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DX-D 400

(type 5420 / 100)

User Manual

Technical Publication
0232F EN 20191213
DX-D 400
User Manual

REVISION HISTORY

REVISION DATE REASON FOR CHANGE

A JAN 10, 2011 First edition

B OCT 16, 2013 IEC Standards Update and Grids Update

C MAR 09, 2015 Removed Detector Models

D OCT 15, 2018 New logo, new system label, Applied parts
warning, IEC fouth Edition, table Emergency
Stop images, new pedal overlay images, Tilting
Wall Stand Images.o.

E JUN 27, 2019 Handle color changes to Grey and Angle


indicator change when tilting to 61o

F DEC 12, 2019 New ON/OFF Box, and tethered Detector


handling

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.

0232F EN 20191213
DX-D 400
User Manual

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.

0232F EN 20191213
DX-D 400
User Manual

TABLE OF CONTENTS

Section Page

1 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.1 General Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.2 Product Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6


1.3.1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3.2 Normal Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3.3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4 Applied Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2 SAFETY AND REGULATORY INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.2 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.3 Maximum Permissible Dose (MPD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2.4 Radiation Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

2.5 Monitoring of Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

2.6 safety symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.7 Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22


2.7.1 Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.7.2 Environmental Statement on the Cycle of the Equipment or System 22
2.7.3 Mode of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.7.4 Protection Against Electric Shock Hazards . . . . . . . . . . . . . . . . . . . . . . 23
2.7.5 Protection against Harmful Ingress of Water or Particulate Matter . . . 23
2.7.6 Protection against Hazards of Ignition of Anaesthetic Mixtures . . . . . 23
2.7.7 Protection Against Hazards from Unwanted or Excessive Radiation . 23
2.7.8 Designated Significant Zones of Occupancy . . . . . . . . . . . . . . . . . . . . . 24
2.7.9 Distribution of Stray Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.8 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

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2.9 Quantitative Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38


2.9.1 Functional Tests Performed to Obtain the Quantitative Information . . 38
2.10 Deterministic Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

2.11 Product Complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

3 START UP AND SHUTDOWN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

3.1 Start up with X-Ray Generator Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

3.2 Shutdown Routine with X-Ray Generator Control . . . . . . . . . . . . . . . . . . . . . . . . 49

4 OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

4.1 Floor Mounted Tube Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51


4.1.1 Column Rotation Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
4.1.2 DX-D 400 Analog Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
4.1.2.1 Vertical SID Reference Label . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4.1.3 DX-D 400 Digital Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.1.4 Ralco Manual Collimator R225/R225 DHHS . . . . . . . . . . . . . . . . . . . . . 58
4.1.5 Ralco Automatic Collimator R225ACS . . . . . . . . . . . . . . . . . . . . . . . . . . 59

4.2 Dosemeter Device (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

4.3 RAD Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60


4.3.1 RAD Table -- Fixed Height Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
4.3.2 RAD Table -- Elevating Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
4.3.3 Hand Grips (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
4.3.4 Compression Band (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.3.5 Lateral Detector Holder (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.3.6 Lateral Detector Holder on Table (Optional) . . . . . . . . . . . . . . . . . . . . . . 68
4.3.7 Lateral Detector Holder with Trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
4.4 RAD Wall Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

4.5 Rad Wall Stand - Manual Tilting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73


4.5.1 Tilting of Receptor Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
4.5.2 Rotation of Receptor Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
4.5.3 Arm Support (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
4.5.4 Hand Supports (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

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4.6 Receptor Assembly (Table and Wall Stand) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79


4.6.1 Travel of the Receptor Assembly (Table and Wall Stand) . . . . . . . . . . 79
4.6.2 Receptors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
4.6.3 Tray for Cassette Film or CR (Table or Wall Stand) . . . . . . . . . . . . . . . 82
4.6.4 Fixed Receptor Assembly (Table or Wall Stand) . . . . . . . . . . . . . . . . . 83
4.6.5 Portable Receptor Assembly (Table or Wall Stand) . . . . . . . . . . . . . . . 84
4.6.5.1 Portable Receptor Assembly with Rotating Tray . . . . . . . . . . . 84
4.6.5.2 Portable Receptor Assembly with non-Rotating Tray . . . . . . . 87
4.6.6 Grids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
4.6.7 Using and Maintaining the Digital Detector . . . . . . . . . . . . . . . . . . . . . . . 91
4.7 X-ray Beam Alignment with Respect to Patient . . . . . . . . . . . . . . . . . . . . . . . . . . 92

5 DX-D TOUCH SCREEN CONSOLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

5.1 Radiography and General Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96


5.1.1 Power ON / OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
5.1.2 Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
5.1.3 Workstation Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
5.1.4 Focal Spot Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
5.1.5 Radiographic Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
5.2 Automatic Exposure Control (AEC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
5.2.1 Rapid Termination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
5.3 Anatomical Programmer (APR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

5.4 Exposure Controls and Status Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

5.5 Self-Diagnosis Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

5.6 Heat Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

5.7 Dosimetry (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

5.8 Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

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6 DX-D OVERLAY CONSOLE AND


DX-D OVERLAY CONSOLE WITH APR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

6.1 Radiography and General Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124


6.1.1 Power ON / OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
6.1.2 Workstations Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
6.1.3 Focal Spot Indicators and Selectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
6.1.4 Radiographic Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
6.2 Automatic Exposure Control (AEC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
6.2.1 Rapid Termination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
6.3 Anatomical Programmer (APR) (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

6.4 Exposure Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

6.5 X-Ray Handswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

6.6 Heat Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

6.7 Exposure Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

6.8 Self-Diagnosis Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

6.9 Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

7 OPERATING SEQUENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

7.1 Start-UP Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

7.2 X-Ray Tube Warm-Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

7.3 Radiographic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

7.4 AEC Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141


7.4.1 How to Verify the Proper Functioning of the AEC . . . . . . . . . . . . . . . . . 141
7.5 APR Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

7.6 Fail-Safe Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

8 PERIODIC MANTEINANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

8.1 Operator Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

8.2 Service Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

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9 TECHNICAL SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

9.1 Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

9.2 X-ray System Positioners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147


9.2.1 Power Line Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
9.2.2 Information Related to Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
9.2.3 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
9.3 X-Ray Generator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
9.3.1 Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
9.3.2 Range of Radiographic Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
9.3.3 Duty Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
9.3.4 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

9.4 X-Ray Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

9.5 Collimators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

APPENDIX A GUIDELINES FOR PEDIATRIC APPLICATIONS . . . . . . . . . . . . . . . . . . . . . A-1

APPENDIX B ANATOMICAL PROGRAMMER MATRIX . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

B.1 Available Language Matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

B.2 Record of the APR Loading Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9

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vi 0232F EN 20191213
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SECTION 1 INTRODUCTION

This manual contains all the necessary information to understand and operate
the DX-D 400 X-ray System. 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. It includes the different configuration possibilities;
Elevating Table or Fixed Height Table and Control Panel.

The Tube Support Column, the RAD Table and the RAD Wall Stand are
associated equipment to the X-ray Generator Unit.

Basically, the Rad System consists of the following associated subassemblies:


Tube Support with variable height, X-ray Tube, Collimator, RAD Table and RAD
Wall Stand. The RAD Table and the RAD Wall Stand can house AR (Analog
Radiography), CR (Computed Radiography) or DR (Digital Radiography).

The Control Panel of the Column is ergonomically built, equipped with controls
and indicators logically arranged and easily accessible. A soft thumb pressure
on the control buttons allows the linear and rotation movements.

Illustration 1-1
DX-D 400 X-ray System

DX-D 400 with RAD Elevating Table,


Column with Digital Control Panel
and RAD Wall Stand - Manual Tilting

DX-D 400 with RAD Fixed Height Table,


Column with Analog Control Panel
and RAD Wall Stand

0232F EN 20191213 1
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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
one of the following Consoles: the DX-D Overlay Console, the DX-D Overlay
Console with APR, the DX-D Touch Screen Console or 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 pushing the corresponding buttons or by
touching directly on the screen, as applicable.

The NX Workstation is used for imaging processing and diagnosis in CR or DR


Systems.

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 X-Ray System are:

 A solid and ergonomic design.

 Easy operation, security and precision of all positioning movements with


respect to patient.

 Controls for Lock release of each equipment in the X--Ray System.

 Floor Mounted Tube Stand:

G Analog or Digital Control Panel.

G Horizontal motion of Column.

G Column rotation in relation to its vertical axis.

G Vertical motion of Tube-Collimator Assembly.

G Tube-Collimator rotation in relation to its transverse axis. Manual


±150o with Detents (--90o, 0o, +90o).

G Tube-Collimator transverse motion related to its horizontal axis.

G Manual Collimator or Automatic Collimator.

G Dosemeter Device (optional).

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 RAD Table:

G Fixed height or Elevating Table.

G RAD Table Receptor Assembly with longitudinal motion.

G Ion Chamber connection (optional).

G Fixed or Removable Grids.

G Accessories: Hand-Grips (pair), Compression Band, Lateral


cassette holder (24x30 cm or 35x43 cm.)

 RAD Wall Stand:

G RAD Wall Stand Receptor Assembly adjusted with internal


counterweights.

G Vertical motion of Receptor.

G Ion Chamber connection (optional).

G Fixed or Removable Grids.

G Right or left load (as per customer order).

G Accessories: Hand Grips and Arm Support.

 RAD Wall Stand - Manual Tilting (optional):

G RAD Wall Stand Receptor Assembly adjusted with internal


counterweights.

G Vertical motion of Receptor.

G Tilting Receptor (+90o --20o).

G Ion Chamber connection (optional).

G Fixed or Removable Grids.

G Right or left load (as per customer order).

G Accessories: Hand Grips and Arm Support.

Note . The Handgrips must not be positioned in the trajectory of the


X--Ray beam.

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 X-Ray Generator:

G Constant potential high frequency.

G 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.

G Anatomical Programmer (APR) for six patient sizes (three adults


and three children), with pre-programmed anatomical views for
automatic selection. The operator may manually modify all the
original APR techniques and store them for later use.

G Automatic Exposure Control (AEC).

G Rapid Termination function.

G Fail-safe function for the detection of the correct alignment of


the Tube-Collimator / Receptor with respect to the selected
workstation.

G Two Buckys or DR Detectors can be directly connected to the


Generator.

G Self-diagnosis indicators identify malfunctions in the system.

G Tube protection circuitry prolongs Tube life and increases system


performance.

G Equipped with closed loop control of X-ray Tube current, kVp and
filaments, which minimizes potential errors and the need for
readjustments.

G Automatic line compensation due to closed loop operation of X-ray


Tube current and kVp.

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1.2 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.

Illustration 1-2
Identification Labels

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1.3 INDICATIONS FOR USE

1.3.1 INTENDED USE

This equipment is intended for medical prescription use by qualified personnel


only.

The DX-D 400 is an equipment 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
diagnostic.

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 400 contributes to the metrics of imaging performance ensuring the
efficient use of radiation.

As example of X-ray image receptors types that can be used: Cassette with
Film, CR (Computed Radiography) or Digital Detector.

1.3.2 NORMAL USE

The Normal Use of this equipment is defined as the Intended Use plus the
Maintenance and Service tasks.

1.3.3 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 pediatric purposes; if children


are to be examined, they should always be accompanied by an adult.

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1.4 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 RAD Table.

 Tabletop of the RAD Wall Stand.

 Hand Grips (optional).

 Arm Support (optional).

 Compression Band (optional).

 Lateral Cassette Holders (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 IEC 60601--2--54:2009


21 CFR 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


1.2 1.2
panel of DIGITAL X-RAY IMAGING DEVICE

Cradle 2.3 2.3

PATIENT SUPPORT, stationary, without articulated joints 1.2 1.2

PATIENT SUPPORT, movable, without articulated joints (including


1.7 1.7
stationary layers)

PATIENT SUPPORT, with radiolucent panel having one articulated


1.7 1.7
joint

PATIENT SUPPORT, with radiolucent panel having two or more


2.3 2.3
articulated joints

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.

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Observe the following rules for radiation protection of the


personnel in the examination room during X-ray exposures:

- Wear radiation protective clothing.

- Wear a personal dosimeter.

- Use the recommended protective materials and devices


against radiation.

- While operating or servicing X-ray equipment, always keep


as large a distance as possible from the Focal Spot and X-ray
beam, never shorter than 2 meters, protect body and do not
expose hands, wrists, arms or other parts of the body to the
primary beam.

- Protect the patient against radiation outside the area of


interest by using protection accessories.

- Use the smallest X-ray field collimation. Make sure that the
area of interest will be completely exposed and the X-ray field
does not exceed the area of interest.

- Select a Focal Spot to patient skin distance (SID) as large


as possible to keep the absorbed dose for the patient as low
as reasonably possible.

The radiation dose decreases or increases according to the


Focal Spot to patient skin distance (SID): the greater the SID
distance, the lower the radiation dose. The radiation dose is
inversely proportional to the distance squared.

- Select as short an examination time as possible. This will


reduce total radiation dose considerably.

- Use Grids and Automatic Exposure Control with Ion


Chambers whenever possible.

- Place the region of interest as close as possible to the


image receptor. This will reduce exposure to radiation and
optimize the exposure.

- Be sure that audible and visual communication between


the patient and operator is established throughout the entire
examination.

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2.5 MONITORING OF PERSONNEL

Monitoring of personnel to determine the amount of radiation to which they have


been exposed provides a valuable cross check to determine whether or not
safety measures are adequate. It may reveal inadequate or improper radiation
protection practices and potentially serious radiation exposure situations.
The most effective method of determining whether or not the existing protective
measures are adequate is the use of instruments to measure the exposure.
These measurements should be taken at all locations where the operator, or
any portion of the body may be exposed. Exposure must never exceed the
accepted tolerable dose.
A frequently used, but less accurate, method of determining the amount of
exposure is the placement of film at strategic locations. After a specified period
of time, develop the film to determine the amount of radiation.
A common method of determining whether personnel have been exposed to
excessive radiation is the use of personal radiation dosimeters. These consist
of X-ray sensitive film or thermoluminescent material enclosed within a holder
that may be worn on the body. Even though this device only measures the
radiation which reaches the area of the body on which they are worn, they do
provide a reasonable indication of the amount of radiation received.

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2.6 SAFETY SYMBOLS

The following safety symbols may appear in the equipment.

Their meaning are described below.

Caution. Consult accompanying documents.

Safety Symbol. Follow instructions for use, especially those


instructions identified with Advisory Symbols to avoid any
risk for the Patient or Operator.
(Only applies to Standard IEC 60601--1:2005 and
IEC 60601-1:2005+AMD1:2012)

Manufacturer.

Date of Manufacture.

Medical Device.

Catalogue Number (Model reference).

Serial Number.

Model Configuration.

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General Mandatory action.

Type B applied part.

IPX0 Protection against harmful ingress of water or particulate matter.


IP Classification: Ordinary.

Ionizing radiation.

Non-ionizing electromagnetic radiation.

Radiation of Laser apparatus.


Do not stare into beam.
(Only applicable to equipment with Laser Pointer)

Dangerous voltage.

General warning, caution, risk of danger.

Warning: Ionizing radiation.

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Warning: Non-ionizing radiation.

Warning: Laser beam.

Warning: Electricity.

Warning: Do not place fingers between mobile and fixed parts of


the equipment, it may cause serious injuries to patient or operator.
As well, make sure the patient extremities are correctly positioned
into limit areas during operation, movement of parts may cause
serious damages to patient.

Electrostatic sensitive devices.

No pushing.

No sitting.

No stepping on surface.

Do not handle.

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Emergency stop.

“Stand-by” power.
(Only applies to IEC 60601-1:2005 and IEC 60601-1:2005+AMD1:2012)

“ON” power.

“OFF” power.

“ON” / “OFF” (push-push).


Each position, “ON” or “OFF”, is a stable position.

Alternating current.

Three-phase alternating current.

Three-phase alternating current with neutral conductor.

N Connection point for the neutral conductor on Permanently


Installed equipment.

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Direct current.

Both direct and alternating current.

Protective Earth (Ground).

Earth (Ground).

This symbol according to the European Directive indicates that the


Waste of Electrical and Electronic Equipment (WEEE) must not be
disposed of as unsorted municipal waste and must be collected
separately. Please contact an authorized representative of the
manufacturer or an authorized waste management company for
information concerning the decommissioning of your equipment.

This separate collection symbol is affixed to a battery or its


packing, to advise that the battery must be recycled or disposed of
in accordance with local or country laws. The letters below the
symbol indicate whether certain elements (Li=Lithium, PB=Lead,
CD=Cadmium, Hg=Mercury) are contained in the battery. All
batteries removed from the equipment must be properly recycled
Li/Pb/Cd/Hg or disposed. Please contact an authorized representative of the
manufacturer or an authorized waste management company for
information concerning the decommissioning of your equipment.

Pollution Control. (Only applicable to People’s Republic of China (PRC)).


This symbol indicates the product contains hazardous materials in
excess of the limits established by the Chinese Standards. It must
not be disposed of as unsorted municipal waste and must be
collected separately. Please contact an authorized representative
of the manufacturer or an authorized waste management company
for information concerning the decommissioning of your
equipment.

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2.7 REGULATORY INFORMATION

2.7.1 CERTIFICATIONS

The DX- D400 covered by this Operation Manual is authorized to be marked


with CE MARKING in accordance with the provisions of the Council Directive
93 / 42 / EEC as amended by 2007/47/EC concerning Medical Devices.

Statement of Compliance with IEC 60601--1--3: DX- D400 with radiation


protection in accordance with IEC 60601-1-3:1994, IEC 60601-1-3:2008 and
IEC 60601-1-3:2008+AMD1:2013.

Statement of Compliance with IEC 60601--2--54: DX- D400 for Radiography


and/or Radioscopy in accordance with IEC 60601-2-54:2009 and IEC
60601-2-54:2009+AMD1:2015.

Statement of Compliance with 21CFR Subchapter J: This DX- D400 conforms


to DHHS radiation Standards of 21CFR subchapter J as of the date of
manufacture.

2.7.2 ENVIRONMENTAL STATEMENT ON THE CYCLE OF THE EQUIPMENT OR SYSTEM

This equipment or system contains environmentally dangerous components


and materials (such as PCBs, electronic components, used dielectric oil, lead,
batteries etc.) which, once the life-cycle of the equipment or system comes to
an end, becomes dangerous and need to be considered as harmful waste
according to the international, domestic and local regulations.

The manufacturer recommends to contact an authorized representative of the


manufacturer or an authorized waste management company once the life-cycle
of the equipment or system comes to an end to remove this equipment or
system.

2.7.3 MODE OF OPERATION

 Continuous operation, in accordance with Standard IEC 60601--1:2005


and IEC 60601--1:2005+AMD1:2012.

 Continuous operation with intermittent load, in accordance with Standard


IEC 60601--1:1998.

 Permanently Installed Equipment.

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2.7.4 PROTECTION AGAINST ELECTRIC SHOCK HAZARDS

Protection against electric shock hazards in accordance with Standards:


IEC 60601-1:1988, IEC 60601-1:2005 and IEC 60601-1:2005+AMD1:2012, IEC
60601-2-7:1998, IEC 60601-2-54:2009 and IEC 60601-2-54:2009+AMD1:2015.
This equipment has been classified as a type-B ( ) device, in accordance with
Standard IEC 60601--1 requirements: Class I -- Type B applied parts.

TO AVOID THE RISK OF ELECTRIC SHOCK, THIS


EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY
MAINS WITH PROTECTIVE EARTH.

ACCORDING TO MDD/93/42/EEC AS AMENDED BY


2007/47/EEC, THIS UNIT IS EQUIPPED WITH EMC FILTERS.
THE LACK OF PROPER GROUNDING MAY PRODUCE
ELECTRICAL SHOCK TO THE USER.

2.7.5 PROTECTION AGAINST HARMFUL INGRESS OF WATER OR PARTICULATE MATTER

Protection against harmful ingress of water or particulate matter: Ordinary


(IPx0), in accordance with Standard IEC 60601-1:1988, IEC 60601-1:2005 and
IEC 60601-1:2005+AMD1:2012.

2.7.6 PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC


MIXTURES

Degree of Safety in the presence of Flammable Anesthetics Mixture with air or


with oxygen or with nitrous oxide: Not suitable for use in the presence of
Flammable Anesthetics Mixture with air or with oxygen or with nitrous oxide, in
accordance with Standard IEC 60601-1:1988, IEC 60601-1:2005 and IEC
60601-1:2005+AMD1:2012.

2.7.7 PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION

Protection against hazards from unwanted or excessive radiation in


accordance with Standards IEC 60601-1:1988, IEC 60601-1:2005 and IEC
60601-1:2005+AMD1:2012, and IEC 60601-1-3:1994, IEC 60601-1-3:2008
and IEC 60601-1-3:2008+AMD1:2013.

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2.7.8 DESIGNATED SIGNIFICANT ZONES OF OCCUPANCY

X-ray equipment specified for examinations that do not need the operator or
staff to be close to the patient during normal use shall be provided with means
to allow the following control functions from a “Protected Area” (refer to
illustration below):

 Selection and control of modes of operation.

 Selection of loading factors for the exposure.

 Actuation of the exposure controls.

 Other necessary controls for the operator during exposure.

Generator

PATIENT ENVIRONMENT

EXAM ROOM

OPERATOR CONTROL

PROTECTED AREA
NO RADIATION AREA

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X-Ray equipment specified for any radiological examination that requires the
operator or staff to be close to the patient during normal use (a.e. some pediatric
examinations or other types of examinations for patients that may require
assistance), shall have at least one “Significant Zone of Occupancy” for the use
of the operator and staff, designated as follows:

Illustration 2-1
Radiographic Examination on the Chest Unit or Front Panel

CHEST UNIT
X-RAY TUBE

Focal Spot

S
140 cm

S = SIGNIFICANT ZONE OF OCCUPANCY


MINIMUM AREA 60 x 60 cm
MINIMUM HEIGHT ABOVE THE FLOOR 200 cm

Focal Spot
S

Protective Device
Wall
Dosimeter d Patient Support
X--Ray Receptor

CHEST UNIT

SIGNIFICANT ZONE OF OCCUPANCY S1 Phantom S2 SIGNIFICANT ZONE OF OCCUPANCY


AT THE LEFT SIDE OF THE CHEST UNIT AT THE RIGHT SIDE OF THE CHEST UNIT
SID 100 cm

Focal Spot
X-RAY TUBE

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Illustration 2-2
Radiographic Examination on any Patient Support or any Table

X-RAY TUBE

Focal Spot

SID 100 cm
Phantom

X--Ray Receptor

Patient Support

RAD TABLE

S = SIGNIFICANT ZONE OF OCCUPANCY


MINIMUM AREA 60 x 60 cm
MINIMUM HEIGHT ABOVE THE FLOOR 200 cm

Focal Spot
S
SIGNIFICANT ZONE OF OCCUPANCY
AT THE LEFT SIDE OF THE RAD TABLE
(CATHODE)

Dosimeter d

S4
SIGNIFICANT ZONE OF OCCUPANCY
AT FRONT SIDE OF THE RAD TABLE

RAD TABLE

S3

X-RAY TUBE
Focal Spot

S5

SIGNIFICANT ZONE OF OCCUPANCY


AT THE RIGHT SIDE OF THE RAD TABLE
(ANODE)

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2.7.9 DISTRIBUTION OF STRAY RADIATION

Measurement conditions to determine the distribution of Stray Radiation in the


Significant Zone of Occupancy are in accordance with IEC 60601--1--3:1994,
2008 and 2013.

 Exposure Parameters: RAD mode, 150 kVp, 20 mAs.

 Collimator opening for Field Size 18 x 18 cm, SID 100 cm.

 Phantom: Rectangular water phantom of 25 x 25 x 15 cm, or a material


having a similar X-Ray attenuation coefficient.

 Radiation measuring instrument: Low Radiation Dosimeter.

Note . The results have been obtained with a configuration that is


representative of the worst case within the different configurations
of the unit.

Refer to Illustration 2-1 for Receptor in Vertical position and refer to


Illustration 2-2 for Receptor in Horizontal Position.

The following illustrations show the Distribution of Stray Radiation in each


examination position.

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Illustration 2-3
Distribution of Stray Radiation with the Receptor in Vertical Position.

200

180

160

140
HEIGHT ABOVE FLOOR (cm)

120

100

80

60

40

20

0
0 1 2 3 4 5 6 7 8 9 10
STRAY RADIATION (μGy/h)
S1

S2

Protective Device
Wall
Patient Support
X--Ray Receptor

CHEST UNIT

SIGNIFICANT ZONE OF OCCUPANCY S1 d Phantom d


S2 SIGNIFICANT ZONE OF OCCUPANCY
AT THE LEFT SIDE OF THE CHEST UNIT AT THE RIGHT SIDE OF THE CHEST UNIT
SID 100 cm

Focal Spot

X-RAY TUBE

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Illustration 2-4
Distribution of Stray Radiation with the Receptor in Horizontal Position.

