Emc Warning Statement; Intended Use - Apex Digital iCH Auto Instruction Manual

iCH Auto/ 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 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.

1.2 Intended Use

This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of
adult Obstructive Sleep Apnea (OSA). The integrated heated humidifier is designed to increase the
humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat that some
people may experience.
Cautions:
NOTE: Equipment not suitable for use in the presence of a flammable anaesthetic mixture with
air or with oxygen or nitrous oxide.
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 a CPAP device. Please consult your
doctor if you have any questions concerning your therapy.
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