Fisher & Paykel ICON User manual

Use and Care Manual

A - 1
ENGLISH
BEFORE YOU START
USA Federal Law restricts this device for sale by or on the order of a physician.
Please read this guide before use and save instructions for future reference. Section 2contains important safety
information about the use of this device. The device is suitable for continuous operation.
If you feel that your device or any accessories are not operating correctly, please contact your healthcare
provider.
NOTE: This device contains no serviceable parts. Refer all therapy and equipment queries to your healthcare
provider.
TABLE OF CONTENTS
SECTION 1 - Quick Start Information
1. Getting Started ........................................................................................................................................ A - 2
2. F&P ICON Menu System ......................................................................................................................... A - 4
Simple Mode
(1) On/Off and Ramp ............................................................................................................................. A - 4
(2) Humidity .......................................................................................................................................... A - 4
(3) Sleep Data ....................................................................................................................................... A - 4
Advanced Mode
(4) On/Off and Ramp ............................................................................................................................. A - 5
(5) Humidity .......................................................................................................................................... A - 5
(6) Alarm On/Off .................................................................................................................................... A - 5
(7) Alarm Time ...................................................................................................................................... A - 6
(8) Alarm Volume .................................................................................................................................. A - 6
(9) Clock Time ....................................................................................................................................... A - 6
(10) Brightness ....................................................................................................................................... A - 6
(11) Sleep Data ....................................................................................................................................... A - 7
(12) SensAwake On/Off ........................................................................................................................... A - 7
(13) User Preferences .............................................................................................................................. A - 7
(13i) Flight Mode ........................................................................................................................... A - 8
(13ii) Display Pressure ................................................................................................................... A - 8
(13iii) Altitude Adjustment .............................................................................................................. A - 8
3. Communicating Sleep Data ..................................................................................................................... A - 9
4. Cleaning and Maintenance ..................................................................................................................... A - 10
SECTION 2 - Other Product Information
1. Intended Use ........................................................................................................................................... A - 11
2. Symbol Definitions ................................................................................................................................. A - 11
3. General Warnings and Cautions .............................................................................................................. A - 11
3.1Contraindications ............................................................................................................................ A - 11
3.2Warnings ......................................................................................................................................... A - 11
3.3Cautions .......................................................................................................................................... A - 13
3.4Replacement Parts .......................................................................................................................... A - 13
4. Product Specifications ............................................................................................................................ A - 14
5. F&P ICON Models and Features Matrix ................................................................................................... A - 16
6. Device and Consumables Disposal Instructions...................................................................................... A - 16
7. Warranty Statement ................................................................................................................................. A - 16
8. Troubleshooting ...................................................................................................................................... A - 17

A - 2
1. GETTING STARTED
Place the device on a level surface, level with or below head height,
to prevent water entering the tubing and the device enclosure.
Plug the power cord into the power supply.
Remove the Chamber Lid and reach inside the Water Chamber with your
fingers to take hold of the circular chamber grip. Pull the Water Chamber up
and out of the device.
CAUTION: Do not fill the Water Chamber while it is in the device; the Water
Chamber should always be removed before filling.
Fill the Water Chamber with distilled water up to the maximum water line,
which is marked on the side of the Water Chamber.
CAUTION: Do not use the device without a Water Chamber. Do not use hot
water, and water should be replaced before each use.
IMPORTANT: The Water Chamber cannot be disassembled.
To replace the Water Chamber, the arrow on the circular chamber grip should
face toward the Elbow.
Fit the Chamber Lid by lining up the large dot on the lid with the large
dot on the top of the device . When the two symbols are aligned, apply
downward force and turn clockwise to align the large dot with the small dot
on the top of the device.
NOTE: The Chamber Lid must be correctly fitted for optimal pressure delivery.
1
2
3
4
5
SECTION 1 - QUICK START INFORMATION

A - 2 A - 3
ENGLISH
When the Chamber Lid is locked into place, it should be flush, with no gaps
for air to leak. It can now be used as a handle for lifting and carrying.
The Chamber Lid can be unlocked by twisting in an anti-clockwise direction,
then removed by lifting away from the device.
Attach the Breathing Tube to the Elbow and connect to your mask.
NOTE: Make sure the electrical connectors on the ThermoSmart™ Breathing
Tube come together with the electrical connectors on the Elbow. Please refer to
Oxygen Elbow user instructions if attaching an Oxygen Elbow.
From the Home Screen, a quick press to the SmartDial™ will start therapy. The
Home Screen will light up and the clock-face of the Menu System will rotate to
indicate therapy is starting. If Ramp is required, press the SmartDial again and
hold for 3seconds to activate. The Ramp symbol will display.
Your device is now ready for use.
Turn the SmartDial to select and adjust settings. Refer to Section 1, Part 2for
a description of the Menu System.
6
7
8
9
10

