Respironics BiPAP Auto Bi Flex Provider Manual NOT Mseries

with
Bi-Flex
PROVIDER MANUAL
This BiPAP system is covered by one or more of the following patents: US Patent Nos.
5,148,802; 5,313,937; 5,433,193; 5,632,269; 5,803,065; 6,029,664; 6,305,374;
6,539,940; 5,239,995; Re 35,295; 5,492,113; 5,551,418; 5,904,141; 5,970,975; and
6,426,689.
2005 Respironics, Inc. All rights reserved.
TABLE
OF
CONTENTS
Chapter 1: Package Contents ............................................................................................1-1

Chapter 2: Warnings and Cautions ...................................................................................2-1
2.1 Warnings .......................................................................................................2-1
2.2 Cautions ........................................................................................................2-3
2.3 Intended Use .................................................................................................2-3
2.4 Contraindications ..........................................................................................2-4
Chapter 3: Introduction.....................................................................................................3-1
3.1 Overview ......................................................................................................3-1
3.2 Therapies .......................................................................................................3-2
3.2.1 Bi-Flex Comfort Feature .....................................................................3-3
3.3 Ramp ...........................................................................................................3-4
3.4 Event Denitions .........................................................................................3-5
3.5 Auto-On and Auto-O Features ....................................................................3-6
3.5.1 Auto-On ............................................................................................3-6
3.5.2 Auto-O ............................................................................................3-6
3.6 Access Levels .................................................................................................3-6
3.6.1 Provider Mode Access Level (Setup) ...................................................3-6
3.6.2 User Mode Access Level ....................................................................3-7
3.7 Denitions, Acronyms, and Abbreviations ....................................................3-8
3.8 Symbol Key .................................................................................................3-9
3.9 How to Contact Respironics........................................................................3-10
Chapter 4: Controls and Displays ......................................................................................4-1
4.1 Controls and Displays ...................................................................................4-1
4.1.1 Display Screen.....................................................................................4-1
4.1.2 Control Buttons ..................................................................................4-3
4.1.3 Audible Alerts and Indicators .............................................................4-4
4.2 Navigating the Screens ..................................................................................4-4
4.2.1 LED Backlight for Buttons .................................................................4-5
4.3 Patient Circuit Connection ..........................................................................4-5
4.4 Rear Panel ....................................................................................................4-5
4.5 SmartCard ....................................................................................................4-6
Chapter 5: Setup ................................................................................................................5-1
5.1 Preparing the Device .....................................................................................5-1
5.1.1 Installing the Air Filters .......................................................................5-1
5.1.2 Assembling the Patient Circuit ............................................................5-2
BiPAP Auto with Bi-Flex Provider Manual
5.1.3 Supplying Power to the Device ............................................................5-2

5.1.4 Startup ................................................................................................5-4
5.1.5 Entering Provider Mode .....................................................................5-6
5.2 Connecting the Patient ..................................................................................5-6
5.3 Setting up the SmartCard ..............................................................................5-6
5.3.1 Downloading Data .............................................................................. 5-6
5.3.2 Programming a SmartCard ..................................................................5-7
5.3.3 Changing Settings Using a SmartCard ................................................5-7
Chapter 6: Changing Settings ............................................................................................6-1
6.1 Changing Settings in the Provider Mode .......................................................6-1
6.1.1 Provider Mode Navigation .................................................................6-1
6.1.1.1 Changing the Provider Mode Settings .......................................6-2
6.2 Changing Settings in User Mode ...................................................................6-9
Chapter 7: Alerts ...............................................................................................................7-1
7.1 Introduction .................................................................................................7-1
7.1.1 Overview of Alert Behavior ................................................................7-1
7.1.1.1 Alert Sounds Behavior ..............................................................7-1
7.1.1.2 Display Behavior .......................................................................7-2
7.2 Alerts ...........................................................................................................7-2
7.2.1 System Error Alert .............................................................................7-2
7.2.2 Card Error Alert .................................................................................7-3
7.3 Patient Disconnect Alert ...............................................................................7-3
7.4 Prescription Complete Screen .......................................................................7-4
7.5 Alert Summary Table ....................................................................................7-5
Chapter 8: Cleaning and Maintenance...............................................................................8-1
8.1 Cleaning the Device .....................................................................................8-1
8.2 Cleaning or Replacing the Inlet Filters ...........................................................8-1
8.3 Cleaning and Disinfection for Multiple Users ...............................................8-3
8.4 Maintenance .................................................................................................8-3
Chapter 9: Adding Supplemental Oxygen .........................................................................9-1
9.1 Adding Supplemental Oxygen .....................................................................9-2
9.2 Supplemental Oxygen Concentrations ........................................................9-2
Chapter 10: Circuits and Accessories ...............................................................................10-1
10.1 Circuit Congurations .............................................................................10-1
10.2 Circuits and Accessories ............................................................................10-1
10.3 Masks, Exhalation Ports, and Related Accessories ....................................10-2
ii
10.4 Humidiers .............................................................................................10-2

10.5 Software ..................................................................................................10-2
Chapter 11: Specications ..............................................................................................11-1
Environmental...................................................................................................11-1
Physical .............................................................................................................11-1
Electrical ...........................................................................................................11-1
Pressure .............................................................................................................11-2
Control Accuracy .............................................................................................. 11-2
Disposal ............................................................................................................11-2
Pressure Drop Versus Flow for Patient Circuits ................................................11-3
Appendix A EMC Information ......................................................................................... A-1
Guidance and Manufacturers Declaration - Electromagnetic Emissions ............. A-1
Guidance
uidance and Manufacturers Declaration - Electromagnetic Immunity ............. A-2
Guidance
uidance and Manufacturers Declaration - Electromagnetic Immunity ............. A-3
Recommended Separation Distances between Portable and Mobile RF Communications
Equipment and This Device ............................................................................... A-4
iii
iv
CHAPTER 1: PACKAGE CONTENTS

NOTE:
Always use these instructions along with the User Manual when assembling
or adjusting this equipment.
Encore Pro SmartCard
Power Cord
BiPAP Auto w/ Bi-Flex
Filter Cap
Disposable Ultrane Filter

Reusable Gray
Foam Filters
User Manual
Flexible Tubing
6 ft. (1.83 m) X 22 mm i.d.
External AC Power Supply
1-1
1-2
CHAPTER 2: WARNINGS
CAUTION!
2.1
AND
CAUTIONS
US federal law restricts this device to sale by or on the order of a physician.
WARNINGS
WARNING:
Indicates the possibility of injury to the patient or the operator.
This manual serves as a reference. The instructions in this manual are not intended to supersede
the health care professionals instructions regarding the use of the device.
The operator should read and understand this entire manual before using the device.
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. See Chapter 10 for
approved patient circuits. 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 suocation.
In the event of a power or device failure, audible and visual alarm signals will activate. The device
must be disconnected from the patient immediately. As is the case with most therapy devices with
passive exhalation ports, when power is lost, sucient air will not be provided through the circuit,
and exhaled air may be rebreathed.
At low EPAP pressures, the ow through the exhalation port may be inadequate to clear all exhaled gas from the tubing. Some rebreathing may occur.
If oxygen is used with the device, the oxygen ow must be turned o when the device is not operating.
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 devices enclosure. Oxygen accumulated in the device enclosure will create a risk of re.
Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an
open ame.
When using oxygen with this system, a Respironics Pressure Valve (Part Number 302418) must
be placed in-line with the patient circuit.
For proper use, the external AC power supply must be placed feet down, in the upright position.
2-1
Operation of the device may be adversely aected by:

Electromagnetic elds exceeding the level of 10 V/m in the test conditions of EN
60601-1-2
Operation of high frequency (diathermy) equipment
Debrillators, or short wave therapy equipment
Radiation (e.g., x-ray, CT)
Magnetic elds (e.g., MRI)
2-2
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 at room temperatures above 95 F (35 C). If the device is used at room
temperatures above 95 F (35 C), the temperature of the airow may exceed 105 F (41 C),
which could cause thermal irritation or injury to the patients airway.
Do not operate the device in direct sunlight or near a heating appliance because these conditions
can increase the temperature of the airow delivered to the patient.
To reduce the risk of contamination, you may place a bacteria lter (Part Number 342077) inline between the device and the patient.
The device does not have an alarm to detect occlusion of the exhalation port. Before each use,
inspect the patient circuit to verify that the port is not occluded. Occlusion or partial occlusion
can reduce airow and result in rebreathing of exhaled air.
Do not use antistatic or electrically conductive hoses or tubing with the device.
When the device is used with a humidier, position the humidier so that the water level in the
humidier is lower than the patient, and the humidier is on the same level or lower than the
device.
If you detect any unexplained changes in the performance of the device, if the device and/or the
power supply is dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is
broken, seek the assistance of Respironics or an authorized service center.
Repairs and adjustments must be performed by Respironics or an authorized service center. Service done by inexperienced or unqualied personnel, or installation of unauthorized parts could
cause injury, invalidate the warranty, or result in costly damage.
Electrical cords, cables, and the power supply device should be periodically inspected for damage
or signs of wear. Replace any damaged parts before using.
To avoid electrical shock, unplug the device before cleaning it.
Pins of connectors identied with the ESD warning symbol 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 discharge (e.g., air
conditioning, humidication, conductive oor coverings, non-synthetic clothing), discharging
ones 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.
Verify the operation of the Patient Disconnect alert with any changes in the patient circuit.
Verify that the Patient Disconnect alert is active if required for medical reasons.
2.2
CAUTIONS
CAUTION:
Indicates the possibility of damage to the device.
The device may only be operated at temperatures between 41 F and 95 F.
Do not immerse the device or allow any liquid to enter the enclosure or the inlet lter.
Condensation may damage the device. Always allow the device to reach room temperature before
use.
Use the AC cable retainer to keep the AC power cord from being unintentionally disconnected.
NOTE:
2.3
Additional warnings, cautions, and notes are located throughout this manual.
INTENDED USE
The BiPAP Auto with Bi-Flex system delivers positive airway pressure therapy for the treatment of
adult Obstructive Sleep Apnea (OSA) only.
The BiPAP Auto with Bi-Flex is to be used only on the instruction of a licensed health care professional. The system can deliver Bi-level therapy or Auto Bi-level therapy, both with and without
Bi-Flex. Your home care provider will make the correct pressure settings according to your health care
professionals prescription.
When set in the Auto Bi-level therapy mode, the system will monitor patient breathing as they sleep
and automatically adjust the pressure to meet patient needs. When in the Bi-level therapy, the system
will deliver a continuous, set pressure during the night.
Several accessories are available to make OSA treatment with the BiPAP Auto with Bi-Flex system
as convenient and comfortable as possible. To ensure that patients receive the safe, eective therapy
prescribed for them, use only Respironics accessories.
IMPORTANT! Read and understand the entire provider manual before operating
this system.
2-3
2.4
CONTRAINDICATIONS
When assessing the relative risks and benets of using this equipment, the clinician should understand
that this device can deliver pressures of up to 25 cm H2O. Also, in the unlikely 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 positive airway pressure therapy for some
patients:
Bullous lung disease
Bypassed upper airway
Pneumothorax
Pathologically low blood pressure
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 the patient exhibits
signs of a sinus or middle ear infection. This therapy is not for use with patients whose upper airways
are by-passed. Should your patient have any of these conditions, a physician will determine if Bi-level
therapy is appropriate.
2-4
CHAPTER 3: INTRODUCTION
3.1
OVERVIEW
WARNING:
The device can operate on AC or DC power. The DC power option is

