Raybow DR - User Manual - 6780002a

EN
series 01 Mobile X-ray device with digital detector
Distributed by:
30-34 av. Henri Matisse
06200 NICE – FRANCE
Tel. : +33 492 292 330
Fax : +33 493 713 520
E-Mail: sales@primaxint.com
Web: www.primaxint.com
The Raybow dR series comes in the following versions:
- STANDARD version
(MANUAL MOVEMENT)
- MOTORIZED version
series 01
NOTE : This manual is also valid for these systems :
ATTENTION:
Read all the enclosed documents thoroughly before using the EM equipment
Part 0 : PREFACE
CONTENTS
pages rev. date
0.1 to 0.9 B 20/03/14

1 DESCRIPTION OF THE EM EQUIPMENT
2 IDENTIFICATION / SERIAL NUMBERS
3 LIABILITY STATEMENT
4 CONFORMITY AND MANUFACTURER’S ADDRESS
5 RETURNS
Raybow dR / Raybow dR-M is a mobile electro-medical (EM) X-ray imaging machine fitted with a large
format solid state detector, designed and built for use alongside patient beds and in Accident and
Emergency departments.
Acquired images are saved in the internal memory, shown on the high resolution touch screen monitor and
can be sent to a diagnostic workstation (or general archive) via a DICOM network.
revision B PART 0 page 0.1

manual preface PRIMAX INT.doc
2 IDENTIFICATION / SERIAL NUMBERS
The EM equipment Raybow dR is identified by the ID label/serial n° label in the position shown in fig. 1, the
EM equipment primo-mR is identified by the ID label/serial n° label in the position shown in fig. 2.
Raybow dR
AAAA-MM
XX XXX 67 XX Follow instructions

for use
230V Vac - 50Hz
16A Max
Apparent resistance: 0,4 ohm
Circuit breaker : In=16A - Characteristic=C
Physiological effects: ionisation radiation Max 125kV
ATS Applicazione Tecnologie Speciali s.r.l.

Via A. Volta, 10 - 24060 Torre de' Roveri (BG) ITALY
http://www.atsmed.it
0051
Fig. 1 – Position of the Raybow

dR serial n° label
primo-mR
230V Vac - 50Hz - 150VA
AAAA-MM
SN XX XXX 88 XX Follow instructions

for use

0051
Fig. 2– Position of the primo-mR serial n° label

The EM equipment Raybow dR-M is identified by the ID label/serial n° label in the position shown in fig. 3,
the EM equipment primo-mR-M is identified by the ID label/serial n° label in the position shown in fig. 4.
Raybow dR-M
AAAA-MM

for use
230V Vac - 50Hz
16A Max
Apparent resistance: 0,4 ohm
Circuit breaker : In=16A - Characteristic=C
Physiological effects: ionisation radiation Max 125kV

0051
Fig. 3 – Position of the Raybow dR-M

serial n° label
primo-mR-M
230V Vac - 50Hz - 100VA
AAAA-MM

for use

0051
Fig. 4 – Position of the primo-mR-M serial n° label

2.1 IDENTIFICATION OF COMPONENTS (TRACEABILITY)
The components making up the equipment are identified by individual serial n° labels, as follows:
Component Serial n° Position Figure
X-ray monoblock Supplier’s Visible, on device Fig. 6

X-ray collimator Supplier’s Visible, on device
Fig. 5
Easy 40 / Easy 40 M module Supplier’s Inside
DRX-1 wireless detector Supplier’s Visible, on device

DRX-1 battery charger Supplier’s Visible, on device Fig. 7
DRX-1 battery Supplier’s Visible, on device
3543EZ PIXIUM wireless detector Supplier’s Visible, on device

3543EZ PIXIUM battery charger Supplier’s Visible, on device Fig. 9
3543EZ PIXIUM battery Supplier’s Visible, on device
DAP (optional) Supplier’s Visible, on device Fig. 8

Grid (optional) Supplier’s Visible, on device Fig. 6
The figures below show the positions of the serial n° labels:
Collimator serial n° label
Easy 40 / Easy 40M module

serial n° label
Fig. 5 - Position of serial n° labels: X-ray collimator, Easy 40 / Easy 40M

Anti-scatter grid
serial n° label
Monoblock serial n° label
Fig. 6 - Position of serial n° labels: monoblock , anti-scatter grid (optional).
Detector serial n°
Battery serial n° Battery charger serial n°
Fig. 7 - Position of serial n° labels – DRX-1 detector, battery and battery charger

DAP serial n°
Fig. 8 - Position of serial n° labels –DAP (optional)
Detector serial n°
Battery charger serial n°

Battery serial n°
Fig. 9 - Position of serial n° labels – 3543EZ PIXIUM detector, battery and battery charger

3 LIABILITY STATEMENT
- The manufacturer can only be held liable for the safety of its products if serviced and repaired by
the manufacturer or by suitably trained and qualified personnel. The manufacturer holds regular
training courses for technicians, fitters and maintenance workers at its head offices for this
purpose.
- The manufacturer cannot be held liable for any malfunction, loss or danger arising from improper
use of the EM equipment or from non observance of the maintenance instructions.
- The user of the EM equipment is responsible for making sure that it is only and exclusively used
by suitably trained and qualified operators.
- Never attempt to modify the EM equipment without first obtaining written authorisation to do so
from the manufacturer.
- The manufacturer provides working diagrams and layout drawings, component lists and
descriptions and calibration instructions to assist the technical personnel when repairing parts of
the EM equipment.

4 CONFORMITY AND MANUFACTURER’S ADDRESS
This X-ray device is produced by:
Applicazione Tecnologie Speciali srl

Via A. Volta, 10
24060 Torre de’ Roveri (BG) - Italy -
TEL. +39/035584311
FAX +39/035580220
e-mail: infoats@atsmed.it
http://www.atsmed.it/
The equipment complies with European Directive 93/42 EEC and subsequent amendments,
2007/47 EEC.
The following harmonised standards apply to the EM equipment:
EN 60 601-1, 3rd edition EM equipment Part 1: General requirements for safety and essential
performance
EN 60 601-1-2, 3rd edition EM equipment Part 1: General requirements for safety and essential
performance – Collateral standards: Electromagnetic compatibility –
Requirements and tests
EN 60601-1-3 2nd edition EM equipment Part 1: General requirements for safety and essential
performance 3: Collateral standards: General requirements for radio-
protection in diagnostic X-ray equipment
EN 60601-2-28 2nd edition EM equipment Part 2: Special standards for the safety of irradiating
X-ray systems and tube/sheath systems for medical diagnosis
EN 60601-2-54, 1st edition EM equipment Part 2: Special standards for the safety and
performance of X-ray equipment for radiography and radioscopy
EN 60 601-6 2nd edition EM equipment Part 1: General requirements for safety and essential
performance. Collateral standards: Usability
EN 62366 1st edition Medical devices – Application of engineering characteristics used

for medical device
EN 62 304 1st edition Software for medical devices – Processes concerning the life cycle
of software
EN ISO 14971:2009 Medical devices. Application of risk management to medical devices
EN 980:2008 Symbols used for labelling medical devices
EN ISO 780:1999 Graphic markings for moving goods
ISO 15223-1 1st edition Medical devices. Symbols used for labelling medical devices

5 RETURNS
When returning the equipment to the manufacturer, the equipment must be packed using the original (or
similar) packaging. We therefore recommend that you keep the original packaging. Any damage caused by
inappropriate packaging or transport shall render the warranty null and void.
Only qualified service centres are authorised to dismantle and return individual equipment components.

USER MANUAL
User Manual
EN code 67 80 002A
MAIN CONTENTS
PART 0: PREFACE
PART 1: GENERAL DESCRIPTION
PART 2: USE
PART 3: TECHNICAL DATA
User Manual
issued on 21/09/12
revised on 20/03/14
series 01
Each part of this User Manual is preceded by a list of contents indicating the latest edition of
each chapter.
MAIN CONTENTS
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USER MANUAL
Part 1: GENERAL DESCRIPTION
CONTENTS
page rev. date
CONTENTS I-1 B 20/03/14
1 DESCRIPTION OF THE EM EQUIPMENT 1.1 to 1.15 B 20/03/14

1.1 Composition
1.1.1 Complete system
1.1.2 Mobile unit - standard version
1.1.3 Mobile unit - motorized version
1.2 Applications and operating modes
1.3 Working frames
1.3.1 Study-List frame
1.3.2 Post-Processing frame
1.3.3 Working frame
1.4 X-ray exposure command
2 SAFETY 2.1 to 2.31 B 20/03/14

2.1 Symbols and graphics
2.1.1 Symbols and graphics - Manuals
2.1.2 Symbols on the EM equipment
2.2 General safety
2.3 Electrical safety devices
2.4 Wireless detector safety devices
2.5 Protection against ionising radiation
2.6 Diagnostic reference levels
2.7 Residual risks
2.8 Working life of the device
2.9 Scrapping the EM equipment
2.10 Warnings
2.10.1 Indications in the message area
2.10.2 Error messages
2.10.3 LED on Wireless DRX-1 detector
2.10.4 LEDS on the DRX-1 battery charger
2.10.5 LED on wireless PIXIUM 3543EZ detector
2.10.6 LEDS on the PIXIUM 3543EZ battery charger
2.11 Manufacturer’s guidelines and statement
2.11.1 Electromagnetic emissions
2.11.2 Electromagnetic immunity
2.11.2.1 Recommended separation distances
2.11.3 Cables and accessories
2.12 Daily checks
2.12.1 Monitor checks
2.12.2 General equipment checks
2.12.3 Movement enabled check (motorized version
only)
revision B PART 1 page I - 1

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USER MANUAL
1.1 COMPOSITION
The electromedical (EM) equipment comes in two different versions, depending on the way the
equipment is moved:
- STANDARD version (manual movement)
- MOTORIZED version (motorized movement)
1.1.1 COMPLETE SYSTEM
The EM equipment consists of:

1. Mobile unit:
- STANDARD version (see paragraph 1.1.2) or
- MOTORIZED version (see paragraph 1.1.3)
2. 35x43cm solid state flat panel detector (FPD):
- Model DRX-1 or
- Model PIXIUM 3543EZ
3. Detector battery (lithium ion polymers)
4. Detector battery charger.
5. Anti-scatter grid (Ratio 1:6 – LPI 215 – Focus 76 - 111 cm) (optional)
6. Dose Area Product – DAP (optional)
2 Detector
DRX-1
1 Mobile unit
3 Battery
DRX-1
5 Anti-scatter grid 4 Battery charger

DRX-1
The Technical Manual, which forms an integral part of the EM equipment, contains a full technical
description of the equipment for its installation, maintenance and adjustment.

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1.1.2 MOBILE UNIT - STANDARD VERSION
1. X-ray monoblock
2. Collimator
3. Articulated arm
4. Articulated arm handle 1 12 3
5. Arm release safety lever
6. Arm releasing/locking knob
7. Touch-screen monitor
8. Magnetothermal switch
9. ON/OFF key
10. Power cable
11. Detector compartment
12. Monoblock fitting sheath
13. CD/DVD burner
14. Push handle
15. X-ray command button
16. Potter connection
17. Remote monitor controls
18. USB ports
19. Ethernet port
20. DAP
21. IrDa interface 9
(optional)
4 2 5 6
8
20
10
16
14
13
11
15
17 21 18 19

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1.1.3 MOBILE UNIT - MOTORIZED VERSION
1. X-ray monoblock
2. Collimator 1 12 3
3. Articulated arm
4. Articulated arm handle
5. Arm release safety lever
6. Arm releasing/locking knob
7. Touch-screen monitor
8. Magnetothermal switch
9. UPS control panel
10. Power cable
11. Detector compartment
12. Monoblock fitting sheath
13. CD/DVD burner
14. Push handle
15. X-ray command button
16. Potter connection
17. Remote monitor controls 4 2 5 6
18. USB ports 23
19. Ethernet port
20. Forwards/backwards movement
22 8
motor drive
21. Motor brake release
10
22. DAP
23. Ignition key
24. IrDa interface (optional)
16
21
20
14
13
11
15
17 24 18 19

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USER MANUAL
1.2 APPLICATIONS AND OPERATING MODES
The mobile EM equipment acquires X-ray images with a large format solid state detector for use
alongside a patient’s bed or in an Accident and Emergency department.
The acquired images are saved in the equipment memory and displayed on a high resolution touch-
screen monitor. The images can also be sent to a printer or diagnostic workstation (or general archive)
via DICOM network.
The EM equipment lets you customise the acquisition parameters and the post-processing and display
of each image to suit the anatomical part and the size of the patient. As a result, you immediately get
correct acquisition and display of the image and so there is no need for adjustments to improve the
image.
Certain post-processing functions let you change the look of the images and manage them.
STANDARD version: the EM equipment only allows X-ray emission when plugged into the electricity
mains. Manual mechanical movement only.
MOTORIZED version: the EM equipment also allows X-ray emission when not plugged into the mains
(battery operation), though with limited exposure data (see the tables in paragraph1.2.5 in Part 3 of
this manual). The electric motor controlled by the operator is responsible for mechanical movement of
the EM equipment.
Note: Both versions allow for exposures using normal cassette radiography.

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USER MANUAL
1.3 WORKING FRAMES
• After switching the equipment on, the Login page appears about 1 minute after the operating
system boot-up:
Note: See paragraph 1.2.4 in Part 2 of this manual for details of the Login procedure.
• After logging in, a test pattern (SMPTE) appears so that you can adjust the Monitor settings if
necessary:
Note: See paragraph 4.3 in Part 2 of this manual for details of the monitor settings checks.

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• A list of the studies stored in the equipment’s memory now appears:

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1.3.1 STUDY LIST FRAME
Short-cut keys for the main functions always appear on the left of the frame:
A Access Study List,

B Create New Study,
C Receive Studies from Worklist,
D DICOM Spooler,
E System Setup (only after Administrator / Advanced login)
F Logout (return to the Login page)
The Study List has the following fields:
- Study status, which may be:

- Accepted: / Suspended (paused): / Completed: / Protected:
- Sent to DICOM Store server: / Sent to DICOM Printer:
- Surname and Name

- Patient ID
- Sex
- Date of birth
- Study description
- Study date and time
- Accession number
- Number of images
- Accumulated dose
- Radiology technique

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The right-hand side of the frame also has these commands:
1 2 1 Multiple selection: To select several images at the same time

(see paragraph 4.4.3 in Part 2).
2 Select all: To select automatically all the studies in the list

3 4
3 Store: STORE DICOM command for the selected studies
(see paragraph 4.5.1.2 in Part 2).
5 6 4 Archive: Command letting you create a CD/DVD of the selected

study/studies or save them to USB PEN DRIVE (see paragraph 4.6.1 in
Part 2).
5 Report Tool: To access the Report Tool (image documenting) menu

7 8 (see paragraph 4.5.2 in Part 2).
6 Edit study: To access a page that lets you enter and edit the data for the
selected study (see paragraph 1.3.1 in Part 2).
7 Protection: To protect the selected study so that it cannot be deleted or

edited (see paragraph 4.4.4.1 in Part 2).
9 11 8 Delete: To delete the selected study/studies

9 Up arrow: To scroll the Study List upwards (one page at a time).
10 12 10 Down arrow: To scroll the Study List downwards (one page at a time).
11 Pg Up: To jump to the first study in the list.
12 Pg Down: To jump to the last study in the list.
To open a study, select the study with double tap on study list:
• The Post-processing frame enters when you open a Completed study in the Study List
(see paragraph 1.3.2 below).
• The Working frame enters when you open an Accepted or Suspended (Paused) study in the
Study List
(see paragraph 1.3.3 below).

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1.3.2 POST-PROCESSING FRAME
The Post-processing frame is split into the following sections:
A preview
B image area
C patient data
D post-processing commands
E extra commands
A B C
A) Preview:
This area shows the images acquired during the study in preview (thumbnail) mode.
B) Image Area:
The image you select in the Preview area is shown here with all the corresponding study data.
The data are grouped as shown in the figure and table below:
1 2 3 4 5 6 7 8
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USER MANUAL
Group Data Example Notes / Meaning
L: 1315 Level
1 Grey scale
W: 4035 Window
kV: 60
2 Exposure parameters mAs: 5.1
ms: 21
Dose for the single image (only available when
3 Patient X-ray dose mGy*cm²: 12.5
the DAP is used)
Function that checks the exposure dose set for
4 Exposure index EI: 102%
the exam in question
UPPER EXTREMITY
5 Exam / Projection Type of exam used for image acquisition
SHOULDER PA
6 Acquisition date and time 30-08-2012 15:15 Automatically added by the system
7 Image number 5/6 5th of 6 images in the study

Image enlargement factor on the monitor
8 Digital zoom Z = 0.29 Z=1 max zoom (one pixel on the monitor
represents one pixel on the detector)
C) Patient Data:
This section shows the personal data for the patient and the
accumulated dose for the entire study.
Group Data Example Notes / Meaning
Surname / name Rossi Mario

Date of birth 23-05-1970
Patient
Identification 123ab456 e.g.: Medical Card number
Accumulated X-ray dose 24 mGy*cm² X-ray dose for the entire study (only
available when the DAP is used)

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D) Post-processing commands:
Note: See chapter 2 in Part 2 of this manual for full details of

the post-processing functions.
E) Extra Commands:
There are 2 extra commands here if you have selected an image that is not yet completed:
Complete study: this function closes the study: no further images may be
acquired and added to the study.
Return to working frame: this function lets you open the working frame to acquire new
images in the study.

