Operation

Digital Mobile X-ray Unit

KONICA MINOLTA

mKDR Xpress

Technical Publication
OM-0481R1_EN_KON
 This manual covers the following equipments / Este manual cubre los siguientes equipos

Ce manuel couvre les équipements suivants / Il presente manuale descrive i seguenti dispositivi

Battery Mobile X-Ray Unit PHOENIX:

PHOENIX

SEDECAL
Sociedad Española de Electromedicina y Calidad S.A.
Pelaya, 9 -- 13. Polígono Industrial “Río de Janeiro”
28110 Algete, Madrid -- España (Spain)

Tel: +34 916 280 544 Fax: +34 902 190 385 www.sedecal.com

Manufactured by SEDECAL for KONICA MINOLTA HEALTHCARE AMERICAS, INC

411 Newark Pompton Turnpike Wayne, NJ 07470 -- USA

Tel: +1 800 366 5343 E-mail: [email protected]

 Mobile X-ray Unit
Operation

REVISION HISTORY

REVISION DATE REASON FOR CHANGE

0 OCT 01, 2021 First Edition.

1 MAR 08, 2022 Manual Cover and some rendered images have
been updated.
New Section: Appendix C -- Administrator User.
Updated Sections: Safety Symbols, Mains
Connection, Smart ON/OFF System: ON/OFF
Button + RFID System, Infrared Remote Control,
Manual Clutch Screws, Collimator Movements, 3.7
Collimator Controls, Power Reduction, System
Snapshot, System Messages, Factors.

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.

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ADVISORY SYMBOLS
The following advisory symbols will be used throughout this manual. Their
application and meaning are described below.

DANGERS ADVISE OF CONDITIONS OR SITUATIONS THAT

IF NOT HEEDED OR AVOIDED WILL CAUSE SERIOUS
PERSONAL INJURY OR DEATH.

ADVISE OF CONDITIONS OR SITUATIONS THAT IF NOT

HEEDED OR AVOIDED COULD CAUSE SERIOUS PERSONAL
INJURY, CATASTROPHIC DAMAGE TO EQUIPMENT
OR DATA.

Advise of conditions or situations that if not heeded or

avoided could cause personal injury or damage to equipment
or data.

Note . Alert readers to pertinent facts and conditions. Notes represent

information that is important to know but which do not necessarily
relate to possible injury or damage to equipment.

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TABLE OF CONTENTS

Section Page

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

1.1 General Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.2 Product Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.3.1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.2 Normal Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4 Applied Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2 SAFETY AND REGULATORY INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.2 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2.3 Maximum Permissible Dose (MPD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2.4 Radiation Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.5 Monitoring of Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

2.6 Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.7 Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

2.7.1 Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.7.2 Environmental Statement on the Life Cycle of the Equipment or
System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.7.3 Mode of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.7.4 Protection against Electric Shock Hazards . . . . . . . . . . . . . . . . . . . . . . . 21
2.7.5 Protection against Harmful Ingress of Water or Particulate Matter . . . 21
2.7.6 Protection against Hazards of Ignition of Flammable Anaesthetic
Mixtures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
2.7.7 Protection against Hazards from Unwanted or Excessive Radiation . 21
2.7.8 Designated Significant Zones of Occupancy . . . . . . . . . . . . . . . . . . . . . 22
2.7.9 Distribution of Stray Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
2.8 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

2.9 Radio Frequency Interference Notice (USA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

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2.10 Quantitative Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

2.10.1 Functional Tests Performed to Obtain the Quantitative Information . . 37
2.11 Deterministic Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

3 GENERAL AND MOTION CONTROLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

3.1 Mains Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

3.2 Control Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

3.2.1 System ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3.2.1.1 Smart ON/OFF System: ON/OFF Button + RFID System . . . 49
3.2.1.2 ON/OFF Button + Keypad System . . . . . . . . . . . . . . . . . . . . . . . 52
3.2.2 System OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3.2.3 Emergency Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
3.2.4 System ON/OFF Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
3.2.5 System ON/OFF Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
3.2.6 Control Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
3.2.7 Battery Charge Level Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
3.2.8 Battery State Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
3.2.9 Power OFF Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
3.2.10 Status Light Indicator (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
3.3 Connections Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

3.4 X-ray Handswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

3.5 Infrared Remote Control (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

3.6 Motion Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

3.6.1 Displacement Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
3.6.1.1 Handlebar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
3.6.1.2 Fine Positioning Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
3.6.1.3 Manual Clutch Screws . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
3.6.1.4 Proximity Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
3.6.1.5 Bumpers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
3.6.1.6 Manual Driving Brake Release (Option) . . . . . . . . . . . . . . . . . . 75
3.6.2 Parking Position of the Arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
3.6.3 Movement Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
3.6.3.1 Column and Telescopic Arm Movements . . . . . . . . . . . . . . . . . 77
3.6.3.2 Head-Assembly Movements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
3.6.3.3 Collimator Movements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3.7 Collimator Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

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3.8 DAP Chamber (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

3.9 Focal-Skin Distance Sensor (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

3.10 Wireless Digital Detectors, Options and Accessories . . . . . . . . . . . . . . . . . . . . 84

3.10.1 Wireless Digital Detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
3.10.2 Detector Back-up Communication Cable (Option) . . . . . . . . . . . . . . . . 86
3.10.3 Barcode Scanner (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
3.10.4 General Use and Maintenance of Wireless Digital Detectors, Options and
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

4 CONTROL CONSOLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

4.1 Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

4.2 Head-Assembly Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

4.2.1 Exposure Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
4.2.2 Heat Units Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
4.2.3 Batteries Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
4.2.4 Parking Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
4.2.5 Motion Speed Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
4.2.6 Mute Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
4.2.7 User Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
4.2.8 Workstation Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
4.2.9 Radiographic Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
4.2.10 Focal Spot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
4.2.11 Power Reduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
4.2.12 Head-Assembly Rotation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
4.2.13 FSD Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
4.2.14 Collimator Filter Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
4.3 Message Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
4.3.1 Message Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
4.3.2 System Snapshot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

5 SYSTEM MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

6 OPERATING SEQUENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

6.1 X-ray Tube Warm-up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

6.2 Radiographic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

6.3 X-ray Beam Alignment with Respect to Patient . . . . . . . . . . . . . . . . . . . . . . . . . . 130

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7 PERIODIC MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

7.1 Operator Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

7.1.1 Batteries Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
7.1.2 Periodic Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
7.1.3 Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
7.2 Service Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

8 TECHNICAL SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

8.1 Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

8.2 X-ray Tube Insert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

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

APPENDIX B -- PROTECT YOUR IMAGING SYSTEM FROM CYBERSECURITY

THREATS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

APPENDIX C -- ADMINISTRATOR USER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

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SECTION 1 INTRODUCTION

This manual contains all the information necessary to understand and operate
the Mobile X-ray Units. It provides a general description, safety and regulatory
information, operating instructions and specifications concerning the system.

It is not intended to teach radiology or to take any type of clinical diagnosis.

This Unit is designed for general radiography. It provides all the advantages of
high frequency waveform Generators including lower patient dose, shorter
exposure times as well as greater accuracy and consistency.

The Unit is controlled by multiple microprocessors which render a higher

exposure consistency, efficiency in operation and an extended Tube life. A high
level of self-diagnostics streamlines serviceability, thereby reducing down time.

All functions, displays and controls are logically arranged, easily accessible and
identified to prevent confusion. Technique factors and functions are selected on
the Control Console.

Illustration 1-1
Mobile X-ray Unit

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X-RAY GENERATION COMPONENTS

 Control Console.

 Ultra software application for image acquisition.

 Generator, that comprises:

G Power Module, containing power and control components.

G Battery Module, with batteries and charge/control components.

 Radiogenic unit, part of the Head-Assembly, that comprises:

G Power Module, containing power and control components.

G HV Tank, HV Transformer.

G X-Ray Tube insert: E7886.

ASSOCIATED EQUIPMENT AND SUBASSEMBLIES

According to IEC 60601-2-32, the following subassemblies are considered

Associated Equipment and conform to the applicable safety requirements
therein stated.

 Unit Motion Assemblies, that comprises:

G Batteries and Charger Module, to power the motors.

G Motor Assembly, Motors and Wheels.

G Driving Control Assembly, Handlebar, Motion Controls at the

Head-Assembly, Gauges and the related Electronic Components.

 Telescopic and rotating Column and Arm, holding the Head-Assembly,

and allowing its positioning.
G Telescopic Column: the Telescopic Column in parking position
reduces the height of the system in order to have complete
visibility and safety when driving the system.
G Telescopic Arm: the 4-Sections Arm, provides a compact size for
handling and storage the system when retracted, plus an extra
length when extended. It also provides smooth Head-Assembly
movements and a second Touch Screen on the Head-Assembly.
 Collimator, part of the Head-Assembly.
 Digital Detector, Grid and Detector Handle (optional). Detector options:
AeroDR 2 1417HQ, AeroDR 2 1417S,
AeroDR 3 1417HD, AeroDR 3 1717HD, AeroDR 3 1012HQ
 Holders for Detectors storage and charge (option); storage for Detector
Handle, Grid, and other Accessories.

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1.1 GENERAL FEATURES

The main features of this Unit are:

 A solid and ergonomic design. Ease of operation; security and precision

of all positioning movements relative to the patient.

 Standard electrical outlet operation with single-phase lines

at 100 -- 240 V~. Automatic line voltage compensation.

 Independent operation without mains connection (Stand-Alone). In

normal operating conditions, the Battery Charger keeps batteries stable
and fully charged, provided the Unit is connected to the mains (charging).

 Constant potential high frequency.

 Controls at the Handlebar and Head-Assembly for motorized

movements of the equipment.

 Controls for lock release of Rotating Column and Telescopic Arm.

Column rotation in relation to its vertical axis (¦317o), telescopic and
vertical motion of the Arm.

 Head-Assembly rotation in relation to its transverse axis (360o) and

horizontal axis (120o). Collimator rotation in relation to its vertical axis
(180o).

 Three Point control by selecting kVp, mA and Exposure Time or Two

Point control by selecting kVp and mAs.

 Anatomical Programmer (APR) and operation through the Digital

Radiographic Application Ultra.

 X-ray Handswitch for X-ray exposures and Collimator Light.

 Infrared Remote X-ray Handswitch (optional) for X-ray exposures and

Collimator Light.

 Dosimetry (optional).

 Manual Collimation.

 Heat Unit storage for the X-ray Tube, even after turning ON/OFF the
equipment.

 Tube protection circuitry prolongs Tube life and increases system

performance.

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

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1.2 PRODUCT IDENTIFICATION

To provide manufacturer and product information, each major item in the

equipment has identification labels attached. The labels contain the following
information:

 Product and Model.

 Reference and Type.

 Date of manufacture.

 Serial number.

 Input Voltage (V), Frequency (Hz), Input Power (kVA).

 Output Power (kW).

 Manufacturer and place of manufacture.

 Standards, Certifications and Symbols.

 Inherent Filtration.

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1.3 INDICATIONS FOR USE

1.3.1 INTENDED USE

This is a Digital Mobile Diagnostic X-ray System intended for use by a

qualified/trained doctor or technician on both adult and pediatric subjects for
taking diagnostic radiographic exposures of the skull, spinal column, chest,
abdomen, extremities, and other body parts. Applications can be performed
with the patient sitting, standing, or lying in the prone or supine position. Not for
mammography. RX ONLY.

Additional description:

 The Mobile X-ray Unit is a piece of equipment designed for general

radiography in hospitals, clinics, radiology imaging centers and medical
practices.

 Patients may be physically abled, disabled, immobilized or in a state of

shock.

 This Mobile X-Ray Unit contributes to the metrics of imaging

performance ensuring the efficient use of radiation.

 The X-Ray image receptors used in this unit are Digital Detectors.

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 mammographic applications.

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 Medical equipment that in Normal Use

necessarily comes into physical contact with the patient for Medical equipment
to perform its function.

This RAD equipment includes the following Applied Parts:

 Digital Detectors.

 Grids (optional)

 Other Accessories.

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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 CONTINUED 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 INSTALLATION, CALIBRATION OR MAINTENANCE
ARE DESCRIBED IN THE RESPECTIVE CHAPTERS OF THE
SERVICE MANUAL 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-RAY 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 , and
21 CFR
IEC60601-2-54:2009+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-ray 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-ray radiation.

IT IS THE RESPONSIBILITY OF THE OPERATOR TO

RESTRICT THE ACCESS TO THE UNIT 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 different 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 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 Receptor distance (SID: Source to Image
Distance): 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 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 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.

Unique Device Identifier.

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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
(Only applies to IEC 60601-1:2005, 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 or disposed.
Li/Pb/Cd/Hg 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 Mobile X-Ray Unit covered by this Operation Manual complies with the
following certifications:

 Statement of Compliance with IEC 60601-1-3: Mobile X-Ray Unit with

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

 Statement of Compliance with IEC 60601-2-54: Mobile X-Ray Unit for

Radiography and/or Radioscopy in accordance with
IEC 60601-2-54:2009 and IEC60601-2-54:2009+AMD1:2015.

 Statement of Compliance with 21CFR Subchapter J: This Mobile X-Ray

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

Note . Mobile X-Ray Unit model or type references are stated at the
back cover of this document.

2.7.2 ENVIRONMENTAL STATEMENT ON THE LIFE 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 its authorized representative 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 with intermittent loading, in accordance with

Standard IEC 60601-1:1988.

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

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

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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 60601-2-54:2009 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.

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 IEC60601-1-3:1994, 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 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

Focal Spot

MOBILE X-RAY UNIT

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
d = DISTANCE FROM THE AXIS OF THE X-RAY
BEAM TO THE DOSIMETER 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

MOBILE X-RAY UNIT

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

Focal Spot

SID 100 cm
MOBILE X-RAY UNIT

Phantom

X-ray Receptor

Patient Support
S
RAD TABLE

S = SIGNIFICANT ZONE OF OCCUPANCY

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

Focal Spot
S

Dosimeter d SIGNIFICANT ZONE OF OCCUPANCY

AT THE RIGHT SIDE OF THE MOBILE UNIT
(CATHODE)
d = DISTANCE FROM THE AXIS OF THE X-RAY
BEAM TO THE DOSIMETER

S4
AT FRONT SIDE OF THE MOBILE UNIT
SIGNIFICANT ZONE OF OCCUPANCY

RAD TABLE

S3

Focal Spot
MOBILE X-RAY UNIT

S5

SIGNIFICANT ZONE OF OCCUPANCY

AT THE LEFT SIDE OF THE MOBILE UNIT
(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,
IEC 60601-1-3:2008 and IEC 60601-1-3:2008+AMD1:2013.

 Exposure Parameters: RAD mode, 150 kVp, 10 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 position of the X-ray Unit during radiographic
examination on the Chest Unit or Front Panel, and refer to Illustration 2-2 for
position of the X-ray Unit during radiographic examination on any Patient
Support or any Table.

The following illustrations show the Distribution of Stray Radiation in each

examination position.

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Illustration 2-3
Distribution of Stray Radiation on the Chest Unit or Front Panel

200

180

160

140
HEIGHT ABOVE FLOOR (cm)

120

100

80

60

40

20

0
0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 5500 6000 6500 7000 7500

STRAY RADIATION (μGy/h)

S11 d = 50 cm

S12 d = 100 cm

S21 d = 50 cm

S22 d = 100 cm

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

MOBILE X-RAY UNIT

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Illustration 2-4
Distribution of Stray Radiation on any Patient Support or any Table

200

180

160

140
HEIGHT ABOVE FLOOR (cm)

120

100

80

60

40

20

0
0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 5500 6000 6500 7000 7500 8000 8500 9000 950010000
STRAY RADIATION (μGy/h)

SIGNIFICANT ZONE OF OCCUPANCY

AT THE RIGHT SIDE OF THE MOBILE UNIT
(CATHODE)

S4
AT FRONT SIDE OF THE MOBILE UNIT
SIGNIFICANT ZONE OF OCCUPANCY

S31 d = 50 cm
RAD TABLE
S32 d = 100 cm
d

S41 d = 50 cm S3 d

S42 d = 100 cm

S51 d = 50 cm
d

Focal Spot
MOBILE X-RAY UNIT
S52 d = 100 cm

S5

SIGNIFICANT ZONE OF OCCUPANCY

AT THE LEFT SIDE OF THE MOBILE UNIT
(ANODE)

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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 radio
communications.

To provide reasonable protection against such interference, this equipment

complies with emissions limits for a Group 1 -- Class A Medical Devices as
stated in EN 60601-1-2: 2007 and IEC 60601-1-2:2014. 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 (FCC).

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.

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It is customer/owner 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
IEC 60601-1-2:2014 Tables as described in this section.

The manufacturer is not responsible for any interference

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

ESSENTIAL PERFORMANCE

The system is designed to use X-rays for diagnostic purposes. The system (e.g.
Tube, Detector, Generator and Patient Support) is designed according to
international standards, to prevent patient, user, and others from electrical and
mechanical hazards by using adequate EMC measures like using filters,
screened cables or housings.

EMC-COMPLIANCE CRITERIA DUE TO THE ESSENTIAL PERFORMANCE

 No unintended movement

 No unintended X-radiation

 No unintended change of generator parameters (kV, mAs)

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GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS

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

This X-ray System is intended for use in the electromagnetic environment specified below.
The customer or user of this X-ray System should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment -- guidance

This Mobile Unit uses RF energy only for its

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

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

NOTE - In accordance with Standard IEC 60601-1-2:2014, 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.