200

180

160

140
HEIGHT ABOVE FLOOR (cm)

120

100

80

60

40

20

0
S3 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

S4 STRAY RADIATION (μGy/h)

S5

SIGNIFICANT ZONE OF OCCUPANCY


AT THE LEFT SIDE OF THE RAD TABLE
(CATHODE)

S4
SIGNIFICANT ZONE OF OCCUPANCY
AT FRONT SIDE OF THE RAD TABLE

RAD TABLE
d

S3 d

X-RAY TUBE
d

Focal Spot

S5

SIGNIFICANT ZONE OF OCCUPANCY


AT THE RIGHT SIDE OF THE RAD TABLE
(ANODE)

0232F EN 20191213 29
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2.8 ELECTROMAGNETIC COMPATIBILITY (EMC)

This equipment generates, uses, and can radiate radio frequency energy.

The equipment may cause radio frequency interference to


other medical or non medical devices and to radio
communications.

To provide reasonable protection against such interference, this equipment


complies with emissions limits for a Group 1 -- Class A Medical Devices
Directive as stated in IEC 60601--1--2: 2007 and 2014. However, there is no
guarantee that interference will not occur in a particular installation.

If this equipment is found to cause interference (which may be determined by


turning the equipment on and off), the operator (or qualified service personnel)
should attempt to correct the problem by one or more of the following measures:

 reorient or relocate the affected device,

 increase the separation between the equipment and the affected device,

 power the equipment from a source different from that of the affected
device,

 consult the service engineers for further suggestions.

To comply with the regulations applicable to an electromagnetic interference for


a Group 1 -- Class A Medical Device, all interconnect cables to peripheral
devices must be shielded and properly grounded. Use of cables not properly
shielded and grounded may result in the equipment causing radio frequency
interference in violation of the European Union Medical Device Directive and of
Federal Communications Commission regulations.

Before using this equipment make sure that all requirements


about EMC included in this manual are accomplished.

Should any interference (EMC) be detected with other


equipment, please position other equipment away from this
one.

30 0232F EN 20191213
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It is customer responsibility to assure that this equipment


and vicinity equipment complies the value of radio frequency
interferences shown in General Regulation for safety
according to IEC 60601-1-2: 2007 and 2014 Tables as
described in this section.

The manufacturer is not responsible for any interference


caused by using other than recommended interconnect
cables, accessories and transducers or by unauthorized
changes or modifications to this equipment.

GUIDANCE AND MANUFACTURER’S DECLARATION -- ELECTROMAGNETIC EMISSIONS


(IEC 60601-1-2:2007 AND IEC 60601-1-2:2014)

The DX--D400 radiographic room is intended for use in the electromagnetic environment specified below.
The customer or the user of The DX--D400 radiographic room should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment -- guidance

The DX--D400 radiographic room uses RF


energy only for its internal function. Therefore, its
RF emissions
Group 1 RF emissions are very low and are not likely to
CISPR 11
cause any interference in nearby electronic
equipment.

RF emissions
Class A
CISPR 11
The DX--D400 radiographic room is suitable for
use in all establishments other than domestic
Harmonic emissions
Class A and those directly connected to the public
IEC 61000--3--2
low voltage power supply network that supplies
low--voltage
buildings used for domestic purposes.
Voltage fluctuations/flicker emissions
Complies
IEC 61000--3--3

NOTE - In accordance with Standard IEC 61601-1-2:2014, the emissions characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 Class A). If it is used in a residential environment (for which CISPR 11 Class B is normally required) this equipment might not
offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or
re-orientating the equipment.

0232F EN 20191213 31
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GUIDANCE AND MANUFACTURER’S DECLARATION -- ELECTROMAGNETIC IMMUNITY


(IEC 60601-1-2:2007)

The DX--D400 radiographic room is intended for use in the electromagnetic environment specified below.
The customer or the user of The DX--D400 radiographic room should assure that it is used in such an environment.

IEC 60601-1-2:2007 Compliance


Immunity test Electromagnetic environment -- guidance
Test level level

Electrostatic discharge (ESD) ¦ 6 kV contact ¦ 6 kV Floors should be wood, concrete or ceramic


tile. If floors are covered with synthetic material,
IEC 61000-4-2 ¦ 8 kV air ¦ 8 kV the relative humidity should be at least 30%.

Electrical fast transient/burst ¦ 2 kV for power supply lines ¦ 2 kV


Mains power quality should be that of a typical
commercial or hospital environment.
IEC 61000-4-4 (*) ¦ 1 kV for input/output lines N/A

Surge ¦ 1 kV line(s) to line(s) ¦1 kV


Mains power quality should be that of a typical
commercial or hospital environment.
IEC 61000--4--5 (**) ¦ 2 kV line(s) to earth ¦ 2 kV

40% UT
60%
(60% dip in UT)
for 5 periods
for 5 cycles

70% UT
30%
(30% dip in UT)
for 25 periods
for 25 cycles
Mains power quality should be that of a typical
Voltage dips, short
commercial or hospital environment. If the user
interruptions and voltage >95%
< 5% UT of the Radiographic Room requires continued
variations on power supply for 250 periods
(>95% dip in UT) operation during power mains interruptions, it is
input lines.
for 250 cycles recommended that the Radiographic Room be
powered from an uninterruptible power supply
IEC 61000--4--11
or a battery.
>95%
< 5% UT
for 0.5 periods
(>95% dip in UT)
for 0.5 cycle

>95%
< 5% UT
for 1 period
(>95% dip in UT)
for 1 cycle

Power frequency (50 Hz)


Power frequency magnetic fields should be at
magnetic field
3 A/m 3 A/m levels characteristic of a typical location in a
typical commercial or hospital environment.
IEC 61000--4--8

NOTE -- UT is the a.c. mains voltage prior to application of the test level.

32 0232F EN 20191213
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GUIDANCE AND MANUFACTURER’S DECLARATION -- ELECTROMAGNETIC IMMUNITY


(IEC 60601-1-2:2007)

The DX--D400 radiographic room is intended for use in the electromagnetic environment specified below.
The customer or the user of The DX--D400 radiographic room should assure that it is used in such an environment.

IEC 60601-1-2:2007
Immunity test Compliance level Electromagnetic environment -- guidance
Test Level

Portable and mobile RF communications


equipment should be used no closer to any
part of the Radiographic Room, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.

Recommended separation distance


Conducted RF 3 Vrms 3 Vrms d = 1.2 P
IEC 61000--4--6 150kHz to 80MHz 150kHz to 80MHz
d = 1.2 P , 80 MHz to 800 MHz
Radiated RF 3 V/m 3 V/m
IEC 61000--4--3 80 MHz to 2.5GHz 80 MHz to 2.5GHz d = 2.3 P , 800 MHz to 2.5 GHz

where ’P’ is the maximum output power rating


of the transmitter in watts (W) according to the
transmitter manufacturer and ’d’ is the
recommended separation distance in meters
(m).

Field strengths from fixed RF transmitters, as


determined by an electromagnetic site
surveya), should be less than the compliance
level in each frequency rangeb).

Interference may occur in the vicinity of


equipment marked with the following symbol:

NOTE 1 -- At 80MHz and 800MHz, the higher frequency range applies.

NOTE 2 -- These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which The DX--D400 radiographic room is used exceeds the applicable RF compliance level above, The DX--D400
radiographic room should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re--orienting or relocating The DX--D400 radiographic room.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

0232F EN 20191213 33
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RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE


AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE RADIOGRAPHIC ROOM
(IEC 61601-1-2:2007)

The DX--D400 radiographic room is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of The DX--D400 radiographic room can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and The DX--D400
radiographic room as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter


Rated maximum output power m
of transmitter
150 KHz to 80MHz 80 MHz to 800MHz 800 MHz to 2.5GHz
W
d = 1.2 P d = 1.2 P d = 2.3 P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

TYPICAL RF DEVICES (Worst-Case scenario)

Device: Power @ Frequency Recommended distance(m)

GMRS device (Professional Walkie--Talkie): 5 W @ 462--467 MHz 2.7

GSM / UMTS cell phone: 2 W @ 850/1700/1900 MHz 3.3

FRS device (Amateur Walkie--Talkie): 500 mW @ 462--467 MHz 0.9

WiFi / Bluetooth devices: 100 mW @ 2400--2500 MHz 0.8

DECT devices (modern cordless phones): 100mW @ 1880--1900 MHz 0.8

RFID reader (3): 10 mW @ 125--150 KHz / 13.56 MHz 0.12

RFID reader (3): 10 mW @ 902--928 MHz / 2400--2500 MHz 0.23

Station transmitter ATSC TV broadcasting: 100 kW @ 54--800 MHz 380

Station transmitter ATSC TV broadcasting: 100 kW @ 800--890 MHz 730

Station transmitter FM radio broadcasting: 100 kW @ 87.5--108 MHz 380

For transmitters rated at a maximum output power not listed above, the recommended separation distance ’d’ in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where ’P’ is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 -- At 80MHz and 800MHz, the separation distance for the higher frequency range applies.

NOTE 2 -- These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.

34 0232F EN 20191213
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GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY


(IEC 61601-1-2:2014)

The DX--D400 radiographic room is intended for use in the electromagnetic environment specified below.
The customer or Operator of The DX--D400 radiographic room should assure that it is used in such an environment.

IEC 60601-1-2:2014 Electromagnetic


Immunity Test Compliance Level
Test Level environment - guidance

Floors should be wood, concrete or


¦ 8 kV contact ¦ 8 kV contact
Electrostatic discharge (ESD) ceramic tile.
If floors are covered with synthetic
¦ 2 kV, ¦  kV, ¦ 8 kV, ¦ 2 kV, ¦  kV, ¦ 8 kV,
IEC 61000-4-2 material, the relative humidity
¦ 15 kV air ¦ 15 kV air
should be at least 30 %.

¦ 2 kV for power supply lines ¦ 2 kV for power supply lines


Electrical fast transient/burst Mains power quality should be that
¦ 1 kV for input/output lines ¦ 1 kV for input/output lines of a typical commercial or hospital
IEC 61000-4-4 environment.
(100 kHz repetition frequency) (100 kHz repetition frequency)

¦ 0.5 kV, ¦ 1 kV ¦ 0.5 kV, ¦ 1 kV


Surge line(s) to line(s) line(s) to line(s) Mains power quality should be that
of a typical commercial or hospital
IEC 61000-4-5 ¦ 0.5 kV, ¦ 1 kV, ¦ 2 kV ¦ 0.5 kV, ¦ 1 kV, ¦ 2 kV environment.
line(s) to earth line(s) to earth

0% UT for 0.5 cycle 0% UT for 0.5 cycle


at 0o, 45o, 90o,135o, 180o, at 0o, 45o, 90o,135o, 180o,
225o, 270o and 315o 225o, 270o and 315o

Mains power quality should be that


of a typical commercial or hospital
0 % UT for 1 cycle 0 % UT for 1 cycle
Voltage dips, short interruptions environment. If the user of the This
at 0o at 0o
and voltage variations on power X-ray System requires continued
supply input lines. operation during power mains
interruptions, it is recommended
IEC 61000-4-11 that this X-ray System is powered
from an Uninterruptible Power
70 % UT for 25/30 cycles 70 % UT for 25/30 cycles
Supply or a battery.
at 0o at 0o

0% UT 250/300 cycles 0% UT 250/300 cycles

Power frequency magnetic fields


Power frequency (50/60 Hz)
should be at levels characteristic of
magnetic field
30 A/m 30 A/m a typical location in a typical
commercial or hospital
IEC 61000-4-8
environment.

NOTE - UT is the a.c. mains voltage prior to application of the test level.

0232F EN 20191213 35
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GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY


(IEC 60601-1-2:2014)

The DX--D400 radiographic room is intended for use in an electromagnetic environment specified below.
The customer or Operator of thisRadiographic Room should assure that it is used in such an environment.

IEC 60601-1-2:2014 Electromagnetic environment -


Immunity Test Compliance Level
Test Level guidance

Radiated RF EM fields 3 Vrms 3 Vrms


IEC 61000-4-3 from 80 MHz to 2.7 GHz from 80 MHz to 2.7 GHz
(80% AM at 1 kHz) (80% AM at 1 kHz)

Proximity fields from RF Refer to next table “IMMUNITY Refer to next table “IMMUNITY
wireless Communications REQUIREMENTS FOR RF REQUIREMENTS FOR RF Portable RF communications equipment
equipment WIRELESS COMMUNICATIONS WIRELESS COMMUNICATIONS (including peripherals such as antenna
IEC 61000-4-3 EQUIPMENT” EQUIPMENT” cables and external antennas) should be
used no closer than 30 cm to any part of the
equipment, including cables specified by
manufacturer. Otherwise, degradation of the
performance of this equipment could result.
Conducted disturbances 3 Vrms 3 Vrms
induced by RF fields from 150 kHz to 80 Mhz from 150 kHz to 80 Mhz
IEC 61000-4-6
6 Vrms in ISM bands 6 Vrms in ISM bands
from 150 kHz to 80 MHz from 150 kHz to 80 MHz

(80% AM at 1 kHz) (80% AM at 1 kHz)

NOTE -- The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz;
26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz; 3.5 MHz to 4.0 MHz; 5.3 MHz to 5.4 MHz; 7 MHz to 7.3 MHz; 10.1 MHz
to 10.15 MHz; 14 MHz to 14.2 MHz; 18.07 MHz to 18.17 MHz; 21.0 MHz to 21.4 MHz; 24.89 MHz to 24.99 MHz; 28.0 MHz to 29.7 MHz; and 50.0 MHz
to 54.0 MHz.

36 0232F EN 20191213
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IMMUNITY REQUIREMENTS TO RF WIRELESS COMMUNICATIONS EQUIPMENT


(IEC 60601-1-2:2014)

The DX--D400 radiographic room is intended for use in an electromagnetic environment specified below.
The customer or Operator of The DX--D400 radiographic room should assure that it is used in such an environment.

Band a) Distance Immunity Test Level


Modulation b)
(MHz) (m) (V/m)

Pulse modulation b)
380 -- 390 27
18 Hz

FM c)
430 -- 470 ¦5 kHz deviation 28
1 kHz sine

Pulse modulation b)
704 -- 787 9
217Hz

Pulse modulation b)
800 -- 960 28
18Hz 0.3

Pulse modulation b)
1700 -- 1990 28
217Hz

Pulse modulation b)
2400 -- 2570 28
217Hz

Pulse modulation b)
5100 -- 5800 9
217Hz

a) For some services, only the uplink frequencies are included.


b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual
modulation, it would be worst case.

0232F EN 20191213 37
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2.9 QUANTITATIVE INFORMATION

Note . The following tables show the Quantitative Information associated


to this equipment according to the StandardIEC 60601--1--3:2008
and IEC 60601--1--3:2008+AMD1:2013. These tables illustrate
loading factors for image performance and supply Dose indication
examples. Therefore, they are an example of the adjustment of
Loading Factors, Focal Spot Selection, SID and Collimator
opening, which affect to the radiation quality or to the radiation
dose rate applied in normal use.

2.9.1 FUNCTIONAL TESTS PERFORMED TO OBTAIN THE QUANTITATIVE INFORMATION

Equipment:

 Rad Positioner with Ralco Collimator.

Instrumentation used:

 Dosimeter: Vacudap

 Dosimeter: Unfors

 Rectangular Phantom made of Polymethyl-methacrylate (PMMA)


layers: 25 cm x 25 cm x 20 cm.

Test Details:

 Minimum SID distance: 100 cm.

 Maximum SID distance: 180 cm.

 Open Collimator size: 13 cm x 13 cm (min.), 43 cm x 43 cm (max.)

 The measurements were made with the exposure parameters shown on


the results table:
KVp Range: 40 KVp, 60 KVp, 80 KVp, 100 KVp, 125 KVp
mAs Range: 1 mAs, 2 mAs, 10 mAs, 50 mAs, 100 mAs

 Performed measurements of Air Kerma or Air Kerma Rate at the


following designated positions:
-- Distance SID doses
-- Patient (Phantom) Entrance doses and Entrance doses Rate
-- Patient (Phantom) Output doses and Output doses Rate
-- Collimator Output doses

38 0232F EN 20191213
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Quantitative Information

Loading Factors Parameter Selection Filtrat. Measured Doses

Source--Image Distance

(min. value allowed)

Output Dose Rate


Collimator blades

Input Dose Rate


Output Dose

Output Dose
Input Dose
Focal Spot

Collimator

SID Dose
Selection

(μGy*m2)

Phantom

Phantom

Phantom

Phantom
opening
Time (s)

(mGy/h)
(mmAl)

(mGy)

(mGy)

(Gy/h)

(μGy)
mAs

HVL
(cm)

(cm)
KVp

SID
mA

160 0.012 2 Small 0.2 0.016 0.025 7.479 10.795 0.036

100 0.1 10 Small 1.1 0.087 0.136 4.906 7.682 0.213


13 13
13x13
200 0.5 100 Large 11 0.836 1.307 9.407 14.125 1.962

400 1 400 Large 40 3.073 4.802 17.286 23.863 6.629


100
160 0.012 2 Small 2.1 0.016 0.025 7.615 18.691 0.062

100 0.1 10 Small 11.8 0.090 0.140 5.038 13.354 0.371


43 43
43x43
200 0.5 100 Large 107.1 0.862 1.347 9.698 23.798 3.305

400 1 400 Large 391.3 3.166 4.947 17.809 41.228 11.452


40 16
1.6
160 0.012 2 Small 0.2 0.005 0.006 1.865 4.273 0.014

100 0.1 10 Small 1.1 0.027 0.034 1.214 3.453 0.096


13 13
13x13
200 0.5 100 Large 11 0.257 0.325 2.343 5.985 0.831

400 1 400 Large 40 0.940 1.190 4.283 11.723 3.257


180
160 0.012 2 Small 2.1 0.005 0.007 1.962 6.243 0.021

100 0.1 10 Small 11.8 0.028 0.035 1.269 4.420 0.123


43 43
43x43
200 0.5 100 Large 107.1 0.267 0.338 2.432 7.400 1.028

400 1 400 Large 391.3 0.979 1.239 4.461 12.763 3.545

Note . Combined standard uncertainty is ¦ 35%


(IEC 60580:2000 / IEC 60601-2-54:2009
and IEC 60601-2-54:2009+AMD1:2015).

0232F EN 20191213 39
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Quantitative Information

Loading Factors Parameter Selection Filtrat. Measured Doses

Source--Image Distance

(min. value allowed)

Output Dose Rate


Collimator blades

Input Dose Rate


Output Dose

Output Dose
Input Dose
Focal Spot

Collimator

SID Dose
Selection

(μGy*m2)

Phantom

Phantom

Phantom

Phantom
opening
Time (s)

(mGy/h)
(mmAl)

(mGy)

(mGy)

(Gy/h)

(μGy)
mAs

HVL
(cm)

(cm)
KVp

SID
mA

160 0.012 2 Small 0.6 0.046 0.072 21.746 113.713 0.379

100 0.1 10 Small 3.9 0.252 0.394 14.195 79.388 2.205


13 13
13x13
200 0.5 100 Large 39.4 2.587 4.042 29.103 157.649 21.896

400 1 400 Large 191.4 10.009 15.639 56.299 295.137 81.983


100
160 0.012 2 Small 7.5 0.048 0.074 22.299 233.322 0.778

100 0.1 10 Small 40.6 0.265 0.414 14.894 161.562 4.488


43 43
43x43
200 0.5 100 Large 389.3 2.691 4.205 30.277 320.682 44.539

400 1 400 Large 1491.3 10.435 16.304 58.696 596.348 165.652


60 22
2.2
160 0.012 2 Small 0.6 0.014 0.018 5.345 53.374 0.178

100 0.1 10 Small 3.9 0.078 0.098 3.538 36.438 1.012


13 13
13x13
200 0.5 100 Large 39.4 0.796 1.007 7.251 72.125 10.017

400 1 400 Large 191.4 3.078 3.896 14.025 145.377 40.383


180
160 0.012 2 Small 7.5 0.015 0.019 5.677 71.217 0.237

100 0.1 10 Small 40.6 0.082 0.103 3.717 48.584 1.350


43 43
43x43
200 0.5 100 Large 389.3 0.832 1.053 7.582 96.355 13.383

400 1 400 Large 1491.4 3.219 4.074 14.667 179.186 49.774

Note . Combined standard uncertainty is ¦ 35%


(IEC 60580:2000 / IEC 60601-2-54:2009
and IEC 60601-2-54:20099+AMD1:2015).

40 0232F EN 20191213
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Quantitative Information

Loading Factors Parameter Selection Filtrat. Measured Doses

Source--Image Distance

(min. value allowed)

Output Dose Rate


Collimator blades

Input Dose Rate


Output Dose

Output Dose
Input Dose
Focal Spot

Collimator

SID Dose
Selection

(μGy*m2)

Phantom

Phantom

Phantom

Phantom
opening
Time (s)

(mGy/h)
(mmAl)

(mGy)

(mGy)

(Gy/h)

(μGy)
mAs

HVL
(cm)

(cm)
KVp

SID
mA

160 0.012 2 Small 1.4 0.087 0.136 40.753 378.000 1.260

100 0.1 10 Small 7.4 0.461 0.702 25.909 256.070 7.113


13 13
13x13
200 0.5 100 Large 74.5 4.674 7.303 52.582 511.763 71.078

400 1 400 Large 366.7 18.374 28.709 103.353 982.017 272.783


100
160 0.012 2 Small 14.3 0.090 0.141 42.391 829.043 2.763

100 0.1 10 Small 77 0.483 0.754 27.162 553.148 15.365


43 43
43x43
200 0.5 100 Large 735.9 4.884 7.632 54.949 1099.409 152.696

400 1 400 Large 2856.2 19.209 30.014 108.049 2111.165 586.435


80 29
2.9
160 0.012 2 Small 1.4 0.026 0.033 9.931 181.096 0.604

100 0.1 10 Small 7.2 0.142 0.179 6.462 120.177 3.338


13 13
13x13
200 0.5 100 Large 74.5 1.449 1.834 13.201 239.228 33.226

400 1 400 Large 366.7 5.703 7.218 25.986 480.835 133.565


180
160 0.012 2 Small 14.3 0.027 0.035 10.419 249.574 0.832

100 0.1 10 Small 77 0.149 0.189 6.799 162.094 4.503


43 43
43x43
200 0.5 100 Large 735.9 1.520 1.924 13.851 328.883 45.678

400 1 400 Large 2856.2 5.988 7.578 27.282 632.661 175.739

Note . Combined standard uncertainty is ¦ 35%


(IEC 60580:2000 / IEC 60601-2-54:2009
and IEC 60601-2-54:2009+AMD1:2015).

0232F EN 20191213 41
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Quantitative Information

Loading Factors Parameter Selection Filtrat. Measured Doses

Source--Image Distance

(min. value allowed)

Output Dose Rate


Collimator blades

Input Dose Rate


Output Dose

Output Dose
Input Dose
Focal Spot

Collimator

SID Dose
Selection

(μGy*m2)

Phantom

Phantom

Phantom

Phantom
opening
Time (s)

(mGy/h)
(mmAl)

(mGy)

(mGy)

(Gy/h)

(μGy)
mAs

HVL
(cm)

(cm)
KVp

SID
mA

160 0.012 2 Small 2.1 0.131 0.205 61.550 854.348 2.848

100 0.1 10 Large 11.2 0.698 1.091 39.282 562.852 15.635


13 13
13x13
200 0.5 100 Large 113 7.136 11.149 80.276 1132.591 157.304

400 1 400 Large 448.9 28.400 44.375 127.800 1784.097 619.478


100
160 0.012 2 Small 21 0.137 0.215 64.362 1829.478 6.098

100 0.1 10 Large 114.8 0.735 0.140 41.371 1221.809 33.939


43 43
43x43
200 0.5 100 Large 1067.6 7.491 1.347 84.277 2346.574 325.913

400 1 400 Large 4373 29.791 4.947 134.061 3901.774 1354.78


100 36
3.6
160 0.012 2 Small 2.1 0.040 0.006 15.334 396.261 1.321

100 0.1 10 Large 11.2 0.217 0.034 9.877 263.614 7.323


13 13
13x13
200 0.5 100 Large 113 2.224 0.325 20.269 536.807 74.557

400 1 400 Large 448.9 8.878 1.190 32.361 861.997 299.304


180
160 0.012 2 Small 21 0.043 0.007 16.187 555.391 1.851

100 0.1 10 Large 114.8 0.228 0.035 10.404 363.757 10.104


43 43
43x43
200 0.5 100 Large 1067.6 2.334 0.338 21.268 743.791 103.304

400 1 400 Large 4373 9.313 1.239 33.946 1173.788 407.565

Note . Combined standard uncertainty is ¦ 35%


(IEC 60580:2000 / IEC 60601-2-54:2009
and IEC 60601-2-54:2009+AMD1:2015).

