BiPAP S/T User Manual

BiPAP

S/T

User Manual

This BiPAP system is covered by one or more of the following patents: U.S.

Patent Nos. 5,148,802; 5,313,937; 5,433,193; 5,632,269; 5,803,065; 6,029,664;

6,305,374 and 6,539,940; Australian Patent Nos. 638054, 661575, 698519,

723681, 734319, and 733655; Canadian Patent Nos. 2,162,981 and 2,259,795;

European Patent Pub. No. 0425092B1; and Japanese Patent Nos. 2832812,

2137336, and 2926392. Other U.S. and Foreign Patents Pending.

Ta b l e o f Co n T e n T s

Ch a p t e r 1: pa C k a g e Co n t e n t s ........................................................................... 1

Ch a p t e r 2: Wa r n i n g s a n d Ca u t i o n s ................................................................. 2

2.1 Wa r n i n g s ................................................................................................ 2

2.2 Ca u t i o n s ................................................................................................. 4

2.3 in t e n d e d us e ........................................................................................... 4

2.4 Co n t r a i n d i C a t i o n s ................................................................................. 5

2.5 pr e C a u t i o n s ............................................................................................ 5

Ch a p t e r 3: in t r o d u C t i o n .................................................................................... 6

3.1 de f i n i t i o n s .............................................................................................. 6

3.2 Wh a t i s t h e Bipap s/t?........................................................................ 7

3.3 sy m B o l s .................................................................................................... 9

3.4 ho W t o Co n t a C t re s p i r o n i C s ................................................................ 9

Ch a p t e r 4: Co n t r o l s a n d di s p l a y fe a t u r e s .................................................... 10

4.1 pr e s s u r e on/of f Bu t t o n .................................................................... 10

4.2 Co n t r o l pa n e l ..................................................................................... 11

4.2.1 Co n t r o l Bu t t o n s ....................................................................... 11

4.2.2 al a r m a n d po W e r in d i C a t o r s ................................................... 12

4.2.3 di s p l a y sC r e e n ............................................................................ 13

4.2.4 Br e a t h i n g Ci r C u i t Co n n e C t i o n ................................................. 15

4.2.5 re a r pa n e l ................................................................................. 15

Ch a p t e r 5: se t t i n g u p t h e de v i C e .................................................................... 17

5.1 in s t a l l i n g t h e ai r fi l t e r s .................................................................... 17

5.2 Wh e r e t o pl a C e t h e Bipap s/t ......................................................... 18

5.3 Co n n e C t i n g t h e Br e a t h i n g Ci r C u i t .................................................... 19

5.4 Co m p l e t e t h e se t u p .............................................................................. 21

5.5 pl u g g i n g it in ....................................................................................... 21

5.5.1 us i n g aC po W e r ........................................................................ 22

5.5.2 us i n g dC po W e r ........................................................................ 23

Ch a p t e r 6: op e r a t i n g t h e Bipap s/t ............................................................ 24

6.1 st a r t i n g t h e de v i C e ............................................................................. 24

6.2 Ch a n g i n g t h e de v i C e se t t i n g s ............................................................ 26

6.2.1 Ch a n g i n g t h e hu m i d i f i e r se t t i n g ............................................ 27

6.2.2 nav i g at i n g t h e us e r di s p l a y sC r e e n s ...................................... 27

6.2.2.1 Ch a n g i n g t h e fl e x se t t i n g ............................................. 28

6.2.2.2 Ch a n g i n g t h e ri s e ti m e se t t i n g ..................................... 29

6.2.2.3 Ch a n g i n g t h e ra m p st a r t i n g pr e s s u r e ......................... 30

6.2.2.4 Ch a n g i n g t h e led Ba C k l i g h t se t t i n g .......................... 31

Ch a p t e r 7: al a r m s ............................................................................................ 32

7.1 in t r o d u C t i o n t o al a r m s ...................................................................... 32

7.2 Wh a t t o do Wh e n a n al a r m oC C u r s ............................................... 34

7.3 al a r m ta B l e s ........................................................................................ 35

7.3.1 hi g h pr i o r i t y al a r m s ................................................................ 35

7.3.2 me d i u m pr i o r i t y al a r m s ........................................................... 36

7.3.3 lo W pr i o r i t y al a r m s ................................................................. 36

Ch a p t e r 8: tr o u B l e s h o o t i n g ............................................................................ 37

Ch a p t e r 9: Cl e a n i n g a n d ma i n t e n a n C e ........................................................ 41

9.1 Cl e a n i n g t h e de v i C e ............................................................................ 41

9.2 Cl e a n i n g o r re p l a C i n g t h e in l e t fi l t e r s ........................................... 41

9.3 Ca r r y i n g Ca s e ...................................................................................... 43

Ch a p t e r 10: aC C e s s o r i e s .................................................................................. 44

10.1 ad d i n g a hu m i d i f i e r .......................................................................... 44

10.2 ad d i n g ox y g e n t o t h e de v i C e .......................................................... 44

Ch a p t e r 11: sp e C i f i C a t i o n s ................................................................................ 45

en v i r o n m e n t a l ........................................................................................... 45

ph y s i C a l ...................................................................................................... 45

el e C t r i C a l ................................................................................................... 45

pr e s s u r e ....................................................................................................... 46

Co n t r o l aC C u r a C y .................................................................................... 46

di s p o s a l ....................................................................................................... 46

ap p e n d i x a: emC in f o r m a t i o n ........................................................................ 47

User Manual

Ch a p T e r 1: pa C k a g e Co n T e n T s

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.

