Respironics BiPAP S/T User manual

BiPAP S/T
User Manual

© 2011 Koninklijke Philips Electronics N.V. All rights reserved.

Table of Contents
Chapter 1: Package Contents ......................................................................... 1
Chapter 2: Warnings and Cautions .............................................................. 2
2.1 Warnings ............................................................................................... 2
2.2 Cautions ................................................................................................ 4
2.3 Intended Use ......................................................................................... 4
2.4 Contraindications .............................................................................. 5
2.5 Precautions ........................................................................................... 5
Chapter 3: Introduction .................................................................................. 6
3.1 Definitions ............................................................................................ 6
3.2 What is the BiPAP S/T? ........................................................................ 7
3.3 Symbols ................................................................................................... 9
3.4 How to Contact Respironics ............................................................. 9
Chapter 4: Controls and Display Features ............................................... 10
4.1 Pressure On/Off Button................................................................... 10
4.2 Control Panel .................................................................................... 11
4.2.1 Control Buttons ..................................................................... 11
4.2.2 Alarm and Power Indicators ................................................ 12
4.2.3 Display Screen .......................................................................... 13
4.2.4 Breathing Circuit Connection ............................................. 15
4.2.5 Rear Panel ................................................................................. 15
Chapter 5: Setting up the Device ................................................................. 17
5.1 Installing the Air Filters ................................................................ 17
5.2 Where to Place the BiPAP S/T ........................................................ 18
5.3 Connecting the Breathing Circuit ................................................ 19
5.4 Complete the Setup ............................................................................ 21
5.5 Plugging It In ...................................................................................... 21
5.5.1 Using AC Power ....................................................................... 22
5.5.2 Using DC Power ....................................................................... 23
Chapter 6: Operating the BiPAP S/T .......................................................... 24
6.1 Starting the Device ........................................................................... 24
6.2 Changing the Device Settings ......................................................... 26
6.2.1 Changing the Humidifier Setting ........................................ 27
6.2.2 Navigating the User Display Screens .................................. 27
6.2.2.1 Changing the Flex Setting .......................................... 28
6.2.2.2 Changing the Rise Time Setting ................................. 29
6.2.2.3 Changing the Ramp Starting Pressure ..................... 30
6.2.2.4 Changing the LED Backlight Setting ....................... 31

Chapter 7: Alarms........................................................................................... 32
7.1 Introduction to Alarms................................................................... 32
7.2 What to Do When an Alarm Occurs ............................................ 34
7.3 Alarm Tables ...................................................................................... 35
7.3.1 High Priority Alarms ............................................................. 35
7.3.2 Medium Priority Alarms ........................................................ 36
7.3.3 Low Priority Alarms .............................................................. 36
Chapter 8: Troubleshooting ......................................................................... 37
Chapter 9: Cleaning and Maintenance .................................................... 41
9.1 Cleaning the Device .......................................................................... 41
9.2 Cleaning or Replacing the Inlet Filters ...................................... 41
9.3 Carrying Case ..................................................................................... 43
Chapter 10: Accessories ................................................................................ 44
10.1 Adding a Humidifier ....................................................................... 44
10.2 Adding Oxygen to the Device ........................................................ 44
Chapter 11: Specifications ............................................................................ 45
Environmental ......................................................................................... 45
Physical ...................................................................................................... 45
Electrical .................................................................................................. 45
Pressure ..................................................................................................... 46
Control Accuracy ................................................................................... 46
Disposal ..................................................................................................... 46
Appendix A: EMC Information ..................................................................... 47

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User Manual
Chapter 1: Package Contents
Your BiPAP S/T should include the following items. If any of these items
are missing, contact your home care provider.
BiPAP S/T with
Encore Pro SmartCard
Power Cord
Filter Cap
Gray Foam Filters
Flexible Tubing
1.83 m (6 ft.) X 22 mm i.d.
Ultrafine Filter
User Manual
External AC Power Supply
Carrying Case

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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
• Thismanualservesasareference.The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.
• Thedeviceisnotintendedtoprovideyourtotalventilatory
requirement.
• Theprescriptionmustonlybeadjustedbyatrainedhomecare
provider.
•The device should be used only with masks and connectors
recommended by Respironics or with those recommended by
the health care professional or respiratory therapist. A mask
should not be used unless the device is turned on and operating
properly. The exhalation port(s) associated with the mask should
never be blocked.
Explanation of the Warning: The BiPAP S/T 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suocation.This
warning applies to most models of CPAP machines.
• Useonlythebreathingcircuitprovidedbyyourhomecare
provider.
• 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.
Doingsocouldresultinsuocation.

