BiPAP Auto Bi-Flex

PROVIDER GUIDE
--
RESPIRONICS -- ---­

IMPORTANTI Remove thIs gUIde before giving the device to the patient Only medical professIOnals should adjust pressure settings.
This guide provides you with instructions on how to access and navigate the provider screens used to modify device settings.
Refer to the User Manual for more information.
Note: The screens shown throughout this guide are examples only. Actual screens may vary slightly.

Accessing the Provider Mode Screens

Accessing provider mode unlocks settings that cannot be modified by the user. To access provider mode:
1. Supply Power to the device. First, plug the socket end of the AC power cord into the power supply. Then plug the pronged
end of the AC power cord into an electrical outlet that is not controlled by a wall switch. Finally, plug the power supply cord's
connector into the power inlet on the back of the device.
2. Once the device is powered, the Home Screen appears, shown below.Turn the wheel to toggle between the four options
and highlight "Setup".

Therapy

Info

Home Screen
3. Once" Setup" is highlighted, press and hold both the Control Wheel and the Ramp Button ~ on the device for at least
5 seconds.
4. You will hear a quick double beep and the Provider Mode Screen will appear, shown below. You are now in provider mode.

Reminder

Setup

Provider Screen
 Navigating the Provider Mode Screens
To navigate these display screens:
Turn the Wheel to toggle between options and settings on the screen. Press the Wheel to choose an option or setting that
is highlighted. If you choose "Back" on any screen, it will take you back to the previous screen.
Note: Choose "EXIT" from the Provider Screen will exit provider mode and the device will return to the Home Screen
in the patient mode.
Note: Provider mode will time out after 1 minute of inactivity and automatically exit the provider mode and return to the
Home Screen in the patient mode.

Provider Mode Screen Descriptions

The following sections will describe the options available under the 3 choices from the Provider Screen (Reminder, Setup, and Info).

Reminder Screen
From the Provider screen, highlight the "Reminder" option and press the wheel. The following Reminder screen will appear.
B.ilck
Reminder off 30 90
180 270 365

Reminder Screen
• Reminder - You can set a reminder on this screen that will let patients know when it is time to perform a certain task,
such as replacing the mask. You can select one of the following settings: Off (no reminder is set), or you can set the device
to display a reminder after 30, 90, 180, 270, or 365 days.
Note: You can set a specific patient reminder message using the Encore Pro software, and put this message on the SD
Card or send it to the patient's device via a modem.

Setup Screen
From the Provider screen, highlight the "Setup" option and press the wheel. The following Setup screen will appear.
Biilck
Mode Auto BiLevel
Mu IPAP (min EPAP + 3) - 25.0
Min EPAP 4.0 - (mu IPAP - 3)
Mu P5 3 - min of [8 or (mu IPAP - min EPAP))
IPAP (EPAP) - 25.0
EPAP 4.0 - (IPAP)
Flex type None Bi-Flex
Bi-Flex 1 2 3
Rise time 0 1 2 3
Bi-Flex lock on off
Rise time lock on off
SYmMONEresistiilnce 0 Xl X2 X3 X4 X5
Lock SYmM ONE on off
Riilmp time 0:00-0:45
Riilmp stiilrt 4.0-(min EPAPj

• Humidifier
Auto on
0 1 2 3 4 5
on off

• Auto off
Miilsk ii1lert
LED biilcklight
on off
on off
on off
Show AHl/leiilklPB on off
Split night off 120 180 240
GMT offset -12 -12
Buk

Setup Screen
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 Note: The screen will only show 4 lines at a time. As you rotate the Wheel to toggle over different options the screen
will slide up and down accordingly. If the text is too long to completely fit on the screen, it will scroll horizontally across
the screen when highlighted.
o Mode - This screen displays the therapy mode setting.You can select Bi-Ievel therapy or Auto Bi-level therapy. Bi-level
therapy provides one level of output pressure during EPAP (Expiratory Positive Airway Pressure) and a second higher
level during IPAP (Inspiratory Positive Airway Pressure).Auto Bi-Ievel therapy delivers spontaneous Bi-Ievel therapy while
automatically adjusting EPAP and IPAP levels to meet the patient's needs.
Note: The menu options will vary between Bi-Ievel mode and Auto Bi-level mode.
o Max IPAP - This screen allows you to modify the Maximum IPAP setting. The setting you specify here will be the ~
maximum level of pressure applied during the inspiratory breath phase. You may adjust the setting from 3 cm H20 above
the Minimum EPAP setting to 25 cm H20.
Note: This screen only displays if Auto Bi-Ievel therapy is enabled.
o Min EPAP - This screen allows you to modify the Minimum EPAP setting. The setting specified here will be the minimum