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GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY

(IEC 60601-1-2:2007)

This X-ray System is intended for use in the electromagnetic environment specified below.
The customer or user of this X-ray System 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 ¦ 1 kV

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

< 5 % UT
(> 95 % dip in UT) > 95 %
for 0.5 cycle for 0.5 periods

40 % UT
Mains power quality should be that of a typical
Voltage dips, short (60 % dip in UT) 60 %
commercial or hospital environment. If the user
interruptions and voltage for 5 cycles for 5 periods
of the Mobile Unit requires continued operation
variations on power supply
during power mains interruptions, it is
input lines.
recommended that the Mobile Unit be powered
70 % UT
from an uninterruptible power supply or a
IEC 61000-4-11 (30 % dip in UT) 30 %
battery.
for 25 cycles for 25 periods

< 5 % UT 100 %
(> 95 % dip in UT) for 250 periods
for 5s

Power frequency (50/60 Hz)

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

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

30 OM-0481R1
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GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY

(IEC 60601-1-2:2007)

This X-ray System is intended for use in the electromagnetic environment specified below.
The customer or user of this X-ray System should assure that it is used in such an environment.

IEC 60601-1-2:2007 Compliance

Immunity Test Electromagnetic environment - guidance
Test Level Level

Portable and mobile RF communications

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

Recommended separation distance

d = 1.2 P
Conducted RF 3 Vrms 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz d = 1.2 P , 80 MHz to 800 MHz
Radiated RF 3 V/m 3 V/m d = 2.3 P , 800 MHz to 2.5 GHz
IEC 61000-4-3 80 MHz to 2.5 GHz 80 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
survey a), should be less than the compliance
level in each frequency range b).

Interference may occur in the vicinity of

equipment marked with the following symbol:

NOTE 1 -- At 80 MHz and 800 MHz, 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 this Mobile Unit is used exceeds the applicable RF compliance level above, this Mobile Unit should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating this
Mobile Unit.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE

AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE X-RAY SYSTEM
(IEC 60601-1-2:2007)

This X-ray System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or user of this X-ray System can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and this X-ray System 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 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
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 80 MHz and 800 MHz, 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.

NOTE 3 -- RFID chips are typically powered from the electromagnetic field, and therefore only the reader can be regarded as an RF
transmitter.

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GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY

(IEC 60601-1-2:2014)

This X-ray System is intended for use in the electromagnetic environment specified below.
The customer or user of this X-ray System 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,

¦ 8 kV contact ¦ 8 kV contact
Electrostatic discharge (ESD) concrete or 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
¦ 1 kV for input/output lines ¦ 1 kV for input/output lines that of a typical commercial or
IEC 61000-4-4 hospital 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
IEC 61000-4-5 ¦ 0.5 kV, ¦ 1 kV, ¦ 2 kV ¦ 0.5 kV, ¦ 1 kV, ¦ 2 kV hospital 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 environment. If the
0 % UT for 1 cycle 0 % UT for 1 cycle
Voltage dips, short interruptions user of the This X-ray System
at 0o at 0o
and voltage variations on power requires continued operation
supply input lines. during power mains
interruptions, it is
IEC 61000-4-11 recommended that this X-ray
System is powered from an
70 % UT for 25/30 cycles 70 % UT for 25/30 cycles
Uninterruptible Power Supply
at 0o at 0o
or a battery.

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

Power frequency magnetic

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

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

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GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY

(IEC 60601-1-2:2014)

This X-ray System is intended for use in an electromagnetic environment specified below.
The customer or user of this X-ray System should assure that it is used in such an environment.

IEC 60601-1-2:2014 Electromagnetic

Immunity Test Compliance Level
Test Level environment - guidance

Radiated RF EM fields 3 V/m 3 V/m

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)

Proximityy fields from RF Refer to next table Refer to next table

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

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.

34 OM-0481R1
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IMMUNITY REQUIREMENTS TO RF WIRELESS COMMUNICATIONS EQUIPMENT

(IEC 60601-1-2:2014)

This X-ray System is intended for use in an electromagnetic environment specified below.
The customer or User of this X-ray System 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.

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2.9 RADIO FREQUENCY INTERFERENCE NOTICE (USA)

This equipment has been tested and found to comply with the limits for a Class A
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed
to provide reasonable protection against harmful interference when the
equipment is operated in a commercial environment. This equipment
generates, uses, and can radiate radio frequency energy and, if not installed
and used in accordance with the instruction manual, may cause harmful
interference to radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which case the user will
be required to correct the interference at his own expense. However, there is
no guarantee that interference will not occur in a particular installation.

If this equipment does cause harmful interference to radio or television

reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the
following measures:

 reorient or relocate the receiving antenna,

 increase the separation between the equipment and the receiver,

 connect the equipment into an outlet on a circuit different from that to

which the receiver is connected,

 consult the dealer or an experienced radio/television technician for help.

Any changes or modifications not expressly approved by the grantee of this

device could void the user’s authority to operate the equipment. The customer
is responsible for ensuring compliance of the modified product.

Only peripherals (computer input/output devices, terminals, printers, etc.) that

comply with FCC class B limits may be attached to this computer product.
Operation with noncompliant peripherals is likely to result in interference to
radio and television reception.

All cables used to connect to peripherals must be shielded and grounded.

Operation with cables, connected to peripherals that are not shielded and
grounded may result in interference to radio and television reception.

36 OM-0481R1
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2.10 QUANTITATIVE INFORMATION

Note . The following tables show the Quantitative Information associated

to this equipment according with the Standard
IEC 60601-1-3:2008 and IEC 60601-1-3:2008+AMD1:2013. This
information illustrates loading factors for image performance and
supplies Dose indication examples. Therefore, these tables are an
instance 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.

2.10.1 FUNCTIONAL TESTS PERFORMED TO OBTAIN THE QUANTITATIVE INFORMATION

Equipment:

Note . These functional tests have been performed with a specific

configuration of Digital Detector, maximum power X-ray Tube and
Collimator. The results obtained with this configuration are
representative of the worst case within the different configurations
of the unit.

Instrumentation used:

 Dosimeters:

G IBA KermaX 120-131 MIC CAN

G Unfors Xi R/F

 Thermohygrometer Testo 608-H2.

 Water Phantom made of Polymethyl-methacrylate (PMMA) layers:

25 cm x 25 cm x 15 cm.

Test details:

 The measurements were made using the most common APR

configurations performed with this unit.

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Quantitative Information

Loading Factors Parameter Selection Measured Doses

Source-Image Distance
Time Current - mAs

Collimator blades

Input Dose Rate

Current - mA

Output Dose
Voltage - kV

Input Dose
Focal Spot

(μGy/mAs)
Collimator
Selection

(μGy*m2)

Phantom

Phantom
opening
Time (s)
Patient

(μGy/s)
(cm)

(cm)
SID
examination

Grid
(orientative)

CHEST AP 95 160 0.020 3.2 Small 120 35 x 43 No 22.39 11035 69.97

NECK 85 100 0.020 2 Small 100 24 x 30 No 96.10 8870 88.70

ABDOMEN AP 80 400 0.025 10 Large 100 35 x 43 No 69.72 31300 78.25

HIP/PELVIS AP 75 400 0.040 16 Large 100 35 x 43 No 99.13 27575 68.94

KNEE AP 65 200 0.025 5 Large 100 24 x 30 No 14.11 10228 51.14

ANKLE AP 50 200 0.050 10 Small 100 18 x 24 No 8.96 5324 26.62

FOOT AP 45 100 0.125 12.5 Small 100 24 x 30 No 13.20 2081.60 20.82

SHOULDER AP 65 250 0.100 25 Large 100 24 x 30 No 69.00 12650 50.60

ELBOW AP 60 100 0.040 4 Small 100 24 x 30 No 9.42 4320 43.20

WRIST PA 45 100 0.100 10 Small 100 18 x 24 No 6.77 2045 20.45

HAND PA 60 100 0.032 3.2 Small 100 24 x 30 No 7.54 4318.75 43.19

SKULL 75 160 0.200 32 Small 120 24 x 30 No 72.12 6920 43.25

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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2.11 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 (ICRP Publication No 60).

Quantitative Information tables (Refer to Section 2.10) 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.

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SECTION 3 GENERAL AND MOTION CONTROLS

Operation is carried out from the different controls:

 Control Panel, with controls to turn ON/OFF the system, System ON/OFF
Indicator, Battery Charge Level Indicator, Emergency Switch OFF.

 Control Console Screen; Head-Assembly Screen.

 X-ray Handswitch; Infrared Remote X-ray Handswitch (option).

 Controls for the unit motion and controls for Telescopic Column and Arm
movements.

 Manual Collimator Panel with controls for opening or closing the

Collimator Blades and to switch ON the Collimator Light.

FOR THE CORRECT OPERATION OF THE X-RAY MOBILE

UNIT, THE USER MUST HAVE DRY HANDS WHEN WORKING
WITH THE SYSTEM.

DO NOT USE OR DRIVE THE SYSTEM WITH WET HANDS OR

IMPREGNATED WITH DISINFECTANT GEL OR ANY OTHER
SUBSTANCE OR LIQUID, SPECIALLY WHEN USING THE
CAPACITIVE TOUCHSCREEN (MAIN SCREEN AND/OR
HEAD-ASSEMBLY SCREEN) AND WHEN MANAGING THE
CAPACITIVE MOVEMENT CONTROLS (HANDLEBAR,
HEAD-ASSEMBLY HANDGRIPS); OTHERWISE, THESE
SUBSTANCES COULD CAUSE SYSTEM MALFUNCTION
AND/OR AN INCORRECT OPERATION OF THE MOTION
CONTROLS.

IN THIS CASE, TURN OFF THE UNIT AND CLEAN THE

AFFECTED PARTS.

Note . For further information about Cleaning and Disinfection, refer to

Section 7.1.3.

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Illustration 3-1
Mobile X-ray unit: General Features

1 Head-Assembly 3 Handlebar 7 Front Wheel

1.1 Status Light Indicator 4 Connections Panel 8 Anti-Collision Bumper

1.2 Handgrips 4.1 Handswitch 9 Power Line Plug

1.3 Head Assembly Screen (option) 4.2 Infrared Remote Control (option) 10 Detector Storage/Charge
1.4 Collimator Panel (option) 4.3 Barcode Scanner 11 Parking System
1.5 Motion Controls (on the Handgrips) 5 Detector Storage/Charge 12 Apron Hook

2 Control Console 6 Back Wheel, Hubcap

2.1 Control Panel

2.2 Main Screen

1
1.5

1.1
12

1.2

1.3
11
1.4

2 2.1

3 2.2
10

4.3

4.2
8
4.1

5
7

42 OM-0481R1
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Illustration 3-2
Mobile X-ray unit

OM-0481R1 43
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3.1 MAINS CONNECTION

The Unit should be plugged into a wall socket compliant with local regulations
and electrical requirements of the equipment.

The plug is the device used as a means of disconnecting the Unit from mains.
Position the Unit so that the plug can be easily disconnected.

Note . Refer to Section 8 for Technical Specifications.

Plug

For safety reasons and for proper functioning, make sure that
the unit is connected to a standard outlet with GND.

THE MOBILE UNIT OPERATES AT AN UNIVERSAL INPUT

RANGE FROM 100 V~ TO 240 V~ THAT MAY BE LIMITED BY
THE POWER LINE CABLE AND/OR PLUG ACCORDING TO
THE LOCAL REGULATIONS.

THE MAIN FUSES INSTALLED IN THE UNIT TO PROTECT THE

EQUIPMENT ARE FACTORY SET ACCORDING TO THE
COUNTRY DESTINATION AND ITS LOCAL REGULATION.
PLEASE, CONTACT TO THE SERVICE PERSONNEL OR
MANUFACTURER IN CASE THAT DESTINATION IS
CHANGED AND ELECTRICAL REQUIREMENTS ARE
DIFFERENT BECAUSE THE EQUIPMENT MAY NOT BE
PROPERLY PROTECTED.

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WHEN NOT GENERATING X-RAYS, KEEP THE UNIT

CONNECTED TO THE MAINS, EVEN WHEN BATTERIES ARE
FULLY CHARGED. THIS ENSURES MAXIMUM STORAGE
ENERGY.

Connect the Power Line Cable to the mains in order to allow the Charging
Circuits to charge the Batteries.

Note . When the Unit is ON and plugged into the mains, a “Lightning” icon
appears on the Control Console (next to the Batteries Indicators)
to display that the battery is charging.

This “Lightning” icon will disappear from the Control Console when
the Unit is unplugged from the mains.

For further information about Batteries Status Indicators, refer to

Section 4.2.3.

Note . The Power Line Cable can only be replaced by the Service
Engineer.

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3.2 CONTROL CONSOLE

SMART ON/OFF SYSTEM: ON/OFF Button +

ON/OFF Button + RFID System Keypad System

1.2.3 1.2.2 1.2.1

1.2.4
1.2

1.3

1.4

1 Control Console 1.2.3 Battery Charge Level Indicators

1.2 Control Panel 1.2.4 Emergency Switch Off

1.2.1 On/Off Control 1.3 Main Screen

1.2.2 System On/Off Indicator 1.4 Pencil Tray

46 OM-0481R1
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The following icons can be displayed on the Control Panel:

" ON/OFF

The ON/OFF button icon enables the user to ON/OFF the unit.

Refer to Sections 3.2.1.1 and 3.2.1.2.

" RFID symbol

The ON/OFF button with the RFID Card Reader symbol (RFID--Radio
Frequency IDentification) enables the user to ON/OFF and access the system
with the RFID Card.

Refer to Section 3.2.1.1 of Smart ON/OFF System.

" Keypad Symbols

The buttons with the symbols at the bottom of the ON/OFF Keypad, enable the
user:

To Accept the Access Code entered (symbol with the checkmark).

To Cancel the system Access (symbol with the crossed circle).

Refer to Section 3.2.1.2 of ON/OFF and Keypad System.

" Battery Charge Level Indicators: X-Ray and Motion

The symbols at the bottom of the Battery Charge Level Indicators, show:

The Battery Level for the unit Motion (right column symbol).

The Battery Level for X-Ray operation (left column symbol).

Refer to Section 3.2.7 of Battery Charge Level Indicators.

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3.2.1 SYSTEM ON

The ON/OFF controls are the means to turn the unit ON and OFF.

Note . The unit can operate in Stand-Alone mode, that is, operating
without mains being present or unplugged from mains.

Do not touch any system control during the starting up

process; it could cause system malfunction.

In this case, restart the unit making sure not to touch any part
of the system (switches, touch screens, motion controls, or
any other control).

There are three ways to turn ON the system, depending on the system
configuration:

 Smart ON/OFF system: ON/OFF button and the RFID system

(RFID-Card and RFID Card Reader) (refer to Section 3.2.1.1).

 ON/OFF button and the Keypad (refer to Section 3.2.1.2).

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3.2.1.1 SMART ON/OFF SYSTEM: ON/OFF BUTTON + RFID SYSTEM

To turn the unit ON, proceed as described in the following steps:

1. Press and hold the ON/OFF button (1) for a few seconds; the System
ON/OFF Indicator (2) will blink white for 5 seconds.

Note . When the Mobile Unit is in Charging Mode it is not necessary to

press the ON/OFF button in the first instance.

2. Within 5 seconds from turning the unit ON, pass the RFID Card (5) over
RFID Reader symbol (4), there is no need to contact the reader. The
system emits a double beep, the ON/OFF Indicator (2) will light cyan and
the Battery Charge Level Indicator (3) will light according to the current
battery status.

3. When the system is ON the System ON/OFF Indicator (2) will light white.

2
1

Note . The system emits 3-beeps and the System ON/OFF Indicator (2)
blinks orange to indicate a wrong RFID Card. In this case, repeat
the ON/OFF process using the right Card.

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Note . The RFID Card is detected automatically by the system.

Depending on the system permissions assigned to each RFID Card, the user
can perform the following actions:

 Movements:

It allows the user to drive the system in Parking position.

When the system is out of the Parking position, it allows the user to
move the Column and the Arm in order to put the system in parking
position.

 Panel Out:

It allows the user to unlock the system from the Parking position and
to move the Arm and the Column in order to get access to the
Detectors.

 X-Rays:

It allows the user to perform any action needed for Radiographic

Operation.

 Admin:

It includes all the previous permissions for Movements; Panel Out,

X-Rays, and the following User Administrator permissions:

G RFID Cards administration:

For registering new cards and for adding, disabling or modifying

the RFID card permissions.
G Usability Settings:

To configure Sound settings, Visual settings, Anticollision

settings, Power OFF settings (for further information, refer to
section 3.2.9 of Power OFF Settings).
G Maintenance:

Useful to consult License data and logs compilation.

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Each mobile unit is provided with several different RFID cards:

 MOVEMENTS RFID Cards, with permission for:

G Movements.

 OPERATOR RFID Cards, with permission for:

G Movements.

G Panel Out.

G X-rays (Radiographic Operation).

 ADMINISTRATOR RFID Card, with permission for:

G Movements.

G Panel Out.

G X-rays (Radiographic Operation).

G User Management.

Note . For detailed information on the Administrator User, System

Permissions and RFID Card Management, refer to Appendix C
(Administrator User).

