Respironics REMstar plus User manual

RESPIRONICS^
vwwv.respironics.com
REMstar! plus
CPAP System
User Manual
o
09 o

IMPORTANT!
Fill intheinformation helow whenyoureceivethe RFMstar Plus
CPAP system.
\
REMstar Plus Serial No.:
.(Located onthe bottom ofthe REMstar Plus)
System Prescribedfor:
DateofPurchaseorRental:
PressureSetting:
cm H2O
Mask Type:
Mask Size:
If youhaveany questions concerningtheSystem,contact:
• HomeCareCompany:—
TelephoneNumber:
• Doctor:—
TelephoneNumber:
• Respironics,Inc.
1001 MurryRidgeLane
Murrysville, Pennsylvania
15668-8550 USA
CustomerService
TelephoneNumber:1-800-345-6443(USandCanada)or1-724-387-4000
REMstar Plus CPAP systems arethesubjectofUS patent #5,239,995. Other patents pending.
REMstar Plus,WfiisperSwivel,andComfort Flap aretrademarksofRespironics,Inc.
©Respironics, Inc.2001

Table of Contents
Symbol Key :..::.v 2
IntendedUse& Contraindications 3
Specifications4
Warnings & Cautions 5
SystemFeatures7
First Time Setup8
oDeviceSettings10
oAssemblingtheCircuit12
Accessories13
oAddinga Humidifier13
oAddingOxygentotheSystem13
oUsingDCPower14
oUsinganUltra-fineFilter14
oCarryingCase14
Routine Use15
oConnectingtheCircuit15^
oAdjustingtheCircuit15
oRampButton16
oTurningtheSystemOff16
oHelpfulHints16
TravelingwiththeSystem17
Routine Maintenance18
O Filter18
O Cleaning18
oReordering19
O Service19
Troubleshooting20
Warranty21
REMstar Plus User Manual O /

SYMBOLS
Display Screen
Elevation
RampStartPressure
XXX. HumidifierSetting
HoursofUse
I
Button Ligtits
Numberofnights
with morethan4
hoursusage
Control Buttons
6
S 5 5
Pressure Start/Stop
Ramp
HumidifierOn/ Off
REMstar Plus Device
Attention, consult
accompanyingdocuments
A
•
ACPower
DCPower
TypeBFAppliedPart
ClassII(DoubleInsulated)
IPXO OrdinaryEquipmentRating
^ ^ EuropeanCEDeclarationofConformity
0123
/tj\d BodyApproval
(f" ^ |rforStandardsCompliance
® Canadian/USCertification
2O REMstar Plus User Manual

Intended Use
IntendedUseThe Respironics REMstar Plus system isa CPAP (ContinuousPositive
Airway Pressure)devicedesignedforthe treatment ofadultObstructive
SleepApneaonly.
The REMstar Plusistobeusedonlyontheinstructionofa licensed
physician. Your home careprovider will makethecorrectpressuresettings
accordingtoyourphysician'sprescription.
Several accessoriesareavailabletomakeyour OSA treatment with the
REMstar Plus CPAP systemasconvenientandcomfortable aspossible.To
ensure that youreceivethesafe,effectivetherapyprescribedforyou,use
only Respironicsaccessories.
IMPORTANT! Read and understand the entire user's manual before operating this
system. If you have any questions concerning the use of this system,
contact your home care provider or doctor.
Contraindicationsstudieshaveshown that thefollowingpre-existingconditionsmay
contraindicatetheuseofpositiveairwaypressuretherapyforsomepatients:
• Bullous Lung Disease
• Pneumothorax
• PathologicallyLow Blood Pressure
• Pneumocephalushasbeenreportedina patientusingnasal
ContinuousPositive Airway Pressure.Cautionshouldbeusedwhen
prescribing CPAP forsusceptiblepatientssuchas those with: cerebral
spinal fluid (CSF) leaks,abnormalitiesofthecribriformplate,prior
historyofheadtrauma, and/or pneumocephalus.
(Chest 1989;96:1425-1426)
The useofpositiveairwaypressuretherapymaybetemporarilycontraindi-
catedifyouexhibitsignsofa sinusormiddleearinfection.Notforuse with
patientswhose upper airwaysarebypassed.Contactyourphysicianifyou
haveanyquestions concerningyourtherapy.
REMstar Plus User Manual O 3

