F&P SleepStyle Auto User manual

Use and Care Guide
F&P SleepStyle Auto
F&P SleepStyle CPAP
English | Español | Français

LANGUAGE SECTION
English A
Español (Spanish) B
Français (French) C
LANGUAGES

A-1
BEFORE YOU START
Before the device is used for the first time, it must be set up by a healthcare provider.
If your device or any accessories are not operating correctly, please contact your healthcare provider.
Healthcare providers: please contact your Fisher & Paykel Healthcare representative for a copy of the F&P SleepStyle Clinician
Guide.
TABLE OF CONTENTS
1. Overview ..................................................................................................................................................A-3
1.1 Intended Use / Indications for Use..................................................................................................................................A-3
1.2 Contraindications ...................................................................................................................................................................A-3
1.3 Warnings ....................................................................................................................................................................................A-3
1.3.1 To avoid death or serious injury ..........................................................................................................................A-3
1.3.2 To avoid electric shock............................................................................................................................................A-3
1.3.3 To avoid burns............................................................................................................................................................A-3
1.3.4 To avoid the risk of fire............................................................................................................................................A-3
1.3.5 To avoid carbon dioxide re-breathing or asphyxiation..............................................................................A-3
1.3.6 To avoid choking, or inhalation of a foreign object .....................................................................................A-4
1.3.7 To avoid injury.............................................................................................................................................................A-4
1.3.8 To avoid incorrect therapy.....................................................................................................................................A-4
1.3.9 General ..........................................................................................................................................................................A-4
1.4 Cautions......................................................................................................................................................................................A-4
1.4.1 To prevent water damage to the device..........................................................................................................A-4
1.4.2 General ..........................................................................................................................................................................A-5
1.5 Precautions................................................................................................................................................................................A-5
1.6 Adverse eects........................................................................................................................................................................A-5
2. Getting started .........................................................................................................................................A-6
2.1 Device and accessories ........................................................................................................................................................A-6
2.2 Setting up your device.......................................................................................................................................................... A-7
3. Using your device .....................................................................................................................................A-9
3.1 Screen icons..............................................................................................................................................................................A-9
3.2 Device controls.........................................................................................................................................................................A-9
3.3 Starting therapy..................................................................................................................................................................... A-10
3.4 Stopping therapy .................................................................................................................................................................. A-10
3.5 Stand-by mode...................................................................................................................................................................... A-10
3.6 Comfort settings ................................................................................................................................................................... A-10
3.6.1 Ramp............................................................................................................................................................................ A-10
3.6.2 Humidity ..................................................................................................................................................................... A-10
3.6.3 Expiratory relief........................................................................................................................................................ A-10
3.6.4 SensAwake™................................................................................................................................................................A-11
ENGLISH

A-2
4. Viewing your therapy data...................................................................................................................... A-11
4.1 View your therapy data on your device.........................................................................................................................A-11
4.1.1 Therapy Data...............................................................................................................................................................A-11
4.2 View your therapy data on the SleepStyle App or website..................................................................................A-12
5. Uploading your therapy data..................................................................................................................A-12
5.1 Modem .......................................................................................................................................................................................A-12
5.2 F&P InfoUSB™..........................................................................................................................................................................A-12
5.2.1 SleepStyle Website..................................................................................................................................................A-13
5.2.2 InfoUSB application.................................................................................................................................................A-13
6. Caring for your device............................................................................................................................ A-14
6.1 Disassembly for cleaning................................................................................................................................................... A-14
6.2 Cleaning your device and accessories at home........................................................................................................ A-14
6.2.1 Wash after each use................................................................................................................................................A-15
6.2.2 After 7 days’ use.......................................................................................................................................................A-15
6.3 Reassembly of the device.................................................................................................................................................. A-16
6.4 Replacement parts............................................................................................................................................................... A-16
6.4.1 Air filter.........................................................................................................................................................................A-17
7. Traveling with your device......................................................................................................................A-17
8. Specifications ......................................................................................................................................... A-18
8.1 SleepStyle device models and features........................................................................................................................A-18
8.2 Symbol definitions.................................................................................................................................................................A-18
8.3 Product specifications......................................................................................................................................................... A-19
8.4 Classifications..........................................................................................................................................................................A-21
8.5 Operating ranges ..................................................................................................................................................................A-22
8.6 Storage and transport conditions ..................................................................................................................................A-22
8.7 Disposal instructions............................................................................................................................................................A-22
8.8 Servicing...................................................................................................................................................................................A-22
8.9 Warranty statement.............................................................................................................................................................A-22
9. Troubleshooting .....................................................................................................................................A-22
9.1 Device troubleshooting ......................................................................................................................................................A-23
9.2 Error messages on sleepstyle screen........................................................................................................................... A-25
ENGLISH

A-3
1. OVERVIEW
WELCOME
Thank you for choosing your F&P SleepStyle device.
