ICON Use and Care Manual Rev B

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MANUFACTURER

Fisher & Paykel Healthcare Ltd

15 Maurice Paykel Place, East Tamaki, Auckland 2013

PO Box 14 348, Panmure, Auckland 1741, New Zealand

Tel: +64 9 574 0100

Fax: +64 9 574 0158

Email: info@fphcare.com

Website: www.fphcare.com

AUSTRALIA

Tel: +61 3 9879 5022

Fax: +61 3 9879 5232

AUSTRIA

Tel: 0800 29 31 23

Fax: 0800 29 31 22

BENELUX

Tel: +31 40 216 3555

Fax: +31 40 216 3554

CHINA

Tel: +86 (20) 3205 3486

Fax: +86 (20) 3205 2132

FRANCE

Tel: +33 1 6446 5201

Fax: +33 1 6446 5221

GERMANY

Tel: +49 7182 93777 0

Fax: +49 7182 93777 99

INDIA

Tel: +91 80 4123 6041

Fax: +91 80 4123 6044

IRISH REPUBLIC

Tel: 1800 409 011

ITALY

Tel: +39 06 7839 2939

Fax: +39 06 7814 7709

JAPAN

Tel: +81 3 3661 7205

Fax: +81 3 3661 7206

Northern Ireland

Tel: +0800 132 189

SPAIN

Tel: +34 902 013 346

Fax: +34 902 013 379

SWEDEN

Tel: +46 8 564 76 680

Fax: +46 8 36 63 10

SWITZERLAND

Tel: 0800 83 47 63

Fax: 0800 83 47 54

UK

(EU Authorised Representative)

Fisher & Paykel Healthcare UK Ltd

Unit 16, Cordwallis Park, Clivemont Road, Maidenhead,

Berkshire SL6 7BU, UK

Tel: +44 1628 626 136

Fax: +44 1628 626 146

USA

Tel: +1 800 446 3908

or +1 949 453 4000

Fax: +1 949 453 4001

185045354 RevB

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Use and Care Manual

AUTO

ICONAT

© Fisher & Paykel Healthcare Ltd

PREMO

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ICONNT

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1. BEFORE YOU START

Please read this manual carefully before use and save these instructions for

future reference.

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.

IMPORTANT CONTACT DETAILS

Home Medical Equipment Provider

Doctor/Physician

Health Insurance Provider

CAUTION: USA Federal law restricts this device for sale by or on the order

of a physician.

2. SYMBOL DEFINITIONS

I PX 2

Type BF Applied Part

Alternating Current

ATTENTION

Consult accompanying documents

Class II Double-insulated

Do not throw away

Conforms with medical device

directive 93/42/EEC

Drip-proof

Date of manufacture

Catalogue number

Serial number

Prescription only

Authorized representative in the

European community

NZ Radio Interference C-tick mark

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Page 5

3. GENERAL WARNINGS AND CAUTIONS

This manual refers to the F&P ICON™ series model as “the device”.

The device treats Obstructive Sleep Apnea (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.

CONTRAINDICATIONS

• 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.

PRECAUTIONS

• 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.

ADVERSE EFFECTS

• Nosebleeds, ear and sinus discomfort may occur from the use of positive pressure

therapy.

WARNINGS

To 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.

To 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 filter is fitted to the device before use.

• Ensure the breathing tube is positioned so it can not become entangled with the

body or furniture during sleep.

To avoid burns:

• Do not fill the chamber with hot water.

• After use, wait for the water to cool before touching, carrying or emptying the Water

Chamber.

• Do not touch the water in the chamber while the device is operating.

• Position the ThermoSmart™ Breathing Tube so it is uncovered and free from bedding

or other materials.

To ensure optimal therapy:

• Do not operate the device, chamber or breathing tube if it is dropped, damaged or

not working as intended.

• Pressure adjustments should only be made by a qualified 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.

• Do not block the exhaust flow holes of the mask as they are designed to allow a

continuous flow of air out of the mask and CO2 re-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 and accordingly CO2 re-breathing may occur which can be hazardous.

• 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 filled water chamber in place.

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Other:

• Refer all repairs and maintenance to your healthcare provider.

• Ensure the device is stored on a level surface, lower than 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 IEC

60601-1-2. 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.

• The operator should not touch the patient while inserting the SmartStick™ into the

USB Port.

Using supplemental oxygen with your device:

1. Supplemental oxygen can be administered at the mask end of the breathing tube.

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.

2. Ensure there is no obstruction downstream of the Oxygen Port as this can affect the

delivered oxygen concentration.