specifications
Device Size
ProductUse,
Transport,and
Storage
StandardsCompliance
Dimensions:
Weight:
9 1/2" X 6 7/8" X 4 1/2"(24x 17x 12cm)
<4.0lbs.(<1.8kg)
OperationTransport& Storage
Temperature: 41to95°F (5to35°C)-4to140°F (-20to60°C)
Humidity: 15to95%Non-condensing15to95%Non-condensing
AtmosphericPressure:76.7to102kPascalsN/A
This device is designed toconformtothefollowingstandard:
lEC 60601-1GeneralRequirementsforSafetyofMedical Electrical Equipment
ModeofOperation
Power Requirements
Type ofProtection
Against Electric Shock
DegreeofProtection
Against Electric Shock
DegreeofProtection
Against IngressofWater
Continuous
AC Power Consumption: 100- 240 VAC, 50/60Hz,1.0A max.
DCPowerConsumption: 12 VDC, 3.0 A max.
Class 11 Equipment
Type BF AppliedPart
IPXO - OrdinaryEquipment
PressureIncrements
PressureDisplay
Accuracy
4to20cmHjO(in1.0cmH,0increments)
+/- (0.15+ 4%ofactualreading)
Maximum Flow
<30 dB(A)
SoundPressure Level 35 LPM
4O REMstar Plus User Manual

Warnings & Cautions
CAUTION!
• us federal law restricts this device to sale by or on the order of a
physician.
WARNING!
Indicates the
possihilityfor
• The instructions in this manual are not intended to supersede established
medical protocols.
• This device is intended for adult use only.
• This device is not intended for life support.
injurytotheuser
or theoperator.
• CPAP devices have the potential to allow rebreathing of exhaled air.
To reduce this potential, observe the following:
- Use Respironics circuit accessories.
- Do not wear the mask and headgear for more than a few minutes
while the device is not operating.
- Do not block or try to seal the vent holes in the exhalation port.
As with most CPAP devices: At low CPAP pressures, some exhaled gas
{CO,) may remain in the mask and be rebreathed.
• Do not use this device if the room temperature is warmer than
95° F (35° C). If this device is used at room temperatures warmer than
95° F (35° C), the temperature of the airflow may exceed 106°F(41°C).
This could cause irritation to your airway.
• This equipment is not suitable for use in the presence of a flammable
anaesthetic mixture in combination with oxygen or air, or in the presence of
nitrous oxide.
• Ifyou notice anyunexplained changes inthe performance ofthisdevice,
if itismakingunusual orharsh sounds, ifithas been dropped or
mishandled,iftheenclosureisbroken,orifwaterhas entered theunit,
discontinue useand contact your home careprovider.
• To avoid electrical shock, disconnect the power cord before cleaning. DO
NOT immerse the device in any fluids
• Contact your health care professional if symptoms of sleep apnea recur.
• Using the REMstar Plus at an incorrect elevation setting could result in
airflow pressures higher than the prescribed setting. Always verify the
elevation setting when traveling or relocating.
CAUTION!
Indicates the
• Tobacco smoke may cause tar build-up within the REMstar Plus that may
result in the REMstar Plus malfunctioning.
possihilityofdamage
to thedevice.