The F&P SleepStyle Auto is an auto-adjusting positive
airway pressure device.
The F&P SleepStyle CPAP is a continuous positive airway
pressure device (CPAP).
This guide refers to the F&P SleepStyle Auto and
F&P SleepStyle CPAP as the “device”. The device is intended
to treat Obstructive Sleep Apnea (OSA) by delivering a
flow of positive airway pressure at a level prescribed by
the physician, to splint open the airway and prevent airway
collapse.
Please read this guide carefully before you use your device.
Keep this guide in a safe place so you can refer to it later if
you need to.
1.1 INTENDED USE / INDICATIONS
FOR 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.
1.2 CONTRAINDICATIONS
Warnings
Do not use this device if you have the following pre-
existing conditions as they may contraindicate the use of
positive airway pressure:
• Pneumothorax
• Bullous lung disease
• Pneumocephalus
• Cerebrospinal fluid leak
• Recent cranial surgery or head trauma
• Abnormalities of the cribriform plate
• Pathologically low blood pressure
• Bypassed upper airways.
If you are unsure about what pre-existing conditions you
have, check with your physician or healthcare provider.
1.3 WARNINGS
To avoid the risk of fire:
Do not use this device with patients
requiring supplemental oxygen.
Connecting supplemental oxygen
to any part of this system, either at
the mask or at the device air outlet,
may cause oxygen to build up in the
device, and could result in a fire.
1.3.1 To avoid death or serious injury:
• The device must only be used on adult patients.
• The device must only be used for the treatment of OSA.
• The device must only be used on prescription of a
physician.
• The device must not be used for life-support
applications.
1.3.2 To avoid electric shock:
• Do not use if the device, power cord or accessories are
damaged, deformed, or cracked.
• Do not pull on the power cord as it may become
damaged.
• Do not use bleach, alcohol, or cleaners with citrus or
other natural oils. These substances may degrade the
device and accessories.
• Do not immerse the device in water or any other liquid.
• Do not modify the device or accessories.
• Do not take apart the device. Taking the device apart, for
example by unscrewing the underside of the device, will
damage pressure seals and electrical components.
1.3.3 To avoid burns:
• Do not lie on, and avoid prolonged skin contact with, the
ThermoSmart™ breathing tube.
• Do not fill the water chamber with hot water as this may
lead to airway burns.
• Do not introduce into or operate the device or
accessories in a magnetic resonance (MR) environment
as there is a risk of burns due to electromagnetic eects.
1.3.4 To avoid the risk of fire:
• Do not cover the ThermoSmart breathing tube as this
may overheat the tube.
• Do not connect electrical accessories not approved for
use with the device.
• Do not use this device with patients requiring
supplemental oxygen. Connecting supplemental oxygen
to any part of this system, either at the mask or at the
device air outlet, may cause oxygen to build up in the
device, and could result in a fire.
• Sources of oxygen must be located more than 1 m
(40 in.) from the device.
1.3.5 To avoid carbon dioxide
re-breathing or asphyxiation:
• Do not use masks that do not contain a vent suitable
for CPAP therapy, or are not recommended by
Fisher & Paykel Healthcare or your healthcare provider.
Failure to use a mask or accessory that permits
spontaneous breathing can cause asphyxiation.
• Remove the mask immediately if the device is powered
o (including in the event of a power failure or device
malfunction). The flow through the mask may be
insucient to clear all exhaled gas.
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A-4
1.3.6 To avoid choking, or inhalation of
a foreign object:
• Ensure the breathing tube and power cord, including
any extension cords, are correctly positioned so they will
not become entangled with the body or furniture during
sleep.
• Do not use the device without the recommended air
filter fitted. The air filter will reduce dust or particles
entering the device and breathing tube.
• Do not place the device above head height to prevent
water from entering the breathing tube.
• Do not use the device with water in the water chamber if
the device is being used in a moving vehicle or ship.
1.3.7 To avoid injury:
• Do not place the device above head height as the device
may fall.
• Do not use breathing tubes, parts, and accessories
that are not distributed for use with this device or
recommended by Fisher & Paykel Healthcare.
• Do not use the breathing tubes or accessories with any
other device.
• Do not use ozone to clean this device. Residual ozone
may result in adverse respiratory eects such as irritation
of the nose, throat and lungs.
1.3.8 To avoid incorrect therapy:
• Do not cover the device or place it where the air inlet
could be obstructed (such as next to curtains).
• Do not use the device adjacent to electrical equipment.
• Do not adjust the pressure. Pressure adjustments should
only be made by a qualified healthcare provider.
• Refer to the mask’s Use and Care Guide prior to use to
ensure correct fit of the mask. Incorrect fit of the mask
may aect consistent operation of this device.
• Only clean the device and accessories according to the
cleaning instructions set out in section 6 – Caring for
Your Device.