A - 4
2. F&P ICON MENU SYSTEM
Simple Mode
The Simple Mode is the default Menu System of the F&P ICON.*
* Not in all models
11. On/Off and Ramp
• AquickpresstotheSmartDialwillstarttherapy.
• ToactivateRamp,presstheSmartDialagainandholdfor
3seconds. The Ramp symbol will appear .
22. Humidity
• Tocontrolthelevelofhumiditydeliveredtothemask,turnthe
SmartDial to select the desired humidity level from 0(off) to 7
(maximum). Press again to accept the change. For example, if the air is
feeling too cold, increase the Humidity setting in increments of 1or 2
over 2to 3nights until you find the level that is comfortable.
NOTE: The default setting is Humidity level 4. If using without water, or
where low power consumption is required (e.g. for aircraft and trucking
use), set the humidity level to 0.
33. Sleep Data
Press and hold the SmartDial for 7seconds to access the Sleep Data
setting. Turn the SmartDial to scroll through each of the following
statistics:
• TotalCompliantHours .
• AverageCompliantHoursoverthelast30 nights . Press the
SmartDial to access the average for the last 7nights and again for the
last night.
• Percentageofnightsusedgreaterthan4hours over the last 30 nights
. Press the SmartDial to access the percentage for the last
7nights.
• Thenumberofnightselapsedsincetherapycommenced .
• CheckSum .
• ExittheSleepDatasetting.
NOTE: A symbol will appear on the Home Screen once the compliance
requirements have been achieved for the North America models only.

A - 4 A - 5
ENGLISH
Advanced Mode
The Advanced Mode is a menu system for users that provides additional features which are not
available in Simple Mode. (Note: This mode may be restricted by your healthcare provider.)
44. On/Off and Ramp
• AquickpresstotheSmartDialwillstarttherapy.
• ToactivateRamp,presstheSmartDialagainandholdfor3seconds.
The Ramp symbol will appear .
55. Humidity
• Tocontrolthelevelofhumiditydeliveredtothemask,turnthe
SmartDial to the Humidity setting . Press to enter and turn the
SmartDial again to select the desired humidity level from 0(off) to 7
(maximum). Press again to accept the change. For example, if the air is
feeling too cold increase the Humidity setting in increments of 1or 2
over 2to 3nights until you find the level that is comfortable.
NOTE: The default setting is Humidity level 4. If using without water, set
the humidity level to 0. The humidity level cannot be adjusted if Flight
Mode is set to on.
• TheBoostcontroloffersthreeadditionallevels(1, 2, 3) to optimize
the Humidity setting. Press and hold the SmartDial for 3seconds while
in the Humidity setting and the Boost symbols will appear. Turn
to select low (1), medium (2) or high (3) and press again to accept
the change.
CAUTION: The Boost control should only be used in extreme situations
when experiencing symptoms from your CPAP therapy. The default
Boost setting (medium) will be suitable for most patients.
66. Alarm On/Off
• TurntheSmartDialtotheAlarmsetting , press to enter, then turn to
select either On or Off . Press again to accept the change.
• IfAlarmOn is chosen, turn the SmartDial to select either the default
bell or the music symbol for AlarmTunes™ , and press again to
accept the change.
• PresstheSmartDialoncetosnoozetheAlarmfor10 minutes, twice to
turn the Alarm off and a third time to discontinue therapy.
NOTE: The AlarmTunes symbol is only visible when the InfoUSB™ is
inserted. F&P Studio™ software is required to utilize the AlarmTunes
feature.

