Respironics DreamStation_BiPAP_User_Manual Vortexer Instruction Manual

DreamStation

BiPAP Pro

Auto BiPAP

User manual

Table of Contents

Intended Use ........................................................................................................................................................... 1

Important ................................................................................................................................................................. 1

Warnings ..................................................................................................................................................................1

Cautions ................................................................................................................................................................... 2

Contraindications .................................................................................................................................................. 2

Symbols Glossary ................................................................................................................................................... 3

System Contents .................................................................................................................................................... 4

How to Contact Philips Respironics ................................................................................................................. 4

System Overview ................................................................................................................................................... 5

Installing/Replacing the Air Filters ...................................................................................................................... 6

Where to Place the Device ................................................................................................................................. 7

Supplying AC Power to the Device ....................................................................................................................7

Connecting the Breathing Circuit ......................................................................................................................8

Navigating the Device Screens ............................................................................................................................9

Starting the Device ................................................................................................................................................ 9

Menu Navigation (Therapy ON) and Optional Humidication Settings ................................................. 10

Ramp Feature ........................................................................................................................................................10

Menu Navigation (Therapy OFF) ...................................................................................................................... 11

Bluetooth® Wireless Technology .........................................................................................................................15

Check Mask Fit .....................................................................................................................................................16

Sleep Progress ......................................................................................................................................................16

Altitude Compensation ......................................................................................................................................16

Device Alerts ........................................................................................................................................................17

Troubleshooting ...................................................................................................................................................20

Accessories ...........................................................................................................................................................22

Traveling with the System ..................................................................................................................................24

Cleaning the Device ............................................................................................................................................24

Caring for the Filters ..........................................................................................................................................24

Cleaning the Tubing ..............................................................................................................................................24

Service .................................................................................................................................................................... 24

Additional Notices ...............................................................................................................................................25

Specications ........................................................................................................................................................25

Disposal ..................................................................................................................................................................27

EMC Information .................................................................................................................................................27

Limited Warranty ...................................................................................................................................Back Page

© Koninklijke Philips N.V. , 2018. All rights reserved.

Caution: U. S. federal law restricts this device to sale by or on the order of a physician.

Intended Use

The Philips Respironics DreamStation systems deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in
spontaneously breathing patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional environment.

Important

The device is to be used only on the instruction of a licensed physician. Your home care provider will make the correct pressure

settings and device congurations including accessories, according to your health care professional’s prescription.

Several accessories are available to make your OSA treatment with the DreamStation system as convenient and comfortable as

possible. To ensure that you receive the safe, effective therapy prescribed for you, use only Philips Respironics accessories.

Warnings

A warning indicates the possibility of injury to the user or the operator.

• 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.

• This device is not intended for life support.

• The device should be used only with masks and connectors recommended by Philips Respironics or with those recommended by the
health care professional or respiratory therapist. A mask should not be used unless the device is turned on and operating properly.
The exhalation port(s) associated with the mask should never be blocked. Explanation of the Warning: The device is intended

to be used with special masks or connectors that have exhalation ports to allow continuous ow of air out of the mask. When
the device is turned on and functioning properly, new air from the device ushes the exhaled air out through the mask exhalation
port. However, when the device is not operating, enough fresh air will not be provided through the mask, and exhaled air may be

rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation.

• If you are using a full face mask (a mask covering both your mouth and your nose), the mask must be equipped with a safety

(entrainment) valve.

• When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen.

• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open ame.

• 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.

• When using oxygen with this system, a Philips Respironics Pressure Valve must be placed in-line with the patient circuit between
the device and the oxygen source. The pressure valve helps prevent the backow of oxygen from the patient circuit into the
device when the unit is off. Failure to use the pressure valve could result in a re hazard.

• Do not connect the device to an unregulated or high pressure oxygen source.

• Do not use the device in the presence of a ammable anaesthetic mixture in combination with oxygen or air, or in the presence

of nitrous oxide.

• Do not use the device near a source of toxic or harmful vapors.

• Do not use this device if the room temperature is warmer than 35° C (95° F). If the device is used at room temperatures warmer

than 35° C (95° F), the temperature of the airow may exceed 43° C (109° F). This could cause irritation or injury to your airway.

• Do not operate the device in direct sunlight or near a heating appliance because these conditions can increase the temperature of
the air coming out of the device.

• Contact your health care professional if symptoms of sleep apnea recur.

• If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been
dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord and

discontinue use. Contact your home care provider.

• 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 damage.

• Do not use any accessories, detachable parts, and materials not recommended by Philips Respironics. Incompatible parts or

accessories can result in degraded performance.

• Use only approved cables and accessories. Misuse may affect EMC performance and should be avoided.

• The Health Industry Manufacturers Association recommends that a minimum separation of six inches be maintained between
a wireless phone and a pacemaker to avoid potential interference with the pacemaker. The DreamStation on-board Bluetooth
communication should be considered a wireless phone in this regard.

• Use only power cords supplied by Philips Respironics for this device. Use of power cords not supplied by Philips Respironics may cause

overheating or damage to the device and may result in increased emissions or decreased immunity of the equipment or system.

• The device should not be used while stacked or in close approximation to other non-approved devices.

• Do not pull or stretch the tubing. This could result in circuit leaks.

1User Manual

• Inspect the tubing for damage or wear. Discard and replace the tubing as necessary.

• Periodically inspect electrical cords and cables for damage or signs of wear. Discontinue use and replace if damaged.

• To avoid electrical shock, always unplug the power cord from the wall outlet before cleaning the device. DO NOT immerse the
device in any uids.

• If the device is used by multiple persons (such as rental devices), a low-resistance, main ow bacteria lter should be installed in-

line between the device and the circuit tubing to prevent contamination.

• Be sure to 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.

• This device is activated when the power cord is connected.

• For safe operation when using a humidier, the humidier must always be positioned below the breathing circuit connection at
the mask. The humidier must be level for proper operation.

Note: Please see the “Limited Warranty” section of this manual for information on warranty coverage.

Cautions

A Caution indicates the possibility of damage to the device.

• Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to EMC information.

Contact your home care provider regarding EMC installation information.

• Mobile RF communications equipment can affect medical electrical equipment.

• 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 (e.g., 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.

• Before operating the device, ensure that the SD card/lter access door and the modem access door are both closed whenever any

of the accessories such as the Link Module or Modem are not installed. Refer to the instructions that came with your accessory.

• Condensation may damage the device. If this device has been exposed to either very hot or very cold temperatures, allow it to
adjust to room temperature (operating temperature) before starting therapy. Do not operate the device outside of the operating
temperature range shown in the Specications.

• Do not use extension cords with this device.

• Make sure the lter area on the side 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.

• Do not place the device directly onto carpet, fabric, or other ammable materials.

• Do not place the device in or on any container that can collect or hold water.

• A properly installed, undamaged Philips Respironics blue pollen lter is required for proper operation.

• Tobacco smoke may cause tar build-up within the device, which may result in the device malfunctioning.

• Clogged inlet lters may cause high operating temperatures that may affect device performance. Regularly examine the inlet lters

as needed for integrity and to check for accumulated debris.

• Never install a wet lter into the device. You must ensure sufcient drying time for the rinsed lter.

• Always ensure that the DC power cord securely ts into your therapy device prior to use. Contact your home care provider or
Philips Respironics to determine if you have the appropriate DC cord for your specic therapy device.

• When DC power is obtained from a vehicle battery, the device should not be used while the vehicle’s engine is running. Damage

to the device may occur.

• Only use a Philips Respironics DC Power Cord and Battery Adapter Cable. Use of any other system may cause damage to the device.

Contraindications

When assessing the relative risks and benets of using this equipment, the clinician should understand that this device can deliver

pressures up to 25 cm H2O. In the event of certain fault conditions, a maximum pressure of 40 cm H2O is possible. Studies have

shown that the following pre-existing conditions may contraindicate the use of CPAP therapy for some patients:

• Bullous Lung Disease

• Pathologically Low Blood Pressure

• Bypassed Upper Airway

• Pneumothorax

• Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway Pressure. Caution should be used when

prescribing CPAP for susceptible patients such as those with: cerebral spinal uid (CSF) leaks, abnormalities of the cribriform
plate, prior history of head trauma, and/or pneumocephalus. (Chest 1989; 96:1425-1426)

The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear

infection. Not for use with patients whose upper airways are bypassed. Contact your health care professional if you have any
questions concerning your therapy.

2 User Manual

Symbols Glossary

The following symbols may appear on the device, power supply and accessories:

Symbol Denition Reference

Operator’s manual; operating instructions

Consult instructions for use.

AC power (Alternating current)

Indicates on the rating plate that the equipment is suitable for
alternating current only; to identify relevant terminals.