level of pressure applied during the expiratory breath phase. You may adjust the setting from 4 cm H 20 to 3 cm H20
below the Maximum IPAP setting.
Note: This screen only displays if Auto Bi-level therapy is enabled.
o Max PS - This screen allows you to modify the Maximum Pressure Support setting. The maximum pressure support is the
maximum difference that is permitted between IPAP and EPAP while Auto Bi-level therapy is active. You may adjust the
setting from 3 cm H20 to 8 cm H20.
Note: The minimum pressure support setting cannot be adjusted and is fixed at 2 cm H20.
Note: This screen only displays if Auto Bi-level therapy is enabled.
o IPAP - This screen allows you to modify the IPAP setting. The initial default setting is 20 cm H 0. You can adjust the
2
setting from the EPAP setting to 25 cm H20.
Note: This screen only displays if Bi-level therapy is enabled. It will not appear if Auto Bi-level therapy is enabled.
o EPAP - This screen allows you to modify the EPAP setting. The initial default setting is 4 cm H 0. You can adjust the
2
setting from 4 cm H 20 to the IPAP setting.
Note: This screen only displays if Bi-level therapy is enabled. It will not appear if Auto Bi-Ievel therapy is enabled.
o Flex type - This screen displays the comfort mode setting. You can select Bi-Flex, or none.

o Bi-Flex - You can modify the Bi-Flex setting on this screen. The Bi-Flex comfort feature allows you to adjust the level of air

pressure relief that the patient feels when exhaling during therapy. The setting of "1" provides a small amount of pressure
relief, with higher numbers providing additional relief.
Note: The patient also has access to this setting, if Bi-Flex is enabled.
o Rise time - Rise time is the time it takes for the device to change from EPAP to IPAP. This screen allows you to adjust the

rise time so you can find the desired setting. This is only available if Bi-Flex has been disabled.
·0 (off) reduces the Rise Time feature to the lowest setting (off = 150 msec).
• 1 sets Rise Time to 1 (200 msec).
• 2 sets Rise Time to 2 (300 msec).
• 3 sets Rise Time to 3 (400 msec).
Note: The patient also has access to this setting, if Rise time is enabled.
o Bi-Flex lock - This enables you to lock the Bi-Flex setting if you do not want the patient to change it.

Note: If you lock this setting, the patient will see a "lock" icon next to the setting.
o Rise time lock - This enables you to lock the Rise time setting if you do not want the patient to change it.
i
I

Note: If you lock this setting, the patient will see a "lock" icon next to the setting.
o SYSTEM ONE resistance ( :( .... ) - This setting allows you to adjust the level of air pressure relief based on the specific
Respironics mask. Each Respironics mask may have a "System One" resistance control setting. System One resistance
compensation can be turned off by choosing the setting "0".
o Lock SYSTEM ONE - This enables you to lock the "System One" resistance control setting if you do not want the

patient to change It.

