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

XT Fit /English
Below description is for Canada only
Le produit à été testé avec des équipements médicaux et respecte les normes ES60601-1:2005/(R)2012 and
CSA CAN/CSA-C22.2 NO. 60601-1:14. prévenant les choc électrique, le feu et les risques de blessures
physiques.
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices for IEC/EN 60601-1-2.
These limits are designed to provide reasonable protection against harmful interference in a typical medical
installation. This unit 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 unit.
 Increase the distance between the conflicting equipment.
 Connect the unit into an outlet that is on a different circuit than the other device(s).
 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: Some patients might have pre-existing contraindications for CPAP therapy, or

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
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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