A - 6
2. F&P ICON MENU SYSTEM (continued)
• IfAlarmTunesisselected,turntheSmartDialtoselectthedesiredmusic
track (from 1to 5, depending on how many songs are loaded onto the
InfoUSB), or if there are two or more songs loaded select Auto for shuffle
and press again to accept the change. Refer to the F&P Studio CD for
instructions to install and transfer music to your InfoUSB.
77. Alarm Time
• TurntheSmartDialtotheAlarmTimesetting and press to enter.
Turn the SmartDial to select the hour; press to accept. Turn to select
the minutes and press again to accept the change.
88. Alarm Volume
• Toadjustthevolumeofthealarm,turntheSmartDialtotheAlarm
Volume setting and press to enter. Turn the SmartDial to adjust the
volume from quiet to loud and press again to accept the change.
• Toadjustthe“click”volumeoftheSmartDial,pressandholdfor
3seconds while in the Alarm Volume setting. The Volume symbol
will be present; turn to select the desired volume and press again to
accept the change.
99. Clock Time
• TurntheSmartDialtotheClockTimesetting and press to enter.
Turn the SmartDial to select the hour, minutes, 12-hr or 24-hr time.
After each selection, press again to accept the change.
10 10. Brightness
• TurntheSmartDialtotheBrightnesssetting and press to enter. Turn
the SmartDial to select the desired Home Screen Brightness and press
to accept the change.
• ToadjusttheActiveScreenBrightness,pressandholdtheSmartDial
for 3seconds and the Device symbol will appear .
NOTE: The Home Screen Brightness controls the level of light emitted
by the LCD when the device is in “stand-by” or “pressure on” mode, and
the Active Screen Brightness controls the level of light emitted by the
LCD whilst navigating the Menu System.

A - 6 A - 7
ENGLISH
11 11. Sleep Data
Turn the SmartDial to the Sleep Data setting and press to enter.
Alternatively, press and hold the SmartDial for 7seconds. Turn the
SmartDial to either the Centers for Medicare and Medicaid (CMS) Report
(US specific) or Patient Report and press to enter.
Turn the SmartDial to scroll through each of the following statistics:
• TotalCompliantHours .
• AverageCompliantHoursoverthelast30 nights . Press the
SmartDial to access the average for the last 7nights and again for the
last night.
• Percentageofnightsusedgreaterthan4hours over the last 30 nights
. Press the SmartDial to access the percentage for the last
7nights.
• Thenumberofnightselapsedsincetherapycommenced .
• CheckSum .
• AHIforlast30, 7, and 1nights.
• Leakforlast30, 7, and 1nights.
• 90th percentile pressure for last 30, 7, and 1nights.
• SensAwakeforlast30, 7, and 1nights.
• ExittheSleepDatasetting.
NOTE: A symbol will appear on the Home Screen when the sleep data
is within the compliance requirements. Once CMS requirements have
been met, the data within the CMS sub-menu will stop logging.
• ExittheSleepDatasetting.
12 12. SensAwake On/Off
The SensAwake setting is available on both Auto and Premo models,
but may be restricted by your healthcare provider. To adjust, turn the
SmartDial to the SensAwake setting and press to enter. Turn the
SmartDial to select On or Off and press again to accept the change.
NOTE: This setting is not available with the Novo model.
13 13. User Preferences
Turn the SmartDial to the User Preferences setting and press to enter.

A - 8
2. F&P ICON MENU SYSTEM (continued)
13i 13i. Flight Mode
Flight Mode allows for the device to operate on a reduced power (75 W).
Situations for use in this mode might include long-haul air flights and
camping.
NOTE: Humidity output will be significantly reduced in this mode and is
not recommended for long-term use.
• TurntheSmartDialtotheFlightModesetting and press to enter.
Turn to select On or Off and press again to accept the change.
• TheFlightModesymbol will be displayed continuously on the
Home Screen while the Flight Mode is activated.
NOTE: If you are intending to use your CPAP during flight, confirm with
your airline for F&P ICON approval prior to travel.
13ii 13ii.Display Pressure
The Display Pressure setting provides two display options for the Home
Screen. Time is the default setting, however this can be changed to
show pressure (cmH2O or hPa) if required.
• TurntheSmartDialtotheDisplayPressuresetting and press
to enter. Turn to select On or Off and press again to accept the
change.
• Ifadifferentunitofmeasureisrequired,presstheSmartDialand
hold for 3seconds. Turn the SmartDial to select either cmH2O or
hPa and press again to accept the change.
13iii 13iii.Altitude 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3seconds 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.

