Introduction - Apex Medical iCH Prime Instruction Manual

English
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 nasal mask. This
constant air pressure can keep your airway open during sleep, 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:
E348970
53DG
Le produit à été testé avec des équipements médicaux et respecte les normes UL 60601-1 & CAN/CSA C22.2
No.601.1. prévenant les choc électrique, le feu et les risques de blessures physiques.
EN 60601-1
EN 60601-1-2
EN 61000-3-2 Class A
EN 61000-3-3
For US and CANADA only
Medical Equipment- CPAP with integrated heated humidifier
WITH RESPECT TO ELECTRICAL SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI
ES60601-1 (2005,3rd ed.) and CAN / CSA C22.2 No.
rd
60601-1 (2008, 3 ed.) and IEC 60601-1-11
3