not intended as a battery backup during use of AC power.
CAUTION:
When DC power is obtained from a vehicle battery, the device should

not be used while the vehicles engine is running. Damage to the device or the vehicle may occur.
FIGURE 31 BIPAP AUTO
WITH
BI-FLEX DEVICE
The device, shown in Figure 3-1, is a low-pressure, electrically driven sleep apnea system with electronic pressure control. The devices pressure controls are adjusted to deliver pressure support to the
patient.
The device is intended to augment patient breathing by supplying pressurized air through a patient
circuit. It senses the patients breathing eort by monitoring airow in the patient circuit and adjusts
its output to assist in inhalation and exhalation. This assistance is provided by the administration of
two levels of positive pressure. During exhalation, pressure is variably positive or near ambient. During
inspiration, pressure is variably positive and always equal to or higher than the expiratory level.
3-1
3.2
THERAPIES
The BiPAP Auto with Bi-Flex device has 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). All breaths are patient-triggered,
patient-cycled, and pressure controlled.
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 with automatically adjusting EPAP and IPAP levels
that adjust to meet the patients 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 device triggers to Inspiratory Positive Airway Pressure (IPAP) in response to spontaneous inspiratory eort and cycle to Expiratory Positive Airway Pressure (EPAP) during exhalation. Figure 3-2
illustrates the trigger and cycle concepts.
FIGURE 3-2 TRIGGERING
AND
CYCLING
The level of pressure support (PS) delivered is determined by the dierence between the IPAP and
EPAP settings (PS = IPAP - EPAP).
When the device is in Provider access mode, you can congure the following settings:
3-2
Therapy mode setting (bPAP for Bi-level mode, bFLE for Bi-level with Bi-Flex mode, AbPAP for
Auto Bi-level mode, and AbFLE for Auto Bi-level with Bi-Flex mode)
IPAP setting
EPAP setting
Min EPAP setting
Max IPAP setting
Max PS setting
Flex setting
Rise time setting
Ramp length setting
Ramp start pressure setting
Split night time setting
Patient disconnect alert (enable/disable)

Erase therapy hours
LED backlight setting (enable/disable)
Humidier heat setting (for Respironics REMstar Heated Humidier only)
3.2.1 BI-FLEX COMFORT FEATURE

The BiPAP Auto device consists of a special comfort feature called Bi-Flex. When the device is in Auto
Bi-level with Bi-Flex or Bi-level with Bi-Flex mode, the Bi-Flex attribute adjusts therapy by inserting a
small amount of pressure relief during the latter stages of inspiration and during active exhalation (the
beginning part of exhalation). In the following diagram, the bold lines represent Bi-Flex in comparison
to the dashed line representing normal BiPAP therapy. Bi-Flex levels of 1, 2, or 3 progressively reect
increased pressure relief that will take place at the end of inspiration and at the beginning of expiration.
Note:
The patient also has access to this setting, if Bi-Flex is enabled.
FIGURE 3-3 BI-FLEX
IN
COMPARISON
TO
TRADITIONAL BI-LEVEL THERAPY
3-3
3.3
RAMP
The device is equipped with a linear ramp function. The Ramp feature will reduce the pressure and
then gradually increase (ramp) the pressure to the prescription pressure setting so patients can fall
asleep more comfortably. Figure 34 illustrates how the devices ramp function works.
Airflow
Turned On
Ramp Button
Pressed
IPAP
Pressure
CPAP/EPAP
Pressure
lta
de
Minimum
Ramp
Pressure
0 cm H2O
Minutes
Ramp Time
Linear Ramp
* The delta is defined as the lesser of 2 cm H2O
and the difference between IPAP and EPAP
pressure settings.
FIGURE 34 THE RAMP FUNCTION

NOTE:
3-4
When the device is in Auto Bi-level or Auto Bi-level with Bi-Flex mode, pressing the Ramp button provides pressure relief by lowering the device output
pressure to the Minimum Auto pressure setting and restoring the Auto Bi-level
algorithm at the new pressure, as long as the device is not congured for split
night therapy or the preset split night Bi-level time period has expired during
split night therapy.
3.4
EVENT DEFINITIONS
The BiPAP Auto monitors breathing and detects apneas and hypopneas:
EVENT
DEFINITION
Apnea Detection
An apnea is indicated if there is an 80% reduction in airow for 10

seconds compared to the average airow over an extended period of
several minutes or if there is no airow detected for 10 seconds.
Flow Limitation
Detection
The ow limitation algorithm analyzes the peak and shape of the inspiratory airow waveform. The algorithm looks for relative changes
in the peak, atness, roundness, or skewness (shape) of the inspiratory portion of the airow waveform. These changes are observed
both over a short period of time (groups of 4 breaths) and over a long
period of time (several minutes). Statistical measures are used to
help minimize false event detection while allowing the device to be
sensitive to even small changes. Also, these measures are disabled
during unstable breathing conditions such as snore, apneas, hypopneas, high leak, and variable breathing.
NOTE:
Hypopnea Detection
Snore Detection
Flow Limitation Detection is only active

during the Auto Bi-level and Auto Bi-level
with Bi-Flex modes.
A hypopnea is indicated if there is approximately a 40% reduction

in airow for a duration of between 10 and 60 seconds, compared
to the average airow over an extended period of several minutes.
Following a reduction, the device must see two recovery breaths in
order to label the event as a potential hypopnea. For the event to be
determined to be a hypopnea, additional criteria are evaluated:
Are the pressures less than or equal to 8 cm H2O
Is ow limitation present in the valley of the hypopnea
Is the hypopnea terminated with breaths having large

tidal volumes
Has a reduction in the energy content of the airow

signal been observed
The pressure signal is only evaluated for the possibility of snoring

when the patient is inhaling. Snoring-related pressure vibrations
detected on exhalation are often linked to mask vibrations. Snore
detection is disabled at IPAP pressure setpoints greater than 20 cm
H2O.
3-5
3.5
AUTO-ON
AND
AUTO-OFF FEATURES
The device includes automatic pressure activation (Auto-On) and automatic pressure cessation (AutoO) features.
3.5.1 AUTO-ON
With the Auto-On feature, the device automatically transitions from the Standby state to the Operate
state when the patient begins breathing on the device (after 3 consecutive breaths).
3.5.2 AUTO-OFF
Setting the Patient Disconnect setting to 1 enables the Auto-O feature (in addition to enabling the
Patient Disconnect alert). When Auto-O is enabled, the device automatically transitions from the
Operate state to the Standby state when the patient removes the mask from the airway. The device will
transition to standby within one and a half to two minutes following removal of the mask.
3.6
ACCESS LEVELS
There are two levels of access for the device: Provider Mode and User Mode.
3.6.1 PROVIDER MODE ACCESS LEVEL (SETUP)

The Provider mode unlocks additional parameters that are not available to the patient. Providers can
temporarily access these parameters via the user interface by completing the following steps:
1.
Press the Left and Right user buttons down simultaneously.
2.
With the user buttons pressed down, plug in the device to power up the unit.
3.
Release the Left and Right user buttons when you see the word SETUP appear in the top right
corner of the display. This indicates that you are now in Provider mode.
NOTE:
If the device is already on, you must rst turn the device off and unplug it
before entering Provider mode.
Left User
Button
Right User
Button
Humidifier
Button
Ramp Button
Start/Stop Button
FIGURE 3-5 DEVICE CONTROL PANEL

3-6
LED Backlight setting
Maximum IPAP and minimum EPAP auto pressure
Split night BiPAP time
Maximum PS
The following is also true in Provider mode:
The IPAP and EPAP setting screens only display if the device is in Bi-level or Bi-level with Bi-Flex
mode.
The Rise Time screen is only displayed if the device is in Bi-level mode and IPAP is not equal to
EPAP, or if the device is in Auto Bi-level mode.
The Ramp Start Pressure screen is only displayed if the device is in Bi-level or Bi-level with Bi-Flex
mode and the Ramp length setting is between 5 and 45 minutes.
The Flex Setting screen is only displayed if the device is in Auto Bi-level with Bi-Flex or Bi-level
with Bi-Flex mode.
The Split Night Time screen only displays if the device is in Auto Bi-level or Auto Bi-level with
Bi-Flex mode.
The Max IPAP, Min EPAP, and Max PS screens only display if the device is in Auto Bi-level or
Auto Bi-level with Bi-Flex mode.
3.6.2 USER MODE ACCESS LEVEL