A - 8 A - 9
ENGLISH
3. COMMUNICATING SLEEP DATA
• TheUSBPorthousestheInfoUSB2which records patient compliance, efficacy and flow data. The
InfoUSB 2must be pushed completely into the USB Port until it clicks into place. To remove, push the
end of the InfoUSB 2for a spring-release retrieval.
• TheInfoUSB2is used to record sleep data from the device memory when it is inserted into the USB
Port of the device and to store music for use with AlarmTunes. The InfoUSB 2can be removed and
sent to your healthcare provider to view and adjust settings. Changes will be automatically transferred
when the InfoUSB 2is next inserted into the USB Port of the device.
InfoUSB 2Application*
The InfoUSB 2application is intended for home and clinical use as an accessory with the InfoUSB 2.
How to install and use
When requested by your healthcare provider, remove the InfoUSB 2from your CPAP device and insert it
into the USB Port of a computer connected to the Internet.
The first time you insert the InfoUSB 2into your computer, open Windows Explorer and navigate to the
drive called FPHCARE.
1. To install an InfoUSB detector on your computer, open this folder and double-click on the Setup.exe file.
Follow the on-screen instructions. Upon successful installation of the InfoUSB 2application, and upon
detection of an InfoUSB 2in your computer, InfoUSB 2will automatically launch and the message below
will appear.
2. To run the InfoUSB 2application once, click on the InfoUSB application. InfoUSB 2will automatically
launch and the message below will appear.
Enter your date of birth and click the Upload button.
After the data has been uploaded successfully, a confirmation message will appear. Remove the
InfoUSB 2from your computer and place it back into your CPAP device. The CPAP device is now ready
to be used for future logging. The InfoUSB detector only needs to be installed once. The next time you
place the InfoUSB 2into your computer, the Start Screen (image above) will appear automatically.
* Not available in all countries.

A - 10
The device should be cleaned as follows:
• Ensurethewallpoweroutletisturnedoffbeforeunpluggingthedevicefromthepowersupplywhere
appropriate.
• Wipetheexteriorandbasinofthedevice(whentheWaterChamberhasbeenremoved)withaclean,
damp (not wet) cloth and mild dishwashing detergent. Do not use harsh abrasives, solvents or alcohol
as these may damage the device.
Daily
Clean the Water Chamber, Chamber Lid and the Breathing Tube:
• UnlocktheChamberLidbytwistingintheanti-clockwisedirectionandliftitawayfromthedevice.
•WashtheChamberLidinamilddishwashingdetergent;rinsethoroughlyanddry.
•DisconnecttheBreathingTubefromthemaskandthedeviceElbow.
•CleantheBreathingTubewithwarm,soapywater;rinsethoroughlyandhangwithbothendspointing
to the floor to dry.
•RemovetheWaterChamberanddiscardanyremainingwater.Donotremovetherubbersealonthe
chamber.
• Theone-pieceWaterChambershouldnotbedisassembled.
•TheWaterChambercanbewashedinadomesticdishwashingmachine,orcleanedandwashedwith
mild dishwashing detergent, then rinsed and dried.
Weekly
Thoroughly clean the Water Chamber, Outlet Seal and the Elbow:
•SoaktheinsideoftheWaterChamberfor10 minutes in a solution of one part white vinegar to two
parts water.
•EmptythevinegarsolutionandrinsetheWaterChamberthoroughlywithwater.
• DisconnecttheElbowfromthedeviceandtheOutletSealcanbeeasilyremovedbylightlypushingit
from the back of the device into the Water Chamber housing.
•TheElbowandtheOutletSealcanbecleanedandwashedwithmilddishwashingdetergent,then
rinsed and dried.
•PleaseplacetheOutletSealbeforetheElbowinsealcavitywhenretting.
Air Filter
The Air Filter is located on the rear of the device. The Air Filter ensures the air is filtered from particles
and dust. To access, first pull out the Filter Grill, then pinch the gauze to remove. The Filter Grill must be
pushed back into the cavity to keep the Air Filter in place.
Replace the Air Filter when it becomes significantly discolored, at least once every three months or after
1,000 hours’ worth of running time.
NOTE: When replacing the Air Filter the black stripe should be on the inside.
Breathing Tube and Water Chamber
It is recommended that you inspect the device and all parts on a regular basis after cleaning. The
equipment should be replaced immediately if there is any sign of cracking, discoloration or leaking.
NOTE: The device is not serviceable and should not be disassembled. Refer all therapy and equipment
queries to your healthcare provider.
The device is intended for single or multiple use. Refer to the high-level disinfection instructions in the
Healthcare Provider Manual for cleaning between users.
4. CLEANING AND MAINTENANCE