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USER MANUAL
1.3.3 WORKING FRAME
The working frame is split into the following sections:
A preview
B image area
C patient data
D UPS charge level
E message area
F exam list
G X-ray parameter console
A B C
A) Preview:
This area shows a preview (thumbnails) of the acquired images.
B) Image Area:
This area shows the acquired image (preview image and then the final image).
C) Patient data:
See paragraph 1.3.2 above.
D) UPS charge level:
STANDARD version:
This area shows the UPS battery charge level and the time remaining before it
runs out if the EM equipment is unplugged from the electricity mains.
MOTORIZED version:
This area shows the UPS battery charge level and the icon indicating that the
equipment is plugged into the electricity mains.

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USER MANUAL
E) Message area:
This has indications of the wireless connection for the detector, its own
battery charge level, the space on the hard disk of the EM equipment
occupied by images, status warnings and alarms.
Note: See paragraph 2.5.2 below for a description of each indication.
F) Exam list:
This area shows the exams/projections for the selected study.
These exams may be set automatically by the exam procedure required
by the specific study or entered manually by the operator.
Note: See paragraph 1.3 in Part 2 of this manual for details of the exam
settings for each study.
G) X-ray parameter console:
The X-ray generator parameters for correct performance of the exam are set automatically when you
select the exam and the patient size:
- 2- or 3-point technique,
- X-ray tube focus,
- KV / mAs / mA / ms, depending on technique,
These parameters are programmed in the equipment during its installation and are specific to each
envisaged exam type and patient size, as agreed with users.
You can, however, change these parameters manually, using the commands on the console
(described below).

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Commands on the console:
• Select patient size (4 possible sizes): Paediatric Small
Medium Large
• Select technique:
- 2-point technique (you can alter the kV and mAs)
- 3-point technique (you can alter the kV, mA and ms)
• Change X-ray generator exposure parameters:
- Select required field:
- Adjust the value using these commands:
• X-ray tube focus: small / large
• Exam with exposure on external potter bucky:
• Exam with anti-scatter grid:
• Switch collimator lamp ON:
ATTENTION:
The collimator lamp may become overheated and heat the surrounding area if you use it
constantly without letting it cool down.
You should, therefore, only use the collimator lamp for a maximum of five consecutive times
and then let it cool down for at least 10 minutes before using it again.

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1.4 X-RAY EXPOSURE COMMAND
The EM equipment has a two-click button:
- click once for the X-ray preparation command,
- click a second time for the X-ray exposure command.
Figure 1 – Button command sequence: REST, PREPARATION, EXPOSURE

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2 SAFETY
2.1 SYMBOLS AND GRAPHICS
2.1.1 SYMBOLS AND GRAPHICS - MANUALS
The following symbols are used to draw your attention to certain instructions:
Operating instructions (ISO 7000-1641)
General caution (ISO 7010-W001)

This symbol draws your attention to special conditions or steps involving a recognised
specific hazard that can lead to personal injury, death or damage to property if the
instructions in question are ignored.
Danger of ionising radiation
Note: Notes provide further useful information. They provide specific information on special
instruments or techniques, prior checks and key factors concerning concepts or
activities.
2.1.2 SYMBOLS USED ON THE EM EQUIPMENT
The serial n° labels on the EM equipment and the instructions in this manual use the following
symbols:
Follow user instructions (ISO 7010-M002)
Live parts (ISO 60878)
Earth (IEC 60417-5019)
Danger of ionising radiation
ON (IEC 60417-5007)
OFF (IEC 60417-5008)
Serial n°

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Alternating current (IEC60417-5032)
Date of manufacture
Manufacturer’s name and address
Radio-wave emitting device
Medical device compliant with European Directive 93/42/EEC
European Directive compliant device, with certain limitations terms of radio

transmission
Equipment to be scrapped in accordance with European Directive

2002/96/EC (Waste Electrical and Electronic Equipment - WEEE)
Degree of protection against electrical risks (CEI EN 60601-1; Type B)
X-ray tube
Total filtering of tube/sheath assembly
Small focus
Large focus
Stand-By
Protect against moisture
Max relative humidity
Accepted temperature range
ON/OFF button (IEC 60417-5011)

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USER MANUAL
2.2 GENERAL SAFETY
ATTENTION:
THE ITALIAN VERSION OF THIS MANUAL IS THE LEGALLY BINDING VERSION. TRANSLATIONS INTO
OTHER LANGUAGES, EVEN IF CHECKED AND APPROVED BY THE MANUFACTURER, ARE ONLY
PROVIDED TO MAKE THE USER’S LIFE EASIER AND CANNOT BE DEEMED ACCURATE FOR LEGAL
PURPOSES.
THE EM EQUIPMENT MUST ONLY BE USED IN ACCORDANCE WITH THE SAFETY INSTRUCTIONS
PROVIDED IN THIS MANUAL AND MUST NOT BE USED FOR ANY PURPOSE OTHER THAN THAT
FORESEEN HEREIN.
THE EM EQUIPMENT MUST NOT BE USED WHEN FAULTY OR IF ANY OF THE WARNING DEVICES OR
ALARMS ARE MALFUNCTIONING.
PRIOR AUTHORISATION MUST BE OBTAINED FROM ATS SRL BEFORE MAKING ANY MODIFICATIONS TO
THE EM EQUIPMENT OR ITS SAFETY DEVICES.
LIKE ANY TECHNICAL DEVICE, THE EM EQUIPMENT MUST BE USED IN AN APPROPRIATE MANNER AND
RECEIVE ROUTINE CHECKS AND SERVICING, AS SPECIFIED IN THE “MAINTENANCE” SECTION OF THIS
MANUAL.
THIS X-RAY DEVICE MAY BE HARMFUL FOR THE PATIENT, MEDICAL STAFF AND OPERATORS IF THE
SAFE EXPOSURE LIMITS, THE INSTRUCTIONS AND THE MAINTENANCE PLANS ARE IGNORED. THE EM
EQUIPMENT MUST ONLY BE USED BY AUTHORISED PERSONNEL.
THIS EM EQUIPMENT IS DESIGNED AND BUILT NOT TO BE USED CLOSE TO A DEFIBRILLATOR. NEVER
USE A DEFIBRILLATOR ON A PATIENT WHILE IN CONTACT WITH ANY PART OF THIS MOBILE X-RAY UNIT.
THE UNIT SHOULD BE SEEN AS A CONDUCTING SURFACE AND THEREFORE MOVED WELL AWAY FROM
A PATIENT BEFORE ATTEMPTING TO RESTART HIS HEART. IF ANY PART OF THE MOBILE X-RAY UNIT
REMAINS IN CONTACT WITH A PATIENT RECEIVING A JOLT FROM A DEFIBRILLATOR, THE VOLTAGE MAY
PASS THROUGH THE PATIENT’S BODY AND DISCHARGE INTO THE EM EQUIPMENT AND SO POSE A
SERIOUS RISK FOR ANY ONE COMING INTO CONTACT WITH THIS. ANY DISCHARGE MAY ALSO DAMAGE
THE MOBILE X-RAY UNIT.
ALWAYS FOLLOW THE MANUFACTURER’S INSTRUCTIONS WHEN USING A DEFIBRILLATOR THAT MAY
HAVE BEEN USED ON A PATIENT RECEIVING X-RAYS FROM THIS MOBILE UNIT.
THIS EM EQUIPMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE GASES.
ALL PORTABLE RF COMMUNICATION DEVICES MAY AFFECT ELECTRO-MEDICAL DEVICES.

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USER MANUAL
THE EM EQUIPMENT MUST ONLY BE USED BY COMPETENT QUALIFIED PERSONNEL WITH PROPER
TRAINING AND FULLY AWARE OF ALL THE RISKS INVOLVED WHEN USING X-RAYS.
THE EM EQUIPMENT MUST ALWAYS BE MANNED WHEN SWITCHED ON.
THE OPERATOR MUST READ ALL THE INFORMATION IN THIS MANUAL BEFORE USING THE EM
EQUIPMENT.
OPERATORS ARE NOT ALLOWED TO OPEN THE PANELS ON THE EM EQUIPMENT. ONLY DULY TRAINED
EXPERT PERSONNEL MAY ACCESS THE INNER PARTS OF THIS DEVICE.
IF WORKING WITH OTHER DEVICES, THE EM EQUIPMENT MAY BE SUBJECT TO ELECTROMAGNETIC

INTERFERENCE. ALWAYS MAKE SURE THAT THERE IS NO RISK OF INTERFERENCE BEFORE USING ANY
DEVICES WITH THE EM EQUIPMENT. IF NECESSARY, ASK QUALIFIED PERSONNEL TO REDUCE THIS
RISK.
THE COLLIMATOR LAMP MAY BECOME OVERHEATED AND HEAT THE SURROUNDING AREA IF YOU
USE IT CONSTANTLY WITHOUT LETTING IT COOL DOWN.
YOU SHOULD, THEREFORE, ONLY USE THE COLLIMATOR LAMP FOR A MAXIMUM OF 5 CONSECUTIVE
TIMES AND THEN LET IT COOL DOWN FOR AT LEAST 10 MINUTES BEFORE USING IT AGAIN.
BEFORE MOVING THE EQUIPMENT, ALWAYS MAKE SURE THAT THE ARM HOLDING THE MONOBLOCK IS
IN ITS TRANSPORT POSITION (RETRACTED) AND SECURELY HOOKED, AS INDICATED IN THE FIGURE
BELOW:
ATTENTION (MOTORIZED VERSION): ALWAYS REDUCE THE SPEED OF THE EQUIPMENT IF THERE ARE
PEOPLE OR OBJECTS IN YOUR PATH.
DISABLE THE MOTOR DRIVE IF THERE ARE SUDDEN OBSTACLES AND APPLY THE BRAKE IMMEDIATELY.
W E RECOMMEND MOVING THE EQUIPMENT BY HAND WHEN CENTERING IT ON THE PATIENT.

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2.3 ELECTRICAL SAFETY
ATTENTION:
THE EM EQUIPMENT MUST NOT BE USED IN EXPLOSIVE CONDITIONS.
THE EM EQUIPMENT MUST NOT BE USED IN OXYGEN-RICH ENVIRONMENTS.
ALWAYS DISCONNECT THE EM EQUIPMENT FROM THE ELECTRICAL POWER SUPPLY BY UNPLUGGING
IT BEFORE CLEANING, DISINFECTING OR STERILISING.
CLEANING PRODUCTS AND DISINFECTANTS CAN FORM EXPLOSIVE GAS MIXTURES. THEREFORE,
ONLY USE PRODUCTS AND METHODS THAT COMPLY WITH THE RELEVANT SAFETY REGULATIONS.
TAKE CARE NOT TO SPILL CONDUCTING LIQUIDS ON THE EM EQUIPMENT AS THESE COULD
INFILTRATE AND SO DAMAGE THE EQUIPMENT AND RENDER IT UNSAFE TO USE.
THE EM EQUIPMENT BELONGS TO EM PROTECTION CLASS I (ELECTRICAL SAFETY): PROTECTION

AGAINST ELECTRIC SHOCKS IS PROVIDED BY CONNECTION TO AN EARTH CONDUCTOR. MAKE SURE
THAT THE ELECTRICAL PLANT IN WHICH THE EM EQUIPMENT IS INSTALLED IS FITTED WITH AN EARTH
CIRCUIT AND COMPLIES WITH THE RELEVANT CURRENT LAWS AND REGULATIONS.
LIVE PARTS! NEVER STICK YOUR FINGERS IN THE EXTERNAL SOCKETS. RISK OF ELECTRIC SHOCKS
AND DISCHARGED ELECTRICITY.
THE EM EQUIPMENT HAS AN ONBOARD POWER SUPPLY (UPS) AND SO MAY STILL BE POWERED UP
EVEN WHEN NOT PLUGGED INTO THE MAINS.

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2.4 WIRELESS F.P. DETECTOR SAFETY
THE DETECTOR BATTERY CHARGER MUST NOT BE PLACED IN THE VICINITY OF THE PATIENT.
The figure shows the correct distances

in the vicinity of the patient.
KEEP ALL ELECTRONIC DEVICES (WIRELESS OR CONNECTED WITH CABLES) AT LEAST 1 METRE FROM
THE DETECTOR WHEN IN USE.
THE DETECTOR MUST NOT BE USED TO SUPPORT THE PATIENT.

THE DETECTOR MUST BE PLACED ON A SUITABLE SURFACE, SUCH AS A TABLE OR THE FLOOR,
BEFORE RESTING THE PATIENT ON IT.
THE LABELS BELOW INDICATE THE MAX LIMITS TO AVOID DAMAGING THE DETECTOR:
DRX-1 detector
PIXIUM 3543 EZ detector

< 100 kg < 150 kg
< 220 lb < 330 lb

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OBSERVE THE FOLLOWING WEIGHT LIMITS TO PROLONG THE LIFE OF THE DRX -1 DETECTOR AND
REDUCE THE RISK OF INTERNAL DAMAGE:
FOR DRX-1 DETECTOR:
- The max weight concentrated on a small area on the surface of the detector (50 mm in
diameter) must not exceed 23 kg.
- The max weight distributed evenly across the surface of the detector must not exceed
125 kg.
FOR PIXIUM 3543 EZ DETECTOR:
- The max weight concentrated on a small area on the surface of the detector (80 mm in
diameter) must not exceed 100 kg.
- The max weight distributed evenly across the surface of the detector must not exceed
150 kg.
See the instructions and warnings in paragraph 1.3.2 in Part 5 of this manual for details on how to
clean the detector.
PLACE THE DETECTOR INSIDE A PROTECTIVE PLASTIC BAG IF THERE IS ANY RISK OF LIQUIDS COMING
INTO CONTACT WITH THIS. IN THIS CASE, REMOVE THE PROTECTION IMMEDIATELY AFTER USE TO
AVOID THE RISK OF THE DETECTOR OVERHEATING.
KEEP THE BATTERIES AND THE DETECTOR AWAY FROM HEAT SOURCES.

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2.5 PROTECTION AGAINST IONISING RADIATION
The EM equipment emits X-rays for medical purposes.
There is always the risk of physical harm if X-ray equipment is not used in an appropriate manner.
Therefore these instructions must be carefully read and thoroughly understood before starting the
equipment.
This device involves two types of exposure to ionising radiation:

 occupational (operators),
 diagnostic (patients being scanned).
Although this equipment provides a high level of protection against X-ray exposure, way beyond the
bandwidth actually produced, none of the precautions taken can guarantee absolute protection. It is,
therefore, up to the operator to adopt all possible safety measures to avoid risks for him/herself, other
medical staff and patients, arising from incorrect or excessive exposure to radiation.
The manual exposure switch provides extra protection against diffused radiation when used at least 2
metres away from the X-ray beam. When fully unwound, the coiled switch cable is about 4 metres
long.
All operators must receive suitable training and take all necessary safety precautions to avoid the risk
health risks.
The EM equipment is sold with the following clause: the Manufacturer, its agents and representatives
cannot be held liable for any damage or injury that may arise from any improper use of this equipment.
MAKE SURE THAT ALL PRECAUTIONS AGAINST RADIATION HAVE BEEN ADOPTED BEFORE STARTING
ANY X-RAY EXPOSURE. ALL PERSONNEL IN THE X-RAY THEATRE MUST RESPECT THE RADIATION
PROTECTION RULES WHEN USING X-RAYS.
ALWAYS PROVIDE THE PATIENT WITH THE NECESSARY RADIATION PROTECTION.
ALWAYS PROVIDE THE PATIENT AND OPERATORS WITH THE NECESSARY RADIATION PROTECTION
WHEN USING X-RAY DEVICES.
USE THE SPECIAL RADIO-PROTECTIVE SUITS. A RADIO-PROTECTIVE MATERIAL EQUIVALENT TO 0.35

MM OF LEAD GIVES 99.95% PROTECTION AGAINST RADIATION OF 50 KV AND 94.5% PROTECTION
AGAINST RADIATION OF 100 KV.

