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The NOMAD Pro 3 Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.

NOMAD Pro 3 Handheld X-ray System is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The NOMAD Pro 3 Handheld X-ray System is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow for the use of the NOMAD Pro 3 Handheld X-ray System where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility.

System Description and Overview: The NOMAD Pro 3 Handheld X-ray System is an X-ray device with a DC generator. The handheld device features a main unit (tube head), rechargeable battery (handset), charger, and charger AC/DC power supply. The power is supplied by a rechargeable Lithium-ion battery core pack built into a handset. This facilitates portability of the device. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient.

To make the system as simple as possible for the operator, NOMAD Pro 3 Handheld X-ray System uses a fixed tube voltage of 65kV and a fixed tube current of 2.5mA. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel.

The battery core pack consists of standard production, high discharge, cylindrical, Lithium-ion cells. The vendor builds the cells into custom, potted enclosure which also contains control and safety circuitry in the form of a semi-custom Battery Management Unit (BMU). The internal potting provides protection against liquid ingress and further inhibits flame propagation in the event of a single cell failure. The BMU provides charge control, discharge control, battery capacity management, safety control and communication. The electrical interface includes a two-wire serial interface which may be used to obtain status of the battery core pack.

Control buttons, display, and a trigger provide the primary operator interface. Exposure settings can be selected and displayed. Voltage (65 kV) and current (2.5 mA) are fixed with the exposure time varying based on patient type, detector type, and anatomical feature. Exposures can be completed using the trigger. The device can be used with three detector types: film, digital imaging intraoral sensors, and phosphor plates.

User warnings and markings will be on the upper portion of the device near the user interface. Technical and regulatory markings will be on the underside of the device, top of the handset (not visible when attached to device), and bottom of charging cradle.

Principles of Operation: The NOMAD Pro 3 Handheld X-ray System is used like any other extraoral dental X-ray source for intraoral application. An image receptor, such as film, is placed in the patient's oral cavity behind the teeth. The device is powered on, and the appropriate exposure time is set by the operator. The operator should follow appropriate instructions to ensure proper alignment of the X-ray beam to the receptor, and proper positioning of the receptor in the patient's mouth. To prevent inadvertent exposure to X-rays, the operator must first press and release the trigger to enable and then ready the device. A flashing green ENABLED indicator light and an audible signal confirm that the NOMAD Pro 3 Handheld X-ray System is enabled. X-rays are initiated by pulling and holding the trigger on the handle for the duration of the exposure. The system has numerous alarms and alerts to communicate with the operator.

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