AGFA DX-D 300 User manual

DX-D 300 U-Arm
User Manual
Technical Publication
0171F EN 20181009

DX-D 300 U-Arm
User Manual
0171F EN 20181009
REVISION HISTORY
REVISION DATE REASON FOR CHANGE
AFEB 03, 2010 First edition
B APR 05, 2010 Added Patient Handle option
C SEP 30, 2011 Removed U-Arm Software Console information
D AUG 01, 2013 IEC Standards update
E APR 27, 2015 New Handle and Receptor Overlay. New cabinet
for Portable Receptor.
FOCT 9, 2018 IEC Fourth Edition, Labels, Applied Parts
Warning, Collimator Rotation every 90 degrees, 4
information messages added, exposure
irradiation time 14 ms and Voltage 230 / 240 V
corrected.
This Document is the English original version, edited and supplied by the manufacturer.
The Revision state of this Document is indicated in the code number shown at the bottom of this page.

DX-D 300 U-Arm
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ADVISORY SYMBOLS
The following advisory symbols will be used throughout this manual. Their
application and meaning are described below.
DANGERS ADVISE OF CONDITIONS OR SITUATIONS THAT
IF NOT HEEDED OR AVOIDED WILL CAUSE SERIOUS
PERSONAL INJURY OR DEATH.
ADVISE OF CONDITIONS OR SITUATIONS THAT IF NOT
HEEDED OR AVOIDED COULD CAUSE SERIOUS PERSONAL
INJURY, OR CATASTROPHIC DAMAGE OF EQUIPMENT OR
DATA.
Advise of conditions or situations that if not heeded or
avoided could cause personal injury or damage to equipment
or data.
Note .Alert readers to pertinent facts and conditions. Notes represent
information that is important to know but which do not necessarily
relate to possible injury or damage to equipment.

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TABLE OF CONTENTS
Section Page
1 INTRODUCTION 1.........................................................
1.1 General Features 2...................................................
1.2 Options 3............................................................
1.3 Product Identification 3................................................
1.4 Indications for Use 5..................................................
1.4.1 Intended Use 5................................................
1.4.2 Normal Use 5.................................................
1.4.3 Contraindications 5............................................
1.5 Applied Parts 6.......................................................
2 SAFETY AND REGULATORY INFORMATION 7..............................
2.1 General 7...........................................................
2.2 Responsibilities 10.....................................................
2.3 Maximum Permissible Dose (MPD) 11...................................
2.4 Radiation Protection 12.................................................
2.5 Monitoring of Personnel 14.............................................
2.6 Safety Symbols 14.....................................................
2.7 Regulatory Information 19..............................................
2.7.1 Certifications 19................................................
2.7.2 Environmental Statement on the Life Cycle of the Equipment
or System 19...................................................
2.7.3 Mode of Operation 19...........................................
2.7.4 Protection against Electric Shock Hazards 20.......................
2.7.5 Protection against Harmful Ingress of Water or Particulate Matter 20...
2.7.6 Protection against Hazards of Ignition of Flammable
Anaesthetic Mixtures 20.........................................
2.7.7 Protection against Hazards from Unwanted or Excessive Radiation 20.
2.7.8 Designated Significant Zones of Occupancy 21.....................
2.7.9 Distribution of Stray Radiation 24.................................