Ultrane Filter

User Manual

External AC Power Supply

Carrying Case

User Manual

Ch a p T e r 2: Wa r n i n g s a n d Ca u T i o n s

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 Wa r n i n g s

• 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 suffocation. 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 suffocation.

User Manual

• Ifoxygenisusedwiththedevice,theoxygenowmustbe

turned off when the device is not in use.

Explanation of the Warning: Whenthedeviceisnotinoperation

andtheoxygenowisleft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attempttowearyourmaskwithoutthedeviceturnedon.

Doing so could result in CO

rebreathing.

• 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.

User Manual

• 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 Ca u T i o n s

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 in T e n d e d us e

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insuf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effectivenessofBi-Flextherapyhasnotbeen

established for pediatric patients at this time.

User Manual

2.4 Co n T r a i n d i C a T i o n s

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 pr e C a u T i o n s

• 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effectsofnoninvasivepositive

pressure therapy:

— Ear discomfort

— Conjunctivitis

— Skin abrasions due to noninvasive interfaces

— Gastric distention (aerophagia)

User Manual

Ch a p T e r 3: in T r o d u C T i o n

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 de f i ni T i o n s

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 attention.

IPAP Inspiratory Positive Airway Pressure

LED Light Emitting 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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.

User Manual

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 Wh a T i s T h e 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

User Manual

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 CO

rebreathing.

The system senses your breathing effort 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 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.

User Manual

3.3 sy m b o l s

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 ho W T o Co n T a C T re s p i r o n i C s

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

1001 Murry Ridge Lane

Murrysville, PA 15668

Visit Respironics web site at: www.respironics.com

User Manual

Ch a p T e r 4: Co n T r o l s a n d

di s p l a y fe a T u r e s

Figure 4–1 shows the location of the device’s alarm power indicators,

control panel, Pressure On/Off button, 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 pr e s s u r e on/of f bu T T o n

The Pressure On/Off button, located on the side of the unit, starts and

stopstheunit’sairow.Pressthebuttonintoturntheairowon.This

puts the device in the Operate state. Depress the button to turn the

airowoff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 off.

The Pressure On/Off button is independent of the display screen.

User Manual

4.2 Co n T r o l pa n e l

The control panel contains the following control buttons and indicators.

4.2.1 Co n T r o l bu T T o n s

The control buttons 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buttoncontrolsthehumidier’sheater

plate setting. Follow the instructions provided with the

humidier.Youcanalsousethisbuttontoadjustthe

settings shown in the user menu screens.

RAMP Whentheairowisturnedonandtherampfunction

isenabled,thisbuttonlowerstheairow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.

SILENCE This button silences the audible portion of an alarm for

one minute. You can also use this button to exit the user

menu screens.

RESET This button allows you to clear an alarm and reset the

device for alarm detection.

User Manual

4.2.2 al a r m a n d po W e r in d i C a T o r s

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)

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.

User Manual

4.2.3 di s p l a y sC r e e n

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

attention as indicated on the screen.

APNEA Indicates that an apnea alarm has occurred.

BPM Indicates that a breath rate setting 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 H

O Indicates that the alphanumeric digits are

displaying a pressure value.

EPAP Indicates that an EPAP pressure setting is

being displayed.

FLEX IndicatesthataBi-Flexcomfortsettingis

being displayed.

HEAT Indicatesthatthehumidieristurnedon

and/or its setting is displayed.

HOURS Indicates that the Therapy Hour Meter is

being displayed.

User Manual

INSP. TIME Indicates that the inspiratory time setting is

being displayed.

IPAP Indicates that an IPAP pressure setting is

being displayed.

LIGHT Indicates that the keypad LED backlight

setting 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 setting is being

displayed.

S The “s” on the right side of the display, above

“cm H

O”, 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 S appears, or the

Spontaneous/Timed mode if the S/T appears.

User Manual

4.2.4 br e a T h i n g Ci r C u i T Co n n e C T i o n

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 re a r pa n e l

Figure 4–6 shows the rear panel.

Communications

Connector Port

Power Inlets

SmartCard

Connector

Filter Cap

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).

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.

User Manual

Ch a p T e r 5: se T T i n g u p T h e de v i C e

This chapter provides instructions on how to:

• Installtheairlters

• Positiontheunit

• Connectthebreathingcircuit

• PlugthedeviceinusingACorDCpower

5.1 in s T a l l i n g T h e ai r fi l T e r s

CAUTION: Aproperlyinstalled,undamagedfoamlterisrequired

for proper operation.

TheBiPAPS/Tusesagrayfoamlterthatiswashableandreusable,and

anoptionalwhite,ultra-nelterthatisdisposable.Onelterofeach

kind is supplied with the unit.

Ifyourhomecareproviderdidnotinstalltheinletairlters,youmust

installatleastthegrayfoamlterbeforeusingthedevice.

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.

Reusable Gray

Foam Filter

(required)

Disposable Ultra-fine

Filter (optional)

Filter

Cap

Figure 5–1 Installing the Filters

User Manual

3. AttachtheltercapasshowninFigure5–2.Positionthecapsothat

the small opening on the cap is facing down. Insert the caps bottom

tabsintotheopeningsbelowthelterarea.Snapthecapintoplace.

Figure 5–2 Attaching the Filter Cap

NOTE: Theltercapshouldbeinstalledwiththeairinletopeningat

the bottom.

SeeChapter9tocleanorreplacethelters.