Unpacking the System
After unpackingthesystem,checktomakesureyouhaveeverythingshown
here:
IMPORTANT! if any of the above parts are missing, contact your home care provider.
6 O REMstar Plus User Manual

System Features
AC InletConnectthe AC powercordhere.
Air OutletConnect flexible tubinghere.
Communications ConnectorFor clinical use with the Encore® Pro Data ManagementSoftware
oran lEC 950approved device. Connectthecommunications
cable here (only on REMstar Plus devices with a serial numberof
2,000,000 orgreater).
DC InletConnecttheoptional DC powercordhere.
Display Screen All System settings,totaloperatingtime,andtherapyhours will be
displayed here. Displays thepressureandelevationsettings.
Filter Cap & Filters The pollen filter screensoutnormalhouseholddustandpollens.
The optional,ultra-fine filter isalsoincludedformorecomplete
filtration of very fine particles.The filter capisdesignedtoreduce
thenoise from the CPAP device.
Humidifier Button This buttonturnsthe REMstar heatedhumidifier on/off and allows
theheatsettingtobeadjusted.Thehumidifierisanoptional
accessory thatmaybepurchasedseparately.
Medical Product Note Foreaseatairportsecuritystations,thereisa note onthebottomof
the REMstar Plus statingthatitismedicalequipment.Itmayhelp
if youalsotakethismanual with youwhenyou travel.
Pressure Start/Stop
Button This buttonturnsstartsorstopsthe airflow.
Ramp Button This buttonstartstheramp cycle.
REMstar Plus User Manual O 7

First TimeSetup
WARNING! Donotusethe REMstar Plussystemuntilan appropriate professional
adjusts thesettings!Toorderanyaccessoriesnotincluded with this System,
contactyourhomecareprovider.
Note to home careprovider: Before beginning setup, be sure that you have
available the REMstar Plus Home Care Provider Setup Instructions. It
contains instructionsfor setting up the REMstar Plus.
WARNING! DO NOT connect any equipment to the REMstar Plus unless recommended by
Respironics oryour health care professional.
CAUTION!
ATTENTION!
CAUTION!
If the REMstar Plus has been exposed to either very hot or very cold
temperatures, allow it to adjust to room temperature (approximately 2 hours)
before beginning setup.
Large elevation changes will affect thepressure being delivered by the
REMstar Plus. Refer to the "Traveling with the System" section if you relocate
or travel to areas with a significantly higher or lower elevation.
Your home careprovider will have installed thefilter(s). The pollen filter must
be inplace at all times when the REMstar Plus is operating. The white ultra-
fine filter is optional and can be used in addition to thepollen filter. The
ultra-fine filter is recommended for people who are sensitive to tobaccosmoke
or other small particles.
8O REMstar Plus User Manual

First TimeSetup
Power Cord
IVPORTAhni
WARNING!
WARNING!
CAUTION!
1. Connectthepowercord.
Plug thesocketendofthepowercordintothe
AC inletonthebackofthe device. Plug the
prongedendofthepowercordintoan
electrical outlet.
To remove AC power, disconnect the power cordfrom the electrical outlet.
Inspect the power cord often for any signs of damage. Replace a damaged
cord immediately.
This device is activated when the power cord is connected. The Pressure Start/
Stop button turns only the airflow on/off.
2. Placethedeviceona firm, flatsurface.
Make sure the device is away from any
heating or cooling equipment (e.g., forced
air vents, radiators, air conditioners).
Also, make sure that bedding, curtains, or
other items are not blocking the filter or
vents of the device. Air must flow freely
around the devicefor the system to work
properly.
REMstar Plus User Manual O 9

First Time Setup
Device
Settings
Once thepowercordisplugged in, thehourglasssymbolandthehoursofuse
will bedisplayed.
Display Screen: All devicesettings will appearhere.
Pressure Start/Stop Button: Usethisbuttontostartorstopthe airflow.
DONOT startthe airflow until the circuit tubingisconnected.
Humidifier Button: Usethisbuttonwhentheoptional REMstar Heated
Humidifier hasbeenprescribed. This button will turntheoptional heated
humidifier's on/off andcontroltheoutput. Follow theinstructionsincluded with
thehumidifier.
Ramp Button: Usethisbuttontostarttheramp cycle (which lowersthe
airflow pressure). This will allow youto fall asleepmore easily.
Display
Screen
Button
Start / Stop
Button
IMPORTANT! When the device is in the Setup Menu, the
humidifier and ramp buttons operate as up and
down keys to change the settings and the pressure
on/off button will take you to the next screen.
10 O REMstar Plus User Manual