• Do not clean or disinfect the ThermoSmart breathing
tube with hot water. This may cause deformation of the
tube and reduce therapeutic pressure.
• Use the elbow when rotating the ThermoSmart
breathing tube. Incorrect handling may damage the tube.
• Do not remove the InfoUSB, or power o the device,
before you see this screen when updating your
prescription using InfoUSB:
Press any button to acknowledge and clear this message.
1.3.9 General:
• Only use the device within the operating ranges
specified, otherwise the performance of the device could
be compromised. See section 8.5 – Operating Ranges.
• Do not place any part of the device or accessories within
30 cm (12 in.) of any portable mobile radio frequency
communication equipment. The device complies with
the electromagnetic compatibility requirements of IEC
60601-1-2. In rare occasions where electromagnetic
interference is experienced you may notice the device
restarting, pressure fluctuations or the humidify being
temporarily reduced which may temporarily interrupt
the therapy. If such interference should occur, try moving
your device or the equipment causing the interference
further away. Alternatively, consult your healthcare
provider.
• Interference caused by common RF emitters such as
diathermy, electrocautery, RFID and security systems
may impact the SleepStyle device. This should be taken
into consideration before placing the device in the
presence of any RF emitters. The SleepStyle device has
not been tested in such environments.
• Do not use accessories or power cables which
are not provided, or recommended, by Fisher &
Paykel Healthcare. This could result in increased
electromagnetic emissions or decreased electromagnetic
immunity.
• This device is not repairable and does not contain any
repairable parts. Please refer queries relating to the
device or accessories to your healthcare provider.
• Do not administer drugs or medications into the device
or breathing tube.
1.4 CAUTIONS
1.4.1 To prevent water damage to the
device:
• Do not use if the water chamber is damaged.
• Do not fill the chamber housing with water. Only place
water in the water chamber.
• Do not fill the water chamber above the maximum
water-level line.
• Replace water before each use.
• Do not use the device without the chamber seal fitted to
the water chamber.
• Do not fill the water chamber while it is in the device.
• Empty the water chamber before transporting or
packing the device.
• Do not use the device with an empty water chamber
unless the humidity level is set to 0.
• Do not add aromatic-based or scented oils to the water
chamber as these oils can cause damage to the device.
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A-5
1.4.2 General:
• Changes or modifications not expressly approved by
Fisher & Paykel Healthcare voids the user’s authority to
operate the device.
• Position the device so the power cord connection to
the power supply is easily accessible and able to be
disconnected.
• Do not use USB drives with the device which are
not provided by Fisher & Paykel Healthcare. Use of
USB drives other than the InfoUSB may cause data
corruption. Do not attempt to change the directories or
view the data without software distributed or designed
for use with the device.
• Replace the device and accessories if there are any signs
of cracking, deformation, discoloration or leaking. It is
recommended that you inspect the device, breathing
tube, water chamber, chamber seal, outlet seal, air filter
and elbow, on a regular basis after cleaning. See section
6.4 – Replacement Parts.
• Use distilled water to reduce residue build-up on the
chamber base. This will extend the life of your water
chamber.
• Do not use ozone to clean the device as it can degrade
the device and its accessories.
1.5 PRECAUTIONS
• The safety and eectiveness of the continuous positive
airway pressure (CPAP) device has not been established
in patients with respiratory failure or chronic obstructive
pulmonary disease (COPD).
• The safety and eectiveness of the auto-adjusting
positive airway pressure device has not been established
in patients with congestive heart failure, obesity
hypoventilation syndrome, or central sleep apnea.
1.6 ADVERSE EFFECTS
• Nosebleeds, perforated ear drum, dryness of the
nasopharynx, sinus infection, and middle ear infection
may occur from the use of positive airway pressure
therapy.
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A-6
2. GETTING STARTED
2.1 DEVICE AND ACCESSORIES
1 x Carry bag
1 x SleepStyle device
1 x Breathing tube
1 x Power cord
1 x F&P SleepStyle Use and Care Guide
1 x F&P SleepStyle Quick Reference Guide
1 x Water chamber
1 x Chamber seal
1 x Outlet seal
1 x F&P InfoUSB (already in InfoUSB port)
1 x Air filter (already in the device)
1 x Spare air filter
1 x Spare elbow (for use with a standard breathing tube)
Device lid
Lid latch
Display screen
Air filter
Power inlet
F&P InfoUSB
Water chamber
Chamber lid
Chamber seal
Outlet seal
Chamber housing
Handle
Chamber tab
Spare elbow
These are in a bag together
Spare air filter
InfoUSB port
Power cord
Air outlet
or
ThermoSmart breathing tube
or standard breathing tube
with elbow
ThermoSmart connection
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A-7
2.2 SETTING UP YOUR DEVICE
1. Place the device below head height on a stable
and level surface, like a bedside table.
Warnings
To avoid injury, choking, or inhalation of a foreign object:
Do not place the device above head height to prevent
water from entering the breathing tube.
