PHILIPS Respironics OmniLab Advanced + Instructions for use

OmniLab Advanced +
Clinical Manual

© 2013 Koninklijke Philips Electronics N.V. All rights reserved.

Table of Contents
Section 1: Introduction..........................................................................................................................................................1
1.1 Package Contents........................................................................................................................1
1.2 Intended Use ................................................................................................................................1
1.3 Warnings and Cautions..............................................................................................................2
1.4 Contraindications........................................................................................................................ 5
1.5 Patient Precautions .....................................................................................................................5
1.6 System Overview ........................................................................................................................6
1.7 Symbols.......................................................................................................................................... 8
1.8 How to Contact Philips Respironics....................................................................................... 9
Section 2: Therapy Modes and Features.........................................................................................................................10
2.1 Device Therapy Modes............................................................................................................10
2.2 Therapy Features.......................................................................................................................11
2.3 Therapy Event Detection ........................................................................................................14
Section 3: Device Setup ......................................................................................................................................................15
3.1 Installing the Air Filter..............................................................................................................15
3.2 Where to Place the Device ....................................................................................................15
3.3 Connecting the Breathing Circuit..........................................................................................15
3.4 Supplying Power to the Device..............................................................................................16
3.5 Lab Setup.....................................................................................................................................17
Section 4: Viewing and Changing Settings.......................................................................................................................18
4.1 Navigating the Menu Screens .................................................................................................18
4.2 Using the Keypad Lock Feature.............................................................................................18
4.3 Accessing the Standby Screen ................................................................................................18
4.4 Accessing the Setup Screen ....................................................................................................19
4.5 Accessing the Monitor Screen ...............................................................................................19
4.6 Changing Settings in Provider Menu Access Mode ...........................................................20
4.7 Display Symbols .........................................................................................................................29

Section 5: Device Alarms....................................................................................................................................................30
5.1 Audible and Visual Alarm Indicators.....................................................................................30
5.2 Silencing an Alarm .....................................................................................................................31
5.3 Resetting an Alarm....................................................................................................................31
5.4 Alarm Descriptions...................................................................................................................31
5.5 What to Do When An Alarm Occurs .................................................................................33
5.6 Alarm Summary Table..............................................................................................................33
5.7 Verifying the Alarms ..................................................................................................................36
Section 6: Cleaning and Maintenance...............................................................................................................................37
6.1 Cleaning the Device..................................................................................................................37
6.2 Cleaning and Replacing the Air Inlet Filter..........................................................................37
6.3 Cleaning the Reusable Tubing ................................................................................................37
6.4 Cleaning for Multiple Patient Use..........................................................................................37
6.5 Service..........................................................................................................................................38
6.6 Verifying the Pressure...............................................................................................................38
Section 7: Accessories.........................................................................................................................................................39
7.1 Adding a Humidier with or without Heated Tube...........................................................39
7.2 SD Card.......................................................................................................................................39
7.3 Supplemental Oxygen...............................................................................................................39
7.4 Nurse Call System.....................................................................................................................39
7.5 Oximeter.....................................................................................................................................39
Section 8: Troubleshooting ................................................................................................................................................40
Section 9: Technical Specications ...................................................................................................................................41
Section 10: EMC Information.............................................................................................................................................44
Limited Warranty ....................................................................................................................................................... Back Page

1
Section 1: Introduction
1.1 Package Contents
The OmniLab Advanced + system may include the following components. Some components are optional accessories
that may not be packaged with the device.
1OmniLab Advanced + device 6 Power cord retainer and screw
2Humidier (optional) 7 AC power adapter
3 Clinical manual 8 Reusable gray foam lter
4Flexible tubing (1.8 m x 22 mm) 9Disposable white ultra-ne lter
5 Power cord 10 SD card (optional)
1.2 Intended Use
The OmniLab Advanced + is intended to provide non-invasive ventilation for pediatric patients 7 years or older
>18.2 kg (40 lbs) with Respiratory Insufciency or Obstructive Sleep Apnea (OSA). It is also intended to treat adult
patients >30 kg (66 lbs) with Respiratory Insufciency or Obstructive Sleep Apnea caused by central and/or mixed
apneas and periodic breathing. The device is intended for use in the hospital.
WARNING: The effectiveness of the A-Flex, Bi-Flex, C-Flex, C-Flex+ or AVAPS therapy features or the autoSV
mode has not been established for pediatric patients at this time.

