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CardeaScreen records and measures a resting ECG from the adult and pediatric (age ≥ 14) body surface. It provides automatic ECG interpretations which are identified as "Unconfirmed" by the product until they have been overread and confirmed by a clinician. CardeaScreen is intended for use on apparently healthy individuals and on symptomatically stable patients with known or potential cardiac conditions. This device is intended for use under the direct supervision of a licensed health care clinician.

The CardeaScreen™, developed by Cardea Associates, Inc. (Cardea), is small, lightweight, portable electrocardiograph, designed for collection of resting (nonambulatory) electrocardiographic (ECG) data. The CardeaScreen device system is composed of 2 main components: - . ECG Transmitter - this type of device is also referred to in the medical community as a "ECG recorder", or "ECG data acquisition unit". The CardeaScreen ECG transmitter is about the size of a small paperback book (~6" x 4" x 1.5") and ~11 ounces. The transmitter is battery powered or it can also be powered via AC mains power by using the medical grade power supply supplied as part of the CardeaScreen system. A patient cable with 10 lead wires is attached to the transmitter. The lead wires terminate in connectors that are attached to commercially available ECG electrodes selected by the clinician for use. The electrodes (not part of the CardeaScreen system) adhere to the patient's skin in the chest region and are used for detecting a patient's ECG. - . CardeaScreen Software - the software is installed by the clinician on the clinician's personal computer (PC). The software controls the ECG transmitter's use. The transmitter cannot function in any manner to collect ECG, without the software. Collected ECG data is transferred from the ECG transmitter to the PC using wireless (Bluetooth) transmission. The software can be used for subsequent analysis of the patient's ECG data.