F&P SleepStyle Auto, SleepStyle CPAP Use And Care Manual
Use and Care Guide
F&P SleepStyle Auto
F&P SleepStyle CPAP
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BEFORE YOU START
Caution: USA Federal Law restricts this device to sale by or on the order of a physician.
Before the device is used for the first time, it must be set up by a healthcare professional.
If your device or any accessories are not operating correctly, please contact your healthcare provider.
Clinicians: please contact your Fisher & Paykel Healthcare representative for a copy of the F&P SleepStyle
Clinician Guide.
TABLE OF CONTENTS
1. Overview ..................................................................................................................................................3
1.1 Intended use ........................................................................................................................................................................... 3
1.2 Contraindications .................................................................................................................................................................3
1.3 Warnings ..................................................................................................................................................................................3
1.3.1 To avoid death or serious injury ........................................................................................................................ 3
1.3.2 To avoid electric shock .......................................................................................................................................... 3
1.3.3 To avoid burns ..........................................................................................................................................................3
1.3.4 To avoid the risk of fire .......................................................................................................................................... 3
1.3.5 To avoid carbon dioxide re-breathing or asphyxiation ............................................................................4
1.3.6 To avoid choking, or inhalation of a foreign object ...................................................................................4
1.3.7 To avoid injury...........................................................................................................................................................4
1.3.8 To avoid incorrect therapy ................................................................................................................................... 4
1.3.9 General ........................................................................................................................................................................4
1.4 Cautions .................................................................................................................................................................................... 5
1.4.1 To prevent water damage to the device ........................................................................................................ 5
1.4.2 General ........................................................................................................................................................................5
1.5 Precautions .............................................................................................................................................................................. 5
1.6 Adverse eects ...................................................................................................................................................................... 5
2. Getting started ....................................................................................................................................... 6
2.1 Device and accessories .......................................................................................................................................................6
2.2 Setting up your device ....................................................................................................................................................... 7
3. Using your device ..................................................................................................................................10
3.1 Screen icons .......................................................................................................................................................................... 10
3.2 Device controls..................................................................................................................................................................... 10
3.3 Starting therapy.....................................................................................................................................................................11
3.4 Stopping therapy ..................................................................................................................................................................11
3.5 Stand-by mode ......................................................................................................................................................................11
3.6 Comfort settings ...................................................................................................................................................................11
3.6.1 Ramp ............................................................................................................................................................................11
3.6.2 Humidity ....................................................................................................................................................................12
3.6.3 Expiratory relief .......................................................................................................................................................12
3.6.4 SensAwake™ .............................................................................................................................................................12
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4. Viewing your therapy data .................................................................................................................... 13
4.1 View your therapy data on your device ......................................................................................................................13
4.1.1 Therapy data ............................................................................................................................................................13
4.2 View your therapy data on the SleepStyle App or website ............................................................................... 14
5. Uploading your therapy data ................................................................................................................ 15
5.1 Modem .....................................................................................................................................................................................15
5.2 F&P InfoUSB™ ........................................................................................................................................................................15
6. Caring for your device .......................................................................................................................... 17
6.1 Disassembly for cleaning ..................................................................................................................................................17
6.2 Cleaning your device and accessories at home .......................................................................................................18
6.2.1 Wash after each use ..............................................................................................................................................18
6.2.2 After 7 days’ use .....................................................................................................................................................19
6.3 Reassembly of the device .................................................................................................................................................19
6.4 Replacement parts ............................................................................................................................................................ 20
6.4.1 Air filter .......................................................................................................................................................................21
7. Traveling with your device ................................................................................................................... 22
7.1 Things to remember before you travel .......................................................................................................................22
8. Specifications ....................................................................................................................................... 23
8.1 SleepStyle device models and features matrix .......................................................................................................23
8.2 Symbol definitions ..............................................................................................................................................................24
8.3 Product specifications.......................................................................................................................................................24
8.4 Classifications ...................................................................................................................................................................... 26
8.5 Operating conditions ......................................................................................................................................................... 27
8.6 Storage and transport conditions ................................................................................................................................27
8.7 Disposal instructions ..........................................................................................................................................................27
8.8 Servicing .................................................................................................................................................................................27
8.9 Warranty statement ........................................................................................................................................................... 27
9. Troubleshooting ................................................................................................................................... 28
9.1 Device troubleshooting ....................................................................................................................................................28
9.2 Screen icons troubleshooting ....................................................................................................................................... 30
9.3 Error messages on SleepStyle screen ........................................................................................................................32
9.4 SleepStyle App troubleshooting...................................................................................................................................32
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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 treats 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
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
To avoid the risk of fire:
Do not use this device with
supplemental oxygen.
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
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.
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 supplemental
oxygen.
• Sources of oxygen must be located more than 1
m (40 in.) from the device.
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1.3.5 To avoid carbon dioxide rebreathing 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.
• 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 insucient to clear all exhaled
gas.
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. This 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.
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 aect 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
conditions specified, otherwise the performance
of the device could be compromised. See section
8.5 – Operating Conditions.
• 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 and the device may aect or be
aected due to the eects of electromagnetic
interference, in certain circumstances. If
interference should occur, try moving your
device or the equipment causing interference.
Alternatively, consult your healthcare provider.
• 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.
• California residents please be advised of the
following, pursuant to Proposition 65: This
product contains chemicals known to the State
of California to cause cancer, birth defects and
other reproductive harm. For more information,
please visit: www.fphcare.com/prop65.
• 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.
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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.
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 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.
• Use distilled water to reduce residue build-up
on the chamber base. This will extend the life of
your water chamber.
1.5 PRECAUTIONS
• The safety and eectiveness of the CPAP
device has not been established in patients
with respiratory failure or chronic obstructive
pulmonary disease (COPD).
• The safety and eectiveness of the autoadjusting 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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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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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 the power supply.
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.
ThermoSmart breathing tube
Connect the ThermoSmart breathing tube into the
air outlet.
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:
Note: Screen may dier, depending on the model
of the device.
Warnings
To avoid incorrect therapy:
Use the elbow when rotating the ThermoSmart
breathing tube. Incorrect handling may damage
the tube.
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Standard breathing tube
Connect the standard breathing tube with the
elbow into the air outlet.
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.
4. Fill the water chamber with water
(i) Peel back the chamber seal on the left-hand
side of the water chamber.
(ii) 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.
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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.
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