2
1.3 Warnings and Cautions
Warnings
A warning indicates the possibility of injury to the user or operator.
Patient Monitoring Prior to placing a patient on the device, a clinical assessment should be performed to determine:
• The device alarm settings
• Needed alternative therapy equipment
• If an alternative monitor (alarming pulse oximeter or respiratory monitor) should be used
Personnel
Qualications
OmniLab Advanced + is a restricted medical device designed for use by trained and qualied personnel.
This manual serves as a reference.The instructions in this manual are not intended to supersede
the health care professional’s instructions regarding the use of the device.
The operator should read and understand this entire manual before using the device.
Battery Back-up
Power
The device 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.
Operating and
Storage Temperatures
Do not use this device if the room temperature is warmer than 40˚ C (104˚ F) because the
temperature of the airow may exceed 43˚ C (109˚ F).This could cause thermal irritation or
injury to the patient’s airway.
Do not use the device while positioned in a warm place, such as direct sunlight.
Device Start-Up Make sure the device is working properly at start-up (when entering standby mode). Always
verify that the audible tone sounds and the alarm LEDs light red then yellow momentarily.
Contact Philips Respironics or an authorized service center for service if these indications do
not occur at start-up. See Sections 3 and 4 for more information about device start-up.
Bacteria Filter Philips Respironics recommends that a main line outlet bacteria lter be used whenever the
device is used on multiple patients.
Therapy Modes/
Features
The effectiveness of the A-Flex, Bi-Flex, C-Flex, C-Flex+ or AVAPS therapy features or the
autoSV mode has not been established for pediatric patients at this time.
Patient Circuits The device should only be used with patient interfaces (ex. 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.
An exhalation port is required. Do not block the exhalation port. This can reduce airow and
result in rebreathing of exhaled air.
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.
When using a patient circuit with a full face mask, the mask must be equipped with a safety
(entrainment) valve. Make sure that the safety (entrainment) valve is functioning properly with
the device.
Improperly
Functioning Device
If you notice any unexplained changes in the performance of the device, if it is making unusual
sounds, if it has been dropped or mishandled, 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.
Circuit Disconnect You should not rely on any single alarm to detect a circuit disconnect condition.The Low Minute
Ventilation and Apnea alarms should be used in conjunction with the Circuit Disconnect alarm.
Test the operation of the circuit disconnect function whenever a change is made to the circuit.
An increase in circuit resistance can prevent proper operation of some alarms.

3
Nurse Call and
Remote Alarm System
The Nurse Call output of this device is designed only for use with SELV (Safety Extra Low
Voltage) as described in IEC 60601-1. Do not connect the Nurse Call output of this device to
potentially hazardous voltages as severe injury or death may result.
The Nurse Call and Remote Alarm features should be considered a back-up to the device’s
alarm system. Do not rely solely on the Nurse Call feature.
When using a remote alarm or nurse call system, make sure you fully test the connector and
cable by verifying that:
• Annunciated alarms on the device are also annunciated on the remote alarm or nurse call
system.
• Disconnecting the remote alarm or nurse call cable from the device or from the remote
alarm or nurse call system results in an alarm notication at the remote alarm.
Power Cord Route the power cord to the outlet in a way that will prevent the cord from being tripped over
or interfered with by chairs or other furniture.
Only use power cords recommended by Philips Respironics with the device. Use of power
cords and cables not supplied by Philips Respironics may cause overheating or damage to the
device.
Accessories When adding any components to the breathing system, the ow resistance and dead space of the
added components (such as humidiers and lters) should be carefully considered in relation to
the potential for adverse effects on the patient’s ventilatory management and device alarms. For
example, adding components to the breathing system may cause the pressure during expiration at
the Air Outlet Port to increase.
The use of accessories, transducers, and cables other than those specied by Philips Respironics
may result in increased emissions or decreased immunity of the device.
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.
When using oxygen with this system, the oxygen supply must comply with local regulations for
medical oxygen.
Do not connect the device to an unregulated or high pressure oxygen source.
When using oxygen with this system, a Philips Respironics Pressure Valve must be placed at the
device outlet. Failure to use the pressure valve could result in a re hazard.
Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of
an open ame.
Do not use the device near a source of toxic or harmful vapors.
When using oxygen with this system, turn the device on before turning on the oxygen.Turn the
oxygen off before turning the device off.This will prevent oxygen accumulation in the device.
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. Oxygen
accumulated in the device enclosure will create a risk of re.
EMC Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in this manual.The device
should not be used adjacent to or stacked with other equipment. For more information, contact
product support.
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
See the EMC section of this manual for distances to observe between RF Generators and the
device to avoid interference.

