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Introduction
Summary of usability specifications (for IEC/EN 60601-1-6 & 62366)
1) Medical purposes
• Reading and provision of diagnostic images for diagnosis of disease and injury.
2) Patient groups
• No patients groups that operate or touch the device.
• No specification of patient groups of read X-ray images.
3) Parts of body or organizations to which the device is mounted or that interact with the device.
• No appropriate points. (Device does not come in contact with the patient.)
4) Unit operator
• Unit operator must be an adult technician who has received education and training in handling the
device (physician, radiologist, etc.).
5) Functional description, including physical principles
• The product prints out on film the image data that are received, via the in-hospital network, from
diagnostic imaging devices: After receiving image data, the product automatically transports the
films from the supply unit to the exposure unit, where latent images are formed by using laser
beam, and then ejects the images developed in the heat process unit.
Disclaimer
(1)
This manual may not be reproduced in whole or in part without the permission of Konica Minolta,
Inc.
(2)
The contents of this manual may be subject to change without prior notice.
(3)
Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage caused
by installation, relocation, modification, maintenance, and repair made by anyone except Konica
Minolta and contractors designated by Konica Minolta.
(4)
Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage to Konica
Minolta products, caused by third-party products not installed by Konica Minolta.
(5)
Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage caused by
maintenance and repair using maintenance parts other than those specified by Konica Minolta.
(6)
Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage caused by
not observing the precautions and operation methods described in the operation manual.
(7)
Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage caused by
the environment that is not suitable for the installation requirements such as power source and
installation environment described in the Installation Requirement or operation manual.
(8)
Konica Minolta, Inc. is not responsible for any claims for malfunction or damage caused by acts
of nature such as fires, earthquakes, floods, or lightning strikes.
(9)
Konica Minolta, Inc. is not responsible for any claims for malfunction or damage caused by using
this device for any purpose other than that specified for this device.
(10) Diagnostic and treatment action is performed under the responsibility of the physician(s). Konica
Minolta, Inc. is not responsible for any diagnostic/treatment conditions or diagnostic/treatment
results.
6
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