Philips BiPAP Auto Bi-Flex User Manual

BiPAP Auto Bi-Flex	USER MANUAL

Table of Contents
Intended Use...........................................................................................................................................................	2
Important.................................................................................................................................................................	2
Warnings..................................................................................................................................................................	2
Cautions...................................................................................................................................................................	3
Contraindications...................................................................................................................................................	3
Symbol Key..............................................................................................................................................................	3
System Contents....................................................................................................................................................	4
System Overview...................................................................................................................................................	4
Control Buttons.....................................................................................................................................................	5
Available Therapies.................................................................................................................................................	5
Installing the Air Filters.........................................................................................................................................	6
Connecting the Breathing Circuit.......................................................................................................................	6
Where to Place the Device.................................................................................................................................	6
Supplying AC Power to the Device....................................................................................................................	6
Navigating the Device Screens............................................................................................................................	7
Starting the Device................................................................................................................................................	7
Ramp Feature..........................................................................................................................................................	8
Mask Fit Check Feature........................................................................................................................................	8
Flex/Rise time Screen............................................................................................................................................	9
Setup Screen..........................................................................................................................................................	10
Info Screen.............................................................................................................................................................	11
Device Alerts.........................................................................................................................................................	13
Troubleshooting....................................................................................................................................................	16
Accessories............................................................................................................................................................	17
Traveling with the System...................................................................................................................................	18
Cleaning the Device.............................................................................................................................................	18
Cleaning or Replacing the Filters......................................................................................................................	18
Cleaning the Tubing..............................................................................................................................................	18
Service....................................................................................................................................................................	18
Specifications.........................................................................................................................................................	19
Disposal..................................................................................................................................................................	20
How to Contact Respironics.............................................................................................................................	20
Limited Warranty....................................................................................................................................	Back Page

User 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 flow of air out of the mask. When the device is turned on and functioning properly, new air from the device flushes 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 flame.

•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 flow 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 fire.

•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 backflow of oxygen from the patient circuit into the device when the unit is off. Failure to use the pressure valve could result in a fire hazard.

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

•Do not use the device in the presence of a flammable 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 airflow 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 fluids.

•If the device is used by multiple persons (such as rental devices), a low-resistance, main flow bacteria filter should be installed inline 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 humidifier, the humidifier must always be positioned below the breathing circuit connection at the mask and the air outlet on the device. The humidifier 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, humidification, conductive floor 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 Specifications.

•Do not use extension cords with this device.

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

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

•A properly installed, undamaged reusable foam inlet filter is required for proper operation.

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

•Dirty inlet filters may cause high operating temperatures that may affect device performance. Regularly examine the inlet filters as needed for integrity and cleanliness.

•Never install a wet filter into the device. You must ensure sufficient drying time for the cleaned filter.

•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 benefits 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 fluid (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:

Symbol	Definition	Symbol	Definition
	Consult accompanying instructions for use.		Separate collection for electrical and electronic
	Consult accompanying instructions for use.		equipment per EC Directive 2002/96/EC.
			equipment per EC Directive 2002/96/EC.
	For Airline Use. Complies with RTCA/DO-160F		Do not disassemble.
	section 21, category M.		Do not disassemble.
	section 21, category M.
	DC Power		Class II (Double Insulated)
	Type BF Applied Part		For Indoor Use Only.
	Drip Proof Equipment

User Manual

System Contents

Your BiPAP Auto Bi-Flex system includes the following items:
• Device	• Reusable gray foam filter
• User manual	• Disposable ultra-fine filter (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)	• Humidifier (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.

	SD Card (Accessory) Slot
	SD Card Cover
	Air Outlet Port
	Power Inlet
	Tab
	Filter Area
	Side Cover
This figure illustrates some of the device features, described in the following table.
Device Feature	Description
Air Outlet Port (conical, 22 mm)	Connect the flexible 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
	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 filter must be placed in the filter area to screen out normal household
	dust and pollens. A white ultra-fine filter can also be used for more complete filtration of
	very fine particles.
Side Cover	If using a humidifier with the device, this side cover can be easily removed with the release
	tab before attaching the humidifier. Refer to the humidifier manual. When not using a
	humidifier, this cover must be in place on the device.

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Control Buttons

	LCD Display Screen
	Humidifier Icon &
	Number Settings
	Control Wheel/Push Button
	Ramp Button
This figure shows the primary control buttons on the device, described in the following table.
Feature	Description
Display Screen	Shows therapy settings, patient data, and other messages. The startup screen is shown temporarily
	when the unit is first powered.
Humidifier Icon	This Icon lights up when the optional humidifier is attached and heat is being applied.The humidifier
	number settings are only visible when the humidifier is attached and therapy is active. Please refer to
	the humidifier user manual for more information.
Control Wheel/Push	Turn the wheel to toggle between options on the screen. Press the wheel to choose an option.
Button	Primary function is to turn airflow on/off.
Ramp Button	When the airflow is on, this button allows you to activate or restart the ramp function. When
	the airflow is off, this button allows you to activate the Mask Fit Check.This button lights up when
	therapy is active or during specific alerts.

AvailableTherapies

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.

User Manual

Installing the Air Filters

CAUTION: A properly installed, undamaged gray foam filter is required for proper operation.

The device uses a gray foam filter that is washable and reusable, and a white ultra-fine filter that is disposable. The reusable filter screens out normal household dust and pollens, while the ultra-fine filter provides more complete filtration of very fine particles. The gray reusable filter must be in place at all times when the device is operating. The ultra-fine filter is recommended for people who are sensitive to tobacco smoke or other small particles.

The reusable gray foam filter is supplied with the device.A disposable ultra-fine filter may also be included. If your filter is not already installed when you receive your device, you must at least install the reusable gray foam filter before using the device.To install the filter(s):

1.If you are using the white disposable ultra-fine filter, insert it into the filter area first, mesh-side facing in, towards the device.

2.Insert the required gray foam filter into the filter area after the ultra-fine filter.

Note: If you are not using the white disposable filter, simply insert the gray foam filter into the filter 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 flexible 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 flow bacteria filter 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 flexible 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 filter to the device air outlet, and then connect the flexible tubing to the outlet of the bacteria filter.

Note: When using the bacteria filter, 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 firm, flat surface somewhere within easy reach of where you will use it at a level lower than your sleeping position. Make sure the filter area on the back of the device is not blocked by bedding, curtains, or other items. Air must flow 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 flammable 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 Specifications.

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 humidifier, refer to the instructions included with your humidifier for details on how to power the device and humidifier.

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