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Section Page
2.8 Electromagnetic Compatibility (EMC) 29..................................
2.9 Quantitative Information 37.............................................
2.9.1 Functional Tests Performed to Obtain the Quantitative Information 37..
2.10 Deterministic Effects 44................................................
2.11 Product Complaints 44.................................................
3 START UP AND SHUTDOWN 45.............................................
3.1 Start Up 45...........................................................
3.2 Shutdown Routine 47..................................................
4 OPERATION OF THE U-ARM 49.............................................
4.1 Systems Movements 50................................................
4.1.1 Emergency Stop for Movements 50...............................
4.1.2 Control Panel 52................................................
4.1.3 Touch Screen Console 55........................................
4.2 X-Ray Beam Alignment with Respect to Patient 58.........................
4.3 DR Detector Assembly Bumper and Anticrushing System 60................
4.4 DR Detector Assembly 62..............................................
4.4.1 Portable DR Detector Assembly Usage 63.........................
4.4.1.1 Loading and unloading the Tray 64.........................
4.4.1.2 Rotating the DR Detector 65...............................
4.4.2 Interchangeable Grids 67........................................
4.5 Tube-Collimator Assembly Positioning 68.................................
4.6 Automatic Collimator 69................................................
4.7 Dosemeter Device (optional) 70.........................................
4.8 Arm Rest (optional) 70.................................................
4.9 Error Messages of the U-Arm 71........................................
4.10 Information Messages of the U-Arm 73...................................

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Section Page
5 OPERATING SEQUENCES 77...............................................
5.1 Start-up Routine 77....................................................
5.2 X-ray Tube Warm-up Procedure 77......................................
5.3 Radiographic Operation 78.............................................
5.4 AEC Operation 79.....................................................
5.4.1 How to Verify the Functioning of the Automatic Exposure Control 79...
6 PERIODIC MAINTENANCE 81...............................................
6.1 Operator Tasks 81.....................................................
6.2 Service Tasks 82......................................................
7 TECHNICAL SPECIFICATIONS 83...........................................
7.1 Environmental Conditions 83............................................
7.2 U-Arm 83.............................................................
7.2.1 Power Line REquirements 83.....................................
7.2.2 Information Related to Radiation 83...............................
7.2.3 Physical Characteristics 84.......................................
7.3 X-Ray Generator 86...................................................
7.3.1 Factors 86.....................................................
7.3.2 Range of Radiographic Parameters 87.............................
7.3.3 Duty Cycle 87..................................................
7.3.4 physical characteristics 88.......................................
7.4 X-Ray Tubes 89.......................................................
7.5 Radiographic Mobile Tables (optional) 90.................................
APPENDIX A GUIDELINES FOR PEDIATRIC APPLICATIONS A-1.....................

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User Manual
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SECTION 1 INTRODUCTION
This manual contains all the necessary information to understand and operate
the DX-D 300 U-Arm. It provides a general description, safety information,
operating instructions and specifications concerning the equipment. This
manual is not intended to teach radiology or to make any type of clinical
diagnosis.
The U-Arm, the DR Detector Assembly, the Control Box and the Patient Mobile
Table are associated equipment to the X-ray Generator Unit.
Basically, the U-Arm consists of the following associated subassemblies:
Vertical Column, Swivel Arm with variable height, X-ray Tube, Collimator,
Control Panel and DR Detector Assembly.
The Control Panel is ergonomically built, equipped with controls and indicators
logically arranged and easily accessible. Duplicate of controls are present at the
DR Detector Assembly and Remote Control for a better accessibility and
handling of the equipment in accordance with the movement to be performed.
All movements of the Swivel U-Arm are motorized. A soft thumb pressure on
the control buttons allows the linear and rotation movements. Undertable and
Thorax positioning of the DR Detector Assembly are automatically performed
by holding pressed the respective controls at the DR Detector Assembly and
Remote Control. The Unit includes different automatic positionings and allows
radiographic exposures to patients in erect, sitting or laying over a mobile table.
Illustration 1-1
DX-D 300 U-Arm
Mobile Table
DR Detector Assembly
Vertical Column
U-Arm
Collimator
X-Ray Tube
Control Panel
(Touch Screen + Control Buttons)
X-Ray Generator
Control Box
(Fixed or Portable DR Detector)