A - 10 A - 11
ENGLISH
2. SYMBOL DEFINITIONS
1. INTENDED USE
The device is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA).
The device is for use in the home or sleep laboratory.
3. GENERAL WARNINGS AND CAUTIONS
This manual refers to the F&P ICONseriesmodelas“thedevice”.
The device treats OSA by delivering a flow of continuous positive airway pressure (CPAP) at a level
prescribed by the physician, to splint open the airway and prevent airway collapse.
3.1Contraindications
Research indicates that the following pre-existing conditions may contraindicate the use of positive
pressure for some patients: pneumothorax, bullous lung disease, pneumocephalus, cerebrospinal
fluid leak, recent cranial surgery or trauma, abnormalities of the cribriform plate, pathologically low
blood pressure or in patients whose upper airways are bypassed.
3.1.1Precautions:
•Thesafetyandeffectivenessofpositivepressurehasnotbeenestablishedinpatientswith
respiratory failure or chronic obstructive pulmonary disease.
•Thesafetyandeffectivenessoftheauto-adjustingdevicehasnotbeenestablishedinpatientswith
congestive heart failure, obesity hypoventilation syndrome or central sleep apnea.
3.1.2Adverse effects:
•Nosebleeds,earandsinusdiscomfortmayoccurfromtheuseofpositivepressuretherapy.
3.2Warnings
3.2.1To avoid electric shock from the device:
•Onlyoperateifthedevice,powercordandplugaredryandingoodworkingorder.
•Ifwaterdamageoccurstoyourdevice,disconnectthepowercord,discontinueuseimmediately
and seek advice from your healthcare provider.
•Donotstoreorusethedevicewhereitcanbepulledintowater.
SECTION 2 - OTHER PRODUCT INFORMATION
Authorized representative in the
European community
Serial number
Catalogue number
Type BF Applied Part Alternating Current
ATTENTION
Consult accompanying documents
Class II Medical Electrical Equipment
Do not discard as regular rubbish Conforms with medical device
directive 93/42/EEC
Date of manufactureDrip-proof
IPX2
Prescription only
NZ Radio Interference C-tick mark
UL Classified symbol
Brazil INMETRO symbol

A - 12
3.2.2To avoid choking, or inhalation of a foreign object:
•Neverplaceanynon-approvedobjectsintoanyopeningofthedevice,BreathingTubeormask.
•Ensuretherecommendedlteristtedtothedevicebeforeuse.
•EnsuretheBreathingTubeispositionedsoitcannotbecomeentangledwiththebodyorfurniture
during sleep.
3.2.3To avoid burns:
•DonotlltheWaterChamberwithhotwater.
•Afteruse,waitforthewatertocoolbeforetouching,carryingoremptyingtheWaterChamber.
•Donottouchtheheater-plateshortlyafterthedevicehasbeenoperating.
•DonottouchthewaterintheWaterChamberwhilethedeviceisoperating.
•PositiontheThermoSmartBreathingTubesoitisuncoveredandfreefrombeddingorother
materials. Do not lie on it and avoid prolonged skin contact.
3.2.4Other:
•Ensurethedeviceisstoredandoperatedonasurface,levelorbelowheadheight,toprevent
water entering the tubing and the device enclosure.
•Thedeviceisnotintendedtobeusedasalife-supportingdevice.
•ThedevicecomplieswiththeelectromagneticcompatibilityrequirementsofIEC60601-1-2. In
certain circumstances the device may affect or be affected by nearby portable mobile radio
frequency communication equipment, due to the effects of electromagnetic interference. If this
should happen, try moving your device or the location of the equipment causing interference, or
alternatively consult your healthcare provider.
•Donotblocktheowthroughthedeviceasthismaycausethemotortooverheat.
•Donotblocktheexhaustowholesofthemaskastheyaredesignedtoallowacontinuousow
of air out of the mask and if blocked CO2re-breathing may occur.
•Intheeventofpowerfailure,machinemalfunctionorifthedeviceisturnedoff,removethemask
immediately as the flow through the mask may be insufficient to clear all exhaled gas, which may
result in CO2re-breathing occuring that can be hazardous.
•Thedeviceisnotsuitableforuseinenvironmentswithammableanaestheticmixtureswithairor
oxygen or nitrous oxide.
3.2.5To ensure optimal therapy:
•Donotoperatethedevice,WaterChamberorBreathingTubeifitisdropped,damagedornot
working as intended.
•Pressureadjustmentsshouldonlybemadebyaqualiedhealthcareprovider.
•Onlyusemasks,breathingtubesandaccessoriescompliantwithISO17510-2, distributed for use
with this device, and recommended by Fisher & Paykel Healthcare or your healthcare provider.
•Itisrecommendedtoonlyusethepartsthathavebeenspeciedinthismanual.
•OnmodelswithoutautomaticAltitudeAdjustment,ensurethealtitudelevelismanuallyadjustedto
ensure optimal pressure delivery.
•DonotusethedevicewithoutaWaterChamberinplace.
•IfusingthedevicewithoutwaterintheWaterChamberitisrecommendedtosetthehumiditylevel
to zero.
•ItisrecommendedtousedistilledwatertoextendthelifeofyourWaterChamber.Thisislikelyto
prevent residue buildup on the chamber base.

