General Information - Apex iX Fit Manual De Instrucciones

iX Fit / English
1. Introduction
This manual should be used for initial set up of the system and saved for reference purpose.

1.1 General Information

Obstructive Sleep Apnea (OSA) is a condition that an intermitted and repetitive obstruction of the
upper respiratory tract causes a complete (apnea) or partial (hypopnea) block of breathing airflow
during sleep. The syndrome varies depending on the degree of relaxation of the tongue and soft
palate muscle.
The most common treatment for OSA is Continuous Positive Airway Pressure (CPAP). CPAP
devices can deliver a constant air pressure into your upper airway via a mask. This constant air
pressure can keep your airway open during sleep, and therefore prevents the OSA.
This device is a micro-processor controlled continuous positive airway pressure device. It features
the illuminated, menu-driven LCD display, universal power supply and ramp time adjustment. The
ramp time adjustment and ultra-quiet operation ensure you to fall asleep comfortably while air
pressure slowly builds up to treatment level. The user compliance meter records the total system's
operating time for physician's reference.
The system has been tested and successfully approved to the following standards:
IEC/EN 60601-1
IEC/EN 60601-1-2
IEC/EN 61000-3-2 Class A
IEC/EN 61000-3-3
CISPR 11 Group 1, Class B
For US and CANADA only
E348970
53DG
The below description for is for Canada only
The product has been tested with medical equipment and meets ANSI / AAMI ES60601-1 (2005) +
AMD 1 (2012) standards; CAN / CSA-C22.2 No. 60601-1: 14. Preventing electric shock, fire and the
risk of physical injury.
Medical Equipment- CPAP
WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS
ONLY IN ACCORDANCE WITH
ANSI / AAMI ES60601-1 (2005) + AMD 1 (2012)
CAN / CSA-C22.2 No. 60601-1:14
4