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• Ifoxygenisusedwiththedevice,theoxygenowmustbe
turnedowhenthedeviceisnotinuse.
Explanation of the Warning: Whenthedeviceisnotinoperation
andtheoxygenowisleon,oxygendeliveredintothe
ventilator tubing may accumulate within the device’s enclosure.
Oxygen accumulated in the ventilator enclosure will create a risk
ofre.
• Ifyouareusingoxygen,theBiPAPS/Tmustbeequippedwith
the Respironics Pressure Valve (Part number 302418). Failure to
usethePressureValvecouldresultinarehazard.
• Oxygensupportscombustion.Oxygenshouldnotbeusedwhile
smokingorinthepresenceofanopename.
• 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iftheroomtemperatureisabove95ºF
(35°C).Ifthedeviceisusedatroomtemperaturesabove95°F,
thetemperatureoftheairowmayexceed106ºF(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.
• Whenusingthisproduct,IEC60601-1-1requirements(safety
requirements for medical electrical systems) must be met.
• Forproperuse,thepowersupplymust be placed feet down, in
the upright position.
• WhentheBiPAPS/Tisusedwithahumidier,positionthe
humidiersothatthewaterlevelinthehumidierislowerthan
you,andthehumidierisonthesamelevelorlowerthanthe
BiPAP S/T.
• Donotaempttowearyourmaskwithoutthedeviceturnedon.
Doing so could result in CO2rebreathing.
• Ifyounoticeanyunexplainedchangesintheperformanceof
the BiPAP S/T, 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 unit, discontinue
use and contact your home care provider.
• RepairsandadjustmentsmustbeperformedbyRespironics-
authorizedservicepersonnelonly.Unauthorizedservicecould
cause injury, invalidate the warranty, or result in costly damage.
• Periodicallyinspectelectricalcords,cables,andthepower
supply device for damage or signs of wear.

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• Toavoidelectricalshock,unplugthedevicebeforecleaningit.
• Pinsofconnectorsidentied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,humidication,
conductiveoor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
CAUTION! U.S.federallawrestrictsthisdevicetosalebyoronthe
order of a physician.
• TheBiPAPS/Tmayonlybeoperatedattemperaturesbetween
41ºF(5°C)and95ºF(35°C).
• Aproperlyinstalled,undamagedreusablefoaminletlteris
required for proper operation.
• 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.
NOTE: Additional warnings, cautions, and notes are located
throughout this manual.
2.3 Intended Use
The BiPAP S/T is intended to provide noninvasive ventilation for pediatric
patients7yearsorolder>40lbs(18.2kg)andadultpatients>66lbs(30kg)
withrespiratoryinsuciencyorobstructivesleepapnea.Thisdevicemaybe
used in the hospital or home.
NOTE: Thedeviceisintendedforusewithnasalmasksandfull-face
masks as recommended by Respironics.
NOTE: The device is to be used only on the instruction of a trained
health care professional.
WARNING: TheeectivenessofBi-Flextherapyhasnotbeen
established for pediatric patients at this time.

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2.4 Contraindications
The BiPAP S/T 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 a patent 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benet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.
• Thefollowingarepotentialsideeectsofnoninvasivepositive
pressure therapy:
 —Eardiscomfort
— Conjunctivitis
— Skin abrasions due to noninvasive interfaces
— Gastric distention (aerophagia)

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Chapter 3: Introduction
This chapter contains the following information:
• Denitionsforcommontermsusedthroughoutthismanual
• Anoverviewofthedevice
• Anexplanationofthesymbolsusedonthedeviceand
throughout this manual
• Contactinformation
3.1 Definitions
The 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
FLEX Atherapyfeaturethatprovidespressurerelief
during exhalation to improve patient comfort.
High Priority Alarm Alarm signal indicating a condition that
requiresimmediateaention.
IPAP Inspiratory Positive Airway Pressure
LED LightEmiingDiode
Low Priority Alarm Alarm signal indicating an informational
message.
Medium Priority Alarm Alarm signal indicating a condition that
requires operator awareness.
Operate State The state of the device when the unit and the
airowarebothon.
Standby State The state of the device when the unit is on,
buttheairowiso.
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seing,soyou
can fall asleep more comfortably.