Note: If you lock this setting, the patient will see a "lock" icon next to the setting.
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• Ramp time - When you set the ramp time, the device increases the EPAP pressure from the value set on the Ramp
Starting Pressure screen to either the EPAP pressure setting (if in Bi-Ievel mode) or the Minimum EPAP pressure setting (if
in Auto Bi-Ievel mode) over the length of time specified here. The range for this setting is 0 to 45 minutes.
Note: If the EPAP pressure (if in Bi-Ievel mode) or Minimum EPAP pressure (if in Auto Bi-Ievel mode) is set to 4 (the
minimum setting), this screen will not display. If the Ramp time is set to 0, the Ramp start screen will not display.
• Ramp start - You can increase or decrease the ramp starting pressure in 0.5 cm H20 increments. The default setting is
4 cm H 20. You can adjust the setting from 4 cm H20 to the EPAP pressure setting (if in Bi-Ievel mode) or the Minimum
EPAP pressure setting (if in Auto Bi-Ievel mode).
Note: This screen will not display if the EPAP pressure (if in Bi-Ievel mode) or Minimum EPAP pressure (if in Auto Bi-Ievel
mode) is set to 4 cm H20 or if the ramp time is set to zero. Additionally. if the ramp starting pressure is set higher than
the EPAP pressure (if in Bi-Ievel mode) or Minimum EPAP pressure (if in Auto Bi-Ievel mode). the ramp starting pressure
will be decreased automatically by the device to match the EPAP or Minimum EPAP pressure.
Note: The patient also has access to this setting, unless the ramp time is set to O.
• Humidifier - This displays the humidifier setting. This will only display if the humidifier is attached. Please refer to the
humidifier manual if using a humidifier.
• Auto on - You can enable or disable this feature if you want the device to automatically turn the airflow on whenever the
patient applies the interface (mask) to their airway.
• Auto off - You can enable or disable this feature if you want the device to automatically turn the airflow off whenever the
patient removes the interface (mask) from their airway.
• Mask alert - You can enable or disable the mask alert setting. If this feature is enabled, the mask alert will appear on the
display screen when a significant mask leak is detected. and an audible alert will sound.
• LED backlight - You can enable or disable the LED backlight for the humidifier icon and settings on the device.
• Show AHl/leaklPB - You can select whether or not the ApnealHypopnea index, System Leak averages, and Periodic
Breathing averages are displayed on the Patient Info screens.
• Split night - You can enable or disable Split Night on this screen. which splits the therapy throughout the night. You can
adjust the amount of time spent in Bi-Ievel therapy before transitioning to Auto Bi-Ievel therapy. You can set it to 120,
180. or 240 minutes.
Note: This screen only displays if Auto Bi-Ievel therapy is enabled.
Note: If Split night is enabled. Ramp start will be disabled.
• GMT offset - Greenwich Mean Time (GMT) is the time along the Prime Meridian which passes through Greenwich.
England. This feature is used to synchronize the time with Encore software if used. It should be set to local GMT offset.

Info Screen
From the Provider screen, highlight the "Info" option and press the wheel. The following Info screen will appear.
Back
Phone-in
Compliance VIC
Therapy hours
Blower hours
Days> 4
Large leak
AHI
Periodic breathing
90% pressure
Reset data
Machine hours
Back

