Konica Minolta KDR AU DDR User manual

Operator’s Manual
KDR™ AU DDR
Advanced U-Arm System with
Dynamic Digital Radiography
KMHA 500-000099
Revision D

3
KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
KMHA 500-000099
Revision D
TABLE OF CONTENTS
I. INTRODUCTION ...................................................................................... 7
1.0 Revision History................................................................................................8
2.0 Overview ..........................................................................................................9
2.1 General Overview........................................................................................................ 9
2.2 Intended Use .............................................................................................................. 9
2.3 Essential Performance Statement ............................................................................... 9
3.0 Document Information....................................................................................10
3.1 Document Information ............................................................................................. 10
3.2 Stylistic Conventions ................................................................................................ 10
3.3 Text Emphasis........................................................................................................... 10
4.0 System Description .........................................................................................11
4.1 Identication Labels ................................................................................................. 11
4.2 Hardware ................................................................................................................. 11
4.3 System Overview ...................................................................................................... 12
5.0 System Documentation ...................................................................................14
II. SAFETY ................................................................................................ 15
6.0 Precautions ....................................................................................................16
6.1 General Precautions.................................................................................................. 16
6.2 Safety and Warning Symbols..................................................................................... 17
6.3 Emergency Stop........................................................................................................ 19
6.4 Radiation and X-Ray Tube ......................................................................................... 19
7.0 Qualications of Personnel ..............................................................................20
7.1 Operating Personnel ................................................................................................. 20
7.2 Service Personnel ..................................................................................................... 20
8.0 Service and Maintenance.................................................................................21
8.1 Operation, Installation, and Repair ........................................................................... 21
8.2 General Safety and Regulatory Information .............................................................. 21
III. USER INTERFACES ............................................................................... 23
9.0 System Operations..........................................................................................24
9.1 System Start Up ........................................................................................................ 24
9.2 System Shut Down .................................................................................................... 26
10.0 Collimator ...................................................................................................... 27
10.1 Description............................................................................................................. 27
10.2 Operating Instructions............................................................................................ 27
10.3 Three-Knob Collimator............................................................................................ 29
11.0 DAP Meter ......................................................................................................32
11.1 DAP Meter............................................................................................................... 32

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
KMHA 500-000099
Revision D
TABLE OF CONTENTS
12.0 Generator.......................................................................................................33
12.1 Generator............................................................................................................... 33
13.0 Positioner.......................................................................................................34
13.1 Using the Positioner Safely...................................................................................... 34
13.2 Turning On the Positioner ........................................................................................ 35
13.3 Turning On the Positioner Control Panel .................................................................. 35
13.4 Emergency Stop Switch........................................................................................... 35
13.5 Grid (Grid Holder) ................................................................................................... 36
13.6 Positioner Control Panel...........................................................................................37
13.7 Positioning ............................................................................................................. 38
IV. SOFTWARE.......................................................................................... 44
14.0 Ultra Screen Overview.....................................................................................45
14.1 Ultra Screen Overview............................................................................................. 45
14.2 Ultra Screen Overview: Upper Icons ......................................................................... 45
14.3 Ultra Screen Overview: Sidebars ............................................................................. 46
14.4 Ultra Screen Overview: Lower Icons ......................................................................... 46
15.0 Performing an Exam in Ultra ............................................................................47
15.1 MWL Worklist.......................................................................................................... 47
15.2 Navigating the Ultra Worklist Screen ....................................................................... 47
15.3 Performing an Exam Without a Worklist .................................................................. 48
15.4 Acquiring DR Images............................................................................................... 51
15.5 Accepting and Rejecting Images.............................................................................. 54
16.0 Adult/Pediatric Patients and Body Habitus......................................................57
16.1 Adult Patients ......................................................................................................... 57
16.2 Pediatric Patients ................................................................................................... 58
17.0 Performing Post Processing Functions.............................................................60
17.1 Viewing an Image .................................................................................................... 60
17.2 Apply Post Processing to Images Before Accepting Them .......................................... 61
17.3 Applying Annotations to Images .............................................................................. 62
17.4 Reset Entire Image to Remove All Applied Post Processing ........................................ 63
17.5 Mouse Functions ..................................................................................................... 63
17.6 Auto W/L................................................................................................................. 64
17.7 Invert Image............................................................................................................ 64
17.8 Rotating and Flipping Images.................................................................................. 64
17.9 Shuttering Images................................................................................................... 66
17.10 Opening the Positioning Guide............................................................................... 68
18.0 Merging Images..............................................................................................69
18.1 Merging Images Manually (Multiple on 1)................................................................ 69
18.2 Merging Images Automatically ................................................................................73

