Intended Use; Contraindications - Apex iX Sense CPAP System Manuel D'instructions

iX Sense / English
1.2 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 to 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.

1.3 Intended Use

This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult
Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighing over 30 kg (66 lbs). It is for
single patient reuse in the home environment.
Caution : Some patients might have pre-existing contraindications for CPAP therapy, or might
experience some potential side effects of using a CPAP device. Please consult your doctor if you
have any questions concerning your therapy.
Warning : Equipment is not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.

1.4 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.
1. Uncooperative or extremely anxious patient
2. Reduced consciousness and inability to protect their airway
3. Unstable cardiorespiratory status or respiratory arrest
4. Trauma or burns involving the face
5. Facial, esophageal, or gastric surgery
6. Air leak syndrome (pneumothorax or bronchopleural fistula)
7. Copious respiratory secretions
8. Severe nausea with vomiting
9. Severe air trapping diseases with hypercarbia asthma or chronic obstructive pulmonary disease
(COPD)
10. Pathologically Low Blood Pressure
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