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3.2.1.2 ON/OFF BUTTON + KEYPAD SYSTEM

To turn the unit ON, proceed as described in the following steps:

1. Press and hold the ON/OFF button (1) for a few seconds; the System
ON/OFF Indicator (2) will blink white for 5 seconds.

2. Enter the four-digit Access Code into the Keypad (3), within 5 seconds
from turning the unit ON, and press the OK button (4); the System
ON/OFF Indicator (2) will light cyan and the Battery Charge Level
Indicator (5) will light according to the current battery status.

3. When the system is ON, the System ON/OFF Indicator (2) will light white.

2 3

Note . The system emits 3-beeps and the System ON/OFF Indicator
Indicator (2) blinks orange to indicate that a wrong code has been
entered; in this case, repeat the ON/OFF process.

The system in the ON status switches ON the Generator, allowing the Mobile
motion and then, Konica-Minolta “Ultra” Software Application for Radiographic
operation will be launched on the Control Console.

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3.2.2 SYSTEM OFF

Place the unit in the Parking position right after turning the
system OFF since positioning controls will remain enabled
for 15 seconds approximately.

Note . After turning OFF the unit, wait at least 10 seconds before turning
it ON again. This action assures a safely start-up of the system.

To turn the Unit OFF, proceed as described in the following steps:

1. Turn OFF the system from the Control Panel, by holding pressed the
ON/OFF button for 3 seconds approximately.

Smart ON/OFF System Keypad System

2. The system ON/OFF Indicator will light cyan for a few seconds and then,
the system will be turned OFF.

Smart ON/OFF System Keypad System

Note . If the system does not turn OFF after pressing the ON/OFF button
for 3 seconds, try it again by holding pressed the ON/OFF button
for 12 seconds approximately; it will turn OFF the system safely.

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3.2.3 EMERGENCY STOP

In the event of an emergency, the unit is turned OFF by forcibly pressing this
switch (red mushroom-shaped switch). The switch is protected by the Cover,
in order to prevent it from being accidentally pressed.

The Emergency Stop must not be used to switch OFF the unit, in order to avoid
damaging the software.

Note . Whenever possible, turn OFF the system as indicated in Section

3.2.2 in order to turn it OFF safely.

3.2.4 SYSTEM ON/OFF ROUTINE

After turning the unit ON as described in Section 3.2.1, Konica-Minolta “Ultra”

Software Application is launched on the Control Console.

Note . The user provided with RFID Card for Smart ON/OFF system, with
permission for Radiographic operation (refer to Section 3.2.1.1),
has direct access to the radiographic operation.

Turn OFF the system as described in Section 3.2.2.

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3.2.5 SYSTEM ON/OFF INDICATOR

The system ON/OFF Indicator (1) is on the Control Panel, over the Battery
Charge Level Indicators.

The System ON/OFF Indicator lights up in different colors, indicating different

system status:

COLORS SYSTEM STATUS

SYSTEM OFF
The ON/OFF Indicator is not illuminated when the system is OFF.
OFF

WAITING FOR USER IDENTIFICATION

The ON/OFF Indicator blinks white to indicate that the system is waiting for
the user identification; e. g. by passing the RFID Card over the RFID Card
Reader, or by entering the Access Code in the Keypad.
WHITE
(Refer to Sections 3.2.1.1 and 3.2.1.2).

USER REJECTED
The ON/OFF Indicator blinks orange indicating that the user has been
rejected by the system; e. g. when a wrong RFID Card has been passed,
ORANGE or when a wrong Code has been entered in the Keypad.
(Refer to Sections 3.2.1.1 and 3.2.1.2.).

SYSTEM INITIALIZATION / SHUTDOWN

The ON/OFF Indicator lights cyan during the System initialization process
(after entering a valid RFID Card / Code) and during the Shutdown process.
CYAN (Refer to Sections 3.2.1.1, 3.2.1.2 and 3.2.2).

SYSTEM ON/STANDBY
The ON/OFF Indicator lights white when the initialization process is
completed and the Positioner is operational, in Standby status.
WHITE

WAITING FOR NEW ACCESS CODE

The ON/OFF Indicator lights magenta indicating that the system is waiting
for a new four-digit Access Code which has to be entered within the next 10
MAGENTA seconds. (For Service personnel only).

Note . For further information, refer to Sections 3.2.1.1 and 3.2.1.2.

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3.2.6 CONTROL CONSOLE

The Control Console houses the Main Screen which consists of a 19” capacitive
Touchscreen Monitor, with pinch and zoom functionalities.

Konica-Minolta “Ultra” Software Application is shown on the Main Screen,

including the RAD Screen (Generator Control Panel) with the controls,
indicators and displays needed to perform radiographic exams.

The system can comprise a second Touchscreen Monitor (9”) located in the
Head-Assembly useful for radiographic parameters selection, technical
settings and patient information.

Note . For further details, refer to Sections 4 and 5.

1 CONTROL CONSOLE
2 MAIN SCREEN
3 HEAD-ASSEMBLYSCREEN

1 2

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3.2.7 BATTERY CHARGE LEVEL INDICATORS

The column with the Exposure symbol indicates the charge level of the Batteries
used for radiographic operations (X-ray exposures) and the column with the
Mobile X-Ray unit symbol indicates the charge level of the Batteries used for
the Mobile motion (motors).

When plugged into the mains (with the Emergency Switch-OFF deactivated),
the Batteries automatically charge. The color Indicators on both columns
illuminate and scroll from the current Generator battery charge level to 100%,
until the Batteries are fully charged. During the charging process, both columns
scroll up from the same level.

Note . The Batteries require approximately 8 hours for a fully charge.

To charge the Batteries, there is no need to have the Console
turned ON. When the Batteries are fully charged, the Battery
charge level Indicators on both columns stop scrolling and all the
Indicators remain illuminated in green.

When unplugged from mains, the Batteries discharge independently on their

use (X-ray exposures or motors) since the Mobile is provided with one battery
module.

Note . Upon disconnecting the unit from the mains if the unit has been
connected for a short period of time, or after several exposures or
after one heavy duty exposure, the Batteries need at least
30 seconds to stabilize the charge, after which the correct charge
level is shown on the Indicator.

The Battery Charge Level Indicator can be:

MOBILE unit MOBILE unit

PLUGGED INTO MAINS UNPLUGGED FROM MAINS

System in “ON” position and

System in “OFF” or “ON” position System in “OFF” position
Console turned ON

Each Column shows the respective

Both Columns are scrolling as
Both Columns are OFF. Battery charge level as described in
described in the following Table.
the following Table.

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Both columns comprise three Indicators, representing a battery status as

described below: Battery Full, Medium, Low, Very Low and Critically Low.

MOBILE unit IN CHARGING MODE MOBILE unit IN STAND-ALONE MODE

(PLUGGED TO MAINS) (UNPLUGGED FROM MAINS)

LED INDICATORS AND STATUS LED INDICATORS AND STATUS

Full Charge:

After a complete charge of the system (during approx.

When the system is at Full charge status, all the indicators
8 hours), the upper indicators on both columns (1+1) light
light steady green and normal operation is allowed.
blinking green for a few seconds and then, all the
Indicators (3+3) light steady green, indicating that the
The batteries charge level is between 60% and 100%
system Batteries are at Full Charge status.

The batteries charge level is at 100% of the total charge.

Medium Charge:
When the system is at Medium Charge status, the lower
The lower 4 indicators on both columns (2+2) light steady indicators light green and normal operation is allowed.
green and the upper 2 indicators on both columns (1+1)
light blinking green and scrolling upwards, indicating that The batteries charge level is between 31% and 59%.
the system Batteries are at Medium Charge status.

Low Charge: When the system is at Low Charge status, the lower
indicator lights green steady, on one or both columns;
The lower 2 indicators on both columns (1+1) light steady normal operation is allowed although it is recommended
green and the upper 4 indicators light blinking green and to charge the system.
scrolling upwards, indicating that the system Batteries are
at Low Charge status. The batteries charge level is between 20% and 30%.

When the system is at Very Low Charge status, the lower

Very Low Charge:
indicator lights orange steady, on one or both columns;
normal operation is allowed although it is urgent to charge
All the indicators on both columns (3+3) are blinking green
the system.
and scrolling upwards, indicating that the system
Batteries are at Very Low Charge status.
The batteries charge level is between 1% and 19%.

When the system is at Critically Low Charge status, the

lower indicator lights blinking orange, on one or both
Critically Low Charge: columns, operation is limited but it is necessary to charge
the system: the indicator on the X-Ray column, indicates
All the indicators on both columns (3+3) are blinking green that exposures are disabled; if is on the Motion column,
and scrolling upwards, indicating that the system indicates that motion is enabled for 30 minutes or 1 km
Batteries are at Critically Charge status. after which, all the indicators will be OFF.

The batteries charge level is 0%.

Indicator colors: Green Orange Indicator OFF Blinking / Scrolling

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3.2.8 BATTERY STATE ALERTS

Note . The following functions may be configured by the Service

Engineer.

For further information, refer to Section 4 of Control Console and

Section 5 of System Messages.

The Following Battery State Alerts can be displayed on the RAD screen:

" Battery Low:

This alert appears when the system batteries are at Low Charge status.
The lower indicators light solid green and the middle and upper indicators are
off, with the unit disconnected from mains (not charging).

It indicates that normal operation is allowed although it is recommended to

connect the unit to the power supply, for better battery usage.

The message disappears after a few seconds or by clicking on the OK button;

then, the work can be continued.

" Battery Very Low:

This alert appears when the system batteries are at Very Low Charge status.
The lower indicators light solid orange and the middle and upper indicators are
off, with the unit disconnected from mains (not charging). It indicates that normal
operation is allowed although it is urgent to connect the unit to the power supply.

The message disappears after a few seconds or by clicking on the OK button;

then, the work can be continued.

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" Battery Critical Low:

This alert appears when the system batteries are at Critically Low Charge
status.
The lower indicator flashes orange, on one or both columns, and the middle and
upper indicators are off, with the unit disconnected from mains (not charging).
This alert indicates that it is necessary to connect the system to a power source
for battery charging, although the operation is limited:

 If the indicator is on the X-ray column, indicates that exposures are

disabled.

 If the indicator on the Motion column, indicates that motion is enabled for
30 minutes or 1 km after which, all the indicators will be OFF.

The system initiates a shutdown with a 30 minutes countdown, that can

be stopped connecting the unit to the mains.

After 25 minutes without connection, the Status Light Indicator on the

Head-Assembly flashes orange.

If the system is still unplugged when the countdown expires, the unit will
automatically shut down.

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3.2.9 POWER OFF SETTINGS

Note . Power OFF settings can be configured by the User Administrator

or the Service Engineer.

" Time Out Switch Off Pressed. Time set by default:: 3 seconds.

Press and hold the Switch OFF button for 3 seconds; the system will start the
turning OFF process.

" Time Out Delay Switch Off. Time set by default:: 50 seconds.

After holding pressed for 3 seconds the Switch OFF button, the system will be
completely turned OFF in 50 seconds; during this time only movements are
enabled (e. g. it is useful for the user to put the system in the Parking position,
if necessary).

" Time Out Inactivity Generator. Time set by default:: 2 minutes.

When the system is disconnected from mains and there is not any Generator
activity during 2 minutes, the Generator Tube Filaments turn off, unless the user
performs any action on the RAD Screen, presses any control of the Handswitch
or Infrared Remote Handswitch, or connects the system to the mains; it will
delay the Time Out Inactivity Generator for another 2 minutes without any
Generator activity.

" Time Out Inactivity Warning. Time Set by default: 15 minutes.

When the system is disconnected from the mains and there is not any
Generator activity for 15 minutes, a Warning message is displayed on the
screens to alert the user of an automatic shutdown after finishing a countdown
timer for another 15 minutes.

If the Operator presses on Accept button or performs any system action

(touches on the RAD Screen, activates any of the movement controls, presses
the Handswitch or Infrared Remote Handswitch, or connects the system to the
mains), within the configured time; it will delay the Time Out Inactivity Warning
for another 15 minutes.

If the Operator does not respond within the countdown time of 15 minutes, the
system will automatically shut down; that is, the system will be completely
turned OFF after 30 minutes without activity.

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3.2.10 STATUS LIGHT INDICATOR (OPTION)

The system can be provided with the Status Light Indicator (1), located at the
Head Assembly, which indicates different system status by colors, as described
in the following table.

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COLORS
SYSTEM STATUS
NOT MOVING MOVING

SYSTEM STANDBY
X-rays are disabled.
The Status Light Indicator is OFF when the system is in Standby.
LIGHT OFF BLINKS WHITE
It blinks white when the system is moving.

SYSTEM READY FOR EXPOSURE

The Status Light Indicator lights solid cyan when the system is ready, i.e., the user only
needs to press the Handswitch for making an exposure: the Detector is ready, the RAD
CYAN BLINKS WHITE technique is correctly set, and there is not System Error or Interlock condition.
It blinks white when the system is moving.

SYSTEM PREPARED FOR EXPOSURE

The Status Light Indicator lights solid green when the handswitch has been pressed
-- halfway to the “Prep” status.
GREEN
Movements are not allowed.

EXPOSURE ON
The Status Light Indicator lights solid yellow during the X-ray Exposure: the Handswitch
--
has been fully pressed to the “Exp” status.
YELLOW
Movements are not allowed.

SYSTEM ERROR
The Status Light Indicator lights solid orange indicating that there is a system Error and it
blinks orange when it is moving.
ORANGE BLINKS ORANGE The Status Light Indicator blinks orange too when the system has been at a Battery Critical
Low status for 25 minutes, without being connected to mains.

FRONT BUMPER ACTIVATED

--
The Status Light Indicator blinks magenta when the Front Bumper is activated.
BLINKS MAGENTA

SERVICE MODE
Only in Service Mode.
RED BLINKS RED

Note . For further information, refer to Section 3.4 about the Exposure
process and to Section 5 about System Messages.

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3.3 CONNECTIONS PANEL

DO NOT CONNECT ANY ACTIVE DEVICES THAT APPLY

EXTERNAL VOLTAGE TO THE SYSTEM THROUGH THE USB
PORTS; ONLY PASSIVE DEVICES CAN BE CONNECTED.

4
2
5 1

9
3

The Mobile unit is provided with a Connections Panel with:

1. Hand Switch (HS), HS Connector, HS Support, (Refer to Section 3.4).

2. Infrared Remote Control (option), (Refer to Section 3.5).

3. USB Ports, to connect USB powered devices; only for Service personnel
(only for passive devices; a. e. Keyboard, Mouse, etc.).

4. Barcode Scanner (option).

5. Ethernet (ETH) Connector, in order to connect to the site Network.

6. WIFI Connection, in order to connect to the site Network.

7. WIFI Connection, in order to connect to the Wireless Digital Detector.

8. Detector Backup Communication Cable (option), to be connected at

the Front Cover (refer to Section 3.10.2).

9. Manual Driving Brake Release Button (option), (refer to Section

3.6.1.6).

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3.4 X-RAY HANDSWITCH

Radiographic exposures are controlled with the “Prep” (preparation) and “Exp”
buttons on the X-ray Handswitch.

The status of the exposure is shown by the “Ready” and “X-ray On” indicators
for the duration of the exposure.

PREP: Press the Handswitch button half-way (“Prep” position) to prepare the
X-ray Tube for exposure. The “Ready” indicator on the Console lights when the
1 X-ray Tube is prepared and there are neither interlock failures nor system faults.
2

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

1 OFF / Prep / Exp  Anode rotation.

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

Note . The unit cannot perform exposures when the Column is in Parking
position; it only can perform exposures out of the Parking position.

EXP: After the “Ready” indicator is illuminated, fully press the Handswitch
button to start an X-ray exposure. If the button is released before the Generator
completes the selected time, the system aborts exposure and the actual mAs
and Exposure Time will be displayed.

The “X-ray On” indicator remains illuminated and a sound is emitted during the
exposure.

Note . For further information, refer to Section 3.2.10 of Status Light

Indicators.

COLLIMATOR LIGHT: This X-ray Handswitch includes an extra Collimator

Light Button that helps patient positioning. Pushing this button will turn on the
Collimator Light. The Light remains illuminated for a few seconds before
automatically switching off.

The handswitch cable must be placed in such a way as not to

interfere the extraction or insertion of the Detector in its
housing inside the Holder.

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3.5 INFRARED REMOTE CONTROL (OPTION)

Note . The unit cannot perform exposures when the Column is in Parking
position; it only can perform exposures out of the Parking position.

DURING AN EXPOSURE, THE IR REMOTE CONTROL MUST

BE POINTED DIRECTLY AT THE MOBILE UNIT AT ALL TIMES.

The Infrared Remote Control permits the operator to perform exposures at a

distance from the X-ray beam (Head-Assembly) to protect against radiation.

When not in use, place the Infrared Remote Control back into the cradle in order
to charge the battery; the Status LED lighting cyan indicates that the Remote
Control has been placed in the correct position and its battery is charging (the
light will remain on as long as the IR Remote Control is stored in its cradle).

Note . A System Message will be displayed on screen when the IR

Remote Control is not placed into its cradle.

A Service Engineer may set the time it would take to display this
informational message, as well as whether it is accompanied by
an acoustic signal (discontinuous beeping).