2. Connect the power cord and the breathing
tube.
Connect the power cord into the power inlet of the device.
Connect the other end of the power cord into a power
outlet.
Warnings
To avoid electric shock:
Do not use if the device, power cord, or accessories are
damaged, deformed or cracked.
To avoid choking, or inhalation of a foreign object:
Ensure the breathing tube and power cord, including
any extension cords, are correctly positioned so they will
not become entangled with the body or furniture during
sleep.
Breathing tube
Connect your breathing tube into the air outlet.
ThermoSmart breathing
tube
Standard breathing tube
Note: Make sure the connectors on the ThermoSmart
breathing tube click into position with the ThermoSmart
connection.
If you have connected the ThermoSmart breathing tube
correctly, the ThermoSmart icon will appear on your
home screen.
Warnings
To avoid incorrect therapy:
Use the elbow when rotating the ThermoSmart breathing
tube. Incorrect handling may damage the tube.
3. Remove the water chamber from the device.
Press the lid latch and open the device lid. Take the water
chamber out of the device.
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A-8
4. Fill the water chamber with water.
Peel back the chamber seal on the left-hand side of the
water chamber. Fill the water chamber with water up to
the maximum water-level line, as indicated on the side and
inside of the water chamber.
Warnings
To avoid burns:
Do not fill the water chamber with hot water as this may
lead to airway burns.
Cautions
To prevent water damage to the device:
• Do not use if the water chamber is damaged.
• Do not fill the chamber housing with water. Only place
water in the water chamber.
• Do not fill the water chamber above the maximum
water-level line.
• Replace water before each use.
• Do not fill the water chamber while it is in the device.
• Do not use the device with an empty water chamber
unless the humidity level is set to 0.
• Do not add aromatic-based or scented oils to the
water chamber as these oils can cause damage to the
device.
General:
Use distilled water to reduce residue build-up on the
chamber base. This will extend the life of your water
chamber.
5. Secure the chamber seal.
Unfold the chamber seal back onto the water chamber.
Push down in the finger holds to secure it in place.
Cautions
To prevent water damage to the device:
Do not use the device without the chamber seal fitted to
the water chamber.
6. Put the water chamber back into the device.
Place the water chamber back into the device. Push the
device lid down until the lid latch clicks into position.
7. Connect the mask to the breathing tube.
Holding the mask and the other end of the breathing tube,
connect the mask swivel firmly into the breathing tube.
ENGLISH

A-9
3. USING YOUR DEVICE
3.1 SCREEN ICONS
When your device is plugged in and switched on, you will
see the home screen appear with up to four icons. These
icons indicate the status of a setting or accessory, as
follows:
ThermoSmart Icon*
Indicates that the ThermoSmart breathing tube is
connected and working correctly
Bluetooth® Icon
Indicates that Bluetooth technology is turned “ON”
on your device and is working correctly
InfoUSB Icon
Indicates that the F&P InfoUSB is connected and
working correctly
Modem Icon*
Indicates that modem is turned “ON” on your device
and is working correctly
Note: If there is a line through one of these icons, or if there is a gap where an icon usually appears, refer to section 9.1 – Device
troubleshooting for more information.
* Not available in all models.
3.2 DEVICE CONTROLS
Start/Stop
• Press to start and stop therapy.
• Press and hold for 3 seconds to start
Ramp.
Menu
• Press to enter the Menu at any time.
• Press to scroll between settings or data
screens.
Down and Up
• Press to decrease or increase a comfort setting.
• Press to move between options in a setting.
• Press to show the “Humidity” setting at any time.
OK
• Press to make a selection.
• Press to accept an instruction on the
display screen.
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A-10
3.3 STARTING THERAPY
1. Fit your mask.
Note: Refer to your mask’s user instructions for more
information on how to fit and remove your mask.
2. Press Start/Stop to begin therapy.
The screen below will appear:
3.4 STOPPING THERAPY
1. Press Start/Stop to stop therapy.
Note: To reduce condensation, please keep the device
plugged in and switched on at the power supply after
stopping therapy.
The screen below will appear:
Your device will then scroll through your therapy data
screens. See section 4.1.1 – Therapy Data for more
information on these screens.
2. Remove your mask.
3.5 STAND-BY MODE
The device will enter stand-by mode after 30 seconds if no
button has been pressed on the device.
The display screen light will dim but will still be visible to
show that your device is still powered on.
Press Down , Up , OK , or Menu to wake up
the device.
3.6 COMFORT SETTINGS
3.6.1 Ramp
Ramp works by gradually increasing to your prescribed
pressure over a 20-minute period.
To start Ramp:
Press and hold Start/Stop for 3 seconds until the Ramp
symbol appears on the display screen:
If you need to restart Ramp, press and hold Start/Stop
for 3 seconds.
3.6.2 Humidity
Humidification is the process by which moisture is added to
the air you breathe.