Info Screen

4
 Note: The screen will only show 4 lines at a time. As you rotate the Wheel to toggle over different options the screen
will slide up and down accordingly.
• Phone-in - This screen displays the total therapy hours for the device. the total blower hours. and the total number
of days used when the sessions were greater than 4 hours since the device was last reset. This screen also displays a
compliance number you can use to validate that the data provided to you is the data taken from this screen.
• Compliance VIC (Visual Inspection Check) - This screen displays the start date and the total number of days used
when the sessions were greater than 4 hours. This screen also displays a check code number used you can use to validate
that the data provided by you is the data taken from this screen.
• Therapy hours - The device is capable of recognizing the difference between the time the patient is actually receiving
therapy and the time when the blower is simply running. This screen displays the average amount of time the patient
is actually receiving therapy on the device over a 7 day and 30 day time frame (provided the device has at least 7 or 30
days of data respectively). If the device has only 5 days of data to use for the calculation. the 5 day average value will be
seen under the 7 day display.
• Blower hours - This screen displays the number of hours that the blower has been active over the life of the device.
• Days> 4 - This screen displays the cumulative number of device therapy sessions that exceeded 4 hours over a 7 day and
30 day time frame.
• Large leak - During any given night, the device recognizes the percentage of time the patient was experiencing what it
deemed to be a large leak. Large leak is defined as the level of leak that is so large. it is no longer possible to determine
respiratory events with statistical accuracy. This screen displays the average of these individual nightly values of
percentage of time in large leak over a 7 day and 30 day time frame (provided the device has at least 7 or 30 days of data
respectively). If the device has only 5 days of data to use for the calculation. the 5 day average value will be seen under the
7 day display.
• AHI - The device accumulates individual ApnealHypopnea indices (AHI) for each session the patient used the device. This
screen displays the average of these individual nightly AHI values over a 7 day and 30 day time frame (provided the device
has at least 7 or 30 days of data respectively). If the device has only 5 days of data to use for the calculation. the 5 day
average value will be seen under the 7 day display.
• Periodic Breathing - During any given night. the device recognizes the percentage of time the patient was experiencing
period breathing. This screen displays the average of these individual nightly values of periodic breathing over a 7 day and
30 day time frame (provided the device has at least 7 or 30 days of data respectively). If the device has only 5 days of data
to use for the calculation, the 5 day average value will be seen under the 7 day display.
• 90% Pressure - During any given night. the device recognizes the 90% Pressure achieved by the Auto Algorithm. 90%
Pressure is defined as the pressure at which the device spent 90% of the session time at or below. For example. If the
device recognized airflow for 10 hours. and 9 hours were spent at or below 11 cm H20, and 1 hour was spent above 11
cm H 20. then the 90% Pressure would be 11 cm H20. This screen displays the average of these individual nightly values of
90% Pressure over a 7 day and 30 day time frame (provided the device has at least 7 or 30 days of data respectively). If the
device has only 5 days of data to use for the calculation, the 5 day average value will be seen under the 7 day display. This
screen only displays in Auto Bi-Ievel therapy.
• Reset data - This screen allows you to erase all 7 and 30 day averages. compliance data. therapy hours and patient
information on the device.
Note: Machine hours are not erased.
• Machine hours - This screen displays the amount of time that the machine has been active over the life of the device.
Note: Therapy hours and blower hours can be reset for new patients. Machine hours are not erased.

5
Bi-Flex Comfort Feature
The BiPAP Auto device consists of a special comfort feature called
Bi-Flex. When the device is in Auto Bi-Ievel with Bi-Flex or Bi-Ievel
with Bi-Flex mode. the Bi-Flex attribute adjusts therapy by inserting a IPAP
small amount of pressure relief during the latter stages of inspiration
and during active exhalation (the beginning part of exhalation). In the
diagram. the bold lines represent Bi-Flex in comparison to the dashed EPAP
line representing normal Bi-Ievel therapy. Bi-Flex levels of 1, 2, or 3
progressively reflect 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.
Time

Ramp
The device is equipped with a linear ramp feature that allows patients to Airflow
Turnedon
reduce the pressure and then gradually increase (ramp) the pressure to
the prescription pressure setting so they can fall asleep more comfortably. / Ramp Button
IPAP / It' Pressed
The diagram illustrates how the ramp feature works. Pressure- r--..,~-",;,,;,,;;,;;;,,;,;;,;;,-'"T-~
Note: When the device is in Auto Bi-Ievel or Auto Bi-Ievel with Bi-Flex
mode. pressing the Ramp button provides pressure relief by lowering CPAP/EPAP-
CPAP/EPAP­
Pressure
the device output pressures to the EPAP = Ramp Start pressure setting
and IPAP = Ramp Start pressure setting + 2 cm H 20 and ramping to
EPAP = Minimum Auto Pressure and IPAP = Minimum Auto Pressure Minimum­
Minimum-
+ 2 cm H20. If patient events are detected during the ramp. the Auto Ramp
Pressure
Bi-Ievel algorithm will treat the events, and then continue the ramp. as
long as the device is not configured for split night therapy or the preset o cm H20 - L - - - - f - - - - - - - - , -
­
I Ramp Time
split night Bi-Ievel time period has expired during split night therapy. Minutes

Linear Ramp
• The delta is defined as the lesser of 2 cm H20
and the difference between IPAP and EPAP
pressure settings