4
Cleaning To avoid electrical shock, always unplug the power cord from the wall outlet before cleaning the
device.
Never operate the device if any parts are damaged or if it is not working properly. Replace
damaged parts before continuing use.
Periodically inspect electrical cords and cables 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 injury, invalidate the warranty, or result in costly device
damage.
Humidier For safe operation, the humidier must always be positioned below the breathing circuit
connection at the mask and the air outlet on the device. The humidier must be level for proper
operation.
Cautions
A caution indicates the possibility of damage to the device.
Electrostatic
Discharge (ESD)
Do not use antistatic or conductive hoses or conductive patient tubing with the device.
Pins of connectors marked with the ESD warning symbol shall not be touched and connections shall
not be made without special precautions. Precautionary procedures include methods to prevent
build-up of electrostatic charge (ex. air conditioning, humidication, conductive oor coverings, non-
synthetic clothing), discharging one’s body to the frame of the equipment or system or to earth. It is
recommended that all individuals that will handle this device understand these precautionary procedures
at a minimum as part of their training.
Condensation Condensation may damage the device. If the device has been exposed to either very hot or very cold
temperatures, allow it to adjust to room temperature (operating temperature) before starting therapy.
Filters A properly installed, undamaged gray foam lter is required for proper operation. Wash periodically and
replace when damaged for proper operation.
Extension Cords Do not use extension cords with this device.
Device Placement Do not place the device in or on any container that can collect or hold water.
Do not place the device directly onto carpet, fabric, or other ammable materials.
Do not plug the device into an outlet controlled by a wall switch.
Humidier The heated humidier can only be used when the device is connected to AC power. It cannot be used
with a battery.
External Battery Do not use the same external battery to operate both the device and any other equipment such as
power chairs.
An external battery should only be connected to the device using the Philips Respironics 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
device.
Cleaning Do not immerse the device or allow any liquid to enter the enclosure or the inlet lter.
Do not steam autoclave the device. Doing so will destroy the device.
Do not use harsh detergents, abrasive cleaners, or brushes to clean the device.
Note: This product is not made with natural latex rubber or dry natural rubber in patient or operator accessible
areas or in the air path or breathing circuit.

5
1.4 Contraindications
The OmniLab Advanced + is not a life support device.
The device system should not be used on patients with the following conditions:
• Patients without a spontaneous respiratory drive
• Existing respiratory failure (failure to treat; risk of increased work of breathing due either to incomplete reversal
of upper airway obstruction or to breathing at high lung volume, leading to worsening respiratory failure)
• Pneumothorax or pneumomediastinum
• Emphysematous bullae or a past history of pneumothorax (risk of pneumothorax)
• Acute decompensated cardiac failure or hypotension, particularly if associated with intravascular volume
depletion (risk of further hypotension or reduction in cardiac output)
• Massive epistaxis or previous history of massive epistaxis (risk of recurrence)
• Pneumoencephalus, recent trauma or surgery (ex. pituitary or nasal) that may have produced cranio-
nasopharyngeal stula (risk of entry of air or other material into the cranial cavity)
• Acute sinusitis, otitis media, or perforated ear drum
• Acute or unstable cardiac failure
• Nocturnal or resting angina (risk of infarction or arrhythmias)
• Unstable arrhythmias
• Severely obtunded or heavily sedated patients
• At risk for aspiration of gastric contents
• Impaired ability to clear secretions
If patients are dehydrated or volume depleted, or have persistent atrial brillation, their cardiac lling pressures may
be low. In these cases, as with any CPAP or ventilatory support, use of the device may lead to a dangerous reduction
in cardiac output. The device should not be used in patients who are dehydrated or volume depleted, and should be
used with extreme care in patients with atrial brillation.
1.5 Patient Precautions
Immediately report any unusual chest discomfort, shortness of breath, or severe headache.
If skin irritation or breakdown develops from the use of the mask, refer to the mask instructions for appropriate
action.
The following are potential side effects of non-invasive positive pressure therapy:
• Ear or sinus discomfort
• Conjunctivitis
• Skin abrasions due to noninvasive interfaces
• Gastric distention (aerophagia)
• Drying of nose, mouth or throat
• Eye irritation
• Skin rashes
• Chest discomfort