3. Oxygen concentration should be measured at the point of delivery to the patient.

4. Avoid the risk of fire:

• 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 flame, 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.

CAUTIONS

To prevent water damage to the device:

• Remove the Water Chamber from the device before filling.

• Do not fill the Water Chamber above the maximum level.

• Do not move, carry, transport or store the device with water in the chamber.

General:

• Only use the device within the Operating Conditions specified in Section 10.

• 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 Section 9

and only when it is disconnected from the power supply.

• Only use the F&P ICON™ SmartStick™ 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™.

4. 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.

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Page 7

Refer to Part A

5. QUICK START GUIDE

Refer to Part A of the Diagram Sheet at the beginning of this manual for illustrative

examples:

1

Select the appropriate plug from the Carry-Case and attach to the end of the

power cord. Place the device on a firm flat surface and plug the power cord into

the wall socket.

2

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 for filling.

3

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 filled Water Chamber.

4

To replace the Water Chamber, the arrow on the circular chamber grip should

face toward the Elbow.

5

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.

6 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.

NOTE: The Chamber Lid must be correctly locked for optimal pressure delivery.

7

The Chamber Lid can be unlocked by twisting in an anti-clockwise direction, then

remove by lifting away from the device.

8

Attach the breathing tube to the Elbow and connect to your mask.

9

Press the SmartDial™ to start pressure delivery. 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 3 seconds to activate

the Ramp. The Ramp symbol

will light up on the display.

10

Turn the SmartDial™ to select and adjust settings. Refer to Section 7 for a

description of the Menu System.

Your device is now ready for use.

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Refer to Part B

6. GETTING TO KNOW YOUR F&P ICON™

Description of Parts and Instructions for Use

Refer to Part B at the beginning of this manual for diagrams of each part. Also refer to

Section 5 Quick Start Guide for additional information.

1

Water Chamber

• Remove the Water Chamber from the device before filling. Fill to the maximum

water line (420 ml), using distilled water only. Do not use hot water.

CAUTION: Do not fill the Water Chamber while it is inside the device and do not

fill above the maximum water line.

• To replace the Water Chamber into the device, the arrow on the circular

chamber grip should face toward the elbow.

NOTE: Replace water before each use.

2

SmartDial™

The SmartDial™ is for operating the device and navigating the Menu System. The

SmartDial™ works on a simple Press, Turn, Press principle. For example:

• Press the SmartDial™ to turn the device on or off.

• Turn the SmartDial™ to find the required setting.

• Press the SmartDial™ to enter the setting.

• Turn the SmartDial™ to adjust the setting.

• Press the SmartDial™ to accept the change.

3

The Display

The Display is where information can be viewed. The Home Screen is the default

display where each point of the Menu System can be viewed. Once a selection

has been made within the Menu System, the Display will dim and return to the

Home Screen after 30 seconds.

4

Menu System

The 16 points of the clock-face on the Home Screen also represent each of the

available settings.

NOTE: These instructions only include functions available for patient use.

Refer to Section 7 for a detailed description of each setting, and PART C of the

Diagram Sheet for illustrative examples.

5

Chamber Lid

• Twist the Chamber Lid anti-clockwise to unlock and remove.

• The Chamber Lid must be correctly locked into place for optimal pressure

delivery.

• Once the Chamber Lid is locked into place, the handle can be used to carry the

device.

6

ThermoSmart™ Breathing Tube

ThermoSmart™ includes a unique heated breathing tube as well as a humidity

algorithm which both work to deliver optimal levels of humidity without the side

effects of condensation.

CAUTION: Do not use the ThermoSmart™ Breathing Tube if there is any visible

damage that exposes copper wires.

7

Elbow

The Elbow is where the breathing tube connects to the device. The Elbow can be

rotated from side to side, depending on your preferred sleeping position.

8

Air Filter

The Air Filter can be found at the rear of the device. 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.

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9

USB Port

• The USB Port houses the SmartStick™ which must be pushed completely into

the USB Port until it clicks into place, flush with the side of the device.

• To remove, push the end of the SmartStick™ for a spring-release retrieval.

NOTE: Only use the SmartStick™ designed and distributed for use with the

F&P ICON™.

10 SmartStick™

11

• The SmartStick™ is 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™. Refer to Section 7 Point 3 for more information.

• The SmartStick™ can be removed and sent to your healthcare provider to

view and adjust settings. Changes will be automatically transferred when the

SmartStick™ is next inserted into the USB Port of the device.

NOTE: The SmartStick™ must be pulled all of the way out of the USB Port

before pushing back in.

