Fisher & Paykel ICON+ User manual

3 Language
HEALTHCARE PROVIDER MANUAL
Healthcare Provider Manual

English ................................................................................................................................................................... A
Español (Spanish) .................................................................................................................................................. B
Français (French) .................................................................................................................................................. C

A-1
HEALTHCARE PROVIDER MANUAL
To be retained by the Clinician
Intended Use: The device is for use on adult patients for the treatment of OSA. The device is for use in the home
or sleep laboratory.
NOTE: This manual is for the healthcare provider only. To prevent patients altering their therapeutic pressure,
ensure the patient does not have access to this manual.
TABLE OF CONTENTS
1. WARNINGS .......................................................................................................................................................... A-2
2. GETTING TO KNOW THE F&P ICON....................................................................................................... A-2
2.1 The SmartDial™......................................................................................................................................... A-2
2.2 Patient Menu..............................................................................................................................................A-3
3. CLINICIAN MENU .............................................................................................................................................A-4
3.1 Accessing the Clinician Menu............................................................................................................A-4
3.2 Pressure Mode ..........................................................................................................................................A-4
3.3 Set Pressure ...............................................................................................................................................A-4
3.4 Menu Level..................................................................................................................................................A-4
3.5 SensAwake™ Pressure...........................................................................................................................A-5
3.6 Display Pressure or Time .....................................................................................................................A-5
3.7 Time Zone Setting................................................................................................................................... A-5
3.8 Sleep Data Setting..................................................................................................................................A-6
3.9 Altitude Adjustment...............................................................................................................................A-6
3.10 Service Sub-Menu ................................................................................................................................... A-7
4. MULTI-PATIENT USE ....................................................................................................................................... A-7
4.1 Deleting Sleep Data Between Patients......................................................................................... A-7
4.2 Cleaning the Device ............................................................................................................................... A-7
4.3 High Level Disinfection.........................................................................................................................A-8
5. SLEEP DATA REPORTING ............................................................................................................................A-8
6. REPLACEMENT PARTS..................................................................................................................................A-8
7. TROUBLESHOOTING......................................................................................................................................A-9
ENGLISH

A-2
1. WARNINGS
 • Reprocessingtheunitbetweenpatientsmustonlybecarriedoutbyauthorizedpersonnel.
 • Thedeviceandaccessoriesarenotsuitableforanautomaticcleaningmethod.
 • RefertotheUseandCareManualforContraindications,WarningsandCautions.
2. GETTING TO KNOW THE F&P ICON+
NOTE: This manual refers to the F&P ICON+ series model as the “device”.
 BeforeusingthisHealthcareProviderManual,pleaseensureyouhavereadandunderstoodtheF&PICON+UserInstructions.
Youmustbefamiliarwiththecontraindications,warnings,cautions,symbols,definitionsandoperatinginstructionswhichapply
to the device.
2.1 The SmartDial
 TheSmartDialisforoperatingthedeviceandfornavigatingtheMenuSystem.TheSmartDialworksonasimplePress,Turn,
Pressprinciple.Refertothediagramsbelow:
Press Press the SmartDial to enter the setting. The setting will flash to
indicate that changes can be made.
Press Press the SmartDial to accept the change.
Turn Turn the SmartDial to adjust the setting.

