Respironics REMstar User manual

1058374
JR 3/05/2009
EN-DOM
REMstar
M Series
with SmartCard

© 2009 Koninklijke Philips Electronics N. V. All rights reserved.
Im p o r t a n t ! Fill in the information below when you receive the
REMstar M Series system.
Serial No.: _______________________________ (located on the bottom of the device)
System Prescribed for: __________________________________________
Date of Purchase or Rental: ______________________________________
Pressure Setting: _____ cm H2O
Mask Type: __________________________________________________
Mask Size: ___________________________________________________
If you have any questions concerning the system, contact:
 • HomeCareCompany:_______________________________________
Telephone Number: _________________________________________
 • HealthCareProfessional:_____________________________________
Telephone Number: _________________________________________
 • Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, Pennsylvania
15668-8550 USA
  CustomerService
Telephone Number: 1-800-345-6443 or 1-724-387-4000

iREMs t a R M sE R i E s Us E R Ma n U a l
ta b l E o f Co n t E n t s
Chapter 1: Introduction ..................................................................................................................1-1
1.1 System Contents........................................................................................................1-1
1.2 Intended Use...............................................................................................................1-2
1.3 Warnings, Cautions, and Contraindications.....................................................1-2
1.3.1 Warnings...........................................................................................................1-2
1.3.2 Cautions............................................................................................................1-3
1.3.3 Contraindications..........................................................................................1-4
1.4 System Overview.......................................................................................................1-4
1.4.1 Breathing Circuit Overview........................................................................1-6
1.5 Glossary.........................................................................................................................1-6
1.6 Symbol Key ..................................................................................................................1-7
1.7 How to Contact Respironics ..................................................................................1-8
Chapter 2: Device Controls and Displays .................................................................................2-1
2.1 Controls and Displays ..............................................................................................2-1
2.1.1 Control Panel Inactivity...............................................................................2-2
2.2 Rear Panel.....................................................................................................................2-2
Chapter 3: Setup................................................................................................................................3-1
3.1 Installing the Air Filters............................................................................................3-1
3.2 Where to Place the Device......................................................................................3-2
3.3 Connecting the Breathing Circuit .......................................................................3-2
3.4 Supplying Power to the Device............................................................................3-4
3.4.1 Using AC Power ............................................................................................3-4
3.4.2 Using DC Power .............................................................................................3-5
3.5 Complete Assembly Example ...............................................................................3-6
Chapter 4: Device Operation ........................................................................................................4-1
4.1 Starting the Device ...................................................................................................4-1
4.2 Using the Ramp Feature..........................................................................................4-2
4.3 Changing the Device Settings ..............................................................................4-3
4.3.1 Navigating the Display Screens................................................................4-3
4.3.1.1 Viewing the Patient Data Screens ...............................................4-3
4.3.1.2 Viewing and Modifying Patient Setup Screens ......................4-5
4.4 FOSQ Questionnaire.................................................................................................4-7
4.5 Patient Reminder Screen ........................................................................................4-8

ii REMs t a R M sE R i E s Us E R Ma n U a l
Chapter 5: Alerts and Troubleshooting..................................................................................... 5-1
5.1 Device Alerts ............................................................................................................... 5-1
5.2 Troubleshooting......................................................................................................... 5-4
Chapter 6: Accessories .....................................................................................................................6-1
6.1 Adding a Humidier .................................................................................................6-1
6.2 Using the SmartCard ................................................................................................6-1
6.3 Adding Supplemental Oxygen............................................................................. 6-2
Chapter 7: Cleaning and Maintenance......................................................................................7-1
7.1 Cleaning the Device ................................................................................................. 7-1
7.2 Cleaning or Replacing the Filters.........................................................................7-1
7.3 Cleaning the Tubing .................................................................................................7-3
7.4 Service ...........................................................................................................................7-3
7.5 Traveling with the System ......................................................................................7-4
7.5.1 International Travel.......................................................................................7-4
Chapter 8: Specications................................................................................................................8-1
Environmental...........................................................................................................8-1
Physical........................................................................................................................ 8-1
Standards Compliance........................................................................................... 8-1
Electrical......................................................................................................................8-1
Pressure .......................................................................................................................8-2
Disposal.......................................................................................................................8-2
Appendix A: EMC Information.......................................................................................................A-1