5.2 Wh e r e T o pl a C e T h e bipap s/T

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 unit is not

blocked.Placetheunitonahard,atsurface.Ifyoublocktheairow

around the unit, the device may not work properly.

WARNING: Positionthehumidiersothewaterlevelislowerthan

you,andthehumidierisonthesamelevelorlowerthan

thedevice.Seethehumidierinstructionsforcomplete

setup information.

User Manual

5.3 Co n n e C T i n g T h e br e a T h i n g Ci r C u i T

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

lter(ifusingone)andconnecttheinletofthebacterialtertothe

large connector on the device as shown in Figure 5–3.

 Ifyouarenotusingabacterialter,connecttheendofthecircuit

tubing directly to the outlet connector on the device.

NOTE: Follow the recommendations of your home care provider for

usingtheoptionalbacterialter.

Circuit

Tubing

Bacteria

Filter

(Optional)

Figure 5–3 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 5–4.

Flexible

Tubing

Connector

Mask's

Connector

Exhalation Port

Figure 5–4 Connecting a Mask with a Built-In Exhalation Port

User Manual

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 5–5. Position the exhalation

device so that the vented air is blowing away from your

face.

Exhalation

Device

Circuit

Tubing

Figure 5–5 Connecting an Exhalation Device

Connect the mask’s connector to the exhalation device, as

shown in Figure 5–6. See the mask instructions for complete

setup information.

Exhalation Device

Mask Connector

Mask or Other

Interface

Figure 5–6 Connecting the Mask

WARNING: The exhalation device is designed to exhaust CO2 from

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.

User Manual

5.4 Co m p l e T e Th e se T u p

Figure 5–7 shows the completed breathing circuit setup.

Breathing

Circuit

Connection

Circuit

Tubing

Patient Interface

Bacteria

Filter

(Optional)

Exhalation Port

Figure 5–7 Complete Breathing Circuit

5.5 pl u g g i n g iT in

You can use AC or DC power to operate the device.

WARNING: The DC power option is not intended as a battery backup

when using AC power.

WARNING: For proper use, the power supply must be placed feet

down, in the upright position, as shown in Figure 5–7.

User Manual

5.5.1 us i n g aC po W e r

Complete the following steps to operate the device using AC power:

1. Plug the pronged end of the AC power supply’s cord into an

electrical outlet.

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 supply’s cord retainer, using the wire tie supplied with your

power supply.

WARNING: Never plug the AC power supply into an outlet that is

controlled by a wall switch.

WARNING: Route the wires to avoid tripping.

3. Leaving a small amount of slack in the cord, connect the cord on

the other side of the power supply to one of the power inlets on

the device, as shown in Figure 5–8. The power cord has a locking

connector. To properly plug the cord in:

a. Pull the locking mechanism back.

b. Push the connector into place.

c. Release the lock.

Figure 5–8 Plugging in the AC Power Supply

User Manual

NOTE: You can plug the cord into either of the power inlets on the

back of the device.

4. Wrapthecordaroundthedevice’spowercordretainer,which

provides strain relief for the power cord.

5. Ensure that all connections are secure.

NOTE: If you need to disconnect the power cord from the device,

slide the locking connector back and then remove the power

cord.

5.5.2 us i n g dC po W e r

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 more information.

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.

CAUTION: WhenDCpowerisobtainedfromavehiclebattery,the

device should not be used while the vehicle’s engine is

running. Damage to the device or the vehicle may occur.

User Manual

Ch a p T e r 6: op e r a T i n g T h e de v i C e

This chapter explains how to start the device and change the settings.

6.1 sT a r T i n g T h e bipap s/T

1. Plug in the device to an AC or DC power source to power up the

unit.Aconrmationalarmsounds,andthecontrolpadbuttonslight

up.

NOTE: If the alarm does not sound or the buttons do not light up, the

device requires servicing. Contact your home care

provider.

Several screens appear initially during this step:

a. TherstscreenthatappearsistheSelfTestscreen,shownin

Figure 6–1. This is the internal test performed by the device.

Figure 6–1 Self Test Screen

b. The next screen displays the software version, as shown in

Figure 6–2:

Figure 6–2 Software Version Screen

NOTE: Version 1.0 shown in Figure 6–2 is an example. Your device

may have a higher software version installed.

User Manual

c. The third screen to appear is the Blower Hours screen, which

displays the blower hours time meter:

Figure 6–3 Blower Hours Screen

NOTE: WiththeexceptionofthePressure On/Off button, the control

padisinactiveduringtheserstthreescreens.Eachofthese

screensappearsforapproximately1-3seconds.

d. The next screen that appears is the Standby screen, shown in

Figure 6–4. This indicates that the device is in the Standby state.

Figure 6–4 Standby Screen

2. Press the Pressure On/Off button to put the unit into the Operate

state. The Monitoring screen, shown in Figure 6–5, appears.

Figure 6–5 Monitoring Screen

Both the Monitoring and the Standby screens display the Patient

Disconnect, Apnea, and LED backlight icons if these features are

enabled. Additionally, the SmartCard icon displays if a SmartCard is

inserted.

The Monitoring screen also displays the actual measured pressure

and the Flex icon if Flex is enabled.

User Manual

3. Putonyourmaskassemblywhentheairstartstoow.

4. Make sure that no air is leaking from your mask into your eyes. If

it is, adjust the mask and headgear until the air leak stops. See the

instructions that came with your mask for more information.

NOTE: A small amount of mask leak is normal and acceptable.

Correct large mask leaks or eye irritation from an air leak as

soon as possible.

5. If you are using the device while sleeping, try placing the tubing

from the device over your headboard. This may reduce tension on

the mask.