1 Infrared Remote Control

2 Cradle
5
3 LED: Correct placement and
1 battery charge indicator

4 IR Emitter

5 IR Receiver Sensor
2

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Take the Remote Exposure Control device out of its cradle. Aim the Remote
Control at the IR Receiver Sensor on the Mobile unit from a maximum
distance of 10 meters.

2
1 OFF / Prep / Exp
1
2 Collimator Light

3 Status LED

COLLIMATOR LIGHT BUTTON:

Press this push-button to turn on the Collimator Light.

The status LED lights cyan.

EXPOSURE CONTROL:

Press this button halfway to prepare the X-ray Tube for exposure (“Prep”
position). When the X-ray Tube is “Ready” (green light on, at the Control
Console), fully press and hold this button (“Exp” position) until the X-ray unit
completes the exposure (yellow light on, at the Control Console).
The status LED lights cyan in “Prep” and “Exp” positions.

The preparation cycle automatically aborts and returns to Stand-by Mode if an

exposure is not initiated within 15 seconds after the “Prep” command or if the
Collimator Light is turned ON during this cycle.

The exposure aborts if the “Exposure” button is released.

When the exposure is completed the icon on the console turns OFF.

Return the Control Remote device back to its cradle on the Mobile unit.

Note . For further information, refer to Section 3.2.10 of Status Light

Indicators.

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3.6 MOTION CONTROLS

DRIVE THE UNIT WITH THE ARM IN PARKING POSITION.

WHEN NOT IN PARKING POSITION, MOVEMENT VELOCITY
IS REDUCED SIGNIFICANTLY.

FOR SAFETY REASONS, DO NOT DRIVE THE UNIT OVER

RAMPS WITH AN INCLINATION ANGLE >8o.

TO AVOID THE RISK OF OVERBALANCE, THE MOBILE UNIT

MUST NOT BE IN STATIONARY POSITION ON SURFACES
WITH THE FOLLOWING INCLINATION ANGLES:

 WITH THE ARM IN PARKING POSITION: >10o

 WITH THE ARM OUT OF PARKING POSITION: >5o

IF FOR ANY REASON THE UNIT EXCEEDS THE INDICATED

INCLINATION ANGLES AND LOSES THE VERTICALITY, THE
ARM COULD RISE SHARPLY TO THE TOP OF THE COLUMN;
THIS COULD CAUSE PERSONAL INJURY AND/OR DAMAGE
TO THE EQUIPMENT.

MONITOR THE SYSTEM MOVEMENTS WITH SPECIAL CARE.

AVOID ANY IMPACT OF THE UNIT WITH WALLS, FURNITURE
OR OTHER ELEMENTS IN THE ROOM THAT MAY CAUSE
DAMAGE TO THE EQUIPMENT.

DO NOT DRIVE THE MOBILE UNIT OVER WET SURFACES

AND/OR IMPREGNATED WITH CLEANING PRODUCTS
(SPECIALLY BLEACH, AMMONIA, ETC), THE UNIT COULD
SLIP AND MOMENTARILY LOSE CONTROL. IT ALSO MAY
BLEACH THE WHEELS CAUSING DAMAGES TO THE FLOOR.

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MONITOR WITH SPECIAL CARE THE PATIENT POSITION OR

ANYONE PRESENT, TO AVOID INJURY CAUSED BY UNIT
MOVEMENTS.

INTRAVENOUS TUBING, CATHETERS AND OTHER PATIENT

CONNECTED LINES SHOULD BE ROUTED AWAY FROM
MOVING EQUIPMENT.

ALWAYS USE THE HAND-GRIPS OF THE HEAD-ASSEMBLY

TO CONTROL AND DRIVE THE COLUMN AND ARM
MOVEMENTS, NEVER PUSH DIRECTLY ON
HEAD-ASSEMBLY OR COLLIMATOR.

DUE TO THE WEIGHT OF THE MOBILE UNIT, THE BRAKING

DISTANCE AT FULL SPEED ON A SMOOTH SURFACE IS
1 METER MAXIMUM.

Motion Controls are only enabled when the System is ON.

Place the unit in the Parking position right after turning the
system OFF since positioning controls will remain enabled
for 15 seconds approximately.

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3.6.1 DISPLACEMENT CONTROLS

Note . Displacement cannot be performed when the unit is connected to

mains.

Note . Velocity and visual signals (Status Light Indicator) can be

configured by the Service Engineer.

3.6.1.1 HANDLEBAR

The unit is driven by holding the Handlebar with the hands, and it stops when
the Handlebar is released by the user.

The Handlebar is provided with internal sensors that control the direction and
speed of each wheel, operating when the Handlebar is touched and released.

The Handlebar height can be adjusted by the Service Engineer to several

positions, in order to fit the user’s height. The unit is provided with a
three-position Handlebar (higher, medium and lower position) (for further
information, refer to Section 8.3 of Physical Characteristics).

When the Arm is in Parking position, the unit travels at the

configured velocity (approx. 5.5 km/h (3.42 mph) forwards
and 2.5 km/h (1.6 mph) backwards).

This velocity reduces considerably when the Arm is not in

Parking Position (approx. 1.6 km/h (1 mph)).

DUE TO THE WEIGHT OF THE MOBILE UNIT, THE BRAKING

DISTANCE AT FULL SPEED ON A SMOOTH SURFACE IS
1 METER MAXIMUM.

In order to avoid uncontrolled displacement of the unit during

the Starting-up, due to a failure of the displacement controls
(Handlebar activated or short-circuited), movements
controlled with the Handlebar are blocked although the unit
can be controlled with the Fine Positioning Controls.
A warning message alerts the user about a failure condition.

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3.6.1.2 FINE POSITIONING CONTROLS

Fine Positioning Controls permit the fine positioning adjustment of the system
respecting the patient, with the operator positioned opposite the
Head-Assembly.

The buttons with the arrow icons located on each Handgrip, control the motion
of each driving wheel independently, at low speed, backward/forward.

The buttons correspond to each motor and operate with the unit in/out of the
Parking Position.

Once any Fine Positioning button is pressed, the Unit starts to move, but
displacement will stop after 5 seconds. It is necessary to release the button and
press again to resume the movement. This safety measure prevents possible
uncontrolled movements due to an internal failure of the Fine Positioning
Controls.

Fine Positioning velocity is reduced as this control is not designed for

displacements.

1 1

Fine Positioning Controls:

1 Backward

2 Forward

2 2

Note . For further information on Fine Positioning Controls, refer

to Illustration 3-3.

In order to avoid uncontrolled displacement of the unit during

the Start-up, due to a failure of the displacement controls
(Fine Positioning Controls activated or short-circuited),
movements controlled with these commands are blocked
although the unit can be controlled with the Handlebar.
A warning message alerts the user about a failure condition.

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The illustration below, details the corresponding movements.

The buttons correspond to each motor and do not change when the unit is in
Parking Position.

Illustration 3-3
Fine Positioning Controls

LB RF
RB LF
RB = Right Back
RF = Right Front
LF = Left Front
LB = Left Back

RB LB

RF LF

LB RB

LF RF

RB LF RF LB

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3.6.1.3 MANUAL CLUTCH SCREWS

When the unit has to be moved manually, the (x2) Clutch Screws (Allen type)
located on each wheel must be removed using the tools provided with the unit.

DRIVE THE UNIT MANUALLY ONLY WHEN MOTORIZED

MOTIONS CANNOT BE PERFORMED (DUE TO A SYSTEM
MALFUNCTION OR THE BATTERIES DISCHARGE).
IN THIS CASE, DO NOT DRIVE THE UNIT ON SLOPES OR
INCLINED SURFACES; DRIVE IT ONLY ON LEVEL
SURFACES, TO AVOID PERSONAL INJURIES OR DAMAGE
TO EQUIPMENT DUE TO ITS HEAVY WEIGHT.

1. Sticker with instructions

2. Separating Plate (Back Holder)

3
3. Tools Support
(situation inside the unit)

4. Magnetic Hubcap 1 2

4 3

 Dismount the Separating Plate of the Back Holder, in order to gain access
to the Tools Holder mounted inside of the Unit.

Sticker

Separating
Plate

Tools

 Take both tools from the holder.

 Use the Wedge tool to dismount the magnetic Hubcap.

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 Use the Allen Wrench to remove the Clutch Screws (x2) of each wheel.
This will uncouple the wheels from the motors (releasing the brakes)
allowing the free motion of the unit.

Clutch Screws (circled)

Magnetic Hubcap

3.6.1.4 PROXIMITY SENSORS

PROXIMITY SENSORS ARE NOT A SAFETY SYSTEM OR AN

ANTI-COLLISION MECHANISM, BUT A DRIVING AID SYSTEM
THAT ACTS BY REDUCING THE SPEED AND ALERTING THE
USER WHEN AN OBSTACLE IS DETECTED.

The Proximity Sensors located under the Front Bumper, reduce the system
speed when detecting an obstacle, at a configured distance.

The system alerts the user with the Status Light Indicator blinking white.

Proximity Sensors

Note . Distance and Status Light Indicator can be configured by the

Service Engineer.

Note . For further information, refer to Section 3.2.10 of Status Light

Indicators.

Proximity Sensors are automatically deactivated by activating the system

motion controls, once the obstacle has been avoided.

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3.6.1.5 BUMPERS

The Front Bumper is provided with several sensors that stop the motor
movement in the event of a frontal collision.

The Status Light Indicator lights magenta when the Front Bumper is activated.

The Front Bumper is automatically deactivated by using the system motion

controls backwards; the Status Light Indicator blinks magenta when the system
is being moved away and becomes white once the bumper sensors deactivate.
Front
Bumper

Note . The Lateral Bumpers are not equipped with sensors.

Note . For further information, refer to Section 3.2.10 of Status Light

Indicators.

3.6.1.6 MANUAL DRIVING BRAKE RELEASE (OPTION)

The Manual Driving Brake Release consists of a push-button that allows to

release the displacement of the Mobile Unit in emergency or breakdown
situations.

To do this, press and hold the release button while using the Handlebar to move
the Unit.

Illustration 3-4
Manual Driving Brake Release Push-Button

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3.6.2 PARKING POSITION OF THE ARM

The unit is in Parking Position when the Parking Detent is secure in the Catch.

Place the Arm in Parking Position as follows:

 Fully retract the Telescopic Arm and turn the Column until the Parking
Detent is aligned with the Catch.

 Lower the Arm and fully insert the Parking Detent into the Catch, until a
“click” is heard; it indicates that it has been properly placed in Parking
Position.

The Parking Position status is indicated by a System Message and an icon

displayed on the Head-Assembly Console (refer to Section 4.2.4).

To release the Arm from Parking Position, press on the Brake Control at the
Head-Assembly.

Parking Detent

Catch

ALWAYS KEEP THE ARM IN PARKING POSITION EXCEPT

WHEN PERFORMING RADIOGRAPHIC EXAMS. THIS WILL
PREVENT INJURIES OR UNIT DAMAGE DURING
DISPLACEMENT.

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3.6.3 MOVEMENT CONTROLS

3.6.3.1 COLUMN AND TELESCOPIC ARM MOVEMENTS

Head-Assembly Handgrips have a Brake Control that releases or locks Column

rotation and vertical and telescopic Arm movements. This control also releases
the Arm Catch when in Parking position.

1 Handgrips

Hold the Handgrips to activate the Brake Control to move the Column and Arm
until the Head-Assembly is positioned. Release the control to lock in place.

ALWAYS USE THE HANDGRIPS TO CONTROL AND DRIVE

THE COLUMN AND ARM MOVEMENTS, NEVER PUSH
DIRECTLY ON THE HEAD-ASSEMBLY OR COLLIMATOR.

CAREFULLY DRIVE THE COLUMN AND ARM MOVEMENTS

AVOIDING ANY POSSIBLE COLLISION WITH THE PATIENT,
THE DETECTOR, THE CONTROL CONSOLE SCREEN OR
ANY OTHER PART OF THE EQUIPMENT OR OTHER
ELEMENTS AROUND IT.

The Column can rotate from its Parking position: ¦317o.

The Arm allows a vertical travel of 1490 mm.

Note . For further information, refer to Section 8.3 of Physical

Characteristics.

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3.6.3.2 HEAD-ASSEMBLY MOVEMENTS

Press the black buttons located on the Handgrips to rotate the Head-Assembly
from its vertical position:

 ¦180o on its transversal axis, i. e. roll rotation (see Illustration 3-5, A).
This movement has detents at --90o, 0o and +90o, and at --180o and 180o.

The angle can be indicated on the Head-Assembly Screen (2).

1

2  120_ on its horizontal axis, i. e. pitch rotation (see to Illustration 3-5, B).
This movement has detents at 0o , and it has stops at +90_, 0o and -- 30_.

The angle is indicated in the Inclinometer (1) located on the

Head-Assembly Support and on the Head-Assembly Screen (2).

Note . Refer to Section 3.6.3.3 for Collimator movements, and Section

4.2 for information on the Head-Assembly Console.

Illustration 3-5
Head-Assembly and Collimator Movements

120o
A
¦180o

¦90o
C

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3.6.3.3 COLLIMATOR MOVEMENTS

The Collimator can rotate ¦90_ on its vertical axis (refer to Illustration 3-5,C),
while the Head-Assembly remains in the same position.

This movement is performed by manually turning the Collimator and has

detents at --90o, 0o and +90o.

Note . Due to geometric restrictions related to the anode angle of the

X-Ray Tube, a minimum SID is required to cover the full image size
of the Detector, depending on the Collimator position:

Required SID
X-ray Tube with Collimator rotated at:
Receptor Size
Anode Angle
0° or ¦90° ¦45°

24X30
SID  70 cm SID  70 cm
30X24

16° 35X43
43X35
SID  100 cm SID  100 cm

43X43

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3.7 COLLIMATOR CONTROLS

3
4
4 1 4
3 3
2
4
1

1 Collimator Light 2 Measuring Tape 3 Handgrips 4 Collimator Knobs

Note . Refer to the Collimator Manual for extended information about

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

The Mobile unit is supplied with the following Collimator:

Ready for EDAP option

Ready for external

Motorized Filters
Measuring Tape

DAP Chamber
Front Knobs

Rear Knobs

Dual Laser
LED Light

Collimator Type

Manual Collimator with front and rear side Knobs, double Laser, Motorized Filters and ready for
p p p p p p p p
both Estimated Dose (EDAP) option and DAP Chamber option

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The Collimator has the following functions:

1. Collimator LED Light push-button.

Press once the Collimator Light push-button to turn the light ON; it will
remain ON for a few seconds before automatically switching OFF.

Collimator light may also be switched ON/OFF by clicking the Collimator

Light push-button located at the Handswitch.

Press two times within 5 seconds to turn ON the Double Laser in order
to adjust the SID.

Press three times to turn OFF the light (if it remains ON).

2. Measuring tape.

To measure the SID.

3. Handgrips with Support .

For easily positioning the Head-Assembly.

4. Collimator knobs to adjust the internal blades.

The Exposure Field is adjusted by setting the Knobs in order to

open/close the internal blades.

Table 3-1
Image Size according to the SID and Collimator Opening

SID
COLLIMATOR
OPENING
90 cm (35.4”) 100 cm (39.4”) 180 cm (70.9”)

13 11.7 cm (4.6”) 13 cm (5.1”) 23.4 cm (9.2”)

15 13.5 cm (5.3”) 15 cm (5.9”) 27 cm (10.6”)

18 16.2 cm (6.4”) 18 cm (7.1”) 32.4 cm (12.8”)

24 21.6 cm (8.5”) 24 cm (9.4”) 43.2 cm (17”)

30 27 cm (10.6”) 30 cm (11.8”) 54 cm (21.3”)

35 31.5 cm (12.4”) 35 cm (13.8”) 63 cm (24.8”)

40 36 cm (14.2”) 40 cm (15.7”) 72 cm (28.3”)

43 38.7 cm (15.2”) 43 cm (16.9”) 77.4 cm (30.5”)

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5. Additional Variable Filtration with the following Motorized Filters:

0 mm AL 1 mm Al + 0.1 mm Cu 1 mm Al + 0.2 mm Cu 2 mm Al

Select the filtration option on the Head-Assembly Screen.

6. External Filtration.

There is a rail system at the rear side of the Collimator, with two guides,
in order to install the external additional filters used for pediatric
examinations (0.1 mm Cu or 3.5 mm Al) in the upper guide.

7. Minimum Source-Skin Distance: 30 cm.

8. Double Laser selector (option), for Image-Receptor alignment.

Press two times the Collimator Light push-button within 5 seconds to turn
ON the Double Laser in order to adjust the SID.

9. Radiation Meter (option), it can be ready for Estimated Dose (EDAP)

option and/or ready for external DAP Chamber option.

If the DAP Chamber is present, it is placed in the lower guide of the rail
system, at the rear side of the Collimator.

3.8 DAP CHAMBER (OPTION)

The external DAP Chamber (Radiation Meter) is installed in the lower guide of
the Collimator rails. It reads the radiation as Dose Area Product (DAP) in
mGy*cm2.

Note . Do not install any accessories between the DAP Chamber and the
patient. This will disturb the radiation reading.

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.

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3.9 FOCAL-SKIN DISTANCE SENSOR (OPTION)

The FSD (Focal-Skin Distance) sensor is installed at the front of the underside
of the Collimator. It reads the distance from the focus of the tube to the surface
of incidence on a patient, measured along the beam axis.

The measured value is displayed on the Head-Assembly Console (refer to

Section 4.2.13).