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Quantitative Information

Loading Factors Parameter Selection Filtrat. Measured Doses

Source--Image Distance

(min. value allowed)

Output Dose Rate


Collimator blades

Input Dose Rate


Output Dose

Output Dose
Input Dose
Focal Spot

Collimator

SID Dose
Selection

(μGy*m2)

Phantom

Phantom

Phantom

Phantom
opening
Time (s)

(mGy/h)
(mmAl)

(mGy)

(mGy)

(Gy/h)

(μGy)
mAs

HVL
(cm)

(cm)
KVp

SID
mA

160 0.012 2 Small 2.9 0.194 0.303 90.897 1611.652 5.372

100 0.1 10 Large 19.1 1.037 1.620 58.304 7.682 0.213


13 13
13x13
200 0.5 100 Large 164.1 10.722 16.753 120.620 2195.061 304.870

400 1 400 Large 823.7 43.078 67.310 121.158 2211.652 1228.696


100
160 0.012 2 Small 29.7 0.204 0.319 95.666 3558.261 11.861

100 0.1 10 Large 163.4 1.090 1.704 61.337 2407.617 66.878


43 43
43x43
200 0.5 100 Large 1595.2 11.243 17.568 126.489 4963.617 689.391

400 1 400 Large 5679.6 45.270 70.734 127.321 4418.609 2454.783


125 45
4.5
160 0.012 2 Small 2.9 0.058 0.073 21.923 776.609 2.589

100 0.1 10 Large 19.1 0.317 0.401 14.449 520.278 14.452


13 13
13x13
200 0.5 100 Large 164.1 3.349 4.238 30.515 1068.730 148.435

400 1 400 Large 823.7 13.470 17.047 30.685 1072.487 595.826


180
160 0.012 2 Small 29.7 0.062 0.078 23.395 1085.478 3.618

100 0.1 10 Large 163.4 0.338 0.428 15.416 728.765 20.243


43 43
43x43
200 0.5 100 Large 1595.2 3.523 4.459 32.108 1509.496 209.652

400 1 400 Large 5679.6 14.191 17.961 32.330 1515.913 842.174

Note . Combined standard uncertainty is ¦ 35%


(IEC 60580:2000 / IEC 60601-2-54:2009
and IEC 60601-2-54:2009+AMD1:2015).

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Quantitative Information

Loading Factors Parameter Selection Filtrat. Measured Doses

Source--Image Distance

(min. value allowed)

Output Dose Rate


Collimator blades

Input Dose Rate


Output Dose

Output Dose
Input Dose
Focal Spot

Collimator

SID Dose
Selection

(μGy*m2)

Phantom

Phantom

Phantom

Phantom
opening
Time (s)

(mGy/h)
(mmAl)

(mGy)

(mGy)

(Gy/h)

(μGy)
mAs

HVL
(cm)

(cm)
KVp

SID
mA

160 0.012 2 Small 3.8 0.253 0.395 118.573 2493.391 8.311

100 0.1 10 Large 24.4 1.375 2.148 77.331 1679.791 46.661


13 13
13x13
200 0.5 100 Large 239.3 14.530 22.704 163.467 3508.591 487.304

400 1 400 Large 882.9 59.548 93.043 133.983 2882.504 2001.739


100
160 0.012 2 Small 38.5 0.262 0.409 122.731 5744.348 19.148

100 0.1 10 Large 210.7 1.444 2.257 81.244 3862.957 107.304


43 43
43x43
200 0.5 100 Large 2124.2 15.252 23.832 171.587 8057.739 1119.130

400 1 400 Large 8581.3 62.748 98.043 141.183 6629.009 4603.478


150 54
5.4
160 0.012 2 Small 3.8 0.077 0.098 29.337 1208.087 4.027

100 0.1 10 Large 24.4 0.426 0.539 19.410 819.235 22.757


13 13
13x13
200 0.5 100 Large 239.3 4.548 5.756 41.442 1714.226 238.087

400 1 400 Large 882.9 18.687 23.651 34.057 1409.948 979.130


180
160 0.012 2 Small 38.5 0.080 0.102 30.467 1700.870 5.670

100 0.1 10 Large 210.7 0.453 0.573 20.646 1152.939 32.026


43 43
43x43
200 0.5 100 Large 2124.2 4.803 6.078 43.764 2436.730 338.435

400 1 400 Large 8581.3 19.748 24.993 35.990 2005.983 1393.043

Note . Combined standard uncertainty is ¦ 35%


(IEC 60580:2000 / IEC 60601-2-54:2009
and IEC 60601-2-54:2009+AMD1:2015).

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2.10 DETERMINISTIC EFFECTS

Deterministic effects may occur when the Radiation dose to a certain organ or
tissue exceeds a specific threshold. Particular organs or tissues of such
concern in diagnostic Radiology are the skin and the eye lens. The numerical
value of the threshold dose is in the range between 1 Gy and 3 Gy.

As shown in the Quantitative Information Tables, the radiation dose effects


measured in this equipment are below the threshold in which the severity of
certain effects would take place on human skin or eyes lens.

This mentioned threshold was established by the International Commission on


Radiological Protection (IRCP Publication No 60).

Quantitative Information tables (Refer to Section 2.9) illustrate examples of


available loading factors for image performance and supply Dose indication,
which affect to the radiation quality or to the radiation dose rate applied in normal
use.

As indicated in the Quantitative Information Tables, the number of exposures


needed to reach the previously described maximum radiation values will
depend on the selected techniques for each radiographic study.

2.11 PRODUCT COMPLAINTS

Any health care professional (for example a customer or a user) who has any
complaints or has experienced any dissatisfaction with the quality, durability,
reliability, safety, effectiveness, or performance of this product must notify Agfa.

If the device malfunctions and may have caused or contributed to a serious


injury of a patient, Agfa must be notified immediately by telephone, fax or written
correspondence to the following address:

Agfa Service Support - local support addresses and phone numbers are listed
on www.agfa.com

Agfa - Septestraat 27, 2640 Mortsel, Belgium

Agfa - Fax +32 3 444 7094

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SECTION 3 START UP AND SHUTDOWN

3.1 START UP WITH X-RAY GENERATOR CONTROL

The System should be powered by the same Room Electrical Cabinet where
the X-ray Generator is connected, that is, the whole System will be powered
from the same Electrical Cabinet.

To turn the System ON:

1. Turn ON Room Electrical Cabinet Switch. The Emergency OFF Switch


must not be activated.

IN THE EVENT OF AN EMERGENCY FORCIBLY DEPRESS


THE X-RAY ROOM “EMERGENCY OFF SWITCH” (USUALLY
A RED MUSHROOM-SHAPED SWITCH).

THIS SWITCH SHOULD BE LOCATED ON OR NEAR THE


X-RAY ROOM ELECTRICAL CABINET, USUALLY PLACED
NEAR THE GENERATOR CONTROL CONSOLE. MORE THAN
ONE OF THESE SWITCHES MAY BE PLACED AROUND THE
ROOM FOR GREATER ACCESSIBILITY.

TO ISOLATE THE EQUIPMENT FROM MAINS, TURN OFF THE


SWITCH LOCATED AT THE ROOM ELECTRICAL CABINET.

2. Check that the Emergency OFF Switch of the Table is not depressed and
the protective Circuit Breaker located at the lower back of the Table, right
side of the lower cover is in ON position to allow Table operation.

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3. Press the X-Ray Generator Control ON button, the Green Lamp turns
ON.

4. Turn ON the NX Workstation.

Illustration 3-1
Start Up sequence

1
Room
Electrical
Cabinet
NX Workstation

2 3
X-Ray
Generator
Control

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3.2 SHUTDOWN ROUTINE WITH X-RAY GENERATOR CONTROL

To turn the System OFF:

1. Turn OFF the NX Workstation.

2. Press the X-Ray Generator Control OFF button, the Green Lamp turns
OFF.

3. Turn OFF the Room Electrical Cabinet Switch (with the Emergency
Switch in OFF position).

Note . It is not necessary to turn OFF the Circuit Breaker or the


Emergency Off Switch of the Table before turning off the Room
Electrical Cabinet Switch.

Illustration 3-2
Shutdown sequence

1 3
NX Workstation Room
Electrical
Cabinet

X-Ray
Generator
Control

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SECTION 4 OPERATION

USE THE EQUIPMENT HAND-GRIPS TO CONTROL AND


DRIVE THE UNIT MOVEMENTS, NEVER PUSH DIRECTLY ON
THE RECEPTOR, X-RAY TUBE OR COLLIMATOR.

MONITOR THE SYSTEM MOVEMENTS WITH SPECIAL CARE.


AVOID ANY IMPACT OF THE SYSTEM ON FLOOR, CEILING
OR OTHER ELEMENTS IN THE ROOM. IT MAY CAUSE
SERIOUS DAMAGE TO THE EQUIPMENT.

MONITOR WITH SPECIAL CARE THE PATIENT POSITION


(HANDS, FEET, FINGERS, ETC.) AND USE THE PATIENT
HAND-GRIPS TO AVOID INJURY TO PATIENT CAUSED BY
TABLE-TOP MOVEMENTS. PATIENT HANDS MUST BE KEPT
AWAY FROM MOBILE COMPONENTS OF THE UNIT.

OPERATOR SHOULD NEVER MOVE TABLE-TOP FROM


LATERAL SIDE (PATIENT HEAD OR FEET). IT MAY CAUSE
FINGERPINCH UNDER THE TABLE-TOP.

INTRAVENOUS TUBING, CATHETERS AND OTHER PATIENT


CONNECTED LINES SHOULD BE ROUTED AWAY FROM
MOVING EQUIPMENT.

4.1 FLOOR MOUNTED TUBE STAND

Operation controls for the Floor Mounted Tube Stand are located at the Control
Panel and on the Semicircular Base of the Column.

4.1.1 COLUMN ROTATION CONTROL

The Column rotation must be manually positioned by the Operator. Step on the
Pedal located at the Base of the Column and then rotate the Column to the
desired angle. Release the Pedal to lock the Column in position.

This motion can reach ±180o with detents at 0o, 90o and --90o.

Rotation may be limited by cables. Avoid strain on the cables


when rotating.

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4.1.2 DX-D 400 ANALOG CONTROL PANEL

Illustration 4-1
DX-D 400 Analog Control Panel

Horizontal Movement Rotational Movement

Vertical Movement Transverse Movement

All Movements Light Indicators

HORIZONTAL MOVEMENT: Activate this button to allow horizontal movement


of Column in order to achieve SID (Source-Image Distance) with respect to RAD
Wall Stand Receptor. Also this control is used to horizontally position Column
with respect to RAD Table Receptor. Release button to lock in position.

VERTICAL MOVEMENT: Activate this button to allow vertical movement of the


Tube-Collimator Assembly in order to achieve the desired SID (Source-Image
Distance) with respect to RAD Table Receptor. Also this control is used to
vertically position Tube-Collimator Assembly with respect to RAD Wall Stand
Receptor. Release button to lock in position.

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VERTICAL MOVEMENT: Press and hold this button to allow vertical movement
of the Tube-Collimator Assembly in order to achieve the desired SID with
respect to the Horizontal Receptor. This control is also used to vertically position
the Tube-Collimator Assembly with respect to the Vertical Receptor. Release
this button to lock the Tube-Collimator Assembly in vertical position.

ROTATION: Press and hold this button to allow rotation of the Tube-Collimator
Assembly to the desired angle. Release this button to lock in position.

This movement has detents at 0o, 90o and --90o which are shown on the Angle
Display. Press this button again to continue with movement.

TRANSVERSE MOVEMENT: Press and hold this button to allow transverse


movement of the Tube-Collimator Assembly. Release this button to lock the
Tube-Collimator Assembly in position.

FREE MOVEMENTS: Press and hold this button to allow Horizontal, Vertical
and Rotation movements at the same time. Release button to lock in position.

Operating this button disables the corresponding detents.

LIGHT INDICATORS: An indicator will illuminate at the Control Panel when one
of the following positions is reached:

Not applicable.

Focal Distance 100 cm (40”) to Vertical Receptor.

Focal Distance 180 cm (72”) to Vertical Receptor.

X--ray Tube axis centered with relationship to either Receptor.

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4.1.2.1 VERTICAL SID REFERENCE LABEL

DX-D 400 with Analog Control Panel and Fixed height Table includes a Vertical
SID reference label to provide the operator a quick SID reference.

The Horizontal Receptor SID reference is indicated as a label stuck in the


Column, which reference point is the lower part of the Column carriage.

Illustration 4-2
Vertical SID Reference Label

Scale Mark 100 cm (40”)

The reference mark is the


lower part of the carriage

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4.1.3 DX-D 400 DIGITAL CONTROL PANEL

Illustration 4-3
DX-D 400 Digital Control Panel

SID Display Angle Display


Centering Indicator

Transversal Movement Horizontal Movement

Rotational Vertical Movement

All Movements All Movements

After the System is turned ON, a start up routine begins and the Control Panel
shows for three seconds the software version (a.e. V01 R0.0 = Vers.01 R0.0).

Then, the Display shows the position data of the Tube-Collimator Assembly.
(Angle and SID).

ANGLE DISPLAY: Indicates the Angle value of the Tube-Collimator Assembly


with respect to its vertical axis. In case of error, this Display flashes the error
code to be referenced (a.e. “E06”).

SID DISPLAY: Indicates the Source-Image Distance (SID). The SID Display
shows “------” when the SID value is not defined, that is, when the
Tube-Collimator Assembly is not within the range of ±45o with reference to its
vertical axis or when it is not perpendicular to the RAD Wall Stand Receptor.

When the Tube-Collimator Assembly is pointing the RAD Wall Stand Receptor,
the Display shows the SID values configured during installation at the time each
distance is reached (a.e 110-150-180).

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HORIZONTAL MOVEMENT: Activate this button to allow horizontal movement


of Column in order to achieve SID (Source-Image Distance) with respect to RAD
Wall Stand Receptor. Also this control is used to horizontally position Column
with respect to RAD Table Receptor. Release button to lock in position.

This movement is provided with detents related to the distance from the RAD
Wall Stand Receptor (that can be modified during the configuration of the
equipment). The detent point is shown at SID Display when the distance is
reached with respect to the RAD Wall Stand Receptor. The Display only shows
configured positions (a.e 110-150-180). Press this button again to continue
movement.

VERTICAL MOVEMENT: Activate this button to allow vertical movement of the


Tube-Collimator Assembly in order to achieve the desired SID with respect to
RAD Table Receptor. Also this control is used to vertically position
Tube-Collimator Assembly with respect to the RAD Wall Stand Receptor (in this
case the Display is not showing height). Release button to lock in position.

This movement is provided with a detent at 100 cm (40”) (shown at SID Display)
when the distance is adjusted with respect to the RAD Table Receptor. Press
this button again to continue movement.

Note . Horizontal and vertical movements always correspond to the


button arrow direction, that is, the buttons for horizontal and
vertical movement interchange its function when the
Tube-Collimator is turned 61 o left or right.

ROTATIONAL MOVEMENT: Activate this button to allow vertical rotation of


Tube-Collimator Assembly to the desired angle. Release button to lock in
position.

This movement has detents at 0o, 90o and --90o shown at Angle Display. Press
this button again to continue with movement.

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TRANSVERSE MOVEMENT: Activate this button to allow transverse


movement of Tube-Collimator Assembly. Release button to lock in position.

This movement is provided with a detent when the Tube-Collimator Assembly


LOCK is centered with respect to the RAD Table Receptor (“LOCK” indicator lits).
Press this button again to continue movement.

ALL MOVEMENTS: Activate this button to allow Horizontal--Vertical--Rotation


movement at the same time. Release button to lock in position.

Operating this button disables the corresponding detents.

DIGITAL CONTROL PANEL ERROR CODES: Error codes indicate the


potential cause of a system failure. They appear on the Digital Control Panel
Display and will enable the operator to indirectly convey the possible source of
error to service personnel. This may prevent the need for a service call or enable
service personnel to anticipate corrective actions prior to arriving on site.

Table 4-1
Error Codes

ERROR DESCRIPTION WHAT TO DO

Turn the Generator OFF,


Exposure” or/and “Preparation” orders are check the proper external cable connections and then turn
“E06“
activated during power-up. the Generator ON. If the equipment remains inoperative,
turn it OFF and call Field Service.

Turn the System OFF / ON. If the error remains, turn it


“E10” Failure in memory Integrated Circuit.
OFF and call Field Service.

Turn the System OFF / ON. If the error remains, turn it


“rAN Err“ Failure in Microcontroller.
OFF and call Field Service.

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4.1.4 RALCO MANUAL COLLIMATOR R225/R225 DHHS

Collimator controls consist of a button to switch on the Collimator lamp and two
knobs to open or close the internal blades of the Collimator.

When pressing the Collimator Lamp push-button, the Collimator light and an
optional Laser light turn on. They remain lighting for 30 seconds before they
switch Off automatically (lighting time can be configured).

Exposure field on the Receptor is adjusted by setting the two knobs. The table
on the Front Panel shows the number to set with the knobs to open the blades
according to the SID and X-ray field to be used.

Illustration 4-4
Collimator Controls

Knobs to open or close


the Collimator blades

Collimator Lamp Push-button

Additional variable filtration with manual settings may be optionally added to the
minimum collimator filtration in the form of an aluminium disk, 1mm thickness,
controlled manually from the front panel.

The disk features a hole for the passage of X-Rays and accommodates the
following three filters:

( ): no filtration.

( _ ): 0,1mm copper 1mm Al. (Al eq. 2.8mm)

( _ _ ) 0,2 mm copper + 1mm Al . (Al eq. 5.6 mm)

( _ _ _ ) 1mm aluminum + 1 mm Al support.

Note . Refer to the corresponding Collimator Manual for extended


information about operation or technical description needed to
maintain compliance with Standard IEC 60601--1--3: 2008.

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4.1.5 RALCO AUTOMATIC COLLIMATOR R225ACS

Collimator controls:

1. Collimator Display
2. Manual Blade Control
3. Automatic Mode Indicator (Green)
4. System not ready Indicator (Red)
5. Manual Mode Indicator (Yellow)
6. Change of Filter
7. Collimator Lamp Control (Led “ON”)
8. Retractable Metric Tape
9. Laser Pointer Window
10. Laser Pointer On/Off Button

Transverse Field Size


Longitudinal Field Size

1 1

Source to Image Distance


3 4 5
Manual Blade Knobs 2

6 2
7

10 9 8

When pressing the Collimator Lamp push-button, the Collimator light and an
optional Laser light turn on. They remain lighting for 30 seconds before they
switch Off automatically (lighting time can be configured).

Exposure field on the Receptor is automatically adjusted, or when in manual


mode by setting the two knobs. The Collimator Display shows the selected field
size (cross / long).

The Collimator can rotate ±90o on its vertical axis while the Tube remains in the
same position. This movement is performed by manually turning the Collimator
and has detents every 90o.

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4.2 DOSEMETER DEVICE (OPTIONAL)

The optional Dosemeter device is related to the Collimator installed in the Tube
Stand. It is used for simultaneously determining the dose area product, dose
area product rate and irradiation time. The usual compatible Dosemeter
devices are VacuDAP 2004 Series.

Note . Refer to the corresponding Dosemeter Manual for extended


information about operation or technical description needed to
maintain compliance with Standard IEC 60601--1--3: 2008.

4.3 RAD TABLE

Follow operation instructions for “RAD Table -- Fixed Height Table” (refer to
Section 4.3.1) or for “RAD Table -- Elevating Table” (refer to Section 4.3.2)
depending on the type of table installed at site.

4.3.1 RAD TABLE -- FIXED HEIGHT TABLE

The Table-Top movement is controlled by the Brake Pedal. Press on the


Receptor Carriage Handle Button to position it.

Table-Top Receptor Carriage Handle

Emergency-Off Switch

Table-Top Brake Pedal Table-Top Lock Switch

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THE MAXIMUM PATIENT WEIGHT SUPPORTED WITH THE


TABLE-TOP AT ANY POSITION IS 350 KG (771 LBS) EVENLY
DISTRIBUTED OVER THE SURFACE OF THE TABLE-TOP.
EXCEEDING THIS LIMIT MAY CAUSE EQUIPMENT DAMAGE
OR INJURY TO THE PATIENT.

ON / OFF / EMERGENCY OFF SWITCH: The Table and the Floor Mounted
Tube Stand are ON whenever the Generator Console is ON and the Table
Emergency OFF Switch is not depressed. The Table and the Floor Mounted
Tube Stand are OFF when the Generator Console is OFF or when the
Emergency OFF Switch is pressed.

IN THE EVENT OF AN EMERGENCY, TURN OFF THE TABLE


PRESSING FORCIBLY THE “EMERGENCY OFF SWITCH”
(RED MUSHROOM-SHAPED SWITCH) ON THE TABLE OR AT
THE ROOM ELECTRICAL CABINET.

CIRCUIT BREAKER: The Table includes a protective Circuit Breaker located


at the lower back cover. This breaker should remain in ON position to allow
Table operation.

TABLE-TOP LOCK SWITCH: This security switch disables Table-Top


horizontal movement avoiding any unexpected Table-Top motion (e.g. patient
steps on Pedal while sitting on Table before positioning or getting off the Table).

BEFORE PATIENT SITS OR GETS OFF THE TABLE PRESS


TABLE-TOP LOCK SWITCH TO AVOID PATIENT INJURY OR
DAMAGE TO EQUIPMENT.

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TABLE-TOP BRAKE PEDAL: The Table-Top is provided with four-way floating


movement for better patient positioning.

Press and hold Pedal in order to release longitudinal and transverse brakes of
Table-Top. Release Pedal to apply brakes.

The transverse motion is blocked when the Table-Top is centered with respect
to its horizontal axis. Step again to continue motion.

The Collimator Lamp turns on automatically when this Pedal is pressed for ease
in patient positioning.

Note . For Receptor Assembly information refer to Section 4.6.

4.3.2 RAD TABLE -- ELEVATING TABLE

The RAD Table with its variable height has been designed for easy access from
beds, wheelchairs or stretchers with patient care and comfort in mind.

The Table-Top travels are controlled with the Pedals located at the Table Base.
Also the Table incorporates two safety devices and a control for the RAD Table
positioning.

Table-Top Receptor Carriage Handle

Emergency-Off Switch

Telescopic Covers

Up Pedal
Table-Top Lock Switch
Down Pedal
Table-Top Motion Pedal

THE MAXIMUM PATIENT WEIGHT SUPPORTED WITH THE


TABLE-TOP AT ANY POSITION IS 350 KG (771 LBS) EVENLY
DISTRIBUTED OVER THE SURFACE OF THE TABLE-TOP.
EXCEEDING THIS LIMIT MAY CAUSE EQUIPMENT DAMAGE
OR INJURY TO THE PATIENT.

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ON / OFF / EMERGENCY OFF SWITCH: The Table and the Floor Mounted
Tube Stand are ON whenever the Generator Console is ON and the Table
Emergency OFF Switch is not depressed. The Table and the Floor Mounted
Tube Stand are OFF when the Generator Console is OFF or when the
Emergency OFF Switch is pressed.

IN THE EVENT OF AN EMERGENCY, TURN OFF THE TABLE


PRESSING FORCIBLY THE “EMERGENCY OFF SWITCH”
(RED MUSHROOM-SHAPED SWITCH) ON THE TABLE OR AT
THE ROOM ELECTRICAL CABINET.

Note . Whenever the Table is powered on it takes twenty seconds


(start-up routine) previous to perform any motion.

CIRCUIT BREAKER: The Table includes a protective Circuit Breaker located


at the lower back cover. This breaker should remain in ON position to allow
Table operation.

TABLE-TOP LOCK SWITCH: This security switch disables Table-Top


horizontal movement avoiding any unexpected Table-Top motion (e.g. patient
steps on Pedal while sitting on Table before positioning or getting off the Table).

BEFORE PATIENT SITS OR GETS OFF THE TABLE PRESS


TABLE-TOP LOCK SWITCH TO AVOID PATIENT INJURY OR
DAMAGE TO EQUIPMENT.

THIS RAD TABLE PROVIDES A SAFETY SYSTEM UNDER


TABLE-TOP WHICH STOPS DOWN PEDAL MOVEMENT
WHEN TRAVEL FINDS AN OBSTACLE.

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Illustration 4-5
Elevating Table Pedals

Table-Top Down Up Table-Top

TABLE-TOP MOVEMENT PEDALS: Step on any of the two pedals (at both
ends of the Pedal row) in order to release longitudinal and transverse brakes,
this allows free movement of Table-Top for better positioning of patient.
Release Pedal to block movement.

The transverse movement is blocked when the Table-Top is centered with


respect to its horizontal axis. Release the pedal and step twice again to continue
movement.

The Service Engineer can modify the configuration of the pedals and change
from the single step to release longitudinal and transverse brakes of the
Table-Top to a double step.

UP PEDAL: Step on Pedal in order to lift Table-Top to desired height. Release


Pedal to stop movement.

DOWN PEDAL: Step on Pedal in order to lower Table-Top to desired height.


Release Pedal to stop movement.

Note . A Height Detent in the Up and Down Travel of the Table-top can
be set by the Service Engineer to stop the Table-Top automatically
at the operator desired height.

Note . For Receptor Assembly information refer to Section 4.6.

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4.3.3 HAND GRIPS (OPTIONAL)

The Hand Grips are used by patients and operators to keep their hands away
from the Tabletop edges and make the patient feel safe while the table-top is
being positioned.