6
1.6 System Overview
This device augments patient breathing by supplying pressurized air through a patient circuit. It senses the patient’s
breathing effort by monitoring airow in the patient circuit and adjusts its output to assist in inhalation and exhalation.
This therapy is known as Bi-level therapy. Bi-level therapy provides a higher pressure, known as IPAP (Inspiratory
Positive Airway Pressure), when the patient inhales, and a lower pressure, known as EPAP (Expiratory Positive
Airway Pressure), when the patient exhales. The higher pressure makes it easier for the patient to inhale, and the
lower pressure makes it easier for the patient to exhale. The device can also provide a single pressure level, known as
CPAP (Continuous Positive Airway Pressure).
Several accessories are available for use with the device. Contact product support to purchase any accessories not
included with the system. The gure below illustrates some of the device connectors and features, described in the
table that follows.
# Feature Description
1 Air outlet port Connect the exible tubing here.
2Nurse call
connector
Connect a nurse call or remote alarm system to the device by connecting a nurse call or remote alarm
adapter cable to this connector.
3Accessory slot
(with cover)
If applicable, optional accessories such as a link module or modem can be installed here. Refer to the
instructions supplied with the accessory.When not using an accessory, the cover must be in place on
the device.
4 SD card slot If applicable, insert the optional SD card here.
5 DC power inlet Connect an external battery here using the Philips Respironics DC power cord.
6 AC power inlet Connect the AC power adapter here.
7 Filter area A reusable, gray foam lter must be placed in the lter area to screen out normal household dust and
pollen. A white ultra-ne lter can also be used for more complete ltration of very ne particles.
8 Side cover If using a humidier with the device, this side cover can be easily removed with the release tab before
attaching the humidier. Refer to the humidier manual for more information.

7
Control Buttons
The gure below shows the display screen and primary control buttons on the device.
Ramp
cm
H2O
S/T AVAPS: 0.5
0 5 10 15 20 25 30
Menu
A
12/30/2010
06:12 PM
1
Humidifier
# Feature Description
1 Display screen Shows therapy settings, patient data, and other messages.
2Alarm indicator/
audio pause button
This button serves two purposes: it temporarily silences the audible portion of an alarm, and it
also acts as an alarm indicator. See Section 5 for more information.
3Start/stop button
Pressing this button when the device is off causes the device to enter Standby mode. Pressing this
button while therapy is being delivered displays a pop-up screen that allows you to either turn the
device off or return to Standby mode.
4Left and right
buttons These buttons allow you to select display options or perform certain actions specied on-screen.
5Up/down button This button allows you to navigate the display menu and edit device settings.

8
1.7 Symbols
The following symbols may appear on the device or the included accessories.
Symbol Description Symbol Description
Consult accompanying instructions for use. Manufacturer
AC Power Reorder Number
DC Power Serial Number
IP22 Dripping water protected equipment (15° tilted);
Solid foreign object protected equipment
(≥ 12.5 mm diameter)
Lot Number
Humidity Limitation Authorized representative in the European
Community
Temperature Limitation Start/Stop
Caution, consult accompanying documents. Alarm Indicator/Audio Pause
Contains or presence of phthalate Nurse Call or Remote Alarm System
Connector
ESD Warning Symbol For Airline Use. Complies with RTCA/DO-
160F section 21, category M.
Do Not Reuse 1081167 Use only with power supply 1081167.
Class II (Double Insulated) AC Power Supply: connection for the AC/DC
power supply
Type BF Applied Part DC Battery Voltage: connection for an external
battery
Keep away from sunlight Separate collection for electrical and electronic
equipment per EC Directive 2002/96/EC.
For indoor use only

9
1.8 How to Contact Philips Respironics
To have the device serviced, contact product support. If you need to contact Philips Respironics directly, call the
Philips Respironics Customer Service department at 1-724-387-4000 or [phone]. You can also use the
following addresses:
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668
Respironics Deutschland
Gewerbestrasse 17
82211 Herrsching, Germany