A-3
2.2Patient Menu
ThePatientMenureferstoallthesettingsthatthepatientcanviewtoaccessandmakeadjustments.TherearetwoMenu
Systemsavailableinthedevice–SimpleModeandAdvancedMode.RefertotheUseandCareManualformoredetails.Belowis
abriefdescriptionofeachsymbolasitisshownbyturningtheSmartDialinaclockwisedirection:
Symbol Description
Ramp RampcanbeactivatedinbothCPAPandAutoMode.PresstheSmartDialandholdfor3secondswhile
thepressureison.Rampisactivefor20 minutes, starting from one third of the set pressure or 4cmH2O,
whicheverisgreater.TheRampsymbolwillappearontheHomeScreenwhiletheRampisoperating.
Humidity Humidity is available from levels 0to 7inbothSimpleModeandAdvancedMode.Thedefaulthumidity
level is 4.InAdvancedMode,ifthepatientrequiresadifferenthumidityrange,pressandholdthe
SmartDial for 3secondswhileintheHumiditysettingandtheBoostsymbolswillappear . Boost
Humiditycanbeselectedfromlow,mediumorhigh.Thedefaultisformedium-humidityBoost.
Alarm On/Off The Alarm function can be turned On or Off in this setting. If Alarm On is selected, the patient can choose
astandardalarmbellsound,orAlarmTunes™,whichallowspersonalizedmusicfromtheInfoUSB™.
RefertotheF&PStudio™CDforinstructionsoninstallationanduse.
Alarm Time Select the time for the Alarm to activate.
Alarm Volume Toadjustthevolumeofthealarmbellormusic,turntheSmartDialtothedesiredlevel.
ToadjusttheclickvolumeoftheSmartDial,pressandholdfor3secondswhileinthissetting.
Clock Time Turn the SmartDial to select the hour, minutes, 12-hror24-hrtime.
Brightness Turn the SmartDial to select the desired Home Screen Brightness and press to accept the change.
NOTE: You can also change the Active Screen Brightness. Press and hold the SmartDial for 3seconds and
thedevicesymbolwillappear .
Sleep Data ThissettingallowsthepatienttoviewtheirSleepDataresults.Thiscouldbeusedasatooltomonitor
therapyprogressortoprovideacompliancecheckoverthetelephone.RefertotheUseandCareManual
for more details about the Sleep Data setting.
SensAwake
On/Off TheusercandisabletheSensAwakefunctionifrequired.SensAwakeisavailablewithAutoandPremo
models.
NOTE:SensAwakeisdefaultedtoOffinPremomodels.
User Preferences Thissettingallowsthepatienttoviewand/oradjusttheFlightMode,DisplayPressure,andAltitude.
Flight Mode FlightModecanbeactivatedifreducedpowerinputisrequired.FlightModewillrun
the CPAP on 75W,howeverhumidityoutputinthismodewillbegreatlyreduced.
NOTE: IfyouareintendingtouseyourCPAPduringight,conrmwithyourairline
for F&P ICON approval prior to travel.
Display Pressure TheDisplayPressuresettingprovidestheabilitytoshowpressureontheHome
Screen during therapy in cmH2OorhPaifrequired.
Altitude
Adjustment FormodelswithoutAutomaticAltitudeadjustment,thealtitudecanbeadjustedby
turning the SmartDial.
ENGLISH