Insert the Hand Grip in the rails and fix it at the desired position by turning
clockwise the Grip.

USE ALWAYS THE HAND GRIPS TO AVOID INJURIES IN


PATIENT HANDS OR FINGERS WHEN THE TABLETOP IS IN
MOVEMENT. PATIENT’S HANDS MUST BE KEPT AWAY FROM
THE TABLETOP EDGES IN EVERY MOMENT.

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4.3.4 COMPRESSION BAND (OPTIONAL)

This device supplies compression to the anatomical area of interest in order to


avoid unnecessary movements.

It is mounted on the Tabletop rails. Install both brackets of the Compression


Band in the Table-top rails, roll the band in the shaft, engage the end of the band
in with the hooks and use the lever lock or unlock the Compression Band to get
the required tension of the Band.

Illustration 4-6
Compression Band Operation

Compression Band as delivered Insert the Band Support and the opposite Support in the Table-top
Rails

Lock Lever

Extend the Band, hook one end and obtain the required tension with the Lock Lever

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4.3.5 LATERAL DETECTOR HOLDER (OPTIONAL)

The Lateral Detector Holder is used for Table lateral work, including knee,
shoulder, skull, etc.

This Lateral Detector Holder is installed directly on the Tabletop rails. Insert the
Hand Grip in the rail and fix it at the desired position by turning clockwise the
Grip.

It can hold a standard Detector of 24 x 30 cm or 35 x 43 cm.

Illustration 4-7
Lateral Detector Holder placement

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4.3.6 LATERAL DETECTOR HOLDER ON TABLE (OPTIONAL)

The Lateral Detector Holder is used for Table lateral work, including knee,
shoulder, skull, etc.

This Lateral Detector Holder is placed directly on the Tabletop.

It can hold a Detector of 35 x 43 cm.

Illustration 4-8
Lateral Detector Holder placement

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4.3.7 LATERAL DETECTOR HOLDER WITH TROLLEY

This mobile detector holder is designed to accommodate portable DR detectors


of 35x43 cm (14”x17”) .

Illustration 4-9
Lateral Detector Holder 35x43 with Trolley

Insert the portable DR Detector in the Support, the orientation is always


landscape.

Illustration 4-10
Detector Installation

Vertical Lock Lever

Note . Make sure that the Vertical Lock is blocked when mounting the
Detector to avoid unexpected falls down and damages of the
Detector and Support.

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The Holder is adjustable for height, the vertical travel of the Detector is 750 mm
(29.5”). To move up/down the Detector Support:

1. Loosen CCW the Vertical Lock Lever To get free the Detector Support.
Hold the Detector Support during this procedure to avoid unexpected
falls down.

Illustration 4-11
Vertical Lock Lever

Release the Lock

Activate the Lock

2. Move the Detector up to the desired height.

3. Tighten CW the Lever to fix again the Support at its new position.

The Holder is also mobile, it is provided with four wheels and each with its own
brake pedal. To lock the wheel step the brake pedal.

Illustration 4-12
Wheel Brake Pedal

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To move the Holder in order to place it in its working position or to store it,
proceed as indicated below:

1. Unlock all wheels.

2. Push the Holder from its Vertical Bar and carry it where corresponds.

DRIVE THE EQUIPMENT WITH CARE. AVOID ANY IMPACT OF


THE UNIT WITH WALLS, FURNITURE OR OTHER ELEMENTS
IN THE ROOM THAT MAY CAUSE DAMAGE TO THE
EQUIPMENT AND/OR THE OTHER ROOM ELEMENTS.

DRIVE THE EQUIPMENT IN FLAT SURFACES. IF IT IS NOT


POSSIBLE, TRAVEL SURFACES SHOULD NOT EXCEED 5o
INCLINATION RAMPS, EXCEEDING THIS ANGLE COULD
CAUSE SERIOUS DAMAGE TO THE EQUIPMENT, AND BY
USING IT UNDER THESE CONDITIONS COULD EVENTUALLY
REPRESENT A DANGER FOR THE USER.
HOLD ALWAYS THE VERTICAL BAR TO DRIVE CORRECTLY
THIS ACCESSORY EQUIPMENT.

Do not try to step over any possible obstacle when moving


the holder, the equipment could fall over.

ASSEMBLY PROCEDURE

Before its first use, the Holder must be mounted in the field as it is shipped
splitted. Refer to the image below for graphical information about its assembly
procedure.

1. Tighten the Column to the Trolley.

2. Mount the Detector Support and lock it with the Vertical Lock Lever.

Illustration 4-13
Detector Holder Assembly Procedure

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4.4 RAD WALL STAND

The RAD Wall Stand enables radiographic operations at different positions


within the range of the Receptor Assembly vertical movement.

ON / OFF: The equipment is turned ON / OFF when the X-ray Generator is


turned ON / OFF.

RECEPTOR ASSEMBLY: The Wall Receptor can house a Cassette Film, CR


or a Digital Detector with the following characteristics:

 Chin Rest.

 Ion Chamber Housing.

 Front Panel with AEC Detector Areas and very low absorption level.

 Fixed or Removable Grid.


Chin Rest

Front Panel

Detector Tray handle

Removable Grid

AEC Areas

Note . Loading of Receptor can be adapted at right or left side as per


installation requirements.

Note . Refer to Section 4.6 for extended information on the Receptor


Assembly.

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4.5 RAD WALL STAND - MANUAL TILTING

The RAD Wall Stand -- Manual Tilting enables radiographic operations at


different positions within the range of the Vertical Carriage travel, adjustable
tilting angles as well as rotation of the Receptor Assembly.

Column

Vertical Carriage

Table-Top

Cassette Tray Control for Vertical Lock

Controls for Tilting Lock

Lever Lock for Rotation Control for Vertical Lock

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ON / OFF: The equipment is turned ON / OFF when the X-ray Generator is


turned ON / OFF.

RECEPTOR ASSEMBLY: The Wall Receptor can house a Cassette Film, CR


or a Digital Detector with the following characteristics:

 Chin Rest.

 Ion Chamber Housing.

 Front Panel with AEC Detector Areas.

 Fixed or Removable Grid.

TILTING AND ROTATION MOVEMENT OF RECEPTOR: Refer to Sections


4.5.1 and 4.5.2 for a detailed information about both movements.

Note . Loading of Receptor can be adapted at right or left side as per


installation requirements as well as the Handle.

Note . Refer to Section 4.6 for extended information on the Receptor


Assembly.

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4.5.1 TILTING OF RECEPTOR ASSEMBLY

The Receptor Assembly allows a tilting range from --20o to a horizontal position
of 90o (0o is the vertical position). A mechanical detent is provided to lock the
Receptor Assembly at 0o (vertical position).

Release the Mechanical Detent. Press and hold the Tilting Lock Button to
release the electrical lock and manually tilt the Receptor Assembly. Place the
hand at the lower part of the Receptor Assembly and push it slightly in opposite
direction of the Tilting movement and hold the Receptor Assembly until it
reaches the desired Angle. The inclination is indicated on both lateral
goniometers.

DRIVE CAREFULLY MOVEMENTS OF THE RECEPTOR


ASSEMBLY WHEN RELEASING THE ANGLE LOCKS, THE
INTERNAL SPRINGS TEND TO GO UP AND THE RECEPTOR
ASSEMBLY MAY HIT THE PATIENT.

Goniometer for Tilting Tilting Lock Button

Tilting Movement Direction


Mechanical Detent

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4.5.2 ROTATION OF RECEPTOR ASSEMBLY

The Receptor Assembly allows a rotation range of 90o clockwise if the


Removable Grid is left loading, or a rotation range of 90o counterclockwise if
the Removable Grid is right loading. The vertical position is 0o.

Push the Lever Lock located at the right side of the Receptor Assembly and
manually rotate the Receptor Assembly to the desired position. The rotation
angle is indicated in the goniometer located at the back side. Once rotated, lock
the Lever for Rotation by placing it in its upper position.

Goniometer for Rotation


Back of Receptor Assembly

Lever Lock for Rotation

Lever Lock for Rotation

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Horizontal Rotation of the Receptor Assembly is not allowed.


The Receptor Assembly may be damaged if it bumps the
Column. From the Horizontal position of the Receptor, tilt the
Assembly a minimum of 45 o. Rotate the Assembly and
position the Assembly at 0 o.

Attention, never do place hands or fingers neither let patient


hands or fingers inside the Tilting Assembly as shown below:
it may cause serious injuries to patient or operator.

As well, make sure that the patient extremities are inside the
tabletop or accessories limits during operation: movement of
parts may cause serious damages to patient.

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4.5.3 ARM SUPPORT (OPTIONAL)

The Wall Stand can be prepared to hold an Arm Support. In that case, the side
of the Column Carriage includes an Arm Support holder with a knob.

Insert the Arm Support in the holder and screw the knob.

4.5.4 HAND SUPPORTS (OPTIONAL)

The Wall Stand may include Hand Supports. In that case, the Assembly will be
provided with the corresponding Hand Supports (x2) on two sides of it.

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4.6 RECEPTOR ASSEMBLY (TABLE AND WALL STAND)

The Receptor Assembly may include a Fixed Receptor (DR) or a Portable


Receptor (Cassette/CR/DR).

The Receptor Assembly for Portable Receptors include a Tray to conveniently


load the Receptor.

The Receptor Assembly may also house other optional parts such as the Grid
(Fixed or Removable) and the Ion Chamber, used for AEC exposures.

A Cassette-size-sensing Tray can be adapted for Automatic Collimators.

Fixed Receptor Assembly in a Rad Table Portable Receptor Assembly in a Wall Stand

4.6.1 TRAVEL OF THE RECEPTOR ASSEMBLY (TABLE AND WALL STAND)

Illustration 4-14
Travel distances of the Receptor Assembly
1500 mm

255 255

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HORIZONTAL MOVEMENT OF THE TABLE RECEPTOR ASSEMBLY

The Receptor can be moved beneath the Tabletop to the desired position. Press
and hold the brake button to unlock the Receptor and move it manually.

Illustration 4-15
Receptor Brake Buttons

Brake Button in Assembly for Fixed Receptor

Brake Button in a Portable Receptor


Assembly with Non-Rotating Tray

VERTICAL MOVEMENT OF THE WALL STAND RECEPTOR ASSEMBLY

The Receptor is assembled to a carriage that slides vertically along the Column
Stand. Hold down the Carriage Handle button in order to perform vertical
positioning with respect to the patient. Release button to stop motion. The
Vertical movement is locked when the equipment is turned OFF.

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4.6.2 RECEPTORS

The Table and Wall Stand are compatible with a wide range of Receptors:

Type of Receptors

Cassette-Film or Computerized Radiography (CR) with Bucky Assembly

Fixed Digital Detector

Portable Digital Detector (wired)

Portable Wireless Digital Detector wifi connected

Note . For extended Receptor Information, refer to the corresponding


Receptor Manual provided with the System Manuals.

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4.6.3 TRAY FOR CASSETTE FILM OR CR (TABLE OR WALL STAND)

The Bucky Assembly is installed on a carriage, below the Tabletop. It contains


a manual Cassette Tray, which accepts all the standard Cassette / CR sizes
from 13x18 cm to 35x43 cm (5x7” to 14x17”).

RECEPTOR TRAY (Cassette / CR): Pull out the Tray to load a Receptor
according to its size and orientation. Place manual clamps at corresponding
numbered notch, open the automatic clamp and insert the Cassette. This Tray
accepts all standard Cassette/CR sizes.

(*) these pictures correspond to a Table Bucky Assembly


but also describe the usage in a Wall Stand.

Fully open the Tray Set the manual clamps at the corresponding number

Open the Automatic Clamp, Insert the Cassette and Lock the Cassette and insert the Tray
adjust it to the Cassette

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4.6.4 FIXED RECEPTOR ASSEMBLY (TABLE OR WALL STAND)

It includes the Detector, Detector Cabinet with fixed or removable Grid and Ion
Chamber Housing.

Rad Tables include the Brake Button to move horizontally the Assembly.

Brake Button
Fixed Detector in a Table

Wall Stands include the Brake Button in the Carriage to move Vertically the
Assembly.

Fixed Detector in a Wall Stand

Brake Button

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4.6.5 PORTABLE RECEPTOR ASSEMBLY (TABLE OR WALL STAND)

4.6.5.1 PORTABLE RECEPTOR ASSEMBLY WITH ROTATING TRAY

Illustration 4-16
Portable Receptor Assembly in the Rad Table

Tabletop

Grid

Digital Detector

Tray

Handle Bar
Assembly Lock Button

Illustration 4-17
Portable Receptor Assembly with Rotating Tray in the Wall Stand

Tray
Chin Rest
Handle Bar

Tabletop

AEC Areas

Digital Detector

Grid

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The Portable Receptor Assembly with Rotating Tray has been designed to
conveniently house a Receptor, an Ion Chamber and a Grid. It can also provide
the system with information about the position and status of the Grid and
Detector. The Digital Detector is always loaded in Landscape position and can
be manually rotated to Portrait position.

The Handle of the Assembly includes a Bar for extracting the Tray. In the RAD
Tables, the Brake Button also allows the horizontal movement of the Receptor
Assembly.

Note . Loading of Receptor can be adapted at right or left side as per


customer order requirements.

The Rotating Tray includes two main detents in its horizontal movement:

 Fully Inserted with the receptor in Horizontal or Vertical Position and


ready for exposition.

 Fully open, for rotation and loading.

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LOADING AND UNLOADING THE TRAY

1. Grab the Handle and pull the Tray until it is completely out.

2. Then place the Detector, centered on the Tray and insert it in the tray.
Push slightly the end-stops with the Detector end until it is fitted in the
frame of the tray.

Illustration 4-18
Tray Loading

3. To unload de Receptor, fully extract the tray.

4. Push the Detector towards the end Stop and carefully lift and remove the
Detector with both hands.

Illustration 4-19
Tray unloading

1
1

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ROTATING THE TRAY

1. Pull out the Receptor Tray to the end of its travel (Rotating Position).

2. Insert the Rceptor in the Tray.

3. Push the Tray Counterclockwise until it rotates 90o to achieve Portrait


position.

4. Guide the Receptor Cable through the Cable Clips and insert the Tray.

Due to moving parts within the Detector Cabinet, all body


parts and objects must be clear of possible Pinch Areas
between the Detector Cabinet and the Rotating Tray.

4.6.5.2 PORTABLE RECEPTOR ASSEMBLY WITH NON-ROTATING TRAY

The Portable Receptor Assembly with Non-Rotating Tray is designed to


conveniently house a Portable Detector, an Ion Chamber and a Grid. The
Operator can load the Digital Detector in Portrait or Landscape position.

The Handle of the Assembly includes a Brake Bar for extracting the Tray.

In Rad Tables, the Handle also contains a Brake Button to move horizontally the
Receptor Assembly.

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Illustration 4-20
Portable Receptor Assembly with Non-Rotating Tray in Rad Table and Wall Stand

RAD Table Wall Stand

Brake Bar

Brake Button in a Portable Receptor


Assembly (only for Rad Table)

LOADING AND UNLOADING THE TRAY

1. Grab the Handle and pull the Tray until it is completely out.

2. Then place the Detector centered in the Tray and push slightly the
end-stops with the Detector until it is fitted in the four stops of the tray.

Illustration 4-21
Detector Loading

3. Guide outside the Detector Cable (if applicable) to avoid cable jams. Use
the Cable Clips to guide the cable out safely and fully insert the Tray.

4. To unload the Detector, grab the Handle and pull the Tray until it is
completely out.

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5. Push the Detector towards the end Stop and carefully remove the
Detector .

CABLE GUIDING IN TETHERED DETECTORS

In Systems with a Single panel for Wall Stand and Table or Systems with
external connection of the Detector, it is recommended to use a Extensible
Cable Hanger (not included in the System) located in a convenient place of the
ceiling, between the Table and the Wall Stand (or any other type of positioners),
to avoid damages to the Detector Cable.

Illustration 4-22
Cable to the Horizontal and Vertical Positioner
Extensible Cable Hanger Extensible Cable Hanger
Digital Detector Cable
Digital Detector Cable

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4.6.6 GRIDS

Grids are intended to reduce scattered radiation and significantly enhance


image quality. Before using the Grid, clean the front and back side with a dry
cloth to remove dust and dirt.

The Wall Stand and the Table may hold a Removable Grid. The Grids are
labelled 100 cm (40”), 150 cm (59”) or 180 cm (70”). Use the corresponding Grid
according to the SID (Source to Image Distance).

When inserting the Grid in the Grid Slot, pay special attention to the type of
focalization distance of each Grid.

Check the correct insertion of the Grid in the slot with the label side facing the
Tube. A click sound means that the Grid is in place.

Handle the Grid with care. Dropping the Grid could cause
damage and reduced image quality.

Grid Handle Removable Grid

Removable Grid

SID Label

Grid Handle

SID Label

Table
Wall Stand

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4.6.7 USING AND MAINTAINING THE DIGITAL DETECTOR

Before Exposure, check the equipment daily and confirm that it works properly.

The action of the Air-Conditioning or Heating may produce condensation in the


equipment, wait until the condensation evaporates before performing an
exposure. As a general rule, raise or lower the room temperature gradually to
avoid condensation.

During exposure, do not use the Detector near devices generating a strong
magnetic field.

For Wireless Detectors, do not cover the IR Data Port with hands or other parts
of the body and do not use the selected frequency channel (2.4 GHz band) for
other wireless devices.

After every examination, wipe with a cloth slightly damped the patient contact
surfaces as well as the handle and Grid with disinfectants such as ethanol. For
cleaning, wipe with a cloth damped in neutral detergent.

Note . For further information on the Digital Detector Handling and


Maintenance, refer to the Digital Detector manuals.

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4.7 X-RAY BEAM ALIGNMENT WITH RESPECT TO PATIENT

After selecting RAD parameters for the technique to be performed:

1. Point the X-Ray Tube-Collimator Assembly to the Image Receptor.

2. Center the Collimator light, which corresponds to the X-Ray beam, with
respect to receptor. For that, use the Collimator Light centering marks
and the laser line on the receptor handle if applicable.

3. Position the patient for the examination.

4. Turn ON the Collimator Lamp and adjust the field size with the Collimator
controls.

5. Perform any adjustment in the patient position, in the receptor or in the


tube collimator assembly to assure that the X-Ray beam is correctly
positioned.

Illustration 4-23
Patient Positioning

Collimator Knobs

Laser Line X-Ray Beam Collimator Light Laser Line


Collimator Knobs

X-Ray Beam Collimator Light

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ALWAYS SELECT THE CORRECT FIELD SIZE TO AVOID


EXCESSIVE RADIATION.

THE X-RAY BEAM AXIS AND THE REFERENCE AXIS OF THE


PLANE OF INTEREST COINCIDE AND ARE ORTHOGONAL
WITH RESPECT TO THE PLANE OF INTEREST, IN EXAMS
PERFORMED WITH THE IMAGE RECEPTOR
PERPENDICULARLY POSITIONED WITH RESPECT TO THE
TUBE-COLLIMATOR ASSEMBLY.

IN CASE OF EXAMS WHERE THE IMAGE RECEPTOR IS NOT


PERPENDICULARLY POSITIONED WITH RESPECT TO THE
TUBE-COLLIMATOR ASSEMBLY, THE X-RAY BEAM AXIS
DOES NOT COINCIDE WITH THE REFERENCE AXIS OF THE
PLANE OF INTEREST AND IT IS NOT ORTHOGONAL WITH
RESPECT TO THE PLANE OF INTEREST. THEREFORE, THE
RESULTING IMAGE WILL BE DEFORMED.

IT IS THE OPERATOR RESPONSIBILITY THE PROPER


POSITIONING OF THE PATIENT AND EQUIPMENT BEFORE
PERFORMING AN EXAM.

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SECTION 5 DX-D TOUCH SCREEN CONSOLE

All controls, indicators and displays located on the DX-D Touch Screen Console
are functionally grouped. Also the Console shows different menus (screens)
according to the selected operations.

Note . Use the operating controls as described in this manual. Any other
non-indicated combination may result in the incorrect operation of
the equipment.

Illustration 5-1
General Controls

2 1

3 5
12
4

6 7
9

10

11 12 13

1. Power Off 8. Exposure Indicators


2. Workstation 9. Service Mode Access
3. Radiographic Values 10. Heat Units Indicator
4. Parameter Selectors 11. Dosimetry
5. Focal Spot 12. Information Area
6. AEC Module 13. Reset Error
7. APR Module

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5.1 RADIOGRAPHY AND GENERAL CONTROLS

5.1.1 POWER ON / OFF

ON: The Generator and the Console are turned ON by pressing and holding for
two seconds the “ON / OFF Switch” of the Console Housing. This starts the
application and the last parameters and workstation used are automatically
selected.

OFF: The Generator and Console are turned OFF by touching this button on the
Touch Screen.
For Generators equipped with “High Speed Rotor Controller”, if the X-ray Tube
is rotating when touching the “OFF” push-button, the Generator will stop the
anode immediately and then the unit will be turned off (approx. 3 seconds). The
equipment only turns off if “Preparation” is not activated.

Note . The proper way for switching OFF the Generator and Console
must be by touching on the “OFF” button on the Touch Screen,
never use the “ON / OFF Switch” of the Console.

IN THE EVENT OF AN EMERGENCY FORCIBLY DEPRESS


THE X-RAY ROOM “EMERGENCY OFF SWITCH” (USUALLY
A RED MUSHROOM-SHAPED SWITCH).

THIS SWITCH SHOULD BE LOCATED ON OR NEAR THE


X-RAY ROOM ELECTRICAL CABINET, USUALLY PLACED
NEAR THE GENERATOR CONTROL CONSOLE. MORE THAN
ONE OF THESE SWITCHES MAY BE PLACED AROUND THE
ROOM FOR GREATER ACCESSIBILITY.

TO ISOLATE THE EQUIPMENT FROM MAINS, TURN OFF THE


SWITCH LOCATED AT THE ROOM ELECTRICAL CABINET.

5.1.2 SERVICE MODE

This button is the access to the “Service Mode” menus.

Only service personnel specifically trained on this medical X-ray equipment


should access to Service Mode for service tasks or maintenance of the
equipment.

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5.1.3 WORKSTATION SELECTION

The Workstations are configured according to the customer preferences during


the installation procedure (Icon, X-ray Tube, Device, Ion Chamber, etc.). Each
button selects its respective Workstation (only the selected button is
highlighted).

The Workstations are directly selected by touching the respective button.

Write down the configuration of the Workstation assigned to each button in the
table.

BUTTON ICON WORKSTATION (Tube, Device, Ion Chamber, etc.)

Note.-- Workstation data such as Icon, X-ray Tube, Receptor, Ion Chambers, etc... must be registered.

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5.1.4 FOCAL SPOT INDICATOR

A Focal Spot indicator shows the selected Focal Spot of the X-ray Tube: “Small”
or “Large”.

The Focal Spot is changed by touching this indicator. It keeps kVp and constant
mAs, whenever it is possible. The mA value available is set according to
maximum power, instantaneous power, space charge, etc.

When a Focal Spot is selected, it sets the highest mA value available for the
selected Focal Spot and the respective Exposure Time in order to keep constant
mAs. If the highest mA value available coincides with the maximum mA station
of the Generator, it sets one mA station below of the maximum mA station of the
Generator.

Note . The Focal Spot change can be done whenever the present
conditions of the X-ray Tube allow it. The mA station set for the
Focal Spot change is configured by the field engineer during the
installation.

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5.1.5 RADIOGRAPHIC PARAMETERS

Note . For Radiographic Operating Modes refer to Section 7.3.

RADIOGRAPHIC DISPLAYS: They are divided in the kVp, mA, mAs and
Time (s) Displays where the following data are shown.

kVp DISPLAY shows the radiographic kVp value selected for the technique.

mA DISPLAY shows the radiographic mA value selected for the technique.

mAs DISPLAY can show:

 The radiographic mAs value selected for the technique.

 When an exposure is made with AEC, it shows the actual mAs at the end
of the exposure, whenever the “Prep” button has not been released.

Time DISPLAY can show:

 The Time value (in seconds) selected for the technique.

 When an exposure is made with AEC, it shows the back-up Time during
the exposure and the actual Time at the end of the exposure whenever
the “Prep” button has not been released.

RAD Displays can also show:

 the values (blinking) of the actual Time, the calculated mAs, and the
selected kVp and mA radiographic parameters of the last exposure, after
touching the “Reset Error” button.

 If an exposure is aborted by releasing the exposure control during the


exposure, the Display shows the actual mAs and Time values, the
messages “Last Exposure Parameters” and “Error 50: Interrupted
Exposure”, until the “Reset Error” button is touched to reset the error
condition.

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INCREASE / DECREASE: Radiographic technique values are increased or


decreased by selecting the respective RAD Display (which will be highlighted)
and changing the value with the “Increase” or “Decrease” buttons.

The values increase or decrease step-by-step each time the corresponding


button is touched, and change faster when either of them is touched
continuously.