First Time Setup
Device
Settings
CAUTION!
IMPORTANT!
WARNING!
3. Verify/Change thedevicesettings.Tostartthesetupmenu,pressthe
rampbutton.(The airflow mustbeturnedoff.)
DO NOT use the REMstar Plus if the display is erratic. Contact your
home careprovider for further instructions.
Eor REmstar Plus devices with serial numbers of2,000,000 or greater, the
display screen has been changed. Both display screens are shown below.
n n
1111
a. Theelevationsymbolandsetting will appear:
1 or Lo =lessthan 2,500 ft.(<762m)
2 or M =2,500to5,000ft. (762m to1524m)
3 or Hi = 5,001 to7,500ft. (1525 mto2286m)
*over 7,500ft.= The airflow pressure may
notbeaccurate.Contactyourhomecare
provider tohaveyourpressuresettingadjusted.
To changethe elevation setting,presstherampor humidifier buttons.Press
and releasethepressurestart/stopbuttontogotothenextsetting.
Using the REMstar Plus at an incorrect elevation setting could result in
airflow pressures higher than the prescribed setting. Always verify the
elevation setting when traveling or relocating.
b.TheRampStartingPressuresymbolandsetting
will appear. (This screen will notappearifyour
medical professionalhasnotprescribedramp.)
To changethesetting,presstheramporhumidi-
fier buttons.Pressthepressurestart/stopbutton
togotothenextsetting.
c. TheButton Lights setting will appear. This
setting allows youtohavethelightsbehindthe
buttons turnedonoroff (when the airflow is
turnedon).
1 - on0 = off
To changethesetting,presstherampor
humidifier buttons.Pressthepressurestart/stop
buttontogotothenextsetting.
d. Thenumberofnights with morethan4 hours
usage will appear. This screen isonlyfor
reference. Your homecareprovidermay
periodically askyouforthisinformation.Press
thepressurestart/stopbuttonto exit thesettings.
LEd
REMstar Plus User Manual

First Time Setup
Assembling
the Circuit
4,Assembletbe circuit. Tousethesystem,you will needthe following
accessories inordertoassembletherecommended circuit.
• Respironics nasal mask with integrated exhalation port
(or Respironics mask with separate exhalation port such as the Whisper Swivel* II)
• Respironics 6ft. (1.83 m)flexible tubing
• Respironics headgear (for the mask; not shown)
WARNING! If the REMstar Plus is used by multiple persons (e.g., rental devices) a low-
resistance, main flow bacteriafilter should be installed in-line between the
REMstar Plus and the circuit tubing. Pressures must be verifiedwhen
alternate or optional accessories are in place.
a. Connecttheflexibletubingtothe
air outletonthefrontofthe
REMstar Plus.
b. Ifyouareusinga maskwitha built-inexhalationport
connectthemask'sconnectortothe flexible tubing
If youareusinga maskwitha separateexhalation
port connectthe flexible tubingtotheexhalationport.
Position theexhalationportsothattheventedairis
blowing away from yourface.Connectthemask's
connectortotheexhalationport.
" Flexible
Tubing
WARNING! Do not block or otherwise try to seal the air openings on the exhalation port.
Explanation of the warning: The REMstar Plus is intended to be used with masks and circuits that have an
exhalation port designed to exhaust COifrom the circuit. When the REMstar Plus is turned on and
functioning properly, new airfrom the REMstar Plus flushes the exhaled air out through the exhalation
port. When the REMstar Plus is turned off, enough fresh air will not beprovided through the mask, and
exhaled air may be rebreathed. Rebreathing of exhaled airfor longer than several minutes can, in some
circumstances, lead to suffocation.
WARNING! If you are using a full face mask (i.e., a mask covering both your mouth and your
nose), the mask must be equipped with a safety (entrainment) valve.
12 O REMstar Plus User Manual