10
Section 2: Therapy Modes and Features
2.1 Device Therapy Modes
Therapy
Modes
Description
CPAP Continuous Positive Airway Pressure; CPAP maintains a constant level of pressure throughout the breathing cycle.
SSpontaneous Pressure Support; A Bi-level therapy mode where breaths are patient-triggered and patient-cycled.
The device triggers to IPAP (Inspiratory Positive Airway Pressure) in response to spontaneous inspiratory effort
and cycles to EPAP (Expiratory Positive Airway Pressure) during exhalation. The device also cycles a patient-
triggered breath if no patient exhalation effort is detected for 3 seconds.The level of Pressure Support delivered
is determined by the difference between the IPAP and EPAP settings (PS = IPAP - EPAP)
S/T Spontaneous/Timed Pressure Support; A Bi-level therapy mode where each breath is patient-triggered and patient-
cycled or machine-triggered and machine-cycled. S/T mode is similar to S mode, except that the device also will
enforce a set minimum breath rate by, if necessary, providing machine (time) triggered breaths. For these breaths,
the inspiratory time is also a set value.
TTimed Pressure Support; A Bi-level therapy mode where breaths are machine-triggered and machine-cycled. T
mode provides mandatory pressure assist with bi-level pressures.The patient’s breathing rate has no effect on the
machine rate or pressure levels.The trigger to IPAP is determined by the breath rate setting, and the cycle time is
determined by the inspiratory time setting.
PC Pressure Control Pressure Support; A Bi-level therapy mode where each breath is patient or machine-triggered
and machine-cycled. PC mode is similar to S/T mode, except that all breaths are machine-cycled. This is a
pressure-limited, machine or patient-triggered, time-cycled mode.The cycle time is determined by the Inspiratory
Time setting.
AVAPS-AE A novel Bi-level therapy mode that provides an automatically adjusting EPAP, Pressure Support, and back-up breath
rate.
In AVAPS-AE mode, the device monitors the patient’s upper airway resistance and automatically adjusts the
delivered EPAP required to maintain a patent airway.
In this mode, the AVAPS feature is always enabled.This allows the device to automatically adjust Pressure Support
to maintain a target tidal volume. (Refer to the description of AVAPS in Section 2.2, Therapy Features.) The
required Pressure Support is delivered above the automatic EPAP setting.
Additionally, when the Breath Rate is set to Auto, the device will automatically adjust the back-up breath rate
based on the patient’s spontaneous respiratory rate.
autoSV The autoSV mode is similar to S mode, except that it also can deliver a machine-triggered breath if the patient
does not spontaneously breathe. In addition, the device may automatically provide pressure support to normalize
patient therapy during sleep disordered breathing events by providing pressure support levels between PS Min
setting and PS Max setting.
WARNING: The effectiveness of the A-Flex, Bi-Flex, C-Flex, C-Flex+ or AVAPS therapy features or the autoSV
mode has not been established for pediatric patients at this time.
Auto-CPAP In Auto-CPAP mode, the device delivers therapy while automatically adjusting the pressure level to meet the
patient’s needs.
Auto-BiLevel In Auto-BiLevel mode, the device delivers therapy with one level of output pressure during EPAP (Expiratory
Positive Airway Pressure) and a second higher level during IPAP (Inspiratory Positive Airway Pressure) while
automatically adjusting EPAP and IPAP levels to meet the patient’s needs.