Also, the value can be directly selected by clicking on its position on the bar.
When this indicator is positioned over a value not allowed, it comes back to the
previous position and the parameter value does not change.

Decrease Button Increase Button

Bar Indicator for value selection

 kVp: Selects the X-ray Tube voltage.

 mA: Selects the X-ray Tube current. The Focal Spot selection can be
changed when the mA value is selected with the “Increase” or “Decrease”
buttons. The slider of the bar can only set the mA values of the selected
Focal Spot.

 mAs: Selects the exposure in mAs.

 s: Selects the exposure Time in seconds.

(Refer to Section 9.3 for Factor ranges).

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Note . If after touching any of these buttons the technique value is


blocked, it could mean that:

Radiographic Parameters Blockage. When any of the


maximum or minimum radiographic parameter limits are reached,
its related Display flashes accompanied by an information
message.

Generator Power Limit. If the Generator power limit (kVp x mA)


is reached, the kVp and mA Displays flash accompanied of an
information message.

Except in “3-Points” Working Mode, if the Generator power limit is


reached by increasing the mA up to a maximum possible value,
kVp could be increased up to its maximum value while mA value
may automatically decrease, as long as mAs value is kept
constant.

Space Charge. If a variation of the kVp or mA values means that


the space charge limit will be reached in the selected Tube, the
parameter is blocked, the kVp and mA Displays flash
accompanied by an information message.

Maximum Energy (60 kJ). Only in AEC mode, if a variation of the


parameters means that the maximum energy (60 kJ) will be
exceeded, the parameter is blocked, the kVp and mAs Displays
flash accompanied by an information message.

Instantaneous Power. If a technique reaches the instantaneous


power limit of the X-ray Tube (ratings limit or the X-ray Tube is
momentarily overheated), some techniques cannot be selected.
The kVp, mA and Time Displays flash accompanied by an
information message.

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The following table indicates the different Information Messages and Display
flashing that may appear in the Console when increasing or decreasing one of
the exposure parameters.

DISPLAY FLASHING
INFORMATION MESSAGE DESCRIPTION
kVp mA mAs s

Min kVp X Minimum kVp (Generator limit)

Max kVp X Maximum kVp (Generator limit)

X Maximum kVp (limited by the X-ray Tube protection


Max kVp Tube
curves or limited during the Generator configuration)

X Minimum mA
Min mA
(Generator limit configured for each Focal Spot)

X Maximum mA
Max mA
(Generator limit configured for each Focal Spot)

Min mAs X Minimum mAs (Generator limit)

Max mAs X Maximum mAs = 500 mAs (Regulatory limit for AEC)

Min ms X Minimum Exposure Time (Generator limit)

Max ms X Maximum Exposure Time (Generator limit)

X X Minimum Exposure Time and minimum mA


Min ms & Min mA
(Generator limit)

X X Maximum Exposure Time and maximum mA


Max ms & Max mA
(Generator limit)

Max Power X X Maximum Power (Generator limit)

X X Filament emission limit for a combination of kVp and mA


Space Charge
in the selected Focal Spot.

X X The Maximum Energy can not exceed of 60 kJ


Max Energy (60kJ)
(kVp x mAs = 60 kJ) (Regulatory limit for AEC).

X X X Instantaneous Power limit of the X-ray Tube depending


Inst. Power on the Anode temperature, the selected Exposure Time,
and the selected Focal Spot.

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5.2 AUTOMATIC EXPOSURE CONTROL (AEC)

Automatic Exposure Control (AEC) produces consistent image density with


excellent contrast regardless of the radiographic technique selected. The AEC
module comprises the controls for the selection of the Exposure Detector Fields
(Ion Chamber), the Film/Screen Combination, Image Density Compensation
and AEC Reset.

The AEC mode is activated by touching any of the three AEC Field buttons. The
AEC mode is deactivated by touching all the selected AEC Field buttons until
none of them is selected.

In AEC mode the back-up time (or back-up mAs) MUST BE SET MANUALLY
by the operator using the Console controls.

Note . The value of the back-up time (or mAs) must be set at a greater
value than the previously considered for the exposure time (or
mAs). A value above 50% of the considered value is the
recommended. Very extreme values of back-up time (or mAs)
should be avoided to prevent patient from excessive exposure
when a control error is produced.

FIELD SELECTION: Each button indicates its related physical location of the
selected field in the AEC Exposure Detector, and it may be selected or
deselected by touching it. Any combination of fields can be selected and the
color of buttons change (highlighted) when active.

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FILM / SCREEN COMBINATION: Each of these buttons allows adjustment of


the mAs in relation to a programmed Film / Screen combination that may be in
use slow, medium, or fast respectively (200, 400, 800). Each time a Film /
Screen button is selected (highlighted), the others are automatically
deselected.

DENSITY: These buttons are used to adjust the radiographic image density.
The selected value is shown on the Density Display. Normal image density is
N (default value).

Image density can be increased or decreased in several steps. The variation


percentage density between steps can be changed during the equipment
calibration by the engineer according to customer preferences (the percentage
by default is 25%).

AEC RESET: If the exposure is aborted by the AEC back-up timer, the “AEC
Reset” button blinks accompanied by an audible alarm and the message “Not
Enough Dose” is shown on the Console. Next exposure is inhibited until the
AEC function is reset by touching the “AEC Reset” button. When the Generator
is in “Prep” mode, the AEC function can not be reset.

Before the exposure, if the message “Wrong AEC Selection” is shown on the
Console, it means that the selected kVp value, AEC Density and/or Film/Screen
Combination set a technique that is out of the operative range with AEC and the
next exposure will be inhibited. Change any parameter (kVp value, AEC Density
or Film / Screen Combination) in order to obtain a technique enabled for AEC.

5.2.1 RAPID TERMINATION

This safety device terminates the X-ray exposure when no radiation is detected
in the Ion Chamber or the selected parameters (short backup time/mAs) are not
appropriate for an exposure with AEC.
AEC Rapid Termination compares the AEC ramp with a 25% of the final value
at the 30% of the Backup Time. It is activated after 30% of the exposure backup
time and after 10 ms of exposure, both conditions have to be fulfilled.

Whenever the AEC is ON it is recommended to select an exposure back-up time


higher than 100 ms for improved operation of Rapid Termination.

The Error Code related to the Rapid Termination is E95.

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5.3 ANATOMICAL PROGRAMMER (APR)

The Anatomical Programmer (APR) module is comprised of the controls which


select the Patient Size and its corresponding “Body Region / Anatomical View
/ Projection”. The process is shown on the APR Display.

The APR techniques are factory pre-programmed according to different


standard technique that combines six Body Regions with their Anatomical
Views and Projections. Besides the radiographic parameters, selections of the
workstation or AEC (Density, Fields and Film / Screen Combination) can be
assigned to the APR techniques. These selections will be always common for
all the patient sizes of each Anatomical View. These techniques may be
modified and stored anew into non-volatile memory by the operator.

The APR techniques are intended only as a guide line, they are only starting
points that can be replaced by more specific protocols developed by the
operator. Accurate exposure factors are dependent among other things on grid
factors, table top absorption, screen film combinations, film processing or
detector features.

APR is activated when one of the three Patient Size (small, medium or large
size) is selected (highlighted) and it is deactivated when all of them are
deselected.

Note . The language of the factory pre-programmed APR techniques is


configured according to the customer order and it can not be
changed by the operator.

(Refer to Appendix B for the available APR Matrix).

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APR DISPLAY: It shows the different Body Regions and Anatomical Views
available for each APR technique and the final APR selection. As the area of
the APR Display is limited in length, the name of some Regions, Views or
Projections is abbreviated.

When a Body Region has been selected, its indication is locked on the screen
and the APR Display show directly all its respective Anatomical Views and then
its respective Projections (if the Anatomical View has different Projections).
(Refer to Appendix B for the APR Regions / Views / Projections factory
pre-programmed).

When the APR selection is finished, the Console shows the final selection (APR
Display), the Workstation, its respective parameters (RAD Displays) and the
AEC controls (if applicable) related to the APR technique.

To go back to the previous level, touch on the right-lower APR selector (“Up”).

PATIENT SIZE: APR is activated when one of the three Patient Size (small,
medium or large size) is selected. These buttons are used to adapt the APR
technique chosen according to patient size. Six patient sizes are available.

The three right-hand buttons select Small, Medium and Large adults sizes (only
one selected at the same time). The left-hand “Pediatric” button changes the
function of the right-hand three buttons from adult patient size to Pediatric
patient size. (In this mode, the “Pediatric” button and one of the other three
buttons may be selected at the same time).

APR SELECTORS: Each button is related to the nearest area of the APR
Display and they are used to select one of the displayed Body Regions,
Anatomical Views or Projections. The selected Region, View or Projection
appears in the middle of the APR Display.

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STORE: All parameters of the APR techniques may be manually rewritten as


required by the operator. If the operator determines that some factors in an APR
technique should be re-programmed, perform the following procedure:

1. Select an APR technique and modify the factors and selections of


Workstations or AEC which require to be re-programmed.

2. Verify that all factors of the technique are at the required values.

3. Touch the “Store” button to store the new technique. The selected
technique is now stored in the “APR Working File” and can be recalled
for future examinations.

Note . This procedure only changes the technique values of the selected
Patient Size, if necessary repeat the procedure for other Patient
Sizes.

Note . If an APR technique is to be stored with AEC parameters, a


suitable back-up Time (or mAs) MUST be stored by the operator
for this APR technique.

Since “Store” modifies the data stored in the “APR Working File”, (according to
the configuration of the Unit), the Console requires the Operator Password to
allow the storage of the new data in the “APR Working File”.

The default Operator Password is “1111”, but it can be replaced by a new one
with the “Change Password” option in the “Edit” menu (refer to “Edit”).

Enter the Operator Password and touch “OK” , then confirm or cancel the
operation.

OK

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MODIFY: After touching this button, the Console shows a Password pop--up
screen, enter the password required to access to the “Modify” options.

The default Operator Password is “1111”, but it can be changed by a new one
with the “Change Password” option in the “Edit” menu (refer to “Edit”).

Enter the Operator Password and touch “OK”. The APR module will show the
following options: Restore Default, Edit and Exit.

EXIT: Touch this button to exit from the “Modify” options and go back to the Main
APR screen.

RESTORE DEFAULT: Touch this button to delete all the modifications made
by the operator in all the APR techniques and restore all of them with the values
and selections stored in the “APR Backup File”.

“Restore Default” requires to confirm or cancel the operation.

Note . “Restore Default” replaces the data stored in the “APR Working
File” with the data stored in the “APR Backup File”.

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EDIT: After touching this button, the Console shows the “Edit” menu with the
different controls to create, modify or delete the APR techniques, or change the
operator password.

Note . Exposures are inhibited when the “Edit” menu is shown on the
Console.

Create a new label Patient Size

Body
Regions
Pediatric

Anatomical
Views Delete a Label

Projections
Modify a
Exit from Label name
“Edit” menu

Change Operator Set the parameters / selections


Password for the selected APR Technique

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This warning message is shown until the parameters / selections Save changes before exiting
for the new created APR Technique are set from “Edit” menu

QUIT: Touch this button to exit from the “Edit” options and go back to the
previous screen (Restore Default / Edit / Exit).

CHANGE PASSWORD: After touching this button, the Console shows a Panel
for entering the new Operator Password.

Follow the “Change Password” procedure and enter twice the new Password
(four digits) then touch “OK” to close this option. Now, the default Password
“1111” is replaced by the new Password.

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PATIENT SIZE: These buttons are used to select the Patient Size (small,
medium or large size) for the APR technique chosen. Six patient sizes are
available.

The three upper buttons select “Small”, “Medium” and “Large” adult sizes (only
one selected at the same time). The lower button selects “Pediatric” , this button
is selected together with one of the “Small”, “Medium” and “Large” sizes.

LABELS OF REGION / VIEW / PROJECTION: Labels are classified in three


levels: Body Regions, Anatomical Views and Projections. The lateral indicator
of the level activated is highlighted.

When a Body Region has been selected, its label is highlighted on the screen
and the View level shows all its respective Anatomical Views.

When an Anatomical View has been selected, its label is highlighted on the
screen and the Projection level shows all its respective Projections (if the
Anatomical View has different Projections).

When the APR selection is finished, the Console shows the Workstation, its
respective parameters (RAD Displays) and the AEC controls (if applicable)
related to the APR technique.

Note . The maximum number of labels for each level is ten (10).

LABEL POSITIONERS: Select a label and change its position inside the level
by touching any of these buttons.

NEW: To create a new Region, View or Projection, first click on the lateral
indicator of the Region, View or Projection or on any Region, View or Projection
label (the lateral indicator of the selected level appears highlighted), then touch
on the “New” button.

Note . Creating a Region, View or Projection will not be allowed in case


all the positions are already filled (maximum ten labels).

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A virtual keyboard appears on the screen. Write the name of the new Region,
View or Projection and click on “Enter”. The new label of the Region, View or
Projection is located in the last position of the list.

Now, if what it was created was a Region, the operator will have to create
(assign) Views and Projections to that new Region, for that, the program
requires to create at least one View for that Region and after that, create the
Projections for that View (if required). Repeat the process to create and name
the new Views and Projections.

The warning message “APR technique not defined ” is displayed on the “Edit”
menu. Set the Patient Size, Radiographic Parameters and Selections
(Workstation and AEC if available) related to that Region / View / Projection and
touch the button “Set Technique” .

Note . If an APR technique is to be stored with AEC parameters, a


suitable back-up Time (or mAs) MUST be stored by the operator
for this APR technique.

SET TECHNIQUE: Touch this button to assign the selected Patient Size,
Radiographic Parameters and Selections (Workstation and AEC if available) to
the new or existing Region / View / Projection. A pop message requires a
confirmation.

MODIFY: Select a label (Region, View or Projection), then touch this button to
modify the label name using the virtual keyboard that appears on the screen.
Write the new name and click on “Enter”.

DELETE: To delete a Region, View or Projection select the respective label and
touch this button. When a Region is deleted, all the labels and APR techniques
(Views and Projections) related to this Region are deleted. When a View is
deleted, all the labels and APR techniques (Projections) related to this View are
deleted.

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SAVE: Touch this button to save all the changes performed in the “Edit” menu
before exiting.

Illustration 5-2
Creating a New APR Technique

1. Touch on “Modify” button. The system requires


1
the operator password and the confirmation.

2
2. Touch on “Edit” button.
New Region

3
3. Select any Region , press on “New” and write
the name of the new Region. Repeat this procedure
in order to assign Views and Projections to the new
created Region. New Region

New View

New Projection

4. Then select the Parameters, AEC selections and


Workstations for the New Region/View/Projection.

5. Touch on “Set Tech” button to set the selected 4


parameters / AEC Selections / Workstations.

6. Touch on “Save” button to save the data.

7. Touch on “Quit” button.


5
6
8. Touch on “Exit” button to go back to the Main 7
screen.
8

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Illustration 5-3
Modifying an existing APR Technique

1. Touch on a Patient size to select an APR Technique

2. Touch on the selector of the Region, View, Projection


to be modified.
1

3. Modify the parameter and/ or AEC selection and/or


workstation.

4. Touch on “Store” button -- The system requires the


operator password and the confirmation. This change is
saved in the “APR Working File”.

OK

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5.4 EXPOSURE CONTROLS AND STATUS INDICATORS

OFF Radiographic exposures from the Console are made with the “Prep”
Prep (preparation) and “Expose” buttons on the Handswitch. The status of the
Exp exposure is indicated by the “Ready” and “X-ray On” indicators for the duration
of the exposure.

PREP: Press the Handswitch half-way (“Prep”) to prepare the selected X-ray
Tube for exposure. The “Ready” indicator on the Console appears in yellow
when the Tube is prepared and there are no interlock failures or system faults.

After pressing this button, the following functions are activated:

 Anode rotation.

 Filament current switches from stand-by to the selected mA.

Note . Press “Prep” only when the technique is selected on the Console
and the patient is ready for the exposure. High Speed Generators
can be configured so that the anode remains running for
approximately one minute when “Prep” is pressed three
consecutive times in intervals shorter than 30 seconds.

EXP: When the “Ready” indicator is ON, completely pressing the Handswitch
commences the exposition. Releasing the button before the Generator
completes the selected time or AEC time will cause the exposure to prematurely
terminate. The Console will then show the actual mAs and Exposure Time
values. The message “Exp aborted by the operator” appears until the “Reset
Error” button is pressed to reset the error condition.

READY: When highlighted, this button indicates that the technique selected is
properly set, there are no interlock failures or system faults, the anode is rotating
and the X-ray Tube is ready for exposure.

X-RAY ON: When highlighted, this button indicates that the X-ray exposure is
in progress. When radiographic exposures are performed, an audible signal
sounds.

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5.5 SELF-DIAGNOSIS INDICATORS

Self-Diagnosis indicators identify a malfunction in the system alerting operator


about error existence that inhibits exposure. During normal operation of the
system, these indicators are directly shown on the lower area of the console or
as an error code close to the “Reset Error” button. (Also refer to Section 5.8).

DOOR DOOR OPEN: Indicates the X-ray room door is open when the X-ray equipment
is in use.

GENERATOR OVERLOAD: Indicates that the exposure was interrupted


GEN. OVERLOAD
because arcing or malfunctioning occurred during exposure on the HV circuitry
(X-ray Tube, HV Transformer and/or HV Cables) or a failure of IGBT module
(overheated or defective IGBTs) was detected.
It can also appear when making a lengthy or high powered exposure with the
X-ray Tube cool (X-ray Tube has not been sufficiently warmed-up).

TUBE OVERLOAD: Indicates that either the technique selected is beyond the
TUBE OVERLOAD
X-ray Tube ratings or present conditions of the X-ray Tube inhibit the exposure
(anode overheated). Parameters for next exposure may be temporally limited
by the Generator (change the exposure values or wait for the X-ray Tube to
cool).
Check that heat units available are lower than the calculated for the next
exposure (heat units close to zero). Reduce exposure factors or wait for the
X-ray Tube to cool. (To display the Heat Units refer to Section 5.6).

ROTOR ERROR: Indicates that the X-ray Tube anode is not rotating while
ROTOR ERROR
“Prep” is active, then exposures are inhibited.

HEAT: Indicates that the X-ray Tube thermostat / pressurestat is open due to
HEAT
overheating of the Tube housing (housing is too hot, wait for the housing to cool)
or a thermostat / pressurestat mal-function (housing is cool). Heat units may
raise to any value.

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TECH TECHNIQUE ERROR: If it activates during exposure it means that:

The exposure has been interrupted by the “Security Timer”


because of a system failure. Call Field Service.

This error can also be shown:

 after an APR technique selection to advise that exposure parameters


displayed on the Console are not the values stored for this APR
technique. Exposure parameters are adapted by the Generator to
another enable values.

 if a failure on the Automatic Collimator has been detected (blades are full
open or in movement during exposure, etc.). In this case the indicator
lights continuously.

5.6 HEAT UNITS

This X-ray Generator is equipped with a Heat Unit Calculator. During


exposures, the Heat Units are calculated and totalled.

The “Heat Units” Display shows the percentage of the thermal capacity of the
Tube that is used. For example, a display of “0%” would indicate that all the Heat
Units capacity of the X-ray Tube remains.

5.7 DOSIMETRY (OPTIONAL)

The Dose Display shows the accumulated radiation value of the X-ray Tube
related to the selected Workstation. The radiation value of each exposure is
added to the accumulated radiation value for the selected X-ray Tube. The
accumulated radiation value is reset by touching the “Dose Reset” button.

Radiation measure is read as DAP value (Dose Area Product) in mGy*cm2 (for
example: 64.50.5 mGy*cm 2).

Accumulated Dose of a patient can be printed (whenever a printer is connected


to the Console) by Touching the “Print” button. At this moment, a keyboard
appears on the Console to enter the Patient Name. Then touch “OK” to print
the Dose information.

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5.8 ERROR CODES

Error codes indicate the potential cause of a system failure. Error codes are
shown on the Console, at the same time an alarm sounds. Correct the error
cause and keep touched the “Reset” button until the Console indication
disappears. (Refer to Table 5-1).

All these error codes are preceded by the letter “E” (i.e., E01) and they will
enable the operator to indirectly convey the possible source of error to service
personnel. This may prevent the need for a service call or enable service
personnel to anticipate corrective actions prior to arriving on site.

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Table 5-1
Error Codes

ERROR DESCRIPTION WHAT TO DO

System failure. This indication may appear together with an


-- -- -- -- -- -- Turn the Generator OFF and ON.
error on the Console, and indicates that the error is not
on Display If the equipment remains inoperative, turn it OFF and call Field Service.
correctable unless the equipment is turned OFF.

Turn the Generator OFF, check the proper external cable connections
E01, E02 Communication error. and then turn the Generator ON. If the equipment remains inoperative,
turn it OFF and call Field Service.

E03 System failure.


Turn the
T th Generator
G t OFF and d ON.
ON
The X-ray Generator has activated “Preparation” without a If the equipment remains inoperative, turn it OFF and call Field Service.
E04
Console command intervention.

Release any external exposure device or buttons.


E05 External exposure activated during power-up. Turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.

Release all the controls.


“Exposure” and/or “Preparation” orders are activated during
E06 Turn the Generator OFF and ON.
power-up.
If the equipment remains inoperative, turn it OFF and call Field Service.

Touch the “Reset” button.


E07, E08 X-ray Tube configuration error. If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.

Generator Overload error. The exposure has been


interrupted because during exposure has been produced
arcing or bad function on the HV circuitry (X-ray Tube, HV It is not necessary to touch the “Reset” button, the error indication will
Transformer and/or HV Cables) or a failure of IGBT module disappear automatically.
E09 (overheated or defective IGBTs) has been detected. If the error code persists, turn the Generator OFF and wait 30 minutes
before turning it ON again.
It can be also shown making a high power and long If the equipment remains inoperative, turn it OFF and call Field Service.
exposure with the X-ray tube cool (X-ray Tube has not been
warmed-up).

Touch the “Reset” button.


E10, E11 System failure. If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.

E12 No mA during exposure or mA value is out of range. Touch the “Reset” button.
Repeat with same technique values, If the error code persists try with
another combinations of kV and mA values.
E13 No kV during exposure or kV value is out of range. If the equipment remains inoperative, turn it OFF and call Field Service.

Touch the “Reset” button.


E14, E15 System failure. If the error code persists, turn the Generator OFF and ON again.
If the equipment remains inoperative, turn it OFF and call Field Service.

Decrease kV, mA or both. touch the “Reset” button.


E16 Invalid value of: kV, mA or kW. If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.

Turn the Generator OFF and ON.


E17 Communication error or system failure.
If the equipment remains inoperative, turn it OFF and call Field Service.

It is not necessary to touch the “Reset” button, the error indication will
Rotor error. The X-ray tube anode is not rotating while
disappear automatically.
E18 “Prep” is active, then exposures are inhibited, or the X-ray
If the error code persists, turn the Generator OFF and ON.
tube anode is rotating without console command.
If the equipment remains inoperative, turn it OFF and call Field Service.

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Table 5-1 (cont.)


Error Codes

ERROR DESCRIPTION WHAT TO DO

Turn the Generator OFF and ON.


E19, E20 System failure.
If the equipment remains inoperative, turn it OFF and call Field Service.

E21, E22 Incorrect selection of the X-ray Tube.

E23 System failure.


Touch the “Reset” button
button.
E24 Bucky not ready for an exposure. p , turn the Generator OFF and ON.
If the error code persists,
If the equipment remains inoperative, turn it OFF
O and call Field S
Service.
E27 System failure.

E28 AEC Reference set failure.

Touch the “Reset” button.


Replace or insert the Receptor.
E32 Removable Receptor has not been replaced or inserted If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.
In this case, the Generator can still work in “Direct” mode.

Touch the “Reset” button.


Check that communication cable between Generator and console is
E33 Serial Communication error. properly connected.
If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.

Technique error. If it activates during exposure it means


that the exposure has been interrupted by the “Security
Timer” because of a system failure. Call Field Service.
This error can also be shown: after an APR technique
E34
selection to advise that exposure parameters displayed on
the console are not the values stored for this APR
technique. Exposure parameters are adapted by the
Generator to another enable values.

Door Open error. The X-ray room door is open when the
E35
X-ray equipment is in use.
It is not necessary to touch the “Reset” button
button, the error indication will
Heat Units error. The X-ray Tube thermostat / pressurestat disappear automatically.
is open due to the Tube housing being overheated (housing If the error code persists, turn the Generator OFF and ON.
E36 is too hot, wait for the housing to cool) or a thermostat / If the equipment remains inoperative, turn it OFF and call Field Service.
pressurestat mal-function (housing is cool). Heat units may
raise to any value.

Tube Overload error. The technique selected is beyond the


X-ray tube ratings or present conditions of the X-ray tube
inhibit the exposure (anode overheated). Parameters for
next exposure may be temporally limited by the Generator
E37
(change the exposure values or wait for the X-ray tube to
cool). Check that heat units available are lower than the
calculated for the next exposure (heat units close to zero).
Reduce exposure factors or wait for the X-ray tube to cool.