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Below are examples of such personal radio-protective equipment:
Protective aprons
for operators
Protective aprons for patients
Head protection for operators
Thyroid protection for operators
Scrotum protection for

male patients

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Ovary protection
for female patients
DISTANCE IS THE BEST PROTECTION AGAINST RADIATION: ALWAYS KEEP AS FAR AWAY FROM THE
SOURCE OF THE X-RAYS AND THE EXPOSURE OBJECTIVE AS POSSIBLE.
USE THE MANUAL SWITCH AT LEAST 2 M FROM THE X-RAY BEAM TO PROTECT YOURSELF FURTHER
FROM THE RISK OF DISPERSED RADIATION.
ACCORDINGLY, THE COILED CABLE OF THE MANUAL SWITCH IS ABOUT 4 LONG WHEN FULLY
EXTENDED.
ALWAYS SET THE SMALLEST EXPOSURE FIELD POSSIBLE BY CLOSING THE COLLIMATOR
SHUTTERS/IRIS. IN FACT, DISPERSED RADIATION DEPENDS TO A LARGE EXTENT ON THE VOLUME OF
THE IRRADIATED OBJECT.
AVOID MOVING OR REMAINING WITHIN THE X-RAY TRAJECTORY.
MAKE SURE THAT THERE ARE NO OBJECTS WITHIN THE X-RAY BEAM THAT MAY REDUCE THE
INTENSITY OF RADIATION TO SUCH A LEVEL THAT THE IMAGE QUALITY IS POOR.
RADIATION LEVELS RECEIVED BY THE PATIENT AND THE OPERATOR MUST BE AS LOW AS
REASONABLY POSSIBLE, WITHOUT COMPROMISING THE BENEFITS FROM THE RADIOLOGICAL
PROCEDURE.
BY LAW, THIS EM EQUIPMENT MAY ONLY BE USED BY DOCTORS AND LEGALLY AUTHORISED
OPERATORS. ALL SAFETY PRECAUTIONS MUST BE RESPECTED AND THE CURRENT STANDARDS FOR
RADIATION PROTECTION IN THE COUNTRY WHERE THE EQUIPMENT IS USED MUST BE COMPLIED
WITH: RADIATION HAS A DAMAGING EFFECT ON THE HUMAN BODY.
MAKE SURE THAT ALL PRECAUTIONS AGAINST RADIATION HAVE BEEN ADOPTED BEFORE STARTING
ANY X-RAY EXPOSURE.
THIS X-RAY UNIT MAY BE DANGEROUS FOR THE PATIENT AND THE OPERATOR IF THE PROPER
EXPOSURE FACTORS AND INSTRUCTIONS ARE NOT RESPECTED.
USE THE FURTHEST FOCUS/SKIN DISTANCE POSSIBLE IN ORDER TO MINIMISE THE DOSE ABSORBED
BY THE PATIENT.
W E RECOMMEND THAT THE DISTANCE BETWEEN THE X-RAY TUBE FOCUS AND THE FLAT PANEL
DETECTOR (FPD) IS MORE THAN 100 CM AND THAT THERE IS AS MUCH CONTACT AS POSSIBLE
BETWEEN THE EXPOSED BODY PART AND THE FPD.

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2.6 DIAGNOSTIC REFERENCE LEVELS
Effective radiological protection generally involves the elimination of all forms of unnecessary or non-
productive exposure to radiation.
In the case of exposure for medical purposes, this objective is interpreted as the administration of the
lowest possible dose to obtain images of the necessary quality to provide the required diagnostic
information.
The concept of DRL – Diagnostic Reference Level – has therefore been introduced.
DRLs add to professional expertise and do not, in themselves, provide a boundary between good and
bad medical practices. The fact that DRLs are respected does not always mean that the procedure is,
in itself, good. A quality assurance plan is therefore necessary, to include quality control, even if the
relevant DRL has not been exceeded or, especially, the doses are way below the foreseen DRL.
It is, in any case, crucial that a doctor should always establish the radiological parameters in special
exams where the patient is to receive a dose higher than the DRL recommended by IAEA.
The dose entering the patient may be detected for DRL purposes by using a DAP meter (Dose Area
Product) or a specific dosimeter.
The table below shows the main projection types and the reference dose levels detected using the
method described below.
Surface dose Dose

entering entering Charge Anti-scatter
Exam Projection
patient detector factors grid
(mGy) (uGy)
AP 0.043 4 125kV Present
CHEST
(0.4)* 1mAs
SID=180cm
AP 0.35 4 85kV Present
ABDOMEN-SPINE
(10)* 8mAs
SID=120
LL 0.36 4 73kV Present
CRANIUM
(3)* 16mAs
SID=120cm
AP 0.043 4 46kV Not present
HAND
8mAs
SID=120cm
* The values in brackets ( ) are limit values obtained from these international documents:
1. SAFETY GUIDE No. RS-G-1.5 – 2002 Radiological Protection for Medical Exposure to
Ionizing Radiation, Annex IV, SCHEDULE III, page 65
2. SAFETY SERIES No. 115 – 2003 International Basic Safety Standards for Protection
against Ionizing Radiations and for the Safety of Radiation Sources

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The values in the table above have been detected using the phantoms indicated in this document:
STANDARDIZED METHODS FOR MEASURING DIAGNOSTIC X-RAY EXPOSURES (AAPM
REPORT n°31).
These are shown below, for a medium-sized adult patient.
CHEST AP
ABDOMEN - LUMBAR SPINE AP

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LATERAL CRANIUM
LIMBS

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• The Surface dose entering the patient has been measured using the following method:
- ANSI phantom simulating a medium-sized adult patient placed at the focal source spot to skin
distance (SSD) foreseen by the exam.
- Dosimeter placed at a distance of about 20cm from the phantom to avoid the risk of diffused
radiation affecting measurement.
The dosimeter reading must be corrected considering the distance of the sensor from the phantom:
2 2
Reading x ( SSD –20) / SSD
Example:
- SSD = 120 cm (source-skin distance)

- Reading = 420 uGy
The dose entering the patient is 420uGy x 10000 / 14400 = 290uGy
Dosimeter
Phantom
Grid
FPD
There are many factors that may cause variations in the dose entering the patient:
- The use of an anti-scatter grid, recommended when exposing large areas of the human body.
- A high voltage at the X-ray tube (kV). An increase of 10kV will roughly double the dose leaving
the X-ray tube.
- The product of mA multiplied by the exposure time (mAs), which is directly proportional to the
dose leaving the X-ray tube.
- The focal source spot – skin distance (SSD).

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2.7 RESIDUAL RISKS
The EM equipment is designed and built in full respect of the safety regulations.
Nevertheless, there are still some risks involved in the use of the EM equipment if it is used incorrectly
or the prescribed safety measures are faulty.
See the instructions and recommendations in the above paragraphs of this chapter for risks due to
improper use of the EM equipment.
With regard to residual risks due to faults in the prescribed safety measures, note that:
- Protection against electric shocks is provided by means of an efficient earth system for all metal
parts covering the EM equipment.
The full earth circuit (for both internal and external parts of the EM equipment) should
therefore be checked for efficiency on a regular basis (see the "Routine Maintenance"
schedule described in the Technical Manual).
ATTENTION (Motorized version):

Always reduce the speed of the equipment if there are people or objects in your path.
Disable the motor drive if there are sudden obstacles and apply the brake immediately.
We recommend moving the equipment by hand when centring it on the patient.

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2.8 WORKING LIFE OF THE DEVICE
The average working life of the device depends on the life of the X-ray tube. The instructions provided
in this manual will help prolong the life of the X-ray tube.
It is not always possible to establish when the X-ray tube is reaching the end of its useful life. This
component could even cease to work suddenly during an exam.
For this reason we recommend you check the focal spot on an annual basis in order to discover any
deterioration in the anode, indicated by an increase in the size of the focal spot and thus a reduction in
image resolution.
The main causes for early wear and tear to the X-ray tube are:
1. Overheating of the cold anode, caused by excessive charges after a long period of inactivity,
leading to crater formation;
2. Discharges in the tube;
3. Overheating of the tube;
4. Prolonged heating of the filament, leading to slow evaporation.
Below are some ways to limit the probability of early wear and tear.
1 - The pre-heating cycle (described in paragraph 1.5.2 of Part 2) lets you avoid overheating by
gradually bringing the X-ray to the required working temperature.
You may irretrievably damage the anode if you start a high-dose exposure when X-ray
tube is still cold.
2 – The tube formation procedure (described in paragraph 1.5.2 of Part 2) lets you reduce the chance
of discharges in the tube.
You may irretrievably damage the anode if you start a high-dose exposure without
first following the formation procedure if the X-ray tube has not been used for a long
period.
3 – Overcharging of the tube can be avoided by running the set kVp and mAs software check. The
equipment prevents any exposure if these values are found to exceed the max values foreseen for the
tube.
4 – The RAD PREP stage gradually takes the filament to the right temperature. We recommend you
only do this once the subject is in the required scanning position.

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2.9 SCRAPPING THE EM EQUIPMENT
When the EM equipment reaches the end of its useful life, all its various components should be
disposed of properly, in compliance with European Directive 2002/96/EC (disposal of waste electrical
and electronic equipment – WEEE).
The batteries used must be disposed of in accordance with European Directive 2002/96/EC (disposal
of waste electrical and electronic equipment - WEEE).
When scrapping the device, you must pay special attention to those components that could pose risks
during their disposal:
- the X-ray monoblock contains dielectric oil and lead,
- the X-ray tube contains glass, Tungsten, Molibdenum, Rhenium, Nickel, Copper and Silver,
- the Wireless F.P. detector contains a Lithium battery,
- STANDARD version: the UPS contains Lead batteries.
- MOTORIZED version: this contains Lithium batteries.
- the touch screen monitor contains a screen that could send shards of gas flying and scatter
toxic substances should it shatter,
- the entire equipment contains printed circuit boards that contain a certain amount of lead
which must be treated as a toxic material.
Other parts of the equipment are made from:

- ferrous material (frames, etc.),
- plastic (panels, etc.),
- electric cables.
These do not pose a risk when scrapping the device.
You must dispose of all elements in compliance with the current legal requirements at the
time of scrapping.
This symbol on the equipment reminds you that it meets the requirements of
environmental European Directives (2002/95/EC, 2002/96/EC and 2003/108/EC)
and that it must be disposed of in accordance with current standards on
differentiated waste disposal.
The EM equipment must not be disposed of as normal urban waste, but must
be taken to a dedicated waste disposal centre or returned to an authorised
dealer should you wish to replace it with a newer model.

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2.10 WARNINGS
2.10.1 WARNINGS IN THE MESSAGE AREA
The message area in the working frame provides you with information on the EM equipment status
and alarm messages, wireless/detector connection and the free space on the video processor archive
hard disk:
EM equipment status and alarms

(see tables 2, 3 and 4)
Detector status
(see table 1)
% of free space still available on archive disk for saving

images.
table 1
Detector status information
READY NOT READY NOT CONNECTED
Detector status
Wireless
(showing strength of signal)
Connection type
BATTERY CHARGED BATTERY ALMOST FLAT BATTERY

FLAT
Battery charge level

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The table below lists all the possible EM equipment status messages:
table 2
Status message Meaning
Equipment ready for acquisition. You can give the X-ray emission command.
READY
Preparing for acquisition.
RAD PREP This occurs after using the RAD PREP command on the X-ray generator.
Preparation completed.
READY FOR RAD
The equipment waits to receive an acquisition request.
IMAGE ACQUISITION Image being transferred by the detector.
WAITING System is busy: please wait.
2.10.2 ALARM MESSAGES
If there is an error, the equipment displays an error message on the monitor to warn the operator.
Below are brief descriptions of:
• the error messages,
• the possible causes,
• the action required to restore proper functioning of the equipment.
Make a note of the error code and the serial number of the equipment and then contact the Technical
Service if, despite your having performed the corrective action (where an intervention by the Technical
Service is not required), the equipment continues to display an error.
The tables below list all the possible EM equipment alarm messages:
table 3
Alarm message:
Meaning Action required
video processor
Check that the X-ray generator
Image acquisition request already
RAD COMMAND ERROR button is not pressed or stuck.
exists when system switched on
Release if necessary.
Release the X-ray command button
The video processor is not ready to and repeat acquisition request.
VIDEOPROCESSOR OFFLINE
acquire images. Contact Technical Service if the
problem persists.
DAM FAULT Malfunctioning of the Dose Area Meter Contact Technical Service
DAM NOT CONNECTED Dose Area Meter is not connected Contact Technical Service
BATTERY LOW: Battery level running low. We recommend changing the
CHANGE BATTERY Detector can still be used. battery.
BATTERY FLAT: Battery flat. The battery must be changed.
CHANGE BATTERY Detector cannot be used.

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table 4
Alarm message:
Meaning Action required
X-ray generator
Current circulating in the X-ray tube Switch the machine off and then
MAX CURRENT during emission of X-rays is more than back on again. Contact Technical
50% the set value. Service if the warning reappears.
Current circulating in the X-ray tube Switch the machine off and then
MIN CURRENT during emission of X-rays is less than back on again. Contact Technical
50% the set value. Service if the warning reappears.
Switch the machine off and then
The anode fails to work when you
STARTER FAIL back on again. Contact Technical
press the PREPATION key.
Service if the warning reappears.
Switch the machine off and then
Too much current is sent to the
OVC back on again. Contact Technical
monoblock during X-ray emission.
Service if the warning reappears.
X-ray stop not correct. The X-ray stop Switch the machine off and then
OVL safety circuit has intervened. Max time back on again. Contact Technical
= 6.3s Service if the warning reappears.
Appears after OVC, OVL or an Switch the machine off and then
OVERCURRENT PROTECTION
imbalance between the two branches back on again. Contact Technical
ACTIVE
of high voltage in the monoblock. Service if the warning reappears.
RAD PREP command has been
PREP. RELEASED Repeat exposure.
released.
MANUAL X-RAY STOP Assess the quality of the acquired
X-ray command has been released
image.
before exposure completed.
Repeat exposure if necessary.
The voltage sent to the X-ray tube Switch the machine off and then
85% MISSED during X-ray emission is less than 85% back on again. Contact Technical
the set value. Service if the warning reappears.

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2.10.3 LED ON WIRELESS DRX-1 F.P. DETECTOR
There is a LED on the side of the detector that can flash either green or blue.
The LED produces a green flash code (indicating the status of the detector) followed by a blue code
(indicating the status of its connection to the system).
The table below lists the typical signals provided by the LED during normal operation:
LED sequence Description Action required

Detected switched on (battery inserted). Wait about 1 minute for the detector to
1 green Detector attempting to connect with the connect to the WIFI access point.
(flashing) wireless access point.
Detector has NOT found the active WIFI

1 green - 5 blue
access point.
Detector connected to WIFI access point, Connection between the detector and the
1 green - 3 blue but no software connection made with the equipment is only possible in this condition.
EM equipment. Use the main ON/OFF switch if the
equipment is switched off.
Detector connected to equipment and ready
2 green - 1 blue for acquisition.
Detector was connected to the equipment, With the equipment switched on, restore the
1 green - 2 blue but is no longer connected after changing connection after changing the battery.
the battery.
2.10.4 LEDS ON THE DRX-1 BATTERY CHARGER
th
5 LED steady = Fully charged
th
5 LED flashing = 80% charged
th
rd
nd
st
1 LED flashing = <20% charged
Yellow LED steady = Battery fault
Yellow LED flashing = Battery too hot / too cold.

Accepted range: 0-45°C
It takes less than 3 hours to fully charge a flat battery, provided the temperature of the room
where the battery charger sits is between +10 and +35°C.
Make sure that the temperature of the battery stays within 0 and 45°C: if too hot or too cold
the yellow LED will start flashing when you insert the battery.
Place the battery charger in a well-ventilated spot.

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2.10.5 LEDS ON THE PIXIUM 3543EZ WIRELESS F.P. DETECTOR
There are three LEDS on one side of the Pixium 3543EZ detector next to the ON/OFF button.
BATTERY
WIFI STATUS
ON/OFF BUTTON
LED name Logo Colour Description
Battery No battery
Off
FPD off
FPD start-up status
Orange, Battery charge less than 5% the maximum charge
flashing rapidly
Battery charge between 5% and 10% the maximum

Orange,
charge
Green Battery charge more than 10% the maximum charge
WIFI disabled
FPD off
Off
WIFI FPD start-up status
FPD not connected to the AP

Orange
FPD connected to the AP
Green
Status Off FPD off
Orange, Internal error

flashing slowly
Orange Operating mode: OFFLINE
Green, Operating mode: LISTEN

flashing slowly
Green Operating mode: READY

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Insert the battery in its seat and secure by turning the battery lock clockwise, as shown in the figure
below:
Press the button shown below for about 1 second until the STATUS LED starts flashing orange.
BUTTON
Wait for all 3 LEDs to light up.
Press the button shown above for about 5 seconds to switch the detector off (the STATUS starts
flashing orange).
You can now remove the battery by turning the battery lock anti-clockwise.
Attention:
ONLY remove the battery after switching the detector off using the ON/OFF button.

