Respironics BiPAPautoSV Advanced User manual

User Manual
with SmartCard

© 2009 Koninklijke Philips Electronics N.V. and its affiliates. All rights reserved.

TABLE OF CONTENTS
C : P C................................................................................................................
C : W  C ......................................................................................................
. W....................................................................................................................................
. C ....................................................................................................................................
. I U.............................................................................................................................
. C....................................................................................................................
. P ...............................................................................................................................
C : I   D ..............................................................................................
. D................................................................................................................................
. W  B- V..................................................................................................
. W   D ..................................................................................................................
. S ......................................................................................................................................
. H  C R ..................................................................................................
C : D C  D F .............................................................................
. P O/O B..........................................................................................................
. C P.........................................................................................................................
.. C B..........................................................................................................
.. A  P I .......................................................................................
.. D S...............................................................................................................
.. B C C...................................................................................
.. R P .....................................................................................................................
C : S   D .......................................................................................................
. I  A F ......................................................................................................
. W  P  D ...................................................................................................
. C  B C .....................................................................................
. C S.......................................................................................................................
. P  D I..........................................................................................................
.. U AC P ............................................................................................................
.. U DC P............................................................................................................
C : O  D.......................................................................................................
. S  D................................................................................................................
. C  D S..............................................................................................
.. C  H S..............................................................................
.. N  U D S .........................................................................
... C  F S ................................................................................
... C  R T S ........................................................................
... C  R S P..............................................................
... C  LED B S..............................................................
. M M P.......................................................................................

C : A.................................................................................................................................
. I  A ........................................................................................................
. W  D W  A O....................................................................................
. A T............................................................................................................................
.. H P A...................................................................................................
.. M P A ..............................................................................................
.. L P A.....................................................................................................
C : T ...............................................................................................................
C : C  M.............................................................................................
. C  D ..............................................................................................................
. C  R  I F.............................................................................
. C C..........................................................................................................................
C : A ......................................................................................................................
. A  H ............................................................................................................
. A O   D.............................................................................................
C : S ...................................................................................................................
A A: EMC I ............................................................................................................

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CHAPTER 1: PACKAGE CONTENTS
Your device should include the following items. If any of these items are missing, contact your health
care professional.
BiPAP autoSV Advanced
with SmartCard™
Power Cord
Filter Cap
Reusable Gray
Foam Filters
Flexible Tubing
1.83 m (6 ft.) x 22 mm i.d.
Disposable
Ultra-fine Filter
External AC Power Supply
User Manual
Carrying Case

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User Manual
CHAPTER 2: WARNINGS AND CAUTIONS
WARNING: Indicates the possibility of injury to the user or operator.
CAUTION: Indicates the possibility of damage to the device.
NOTE: Places emphasis on an operating characteristic.
2.1 WARNINGS
• is manual serves as a reference. e instructions in this manual are not intended to supersede
the instructions of your health care professional.
• You should read and understand this entire manual before using the device.
• e device is not intended to provide your total ventilatory requirement.
• e prescription must only be adjusted by a trained health care professional.
• Use only the breathing circuit provided by your health care professional.
• When using a breathing circuit that contains a mask with an integrated exhalation port or a
circuit with a separate exhalation device, do not tape, seal, or otherwise block the vent openings.
• If oxygen is used with the device, the oxygen flow must be turned off when the device is not in use.
• If you are using oxygen, the device must be equipped with the Respironics Pressure Valve (Part
number 302418). Failure to use the Pressure Valve could result in a fire hazard.
• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an
open flame.
• Do not use the device in the presence of a flammable anaesthetic mixture in combination with
oxygen or air, or in the presence of nitrous oxide.
• Do not use the device if the room temperature is above 35°C. If the device is used at room
temperatures above 35° C, the temperature of the airflow may exceed 41°C, which could cause
irritation to your airway.
• Do not operate the device in direct sunlight or near a heating appliance because these conditions
can increase the temperature of the air coming out of the device.
• In order to ensure proper protection against electrical shock, only communications accessories
with an IEC 60601-1 approved power supply may be connected through the SleepLink interface.
All IEC 950 devices must only be connected to the 7-pin connector with the Respironics
Isolation cable (Part Number 1012865).
• For proper use, the power supply must be placed feet down, in the upright position.
• When the device is used with a humidifier, position the humidifier so that the water level in the
humidifier is lower than you, and the humidifier is on the same level or lower than the device.
• Do not attempt to wear your mask without the device turned on. Doing so could result in
CO2rebreathing.