A-4
 ThehealthcareproviderwillhaveautomaticaccesstoallofthesettingsbelowoncetheyhaveenteredtheClinicianMenu.
3.2Pressure Mode
 Inthismenu,thePressureModecanbechangedfromCPAPtoAUTOindevicemodelswiththisfeature(ICONAutoonly).
3.3Set Pressure
 Thissettingallowstheprescribedpressuretobeset,whetheritisforfixedorauto-adjustingpressureparameters.
• CPAPFixedPressure:Thedevicehasadefaultfixedpressuresettingof10 cmH2O but can be
adjustedwithintherangeof4to 20 cmH2O.
• MinimumPressure:Fordevicemodelswiththeauto-adjustingpressurefeature,theminimum
default setting is 4cmH2O. This is also the minimum starting pressure of the device.
• MaximumPressure:Fordevicemodelswiththeauto-adjustingpressurefeature,
themaximumdefaultsettingis18 cmH2O,howeverthiscanbeincreasedupto
20 cmH2Oordecreasedifrequired.
3.4Menu Level
 InthissettingyoucanchoosetoallowortorestrictsomeofthefeaturesavailableinthePatientMenu.Therearetwolevels,
SimpleMode(Level1)andAdvancedMode(Level2).
Simple Mode
In this menu patients can perform functions that are outlined in Section 1, Part 2of the Use and
CareManual.Thisincludesturningthedeviceonandoffandadjustingthehumidity.Basicsleep
datacanbeviewedontheDisplayScreenbyholdingdowntheSmartDialfor7seconds.
Advanced Mode
In this menu patients can perform functions that are outlined in Section 1, Part 2of the Use and
CareManual.Thisincludesadjustingthehumidity,clockandalarmfunctions,altitudeadjustment
(formodelswithoutAutomaticAltitudeadjustment)andadditionalsleepdatasuchasAHI,leak,
90%pressureandSensAwakestatistics.
3. CLINICIAN MENU
3.1Accessing the Clinician Menu
TheClinicianMenuconsistsofothersettingsthatarehiddenfromthePatientMenu.ToentertheClinicianMenu,followthe
instructionsbelow:
1. PressandholdthebuttoninthemiddleoftheSmartDial,anduseyourotherhandtoturntheSmartDialinaclockwise
direction to 180°.DonotreleasetheSmartDialbuttonwhileturning.
2. YoucannowreleasetheSmartDialbutton.
NOTE:TheClinicianMenuwilldefaultbacktothePatientMenuafter30seconds,oriftheunitisturnedoffatthepowersupply.
Press and hold the button of the
SmartDial
TurntheSmartDialinaclockwisedirection,180°

A-5
3.5SensAwake Pressure
 InthismenuSensAwakecanbeturnedONorOFFandtheSensAwakepressureset.
 ThedefaultsettingforF&PICONAutoisSensAwakeON.
 ThedefaultsettingforF&PICONPremoisSensAwakeOFF.
 ToactivateSensAwakefollowtheinstructionsbelow:
1. Set the pressure as outlined in Section 3.3.
2. TurntheSmartDialtotheSensAwakesetting.
3. PresstoenterandturntheSmartDialtoadjustSensAwakeOnorOff.
4. OnceSensAwakeisselected,pressagaintoadjustthepressureoracceptthedefaultpressure
of 4cmH2O.
NOTE: IfSensAwakeisdisabledwithintheClinicianMenu,itwillremovetheSensAwakefeature
fromthePatientMenu.
3.6Display Pressure or Time
TheDisplayPressuresettingprovidestheabilitytoshowpressure(cmH2OorhPa)ortimeonthe
HomeScreenduringtherapyifrequired.
3.7Time-zone Setting
 InordertoachieveaccuratenightlyaveragesforLCDcompliancereporting,thedeviceneedstoknowwhereitisintheworld.
Thisisachievedbyspecifyingthepatient’stime-zone.Inordertochangethedevice’stime-zonesetting:
1. EnableClinicianMenu.
2. TurntheSmartDialtothe“ClockTime”menusetting.
3. Set the time for the device and press SmartDial to confirm
the time.
4. TurntheSmartDialtoselectthedesiredtime-zone.
5. Press the SmartDial to confirm the setting change.
NOTE:TheTime-zonemenudisplaysthecurrenttime-zonesettingasanoffsetfromGreenwichMeanTime(GMT).
Forexample,“GMT+06:00” is displayed as “6hr”and“GMT–11:00” is displayed as “–11hr”.Refertothefollowingtablefor
commontime-zones.
Country/Region Time-Zone F&P ICON Setting
USA Pacific Standard Time – 8hr
MountainStandardTime – 7hr
Central Standard Time – 6hr
Eastern Standard Time – 5hr
Atlantic Standard Time – 4hr
Europe GreenwichMeanTime 0hr
WesternEuropeanTime 0hr
Central European Time 1hr
Eastern European Time 2hr
MoscowStandardTime 3hr
Australia WesternStandardTime 8hr
Central Standard Time 9hr*
Eastern Standard Time 10 hr
Asia/Pacic Japan Standard Time 9hr
NewZealandStandardTime 12 hr
* GMT+09:30 rounded down to the nearest whole hour.
ENGLISH