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The Generator Cabinet comprises the Power Module (which contains the
power and control components) and the High Voltage Transformer.
The operator controls and displays for radiographic operations are shown on
the U-Arm Touch Screen and on the Software Console of the NX Workstation.
All functions, displays and controls are logically arranged, easily accessible
and identified to prevent confusion. Technique factors and functions are
selected by touching directly on the screen.
The High Frequency X-ray Generator provides all the advantages of high
frequency waveform Generators including lower patient dose, shorter exposure
times and greater accuracy and consistency.
The Generator is controlled by multiple microprocessors providing increased
exposure consistency, efficient operation and extended Tube life. A high level
of self-diagnosis greatly increases serviceability and reduces down time.
1.1 GENERAL FEATURES
The main features of the U-Arm are:
A solid and ergonomic design.
Rotation and vertical motorized movements of U-Arm, and motorized
SID adjustment of the Tube-Collimator Assembly.
Automatic motorized and programmable movements for DR Detector
Assembly positioning - Undertable, Thorax and Customized positioning.
Motorized rotation movement of DR Detector Assembly in relation to its
transverse axis.
Touch Screen PC for operation.
Wireless IR Remote Control Unit.
Manual rotation movement of Tube-Collimator Assembly in relation to its
transverse axis.
Universal Radiographic Mobile Table with accessories.
Grid: Interchangeable Grids.
Automatic Collimator with internal filtering.

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The main features of the Generator are:
Constant potential high frequency.
Three point control by selecting kVp, mA and ms, two point control by
selecting kVp and mAs (no AEC), or one point control by selecting kVp
with AEC operations.
Five patient sizes.
Self-diagnosis indicators identify malfunctions in the system.
Tube protection circuitry prolongs Tube life and increases system
performance.
Equipped with closed loop control of X-ray Tube current, kVp and
filaments, which minimizes potential errors and the need for
readjustments.
Automatic line compensation due to closed loop operation of X-ray Tube
current and kVp.
1.2 OPTIONS
Radiographic Mobile Table with Carbon Fiber Table-Top.
Radiographic Mobile Table with Laminated Table-Top.
Arm Rest.
1.3 PRODUCT IDENTIFICATION
The major items in the equipment have some identification labels attached to
them which provide the following manufacturer and product information.
Product.
Model.
Volts (V), Line Phases, Frequency (Hz), and Power (kVA, kW).
Date of manufacture.
Serial number.
Reference.
Manufacturer.
Place of manufacture.
Certification.

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Illustration 1-2
Identification Labels
Laminated Table
(Optional)
Carbon Fibre Table (Optional)
U-Arm
Control Box
Label at bottom right side

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1.4 INDICATIONS FOR USE
1.4.1 INTENDED USE
This equipment is intended for use by qualified personnel only.
The DX-D 300 U-Arm is an equipment included in a Medical Equipment System
designed for general radiography in hospitals, clinics and medical practices to
provide X-ray radiographic images of the skeleton, skull, chest, abdomen,
extremities and other body parts for diagnosis.
Images can be obtained with the patient in the sitting, standing or lying position.
Examinations can be performed to any kind of patient group. Patients may be
physically abled, disabled, immobilized or shocked.
This DX-D 300 U-Arm contributes to the metrics of imaging performance
ensuring the efficient use of radiation.
The X-Ray image receptor used in this equipment is a DR Detector (fixed or
portable).
1.4.2 NORMAL USE
The Normal Use of this equipment is defined as the Intended Use plus the
Maintenance and Service tasks.
1.4.3 CONTRAINDICATIONS
Do not use the equipment for any purposes other than those for which it is
intended. Operation of the equipment for unintended purposes could lead to
fatal or other serious injury.
This equipment is not intended for mammography applications.
This equipment is not especifically designed for paediatric purposes; if children
are to be examined, they should always be accompanied by an adult.

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1.5 APPLIED PARTS
Applied Parts refer to parts of the medical equipment that in Normal Use
necessarily comes into physical contact with the patient for the medical
equipment to perform its function. This RAD equipment includes the following
Applied Parts:
Tabletop of the Radiographic Mobile Table.
Tabletop of the Positioner.
Arm Rest (optional).
Other accessories.
BEAR IN MIND THAT SOME APPLIED PARTS MAY HEAT UP
TO 48oC (118.4oF) WHEN THE AMBIENT TEMPERATURE
FOR OPERATION IS ON THE LIMIT. THIS IS COMPLETELY
NORMAL AND DOES NOT MEAN A MALFUNCTION OF THE
EQUIPMENT.