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• If you notice any unexplained changes in the performance of the device, if it is making
unusual or harsh sounds, if it and/or the power supply has been dropped or mishandled, if
the enclosure is broken, or if water has entered the device, discontinue use and contact your
health care professional.
• Repairs and adjustments must be performed by Respironics - authorized service personnel only.
Unauthorized service could cause injury, invalidate the warranty, or result in costly damage.
•
Periodically inspect electrical cords, cables, and the power supply device for damage or signs of wear.
• To avoid electrical shock, unplug the device before cleaning.
• Pins of connectors identified 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, humidification, conductive floor coverings, non-synthetic clothing), discharging
one’s body to the frame of the equipment or system or to earth or a large metal object, and
grounding oneself by means of a wrist strap to the equipment or system or to earth.
2.2 CAUTIONS
• e device may only be operated at temperatures between 5°C and 35°C.
• A properly installed, undamaged reusable foam inlet filter is required for proper operation.
• Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter.
• Do not place the device in or on any container that can collect or hold water.
• Condensation may damage the device. Always allow the device to reach room temperature
before use.
• Use the power cable retainer to keep the power cord from being unintentionally disconnected.
NOTE: Additional warnings, cautions, and notes are located throughout this manual.

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2.3 INTENDED USE
e BiPAP autoSV Advanced is intended to provide mask-applied non-invasive ventilatory support to
adult patients (>30 kg) for the primary treatment of obstructive sleep-disordered breathing with secondary
Central Sleep Apnea or Cheyne-Stokes Respiration (CSR). e device may be used in the hospital or
home. e device is intended for use with nasal masks and full-face masks as recommended by Respironics.
e device is to be used only on the instruction of a trained health care professional.
2.4 CONTRAINDICATIONS
e device should not be used if you have severe respiratory failure without a spontaneous respiratory
drive.
If any of the following conditions apply to you, consult your physician before using the device:
• Inability to maintain an open airway or adequately clear secretions
• At risk for aspiration of gastric contents
• Diagnosed with acute sinusitis or otitis media
• Allergy or hypersensitivity to the mask materials where the risk from allergic reaction outweighs
the benefit of ventilatory assistance
• Epistaxis, causing pulmonary aspiration of blood
• Hypotension
2.5 PRECAUTIONS
• Immediately report any unusual chest discomfort, shortness of breath, or severe headache.
• If skin irritation or breakdown develops from the use of the mask, refer to the mask instructions
for appropriate action.
• e following are potential side effects of noninvasive positive pressure therapy:
— Ear discomfort
— Conjunctivitis
— Skin abrasions due to noninvasive interfaces
— Gastric distention (aerophagia)

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CHAPTER 3: INTRODUCTION TO THE DEVICE
3.1 DEFINITIONS
e following terms appear throughout this manual:
Apnea A condition marked by the cessation of spontaneous breathing.
BPM Breaths Per Minute
CPAP Continuous Positive Airway Pressure
EPAP Expiratory Positive Airway Pressure
Exhaled Tidal Volume (VTE )e exhaled volume of each breath
High Priority Alarm An alarm signal indicating a condition that requires immediate attention.
IPAP Inspiratory Positive Airway Pressure
LED Light Emitting Diode
LEAK e amount of airflow leak detected by the device.
Low Minute Ventilation A condition in which you are not receiving a specified volume of air on
a per minute basis.
Low Priority Alarm An alarm signal indicating an informational message.
Max EPAP pressure e maximum EPAP setting established by the health care professional.
Max PS pressure e maximum Pressure Support setting established by the health care
professional.
Max Pressure e maximum pressure setting established by the health care
professional.
Medium Priority Alarm An alarm signal indicating a condition that requires operator awareness.
Min EPAP pressure e minimum EPAP setting established by the health care professional.
Min PS pressure e minimum Pressure Support setting established by the health care
professional.
Minute Ventilation (MinVent) e volume of air received by the patient on a per minute basis.
Operate State e state of the device when the device and the airflow are both on.
OSA Obstructive Sleep Apnea
Ramp A feature that may increase patient comfort when therapy is started. e
ramp feature reduces the pressure and then gradually increases (ramps) the
pressure to the prescription setting, so you can fall asleep more comfortably.
Respiratory Rate (RR) e patient’s rate of respiration.
Rise Time e time it takes for the device to change from EPAP to IPAP. You can
adjust this time for your comfort.
Standby State e state of the device when the device is on, but the airflow is off.