Accessories
Addinga
Humidifier
WARNING!
Contact yourhomecareproviderforadditionalinformationonthe
accessoriesavailableforthe REMstar Plussystem. Whenusing
optionalaccessories,alwaysfollowtheinstructionsenclosedwiththe
accessories.
The REMstar Heated Humidifier
and REMstar Pass-over Humidifier
areavailablefromyourhomecare
provider. A humidifiermayreduce
nasal drynessandirritationby
addingmoisture(andheat if
applicable) tothe airflow.
For safe operation, the humidifier must always be positioned below the
circuit connection at the mask and the air outlet on the device. The
humidifier must be levelfor proper operation.
AddingOxygen
to theSystem
Oxygen maybeaddedatthemaskconnection.Please note thewarnings
listed belowwhenusingoxygen with thisdevice.
WARNING!
WARNING!
WARNING!
WARNING!
When using oxygen with this system, the oxygen supply must comply with
the local regulationsfor medical oxygen.
When using oxygen with this system, a Respironics Pressure Valve (Part
number 302418) must beplaced in-line with the patient circuit.
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.
Oxygen accelerates fires. Keep the device and the oxygen container away
from heat, open flames, any oily substance, or other sources of ignition.
DO NOT smoke in the area near the device or the oxygen container.
RFMstar Plus User Manual O 13

Accessories
Using a DC
Power System
CAUTION!
CAUTION!
You canalsousethisdeviceina stationary
recreational vehicle, boat ormotorhome with a 12
volt DC powersource. Donot operate thisdevice
while thevehicleisinmotion. Contactyourhome
careproviderforadditionalinformation.
Use only the Respironics DC Power system
available from your home care provider. Use of any other system may
cause damage to the device oryour vehicle.
DC Power is not intended to be used as battery back-up. DO NOT
connect the DC Power system while the device is operating on AC
power. System damage may occur.
Carrying CaseThe carrying caseholdsthedeviceandaccessories.Whentravelingby
airplane, thecarryingcaseisforcarry-onluggageonly. Nevercheckthis
device throughthe baggage department.
14 O REMstar Plus User Manual

Routine Use
Connectingl-Connectthecircuit.
theCircuit
IMPORTANT!Before each use, examine the flexible tubing for any damage or
debris. If necessary, clean the tubing to remove the debris. Replace
any damaged tubing.
a. Connectthemasktothe headgear, followingtheinstructions
included with the headgear.
b.Putonthemaskand headgear. PressthePressureStart/Stop
button onthetopofthe REMstar Plustoturnthe airflow ON.
Breathenormallythroughyournose.
Adjusting2.Adjustthecircuit. Lie downonyourbedandadjustthe flexible tubing
theCircuit^° ^° move if you turninyoursleep.Adjustthemaskand
headgear untilyouhavea comfortablefitand there areno airflow leaks
intoyoureyes.
REMstar Plus User Manual O 15

Routine Use
Using thePressingtheRampbutton will reducetheairpressure whenyouaretryingto fall
RampButtonasleep. Theairpressure will graduallyincrease until yourprescriptionpressure
is reached. You alsohavetheoptionofnotusingtherampfeatureat all.
3. PresstheRampbuttononthetopofthe
REMstar Plus. You canusetherampbutton
asoftenasyou wish duringthenight.
Turningthe
System OFF 4.Removethemaskandheadgear.
Press thePressureStart/Stopbutton
onthetopofthe REMstar Plustoturn
theairflow OFF.
Pressure
Start/Stop
Button
IMPORTANT!
The humidifier button is active only when a Respironics Heated
Humidifier is connected or when the REMstar Plus is in the Setup
Menu (refer to page 10).
HelpfulHints• Makesure that bedding,curtains,orotheritems arenotblockingthe filter or
ventsofthe REMstar Plus. Airmust flow freelyaroundthe REMstar Plusfor
thesystemtoworkproperly.
• Ifthe airflow fromthe REMstar Plusfeels cold,repositionthe circuit tubing
so that itrunsunderyourbedcoverstoreduce heat loss while yousleep.
16 O REMstar Plus User Manual