1-1
REMs t a R M sE R i E s Us E R Ma n U a l
Ch a p t E R 1: in t R o d U C t i o n
is chapter provides information on:
• Systemcontents
• Intendeduse
• Warnings,cautions,andcontraindications
• Systemoverview
• Glossaryandsymbolkey
• HowtocontactRespironics
1.1 sy s t E M Co n t E n t s
YourREMstarMSeriessystemincludesthefollowingitems:
Device
Flexible Tubing
Reusable Gray Foam
Filter
Disposable Ultra-fine
Filter
Power Supply
AC Power Cord
Carrying Case
User Manual
fi g U R E 1–1 sy s t E M Co n t E n t s
Note: If your system includes a humidier, you will receive additional items with your
package. See the instructions included with your humidier for more informa-
tion.
Note: If any of the above items are missing, contact your home care provider.

1-2 REMs t a R M sE R i E s Us E R Ma n U a l
1.2 in t E n d E d Us E
eRespironicsREMstarMSeriessystemisaCPAP(ContinuousPositiveAirwayPressure)
device designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing
patientsweighingmorethan66lbs(30kg).
e device is to be used only on the instruction of a licensed physician. Your home care provider
willmakethecorrectpressuresettingsaccordingtoyourhealthcareprofessional’sprescription.
1.3 Wa R n i n g s , Ca U t i o n s , a n d Co n t R a i n d i C a t i o n s
Caution: US federal law restricts this device to sale by or on the order of a physician.
1.3.1 Wa R n i n g s
A warning indicates the possibility of injury to the user or the operator.
• ismanualservesasareference.einstructionsinthismanualarenotintendedtosuper-
sedethehealthcareprofessional’sinstructionsregardingtheuseofthedevice.
•The operator should read and understand this entire manual before using the device.
• isdeviceisnotintendedforlifesupport.
•e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. e exhalation
port(s)associatedwiththemaskshouldneverbeblocked.
Explanation of the Warning: edeviceisintendedtobeusedwithspecialmasksorcon-
nectors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.
• 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
lefton,oxygendeliveredintothetubingmayaccumulatewithinthedevice’senclosure.Oxy-
genaccumulatedinthedeviceenclosurewillcreateariskofre.
• Oxygensupportscombustion.Oxygenshouldnotbeusedwhilesmokingorinthepresence
ofanopename.
• Whenusingoxygenwiththissystem,aRespironicsPressureValvemustbeplacedin-line
withthepatientcircuit.Failuretousethepressurevalvecouldresultinarehazard.
• 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.

1-3
REMs t a R M sE R i E s Us E R Ma n U a l
• Donotusethisdeviceiftheroomtemperatureiswarmerthan95°F(35°C).Ifthedeviceis
usedatroomtemperatureswarmerthan95°F(35°C),thetemperatureoftheairowmay
exceed106°F(41°C).iscouldcauseirritationorinjurytoyourairway.
• Donotoperatethedeviceindirectsunlightornearaheatingappliancebecausethesecondi-
tions can increase the temperature of the air coming out of the device.
•Contactyourhealthcareprofessionalifsymptomsofsleepapnearecur.
• Ifyounoticeanyunexplainedchangesintheperformanceofthisdevice,ifitismakingun-
usualorharshsounds,ifthedeviceorthepowersupplyaredroppedormishandled,ifwater
is spilled into the enclosure, or if the enclosure is broken, 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fordamageorsignsofwear.
Discontinue use and replace if damaged.
• Toavoidelectricshock,unplugthedevicebeforecleaningit.DONOTimmersethedevice
inanyuids.
• Usingthisdeviceatanincorrectelevationsettingcouldresultinairowpressureshigherthan
theprescribedsetting.Alwaysverifytheelevationsettingwhentravelingorrelocating.
• 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bondingoneselfbymeansofawriststraptotheequipmentorsystem
or to earth.
1.3.2 Ca U t i o n s
A Caution indicates the possibility of damage to the device.
•edevicemayonlybeoperatedattemperaturesbetween41°F(5°C)and95°F(35°C).
• Ifthisdevicehasbeenexposedtoeitherveryhotorverycoldtemperatures,allowittoadjust
to room temperature before starting therapy.
• 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.
• Aproperlyinstalled,undamagedreusablefoaminletlterisrequiredforproperoperation.
• Tobaccosmokemaycausetarbuild-upwithinthedevice,whichmayresultinthedevice
malfunctioning.
Note: Additional warnings, cautions, and notes are located throughout this manual.