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3.2 WHAT IS BI-LEVEL VENTILATION?
Bi-level ventilation with the device helps you to breathe by supplying two levels of air pressure. e device
provides a higher pressure—known as IPAP (Inspiratory Positive Airway Pressure)—when you inhale, and
a lower pressure—known as EPAP (Expiratory Positive Airway Pressure)—when you exhale. e higher
pressure makes it easier for you to inhale, and the lower pressure makes it easier for you to exhale.
IPAP
Pressure
EPAP
Pressure
Rise Time
Time
Figure 3–1 IPAP and EPAP Breathing Levels
You can adjust the Rise Time to make the pressure change more comfortable.
3.3 WHAT IS THE DEVICE?
e device, shown in Figure 3–2, supplies air pressure through a breathing circuit.
Figure 3–2 e Device

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A breathing circuit, shown in Figure 3–3, consists of:
• Circuit tubing to deliver air from the device to your interface (e.g., mask)
• A mask or other patient interface device to deliver the prescribed pressure to your nose or nose
and mouth, depending on which interface has been prescribed for you
• An exhalation device to vent exhaled air from the circuit
Circuit
Tubing
Exhalation
Device
Patient
Interface
(Typical)
Circuit with Separate
Exhalation Device
Circuit
Tubing
Exhalation
Port
Patient
Interface
(Typical)
Circuit with Mask with
Integrated Exhalation Port
Flexible
Tubing
Connector
Mask's
Connector
Figure 3–3 Two Typical Breathing Circuits
NOTE: e exhalation port may be part of the mask or may be part of a separate exhalation device, but
is required to minimize the potential for CO2rebreathing.
e system senses your breathing effort and changes pressure levels when you inhale and exhale depending
on the mode of operation.
WARNING: e device can operate on AC or DC power. e DC power option is not intended as a
battery backup.
CAUTION: When DC power is obtained from a vehicle battery, the device should not be used while
the vehicle’s engine is running.

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3.4 SYMBOLS
e symbols shown below are used on the device, the AC power supply, and throughout this manual.
Attention, consult accompanying documents
DC Power
Pressure On/Off
Type BF Applied Part
Class II (Double Insulated)
European CE Declaration of Conformity
Canadian/US Certification
Electrostatic Discharge
Drip Proof Equipment
UL Recognized for Canada and the United States
TUV Safety Standard Compliance
No User Serviceable Parts
Compliant with the Waste Electrical and Electronic
Equipment/Restriction of the Use of Certain Hazardous
Substances in Electrical and Electronic Equipment
(WEEE/RoHS) recycling directives.
Symbol Meaning
IPX1
3.5 HOW TO CONTACT RESPIRONICS
To have your device serviced, contact your health care professional. If you need to contact Respironics directly,
call the Respironics Customer Service department at 1-724-387-4000 or [phone]. You can also use
one of the following addresses:
Respironics Respironics Deutschland
1001 Murry Ridge Lane Gewerbestrasse 17
Murrysville, PA 15668 82211 Herrsching, Germany
Visit Respironics web site at: www.respironics.com

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CHAPTER 4: DEVICE CONTROLS AND DISPLAY FEATURES
Figure 4–1 shows the location of the device’s alarm power indicators, control panel, Pressure On/Off
button, and the breathing circuit connection.
Breathing Circuit
Connection
Pressure On/Off Button
Control Panel
Alarm and Power
Indicators
Figure 4–1 Device Front and Top
4.1 PRESSURE ON/OFF BUTTON
e device’s Pressure On/Off button, located on the side of the device, starts and stops the device’s
airflow.
• To turn the airflow on, press the button in, as shown in Figure 4–2. is puts the device in the
Operate state.
• To turn the airflow off, press the button again. is puts the device in the Standby state.
HEAT
A
irflow
On
HEAT
Airflow
Off
Figure 4–2 Pressure Button On/Off Positions
When the device is in Standby, any ramp in progress is terminated, the alarms are reset (except for the
System Errors alarm), and the humidifier is turned off.
e button is independent of the display screen.