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2.10.6 LEDS ON THE PIXIUM 3543EZ BATTERY CHARGER.
Green LED
Red LED
LED name Colour Description

Charging Green, Battery is being charged
flashing
Green Battery fully charged
Charge status Red Battery charging error
The life of the battery may be reduced if you remove the battery before it has been fully
charged.
Keep the battery charger in a well-ventilated area.

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2.11 MANUFACTURER’S GUIDELINES AND STATEMENT
2.11.1 ELECTROMAGNETIC EMISSIONS
In accordance with EN standard 60601-1-2 (third edition), the equipment is intended for use in the
electro-magnetic environment specified below.
The customer/user of the EM equipment must ensure that it is used in such an environment.
table 5
Emissions test Compliance Electromagnetic environment - guidelines
RF emissions Group 1 The EM equipment uses RF energy only for us internal

CISPR 11 function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
RF emissions Class A The EM equipment is suitable for use in all establishments,
CISPR 11 excluding domestic establishments and those directly
Harmonic emissions Not Applicable connected to the public low-voltage power supply network that
EN 61000-3-2 supplies buildings used for domestic purposes.
Voltage fluctuation / flicker Not Applicable
emissions
EN 61000-3-3

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2.11.2 ELECTROMAGNETIC IMMUNITY
In accordance with EN standard 60601-1-2 (third edition), the equipment is intended for use in the
electro-magnetic environment specified below.
The customer/user of the EM equipment must ensure that it is used in such an environment.
table 6
Test level Electromagnetic environment
Immunity test Compliance level
EN 60601-1-2 - guidelines
Electro-static ±6kV contact ±6kV contact Floors should be wood,
discharge (ESD) concrete or ceramic tile. If floors
±8kV air ±8kV air are covered with synthetic
EN 61000-4-2 material, the relative humidity
should be at least 30%.
Electrical fast transient ±2kV for power lines ±2kV for power lines Mains power quality should be
/ burst that of a typical commercial or
±1kV for input/output ±1kV for input/output hospital environment.
EN 61000-4-4 lines lines
Surge ±1kV differential mode ±1kV differential mode Mains power quality should be
that of a typical commercial or
EN 61000-4-5 ±2kV common mode ±2kV common mode hospital environment.
Voltage dips, short <5% UT (>95% dip in UT) 5% UT (>95% dip in UT) for Mains power quality should be
interruptions and for 0.5 cycles 0.5 cycles that of a typical commercial or
voltage variations on hospital environment.
power supply input 40% UT (60% dip in UT) 40% UT (60% dip in UT) for If the system user requires
lines for 5 cycles 5 cycles continuous use even during
blackouts, a UPS
EN 61000-4-11 70% UT (30% dip in UT) 70% UT (30% dip in UT) for (uninterruptible power supply)
for 25 cycles 25 cycles unit should be used.
<5% UT (>95% dip in UT) <5% UT (>95% dip in UT)

for 5 s for 5 s
Power frequency 3 A/m 3 A/m

(50/60Hz) magnetic
field
EN 61000-4-8
Note: UT is the AC mains voltage prior to application of the test level

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table 7
Immunity test Test level Electromagnetic environment
Compliance level
EN 60601-1-2 - guidelines
Conducted RF 3 Veff 3 Veff Portable (cordless) and mobile
150 kHz - 80 MHz RF communication devices
EN 61000-4-6 should not be used closer to the
system, including the cables,
than the recommended
separation distance calculated
using the correct equation for
the transmitter frequency.
Recommended separation
distance:
d = 1.2 √P
Irradiated RF 3 V/m 3 V/m Recommended separation
80 MHz - 2.5 GHz distance:
EN 61000-4-3
d = 1.2 √P
80 MHz - 800 MHz
d = 2.3 √P
800 MHz - 2.5 GHz
Where P is the maximum

nominal output rate of the
transmitter in Watts according
to the transmitter manufacturer
and d is the recommended
separation distance in metres.
The field intensity for fixed RF

transmitters, as measured
during an electromagnetic
survey of the area, could be
less than the compliance level
for each interval of frequency.
Interference may occur close to

devices marked with the
following symbol:

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2.11.2.1 RECOMMENDED SEPARATION DISTANCES FOR PORTABLE AND MOBILE RADIO-

COMMUNICATION DEVICES
The EM equipment is designed to work in an electromagnetic environment where irradiated RF

interference is kept under control.
The client or operator of the EM equipment can help prevent electromagnetic interference by ensuring
a minimum distance between mobile/portable RF communication devices (transmitters) and the
system as indicated below (with reference to the max output power of the radio-communication
devices.
table 8
Max nominal output Separation distance / Transmitter frequency
power of the m
transmitter 150 kHz - 80 MHz 80 MHz - 800 MHz 800 MHz - 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
Note 1: In the case of transmitters with a max nominal output rate not indicated above, the recommended
separation distance d (in metres) can be calculated by using the correct equation for the transmitter
frequency, where P is the maximum nominal output rate of the transmitter in Watts according to the
transmitter manufacturer.
Note 2: These guidelines might not apply to all situations. Electromagnetic wave propagation is influenced by
the absorption and reflection properties of structures, objects and people.
2.11.3 CABLES AND ACCESSORIES
In accordance with standard EN 60601-1-2 (third edition), the use of transducers and cables other
than those specified (except for those provided by the manufacturer of the EM equipment as spare-
parts for internal components) may lead to an increase in emissions or a reduction in the immunity of
the EM equipment.

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2.12 DAILY CHECKS
2.12.1 MONITOR CHECKS
You must check the correct monitor adjustments every day as soon as the EM equipment is switched
on.
A test image appears after logging in as the User, used to adjust the monitor settings:
A B
Make sure that you can see this Test Pattern properly and, if necessary, adjust the monitor brightness
and contrast settings.
More specifically, it must be possible to see:
- the entire grey scale (boxes 0% - 100%)
- the grey square in the 0% black box (A),
- the grey square in the 100% white box (B).
Note: See paragraph 4.3 in Part 2 of this manual for details on how to adjust these settings.

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2.12.2 GENERAL EQUIPMENT CHECKS
To avoid the risk of incorrect X-ray exposure for a patient, you must check the efficiency of the
equipment every day, immediately after switching the system on and before starting X-ray emission for
the patient.
This is done by using a TEST exam especially designed during installation of the equipment, having
agreed with the operators which X-ray beam filter and radiological parameters are to be used.
The TEST procedure involves these steps:
• Open a temporary study and select the TEST exam: TEST- TEST LINEAR.
• Make sure that the actual radiological parameters match those in the TEST exam.
• Give the exposure command with the required filter (e.g.: 1 mm CU) and at the required focal
distance.
• Check that the exposure index for the acquired image falls within 80% and 120%. If correct, the
word OK (green) also appears.

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2.12.3 MOVEMENT ENABLED CHECK (Motorized version only)
In order to avoid the residual risk of accidental movement of the EM equipment, we recommend that
you check the movement enabling mechanism every day, immediately after switching the system on
and before starting X-ray emission for the patient.
With the brake lever in the rest position (brake engaged), use the joystick to check that it is impossible
to move the equipment forwards or backwards. Contact Technical Service if the equipment moves.

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Part 2: USE
CONTENTS
page rev. date
CONTENTS I-1 to I-3 B 20/04/14
1 INSTRUCTIONS FOR USE 1.1 to 1.58 B 20/04/14

1.1 Introduction
1.1.1 Best practice and PPEs
1.2 Moving, positioning and switching the equipment on:
standard version
1.2.1 Moving the equipment
1.2.2 Positioning the articulated arm
1.2.3 Locking the articulated arm
1.2.3.1 Locked under normal working
conditions
1.2.3.2 Locking the arm during malfunctions
1.2.4 Positioning the generator unit
1.2.5 Positioning the monoblock
1.2.6 Switching the EM equipment ON
1.3 Moving, positioning and switching the equipment on:
motorized version
1.3.1 Switching the equipment ON
1.3.2 Moving the equipment when the batteries are flat
1.3.3 Moving the equipment with fully charged
batteries
1.3.4 Positioning the articulated arm
1.3.5 Locking the articulated arm
1.3.5.1 Locked under normal conditions of
use
1.3.5.2 Locking the arms a malfunction
1.3.6 Positioning the generator unit
1.3.7 Positioning the monoblock
1.4 Preliminary operations and opening a study
1.4.1 Login
1.4.2 Checking the monitor settings
1.4.3 DRX-1 detector offset calibration
1.4.4 Accessing the Study List
1.4.5 Opening a study
1.4.5.1 Existing study in archive
1.4.5.2 Creating a study from the Worklist
1.4.5.3 Creating a new study manually
1.4.5.4 Procedures
1.5 Working frame
1.5.1 Setting the exposure parameters
1.5.2 Monoblock pre-heating and formation cycles
1.6 X-ray field settings
1.6.1 Positioning of the FPD and the anti-scatter grid
1.7 Image acquisition

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1.7.1 Detector battery charge level

1.7.1.1 Replacing the DRX-1 detector battery
1.7.1.2 Replacing the 3543 EZ PIXIUM
detector battery
1.8 Dose measurement (optional)
1.9 Image records (optional)
1.10 Closing a study
1.11 Exposure with cassette radiography
1.12 Next patient and end of use: standard version
1.12.1 Next patient
1.12.2 End of use
1.12.2.1 Charging the UPS batteires
1.12.2.2 Detector battery
1.13 Next patient and end of use: motorized version
1.13.1 Next patient
1.13.2 Next patient
1.13.2.1 Charging the UPS batteires
1.13.2.2 Detector battery
2 POST-PROCESSING 2.1 to 2.20 0 21/09/12

2.1 Image management
2.1.1 Finding an image
2.1.2 Duplicating an image
2.1.3 Deleting a single image
2.1.4 Overview
2.2 Window and Level corrections
2.2.1 Changing the gamma correction curve
2.3 Zoom
2.4 Spatial filters
2.5 Harmonization (ATH)
2.6 Electronic collimation
2.6.1 Automatic electronic collimation
2.6.2 Manual electronic collimation
2.7 Measurements
2.7.1 Measuring distances
2.7.1.1 Calibration
2.7.2 Measuring angles
2.8 Adding objects and text
2.8.1 Rectangle
2.8.2 Arrow
2.8.3 Text
2.9 Image orientation
2.10 Statistics
2.10.1 Local archives
3 MAINTENANCE 3.1 to 3.4 B 20/04/14

3.1 Routine maintenance
3.1.1 Checks and inspections
3.2 Cleaning and disinfecting
3.2.1 Cleaning the touch screen monitor
3.2.2 Cleaning the detector

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4 ANNEXES 4.1 to 4.32 A 20/04/14

4.1 Using the keyboard on the touch screen monitor
4.2 In-line manual
4.3 Monitor adjustments
4.4 Study-List management
4.4.1 Sort list
4.4.2 Find study
4.4.3 Select multiple studies
4.4.4 Delete study
4.4.4.1 Protecting a study against deletion
4.5 Transferring images via DICOM network
4.5.1 DICOM Store
4.5.2 DICOM Print
4.5.2.1 Manual composition
4.5.3 DICOM Spooler
4.6 Saving images to CD/DVD or USB PEN DRIVE
4.6.1 Opening DICOM archives on removable devices
4.6.1.1 Function list
4.6.1.2 DICOM tags
4.7 Changing the User password
4.8 Potter bucky
4.9 Detector setup using the infrared interface

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1 INSTRUCTIONS FOR USE
1.1 INTRODUCTION
The EM equipment MUST be installed and set up by authorised expert personnel.

See the Technical Manual for details before using the equipment.
The touch screen monitor provides the main operator/equipment interface.
Functions are generally selected by touching the relevant button on the monitor.
An active function is shown in a light shade.

Non active functions/keys are shown in a darker shade.
The touch screen needs to be calibrated if its response is not as expected for the
position you have touched (see Technical Manual).
The instructions for the main stages when using the EM equipment are described below:
1. Moving, positioning and switching the EM equipment

on: STANDARD version - see paragraph 1.2
2. Moving, positioning and switching the EM equipment

on: MOTORIZED version - see paragraph 1.3
3. Preliminary operations and opening a study - see paragraph 1.4
4. Working frame - see paragraph 1.5
5. Setting the X-ray field - see paragraph 1.6
6. Image acquisition - see paragraph 1.7
7. Dose measurement (optional) - see paragraph 1.8
8. Image records (optional) - see paragraph 1.9
9. Closing a study - see paragraph 1.10
10. Exposure with cassette radiography - see paragraph 1.11
11. Next patient and end of use: STANDARD version - see paragraph 1.12
12. Next patient and end of use: MOTORIZED version - see paragraph 1.13
13. Post-processing of images - see chapter 2

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1.1.1 BEST PRACTICE AND PPE
• Always wear a lead apron when carrying out any exam involving X-ray exposure.
• Move at least 2 m away from the X-ray beam or fully extend the manual switch cable and
stand at that distance before commanding X-ray exposure.
• Always use the most appropriate field size and technical factors for each procedure in order to
minimise X-ray exposure and get the best diagnostic results.
• Carefully check the digital display before any exposure: make sure that the technique is right.
Pay special attention to the position of the decimal points in the mAs settings to guarantee that
whole numbers are not confused with a fractional mAs number.
• Move as far away from other patients as possible when scanning a patient on a bed.
• Ask visitors to leave the ward during X-ray exposure.
• Whenever possible, use shields for the patient’s reproductive organs.
• Make sure you have read and followed the maintenance schedule described in the
Maintenance section of this manual.
• In most cases, the accumulated dose will never exceed the max recommended levels for
operators. However, as with all devices that generate radiation, a qualified X-ray expert should
always assess those situations where frequent exposures are required using kVp and mAs
techniques in order to decide upon the need for extra protection.

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1.2 MOVING, POSITIONING AND SWITCHING THE EQUIPMENT ON: STANDARD VERSION
1.2.1 MOVING THE EM EQUIPMENT
The compact line and front castor wheels mean that the EM equipment is easy to manoeuvre.
Before moving the equipment, always make sure that the power cable is unplugged.
Take the device into its transport position

before attempting to move it (see Fig. 1)
Fig.1 – Transport position
As shown on the label on the arm holding the monoblock (see

figure on right), the equipment may ONLY be moved when the
arm is securely hooked in the rest position.
Never attempt to move the equipment if the arm is

NOT hooked up.
• Take the arm to its transport position and lock with its
lever (see Fig. 2).
Fig.2 – Locking the arm

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• To move the equipment:

- turn the push handle to release the parking brake;
- keep the handle pushed down and start moving in the
required direction.
Note: As soon as you release the handle, it returns to its

normal rest position (thereby engaging the parking
brake).
Fig.3 – Releasing the brakes
• If you need to avoid small obstacles (e.g. getting into/out of

elevators), use your foot to press the lifting pedal to lift the
front of the equipment and so get past the obstacle.
Fig.4 – Getting past obstacles
Never use the front of the equipment to push doors open.

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1.2.2 POSITIONING THE ARTICULATED ARM
• Use the lever to release the articulated arm.
Fig.5 – Releasing the arm
• Grasp the positioning handle and push the arm upwards. Position the monoblock/X-ray tube unit as
required.
Fig.6 - Positioning the arm

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1.2.3 LOCKING THE ARTICULATED ARM
1.2.3.1 LOCKED UNDER NORMAL CONDITIONS OF USE
The mechanical lock is automatically engaged when you raise the arm to a height of more than 170
cm: this stops the arm from moving any lower unless you use the handles at the back of the
monoblock (see Fig.7) .
Fig.7 – Arm release lever
To release the arm:
• raise the arm slightly,
• move the lever as shown in Fig. 7 above until the locking system is released,
• lower the arm by about 10 cm, keeping the lever in the released position,
• release the lever and take the arm to a different working position (less than 170 cm).
1.2.3.2 LOCKING THE ARM DURING A MALFUNCTION
If there is a problem with the suspension system (e.g. no gas in the gas-operated springs), the locking
system automatically prevents the arm from dropping below a height of 170 cm. The machine is no
longer safe to use and so should not be used until the gas-operated springs are refilled.
Only authorised/expert personnel should be allowed to replace the gas-operated

spring unit.

