General Information - Apex iX Sense CPAP System Manual De Instrucciones

iX Sense / 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 complies with 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
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