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4.2 CONTROL PANEL
e control panel contains the following control buttons and indicators.
4.2.1 CONTROL BUTTONS
e control buttons on the control panel are shown in Figure 4–3.
Alarm
Silence
Button
Ramp
Button
Heated
Humidifier
Button
User
Buttons
RAMP
HEAT
SILENCE
RESET
Alarm
Reset
Button
SILENCE
RESET
RESET
RESET
Scroll
Button
Figure 4–3 Control Panel
HEAT
When the optional REMstar Heated Humidifier has been
prescribed, this button controls the humidifier’s output. Follow
the instructions included with the humidifier. You can also use
this button to adjust the settings shown in the user menu screens.
RAMP
When the airflow is turned on and the ramp function is enabled,
this button lowers the airflow pressure, allowing you to fall asleep
more easily. You can also use this button to adjust the settings
shown in the user menu screens.
Press the left and right user buttons to navigate the user menu
screens.
SILENCE
SILENCE
is button silences the audible portion of an alarm for one
minute. You can also use this button to exit the user menu
screens.
RESET
RESET
is button allows you to clear an alarm and reset the device for
alarm detection.
Use this button to scroll through the monitoring parameters.

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4.2.2 ALARM AND POWER INDICATORS
Figure 4–4 shows the device’s alarm and power indicators.
Low/Medium Priority
Alarm LED (Yellow)
AC Power
Indicator (Green)
DC Power
Indicator (Green)
High Priority
Alarm LED (Red)
Figure 4–4 Alarm and Power Indicators
e green AC Power LED lights up when the device is connected
to AC Power.
e green DC Power LED lights up when the device is connected
to DC power.
e red High Priority Alarm LED lights up when a high priority
alarm occurs.
e yellow Low/Medium Alarm LED lights up when a medium
or low priority alarm occurs.
NOTE: All LED indicators temporarily turn on when the device is first plugged in.
4.2.3 DISPLAY SCREEN
e display shows you the measured pressure and displays alarm messages. A backlight activates when any
of the buttons are pressed and remains on until there are no buttons pressed for one minute. Figure 4–5
shows the display screen.
Figure 4–5 Display Screen

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e information shown on the display screen is defined as follows:
Indicates that the device requires user attention as indicated on the screen.
A
Indicates that an apnea alarm has occurred.
BPM Indicates that a breath rate setting is being displayed. is symbol flashes when the device
is providing timed backup breaths.
Indicates that a SmartCard is inserted and detected.
cm H2OIndicates that the alphanumeric digits are displaying a pressure value.
EPAP Indicates that a maximum EPAP pressure setting is being displayed.
EPAP Indicates that a minimum EPAP pressure setting is being displayed.
FLEX Indicates that Bi-Flex is turned on and/or its setting is displayed.
Indicates that the humidifier is turned on and/or its setting is displayed.
Indicates that the erapy Hour Meter is being displayed.
LEAK Indicates that the Estimated Leak Rate is being displayed.
Indicates that the control pad LED backlight setting is being displayed or is active.
LPM Indicates that the value displayed is in liters per minute.
MinVent Indicates that the Estimated Minute Ventilation is being displayed.
ml Indicates that the value displayed is in milliliters.
Indicates that a Patient Disconnect alarm is active.
Indicates that the maximum Pressure setting is being displayed.
Indicates that the maximum Pressure Support setting is being displayed.
Indicates that the minimum Pressure Support setting is being displayed.
Indicates that the Ramp function is in progress.
Indicates that the Ramp Starting Pressure is being displayed.
RR Indicates that the Respiratory Rate (RR) is being displayed.
Indicates that a rise time setting is being displayed.
se small “s” on the right side of the display (above “cm H2O”) indicates that the
alphanumeric digits are displaying a time value, in seconds.
VTE Indicates that the Estimated Exhaled Tidal Volume is being displayed.