You can set the humidity level from 0 (all droplets are
transparent) to 7 (all droplets are shaded).
To use humidity, you will need to fill your water chamber
with water and ensure the humidity level is at least 1 (one
droplet shaded).
To adjust humidity at any time:
1. Press Down , Up or Menu .
2. Press Down or Up to change the level of
humidity.
The device will save your changes and time out after
a period of no interaction. Alternatively, you can exit
this setting by pressing Menu until you reach the
previous screen.
Note: The default humidity level is 5. If using without
a water chamber, or where low power consumption is
required, set the humidity level to 0.
3.6.3 Expiratory relief
Expiratory relief reduces the pressure when you breathe
out, and returns to your prescribed pressure when you
breathe in.
How to set the expiratory relief level:
1. Press Menu to scroll to the “Expiratory relief”’
setting.
2. Press Down or Up to change the level of
expiratory relief:
• O (no circles shaded)
• Low (1 circle shaded)
• Medium (2 circles shaded)
• High (3 circles shaded).
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A-11
Note: Expiratory relief may be restricted by your healthcare
provider.
3.6.4 SensAwake™
We all experience subconscious waking during the night.
When this happens, SensAwake will provide pressure relief
to help ease your return to sleep.
How to turn SensAwake on or off:
1. Press Menu to scroll to the “SensAwake” setting.
2. Press Down or Up to move between “ON” and
“OFF”.
Note: SensAwake may be restricted by your healthcare
provider.
4. VIEWING YOUR
THERAPY DATA
4.1 VIEW YOUR THERAPY DATA
ON YOUR DEVICE
Your device records your therapy data for the last night, last
7 days, and last 30 days, which you can view at any time.
How to view your therapy data on your device:
1. Press Menu to scroll to “My Data”.
2. Press Down or Up to move between the
following options:
• “D” – Day (last night’s therapy data)
• “W” – Week (average over the last 7 days of therapy
data)
• “M” – Month (average over the last 30 days of therapy
data).
3. Press OK to view the range of therapy data you
would like see.
The device will automatically scroll through the
following therapy data:
Note: If you would like to bypass this automated scrolling,
press Menu to scroll through the data screens manually.
4.1.1 Therapy Data:
THERAPY HOURS
Day View: Displays the number of hours that you used your
device last night.
Week View: Displays the average number of hours that you
used your device over the last 7 days.
Month View: Displays the average number of hours that
you used your device over the last 30 days.
MASK LEAK
Day View: Indicates whether the leak from your mask last
night was “NORMAL” or “HIGH”.
Week View: Indicates whether, on average, the leak from
your mask was “NORMAL” or “HIGH” over the last 7 days.
Month View: Indicates whether, on average, the leak from
your mask was “NORMAL” or “HIGH” over the last 30 days.
Apnea Hypopnea Index - (AHI)
Day View: Displays the average number of airway breathing
events you had per hour last night.
Week View: Displays the average number of airway
breathing events you had over the last 7 days.
Month View: Displays the average number of airway
breathing events you had over the last 30 days.
Note:
• The AHI screen may be restricted by your healthcare
provider.
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A-12
4.2 VIEW YOUR THERAPY DATA
ON THE SLEEPSTYLE APP OR
WEBSITE
Your SleepStyle device allows you to view your therapy
data on the SleepStyle App* or website*. The SleepStyle
App uses Bluetooth wireless technology to communicate
with your device.
The SleepStyle App is compatible with iPhone and Android.
You can download the SleepStyle App, available on the
Apple App Store or on Google Play™ for Android™.
*Not available in all countries
To pair your SleepStyle device to your mobile
device, follow these steps:
1. Turn on your SleepStyle device. The device will remain
discoverable for a period of 15 minutes. Make sure your
mobile device is within range.
Note: Changing the SleepStyle device’s Bluetooth setting
to “ON” will also make it discoverable for 15 minutes. See
below for instructions on how to change your Bluetooth
setting.
2. Open your mobile device’s Settings menu and turn on
the Bluetooth setting.
Note: You might need to refer to your mobile phone’s
user manual for specific instructions on how to turn on
the Bluetooth setting.
3. Open the SleepStyle App and follow the instructions on
how to register an account.
4. Follow the instructions in the app on how to pair your
mobile device with your SleepStyle device.
Your devices should now be paired. The SleepStyle App
will stay up to date with daily therapy data from your
SleepStyle device as long as the Bluetooth setting is turned
on for both devices.
You only need to do the pairing once. After you have paired
your SleepStyle device to your mobile device, it will stay
paired and will re-connect automatically until you choose to
unpair them.
Should you have any problems pairing your SleepStyle
device to your mobile device, try turning your Bluetooth
setting o and on again on your mobile device. If the
problem continues, try turning your Bluetooth setting o
and on again on your SleepStyle device (see below). For
more information, visit fpsleepstyle.com.