DC power (Direct current)

Indicates on the rating plate that the equipment is suitable for direct
current only; to identify relevant terminals.

IP22

Drip Proof Equipment

Caution, consult accompanying documents.

Electrostatic sensitive devices (ESD warning symbol)
Attention – Observe precautions for handling electrostatic sensitive
devices.

Class II equipment (Double Insulated)
To identify equipment meeting the safety requirements specied for
Class II equipment.

Type BF applied part

To identify a type BF applied part complying with IEC 60601-1.

For indoor use only

Equipment is designed primarily for indoor use.

Approved for airline use.

IEC 60878
ISO 7000-1641
Symbol 5.4.3, ISO 15223-1

IEC 60417-5032

IEC 60417-5031

IEC 60529

IEC 60878
Symbol 5.1.2, ISO 15223-1

IEC 60878
IEC 60417-5134

IEC 60878
IEC 60417-5172

IEC 60878
IEC 60417-5333

IEC 60878
IEC 60417-5957

RTCA/DO-160G section 21,

category M.

Separate collection for electrical and electronic equipment per EC

Directive 2012/19/EU.

Bluetooth® symbol

Indicates the device has Bluetooth capabilities.

Non-ionizing electromagnetic radiation Indicates that the equipment

includes RF transmitters.

Oximeter Connection -

Serial Connection

Identies a connector for a serial data connection.

Keep away from sunlight
Indicates the medical device needs protection from light sources.

Prescription device

Caution: U. S. federal law restricts this device to sale by or on the

order of a physician.

Do not disassemble. -

Therapy on/off (Stand-by)
Identies the button to turn therapy on or off (puts the device in a
stand-by condition).

-

-

IEC 60878
IEC 60417-5140

IEC 60878
IEC 60417-5850

IEC 60878
ISO 7000-0624
Symbol 5.3.2, ISO 15223-1

-

IEC 60878
IEC 60417-5009

3User Manual

Symbol Denition Reference

Ramp (Variability)
To identify the control device by means of which a quantity is
controlled. The controlled quantity increases with the gure width.

Keep dry
Indicates the medical device that needs to be protected from
moisture.

Fragile, handle with care

Indicates the medical device can be broken or damaged if not handled
carefully.

Temperature limit
Indicates the storage temperature limits to which the medical device
can be safely exposed.

Humidity limitation
Indicates the range of humidity to which the medical device can be
safely exposed.

Manufacturer
Indicates the medical device manufacturer.

Date of manufacture
Indicates the date when the medical device was manufactured.

Reorder number

Indicated the manufacturer’s catalogue number so the medical device
can be identied.

Serial number

Identify the manufacturer’s serial number for the medical device.

Standards Reference

ISO 7000:2014, Graphical symbols for use on equipment – Registered symbols
ISO 15223-1:2012, Medical devices—Symbols to be used with medical devices labels - General requirements
IEC 60417:2002 DB, Graphical symbols for use on equipment
IEC/TR 60878:2015, Graphical symbols for electrical equipment in medical practice
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)

IEC 60878
IEC 60417-5004

IEC 60878
ISO 7000-0626
Symbol 5.3.4, ISO 15223-1

IEC 60878
ISO 7000-0621
Symbol 5.3.1, ISO 15223-1

IEC 60878
ISO 7000-0632
Symbol 5.3.7, ISO 15223-1

IEC 60878
ISO 7000-2620
Symbol 5.3.8, ISO 15223-1

IEC 60878
ISO 7000-3082
Symbol 5.1.1, ISO 15223-1

IEC 60878
ISO 7000-2497
Symbol 5.1.3, ISO 15223-1

ISO 7000-2493
Symbol 5.1.6, ISO 15223-1

IEC 60878
ISO 7000-2498
Symbol 5.1.7, ISO 15223-1

System Contents

Your DreamStation system may include the following items:

• Device • SD card

• User manual • Flexible tubing

• Carrying case • Reusable blue pollen lter

• Power cord • Disposable light-blue ultra-ne lter (optional)

• Power supply ( 1118499) • Humidier (optional)

Note: If any of these items are missing, contact your home care provider.

How to Contact Philips Respironics

Should you experience trouble with this equipment or require assistance setting up, using, or maintaining the device
or accessories, please contact your home care provider. If you need to contact Philips Respironics directly, call
the Philips Respironics Customer Service department at 1-800-345-6443 or 1-724-387-4000. You can also use the
following address:
Respironics, Inc.

1001 Murry Ridge Lane

Murrysville, PA 15668

4 User Manual

System Overview

The DreamStation therapy device is designed for the treatment of Obstructive Sleep Apnea (OSA). The DreamStation

BiPAP Pro can be set up as a Bi-level device, which delivers two different positive pressure levels: IPAP (Inspiratory

Positive Airway Pressure) and EPAP (Expiratory Positive Airway Pressure). The DreamStation BiPAP Auto can also

be set up as an Auto Bi-level device. Both BiPAP systems can also be set up as a CPAP (Continuous Positive Airway

Pressure) device. Your home care provider will choose the appropriate pressure settings for you.

When prescribed for you, the device provides several special features to help make your therapy more comfortable.

The ramp function allows you to lower the pressure when you are trying to fall asleep. The air pressure will gradually

increase until your prescription pressure is reached. Also, the Flex comfort feature provides you with pressure relief

when you exhale during therapy.
Several accessories are also available for use with your device. Contact your home care provider to purchase any

accessories not included with your system.

This gure illustrates some of the device features, described in the following table.

# Device Feature Description

Starts and stops the airow for therapy.

Therapy On/Off Button

1

2 Ambient Light Sensor

Ramp Button

3

If the Therapy On/Off button LED is ashing, you may have a pending

message. Press or turn the knob to display the message.

Detects room light levels and adjusts brightness of LCD Display

Screen.

Activates the ramp feature during therapy.

4 Door, SD card & Filter Access This door lifts open for access to the SD card and lter area.

5 LCD Display Screen This is the User Interface for the therapy device.

6 Control Dial

7 Door, Accessory Access This door lifts open for access to the (optional) accessories.

8 Humidier Connector

9 Air Outlet Port Connect the tubing here.

10 Power Inlet Connect the power cord here.

Turn the dial to scroll between options on the screen. Press the dial to
choose an option.

Humidier connects to the back of the therapy device. The humidier

pin connector will attach here.

5User Manual

Installing/Replacing the Air Filters

Caution: A properly installed, undamaged Philips Respironics blue pollen lter is required for proper operation.

The device uses a reusable blue pollen lter that can be rinsed and and a disposable light-blue ultra-ne lter. The
reusable blue lter screens out normal household dust and pollens, while the light-blue ultra-ne lter provides more
complete ltration of very ne particles. The reusable blue 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.

The reusable blue lter is supplied with the device. A disposable light-blue ultra-ne lter may also be included. If your
lter is not already installed when you receive your device, you must at least install the reusable lter before using the

device.

This device has an automatic air lter reminder. Every 30 days, the device will display a message reminding you to
check your lters and replace them as directed.

Note: This message is a reminder only. The device does not detect the performance of the lters nor does it
recognize when a lter has been rinsed or replaced.

1. Lift up on the lter access door and swing open. If replacing, pull out the old lter assembly.

2. If applicable, place a dry, reusable blue pollen lter (1) on top of a new, optional disposable light-blue ultra-ne lter
(2) and rmly snap them together.

3. Place the new lter assembly back in the side of the therapy device. Swing the door closed.

6 User Manual

Where to Place the Device

Place the device on a rm, at surface somewhere within easy reach of where you will use it at a level lower than
your sleeping position. Make sure the device is away from any heating or cooling equipment (e.g., forced air vents,
radiators, air conditioners).

Note: When positioning the device, make sure that the power cable is accessible because removing power is the

only way to turn off the device.

Caution: Make sure the lter area on the side 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.

Caution: Do not place the device directly onto carpet, fabric, or other ammable materials.
Caution: Do not place the device in or on any container that can collect or hold water.

Supplying AC Power to the Device

Complete the following steps to operate the device using AC power:

1. Plug the socket end of the AC power cord (included) into the power supply (also included).

2. Plug the pronged end of the AC 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 side of the device.

4. Verify that the plug at the side of the device, at the power supply, and at the electrical outlet are fully inserted. This
will help to ensure that a secure, reliable electrical connection has been made.

Note: If the following Check Power icon appears on the screen, please repeat step 4.

Important: To remove AC power, disconnect the power supply cord from the electrical outlet.
Warning: Periodically inspect electrical cords and cables for damage or signs of wear. Discontinue use and replace

if damaged.

Caution: Do not use extension cords with this device.

7User Manual

Connecting the Breathing Circuit

To use the system, you will need the following accessories in order to assemble the recommended breathing 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, 1.83 m (6 ft.)