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
KMHA 500-000099
Revision D
TABLE OF CONTENTS
19.0 Stitching Images............................................................................................. 74
19.1 Auto Stitching a Leg Length Study.............................................................................74
19.2 Manually Stitching a Leg Length Study .................................................................... 79
19.3 Auto Stitching a Scoliosis Study............................................................................... 81
19.4 Manually Stitching a Scoliosis Study........................................................................ 86
20.0 Adjusting Views and Exams .............................................................................88
20.1 Adding Additional Views to an Exam Procedure........................................................ 88
20.2 Adding Additional Procedures................................................................................. 88
20.3 Removing a View From an Exam .............................................................................. 89
20.4 Change the Name of a View in an Exam.................................................................... 89
20.5 Adding Exams from the Acquire Screen .................................................................... 90
20.6 Editing Patient and Exam Information..................................................................... 90
20.7 Deleting Exams....................................................................................................... 91
20.8 Adding an Exam Procedure to a Completed Patient Exam......................................... 91
20.9 Adding an Image to a Completed Exam.................................................................... 91
20.10 Moving an Image to Another Exam within the Same Patient Acquisition Screen ........ 92
20.11 Moving an Image to Another Exam.......................................................................... 93
20.12 Move/Copy/Resend ............................................................................................... 94
21.0 Storing and Sharing Images ............................................................................95
21.1 Manually Send Images to A PACS Destination .......................................................... 95
21.2 Printing and Saving Exam Studies to a Storage Device ............................................. 96
21.3 Burning a Study to a CD/DVD .................................................................................. 96
21.4 Copying a Study to a USB Drive.................................................................................97
21.5 Printing a Study to a DICOM Printer ......................................................................... 98
22.0 Settings and Adjustments ...............................................................................99
22.1 Adjust the Annotation Order in Settings................................................................... 99
22.2 Adjust the Annotation Text Color in Settings............................................................. 99
22.3 Procedure Template Editor in Settings – Unassign, Remove Selected, and Copy....... 100
22.4 Regius Tuner Popup – Fine Tune.............................................................................. 102
22.5 Techniques Manager Export to CSV Format............................................................ 103
22.6 Changing Options Shown in Toolbar ...................................................................... 104
22.7 Physicist Mode - ROI.............................................................................................. 105
22.8 EI Calibration Tool................................................................................................. 107
23.0 Software Settings (for System Administrators) ..............................................109
23.1 Software Settings (for System Administrators) ...................................................... 109
24.0 Button Guide ................................................................................................111
24.1 Button Guide ........................................................................................................ 111

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
KMHA 500-000099
Revision D
TABLE OF CONTENTS
25.0 Positioner Control Panel Software Functions..................................................112
25.1 Performing an Exam with a Worklist on the Positioner Control Panel ...................... 112
25.2 Adding a View During an Exam .............................................................................. 113
25.3 The Exit Button on the Positioner Control Panel ...................................................... 114
V. DYNAMIC MODE................................................................................. 116
26.0 Dynamic Mode.............................................................................................. 117
26.1 Operational Controls .............................................................................................117
26.2 Adjusting a Video Recorded in Dynamic Mode ........................................................ 118
VI. CLEANING......................................................................................... 124
27.0 Cleaning Maintenance ...................................................................................125
VII. FUNCTION AND SAFETY CHECKS........................................................127
28.0 Monthly Checks ............................................................................................128
28.1 General ................................................................................................................ 128
28.2 Checklist............................................................................................................... 128
29.0 Annual Checks ..............................................................................................128
VIII. TECHNICAL SPECIFICATIONS ........................................................... 129
30.0 Technical Data...............................................................................................130
30.1 Irradiation............................................................................................................ 130
30.2 Positioner Movement ............................................................................................ 130
30.3 Standby Mode ...................................................................................................... 131
30.4 Power Input Information....................................................................................... 131
30.5 Radiated Immunity Test Frequencies ..................................................................... 131
30.6 Environmental Requirements ................................................................................ 132
31.0 Exposure Index .............................................................................................133
31.1 Exposure Index Calculation Flow ........................................................................... 133
31.2 Calculation of Deviation Index............................................................................... 133
31.3 EI, TI, and DI Precautions....................................................................................... 134
31.4 List of Exposure Parameters (Reference)................................................................ 135
32.0 AEC Verication ............................................................................................136
IX. WASTE DISPOSAL...............................................................................137
33.0 Waste Disposal .............................................................................................138
X. APPENDIX A: CONFIGURATIONS ......................................................... 139
34.0 Congurations..............................................................................................140
XI. APPENDIX B: MONTHLY CHECKLIST ................................................... 141
35.0 Monthly Checklist .........................................................................................142

