Konica Minolta AeroDR SKR 4000 User manual

EN 02

3
Contents
Introduction � � � � � � � � � � � � � � � � 5
USA only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Summary of usability specications (for IEC/
EN 60601-1-6, IEC/EN 62366) . . . . . . . . . . . . . . . 6
Trademark. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Term description . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Chapter 1
Chapter1 Safety Precautions &
Warnings� � � � � � � � � � � � � � � � � 9
1.1 Symbols relating to safety . . . . . . . . . . . . 10
1.1.1 Safety alert symbol . . . . . . . . . . . . . . 10
1.1.2 Warning notice (signal words) . . . . . . 10
1.1.3 Description of graphic symbols . . . . . 10
1.2 Warning labels. . . . . . . . . . . . . . . . . . . . . 11
1.2.1 DR Detector . . . . . . . . . . . . . . . . . . . . 11
1.2.2 Battery Charger . . . . . . . . . . . . . . . . . 11
1.3 Safety precautions. . . . . . . . . . . . . . . . . . 12
1.3.1 Precautions before usage . . . . . . . . . 12
1.3.2 Precautions for usage . . . . . . . . . . . . 12
1.3.3 Precautions regarding
electromagnetic waves . . . . . . . . . . . 15
1.3.4 Precautions regarding wireless
communication. . . . . . . . . . . . . . . . . . 19
1.3.5 Precautions for installing, moving,
and storing . . . . . . . . . . . . . . . . . . . . . 20
1.3.6 Precautions regarding maintenance. . . . 21
1.3.7 Precautions on service life. . . . . . . . . 21
Chapter 2
Chapter2 Product Overview � � � � � � � � 23
2.1 Overview of this device . . . . . . . . . . . . . . 24
2.1.1 Basic conguration example . . . . . . . 24
2.1.2 Connection examples . . . . . . . . . . . . 24
2.2 Component names and functions . . . . . . 26
2.2.1 DR Detector . . . . . . . . . . . . . . . . . . . . 26
2.2.2 Battery . . . . . . . . . . . . . . . . . . . . . . . . 27
2.2.3 Battery Charger . . . . . . . . . . . . . . . . . 27
2.2.4 DC Power Cable . . . . . . . . . . . . . . . . 28
Chapter 3
Chapter3 General Operations � � � � � � � 29
3.1 Startup and shutdown . . . . . . . . . . . . . . . 30
3.1.1 Startup of this device . . . . . . . . . . . . . 30
3.1.2 Shutdown of this device. . . . . . . . . . . 30
3.2 Operation of DR Detector . . . . . . . . . . . . 32
3.2.1 Exposure with basic exposure . . . . . . 32
3.2.2 Exposure using Image Storage . . . . . 32
3.2.3 DR Detector orientation . . . . . . . . . . . 33
3.2.4 Precautions for exposure. . . . . . . . . . 33
3.3 Inserting and removing the Battery . . . . . . . . . 36
3.3.1 Insertion . . . . . . . . . . . . . . . . . . . . . . . 36
3.3.2 Removal. . . . . . . . . . . . . . . . . . . . . . . 36
3.4 Charging of Battery . . . . . . . . . . . . . . . . . 37
3.4.1 Charging with Battery Charger. . . . . . 37
3.4.2 Charging with the DC Power Cable . . 38
3.5 LED display of respective devices. . . . . . 39
3.5.1 DR Detector . . . . . . . . . . . . . . . . . . . . 39
3.5.2 Battery Charger . . . . . . . . . . . . . . . . . 40
3.6 Position to a󰀩x DR Detector
identication label . . . . . . . . . . . . . . . . . . 41
Chapter 4
Chapter4 Troubleshooting� � � � � � � � � � 43
4.1 Various problems and countermeasures . . . . . 44
4.1.1 DR Detector . . . . . . . . . . . . . . . . . . . . 44
4.1.2 Battery Charger . . . . . . . . . . . . . . . . . 45
Chapter 5
Chapter5 Maintenance � � � � � � � � � � � � � 47
5.1 Maintenance and inspection items . . . . . 48
5.1.1 Maintenance schedule. . . . . . . . . . . . 48
5.1.2 Cleaning. . . . . . . . . . . . . . . . . . . . . . . 48
5.1.3 Disinfection of the DR Detector . . . . . 49
5.1.4 Consumables. . . . . . . . . . . . . . . . . . . 49

4
Contents
Chapter 6
Chapter6 Specications � � � � � � � � � � � 51
6.1 Specications . . . . . . . . . . . . . . . . . . . . . 52
6.1.1 DR Detector . . . . . . . . . . . . . . . . . . . . 52
6.1.2 Battery . . . . . . . . . . . . . . . . . . . . . . . . 53
6.1.3 Battery Charger . . . . . . . . . . . . . . . . . 53
6.1.4 AC Adapter. . . . . . . . . . . . . . . . . . . . . 54
6.1.5 DC Power Cable . . . . . . . . . . . . . . . . 54
6.1.6 SKR 4000. . . . . . . . . . . . . . . . . . . . . . 54
6.2 Characteristics and performance of the
DR Detector. . . . . . . . . . . . . . . . . . . . . . . 55