Touch the “Reset” button.


E38 Wrong X-ray Tube orientation for Table Workstation Correct the X-ray Tube orientation respect to the selected Workstation.
If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.
E39 Wrong X-ray Tube orientation for Wall Stand Workstation In this case, the Generator can still work in “Direct” mode and with the
other Workstation.

Touch the “Reset” button.


If the error code persists, turn the Generator OFF and ON.
E40 Alignment hardware error.
If the equipment remains inoperative, turn it OFF and call Field Service.
In this case, the Generator can still work in “Direct” mode.

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Table 5-1 (cont.)


Error Codes

ERROR DESCRIPTION WHAT TO DO

E41 to E46 System failure related to Dosimeter.

Collimator Error. A failure on the Automatic Collimator has


E48 been detected (blades are full open or in movement during Touch the “Reset” button.
exposure, etc. ) If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative
inoperative, turn it OFF and call Field Service
Service.
E50 Exposure has been aborted by the Operator.

E51 to E93 System failure related to High Speed Rotor Controller.

Touch the “Reset” button.


Select the correct Ion Chamber or modify parameters.
E95 Exposure aborted by the Rapid Termination.
Repeat the exposure.
If the equipment remains inoperative, turn it OFF and call Field Service.

Touch the “Reset” button.


X-ray order not acknowledged.
Repeat the exposure.
E97 The Receptor (Digital Detector) did not receive or
If the error code persists, turn the Generator OFF and ON.
acknowledge the X-ray order sent by the Generator.
If the equipment remains inoperative, turn it OFF and call Field Service.

Touch the “Reset” button and call Field Service. This error does not
E98 Service Mode Active.
inhibit normal operation.

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SECTION 6 DX-D OVERLAY CONSOLE AND


DX-D OVERLAY CONSOLE WITH APR

All controls, indicators and displays located on the Control Console are
positioned depending upon their functions.

Note . Use the operating controls as described in this manual, any other
non-indicated combination may cause an incorrect operation of
the equipment.

Illustration 6-1
Rad Console

2 1

7 8

9
11
4

10 10

5 6

12

1. Power On 7. Radiographic Values


2. Power Off 8. AEC Density Values
3. Workstations Selection 9. Patient Size Selection (APR) (Optional)
4. AEC Reset 10. Body Regions / Anatomical View Selection (APR) (Option-
5. AEC Field Selection al)
6. Film / Screen Combination 11. Focal Spot Indicators and Selectors
12. Exposure Indicators and Controls

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6.1 RADIOGRAPHY AND GENERAL CONTROLS

6.1.1 POWER ON / OFF

ON: The Generator is turned ON by pressing this push-button. This starts a


power-up routine which is shown on the Console (a.e. P05.3 = Vers.5, Rev.3).
After the power-up routine the last workstation used will be automatically
selected.

OFF: The Generator is turned OFF by pressing this push-button.

For Generators equipped with “High Speed Rotor Controller”, if the X-ray Tube
is rotating when pressing the “OFF” push-button, the Generator will stop the
anode immediately and then the unit will be turned off (approx. 3 seconds). The
equipment only turns off if “Preparation” is not activated.

IN THE EVENT OF AN EMERGENCY FORCIBLY DEPRESS


THE X-RAY ROOM “EMERGENCY OFF SWITCH” (USUALLY
A RED MUSHROOM-SHAPED SWITCH).

THIS SWITCH SHOULD BE LOCATED ON OR NEAR THE


X-RAY ROOM ELECTRICAL CABINET, USUALLY PLACED
NEAR THE GENERATOR CONTROL CONSOLE. MORE THAN
ONE OF THESE SWITCHES MAY BE PLACED AROUND THE
ROOM FOR GREATER ACCESSIBILITY.

TO ISOLATE THE EQUIPMENT FROM MAINS, TURN OFF THE


SWITCH LOCATED AT THE ROOM ELECTRICAL CABINET.

6.1.2 WORKSTATIONS SELECTION

The workstations are configured according to the customer preferences during


the installation procedure. The following push-buttons select their respective
workstation (illuminated push-buttons).

If a push-button is not configured during the installation, the respective


push-button(s) can not be selected during operation.

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Note in the following table the configuration of the Workstation assigned for
each push-button.

PUSH-BUTTONS WORKSTATION (Tube, Device, etc.)

+ 1
1

2
1 +

1 +

+ 1
2

2
2 +

2 +

Note.-- Workstation data such as X-ray Tube, Device, Ion Chambers, etc... must be registered.

6.1.3 FOCAL SPOT INDICATORS AND SELECTORS

LARGE FOCAL SPOT: Indicates that the “Large Focal Spot” of the X-ray Tube
has been selected.

SMALL FOCAL SPOT: Indicates that the “Small Focal Spot” of the X-ray Tube
has been selected.

FOCAL SPOT SELECTORS: Each push-button selects the related Focal Spot
of the X-ray Tube, keeping kVp and mAs constant (maximum mA available and
minimum Exposure Time).

Note . The Focal Spot change can be done whenever the present
conditions of the X-ray Tube allow it.

Note . The mA station set for the Focal Spot change is configured by the
field engineer during the installation.

The Focal Spot may also be selected:

 according to the selected mA station.

 by pressing “ON” + “mA or mAs increase” push-buttons to select Large


Focal Spot, or by pressing “ON” + “mA or mAs decrease” push-buttons
to select Small Focal Spot.

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6.1.4 RADIOGRAPHIC PARAMETERS

kV DISPLAY can show:

 The radiographic kV value selected for the technique.

 The actual X-ray Tube heat unit value after pressing the “On” push-button
(Refer to Section 6.6).

 The error messages during a system fault, preceded by the letter “E”
(a.e., E02) (Refer to Section 6.9).

mAs DISPLAY can show:

 The radiographic mAs value selected for the technique.

 When an exposure is made with AEC, it shows the actual mAs at the end
of the exposure whenever the “Prep” push-button has not been released.

 If an exposure is aborted by releasing the “Exp” push-button during the


exposure, it shows the actual mAs value until the “AEC Reset”
push-button is pressed to reset the error condition.

mA DISPLAY: Shows the radiographic mA value selected for the technique.

Time DISPLAY can show:

 The Time value (in seconds) selected for the radiographic technique.

 When an exposure is made with AEC, it shows the back-up time during
the exposure and the actual Time at the end of the exposure whenever
the “Prep” push-button has not been released.

 If an exposure is aborted by releasing the “Exp” push-button during the


exposure, it shows the actual Time until the “AEC Reset” push-button is
pressed to reset the error condition.

RAD Displays can also show:

 The actual Time, the calculated mAs, and the selected kVp and mA
radiographic parameters of the last exposure, with or without AEC, after
pressing the “AEC Reset” push-button (values flashing).

 The exposure counters (Refer to Section 6.7).

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INCREASE / DECREASE: Radiographic technique values are increased or


decreased by pressing the respective push-buttons. The values increase or
decrease step-by-step each time the corresponding push-button is pressed,
and changes faster when either of them is pressed continuously.

 kV: Selects the X-ray Tube voltage.

 mAs: Selects the exposure in mAs.

 mA: Selects the X-ray Tube current.

 s: Selects the exposure time in seconds.

(Refer to Section 9.3 for Factor ranges)

Note . If after pressing any of these push-buttons, the technique value is


blocked and an acoustic signal is emitted it could mean that:

Radiographic Parameters Blockage. When any of the


maximum or minimum radiographic parameter limit is reached, its
related Display blinks.

Generator Power Limit. If the power limit (kV x mA) is reached


by increasing the mA up to a maximum possible value, the mA
value is blocked. Flashing values on kV and mA Displays will alert
operator about the situation.

If required, kV could be increased up to its maximum value while


mA value may automatically decrease, as long as mAs value is
kept the same.

Space Charge. If a variation of the kV or mA induces to reach


space charge limit in the selected tube, the parameter is blocked,
and flashing value on the kV Display will alert operator about the
situation.

Maximum Energy (60 kJ). Only in AEC mode, if a variation of the


parameters means that the maximum energy (60 kJ) will be
exceed, the parameter is blocked. Flashing values on kV and mAs
Displays will alert operator about the situation.

Instantaneous Power. If a technique reaches the instantaneous


power limit of the X-ray Tube (ratings limit or the X-ray Tube is
momentarily overheated), some techniques cannot be selected.
Flashing values on kV and mAs Displays will alert operator about
the situation.

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6.2 AUTOMATIC EXPOSURE CONTROL (AEC)

Automatic Exposure Control (AEC) produces consistent film density with


excellent contrast regardless of the radiographic technique selected. The AEC
module comprises the controls for the selection of the Exposure Detector Fields
(Ion Chamber), the Film/Screen Combination, Film Density Compensation and
AEC Reset.

The AEC mode is selected by pressing any of the three AEC Field push-buttons.
To exit the AEC mode, press all the illuminated AEC Field push-buttons until
none are lit.

In AEC mode the back-up time (or back-up mAs) MUST BE SET MANUALLY
by the operator using the Console controls.

Note . The value of the back-up time (or mAs) must be set at a greater
value than the previously considered for the exposure time (or
mAs). A value above 50% of the considered value is the
recommended. Very extreme values of back-up time (or mAs)
should be avoided to prevent patient from excessive exposure
when a control error is produced.

FIELD SELECTION: Each push-button indicates its related physical location


of the selected field in the AEC Exposure Detector, and it may be selected or
deselected by pressing it. Any combination of fields can be selected and the
push-buttons illuminate when active.

FILM / SCREEN COMBINATION: Each of these push-buttons allows


adjustment of the mAs in relation to a programmed Film / Screen combination
that may be in use slow, medium, or fast respectively (200, 400, 800). Each time
a Film / Screen push-button is selected (illuminated), the others are
automatically deselected.

DENSITY: These push-buttons are used to adjust the radiographic film density.
Normal film density (0) is the automatic default value when AEC is selected.

Film density can be proportionally increased or decreased in steps. The


variation percentage density between steps can be changed during the
equipment calibration by the engineer according to customer preferences (the
percentage by default is 25%).

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AEC RESET: If the exposure is aborted by the AEC back-up timer, the indicator
on the “AEC Reset” push-button blinks accompanied of an audible alarm. Next
exposure is inhibited until the AEC function is reset by pressing the “AEC Reset”
push-button. When the Generator is in “Prep” mode, the AEC function can not
be reset.

The “AEC Reset” push-button may blink when the kVp value, AEC Density and
Film / Screen Combination select a technique that is out of the operative range
with AEC, it inhibits the next exposure. Change any parameter (kVp value, AEC
Density or Film / Screen Combination) in order to obtain a technique enabled
for AEC.

6.2.1 RAPID TERMINATION

This safety device terminates the X-ray exposure when no radiation is detected
in the Ion Chamber or the selected parameters (short backup time/mAs) are not
appropriate for an exposure with AEC.
AEC Rapid Termination compares the AEC ramp with a 25% of the final value
at the 30% of the Backup Time. It is activated after 30% of the exposure backup
time and after 10 ms of exposure, both conditions have to be fulfilled.

Whenever the AEC is ON it is recommended to select an exposure back-up time


higher than 100 ms for improved operation of Rapid Termination.

The Error Code related to the Rapid Termination is E95.

6.3 ANATOMICAL PROGRAMMER (APR) (OPTIONAL)

Anatomical Programmer (APR) module is comprised of the controls which


select the Patient Size and Display Selectors. The process is shown on the APR
Display.

The APR techniques are factory pre-programmed according to different


standard technique that combines six Body Regions with their Anatomical
Views (Organ + Projection). Besides the radiographic parameters, selections
of the workstation or AEC (density, fields and film / screen combination) can be
assigned to the APR techniques. These selections will be always common for
all the patient sizes of each Anatomical View. These techniques may be
modified and stored anew into non-volatile memory by the operator.

The APR techniques are intended only as a guide line, they are only starting
points that can be replaced by more specific protocols developed by the
operator. Accurate exposure factors are dependent among other things on grid
factors, table top absorption, screen film combinations, film processing or
detector features.

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The APR is activated when one of the three Patient Size (small, medium or large
size) is selected (push-button lighted), and it is deactivated when all of them are
deselected.

Note . The language pack of the factory pre-programmed APR


techniques is configured according to the customer order and it
can not be changed by the operator.

APR language in the pack (three languages) may be changed, just


after selecting one of the patient size (APR activation), pressing
the “Power ON” push-button. Language selected remains stored
even after the equipment is turned Off.

(Refer to Appendix B for the available APR Matrix).

APR DISPLAY: Shows the different Body Regions and Anatomical Views
available for each APR technique, and the final APR selection.

Because each area of the APR Display is limited in length to eight characters,
some regions and views are abbreviated.

PATIENT SIZE: These push-buttons are used to adapt the APR technique
chosen according to patient size. Six patient sizes are available. The three
right-hand push-buttons select Small, Medium and Large adult sizes (one only
illuminated when selected). The left-hand pediatric push-button changes the
function of the right-hand three push-buttons from adult patient size to pediatric
patient size. (In this mode, the pediatric push-button and one of the other three
buttons may be illuminated at the same time).

ANATOMICAL VIEW SELECTORS: Each push-button is related with the


nearest area of the APR Display and they are used to select one of the displayed
Body Regions, Organs and Projections. The selected Region and Views
appears in negative block ( SKULL ).

The APR display shows the Body Regions, Organs and Projections. When a
Body Region has been selected its indication is locked on the screen and the
APR Display shows directly all its respective Organs. In some cases, an Organ
may show several Projections.

When the APR selection is finished, the Console shows the final selection (APR
Display), its respective parameters (RAD Display), the Workstation and AEC
controls related to the technique. (Refer to Appendix B for the APR Regions /
Organs / Projections factory pre-programmed).

To go back to the previous level, press on the right-lower APR push-button


which shown the “return” symbol.

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APR TECHNIQUE CHANGES

The APR techniques are factory pre-programmed to standard technique sets.


All the parameters and selections for the APR techniques may be modified by
the operator and stored in the non-volatile memory for later use.

If the operator determines that some factors in an APR technique should be


re-programmed, use the following procedure:

1. Select an APR technique and modify the factors and selections of


Workstations or AEC which require to be re-programmed.

2. Verify that all factors of the technique are at the required values.

3. Store the new technique by first pressing the selected Patient Size and
without releasing it press the Projection selected. (Refer to
Illustration 6-2.)

The newly selected technique is now stored in memory and can be


recalled for future examinations.

Note . This procedure only changes the technique values of the selected
patient size, repeat the procedure for other patient sizes.

Note . If an APR technique is to be stored with AEC parameters, a


suitable back-up Time (or mAs) MUST be stored by the operator
for this APR technique.

Illustration 6-2
APR Storage Push-buttons

AP/PA SPECIAL
SKULL
LATERAL
SKULL
SEMIAX.
LATERAL
AXIAL

Example : press push-buttons: 1 st Medium Patient Size and Lateral Projection, to store the APR technique selected.

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6.4 EXPOSURE CONTROLS AND INDICATORS

Radiographic exposures from the Control Console are made with the “Prep”
(preparation) and “Expose” (X-ray exposure) push-buttons or with the
Handswitch. The status of the exposure is indicated by the “Ready” and “X-ray
On” indicators for the duration of the exposure.

PREP: Press the ”Prep” push-button to prepare the selected X-ray Tube for
exposure. The “Ready” indicator on the Console will light when the X-ray Tube
is prepared and there are no interlock failure or system faults.

After pressing this push-button, the following functions are activated:

 Anode rotation.

 Filament current switches from stand-by to the selected mA.

Note . Press “Prep” only when the technique is selected on the Console
and the patient is ready for the exposure. High Speed Generators
can be configured so that the anode remains running for
approximately one minute when “Prep” is pressed three
consecutive times in intervals shorter than 30 seconds.

EXP: After the “Ready” indicator is illuminated, press this push-button to start
a X-ray exposure. If the push-button is released before the Generator
completes the selected time or the AEC time, the exposure will be prematurely
terminated and the actual mAs and Exposure Time will be displayed.

The “X-ray On” indicator remains illuminated during the length of exposure.

READY: Indicates that the technique selected is properly set, there are no
interlock failures or system faults, the anode is rotating and the X-ray Tube is
ready for exposure.

X-RAY ON: Indicates that the X-ray exposure is in progress. At the same time
that radiographic exposures are being made, an audible signal sounds.

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6.5 X-RAY HANDSWITCH

OFF Radiographic exposures can also be initiated with the X-ray Handswitch which
Prep is connected to the Control Console.
Exp
The X-ray Handswitch button has three positions: “Off”, “Preparation”, and
“X-ray Exposure”, which operate in the same way that “Prep” and “Exp”
push-buttons on the Control Console.

Press the Handswitch half-way for “Prep” and fully for “Exp”.

6.6 HEAT UNITS

This X-ray Generator is equipped with a Heat Unit Calculator. During


exposures, the Heat Units are calculated and totalled.

To view the remaining Heat Units, press the “On” push-button. The kVp Display
shows the percentage of Heat Units that remain preceded by the letter “H”. For
example, a display of “H75” would indicate that 75% of Heat Units capacity of
the X-ray Tube remains. “H -- -- ” indicates that all the capacity remains. The kVp
Display reverts to its normal function after releasing the “On” push-button.

6.7 EXPOSURE COUNTERS

The operator can read the number of exposures made by the Generator, as
indicated below:

RAD EXPOSURES Press and hold and press once


IN TUBE-1

RAD EXPOSURES Press and hold and press once


IN TUBE-2

The number of exposures is shown on the kVp and mAs Displays, up to a


maximum of 999,999 exposures.

= 123.456 exposures

kV mAs

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6.8 SELF-DIAGNOSIS INDICATORS

Self-Diagnosis indicators identify a malfunction in the system alerting operator


about error existence that inhibits exposure. During normal operation of the
system, these indicators are directly shown on the APR Display or as an error
code on the kV Display. (Also refer to Section 6.9).

DOOR OPEN: Indicates the X-ray room door is open when the X-ray equipment
DOOR
is in use.

GENERATOR OVERLOAD: Indicates that the exposure has been interrupted


G.OVL
because during exposure has been produced arcing or bad function on the HV
circuitry (X-ray Tube, HV Transformer and/or HV Cables) or a failure of IGBT
module (overheated or defective IGBTs) has been detected.

It can be also shown making a high power and long exposure with the X-ray
Tube cool (X-ray Tube has not been warmed-up).

TUBE OVERLOAD: Indicates that either the technique selected is beyond the
T.OVL
X-ray Tube ratings or the present conditions of the X-ray Tube inhibit the
exposure (anode overheated). Parameters for next exposure may be
temporally limited by the Generator (change the exposure values or wait for the
X-ray Tube to cool).
Check that heat units available are lower than the calculated for the next
exposure (heat units close to zero). Reduce exposure factors or wait for the
X-ray Tube to cool. (To display the Heat Units refer to Section 6.6).

ROTOR ERROR: Indicates that the X-ray Tube anode is not rotating while
ROTOR
“Prep” is active, then exposures are inhibited.

HEAT: Indicates that the X-ray Tube thermostat / pressurestat is open due to
HEAT
overheating of the Tube housing (housing is too hot, wait for the housing to cool)
or to a thermostat / pressurestat mal-function (housing is cool). Heat units may
raise to any value.

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TECHNIQUE ERROR: If activates during exposure it means that:


TECH

The exposure has been interrupted by “Security Timer”


because of a failure in the system. Call Field Service.

This error can also be shown:

 after an APR technique selection to advise that exposure parameters


displayed on the Console are not the values stored for this APR
technique. Exposure parameters are adapted by the Generator to
another enable values.

 if a failure on the Automatic Collimator has been detected (blades are full
open or in movement during exposure, etc.). In this case the indicator
lights continuously.

6.9 ERROR CODES

Error codes indicate the potential cause of a system failure. Error codes are
shown on the kVp Display at the same time an audio signal is emitted. Correct
the error cause and keep pressed the “AEC Reset” push-button till the Console
indication disappears. (Refer to Table 6-1).

All these error codes are preceded by the letter “E” (i.e., E01) and they will
enable the operator to indirectly convey the possible source of error to service
personnel. This may prevent the need for a service call or enable service
personnel to anticipate corrective actions prior to arriving on site.

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Table 6-1
Error Codes

ERROR DESCRIPTION WHAT TO DO

System failure. This indication may appear together with an


-- -- -- -- -- -- Turn the Generator OFF and ON.
error on the Console, and indicates that the error is not
on Display If the equipment remains inoperative, turn it OFF and call Field Service.
correctable unless the equipment is turned OFF.

Turn the Generator OFF, check the proper external cable connections
E01, E02 Communication error. and then turn the Generator ON. If the equipment remains inoperative,
turn it OFF and call Field Service.

E03 System failure.


Turn the
T th Generator
G t OFF and d ON.
ON
The X-ray Generator has activated “Preparation” without a If the equipment remains inoperative, turn it OFF and call Field Service.
E04
Console command intervention.

Release any external exposure device or push-buttons.


E05 External exposure activated during power-up. Turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.

Release all the controls.


“Exposure” or/and “Preparation” orders are activated during
E06 Turn the Generator OFF and ON.
power-up.
If the equipment remains inoperative, turn it OFF and call Field Service.

Press the “AEC Reset” push-button.


E07, E08 X-ray Tube configuration error. If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.

Generator Overload error. The exposure has been


interrupted because during exposure has been produced
arcing or bad function on the HV circuitry (X-ray Tube, HV This error does not require to press the “AEC Reset” push-button, its
Transformer and/or HV Cables) or a failure of IGBT module indication disappears automatically.
E09 (overheated or defective IGBTs) has been detected. If the error code persists, turn the Generator OFF and wait 30 minutes
before turning it ON again.
It can be also shown making a high power and long If the equipment remains inoperative, turn it OFF and call Field Service.
exposure with the X-ray tube cool (X-ray Tube has not been
warmed-up).

Press the “AEC Reset” push-button.


E10, E11 System failure. If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.

E12 No mA during exposure or mA value is out of range. Press the “AEC Reset” push-button.
Repeat with same technique values, If the error code persists try with
another combinations of kV and mA values.
E13 No kV during exposure or kV value is out of range. If the equipment remains inoperative, turn it OFF and call Field Service.

Press the “AEC Reset” push-button.


E14, E15 System failure. If the error code persists, turn the Generator OFF and ON again.
If the equipment remains inoperative, turn it OFF and call Field Service.

Decrease kV, mA or both. Press the “AEC Reset” push-button.


E16 Invalid value of: kV, mA or kW. If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.

Turn the Generator OFF and ON.


E17 Communication error or system failure.
If the equipment remains inoperative, turn it OFF and call Field Service.

This error does not require to press the “AEC Reset” push-button, its
Rotor error. The X-ray tube anode is not rotating while
indication disappears automatically.
E18 “Prep” is active, then exposures are inhibited, or the X-ray
If the error code persists, turn the Generator OFF and ON.
tube anode is rotating without console command.
If the equipment remains inoperative, turn it OFF and call Field Service.

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Table 6-1 (cont.)


Error Codes

ERROR DESCRIPTION WHAT TO DO

Turn the Generator OFF and ON.


E19, E20 System failure.
If the equipment remains inoperative, turn it OFF and call Field Service.

E21, E22 Incorrect selection of the X-ray Tube.

E23 System failure.


Press the “AEC Reset” push
push-button.
button
E24 Bucky not ready for an exposure. p , turn the Generator OFF and ON.
If the error code persists,
If the equipment remains inoperative, turn it OFF
O and call Field S
Service.
E27 System failure.

E28 AEC Reference set failure.

Press the “AEC Reset” push-button.


Replace or insert the Receptor.
E32 Removable Receptor has not been replaced or inserted. If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.
In this case, the Generator can still work in “Direct” mode.

Press the “AEC Reset” push-button.


Check that communication cable between Generator and console is
E33 Serial Communication error. properly connected.
If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.

Technique error. If it activates during exposure it means


that the exposure has been interrupted by the “Security
Timer” because of a system failure. Call Field Service.
This error can also be shown: after an APR technique
E34
selection to advise that exposure parameters displayed on
the console are not the values stored for this APR
technique. Exposure parameters are adapted by the
Generator to another enable values.

Door Open error. The X-ray room door is open when the
E35
X-ray equipment is in use.
These errors do not require to press the “AEC Reset” push-button,
push button theirs
Heat Units error. The X-ray Tube thermostat / pressurestat indications disappear automatically.
is open due to the tube housing is overheated (housing is If the error code persists, turn the Generator OFF and ON.
E36 too hot, wait for the housing to cool) or a thermostat / If the equipment remains inoperative, turn it OFF and call Field Service.
pressurestat mal-function (housing is cool). Heat units may
raise to any value.

Tube Overload error. The technique selected is beyond the


X-ray tube ratings or present conditions of the X-ray tube
inhibit the exposure (anode overheated). Parameters for
next exposure may be temporally limited by the Generator
E37
(change the exposure values or wait for the X-ray tube to
cool). Check that heat units available are lower than the
calculated for the next exposure (heat units close to zero).
Reduce exposure factors or wait for the X-ray tube to cool.