11
2.2 Therapy Features
The device can provide the following therapy features.
AVAPS
Average Volume Assured Pressure Support (AVAPS) is a feature available in the S, S/T, PC, and T modes. (In
AVAPS-AE mode, the AVAPS feature is always enabled.) AVAPS helps patients maintain a tidal volume (Vte) equal
to or greater than the target tidal volume (Tidal Volume setting) by automatically controlling the pressure support
(PS) provided to the patient. The AVAPS feature adjusts PS by varying the IPAP level between the IPAP Min and
IPAP Max settings (or Pressure Support Min and Pressure Support Max in AVAPS-AE mode). AVAPS will retain the
learned PS for the patient so that each time therapy is started the PS will start at the learned PS.
The AVAPS algorithm in the OmniLab Advanced + contains an improvement to more accurately achieve and maintain
the target tidal volume. The muscle effort of a spontaneous breath typically results in a larger tidal volume than a
machine breath delivered at the same pressure. The new AVAPS algorithm will adjust the pressure slightly on machine
delivered breaths to compensate for this difference, and throughout the night, the algorithm will “learn” the correct
amount of pressure adjustment to apply to machine triggered breaths.
If IPAP Max is reached and the target tidal volume is not achieved, the Low Tidal Volume alarm activates (if enabled).
WARNING: The effectiveness of the A-Flex, Bi-Flex, C-Flex, C-Flex+ or AVAPS therapy features or the autoSV
mode has not been established for pediatric patients at this time.
AVAPS Rate
The AVAPS Rate setting allows you to adjust the maximum rate at which the pressure support automatically
changes to achieve the target tidal volume. The actual rate may be less than this maximum setting depending
on how far the current estimated tidal volume is from the target tidal volume. A higher rate allows the AVAPS
algorithm to change pressure support faster to meet the target tidal volume. It can be set from 0.5 cm H2O per
minute to 5.0 cm H2O per minute in increments of 0.5 cm H2O per minute.
C-Flex Comfort Feature
The device provides the C-Flex feature in CPAP and Auto-CPAP
modes. The C-Flex attribute adjusts therapy by providing pressure
relief during active exhalation (the beginning part of exhalation). In
the diagram, the bold lines represent C-Flex in comparison to the
dashed line representing normal CPAP therapy. C-Flex levels of 1,
2, or 3 progressively reect increased pressure relief that will take
place at the end of inspiration and at the beginning of expiration.
WARNING: The effectiveness of the A-Flex, Bi-Flex, C-Flex,
C-Flex+ or AVAPS therapy features or the autoSV mode has
not been established for pediatric patients at this time.
CPAP
Time
1
2
3
C-Flex

12
A-Flex (C-Flex+) Comfort Feature
The device is equipped with a special comfort feature called
A-Flex if in Auto-CPAP (or C-Flex+ if in CPAP mode).
When A-Flex (C-Flex+) is enabled, it enhances patient
comfort in three ways: 1) by smoothing the transition
between the end of inhalation and the beginning of
exhalation, 2) by providing signicant pressure relief during
the beginning of exhalation, and 3) by reaching an end
exhalation pressure of no more than 2 cm H2O below the
high point of inspiration.
In the diagram, the dashed line represents CPAP
pressure in comparison to the bold line representing
A-Flex (C-Flex+). A-Flex (C-Flex+) levels of 1, 2, or 3
progressively reect increased pressure relief during the beginning of exhalation.
With A-Flex (C-Flex+), the level of pressure relief at the beginning of exhalation is determined by the A-Flex
(C-Flex+) setting and the amount of patient ow in any one breath.
Note: A-Flex (C-Flex+) transitions from no A-Flex (C-Flex+) at 4.0 cm H2O to full A-Flex (C-Flex+) at 6 cm H2O.
A-Flex (C-Flex+) is top limited at 20.0 cm H2O pressure.
WARNING: The effectiveness of the A-Flex, Bi-Flex, C-Flex, C-Flex+ or AVAPS therapy features or the autoSV
mode has not been established for pediatric patients at this time.
Bi-Flex Comfort Feature
If enabled, the device provides a comfort feature called Bi-Flex
in S, autoSV, and Auto-BiLevel modes. The Bi-Flex attribute
adjusts therapy by inserting a small amount of pressure relief
during the latter stages of inspiration and during active exhalation
(the beginning part of exhalation). Bi-Flex levels of 1, 2, or 3
progressively reect increased pressure relief that will take place at
the end of inspiration and at the beginning of expiration.
WARNING: The effectiveness of the A-Flex, Bi-Flex, C-Flex,
C-Flex+ or AVAPS therapy features or the autoSV mode has not
been established for pediatric patients at this time.
Ramp
The device is equipped with an optional ramp feature.
The ramp feature is designed to offer lower pressures
when activated and then gradually increase to allow
the patient to fall asleep.
If ramp is activated with AVAPS enabled or in AVAPS-
AE mode, it will reduce the maximum pressure
support capability to IPAP Min or Pressure Support
Min and ramp to the IPAP Max or Pressure Support
Max. In AVAPS-AE mode, the EPAP will reduce to the
EPAP Min setting but is not ramped, and Auto-EPAP
adjusts the pressure according to the patient’s needs.
During the ramp period, the IPAP or pressure support applied will be adjusted by the AVAPS algorithm but will be
constrained by the current maximum ramp pressure set point. The pressures (with exception of EPAP in AVAPS-AE
mode) will then ramp up to the original patient settings over the ramp time period.
Therapy
Pressure
Time
Inhalation
Exhalation
A-Flex Le
vels
(1, 2 and 3)
1
2
3
Exhalation starts and
pressure level decreases
TIME