5
Introduction
The digital radiography SKR 4000 (hereinafter, both are referred to as this device) perform X-ray imaging of the hu-
man body using an X-ray planar detector that outputs a digital signal, which is then input into an image processing
device, and the acquired image is then transmitted to a ling system, printer, and image display device as diagnostic
image data.
• Diagnostic X-ray image data of this device does not provide mammographic images.
The ImagePilot (hereafter referred to as the image processing controller), which controls the receiving, processing,
and output of image data, is required for operation. For the operation of the image processing controller, refer to the
"Operation Manual" of the image processing controller. Also, regarding the connectable devices, contact Konica Mi-
nolta technical representative.
This operation manual provides instructions on the basic functions for operation of this device. Those operating this
device for the rst time should read this manual beforehand.
Also, store this manual close to this device after reading it through, so it can be used as a guide to allow optimum
operating conditions.
IMPORTANT
• This operation manual (English version) is e󰀨ective only outside Japan.
• "AeroDR NS 1417" denoted in this document refers to the operation manual name of the product name P-41.
• If the pages of the operation manual are smudged and illegible, replace it with a new one. (There is a fee for this service.)
USA only
Indications for Use
This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace a
radiographic lm/screen system in general-purpose diagnostic procedures.
This device is not indicated for use in mammography, uoroscopy, and angiography applications.
CAUTION
• Federal law restricts this device to sale by or on the order of a physician.

6
Introduction
Summaryofusabilityspecications(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 specied.
(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
wireless communication.
There are two ways to supply the power to the DR Detector: from removable Battery and wired connection
through the AC Adapter.
• Battery Charger charges Battery inserted.
(5) Signicant physical characteristics
• Refer to “6.1 Specications”.
(6) Signicant 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/qualications who has fully understood the content of
this document. (Such as a doctor or radiological technologist)
Trademark
Company names and product names in this manual are trademarks or registered trademarks of their respective own-
ers.
Please note that ©, ® and ™ marks are omitted hereafter.
Copyright © 2019 - 2020 Konica Minolta, Inc. All Rights Reserved.

7
Introduction
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, modication, maintenance, and repair made by anyone except Konica Minolta and contractors desig-
nated by Konica Minolta.
(4) Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage to Konica Minolta prod-
ucts, 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 maintenanc
and repair using maintenance parts other than those specied 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 environ-
ment that is not suitable for the installation requirements such as power source and installation environment de-
scribed 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 res, earthquakes, oods, 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 specied 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.
(11) Konica Minolta, Inc. is unable to assume any liability relating to the following events arising due to systems in-
fected by computer viruses, worms and other malicious software potentially harmful to computers (hereunderre-
ferred to as "malwares"):
— The erasure, corruption, or unwanted disclosure of data stored within this device, including personal andsen-
sitive patient information.
— Malfunction of the device or accidents occurring as a result of the malfunction of the device.
— Infection of other products upon connection with the device, or damages arising therefrom.
(12) Whenever you use this service, you are required to take some security or safety measures for the following
items related to the service:
Please understand that Konica Minolta, Inc. is unable to assume liability for certain events, such as malfunctions
or incidents of information leakage resulting from such events.
— Client and network equipment managed by our facility
— The network and ISP in our facility used for connection with this service
— Your equipment to be connected to the same network as that of this service
(13) When this device is used, various user and patient data stored within the device and external storage devices
must be adequately managed under the full responsibility of the user. Konica Minolta, Inc. is unable to assume
any liability relating to damages arising due to leakage of various data at the time of disposal.
Term description
Terms Explanation
DR Detector Collective term indicating AeroDR NS 1417.
Image processing controller The ImagePilot is referred to as the image processing controller.
AED
• It used as an abbreviation of Automatic Exposure Detection.
• This is a mode in which exposure is performed without being synchronized with the X-ray
device.
Image Storage This function allows you to expose without using the image processing controller.
Internal AP function A function that enables radio communication utilizing the wireless communication functionality
inside the DR Detector.
External AP function This function enables wireless communication by using a general purpose access point.

8

9
Chapter 1
Safety Precautions & Warnings
Chapter 1
Chapter 1 Safety Precautions & Warnings

10
1�1 Symbols relating to safety
1�1�1 Safety alert symbol
This is a "safety alert symbol". This symbol alerts you
to matters and/or operation potentially hazardous to
yourself and other people. Read these messages and
follow the instructions carefully.
1�1�2 Warningnotice(signal
words)
Signal words indicate the degree of potential hazards
in the use of the product.
Signal words include the following three types, which
are used according to risk of damage caused by dan-
ger and the severity of damage.
DANGER
Indicates an imminently hazardous situation which, if
not avoided, will result in death or serious injury.
WARNING
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if
not avoided, could result in minor or moderate injury.
It may also be used to indicate hazardous situation
where only physical damage is likely to occur.
1�1�3 Description of graphic
symbols
Graphic
symbols
Explanation
Indicates the on or standby position for the
power switch of this device.
Indicates a B-type Applied Parts medical
device.
Graphic
symbols
Explanation
Indicates that full caution is required when
handling this device.
This indicates to reference to the instruction
manual for general information.
Indicates that it is necessary to read the
User's Manual before use or operation of this
device.
Indicates devices including radio frequency
transmitters.
IPX1
Indicates that the level of water ingress pro-
tection is equivalent to IPX1.
IP20
It indicates that the protection level against
intrusion of foreign solid object or water is
equivalent to IP20.
It indicates the manufacturer.
It indicates the manufacturing date.
It indicates the serial number.
This is the recycle mark for the lithium ion
batteries.
0197
This symbol indicates that this device is in
conformity with the Directive 93/42/EEC.
It means conformity with the Radio Equip-
ment Directive 2014/53/EU.
This symbol means: Do not dispose of this prod-
uct together with your household waste!
Please refer to the information of your local
community or contact our dealers regarding the
proper handling of end-of-life electric and elec-
tronic equipments.
Recycling of this product will help to conserve
natural resources and prevent potential negative
consequences for the environment and human
health caused by inappropriate waste handling.
It indicates that the used batteries must be
collected.