How to change your Bluetooth setting:
If the Bluetooth setting is “OFF” on your device, there will
be a line through the Bluetooth icon on your home
screen.
To change your Bluetooth setting, follow these steps:
1. From the home screen, hold Menu for 5 seconds.
2. Press Menu to scroll to the ‘Bluetooth’ setting.
3. Press Down or Up to change the setting. Your
selection will flash to confirm your selection.
5. UPLOADING YOUR
THERAPY DATA
5.1 MODEM
If your SleepStyle device has a cellular modem, therapy
data will automatically upload to your healthcare provider.
This will occur as long as your SleepStyle device is plugged
in and switched on at the wall. Only your healthcare
provider has access to this data.
Note: The modem is not available in all models. To identify
whether your SleepStyle device has a modem, look for the
modem icon on the front of your device. If your device
has a modem, and modem is turned on, ensure that the
device is placed at least 20 cm (8 in.) away from your body
while in use.
How to change the modem setting:
Your modem should remain “ON” so that your therapy data
will upload to your healthcare provider.
If you need to change your modem setting, follow these
steps:
1. From the home screen, hold Menu for 5 seconds.
2. Press Menu to scroll through the screens until you
reach the “Cellular Modem” setting.
3. Press Down or Up to change the setting. Your
selection will flash to confirm your selection.
If you have turned the modem “OFF”, it will turn back on
automatically after 3 days.
5.2 F&P INFOUSB™
The InfoUSB automatically stores your therapy data. To
ensure your therapy data is recorded to the InfoUSB, you
will need to make sure that the InfoUSB is in the InfoUSB
port.
If the InfoUSB is connected correctly, the InfoUSB icon
will appear on the device home screen.
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A-13
You can remove the InfoUSB from the InfoUSB port if
requested by your healthcare provider. You can then upload
your therapy data, or take your InfoUSB with you when you
visit them next, or post the InfoUSB to them.
If your healthcare provider updates your prescription
or device settings on the InfoUSB, these changes will
automatically transfer to your device when the InfoUSB is
next inserted into the InfoUSB port.
Note: The InfoUSB icon will not appear on the display
screen while it is in stand-by mode. To check that the
InfoUSB is connected correctly, press any button to wake up
the device. You should see the InfoUSB icon on screen.
Cautions
General:
Only use the 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 device.
5.2.1 SleepStyle website
You can easily upload your therapy data for viewing on the
SleepStyle website. This information will also be accessible
by your healthcare provider.
1. Visit fpsleepstyle.com
On the registration page, enter your name, email address
and date of birth, then click “Register”. You will be required
to validate your email address and create a password before
entering the website. If you have already registered in the
SleepStyle App on your mobile device, you can use your
email and password to log into the SleepStyle website.
Select the option to link your device. You may be asked to
download a plug-in. This allows the SleepStyle website to
upload data from your InfoUSB stick.
2. Insert the InfoUSB into a computer’s USB port
Remove the InfoUSB from your device and insert it into
the USB port of a computer. A small light illuminates when
connected to your computer. If the light does not illuminate,
please turn the InfoUSB around or make sure that it is
inserted fully into the USB port.
Note: To avoid getting computer viruses on the InfoUSB,
keep your computer’s anti-virus software up-to-date and
do not use the InfoUSB to transfer and store files from your
computer.
3. Follow the on-screen steps to complete linking
your device
Your therapy data on your InfoUSB will be uploaded to the
SleepStyle website and can be viewed in the “My Data”
page. Your healthcare provider will also be able to view this
data, if they require it.
5.2.2 InfoUSB application
The InfoUSB application allows you to upload your therapy
data to your healthcare provider in 5 easy steps.
1. Insert the InfoUSB into a computer’s USB port,
as above
2. Install InfoUSB application
From the Mac App Store
Launch the Mac App Store and search for the InfoUSB app.
Install this free application. Upon successful installation,
open Launchpad and then open the InfoUSB app.
Note: A Mac running OS X 10.8 or later with a USB port and
an internet connection are required.
From the Windows® Store
Launch the Windows Store and search for the InfoUSB app.
Install this free application. Upon successful installation,
open the app.
Note: A PC or tablet running on Windows 8 or later with a
USB port and an Internet connection are required.
From the InfoUSB
If you cannot access the Windows Store, click on the Start
button and open “My Computer”. Navigate to the drive
called “FPHCARE”. Open this folder and double-click on the
Setup.exe file. Follow the on-screen instructions.
Note: A PC running a Windows operating system with a
USB port and an internet connection are required.
3. Data transfer
Upon detection of an InfoUSB in your computer, you will be
asked to enter your Date of Birth. Enter your Date of Birth
and select the Upload button. Ensure that your computer
is connected to the internet for successful data transfer to
your healthcare provider.
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4. Confirmation
After the data has been sent successfully, a confirmation
message will appear. If your prescription is updated, you
will also see the message “Your healthcare provider has
updated your prescription.”