Press the “AEC Reset” push-button.


E38 Wrong X-ray Tube orientation for Table Workstation. Correct the X-ray Tube orientation respect to the selected Workstation.
If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative, turn it OFF and call Field Service.
E39 Wrong X-ray Tube orientation for Wall Stand Workstation. In this case, the Generator can still work in “Direct” mode and with the
other Workstation.
Press the “AEC Reset” push-button.
If the error code persists, turn the Generator OFF and ON.
E40 Alignment hardware error.
If the equipment remains inoperative, turn it OFF and call Field Service.
In this case, the Generator can still work in “Direct” mode.

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Table 6-1 (cont.)


Error Codes

ERROR DESCRIPTION WHAT TO DO

E41 to E46 System failure related to Dosimeter.

Collimator Error. A failure on the Automatic Collimator has


E48 been detected (blades are full open or in movement during Press the “AEC Reset” push-button.
exposure, etc.) If the error code persists, turn the Generator OFF and ON.
If the equipment remains inoperative
inoperative, turn it OFF and call Field Service
Service.
E50 Exposure has been aborted by the Operator.

E51 to E93 System failure related to High Speed Rotor Controller.

Press the “AEC Reset” push-button.


Select the correct Ion Chamber or modify parameters.
E95 Exposure aborted by the AEC Rapid Termination.
Repeat the exposure.
If the equipment remains inoperative, turn it OFF and call Field Service.

Press the “AEC Reset” push-button.


X-ray order not acknowledged.
Repeat the exposure.
E97 The Receptor (Digital Detector) has not received or
If the error code persists, turn the Generator OFF and ON.
acknowledged the X-ray order sent by the Generator.
If the equipment remains inoperative, turn it OFF and call Field Service.

Press the “AEC Reset” push-button and call Field Service. This error
E98 Service Mode Active.
does not inhibit normal operation.

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SECTION 7 OPERATING SEQUENCES

7.1 START-UP ROUTINE

Start-up the System as described in Section 3.

7.2 X-RAY TUBE WARM-UP PROCEDURE

Before effecting X-ray exposures ensure that the Tube is


properly warmed-up. Make sure that no persons will be
inadvertently exposed to unnecessary X-rays during this
procedure.

Routine exposures should not be effected unless the Tube is previously


warmed-up, this prolongs X-ray Tube life.

It is recommended that the following procedure will be performed for X-ray Tube
warm-up, at the start of each day and when the Tube selected has not been in
use for approximately one hour.

This warm-up procedure is used for a typical X-ray Tube.


Consult the X-ray Tube manufacturer instructions for the
actual Tube in use, comparing its recommendations with
this procedure. If there is conflict with this procedure,
comply with the Tube manufacturer’s instructions.

Perform X-ray Tube warm-up as follows:

 Close the collimator blades fully.

 Select 70 kVp, 100 mAs, 200 mA and 500 ms exposure.

 Make sure that no one will be exposed.

 Make a total of three exposures, 15 seconds apart.

Excessive filament evaporation shortens X-ray Tube life.


Minimize evaporation by keeping Exposure “Preparation”
time to an absolute minimum.

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7.3 RADIOGRAPHIC OPERATION

RAD operation can be performed in the following modes:

 Three point control by selecting kVp, mA and Exposure Time


independently.

 Two point control by selecting kVp and mAs independently. mAs


selection sets the maximum mA available for the selected Focal Spot
and the respective Exposure Time. In this control mode, when kVp value
is increased, the Generator will automatically look for the adequate
combination of mA and Exposure Time factors to avoid the “Tube
Overload” warning, keeping constant mAs.

 One point control by selecting kVp with AEC operations.

 Anatomical Programs (APR).

A typical RAD examination sequence is as indicated below:

1. Make sure that the X-ray Tube to be used is properly warmed-up.

2. Position the patient for the examination.

3. Select the “workstation” and technique parameters using the RAD


controls on the NX Station or on the DX-D Console.

4. Instruct patient to maintain the required position. Prepare the X-ray Tube
by pressing the handswitch button to the “Prep” position and maintain it
until the “Ready” indicator is illuminated.

5. Instruct patient to remain still and to hold their breath as required, then
make the X-ray exposure by pressing the handswitch button fully to the
“Exp” position and maintain it throughout the exposure. The “X-ray On”
indicator will light and an alarm will sound during the exposure.

6. When the exposure is finished, release the handswitch button.

7. Repeat the procedure if additional exposures are desired.

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7.4 AEC OPERATION

To proper use of AEC requires accurate patient positioning. For examination


using AEC, the operator will need to select the desired AEC parameters as
follows:

1. Make sure that the X-ray Tube to be used is properly warmed-up.

2. Position the patient for the examination.

3. Select the “workstation” and enter in AEC mode by selecting at least one
Area Detector “Field” on the NX Station or on the DX-D Console.

4. If required, choose another “Film Screen Combination” and adjust the


“Film Density” setting (“0” is the normal setting).

5. Select the technique parameters (back-up time / mAs) using the RAD
controls on the Console.

6. Continue with the radiographic operation. (Refer to Section 7.3 -- step 4.)

7.4.1 HOW TO VERIFY THE PROPER FUNCTIONING OF THE AEC

Note . This procedure is not mandatory, it is only a method so that the


operator can verify the proper functioning of the Automatic
Exposure Control.

1. Ensure that X-ray Tube has been properly warmed up.

2. Align and center the X-Ray Tube to the image receptor.

3. Set a SID of 1 m (40”).

4. Collimate the X-Ray beam so that it completely covers all three Ion
Chambers (Left, Center and Right).

5. Place on the Table-Top and within the X-Ray beam a homogeneous


phantom (e.g. a bucket with 10 cm of water) that covers all three Ion
Chambers.

6. Set a technique, for example: 70 kVp, 250 mA, 1.0 second back-up time.

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7. Select “Center” Ion Chamber and Density “Normal -- 0”.

Make a RAD exposure and note the exposure mAs and time. For a
proper functioning of the AEC, the exposure must not be aborted by the
AEC back-up timer, that is, the “AEC Reset” push-button is not flashing.

8. Deselect “Center” and select “Left” Ion Chamber.

Make a RAD exposure and note the exposure mAs and time. For a
proper functioning of the AEC, the exposure must not be aborted by the
AEC back-up timer, that is, the “AEC Reset” push-button is not flashing.

9. Deselect “Left” and select “Right” Ion Chamber.

Make a RAD exposure and note the exposure mAs and time. For a
proper functioning of the AEC, the exposure must not be aborted by the
AEC back-up timer, that is, the “AEC Reset” push-button is not flashing.

10. The noted Exposure mAs and time have to be equal ¦10% between
all three Ion Chambers. If not, contact Service.

11. Repeat the above steps changing the Density and/or the homogeneous
phantom (e.g. a bucket with 5 cm of water).

Compare the Exposure mAs and time between each Ion Chamber and
between the values noted before (for a lower density or less water, lower
mAs and a shorter time; for half of density or half of water, half of mAs
/ time). If not, contact Service.

12. Finally, check the proper functioning of the AEC back-up timer by making
a RAD exposure with the selections indicated in step 6., but with the
Collimator blades fully closed.

The exposure must be finished by the AEC back-up timer, that is, the
exposure length is 1.0 second and the “AEC Reset” Push-button is
flashing. If not, contact Service.

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7.5 APR OPERATION

An examination using an APR technique could consist of the following:

1. Make sure that the X-ray Tube to be used is properly warmed-up.

2. Position the patient for the examination.

3. Select the “Patient Size” corresponding to the patients anatomy. This


operation starts the APR mode. Select the “Pediatric” button if the
patient is not an adult.

4. Select a general “Body Region / Anatomical View / Projection” of the


indicated on the APR Display.

5. The technique parameters, Workstation information, Focal Spot, AEC,


etc... corresponding to the APR selection are displayed and indicated on
the Console. If needed, the parameters and selections can be directly
modified by the operator.

6. Continue with the normal procedure for a typical RAD examination.


(Refer to Section 7.3 - step 4.)

7.6 FAIL-SAFE FUNCTION

The Fail-Safe function inhibits X-ray exposures when:

 the removable Receptor (Portable Detector, CR / Film) has not been


replaced or inserted by the operator after an exposure, or

 the Workstation selected by the operator is not the Workstation (Table


or Wall Stand) to which the X-ray Tube is aligned.

If any of these situations occur and the “Preparation” button on the Handswitch
is pressed, one of the following messages appears on the Console
accompanied by an error code (depending on the type of Console used in the
System):

 Receptor has not been replaced or inserted (E32).

 Wrong X-ray Tube orientation for Table Workstation (E38).

 Wrong X-ray Tube orientation for Wall Stand Workstation (E39).

 Alignment hardware error (E40).

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SECTION 8 PERIODIC MANTEINANCE

In order to ensure continued safe performance of the equipment, a periodic


maintenance program must be established. It is the owner’s responsibility to
supply or arrange for this service.

There are two levels of maintenance, the first consists of tasks which are
performed by the user/operator, and the second are those tasks to be
performed by qualified X-ray service personnel.

Service tasks here described must be performed exclusively by service


personnel specifically trained on medical X-ray Units. The first periodic
maintenance service should be performed six (6) months after installation, and
the subsequent services at twelve (12) month intervals.

Heavy duty installations (more than125 patients per day) require a regular six
(6) month maintenance.

The manufacturer undertakes to have available spare parts for this equipment
at least for ten (10) years after the unit manufacturing.

NEVER ATTEMPT TO PERFORM MAINTENANCE TASKS


WHILE THE ME EQUIPMENT IS IN USE WITH A PATIENT.

8.1 OPERATOR TASKS

The tasks of this periodic maintenance shall include the following items:

DO NOT REMOVE ANY COVER, DISASSEMBLE OR


MANIPULATE INTERNAL COMPONENTS IN THE UNIT.
THESE ACTIONS COULD CAUSE SERIOUS PERSONAL
INJURIES AND / OR EQUIPMENT DAMAGE.

NEVER ATTEMPT TO CLEAN ANY PART OF THE UNIT WHEN


IT IS SWITCHED ON. ALWAYS SWITCH OFF THE EQUIPMENT
AND ISOLATE THE MAINS ELECTRICAL SUPPLY BEFORE
CLEANING.

1. Switch the System OFF.

2. Externally, check the proper cable connections between each major


component in the X-ray system (Table, Wall Stand, Tube Stand,
Generator Cabinet, etc ... ).

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3. Clean the equipment frequently, particularly if corroding chemicals are


present. Clean external covers and surfaces, specially parts in contact
with patients, with a cloth moistened in warm water with mild soap. Wipe
with a cloth moistened in clean water. Do not use cleaners or solvents
of any kind.

When it is needed to disinfect any surface, clean it with a cloth


impregnated with isopropyl alcohol.

Do not apply directly any liquid on the surfaces, nor use cleaners
containing bleach, ammonia or any other abrasive or solvent liquid, it
could cause damage to the equipment.

8.2 SERVICE TASKS

Only service personnel specifically trained on this medical X-ray equipment


should work on service tasks (installation, calibration or maintenance) of the
equipment. (Refer to the respective chapters of the Service Manual provided
with this equipment.)

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SECTION 9 TECHNICAL SPECIFICATIONS

9.1 ENVIRONMENTAL REQUIREMENTS

ATMOSPHERIC PRESSURE (hPa) RELATIVE HUMIDITY (%) AMBIENT TEMPERATURE

MIN MAX MIN MAX MIN MAX

WORKING

700 hPa 1060 hPa 30% 75% 10 oC (50 oF) 35 oC (95 oF)

TRANSPORT & STORAGE

500 hPa 1060 hPa 10% 90% -20 oC (--4 oF) 70 oC (158 oF)

Note . These environmental conditions do not include the Digital


Detector. Refer to the Digital Detector Documentation.

9.2 X-RAY SYSTEM POSITIONERS

9.2.1 POWER LINE REQUIREMENTS

MINIMUM INPUT
POWER BRAKE POWER
EQUIPMENT VOLTAGE FREQUENCY POWER
OUTPUT SUPPLY
REQUIRED

110 - 230 VAC,


RAD TABLE -- ELEVATING TABLE 50/60 Hz 0.6 kVA 0.18 kW --
Single Phase

RAD TABLE -- FIXED HEIGHT 110 - 230 VAC,


50/60 Hz 0.4 kVA 0.18 kW --
TABLE Single Phase

RAD WALL STAND * See Note 0.5 kVA 0.10 kW (4A) 24 VDC, 2A

* NOTE: Power Line for the RAD Wall Stand is supplied by the X-ray Generator (110 -- 230 VAC, Single Phase, 50 / 60 Hz)

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9.2.2 INFORMATION RELATED TO RADIATION

Radiation Output Accuracy: C.V. (Coefficient of Variation) ≤ 0.05


(Reproducibility related to loading factors)

Maximum Symmetrical Radiation Field:


Measured at 75 kVp: 160 mm in “X” axis and 240 mm in “Y” axis.
Measured at 125 kVp: 160 mm in “X” axis and 240 mm in “Y” axis.
(Test performed at a distance from the Focal Spot of 1200 mm, in accordance with IEC 60806: 1984)

9.2.3 PHYSICAL CHARACTERISTICS

FLOOR MOUNTED TUBE STAND

(Refer to Illustration 9-1 and Illustration 9-2)

Dimensions
Height . . . . . . . . . . . . . . . . . . . . . . . . . . . 2370 mm
Width . . . . . . . . . . . . . . . . . . . . . . . . . . . 2755 mm
Length . . . . . . . . . . . . . . . . . . . . . . . . . . 1267 mm

Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 345 kg

Maximum Height of X-ray Tube focus


(vertical position) . . . . . . . . . . . . . . . . . . . . . . . 2020 mm

SID from horizontal axis of X-Ray Tube facing


the RAD Table - Fixed Height (maximum) . 1270 mm

SID from horizontal axis of X-Ray Tube facing


the RAD Table - Elevating Table (maximum) 1620 mm

Distances from vertical axis of X-Ray tube


facing the RAD Wall Stand
Minimum height . . . . . . . . . . . . . . . . . . 400 mm
Maximum height . . . . . . . . . . . . . . . . . . 1900 mm

SID from Horizontal axis of X-Ray Tube


facing the RAD Wall Stand
Minimum SID . . . . . . . . . . . . . . . . . . . . . 874 mm
Maximum SID . . . . . . . . . . . . . . . . . . . . 2884 mm

Column longitudinal travel . . . . . . . . . . . . . . . 2010 mm


(optional longitudinal travel with 3755 mm base) (3010 mm)

Rotation of Column with respect to its vertical


axis (Rotation may be limited by cables) . . . . . . . . . ±180o

Rotation of Tube-Collimator Assembly with respect


to its transverse axis (Rotation may be limited by cables) +135o / - 180o

High Voltage Cables . . . . . . . . . . . . . . . . . . . . 12 m

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RAD TABLE -- FIXED HEIGHT

(Refer to Illustration 9-1 and Illustration 9-2)

Dimensions
Height . . . . . . . . . . . . . . . . . . . . . . . . . . . 750 mm
Width . . . . . . . . . . . . . . . . . . . . . . . . . . . 2200 mm
Length . . . . . . . . . . . . . . . . . . . . . . . . . . 800 mm

Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 kg

Dimensions of Floating Table-Top . . . . . . . . . 2200 x 800 mm

Maximum Patient Weight supported . . . . . . . 350 kg

Table-Top / Receptor distance . . . . . . . . . . . 85 mm

Table-Top Attenuation . . . . . . . . . . . . . . . . . . . <1.0 mm Al eq.

Longitudinal motion of Table-Top . . . . . . . . . . 1100 mm

Transverse motion of Table-Top . . . . . . . . . . 240 mm

Longitudinal motion of Receptor . . . . . . . . . . 510 mm

Ion Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . Claymount SSMC--617

Cassettes sizes . . . . . . . . . . . . . . . . . . . . . . . . from 18 to 43 cm

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RAD TABLE -- ELEVATING TABLE

(Refer to Illustration 9-1 and Illustration 9-2)

Dimensions
Maximum Height . . . . . . . . . . . . . . . . . . 900 mm
Minimum Height . . . . . . . . . . . . . . . . . . 500 mm
Width . . . . . . . . . . . . . . . . . . . . . . . . . . . 2200 mm
Length . . . . . . . . . . . . . . . . . . . . . . . . . . 800 mm

Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280 kg

Dimensions of Floating Table-Top . . . . . . . . . 2200 x 800 mm

Maximum Patient Weight supported . . . . . . . 350 kg

Table-Top / Receptor distance . . . . . . . . . . . 85 mm

Table-Top Attenuation . . . . . . . . . . . . . . . . . . . <1.0 mm Al eq.

Longitudinal travel of Table-Top . . . . . . . . . . . 1100 mm

Transverse travel of Table-Top . . . . . . . . . . . 240 mm

Ion Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . Claymount SSMC--617

Cassettes sizes . . . . . . . . . . . . . . . . . . . . . . . . from 18 to 43 cm

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RAD WALL STAND

(Refer to Illustration 9-3)

Dimensions
Height . . . . . . . . . . . . . . . . . . . . . . . . . . . 2235 mm
Width . . . . . . . . . . . . . . . . . . . . . . . . . . . 657 mm
Length . . . . . . . . . . . . . . . . . . . . . . . . . . 381 mm

Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 kg

Dimensions of Receptor Assembly . . . . . . . . 657 x 570 mm

Table-Top Dimensions . . . . . . . . . . . . . . . . . . . 559 x 485 mm

Table-Top / Receptor distance . . . . . . . . . . . . 46.5 mm (± 2)

Table-Top Attenuation . . . . . . . . . . . . . . . . . . . <0.8 mm Al eq.

Height from horizontal axis of receptor


Minimum height . . . . . . . . . . . . . . . . . . 360 mm
Maximum height . . . . . . . . . . . . . . . . . . 1860 mm

Receptor vertical motion . . . . . . . . . . . . . . . . . 1500 mm

Ion Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . Claymount SSMC--617

Cassettes sizes . . . . . . . . . . . . . . . . . . . . . . . . from 18 to 43 cm

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RAD WALL STAND -- MANUAL TILTING

(Refer to Illustration 9-4)

Dimensions
Height . . . . . . . . . . . . . . . . . . . . . . . . . . . 2235 mm
Width . . . . . . . . . . . . . . . . . . . . . . . . . . . 657 mm
Length . . . . . . . . . . . . . . . . . . . . . . . . . . 890 mm

Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175,5 kg

Dimensions of Receptor Assembly . . . . . . . . 657 x 570 mm

Table-Top Dimensions . . . . . . . . . . . . . . . . . . . 559 x 485 mm

Table-Top / Receptor distance . . . . . . . . . . . . 46.5 mm (± 2)

Table-Top Attenuation . . . . . . . . . . . . . . . . . . . <0.8 mm Al eq.

Height from horizontal axis of receptor


Minimum height . . . . . . . . . . . . . . . . . . 360 mm
Maximum height . . . . . . . . . . . . . . . . . . 1860 mm

Receptor Vertical and Horizontal Travel . . . . 1500 mm

Tilting Angle . . . . . . . . . . . . . . . . . . . . . . . . . . . +90o , --20o

Ion Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . Claymount SSMC--617

Cassette sizes . . . . . . . . . . . . . . . . . . . . . . . . . from 18 to 43 cm

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GRIDS

 Configurations with non--removable moving grid:

Grids for Table . . . . . . . . 1 m -- 215 lines/inch -- 12:1 (Carbon Fibre)

Grids for Wall Stand . . . 1 m -- 215 lines/inch -- 12:1 (Carbon Fibre)


1.3 m -- 215 lines/inch -- 8:1 (Carbon Fibre)
1.8 m -- 215 lines/inch -- 12:1 (Carbon Fibre)

 Configurations with removable static grid:

Grids for Table . . . . . . . 1 m -- 132 lines/inch -- 10:1 (Carbon Fibre)

Grids for Wall Stand . . . 1 m -- 132 lines/inch -- 10:1 (Carbon Fibre)


1.5 m -- 132 lines/inch -- 10:1 (Carbon Fibre)
1.8 m -- 132 lines/inch -- 10:1 (Carbon Fibre)

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Illustration 9-1
Dimensions of the Equipments in the X-ray System (RAD Table -- Elevating Table).

1626
64”
1106.5
43.6”
o
180
o
135

50”
1267

8.9”
225

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Illustration 9-2
Dimensions of the Equipments in the X-ray System (RAD Table -- Fixed Height Table).

1626
64”
1106.5
43.6”
o
180
o
135

50”
1267

8.9”
225

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Illustration 9-3
Dimensions of the RAD Wall Stand

381 (15”)

2235 (88”)
1860 (73.2”)
1500 (59”)

200 (7.8”)
360 (14.1”)

657 (25.8”)
485 (19”)

559 (22”)

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Illustration 9-4
IDimensions of the RAD Wall Stand - Manual Tilting

1500 (59”)
1500 (59”)

2155 (84.8”)
1860 (73.2”)

399 (15.7”)
512 (20.1”)

655 (25.7”)
360 (14.1”)

693 (27.2”) 582 (22.9”)


980 (35”)
180 (7.1”)

90º
570 (22.4”)

20º
2235 (88”)

657 (25.8”)

Receptor Assembly
485 (19”)

559 (22”)

Table-top

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9.3 X-RAY GENERATOR

9.3.1 FACTORS

GENERATOR SHF-335-1T-LS SHF-335-1T-HS SHF-535-1T-LS SHF-535-1T-HS SHF-635-1T-HS SHF-835-1T-HS


MODEL RAPIDT RAPIDT RAPIDT RAPIDT RAPIDT RAPIDT

Maximum Power kW 32 kW 50 kW 64 kW 80 kW

Maximum mA 400 mA 640 mA 640 mA 800 mA

Maximum kVp 150 kVp 150 kVp 150 kVp 150 kVp

Power Line C/D A/C/D C/D C/D D

400 mA @ 80 kVp 640 mA @ 78 kVp


640 mA @ 100 kVp 800 mA @ 100 kVp
Power Output 320 mA @ 100 kVp 500 mA @ 100 kVp
500 mA @ 128 kVp 640 mA @ 125 kVp
(@ 0.1 s) 250 mA @ 128 kVp 400 mA @ 125 kVp
400 mA @ 150 kVp 500 mA @ 150 kVp
200 mA @ 150 kVp 320 mA @ 150 kVp

POWER LINE AND NOMINAL WORKING FREQUENCY

A C D

230 / 240 VAC, Single-Phase, 50 / 60 Hz 400 / 415 / 440 VAC, Three-Phase, 50 / 60 Hz 480 VAC, Three-Phase, 50 / 60 Hz

Line voltage automatic compensation: ±10%.

Maximum line regulation for maximum kVA demand: 5%.

NOTES: -- For Generators operating with lines at 208 VAC or below an Auxiliary Boost Transformer is required to adequate the
line voltage to 230 / 240 VAC.
-- For 80 kW Generators operating with lines at 400 / 415 / 440 VAC an auxiliary boost transformer is required to adequate
the line voltage to 480 VAC.

9.3.2 RANGE OF RADIOGRAPHIC PARAMETERS

PARAMETER RANGE

kVp From 40 kVp to 150 kVp in 1 kV steps.

From 10 mA to 800 mA through the following mA stations:


mA 10, 12.5, 16, 20, 25, 32, 40, 50, 64, 80, 100, 125, 160, 200, 250, 320, 400, 500, 640, 800.
(Depending on the Generator model)

mAs Product of mA x Time values from 0.1 mAs to 500 mAs (640 mAs under request).

From 1 to 10000 milliseconds through the following Time stations:


Exposure Time 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 25, 32, 40, 50, 64, 80, 100, 125, 160, 200, 250, 320, 400, 500, 640, 800,
1000, 1250, 1600, 2000, 2500, 3200, 4000, 5000, 6400, 8000 and 10000.

mAs: 0.1 mAs to 500 mAs


AEC
Exposure Time: Nominal shortest irradiation Time = 8 ms

9.3.3 DUTY CYCLE

The Generator duty cycle is continuous, but limits should be set during
installation depending on the capacity of the X-ray Tube.