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Rise Time The time it takes for the device to change
fromEPAPtoIPAP.Youcanadjustthistime
for your comfort.
RR Respiratory Rate
Spontaneous(S) Abi-levelmodewhichrespondstoboth
your inhalation and exhalation by increasing
pressure when you start to inhale and
decreasing pressure when you start to exhale.
There is no automatic delivery of a breath if
you do not inhale.
Spontaneous/Timed
(S/T) Abi-levelmodewhichrespondstoboth
your inhalation and exhalation by increasing
pressure when you start to inhale and
decreasing pressure when you start to exhale.
If you do not start inhaling within a set time,
the device automatically starts inhalation.
Whenthedevicestartsinhalation,itcontrols
the time of inhalation and automatically
decreases the pressure for exhalation within a
set time.
3.2 What is the BiPAP S/T?
The BiPAP S/T, shown in Figure 3–1, supplies air pressure through a
breathing circuit.
Figure 3–1 The BiPAP S/T Unit

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The circuit, shown in Figure 3–2, 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 with Mask with
Integrated Exhalation Port
Flexible
Tubing
Connector
Mask's
Connector
Exhalation
Port
Figure 3–2 Typical Breathing Circuits
NOTE: The 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.
Thesystemsensesyourbreathingeortandchangespressurelevels
when you inhale and exhale depending on the mode of operation.
WARNING: The device can operate on AC or DC power. The DC
poweroptionisnotintendedasabaerybackup.
CAUTION: WhenDCpowerisobtainedfromavehiclebaery,the
device should not be used while the vehicle’s engine is
running.

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3.3 Symbols
The symbols shown below are used on the device 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
Symbol Meaning
IPX1
3.4 How to Contact Respironics
To have your device serviced, contact your home care provider. If you
need to contact Respironics directly, call the Respironics Customer Service
departmentat1-724-387-4000or1-800-345-6443.Youcanalsousethe
following address:
Respironics Inc.
1001 Murry Ridge Lane
Murrysville,PA15668 

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Chapter 4: Controls and
Display Features
Figure 4–1 shows the location of the device’s alarm power indicators,
control panel, Pressure On/Obuon,andbreathingcircuitconnection.
Breathing Circuit
Connection
Control Panel
Pressure On/Off
Button
Alarm and Power Indicators
Figure 4–1 Front and Top
4.1 Pressure On/Off Button
The Pressure On/Obuon,locatedonthesideoftheunit,startsand
stopstheunit’sairow.Pressthebuonintoturntheairowon.This
puts the device in the Operate state.Depressthebuontoturnthe
airowoandputthedeviceintheStandby state.
WhenthedeviceisinStandby,anyrampinprogressisterminated,the
alarmsarereset(exceptfortheSystemErrorsalarm),andthehumidier
isturnedo.
The Pressure On/Obuonisindependentofthedisplayscreen.

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4.2 Control Panel
Thecontrolpanelcontainsthefollowingcontrolbuonsandindicators.
4.2.1 Control Buttons
ThecontrolbuonsonthecontrolpanelareshowninFigure4–2.
Alarm
Silence
Button
Ramp
Button
Heated
Humidifier
Button
User
Buttons
RAMP
HEAT
SILENCE
RESET
Alarm
Reset
Button
Display
Screen
Pressure On/Off
Button
Figure 4–2 Control Panel
HEAT WhentheoptionalREMstarheatedhumidieris
prescribed,thisbuoncontrolsthehumidier’sheater
plateseing.Followtheinstructionsprovidedwiththe
humidier.Youcanalsousethisbuontoadjustthe
seingsshownintheusermenuscreens.
RAMP Whentheairowisturnedonandtherampfunction
isenabled,thisbuonlowerstheairowpressure,
allowing you to fall asleep more easily. You can also use
thisbuontoadjusttheseingsshownintheusermenu
screens.
USER Theleandrightuserbuonsallowyoutonavigatethe
display screens.
SILENCE Thisbuonsilencestheaudibleportionofanalarmfor
oneminute.Youcanalsousethisbuontoexittheuser
menu screens.
RESET Thisbuonallowsyoutoclearanalarmandresetthe
device for alarm detection.