A - 12 A - 13
ENGLISH
3.2.6Using supplemental oxygen with your device:
•SupplementaloxygencanbeadministeredatthemaskendoftheBreathingTubeorwithanOxygen
Elbow.
NOTE: At a fixed flow rate of supplemental oxygen the inhaled oxygen concentration will vary,
depending on the pressure settings, the patient’s breathing pattern, mask selection and leak rate.
•EnsurethereisnoobstructiondownstreamoftheOxygenPortasthiscanaffectthedelivered
oxygen concentration.
•Oxygenconcentrationshouldbemeasuredatthepointofdeliverytothepatient.
•Avoidtheriskofre:
•Onlyuseoxygenwhenthedeviceisoperating.Ifthedeviceisturnedoffitcanleadto
accumulation of oxygen within the device.
•Ensureadequateventilationisprovidedaroundthedevice.
•Removeanysourceofignition,suchascigarettes,anopename,ormaterialswhichburnor
ignite easily at high oxygen concentration.
•Keepoxygenregulators,cylindervalves,tubing,connectionsandallotheroxygenequipment
away from oil, grease or greasy substances. Spontaneous and violent ignition may occur if these
substances come into contact with oxygen under pressure.
3.3Cautions
3.3.1To prevent water damage to the device:
•RemovetheWaterChamberfromthedevicebeforelling.
•DonotlltheWaterChamberabovethemaximumlevel.
•Donotmove,carry,transportorstorethedevicewithwaterintheWaterChamber.
3.3.2General:
•OnlyusethedevicewithintheOperatingConditionsspeciedinSection2, Part 4.
•Positionthedevicesothepowercordconnectiontothepowersupplyiseasilyaccessible.
•OnlycleanthedeviceinaccordancewiththecleaninginstructionssetoutintheCleaningand
Maintenance section (Section 1, Part 4) and only when it is disconnected from the power supply.
•OnlyusetheF&PICONInfoUSBwiththedevice.UseofanyotherUSBdrivesmaycausedata
corruption. Do not attempt to change the directories or view the data without software distributed
or designed for use with the F&P ICON.
3.4Replacement Parts
900ICON200 Water Chamber (10 Pack)
900ICON202 InfoUSB 2(5Pack)
900ICON203 InfoUSB 2* (5Pack)
900ICON112 F&P Studio CD
900ICON204 Elbow
900ICON205 Oxygen Elbow
900ICON206 Outlet Seal
900ICON208 ThermoSmart Breathing Tube**
900HC221 Standard Breathing Tube**
900ICON214 Silver Gloss Lid
900ICON216 Matt Gray Lid
900ICON217 Charcoal Lid
900ICON218 Filter Grill
900ICON503 Air Filter (Single Pack)
900ICON213 Air Filter (2Pack)
900ICON315 Carry-bag
* Not available in all countries.
** Applied Parts – to fit 0.86 inches (22 mm) Conical Connector.

A - 14
4. PRODUCT SPECIFICATIONS
DIMENSIONS: 6.3H x 6.7W x 8.7D in. (160 H x 170 W x 220 D mm)
WEIGHT: 4.8lb (2.2kg) Packed Weight 8.7lb (4.0kg)
PERFORMANCE: Pressure Range:
4to 20 cmH2O/hPa (in the unlikely event of fault conditions, pressure may reach up
to 29 cmH2O)
Maximum Flow Rates
CPAP Pressure Setting (cmH2O) 4 8 12 16 20
Measured flow at patient connection port (Lpm)
– Auto/Premo 62.1 101.5 129.4 148.8 143.3
Measured flow at patient connection port (Lpm)
– Novo 46.7 52.4 56.5 60.6 64.5
Dynamic Pressure Stability
Breath Rate
BPM
Test Pressure
Pmin
4.0cmH2O
Pmin
1⁄4(Pmax-Pmin)
8.0cmH2O
Pmin
1⁄2(Pmax-Pmin)
12.0cmH2O
Pmin
3⁄4(Pmax-Pmin)
16.0cmH2O
Pmin
20.0cmH2O
Novo
Dynamic Pressure
Stability (cmH2O)
10 0.76 0.84 0.90 0.99 1.04
15 0.76 0.84 0.91 0.99 1.04
20 1.16 1.22 1.28 1.38 1.44
Auto/Premo
Dynamic Pressure
Stability (cmH2O)
10 0.13 0.16 0.22 0.28 0.33
15 0.27 0.26 0.31 0.37 0.44
20 0.52 0.47 0.47 0.52 0.54
THE PNEUMATIC FLOW PATH:
Air flow from rear of device to blower Air flow from blower to mask
Air flow
Air flow
continues
in next
figure
Inlet filter
Blower
Air flow
Blower
Mask
Breathing tube
Inlet filter
Continued from
previous figure
Chamber

