Philips BiPAP Pro Bi-Flex, Respironics BiPAP Pro Bi-Flex User Manual
BiPAP Pro Bi-Flex
USER MANUAL
© 2012 Koninklijke Philips Electronics N.V. All rights reserved.
1User Manual
Table of Contents
Intended Use ........................................................................................................................................................... 2
Important ................................................................................................................................................................. 2
Warnings ..................................................................................................................................................................2
Cautions ................................................................................................................................................................... 3
Contraindications ..................................................................................................................................................3
Symbol Key .............................................................................................................................................................. 4
System Contents .................................................................................................................................................... 5
System Overview ................................................................................................................................................... 5
Control Buttons ..................................................................................................................................................... 6
Available Therapy Modes ......................................................................................................................................6
Available Flex Comfort Features ........................................................................................................................6
Installing the Air Filters ......................................................................................................................................... 7
Connecting the Breathing Circuit ......................................................................................................................7
Where to Place the Device ................................................................................................................................. 7
Supplying AC Power to the Device ....................................................................................................................7
Navigating the Device Screens ............................................................................................................................ 8
Starting the Device ................................................................................................................................................ 8
Ramp Feature ..........................................................................................................................................................9
Humidier Preheat ................................................................................................................................................9
Flex/Rise time Screen..........................................................................................................................................10
Setup Screen .........................................................................................................................................................11
Info Screen .............................................................................................................................................................13
Device Alerts ........................................................................................................................................................15
Troubleshooting ...................................................................................................................................................18
Accessories ...........................................................................................................................................................19
Traveling with the System ..................................................................................................................................20
Cleaning the Device ............................................................................................................................................20
Cleaning or Replacing the Filters .....................................................................................................................20
Cleaning the Tubing ..............................................................................................................................................20
Service ....................................................................................................................................................................20
Specications ........................................................................................................................................................21
Disposal ..................................................................................................................................................................22
How to Contact Philips Respironics ...............................................................................................................22
EMC Information .................................................................................................................................................23
Limited Warranty ...................................................................................................................................Back Page
2 User Manual
CAUTION: U. S. federal law restricts this device to sale by or on the order of a physician.
Intended Use
The Philips Respironics BiPAP Pro 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 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.
Several accessories are available to make your OSA treatment with the BiPAP Pro Bi-Flex 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 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 Philips 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.
Note: Please see the “Limited Warranty” section of this manual for information on warranty coverage.
3User Manual
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,
humidication, 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 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.
• 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 specic 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 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.
4 User Manual
Symbol Key
The following symbols may appear on the device and power supply:
Sy m b o l De fi ni t io n
Consult accompanying instructions for use.
AC Power
DC Power
IP22
Drip Proof Equipment
Caution, consult accompanying documents.
ESD Warning symbol
Class II (Double Insulated)
Type BF Applied Part
For Indoor Use Only.
Do not disassemble.
For Airline Use. Complies with RTCA/DO-160F section 21, category M.
Separate collection for electrical and electronic equipment per EC Directive
2002/96/EC.
Use only with the standard 60W power supply 1091398.
(not for use with Heated Tubing)
Use only with the Heated Tubing compatible 80W power supply 1091399.
(can also be used when Heated Tubing is not in use)
5User Manual
System Contents
Your BiPAP Pro Bi-Flex system may include the following items:
• Device • SD card
• User manual • Side cover panel (optional)
• Carrying case • Reusable gray foam lter
• Flexible tubing • Disposable ultra-ne lter (optional)
• Power cord • Humidier (optional)
• Power supply (60W 1091398, or 80W 1091399)
Note: If any of these items are missing, contact your home care provider.
System Overview
The BiPAP Pro 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 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 Pro device. Contact your home care provider to
purchase any accessories not included with your system.
Air Outlet Port
Power Inlet
Filter Area
SD Card (Accessory) Slot
Side Cover
T a b
SD Card Cover
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 15 or 22 mm Philips Respironics exible tubing here.
Note: Heated Tubing should only be connected to the Air Outlet Port of the compatible
System One Heated Humidier and not to the Air Outlet Port of the therapy device.
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
here. Refer to the instructions supplied with the accessory. When not using an accessory,
this cover must be in place on the device.
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
dust and pollens. A white ultra-ne lter can also be used for more complete ltration of
very ne particles.
Side Cover (optional) If using a humidier with the device, this side cover can be easily removed with the release
tab before attaching the humidier. Refer to the humidier manual.
6 User Manual
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
when the unit is rst powered.
Humidier Icon This Icon lights up (different colors) when the optional humidier and/or heated tube is attached
and heat is being applied. White means classic humidication is selected. Blue means System One
humidication is selected. Orange means the heated tube is attached. Please refer to the humidier
user manual for more information.
Humidier Numbers The humidier number settings are only visible when the humidier is attached and therapy is active.
You can use the control wheel to change the number settings for the humidier. When the heated
tube is being used with the humidier, these numbers will control the heated tube setting.
Control Wheel/Push
Button
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.
Ramp Button When the airow is on, this button allows you to activate or restart the ramp function. This button
lights up when therapy is active or during specic alerts.
Available Therapy Modes
The BiPAP Pro Bi-Flex device offers the following therapy modes:
• Bi-level – This mode provides one level of output pressure during EPAP (Expiratory Positive Airway Pressure) and
a second higher level during IPAP (Inspiratory Positive Airway Pressure).
• CPAP – This mode delivers Continuous Positive Airway Pressure; CPAP maintains a constant level of pressure
throughout the breathing cycle.
Available Flex Comfort Features
The BiPAP Pro Bi-Flex device offers the following optional Flex comfort features:
• Bi-Flex – Provides pressure relief upon exhalation to improve comfort based on your needs during Bi-level
therapy.
• C-Flex – Provides pressure relief upon exhalation to improve comfort based on your needs during CPAP therapy.
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