Intended Use; Contraindications - Apex XT Prime Instructions D'utilisation

XT Prime /English
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices to the
IEC/EN 60601-1-2. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to other devices, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following measures:
 Reorient or relocate the receiving device.
 Increase the separation between the equipment.
 Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
 Consult the manufacturer or field service technician for help.

1.2 Intended Use

This device is intended to provide continuous positive airway pressure (CPAP) for the treatment
of adult Obstructive Sleep Apnea (OSA).
Cautions:

1.3 Contraindications

Studies have shown that the following pre-existing conditions may contraindicate the use of
CPAP therapy for some patients. Should you have any of these conditions, your physician will
determine if CPAP therapy is appropriate for you.
 Bullous lung disease
 Pneumothorax
 Pathologically low blood pressure due to or associated with intravascular volume depletion
 Severe cardiac arrhythmias or coronary artery disease
 Stroke
 Seizures
 Pneumocephalus has been reported in a patient using nasal Continuous Airway pressure
Some patients might have pre-existing contraindications for CPAP therapy, or might
experience some potential side effects of using CPAP device, please
consult your physician if you have any questions concerning your therapy.
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