13
Rise Time
If enabled, the device provides a feature called
Rise Time in S, S/T, T, PC, autoSV, and Bi-level
modes. Rise time is the amount of time it
takes the device to change from the expiratory
pressure setting to the inspiratory pressure
setting. Rise time levels of 1, 2, 3, 4, 5, or 6
progressively reect slowed response of the
pressure increase that will take place at the
beginning of inspiration. A setting of 1 is the
fastest rise time while a setting of 6 is the slowest. Adjust the rise time to nd the most comfortable setting for the
patient. Rise time cannot be adjusted when Bi-Flex is enabled.
Digital Auto-Trak
An important characteristic of the device is its ability to recognize and compensate for unintentional leaks in the
system and to automatically adjust its trigger and cycle algorithms to maintain optimum performance in the presence
of leaks. This feature is known as Digital Auto-Trak.
The device continuously monitors ow and adjusts the estimate of patient ow as circuit leak changes. The
compensation provides a better estimate of patient ow to be used to track patient breathing patterns and calculate
ow-based parameters, such as exhaled tidal volume.
The device continually tracks breathing patterns and automatically adjusts sensitivity thresholds to ensure optimum
patient and machine synchrony as breathing patterns change or as circuit leak varies.
Sensitive Auto-Trak is an enhancement to the Auto-Trak algorithm that improves patient and machine synchrony
for patients with minimal respiratory effort. Sensitive Auto-Trak renes the baseline trigger and cycle sensitivity
thresholds.
PRESSURE
IPAP
EPAP
TIME
Rise Time

14
2.3 Therapy Event Detection
The device monitors breathing and detects apneas, hypopneas, and other therapy events (as available).
Event Denition
Obstructed
Airway
Apnea/Clear
Airway Apnea
Detection
An apnea is detected when there is an 80% reduction in airow from baseline for at least 10 seconds or
if there is no airow detected for 10 seconds. During the apnea, one or more pressure test pulses are
delivered by the device. The device evaluates the response of the patient to the test pulse(s) and assesses
whether the apnea has occurred while the patient has a clear airway or an obstructed airway.The airway
is determined to be clear if the pressure test pulse generates a signicant amount of ow; otherwise, the
airway is determined to be obstructed.
Note: If the device is in a mode that delivers its own backup breath, (S/T, PC, T, or AVAPS-AE mode),
then the device will NOT deliver the test pulse. Instead, it will use the machine back-up breath and
evaluate it for which (if any) type of apnea to score.
RERA
Detection
RERA (Respiratory effort-related arousal) is dened as an arousal from sleep that follows a 10 second
or longer sequence of breaths that are characterized by increasing respiratory effort, but which does not
meet criteria for an apnea or hypopnea. Snoring, though usually associated with this condition, need not
be present.The RERA algorithm monitors for a sequence of breaths that exhibit both a subtle reduction
in airow and progressive ow limitation. If this breath sequence is terminated by a sudden increase in
airow along with the absence of ow limitation, and the event does not meet the conditions for an apnea
or hypopnea, a RERA is indicated.
Periodic
Breathing
A persistent waning and waxing breathing pattern which repeats itself between 30 and 100 seconds.The
nadir of the breathing pattern is characterized by at least a 40% reduction in airow from an established
baseline ow. The pattern must be present for several minutes before it can be identied as periodic
breathing.
Hypopnea
Detection
A hypopnea is detected when there is an approximately 40% reduction in airow from baseline for at least
10 seconds.
Snore
Detection
Vibration snore is disabled at pressures greater than 16 cm H2O in CPAP mode.Vibration snore is disabled
at IPAP settings greater than 20 cm H2O or max pressure support (IPAP – EPAP) greater than or equal to
10 cm H2O in bi-level modes. It is also disabled during any machine triggered breaths when EPAP settings
are greater than or equal to 10 cm H2O.
Large Leak The level of leak is so large, it is no longer possible to determine respiratory events with statistical
accuracy.