The device defaults to User mode upon startup. Users can access user mode settings by pressing and
holding the Ramp button while the device is in standby.
NOTE:
If you temporarily set the device to Provider mode by pressing the Left and
Right User buttons, the unit will return to User mode when any of the following occurs:
The Start/Stop button is pressed.
Any user interface button is not pressed for more than 60 seconds.
The device is unplugged and then powered up again.
The following settings can be modied in User mode when the user presses and holds the Ramp button for several seconds:
Flex setting (when Bi-Flex is enabled by the Provider)
Rise time setting (when in Bi-level or Auto Bi-level mode)
Ramp start pressure setting (when ramp enabled by Provider)
LED backlight for control buttons (enable/disable)
Patient disconnect alert (enable/disable)
Answers to FOSQ test questions (when the SmartCard is inserted)
Additionally, the Humidier heat setting can be modied by pressing and holding the Heat button.
3-7
The following is also true in User mode:
The Flex Setting screen is only displayed if the device is in Auto Bi-level with Bi-Flex or Bi-level
with Bi-Flex mode.
The Rise Time screen is only displayed if the device is in Bi-level mode and IPAP is not equal to
EPAP, or if the device is in Auto Bi-level mode.
The Ramp Start Pressure Setting screen is only displayed if the device is in Bi-level or Bi-level with
Bi-Flex mode and the Ramp length is between 5 and 45 minutes.
The FOSQ screen is only displayed if the SmartCard is inserted prior to entering the user mode
setting screens.
3.7
DEFINITIONS, ACRONYMS,
AND
ABBREVIATIONS
The following terms appear in this manual:

TERM/
DEFINITION
ACRONYM
3-8
Apnea
A condition marked by the cessation of spontaneous breathing.
Auto-OffThis feature
When enabled through the Patient Disconnect setting, causes the device to automatically transition from the Operate state to the Standby
state whenever the mask is removed from the airway.
Auto-On
The device automatically transitions from the Standby state to the

Operate state when you begin breathing (3 consecutive breaths) on
the device.
Bi-Flex
A therapy feature that establishes a level of pressure relief taking

place at the end of inhalation and at the start of exhalation.
EPAP
Expiratory Positive Airway Pressure
High Priority Alert
Alert signal indicating a condition that requires immediate attention.
IPAP
Inspiratory Positive Airway Pressure
Low Priority Alert
Alert signal indicating an informational message.
Medium Priority Alert
Alert signal indicating a condition that requires operator awareness.
Operate State
The state of the device when the unit and the airow are both on.
Standby State
The state of the device when the unit is on, but the airow is off.
OSA
Obstructive Sleep Apnea
Ramp
A feature that may increase patient comfort when therapy is started.

The ramp feature reduces the pressure and then gradually increases
(ramps) the pressure to the prescription setting, so you can fall asleep
more comfortably.
Rise Time
The time it takes for the device to change from EPAP to IPAP. You can
adjust this time for your comfort.
3.8
SYMBOL KEY
The following symbols appear on the device label:

SYMBOL
DESCRIPTION
Consult accompanying instructions for use.
DC Power
Type BF Applied Part
Class II (Double Insulated)
IPX1
Drip Proof Equipment

Electrostatic Discharge
European Declaration of Conformity
0123
Canadian/US Certication
Notied Body Approval for Standards Compliance
TUV Safety Standard Compliance
UL Recognized for Canada and the United States
No User Serviceable Parts
3-9
3.9
HOW
TO
CONTACT RESPIRONICS
To have your unit serviced, contact your home care provider. If you need to contact Respironics
directly, call 1-800-345-6443 or use the following address:
3-10
CHAPTER 4: CONTROLS
AND
DISPLAYS
This chapter describes the device control panel and displays, patient circuit connections, and rear panel
connections.
4.1
CONTROLS
AND
DISPLAYS
Display
Screen
Heated
Humidifier
Button
Start/Stop
Button
Ramp
Button
FIGURE 4-1 CONTROL PANEL

Figure 4-1 illustrates the device control panel, which includes:
A display screen where all device settings appear
Control buttons
4.1.1 DISPLAY SCREEN

The display screen shows operating parameters, instructions, and messages. Figure 4-2 shows the
devices display screen.
FIGURE 42 DISPLAY SCREEN

The information shown on the display screen is dened as follows:
TEXT
DESCRIPTION
ALERT
Indicates that the device requires user attention as

indicated on the screen.
AUTO
Indicates that Auto mode is active.
CARD
Indicates that a SmartCard is inserted and detected.
4-1
TEXT
4-2
DESCRIPTION
cm H2O
Indicates that the alphanumeric digits are displaying

a pressure value.
EPAP
Indicates that the EPAP pressure or Max EPAP pressure is being displayed.
Erase
Indicates that the user may clear the Therapy Session

Counter.
FLEX
Indicates that a Bi-Flex comfort setting is being displayed or that Bi-Flex is active.
FOSQ
Indicates that the user may begin the FOSQ test or

that the FOSQ test is active.
HEAT
Indicates that the humidier is turned on and/or its

setting is displayed.
HOURS
Indicates that the Therapy Time is being displayed.
IPAP
Indicates that the IPAP pressure or Max IPAP pressure

is being displayed.
Light
Indicates that the control panel LED backlight setting

is being displayed or is active.
Max IPAP/Max PS
Indicates that the Max IPAP setting or Max PS setting

is being displayed.
Min EPAP
Indicates that the Min EPAP setting is being displayed.
NIGHTS
Indicates that the session counter is being displayed.
PATIENT
Indicates that a Patient Disconnect alert is active.
PS
Indicates that the Pressure Support setting is being

displayed.
RAMP
Indicates that the ramp function is in progress.
RAMP START
Indicates that the ramp starting pressure is being

diplayed.
RISE
Indicates that a rise time setting is being displayed.
Setup
Indicates that the device is in Provider mode and not

in User mode.
4.1.2 CONTROL BUTTONS

The device control buttons, shown in Figure 4-3, are dened below.
Display
Screen
Heated
Humidifier
Button
User
Buttons
Start/Stop
Button
Ramp
Button
FIGURE 43 CONTROL BUTTONS

BUTTON
DESCRIPTION
START/STOP
This button starts or stops the units airow. Press the button in
to turn the airow on and put the device in the Operate state.
When the button is turned off, the device is in the Standby state.
When in Standby, any ramp in progress is terminated, the alerts
are reset (except for the System Errors alert), and the humidier is turned off. This button is also used to exit the parameter
screens.
HEAT
When the optional REMstar Heated Humidier is prescribed,

this button controls the humidiers heater plate setting. Follow the instructions provided with the humidier. You can also
use this button to adjust the settings shown in the user menu
screens.
RAMP
When the airow is turned on and the ramp function is enabled,

this button lowers the airow pressure, allowing you to fall
asleep more easily. You can also use this button to adjust the settings shown in the user menu screens.
USER
The left and right user buttons allow you to navigate the display
screens.
NOTE:
Additionally, you can press any of the above buttons to clear the patient disconnect alert or to silence the high priority alert.
4-3
4.1.3 AUDIBLE ALERTS
AND INDICATORS
The device provides audible and visual indicators of alert conditions. These indicators occur in the
following situations:
Power On All visual indicators appear momentarily, and the audible indicator briey sounds to
signify that all indicators are functioning properly.
Continuous alerts An alert sounds continuously.
High priority alerts An alert consisting of three beeps, a pause, and then two more beeps sounds
several times at intervals for a high priority alert.
Medium priority alerts An alert sounds repeatedly, with a brief interval between alerts for a
medium priority alert.
Low priority system alerts An alert sounds repeatedly, with a longer interval between alerts for a
low priority alert.
Provider mode An alert sounds when the provider mode is accessed using the button sequence
described in Section 3.6.1.
SmartCard activity An alert sounds once when the SmartCard is inserted or removed.
SmartCard error A medium priority alert sounds and the CARD icon and an error code appear
on the display when a card error occurs.
Patient Disconnect A low priority alert sounds and the ALERT and PATIENT icons ash on
the display.
Conrmation An alert sounds once when the humidier setting screen is entered and when the
humidier is turned on.
4.2
NAVIGATING
THE
SCREENS
Note the following when navigating the Provider or User mode screens:
4-4
The Left and Right User buttons allow you to go to the previous or next setting, respectively.
The Heat and Ramp buttons operate as up and down buttons to adjust the settings. Pressing and
holding the Heat or Ramp button down for at least 2 seconds will change the settings at a faster
rate.
The Start/Stop button allows you to exit a provider or user mode screen.
The alphanumeric digits and icons ash to indicate setting adjustment.
4.2.1 LED BACKLIGHT
FOR
BUTTONS
The Start/Stop, Ramp, and Heat buttons can be lit by an LED backlight. The LED backlight is on
when the device is in the Standby state. When the device is in the Operate state, the LED backlight is
lit according to the setting in the LED backlight setting. The LED backlight may ash to indicate an
alert condition.
CONTROL PAD INACTIVITY

Some screens have timeout periods. The screens timer starts when the screen is initially displayed, and
is restarted whenever a button is pressed. When a screen times out, the Monitoring/Standby screen is
displayed.
4.3
PATIENT CIRCUIT CONNECTION
The patient circuit is connected to the breathing circuit connection shown in Figure 44. The breathing circuit connection accepts a bacteria lter or a tubing connector for reusable or disposable tubing.
Breathing Circuit Connection
FIGURE 44 BREATHING CIRCUIT CONNECTION
4.4
REAR PANEL
Figure 45 shows the rear panel of the BiPAP Auto with Bi-Flex.
FIGURE 45 REAR PANEL