6. Relax. Take normal, relaxed breaths through your nose.

NOTE: If you are having trouble with your mask, see Chapter 8,

Troubleshooting, for some suggestions.

6.2 Ch a n g i n g T h e de v i C e se T T i n g s

You can view the following settings and indicators on the device display screen:

• Measuredpressure

• Mode

• SmartCard

• Patientalarms

Additionally, you can view and modify the following settings using the

display screens:

• Humidierheat

• Flex

• RiseTime

• Rampstartpressure

• LEDbacklight

NOTE: Whenchanginganysetting(exceptfortheRampStart

Pressure setting), once a maximum setting is reached, the

setting rolls back over to the minimum setting, and likewise,

once a minimum setting is reached, it rolls back over to the

maximum setting provided. For example, the minimum

humidiersettingis1 and the maximum is 5. Once the

humidiersettingisincreasedto5, if you press the Heat

button again, the setting will go back to 1. Or, once the

humidiersettingisdecreasedto1, if you press the Ramp

button again, the setting will go back to 5.

User Manual

6.2.1 Ch a n g i n g T h e hu m i d i f i e r se T T i n g

IfyouareusingtheREMstarHeatedHumidierwithyourBiPAPS/T,

youcanadjustthehumidierheatsettingbycompletingthefollowing

steps:

1. From either the Standby or Monitoring screen, press and hold the

Heat buttonforapproximately4seconds.TheHumidierSetting

screen appears, as shown in Figure 6–6.

Figure 6–6 Humidier Setting Screen

2. Press the Heat buttontoincreasethehumidiersetting,orpressthe

Ramp button to decrease the setting. You can adjust the setting from

1 to 5. The change takes effect immediately as you adjust the setting.

3. You can exit this screen by pressing the Left or Right User buttons or

the Silence button.

 Foradditionalinformationonusingahumidierwiththedevice,see

Chapter 10.

6.2.2 na v i g a T i n g T h e us e r di s p l a y sC r e e n s

You can navigate the rest of the user display screens by pressing the Left

and Right User buttons.

You can change the settings on any of the display screens by pressing the

Heat and Ramp buttons to increase or decrease the setting.

You can exit any of the user display screens by pressing the Silence

button.

User Manual

Figure 6–7 shows how to navigate the user display screens.

Right User

Button

Right User

Button

Right User

Button

Left User

Button

Left User

Button

Left User

Button

Only displayed if the Flex feature

is prescribed for you.

Only displayed if the rise time feature

is prescribed for you.

Only displayed if the ramp feature

is prescribed for you.

Flex Setting Screen

Rise Time Setting Screen

Ramp Start Pressure Setting Screen

LED Backlight Setting Screen

Figure 6–7 Navigating the User Display Screens

6.2.2.1 Ch a n g i n g T h e fl e x se T T i n g

The Flex setting allows you to adjust the level of air pressure relief that

you feel when you exhale during therapy.

WARNING: TheeffectivenessofBi-Flextherapyhasnotbeen

established for pediatric patients at this time.

NOTE: The Flex feature is not prescribed for all users. If the screen

shown in Figure 6–8 does not appear on your display, you

cannot adjust this setting.

User Manual

To change the Flex setting, complete the following steps:

1. From either the Monitoring or Standby screens, press the Right User

button. The Flex Setting screen appears, as shown in Figure 6–8.

Figure 6–8 Flex Setting Screen

2. To increase or decrease the Flex setting, press the Heat or Ramp

button until the correct setting appears. You can choose from 1 to 3.

NOTE: It is recommended that you start with the minimum setting of

1, which provides the least relief. Levels 2 and 3 progressively

increase the pressure relief.

6.2.2.2 Ch a n g i n g T h e ri s e Ti m e se T T i n g

Rise time is the time it takes for the device to change from EPAP to IPAP.

Youcanadjusttherisetimetondthesettingthatprovidesyouwiththe

most comfort.

NOTE: The rise time feature is not prescribed for all users. If the

screen shown in Figure 6–9 does not display, you cannot

adjust this setting.

Additionally, if the Flex feature has been prescribed for you,

whenFlexisenabled,therisetimeisxedatasettingof3.

The Rise Time screen will not display, and you won’t be able

to adjust the setting.

User Manual

To change the rise time setting, complete the following steps:

1. From either the Monitoring or Standby screens, press the Right User

button until you reach this screen. The Rise Time Setting screen is

shown in Figure 6–9.

Figure 6–9 Rise Time Setting Screen

2. Increase or decrease the rise time setting from 1 to 6 by pressing the

Heat or Ramp buttonuntilyoundtherightsetting.Asettingof1 is

the fastest rise time, while 6 is the slowest.

6.2.2.3 Ch a n g i n g T h e ra m p sT a r T i n g pr e s s u r e

The device is equipped with an optional ramp feature. This feature will

reduce the pressure and then gradually increase (ramp) the pressure to

the prescription pressure setting so you can fall asleep more comfortably.

NOTE: The ramp feature is not prescribed for all users. If the screen

shown in Figure 6–10 does not appear on your display, you

cannot adjust this setting.

To change the ramp starting pressure setting, complete the following steps:

1. From either the Monitoring or Standby screens, press the Right User

button until the Ramp Start Setting screen appears, as shown in

Figure 6–10.

Figure 6–10 Ramp Start Setting Screen

2. Press the Heat or Ramp button to increase or decrease the ramp

starting pressure as needed. You can adjust the setting from 4.0 cm

O to your EPAP or CPAP setting.

