Apex Digital iX Fit Instruction Manual page 8

iX Fit / 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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