NOTE:
The SmartCard Connector is located on the side of the BiPAP Auto with BiFlex unit.
4-5
The BiPAP Auto with Bi-Flex rear panel contains the following:
A power inlet for connecting either the external AC power supply or a DC power adapter.
The lter cap that is removed to inspect the inlet air lters.
4.5
SMARTCARD
The BiPAP Auto with Bi-Flex is delivered with the SmartCard installed. The SmartCard is a plastic
card similar in size and shape to a normal credit card. However, instead of holding information on a
magnetic strip, it holds it in a small silicon chip embedded in the card. When installed into a BiPAP
Auto with Bi-Flex device, the SmartCard records the following data:
Date
Time
Leak
Pressure
Apnea/Hypopnea events
Non-Responsive Apnea/Hypopnea events (Auto Bi-level & Auto Bi-level with Bi-Flex modes)
Snoring
Duration of each use (minimum storage capacity: six months)
Flow Limitation (Auto Bi-level & Auto Bi-level with Bi-Flex modes)
When capacity is reached, the oldest data is overwritten. Using the Respironics SmartCard reader/writer and the Encore Pro software, you can download and view the usage data. Follow the instructions
included with the Encore Pro software to download the data.
NOTE:
If the card is not installed, the device usage will not be recorded. When a
SmartCard is installed, the word CARD appears in the upper right corner of
the display screen.
The SmartCard can also be programmed with the patients prescription by using applicable Respironics software and the SmartCard reader/writer (available from Respironics). When the programmed
SmartCard is inserted into the BiPAP Auto with Bi-Flex, the prescription settings are automatically
transferred into the device and erased from the SmartCard. The SmartCard will then start to collect
patient data.
4-6
CHAPTER 5: SETUP
5.1
PREPARING
THE
DEVICE
This section contains information on:
Installing the air lters
Assembling the patient circuit
Supplying power to the device
Startup
Entering Provider mode
5.1.1 INSTALLING
THE
AIR FILTERS
The device uses one or two removable lters at the air inlet. You must install the gray foam lter before
operating the device. The foam lter is washable and reusable. The disposable white ultra-ne lter is
optional.
CAUTION:
A properly installed, undamaged foam lter is required for proper operation.
Reusable Gray
Foam Filter
(required)
Filter
Cap
Disposable Ultra-fine
Filter (optional)
FIGURE 5-1 INSTALLING
THE
AIR FILTERS
To install the air lter, complete the following steps:

1.
Place the gray foam lter on top of the ultra-ne lter (if using the ultra-ne lter).
2.
Slide the lters into the air inlet at the rear of the device, and push them down into the recess as
shown in Figure 5-1.
3.
Place the bottom of the lter cap into the bottom of the air inlet opening. Position the cap so that
the small opening on the cap is facing down.
4.
Insert the caps bottom tabs into the opening below the lter area. Snap the cap into place.
See Chapter 8 to clean or replace the lters.

NOTE:
The lter cap should be installed with the air inlet opening at the bottom.
5-1
5.1.2 ASSEMBLING
WARNING:
THE
PATIENT CIRCUIT
The exhalation device (e.g., the Whisper Swivel II) or exhalation port
(on masks with an integrated exhalation port) is designed to exhaust
CO2 from the patient circuit. Do not block or seal the ports on the
exhalation device.
1.
Assemble the patient circuit according to the congurations described in Chapter 10.
2.
If required, connect a bacteria lter to the patient interface port (shown in Figure 5-2), and connect the patient tubing to the outlet of the bacteria lter.
If the bacteria lter is not required, connect the patient tubing directly to the breathing circuit
connection.
If you are using a humidier, connect the inlet to the bacteria lter outlet or to the breathing
circuit connection.
A completed assembly appears in Figure 5-2.

NOTE:
A bacteria lter should be used to prevent contamination if the device is

intended for use by multiple patients.
Patient Interface
Exhalation Port
Breathing
Circuit
Connection
FIGURE 5-2 AN EXAMPLE
5.1.3 SUPPLYING POWER
5-2
TO THE
OF A
TYPICAL CIRCUIT
DEVICE
WARNING:
The device can operate on AC or DC power. The DC power option is

not intended as a battery backup when using AC power.
WARNING:
Route the wires to avoid tripping.
AC OPERATION
WARNING:
For proper use, the external AC power supply must be placed feet
down, in the upright position, as shown in Figure 53.
1.
Plug the pronged end of the AC power supplys cord into an electrical outlet that is not controlled
by a wall switch.
2.
The external AC power supply features a cord retainer to provide strain relief for the AC power
cord. Wrap the cord around the AC power supplys cord retainer, using the wire tie supplied with
your power supply.
3.
Leaving a small amount of slack in the cord, connect the cord on the other side of the power
supply to the power inlet on the device. The power cord has a locking connector. To properly plug
the cord in:
4.
a.
Pull the locking mechanism back.
b.
Push the connector into place.
c.
Release the lock.
Ensure that all connections are secure.
FIGURE 5-3 USING

NOTE:
THE
EXTERNAL POWER SUPPLY
If you need to disconnect the power cord from the device, slide the locking
connector back and then remove the power cord.
DC OPERATION
You can operate the device on DC power by using the Respironics DC power adapter accessory (when
available). See the DC power adapter instructions for information on how to operate the device using
DC power.
CAUTION:
When DC power is obtained from a vehicle battery, the device should

not be used while the vehicles engine is running. Damage to the vehicle or the device may occur.
CAUTION:
Only use the Respironics DC power adapter available from your home
care provider. Use of any other system may cause damage to the device or the vehicle.
5-3
5.1.4 STARTUP
When the power cord is plugged into an AC or DC power source, the device sounds a conrmation
alarm, and the control panel buttons light up.
NOTE:
1.
If the alarm does not sound or the buttons do not light up, the device requires
servicing. Additionally, if any of the alphanumeric digits shown in Figure 54
do not display on the Self Test screen, the device requires servicing.
The rst screen to appear is the Self Test screen:
FIGURE 5-4 SELF TEST SCREEN

2.
The next screen displays the software version:
FIGURE 5-5 SOFTWARE VERSION SCREEN

3.
The Blower Hours Screen then appears, which displays the Blower Hours Time Meter:
FIGURE 5-6 BLOWER HOURS SCREEN
5-4
NOTE:
The control panel is inactive during these rst three screens.
NOTE:
Each of the rst three screens appears for approximately 1-3 seconds.
4.
The next screen to appear is the Standby screen:
FIGURE 5-7 STANDBY SCREEN

The Standby screen appears when the device is in the Standby state and displays the Therapy
Time Meter. Pressing the Start/Stop button puts the device in the Operate state. The Monitoring screen then appears, displaying the current pressure setting:
FIGURE 5-8 MONITORING SCREEN

Both the Monitoring and the Standby screens display the PATIENT, FLEX, and
LIGHT icons if these features are enabled. Additionally, the CARD icon displays if a
SmartCard is inserted, and the AUTO icon displays if the device is in Auto Bi-level
or Auto Bi-level with Bi-Flex mode. The HEAT icon also displays if the humidier is
turned on. The RAMP icon is displayed in Monitoring Screen if ramp is active.
5.
When in the Standby or Monitoring screens, you can modify the humidier setting
by pressing and holding the Heat button until the screen below appears (Figure
59).
FIGURE 59 HUMIDIFIER SETTING SCREEN

You can increase or decrease the humidier setting from 1 to 5 in increments of 1. The
setting changes immediately as you adjust it. When the START/STOP button is pressed
to exit this screen, the Operate/Standby state does not change.
5-5
5.1.5 ENTERING PROVIDER MODE

Enter Provider mode by completing the following steps:
1.
Unplug the device if it is already plugged in.
2.
Hold down the Left and Right User buttons simultaneously.
3.
Plug the device in. The SETUP icon appears in the upper right corner of the screen to indicate
that the device is in Provider mode. Release the Left and Right User buttons.
IMPORTANT: Prescribed therapy settings can only be set in Provider mode. To

prevent patients from tampering with the settings, do not show them
how to access Provider mode.
5.2
NOTE:
CONNECTING
THE
PATIENT
Before connecting the patient to the device, check the integrity of the patient
circuit, exhalation port, and alarms.
1.
Turn the devices airow on by pressing the Start/Stop button.
2.
If oxygen is being used, turn on the oxygen ow. Make sure you place the Respironics Pressure
Valve (Part Number 302418) in-line with the patient circuit.
WARNING:
Always turn the airow on before turning on the oxygen, and always
turn the oxygen off before turning off the airow.
3.
Place the mask on the patient.
5.3
SETTING
UP THE
SMARTCARD
This section provides information on:
Downloading data
Programming a SmartCard
Changing Settings using a SmartCard
5.3.1 DOWNLOADING DATA

You can download data from the SmartCard by completing the following steps:
1.
Connect a Respironics SmartCard reader/writer directly to a Windows-compatible computer following the instructions included with the reader/writer. Remove the SmartCard from the device
and insert it into the reader/writer.
2.
Follow the instructions included with your Encore Pro software to download the data.
WARNING:
5-6
Any IEC 60950 device must be connected through the 7-pin mini-din
connector with a Respironics-supplied isolation cable.
5.3.2 PROGRAMMING
SMARTCARD
1.
Connect a Respironics SmartCard reader/writer directly to a Windows-compatible computer following the instructions included with the reader/writer. Remove the SmartCard from the device
and insert it into the reader/writer.
2.
Follow the instructions included with your Encore Pro software to program the SmartCard.
3.
Remove the SmartCard from the reader/writer. If desired, write the patients name on the front of
the card.
5.3.3 CHANGING SETTINGS USING
SMARTCARD
To change the settings in the device using a programmed SmartCard:

1.
Make sure the device is plugged in. Insert the programmed SmartCard into the slot on the left
side of the device (logo side facing up). When the Monitoring or Standby screen displays, the
word CARD appears in the upper right corner indicating that the card is inserted correctly.
2.
Turn the airow on to verify the new prescription setting. The card can now be removed or you
can leave the card in the device to record device usage. Once the prescription settings have been
transferred to the device, they will be deleted from the SmartCard.
5-7
5-8
CHAPTER 6: CHANGING SETTINGS

This chapter describes the settings that can be changed when the device is in the Provider and User
modes.
6.1
CHANGING SETTINGS
IN THE
PROVIDER MODE
Accessing the Provider mode setup level unlocks additional settings that cannot be changed while in
User mode.
6.1.1 PROVIDER MODE NAVIGATION

Figure 61 shows how to navigate the Provider mode screens using the Left and Right User buttons.
The parameter icon and setting will ash.
Mode Setting Screen
Right User
Button
Left User
Button
Rise Time Setting Screen

Right User
Button
Only displayed if the device

is in Bi-level mode and IPAP does not
equal EP
EPAP, or if the device is in
Auto Bi-level mode.
Left User
Button
IP
IPAP
Setting Screen
Right User
Button

is in Bi-level or Bi-level with
Bi-Flex mode.
Right User
Button
Ramp Length Setting Screen
Left User
Button
Only displayed if the device is in

Bi-level or Bi-level with Bi-Flex mode.
EP
EPAP
Setting Screen
is in Bi-level or Bi-level with
Bi-Flex mode.
Right User
Button
Right User
Button
Ramp Start Pressure

Setting Screen
Right User
Button

is in Auto Bi-level or Auto
Bi-level with Bi-Flex mode.

Right User
Button
Left User
Button
LED Backlight
Setting Screen
Left User
Button
Flex Setting Screen
Right User
Button
Left User
Button
Reset Session Counter

Setting Screen
Left User
Button
FIGURE 61 NAVIGATING

Auto Bi-level or Auto Bi-level with
Bi-Flex mode.
Patient Disconnect Alert

Setting Screen

Right User
Button
Left User
Button
Left User
Button
Max PS Setting Screen

is in Bi-level with Bi-Flex or
Auto Bi-level with Bi-Flex
mode.

Bi-level or Bi-level with Bi-Flex
mode and the Ramp Length Setting
is between 5 and 45 minutes.
Split Night Time

Setting Screen
Right User
Button
Right User
Button
Left User
Button
Left User
Button
Max IP
IPAP Setting Screen
Right User
Button
Left User
Button
Left User
Button
Min EP
EPAP Setting Screen
Right User
Button
Left User
Button
THE
PROVIDER MODE SCREENS

6-1
6.1.1.1
1.
CHANGING
THE
PROVIDER MODE SETTINGS
Mode Setting Screen
For BiPAP Auto with Bi-Flex devices, the Mode Setting screen appears after the Software Version
screen when you rst enter Provider mode. This screen, shown in Figure 62, allows you to select
the therapy mode. The available modes are: Bi-level, Bi-level with Bi-Flex, Auto Bi-level, and Auto
Bi-level with Bi-ex (bPAP, bFLE, AbFLE, and AbPAP on the display).
To change the selection, press the Heat or Ramp buttons until the correct setting appears. The icons
ash when selected to indicate the current therapy.
FIGURE 62 MODE SETTING SCREEN

Press the Right User button to access the Pressure Setting screens.
2.
Bi-level and Bi-level with Bi-Flex Pressure Settings
NOTE:
These screens are only displayed if the device is in Bi-level or Bi-level with BiFlex mode.
NOTE:
IPAP cannot be set lower than EPAP, and EPAP cannot be set higher than
IPAP.
a.
IPAP Setting Screen

The IPAP Setting screen is shown in Figure 63. It allows you to modify the IPAP setting.
FIGURE 63 IPAP SETTING SCREEN

Increase or decrease the IPAP pressure by pressing the Heat and Ramp buttons until the correct pressure appears. You can adjust the pressure in 0.5 cm H2O increments. The setting can be adjusted from
4 to 25 cm H2O.
Press the Right User button to access the EPAP pressure setting.
6-2
b.
EPAP Setting Screen

The EPAP Setting screen is shown in gure 6-4. It allows you to modify the EPAP setting.
FIGURE 64 EPAP SETTING SCREEN

Increase or decrease the EPAP pressure by pressing the Heat and Ramp buttons until the correct pressure appears. You can adjust the pressure in 0.5 cm H2O increments. The setting can
be adjusted from 4 to 25 cm H2O.
WARNING:
High EPAP pressures can cause the patient discomfort. Carefully evaluate the patient if you set the EPAP level above 15 cm H2O.
If the EPAP is set to less than the ramp start pressure, the ramp start pressure automatically
sets to the EPAP.
Press the Right User button to access the Flex setting (if in Bi-level with Bi-Flex mode) or the
Rise Time setting (if in Bi-level mode).
3.
Auto Bi-level and Auto Bi-level with Bi-Flex Pressure Settings
NOTE:
These screens are only displayed if the device is in Bi-level or Bi-level with BiFlex mode.
NOTE:
The settings for Min EPAP, Max IPAP, and Max PS are highly interdependent.
Consider the range of allowable pressures as bounded at the top by the Max
IPAP setting and at the bottom by the Min EPAP setting. While setting up one
parameter, another may change according to the following set of rules:
The device will not allow a Max PS setting outside the range of 3.0 to
8.0 cm H2O,
O, and the device will prohibit other settings to ensure that
this rule is not violated.
Within the range of 3.0 to 8.0 cm H2O,

O, any setting can be chosen for
Max PS, but it is further subject to the following rule: The Max PS setting cannot exceed Max IPAP setting minus Min EPAP setting.
If the Min EPAP setting is incremented greater than Max IPAP setting
minus Max PS setting, it will force the Max PS to decrease. The Max PS
setting will only decrease down to the minimum setting of 3.0
cm H2O,
O, so Min EPAP setting cannot be incremented greater than Max
IPAP setting minus 3.0.
If the Max IPAP setting is decremented less than Min EPAP setting plus
Max PS setting, it will force the Max PS to decrease. The Max PS setting
will only decrease down to the minimum setting of 3.0 cm H2O, so
Max IPAP setting cannot be decremented less than Min EPAP setting
plus 3.0.
6-3
a.
Min EPAP Setting Screen

This screen (shown in Figure 6-5) allows you to modify the Auto Min EPAP setting. You can
adjust the Min EPAP setting in 0.5 cm H2O increments by pressing the Heat and Ramp buttons. The setting can be adjusted from 4 to 22 cm H2O.
FIGURE 65 MIN EPAP SETTING SCREEN

Press the Right User button to access the Max IPAP setting.
b.
Max IPAP Setting Screen

This screen (shown in Figure 6-6) allows you to modify the Auto Max IPAP setting. You can
adjust the Max IPAP setting in 0.5 cm H2O increments by pressing the Heat and Ramp buttons. The setting can be adjusted from 7 to 25 cm H2O.
FIGURE 66 MAX IPAP SETTING SCREEN

Press the Right User button to access the Max PS setting.
c.
Max PS Setting Screen

This screen (shown in Figure 6-7) allows you to modify the Auto Max PS setting. You can
adjust the Max PS setting from 3.0 to 8.0 cm H2O. Press the Heat and Ramp keys to increase
or decrease the setting in 0.5 cm H2O increments.
FIGURE 67 MAX PS SETTING SCREEN

Press the Right User button to access the Flex setting (if in Auto Bi-level with Bi-Flex mode)
or the Rise Time setting (if in Auto Bi-level mode).
6-4
4.
Flex Setting Screen

The Flex Setting screen, shown in Figure 68, allows you to adjust the level of air pressure
relief that the patient feels when he or she exhales during therapy. It is only displayed when
the device is in Bi-level with Bi-Flex or Auto Bi-level with Bi-Flex mode.
To change the selection, press the Heat or Ramp buttons until the correct setting appears.
The settings range from 1-3. It is recommended that you start with the minimum setting of
1, which provides the least relief. Levels 2 and 3 progressively reect increased pressure relief.
FIGURE 68 FLEX SETTING SCREEN

Press the Right User button to access the Ramp Length setting (if in Bi-level with Bi-Flex
mode) or the Split Night Time setting (if in Auto Bi-level with Bi-Flex mode).
5.
Rise Time Setting Screen

Rise Time Setting screen is shown in Figure 69. 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 most comfortable setting for the patient. The Rise Time Setting screen only displays if the
device is in Bi-level mode and IPAP is not equal to EPAP, or if the device is in Auto Bi-level
mode.
FIGURE 69 RISE TIME SETTING SCREEN

Increase or decrease the rise time setting from 0 to 3 by pressing the Heat and Ramp buttons
until you nd the right setting. The rise time of 0 to 3 corresponds to tenths of a second (e.g.,
a setting of 0 equals 0.1 second rise time, 1 = 0.2 seconds, etc.).
Press the Right User button to access the Ramp Length setting (if in Bi-level mode) or the
Split Night Time setting (if in Auto Bi-level mode).
6-5
6.
Ramp Length Setting Screen

The Ramp Length Setting screen, shown in Figure 610, allows you to change the ramp time.
FIGURE 610 RAMP LENGTH SETTING SCREEN

NOTE:
The Ramp length setting screen only displays if the device is in Bi-level or Bilevel with Bi-Flex mode.
To change the ramp time, press the Heat and Ramp buttons until the correct time appears. The
setting increases or decreases from 0 to 45 minutes in 5 minute increments. If you do not want
ramp, set the time to zero.
Press the Right User button to access the ramp start pressure setting (if ramp length is between 5
and 45 minutes) or the Patient Disconnect setting (if ramp length is set to 0).
7.
Ramp Start Pressure Setting Screen