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1.2.4 POSITIONING THE GENERATOR UNIT
• Use the positioning handle to move the monoblock/collimator unit. Bear in mind that the monoblock
can be rotated:
- Horizontally: ±180°,
- Vertically: 0° to +90°.
Fig.8 – Rotating the generator unit
1.2.5 POSITIONING THE MONOBLOCK
The collimator can be rotated by +/- 90° around the axis of the X-ray beam. A mechanical stopper
limits the rotation of the collimator.
• Before rotating the collimator, release the anti-rotation lever.
Fig.9 – Collimator anti-rotation lever

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1.2.6 SWITCHING THE EM EQUIPMENT ON
• To avoid potential WIFI connection problems with the detector, always remove the detector battery
(see paragraph 1.7.1.1 below) before switching the equipment on.
• Plug the power cable into the mains.
Use plugs protected by a trip switch (C = 16A, nominal differential current In =

30mA, t = 0sec).
The power voltage and current must comply with those indicated on the
ratings plate on the machine.
• Switch the magnetothermal switch ON.

The equipment is now powered up.
• Turn the ON/OFF key to position 1:
• The equipment runs the initializing test, as shown on the monitor:
• You can now insert a fully charged battery in the detector and wait until the LEDs on the detector
tell you that the FPD is ready.
This should happen about 1 minute after inserting the battery.
Remove and insert the battery again if there is a different sequence of flashes for more
than 2 minutes.
Note: See paragraph 1.4 below for details of the preliminary operations and how to open a study.

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1.3 MOVING, POSITIONING AND SWITCHING THE EQUIPMENT ON: MOTORIZED VERSION
1.3.1 SWITCHING THE EQUIPMENT ON
The compact line and front castor wheels mean that the EM equipment is easy to manoeuvre.
To avoid potential WIFI connection problems with the detector, always remove the detector battery
(see paragraph 1.7.1.1 below) before switching the equipment on.
The equipment must be switched on before you can use the motorized movement commands. To
switch it on:
Use plugs protected by a trip switch C = 16A, nominal differential current In =

30mA, t = 0sec.
The power voltage and current must comply with those indicated on the
ratings plate on the machine.
• Turn the small cover to access the UPS control panel:
• Turn the magnetothermal switch to ON.
The equipment is now powered up.
The UPS display will read:
IN  230V AC / OUT  000V AC
• Press the ON/OFF button for about 10 seconds until the UPS output is
activated:
IN  220V AC / OUT  230V AC
The equipment is now switched on.

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Take the device into its transport position

before attempting to move it (see Fig.10)
Fig.10 – Transport position
As shown on the label on the arm holding the monoblock (see

figure on right), the equipment may ONLY be moved when the
arm is securely hooked in the rest position.
Never attempt to move the equipment if the arm is NOT

hooked up.
• Take the arm to its transport position and lock with its lever
(see Fig.11).
Fig.11 – Locking the arm

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The batteries must be properly charged before you can move the equipment using the motor. Their
charge level is indicated on the monitor (both in the Study List and the Working Frame):
Note: To move the equipment:

- if the batteries are flat: see paragraph 1.3.2
- if the batteries are charged: see paragraph 1.3.3
1.3.2 MOVING THE EQUIPMENT WHEN THE BATTERIES ARE FLAT
You cannot use the motorized movement option if the batteries are flat: the equipment must be
plugged into the mains for at least 5 hours to charge the batteries fully.
You need to release the parking brake in order to move the equipment manually when this is switched
on:
• Press the release button (this turns blue):
• Check that the motorized movement command is disabled

(green LED off):

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• Turn the magnetothermal switch to OFF.
• Unplug the equipment at the mains and rewind its power cable using the spring-loaded winder.
To do this, you need to pull on the cable slightly (a few centimentres) to release the clamp and then
accompany it until the plug reaches the cable stop.
Danger: the cable will flail about during rewinding if not accompanied.
You must accompany the cable until it is fully rewound.
o You can now move the equipment manually:
- Lift the handle to release the parking brake (see Fig.12).
- Keep the handle raised and push the equipment to the

required position.
Note: As soon as you release the handle, it returns to its

normal rest position (thereby engaging the parking
brake).
Fig.12 – Releasing the brake system

front of the equipment and so get past the obstacle (see Fig.
13).

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1.3.3 MOVING THE EQUIPMENT WITH FULLY CHARGED BATTERIES
To move the equipment using the motor with fully charged batteries:
• Turn the magnetothermal switch to OFF.
• Unplug the equipment at the mains and rewind its power cable using the spring-loaded winder.
To do this, you need to pull on the cable slightly (a few centimentres) to release the clamp and then
accompany it until the plug reaches the cable stop.
• Check that the motorized movement command is enabled

(green LED on):
Note: If this LED is off, check to see if the motor brake

release button is engaged (see paragraph above).
• Lift the handle to release the parking brake (see Fig.14).
Fig.14 – Releasing the brake system

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• Keep the handle raised and press the FORWARDS or

BACKWARDS motor command to move the equipment to
the required position (see Fig.15 and Fig.16).
You cannot move the equipment until the parking brake has
been released.
Fig.15 – To move FORWARDS
Fig.16 – To move BACKWARDS

front of the equipment and so get past the obstacle (see
Fig.17).

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• To stop the equipment: simply move the motor command

to its central position and release the handle.
The handle now returns to its rest position with the
parking brake engaged (see Fig.18).
Fig.18 – To stop the equipment
ATTENTION: SLOW DOWN NEAR PEOPLE OR OBJECTS.

DISABLE THE MOTOR AND ENGAGE THE PARKING BRAKE IMMEDIATELY IF THERE IS A SUDDEN
OBSTACLE.
W E RECOMMEND MOVING THE EQUIPMENT MANUALLY WHEN CENTRING THIS ON THE PATIENT.

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1.3.4 POSITIONING THE ARTICULATED ARM
• use the lever to release the articulated arm.
Fig.19 – Releasing the arm
• Grasp the positioning handle and push the arm upwards.

Position the monoblock/X-ray tube unit as required.
Fig.20 - Positioning the arm

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1.3.5 LOCKING THE ARTICULATED ARM
1.3.5.1 LOCKED UNDER NORMAL CONDITIONS OF USE
The mechanical lock is automatically engaged when you raise the arm to a height of more than 170
cm: this stops the arm from moving any lower unless you use the handles at the back of the
monoblock (see Fig.21) .
Fig. 21 - Arm release lever
To release the arm:
• raise the arm slightly,
• move the lever as shown in Fig. 21 above until the locking system is released,
• lower the arm by about 10 cm, keeping the lever in the released position,
• release the lever and take the arm to a different working position (less than 170 cm).
1.3.5.2 LOCKING THE ARM DURING A MALFUNCTION
If there is a problem with the suspension system (e.g. no gas in the gas-operated springs), the locking
system automatically prevents the arm from dropping below a height of 170 cm. The machine is no
longer safe to use and so should not be used until the gas-operated springs are refilled.
Only authorised/expert personnel should be allowed to replace the gas-operated spring

unit.

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1.3.6 POSITIONING THE GENERATOR UNIT
• Use the positioning handle to move the monoblock/collimator unit. Bear in mind that the monoblock
can be rotated:
- Horizontally: ±180°,
- Vertically: 0° to +90°.
Fig.22 - Rotating the generator unit
1.3.7 POSITIONING THE MONOBLOCK
The collimator can be rotated by +/- 90° around the axis of the X-ray beam. A mechanical stopper
limits the rotation of the collimator.
• Before rotating the collimator, release the anti-rotation lever .
Fig.23 - Collimator anti-rotation lever
Note: See paragraph 1.4 below for a description of the preliminary operations and how to open a
study.

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1.4 PRELIMINARY OPERATIONS AND OPENING A STUDY
1.4.1 LOGIN
The LOGIN screen automatically appears after the initializing test:
• Press to get a list of authorised users.
Select a user and log in with the right password.
Notes: - The system requires that each password is valid for only 90 days. The user will not be
able to use the same password for more than 90 days and so needs to change the
password. See paragraph 4.7 in the Annex at the end of this Part of the manual for
details.
- The Emergency user (without the need to enter a LOG-IN password) lets you enter
patient data, acquire images and print them, but does not let you access the complete
Study List. You go directly to the Create Study page when you select the Emergency
user.

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1.4.2 CHECKING THE MONITOR SETTINGS
After logging in, a test pattern (SMPTE) appears.
Check the monitor brightness and contrast settings by checking the appearance of the grey scale (see
also paragraph 2.12.1 in Part 1, DAILY CHECKS).
• If you press (do not accept), a message appears telling you to calibrate the monitor settings:
Note: See paragraph 4.3 in the Annex at the end of this Part of the manual for details on how to
adjust the settings.
• If you press (accept), the EM equipment connects with the detector.
If connection fails, the following window appears on the monitor:

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• Press Reconnect to connect with the detector.
Note: if the same window appears again:

- check the battery charge level,
- remove and replace the battery to see if the LED on the detector flashes before you press
Reconnect. (See paragraph 2.10 in Part 1 of this manual for details of the detector LED).
1.4.3 CALIBRATING THE DETECTOR OFFSET (ONLY FOR DRX-1 DETECTOR)
• If the detector needs Offset* calibration (Daily Dark Calibration) after connection, this is done
automatically and lasts about 1 minute (only for DRX-1 detector).
Note*: Offset calibration is only done if at least 24 hours have passed since the last calibration
(only for DRX-1 detector).

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1.4.4 ACCESSING THE STUDY LIST
After connection with the detector, the system automatically opens the Study List:
Here you can:
- Select and open a study in the archive - select:
- Create a new study manually - select:
- Create a new study from the Worklist - select:
- Access the DICOM Spooler page - select:
- Access the set-up menus - select:

(Advanced users only)
- Quit the application - select:
Warning: A series of efficiency tests should be performed each day to avoid the risk of accidental
X-ray emissions if the system is faulty. These must be done before scanning the patient.
See paragraph 2.12.2 for details of this procedure (“General equipment checks”) in Part 1
of this manual.

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1.4.5 OPENING A STUDY
From the Study List you can:
• Select an existing study in the archive for post-processing of the images or to change the
patient data.
If this has not already been completed (i.e. with the symbol: ), you can also add new
acquisitions to the existing images in the study.
• Create a new study:

The new study can be received via RIS using the DICOM Worklist function or created manually
by entering the patient data and the type of exam required.
1.4.5.1 EXISTING STUDY IN ARCHIVE
Select the study in the Study List by touching it on the screen: the study is highlighted on the screen
and previews (thumbnails) of the images appear in the left margin.
Note: If the archive includes a long patient list, it is a good idea to re-sort the list or use the search
functions to make it easier to find the study you want. See paragraph 4.4 at the end of in this
Part of the manual for details.

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“Double-click” on the study to open the Post-Processing frame:
• Here you can:
- carry out post processing operations on the saved images using the commands on the right of
the screen (see chapter 2 “Post-processing” for details),
- open the Working frame to acquire new images, using the command: (this is not possible
if the study has already been completed).
• To change the study data, go back to the Study List and then use the Edit command:
The “Study Data” frame opens: see paragraph 1.4.3 below (“Creating a new study manually”).

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1.4.5.2 CREATING A STUDY RECEIVED FROM THE WORKLIST
The Worklist function lets you receive the list of required studies from the hospital’s computer network
(RIS).
• To connect to the RIS, plug the communication cable into the Ethernet port on the
back of the equipment (on the left side):
This means that you do not need to enter the study data by hand, but simply load the
received study, or studies, in the work archive.
● Open the Worklist menu from the Study List by touching the relevant command:

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● To request the Worklist from the RIS:
- set the date interval. This is normally the same day, though you can
also use the From and To commands (start and end dates):
- set the DICOM reception mode by selecting DX, CR or ALL.
● Use the Worklist command to get the list from the RIS:
After receiving the Worklist received from the RIS, you can:
• Transfer one or more selected studies to the Study List: Select
• Delete one or more selected studies: Delete
• Delete the entire list of studies received from the RIS Delete All
• Browse the list, if there is more than one page: Up and Down
Notes: - If you request the Worklist several times, any studies already present in the Study List are
overwritten.
- Several studies/procedures for the same patient may be received from the Worklist.
In this case, each time you transfer such a study to the Study List a “same patient” folder is
created to contain this each time, identified by an Accession number. This lets you acquire
the images as per a single study, while still keeping the studies separate.

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1.4.5.3 CREATING A NEW STUDY MANUALLY
You can create a new study in the Study List manually by touching the relevant command:
A window appears letting you enter the data for the new study:
• Enter the data requested in the Patient information box using the keyboard:
- Last name and First Name (Last name e First Name)

- Patient ID (Patient ID)
- Date of birth (Date of birth)
- Sex (Male-Female-Unknown-Other)
Note: The Last name and First name fields accept a maximum of 30 characters.

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Follow the steps explained in paragraph 1.4.4 below to associate one or more procedures to the study
(Procedure List box).
If you do not wish to select a procedure, the study is now set up and ready for the following
operations:
• Select Cancel to close the new study window without saving any settings.
• Select Apply and the system asks you to select the exam type you want to use:
• Select:
- the anatomical part,
- the projection type associated to this.
After selecting the exam, the study is saved in the Study List and the “Working frame” for that study
automatically opens (see paragraph 1.5 below).
1.4.5.4 PROCEDURES
You can set a Procedure to guide you through the performance of the exposures required for a study.
Procedures define the exam/projection types needed for the study.
Procedures are defined during installation of the system, in accordance with the operators and
depending on the type of work required in the radiology theatre.
A procedure can be associated to:
- a single exam (projection) (e.g.: Std Thorax with just the PA projection of the thorax),
- or several exams (projections) (e.g.: Full Thorax with both PA and LAT projections).
You can either receive the Procedure from RIS via the Worklist function or chose it manually, e.g.
when creating a new study manually.
When a procedure is associated to a study, the system guides you during image acquisition and
automatically presents the exams required.
Otherwise, you need to select the exam type manually from those foreseen by the system, as
described in paragraph 1.5 below.

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• Select the Add Procedure command to set the procedure (or procedures) when creating a study
manually. The following page appears:
• Select the first option to view the list of possible procedures (set during installation) and then
choose the one you want to use:
• Then select the second select option to view a list of accredited users (“Physician” field) and select
the relevant user:

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• Other options (manual entry) are:
- the Accession Number,
- the default DICOM mode (select CR or DX):
• Confirm by using this command:

The procedure is added to the
Procedure List:
• Select the Add Procedure command again to enter another procedure and repeat the above
steps.
You can also edit or delete the procedure settings using these commands:
- Modify Procedure
- Delete Procedure
Once you have selected the procedure(s),

the study is set up and you can perform the
following operations:
• Select Cancel to close the new study window without saving any settings.
• Select Apply and the “Working frame” automatically appears (see paragraph 1.5
below).

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1.5 WORKING FRAME
When you open a new study, the Working Frame appears:
• If there is a set Procedure for the study, the system automatically sets:
- The first exam with the procedure selected for the study,
showing the set body part and projection.
- The set size for the exam. If the exam involves more than
one size, the medium size is used. Other sizes can then be
selected.
- The preview image strip. The first image in the first exam is
highlighted.
- After the first exposure, the system automatically prepares for the next exam (if programmed)
and so on, until the full procedure is completed:
- You can, however, alter the order in which the exams are done by manually selecting an exam
in the procedure box.
- After performing this exam, the automatic sequence continues for the remaining exposures.

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- You can, however, repeat one of the exams or perform an extra exam not included in the
procedure.
Use the Add Projections command to view a complete list of possible exams and then select
the body part and projection type you want to use.
• If, on the other hand, the study has no specific Procedure, the Working frame appears with the
exam type chosen at the time of creating the study. This frame indicates:
- The anatomical part and projection type.
- The set size for the exam. If the exam involves more than
one size, the medium size is used. Other sizes can then
be selected.
- To perform a different exam Use the Add Projections command to view the complete list of
possible exams and then select the body part and projection type you want to use.

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1.5.1 SETTING THE EXPOSURE PARAMETERS
On selecting the exam and patient size, the X-ray generator data are automatically set to suit the
parameters already set for the exam in question:
- 2-point technique or 3-point technique,
- X-ray tube focus,
- KV / mAs / mA / ms (depending on technique).
ATTENTION
These parameters (clinical protocols) have been programmed by the manufacturer and
entered in the equipment merely by way of example. The operator can always change the
settings manually, using the commands on the console.
You can also alter the parameters saved on the equipment (in agreement with the
organisation responsible for the same), as explained in the Technical Manual accompanying
this equipment.
The commands are:
• Select patient size (4 possible sizes): Paediatric Small
Medium Large
• Select the technique:
- 2-point technique (kV and mAs)
- 3-point technique (kV, mA and ms)

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• Altering the exposure data:
The parameters automatically set when you select the exam can be modified to suit specific needs:
- kV: 40 - 125 kV (steps of 1 kV)
2-point technique:
- mAs: 0.5 - 80 mAs (23 steps)
3-point technique:
- mA: 50 - 200 mA (7 steps)
- ms : 3 - 500 ms (21 steps)
Note: The MOTORIZED version of the equipment, when battery powered, limits
the exposure settings to 50mAs.
- To change the parameters, select the relevant field:
- Change the value using these commands:

You cannot scroll beyond the max or min values.
Carefully check the value of the parameters shown on the display before any
exposure to guarantee that the selected factors are correct.
• X-ray tube focus: small / large
• Exam with exposure on external Bucky potter:
The selected exam foresees exposure with the detector on an external Bucky potter, fitted with a
mobile grid (see Annex 4.8 at the end of this part of the manual).
• Exam with anti-scatter grid:
The selected exam foresees exposure with an anti-scatter grid.
• Collimator light on:
The light stays on for 30 seconds.