Power Cord

Four Multi-region plugs are housed in the Carry-Case for personal convenience

when traveling. Fit the appropriate plug to the end of the power cord.

12 F&P ICON™ Support Tools CD

13

The CD contains SmartStick™ Studio Software for transferring music to the

SmartStick™, as well as a demonstration video to help with the set-up, and cleaning

of the device.

Adjustable Straps

Two straps are included with the device. One or both straps can be attached to

the Carry-Case according to personal preference when traveling.

14 Carry-Case

The Carry-case has been specially designed to protect the device during

transportation. There is a space provided at the handle end of the Carry-Case

to store your mask when travelling. Simply remove the Headgear and Elbow to

fit. Refer to Diagram 14 in PART B for the correct location of each item when

packing.

NOTE: The Carry-Case will not close until the Chamber Lid is removed from

the device. This is to ensure water is emptied from the Water Chamber before

traveling. Place the Chamber Lid in the partition next to the hinge of the CarryCase.

15 Use and Care Manual

Read this manual carefully and save these instructions for future reference. If you

have any questions please contact your healthcare provider.

Replacement Parts

900ICON108 F&P ICON™ Support Tools CD

900ICON212

900ICON200 Water Chamber

900ICON214 Auto/Premo Lid

Air Filters

900ICON202 SmartStick™

900ICON216 Novo Lid

900ICON204 Elbow

900ICON218 Filter Grill

900ICON206 Outlet Seal

900ICON302 Multi-Region Plug Pack

900ICON208 ThermoSmart™ Breathing Tube*

900ICON306 Carry-Case Straps

900ICON210 Breathing Tube*

900ICON308 Carry-Case

* Applied Parts - to fit .86 inches (22 mm) Conical Connector

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Refer to Part C

7. MENU SYSTEM

Refer to Part C of the Diagram Sheet at the beginning of this manual for illustrative

examples.

1

On/Off and Ramp

• Press the SmartDial™ to start therapy.

• To activate Ramp, press the SmartDial™ again and hold for 3 seconds. The

.

Ramp symbol will appear

• To stop and start pressure delivery, press the SmartDial™ while in the Home

Screen.

2

Humidity

• Turn the SmartDial™ to the Humidity setting . Press to enter and turn the

SmartDial™ again to select the desired humidity level from 0 to 7 (low to high).

Press again to accept the change.

NOTE: The default setting is Humidity level 4.

• For additional humidity control, press and hold the SmartDial™ for 3 seconds

. Turn to

while in the Humidity setting and the Boost symbols will appear

select low, medium or high and press again to accept the change.

NOTE: The default setting is for medium boost humidity.

3

Alarm On/Off

• Turn the SmartDial™ to the Alarm On/Off setting

, and press to enter. Turn

, On with the

the SmartDial™ again to select either On with the default bell

, or Off . Press the SmartDial™ again to

music symbol for AlarmTunes™

accept the change.

NOTE: The AlarmTunes™ symbol is only visible when the SmartStick™ is

inserted.

• If AlarmTunes™ is selected, turn the SmartDial™ to select the desired music track

(from 1 to 5 depending on how many tracks are loaded onto the SmartStick™),

or select Auto for shuffle and press again to accept the change. Refer to the

F&P ICON™ Support Tools CD for SmartStick™ Studio software, as well as

instructions for installing and transferring music to your SmartStick™.

• Press the SmartDial™ once to snooze the Alarm for 10 minutes or twice to turn

the device and Alarm off.

4

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.

5

Alarm Volume

• To adjust the volume of the alarm, turn the SmartDial™ to the Alarm Volume

and press to enter. Turn the SmartDial™ to adjust the volume from

setting

quiet to loud and press again to accept the change.

• To adjust the click volume of the SmartDial™, press and hold for 3 seconds

will appear, turn to

while in the Alarm Volume setting. The volume symbol

select the desired volume and press again to accept the change.

6

Clock Time

and press to enter. Turn the

• Turn the SmartDial™ to the Clock Time setting

SmartDial™ to select the hour, minutes, 12-hr or 24-hr time. After each selection,

press again to accept the change.

7

Brightness

and press to enter. Turn the

• Turn the SmartDial™ to the Brightness setting

SmartDial™ to select the Home Screen brightness level and press to accept

the change. To adjust the brightness of the display while accessing the Menu

System, press and hold the SmartDial™ for 3 seconds and the Active Brightness

.

symbol will appear

• Turn to select the desired brightness and press again to accept the change.

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8

Sleep Data

Turn the SmartDial™ to the Sleep Data setting

and press to enter.