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4.2.2 Alarm and Power Indicators
Figure 4–3 shows the device’s alarm and power indicators.
AC Power
Indicator (Green)
DC Power
Indicator (Green)
High Priority
Alarm LED (Red)
Low/Medium Priority
Alarm LED (Yellow)
AC
DC
Alarms
Power
Figure 4–3 Alarm and Power Indicators
AC Power Indicator ThisgreenLEDlightsupwhenthedeviceis
connected to AC Power.
DC Power Indicator ThisgreenLEDlightsupwhenthedeviceis
connected to DC power.
Red Alarm Indicator TheredLEDlightsupwhenahighpriority
alarm occurs.
Yellow Alarm Indicator ThisyellowLEDlightsupwhenamediumor
low priority alarm occurs.
NOTE: AllLEDindicatorstemporarilyturnonwhentheunitisrst
plugged in.

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User Manual
4.2.3 Display Screen
The display shows you the measured pressure and displays alarm
messages. A backlight activates when any of the keys are pressed and
remains on until there are no keystrokes for one minute.
Figure 4–4 shows the display screen.
Figure 4–4 Display Screen
Theinformationshownonthedisplayscreenisdenedasfollows:
ALARM Indicates that the device requires user
aentionasindicatedonthescreen.
APNEA Indicates that an apnea alarm has occurred.
BPM Indicatesthatabreathrateseingisbeing
displayed. BPMashesonthescreenwhen
the device is providing timed backup breaths
in S/T mode.
CARD Indicates that a SmartCard is inserted and
detected.
CPAP Indicates that the device is in the Continuous
Positive Airway Pressure (CPAP) mode.
cm H2OIndicates that the alphanumeric digits are
displaying a pressure value.
EPAP IndicatesthatanEPAPpressureseingis
being displayed.
FLEX IndicatesthataBi-Flexcomfortseingis
being displayed.
HEAT Indicatesthatthehumidieristurnedonand/
oritsseingisdisplayed.
HOURS Indicates that the Therapy Hour Meter is
being displayed.

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User Manual
INSP. TIME Indicatesthattheinspiratorytimeseingis
being displayed.
IPAP IndicatesthatanIPAPpressureseingis
being displayed.
LIGHT  IndicatesthatthekeypadLEDbacklight
seingisbeingdisplayedorisactive.
PATIENT Indicates that a Patient Disconnect alarm is
active.
RAMP Indicates that the Ramp function is in
progress.
RAMP START Indicates that the Ramp Starting Pressure is
being displayed.
RISE TIME  Indicatesthatarisetimeseingisbeing
displayed.
S The “s” on the right side of the display, above
“cm H2O”, indicates that the alphanumeric
digits are displaying a time value, in seconds.
S or S/T Indicates that the device is in the Spontaneous
mode if only the Sappears, or the
Spontaneous/Timed mode if the S/T appears.

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User Manual
4.2.4 Breathing Circuit Connection
Figure4–5showswherethecircuittubingconnectstothedevice.
Breathing
Circuit
Connection
Circuit
Tubing
Patient Interface
Bacteria
Filter
(Optional)
Exhalation Port
Figure 4–5 Typical Breathing Circuit Connection
4.2.5 Rear Panel
Figure4–6showstherearpanel.
Communications
Connector Port Power Inlets
SmartCard
Connector
Filter Cap
Cord Retainer
Cord Retainer
Figure 4–6 Rear Panel
NOTE: The SmartCard Connector is located on the side of the device.
WARNING: In order to ensure proper protection against electric 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).

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User Manual
The rear panel contains the following:
Communications Connector This 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 There 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 Theltercapcanberemovedtoinspectthe
inletairlters.
Cord Retainers Two cord retainers are located on the rear
panel to provide strain relief for the power
cord.