The Ramp Start Pressure Setting screen is shown in Figure 611.
NOTE:
This screen only displays if the device is in Bi-level or Bi-level with Bi-Flex
mode and the ramp length setting is greater than zero.
FIGURE 611 RAMP START PRESSURE SETTING SCREEN

To change the ramp starting pressure, press the Heat and Ramp buttons until the correct pressure
appears. The setting increases or decreases in 0.5 cm H2O increments. The user can adjust the
setting from 4 cm H2O to the EPAP pressure setting.
Press the Right User button to access the Patient Disconnect setting.
6-6
8.
Split Night Time Setting Screen

The Split Night Time Setting screen is shown in Figure 612. This screen allows you to modify
the setting for Split Night Time, which indicates the amount of time spent in Bi-level or Bi-level
with Bi-Flex mode before transitioning to Auto Bi-level or Auto Bi-level with Bi-Flex mode. It
can be set to 0 (o) and from 2 to 4 hours in 1 hour increments when the Heat or Ramp button
is pressed.
FIGURE 612 SPLIT NIGHT TIME SETTING SCREEN

NOTE:
This screen is only displayed if the device is in the Auto Bi-level or Auto Bilevel with Bi-Flex mode.
Press the Right User button to access the Patient Disconnect setting.
9.
Patient Disconnect Setting Screen
The Patient Disconnect Setting screen is shown in Figure 613.
FIGURE 613 PATIENT DISCONNECT SETTING SCREEN

This setting enables or disables the audible alert (a beeping sound) when a large, continuous air
leak (such as mask removal) has been detected in the circuit. Press the Heat and Ramp buttons to
select the desired setting to enable or disable the alert. A setting of 0 disables the Patient Disconnect alert, while a setting of 1 enables the alert.
NOTE:
Setting the Patient Disconnect setting to 1 also enables the Auto-Off feature,
which causes the unit to automatically change from the Operate state to the
Standby state whenever the mask is removed from the patients airway.
Press the Right User button to access the LED Backlight Setting screen.
6-7
10. LED Backlight Setting Screen

The LED Backlight Setting screen is shown in Figure 614. This setting allows you to have the
control panel lights behind the buttons turned on or o while the airow is turned on and the
device is in the Operate state.
NOTE:
The lights will always be on when the airow is off and the device is in
Standby.
FIGURE 614 LED BACKLIGHT SETTING SCREEN

To change the LED backlight setting, press the Ramp or Heat button until the correct setting appears. 1 means the light is on, while 0 means the light is o.
Press the Right User button to access the Reset Session Counter screen.
14. Reset Session Counter Screen
The Reset Session Counter screen is shown in Figure 615.
FIGURE 615 RESET SESSION COUNTER SETTING SCREEN

This screen displays the number of hours that the device delivered therapy to the patient. The
screen allows you to reset the session counter. Resetting the session counter also resets the Therapy
Time Meter.
To erase the totals and go back to zero, press and hold the Ramp or Heat button. The ERASE
icon displays on the screen. Hold the button down until the time changes to zero and the ERASE
icon disappears. The NIGHTS icon also displays on this screen.
6-8
6.2
CHANGING SETTINGS
IN
USER MODE
With the device in User mode, the patient is restricted to viewing the current pressure setting.
The patient can also view and change the following settings in User mode by pressing and holding the
Heat or Ramp button while the device is in Standby:
Session counter (cannot be changed in User Mode)
Flex setting (when Bi-Flex is enabled at the Provider level)
FOSQ Questionnaire
Rise time (when in Bi-level mode and IPAP is not equal to EPAP or when in Auto Bi-level mode)
Ramp start pressure (when in Bi-level or Bi-level with Bi-Flex mode and ramp length is set between 5 and 45 minutes)
Patient disconnect
LED backlight
Additionally, the patient can change the Humidier (heat) setting by pressing and holding the Heat
button to access the Humidier Setting screen.
See the BiPAP Auto with Bi-Flex User Manual for additional information.
6-9
6-10
CHAPTER 7: ALERTS
This chapter describes the device alerts, how to set them, and what corrective actions to take for the
alert conditions.
7.1
INTRODUCTION
The device provides three alert levels: high, medium, and low priority.
ALERT
DESCRIPTION
High Priority
These alerts require immediate operator

response. The alert signal consists of a high
priority sound. The display has the message
ALERT at the top of the screen.
Medium Priority
These alerts require prompt operator response.

The alert signal consists of a medium priority
sound. The display has the message ALERT at
the top of the screen.
Low Priority
These alerts require operator awareness. The

alert signal consists of a low priority sound.
The display has the message ALERT at the top
of the screen.
Some audible alerts are self-cancellable. This means that the alert sound stops when the cause of the
alert is corrected. See section 7.5 for detailed descriptions of the alert indicators and sounds.
7.1.1 OVERVIEW
OF
ALERT BEHAVIOR
Alert conditions are signalled by the device in two ways: a sound and a display message. Each signal
type behaves dierently depending on the type of alert.
7.1.1.1
1.
ALERT SOUNDS BEHAVIOR
High Priority Sounds

There are two possible high priority sounds:
High Priority The sound repeats a pattern of three beeps followed by a pause and then
two more beeps until a button is pressed. This pattern is indicated in Section 7.5 as

Continuous An audible alert sounds continuously. This pattern is indicated in Section

7.5 as
7-1
2.
Medium Priority Sound

The medium priority sound repeats a pattern of beeps with a short interval between each beep
until the cause of the alert is corrected.
This pattern is indicated in Section 7.5 as
3.
Low Priority Sound

The low priority sound repeats a pattern of beeps with a longer interval between each beep until a
button is pressed or until the cause of the alert is corrected.
This pattern is indicated in Section 7.5 as
7.1.1.2
DISPLAY BEHAVIOR
For high, medium, and low priority alerts, the display shows ALERT and the name of the alert.
7.2
ALERTS
The device has system, card, and patient alerts.
7.2.1 SYSTEM ERROR ALERT

The System Error alert is a high priority alert. It indicates that there is a problem with the device.
The System Error screen is shown in Figure 71.
FIGURE 71 SYSTEM ERROR SCREEN

A three digit error code displays on the screen, indicating the type of system error (e.g., error code 57
displays as E57). When a system error occurs, the system error audible alert sounds and the blower
and humidier turn o. Pressing any button while the System Error alert is active shuts o the audible
alarm.
7-2
7.2.2 CARD ERROR ALERT

The Card Error alert is a medium priority alert. It indicates that a problem exists with the card inserted
in the SmartCard connectivity slot. Removing the SmartCard automatically resets this alert.
The Card Error screen is shown in Figure 72.
FIGURE 72 CARD ERROR SCREEN

A three digit error code displays on the screen, indicating the type of card error (e.g., error code 57 displays as C57). The SmartCard must be removed to exit this screen and return to the previous screen.
7.3
PATIENT DISCONNECT ALERT
Figure 73 shows the Patient Disconnect alert screen.
FIGURE 73 PATIENT DISCONNECT ALERT SCREEN

The Patient Disconnect alert is a low priority alarm. If the Patient Disconnect alert is enabled, the alert
occurs when the patient is disconnected from the device. See Chapter 6 for information on how to
enable or disable the Patient Disconnect alert.
When a patient disconnect alert occurs, the PATIENT and ALERT icons ash on the display. Press
any button to shut o the alert.
7-3
7.4
PRESCRIPTION COMPLETE SCREEN
Figure 74 shows the Prescription Complete screen.
FIGURE 74 PRESCRIPTION COMPLETE SCREEN

If a prescription-only SmartCard is inserted, the CARD, ALERT
ALERT, and cm H2O icons ash and a
Card Error audible alert sounds when the prescription has been successfully written to the device. The
SmartCard must be removed to exit this screen and return to the previous screen.
7-4
7.5 ALERT SUMMARY TABLE

The following table summarizes the alert information.
Alert
Display
Message
System
Error
ALERT
T icon
flashes and
system error
code ("Exx")
displays
Card Error
CARD icon
flashes and
card error
code ("Cxx")
displays
Patient
Disconnect
ALERT
T and
PATIENT
icons flash
Audible
Indicator
Device Action
Possible Cause
Shuts down and

blower cannot
be restarted.
Device failure.
Operates
Operates
A problem exists
with the Smart
Card inserted in
the SmartCard
connectivity slot.
The card may be
inserted upside
down or
backwards.
Patient circuit is
disconnected or
has a large leak.
Patient Action
Provider Action
Press any button

to silence
the alarm.
Remove power
from the device.
Restore power. If
the alarm
continues to occur,
contact your home
care provider.
Have the device

serviced by either
an authorized
service
representative or
Respironics.
Confirm
that the card is
properly inserted.
Confirm that the