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1.5.2 MONOBLOCK PRE-HEATING AND FORMATION CYCLES
Always check whether or not the exposure cycles described below are needed
before using the equipment. Non observance of these instructions may cause
damage to the monoblock.
Close the collimator during the exposure cycle to minimise the emission of radiation
in the local area.
Interrupt the procedure and wait an hour before trying again if you hear discharge
noises in the generator unit or detect other irregularities.
• If the EM equipment has not been used for more than 15 days, you must follow the pre-heating
procedure, described below:
- Select the cassette radiography mode (see paragraph 1.11).
- Make 6 exposures in the order below (total duration = 2 min):
kVp mAs Esp Interval

60 4 1 20 sec
60 10 1 20 sec
80 4 1 20 sec
80 10 1 20 sec
100 4 1 20 sec
100 10 1 20 sec
Table 1 – Monoblock pre-heating cycle

• If the EM equipment has not been used for more than 3 months, you must follow the formation
procedure, described below:
- Select the cassette radiography mode (see paragraph 1.11).
- Make 35 exposures in the order below (total duration = 1 hour 10 minutes):

40 6.3 3 20 sec
Pause 120 sec
50 6.3 3 20 sec
Pause 120 sec
60 6.3 3 20 sec
Pause 120 sec
70 6.3 3 20 sec
Pause 120 sec
80 6.3 3 20 sec
Pause 120 sec
90 6.3 3 20 sec
Pause 120 sec
100 6.3 3 20 sec
Pause 120 sec

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110 6.3 3 20 sec
Pause 120 sec
120 6.3 3 20 sec
Pause 120 sec
125 6.3 3 20 sec
Pause 30 min
40 20 1 180 sec
50 20 1 180 sec
60 20 1 180 sec
70 20 1 180 sec
80 20 1 180 sec
Table 2 - Monoblock formation cycle
The equipment is ready for normal use if there are no anomalies.

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1.6 X-RAY FIELD SETTINGS
The collimator is needed to limit the X-ray field to the useful area.
• Press the field lamp key to view the amplitude of the field to be radiated (light beam). This
command is found on both the monitor and the collimator. The light automatically switches off when
you press the RAD PREP button or at the timeout (30 seconds).
Wait ten minutes after using the light five times to prevent the surrounding area
from becoming overheated.
• Position the collimator monoblock unit using as a reference the field shown by the luminous
centring device and the cross (indicating the axis of the X-ray beam and the point where it hits the
patient).
• Adjust the size of the field by using the control knobs on the front of the collimator. The right-hand
knob controls the longitudinal shutter plates; that on the left the lateral ones.
Possible fields: 0 x 0 to 43 x 43 cm (17”x17”) with a focal distance of 100 cm (40 ”).
The scales under the knobs show the field at 100 cm (40”).
Use the table on the front panel to find the number to be set on the scale under each knob for cassette
radiography size (DFF 100 - 200 cm); the number is reached using the current DFF row and the
cassette radiography column.
DFF in cm DFF in inches
cm 13 18 24 30 35 40 43 Cassette size in cm
100 13 18 24 30 35 40 43 40”
150 10 12 16 20 23.5 26.5 28 60”
200 6.5 9 12 15 17.8 20 21.6 78”
5” 7” 9.5” 12” 14” 16” 17” inch Cassette size in inches
Example: setting the field with a 30cm cassette at DFF 150cm

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1.6.1 POSITIONING THE FPD AND THE ANTI-SCATTER GRID
Always respect the following requirements when positioning the Flat Panel Detector:
- Distance from the X-ray tube focus: 100 - 200 cm

- Centred on the X-ray beam, using the lamp on the X-ray collimator
If required to perform X-rays with an anti-scatter grid (e.g. THORAX or ABDOMEN), you need to insert
the FPD in the support with a grid (optional), as shown in the figure below:
Position the FPD along edge “A”.

Press down on the FPD ( “B” ) and then lower it (“C”).
Repeat the above steps in reverse order to remove the FPD.
“A”
“C”
“B”
“A”
When using the FPD with an anti-scatter grid, the distance between the focus and the FPD must be 76
- 110cm.
It is strictly forbidden to hold the FDP in your hands during X-ray emission.
Any exceptions must be agreed beforehand with the organisation responsible for the equipment.

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1.7 IMAGE ACQUISITION
Use the double-click button to command X-ray exposure and so acquire an

image using the detector.
• Press RAD PREP (1st click on button) to launch the anode.

The rotor takes about 1.5 seconds to reach the required speed.
• Press EXPOSURE (2nd click on button) to command an exposure.

An acoustic warning sounds and the X-ray emission light comes on.
Note: You can also simply press the button all the way down: the preparation cycle (1.5 sec) is
automatic.
The preparation and emission stages in the generator are shown:
- By messages ion the dedicated - By symbols on the console:

area of the working frame:
PREP
RAD
• After exposure, the acquired image is shown on the monitor about 20 seconds later, i.e. the time
needed to transfer the data from the detector. The Image acquisition message appears during
data transfer.
• A low resolution Preview image appears on the monitor about 6 seconds after exposure if the
Preview function was enabled during installation; this is then replaced by the final (full) image.
In this case, you get the following sequence of images:
The touch screen monitor is not suitable for viewing images of sufficient quality for
diagnostic use.
For diagnostic use the images should be viewed on films or on a high quality (high
resolution) reporting monitor.

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PREVIEW IMAGE (ONLY FOR DRX-1 DETECTOR):
FULL IMAGE:
Exposure index

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• The equipment includes an exposure dose verification function: the dose is checked by measuring
the image levels.
The result is then shown in the Exposure index by means of 3 colours and a percentage. The
meaning of each colour is:
green: correct dose blue: underexposed red: overexposed
The percentage shows the result in numbers, for instance:
- 40% : the detected dose is only 40% that envisaged,

- 220% : the detected dose is 220% that envisaged,
- ok : the detected dose is equal to that envisaged (variation range set during installation,
typically 50% - 200%).
• The image is automatically saved to HD and displayed already processed using the acquisition
parameters and post-processing parameters associated to the chosen exam type.
The image quality is normally good enough for printing or transfer to an external display
workstation.
• You can change the contrast (W) and brightness (L) of the image by dragging your finger on the
touch screen along the edges of the image:
reduce W
- along the bottom edge: horizontally to change the L
- along the right-hand edge: vertically to change the W reduce L increase L
increase W
Note: Use the automatic correction command to return to the original W and L
values at the time of image acquisition:
• See chapter 2 (“Post-processing”) if you need to process the image.
• Simply give the X-ray command again if you need to repeat the image acquisition, for whatever
reason:
- without selecting a new exam, if the study does not have a specific procedure,
- by manually intervening in the procedure if the exam has an associated procedure, as
explained in paragraph 1.4 above.
• Each image in the study is numbered progressively (e.g. 2/3 means the second image in a study
containing 3 images).

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1.7.1 DETECTOR BATTERY CHARGE LEVEL
You need to replace the detector battery whenever the charge level drops below the minimum working
level (20% total charge).
You are warned that the charge has reached the minimum level in two ways on the monitor:
- a warning in the message area:
- a warning in the centre of the monitor:
Note: The detector can no longer acquire images when the battery is running low.
A “low battery” message appears as soon as the battery charge drops below the Low Battery
Threshold level (usually 30%).
Replace the detector battery with a fully charged one in the battery charger, following the procedure
explained in the next paragraph (1.7.1.1 and 1.7.1.2).
Note: You do not need to close the application before changing

the battery. After removing the battery or connecting the
cable, the detector automatically disconnects from the
system. The reconnection window appears after a few
seconds.

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1.7.1.1 REPLACING THE DRX-1 DETECTOR BATTERY
A new battery lets you acquire roughly 90 images (c. 3 hours of intense work). Bear in mind, however,
that the battery charge level drops even when the equipment is not in use, as it helps keep the
electronic circuits in the detector powered up.
Remove the flat battery from the detector and place in its battery charger.
Recharging time depends on the state of the battery; about 2 hours are generally needed.
A battery is fully charged when all the LEDs for the slot on the charger holding the battery light up.
• To remove a flat battery from the detector:
- Insert a pointed object (e.g. the tip of a ballpoint

pen) in the hollow on the battery clip and then
slide towards the release position.
- The battery is now released and lifts up, making

it easy to remove.
• To insert a fully charged battery in the detector:
- The battery can only be inserted in one

way.
- Place the new battery in the recess,

making sure that the contacts on the side
of the battery are inserted first.
- Then press the battery down until the clip

engages.
• After replacing the battery, check that the LED on the

detector is flashing and then wait for the following
sequence: one green flash and three blue flashes
(wait about a minute). Then touch the Reconnect
command:
ALWAYS use the battery charger supplied

with the detector to charge the batteries.
The batteries DO NOT require maintenance.

Handle with care.
Do not expose to heat sources.
Do not short-circuit the battery contacts.

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1.7.1.2 REPLACING THE PIXIUM 3543EZ DETECTOR BATTERY
A new battery lets you acquire roughly 600 images (c. 4 hours’ work). Bear in mind, however, that the
battery charge level drops even when the equipment is not in use, as it helps keep the electronic
circuits in the detector powered up.
Remove the flat battery from the detector and place in its battery charger.
Recharging time depends on the state of the battery; about 2 hours are generally needed.
A battery is fully charged when the green LED on the battery charger next to the slot holding the
battery stops flashing.
BUTTON
To switch off the FPD: press the button shown above for about 5 seconds, until the STATUS LED
starts flashing orange.
You can now remove the battery by turning the battery lock anti-clockwise.
Attention:
NEVER remove the battery before switching the FPD off using the ON/OFF button.

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Insert the new battery in its seat and secure by turning the battery lock clockwise (see figure below):
Press the button shown below for about 1 second until the STATUS LED starts flashing orange.
BUTTON
Wait for the 3 LEDs to light up.
• Always check that the LEDs on the detector light up

again after replacing the battery and then wait for the
“Ready” status (about 1 minute).
• Press the Reconnect command:
ALWAYS use the battery charger provided to

charge the battery.
The batteries do NOT require maintenance.

Handle with care.
Do not expose to heat sources.
Do not short-circuit the battery contacts.

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In order to increase the battery performance of the PIXIUM 354EZ detector:
• If the application stays in the Study List for more than 2 minutes, the detector will switch to
energy saving mode (LOW POWER mode) and the STATUS LED will start blinking.
As soon as you return to the acquisition screen, the PIXIUM 3543EZ will interrupt the energy
saving mode and will switch automatically to operational state.
• After more than one hour in LOW POWER mode, the PIXIUM 3543EZ will switch to POWER
OFF mode - WAKE ON SHAKE, and will thus be fully turned off (all LEDs off). Energy
consumption is further reduced in this mode.
Just shake the detector to wake it up: the detector will then turn itself on automatically and will
be ready to connect with the application again after a few seconds.

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1.8 DOSE MEASUREMENT (OPTIONAL)
If the EM equipment is fitted with a DAP module (Dose Area Product), the dose for each patient is
shown:
- In the image area, with details of the

X-ray dose for that specific exposure.
- In the “patient data” box in the Working frame, with details of

the total X-ray dose accumulated during the study.
- In the Dose field in the Study List, with details of the total X-ray dose for the study.
2
Notes: - The X-ray dose is expressed in mGy*cm .
- The X-ray dose values are automatically updated and saved after each exposure.

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1.9 IMAGE RECORDS (OPTIONAL)
The following (optional) DICOM functions can be used to produce image records:
- Transfer images to CD/DVD or USB PEN DRIVE
- Send images to Workstation / PACS DICOM
- Send images to DICOM printer
You need to connect the equipment to the hospital computer network (RIS) in order to send images to
a DICOM device. To do this, connect an Ethernet cable to the relevant port on the left side of the
equipment:
Note: The physical characteristics of the network connection are described in the Technical Manual.
 Saving images to CD/DVD or USB PEN DRIVE
This function is found in:

- the Study List frame, for saving the images for a single patient from one or more studies,
- the Report Tool frame, for saving specific images selected from within a study.
See Annex 4.6 at the end of this Part of the manual for details.
 Send images to workstation/ PACS DICOM
The STORE DICOM function is found in:

- the Study List frame, for transferring the images for a single patient from one or more studies,
- the Report Tool frame, for transferring specific images selected from within a study,
- the Working frame, to transfer single images after post processing.
See paragraph 4.5.1 in the Annex at the end of this Part of the manual for details.
 Send images to DICOM printer
The PRINT DICOM function is found in the Report Tool frame and lets you get a print-out of the
images selected from within a study.
See paragraph 4.5.2 in the Annex at the end of this Part of the manual for details.

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1.10 CLOSING A STUDY
• After acquiring new images, you can close the study in one of two ways:
- Using command
This command closes the study as a Completed study.
In this case you can no longer acquire any more images within this study.
- Using command
This command closes the study as a Suspended study, thus allowing for the addition of new
images at a later date.
• After closing the study, you return to the Study List. Here you can see the updated status of the
study:
- Completed study
- Paused study

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1.11 EXPOSURE WITH CASSETTE RADIOGRAPHY
The equipment also lets you make exposures using a normal radiography cassette.
This function is found in the Acquisition frame:
• Press the detector symbol to disable acquisition using the detector and so get exposure with
cassette radiography when you use the normal radiography command.
- Example:

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• The radiological parameters can be modified in this mode to suit special needs:
- kV: 40 - 125 kV (steps of 1 kV)
2-point technique:
- mAs: 0.5 - 320 mAs (29 steps)
3-point technique:
- mA: 50 - 400 mA (10 steps)
- ms : 3 - 6300 ms (32 steps)
Note: The MOTORIZED version of the equipment, when battery powered, limits
the exposure settings to 50mAs.

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1.12 NEXT PATIENT AND END OF USE: STANDARD VERSION
1.12.1 NEXT PATIENT
If there is no need to unplug the mobile X-ray unit in order to move to the next patient to be scanned,
all you need do is enter the patient data and then carry out the operations described above.
Normally, however, you will need to unplug the mobile X-ray unit in order to move to the next patient to
be scanned. The equipment is fitted with a UPS unit for this purpose. This automatically cuts in when
the unit is unplugged and keeps the control circuits in stand-by. This means that the equipment quickly
returns to full operating mode, avoiding the initialising stage (only required when the equipment has
been completely shut down and switched off).
The stand-by time is always shown on the monitor, together with the UPS battery charge level (both in
Study List and the Working frame).
These data let you decide whether there is enough stand-by to cover the time it will take to move to
the next patient. You will need to shut the equipment down completely if there is not enough stand-by.
To go to the next patient without shutting down the equipment:
• Return to the Study List page (close the previous study).
• Turn the magnetothermal switch OFF.
• Unplug the equipment and rewind the power cable using the spring device.
To do this, pull the cable slightly (a few cm) until it is released from its clip and then accompany it
until fully rewound.

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Never unplug the equipment while in the process of acquiring images or post-processing.
It is best to unplug the equipment only when the Login or Study List frames are displayed.
• The equipment automatically switches to stand-by mode when the mains power supply is cut; the
monitor goes blank.
An intermittent beep from the UPS unit warns you that the equipment has no mains power.
• Move the equipment to the right position for the new exam, plug it into the mains and then turn the
magnetothermal switch ON.
After a few seconds the equipment returns to its previous condition (when you unplugged it). The
reconnect detector window appears:
• Press Reconnect and wait a few seconds for it to reconnect.

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1.12.2 END OF USE
After closing the last study, shut the equipment down and then switch off as follows:
• Press Exit in the Study List frame:
• Press Shutdown in the Login frame:
• Then select Turn off:
Note: The Close command closes the video processor application, but does not switch the equipment
off. Use this command only in special circumstances (technical checks).