• Philips Respironics headgear (for the mask)

To connect your breathing circuit to the device, complete the following steps:

1. Connect the exible tubing to the air outlet on the back of the therapy device. Line up the connector (1) at the top

of the heated tube to the top of the air outlet port on the back of the device.

2. Press the tubing into place over the air outlet port until the tabs on the side of the tube click into place in the slots

on the sides of the outlet port.

Note: If you are using a standard tube (not shown) instead of a heated tube, simply slide the tubing over the air

outlet port on the therapy device.

Note: If you are using the optional 12 mm tubing, an adaptor is required to connect to the therapy 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.

3. Connect the tubing to the mask. For proper placement and positioning, refer to the instructions that came with

your mask.

Warning: Do not pull or stretch the tubing. This could result in circuit leaks.
Warning: Inspect the tubing for damage or wear. Discard and replace the tubing as necessary.

4. Attach the headgear to the mask if necessary. Refer to the instructions that came with your headgear.

Warning: If you are using a full face mask (a mask covering both your mouth and your nose), the mask must be equipped

with a safety (entrainment) valve.

Warning: If the device is used by multiple persons (such as rental devices), a low-resistance, main ow bacteria lter

should be installed in-line between the device and the circuit tubing to prevent contamination.

8 User Manual

Navigating the Device Screens

The User Interface (UI) on this device allows you to adjust the device settings and view information about your

therapy. The UI is comprised of the display screen and the control dial. Rotate the control dial in either direction to
scroll through the menu options on the display screen.
Note: The display is not a touch screen. You must use the control dial to navigate the device menu.

To adjust a setting:

1. Rotate the control dial to your desired menu option.

2. Press the control dial to select that setting.

3. Rotate the control dial to change the setting.

4. Press the control dial again to save the change.

Note: The rotate dial icon on any screen indicates to rotate the dial to perform an action. The click dial icon

on any screen indicates to press the dial to perform an action.

Note: Pressing the dial when the down arrow appears on any screen will take you to a sub-menu with more

menu options. Pressing the dial when the up arrow appears on any sub-menu will return you back to the main
menu.

Note: The screens shown throughout this manual are examples for reference only. Actual screens may vary based

upon device model and provider settings.

Starting the Device

1. Ensure power is supplied to the device. The rst screen to display will be the Philips Respironics logo, followed by
the device model screen, and then the Home screen.

Home Screen

The rst time the device is powered on, a pop-up may prompt you to set the time on the device. The default setting

is Greenwich Mean Time, but if prompted you may adjust the time in 30 minute increments to match your local
time zone. The time can always be adjusted under the “My Setup” menu.

Note: This time setting is not displayed as a clock function on the device. It is only used to align your therapy data

for your Provider’s data reports.

2. Put on your mask assembly. Refer to the instructions supplied with the mask.

3. Press the Therapy button ( ) on top of the device to turn on airow and begin therapy. The current delivered
pressure will display on the screen.

4. Make sure that no air is leaking from your mask. If necessary, adjust the mask and headgear until the air leak stops.

See the instructions provided with your mask for more information.

Note: A small amount of mask leak is normal and acceptable. Correct large mask leaks or eye irritation from an air

leak as soon as possible.

5. If you are using the device in a bed with a headboard, try placing the tubing over the headboard. This may reduce

tension on the mask.

6. Press the Therapy button again to turn off therapy.

Note: During therapy, if there is a mains interruption (i.e. power loss) the device will return to the Home screen

once power is restored. You may resume therapy as needed.

9User Manual

Menu Navigation (Therapy ON) and Optional Humidication Settings

While the device is delivering therapy, you can adjust Tube Temperature or Humidier Settings. Rotate the control dial

to choose either setting. Press and rotate the dial to change the setting.

Note: If you are using the Humidier without the Heated Tube, simply just rotate the control dial to change the
Humidier setting.

Therapy Pressure Screen

# Feature Description

1 Therapy Pressure Displays the current delivered pressure.

Adjustable Tube Temperature

2

Setting

3 Adjustable Humidier Setting

4 Enabled Features

You can change this setting from 0 to 5. Only displays when optional
heated tube is connected.

You can change this setting from 0 to 5. Only displays when

humidier is attached.
Depending on setup, certain enabled therapy features will display

here.

Ramp Feature

The device is equipped with an optional ramp feature that your home care provider can enable or disable. This

feature reduces the air pressure when you are trying to fall asleep and then gradually increases (ramps) the pressure

until your prescription setting is reached, allowing you to fall asleep more comfortably.
If ramp is enabled on your device, after you turn on the airow, press the Ramp ( ) button on the top of the

device. You can use the Ramp button as often as you wish during the night.

When you click the ramp button, the Therapy screen will change to reect the Ramp pressure, and the green circle
will reect the gradual increase in pressure.

Ramp Pressure Screen

Your device has two ramp modes. Your Provider will select the one that is most appropriate for you. The standard

ramp mode increases pressure at a steady rate. Alternately, the SmartRamp mode maintains a constant lower
pressure until the device detects that you require more pressure.

10 User Manual

Menu Navigation (Therapy OFF)

From the Home screen, you can scroll between the following menus. Only the menus available and enabled on your

device will display.

My Info Preheat My Provider My Setup

My Info: This menu provides summary statistics of your therapy use.
Preheat (if available): This function lets you warm up your humidier for 30 minutes before starting a therapy

session.
My Provider: This menu contains information that your provider may direct you to read to them so they can

better assist you over the phone.

My Setup: This menu contains comfort settings that you can adjust as needed.

My Info:

When you select “My Info”, you will be able to view the following screens. These screens will only display if they

are available and enabled on your device. You cannot change settings in the Info menu. These screens are only for
reference. Your home care provider may periodically ask you for this information.

Icon Text Description

Therapy Hours This screen displays the amount of time the user is actually receiving therapy

on the device for the most recent 1 day time frame. It also displays the

average amount of time the patient is actually receiving therapy over the last 7

days and 30 days.

AHI AHI This screen displays the nightly Apnea/Hypopnea indices (AHI) value for the most

recent 1 day time frame. It also displays the average of these individual nightly

AHI values over a 7 day and a 30 day time frame. This screen only displays if your

home care provider has enabled it.

Mask Fit Displays the value “100% minus Large Leak”. Large Leak is the percentage of

time that the mask leak was so high that it is no longer possible for the device
to identify respiratory events with statistical accuracy. Displays the value for the

most recent 1 day, as well as the values over last 7 days and 30 days. This screen

only displays if your home care provider has enabled it.

Periodic

Breathing

Periodic
Breathing

Displays the percentage of time that the user experienced periodic breathing.

Displays the value for the most recent 1 day time frame, as well as values for the
last 7 days and 30 days. If you observe a large increase in the percent of time in
periodic breathing indicated here, contact your home care provider for assistance.

This screen only displays if your home care provider has enabled it.

11User Manual

Icon Text Description

90%

Pressure

IPAP: 90%

Pressure

EPAP: 90%

Pressure

90% Pressure This screen displays the nightly value of 90% Pressure for the most recent 1 day

time frame. It also displays the average of these individual nightly values of 90%

Pressure over a 7 day and a 30 day time frame. Available on the Auto model.

IPAP: 90%

Pressure

EPAP: 90%

Pressure

Displays the value of 90% inhalation pressure for the most recent 1 day, as well as the
average values over the last 7 days and 30 days. Available on the BiPAP Auto model.

Displays the value of 90% exhalation pressure for the most recent 1 day, as well as the
average values over the last 7 days and 30 days. Available on the BiPAP Auto model.

Preheat (if available):

Preheat On Screen Preheat Off Screen

Note: The Preheat menu will only display if it is available on your device.

When using a humidier, the device can preheat the water tank for up to 30 minutes prior to starting therapy.
In order to activate the preheat mode, the blower must be “off ” and a humidier must be attached. When “Preheat”
is selected, you will be able to turn the control dial to choose between “on” or “off”. Press the control dial again to
make your selection. During the 30 minute preheat, you will still be able to use the control dial to select other menu

options from the Home screen.

My Provider:

When you select “My Provider”, you will be able to view the following screens. These screens will only display if they

are available and enabled on your device. You cannot change settings in the Provider menu. These screens are only for
reference. Your home care provider may periodically ask you for this information.

Icon Text Description

Device Info This screen displays your therapy device information: serial number, model and

software version.

Provider Contact
Info

Phone-In This screen displays the total therapy hours for the device, the total blower

12 User Manual

This screen will display the contact information for your provider if it has been
uploaded to your device.

hours, the total number of days used when the sessions were greater than 4
hours, and a compliance check number used by your home care provider to

validate that the data provided by you is the data taken from this screen.