A - 14 A - 15
ENGLISH
Static Pressure Stability
Auto/Premo Novo
Pressure change (cmH2O) at connection port at a
pressure setting of 10 cmH2O0.2 0.4
Humidity
With ThermoSmart Breathing Tube
Maximum Humidity 36 mg/L Body Temperature and Pressure Saturated (BTPS), 82% RH at 10 cmH2O, with
Humidity level 7and Boost level high.
Typical Humidity 24 mg/L (BTPS), 90% RH at 10 cmH2O, with Humidity level 4and Boost level medium.
With Standard Breathing Tube
Maximum Humidity 32.24 mg/L, 73.21% RH at 10 cmH2O with Humidity level 7and Boost level high.
Typical Humidity 17.97 mg/L, 85.88% RH at 10 cmH2O with Humidity level 4and Boost level medium.
Electrical Ratings
Rated Supply Voltage Rated Current Input Rated Supply Frequency
100 - 115 V 1.27 A (1.43 A Max) 50 - 60 Hz/400 Hz
220 - 240 V 1.07 A (1.21 A Max) 50 - 60 Hz
GAS TEMPERATURES: Maximum = 100 °F (38 °C)
NOISE LEVEL: Sound Pressure Level <29 dBA
Average Sound Power Level <37 dBA
WATER CHAMBER VOLUME: 420 mL up to the maximum fill line
STANDARDS COMPLIANCE: IEC60601-1: 1988 + A1& A2; AS/NZS 3200.1.0: 1998
EN60601-1: 1990 + A1-A2; UL60601-1: 2003
DATA RECORDING: The InfoUSB records up to 365 days of summary efficacy data,
7days of detailed efficacy data (AHI, Leak), Pressure and Leak data
(50 Hz), as well as cumulative data from first use. The device memory can
also record up to 365 sessions of summary data or up to 200 sessions
(400 hours) of detailed efficacy data.
STORAGE AND TRANSPORT: The device should always be stored and transported within the following
temperatures:
Transport: 14 to 140 °F (–10 °C to 60 °C)
Storage: 14 to 140 °F (–10 °C to 60 °C)
CAUTION: Ensure water is emptied from the Water Chamber before traveling.
OPERATING CONDITIONS: Ambient Temperature: 41 to 95 °F (5to 35 °C)
Humidity: 15 to 95% Relative Humidity
Altitude: 0to 9,000 ft (0to 3,000 m)
NOTE: Above 4,500 ft (1,500 m) the maximum operating pressure will be
reduced.

A - 16
5. F&P ICON MODELS AND FEATURES MATRIX
Performance Features Auto Premo Novo
Fully Integrated • • •
ThermoSmart Technology* • • •
Auto-Adjusting Pressure •
Efficacy Reporting • •
Compliance Reporting • • •
InfoUSB • • •
SensAwake • •
Proportional Ramp • • •
Altitude Adjusting Automatic Automatic Manual
Leak Compensation • •
Clock and AlarmTunes • • •
InfoSmart Software • • •
Plug Type Auto Premo Novo
Australasia/China ICONAAA ICONPBA ICONNAA
Europe ICONAAE/ICONAHE** ICONPAE**/ICONPBE/ICONPHE** ICONNAE
UnitedKingdom/HongKong ICONAAK ICONPBK ICONNAK
North America (model numbers with
HT include Heated Breathing Tube) ICONAAN/ICONAAN-HT ICONPBN/ICONPBN-HT ICONNAN/ICONNAN-HT
Brazil ICONAAB+ ICONPBB+ ICONNAB+
Japan/Taiwan ICONAAJ ICONPBJ ICONNAJ
* In some countries the ThermoSmart Breathing Tube needs to be purchased as an accessory to activate ThermoSmart Technology.
** Part may vary depending on country.
6. DEVICE AND CONSUMABLES DISPOSAL INSTRUCTIONS
Device Disposal Instructions
This device contains electronics. Please do not discard as regular rubbish.
Dispose of electronics according to local guidelines.
Consumable Disposal Instructions
Place the mask, Breathing Tube and Water Chamber in a rubbish bag at the end of use and
discard with normal rubbish.
7. WARRANTY STATEMENT
Fisher & Paykel Healthcare warrants that the CPAP (excluding consumable items forming part of the
CPAP delivery system), when used in accordance with its instructions for use, shall be free from defects
in workmanship and materials and will perform in accordance with Fisher & Paykel Healthcare’s official
published product specifications for a period of two years from the date of purchase by the end user.
This warranty is subject to the limitations and exceptions set out in detail in www.fphcare.com/osa/cpap-
solutions/cpap-warranty.html.