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4.2.4 BREATHING CIRCUIT CONNECTION
Figure 4–6 shows where the circuit tubing connects to the device.
Breathing
Circuit
Connection
Circuit
Tubing
Patient Interface
Bacteria
Filter
(Optional)
Exhalation Port
Figure 4–6 Typical Breathing Circuit Connection
4.2.5 REAR PANEL
Figure 4–7 shows the device’s rear panel.
Communications
Connector Port Power Inlets
SmartCard
Connector
Filter Cap
Cord Retainer
Cord Retainer
Figure 4–7 Rear Panel
NOTE: e SmartCard Connector is located on the side of the device.
WARNING: In order to ensure proper protection against electrical shock, only communications
accessories with an IEC 60601-1 approved power supply may be connected through the
SleepLink interface. All IEC 950 devices must only be connected to the 7-pin connector
with the Respironics Isolation cable (Part Number 1012865).
e rear panel contains the following:
Communications
Connector
is connector accepts the Respironics Communications cable for computer
and external communications or a remote alarm. (Use only with an IEC 60950
approved computer.)
Power Inlets ere are two power inlets on the rear panel, one for connecting the external AC
power supply and another for connecting the external DC power adapter.
Filter Cap e filter cap can be removed to inspect the inlet air filters.
Cord Retainers Two cord retainers are located on the rear panel to provide strain relief for the
power cord.

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CHAPTER 5: SETTING UP THE DEVICE
5.1 INSTALLING THE AIR FILTERS
e device uses one or two removable filters at the air inlet. e disposable white ultra-fine filter is optional.
You must install the gray foam filter before operating the device. e foam filter is washable and reusable.
CAUTION: A properly installed, undamaged foam filter is required for proper operation.
Reusable Gray
Foam Filter
(required)
Disposable Ultra-fine
Filter (optional)
Filter Cap
Communication Port
Figure 5-1 Installing the Air Filters
To install the air filters, complete the following steps:
. If you are using the optional white ultra-fine filter, place it against the gray foam filter so the soft side
of the ultra-fine filter touches the gray foam filter. When the filters are installed, the hard plastic side of
the white filter will touch the inside of the device.
. Slide the filters into the air inlet at the rear of the device (with the white filter going in first, if it’s
used). Push them down into the recess as shown in Figure 5-1.
. Position the cap so that the small opening on the cap is facing down.
. Snap the cap into place.
NOTE: e filter cap should be installed with the air inlet opening at the bottom.
See Chapter 9 for information about cleaning or replacing the filters.
5.2 WHERE TO PLACE THE DEVICE
Place the device on its base somewhere within easy reach of where you will use it. Make sure that the air
inlet on the rear of the device is not blocked. Place the device on a hard, flat surface. If you block the air
flow around the device, the device may not work properly.
WARNING: Position the humidifier so the water level is lower than you, and the humidifier is on the same
level or lower than the device. See the humidifier instructions for complete setup information.

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5.3 CONNECTING THE BREATHING CIRCUIT
To connect your breathing circuit to the device, complete the following steps:
1. Connect one end of the circuit tubing to the outlet of the bacteria filter (if using one) and connect the
inlet of the bacteria filter to the large connector on the device as shown in Figure 5–2.
If you are not using a bacteria filter, connect the end of the circuit tubing directly to the outlet
connector on the device.
NOTE: Follow the recommendations of your health care professional for using the optional bacteria filter.
Circuit
Tubing
Bacteria
Filter
(Optional)
Figure 5–2 Connecting the Tubing to the Outlet
2. Connect the tubing to the mask:
A. If you are using a mask with a built-in exhalation port, connect the mask’s connector to the
circuit tubing, as shown in Figure 5–3.
Flexible
Tubing
Connector
Mask's
Connector
Exhalation
Port
Figure 5–3 Connecting a Mask with a Built-In Exhalation Port

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B. If you are using a mask with a separate exhalation device, connect the open end of the circuit
tubing to the exhalation device as shown in Figure 5–4. Position the exhalation device so
that the vented air is blowing away from your face.
Exhalation Port Circuit Tubing
Figure 5–4 Connecting a Exhalation Device
Connect the mask’s connector to the exhalation device, as shown in Figure 5–5. See the
mask instructions for complete setup information.
Exhalation Port
Mask Connector
Mask or Other Interface
Figure 5–5 Connecting the Mask
WARNING: e exhalation device is designed to exhaust CO2from the patient circuit. Do not block or
seal the ports on the exhalation device.
3. Attach the headgear to the mask. See the instructions that came with your headgear.