7KMHA 500-000099
Revision D
KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
I. INTRODUCTION

8KMHA 500-000099
Revision D
KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
I. INTRODUCTION
1.0 REVISION HISTORY
Revision Date Document Name (Reason for Change)
A 11/01/2019 Original document
B 12/13/2019 Updates to clarications of use
C 02/25/2020 Updates to dynamic mode, DAP meter, and exposure index sections
D 07/06/2020
Updates to chapter and section organization, template numbering, addi-
tional software information, general formatting, and updates surrounding
the addition of the Sedecal generator option.

9KMHA 500-000099
Revision D
KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
I. INTRODUCTION
2.0 OVERVIEW
2.1 General Overview
The KDR™ AU DDR Advanced U-Arm System with Dynamic Digital Radiography is a versatile digital radiography system
that improves workow and provides exceptional dose efciency. The KDR AU DDR features the latest developments
in high-technology construction and design, including the potential for Dynamic Digital Radiography (DDR), making it
possible to rapidly capture sequential radiographs in a single exam. It consists of the following subassemblies: X-ray tube,
positioner, automatic exposure control, collimator, X-ray generator, patient mobile table, and acquisition station with
ULTRA software.
Two KDR AU sub-models are available. The KDR AU DDR Advanced U-Arm System with Dynamic Digital Radiography is
capable of both dynamic digital radiography (or “dynamic mode,”) and single-frame radiology (or “static mode.”) The KDR
AU Advanced U-Arm System (KDR™ AU) is capable of single-frame radiology only.* The name “KDR AU DDR” will be used
to refer to both models throughout this manual.
This operator’s manual describes the operation, safety, and care of the KDR AU DDR and can be used as a general refer-
ence. The operator must be familiar with all sections of this manual before attempting to operate the KDR AU DDR. For
more information on individual components, see the component manuals.
Installation of the KDR AU DDR should be performed by a qualied eld service engineer. Follow all safety guidelines for
the safe handling of the KDR AU DDR. Follow all instructions exactly as given.
* The optional HD / FNB at panel detector (FPD) is required for dynamic digital radiography in the KDR AU DDR. The
optional HQ / KDR at panel detector (FPD) is for use with single frame radiology only in the KDR AU. DDR functionality
is only available with KDR AU DDR.
2.2 Intended Use
The KDR AU DDR Advanced U-Arm System with Dynamic Digital Radiography is indicated for use by a qualied/trained
doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial radiographic exposures
of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the
patient sitting, standing, or lying in the prone or supine position (this system is not for mammography or uoroscopy.)
The KDR AU DDR is designed for general radiography in hospitals, clinics, radiology imaging centers, and medical practic-
es.
2.3 Essential Performance Statement
The KDR AU DDR System does not have essential performances.

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
I. INTRODUCTION
3.0 DOCUMENT INFORMATION
3.1 Document Information
It is important to keep this document for the life of the equipment and pass it on to any subsequent user of the equipment.
The original version of this manual was written in the English language.
3.2 Stylistic Conventions
All warning label texts are shown in italic style in this manual. All references are shown in italic style in this manual.
3.3 Text Emphasis
WARNING! All texts labelled with “WARNING” call attention to potential risk to health or life.
CAUTION: All texts labelled with “CAUTION” contain information about dangerous situations and measures to
avoid risk.
NOTE: All texts labelled with “NOTE” contain additional information regarding the work step and are provided
for better understanding and/or to avoid unnecessary difculties.

