Philips BiPAP Auto Bi-Flex User Manual
BiPAP Auto Bi-Flex
USER MANUAL
© 2010 Koninklijke Philips Electronics N.V. All rights reserved.
Table of Contents
Intended Use ........................................................................................................................................................... 2
Important
Warnings
Cautions
Contraindications
Symbol Key
System Contents
System Overview
Control Buttons
Available Therapies
Installing the Air Filters
Connecting the Breathing Circuit
Where to Place the Device
Supplying AC Power to the Device
Navigating the Device Screens
Starting the Device
Ramp Feature
Mask Fit Check Feature
Flex/Rise time Screen............................................................................................................................................9
Setup Screen
Info Screen
Device Alerts
Troubleshooting
Accessories
Traveling with the System
Cleaning the Device
Cleaning or Replacing the Filters
Cleaning the Tubing
Service
Specications
Disposal
How to Contact Respironics
Limited Warranty
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1User Manual
CAUTION: U. S. federal law restricts this device to sale by or on the order of a physician.
Intended Use
The Respironics BiPAP Auto Bi-Flex system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in
spontaneously breathing patients weighing over 30kg (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. The system can deliver Bi-level therapy or Auto Bi-level therapy,
both with and without Bi-Flex. The system can also deliver CPAP therapy. For enhanced pressure relief in CPAP mode, the device can
deliver C-Flex. Your home care provider will make the correct pressure settings according to your health care professional’s prescription.
When set in the Auto Bi-level therapy mode, the system will monitor your breathing as you sleep and automatically adjust the pressure to
meet your needs. When in Bi-level or CPAP therapy, the system will deliver a continuous, set pressure during the night.
Several accessories are available to make your OSA treatment with the BiPAP Auto Bi-Flex system as convenient and comfortable as
possible. To ensure that you receive the safe, effective therapy prescribed for you, use only 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 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.
• If you are using the optional Respironics 15 mm tubing, the device tubing type setting must be set to 15. If your device does not have the
tubing type setting, you must use the Respironics 22 mm tubing.
• 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 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 backow 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 airow 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 Respironics-authorized service personnel only. Unauthorized service could cause
injury, invalidate the warranty, or result in costly damage.
• 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 humidier, the humidier must always be positioned below the breathing circuit connection at
the mask and the air outlet on the device. The humidier must be level for proper operation.
2 User Manual
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.
• 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,
humidication, 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.
• Before operating the device, ensure that the SD card cover is replaced 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 Specications.
• Do not use extension cords with this device.
• 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 reusable foam inlet lter is required for proper operation.
• Tobacco smoke may cause tar build-up within the device, which may result in the device malfunctioning.
• Dirty inlet lters may cause high operating temperatures that may affect device performance. Regularly examine the inlet lters as
needed for integrity and cleanliness.
• Never install a wet lter into the device. You must ensure sufcient drying time for the cleaned lter.
• 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 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 benets 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 35 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.
Symbol Key
The following symbols may appear on the device and power supply:
Sy m b o l Def i ni t io n Sy m b o l Def i ni t io n
Consult accompanying instructions for use.
For Airline Use. Complies with RTCA/DO-160F
section 21, category M.
DC Power Class II (Double Insulated)
Type BF Applied Part For Indoor Use Only.
Drip Proof Equipment
Separate collection for electrical and electronic
equipment per EC Directive 2002/96/EC.
Do not disassemble.
3User Manual
System Contents
Air Outlet Port
Power Inlet
Filter Area
SD Card (Accessory) Slot
Side Cover
T a b
SD Card Cover
Your BiPAP Auto Bi-Flex system includes the following items:
• Device • Reusable gray foam lter
• User manual • Disposable ultra-ne lter (optional)
• Carrying case • Side cover panel
• Power cord and power supply (Part # 1058190) • SD card
• Flexible tubing, 22 mm (optional 15 mm tubing is also available) • Humidier (optional)
Note: If any of these items are missing, contact your home care provider.
System Overview
The BiPAP Auto system offers several options in how therapy is delivered, so treatment can be personalized to meet
your needs for the treatment of Obstructive Sleep Apnea (OSA).
The system can be set up as a Bi-level or Auto Bi-level device, which delivers two different positive pressure levels:
IPAP (Inspiratory Positive Airway Pressure) and EPAP (Expiratory Positive Airway Pressure). The system 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. You also have the option of not using the ramp feature at all.
