Contra-indications
• Electrode placement over malignant tumors
• Transcerebral and/or carotid sinus electrode placement
• Use over mucous membranes
• Undiagnosed pain (until etiology is established)
• Patients who are prone to seizures (e.g. patients with epilepsy)
• Use over pharyngeal or laryngeal muscles. The electrical impulses
generated may cause muscle spasm resulting in difficulty in breathing
• Patients that have a demand-type cardiac pacemaker
Warnings
Federal (U.S.A.) law restricts this device to sale by, or on the order of a
practitioner licensed by the law of the State in which he/she practices to use,
or order the use of the device.
Federal (U.S.A.) law requires the InterX 5002 be used only by a trained
healthcare practitioner or under the continued supervision of a licensed
healthcare practitioner. The InterX 5002 must be used only by the person for
whom it is prescribed. Electrode placement and stimulation settings should
be based on the guidance of the prescribing practitioner.
Safe use of the InterX 5002 is the primary responsibility of the user. The user
is responsible for the monitoring of the product. Contact clinical/technical
support if the InterX 5002 appears to be operating incorrectly.
The user must keep this device out of reach of children.
The InterX 5002 is not effective for pain of central origin including
headaches.
The InterX 5002 is a symptomatic treatment and as such could suppress the
sensation of pain which would otherwise serve as a protective mechanism.
The safety of the use of the InterX 5002 has not been established during
pregnancy or childbirth.
Do not operate the InterX 5002 before verifying that other medical devices
will not be adversely affected by the electrical impulses generated. (eg.
electrical implants)
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