Respironics BiPAP S/T Bedienungsanleitung

BiPAP S/T

User Manual

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

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

User Manual

Chapter 2: Warnings and Cautions

WARNING: Indicates the possibility of injury to the user or operator.

CAUTION: Indicates the possibility of damage to the device.

NOTE: Places emphasis on an operating characteristic.

2.1 Warnings

• 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.

User Manual

• 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.

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 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.

User Manual

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)

User Manual

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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