Icon Text Description

Compliance This screen displays your start date, the total number of days used when the

sessions were greater than 4 hours, and a check code number used by your

home care provider.

VIC90 VIC90 This Visual Inspection Check screen will display a check code number created

from information gathered over the most recent 90 day period. This 15 digit
number will display as: xxx.xxxx.xxxx.xxxx. Your home care provider may
periodically ask you for this information.

A-TRIAL A-Trial If Auto-Trial mode is available, this screen displays Days: xx/xx (where xx/xx is

the number of accumulated trial days / number of selected trial days). Available

on the Pro, Auto, BiPAP Pro, and BiPAP Auto models.

Upload Allows user to initiate a modem call when an optional Cellular Modem or Wi-Fi

Accessory is installed. Signal strength is indicated at the top right of this screen.

After the modem upload has nished, the screen will either display a green
checkmark with the text “Completed” to indicate a successful upload, or a red X
with the text “Failed” to indicate an unsuccessful upload. If the upload fails, initiate
an upload a second time, or contact your home care provider if the issue persists.

This screen is locked if modem is off.

Performance
Check

Your device is equipped with a self-diagnostic tool called “Performance Check.”

This tool can evaluate your device for certain errors. It also allows you to share
key device settings with your home care provider. Use Performance Check when
directed to by your home care provider.

At conclusion of the scan, the screen displays a green checkmark if no issue is
detected. If device displays a red “X,” please contact your home care provider for

assistance.

My Setup:

When you select “My Setup”, you will be able to view the following screens. These screens will only display if they are

available and enabled on your device. You can change the settings in the Setup menu.

Icon Text Description

Ramp This displays the ramp starting pressure. You can increase or decrease the ramp

starting pressure in 0.5 cm H2O increments.

Ramp Time When you set the Ramp time, the device increases the pressure from the value

set on the Ramp screen to the therapy pressure setting over the length of time
specified here.

13User Manual

Icon Text Description

Flex This allows you to adjust the level of air pressure relief that you feel when you

exhale during therapy. Your home care provider can enable or disable this

feature. When your provider enables Flex, a level will already be set for you on

the device. You can increase or decrease the setting from 1 to 3. The setting of

“1” provides a small amount of pressure relief, with higher numbers providing

additional relief.

Note: If a lock icon is displayed on this screen, it indicates that your
provider has locked this setting and you cannot change it.

Rise Time Rise time is the time it takes for the device to change from EPAP to IPAP. This

screen allows you to adjust the rise time so you can nd the desired setting.

Humidication This displays the Humidication Mode being used. You can choose between

Fixed or Adaptive Humidication. If a heated tube is being used, the device will
automatically switch to Heated Tube Humidication Mode. A “lock” symbol will

appear next to the mode setting indicating that so long as the heated tube is

attached to the device, this mode cannot be changed. However, the heater plate
and tube temperature settings can still be adjusted on the device Therapy screen

as normal.

Mask Type This setting allows you to adjust the level of air pressure relief based on the

specic Philips Respironics mask. Each Philips Respironics mask may have a
“System One” resistance control setting. Contact your home care provider if
you cannot nd this resistance setting for your mask.

Note: If a lock icon is displayed on this screen, it indicates that your
provider has locked this setting and you cannot change it.

Tube Type This setting allows you to select the correct size diameter tubing that you are

using with the device. You can choose either (22) for the Philips Respironics 22

mm tubing, (15) for the Philips Respironics 15 mm tubing, or (12) for the optional
Philips Respironics 12 mm tubing.. When using Heated Tubing, the device will

automatically change this setting to the appropriate tubing type (15H) and you
will not be able to change it.

Note: Tubing is identied on the cuff with the tubing identier symbol: “12”,
“15”, or “15H”. 22 mm tubing contains no symbol.

Note: If a lock icon is displayed on this screen, it indicates that your
provider has locked this setting and you cannot change it.

Language This feature allows you to choose which language to display on the interface. You

can choose English or Spanish.

Check Mask Fit This feature allows you to check the t of your mask prior to starting therapy.

This is done by measuring the amount of leak.

14 User Manual

Icon Text Description

Modem Allows you to turn modem off temporarily or turn it back on. When modem

is turned off, it will automatically turn on again after 3 days. Only displays when

modem is installed.

Bluetooth Allows you to turn Bluetooth off and on. Also, it allows you to clear the pairing

with a compatible Bluetooth device.

Time Allows you to adjust the time. The default setting is Greenwich Mean Time, but

you may adjust the time in 30 minute increments to match your local time zone.

Note: This time setting is not displayed as a clock function on the device. It is

only used to align your therapy data for your Provider’s data reports.

Bluetooth Wireless Technology

Your device has Bluetooth wireless technology. which is one method by which you can transfer your therapy device’s
data to DreamMapper. DreamMapper is a mobile and web-based system designed to help Obstructive Sleep Apnea

(OSA) patients enhance their sleep therapy experience.

Pairing your therapy device to your Bluetooth enabled Mobile Device

Note: You can only pair your therapy device to one mobile device at any given time.
Note: Pairing works best when your therapy device and mobile device are in the same room.

Note: The current version of DreamMapper will guide you through these instructions.
Note: After initiating pairing, you will have 30 seconds to complete the setup. After this time, it will be

cancelled automatically.

Follow the steps below to manually pair to your mobile phone or tablet.

1. With your therapy device powered up and the blower off, initiate Bluetooth Setup from the DreamMapper mobile
app.

2. If you need to select from a list of available Bluetooth devices, the therapy device will appear as “PR BT XXXX”

(XXXX will be the last four digits of the serial number listed on your therapy device).

3. You will be required to conrm pairing via one of these two methods:

• Your mobile device may ask you to enter a PIN code

The following icon will appear on your therapy device screen with “Pair?”:

Rotate the therapy device’s Control Dial to select “yes,” and press the Control Dial. Your therapy device will display

a 6 digit PIN. Enter this PIN on your mobile device to complete pairing.

• Your mobile device may ask you to conrm a PIN code

The following icon will appear on your therapy device screen with a 6 digit PIN and “Pair?”:

Verify that the PIN is the same on both the therapy device and the mobile device. If so, rotate the therapy device’s

Control Dial to select “yes” and press the Control Dial. Then, accept on the mobile device to complete pairing.

15User Manual

Check Mask Fit

The optional check mask t feature can be enabled or disabled by your home care provider. This feature allows you to
check the t of your mask prior to starting therapy. This is done by measuring the amount of leak. Put on your mask
assembly. Refer to your mask instructions if needed. Navigate to the Check Mask Fit screen under “My Setup” and

press the control dial to initiate the check.

The device will deliver a test pressure while the screen counts down 40 seconds. A green bar indicates good t, while
a red bar indicates improvement is needed. After the test, normal therapy will start and the screen will either display
a green checkmark or a red “X”. The green checkmark indicates that the leak found allows for optimal performance
of the device. The red “X” indicates that the leak may affect device performance, however, the device will remain

functional and deliver therapy.

Check Mask Fit Screen

Note: If you choose to try to improve your mask t, you can stop therapy, adjust the t of your mask, and rerun

the check mask t. Please refer to the instructions that came with your mask and headgear for the proper tting

procedure.

Sleep Progress

Your device provides summary information about your therapy use each time the therapy is turned off. The rst
screen displays your “Three Night Summary.” It shows your nightly usage for the last 3 sleep sessions (measured in
24 hour periods, ending at noon each day). The most recent session is displayed in the right hand bar, labeled with the
number of hours slept. A green bar indicates that you slept more than 4 hours, and a yellow bar indicates less than 4

hours of use.

The second screen shows the total number of 4+ hour nights that you have slept in the last 30 days. It provides a goal
of sleeping at least 4 hours per night for 70% of the last 30 nights. Therefore the goal is 21 “good nights” of use. This
screen provides a simple way to track your progress. The screen will stop displaying when you reach the goal, or after
the rst 90 days of use has passed, whichever comes rst.

Three Night Summary Screen Goal Progress Screen

Altitude Compensation

This device automatically compensates for altitude up to 7,500 feet. No manual adjustment is necessary.

16 User Manual

Device Alerts

Device alerts are pop-ups that show up on the UI screen. There are 5 types of alerts described here:

• Status: These alerts are just the pop-up screen.

• Notication: These alerts consist of the pop-up screen in addition to a blinking Power LED on top of the device.

• Alert 1: These alerts consist of the pop-up screen, a blinking Power LED and an audible beep when displayed. This

alert will not occur during therapy.

• Alert 2: These alerts consist of the pop-up screen, a blinking Power LED and an audible beep when displayed. This

alert can occur during therapy.

• Safe State: These alerts consist of the pop-up screen, a blinking Power LED and a repeating audible beep.