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SECTION 2 SAFETY AND REGULATORY INFORMATION
This section describes the safety considerations, general precautions for
patient, operator and equipment in order to perform a safe operation and
service tasks.
Regulatory Information and symbols used in the equipment are detailed in this
section to operate it safely.
2.1 GENERAL
FOR CONTINUE SAFE USE OF THIS EQUIPMENT FOLLOW
THE INSTRUCTIONS IN THIS OPERATING MANUAL. BOTH
OPERATOR AND SERVICE PERSONNEL HAVE TO STUDY
THIS MANUAL CAREFULLY, INSTRUCTIONS HEREIN
SHOULD BE THOROUGHLY READ AND UNDERSTOOD
BEFORE ATTEMPTING TO PLACE THE EQUIPMENT IN
OPERATION, ESPECIALLY THE INSTRUCTIONS
CONCERNING SAFETY, REGULATIONS, DOSAGE AND
RADIATION PROTECTION. KEEP THIS OPERATING
MANUAL WITH THE EQUIPMENT AT ALL TIMES AND
PERIODICALLY REVIEW THE OPERATING AND SAFETY
INSTRUCTIONS.
TECHNICAL INSTRUCTIONS FOR SERVICE PERSONNEL
SUCH AS PRE-INSTALLATION REQUIREMENTS,
INSTALLATION, CALIBRATION OR MAINTENANCE ARE
DESCRIBED IN THE RESPECTIVE CHAPTERS OF THE
PRE-INSTALLATION AND SERVICE MANUALS PROVIDED
WITH THIS EQUIPMENT.
PLEASE STUDY THIS MANUAL AND THE MANUALS FOR
EACH SYSTEM COMPONENT TO BE FULLY AWARE OF ALL
THE SAFETY AND OPERATIONAL REQUIREMENTS.

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OPERATOR AND SERVICE PERSONNEL AUTHORIZED TO
USE, INSTALL, CALIBRATE AND MAINTAIN THIS
EQUIPMENT MUST BE AWARE OF THE DANGER OF
EXCESSIVE EXPOSURE TO X-RAY RADIATION. IT IS
VITALLY IMPORTANT THAT EVERYONE WORKING WITH
X-RAY RADIATION IS PROPERLY TRAINED, INFORMED ON
THE HAZARDS OF RADIATION AND TAKE ADEQUATE
STEPS TO ENSURE PROTECTION AGAINST INJURY.
OPERATOR MUST HAVE SUFFICIENT KNOWLEDGE TO
COMPETENTLY PERFORM THE DIFFERENT DIAGNOSTIC
IMAGING PROCEDURES WITH X-RAY DEVICES. THIS
KNOWLEDGE IS ACQUIRED THROUGH A VARIETY OF
EDUCATIONAL METHODS INCLUDING CLINICAL WORKING
EXPERIENCE, AND AS PART OF MANY COLLEGE AND
UNIVERSITY RADIOLOGIC TECHNOLOGY PROGRAMS IN
ACCORDANCE WITH LOCAL LAWS OR REGULATIONS.
SERVICE PERSONNEL MUST HAVE SUFFICIENT
KNOWLEDGE TO COMPETENTLY PERFORM THE SERVICE
TASKS RELATED TO X-RAY DEVICES AND PARTICULARLY
TO THE EQUIPMENT DESCRIBED IN THIS MANUAL. THIS
KNOWLEDGE IS ACQUIRED THROUGH A VARIETY OF
EDUCATIONAL METHODS FOR TECHNICIANS IN
ACCORDANCE WITH LOCAL LAWS OR REGULATIONS,
INCLUDING SPECIFIC TRAINING ON THIS EQUIPMENT.
X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND
OPERATOR UNLESS PROTECTION MEASURES ARE
STRICTLY OBSERVED. IF THE EQUIPMENT IS NOT
ACCURATELY USED, IT MAY CAUSE INJURY.
ALTHOUGH X-RADIATION CAN BE HAZARDOUS, X-RAY
EQUIPMENT DOES NOT POSE ANY DANGER WHEN IT IS
PROPERLY USED.