Illustration 3-6
FSD Sensors Location

FSD Sensor

Measuring Tape

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3.10 WIRELESS DIGITAL DETECTORS, OPTIONS AND ACCESSORIES

Wireless Digital Detectors:

AeroDR 2 1417HQ, AeroDR 2 1417S,
AeroDR 3 1717HD, AeroDR 3 1417HD, AeroDR 3 1012HQ

Some Wireless Digital Detectors can be fitted in an optional Detector Handle

Support with an Antiscatter Grid.

Depending on the option, the Digital Detector can be stored and/or charged in
the Holders at the Back and/or at the Front Cover. The behavior regarding the
power supply of the Holders for Detectors charging is as follows:

 Whenever one or two Detectors are being charged in the Unit’s Holders,
power is continuously supplied to the charging slots.

 In case three Detectors are being charged at the same time:

G Charging will be always continuous in the slot of the Back Holder (1).

G Power is supplied alternately every 30 seconds at the charging

slots of the Front Bracket (2).

Illustration 3-7
Wireless Digital Detectors, Options and Accessories

2
1

2
3

1 Back Cover Holder for Detector Charge and Storage,

with / without Grid (1 Slot for Charging + 1 Slot for Storage)

2 Front Cover Holder for Detector Charge and Storage,

with / without Grid (2 Slots for Charging + 1 Slot for Storage)

3 Detector Bags Holder

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3.10.1 WIRELESS DIGITAL DETECTORS

Wireless Digital Detectors communicate with the Mobile unit through the
internal Access Point.

Wireless Digital Detector configuration can include a built-in Detector Battery

Charger (option), and a Back-up Cable.

AeroDR 2 1417HQ AeroDR 2 1417S

AeroDR 3 1717HD AeroDR 3 1417HD AeroDR 3 1012HQ

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3.10.2 DETECTOR BACK-UP COMMUNICATION CABLE (OPTION)

Detector Back-up Communication Cable (1) allows to expand the Wireless

Digital Detector, from wireless to wired configuration.

Connect the Cable to the Detector and to the connector at the Front Cover (2).

When not in use, the Back-up Cable can be stored at the Detector Holders.

3.10.3 BARCODE SCANNER (OPTION)

The Mobile unit can be equipped with a Barcode Scanner (1), for registering
patient information.

The Barcode Scanner is placed in the Connections Panel.

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3.10.4 GENERAL USE AND MAINTENANCE OF WIRELESS DIGITAL DETECTORS, OPTIONS AND
ACCESSORIES

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.

Note . If at any time the Detector does not connect properly after starting,
try again by turning on the Detector once the unit and the Image
Acquisition Software are operative.

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

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 . It is recommended that Digital Detectors be placed in a plastic

radio-transparent bag for each use, thus avoiding the excess of
cleaning and disinfection processes directly on the Digital
Detector surfaces.

Note . For further information on the Wireless Digital Detector Handling

and Maintenance, refer to the Wireless Digital Detector manuals.

Grids are intended to reduce scattered radiation and significantly enhance

image quality. Each Grid has an attached label that specifies its features (size,
focal distance, ratio, density).

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

Wireless Digital Detectors are prepared to fit into a Frame with a Removable
Grid. Consult the corresponding installation instructions and check that the Grid
is correctly mounted. Usually, a click sound means that the Grid is in place.

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SECTION 4 CONTROL CONSOLE

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.

4.1 MAIN SCREEN

Konica-Minolta “Ultra” Software Application is shown on the Main Screen of the

Control Console, it includes the Generator Control Panel with the controls,
indicators and displays needed to perform radiographic exams.

For further details, refer to the User Manual of the Konica-Minolta “Ultra”
Software Application.

Illustration 4-1
Ultra Software Application

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4.2 HEAD-ASSEMBLY CONSOLE

The Head-Assembly Console displays the Radiographic Parameters, System

Messages and some other useful information for the operator.

Illustration 4-2
Head-Assembly Console

Heat Units Parking Position

Battery Charge Level Motion Speed System Status and Patient Information
Exposure Indicator

Rotation and
angulation angles
of the X-ray Tube Workstation

Mute
User actions
Focal-Skin Distance
(Optional)

Collimator
Filter Options

Radiographic
Parameters
& Focal Spot

Message Bar

4.2.1 EXPOSURE INDICATORS

The “Status” icon of the Head-Assembly Console can vary according to the
operating status, as described below.

NORMAL STATUS: The detector is ready, the RAD technique is correctly set
and there is not Error or Interlock condition in the system.

HANDSWITCH PRESSED: The Handswitch half-way has been pressed

(“Prep” position) to prepare the X-ray Tube for exposure.

READY: Indicates that the technique selected is properly set, there are no
interlock failures nor system faults, the anode is rotating and the X-ray Tube is
ready for exposure.

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EXPOSURE: Indicates that the X-ray exposure is in progress. It remains

illuminated during the length of exposure. At the same time that radiographic
exposure is being made, an audible signal sounds.

INHIBITION CONDITIONS (ENABLED FILAMENTS): There are one or more

reasons causing an inhibition of exposure, despite the Tube Filaments being
properly enabled.

INHIBITION CONDITIONS (DISABLED FILAMENTS): There are one or more

reasons causing an inhibition of exposure. When the Filaments are disabled
(regardless of whether they have been deactivated via software or some other
issue), the inhibit status icon is shown in blue.

BEFORE PERFORMING AN EXPOSURE, IT IS THE

RESPONSIBILITY OF THE OPERATOR TO CHECK THAT THE
RADIOGRAPHIC PARAMETERS AND SELECTIONS ARE
APPROPRIATED FOR EACH EXAM.

BE SURE THAT NO LIQUID DROPS NOR OBJECTS ON THE

CONTROL CONSOLE HAVE MODIFIED THE RADIOGRAPHIC
PARAMETERS / SELECTIONS.

4.2.2 HEAT UNITS INDICATOR

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

exposures, the Heat Units are calculated and totalled.

The “Heat Units” shows the percentage of utilized thermal capacity of the Tube.
For example, “25%” would indicate that 25% of Heat Units capacity is used
(it can be configured by the service engineer).

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4.2.3 BATTERIES STATUS

Full Charge (Stand--alone mode): The Battery icons are displayed in steady
green when the battery charge levels for X-ray and Motion are between 60%
and 100%, and the unit is unplugged from mains.

Full Charge (Charging mode): The Battery icons are displayed in steady
green when the battery charge levels for X-ray and Motion are between 60%
and 100%, and the unit is plugged to mains.
The “Lightning” icon indicates that the batteries are charging.

Medium Charge (Stand--alone mode): The Battery icons are displayed in

steady green when the battery charge levels for X-ray and Motion are between
31% and 59%, and the unit is unplugged from mains.

Medium Charge (Charging mode): The Battery icons are displayed in steady
green when the battery charge levels for X-ray and Motion are between 31%
and 59%, and the unit is plugged to mains.
The “Lightning” icon indicates that the batteries are charging.

Low Charge (Stand--alone mode): The Battery icons are displayed in steady
green when the battery charge levels for X-ray and Motion are between 20%
and 30%, and the unit is unplugged from mains.

Low Charge (Charging mode): The Battery icons are displayed in steady
green when the battery charge levels for X-ray and Motion are between 20%
and 30%, and the unit is plugged to mains.
The “Lightning” icon indicates that the batteries are charging.

Very Low Charge (Stand--alone mode): The Battery icons are displayed in
steady orange when the battery charge levels for X-ray and Motion are between
1% and 19%, and the unit is unplugged from mains.
The icons change the color from steady orange to steady green when the unit
is plugged to mains.

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Very Low Charge (Charging mode): The Battery icons are displayed in
steady green when the battery charge levels for X-ray and Motion are between
1% and 19%, and the unit is plugged to mains.
The “Lightning” icon indicates that the batteries are charging.

Critically Low Charge (Stand--alone mode): The Battery icons are displayed
in blinking orange when the battery charge level for X-ray and Motion is 0%, and
the unit is unplugged from mains.
The icons change the color from blinking orange to steady green when the unit
is plugged to mains.

Critically Low Charge (Charging mode): The Battery icons are displayed in
steady green when the battery charge level for X-ray and Motion is 0%, and the
unit is plugged to mains.
The “Lightning” icon indicates that the batteries are charging.

Note . The battery charge level is displayed on a scale from 0% to 100%

in 10% increments(i.e. 10%, 20%, 30%, etc).

4.2.4 PARKING INDICATOR

When the Mobile Unit is in Parking Position, this indicator is displayed.

4.2.5 MOTION SPEED INDICATOR

This indicator can display:

Limited Motion Speed: “Turtle” icon appears when an obstacle is detected

and speed limitation is active. It also appears when using the Fine Positioning
Controls on the Head-Assembly handles.

Free Motion Speed: “Rabbit” icon appears when the Mobile Unit is in
movement and there is no obstacle.

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4.2.6 MUTE BUTTON

This button displays the selected sound option. Press on it to

activate/deactivate the acoustic signals of the Mobile Unit.

4.2.7 USER ACTION

Active when manual adjustments from the operator are required before making
the exposure (e.g. if the Grid is not inserted). If more than one action is required,
the number of actions to perform is shown in the icon.

4.2.8 WORKSTATION SELECTION

Press on this button to display the Workstation Selection window.

Workstations are automatically selected by the APR configuration. Each icon

corresponds to its related workstation and remains highlighted on the RAD
Screen when selected.

Although the operator does not need to select any workstation as they are
always associated to an APR technique, a specific workstation may be selected
if needed.

Press on the desired Workstation to select it and return to the main menu by
pressing again on this icon or on the “Home” icon.

Illustration 4-3
Workstation Selection Window

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4.2.9 RADIOGRAPHIC PARAMETERS

Radiographic Parameters are divided into kV, mAs, mA, and Time
(seconds “s”).

Illustration 4-4
Radiographic Parameters Selection

kV shows:

 The radiographic kV value selected for the technique.

mA shows:

 The radiographic mA value selected for the technique.

mAs can show:

 The radiographic mAs value selected for the technique.

 If an exposure is aborted by releasing the Handswitch button, the actual

mAs value flashes for five seconds, the message “Aborted Exposure
Error” appears in the Information Area and an alarm sounds, until the
“Accept” control is pressed to reset the error condition.

Time (s) can show:

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

 If an exposure is aborted by releasing the Handswitch button, the actual

Time (s) value flashes for five seconds, the message “Aborted Exposure
Error” appears in the Information Area and an alarm sounds, until the
“Accept” control is pressed to reset the error condition.

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INCREASE / DECREASE: Radiographic technique values are increased or

decreased by changing the value moving the “Slider” position.

When the “Slider” is positioned over a value not allowed, its pointer comes back
to the nearest allowed value, according to the limit of the Tube and the Unit.

Illustration 4-5
Slider for Value Selection

Min value Max value

Slider for value selection

 kV: Selects the X-ray Tube voltage.

 mA: Selects the X-ray Tube current, changing the mAs value and
keeping constant the select Exposure Time, whenever possible.

 mAs: Selects the exposure in mAs, setting the maximum mA available

for the selected Focal Spot and the respective Exposure Time.

 s: Selects the Exposure Time in seconds.

(Refer to Section 8 for Factor ranges)

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

blocked, it could mean that it may have been selected a wrong
combination of radiographic parameters that could have caused
a warning condition (for further information about System
Messages, refer to Section 5).

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4.2.10 FOCAL SPOT

This indicator displays the selected Focal Spot of the X-ray Tube: “Small” or
“Large”. The Focal Spot is changed by pressing on this indicator. It keeps kVp
and constant mAs, whenever it is possible.

Small and Large Focal Spots can overlap each other, refer to the graphic below
to view an example of Focal Spot change.

Illustration 4-6
Small and Large Focus Overlap

10 (min. mA) 200 (Small Focus max mA) (max. mA)

mA stations in Small Focus

mA stations in Large Focus

Large Focus min mA

Note . The maximum mA station for the Small Focal Spot and the
minimum mA station for the Large Focal Spot can be configured
by the field engineer during the installation.

4.2.11 POWER REDUCTION

Tube Capability can be limited to 80% by pressing on the “Power Reduction”

button and selecting the desired power percentage (100% or 80%). In this case,
if the 80% limitation is selected, the range of radiographic parameters may be
conditioned and the values selection could be automatically adjusted.

4.2.12 HEAD-ASSEMBLY ROTATION

It displays the rotation and angulation of the X-ray Tube.

 The value displayed beside the upper symbol, indicates the

Head-Assembly rotation on its transversal axis (roll rotation).

 The value displayed beside the lower symbol, indicates the

Head-Assembly rotation on its horizontal axis (pitch rotation).

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4.2.13 FSD VALUE

This option displays the value of the current distance between focus and patient
measured by the Focal-Skin Distance sensor (refer to Section 3.9).

4.2.14 COLLIMATOR FILTER SELECTION

To set a Collimator filter, press on the option to be selected. Filter Selection is

always displayed on the screen with one of the four available filter options
selected (“None”, by default):

 None.

 2 mm Al

 1 mm Al + 0.1 mm Cu

 1 mm Al + 0.2 mm Cu

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4.3 MESSAGE BAR

The Message Bar shows informative messages (warning, information,

inhibition condition, user action, error).
Active messages, i.e. those that require action by the operator or report an error
or a warning, will be displayed consecutively in this area.

The Message Bar is located in the bottom area of the Main Menu of the
Head-Assembly Console.

Illustration 4-7
Message Bar

Tap to view the Message List

Number of the active/relevant message shown in the Message Bar

To check the message history, press on the Message bar. A pop-up window
(titled “Message List”) will be displayed. To close it, tap on the upper arrow of
the Message List window and go back to the previous screen.

Illustration 4-8
Message List
Tap to return to the Main Menu

Note . For information about the different message windows refer to the
Section 4.3.1.

For information about the Types of Messages and Messages List

refer to the Section 5 “System Messages”.

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4.3.1 MESSAGE WINDOWS

The main message window is the Message List, available from the Message
Bar of the Main Menu, which contains all system messages.

In addition, there are different pop-up message windows depending on the

source of the messages and how to access them. General features of these
windows are described in Section 4.3 “Message Bar”, however some of their
particularities are described as follows.

Press on any message to display the date, code and a brief description.

Illustration 4-9
Message Displayed

Press the “Start” button in any of these windows to return to the Main Menu.

Each of the message windows is detailed below:

NOTIFICATIONS

Notifications of important information to be noticed by the operator can appear

during normal operation as pop-up messages in Message Bar, allowing to
access the Notifications window. Two types of different messages can appear
in this pop-up window during normal operation:

 Information messages that do not require confirmation by the user.

Automatically cleared by the system after a few seconds.

 Messages that require user confirmation. It is needed to tap on the

“Accept” button to continue.

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Illustration 4-10
Notifications Pop-up Window

INHIBIT CONDITIONS MESSAGES

Whenever the System Status is “Inhibit Conditions”, it is possible to press the

status icon to display the messages of conditions that inhibit exposures (refer
to Section 5).

Illustration 4-11
Inhibit Conditions Messages

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4.3.2 SYSTEM SNAPSHOT

The “System Snapshot” button, located in the upper right corner of the
“Message List” screen, allows the user to generate event logs files, collecting
general information about the system status, which could be useful for the
Service personnel.

1. Press the “System Snapshot” button and confirm the pop-up message.

2. The “Logs Capture” window will be displayed indicating that the process
is in progress.

3. Tap on the arrow in order to expand this window and display the export
progress for each system component and the results. Tap it again in
order to hide this view.

4. To cancel the System Snapshot in progress, touch the “Close” button and
then confirm on the a pop-up window in order to return to the Main Menu.

Illustration 4-12
System Snapshot Confirmation and Logs Capture Window

3
“Close” Button

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The following icons indicate a different status of the Logs Capture, for
each system component:

G Logs export in progress, for that component.

G Successful logs export, for that component.

G Failed logs export, for that component.

Note . When the Logs Capture process is not completed for one or more
components, the system continues with the processing.

5. Once the logs Capture process has finished successfully, touch the
“Close” button and the system will return to the Main Menu.

Illustration 4-13
Exiting the Logs Capture Window

Note . Only for Service purposes: the resulting system logs files are
generated in folder C:\OEM\Snapshots.

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SECTION 5 SYSTEM MESSAGES

The System Messages are displayed in the Head-Assembly Console. The

console shows inhibit conditions, informative and error messages related to the
whole operative of the Mobile X-ray Unit, including messages related to the
Image Acquisition Software.

 Warning. Alerts the operator about conditions that do not disable or

abort exposures (e.g. maximum kV value reached while modifying the
exposure parameters).

A blinking message is displayed to the Operator for a few seconds

notifying this event.

 Information. Indicates to the operator any information related to the

status of the different Mobile X-ray Unit components, status of the
procedure that is being accomplished, and also to issues related to the
configuration of the exposure, etc. Causes can be many of them,
originated by the Unit itself, the X-ray Generator or the Acquisition
Workstation.

The messages are displayed momentarily, do not require any action of

the operator and disappear once the cause has been solved
automatically by the System.

 Inhibit condition. These messages are displayed when the Unit itself
or the Image Acquisition System request the Generator not to expose or
inhibit a movement because of multiple reasons: the tube is not pointing
to the detector, acquisition workstation is not ready, etc. But also, there
are originated by the same X-ray Generator. There are different kind of
Interlocks: those that cause an exposure inhibition, movements inhibition
or both at the same time.