Note: Status alerts automatically time out after 30 seconds and their pop up screens disappear. All other alerts

must be acknowledged to clear.

Alert Summary Table: The following table summarizes the alerts.

Alert Icon Type Description Possible Cause Action

Data Activity: Do

not remove SD
card.

Change Accepted Status Conrms acceptance

EZ-Start Pressure

Incremented to
xx.x

Oximetry: Good

Connection
(icon only)

Pair?: 123456
Yes/No

Status SD card read/write

underway.

of prescription change
or device upgrade.

Status Displays when

EZ-Start mode is

enabled and device
is increasing therapy
pressure setting for
the next session.

Status Displays on the

therapy screen when
the blower is on
and 3 seconds of
good connection is
detected. Appears
at the beginning of
therapy. This screen
will not display again

if the nger probe is

removed and reapplied
unless therapy is
stopped and restarted.

Status Prompts to accept or

decline pairing to a
Bluetooth compatible
device. This device can

be identied by the

digits displayed.

n/a No action needed.

n/a No action needed.

n/a No action needed.

n/a No action needed.

n/a Rotate control dial to

accept pairing (Yes),
or decline (No), then

press control dial to

conrm selection.

17User Manual

Alert Icon Type Description Possible Cause Action

SD Card
Removed.

Notication

or Alert 2

Indicates SD card has
been removed from

SD card was not
reinserted into device.

Reinsert SD card, or

click to clear alert.
therapy device and not
reinserted before the
start of the current
therapy session.

Oximetry: Good

Study
(icon only)

Notication Noties that user has

a achieved at least 4

hours of therapy and

n/a Press Control Dial to

acknowledge and clear

the message.
oximetry use. Appears
at the end of therapy.

SD Card Error:

Remove and
Reinsert

Notication SD card error

detected

Device cannot read
the SD card. A
problem may exist
with the SD card or

it was ejected during
a writing activity,

Remove SD card

and reinsert. If alert

continues to occur,

replace with another

card or contact your

provider.

or it was inserted
incorrectly.

SD Card Full. Notication SD card is full. SD card is full. Remove SD card and

replace with a new

card, or contact your

provider for a new SD

card.

Patient Message
(Refer to section)

Notication Message from your

Provider.

n/a Press Control Dial to

acknowledge and clear

the message.

Change Rejected Alert 1 A prescription or

settings change was

Change missing or
incorrect.

Contact your provider.

rejected.

Humidication

Error. Contact
support if the
problem persists.

Status Humidier error (only

when humidier is

present)

Humidier heater

plate error or

humidier not

properly connected to
therapy device

Turn off device and

disconnect from

power. Detach the

humidier, visually

check that electrical

contacts are clear, then

reconnect humidier

and power cord. If

alert continues,

contact your provider.

18 User Manual

Alert Icon Type Description Possible Cause Action

Heated Tube
Error. Contact
support if the

Status Heated tube error

(only when heated
tube is present)

Heated tube may
be overheated or
damaged.

problem persists.

The attached
power supply
does not support

humidication.

Alert 2 Indicates that the

attached power
supply is not capable
of supporting

Incorrect power
supply.

humidication or

heated tube.

Service Required Safe State Indicates an error

Device error. Press Control Dial

which enters device

into “Safe State.”

This allows power to

remain on but airow

is disabled.

Check Power Notication Indicates an

incompatible power
supply is attached.

Incompatible power

supply, or power cord

is not fully inserted

into device’s power

inlet.

Low Voltage Notication Low voltage. Incompatible power

supply is attached.

Automatic Off Status Displayed when

therapy ends due to

The mask has been
removed.

automatic off function.

Turn off device.

Detach heated tube

from humidier, make

sure that tube is not

covered or obstructed,

and then reattach

to humidier. If alert

continues, contact

your provider.

Switch to a Philips

Respironics

DreamStation

power supply that is

capable of supporting

humidication. Or

operate therapy device

without humidier.

to silence alert.

Disconnect device

from power. Reattach

power cord to restore

power. If the alert

continues to occur,

contact your home

care provider.

Conrm power cord

is fully inserted into

device’s power inlet.

Conrm a compatible

Philips Respironics

power supply is

attached. Switch to

compatible power

supply if needed.

Conrm a compatible

Philips Respironics

power supply is

attached. Switch to

compatible power

supply if needed. If

battery is being used,

ensure battery is

adequately charged.

Put your mask back

on, conrm good t,

and turn airow on to

resume therapy.

19User Manual

Alert Icon Type Description Possible Cause Action

Inlet blocked.

Check lter.

Low Leak: Check

Mask and Tube

Check Mask Fit n/a Status Displayed when Check

Notication Blocked airway Blockage at device

inlet.

Notication Blocked airway Blockage at tube or

mask.

n/a This alert can be
Mask Fit function is
enabled from Patient
Menu.

Loading Language
and Rebooting

Status Displayed when a new

language is selected

n/a No action needed.

from the menu.

Busy Status Displayed when the

n/a No action needed.
device is temporarily
inaccessible due to
data communication.

“Sleep Progress” n/a Status Displays last 3 nights

n/a Press Control Dial

hourly use on rst
screen, and nights of

use on second screen.

Check device air inlet
is not obstructed.

Check air lter(s)
are installed properly;

replace if needed.
Check tube is not

crushed or folded

such that air ow is

restricted. Check mask
is attached properly
and without any
obstruction.

cleared by pressing
the Control Dial.
Otherwise it will time
out after 60 seconds.

Times out when
complete.

to acknowledge and
clear each screen.
Otherwise message
times out after 30
seconds.

Troubleshooting

Your device is equipped with a self-diagnostic tool call “Performance Check”. This tool can evaluate your device for certain errors. It

also allows you to share key device settings with your Provider. Use Performance Check when directed by your provider.

The table below lists some of the problems you may experience with your device and possible solutions to those problems.

Problem Why It Happened What To Do

Nothing happens

when you apply
power to the device.
The backlights on the
buttons do not light.

20 User Manual

There’s no power

at the outlet or the
device is unplugged.

If you are using AC power, check the outlet and verify that the device is properly

plugged in. Make sure there is power available at the outlet. Make sure the AC
power cord is connected correctly to the power supply and the power supply cord

is securely connected to the device’s power inlet. If the problem continues to occur,

contact your home care provider. Return both the device and power supply to your

provider, so they can determine if the problem is with the device or power supply.
If you are using DC power, make sure your DC power cord and battery adaptor

cable connections are secure. Check your battery. It may need recharged

or replaced. If the problem persists, check the DC cord’s fuse following the

instructions supplied with your DC cord. The fuse may need to be replaced. If the

problem still occurs, contact your home care provider.

Problem Why It Happened What To Do

The airow does not

turn on.

The device’s display

is erratic.

The Ramp feature
does not work when
you press the Ramp
button.

The airow is

much warmer than
usual.

The airow pressure

feels too high or too
low.

Tube Temperature is

turned on in “Setup”

screen but Heated
Tubing is not warm.

I’m having difculty
adjusting the heated
humidier setting

or the heated tube
temperature setting.

There may be a
problem with the
blower.

The device has
been dropped or

mishandled, or

the device is in
an area with high
Electromagnetic
Interference (EMI)
emissions.

Your home care
provider did not
prescribe Ramp

for you, or your

therapy pressure is
already set to the
minimum setting.

The air lters may

be dirty. The device
may be operating
in direct sunlight or
near a heater.

The Tubing type
setting may be
incorrect.

Incorrect power
supply is being used.

The blower is not

turned on, or the
humidier or heated

tube is not fully
connected.

Make sure the device is powered correctly. Make sure the Home screen appears on

the user interface. Press the Therapy button on top of the device to start airow.
If the airow does not turn on, there may be a problem with your device. Contact

your home care provider for assistance.

Unplug the device. Reapply power to the device. If the problem continues, relocate
the device to an area with lower EMI emissions (away from electronic equipment
such as cellular phones, cordless phones, computers, TVs, electronic games, hair
dryers, etc.). If the problem still occurs, contact your home care provider for

assistance.

If Ramp has not been prescribed for you, discuss this feature with your home care

provider to see if they will change your prescription.

If your provider has enabled Ramp, but the feature still does not work, check the

current pressure setting on the Therapy screen. If the therapy pressure is set to the

minimum setting (4.0 cm H2O), or the Ramp starting pressure is the same as the
therapy pressure, the Ramp feature will not work. Make sure that the ramp time

setting is >0.

Rinse or replace the reusable air lter or replace the disposable ultra-ne lter.

The temperature of the air may vary somewhat based on your room temperature.
Make sure that the device is properly ventilated. Keep the device away from bedding

or curtains that could block the ow of air around the device. Make sure the device
is away from direct sunlight and heating equipment.