5. Future data transfer
Remove the InfoUSB from your computer and place it back
into the InfoUSB port of your device. You can now use your
device.
The next time you need to upload your therapy data to your
healthcare provider, simply insert the InfoUSB into your
computer. The message in Step 3 above will automatically
appear.
6. CARING FOR YOUR
DEVICE
6.1 DISASSEMBLY FOR CLEANING
BREATHING TUBE
1. Hold the elbow of your breathing tube and gently pull it
away from the device.
ThermoSmart breathing
tube
Standard breathing tube
2. Hold both the mask end of the tube and the mask swivel
and gently pull them apart.
WATER CHAMBER AND CHAMBER SEAL
1. Press the lid latch and open the device lid.
2. Take the water chamber out of the device.
3. Remove the chamber seal from the top of the water
chamber and put aside.
4. Lift the tab on the side of the water chamber and lift the
chamber lid to open.
OUTLET SEAL
1. Grip the outlet seal tab.
2. Gently pull the outlet seal out of the device.
6.2 CLEANING YOUR DEVICE AND
ACCESSORIES AT HOME
Cleaning your device and accessories can help extend
their life and ensure that you continue to receive eective
therapy. Below is information on when and how to clean
the device and accessories. Refer to your mask’s user
instructions on how to clean your mask.
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A-15
Warnings
To avoid electric shock:
Do not use bleach, alcohol, or cleaners with citrus or
other natural oils. These substances may degrade the
device and accessories.
To avoid incorrect therapy:
Only clean the device and accessories according to the
cleaning instructions below.
To avoid adverse eects:
Do not use ozone to clean this device. Residual ozone
may result in adverse respiratory eects such as irritation
of the nose, throat and lungs.
Cautions
General:
Replace the device and accessories if there is any sign
of cracking, deformation, discoloration or leaking. It is
recommended that you inspect the device, breathing
tube, water chamber, chamber seal, outlet seal, air filter
and elbow, on a regular basis after cleaning. See section
6.4 – Replacement Parts.
Do not use ozone as it can degrade the device and
accessories.
6.2.1 Wash after each use
The following accessories should be cleaned after each use:
• Breathing tube
• Water chamber
• Chamber seal.
Warnings
To avoid incorrect therapy:
Do not clean or disinfect the ThermoSmart breathing
tube with hot water. This may cause deformation of the
tube and reduce therapeutic pressure.
1. Hand-wash the elbow, water chamber, chamber seal
and breathing tube in a tub of warm, soapy water with a
mild dishwashing detergent. Ensure that all visible soil is
removed.
2. Rinse the elbow, water chamber, chamber seal and
breathing tube thoroughly in a tub of clean water for
30seconds. Ensure that all soap residue has been
removed.
3. Repeat the rinsing process again, using clean water.
4. Hang the breathing tube, with both ends pointing to the
floor, to dry away from direct sunlight or heat e.g. heated
towel rails.
5. Leave the water chamber and chamber seal to dry out of
direct sunlight or heat.
Note: The elbow and the standard breathing tube need to
be separated when washing after each use. If dirt remains
inside the breathing tube after rinsing, use a soft, non-
metallic brush to remove it. Rinse the tube again. If the dirt
cannot be removed, the breathing tube should be replaced.
The use of distilled water is recommended during therapy to
reduce mineral deposits and stains. Should mineral deposits
occur, you can reduce these by soaking the water chamber
for 10 minutes in a solution of 1 part white vinegar to 2
parts water. Empty the solution and rinse thoroughly with
clean water. Repeat the rinsing process again, using clean
water. Leave to dry out of direct sunlight or heat before
reassembling.
6.2.2 After 7 days’ use
The device and accessories below should be washed after
7 days’ use:
• Outlet seal
• Elbow
• Device.
Outlet seal and elbow
1. Disconnect the elbow from the standard breathing tube.
2. Hand-wash the outlet seal and elbow in a tub of warm,
soapy water with a mild dishwashing detergent. Ensure
that all visible soil is removed.
3. Rinse the outlet seal and elbow thoroughly in a tub of
clean water for 30 seconds. Ensure that all soap residue
has been removed.
4. Repeat the rinsing process again, using clean water.
5. Leave to dry out of direct sunlight or heat.
6. Reconnect the elbow to the standard breathing tube.
Device
1. Turn the device o at the power supply, then remove the
power cord from the rear of the device.
2. Wipe the exterior and chamber housing of the device
with a clean, damp (not dripping wet) cloth and warm,
soapy water using a mild dishwashing detergent.
3. Leave to dry out of direct sunlight or heat.
Warnings
To avoid electric shock:
• Do not pull on the power cord as it may become
damaged.
• Do not immerse the device in water or any other
liquid.
Dishwashing
Once every 7 days, you can clean the water chamber,
chamber seal, and outlet seal in a domestic dishwasher.
