icon_use_and_care_manual_rev_b.pdf
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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
ICONPT
NOVO
ICONNT
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TABLE OF CONTENTS
1.
Before you Start ...................................................................................................... A - 1
2.
Symbol Definitions ................................................................................................. A - 1
3.
General Warnings and Cautions ..................................................................... A - 2
4.
Intended Use ............................................................................................................ A - 3
5.
Quick Start Guide .................................................................................................. A - 4
6.
Getting to Know Your F&P ICON™ ................................................................ A - 5
Replacement Parts ................................................................................................ A - 6
7.
Menu System ............................................................................................................ A - 7
(1) On/Off and Ramp ......................................................................................... A - 7
(2) Humidity ............................................................................................................ A - 7
(3) Alarm On/Off ................................................................................................. A - 7
(4) Alarm Time ....................................................................................................... A - 7
(5) Alarm Volume ................................................................................................. A - 7
(6) Clock Time ........................................................................................................ A - 7
(7) Brightness ......................................................................................................... A - 7
(8) Sleep Data ......................................................................................................... A - 8
(9) SensAwake™ On/Off or Altitude Adjustment................................... A - 8
(10) ECO Mode ......................................................................................................... A - 8
(11) Display Pressure ........................................................................................... A - 8
(12) Service Setting .............................................................................................. A - 8
8.
Communicating Sleep Data ............................................................................. A - 9
Telephone Reporting ........................................................................................... A - 9
Downloading Data to the SmartStick™ ....................................................... A - 9
9.
Cleaning and Maintenance ................................................................................ A - 9
10. Product Specifications ...................................................................................... A - 10
11.
Device and Consumables Disposal Instructions....................................... A - 11
12. Troubleshooting ...................................................................................................... A - 11
13. F&P ICON™ Models and Features Matrix .................................................... A - 11
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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
A-1
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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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.
A-4
Page 8
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.
A-5
Page 9
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
A-6
Page 10
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.
A-7
Page 11
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.
A-8
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.
A-9
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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