If using the humidier with the device, check the humidier settings. Refer to the
humidier instructions to make sure the humidier is working properly.

If the problem continues, contact your home care provider.

Make sure the Tubing type setting (22 or 15) matches the tubing that you are using
(Philips Respironics 22 or 15 mm tubing).

If you are using the Heated Tubing, this setting will be 15H and you cannot change it.

Make sure the 80W power supply is being used or a compatible battery or DC cable

is being used.

The humidier setting and tube temperature settings can only be adjusted from the
Therapy ON display screen. Conrm that the blower is turned on, and that the
settings are visible on the right side of the screen, then adjust to desired comfort. If
the blower is on but the humidier settings are not displayed on the Therapy ON
screen, then unplug the device. Conrm that the humidier and/or heated tube
electrical contacts are not obstructed or damaged. Then reconnect the humidier
and/or heated tube, and reconnect the device’s power supply. Turn the blower on; if
the settings are still not visible, contact your provider for assistance.

21User Manual

Problem Why It Happened What To Do

The water in the
water chamber runs
out before morning.

I hear a leak or
whistling sound
coming from my
therapy device or

humidier (not

related to mask leak).

I accidentally spilled
water into my

humidier basin.

Water chamber

was not full at start
of session. Mask
leak is excessively
high. The ambient
conditions are very
dry/cool.

The therapy device
air inlet may be
obstructed. The

humidier or tube is

not fully connected.

The humidier seals

are not fully seated
or are missing.

The water
chamber has been

lled beyond the
maximum ll line.

Under most conditions, a full water chamber should last for a typical sleep
session. However, many factors impact water consumption, including: the ambient
temperature and humidity in your bedroom, your humidier or heated tube settings,
the level of mask leak, and the duration of your sleep session.

First, make sure that the water chamber is lled to the maximum ll line at the start
of your sleep session. Check that your mask is tted properly, and adjust as needed

to reduce mask leak to normal levels. You may use the Check Mask Fit function to

evaluate your mask t. Also, conrm that the device, humidier, humidier seals

and tube are connected properly and not leaking. You may also choose to lower

your humidier and/or heated tube settings or change the humidication mode from
Fixed to Adaptive humidication mode to increase the time that your humidier

water will last.

Check therapy device air inlet is not obstructed, and lters are free of debris and
properly inserted. Conrm that the device, humidier, and tube are connected
properly and not leaking. Conrm that the humidier lid seal and dry box seal are
present and properly seated; if needed, gently press around the perimeter of the

seals to reseat them.

A small amount of water spilled in the basin of the humidier will not harm your
device. A small spill in the humidier will evaporate under normal humidier use.
However, too much water in the humidier basin could spill over the humidier lid

hinge and might damage your furniture.

Disconnect power from the device. Remove the water chamber, pour out any
excess water until the water level is at or below the maximum ll line and set the
chamber aside. Separate the humidier from the therapy device, and pour out the
spilled water. Once the heater plate has cooled, wipe the inside of the humidier
with a paper towel or soft cloth. If needed, dry the underside of the humidier and
conrm that your table top is dry. Reconnect the humidier and power supply, and

reinstall the water chamber.

Accessories

There are several accessories available for your DreamStation system such as a Humidier, Cellular Modem,
Wi-Fi Accessory or a Link Module. Contact your home care provider for additional information on the available
accessories. When using optional accessories, always follow the instructions enclosed with the accessories.

Caution: Pins of connectors should not be touched. Connections should not be made to these connectors

unless ESD precautionary procedures are used. Precautionary procedures include methods to prevent build-up
of electrostatic charge (e.g., 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 or a large metal object, and bonding

oneself by means of a wrist strap to the equipment or system or to earth.

Adding a Humidier with or without Heated Tubing

You can use the heated humidier and the heated tube with your device. They are available from your home care
provider. A humidier may reduce nasal dryness and irritation by adding moisture to the airow.

Warning: For safe operation, the humidier must always be positioned below the breathing circuit connection
at the mask. The humidier must be level for proper operation.

Note: Refer to the humidier’s instructions for complete setup information.

Using the SD Card

The DreamStation system comes with an SD card inserted in the SD card slot on the side of the device to record
information for the home care provider. Your home care provider may ask you to periodically remove the SD card
and send it to them for evaluation.

Updating Software Using the SD card

To check which version of software is currently on your device, navigate to My Provider and select Device Info.

You can update the device software using the SD card. The software update must be done when the therapy is off.

22 User Manual

1. Insert an SD card with the new software version into the device. A pop-up screen appears asking “Would you

like to upgrade software?”

2. Turn the control dial to select Yes and then press the control dial to start the upgrade. The busy icon appears
while the upgrade is in progress. Do not remove power from the device.

3. If the software update is successful, the Change Accepted icon appears on the screen. Removed the SD card
from the device to restart the device and use the new software.

4. If an SD card error is detected, the Change Rejected icon appears . Remove the SD card and reinsert. If the
alert continues to occur, contact Philips Respironics at 1-800-345-6443 or 1-724-387-4000 for a new SD card.

Using the DreamStation Link Module

The Link Module is able to receive oximetry data and transfer it to the therapy device for home use or in a laboratory

setting. For use in a laboratory setting, the Link Module also includes an RS-232 (or “DB9”) port to allow remote

control of the DreamStation Sleep Therapy Device by a personal computer.
Note: Please consult the instructions that accompany the Link Module for installation and removal.
Note: There are no SpO2 alarms available.
Note: Oximetry data is not displayed.
Dispose of the module following the same disposal instructions for your therapy device.

Warnings:

• If you notice any unexplained changes in the performance of this device, if it has been dropped or mishandled,
if water is spilled into the enclosure, or if the enclosure is broken, discontinue use. Contact your home care

provider.

• 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 damage.

• Do not use any accessories, detachable parts, and materials not recommended by Philips Respironics.

Incompatible parts or accessories can result in degraded performance.

Adding Supplemental Oxygen

Oxygen can be added to the patient circuit. Please note the warnings listed below when using oxygen with the device.

Warnings:

• When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen.

• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open ame.

• If supplemental oxygen is added at the exit of the ow generator or humidier, a Philips Respironics Pressure Valve
must be placed in-line with the patient circuit between the device and the oxygen source. The pressure valve helps
prevent the backow of oxygen from the patient circuit into the device when the unit is off. Failure to use the
pressure valve could result in a re hazard.

• When adding oxygen at the mask end of the hose, a Philips Respironics Pressure Valve is not required for oxygen
ow rates of ≤4 liters per minute. However, the reusable and disposable lters must be in place on the ow
generator. Failure to install both the reusable and disposable lters could result in a re hazard.

Note: Refer to the pressure valve’s instructions for complete setup information.

• 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.

• Do not connect the device to an unregulated or high pressure oxygen source.

Supplying DC Power to the Device

A Philips Respironics DC power cord can be used to operate this device in a stationary recreational vehicle, boat,
or motor home. In addition, a Philips Respironics DC battery adapter cable, when used with a DC power cord,
allows the device to be operated from a 12 VDC free-standing battery.

Caution: Always ensure that the DC power cord securely ts into your therapy device prior to use. Contact

your home care provider or Philips Respironics to determine if you have the appropriate DC cord for your

specic therapy device.
Caution: When DC power is obtained from a vehicle battery, the device should not be used while the vehicle’s

engine is running. Damage to the device may occur.
Caution: Only use a Philips Respironics DC Power Cord and Battery Adapter Cable. Use of any other system

may cause damage to the device.
Refer to the instructions supplied with the DC power cord and adapter cable for information on how to operate
the device using DC power.

23User Manual

Traveling with the System

When traveling, the carrying case is for carry-on luggage only. The carrying case will not protect the system if it is put
through checked baggage. If traveling with the optional humidier, do not travel with water in the water tank.
For your convenience at security stations, there is a note on the bottom of the device stating that it is medical
equipment and is suitable for airline use. It may be helpful to bring this manual along with you to help security

personnel understand the DreamStation device.

If you are traveling to a country with a line voltage different than the one you are currently using, a different power
cord or an international plug adaptor may be required to make your power cord compatible with the power outlets

of the country to which you are traveling. Contact your home care provider for additional information.

Airline Travel

The device is suitable for use on airlines when the device is operating from an AC or DC power source.

Note: It is not suitable for airline use with any of the modems or humidiers installed in the unit.

Cleaning the Device

Warning: To avoid electrical shock, always unplug the power cord from the wall outlet before cleaning the device.

DO NOT immerse the device in any uids.

1. Unplug the device, and wipe the outside of the device with a cloth slightly dampened with water and a mild

detergent. Let the device dry completely before plugging in the power cord.