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
I. INTRODUCTION
4.0 SYSTEM DESCRIPTION
4.1 Identication Labels
Figure 4.1.1 shows the location of the identication labels on the KDR AU DDR.
Figure 4.1.1
KDR AU DDR Idencaon Labels
4.2 Hardware
The KDR AU DDR is a compact radiographic system with proprietary software. The system consists of a rotating and linear
moving oor-mounted stand with integrated software, at panel digital radiography detector system, generator, GUI
interface station, computer workstation, and table (optional: stitch stand or weight bearing stand).
There are two modes within the software package, “static mode,” which may be used to generate static images, and “dy-
namic mode” (or “Dynamic Digital Radiography,” abbreviated “DDR,”) which may be used to generate a cine loop present-
ing the physician with a diagnostic view of dynamic density and anatomic motion without using uoroscopy.
The KDR AU DDR is also capable of quickly assuming a preprogrammed position when a new exam is selected, saving
time when positioning the patient. This is referred to as “auto positioning,” and made possible by the detector and image
processing software working together.

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
I. INTRODUCTION
4.3 System Overview
Figure 4.3.1 and Table 4.3.1 illustrate and describe all components of the KDR™ AU DDR system.
Figure 4.3.1
KDR AU DDR
Table 4.3.1
KDR AU DDR Component Descripons
Figure Number Component Description
1-13 KDR AU DDR The enre KDR AU DDR system
1Generator
1.1 Generator – main cabinet Generates the high voltage (40-150 KV) required
by the X-ray tube; interfaces with the X-ray tube,
automac exposure control (AEC,) at panel de-
tector, and acquision staon.
1.2 Generator Exposure Control On/o and exposure buon.
2Generator Interface Unit Interface unit for imaging system synchronizaon
with the generator. Enables start synchronizaon
between the generator and the FPD.
3Interface Power Supply Power supply unit for the FPD and the generator
interface unit.
4PC, Keyboard, Mouse PC used for the acquision staon. DDR Minimum
requirements: i7, 16GB, 512 SSD.
5Monitor Touch screen monitor

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
I. INTRODUCTION
Table 4.3.1
KDR AU DDR Component Descripons
Figure Number Component Description
6Posioner Posions the X-ray tube and imaging receptor.
6.1 Posioner – control panel User interface for the KDR AU DDR system and
posioner.
6.2 Posioner – remote Movements remote control.
7Collimator Collimates (focuses) the X-ray beam from the X-ray
tube. It uses an LED to mark the radiated area.
8DAP Meter (oponal) Measures the dose of radiaon exing the colli-
mator.
9X-Ray Tube The tube produces an X-ray when a high voltage
from the generator is applied. The tube assembly
shields the X-ray except for the exposure window
(where it mounts to the collimator).
10 Flat Panel Detector (FPD) Converts X-ray informaon to a digital image.
11 Automac Exposure Control
(AEC)
Provides image density control by feeding back
dose informaon to the generator.
12 Grid Reduces the amount of scaer radiaon reaching
the at panel detector (FPD).
13 High Voltage Cables Connect the X-ray tube to the generator.

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
I. INTRODUCTION
5.0 SYSTEM DOCUMENTATION
The following documentation is available for the system:
• KDR™ AU DDR Operator’s Manual (this manual)
• KDR™ AU DDR Pre-Installation, Installation, and Service Manual
• Ultra Operator’s Manual
• Positioner documentation
• Generator documentation (technical manual)
• X-ray Tube documentation
• Collimator documentation
• DAP meter documentation
• AEC chamber documentation
• Stitching stand documentation
• Weight bearing stand
• Automatic motorized vertical movement table documentation
• Fixed height table documentation

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
II. SAFETY

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
II. SAFETY
6.0 PRECAUTIONS
6.1 General Precautions
WARNING! Do not use this device if you see smoke or notice unusual odors or noises. If smoke, unusual odors or
noise are being generated, continued use of this product may result in a re. Turn OFF the power source breaker
immediately, unplug the device, and contact your nearest service representative. Do not attempt to repair it.
WARNING! Although the precautions indicated on this device, in this document, or in component manuals are
provided based on various considerations, unpredictable events may still occur. While operating this device,
pay constant attention to possible hazards in addition to observing the instructions.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
CAUTION:Before using this device, read the manuals accompanying this device in order to understand func-
tions, operation, and performance.
CAUTION: Make sure this device operates correctly and safely after a prolonged discontinuance of use.
CAUTION: Follow the Operator’s Manual for correct operation procedures.
CAUTION: While using the device, always monitor all devices and patients to prevent unfavorable conditions.
CAUTION: After using the device, return the switches and dials to the original positions using the specied pro-
cedures, and turn the power OFF.
CAUTION: The system is provided with air intakes and outlets to prevent the machine from overheating. Do not
block them.
CAUTION: When operating this device, be sure to follow the instructions and procedures described in this docu-
ment and component manuals.
CAUTION: Be sure to observe the precautions indicated on this device, in this document, or in component manu-
als. Failure to observe them can cause personal injury or damage to this device.
CAUTION: When using this device, be sure to observe the installation environment requirements (temperature,
humidity, and power rating conditions, or restriction of use near a device generating strong magnetic or electro-
magnetic waves).
CAUTION: Do not use any ammable or explosive gases near the machine.
CAUTION: The installation environment and location, device conguration, network, power supply, and other
conditions are optimized for this device. If you want to change any condition, contact your service representa-
tive. Otherwise, the functions and performance of this machine may be impaired.
CAUTION: Do not put liquids or foreign objects into the device. Fires, electric shocks, or malfunctions may result.
If any foreign objects have fallen into the machine, turn OFF the power source breaker immediately and unplug
the machine. Contact your nearest service representative. Never disassemble the device.
CAUTION: If the positioner control panel is broken, and the liquid inside it leaks out, do not put it in your mouth.
If the liquid gets on part of your body or clothes, immediately wash it off with soapy water.