6
Event Definitions
The BiPAP Auto monitors breathing and detects apneas and hypopneas.
EVENT Definition
Obstructed Airway An apnea is detected when there is an 80% reduction in airflow from baseline for at least 10 seconds or if there is no
Apnea I Clear airflow detected for 10 seconds.
Airway Apnea
Durrng the apnea, one or more pressure test pulses are delivered by the device. The device evaluates the response of
Detection
the patient to the test pulse(s) and assesses whether the apnea has occurred while the patient has a clear airway or
an obstructed airway. The airway is determined to be clear if the pressure test pulse generates a significant amount of
flow; otherwise the airway is determined to be obstructed.
RERA RERA (Respiratory effort-related arousal) is defined as an arousal from sleep that follows a 10 second or longer
Detection sequence of breaths that are characterized by increasing respiratory effort, but which does not meet crrterra for an
apnea or hypopnea. Snoring, though usually associated with thiS condition need not be present. The RERA algorithm
monitors for a sequence of breaths that exhibit both a subtle reduction In airflow and progressive flow limitation. If
this breath sequence is terminated by a sudden increase In airflow along with the absence of flow limitation, and the
event does not meet the conditions for an apnea or hypopnea, a RERA is indicated.
Periodic BreathIng A persistent waning and waxing breathing pattern which repeats itself between 30 and 100 seconds.The nadir of
the breathing pattern IS characterized by at least a 40% reduction in airflow from an established baseline flow. The
pattern must be present for several minutes before it can be identified as periodic breathing.

No therapy adjustments are made in response to periodic breathing.

Flow Limitation The device looks for relative changes in the peak, flatness, roundness, or shape (skewness) of the inspiratory portion
Detection of the airflow 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.
Hypopnea A hypopnea IS detected when there IS an approximately 40% reduction in airflow from baseline for at least 10
Detection seconds.
Snore Vibratory snore is detected when a specific frequency IS detected durrng the inspiratory portion of the patient's
Detection breath.Vibratory snore is disabled at pressures greater than 16 cm H2O.

Cleaning for Multiple Users

WARNING: If you are using the device on multiple users, discard and replace the bacteria filter each time the device is
used on a different person.
If you are using the device on multiple users, complete the following steps to clean the device before each new user.
1. Unplug the device before cleaning.
2. Clean the outside of the device only. Use a cloth with one of the following cleaning agents to clean the exterior of the device:
• Mild Detergent
• 70% Isopropyl Alcohol
• DisCide Towelettes
• 10% Chlorine Bleach solution
3. Allow the device to dry completely before plugging in the power cord. •

•
7
Verifying the Pressure
WARNING: Ifthe device fails to perform within the stated specifications. have the system serviced by a qualified
Respironics-approved service facility.
If part of your patient setup procedure is to verify actual pressure with a manometer, please use the following instructions to
ensure that the device is functioning properly. You will need the following equipment to verify the pressure:
Respironics Pressure Calibration Kit includes:
• Respironics Whisper Swivel 11
• Respironics 02 Enrichment Final Assembly
• Closed end cap
• Respironics flexible tubing
• Pressure tubing
• Respironics Digital Manometer or equivalent
Minimum Specifications:
0- 25 cm H20 (or better)
Whisper SWIvel 11
±0.3 cm H20 accuracy
±0.1 cm H20 resolution Pressure Tubing

• Foam filter
Manometer
To verify the pressure, complete the following steps:
1. Install the foam filter into the back of the device.
2. With the device unplugged. connect the system as illustrated in the diagram.
3. Turn the manometer on. If it does not display a reading of zero, adjust the manometer to calibrate it. If the manometer has
variable settings for devices, set it to cm H20.
4. Supply power to the device then place the device in prOVider mode.
5. Set the therapy parameters according to the patient specific data.
6. Set the device to the specific pressure value for the patient.
7. Verify that the pressure setting matches the pressure displayed on the manometer. If the pressure setting does not match
the measured value for the device, contact Respironics or an authorized service center to have the device serviced.
Note: Output pressures may vary at local altitude and barometric pressure. Because of these factors, devices may slightly
vary in output pressure over the range of the altitude settings.
8. Set up the remaining parameters and exit provider mode. The unit is ready for patient use.

[MF] 1061639

.
Respironics Inc.
312Alvin Drive 1061631
New Kensington, PA 15068 USA JR 9/412009
EN-DOM