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9.3.4 PHYSICAL CHARACTERISTICS

DIMENSIONS
COMPONENT WEIGHT
LENGTH WIDTH HEIGHT

X-ray Generator (1 Tube, HSS) 592 mm 360 mm 690 mm 95 Kg

X-ray Generator (1 Tube, LSS) 445 mm 360 mm 568 mm 72 Kg

X-ray Generator Control 32 mm 165 mm 131 mm 0.6 kg

DX-D Touch Screen Console 360 mm 290 mm 114 mm 8 kg

DX-D Overlay Console and


430 mm 290 mm 50 mm 6 kg
DX-D Overlay Console with APR

Illustration 9-5
Dimensions

Cable Access
Cable Access
568

GENERATOR GENERATOR
(1 TUBE, HSS) (1 TUBE, LSS)
690

DX-D TOUCH SCREEN CONSOLE


131

X-RAY GENERATOR CONTROL

DX-D OVERLAY CONSOLES

TABLE SUPPORT

PEDESTAL

WALL SUPPORT

THESE CONSOLES CAN BE MOUNTED ON A TABLE SUPPORT, WALL SUPPORT OR PEDESTAL

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9.4 X-RAY TUBES

Low Speed -- Rotating Anode, Focal Spots: 0.6 mm / 1.2 mm


Anode kHU / kVp: 300 kHU / 150 kVp, Target Angle: 12°
E7884X
Maximum Specified Energy Input in 1 hour: 150 kVp @ 3408 mAs
Inherent Filtration of X-ray Source (Tube + Collimator): refer to Identification Label

High Speed -- Rotating Anode, Focal Spots: 0.6 mm / 1.2 mm


Anode kHU / kVp: 300 kHU / 150 kVp, Target Angle: 12°
E7252X
Maximum Specified Energy Input in 1 hour: 150 kVp @ 5760 mAs
Inherent Filtration of X-ray Source (Tube + Collimator): refer to Identification Label

High Speed -- Rotating Anode, Focal Spots: 0.6 mm / 1.2 mm


Anode kHU / kVp: 400 kHU / 150 kVp, Target Angle: 12°
E7254FX
Maximum Specified Energy Input in 1 hour: 150 kVp @ 4800 mAs
Inherent Filtration of X-ray Source (Tube + Collimator): refer to Identification Label

High Speed -- Rotating Anode, Focal Spots: 0.6 mm / 1.2 mm


Anode kHU / kVp: 600 kHU / 150 kVp, Target Angle: 12°
E7869XX
Maximum Specified Energy Input in 1 hour: 150 kVp @ 5189 mAs
Inherent Filtration of X-ray Source (Tube + Collimator): refer to Identification Label

9.5 COLLIMATORS

Model R225 / R225 DHHS MANUAL R225 ACS AUTOMATIC

Shape Rectangular Rectangular

430 x 430 mm SID 110 cm 430 x 430 mm SID 90 cm


Field Maximum field
(¦1% SID) (¦1% SID)

Minimum field 00 x 00 mm (¦1% SID) 00 x 00 mm (¦1% SID)

Average illumination > 160 lx > 160 lx

Edge contrast ratio > 4:1 > 4:1

Accuracy < 2% SID < 2% SID


Li ht fi
Light field
ld
Display of center Cross lines Cross lines

Inherent filtration Min. 2.0 mmAl. Min. 2.0 mmAl.

Type of lamp White LED White LED

Drive of leaves Manual Automatic

External dimension (W x D x H ) 244 x 282 x 216 244 x 282 x 216

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APPENDIX A GUIDELINES FOR PEDIATRIC


APPLICATIONS

THE PRACTITIONER WILL BE THE ULTIMATE


RESPONSIBLE OF APPLYING THE PROPER DOSE TO THE
PATIENT FOR RADIOGRAPHIC PROCEDURES. THE
PURPOSE OF THESE GUIDELINES IS TO HELP THE
PRACTITIONER TO MINIMIZE POTENTIAL RISKS.

Use special care when imaging patients outside the typical


adult size range.

Children are more radiosensitive than adults. Adopting the


Image Gently campaign guidelines and reducing dose for
radiographic procedures while maintaining acceptable
clinical image quality will benefit patients.

Please review the following link and reduce pediatric technique factors
accordingly: http://www.pedrad.org/associations/5364/ig/

As a general rule, next recommendations shall be observed in pediatrics:

 X-Ray Generator must have short exposures times.

 AEC must be used carefully, preferably use manual technique setting,


applying lower doses.

 If possible, use high kVp techniques.

 As the use of Grids require higher doses, never use Grids in pediatric
exams. Remove the Grid from the receptor assembly and select the
lower possible doses. If the Grid can not be detached, pediatric exams
can not be performed using this device.

Appendix A A-1
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Positioning the pediatric patient:

Pediatric patients are not as likely as adults to understand the need to remain
still during the procedure. Therefore it makes sense to provide aids to
maintaining stable positioning. It is strongly recommended the use of
immobilizing devices such as bean bags and restraint systems (foam
wedges, adhesive tapes, etc.) to avoid the need of repeating exposures due to
the movement of the pediatric patients. Whenever possible use techniques
based on the lowest exposure times.

Shielding:

We recommend you provide extra shielding of radiosensitive organs or


tissues such as eyes, gonads and thyroid glands. Applying a correct
collimation will help to protect the patient against excessive radiation as well.
Please review the following scientific literature regarding pediatric
radiosensitivity: GROSSMAN, Herman. “Radiation Protection in Diagnostic
Radiography of Children”. Pediatric Radiology, Vol. 51, (No. 1): 141--144,
January, 1973: http://pediatrics.aappublications.org/cgi/reprint/51/1/141.

Technique factors:

You should take steps to reduce technique factors to the lowest possible levels
consistent with good image acquisition.

For example if your adult abdomen settings are: 70--85 kVp, 200--400 mA,
15--80 mAs, consider starting at 65--75 kVp, 100--160 mA, 2.5--10 mAs for a
pediatric patient. Whenever possible use high kVp techniques and large SID
(Source Image Distance).

Summary:

 Image only when there is a clear medical benefit.

 Image only the indicated area.

 Use the lowest amount of radiation for adequate imaging based on size
of the child (reducing tube output -- kVp and mAs).

 Try to use always short exposure times, large SID values and
immobilizing devices.

 Avoid multiple scans and use alternative diagnostic studies (such as


ultrasound or MRI) when possible.

A-2 Appendix A
DX-D 400
User Manual

APPENDIX B ANATOMICAL PROGRAMMER MATRIX

Note . For DX-D Touch Screen Console, the language of the factory
pre-programmed APR techniques is configured according to the
customer order and it can not be changed by the operator (refer
to Section B.1).

The APR languages available are:

CONSOLE TYPE ENGLISH FRENCH SPANISH GERMAN POLISH TURKISH RUSSIAN

DX-D TOUCH SCREEN CONSOLE p p p p p p p

Note . For DX-D Overlay Console with APR, the language pack of the
factory pre-programmed APR techniques is configured according
to the customer order and it can not be changed by the operator
(refer to Section B.1).

APR language packs available are:

ENGLISH ENGLISH ENGLISH ENGLISH


CONSOLE TYPE FRENCH FRENCH FRENCH FRENCH
SPANISH GERMAN POLISH TURKISH

DX-D OVERLAY CONSOLE WITH APR p p p p

Note . In accordance with Standard IEC 60601--2--54:2009, Tables in


Section B.2 are provided to record the Loading Factors of the
Anatomical Programmer at the time of the Installation and futher
modifications. Write down the data with a pencil in order to allow
future changes in the table parameters.

Appendix B B-1
DX-D 400
User Manual

B.1 AVAILABLE LANGUAGE MATRIX

APR MATRIX (ENGLISH VERSION)

BODY REGION / ORGAN / PROJECTION


AP/PA

LATERAL
AP
SKULL SEMIAXIAL THORAX ODONTOID AP
LATERAL
AXIAL

SPECIAL

AP
AP/PA
ORBITA -- UPPER RIBS C-SPINE LATERAL
OBLIQUE
OBLIQUE

AP
PETROUS AP/PA
BONES -- LOWER RIBS T-SPINE LATERAL
SKULL / STENVERS THORAX OBLIQUE SPINE
OBLIQUE

AP
LATERAL
MASTOID -- STERNUM L-SPINE LATERAL
OBLIQUE
OBLIQUE

AP/PA
AP
PARANASAL
-- SCAPULA LATERAL L5-- S1
SINUSES
LATERAL
OBLIQUE

AP
SELLA LATERAL CLAVICLE AP/PA SACRUM
LATERAL

NOSE LATERAL

AP/PA
AP
LATERAL AP
ABDOMEN FEMUR SHOULDER SEMIAXIAL
DECUBITUS LATERAL
OBLIQUE
STANDING

AP AP
KIDNEY AP KNEE HUMERUS
LATERAL LATERAL

LATERAL PA
KIDNEY
AP PATELLA ELBOW
/ URETER
AXIAL LATERAL

AP AP PA
ABDOMEN / GALL- LOWER UPPER
LOWER LEG FOREARM
PELVIS BLADDER EXTREMITIES EXTREMITIES
OBLIQUE LATERAL LATERAL

AP AP
AP
PELVIS ANKLE LATERAL WRIST LATERAL
LATERAL
OBLIQUE OBLIQUE

AP AP AP

HIP MED / LAT FOOT LATERAL HAND LATERAL

AXIAL OBLIQUE OBLIQUE

AP
TOES AP/LAT/OBLIQ FINGER
LATERAL

B-2 Appendix B
DX-D 400
User Manual

APR MATRIX (FRENCH VERSION)

REGION DU CORPS / ORGANE / PROJECTION

AP/PA

LATERAL
AP
CRANE SEMIAXIAL THORAX ATLAS AP
LATERAL
AXIAL

SPECIAL

AP
AP/PA
ORBITAE -- COTES SUP. COL. CERV LATERAL
OBLIQUE
OBLIQUE

AP
AP/PA
M. PEDRO -- COTES INF. COL. DORS LATERAL
CRANE THORAX OBLIQUE COLONNE
OBLIQUE

AP
LATERAL
MASTOID -- STERNUM COL. LOMB LATERAL
OBLIQUE
OBLIQUE

AP/PA
AP
SINUS -- OMOPLATE LATERAL L5-- S1
LATERAL
OBLIQUE

AP
SELLA LATERAL CLAVICLE AP/PA SACRUM
LATERAL

NEZ LATERAL

AP/PA
AP
LATERAL AP
ABDOMEN FEMUR EPAULE SEMIAXIAL
DECUBITUS LATERAL
OBLIQUE
DEBOUT

AP AP
REINS AP GENOU HUMERUS
LATERAL LATERAL

LATERAL PA
URETERE AP ROTULE COUDE
AXIAL LATERAL

AP AP PA
ABDOMEN / EXTREMITES EXTREMITES
VES. BIL. JAMBE INF. BRAS. INF.
BASSIN INFERIEUR SUPERIEUR
OBLIQUE LATERAL LATERAL

AP AP
AP
PELVIS CHEVILLE LATERAL POIGNET LATERAL
LATERAL
OBLIQUE OBLIQUE

AP AP AP

HANCHE MED / LAT PIED LATERAL MAIN LATERAL

AXIAL OBLIQUE OBLIQUE

AP
ORTEIL AP/LAT/OBLIQ DOIGTS
LATERAL

Appendix B B-3
DX-D 400
User Manual

APR MATRIX (SPANISH VERSION)

ZONA CUERPO / ORGANO / PROYECCION

AP/PA

LATERAL
AP
CRANEO SEMIAXIAL TORAX ODONTAL AP
LATERAL
AXIAL

ESPECIAL

AP
AP/PA
COSTILLAS COLUMNA
ORBITA -- LATERAL
SUPERIORES CERVICAL
OBLICUO
OBLICUO

AP
AP/PA
COSTILLAS COLUMNA
PEÑASCO -- LATERAL
INFERIORES DORSAL
CRANEO TORAX OBLICUO COLUMNA
OBLICUO

AP
LATERAL
COLUMNA
MASTOID -- ESTERNON LATERAL
LUMBAR
OBLICUO
OBLICUO

AP/PA
AP
SEN. PAR. -- ESCAPULA LATERAL L5-- S1
LATERAL
OBLICUO

AP
SILLA TURCA LATERAL CLAVICULA AP/PA SACRO
LATERAL

NARIZ LATERAL

AP/PA
AP
LATERAL AP
ABDOMEN FEMUR HOMBRO SEMIAXIAL
DECUBIT0 LATERAL
OBLICUO
CARGA

AP AP
RIÑON AP RODILLA HUMERO
LATERAL LATERAL

LATERAL PA
RIÑON /
AP ROTULA CODO
URETRA
AXIAL LATERAL

AP AP PA
ABDOMEN / VESICULA EXTREMIDADES PIERNA EXTREMIDADES
ANTEBRAZO
PELVIS BILIAR INFERIORES INFERIOR SUPERIORES
OBLICUO LATERAL LATERAL

AP AP
AP
PELVIS TOBILLO LATERAL MUÑECA LATERAL
LATERAL
OBLICUO OBLICUO

AP AP AP

CADERA MED / LAT PIE LATERAL MANO LATERAL

AXIAL OBLICUO OBLICUO

AP
DEDOS DEDOS DE
AP/LAT/OBL
DEL PIE LA MANO
LATERAL

B-4 Appendix B
DX-D 400
User Manual

APR MATRIX (GERMAN VERSION)

REGION / ORGAN / PROJEKTION

AP/PA

LATERAL
AP
SCHÄEDEL HALBAX. THORAX DENS AP
LATERAL
AXIAL

SPEZIAL

AP
AP/PA
OBERER
ORBITA -- HWS LATERAL
RIPPEN
OBLIQUE
OBLIQUE

AP
AP/PA
UNTERER
STENVERS -- BWS LATERAL
RIPPEN
SCHÄEDEL THORAX OBLIQUE W. SAEULE
OBLIQUE

AP
LATERAL
MASTOID -- STERNUM LWS LATERAL
OBLIQUE
OBLIQUE

AP/PA
AP
NNH -- SCAPULA LATERAL L5-- S1
LATERAL
OBLIQUE

AP
SELLA LATERAL CLAVICUL AP/PA SAKRUM
LATERAL

NASE LATERAL

AP/PA
AP
LATERAL AP
ABDOMEN O. SCHENKEL SCHULTER HALBAX.
DECUBIT. LATERAL
OBLIQUE
STEHEND

AP AP
NIERE AP KNIE OBERARM
LATERAL LATERAL

LATERAL PA
NIERE / UR AP PATELLA ELLENBOGEN
AXIAL LATERAL

AP AP PA
ABDOMEN / GALLEN- UNTERER OBERER
U. SCHENKEL UNTERARM
BECKEN BLASE EXTREM. EXTREM.
OBLIQUE LATERAL LATERAL

AP AP
AP
BECKEN SPRGEL. LATERAL HANDGELENK LATERAL
LATERAL
OBLIQUE OBLIQUE

AP AP AP

HUEFTE MED / LAT FUSS LATERAL HAND LATERAL

AXIAL OBLIQUE OBLIQUE

AP
ZEHEN AP/LAT/OBLIQ FINGER
LATERAL

Appendix B B-5
DX-D 400
User Manual

APR MATRIX (POLISH VERSION)

REGION APR / ORGAN / PROJEKCJA

AP/PA

BOCZNE
AP
CZASZKA POLOSIOWE KLATKA P OBROTNIK AP
BOCZNE
OSIOWE

SPECIAL

AP
AP/PA
OCZODOLY -- ZEBRA G. KR. SZYJ. BOCZNE
SKOS
SKOS

AP
AP/PA
USZY SR. -- ZEBRA D. KR. PIER. BOCZNE
CZASZKA KLATKA P SKOS KREGOSL.
SKOS

AP
BOCZNE
PODSTAWA -- MOSTEK KR. LEDZ. BOCZNE
SKOS
SKOS

AP/PA
AP
ZATOKI -- LOPATKA BOCZNE C. L5-- S1
BOCZNE
SKOS

AP
SIODELKO BOCZNE OBOJCZYK AP/PA K. KRZYZ.
BOCZNE

NOS BOCZNE

AP/PA
AP
BOCZNE AP
J. BRZUSZ UDO BARK POLOSIOWE
BOK-LEZ BOCZNE
SKOS
BOK-STOJ

AP AP
NERKI AP KOLANO RAMIE
BOCZNE BOCZNE

BOCZNE PA
P. MOCZ. AP RZEPKA LOKIEC
OSIOWE BOCZNE

AP AP PA
J. BRZUSZ P. ZOLCI. KONCZ D. GOLEN KONCZ G. PRZEDR.
SKOS BOCZNE BOCZNE

AP AP
AP
MIEDNICA STAW ZK. BOCZNE NADGARS. BOCZNE
BOCZNE
SKOS SKOS

AP AP AP

BIODRA BOCKNE STOPA BOCZNE DLON BOCZNE

OSIOWE SKOS SKOS

AP
PALCE AP/BOK PALCE
BOCZNE

B-6 Appendix B
DX-D 400
User Manual

APR MATRIX (TURKISH VERSION)

VÜCUT KISMI / ORGAN / PROJEKSIYON

AP/PA

LATERAL
AP
KAFA SEMIAKSIYAL TORAKS ODONTOID AP
LATERAL
AKSIYAL

ÖZEL

AP
AP/PA
GÖZ ÇUK -- Ü. KABUR. C. OMUR LATERAL
OBLIK
OBLIK

AP
AP/PA
STENVERS -- A. KABUR. T. OMUR LATERAL
KAFA TORAKS OBLIK OMURGA
OBLIK

AP
LATERAL
MOSTOID -- STERNUM L. OMUR LATERAL
OBLIK
OBLIK

AP/PA
AP
SIN.PAR. -- SKAPULA LATERAL L5-- S1
LATERAL
OBLIK

AP
SELLA LATERAL KLAVICU. AP/PA SAKRUM
LATERAL

BURUN LATERAL

AP/PA
AP
LATERAL AP
BATIN FEMUR OMUZ SEMIAKS
DEKUBIT LATERAL
OBLIK
AYAKTA

AP AP
BÖBREK AP DIZ KOL
LATERAL LATERAL

LATERAL PA
ÜRINER AP PATELLA DIRSEK
AKSIYAL LATERAL

AP AP PA
A. Ü.
BATIN/PELVIS SAFRA K. CRURAL ÖN KOL
EXTREM EXTREM
OBLIK LATERAL LATERAL

AP AP
AP
PELVIS A. BILEGI LATERAL BILEK LATERAL
LATERAL
OBLIK OBLIK

AP AP AP

KALÇA MED / LAT AYAK LATERAL EL LATERAL

AKSIYAL OBLIK OBLIK

AP
A. PARMAK AP/LAT/OBLIK PARMAK
LATERAL

Appendix B B-7
DX-D 400
User Manual

APR MATRIX (RUSSIAN VERSION)

B-8 Appendix B
DX-D 400
User Manual

B.2 RECORD OF THE APR LOADING FACTORS

BODY REGION PATIENT SIZE - APR LOADING FACTORS

ORGAN / PROJECTION ADULT SMALL ADULT MEDIUM ADULT LARGE

SKULL kV mAs mA s kV mAs mA s kV mAs mA s

AP/PA

LATERAL

SKULL SEMIAXIAL

AXIAL

SPECIAL

ORBITA

PETROUS BONES / STENVERS

MASTOID

PARANASAL

SELLA LATERAL

NOSE LATERAL

BODY REGION PATIENT SIZE - APR LOADING FACTORS

ORGAN / PROJECTION PEDIATRIC SMALL PEDIATRIC MEDIUM PEDIATRIC LARGE

SKULL kV mAs mA s kV mAs mA s kV mAs mA s

AP/PA

LATERAL

SKULL SEMIAXIAL

AXIAL

SPECIAL

ORBITA

PETROUS BONES / STENVERS

MASTOID

PARANASAL

SELLA LATERAL

NOSE LATERAL

Appendix B B-9
DX-D 400
User Manual

BODY REGION PATIENT SIZE - APR LOADING FACTORS

ORGAN / PROJECTION ADULT SMALL ADULT MEDIUM ADULT LARGE

THORAX kV mAs mA s kV mAs mA s kV mAs mA s

AP
THORAX
LATERAL

AP/PA
UPPER RIBS
OBLIQUE

AP/PA
LOWER RIBS
OBLIQUE

LATERAL
STERNUM
OBLIQUE

AP/PA

SCAPULA LATERAL

OBLIQUE

CLAVICLE AP/PA

BODY REGION PATIENT SIZE - APR LOADING FACTORS

ORGAN / PROJECTION PEDIATRIC SMALL PEDIATRIC MEDIUM PEDIATRIC LARGE

THORAX kV mAs mA s kV mAs mA s kV mAs mA s

AP
THORAX
LATERAL

AP/PA
UPPER RIBS
OBLIQUE

AP/PA
LOWER RIBS
OBLIQUE

LATERAL
STERNUM
OBLIQUE

AP/PA

SCAPULA LATERAL

OBLIQUE

CLAVICLE AP/PA

B-10 Appendix B
DX-D 400
User Manual

BODY REGION PATIENT SIZE - APR PARAMETERS

ORGAN / PROJECTION ADULT SMALL ADULT MEDIUM ADULT LARGE

SPINE kV mAs mA s kV mAs mA s kV mAs mA s

ODONTOID AP

AP

CSSPINE LATERAL

OBLIQUE

AP

T-SPINE LATERAL

OBLIQUE

AP

L-SPINE LATERAL

OBLIQUE

AP
L5 S1
L5-S1
LATERAL

AP
SACRUM
LATERAL

BODY REGION PATIENT SIZE - APR PARAMETERS

ORGAN / PROJECTION PEDIATRIC SMALL PEDIATRIC MEDIUM PEDIATRIC LARGE

SPINE kV mAs mA s kV mAs mA s kV mAs mA s

ODONTOID AP

AP

CSSPINE LATERAL

OBLIQUE

AP

T-SPINE LATERAL

OBLIQUE

AP

L-SPINE LATERAL

OBLIQUE

AP
L5 S1
L5-S1
LATERAL

AP
SACRUM
LATERAL

Appendix B B-11
DX-D 400
User Manual

BODY REGION PATIENT SIZE - APR PARAMETERS

ORGAN / PROJECTION ADULT SMALL ADULT MEDIUM ADULT LARGE

ABDOMEN / PELVIS kV mAs mA s kV mAs mA s kV mAs mA s

AP / PA

LATERAL
ABDOMEN
DECUBITUS

STANDING

KIDNEY AP

KIDNEY / URETER AP

AP
GALLBLADDER
OBLIQUE

AP
PELVIS
LATERAL

AP

HIP MED / LATERAL

AXIAL

BODY REGION PATIENT SIZE - APR PARAMETERS

ORGAN / PROJECTION PEDIATRIC SMALL PEDIATRIC MEDIUM PEDIATRIC LARGE

ABDOMEN / PELVIS kV mAs mA s kV mAs mA s kV mAs mA s

AP / PA

LATERAL
ABDOMEN
DECUBITUS

STANDING

KIDNEY AP

KIDNEY / URETER AP

AP
GALLBLADDER
OBLIQUE

AP
PELVIS
LATERAL

AP

HIP MED / LATERAL

AXIAL

B-12 Appendix B
DX-D 400
User Manual

BODY REGION PATIENT SIZE - APR PARAMETERS

ORGAN / PROJECTION ADULT SMALL ADULT MEDIUM ADULT LARGE

LOWER EXTREMITIES kV mAs mA s kV mAs mA s kV mAs mA s

AP
FEMUR
LATERAL

AP
KNEE
LATERAL

LATERAL
PATELLA
AXIAL

AP
LOWER LEG
LATERAL

AP

ANKLE LATERAL

OBLIQUE

AP

FOOT LATERAL

OBLIQUE

TOES AP/LAT/OBLIQ

BODY REGION PATIENT SIZE - APR PARAMETERS

ORGAN / PROJECTION PEDIATRIC SMALL PEDIATRIC MEDIUM PEDIATRIC LARGE

LOWER EXTREMITIES kV mAs mA s kV mAs mA s kV mAs mA s

AP
FEMUR
LATERAL

AP
KNEE
LATERAL

LATERAL
PATELLA
AXIAL

AP
LOWER LEG
LATERAL

AP

ANKLE LATERAL

OBLIQUE

AP

FOOT LATERAL

OBLIQUE

TOES AP/LAT/OBLIQ

Appendix B B-13
DX-D 400
User Manual

BODY REGION PATIENT SIZE - APR PARAMETERS

ORGAN / PROJECTION ADULT SMALL ADULT MEDIUM ADULT LARGE

UPPER EXTREMITIES kV mAs mA s kV mAs mA s kV mAs mA s

AP

SHOULDER SEMIAXIAL

OBLIQUE

AP
HUMERUS
LATERAL

PA
ELBOW
LATERAL

PA
FOREARM
LATERAL

AP

WRIST LATERAL

OBLIQUE

AP

HAND LATERAL

OBLIQUE

AP
FINGER
LATERAL

BODY REGION PATIENT SIZE - APR PARAMETERS

ORGAN / PROJECTION PEDIATRIC SMALL PEDIATRIC MEDIUM PEDIATRIC LARGE

UPPER EXTREMITIES kV mAs mA s kV mAs mA s kV mAs mA s

AP

SHOULDER SEMIAXIAL

OBLIQUE

AP
HUMERUS
LATERAL

PA
ELBOW
LATERAL

PA
FOREARM
LATERAL

AP

WRIST LATERAL

OBLIQUE

AP

HAND LATERAL

OBLIQUE

AP
FINGER
LATERAL

B-14 Appendix B
Manufacturer: Agfa NV,
Septestraat 27, B--2640 Mortsel -- Belgium

This product bears a CE marking in accordance with the provisions


of the 93/42/EEC MDD dated June 14, 1993, as amended by
2007/47/EC dated September 5, 2007.

0413 Published by Agfa N.V., B--2640 Mortsel--Belgium

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