User Manual

6.2.2.4 Ch a n g i n g T h e led ba C k l i g h T se T T i n g

WhenairowisturnedonandthedeviceisintheOperatestate,youcan

turn the control pad lighting behind the buttons on or off using the LED

backlight setting.

NOTE: Thelightsarealwaysonwhentheairowisoffandtheunitis

in Standby.

To change the LED backlight setting, complete the following steps:

1. From either the Monitoring or Standby screens, press the Right User

button until the LED Backlight Setting screen appears, as shown in

Figure 6–11.

Figure 6–11 LED Backlight Setting Screen

2. Press the Heat or Ramp button to select a new setting. A setting of 1

means the light is on, while 0 means the light is off.

User Manual

Ch a p T e r 7: al a r m s

This chapter describes the BiPAP S/T alarms and what you should do if

an alarm occurs.

7.1 in T r o d u C T i o n T o al a r m s

The device provides three alarm levels: high, medium, and low priority.

High Priority These alarms require immediate response.

The alarm signal consists of a red LED

indicator and a sound that is either a periodic

patternconsistingofatwo-secondbeep

followedbytwo-secondsofsilenceora

pattern of three beeps, a pause, and then two

more beeps. The display has the message

ALARM at the top of the screen. The tables

in Section 7.3 display these sounds using the

following symbols: or•••••

Medium Priority These alarms require prompt response. The

alarm signal consists of a yellow LED and a

sound that repeats a pattern of three beeps.

The display has the message ALARM at the

top of the screen. The tables in Section 7.3

display these sounds using the following

symbols:•••

Low Priority These alarms require your awareness. The

alarm signal consists of a yellow LED and a

sound that repeats a pattern of two beeps. The

display has the message ALARM at the top

of the screen. The tables in Section 7.3 display

thesesoundsusingthefollowingsymbols:••

Someaudiblealarmsareself-cancellable.Thismeansthatthealarm

sound stops when the cause of the alarm is corrected.

User Manual

The alarm LED indicators are located on the right side of the control pad,

as shown in Figure 7–1.

High Priority

Alarm LED (RED)

Low/Medium Priority

Alarm LED (Yellow)

Alarms

Power

Figure 7–1 Alarm LED Indicators

In addition to the alarm LED indicators, the control pad also contains

Alarm Reset and Alarm Silence buttons, as shown in Figure 7–2.

Alarm

Silence

Button

RAMP

HEAT

SILENCE

RESET

Alarm

Reset

Button

Figure 7–2 Alarm Buttons

User Manual

7.2 Wh a T T o do Wh e n a n al a r m oC C u r s

The following example applies to most alarm conditions. Follow these

steps unless otherwise directed by the alarm tables that follow.

1. Look at the alarm indicators and listen to the alarm sound.

Alarm LED

Lights Up

Alarms

Power

Figure 7–3 Alarm LED Lights Up

 NotethecoloroftheLEDandwhethertheLEDissolidorashing.

2. Look at the display for text.

Figure 7–4 Sample Alarm Display

The word ALARM appears at the top of the screen to indicate an

alarm. Additional codes and icons may also appear depending on

the type of alarm.

3. Press the Silence button to temporarily silence the alarm (for one

minute). The display returns to the screen that was showing when

the alarm occurred.

4. Look up the alarm in the alarm tables in Section 7.3 and perform the

actionspecied.

5. Press the Reset button to clear the alarm.

User Manual

7.3 al a r m Ta b l e s

Thefollowingtablessummarizethehighpriority,mediumpriority,and

low priority alarms.

7.3.1 hi g h pr i o r i T y al a r m s

Alarm

LED

Alarm

Sound

Display

Message

Action

Possible

Cause

Your

Action

Red Flash

• • • • •

ALARM and

PATIENT

icons

flash

Operates Breathing circuit is

disconnected or has

a large leak.

Reconnect the circuit

or fix the leak.

Red Flash

• • • • •

ALARM

and APNEA

icons flash

Operates

An apnea event

occurred during

therapy.

Continue using the

device. Report the

alarm to your home

care provider.

Red Flash

• • • • •

ALARM

flashes and

an error

code ("Exx")

displays

Shuts down.

Blower cannot

be restarted.

Device failure

Press the

RESET button to

reset the alarm.

Remove power from the

unit. Restore power. If

the alarm continues,

contact your home care

provider.

Red Flash

• • • • •

ALARM

and

cm H

icons flash

Operates

Excessive leak

or blockage;

malfunctioning unit.

Press the RESET

button to reset the

alarm. Check for the

following: dirty inlet

filters, blocked air

intake, excessive leak

in the circuit. If the

alarm continues, call

your home care

provider.

Red Solid

Blank

screen

Shuts down

Battery is discharged.

-or-

Power was lost

while the unit was

providing therapy.

Remove the DC power

source from the unit.

Replace the battery and

restore power to the

unit. Or, seek a reliable

AC power source.

Press the Pressure On/

Off button to silence

the alarm. Restore

power.

User Manual

7.3.2 me d i u m pr i o r i T y al a r m s

Alarm

LED

Alarm

Sound

Display

Message

Harmony

Action

Possible

Cause

Your

Action

Ye llow Flash

• • •

DC Power

LED Flashes

Operates Battery nearly

discharged.

Press the RESET button to

reset the alarm. Replace

the battery. If the alarm

continues, contact your

home care provider.

