Usa Only; Summary Of Usability Specifications; 60601-1-6, Iec/En 62366) - Konica Minolta AeroDR SYSTEM Operation Manual

USA only

Indications for Use
This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace
radiographic film/screen system in general-purpose diagnostic procedures.
This device 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.
• DR Detector contacts the body surfaces of a patient and an operator.
• Devices other than DR Detector contact the body surface of an operator.
(4) Operating principle
• DR 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.
• In the serial radiography mode, it allows to capture multiple frames of radiography image serially taken by the
pulse irradiation from an X-ray generator device during one time. This device continues not to be intended to
connect with the x-ray device for mammography, fluoroscopy, angiography and cone-beam CT, and not to be
used for such procedures.
• AeroDR Interface Unit and AeroDR Interface Unit2 supply the power to DR Detector, AeroDR Generator In-
terface Unit, AeroDR Generator Interface Unit2, and access point (radio communication device). It also relays
wired communication.
• Detector Interface Unit and Detector Interface Unit 2 supply the power to DR Detector. It also relays wired
communication
• Power Supply Unit supply the power to Detector Interface Unit, Detector Interface Unit 2, AeroDR Generator
Interface Unit, AeroDR Generator Interface Unit2 and Generator Interface Unit 3. It also relays wired commu-
nication
• AeroDR Interface Unit2, AeroDR Generator Interface Unit, AeroDR Generator Interface Unit2 and Generator
Interface Unit 3 interfaces with an X-ray device.
• Access point (radio communication device) performs a wireless communication with DR 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 DR Detector. It registers the using DR
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