User Manual: UM19893-EN
Harmony3 series
Revision: 5.0
Date of release: 2019-01-29
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www.vareximaging.com
2.
Product description
2.1.
INTENDED USE
The device is intended to be used in medical diagnostic applications with restrictions to human
diagnostics. The device is intended to be used as accessory of an X-ray system in a professional
healthcare facility environment. The device is intended to be holding a portable image receptor.
The device is not intended to be used near active HF Surgical Equipment or in the RF shielded room
of a system for magnetic resonance imaging, where the intensity of Electromagnetic Disturbances is
high.
Use, other than above, is identified as abnormal use.
The intended user of the device is defined as the operator of an X-ray system. The operator shall be
qualified and/or trained to operate the X-ray system.
2.2.
Description of the device
The Varex Imaging Nederland B.V. Harmony3 series (also known as a Harmony3 series) is a device
which holds an imaging device, such as a digital X-ray detector or film-based X-ray cassette.
The NR version differs from the base model in the following way: the detector can only be placed in a
fixed orientation on the drawer. It is not possible to change the orientation of the detector by rotating.
The ST version differs from the base model in the following way: the detector is mounted inside the
enclosure and cannot be removed by the operator.
The device also provides a slot for mounting a grid and an AEC measuring chamber.
2.3.
Principle of operation
The Harmony3 series is a component which is integrated in a regular X-ray system, used for RAD
diagnostic purposes and can be found at the following locations (depending on the version):
•
Underneath the X-ray table top, in horizontal position. The device is intended to be integrated
in the table construction.
•
Onto a wall stand, in vertical position. The Harmony3 series can also be equipped with a cover
to position a patient against.
The main functionality of the Harmony3 series is to hold several components in order to make an X-
ray image. It contains a facility to mount/fix an AEC-chamber and a facility to place a grid (used for
reducing X-ray scattering) at the correct position. Also, the Harmony3 series NR version hold and
position a portable image receptor. This receptor is placed in a drawer-like construction which can be
pulled out and pushed in the enclosure. The Harmony3 series does not include any of these parts but
only operates as a holder for these components.