7.3.3 lo W pr i o r i T y al a r m s

Alarm

LED

Alarm

Sound

Display

Message

Device

Action

Possible

Cause

Your

Action

Yellow Solid

• •

CARD

flashes

and

card error

code ("Cxx")

displays

Operates

There is a problem

with the SmartCard

inserted in the

SmartCard

connectivity slot.

Perhaps the

SmartCard is

inserted upside down

or backwards.

Confirm that the

SmartCard is properly

inserted.

If the alarm continues

to occur, remove the

SmartCard from the

device and contact

your home care

provider.

Operates

Device lost AC

power and is now

operating on DC

power.

Press the RESET

button to reset the

alarm. Check the

AC power. Seek a

reliable power

source. Provide AC

power if you do not

want to use a battery;

otherwise, no further

action is needed.

At start-up only,

alarm notifies you

that a battery is

being used

to provide power.

Yellow Solid

DC power

LED flashes

• •

Unchanged

Operates

Yellow Solid

AC power

LED flashes

Yellow Solid

• •

The device

has successfully

downloaded the

prescription from

the SmartCard.

Remove the

SmartCard from the

device. If alarm

continues to occur,

contact your home

care provider.

ALARM,

CARD and

cm H

symbols

flash

The DC output

voltage from the AC

power supply is out

of spec (< 22 VDC)

or there is a

defective battery

sense line on the

DC power adapter.

Remove AC power

from the power supply

and then restore

power. If alarm

continues to occur,

contact your home

care provider.

User Manual

Ch a p T e r 8: Tr o u b l e s h o o T i n g

This chapter describes problems that you may experience with your

BiPAP S/T or mask and provides possible solutions.

Problem Why It Happened What To Do

Check the outlet

power and verify

that the device

is plugged in. If the

problem continues,

call your home care

provider.

Theinletltersmay

be dirty.

The unit may be

operating in direct

sunlight or near a heater.

Clean or replace the

inletairltersas

described in Chapter

9. Make sure the unit is

away from bedding or

curtains that could

blocktheowofair

around the device.

Make sure the unit is

away from direct

sunlight and heating

equipment.

If the problem

persists, contact your

home care

provider.

The air out of

the mask is

much warmer

than usual.

This could be due to

improper headgear

adjustment or improper

masktting.

Check the headgear

adjustment as

described in the

headgear instructions.

Refer to your mask

instructions to make

sure the mask is

properlytted.Ifthe

problem continues,

contact your home care

provider for a

rettingoradifferent

sizemask.

The mask feels

uncomfortable

to wear.

If the power LED is off,

there’s no power at the

outlet or the device is

unplugged. If the power

LED is on, the problem is

in the device.

The device does

not operate

when you press

the Pressure On/

Off button.

User Manual

Problem Why It Happened What To Do

Be sure to rinse the mask

thoroughly after cleaning

to remove residue. See

the mask cleaning

instructions for detailed

information. If the

problem continues,

contact your home care

providerforaretting

oradifferentsizemask.

Irritation or allergic

reaction to the mask

material.

Use a barrier between

your skin and the mask,

such as 3M’s Microfoam

or Squibb’s Duoderm

Refer to your mask

instructions for additional

information.

Redness occurs

when the mask

cushion accessory

comes in contact

with the skin.

The mask may not be

positioned correctly, or

the mask is not

properlytted.

Check the headgear

adjustment as described

in the headgear

instructions. Refer to your

mask instructions to make

sure the mask is properly

tted.Iftheproblem

continues, contact your

home care provider

forarettingora

differentsizemask.

Sore or dry eyes.

This could be due to

impropermasktting

or improper mask

cleaning.

This could be due to

improper headgear

adjustment or

improper

masktting.

Check the headgear

adjustment as

described in the

headgear instructions.

Refer to your mask

instructions to make

sure the mask is

properlytted.Ifthe

problem continues,

contact your home care

provider for a

rettingoradifferent

sizemask.

There is

signicant

air leakage

around

the mask.

Redness occurs

when the mask

cushion comes

in contact with

the skin.

User Manual

Discontinue use.

Contact your home

care provider or

Respironics for

directions on how to

have your unit

serviced.

Please have the serial

number ready when

you call.

The tubing has become

disconnected from the

system.

Press the RESET button

to reset the alarm.

Reconnect the tubing

and press the Pressure

On/Off button to

restarttheairow.If

theairowdoesnot

restart, the device

may not be operating

correctly. Contact your

home care provider

or Respironics for

directions on having

the unit serviced. Please

have your serial number

ready when you call.

A patient

disconnect alarm

occurs.

Problem Why It Happened What To Do

The unit or power

supply has been

dropped or mishandled,

or water has been

spilled onto or into the

device or

the power supply.

There are

unexplained

changes in the

performance of

the unit.

Runny nose.

Nasal reaction to the

airow.

Call your health care

professional.

User Manual

The unit or power supply

has been dropped or

mishandled, or the unit or

power supply is in an

area with high EMI

emissions.

Unplug the unit and

the power supply.

Relocate the unit to

an area with lower EMI

emissions.

The unit’s

display is erratic.

Problem Why It Happened What To Do

The SmartCard is not

inserted properly. It may

be inserted upside down

or backwards.

Remove the SmartCard

and reinsert it so that

the printed side of the

card is facing up and

the end with the arrow

goes into the device

rst.Iftheerror

message appears again,

contact your home

care provider or

Respironics for

directions on having

your unit

serviced. Please have

your serial number

ready when you call.

A SmartCard

error occurs.

User Manual

Ch a p T e r 9: Cl e a n i n g a n d ma i n T e n a n C e

This chapter provides information on how to clean and maintain your

BiPAP S/T system.

