilator.
Do not use harsh detergents, abrasive cleaners, or brushes to clean the
ventilator system. Use only cleaning agents and methods listed in this
manual.
Patient Circuit Exhalation valves, patient circuits, and water traps are shipped clean,
not sterile. Cleaning and disinfection of these parts should follow
individual institution processes and conform to guidelines provided by
Philips Respironics with each accessory.
External DC Power Do not use the same external battery to operate both the ventilator
and any other equipment such as power chairs.
An external battery should only be connected to the ventilator using
the Philips Respironics Trilogy External Battery Cable. This cable is
fused, pre-wired, and properly terminated to ensure safe connection
to a standard deep-cycle, lead acid battery. Use of any other adapter or
cable may cause improper operation of the ventilator.
The ventilator should only be connected to an automotive electrical
system using the Philips Respironics Trilogy Automotive Adapter
(when available). This adapter is fused, ltered, and designed for safe
connection to a standard automotive electrical system. Use of any
other adapter or cable may cause improper operation of the ventilator.
Do not operate the ventilator from a car electrical system when
starting the vehicle or jump-starting the vehicle. Electrical transients
during starting may cause improper operation of the ventilator.
Electrostatic
Discharge (ESD)
Do not use antistatic or conductive hoses or conductive patient tubing
with the device.
Notes
•This product does not contain natural latex rubber or dry
natural rubber in patient or operator accessible areas or
in the air path or breathing circuit.

Trilogy100 clinical manual
12
Contraindications
If the patient has any of the following conditions, consult their health
care professional before using the device in a non-invasive mode:
•Inability to maintain a patent airway or adequately clear
secretions
•At risk for aspiration of gastric contents
•Diagnosed with acute sinusitis or otitis media
•Epistaxis, causing pulmonary aspiration of blood
•Hypotension
System Overview
This ventilator provides both pressure control and volume modes of
therapy. The device can provide non-invasive or invasive ventilation.
It can be used to provide total therapy to patients as they progress
from non-invasive to invasive ventilation.
When prescribed, the device provides numerous special features to
help make patient therapy more comfortable. For example, the ramp
function allows you to lower the pressure when trying to fall asleep.
The air pressure will gradually increase until the prescription pressure
is reached. Additionally, the Flex comfort feature provides increased
pressure relief during the expiratory phase of breathing.
The ventilator can be operated using several dierent power
sources, including an internal Lithium-Ion battery. This battery is
automatically used when the detachable Lithium-Ion battery pack,
external Lead Acid battery, or AC power are not available.

Chapter 1 Introduction
13
Symbols
The following symbols appear on the device.
Front Panel
Symbol Description
Therapy Start/Stop
Alarm Indicator/Audio Pause
~
AC Power Indicator
Rear and Side Panels
Symbol Description
~
AC Power Connector
Secure Digital (SD) Card Slot
Serial Port Connector
Remote Alarm Connector
DC Power Connector
O2
Oxygen Inlet
Consult accompanying instructions for use.
Type BF Applied Part
Class II (Double Insulated)