User Manual
MK/YF38-07 – V2.01CS
© 2019 All Rights Reserved
Page 7 of 60
Chapter 1 Product overview
1.1 Intended purpose, product usage and application
This Class IIa Medical Device has been registered and approved by the Australian Therapeutic
Goods Administration (TGA) for supply by CPAP Sales Pty Ltd.
It is a portable, mains electricity (AC-powered) device, which may include rechargeable
batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway)
using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to
treat adult patients affected by obstructive sleep apnea (OSA); it may also be intended to treat
snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway
pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor
(auto CPAP). The device is intended for use in the home but may also be used in healthcare
facilities.
Models C2 (CPAP) and C5 (AUTO) are Obstructive Sleep Apnea Therapy Devices (hereinafter
referred to as a “CPAP Machine”) providing non-invasive ventilation treatment for patients with
obstructive sleep apnea syndrome (OSAS). These CPAP Machines are for use by pediatric
patients aged over 7 (with a weight being over 18.1kg or 40lbs) and adult patients (with a
weight being over 30kg and 66lbs) only.
This CPAP Machine should be used by patients under the guidance of professionally trained
medical staff, with patient as the intended end user/operator. Patients with severe respiratory
failure but spontaneous breath should not use a CPAP Machine unless instructed to do so by a
medically trained professional.
CPAP Machines need to be used together with a breathing hose and a nasal/face mask
suitable to the patient.
To download this User Manual, please visit: cpapsales.com.au/manuals