There can be more than one active Inhibition message or Interlock

message at the same time. They will disappear when all the reasons are
corrected by the operator one by one.

OM-0481R1 105
Mobile X-ray Unit
Operation

 User action. These messages disappear once the required action is

performed by the user.

 Error. Indicates to the operator the potential cause of a system failure

that abort or inhibit the exposure or procedure. At the same time that they
are displayed an alarm sounds.

Correct the error cause and keep touched the “Accept” button until the
Console indication disappears and exposure or procedure can be
accomplished.

All these System Messages are reported in the Message Bar, which is located
in the bottom area of the Console Main Menu. Active messages, i.e. those that
require action by the operator or report an error or warning, will be displayed
consecutively in this area.

Illustration 5-1
Message Bar

Tap to view the Message List

Number of the active/relevant message shown in the Message Bar

Note . For additional information about the Message Area refer to the
Section 4.3.

106 OM-0481R1
 Mobile X-ray Unit
Operation

There are also different Message Windows, which are accessed depending on
the origin of the messages, in which detailed information about them can be
consulted (refer to Section 4.3.1).

The main message window is the Message List. To enter it, press on the
Message Bar. A pop-up window will be displayed. To close it, tap on the
message area again to go back to the previous screen.

Illustration 5-2
Message List

Note . The following pages show a complete list of System Messages

ordered by their Identifier (ID).

OM-0481R1 107
Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

100250 Communication lost with UARC Device Press Accept.

Error If the error persists,
persists restart the System.
System
100251 Communication lost with Power Control Device If the error persists, call Service.

Timeout for receiving the Ready State from Power

100252
Control has elapsed Press Accept. Release the PREP and EXP orders
Error from the Handswitch and try the exposure again.
Timeout for receiving the Synch State from Power If the error persists, call Service.
100253
Control has elapsed

100254 Power Control Protocol Version mismatch

Restart the System.
y
Error
If the error persists, call Service.
100255 UARC Protocol Version mismatch

100256 Starter is not supported by License Error Call Service.

100257 High Speed is not supported by License

Error --
100258 FPGA running with Golden Firmware

Inhibit Change the exposure values or wait for the X--ray

100803 Activated Procedure is not allowed
Exposure Tube to cool.

100930 Tube file wrong format

Error --
Current Image Receptor Synchronization Type is
100941
not supported. Please, select other workstation.

100942 Preheating Filament Information Wait for 10 seconds.

100944 Maximum Preparation Time Reached. Information Remove preparation and exposure order.

Inhibit
101008 INTERLOCK_2
Exposure

101015 Generator has not been calibrated yet

Information --
101017 Configurated Tube is different to Calibrated Tube

Inhibit
101018 Exposure does not allowed in this Desktop
Exposure

101019 The system has to be rebooted for being upgraded Information Press Accept and wait for the System to restart

Inhibit
101021 Inhibit Xray due to system communication lost --
Exposure

108 OM-0481R1
 Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

101022 Generator inactivity state, preheating filament Information Wait for 10 seconds.

Upgrade is ongoing, xray disabled during this

101023 Information --
process

KVM button has been pressed, switching between Inhibit

101024 If KVM has not been pressed, call Service
computers Exposure

Please, decrease mA and increase ms to keep mAs.

The exposure selected exceeds the current battery Otherwise, connect the system to power source and
Inhibit
101025 capacity power. Exposures are not allowed in this wait.
Exposure
state.
If the error persists, call Service.

Upgrading is performing, when the process finishes

101026
click on accept to apply the changes.

102001 Value requested exceeds generator power

102002 Value requested exceeds tube maximum rating

Technique requested not allowed due to tube space

102003
charge

102004 kVp requested out of range

Information --
102005 mAs requested out of range

102006 mA requested out of range

102007 ms requested out of range

Focal spot change not allowed due to mA--mAs

102008
selection

102009 APR warning

102010 Generator thermal limit

102023 Number of exposure reached. Exposure finished. Information No user action required.

102024 Exposure finished due to limit mAs reached. Information No user action required.

Exposure finished due to limit energy for serial

102025 Information No user action required.
radiographic exposures.

103001 Filaments disabled by software

I f
Information
ti C ll Service.
Call S i
103002 Filaments disabled by hardware

OM-0481R1 109
Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

Time Stamp has not been updated from SNTP

103003 Information Call Service.
Server

File has not been uploaded. File Manager Service

103008
has not found
Information Call Service.

103009 Demo Mode Enabled by License

103010 Upgrade only allowed in Service Mode Information --

103011 Demo Mode enabled by Dip Switch Information Call Service.

Press Accept.
140301 Generator DSP Control. Register configuration Error If the error persists, restart the System.
If the error persists, call Service.

140302

140303

Restart the System.

140304 Xray generator internal error. Error
If the error persists, call Service.

140305

140306

140307 Generator DSP Control. Internal temperature

140308 Xray generator internal error.

140309 Generator DSP Control. Exposition Safety Timer

140310 Generator DSP Control. kV converter Overcurrent

Press Accept.
140311 Generator DSP Control. kV Overvoltage
Error p , restart the System.
If the error persists, y
If the error persists, call Service.
Generator DSP Control. kV Converter
140312
Undercurrent

140313
Generator DSP Control.
Control Internal HW protection
140314

140315 Generator DSP Control. IGBT bridge fault.

110 OM-0481R1
 Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

140316 Press Accept.

Generator DSP Control.
Control IGBT bridge fault branch Error If the error persists,
persists restart the System.
System
140317 If the error persists, call Service.

Press Accept. If the error persists, restart the System

140318 Generator DSP Control. kV out of range and reduce power of the exposition. If the error
persists, call Service.
Error
Press Accept. If the error persists, restart the System
140319 Generator DSP Control. mA Overcurrent and reduce mA of the exposition. If the error persists,
call Service.

Generator DSP Control. Undercurrent in small

140320
filament during exposure.

Generator DSP Control. Undercurrent in the power

140321
converter using small filament during exposure.
Press Accept.
p
Error If the error persists, restart the System.
140322
Generator DSP Control. Overcurrent in small If the error persists,
persists call Service.
Service
filament.
140323

Generator DSP Control. Small Filament Current out

140324
of range

Generator DSP Control. Fault on small filament

140325
inverter.
Restart the System.
y
Error
If the error persists, call Service.
Generator DSP Control. Thermal fault on small
140326
filament inverter.

Generator DSP Control. Undercurrent in large

140330
filament during exposure.

Generator DSP Control. Undercurrent in the power

140331
converter using large filament during exposure.

140332 Press Accept.

Generator DSP Control. Overcurrent in large
filament. E
Error If the error persists,
persists restart the System.
System
140333 If the error persists, call Service.

Generator DSP Control. Large Filament Current out

140334
of range

Generator DSP Control. Fault on large filament

140335
inverter.

OM-0481R1 111
Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

Generator DSP Control. Thermal fault on large

140336
filament inverter.

Generator DSP Control. Undercurrent in super

140340
small filament during exposure.

Generator DSP Control. Undercurrent in the power

140341 converter using super small filament during
exposure.

140342
Generator DSP Control. Overvoltage in super small
filament.
140343

Generator DSP Control. Following error loop on

140344
super small filament.

Generator DSP Control. IGBT fault on the super

140345
small filament.

Generator DSP Control. Thermal fault on the super

140346
small filament.

Press Accept.
140350 Generator DSP Control. Master Heartbeat error.
Error If the error persists, restart the System.
If the error persists, call Service.
Generator DSP Control. Emergency signal
140351
activated by master.

Generator DSP Control. Synchronism signal

140352 (exposure order) has been received before
preparation signal.

Generator DSP Control. Filament current demand

140353
is out of range

140354 Generator DSP Control. Frequency out of range.

140355 Generator DSP Control. UDC undervoltage

Generator DSP Control. End exposure not

140356
detected

140357 Generator DSP Control. Internal Status Fail

Generator DSP Control. Monoblock connector

140358
error

140359 Generator DSP Control. mA out of range

112 OM-0481R1
 Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

140360

140361

140362

140363

140364

140365

140366

140367

140368

140369

140370 Press Accept.

Generator DSP Control. Power Control Calibration
Error If the error persists,
persists restart the System.
System
data error
140371 If the error persists, call Service.

140372

140373

140374

140375

140376

140377

140378

140379

140380

140381

OM-0481R1 113
Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

140382

140383

140384

140385

140386

140387

140388

140389

140390

140391
Press Accept.
Accept
Generator DSP Control. Power Control Calibration
140392 Error If the error persists, restart the System.
data error.
Iff the error persists, call Service.
S
140393

140394

140395

140396

140397

140398

140399

140400

140401

140402

Press Accept. Retake exposition. If error persists,

140403 Generator DSP Control. Feedback KV error.
restart the system. If error persists, call Service.
E
Error
Generator DSP Control. Generator Wrong mA. Press Accept. If error persists, restart the system. If
140404
Filament calibration. error persists after the restart, autocalibrate the Tube.

114 OM-0481R1
 Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

Press Accept. Retake exposition.

Generator DSP Control. Overcurrent in the main
140408 Error If error persists, restart the system.
inverter
If error persists call Service.

Press Accept.
Generator DSP Control. ROTOR_UDC
140420 Error If the error persists, restart the System.
undervoltage
If the error persists, call Service.

140501

140502

140503

Restart the System.

140505 X-ray generator internal error. Error
If the error persists, call Service.

140506

140509

140511

140512 Generator Starter powered Off Information Information - Generator Starter. System Powered Off.

140533 Generator Starter comms error.

140534 Generator Starter. Tube1 mismatch error.

140539 Generator Starter Configuration Error.

Press Accept.
Accept
140540 Generator Starter EEPROM Error. Error If the error persists, restart the System.
Iff the error persists, call Service.
S
140541
Generator Starter communications Error
Error.
140542

140543 HW version mismatch.

Reset error.
140544 Wrong Dropout Station selection Error If the error persists, restart the System.
If the error persists, call Service.

140554 Generator Starter. Minimum input voltage Error. Press Accept.

E
Error If the error persists,
persists restart the System.
System
140555 Generator Starter. Maximum input voltage Error. If the error persists, call Service.

OM-0481R1 115
Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

Reboot is required.
140557 Generator Chopper Time Out. If the error persists, restart the System.
If the error persists, call Service.

140558

140559

140560

140561

140562

140563

140564

140565

140566

140567
Error
140568 Press Accept.
Generator Starter.
Starter Current Error.
Error If the error persists,
persists restart the System.
System
140569 If the error persists, call Service.

140570

140571

140572

140573

140574

140575

140576

140577

140578

140579

116 OM-0481R1
 Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

140580

140581

140583

140589

140590
Generator Starter.
Starter Current Error.
Error Press Accept.
Accept
140591 Error If the error persists, restart the System.
Iff the error persists, call Service.
S
140592

140593

140594

140595

140598 Generator Starter. Acceleration rejected Error.

Unknown error type - Generator Starter. Error

140599 Generator Starter. Error Mismatch. Error
Mismatch

Generator Starter will be reset.

If the error persists, call Service.
140601 Generator Starter. Internal debug information. Information
Generator Starter.
Internal debug information.

Design Information - Generator Starter.

140602 Generator Starter. Software Warning. Information
ADC_Mailbox_Input_ADCSWI_Warning

Generator Starter will be reset.

140603 Generator Starter. Internal test interlock. Error Enable UARC logs.
If the error persists, call Service.

Generator Starter. Tube 1 Thermal Switch Tube 1 Temperature. Interlock. - Generator Starter.
140604 Error
Interlock. Tube 1 Thermal Switch

Default tube is selected. - Generator Starter.

140606 Generator Starter. Default Tube. Information
Hardcoded Tube definition.

OM-0481R1 117
Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

Design Information - Generator Starter.

140608 Generator Starter. Voltage Warning. Information
V_ACC Maximum Duty Warning.

Design Information - Generator Starter. V_HOLD

140609 Generator Starter. Voltage Warning. Information
Maximum Duty Warning.

Design Information - Generator Starter.

140610 Generator Starter. Voltage Warning. Information
V_DC Maximum Duty Warning.

Generator Starter. Tube Impedance Read Design Information - Generator Starter. Tube
140611 Information
Information. Impedance Read Value.

140612
Generator Starter Interlock.
Interlock Error Wait until the message dissapears.
dissapears
140613

140616 Generator Starter powered Off Information No user action required.

Restart the System.

290001 System Communication Error with GPIO Head Error
If the error persists, call Service.

290002 System Communication Error with Battery Monitor

Restart the System and try to repeat the operation.

290003 System Communication Error with RFID Error
If the error persists, call Service.

290004 System Communication Error with ADMC

290005

290006
Component Identification Mismatch Error Call Service.
Service
290007

290008

290020 Collimator Apertures Error Warning Call Service.

Restart the System and try to repeat the operation.

290100 Positioner configuration checksum is wrong Error
If the error persists, call Service.

290101 Configuration file not loaded

Restart the System.
y
E
Error
If the error persists, call Service.
290102 Configuration file not loaded

118 OM-0481R1
 Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

Invalid configuration parameters according to the

290103
license installed.

290104 System will power off: Incorrect system in license Error Call Service.

System will power off: Incorrect startup mode in

290105
license

290106 Updating license client. Information

--
Inhibit
290200 Collision detected
Movement

CRITICAL BATTERY LEVEL. Operation is not Connect the System to mains.

290201 allowed. Please, connect the system to a power Warning
source. Time remaining before shutdown 00:{0}:{1} If the error persists, call service

Battery Very Low, please connect the system to

290202 Warning
power supply.
--
Battery Low, please connect the system to power
290203 Information
supply

290205 Collimator Apertures have not been calibrated Collimator Blades calibration is needed. Call Service.

Focal Skin Distance sensor calibration is needed. Call

290206 Focal Skin Distance has not been calibrated
Service.
Warning

290207 Head--assembly handles pressed during booting up

290208 Head--assembly buttons pressed during booting up

290300 System communication error located in the Head.

Restart the System and try to repeat the operation.
System communication error located in the smart
290301 If the error persists, call Service.
on/off.
Error
290302 System communication error located in the RFID.

System communication error located in the motion

290303
control.

The system has not been used for long time and
290400 will shutdown in 00:{0}:{1} unless you connect it to Warning
power source or click here.
--

290401 System is powering off. Please wait... Information

OM-0481R1 119
Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

Remote Handswitch is out of the placement longer Return the remote Handswitch to its placement or click
290402 Information
than configuration time on “Accept button” to disable the warning.

290454 Internal error located in the head Error Reboot the system and try to repeat the operation.

usability_setting.xml is outdated. Please, enter in

290500 Warning --
service mode and update this file

positioner_1.xml is outdated. Please, enter in

290501 Warning
service mode and update this file

Inhibit X-ray due to current RFID tag does not allow --

290700
X-ray Inhibit
Exposure
290701 Inhibit X-ray due to screen has been powered off

Inhibit Check if unit is in parking position. If it is not, call

290702 Inhibit X-ray due to parking position
Exposure Service.

290703 Inhibit X-ray due to system is moving

Inhibit
--
Exposure
290704 Inhibit X-ray due to brakes are released

Inhibit
290705 Inhibit X-ray due to board configuration pending Call Service.
Exposure

Inhibit
290706 Inhbit X-ray due to System in Critical Battery Level If after charging the unit the error persists, call Service
Exposure

Inhibit
290707 Inhibit X-ray due to Dosimeter is not ready Call Service.
Exposure

Inhibit
290708 Inhibit X-ray due to Collimator filters are moving --
Exposure

Inhibit Wait for the X--ray Tube to cool.

290709 Inhibit X-ray due to tube thermostat is released
Exposure If the error persists, call Service

Inhibit
290710 Inhibit X-ray due to tube fan is released Call Service.
Exposure

290711 Fan Tube released Information No user action required.

Fine positioning buttons pressed longer than

290712 Information Release the Fine positioning buttons.
allowed

120 OM-0481R1
 Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

Dosemeter values have not been received from Try to repeat the operation.
290750
GPIO Head If the error persists, call Service.
Information
ExposureSoundOn Acknowledge Message has not
290751 If the problem persists, call Service
been received from RFID Board

291001

291002

291003 Internal error located in the battery monitor.

291004 Restart the System and try to repeat the operation.

If the error persists, call Service.
291005 Error

291014

291015
System communication error located in the battery
monitor.
291016

291017

291018

291019
Peripheral communication error located in the
Error -
battery monitor.
291020

291021

291023 Internal error located in the battery monitor.

Restart the System and try to repeat the operation.
operation
Error
System communication error located in the battery If the error persists, call Service.
291024
monitor.

291039 Internal error located in the battery monitor. Error -

291040
Peripheral communication error located in the Restart the System
y and tryy to repeat
p the operation.
p
E
Error
battery monitor. If the error persists, call Service.
291041

OM-0481R1 121
Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

291050

291051
Restart the System
y and tryy to repeat
p the operation.
p
Internal error located in the battery monitor.
monitor Error
If the error persists, call Service.
291052

291053

Battery below critically low, shutting down the

291100 Warning -
system.

291101 Download not performed due to a hardware failure Information Download not performed due to a hardware failure.

292001

292002

Restart the System and try to repeat the operation.

