Intended Use - Apex Medical iCH Prime Instruction Manual

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EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices to the
EN 60601-1-2:2007. 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.
This system has been tested for compliance to the following volunteer standards:
FDA

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: Some patients might have pre-existing contraindications for CPAP therapy,
NOTE: Equipment not suitable for use in the presence of a flammable anaesthetic
or might experience some potential side effects of using a CPAP device.
Please consult your doctor if you have any questions concerning your
therapy.
mixture with air or with oxygen or nitrous oxide.
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