card is properly
inserted.
If the alarm
If the alarm
continues to
continues, replace
occur, remove the the SmartCard.
SmartCard from
the device and
contact your home
care provider.
Press any
button to clear
the alarm.
Reconnect the
patient circuit or
fix the leak.
Reconnect the
patient circuit or
correct the leak.
If the alarm
continues, contact
an authorized
service
If the alarm
representative or
continues, contact Respironics to
your home care
have the device
provider.
serviced.
Prescription
Complete
ALERT,
T, CARD,
T
and cm H2O
icons flash
Operates
Prescription
SmartCard
inserted into
device.
Remove the
SmartCard to
exit this screen
and return to the
previous screen.
Remove the
SmartCard to
exit this screen
and return to the
previous screen.
Audible alert
sounds when
prescription has
been successfully
written to the
device.
7-5
7-6
CHAPTER 8: CLEANING
AND
MAINTENANCE
This chapter describes how to clean the device and its lters and how to maintain the unit.
8.1
CLEANING
THE
DEVICE
WARNING:
To avoid electrical shock, always unplug the device power cord from
the AC (wall outlet) or DC power source before cleaning the device.
CAUTION:
Do not immerse the device in liquid or allow any liquid to enter the
enclosure, inlet lter, or any opening.
WARNING:
If you are using the device on multiple users, discard and replace the
bacteria lter each time the device is used on a different person.
Unplug the device and clean the front panel and exterior of the enclosure as needed using a cloth
dampened with water and a mild detergent. Allow the device to dry completely before plugging in the
power cord.
The mask and tubing should be cleaned daily. For details on cleaning your mask and accessories, refer
to the cleaning instructions packaged with the accessories.
CAUTION:
8.2
Dirty inlet lters may cause high operating temperatures that may affect
device performance. Regularly examine the inlet lters as needed for
integrity and cleanliness.
CLEANING
OR
REPLACING
THE INLET
FILTERS
The device uses two removable lters at the air inlet. The gray foam lter is washable and reusable. The
optional white ultra-ne lter is disposable. Under normal usage, clean the gray foam lter at least
once every two weeks and replace it with a new one every six months.
1.
If the device is operating, stop the airow by pressing the Start/Stop button. Disconnect the
device from the power source.
2.
Remove the lter cover by gently pressing down on the two latches on top of the lter cover (Figure 81).
FIGURE 81 REMOVING
THE
FILTER COVER
8-1
3.
Remove the lters from the enclosure by gently pulling around the edges of the lters. The top
lter is the reusable gray foam lter. The bottom lter is the optional disposable white ultra-ne
lter (Figure 82).
Reusable Gray
Foam Filter
Disposable Ultra-fine
Filter
FIGURE 82 REMOVING
FILTERS
4.
Examine the lters regularly for cleanliness and integrity.
5.
If needed, wash the gray foam lter in warm water with a mild detergent. Rinse thoroughly to
remove all detergent residue. Allow the lter to dry completely before reinstalling it. If the foam
lter is torn, replace it. (Only Respironics-supplied lters should be used as replacement lters.)
6.
If the ultra-ne lter is dirty or torn, replace it.
7.
Reinstall the lters, with the ultra-ne lter on the bottom. Slide the lters into the air inlet at the
rear of the device and push them down into the recess.
CAUTION:
8.
8-2
THE
Never install a wet lter into the device. It is recommended that you
clean the lter in the morning and alternate using the two foam lters
provided with the system to ensure sufcient drying time for the
cleaned lter.
Reinstall the lter cover.
8.3
CLEANING
AND
DISINFECTION
FOR
MULTIPLE USERS
If you are using the device on multiple users, complete the following steps to clean and disinfect the
unit before each new user.
1.
Unplug the device before disinfecting.
2.
Disinfect the outside of the unit only. Use a cloth with one of the following cleaning agents to
clean the exterior of the device: hydrogen peroxide, 3%; 100% isopropyl alcohol; vinegar, 5%
acidity; water; or household chlorine bleach, 5.25% sodium hypochloride, 1 to 5 part reduction
with water.
3.
Allow the device to dry completely before plugging in the power cord.
WARNING:
Do not immerse the device in liquid or allow any liquid to enter the
enclosure, inlet lter, or any opening. This may result in equipment
damage.
WARNING:
If you are using the device on multiple users, discard and replace the
bacteria lter every time the device is used on a different person.
8.4
MAINTENANCE
WARNING:
Electrical cords or cables should be periodically inspected for damage
or signs of wear.
See the BiPAP Auto with Bi-Flex Service Manual for recommended periodic maintenance.
8-3
8-4
CHAPTER 9: ADDING SUPPLEMENTAL OXYGEN

Oxygen may be added at the mask connection. Please note the warnings listed below when using
oxygen with the device.
WARNING:
The oxygen supply must comply with local regulations for oxygen use.
WARNING:
When using oxygen with this system, a Respironics Pressure Valve (Part
number 302418) must be placed in-line with the patient circuit. Place
the valve in-line with the patient circuit and connect the oxygen as
shown here:
To Controlled
Oxygen Source
O2 Enrichment
Attachment
FIGURE 91 USING
THE
RESPIRONICS PRESSURE VALVE
WARNING:
Oxygen should be administered only on the order of a physician.
WARNING:
Supplemental oxygen should not be added to the breathing circuit by

placing the source where the gas will be entrained through the inlet
lter on the rear of the device.
WARNING:
Continuous patient monitoring is recommended while administering

oxygen. Patient monitoring should consist of, at a minimum, patient
observation and pulse oximetry. Arterial blood gas measurements
should be used when necessary.
WARNING:
If administering xed-ow supplemental oxygen, the oxygen concentration may not be constant. The inspired oxygen concentration will
vary, depending on the IPAP and EPAP settings, patient breathing pattern, and the leak rate. Substantial leaks around the mask may reduce
the inspired oxygen concentration to less than the expected concentrations shown in section 9.2. Appropriate patient monitoring should be
implemented.
WARNING:
When using oxygen with this system, turn the device on before turning the oxygen on. Turn the oxygen off before turning the device off.
This will prevent oxygen accumulation in the device.
9-1
WARNING:
Oxygen accelerates res. Keep the device and the oxygen container
away from heat, open ames, any oily substance, or other sources of ignition.
Do not smoke in the area near the device or the oxygen.
9.1
ADDING SUPPLEMENTAL OXYGEN
The delivered oxygen concentration varies with changes in ow in the circuit. The following may have
an impact on oxygen concentration:
Pressure settings
Patient Tidal Volume
Peak Inspiratory Flow
I:E Ratio
Respiratory rate
Circuit leak rate
Oxygen ow rate
To add oxygen to the circuit, the oxygen supply must comply with the local regulations for medical oxygen. The oxygen ow into the oxygen valve cannot exceed 15 L/min and the pressure cannot
exceed 50 psi.
9.2
SUPPLEMENTAL OXYGEN CONCENTRATIONS
Figures 92 and 93 illustrate the potential range of oxygen concentration available to the patient at
a given tidal volume, supplemental oxygen ow, and pressure setting. These gures represent bench
test results without inadvertent mask leaks when oxygen is administered at the mask. Substantial leaks
around the mask may reduce the expected oxygen concentration to below the levels shown in Figures
92 and 93. This guideline may be used as a starting point for initiating oxygen therapy. Oxygen
ow should be gradually adjusted until the patients oxygen needs are adequately met.
9-2
FIGURE 92 OXYGEN CONCENTRATION
FOR
600
ML
TIDAL VOLUME
90
Oxygen Concentration (%)
80
70
60
50
40
30
20
10
0
10/5
20/5
30/5
IPAP/EPAP
IPAP/EP
AP/EPAP Settings
1000 ml Tidal
idal V
Volume. Respiratory Rate: 20 BPM
Supplemental
FIGURE 93 OXYGEN CONCENTRATION
FOR
1000
ML
TIDAL VOLUME
9-3
9-4
CHAPTER 10: CIRCUITS
AND
ACCESSORIES
This chapter details the Respironics-approved breathing circuit and accessories.

WARNING:
Refer to each accessorys instruction sheets for the applicable warnings,

cautions, and notes.
10.1 CIRCUIT CONFIGURATIONS

WARNING:
Do not connect any equipment to the device unless recommended by

Respironics or the health care professional. Verify that an exhalation
port is present to exhaust CO2 from the circuit. If circuit accessories
other than those recommended by Respironics are connected to the
device, then pressures must be veried. Use of these accessories may
alter the pressure received, reducing the effectiveness of treatment.
The device is intended for use with Respironics-approved patient circuits.

Typical components are:
Bacteria lter (optional)
22 mm reusable circuit tubing
Exhalation device
Respironics patient interface (e.g., mask)
Respironics Pressure Valve (Part Number 302418), if adding supplemental oxygen
Humidier (optional)
Additional accessories may be added to the circuit to meet specic needs.
10.2 CIRCUITS
1.
2.
3.
AND
ACCESSORIES
Reusable or Disposable Circuit
Reusable smooth inner lumen circuit tubing and exhalation port
Disposable smooth inner lumen circuit tubing and exhalation port
Circuit Accessories
6 disposable circuit tubing
O2 enrichment attachment
Bacteria lter
Device Accessories
DC power adapter, when available
Respironics Communication cable
10-1
10.3 MASKS, EXHALATION PORTS,

1.
RELATED ACCESSORIES
Masks
2.
AND
Respironics mask with built-in exhalation port or Respironics mask with separate exhalation
device
Accessories
Disposable headgear
Reusable headgear
Chin strap
10.4 HUMIDIFIERS
1.
Respironics REMstar Heated humidier
2.
Respironics REMstar Integrated humidier
When using other humidiers, verify that the delivered pressure is correct and that proper therapy is
being delivered.
NOTE:
Refer to the humidiers instructions for information on how to set up the

device with the humidier.
10.5 SOFTWARE
Respironics Encore Pro Data Management software for reading compliance data and setting up a
prescription via a SmartCard.
10-2
CHAPTER 11: SPECIFICATIONS

ENVIRONMENTAL
Operating
Storage
Temperature
41 F to 95 F
-4 F to 140 F
Relative Humidity
15 to 95%
(non-condensing)
15 to 95%
(non-condensing)
Atmospheric Pressure
83 to 102kPa
(5600 feet to sea level)
PHYSICAL
Dimensions:
9.75 L x 6.625 W x 4.4 H
Weight: Less than 7 lbs.
ELECTRICAL
AC Voltage Source:
100 to 240 V, 50/60 Hz
DC Voltage Source:
24 V (when operated with the external DC

power adapter accessory)
AC Current:
1.25 A maximum
DC Current:
3.0 A maximum
Protection against electric shock:
Class II
Degree of protection against electric shock:
Type BF Applied Part
Degree of protection against harmful ingress of water: Device: Ordinary Equipment, IPX0
AC Power Supply (Reorder number
1012832): Drip Proof, IPX1
DC Power Adapter (when available):
Drip Proof, IPX1
Modes of Operation:
Continuous
Electromagnetic Compatibility:
The device meets the requirements of