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• You can switch the equipment when the monitor is blank:
- turn the ON/OFF key to 0:
• If you do not need to charge the UPS unit batteries (see paragraph 1.13.1 below):
- turn the magnetothermal switch to OFF.
- unplug the equipment.
Keep the equipment unplugged when not in use.
Note: The image disk in the EM equipment must not be considered a permanent archive: we
recommend that you transfer all the images to an external archive (e.g. using the STORE
DICOM function) before closing the application and switching the system off.
1.12.2.1 CHARGING THE UPS UNIT BATTERIES
The batteries in the UPS unit must be kept fully charged in order to ensure effective use of the stand-
by function when moving the equipment between patients.
These are normally charged while using the equipment, when this is switched on and plugged in.
If, however, there is insufficient charge, you can keep the equipment plugged into the mains power
supply (magnetothermal switch ON) after shutting the equipment down.
We recommend charging the UPS unit batteries as soon as the charge level
(shown in the Working frame) drops below 50%.
1.12.2.2 DETECTOR BATTERY
We recommend removing the battery from the detector and placing in its charger after switching the
equipment off.
If you leave the battery in the detector, it will gradually run down after a few hours, even
when the detector is not being used.
ALWAYS use the battery charger provided to recharge the battery.
Keep the battery away from heat sources.

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1.13 NEXT PATIENT AND END OF USE: MOTORIZED VERSION
1.13.1 NEXT PATIENT
If there is no need to unplug the mobile X-ray unit in order to move to the next patient to be scanned,
all you need do is enter the patient data and then carry out the operations described above.
Normally, however, you will need to unplug the mobile X-ray unit in order to move to the next patient to
be scanned. The equipment is fitted with a UPS unit for this purpose. This automatically cuts in when
the unit is unplugged and keeps the control circuits in stand-by. This means that the equipment quickly
returns to full operating mode, avoiding the initialising stage (only required when the equipment has
been completely shut down and switched off).
Thanks to the UPS battery, the motorized version of the equipment lets you continue expsoures
without the need to be plugged into the mains.
The UPS battery charge level is always shown on the monitor (both in Study List and the Working
frame).
Therefore, all you need to do is to move the equipment (stull switched on) to the next patient without
having to plug it into the mains.
Then, to acquire images, simply enter the data and follow the acquisition procedures described above.
Note: The MOTORIZED version of the equipment, when battery powered, limits the exposure
settings to 50mAs. You must plug it into the mains if you want to use it without
limitations.
If you need to plug the equipment into the mains because the batteries are flat or you want to work
without exposure limitations:
• Turn the magnetothermal switch to ON.
The EM equipment is now mains powered.

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1.13.2 END OF USE
After closing the last study, shut the equipment down and then switch off as follows:
• Press Exit in the Study List frame:
• Press Shutdown in the Login frame:
• Then select Turn off:
Note: The Close command closes the video processor application, but does not switch the equipment
off. Use this command only in special circumstances (technical checks).

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• You can switch the equipment when the monitor is blank.
• If you do not need to charge the UPS unit batteries (see paragraph 1.13.2.1 below):
- Turn the magnetothermal switch to OFF.
- Unplug the equipment at the mains.
- Press the ON/OFF button for about 10 seconds until the UPS switches off.
The equipment is now completely switched off.
Keep the equipment unplugged when not in use.
Note: The image disk in the EM equipment must not be considered a permanent archive: we
recommend that you transfer all the images to an external archive (e.g. using the STORE
DICOM function) before closing the application and switching the system off.

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1.13.2.1 CHARGING THE UPS UNIT BATTERIES
The batteries in the UPS unit must be kept fully charged in order to ensure effective use of the
motorized movement.
To charge these batteries:

- keep the equipment plugged into the mains and the magnetothermal switch turned ON,
- keep the UPS switched ON.
We recommend charging the UPS batteries as soon as the charge level

(shown in the Working Frame) drops below 50%.
1.13.2.2 DETECTOR BATTERY
We recommend removing the battery from the detector and placing in its charger after switching the
equipment off.
If you leave the battery in the detector, it will gradually run down after a few hours, even
when the detector is not being used.
ALWAYS use the battery charger provided to recharge the battery.
Keep the battery away from heat sources.

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2 POST-PROCESSING
2.1 IMAGE MANAGEMENT
2.1.1 FINDING AN IMAGE
After selecting a study in the Study List, you can preview the images in that study:
If there are more than 4 images in the study, use the up/down arrows to browse these.
Select an image by touching its preview image.

Once selected it has a light blue border:
revision 0 PART 2 page 2.1

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After selecting an image, the Post-Processing frame opens with all the post-processing functions:
W & L correction
(see para. 2.2)
Zoom
(see para. 2.3)
Harmonization (see para. 2.5)

Spatial filters
(see para. 2.4)
Add objects and text
(see para. 2.8)
Electronic collimation
(see para. 2.6) Measurements (see para. 2.7)
Image orientation
Duplicate image (see para. 2.9)
(see para. 2.1.2)
Overview (see para. 2.1.4)
DICOM Store Statistics (*)

(see para. 2.10)
(see para. 4.5.1)
Report Tool
(see para. 4.5)
Delete image
(see para. 2.1.3)
Note (*): This function is only enabled for Advanced users (Technical Service).

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2.1.2 DUPLICATING AN IMAGE
If necessary, you can duplicate (copy) an image in the

study.
The duplicated image can then be managed like a normal
image using the post-processing functions.
Select the image you want to duplicate and then use the
Duplicate image command:
The system asks you to confirm this:
The duplicated image is tagged with the word - COPY-

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2.1.3 DELETING A SINGLE IMAGE
You can delete the image currently shown on the monitor

by using the Delete image command:
The system asks you to confirm this:
Note: You can delete an entire study from the Study List frame (see Annex 4.4.4 in this Part of the
manual).
2.1.4 OVERVIEW
you can view several images on the monitor at the same time.
Select the Overview command:
• There are 3 display options:
- 2 images, horizontally arranged
- 2 images, vertically arranged
- 4 images

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• On selecting the function, the current image is automatically loaded in the first box in the overview.
The other images can then be loaded manually, by selecting their preview images and dragging
them to the empty boxes:
• Overview images can be enlarged or minimised

using the Zoom commands:
• Drag the image in the box to centre the part of interest.
• Quit this function using the Exit

key:

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2.2 WINDOW & LEVEL CORRECTION
You can change the appearance of an image in terms of its brightness and contrast by changing the
W (Window) and L (Level) parameters.
change the contrast (W) and brightness (L) by dragging you finger on the touch screen along the
edges of the image:
decrease W
- horizontally, along the bottom edge of the image to change

the L,
decrease L increase L
- vertically, along the right border of the image to change the
W.
increase W
Note: You can restore the original W and L values at the time of acquiring the
image by enabling the automatic correction option:
There is also a specific correction menu.

Select the W & L correction command:
AUTOMATIC W & L correction
REVERSE POLARITY
WINDOW correction
LEVEL correction
Restore original W & L values prior

Exit
to entering the menu

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This menu lets you:
• Invert the grey scale (reverse polarity).
• Correct the W & L manually.
• Enable automatic L & W settings, to suit the contents of the image inside the
applied ROI (this function is also found directly in the Post-processing frame).
• Touch Exit to save the changes and quit the menu, thus
returning to the Post-Processing menu.

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2.2.1 CHANGING THE GAMMA CORRECTION CURVE
You can also use the Gamma Correction function to change the way an image looks. This alters the
image levels – within the set W – thanks to a series of set LUT curves.
Select this function by touching the

Gamma correction command in the
Post-Processing menu:
Apply: CURVE 1
Apply: CURVE 2
Apply: CURVE 3
NO CURVE APPLIED
Exit
• You can choose one of 3 LUT curves.
• After selecting a LUT curve, the image is automatically corrected (see the images in the example
below):
• Touch Exit to save the changes and quit the menu, thus returning
to the Post-Processing menu.

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2.3 ZOOM
The Wireless F.P. detector always acquires images with a full 2544x3056 matrix.
However during installation you can set the full-screen mode for a smaller matrix for each exam type,
up to an enlargement (zoom) factor where 1 pixel on the monitor corresponds to 1 pixel on the
detector.
The zoom factor can be set within this range:
 Full image on the detector (Z = 0.26 horizontal image orientation, “landscape”)

(Z = 0.29 vertical image orientation, “portrait”)
 1 monitor pixel = 1 detector pixel (Z = 1.0)
You can also change these settings after acquisition by using the
Zoom commands in the Post-Processing frame:
Zoom - Zoom FIT Zoom +
Zoom + : enlarge image.
Zoom FIT : adapt image to display window.
Zoom - : minimize image.
Simply drag your finger on the screen to shift the enlarged image and so centre the specific area of
interest.
You can use the zoom factor for the whole image on the detector or just a specific area of this by
using the electronic shutters.
The Z factor is shown in the bottom bar on the image (see figure below):
Zoom factor

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2.4 SPATIAL FILTERS
You can apply 2 different types of spatial filters (smooth or sharp). Use the commands in the Post-
Processing frame:
Apply Apply
SMOOTH filter SHARP filter
The image is automatically corrected when you select a spatial filter:
- SMOOTH filter: this softens the edges of the image
- SHARP filter: this sharpens (enhances) the edges of the image
- SMOOTH + SHARP: both corrections are applied
Note: The fixed parameters for these 2 filters are set during installation.

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2.5 HARMONIZATION (ATH)
Harmonization algorithms (Anatomical Tissue Harmonization) are used to optimise the dynamics of
the images on the monitor. These depend on the type of exam selected.
These algorithms are associated to the exams mainly on the basis of the body part to be X-rayed.
You can always apply a different algorithm to an

image after acquisition by selecting the
Harmonization command in the Post-Processing
frame:
Algorithm: ATH 1 Algorithm: ATH 2
Algorithm: ATH 3 Algorithm: ATH 4
Algorithm: ATH 5
NO
HARMONIZATION
APPLIED
Exit
• There are 5 different set ATH algorithms.

The image is instantly corrected when you select one of these.
The example in the figure above shows that ATH 2 has been selected (command highlighted).
• Touch Exit to save the changes and quit the menu, thus

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2.6 ELECTRONIC COLLIMATION
You can apply electronic shutters to the acquired image to hide unimportant parts.
2.6.1 AUTOMATIC ELECTRONIC COLLIMATION
If the Auto Collimator function was set for the current type of exam during installation, the electronic
(virtual) shutters are automatically positioned to reflect the real ones (see image):
You can also use the Electronic collimation command in

the Post-Processing menu to set the automatic function, as
follows:

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2.6.2 MANUAL ELECTRONIC COLLIMATION
Use the Electronic collimation command in the Post-

Processing menu:
• Drag a finger over the image to draw a diagonal line

corresponding to the rectangle you want to crop (all parts of the
image outside this rectangle will be covered by a black).
• After drawing this rectangle you can:
- Change its dimensions, by touching one of its sides and then

moving this as required:
Rotate it, by touching one of the corners and then dragging it to

the required position:

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• To quit this function, simply confirm the collimation

by using the same Electronic collimation
command:
The collimated image is then centred on the monitor and enlarged to the max size permitted by the
monitor.

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2.7 MEASUREMENTS
You can measure distances and angles on the image.
Select the Measurements function in the

Post-Processing frame:
Measure distance
Measure angle
Shift
selected element
Calibrate distance
Decrease / Increase
size of text showing
measurement
Undo selected
measurement Exit (SAVING MEASUREMENTS)
2.7.1 MEASURING DISTANCES
The Measure distance function lets you measure linear distances on the
image. Select this function and then:
• Draw a segment (line) on the image between the two points whose distance you
want to measure. A line automatically appears with the measurement shown in
mm.
• To correct this measurement, simply shift:
- either end of the segment, by touching this and then dragging it or by using
the 4 direction arrows.
- the entire segment, by touching the centre of the line and then dragging this or
by using the 4 direction arrows.
Note: The direction arrows move the line by 1 pixel every time you touch them.
• You can also select the segment for a saved distance to:
- increase or decrease the font size used to show the

measurement by using these commands:
- delete the segment, by touching:
If the equipment has not been calibrated (see paragraph 2.7.1.1 below), the measurement is shown in
round brackets (……mm). In this case, the measurement is obtained from the actual dimensions of the
pixels (real pixels) on the Flat Panel Detector.

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2.7.1.1 CALIBRATION
The Calibrate distance function lets you correct the distance measurements by setting a known
distance on the image.
• Draw a segment over a detail of the image whose dimensions are known (gauge).
• Set the measurement of this gauge in the appropriate

field (in mm) and then touch the set button:
Note: All the measurements on the image are automatically recalculated using this new calibration.
Measurements that have been corrected after calibration are distinguished from those that have
NOT been calibrated: non-calibrated measurements are shown with round brackets; calibrated
measurements have no round brackets.
Example:
(110mm) = NOT calibrated 110mm = calibrated
2.7.2 MEASURING ANGLES
The Measure angle function lets you measure angles in the image.
After selecting this function:
• Touch the screen to select the end of the 1st line, then the vertex and finally the
nd
end of the 2 line.
The angle is automatically drawn and its value shown.
Note: The angle measurement shown is always that of the angle smaller than 80°.
• To correct this measurement, simply shift:
- either end of the line or the vertex of the angle, by touching one of these and
then dragging it or by using the 4 direction arrows.
- the entire angle, by touching the centre of either of the two lines and then
dragging this or by using the 4 direction arrows.
Note: The direction arrows move the line/angle by 1 pixel every time you touch them.
• You can also select a saved angle to:
- increase or decrease the font size used to show the

measurement by using these commands:
- delete the angle by touching:
• Touch Exit to save the measurements and quit the menu,

thus returning to the Post-Processing menu.

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2.8 ADDING OBJECTS AND TEXT
You can add graphic objects and texts to the image.
Select the Add objects and text command in the Post-Processing frame to open the menus:
Select rectangle Select arrow
Enter free text
Select string
Decrease / Increase size of

rectangle and text
Exit (SAVING OVERWRITING)

Delete selected
text or object
2.8.1 RECTANGLE
This lets you cover parts of the image you wish to hide.
After selecting this function:
• Draw a diagonal line from one corner of the rectangle to the other and so
create a rectangle over the part of the image you wish to hide. A black
rectangle automatically appears here.
• Touch the rectangle again to:
- drag and drop it using your finger,
- increase/decrease its size using the commands:
- delete it using this command:

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2.8.2 ARROW
The Arrow function lets you draw an arrow on the image.

After selecting the function:
• Draw a line on the image (in the required direction) to create the arrow. A
white arrow with its tip facing the end of the line automatically appears.
• Touch the arrow again to:
2.8.3 ENTERING TEXT
You can add comments on the image. The EM equipment has some default strings you can use;
alternatively, you can enter free text.
• Select the Enter string function. Select the string you want and then touch
position in the image where you want this to appear.
• To enter free text, select the Enter free text function and then:
- type in the text in the box,
- touch Set,
- touch the image where you want it to appear.
• Touch the text again to:
- increase/decrease its size using the commands:
• Touch Exit to save the new text and quit the menu, thus

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2.9 IMAGE ORIENTATION
You can change the orientation of the acquired images.
• Select the Image orientation command in the Post-

Processing frame to open the menu:
Options:
- Rotate image by 90° anti-clockwise
- Rotate image by 90° clockwise
- Horizontal flip
- Manual rotation
Touch the image and then “rotate” at will:
• Touch Exit to save the new orientation and quit the

menu, thus returning to the Post-Processing menu.

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2.10 STATISTICS
The Statistics function can only be accessed by an Advanced or Administrator user.

It lets you find the co-ordinates and pixel values for the image.
Select the Statistics function in the Post-processing

frame to open the menu:
9x9 pixel measuring square

Rectangle of a
size set by the
x and y co-ordinates at the operator
centre of the measuring
square on the image
Statistica
dell’immagine
grezza (RAW)
Equalised
image
statistics
Applied parameters:
- Harmonization algorithm (ATH)
- ROI for automatic W and L correction
Local archive - Gamma correction curve (LUT)
Exit
• Select the part of the image whose pixel values you want to read.
The size of this area may be a:
- fixed 9x9 pixels square:
- variable rectangle:
• After touching the area you are interested in, the relevant values automatically appear in the
relevant reading field. These are given as the raw image values detected by the detector (RAW)
and those for the processed image on the monitor (equalised):
- Minimum
- Maximum
- Average
- Standard dev.: standard deviation
- SNR: signal/noise ratio
2.10.1 LOCAL ARCHIVE
The Local archive function is used by the Technical Service when checking the EM equipment and so
can only by accessed by the Advanced user.
It lets you save the selected image in DICOM or RAW format to the equipment HD.
Select the relevant commands in the Statistics frame:
Note: See the Technical Manual for details on how to use these functions.