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
II. SAFETY
CAUTION: If the positioner control panel breaks or cracks, immediately stop using it. Never use the positioner
control panel if it is damaged.
NOTE: The following radio interference standards apply to this machine: Voluntary Control Council for Informa-
tion Technology Equipment (VCCI) Class B.
NOTE: The following radio interference standards apply to this machine: Federal Communications Commission
(FCC) Part 15 Class B.
CAUTION: DDR is not intended for diagnosis during the exam sequence. Diagnosis should only be per-
formed after the exam is complete and the images are sent to a diagnostic workstation. The preview of
images during the exposure sequence is not for diagnostic purposes, is not real time, and is at a lower framerate
then the acquisition.
6.2 Safety and Warning Symbols
Table 6.2.1
Safety and Warning Symbols
Symbol Note
Attention: consult accompanying documents
Type B applied part
Protective earth terminal
Earth terminal
NConnection point for the neutral conductor on
permanently installed equipment
Squeezing hazard

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
II. SAFETY
Table 6.2.1
Safety and Warning Symbols
Symbol Note
Indicates compliance of the equipment with Direc-
tive 93/42/EEC
Separate collection for electrical and electronic
equipment
Manufacturer
Indicates the emission or the imminent emission of
X-radiation

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KDRTM AU-DDR Advanced U-Arm System with
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II. SAFETY
6.3 Emergency Stop
The emergency stop is located on the outer right corner of the bucky assembly. If the stand is not working properly or
making unintended movements, the emergency stop switch can be pressed to immediately stop the stand from moving.
The emergency stop only disables motorized mechanical movements of the stand and does not affect the generator and
other components of the system. To recover movement capability, make sure the area around the stand is clear and free of
obstructions, then pull the switch directly out and rotate it clockwise. Contact your service engineer if there are persistent
erratic movements in the stand.
Figure 6.3.1
Emergency Stop
6.4 Radiation and X-Ray Tube
WARNING! Make sure that patients, operators, and third parties are protected against unnecessary X-ray radi-
ation according to local regulations.
WARNING! The collimator lter must be veried so that the correct lter is used during exposure.
NOTE: Verbal and visual communication must be possible between the operator and the patient when expo-
sures are performed.
NOTE: The X-ray beam must never be outside the boundaries of the image receptor holder.

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KDRTM AU-DDR Advanced U-Arm System with
Dynamic Digital Radiography (KDR AU DDR)
II. SAFETY
7.0 QUALIFICATIONS OF PERSONNEL
CAUTION: This equipment is intended for use in radiographic examinations under the guidance of trained
health care professionals.
7.1 Operating Personnel
Before using this system, operating personnel must be thoroughly familiar with the system and its operating instructions.
7.2 Service Personnel
The equipment should be serviced only by qualied personnel who:
• are completely familiar with the system,
• have read and understood the operator’s manual and the pre-installation, installation, and service manual,
• know how to remove power to the unit in case of an emergency, and
• are trained in the use of equipment and procedures of this type.
Failure to follow the instructions given in this manual could result in serious injury to the service person, patient, and oper-
ator.
NOTE: It is the responsibility of the owner to ensure that the product is operated only by certied radiology tech-
nologists.
NOTE: It is the responsibility of the supplier to ensure that the technicians have the right training and knowledge
to perform service and maintenance.