Traveling with the System
Packing
theSystem
When traveling,thecarryingcaseisforcarry-on luggage only. Thecarryingcase
will not protect thesystemifitisputthroughchecked baggage.
SecurityStationsForconvenienceatsecuritystations, there isa note onthe bottom ofthe
REMstar Plusstating that itismedicalequipment.Itmaybehelpfultobringthis
manualalong with youtohelpsecuritypersonnelunderstandthe REMstar Plus.
Checkingthe
Power Cord
If youaretravelingtoa country with a line
voltage differentthantheoneyouarecurrently
using, a differentpowercordoraninterna-
tional plug adapter mayberequiredtomake
yourpowercordcompatible with thepower
outletsofthecountryto which youare
traveling. Contactyour home careprovider
for additionalinformation.
Changesin
Elevation
WARNING!
Elevation changescanaffectthepressurebeingdeliveredbythe REMstar Plus.
If youaretravelingormovingtoa newarea,confirmtheelevation.
Using the REMstar Plus at an incorrect elevation setting could result in airflow
pressures higher than the prescribed setting.
To verify/changetheelevationsetting:
1. Makesurethe REMstar Plusis plugged inandtheairflowisturned
OFF.
2. Presstherampbutton.Theelevationsymboland setting will be
displayed.
1 orLo= less than 2,500 ft.(<762m)
2orM = 2,500 to 5,000 ft.(762mto1524m)
3 orHi- 5,001to 7,500 ft.(1525m to 2286 m)
*over 7,500 ft= Theairflowpressuremaynotbeaccurate.
Contact your home careprovidertohaveyour
pressure setting adjusted.
3. Tochangetheelevationsetting,presstheramporhumidifierbutton.
The mainscreen will displayafter5-10seconds.
REMstar Plus User Manual O 17

Routine Maintenance
Cleaning
the Filter
CAUTION!
The graypollen filter shouldbecleanedatleastonceeverytwo weeks
undernormalusageandreplaced with a newoneeverysixmonths.The
white ultra-fine filter isdisposableandshouldbereplacedafter30nightsof
useorsoonerifitappearsdirty.DO NOT cleantheultra-fine filter.
Operating the REMstar Plus with a dirty filter may keep the system from
working properly and damage the REMstar Plus.
1. Removethefilter capby gently pressingdownonthetwolatcheson
thetopofthefilter cap.
2. Clean thefilter.
a. Removethe filter bygentlypullingaroundthe edges ofthe filter.
Rinse the filter ina steadystreamofrunningwater.Squeezeoutthe
water and repeat. Air dryona rackfor8 to12hoursorina clothes
dryer for15to20minutes.
b. Inserttheclean filter intothe filter areaonthebackofthe REMstar
Plus. Replacethe filter cap.
CAUTION! Never install a wet filter into the REMstar Plus. We recommend that you
clean the filter in the morning and alternate using the two filters provided
with the System to ensure enough drying time for the cleaned filter.
Clean themaskandtubingdaily.
To avoid electrical shock, unplug the REMstar Plus before cleaning.
Do not immerse the REMstar Plus in any fluids.
1. Disconnecttheflexibletubingfromthe REMstar Plus.Gentlywash
theflexibletubingina solutionof warm wateranda milddetergent.
Rinse thoroughly. Air dry.
2. Wipetheoutsideofthe REMstar Pluswitha clothslightlydamp-
enedwithwateranda milddetergent.Letthe REMstar Plusdry
beforeplugginginthepowercord.
3. Inspectthe REMstar Plusandallcircuitpartsforanydamageafter
cleaning. Replaceanydamagedparts.
4.Fordetailsoncleaningyourmaskandaccessories,refertothe
cleaninginstructionspackaged withtheaccessories.
18 O REMstar Plus User Manual
Cleaning
the System
WARNING!