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SPECIAL ATTENTION MUST BE GIVEN TO DIAGNOSTIC
X-RAY EQUIPMENT SPECIFIED TO BE USED IN
COMBINATION WITH ACCESSORIES OR OTHER ITEMS. BE
AWARE OF POSSIBLE ADVERSE EFFECT ARISING FROM
THESE MATERIALS LOCATED IN THE X--RAY BEAM. (SEE
THE TABLE BELOW FOR THE MAXIMUM EQUIVALENT
ATTENUATION OF MATERIALS POSSIBLY LOCATED IN THE
X-RAY BEAM).
MAXIMUM ATTENUATION EQUIVALENT mm AL
ITEM
21 CFR
IEC 60601--2--54:2009
AND
IEC 60601--2--54:2009/AMD1:2015
Total of all layers composing the front panel of cassette holder 1.2 1.2
Total of all layers composing the front panel of FILM CHANGER 1.2 1.2
Total of all layers, excluding detector itself, composing the front panel
of DIGITAL X-RAY IMAGING DEVICE 1.2 1.2
Cradle 2.3 2.3
PATIENT SUPPORT, stationary, without articulated joints 1.2 1.2
PATIENT SUPPORT, movable, without articulated joints (including
stationary layers) 1.7 1.7
PATIENT SUPPORT, with radiolucent panel having one articulated
joint 1.7 1.7
PATIENT SUPPORT, with radiolucent panel having two or more
articulated joints 2.3 2.3
PATIENT SUPPORT, cantilevered 2.3 2.3
Note 1.-- Devices such as RADIATION DETECTORS are not included in the item listed in this table.
Note 2.-- Requirements concerning the ATTENUATION properties of RADIOGRAPHIC CASSETTES and of INTENSIFYING SCREENS
are given in ISO 4090 [3], for ANTI--SCATTER GRIDS in IEC 60627[1].
Note 3.-- ATTENUATION caused by table mattresses and similar accessories is not included in the maximum ATTENUATION
EQUIVALENT for PATIENT SUPPORT.
Note 4.-- Maximum ATTENUATION EQUIVALENT mm Al is only applied to the corresponding item. If several items given in this table are
located in the path of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE RECEPTOR, each corresponding maximum
ATTENUATION EQUIVALENT mm Al is separately applied to each item.

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2.2 RESPONSIBILITIES
THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND
OPERATOR UNLESS SAFE EXPOSURE FACTORS,
OPERATING INSTRUCTIONS AND MAINTENANCE
SCHEDULES ARE OBSERVED.
THE EQUIPMENT HEREIN DESCRIBED IS SOLD WITH THE
UNDERSTANDING THAT THE MANUFACTURER, ITS
AGENTS, AND REPRESENTATIVES ARE NOT LIABLE FOR
INJURY OR DAMAGE WHICH MAY RESULT FROM
OVEREXPOSURE OF PATIENTS OR PERSONNEL TO X-RAY
RADIATION.
THE MANUFACTURER DOES NOT ACCEPT ANY
RESPONSIBILITY FOR OVEREXPOSURE OF PATIENTS OR
PERSONNEL TO X-RAY RADIATION GENERATED BY THIS
EQUIPMENT WHICH IS A RESULT OF POOR OPERATING
TECHNIQUES OR PROCEDURES.
NO RESPONSIBILITY WILL BE ASSUMED FOR ANY
EQUIPMENT THAT HAS NOT BEEN SERVICED AND
MAINTAINED IN ACCORDANCE WITH THE
MANUFACTURER INSTRUCTIONS, OR WHICH HAS BEEN
MODIFIED OR TAMPERED WITH IN ANY WAY.
IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE
THE SAFETY OF THE PATIENT WHILE THE X-RAY
EQUIPMENT IS IN OPERATION BY VISUAL OBSERVATION,
PROPER PATIENT POSITIONING, AND USE OF THE
DEVICES THAT ARE INTENDED TO PREVENT PATIENT
INJURY.
ALWAYS WATCH ALL PARTS OF THE SYSTEM TO VERIFY
THAT THERE IS NEITHER INTERFERENCE NOR
POSSIBILITY OF COLLISION WITH THE PATIENT OR WITH
OTHER EQUIPMENTS.