EN 60601-1-2, second edition (2001).
Fuses:
There are no user-replaceable fuses.
11-1
PRESSURE
Output:
4 to 25 cm H2O
Pressure Stability:
4.0 to 10.0 cm H2O (0.5 cm H2O)

>10.0 to 25.0 cm H2O (1.0 cm H2O)
Measured in accordance with EN ISO 17510-1 @ 6.6, 13.2, and 20 cm H2O @ 500 ml with BPM
set to 10, 15 & 20 BPM @ 23 C (2.0 C), 50% RH (5%), and an atmospheric pressure of 101.54
kPascals.
Sound Pressure Level:
<45 dB(A)
Measured in accordance with EN ISO 17510-1 @ 10 cm H2O at the patient circuit. This measurement applies to the BiPAP Auto with Bi-Flex with or without the optional REMstar Heated Humidier.
Maximum Flow: <35 LPM
Measured in accordance with EN ISO 17510-1 @ 8, 16.5, and 25 cm H2O @ 500 ml with BPM set
to 10, 15 & 20 BPM @ 23 C (2.0 C), 50% RH (5%), and an atmospheric pressure of 101.54
kPascals.
CONTROL ACCURACY
Parameter
Range
Accuracy
IPAP
4 to 25 cm H2O
1.5 cm H2O from static setpoint*/****
EPAP
4 to 25 cm H2O
1.5 cm H2O from static setpoint*/****
Ramp Duration
0 to 45 minutes
10% of setting
Rise Time
0 to 3**
25%***
* Dynamic pressure accuracy is measured at the patient end of the circuit with a Whisper Swivel II and
varying ow conditions.
** The range of values correspond to tenths of seconds (0 to 3 corresponds to 0.1 to 0.4 seconds).
*** Measured at the patient end of circuit with a Whisper Swivel II exhalation device and no patient
ow.
**** Measured in accordance with EN ISO 17510-1 @ 4, 8, 16.5, and 25 cm H2O @ 500 ml with
BPM set to 10, 15 & 20 BPM @ 23 C (2.0 C), 50% RH (5%), and an atmospheric pressure of
101.54 kPascals.
DISPOSAL
When necessary, dispose of the device and accessories in accordance with local regulations.
11-2
PRESSURE DROP VERSUS FLOW
FOR
PATIENT CIRCUITS
The device automatically compensates for pressure drops associated with a 6-foot smooth bore tube.
Additional pressure drop will occur when restrictive elements are added to the patient circuit. The
following graph shows the additional pressure drop when adding: 1. a bacteria lter; 2. a bacteria lter
and a Respironics humidier.
NOTE:
Always use a manometer to verify patient mask pressure.
FIGURE 111 PRESSURE DROP VERSUS FLOW
FOR
PATIENT CIRCUITS
11-3
11-4
APPENDIX A
GUIDANCE
EMC INFORMATION
AND
MANUFACTURERS DECLARATION - ELECTROMAGNETIC EMISSIONS
This device is intended for use in the electromagnetic environment specied 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
Group 1
The device uses RF energy only for

its internal function. Therefore, its
RF emissions are very low and are
not likely to cause any interference
in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations/Flicker
emissions
IEC 61000-3-3
Complies
The device is suitable for use in all

establishments, including domestic
establishments and those directly
connected to the public low-voltage power supply network.
A-1
GUIDANCE
AND
MANUFACTURERS DECLARATION - ELECTROMAGNETIC IMMUNITY
This device is intended for use in the electromagnetic environment specied below. The user of
this device should make sure it is used in such an environment.
IMMUNITY TEST
Electrostatic
Discharge (ESD)
IEC 60601 TEST

LEVEL
COMPLIANCE LEVEL
+6 kV contact
+6 kV contact
+8 kV air
+8 kV air
Electrical fast
Transient/burst
+2 kV for power
supply lines
+2 kV for supply
mains
IEC 61000-4-4
+1 kV for input-output lines
+1 kV for input/output lines
Surge
IEC 61000-4-5
+1 kV differential
mode
+1 kV differential
mode
+2 kV common
mode
+2 kV for common
mode
<5% UT
(>95% dip in UT) for
0.5 cycle
40% UT
(60% dip in UT) for
5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip
in UT) for 5 sec
<5% UT
(>95% dip in UT) for
0.5 cycle
40% UT
(60% dip in UT) for 5
cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip
in UT) for 5 sec
IEC 61000-4-2
Voltage dips, short

interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
ELECTROMAGNETIC
ENVIRONMENT GUIDANCE
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
Mains power quality
should be that of a
NOTE: UT is the a.c. mains voltage prior to application of the test level.
A-2
GUIDANCE
AND
MANUFACTURERS DECLARATION - ELECTROMAGNETIC IMMUNITY
This device is intended for use in the electromagnetic environment specied below. The user of this
device should make sure it is used in such an environment.
IMMUNITY TEST
Power frequency (50/60
Hz) magnetic eld
IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
+6 kV contact
+6 kV contact
+8 kV air
+8 kV air
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80
MHz
3 Vrms
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5
GHz
3 V/m
IEC 61000-4-8
ELECTROMAGNETIC ENVIRONMENT GUIDANCE

Floors should be wood, concrete or ceramic
tile. If oors are covered with synthetic material, the relative humidity should be at least
30%.
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
d = 1.2 P
d = 1.2 P
d = 2.3 P
80 MHz to 800 MHz

800 MHz to 2.5 GHz
where P is the maximum output power rating

of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from xed RF transmitters, as
determined by an electromagnetic site surveya, should be less than the compliance level
in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reection from structures, objects, and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the device is
used exceeds the applicable RF compliance level above, the device should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, the eld strengths should be less than 3 V/m.
A-3
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE

COMMUNICATIONS EQUIPMENT AND THIS DEVICE
AND
MOBILE RF
The device is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of this device can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and this device as recommended below, according to the maximum output power of the
communications equipment.
RATED MAXIMUM
POWER OUTPUT OF
TRANSMITTER
W
SEPARATION DISTANCE ACCORDING
TO
FREQUENCY
OF
TRANSMITTER
150 KHZ TO 80
MHZ
d = 1.2 P
80 MHZ TO 800
MHZ
d = 1.2 P
800 MHZ TO 2.5

GHZ
d = 2.3 P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reection from structures, objects, and people.
A-4
LIMITED WARRANTY
Respironics, Inc. warrants that the device shall be free from defects of workmanship and
materials and will perform in accordance with the product specications 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 specications, 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, and other defects not related to material or
workmanship.
Respironics, Inc. disclaims all liability for economic loss, loss of prots, 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 specic 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
1023859
HM 7/6/05

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Chapter 1: Package Contents ............................................................................................1-1

5.1.3 Supplying Power to the Device ............................................................5-2

BiPAP Auto with Bi-Flex Provider Manual

10.4 Humidiers .............................................................................................10-2

BiPAP Auto with Bi-Flex Provider Manual

BiPAP Auto with Bi-Flex Provider Manual

CHAPTER 1: PACKAGE CONTENTS

Encore Pro SmartCard

BiPAP Auto w/ Bi-Flex

Disposable Ultrane Filter

BiPAP Auto with Bi-Flex Provider Manual

External AC Power Supply

BiPAP Auto with Bi-Flex Provider Manual

US federal law restricts this device to sale by or on the order of a physician.

Indicates the possibility of injury to the patient or the operator.

BiPAP Auto with Bi-Flex Provider Manual

Operation of the device may be adversely aected by:

To avoid electrical shock, unplug the device before cleaning it.

BiPAP Auto with Bi-Flex Provider Manual

Indicates the possibility of damage to the device.

The device may only be operated at temperatures between 41 F and 95 F.

BiPAP Auto with Bi-Flex Provider Manual

Bullous lung disease

Bypassed upper airway

Pathologically low blood pressure

BiPAP Auto with Bi-Flex Provider Manual

The device can operate on AC or DC power. The DC power option is

When DC power is obtained from a vehicle battery, the device should

FIGURE 31 BIPAP AUTO

BiPAP Auto with Bi-Flex Provider Manual

FIGURE 3-2 TRIGGERING

Min EPAP setting

Max IPAP setting

Rise time setting

Ramp length setting

Ramp start pressure setting

Split night time setting

Patient disconnect alert (enable/disable)

Erase therapy hours

LED backlight setting (enable/disable)

Humidier heat setting (for Respironics REMstar Heated Humidier only)

3.2.1 BI-FLEX COMFORT FEATURE

The patient also has access to this setting, if Bi-Flex is enabled.

FIGURE 3-3 BI-FLEX

BiPAP Auto with Bi-Flex Provider Manual

TRADITIONAL BI-LEVEL THERAPY

FIGURE 34 THE RAMP FUNCTION

BiPAP Auto with Bi-Flex Provider Manual

An apnea is indicated if there is an 80% reduction in airow for 10

Flow Limitation Detection is only active

A hypopnea is indicated if there is approximately a 40% reduction

Is ow limitation present in the valley of the hypopnea

Is the hypopnea terminated with breaths having large

Has a reduction in the energy content of the airow

The pressure signal is only evaluated for the possibility of snoring

BiPAP Auto with Bi-Flex Provider Manual

3.6.1 PROVIDER MODE ACCESS LEVEL (SETUP)

Press the Left and Right user buttons down simultaneously.