15
Section 3: Device Setup
3.1 Installing the Air Filter
The device uses a gray foam lter that is washable and reusable, and a white ultra-ne lter that is disposable. The
reusable lter screens out normal household dust and pollen, while the ultra-ne lter provides more complete
ltration of very ne particles. The gray reusable lter must be in place at all times when the device is operating.
The ultra-ne lter is recommended for people who are sensitive to tobacco smoke or other small particles. One
reusable gray foam lter is supplied with the device. A disposable ultra-ne lter may also be included.
If the lter is not already installed when you receive the device, you must
at least install the reusable gray foam lter before using the device. To
install the lter(s):
1. If you are using the white disposable ultra-ne lter, insert it into the
lter area rst, with the smooth side facing toward the device.
2. Insert the required gray foam lter into the lter area after the ultra-ne
lter.
Note: If you are not using the white disposable lter, simply insert the
gray foam lter into the lter area.
3.2 Where to Place the Device
Place the device upright on a rm, at surface somewhere within easy reach of where the patient will use it, at a
level lower than their sleeping position. Make sure the lter area on the back of the device is not blocked by bedding,
curtains, or other items. Air must ow freely around the device for the system to work properly. Make sure the
device is away from any heating or cooling equipment (ex. forced air vents, radiators, or air conditioners).
3.3 Connecting the Breathing Circuit
You will need the following accessories in order to assemble the recommended circuit:
• Philips Respironics interface (nasal mask or full face mask) with integrated exhalation port, or Philips Respironics
interface with a separate exhalation device (such as the Whisper Swivel II)
• Philips Respironics exible tubing (22 or 15 mm) or heated tubing
• Philips Respironics headgear (for the mask)
Note: See Section 6 for information on how to clean Philips Respironics exible tubing prior to use. Refer to the
instructions that accompany any other breathing circuit components for any necessary cleaning prior to use.
Complete the following steps to connect the breathing circuit to the device:
1. Connect the exible tubing to the air outlet on the side of the device.
Note: If required, connect a bacteria lter to the device air outlet, and then connect the exible tubing to the
outlet of the bacteria lter. When using the bacteria lter, the device performance may be affected. However, the
device will remain functional and deliver therapy.
Note: When using the optional heated tubing, attach the heated tubing to the humidier’s modied air outlet port,
with the bacteria lter installed in-line, but at the opposing end of the tubing.
2. Connect the tubing to the mask. Refer to the instructions that came with the mask.
3. Attach the headgear to the mask if necessary. Refer to the instructions that came with the headgear.

16
3.4 Supplying Power to the Device
The device can operate on AC or DC power.
Using AC Power
An AC power cord and power supply is included with the device.
1. Plug the socket end of the power cord into the power supply.
2. Plug the pronged end of the power cord into an electrical outlet that is not controlled by a wall switch.
3. Plug the power supply cord’s connector into the power inlet on the back of the device.
4. Ensure that all connections are secure.
5. There is an accessory clip that can be used to secure the power cord to prevent accidental disconnection. Route
the cords through the clip and secure the clip to the enclosure of the device using the supplied screw, as shown in
these four steps.
1
2
3 4
Note: Some devices have a locking-type power connector. To avoid damage to the connector, when disconnecting
the power cord, pull the connector at its base, not the cord, to disengage the lock.
Using DC Power
The device can operate from a 12 VDC lead acid battery using the Philips Respironics External Battery Cable. This
cable is pre-wired and properly terminated to ensure safe connection of an external battery to the device. Battery
operating time depends on the characteristics of the battery and usage of the device.
Due to a variety of factors, including battery chemistry, age, and use prole, the capacity of the external battery as
shown on the device display is only an estimate of the actual remaining capacity.
Refer to the instructions supplied with the External Battery Cable for detailed information on how to operate the
device using an external battery.
Device Power Source Indicators
There are many power source indicators on the device and the display screen. These indicators are described in
detail below.
AC Power Indicators
When AC power is applied to the device and the airow is off, the green AC LED indicator on the Start/Stop button
lights. When AC power is applied and the airow is on, the white AC LED indicator on the Start/Stop button lights.
DC Power Indicators
When DC power is applied to the device, battery symbols will appear on-screen to indicate the battery status. The
shading in the battery icon indicates the power remaining in the battery. Refer to the Display Symbols table in Section
4.9 for information on each battery symbol.