2. Inspect the device and all circuit parts for damage after cleaning. Replace any damaged parts.

Caring for the Filters

Under normal usage, you should rinse the reusable blue pollen lter at least once every two weeks and replace it with
a new one every six months. The disposable light-blue ultra-ne lter should be replaced after 30 nights of use or
sooner if it appears dirty or damaged. DO NOT rinse the ultra-ne lter.
Caution: Dirty inlet lters may cause high operating temperatures that may affect device performance. Regularly

examine the inlet lters as needed for integrity and to check for accumulated debris.

This device has an automatic air lter reminder. Every 30 days, the device will display a message reminding you to
check your lters and replace them as directed.

Note: This message is a reminder only. The device does not detect the performance of the lters nor does it
recognize when a lter has been rinsed or replaced.

1. If the device is operating, stop the airow. Disconnect the device from the power source.

2. Remove the lter(s) from the device. Refer to the “Installing/Replacing the Air Filters” section of this manual.

3. Take the reusable lter to a sink, turn it upside down, and run warm tap water through the white middle portion of
the lter to rinse away any debris.

4. Shake the lter to remove as much water as possible.

5. Allow the lter to air dry completely before reinstalling it. If the lter is damaged, replace it. (Only Philips
Respironics-supplied lters should be used as replacement lters.)

6. Reinstall the lters. Refer to the “Installing/Replacing the Air Filters” section of this manual.

Caution: Never install a wet lter into the device. You must ensure sufcient drying time for the lter.
Note: Only Philips Respironics-supplied lters should be used as replacement lters.
Note: Replace the disposable, ultra-ne lter if it is damaged for has accumulated debris.

Cleaning the Tubing

Hand wash the tubing and the mask adaptor (if included) before rst use and daily.
For daily cleaning, disconnect the tubing from the device and the mask, and, if included, disconnet the mask
adaptor from the tubing. For the 12, 15, or 22 mm exible tubing, gently wash the tubing and mask adaptor in a
solution of warm water and a liquid dish soap. Rinse thoroughly. Air dry. Inspect the tubing and mask adaptor for

damage or wear. Discard and replace if necessary.

Note: Refer to the humidier manual for the instructions on how to clean the heated tube.
Caution: Do not clean the tubing and mask adaptor with bleach, alcohol, solutions containing bleach or alcohol, or

solutions containing conditioners or moisturizers.

Caution: Any deviation from these instructions may impact the performance of the product.

Service

The device does not require routine servicing.
Warning: If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh

sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken,

disconnect the power cord and discontinue use. Contact your home care provider.

24 User Manual

Additional Notices

Notice: The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks

Notice: The DreamStation Therapy Device is capable of transmitting data between the therapy device and a mobile device. This

Notice: A small portion of the rmware that performs data encryption on the DreamStation device is being utilized under the

www.apache.org/licenses/LICENSE-2.0 and https://www.mozilla.org/en-US/MPL/2.0/
Notice: This device contains a FCC certied Bluetooth radio module (located on the main board).
Only the co-location of this Bluetooth radio with the radio transceivers of the DreamStation Wi-Fi Accessory and Cellular

For compliance with FCC RF exposure guidelines a minimum distance of 20 cm between the Wi-Fi Accessory or the

Notice: FCC ID: THO1116426
Notice: THO1116426 is the FCC ID of the FCC certied Bluetooth module contained in this device.
Notice: Use of non-original manufacturer-approved accessories may violate your local RF exposure guidelines and should be

Notice: This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of

• Reorient or relocate the receiving antenna (on the radio, TV, or other device).

• Increase the separation between the equipment and receiver.

• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

• Consult the dealer of the device for help.

Notice: Any changes or modications made to the device that are not expressly approved by Respironics may void the user’s

by Philips Respironics is under license. Other trademarks and trade names are those of their respective owners.

connection between the therapy device and a mobile device is encrypted.

Apache 2.0 and Mozilla 2.0 licenses. These licenses are available at:

Modem has been FCC approved and is permitted.

Cellular Modem and the user’s body should be maintained during operation of one of those accessories together with the

DreamStation.

avoided.

may not cause harmful interference, and (2) this device must accept any interference received, including interference that

may cause undesired operation.

the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential

installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference
to radio, TV reception, or other devices which can be determined by turning the equipment on and off, the user is
encouraged to try to correct the interference by one or more of the following measures:

authority to operate the equipment.

Specications

Environmental

Operating Temperature: 5° to 35° C (41° to 95° F)
Storage Temperature: -20° to 60° C (-4° to 140° F)
Relative Humidity (operating & storage): 15 to 95% (non-condensing)
Atmospheric Pressure: 101 to 77 kPa (0 - 2286 m / 0 - 7500 ft)

Physical

Dimensions: 15.7 x 19.3 x 8.4 cm (6.2” L x 7.6” W x 3.3” H)
Weight (Device with power supply): Approximately 1.33 kg (2.94 lbs)

Service Life

The expected service life of the DreamStation Therapy Device and Link Module is 5 years.

Standards Compliance This device is designed to conform to the following standards:

IEC 60601-1 General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment

EN 60601-1-2 Electromagnetic Compatibility
RTCA/DO-160G section 21, category M; Emission of Radio Frequency Energy

IEC 60601-1 Classication

Type of Protection Against Electric Shock: Class II Equipment
Degree of Protection Against Electric Shock: Type BF Applied Part
Degree of Protection against Ingress of Water:
Device: Drip Proof, IP22
Link Module: Drip Proof, IP22
80W power supply: Drip Proof, IP22
Mode of Operation: Continuous

ISO 80601-2-70 Sleep Apnea Breathing Therapy Equipment

25User Manual

Electrical

AC Power Consumption (with 80W power supply): 100 – 240 VAC, 50/60 Hz, 2.0-1.0 A
Note: Power supply is part of the medical electrical equipment.
DC Power Consumption: 12 VDC, 6.67 A
Fuses: There are no user-replaceable fuses.

Radio Specications

Operating Frequency Range: 2402 - 2480 MHz
Maximum Output Power: <10 dBm
Modulation: GFSK, P/4 DQPSK, 8DQPSK

Intake Port Filters

Pollen Filter: 100% Polyester
88% Efcient @ 7-10 micron size
Ultra-ne Filter: Blended Synthetic Fiber
95% Efcient @ 0.5-0.7 micron size

Declared Dual-Number Noise Emissions Values In accordance with ISO 4871

The A-weighted sound pressure level is:
Device: 26.1 dB(A) with and uncertainty of 2 dB(A).
Device with Humidier: 27.3 dB(A) with and uncertainty of 2 dB(A).
The A-weighted sound power level is:
Device: 34.1 dB(A) with an uncertainty of 2 dB(A).
Device with Humidier: 35.3 dB(A) with an uncertainty of 2 dB(A).

Note: Values determined according to noise test code given in ISO 80601-2-70:2015, using the basic standards
ISO 3744 and ISO 4871.

Pressure Accuracy

Bi-level Pressure Increments: 4.0 to 25.0 cm H2O (in 0.5 cm H2O increments)
Bi-level maximum static pressure accuracy, according to ISO 80601-2-70:2015:

Pressure Static Accuracy

10 cm H2O ± 0.3 cm H2O

Static pressure accuracy has a measurement uncertainty of 3.7%

Bi-level maximum dynamic pressure variation, according to ISO 80601-2-70:2015:

Pressure 10 BPM 15 BPM 20 BPM

< 10 cm H2O ± 0.4 cm H2O ± 0.5 cm H2O ± 0.8 cm H2O

≥ 10.0 to 25 cm H2O ± 0.5 cm H2O ± 0.8 cm H2O ± 1.0 cm H2O
Dynamic pressure accuracy has a measurement uncertainty of 4.3%
Note: All tests were performed with and without humidier and with 22 mm and 12 mm standard tubes and 15 mm heated tube.

Bi-level accuracy: Tests were performed according to ISO 80601-2-70:2015

Avg. Max

Deviation

IPAP EPAP BPM

8 4 10 0.38 0.02 0.29 0.01
8 4 15 0.39 0.03 0.29 0.01
8 4 20 0.26 0.17 0.22 0.02

11 7 10 0.37 0.02 0.38 0.01
11 7 15 0.37 0.03 0.36 0.01
11 7 20 0.39 0.05 0.30 0.04

17 13 10 0.35 0.03 0.48 0.01
17 13 15 0.33 0.04 0.47 0.02
17 13 20 0.58 0.04 0.40 0.03

22 18 10 0.36 0.04 0.45 0.02
22 18 15 0.39 0.05 0.53 0.02
22 18 20 0.68 0.11 0.51 0.07
25 21 10 0.42 0.03 0.50 0.02
25 21 15 0.38 0.06 0.58 0.02
25 21 20 0.59 0.22 0.57 0.07

Bi-level accuracy has a measurement uncertainty of 4.3%
The data was analyzed with 25% of the inspiratory and expiratory windows, beginning halfway through each phase (from time=50% to t=75%).