NOTE: The model name will display while in the Sleep Data setting.

Turn the SmartDial™ to scroll through each of the following statistics:

• Total Compliant Hours

• Compliant hours during the last 30 nights

• Percentage Compliant hours over the last 30 nights

• Day that 70% compliance was achieved in 30 consecutive days within the first

90 days of use.

NOTE: A  symbol will appear on the Display Screen when the Sleep Data is

within the compliance requirements.

• Set Pressure (for fixed pressure models only)

• Check Sum ( this symbol will only appear if Additional Sleep Data is restricted)

• Exit the Sleep Data setting (

this symbol will only appear if Additional Sleep

Data is restricted)

Additional Sleep Data (NOTE: this information may be restricted by your

healthcare provider.)

• Leak for last night

• AHI for last night

• 90th percentile pressure for last night

• SensAwake™

• Check Sum

• Exit the Sleep Data setting.

9

SensAwake™ On/Off or Altitude Adjustment

• SensAwake™ is activated as a default setting. To deactivate from models with

this feature, 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.

• 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 0 to 10,000 ft and press to accept the change.

• To choose meters, press the SmartDial™ and hold for 3 seconds while in 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.

10 ECO Mode

ECO Mode allows for the device to operate on a reduced power (75 W).

NOTE: Humidity output will be significantly reduced in this mode.

Situations for use in this mode might include long-haul air flights and camping.

• Turn the SmartDial™ to the Eco setting

and press to enter. Turn to select

On

or Off

and press again to accept the change.

• The Eco symbol

will be displayed continuously on the Home Screen while

the Economy mode is activated.

11

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 3

appears. Turn the SmartDial™ to select either

seconds until the symbol

cmH2O or hPa and press again to accept the change.

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Page 12

12 Service Setting

The Service setting will only appear if an error has occurred. If the Error symbol

flashes on the Home Screen, turn the SmartDial™ to the Service setting

and

write down the number displayed. Contact your healthcare provider for

further instructions.

8. COMMUNICATING SLEEP DATA

Telephone Reporting

Many healthcare providers will ask for sleep data over the telephone to track CPAP

therapy progress. Follow the steps outlined under Sleep Data (Section 7, Point 8) which

explains how to access this data.

Downloading Data to the SmartStick™

If your healthcare provider requests a copy of your sleep data from the SmartStick™

please follow the steps below to download this information:

(1) If the SmartStick™ is already inserted into the USB Port of the device, check

flashing on the

that the pressure is off and there is no SmartStick™ symbol

Home Screen. The SmartStick™ can now be safely removed by pushing the

end for a spring-release retrieval.

(2) If the SmartStick™ has been removed, ensure the pressure is off before

inserting the SmartStick™ back into the USB Port of the device. Wait until the

has stopped flashing on the Home Screen before

SmartStick™ symbol

removing the SmartStick™ again.

(3) Data from the SmartStick™ should then be sent in the manner requested by

your healthcare provider.

NOTE: The flashing symbol indicates that data is being transferred from the

device memory to the SmartStick™. Removal of the SmartStick™ during this

time may cause data corruption.

9. CLEANING AND MAINTENANCE

The device should be cleaned as follows:

• Unplug the device from the power supply.

• 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 or solvents, as these may damage the device.

Daily

Clean the Water Chamber and the breathing tube:

• 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.

• The Water Chamber can be washed in a domestic dishwashing machine, or

cleaned and washed with mild dishwashing detergent, then rinse and dry.

Weekly

Thoroughly clean the Water Chamber:

• 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.

Replace the Air Filter when it becomes significantly discolored, at least once every

three months or after 1,000 hours’ worth of running time.

With a regular cleaning routine, it is recommended to replace your breathing tube and

Water Chamber every six months. However equipment should be replaced immediately

if there is any sign of cracking, discoloration or leaking.

NOTE: This device is not serviceable and should not be disassembled. Refer all

therapy and equipment queries to your healthcare provider.