A-6
* Not available in all models.
NOTE: A symbolwillappearontheDisplayScreenwhenthesleepdataiswithinthecompliancerequirements.OnceCMS
requirementshavebeenmet,thedatawithintheCMSsub-menuwillfreeze.
3.9Altitude Adjustment
• FormodelswithoutautomaticAltitudeAdjustment,turntheSmartDialtotheAltitudeSetting
and press to enter. Turn the SmartDial to select the Altitude level from 0to 9,000 ft and press
to accept the change.
• To choose meters, press the SmartDial and hold for 3secondswhileattheAltitudeAdjustment
setting.Whenthesymbolstartstoflash,turntoselectmetersandpresstoacceptthechange.
PresstheSmartDialagaintoenterthemenuandturntoadjusttothedesiredAltitudelevel.
Press again to accept the change.
3.8Sleep Data Setting
 Therearetwotypesofsleepdataavailable:theCMSReport andthePatientReport .*TheCMSreportreferstoUS-specific
statistics.EachofthesleepdataDisplayScreensareoutlinedbelow:
PatientReportScreen
Additional Sleep Data (Advanced Mode Only)
The AHI for the last 30 nights. Press
the SmartDial to access the average
for the last 7nights and again for the
last night.
Theamountofleakthathasoccurred
in the last 30 nights. Press the
SmartDial to access the average for
the last 7nights and again for the
last night.
90th percentile pressure for the
last 30 nights. Press the SmartDial
to access the average for the last
7nights and again for the last night.
SensAwakeactivationforthelast
30 nights. Press the SmartDial to
access the average for the last
7nights and again for the last night.
ExittheSleepDataSetting.
Sleep Data Sub-Menus
Total Compliant Hours
Average Compliant Hours for the last
30 nights. Press the SmartDial to
access the average last 7nights and
again for the last night.
Percentage of nights greater than
4hours for the last 30 nights. Press
the SmartDial to access the average
for the last 7nights and again for the
last night.
Number of nights since first use.
CheckSum
CMSReportScreen

A-7
4. MULTI-PATIENT USE
 Thedevicedoesnotrequireroutineservicingorcalibration.High-leveldisinfectioncleaningisrequiredwhenthedeviceis
intendedformultiplepatientuseandmustbecarriedoutbyqualifiedpersonnel.
4.1Deleting Sleep Data Between Patients
 Foraccuratecompliancereports,datamustbeclearedfromthedevicememoryaswellastheInfoUSBbeforeusebyanother
patient.FollowtheinstructionsbelowtodeleteSleepDatafromthedevicememory:
 • TurntheSmartDialtothesleepdatasetting whileintheClinicianMenu.
 • Presstoenter.
 • Pressagainandholdfor3seconds for the hours to start flashing.
 • PresstheSmartDialtodeletethepatientdata,orturntoretain.
North American Models
 • TurntheSmartDialtoSleepDatasetting whileintheClinicianMenu.
 • TurntothePatientReport orCMSreport and press to enter.
 • Pressagainandholdfor3seconds for the hours to start flashing.
 • PresstheSmartDialtodeletethepatientdata,orturntoretain.
4.2 Cleaning the Device
 Tomaintaintheoptimallifeandpresentationofthedevice,regularcleaningisrecommended.Refertocleaninginstructionsin
theUse&CareManual.Forcleaningbetweenpatients,followtheinstructionsoutlinedbelow:
 • Disconnectthedevicefromthepowersupply
 • Wipetheexteriorofthedevicewithaclean,damp(notwet)clothandmilddishwashingdetergent
 • RemovetheChamberLid,WaterChamber,BreathingTube,ElbowandOutletSeal
 • Wipetheinsidebasinofthedevicewithaclean,damp(notwet)clothandmilddishwashingdetergent
 • Theone-pieceWaterChambershouldnotbedisassembled.
NOTE: Do not use harsh abrasives or solvents as these may damage the device.
NOTE: Thisisaread-onlymenu.PleasereferanyErrorCodestoFisher&PaykelHealthcare.
3.10 Service Sub-menu
Service Setting
ErrorCode(Pressthe
SmartDial to access the Error
CodeMenu)
CPAPModelIdentifier
InthisexamplethemodelisanAuto
withThermoSmart™andSensAwake
Technology
TotalNon-resettable
RunHours
CurrentSoftwareVersion
ReturntotheClinicianMenu
Remove Water Chamber Remove Breathing Tube Remove Elbow Remove Outlet Seal
Remove Chamber Lid
ENGLISH