(cm H2O)

IPAP EPAP

StDev Max

Deviation
(cm H2O)

Avg. Max

Deviation
(cm H2O)

StDev Max

Deviation
(cm H2O)

26 User Manual

CPAP Pressure Increments: 4.0 to 20.0 cm H2O (in 0.5 cm H2O increments)
CPAP maximum static pressure accuracy, according to ISO 80601-2-70:2015:

Pressure Static Accuracy

10 cm H2O ± 0.3 cm H2O

Static pressure accuracy has a measurement uncertainty of 3.7%

CPAP Maximum dynamic pressure variation, according to ISO 80601-2-70:2015:

Pressure 10 BPM 15 BPM 20 BPM

< 10 cm H2O ± 0.4 cm H2O ± 0.5 cm H2O ± 0.8 cm H2O

≥ 10.0 to 20 cm H2O ± 0.5 cm H2O ± 0.8 cm H2O ± 1.0 cm H2O
Dynamic pressure accuracy has a measurement uncertainty of 4.3%

Note: All tests were performed with and without humidier and with 22 mm and 12 mm standard tubes and 15 mm heated tube.

Maximum Flow Rate (typical)

Bi-level:

22 mm
tubing

15 mm
tubing

(heated

or non-

heated)

12 mm
tubing

CPAP:

22 mm
tubing

15 mm
tubing

(heated

or non-

heated)

12 mm
tubing

Measured pressure at the patient
connection port (cm H2O)

Average ow at the patient connection

port (l/min)
Measured pressure at the patient

connection port (cm H2O)

Average ow at the patient connection

port (l/min)

Measured pressure at the patient
connection port (cm H2O)

Average ow at the patient connection

port (l/min)

Measured pressure at the patient
connection port (cm H2O)

Average ow at the patient connection

port (l/min)
Measured pressure at the patient

connection port (cm H2O)

Average ow at the patient connection

port (l/min)

Measured pressure at the patient
connection port (cm H2O)

Average ow at the patient connection

port (l/min)

Test pressures (cm H2O)

4.0 9.0 15.0 20.0 25.0

3.7 8.4 13.8 18.7 23.6

85 132 131 135 119

3.7 8.3 13.9 18.8 23.8

85 127 135 118 108

4.0 8.0 14.0 19.0 24.0

85 93 91 102 101

Test pressures (cm H2O)

4.0 8.0 12.0 16.0 20.0

3.7 7.7 11.2 14.9 18.9

85 124 131 132 128

3.7 7.4 10.9 14.9 18.8

86 127 134 133 117

4.0 7.0 11.0 15.0 19.0

85 95 94 100 102

Disposal

Separate collection for electrical and electronic equipment per EC Directive 2012/19/EU. Dispose of this device in

accordance with local regulations.

EMC Information

Your unit has been designed to meet EMC standards throughout its Service Life without additional maintenance. There is always
an opportunity to relocate your DreamStation Therapy Device within an environment that contains other devices with their own

unknown EMC behavior. If you believe your unit is affected by locating it closer to another device, simply separate the devices to

remove the condition.

Pressure and Flow Accuracy

The DreamStation Therapy Device is designed to perform within the pressure and owrate accuracies specied in the user manual.
If you suspect that the pressure and/or ow rate accuracy is affected by EMC interference remove power and relocate the device to

another area. If performance continues to be affected discontinue use and contact your home care provider.

27User Manual

SpO2 and Pulse Rate Accuracy

The DreamStation Therapy Device is designed to capture the SpO2 and Pulse Rate oximetry data within the accuracy specication

described in the sensor manufacture’s instructions for use. When 4 hours of successful oximetry data have been achieved the device
indicates this to the user by displaying “Oximetry: Good Study”. If you suspect that your unit is affected by EMC interference remove

power and relocate the device to another area. If performance continues to be affected discontinue use and contact your home care
provider.

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions – This device is intended for use in the electromagnetic
environment specied below. The user of this device should make sure it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions
CISPR 11

RF emissions
CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage uctuations/Flicker emissions
IEC 61000-3-3

Emission of Radio Frequency Energy
RTCA/DO-160G Section 21

Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions

Class B The device is suitable for use in all establishments, including domestic establishments

Class A

Complies

Category M This device is suitable for use onboard commercial airplanes inside passenger cabin.

are very low and are not likely to cause any interference in nearby electronic

equipment.

and those directly connected to the public low-voltage power supply network.

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity – This device is intended for use in the electromagnetic
environment specied below. The user of this device should make sure it is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance

Electrostatic Discharge (ESD)

IEC 61000-4-2

Electrical fast Transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short

interruptions and voltage
variations on power supply
input lines

IEC 61000-4-11

Power frequency (50/60 Hz)
magnetic eld
IEC 61000-4-8

NOTE: UT is the a.c. mains voltage prior to application of the test level.

±8 kV contact

±15 kV air

±2 kV for power supply lines

±1 kV for input-output lines

±1 kV differential mode

±2 kV common mode

<5% UT (>95% dip in UT) for

0.5 cycle at 45 degree

increments

70% UT (30% dip in UT) for 0.5

seconds

<5% UT (>95% dip in UT) for

5 seconds

30 A/m 30 A/m Power frequency magnetic elds should be at

±8 kV contact

±15 kV air

±2 kV for supply mains

±1 kV for input/output lines

±1 kV differential mode

±2 kV for common mode

<5% UT (>95% dip in UT) for

0.5 cycle at 45 degree

increments

70% UT (30% dip in UT) for 0.5

seconds

<5% UT (>95% dip in UT) for

5 seconds

Floors should be wood, concrete or ceramic tile.
If oors are covered with synthetic material, the

relative humidity should be at least 30%.

Mains power quality should be that of a typical

home or hospital environment.

Mains power quality should be that of a typical

home or hospital environment.

Mains power quality should be that of a typical

home or hospital environment. If the user of the

device requires continued operation during power
mains interruptions, it is recommended that the

device be powered from an uninterruptible power
supply or a battery.

levels characteristic of a typical location in a typical
hospital or home environment.

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity – This device is intended for use in the electromagnetic
environment specied below. The user of this device should make sure it is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms
150 kHz to 80 MHz

6 Vrms
Amateur Radio & ISM
Bands between 150 kHz
and 80 MHz

10 V/m
80 MHz to 2.7 GHz

3 Vrms
150 kHz to 80 MHz

6 Vrms
Amateur Radio & ISM
Bands between 150 kHz
and 80 MHz

10 V/m

Portable and mobile RF communications equipment should be
used no closer to any part of the device, including cables, than the

recommended 30 cm separation distance.

Interference may occur in the vicinity of equipment marked with the
following symbol:

28 User Manual

Limited Warranty

Respironics, Inc. warrants that the system shall be free from defects of workmanship and materials and will perform in

accordance with the product specications for a period of two (2) years from the date of sale by Respironics, Inc. to
the dealer. If the product fails to perform in accordance with the product specications, Respironics, Inc. will repair

or replace – at its option – the defective material or part. Respironics, Inc. will pay customary freight charges from
Respironics, Inc. to the dealer location only. This warranty does not cover damage caused by accident, misuse, abuse,
alteration, water ingress, and other defects not related to material or workmanship. The Respironics, Inc. Service
department shall examine any devices returned for service, and Respironics, Inc. reserves the right to charge an
evaluation fee for any returned device as to which no problem is found after investigation by Respironics, Inc. Service.

This warranty is non-transferable by unauthorized distributors of Respironics, Inc. products and Respironics, Inc.
reserves the right to charge dealers for warranty service of failed product not purchased directly from Respironics,
Inc. or authorized distributors.

Respironics, Inc. disclaims all liability for economic loss, loss of prots, overhead, or consequential damages which

may be claimed to arise from any sale or use of this product. Some states do not allow the exclusion or limitation of

incidental or consequential damages, so the above limitation or exclusion may not apply to you.

This warranty is given in lieu of all other express warranties. In addition, any implied warranties – including any

warranty of merchantability or tness for the particular purpose – are limited to two years. Some states do not allow

limitations on how long an implied warranty lasts, so the above limitation may not apply to you. This warranty gives

you specic legal rights, and you may also have other rights which vary from state to state.

To exercise your rights under this warranty, contact your local authorized Respironics, Inc. dealer or contact
Respironics, Inc. at:

1001 Murry Ridge Lane

Murrysville, Pennsylvania 15668-8550

1-724-387-4000

1120831

1120831 R08

HM 02/28/2018

EN-DOM