292003 Internal error located in the RFID. Error
If the error persists, call Service.

292004

292005

292014

292015
System communication error located in the RFID
RFID.
292016

292017
Restart the System
y and tryy to repeat
p the operation.
p
Error
If the error persists, call Service.
292023 Internal error located in the RFID.

292024 RFID System Communication Error

292040
RFID Peripheral Communication Error
292041

292100 RFID reset by WDT Information No user action.

292101 RFID not available Information Check RFID device.

122 OM-0481R1
 Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

293004 Motion Control: Left Motor Differential Signal error

293005 Motion Control: Right Motor Differential Signal error

Motion Control: Power Supply error in left motor

293006
power isolated area

Restart the System.

Motion Control: Power Supply error in right motor Error
293007 If error persists, call Service.
power isolated area

293008 Motion Control: Left Motor IGBTs error

293009 Motion Control: Right Motor IGBTs error

293010 Motion Control: Left Motor AC Overcurrent error

293011 Motion Control: Right Motor AC Overcurrent error

293012 Motion Control: Left 1 Force Sensor Error

293013 Motion Control: Left 2 Force Sensor Error

293014 Motion Control: Right 1 Force Sensor error Restart the System.
Error
If error persists, call Service.
293015 Motion Control: Right 2 Force Sensor error

Motion Control: Left Motor AC Current Presence

293019
previously to start up error

Motion Control: Right Motor AC Current Presence

293020
previous to start up error

Wait for the System to cool up during half an hour.

293024 Motion Control: Overheating error Error If error persists, restart the System.
If the error persists, call Service.

Restart the System.

293029 Motion Control: FPGA Heartbeat error Error
If error persists, call Service.

Restart the System and try to repeat the operation.

293030 Motion control: FPGA Golden FW Error
If error persists, call Service.

293032 Motion Control: Proximity Sensors fault detection

Restart the System.
y
W i
Warning
If error persists, call Service.
293033 Motion Control: Bumper fault

OM-0481R1 123
Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

Unplugged and plug the System again.

293034 Motion Control: Stop due to Battery charging Information If failure persists, restart the System.
If the error persists, call Service.

Release and push the deadman.

If failure persists, push the Handlebar.
Motion Control: Stop due to Deadman pressed at
293035 Information If failure persists, restart the System and try to repeat
start up
the operation.
If the error persists, call Service.

Release the Handlebar and push it again.

Motion Control: Stop due to Handle bar pressed at If failure persists, restart the System and try to repeat
293036 Information
start up the operation.
If the error persists, call Service.

Release the Header key pressed.

If fine positioning is desired, press the desired key
Motion Control: Stop due to Header key pressed at again.
293037 Information
start up
If failure persists, restart the System.
If the error persists, call Service.

Please, verify the force sensors connection.

Motion Control: Stop due to Force Sensors
293038 Information Calibrate the force sensors again.
Calibration Fault
Restart the unit and if error persists, call Service.

293051 Motion Control: Header key not working properly Warning Restart System. If error persists call Service.

294001

294002

294003 Internal error located in the head.

294004

294005 Restart the System and try to repeat the operation.

Error
If the error persists,
p , call Service

294014

294015
S t
System communication
i ti error llocated
t d iin th
the h
head.
d
294016

294017

124 OM-0481R1
 Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

294018

294019
Peripheral communication error located in the Restart the System and try to repeat the operation.
head. If the error persists, call Service.
294020

294021

294023 Internal error located in the head.

294024 System communication error located in the head.

294027 Collimator Internal Error

294028 Collimator Configuration Error

294030 Dosimeter Internal Error

294031 Dosimeter Configuration Error

294032 Dosimeter Communication Error

294033 Dosimeter restarted error.

Error
Internal communication bus error located in the
294039
head.

294040 Restart the System and try to repeat the operation.

Peripheral communication error located in the If the error persists,
p , call Service.
head.
294041

294045
Internal error located in the head.
head
294046

Peripheral communication error located in the

294050
head.

294051
Internal error located in the head.
head
294052

294053 Digital accelerometer error located in the head.

294054
I t
Internal
l error located
l t d in
i the
th head.
h d
294059

OM-0481R1 125
Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

300002 Positioner configuration could not be loaded

300003 Switches configuration could not be loaded

Error Call Service.
Service
300006 Generator configuration could not be loaded

300007 Workstations configuration could not be loaded

300008 Image receptors configuration could not be loaded Error Call Service.

If the error appears during start--up, please wait. If it is

300009 Positioner disconnected Error not the case, restart the System and try to repeat the
operation. If the error persists, call Service.

300010 Console disconnected

Restart the System and try to repeat the operation. If
Error
the error persists, call Service
300011 Generator disconnected

300012 Workstation mismatch for Generator and Positioner Try to select another workstation or another
radiographic procedure.
Error If the error persists, restart the System and try to
Active Procedure mismatch for Generator and repeat the operation.
300013
Positioner
If the error persists, call Service

300014 Positioner configuration could not be loaded Error Call Service.

300015 Configuration changes could not be saved Error --

If message does not disappear after the start--up is

300016 Initializing communications ... Information
finished, call Service

300019 Generator working in Service mode Warning Please restart the System

300020 Positioner working in Service mode Warning Please restart the System

300021 Could not verify Service access Warning --

300024 Usability settings configuration could not be loaded

Error Call Service.
Service
300025 Layout settings calibration data could not be loaded

Inhibit If the message does not disappear in a period of time,

300029 Snapshots in progress
Exposure please restart the System.

The exposure settings have been modified during

calibration. Please make sure to recover the Inhibit Recover the exposure settings from the Image System
300031
exposure settings from the Image System Exposure application.
application.

126 OM-0481R1
Mobile X-ray Unit
Operation

ID DESCRIPTION TYPE USER HELPTEXT

Inhibit
300032 Error loading Fluoro technique. Restart fluoro calibration.
Exposure

300035 Calibration file could not be loaded. Error Call Service.

If message does not disappear after the start up is

300036 Waiting for generator license... Information
finished, call Service.

Waiting for generator operation mode to be If message does not disappear after the start up is
300037 Information
initialized... finished, call Service.

Waiting for positioner operation mode to be If message does not disappear after the start up is
300038 Information
initialized... finished, call Service.

Inhibit Refer to the detailed information displayed by the

599999 Inhibit Exposure from IS
Exposure Acquisition Software on the Main Screen.

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SECTION 6 OPERATING SEQUENCES

6.1 X-RAY TUBE WARM-UP PROCEDURE

Before effecting X-ray exposures, ensure that the Tube is

properly warmed-up. Make sure that no one will be
inadvertently exposed to unnecessary X-rays during this
procedure.

Do not perform routine exposures unless the Tube is previously warmed-up, to

preserve an optimal X-ray Tube life.

It is recommended that the following procedure 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 a 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 kV, 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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6.2 RADIOGRAPHIC OPERATION

RAD operation can be performed in the following modes:

 Three Point control by selecting kV, 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.

 Anatomical Programs (APR) through the Image Acquisition Software.

A typical RAD examination sequence is as indicated below:

1. Make sure that the X-ray Tube is properly warmed-up.

2. Position the patient for the examination.

3. Select the technique parameters using the controls on the 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 his 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 audible signal will sound during the exposure.

6. When the exposure is finished, release the Handswitch button.

7. Repeat the procedure if additional exposures are desired.

6.3 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.

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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 on the patient position, receptor or tube

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

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.

Illustration 6-1
Patient Positioning

X-ray Beam - Collimator Light

RECEPTOR Laser Line

Laser Line

X-ray Beam - Collimator Light RECEPTOR

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SECTION 7 PERIODIC MAINTENANCE

In order to assure 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.

The first periodic maintenance service should be performed six (6) months after
installation, and the subsequent services at twelve (12) month intervals.

The manufacturer undertakes the responsibility to have available spare parts

for this equipment for at least ten (10) years from the date of manufacturing.

NEVER ATTEMPT TO PERFORM MAINTENANCE TASKS

WHILE THE MEDICAL EQUIPMENT IS IN USE WITH A
PATIENT.

7.1 OPERATOR TASKS

7.1.1 BATTERIES MAINTENANCE

If the unit has not been used or it has been stored for two
months, it should be energized to prevent deep discharge of
the batteries. A deep discharge will cause permanent damage
to the batteries.

Tasks for a proper maintenance of the batteries:

 Recharge the batteries for at least 30 minutes at the beginning of the day
before using the unit.

 Recharge the batteries for at least 30 minutes at the end of the day after
using the unit.

 Fully recharge the batteries when the unit is going to be disconnected for
more than 3 weeks.

 Fully recharge the batteries when the unit has been disconnected for
more than 3 weeks.

 Keep the unit connected to the mains whenever possible to maintain the
batteries at the floating maintenance level, this increases their lifetime.

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 Do not allow the batteries to be deeply discharged because they will lose
storage capacity and will never be able to recover the 100% of their
original capacity.

Note . For more information, refer to “Battery Charge Level Indicators” in

Section 3.2.7 and “Battery Capacity for the Generator and the
Motors” in Section 8.1.

7.1.2 PERIODIC MAINTENANCE

The first periodic maintenance service should be performed six (6) months after
installation, and the subsequent services at twelve (12) month intervals.

Periodic maintenance tasks 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.

1. With the Unit OFF, plug it in and leave it sufficient time to completely
charge. The recommended time is approximately 8 hours, until the
Battery Charge Level Indicators on both columns stop scrolling and all
the Indicators light Green.

2. Once fully charged, unplug the Unit from the mains power. Wait a few
minutes and reconnect the Unit to the mains. The upper Green Indicators
should scroll up for approximately one minute.

If the Battery charge level Indicators begin to scroll up from any other
Indicator below, contact the Service Department.

3. Switch the equipment OFF by shutting down the computer. Turn OFF the
switch ON/OFF control and unplug the unit from mains.

4. Check the external cable connections.

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7.1.3 CLEANING AND DISINFECTION

NEVER ATTEMPT TO CLEAN ANY PART OF THE UNIT WHEN

IT IS SWITCHED ON.

Clean the equipment frequently. Clean external covers and surfaces, especially
parts which might be in contact with patients, with a cloth moistened in warm
water with neutral soap. Wipe with a cloth moistened in clean water.

When it is needed to disinfect the Control Console, clean it with a cloth

impregnated with isopropyl alcohol.

DO NOT APPLY DIRECTLY ANY LIQUID ON THE SCREEN OR

OTHER SURFACES, NOR USE CLEANERS CONTAINING
AMMONIA OR ANY OTHER ABRASIVE OR SOLVENT LIQUID,
IT COULD CAUSE DAMAGE TO THE EQUIPMENT.

7.2 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 Sections of the Service Manual provided with
this equipment).

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SECTION 8 TECHNICAL SPECIFICATIONS

8.1 FACTORS

Maximum Power kW
(Refer to 20 kW 32 kW 40 kW 50 kW
Identification Label)

40 to 150
kVp Range
From 40 kVp to 150 kVp in 1 kVp steps

mAs Range Product of mA x Time values from 0.1 mAs to 500 mAs

10 to 400 10 to 500

mA Range From 10 mA to 400 mA or 500 mA, through the following mA stations:

10, 12.5, 16, 20, 25, 32, 40, 50, 63/64, 80, 100, 125, 160, 200, 250, 320, 400, 500.
(Depending on the Generator model)

From 1 millisecond to 10 seconds through the following Time stations:

Milliseconds: 1, 1.25, 1.6, 2, 2.5, 3.2, 4, 5, 6.3/6.4, 8, 10, 12.5, 16, 20, 25, 32, 40,
Exposure Time Range 50, 63/64, 80, 100, 125, 160, 200, 250, 320, 400, 500, 630/640, 800.
Seconds: 1, 1.25, 1.6, 2, 2.5, 3.2, 4, 5, 6.3/6.4, 8, 10.

Maximum Exposure Time Range for DR: From 1 millisecond to 4 seconds.

Focal Spot Size Small / Large

150 kVp @ 125 mA 150 kVp @ 200 mA

125 kVp @ 160 mA 128 kVp @ 250 mA 150 kVp @ 250 mA
150 kVp @ 320 mA
100 kVp @ 200 mA 125 kVp @ 250 mA 125 kVp @ 320 mA
Power Output (@ 0,1s) 125 kVp @ 400 mA
80 kVp @ 250 mA 100 kVp @ 320 mA 100 kVp @ 400 mA
100 kVp @ 500 mA
62 kVp @ 320 mA 80 kVp @ 400 mA 80 kVp @ 500 mA
50 kVp @ 400 mA 64 kVp @ 500 mA

18 exposures per hour at

100 kV, 200 mA, 320 ms
18 exposures per hour at 120 kV, 250 mA, 250 ms (lapse time between exposure: 3 min.)
(lapse time between
Duty Cycle exposure: 3 min.)

Maximum leakage radiation depends on the type of X-ray Tube (<0.88 mGy/h)

Ripple Factor < 4% (constant voltage)

Manual Collimator with front and rear side Knobs, double Laser, Motorized Filters
Collimator
and ready for both Estimated Dose (EDAP) option and DAP Chamber option

X-ray Tube Refer to Section 8.2

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Maximum Power kW
(Refer to 20 kW 32 kW 40 kW 50 kW
Identification Label)

100--240 V~ -- Single-Phase 50/60 Hz

Automatic Line Compensation ¦10% V~
Connection to standard outlets with GND that complies with local regulations
Power Line Operation
(Depends on Region Con-
figuration) The Power Line Installation should be provided with a Differential of 30 mA Sensitivity

Power Line Impedance must be less than the maximum indicated value:
300 m for 100 V~, 1  for 110 V~, 2.5  for 230 V~, 2.6  for 240 V~

Total Cable Length: 5 m

Power Line Cable
Usable Cable Length: 4.75 m

Maximum Input Power 1.2 kVA

Operation independent
from mains supply Standard
(Stand-Alone)

Optimized Battery Management for extended Battery life.

Charge Capacity: 15 Ah.

The required time for the Batteries to be 100% charged is approximately: 8 hours,
(80% of the total charge is available after 4 hours charging; approximately 20% per hour).
Battery Capacity Total Energy storage Capacity: 5760 Wh

With the Batteries fully charged and disconnected from the mains,
the Mobile system can be in continuous movement during approximately 25 km, at 5.5 km/h
Once the exposure capacity is exhausted, the system motion is enabled for 1 km.

The Mobile Unit in Stand-Alone (disconnected from the mains) will be 100% discharged from full charge
in approximately: 11 hours.

Radiation Output
Accuracy (Reproducibility C.V. (Coefficient of variation) ≤ 0.05
related to loading factors)

Measured at 75 kV: 220 mm in “X” axis and 240 mm in “Y” axis.

Maximum Symmetrical Measured at 125 kV: 210 mm in “X” axis and 250 mm in “Y” axis.
Radiation Field
(Test performed at a distance from the Focal Spot of 1200 mm, in accordance with IEC 60806:1984).

Maximum Heat Output 260 W (1130 BTU/h)

Storage / Transport Temperature range of --10oC to 40oC

Environmental Relative Humidity range of 20% to 90%
Conditions Atmospheric Pressure range of 700 hPa to 1060 hPa

Temperature range of 10oC to 35oC

Operating
(the recommended temperature for a longer life cycle of batteries is around 22 oC)
Environmental
Relative Humidity (no condensing) range of 30% to 75%
Conditions
Atmospheric Pressure range of 700 hPa to 1060 hPa

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8.2 X-RAY TUBE INSERT

Maximum Power kW
20 kW 32 kW 40 kW 50 kW
(Refer to Identification Label)

X-ray Tube Inserts E7886 Low Speed / High Speed E7886 High Speed

Low Speed / High Speed -- Rotating Anode

Focal Spots: 0.7 mm / 1.3 mm
Anode kHU / kVp: 300 kHU / 150 kVp
Target Angle: 16°
E7886
Inherent Filtration of X-ray Source:
Tube + Collimator: 3.1 mm Al
Tube + Collimator + eDAP: 3.1 mm Al
Tube + Collimator + DAP: 3.4 mm Al

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8.3 PHYSICAL CHARACTERISTICS

LENGTH WIDTH HEIGHT WEIGHT

minimum 1220 mm minimum 1290 mm 520 kg

540 mm
maximum 2520 mm maximum 2230 mm (without Detectors and/or Accessories

Dimensions in mm.
Tolerance in Dimensions ±1%

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120o

¦180o

¦90o

Dimensions in mm.
Tolerance in Dimensions ±1%

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APPENDIX A GUIDELINES FOR PEDIATRIC APPLICATIONS

THE PRACTITIONER WILL BE THE ULTIMATE

RESPONSIBLE OF APPLYING THO THE PATIENT THE
PROPER DOSE 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 rule, the 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 cannot be detached, pediatric exams
cannot be performed using this device.

Appendix A A-1
Mobile X-ray Unit
Operation

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 radio
sensitivity: 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
 Mobile X-ray Unit
Operation

APPENDIX B PROTECT YOUR IMAGING SYSTEM FROM

CYBERSECURITY THREATS

Because Digital Radiography Systems may be connected by Wi-Fi or Ethernet

to the Host Computer containing the Software, and the Host Computer may in
turn be connected to the hospital information system, and ultimately the
Internet, cybersecurity may become an issue for you. Here are some tips to
keep your system and your medical images secure.

The medical devices security is a shared responsibility

between manufacturer and responsible organization.

