Overview; Intended Use / Indications For Use; Contraindications; Warnings - F&P SleepStyle Auto Technical Manual

Use and Care Guide – Page 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 effects.
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
off (including in the event of a power failure or device
malfunction). The flow through the mask may be
insufficient to clear all exhaled gas.
ENGLISH A-3
F&P SleepStyle Product Technical Guide | 18