A-8
4.3 High Level Disinfection
 TheChamberLid,WaterChamber,BreathingTube,Elbow,OutletSealandAirFilterareallsuppliedasreplacementparts(refer
to Section 6forReordernumbers).ApartfromtheAirFilter,thesepartsmaybedisinfected(High-LevelDisinfection)forusewith
otherpatientsasfollows:
 • TheWaterChambercanbecleanedinastandarddishwasher,pasteurizedat70 °C for 30minutes,ordisinfectedbysoaking
inCidexOPAfor30 minutes at 20 °C
 • TheChamberLidandHeatedBreathingTubecanbedisinfectedbypasteurizingat70 °C for 30minutesorsoakedinCIDEX
OPA for 30 minutes at 20 °C
 • TheElbowandOutletSealcanbedisinfectedbypasteurizingat70 °C for 30minutes,orsoakinginCidexOPAfor30 minutes
at 20 °C
NOTE: These parts are validated for 20re-processingcycles.
5. SLEEP DATA REPORTING
 Theretrievalofcompliancedataisavailableinarangeofsolutionstosuitdifferentpatientneeds.RefertotheInfoSmart™
OperatingManualformoredetailsaboutreportingoptions.
 • InfoView™:ThepatientcanrelaytheirCPAPprogressoverthetelephonefromtheSleepDatasettinginthePatientMenu
(refertoUseandCareManual,Section1, Part 2).EachofthefigurescanbeverifiedusingInfoSmartsoftware.
 • TheInfoUSB2(storedintheUSBPort)recordssleepdatafromtheinternalmemoryofthedevice,andthisdatacanbe
transferredtoareportformatusingInfoSmartsoftware.ThefollowingdataisrecordedinInfoSmartreports:
i. 7days’detailedefficacydata(includingAHI,PressureandLeak)
  ii. Customizablesummarydataupto12 months
iii. Cumulative summary data from first use
iv. A choice of 30, 60, 90 or 180days’summarydataviaaquicklink
 • InfoUSB2Application*:WithInfoSmartWebandtheInfoUSB2application,patientswillhavetheabilitytosendCPAPdata
andreceiveremoteprescriptionchangesviatheInternet.InfoSmartWebhasbuiltincustomizableautomatedtelephone,
emailandtextmessagesthatcanbesettoremindthepatienttocompletethedatatransferinatimelymanner.
NOTE:OnlyuseanInfoUSBdesignedforusewiththeF&PICON+.UseofanyotherUSBdrivesmaycausedatacorruptionor
damage to the casing of the device.
* Not available in all countries
6. REPLACEMENT PARTS
900SW100 F&P InfoSmart CD 900HC221 Breathing Tube**
900ICON200 WaterChamber(10Pack) 900ICON214 SilverGlossLid
900ICON202 InfoUSB 2(5Pack) 900ICON216 MattGrayLid
900ICON203 InfoUSB 2*(5Pack) 900ICON217 CharcoalLid
900ICON204 Elbow 900ICON218 FilterGrill
900ICON205 OxygenElbow 900ICON503 AirFilter(SinglePack)
900ICON206 Outlet Seal 900ICON213 AirFilters(2Pack)
900ICON208 ThermoSmart Breathing Tube** 900ICON315 Carry-bag
* Not available in all countries
** Applied Parts – to fit .86 inches (22 mm) Conical Connector