9.1 Cl e a n i n g T h e de v i C e

Before cleaning or performing any routine maintenance, always make

sure the unit is not operating and disconnect the device from the power

source.

NOTE: The following cleaning instructions are for the BiPAP S/T

unit only. To clean the accessories, refer to each accessory’s

instruction sheet.

CAUTION: Do not immerse the unit or allow any liquid to enter the

enclosure,inletlter,oranyopenings.

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.

Gently wash the reusable circuit tubing in a solution of warm water and

a mild detergent. Rinse thoroughly and allow to air dry.

9.2 Cl e a n i n g o r re p l a C i n g T h e in l e T fi l T e r s

Thedevicehastworemovableltersattheairinlet.Thegrayfoam

lteriswashableandreusable.Theoptionalwhite,ultra-nelteris

disposable.Thegrayfoamltershouldbecleanedatleastonceevery

two weeks under normal usage and replaced with a new one every six

months.Thewhiteultra-nelterisdisposableandshouldbereplaced

after 30 nights of use or sooner if it appears dirty. Do not attempt to clean

theultra-nelter.Itwilldamagethelter.

NOTE: Dirtyinletltersmaycausehighoperatingtemperaturesand

mayaffectperformance.Regularlyexaminetheinletltersas

needed for integrity and cleanliness.

User Manual

1. Make sure the device is not operating, and disconnect the power

cord from the wall outlet or DC source.

2. AsshowninFigure9–1,removetheltercapbygentlypressing

down on the top panel and pulling the cap out, away from the

device.

Figure 9–1 Removing the Filter

3. RemovetheltersfromtheenclosureasshowninFigure9–2.The

toplteristhereusablegrayfoamlter.Thebottomlteristhe

optionaldisposable,white,ultra-nelter.

Reusable Gray

Foam Filter

Disposable Ultra-fine

Filter

Figure 9–2 Removing the Air Filters

4. Checkthelterstoseeiftheyaredirtyortorn.

User Manual

5. Ifneeded,washthegrayfoamlterinwarmwaterandamild

detergent.Rinsethelterthoroughlytoremovealldetergentresidue.

Allowtheltertocompletelydrybeforereinstallingit.Ifthepollen

lteristorn,replaceit.

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.

8. Replacetheltercap.

Contactyourhomecareprovidertoorderadditionallters.

NOTE: To clean the breathing circuit accessories, refer to each

accessory’s instruction sheet.

9.3 Ca r r y i n g Ca s e

A carrying case is now included with your BiPAP S/T system (reorder

number: 1005965). The case is designed to hold your BiPAP S/T system,

alongwithyourbreathingcircuitaccessoriesandhumidier.

Whenyouaretraveling,thecarryingcasecanbeusedforcarry-on

luggage only. The carrying case will not protect the device if it is put

through checked baggage.

NOTE: Iftravelingwithyourhumidier,makesureyouemptythe

water chamber before placing it in the carrying case.

User Manual

Ch a p T e r 10: aC C e s s o r i e s

There are several accessories you can use with the device.

10.1 ad d i n g a hu m i d i fi e r

TheREMstarHeatedHumidier,REMstarPass-overHumidier,and

H2HeatedHumidierareavailablefromyourhomecareprovider.The

humidiersmayreducenasaldrynessandirritationbyaddingmoisture

(andheat,ifapplicable)totheairow.

CAUTION: Forsafeoperation,thehumidiermustalwaysbe

positioned below the circuit connection at the mask and

theairoutletonthedevice.Thehumidiermustbelevel

for proper operation.

Refertothehumidierinstructionsforcompletesetupinformation.

10.2 ad d i n g ox y g e n T o T h e de v i C e

Oxygen may be added to the mask connection. Please note the warnings

listed below when using oxygen with the device.

WARNING: If you are using oxygen, your 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.

WARNING: Oxygenacceleratesres.Keepthedeviceandthe

containersawayfromheat,openames,anyoily

substance, or other sources of ignition. Do not smoke in

the area near the device or the O

container.

WARNING: Whenusingoxygenwithyourdevice,theoxygensupply

must comply with the local regulations for medical

oxygen.

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.

User Manual

Ch a p T e r 11: sp e C i f i C a T i o n s

en v i r o n m e n T a l

Operating Storage

Temperature 41ºFto95ºF -4ºFto140ºF

Relative Humidity 15 to 95%

(non-condensing)

15 to 95%

(non-condensing)

Atmospheric Pressure

(5600 feet to sea level)

83 to 102kPa

ph y s i C a l

Dimensions: 9.75”Lx6.625”Wx4.4”H

Weight: Approximately 4 lb.

el e C T r i C a l

AC Voltage Source: 100to240V,50/60Hz

DC Voltage Source: 12 VDC (when operated with the

external DC power adaptor 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:

S/T unit: Ordinary Equipment, IPX0

AC Power Supply (Reorder number 1012832): Drip Proof, IPX1

DC Power Adapter (Reorder number 1012975): Drip Proof, IPX1

Modes of Operation: Continuous

Electromagnetic Compatibility: The BiPAP S/T meets the requirements

ofEN60601-1-2,secondedition(2001).

Fuses: Therearenouser-replaceablefuses.