A - 16 A - 17
ENGLISH
8. TROUBLESHOOTING
If you feel that your device is not operating correctly, please refer to the following suggestions. If the
problem persists, please consult your healthcare provider. Do not attempt to repair the device yourself.
Problem Possible Cause Solution
I can not turn the
pressure on or off
The device is likely to be in the Advance
Mode of the Menu System and the selection
may not be at the 12 o’clock position.
Turn the selection circle to the 12 o’clock
position and press the SmartDial to turn the
pressure On or Off.
Insufficient air is delivered
from the device
The Chamber Lid may not be correctly fitted
to the device. Ensure the Water Chamber is
in the device.
Refer to Section 1, Part 1.
“Error”isdisplayedon
the Home Screen of the
device
An error may have been detected with the
device.
Disconnect from power, then connect and
re-start device. If the error persists, record the
number displayed and contact your healthcare
provider for further instructions.
AlarmTunes does not
work
TheAlarmmaybesetto“off”.
TheAlarmmaybesetto“buzzer”.
F&P Studio software may not have been
installed.
The Alarm volume may not be set loud
enough.
The InfoUSB may not be inserted all the way
into the USB port.
Refer to Section 1, Part 2for instructions on
the Alarm Setting.
Once F&P Studio software has been installed
onto your computer and your favorite songs
selected, download onto your InfoUSB and
then ensure the InfoUSB is inserted into the
USB Port of the device.
The Heater-Plate and/or
Water Chamber base is
warm to the touch even
though the device isn’t
being used
The power supply is located directly
underneath the Heater-Plate and in stand-by
mode generates approximately 5W of power,
which causes the feeling of warmth. The
Water Chamber is also fully insulated by the
device which can cause heat to be retained.
This is perfectly normal and should not cause
concern.
If concerned about overheating, unplug the
device from the power supply when it is not
being used.
I think my Water Chamber
is leaking because there
is a buildup of water on
the Heater-Plate
After therapy the device will cool, which may
result in condensation forming inside the
Water Chamber and pooling on the Heater
Plate.
Before each use remove the Water Chamber
and dry the basin of the device with a cloth.
If the water buildup becomes excessive,
please contact your healthcare provider.
I don’t think my
Humidifier is working
Check the Humidity setting is above 1. Check
your Water Chamber as it may be empty.
Refer to Section 1, Part 2for more
information on the humidity controls.
The InfoUSB symbol
is constantly flashing on
the Home Screen
The InfoUSB may not be inserted correctly. Take the InfoUSB completely out of the USB
Port, then insert again until it clicks.
The device seems noisy;
there is a hissing noise
coming from the device
The Chamber Lid may not be properly fitted,
causing air to leak.
Remove the Chamber Lid and replace again
so that it is completely flush with the device,
by following the instructions set out in
Section 1.

185046221 REV G 2013-01 © 2013 Fisher & Paykel Healthcare Limited
Manufacturer Fisher & Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, Auckland 2013, PO Box 14 348, Panmure,
Auckland 1741, New Zealand Tel: [phone] Fax: [phone] Email: [email protected] Web: www.fphcare.com
Australia Fisher & Paykel Healthcare Pty Limited, 36-40 New Street, PO Box 167, Ringwood, Melbourne, Victoria 3134, Australia
Tel: [phone] Fax: [phone] Austria Tel: [phone] Fax: [phone] Benelux Tel: [phone]
Fax: [phone] China Tel: [phone] Fax: [phone] France Tel: [phone] Fax: [phone]
Germany Tel: [phone] Fax: [phone] India Tel: [phone] Fax: [phone]
Irish Republic Tel: [phone] Italy Tel: [phone] Fax: [phone] Japan Tel: [phone]
Fax: [phone] Northern Ireland Tel: [phone] Spain Tel: [phone] Fax: [phone]
Sweden Tel: [phone] Fax: [phone] Switzerland Tel: [phone] Fax: [phone]
Taiwan Tel: [phone] Fax: [phone] Turkey Fisher Paykel Sağlık Ürünleri Ticaret Limited Şirketi,
P.O. Box 06371 Ostim, Alinteri Bulvari 1161/1 Sokak No. 12-14, Ankara, Turkey Tel: [phone] Fax: [phone]
UK Fisher & Paykel Healthcare Ltd, Unit 16, Cordwallis Park, Clivemont Road, Maidenhead, Berkshire SL67BU, UK
Tel: [phone] Fax: [phone] USA/Canada Tel: [phone] or [phone] Fax: [phone]