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IT IS THE RESPONSIBILITY OF THE PURCHASER /
CUSTOMER TO PROVIDE THE MEANS FOR AUDIO AND
VISUAL COMMUNICATION BETWEEN THE OPERATOR AND
THE PATIENT.
IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE
THAT ALL THE EXPOSURE PARAMETERS ARE CORRECT
BEFORE PERFORMING AN EXAM TO THE PATIENT, BY
VERIFYING THAT THE PARAMETER SELECTION HAS NOT
BEEN MODIFIED UNINTENTIONALLY OR BY THE CONTACT
OF EXTERNAL ELEMENTS ON THE CONTROL CONSOLE, IN
ORDER TO AVOID THE OVEREXPOSURE OR THE NEED OF
PERFORMING A NEW EXAM TO THE PATIENT.
MAKE SURE THAT THE X-RAY TUBE IS SET IN WORKING
POSITION WITH THE REFERENCE AXIS (X-RAY BEAM)
POINTING TO THE RECEPTION AREA.
2.3 MAXIMUM PERMISSIBLE DOSE (MPD)
Before operation, people qualified and authorized to operate this equipment
should be familiar with the Recommendations of the International Commission
on Radiological Protection, contained in Annals Number 60 of the ICRP, with
applicable National Standards; and should have been trained in use of the
equipment.
THE OPERATOR SHALL USE THE LARGEST POSSIBLE
DISTANCE FROM THE FOCAL SPOT TO SKIN IN ORDER TO
KEEP THE ABSORBED DOSE AS LOW AS REASONABLY
ACHIEVABLE.

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2.4 RADIATION PROTECTION
Although this equipment is built to the highest safety standards and
incorporates a high degree of protection against X-radiation other than the
useful beam, no practical design of equipment can provide complete protection,
nor can any practical design compel the operator to take adequate precautions
to prevent the possibility of any persons carelessly, unwisely, or unknowingly
exposing themselves or others to X-radiation.
IT IS THE RESPONSIBILITY OF THE OPERATOR TO
RESTRICT ACCESS TO THE EQUIPMENT IN ACCORDANCE
WITH LOCAL REGULATIONS FOR RADIATION
PROTECTION.
Because exposure to X-ray radiation can be damaging to the health, use great
care to ensure protection against exposure to the primary beam. Some of the
effects of X-ray radiation are cumulative and may extend over a period of
months or years. The best safety rule for an X-ray operator is “Avoid exposure
to the primary beam at all times”.
Any object in the path of the primary beam produces secondary (scattered)
radiation. The intensity of secondary radiation depends on the energy and
intensity of the primary beam and the atomic number of the object material
struck by the primary beam. Secondary radiation may be of greater intensity
than that of the radiation reaching the receptor. Take protective measures to
safeguard against it.
An effective protective measure is the use of lead shielding. To minimize
dangerous exposure, use such items as lead screens, lead impregnated
gloves, aprons, thyroid collars, etc. Lead screens should contain a minimum of
2.0 mm of lead or equivalent and personal protective devices (aprons, gloves,
etc.) must contain a minimum of 0.25 mm of lead or equivalent. For confirmation
of the local requirements at your site, please refer to your “Local Radiation
Protection Rules” as provided by your Radiation Protection Advisor.