Place the water chamber on the top shelf of the dishwasher
and ensure the chamber seal and outlet seal are placed in a
secure location.
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A-16
6.3 REASSEMBLY OF THE DEVICE
Once the parts you have cleaned are dry, you can
reassemble the parts.
BREATHING TUBE
1. Hold the elbow end of the breathing tube and push it
into the air outlet of the device.
Note: If you have a ThermoSmart breathing tube, make
sure the electrical connectors on the elbow click into
position with the ThermoSmart connection.
2. Holding the mask and the other end of the breathing
tube, push the mask swivel firmly into the breathing
tube.
OUTLET SEAL
Hold the tab on the outlet seal and push it into the chamber
housing inlet. Ensure the tab is sitting flat against the wall
of the chamber.
WATER CHAMBER AND CHAMBER SEAL
1. Close the chamber lid. Press the water chamber tab
down until it clicks into place.
2. Fill the water chamber with water through either of the
filling holes in the top.
3. Secure the chamber seal back onto the water chamber.
Ensure it is sitting flat and seals the holes on the
chamber lid.
4. Place the water chamber back into the device.
6.4 REPLACEMENT PARTS
Below is a list of replacement parts that are available.
Contact your healthcare provider to order these.
900SPS100 Water chamber
900SPS101 Chamber seal
900SPS111 Air filter (single)
900SPS110 Air filters (2-pack)
900SPS120 ThermoSmart breathing tube*
900SPS121 Standard breathing tube with elbow*
900SPS122 Elbow (for use with a standard
breathing tube)
900SPS140 Device lid
900SPS141 Outlet seal
900SPS142 Carry bag
900SW101 F&P InfoUSB
900SPS160 North American power cord
900SPS161 Australasian power cord
* Applied Parts – to fit 22 mm (0.86 in.) Conical Connector.
Warnings
To avoid injury:
Do not use breathing tubes, parts, and accessories
that are not distributed for use with this device or
recommended by Fisher & Paykel Healthcare.
General:
Do not use accessories or power cables which are
not provided, or recommended, by Fisher & Paykel
Healthcare. This could result in increased electromagnetic
emissions or decreased electromagnetic immunity.
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A-17
6.4.1 Air filter
The air filter is located at the rear of the device. Replace the
air filter at least once every 3 months, or more frequently if
it becomes blocked with dirt or dust. To replace the air filter,
please follow the instructions below.
Warnings
To avoid choking, or inhalation of a foreign object:
Do not use the device without the recommended air
filter fitted. This will reduce dust or particles entering the
device and breathing tube.
1. To remove, pinch the air filter with your fingers and pull it
out of the device.
2. Hold onto the short side of the new air filter. Push into
the device so there are no gaps.
7. TRAVELING WITH YOUR
DEVICE
The device has a universal voltage feature that allows it to
operate on any domestic AC mains voltage. With the use of
the appropriate pin/plug adapter the device can operate in
most countries.
Below is a checklist of what to take with you
when you travel:
• Carry bag
• SleepStyle device
• Water chamber (empty)
• Chamber seal
• ThermoSmart breathing tube or standard breathing tube
with elbow
• F&P InfoUSB
• Power cord
• Air filter
• Outlet seal
• F&P SleepStyle Use and Care Guide
• Mask
You may also need:
• Extension cord
• Plug adapter
Cautions
To prevent water damage to the device:
Empty the water chamber before transporting or
packing.
Note: The device is not certified for use on an aircraft.
Confirm with your airline whether you can take the device
with you as carry-on luggage.
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8. SPECIFICATIONS
8.1 SLEEPSTYLE DEVICE MODELS AND FEATURES
Device model SleepStyle Auto SleepStyle CPAP
Australasia SPSAAA/SPSABA SPSCAA/SPSCBA
North America SPSAAN/SPSABN SPSCAN
Latin America SPSAAN/SPSABN SPSCAN/SPSCBN
Performance features
Fully integrated humidifier* Leak compensation
ThermoSmart technology** Ecacy reporting
Auto-adjusting pressure†Compliance reporting
SensAwake F&P InfoUSB
Expiratory relief Bluetooth wireless technology
Ramp Cellular modem*
Auto-altitude adjustment
Compatible with
F&P SleepStyle App and Web‡
* Not available in all models.
** The ThermoSmart Breathing Tube is required to activate ThermoSmart.
† SleepStyle Auto only.
‡Not available in all countries.
8.2 SYMBOL DEFINITIONS
For safety reasons, refer to the instructions for
use
Catalogue number
Caution Serial number
Consult instructions for use Batch code
Do not use this device with patients requiring
supplemental oxygen
Humidity range
Fill with water here Temperature range
Maximum water level (do not fill above the
water line)
Protected against ingress of small objects and
water drops
Manufacturer Do not use if package is damaged
Date of manufacture Regulatory Compliance Mark
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