User Manual

pr e s s u r e

Output: 4 to 30 cm H

Co n T r o l aC C u r a C y

Parameter Range Accuracy

IPAP 4 to 30 cm H

O* ±5 cm H

O**

EPAP 4 to 25 cm H

O* ±5 cm H

O**

CPAP 4 to 20 cm H

O ±5 cm H

O**

Breath Rate 0 to 30 BPM Greater of ± 1 BPM or

±10% of the setting

(when measured over a

4 minute period)

Timed Inspiration 0.5 to 3.0 seconds ±(0.1 + 10% of the

setting) seconds

Ramp Duration 0 to 45 minutes ±10% of the setting

Rise Time 1 to 6*** ±25%****

* Limited to 20 cm H

OwhenusingtheBi-FlexfeatureinSmode.

** Dynamic pressure accuracy is ± 5 cm H

O measured at the patient end

ofthecircuitwithaWhisperSwivelIIandvaryingowconditions.

Static pressure accuracy is ± 2 cm H

O measured at the patient end of

thecircuitwithaWhisperSwivelIIandnopatientow.

*** The range of values correspond to tenths of seconds (e.g., a setting of

4 indicates a Rise Time of 0.4 seconds).

****MeasuredatthepatientendofcircuitwithaWhisperSwivelII

exhalationdeviceandnopatientow.

di s p o s a l

Whennecessary,disposeoftheBiPAPS/Tandaccessoriesinaccordance

with local regulations.

User Manual

ap p e n d i x a: emC in f o r m a T i o n

Gu i d a n c e a n d Ma n u f a c t u r e r ’s de c l a r a t i o n - el e c t r o M a G n e t i c eM i s s i o n s : is device

is intended for use in the electromagnetic environment speciﬁed below. e user of this device should

make sure it is used in such an environment.

eM i s s i o n s te s t co M p l i a n c e el e c t r o M a G n e t i c en v i r o n M e n t - Gu i d a n c e

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 The device is suitable for use in all establishments,

including domestic establishments and those directly

connected to the public low-voltage power supply

network.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage uctuations/Flicker

emissions

IEC 61000-3-3

Complies

User Manual

Gu i d a n c e a n d Ma n u f a c t u r e r ’s de c l a r a t i o n - el e c t r o M a G n e t i c iM M u n i t y : is device

is intended for use in the electromagnetic environment speciﬁed below. e user of this device should

make sure it is used in such an environment.

iM M u n i t y te s t iec 60601 te s t

le v e l

co M p l i a n c e le v e l el e c t r o M a G n e t i c en v i r o n M e n t

Gu i d a n c e

Electrostatic

Discharge (ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete

or ceramic tile. If oors are covered

with synthetic material, the relative

humidity should be at least 30%.

Electrical Fast

Transient/Burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input-output lines

±2 kV for supply mains

±1 kV for input/output lines

Mains power quality should be

that of a typical home or hospital

environment.

Surge

IEC 61000-4-5

±1 kV dierential mode

±2 kV common mode

±1 kV dierential mode

±2 kV for common mode

Mains power quality should be

that of a typical home or hospital

environment.

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines

IEC 61000-4-11

<5% U

(>95% dip in U

)

for 0.5 cycle

40% U

(60% dip in U

) for

5 cycles

70% U

(30% dip in U

) for

25 cycles

<5% U

(>95% dip in U

)

for 5 sec

<5% U

(>95% dip in U

)

for 0.5 cycle

40% U

(60% dip in U

) for

5 cycles

70% U

(30% dip in U

) for

25 cycles

<5% U

(>95% dip in U

)

for 5 sec

Mains power quality should be

that of a typical home or hospital

environment. If the user of

the device requires continued

operation during power mains

interruptions, it is recommended

that the device be powered from

an uninterruptible power supply

or a battery.

Power frequency

(50/60 Hz)

magnetic eld

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic elds

should be at levels characteristic

of a typical location in a typical

hospital or home environment.

NOTE: U

is the a.c. mains voltage prior to application of the test level.

User Manual

Gu i d a n c e a n d Ma n u f a c t u r e r ’s de c l a r a t i o n - el e c t r o M a G n e t i c iM M u n i t y : is device

is intended for use in the electromagnetic environment speciﬁed below. e user of this device should

make sure it is used in such an environment.

iM M u n i t y te s t iec 60601 te s t

e v e l

co M p l i a n c e

e v e l

l e c t r o M a G n e t i c en v i r o n M e n t - Gu i d a n c e

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

3 Vrms

3 V/m

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

150 kHz to 80 MHz

d = 1.2

80 MHz to 800 MHz

d = 2.3

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 survey

should be less than the compliance level in each

frequency range

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 aected by absorption

and reection 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.

User Manual

e c o M M e n d e d se p a r a t i o n di s t a n c e s b e t w e e n po r t a b l e a n d Mo b i l e rf co M M u n i c a t i o n s

eq u i p M e n t a n d th i s de v i c e : e device is intended for use in an electromagnetic environment in

which radiated RF disturbances are controlled. e 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.

ra t e d Ma x i M u M po w e r

ou t p u t o f tr a n s M i t t e r

(w)

se p a r a t i o n di s t a n c e ac c o r d i n G t o fr e q u e n c y o f tr a n s M i t t e r

(M)

150

khz t o 80 Mhz

d = 1.2

80 Mhz t o 800

Mhz

d = 1.2

800 Mhz t o 2.5

Ghz

d = 2.3

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 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 aected by

absorption and reection from structures, objects, and people.

li m i T e d Wa r r a n T y

Respironics, Inc. warrants that the BiPAP S/T system shall be free from defects

of workmanship and materials and will perform in accordance with the product

specications 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

specications, 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 prots,

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 specic 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

1006776

JR 1/4/08

EN-DOM