Additionally, the Flex comfort features provide you with pressure relief when you exhale during therapy.
Several accessories are also available for use with your BiPAP Auto 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.
De v i c e fe a t u r e De S c r i p t i o n
Air Outlet Port (conical, 22 mm) Connect the exible tubing here.
SD Card (Accessory) Slot If applicable, insert the optional accessory SD card here.
SD Card Cover If applicable, the optional accessories such as a Link Module or Modem can be installed
Power Inlet Connect the power cord here.
Filter Area A reusable, gray foam lter must be placed in the lter area to screen out normal household
Side Cover If using a humidier with the device, this side cover can be easily removed with the release
4 User Manual
here. Refer to the instructions supplied with the accessory. When not using an accessory,
this cover must be in place on the device.
dust and pollens. A white ultra-ne lter can also be used for more complete ltration of
very ne particles.
tab before attaching the humidier. Refer to the humidier manual. When not using a
humidier, this cover must be in place on the device.
Control Buttons
LCD Display Screen
Ramp Button
Control Wheel/Push Button
Humidifier Icon &
Number Settings
This gure shows the primary control buttons on the device, described in the following table.
fe a t u r e De S c r i p t i o n
Display Screen Shows therapy settings, patient data, and other messages. The startup screen is shown temporarily
Humidier Icon This Icon lights up when the optional humidier is attached and heat is being applied.
Control Wheel/Push
Button
Ramp Button When the airow is on, this button allows you to activate or restart the ramp function. When
when the unit is rst powered.
The humidier
number settings are only visible when the humidier is attached and therapy is active. Please refer to
the humidier user manual for more information.
Turn the wheel to toggle between options on the screen. Press the wheel to choose an option.
Primary function is to turn airow on/off.
the airow is off, this button allows you to activate the Mask Fit Check. This button lights up when
therapy is active or during specic alerts.
Available Therapies
The BiPAP Auto Bi-Flex device delivers the following therapies:
• Bi-level – Provides one level of output pressure during EPAP (Expiratory Positive Airway Pressure) and a second
higher level during IPAP (Inspiratory Positive Airway Pressure).
• Bi-level with Bi-Flex – Bi-level therapy with pressure relief upon exhalation to improve patient comfort based on
patient needs.
• Auto Bi-level – Delivers spontaneous Bi-level therapy while automatically adjusting EPAP and IPAP levels to meet
the patient’s needs.
• Auto Bi-level with Bi-Flex – Auto Bi-level therapy with pressure relief upon exhalation to improve patient
comfort based on patient needs.
The following therapy modes may also be available:
• CPAP – Delivers Continuous Positive Airway Pressure; CPAP maintains a constant level of pressure throughout
the breathing cycle.
• CPAP with C-Flex – Delivers CPAP therapy with pressure relief upon exhalation to improve patient comfort
based on patient needs.
5User Manual
Installing the Air Filters
CAUTION: A properly installed, undamaged gray foam lter is required for proper operation.
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 pollens, 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.
The reusable gray foam lter is supplied with the device. A disposable 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 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, mesh-side facing in, towards 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.
Connecting the Breathing Circuit
To use the system, you will need the following accessories in order to assemble the recommended circuit:
• Respironics interface (nasal mask or full face mask) with integrated exhalation port, or Respironics interface with a
separate exhalation device (such as the Whisper Swivel II)
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.
• Respironics 22 mm exible tubing, 1.83 m (6 ft.) (optional Respironics 15 mm tubing for compatible devices)
• Respironics headgear (for the mask)
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.
To connect your breathing circuit to the device, complete the following steps:
1. Connect the exible tubing to the air outlet on the side of the device.
WARNING: If you are using the optional Respironics 15 mm tubing, the device tubing type setting must be set to 15. If
your device does not have the tubing type setting, you must use the Respironics 22 mm tubing.
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.
Note: When using the bacteria lter, the device performance may be affected. However, the device will remain
functional and deliver therapy.
2. Connect the tubing to the mask. Refer to the instructions that came with your mask.
3. Attach the headgear to the mask if necessary. Refer to the instructions that came with your headgear.
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 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 (e.g., forced air vents, radiators, air conditioners).
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
CAUTION: 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 Specications.
WARNING: 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.
WARNING: This device is activated when the power cord is connected.
IMPORTANT: If you are using your device with a humidier, refer to the instructions included with your
humidier for details on how to power the device and humidier.
6 User Manual
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