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Page 13

10. PRODUCT SPECIFICATIONS

DIMENSIONS:

6.3 H x 6.7 W x 8.7 D in. (160 H x 170 W x 220 D mm)

WEIGHT:

4.8 lb (2.2 kg) Packed weight 8.7 lb (4.0 kg)

PERFORMANCE:

Pressure Range:

4 to 20 cmH2O (in the unlikely event of fault conditions, pressure

may reach up to 29 cmH2O)

Maximum Flow Rates – AUTO/PREMO

CPAP Pressure Setting (cmH2O)

Measured pressure at patient

connection port (cmH2O)

4

8

12

16

20

3

7

11

15

19

99

106

120

118

120

CPAP Pressure Setting (cmH2O)

4

8

12

16

20

Measured pressure at patient

connection port (cmH2O)

3

7

11

15

19

49

56

60

65

67

Maximum flow rate (L/min) at mask

connection port

Maximum Flow Rates – NOVO

Maximum flow rate (L/min) at mask

connection port

Static Pressure Stability:

-0.07 to -0.09 cmH2O pressure difference, measured at the mask

connection port, at the pressure setting of 10 cmH2O

Dynamic Pressure Stability

CPAP Pressure Setting (cmH2O)

Pressure difference (cmH2O)

at mask connection port

HUMIDITY:

4

8

12

16

20

-0.29 to +0.27 -0.33 to +0.22 -0.40 to +0.21 -0.43 to +0.21 -0.60 to +0.76

Maximum humidity = 35 mg/L (BTPS), 85% RH at 10 cmH2O, with

humidity level 7 and Boost level high.

Typical humidity = 21 mg/L (BTPS), 78% RH at 10 cmH2O, with

humidity level 4 and Boost level medium.

GAS TEMPERATURES:

Maximum = 100 °F (38 °C)

NOISE LEVEL:

Sound Pressure Level = < 30 dBA

Average Sound Power Level = < 38 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

DATA RECORDING:

The SmartStick™ records up to 365 days of summary efficacy data,

30 days of detailed efficacy data (AHI, Leak), 7 days of high

frequency Flow, Pressure and Leak data (50 Hz), as well as

cumulative data from first use.

Electrical Ratings

Rated supply voltage

Rated current input

Rated supply frequency

110 - 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

STORAGE AND TRANSPORT:

The device should always be stored and transported within the

following temperatures:

Transport:

Storage:

CAUTION: Ensure water is emptied from the Water Chamber

before traveling. The Carry-Case will not close until the Chamber

Lid is removed from the device.

OPERATING CONDITIONS:

14 to 140 °F (-10 °C to 60 °C)

14 to 140 °F (-10 °C to 60 °C)

41 to 95 °F (5 to 35 °C)

Ambient Temperature:

Humidity:

5 to 95% Relative Humidity

Altitude:

0 to 9,000 ft (0 to 3,000 m)

NOTE: Above 4500 ft (1500 m) the maximum operating pressure

will be reduced.

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Page 14

11. DEVICE AND CONSUMABLES DISPOSAL INSTRUCTIONS

Unit Disposal Instructions

This unit 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.

12. 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

There is no visible

display or power

The plug may not be correctly

attached to the power cord

Ensure the correct plug from the CarryCase is attached to the power cord, and is

connected to the power supply.

Insufficient air is

delivered from the

device

The Chamber Lid may not be

correctly fitted to the device

Refer to Section 5 and Part B for detailed

instructions for fitting the Chamber Lid.

“Error” is

displayed on the

Home Screen of

the device

An error may have been detected

with the device

Turn the SmartDial™ to the Service setting

and press to enter. Write down the number

displayed and contact your healthcare

provider for further instruction.

The Carry-Case

won’t close

The Chamber Lid may not be

removed from the device

The Carry-Case has been designed to protect

the device during travel. The Chamber Lid

must be removed before closing the CarryCase, and water must be removed from the

Water Chamber.

AlarmTunes™ does

not work

The Alarm may be set to “off”

Refer to Section 7, point 3 for instructions on

the Alarm setting

The Alarm may be sent to

“buzzer”

The SmartStick™ may not have

been inserted into the USB Port

correctly

Once SmartStick™ Studio software has

been installed onto your computer and your

favorite songs selected, download onto your

SmartStick™ and then ensure the SmartStick™

is inserted into the USB Port of the device.

13. F&P ICON™ MODELS AND FEATURES MATRIX

The model name of each device is located on the base, as well as in the Sleep Data

setting of the Menu System. Refer to Section 7, Point 8 for more information.

Features

AUTO

PREMO

NOVO

with humidification

•

•

•

ThermoSmart™ Heated Breathing Tube

•

•

•

Auto Adjusting Pressure

•

*Efficacy Reporting (AHI, Leak)

•

•

Compliance Reporting

•

•

•

SmartStick™ Removable Media

•

•

•

SensAwake™ Pressure Relief

•

Proportional Ramp

•

•

•

Auto-Altitude Adjusting

•

•

Manual

Leak Compensation

•

•

Fully integrated CPAP

* NOTE: The display of efficacy data may be restricted by your healthcare provider.

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