Use only materials supplied by Official Support/Technical

Service for your Image Management software updates.

REQUIRED STRATEGIES BY THE OWNER / OPERATOR

Antivirus protection:

Use antivirus programs such as:

 Total AV

 ScanGuard Security Suite

 Norton by Symantec

 PC Protect

 McAfee Antivirus Plus.

 Microsoft Security Essentials.

 Microsoft Windows Defender.

Keep these products up to date.

Limit access to trusted users only:

Limit access to devices through the authentication of users (e.g. user ID and
password or smart card).

Appendix B B-1
Mobile X-ray Unit
Operation

Ensure trusted content:

Restrict software or firmware updates to authenticated code.

Detect, respond, recover:

 Watch for on-screen warnings of possible virus infections.

 Respond by scanning for and removing possible virus infections.

 Recover from possible virus infections by having up to date backups of

your host computer.

REQUIRED STRATEGIES BY THE MEDICAL DEVICE MANUFACTURER

/ SOFTWARE MANUFACTURER

We affirm our commitment to providing you with validated software updates and
patches as needed throughout the life cycle of the medical device to continue
to assure its continued safety and effectiveness.

Please promptly apply software updates and patches provided by us and never
use image management software supplied by anyone else. Our development
process utilizes the CISCO AMP protection. We are constantly scanning our
development computers for malware. We hope you are doing the same.

A summary of our integrity controls:

 Our development computers are constantly being scanned for malware,

and our supplier for anti-virus software automatically updates the
software continuously as new threats are revealed.

 We perform daily backups to our external hard drives. The backups are
in another place.

 During software development we disconnect from the Internet to prevent

external attacks.

 Our development process utilizes the CISCO AMP protection.

 Copies of software updates we will be sending you are individually

scanned for malware.

CONCLUSION

It is our JOINT responsibility to ensure your medical image software and image
collection is safe and secure. We must both do our parts.

B-2 Appendix B
 Mobile X-ray Unit
Operation

APPENDIX C ADMINISTRATOR USER

TABLE OF CONTENTS

Section Page

C.1 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

C.2 ADMINISTRATOR MENU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

C.2.1 Entering Administrator Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

C.2.2 Administrator Menu Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6

C.2.3 Operator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-8

C.2.3.1 Culture Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-9
C.2.3.2 Usability Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-13
C.2.4 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-16
C.2.4.1 Software / Hardware Versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-17
C.2.4.2 License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-18
C.2.4.3 System Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-19
C.2.4.4 Tag Admin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-23

Appendix C C-1
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C-2 Appendix C
 Mobile X-ray Unit
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C.1 INTRODUCTION

Note . This Appendix only applies to Units equipped with RFID ON/OFF
System.

Administrator users have permissions to access certain system settings from

both the Acquisition Software and the Head-Assembly Console.

Administrator users can access a specific window of the Head-Assembly

Control Console (Service Mode Protection) where several Administrator
settings for Base Unit can be managed. Refer to Section C.2 of this Appendix
for detailed information.

Use the corresponding RFID Card to turn on the unit and access the software
with Administrator permissions. (Refer to System ON Section in the Operation
Manual for detailed information).

Note . Depending on the installed Acquisition Software or Customer

Configuration, the appearance of the graphical interface may be
different from the one shown in these illustrations.

Appendix C C-3
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C-4 Appendix C
 Mobile X-ray Unit
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C.2 ADMINISTRATOR MENU

C.2.1 ENTERING ADMINISTRATOR MENU

Press and hold for a few seconds on the System Status icon, located at the
upper left corner of the Head-Assembly Control Console Screen.

System Status Icon

After a few seconds, the Administrator Menu (Service Mode Protection utility)
screen will be displayed.

Appendix C C-5
Mobile X-ray Unit
Operation

The following options are displayed in Administrator Menu main screen:

OPERATOR SETTINGS
Refer to Section C.2.3.

Press the “Operator Settings” button to display the configurations related to the
system operation.

MAINTENANCE
Refer to Section C.2.4.

Press the “Maintenance” button to access to the equipment maintenance

information.

C.2.2 ADMINISTRATOR MENU CONTROLS

The following icons and buttons can be displayed in the Administrator Menu
main screen:

ENABLED FILAMENTS

This button indicates that filaments are enabled; radiation will be produced
during the exposure. Press on this icon to disable filaments.

DISABLED FILAMENTS

This button indicates that filaments are disabled; no radiation will be produced
during the exposure. Press on this icon to enable filaments.

BACK

Press on the “Back” button to leave the current menu. This button can be found
in every screen of the Administrator Menu to turn back to the Main Menu.

Note . Every time the “Back” button is used to leave the Administrator
Settings Menu, after making configuration changes, the System
requires a reboot to transfer the new data.

Press this button from the main menu window to return to the Control Console
in operation mode.

C-6 Appendix C
 Mobile X-ray Unit
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The following buttons may appear along some menus:

SAVE DATA

Press to save the modified values.

RESTORE DATA

Press to load the previous initial configuration.

NEXT STEP

Press to proceed to the next Calibration step or to skip the current one before
starting its Calibration.

PREVIOUS STEP

Press to return to the previous Calibration step.

Note . All the other buttons and indicators on the upper toolbar (common
in the Operation Mode) are described in Section 4 of the Operation
Manual.

Note . The lower toolbar (System Messages Area) is described in

Section 5 of the Operation Manual.

Appendix C C-7
Mobile X-ray Unit
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C.2.3 OPERATOR SETTINGS

“Operator Settings” menu comprises two configuration options for system

operation: Culture Settings and Usability Settings.

Illustration C-1
Operator Settings

C-8 Appendix C
 Mobile X-ray Unit
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C.2.3.1 CULTURE SETTINGS

" LANGUAGE

Press the “Language” icon to switch between the available languages.

The Administrator Menu and the Operator application will be automatically

updated to match the selected language.

Illustration C-2
Operator Settings: Culture Settings, Language Selection

Appendix C C-9
Mobile X-ray Unit
Operation

" MEASURE UNITS

Use the “Measure Units” button to switch between the Metric system and the
American/Imperial system. Available options are “Centimeters” or “Inches”.

Note . It is necessary to reboot the Console to apply the change of

Measurement Units.

Illustration C-3
Operator Settings: Culture Settings, Measuring units

C-10 Appendix C
 Mobile X-ray Unit
Operation

" TIME ZONES

Use the “Time Zones” button to to select the relevant time zone. Press the
“Store” button to save the selected zone.

Illustration C-4
Time Zone Selection

Appendix C C-11
Mobile X-ray Unit
Operation

" TIME UNITS

Use the “Time Units” menu to select “Milliseconds” or “Seconds” as the time unit
in the exposure parameters.

Note . It is necessary to reboot the Console to apply the change of Time

Units, but not the whole system.

Illustration C-5
Operator Settings: Culture Settings, Time Units

C-12 Appendix C
 Mobile X-ray Unit
Operation

C.2.3.2 USABILITY SETTINGS

The “Usability Settings” screen is used to set the Sound Settings, Visual
Settings, Anticollision Settings and the Power Off settings of the system.

Illustration C-6
Usability Settings

" SOUND SETTINGS

To set parameters such as enable mute, Volume, and discontinuous beeping

during Motion.

" VISUAL SETTINGS

To set the brightness percentage and the colors for Standby and Prepared
status of the Mobile Unit.

" ANTICOLLISION SETTINGS

Speed Limit option can be selected in this Section.

Appendix C C-13
Mobile X-ray Unit
Operation

" POWER OFF SETTINGS

Time Out Switch Off Pressed.

Default configured time: 3 seconds.

Press and hold the Switch OFF button for 3 seconds; the system will start the
turning OFF process.

Time Out Delay Switch Off.

Default configured time: 50 seconds.

After holding pressed for 3 seconds the Switch OFF button, the system will be
completely turned OFF in 50 seconds; during this time only movements are
enabled (e.g., it is useful for the user to put the system in the Parking position,
if necessary).

Time Out Inactivity Generator.

Default value: 0 (Disabled).

Filaments deactivation due to inactivity is disabled. The following is an example

of how the equipment would behave if the value “2” (minutes) were entered:

When the system is disconnected from mains and there is not any
Generator activity during 2 minutes, the Generator Tube Filaments turn
off, unless the user performs any action on the RAD screen, presses the
handswitch/remote control (option) or connects the system to the mains;
it will delay the “Time Out Inactivity Generator” for another 2 minutes
without any Generator activity.

Time Out Inactivity Warning.

Default value: 0 (Disabled).

No system shutdown due to inactivity. The following is an example of how the

equipment would behave if the value “15” (minutes) were entered:

When the system is disconnected from the mains and there is not any
Generator activity for 15 minutes, a Warning message is displayed on the
screens to alert the user of an automatic shutdown after finishing a
countdown timer for another 15 minutes.

C-14 Appendix C
 Mobile X-ray Unit
Operation

If the Operator presses on Accept button or performs any system action

(touches on the RAD Screen, activates any of the movement controls,
presses the handswitch/remote control (option) or connects the system
to the mains), within the configured time; it will delay the “Time Out
Inactivity Warning” for another 15 minutes.
If the Operator does not respond within the countdown time of 15
minutes, the system will automatically shut down; i.e., the system will be
completely turned OFF after 30 minutes without activity.

" REMOTE HANDSWITCH SETTINGS

Timeout Remote Handswitch Out of Holder.

Default configured time: 0.

To configure the time (in minutes) that the system will take to display an
informational message if the IR Remote Control is not placed in its holder.

Beeping Remote Handswitch.

Disabled by default.

Enable this radio button to add a discontinuous beeping to the previous

informational message each time the timeout specified in the “Timeout Remote
Handswitch Out of Holder” field is exceeded.

" FINE POSITIONING BUTTONS SETTINGS

Timeout: Seconds.

Default configured time: 5.

Allows to set the time it will take for the Unit to stop automatically when a
displacement is being performed using the Fine Positioning buttons.

Appendix C C-15
Mobile X-ray Unit
Operation

C.2.4 MAINTENANCE

The “Maintenance” menu is used to check the system information (components

versions, license functionalities), check the system logs and configure RFID
tags.

Illustration C-7
Maintenance Options

C-16 Appendix C
 Mobile X-ray Unit
Operation

C.2.4.1 SOFTWARE / HARDWARE VERSIONS

Press the “Software / Hardware Versions” button to display the software and
hardware versions of all the system components.

Press the “Back” button to go back to the main menu.

Illustration C-8
Software / Hardware Versions Screen

Appendix C C-17
Mobile X-ray Unit
Operation

C.2.4.2 LICENSE

Press the “License” button to display all the system functionalities (Standard
and Extended) enabled by license.

Press the “Back” button to go back to the main menu.

Illustration C-9
License Screen

C-18 Appendix C
 Mobile X-ray Unit
Operation

C.2.4.3 SYSTEM LOGS

The purpose of the “System Logs” menu is to display the logs files generated
by the system, as well as to enable them to be exported.

Illustration C-10
System Logs Menu

Appendix C C-19
Mobile X-ray Unit
Operation

The available options are:

 Counters

Press this button to display a counter with accumulated data of

exposures performed with the system (corresponding to each focus
selection of the tube as the cumulative of the Unit), counting the following
elements:

G RAD Exp. (#): Number of exposures registered.

G RAD Energy (J): Accumulated energy (in joules) used in

exposures.

G RAD mAs (mAs): Accumulated mAs in exposures.

G Flouro Time (h.m): [Not Applicable].

G Flouro Energy (J): [Not Applicable].

G Filament Time (h.m): Time period of operation (in hours and

minutes) with selected Small Focus or Large Focus.

Illustration C-11
Counters

Note . The values are displayed in Scientific E Notation.

C-20 Appendix C
 Mobile X-ray Unit
Operation

 Exposures

Press this button to display the a detailed record of all the exposures
performed with the system.

Illustration C-12
Exposures

 Errors

Press this button to display a detailed list with all the system messages
stored during system operation.

Illustration C-13
Errors

Appendix C C-21
Mobile X-ray Unit
Operation

Note . The generation of error log files (System Snapshot) is available in

the Message History window of the Operator Mode (refer to
Operation Manual for further details).

 Export to USB Drive

Use this functionality to export the log files to a USB flash drive. (This
option is only available when an operating memory stick is connected to
a USB port).

Illustration C-14
Log Export

Select an stored log file by its date and press the “Export” button. When
the export process is finished, a confirmation message will indicate that
the files have been successfully copied to the USB drive.

C-22 Appendix C
 Mobile X-ray Unit
Operation

C.2.4.4 TAG ADMIN

The “Tag Admin” screen enables the local tags (RFID Cards) management
used to initiate the system and access it with the privileges assigned to them.

The available options in the “Tag Admin” window are “Add tag”, “Delete tag” and
“Show tags”.

Note . The tags (RFID Cards) managed in this menu only apply to the
local database of the Base Unit and are not synchronized with the
Acquisition Software.

Illustration C-15
Tag Admin Window

Appendix C C-23
Mobile X-ray Unit
Operation

ADDING A NEW TAG

1. Press on the “Add tag” button. Swipe the RFID card through the RCC
reader to register the tag, according to the instructions in the new window
displayed.

Illustration C-16
Add Tag Window

If the entered card is already included in the RFID tag record, the
following message will be displayed:

Illustration C-17
Tag Already Registered Message

C-24 Appendix C
 Mobile X-ray Unit
Operation

2. In the next window, the tag name and the user’s access permissions, can
be defined.

Illustration C-18
Tag Edition Window

Depending on the system permissions assigned to the tag (RFID Card) in this
window, the user can perform the following actions:

 Movements:

It allows the user to drive the system in Parking position.

When the system is out of the Parking position, it allows the user to
move the Column and the Arm in order to put the system in parking
position.

 Panel Out:

It allows the user to unlock the system from the Parking position and
to move the Arm and the Column in order to get access to the
Detectors.

 X-Rays:

It allows the user to perform any action needed for Radiographic

Operation.

Appendix C C-25
Mobile X-ray Unit
Operation

 Admin:

It includes all the previous permissions for Movements; Panel Out,

Radiographic Operation, and the facility to access the Administrator
Menu.

3. Press the “Store” button to register the tag. If the registration is

successful, a message will be displayed in the previous window.

Illustration C-19
Registration Confirmation Message

4. Now it is possible to register another tag or press the “Previous Step”

button to return to the Tag Admin menu.

5. Press the “Back” button to return to the main menu.

C-26 Appendix C
 Mobile X-ray Unit
Operation

DELETING A TAG

1. Press on the “Delete tag” button. Swipe the RFID card through the RCC
reader to unregister the tag, according to the instructions in the new
window displayed.

Illustration C-20
Delete Tag Window

If the entered card has not been previously registered in the RFID tag
record, the following message will be displayed:

Illustration C-21
Tag Not Registered Message

Appendix C C-27
Mobile X-ray Unit
Operation

2. A pop-up window requests confirmation of the tag unregistration.

Illustration C-22
Confirmation Window of the Tag Removal

3. Press the “Store” button to finish unregistering the tag. If the tag deletion
is successful, a message will be displayed in the previous window.

Illustration C-23
Tag Deletion Confirmation Message

4. Now it is possible to delete other tag or press the “Previous Step” button
to return to the Tag Admin menu.

5. Press the “Back” button to return to the main menu.

C-28 Appendix C
 Mobile X-ray Unit
Operation

EDITING TAGS

Press on the “Show tags” button to display a list of the different tags with the
name and permissions with which they were registered.

This window displays, for each tag, a text box with the name registered and the
permissions assigned to it (Movements, Panel out, X-rays, Admin, Service, RFID
Tag ID and Sync). Assigned permissions are represented with a green check mark,
while those that have not been granted are shown with a red ban icon.

Illustration C-24
Show Tags Window

The “Synchronization” icon is used to indicate that the tag is also registered in
the Acquisition Software.

Note . A tag registered in the Acquisition Software will show a green

check mark at the Synchronization icon.

Deleting a sync tag from this window may cause inconsistencies

in the system.

The code displayed in the ”RFID Tag ID” would allow the RFID
Card to be identified in the Acquisition Software.

Appendix C C-29
Mobile X-ray Unit
Operation

REMOVING MULTIPLE TAGS

1. From the “Show Tags” menu, multiple tags can be selected to be

removed. Select one or more Tags by pressing on its corresponding radio
button.

Note . The radio button on the first row allows to select all the listed tags.

2. Once selected, press the “Trash” button to proceed.

Illustration C-25
Removing Tag(s) - Selection and Trash Button

3. A confirmation message appears on screen. Press “Ok” to confirm.

Illustration C-26
Removing Tag(s) - Confirmation Message

C-30 Appendix C
 Mobile X-ray Unit
Operation

RENAMING TAGS

From the “Show tags” menu, each tag can be renamed.

1. Press on the text box of the tag name.

2. Use a keyboard to enter a new tag name.

3. Once renamed, press on the “Update” button.

Illustration C-27
Renaming Tag

Note . When a green check mark is related to the “Synchronization” icon,

renaming that tag is not allowed.

4. A confirmation message appears on screen. Press “Ok” to confirm.

Illustration C-28
Renaming Tag(s) - Confirmation Message

Appendix C C-31
Mobile X-ray Unit
Operation

5. Now it is possible to rename/delete other tag or press the “Previous Step”

button to return to the Tag Admin menu.

6. Press the “Back” button to return to the main menu.

C-32 Appendix C