1-4 REMs t a R M sE R i E s Us E R Ma n U a l
1.3.3 Co n t R a i n d i C at i o n s
Whenassessingtherelativerisksandbenetsofusingthisequipment,theclinicianshould
understand that this device can deliver pressures up to 20 cm H2O. In the event of certain fault
conditions, a maximum pressure of 30 cm H2Oispossible.Studieshaveshownthatthefollowing
pre-existingconditionsmaycontraindicatetheuseofCPAPtherapyforsomepatients:
• BullousLungDisease
• PathologicallyLowBloodPressure
• BypassedUpperAirway
• Pneumothorax
• PneumocephalushasbeenreportedinapatientusingnasalContinuousPositiveAirwayPres-
sure.CautionshouldbeusedwhenprescribingCPAPforsusceptiblepatientssuchasthose
with:cerebralspinaluid(CSF)leaks,abnormalitiesofthecribriformplate,priorhistoryof
headtrauma,and/orpneumocephalus.(Chest1989;96:1425-1426)
euseofpositiveairwaypressuretherapymaybetemporarilycontraindicatedifyouexhibit
signsofasinusormiddleearinfection.Notforusewithpatientswhoseupperairwaysareby-
passed.Contactyourphysicianifyouhaveanyquestionsconcerningyourtherapy.
1.4 sy s t E M ov E R v i E W
eREMstarMSeriesdevice,showninFigure1–2,isasleepapneatherapysystemthat
deliversContinuousPositiveAirwayPressure(CPAP).CPAPmaintainsaconstantlevelofpres-
sure throughout the breathing cycle.
Whenprescribedforyou,thedeviceprovidesaspecialfeaturetohelpmakeyourtherapymore
comfortable.erampfunctionallowsyoutolowerthepressurewhenyouaretryingtofall
asleep.eairpressurewillgraduallyincreaseuntilyourprescriptionpressureisreached.Youalso
have the option of not using the ramp feature at all.
fi g U R E 1–2 REMs t a R M sE R i E s dE v i C E

1-5
REMs t a R M sE R i E s Us E R Ma n U a l
Figure1–3illustratesmanyofthedevicefeatures,describedinthetablebelow.
Ramp Button Start/Stop
Button
Power Inlet
Filter Area
Air Outlet
Accessory
Module
Medical
Equipment Note
(on bottom)
Display Screen
(under door)
fi g U R E 1–3 sy s t E M ov E R v i E W
dE v i C E fE a t U R E dE s C R i p t i o n
Accessory Module If applicable, insert optional accessory module here.
Air Outlet Connect the exible tubing here.
Display Screen Shows therapy settings and patient data.
Filter Area A reusable, gray foam lter must be placed in the
lter area to screen out normal household dust and
pollens. An optional, white ultra-ne lter can also
be used for more complete ltration of very ne
particles.
Medical Equipment Note For ease at airport security stations, there is a note
on the bottom of the device stating that it is medical
equipment. It may help if you also take this manual
with you when you travel.
Power Inlet Connect the power cord here.
Ramp Button This button starts or restarts the ramp cycle.
Start/Stop Button This button starts or stops the airow.

1-6 REMs t a R M sE R i E s Us E R Ma n U a l
1.4.1 bR E a t h i n g Ci R C U i t ov E R v i E W
epatientbreathingcircuit,showninFigure1–4,consistsofthefollowing:
• 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
fi g U R E 1–4 ty p i C a l bR E a t h i n g Ci R C U i t s
Note: The exhalation port may be part of the interface or may be part of a separate
exhalation device, but is required to minimize the potential for CO2rebreathing.
1.5 gl o s s a R y
efollowingtermsandacronymsappearthroughoutthismanual:
tE R M /aC R o n y M dE f i n i t i o n
Active State The state of the device when power is applied, the airow is on, and the
device is capable of providing therapy.
Apnea A condition marked by the cessation of spontaneous breathing.
Auto-O When this feature is enabled, the device automatically discontinues
therapy whenever the mask is removed.
Auto-On With this feature, the device automatically initiates therapy when you begin
breathing on the device. This feature is always enabled.
BPM Breaths Per Minute
Compliance
Check Value
Represents a code used by the provider to determine the accuracy of
reported therapy data.
CPAP Continuous Positive Airway Pressure
FOSQ Functional Outcomes of Sleep Questionnaire – A“quality of life”question-
naire designed specically for people with sleep disorders. The results allow
health care professionals to assess how CPAP therapy has improved the
quality of their patients’lives.