Indications For Use - Konica Minolta AeroDR System Operation Manual

Indications for Use

The AeroDR SYSTEM is indicated for use in generating radiographic images of human anatomy. It is intended to re-
place radiographic film/screen systems in general-purpose diagnostic procedures.
<Only for USA>
The AeroDR SYSTEM with P31 is not indicated for use in mammography, fluoroscopy, tomography and angiography
applications.
Federal law restricts this device to sale by or on the order of a physician .
Summary of usability specifications (for IEC/EN 60601-1-6, IEC/EN 62366)
1) Medical purposes
• Provision and reading of disease and injury diagnostic images.
2) Patient groups
• No patient population exists who uses the device.
• Patient population for the X-ray images read is not specified.
3) Parts of body or organizations to which the device is mounted or that interact with the device.
• AeroDR Detector contacts the body surface of a patient.
• AeroDR Interface Unit, AeroDR Interface Unit2, AeroDR Battery Charger and AeroDR Battery Charger2 contact
the body surface of an operator.
4) Operating principle
• AeroDR Detector forms the still images according to the X-ray energy passing through the human and animal
body; after digitizing the exposed image, it is transmitted to the console (the image processing controller) with
wired communication or wireless communication.
• AeroDR Interface Unit and AeroDR Interface Unit2 supply the power to AeroDR Detector, AeroDR Generator
Interface Unit, AeroDR Generator Interface Unit2, and access point (radio communication device). It also relays
wired communication.
• AeroDR Interface Unit2, AeroDR Generator Interface Unit or AeroDR Generator Interface Unit2 interfaces with
an X-ray device.
• Access point (radio communication device) performs a wireless communication with AeroDR Detector.
• The console (the image processing controller) processes the image data into the diagnostic image, and then
stores and outputs the images added with the patient information.
• The AeroDR Battery Charger and AeroDR Battery Charger2 charge the AeroDR Detector. It registers the using
AeroDR Detector with the exposure room.
5) Significant physical characteristics
• Refer to "7.1 Specifications".
6) Significant performance characteristics
• Refer to "2.1 Overview of this device".
7) User of this device
• No special training is required to use this device. The intended users of this device are as follows.
A professional in good health with specialist knowledge/qualifications who has fully understood the content of
this document. (Such as a doctor or radiological technologist)
CAUTION
7
Introduction