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3 MAINTENANCE
Always contact the Technical Service and follow the instructions in the Technical Manual if
extraordinary maintenance is required or components malfunction and/or need to be replaced.
This manual deals only with routine maintenance.
3.1 ROUTINE MAINTENANCE
The EM equipment needs to be checked and serviced on a regular basis. The recommendations
below are aimed at maintaining the efficiency and safety of the equipment.
Routine inspections and maintenance are also needed to protect patients and medical staff from the
risk of injury due to malfunctions.
Correct adjustment of the electronic modules has a direct effect on the performance of the equipment,
image quality, electrical safety and the level of radiation to which the medical staff, hospital staff and
patients are exposed.
The maintenance plan includes checks and inspections to be carried out by expressly authorised and
competent staff. These are the responsibility of the organisation owning the EM equipment.
Always use original parts to replace components that may affect the safety of the EM equipment.
3.1.1 CHECKS AND INSPECTIONS
Only expert personnel authorised by the manufacturer may install, update and repair
X-ray equipment. They must be fully familiar with the relevant safety standards for
Electro-Medical devices.
The next page has a list of the checks for which the user is responsible.
The user must train its operators so that they can carry out these daily checks.
All other checks (preventive maintenance) are detailed in the Technical Manual and may out be
carried out by the Technical Service. Contact the Technical Service immediately if the equipment fails
any check.

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Frequency Part Checks

Daily • Power cable • Visually check for damage (cuts, scratches,
• Spiral cable and manual X-ray cracks).
button
• Monoblock fitting sheath
• Monitor settings • Visually check correct settings (see Annex 4.3).
• Collimator • Check that light switches on and off correctly.

• Motorized movement of the • Check that it is not possible to start the motor
equipment (motorized version only) when the parking brake is engaged.
Monthly • Labels • Visually check their state and legibility.
• Collimator • Check for play in the anti-rotation lever
(see Fig. 9 in paragraph 1.2.5).
• Check that it is fixed securely to the monoblock
flange.
Six-monthly • X-ray monoblock • Check its stability on the rotation axes.
• Check the max rotation on the vertical and
horizontal axes (see Fig. 8 in paragraph 1.2.4).
• Check the rotation of the anode (abnormal noise
during preparation for X-rays)
• Check that the positioning handle is fixed securely.
• Visually check for any oil leaks.
• Articulated arm • Check its vertical stability.
• Check its positioning at max height.
• Check for play in the hooking unit (see figure in
paragraph 1.2.2).
• Magnetothermal switch • Check that it trips/releases properly.
• Transport handles • Check brakes.

• Check brake release.
• Wheels • Visually check for damage.
• Check that the front wheels roll smoothly and
rotate correctly around their axis.
• Bumpers and panels • Visually check for damage (cuts, scratches,
cracks, dents, loose fittings).
• Detector • Check image quality and, if necessary, ask the
Technical Service to recalibrate the detector.
See the Technical Manual for details of any other planned maintenance to be carried out by the
organisation responsible for the equipment and/or the Technical Service.

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3.2 CLEANING AND DISINFECTING
Proper cleaning of the equipment will ensure that your equipment lasts longer.
Clean all the external surfaces at least once a month.
Do not use cleaning products that have a high alcohol content to clean the EM equipment. Do not use
corrosive detergents, abrasive products or solvents.
Use only disinfectant and sterilising products that fully comply with existing disinfecting and explosion
prevention procedures to disinfect and, if necessary, sterilize the EM equipment.
The following precautions must be adopted when cleaning and disinfecting the equipment:
• Switch the EM equipment off and unplug at the mains.
• Use a solution of neutral soap and water to clean the equipment.
• First apply the soapy water to a clean cloth and then proceed to clean the parts. Any liquid applied
directly to the equipment could penetrate inside and cause damage.
• Dry and clean the equipment immediately should any liquid be split on this.
• Wait for the cleaned parts to dry completely before switching the equipment back on.
• Soak a clean cloth in a water + quaternary ammonia solution to disinfect the equipment.
If using disinfectants that form flammable gases, make sure that the gases have had time
to disperse before using the EM equipment again.
The EM equipment must not be used in presence of flammable anaesthetics and/or

disinfectants and cleaning products.
Do not use the equipment while it is being cleaned.
If the intended use of the system requires sterilization of the EM equipment, this must be
done by the user using methods and products that comply with current laws.

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3.2.1 CLEANING THE TOUCH SCREEN MONITOR
• Switch the EM equipment off and unplug before cleaning the monitor.
• Never use alcohol (methyl, ethyl or isopropyl alcohol) or strong solvents. Never use thinners or
benzene, abrasive detergents or compressed air.
• Use a slightly damp cloth and a little delicate detergent to clean the touch screen casing.
• Do not allow liquids to penetrate the monitor. If this should happen, contact a qualified technician
before switching the monitor on again.
• Take care not to scratch the screen. Do not use abrasive materials.
• Use window-cleaning products to clean the touch screen. Wipe with a soft clean cloth soaked in the
detergent. Never apply the detergent directly to the screen.
3.2.2 CLEANING THE DETECTOR
The Wireless F.P. detector can be used in contact with the patient and so requires special cleaning.
To clean the detector:
- Remove the battery.
- Use only a neutral soapy solution to clean the detector.

First apply the soapy water to a clean cloth and then clean the equipment. If you spray the soapy
water directly on the detector, there is the risk of it penetrating and thus damaging the detector.
To clean the battery compartment:

- Use a clean soft cloth to remove any dust or dirt in and around the compartment,
- Use a toothbrush or vacuum cleaner to clean the contacts on the side of the battery compartment (or
contact the Technical Service).
Never immerse the detector in liquid.
Never immerse the battery in liquid and keep it away from heat sources.

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4 ANNEXES
4.1 USING THE KEYBOARD ON THE TOUCH SCREEN MONITOR
The touch screen monitor provides all the necessary man/machine interface.
An alphanumerical keyboard appears at the bottom of the monitor whenever you need to enter
characters (e.g. the LOGIN page, as shown in the photo below). You can drag and drop this keyboard
to any part of the monitor:
A number-pad appears at the bottom of the monitor whenever you need to enter numbers (e.g. a date
of birth, as shown in the figure below). Again, you can drag and drop this to any part of the monitor:
revision A PART 2 page 4.1

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4.2 IN-LINE MANUAL
The User Manual for the EM equipment (as well as the Technical Manual) can be recalled online in
PDF format:
• Select primo mr in the home page:
• The software release appears. Select this command:
Operator manual to consult the user manual.
The Acrobat Reader application now opens and shows the manual plus its index (bookmarks).
Note: Each heading in the contents page is linked to the relevant page to speed things up.

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4.3 MONITOR ADJUSTMENTS
You must check the correct monitor settings every time the EM equipment is switched on.
For this reason, a test pattern (SMTPE) appears after logging in:
A B
If necessary, the brightness and contrast of the monitors must be adjusted so that the entire grey
scale is visible (each box indicates the brightness %). More specifically, it must be possible to see:
- the full grey scale (boxes from 0% to 100%),

- the grey square in the black box (A),
- the grey square in the white box (B).
Below are details of the monitor adjustment procedure.
The remote commands needed to access the monitor settings and control menus are found on the
right of the monitor base:
1 2 3 4
Buttons:
1- Auto/Sel Self-configuration / Selection

2- Down Search backwards
3- Up Search forwards
4- Menu Open the settings menu / Exit
• Touch “Auto/Sel” and the monitor automatically configures itself.

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• Press “Menu“ to access the manual settings:

- use “Up” and “Down” to select a function and adjust its parameters,
- touch “Auto/Sel” to enable a selected function.
• Touch “Menu”, select CONTRAST and then adjust the parameter to get the best possible display
of the test pattern.
• Select BRIGHTNESS and then adjust the parameter to get the best possible display of the test
pattern.

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4.4 STUDY LIST MANAGEMENT
The following functions help you quickly manage the Study List:
- Sort list
- Find study
- Select study
- Delete study
4.4.1 SORT LIST
The Study List can be sorted:
- in chronological order (study date or date of birth),
- in alphabetical order by:

- Patient name,
- Patient ID,
- Sex,
- Description,
- Accession number,
- Physician.
Touch the top of the sort parameter column you want to use to sort the list. Touch the same column
again to reverse the order (increasing/decreasing).
Indicator to sort by
“study date”

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4.4.2 FIND STUDY
There is a search box that lets you enter a given parameter to find a study in the list.
You can use this search function for any of the columns in the list (e.g. the “Patient name” search
box).
Search box for finding a

name in the list
4.4.3 SELECT MULTIPLE STUDIES
Use the relevant command to select more than one study in the list (e.g. to send to
a DICOM device or to delete these):
You can now select the studies you want.

They become highlighted.

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• You can also select all the studies in the list by using the
relevant command:
4.4.4 DELETE STUDY
After selecting one or more studies in the list, you can delete
these (provided they are not protected against deletion) by
using the relevant command:
• The system asks you to confirm their deletion. Touch the YES
command:
Note: See next paragraph for details on how to protect a study against deletion.

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4.4.4.1 PROTECTING A STUDY AGAINST DELETION
You can protect images in a study against accidental deletion by selecting the study and then using
the Lock command:
Protected studies are marked with a padlock symbol:
Note: Even single images in a protected study cannot be deleted.

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4.5 TRANSFERRING IMAGES VIA DICOM
You can send images via the DICOM-3.0 protocol network:
• to a workstation, by using the STORE DICOM function (see paragraph 4.5.1 below). The options
are:
1) send a single image from the Post-Processing frame

2) send a full study from the Study List frame
3) send one or more images in a study from the Report Tool menu
• to a printer, by using the PRINT DICOM function.
You can also send one or more manually or automatically composed images in one or more films
using the Report Tool menu (see paragraph 4.5.2 below).
The DICOM Spooler menu indicates when transfer is successful (see paragraph 4.5.3 below).
In order to send an image to a DICOM device, you need to connect the EM equipment to the hospital
computer network (RIS) using an Ethernet cable in the correct port on the left side of the equipment:
Note: The physical characteristics of the network connection are detailed in the Technical Manual.
4.5.1 STORE DICOM
1) Touch the relevant command in the Post-Processing frame to transfer the single image currently
displayed on the monitor:

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2) Select one or more studies in the Study List and then use the relevant command to transfer these
via DICOM:
3) Still in the Study List frame, select a study and use the relevant command to access the Report
Tool menu and then select the images you want to transfer:

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• The Report Tool menu shows you all the images in the study.
You can select these manually by touching their preview images or use the commands on the right:
- Select all images
- Select none (undo selection)
- Reverse selection.
Touch Store to send the selected images.
• Images are sent to the transmission queue (Spooler). The Image sent to spooler message now
appears:
Note: If the system has more than one archive workstation, a window appears letting you select the
workstation to receive the images/study once you touch the STORE command:

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4.5.2 PRINT DICOM
• Select a study in the Study List frame and use the relevant command to access the Report Tool
menu and then select the images you want to print using the PRINT DICOM function:
• The Report Tool menu shows you all the images in the study.
- Select all images

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• Touch the Print command to open the Automatic Composition screen that then
automatically composes the film(s) with the selected images, according to the set
print layout:
• Here you can:
- Print all the films shown by touching Print:
- Cancel the composition and return to the previous page

by touching Cancel:
- Switch to manual mode by touching Manual:

(see paragraph below)
4.5.2.1 MANUAL COMPOSITION
Manual composition of the film for printing is

done via the Manual Composition page:
• Touch the Manual command to open the box

that lets you select the printer and the print
layout from among those set up during
installation.

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USER MANUAL
• Alternatively, select one of the printers shown and then compose the layout manually by selecting
the relevant options:
- orientation: vertical (PORTRAIT) horizontal (LANDSCAPE)
- true size 1:1: disabled (OFF) enabled (ON)
- true scale: disabled (OFF) enabled (ON)
- n° copies and annotations:
- film size:
- film format:

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USER MANUAL
• Select the print options and then touch the Accept

command to create the film layout:
• Now select the preview images in the box at

the bottom of the screen to compose the film
to be printed (drag and drop into the frames):
• Once you have completed the film, you can:
- create an identical layout

by touching:

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USER MANUAL
- create a new layout by touching:
Note: You can also delete the last layout by touching:
• Having created the film(s), touch the Print command to send it/them to the DICOM network:
• Transmission of the film(s) to the print queue (Spooler) now starts. The Images sent to spooler
message appears.

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USER MANUAL
4.5.3 DICOM SPOOLER
The DICOM Spooler function manages the transmission of images to the DICOM network via a buffer
memory (on the Hard Disk) where the images to be transmitted are stored in a queue.
You can access the menu for this function by touching the relevant command in the Study List frame:
List of images in the transmission queue
Warning Options
The DICOM Spooler button also shows you the spooler status, as it changes to reflect the various
situations, as follows:
Status: normal
Status: studies waiting to be sent (queued)
Status: studies being sent

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USER MANUAL
Here you can manage any images that have not been sent yet (i.e. still in the queue).
Operations Status
The Status panel shows the status of the images and their transmission in real time. It shows the
following details:
Spool Spooler status (active / disabled)
Waiting Number of images in the queue
Failed
Number of images not sent (error or system
malfunction)
In progress Number of images currently being sent
Queue filling
Filling level (in %) of the transmission queue
level

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USER MANUAL
The status of each image in the transmission queue is also shown in the main window, in the
corresponding column: St (State).
Image status:
Waiting Waiting Failed

(first try) (subsequent tries)
In progress DICOM error Construction

DICOM object
Manual delete (print) Manual (store)
Use the commands in the Operations panel to manage the images still in the queue:
Scheduled date Priority Item Uid / Study
Reschedule Delete Stop / Start

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USER MANUAL
Touch Stop to stop any further filling of the transmission queue (Spool: Disabled). This also
enables the Operations commands:
Now you can:
• delete one or more selected images in the transmission queue by touching the
Delete command:
• set the re-transmission date for a selected image using the Scheduled date
command and then order the new transmission request by touching the Reschedule
command:
• set the transmission priority for the selected image using these commands:
- 1 = low priority, 3 = normal priority, 5 = top priority
• change the description field of an image in the Spooler. The options are:
- Item Uid
- Study description
Touch the Start command to restore normal Spooler operation:
Filling of the transmission queue now continues (Spool: Active) and the commands in the Operations
panel are disabled:

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USER MANUAL
4.6 SAVING IMAGES TO CD/DVD OR USB PEN DRIVE
The EM equipment lets you save images in DICOM format to a CD/DVD or USB PEN DRIVE in two
modes, as described below.
1) Save a complete study selected in the Study List: select the study and then copy by touching the
relevant command:
2) Save selected images in a study.

Again from the Study List, select a study and then access the Report Tool menu by touching the
relevant command. You can now copy the individual image(s):

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USER MANUAL
The Report Tool shows all the images in the study.

- Select all images
• Whichever mode you use, touch the command: or
To open the archiving frame:
Recording device
Volume label for the medium
Size of data to be saved and

recommended medium
• Now you can start saving the data by touching the Burn command:

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USER MANUAL
• After completing the recording, the Status field reads Write completed and you can now remove
the CD/DVD from the CD drive or the USB PEN DRIVE:
• Touch to end the procedure and return to the Study List.
Note: The following two extra CD/DVD functions can be used by the Advanced user:
- Multisession: select if you want to keep the DC/DVD burning session

open and so add further studies at a later date.
- Erase disk to delete the data on the disk (if rewritable).

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USER MANUAL
4.6.1 OPENING A DICOM ARCHIVE ON A REMOVABLE DEVICE
When saving images to CD/DVD or USB PEN DRIVE, the DICOM Open Viewer program is
automatically added to it. This lets you view the DICOM images on a PC (the example below refers to
images on a CD/DVD).
• The DICOM Open Viewer program automatically opens a few seconds after inserting the CD/DVD
in the relevant drive on the PC:
• If the images are not automatically opened (this happens when several studies are saved on the
same CD/DVD), click on Open and then select the file “DICOMDIR” on the CD in the folder
containing the study you want to view:

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USER MANUAL
• After selecting the DICOMDIR file, click on Open to open the images in the folder:
The Series Preview menu (on the right of the screen) has the following functions:
Select next/last run
Show only selected images in the run
Show all images in the run
Return to the Image Tools menu

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USER MANUAL
• Double-click on a preview image to open the full image:
4.6.1.1 FUNCTIONS LIST
The Image Tools menu has the following functions:
Exit
Open file
Show/hide patient data
Display grid
Find image
Show only selected images

NAVIGATION
GROUP Select all
Undo selection
Show all
Vertical flip
Horizontal flip
GEOMETRY
Rotate 90° clockwise
GROUP
Rotate 90° anti-clockwise

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USER MANUAL
Cineloop functions
(NOT USED)
CINE
GROUP
Zoom 1:1 Adapt zoom to window
ZOOM Select zoom

GROUP
Left key functions Select / Pan / Lens

MOUSE
GROUP Centre key functions Find / Zoom
Right key functions Window,Level / Dicom Tags
Adjust Center
WL GROUP Adjust Window

(WINDOW-LEVEL)
Adjustment sensitivity
Reverse grey scale Reset
Automatic W-L

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USER MANUAL
4.6.1.2 DICOM TAGS
DICOM Open Viewer also lets you view the DICOM parameters (DICOM TAGS) for a selected image.
Select the DICOM Tags menu to open the DICOM parameters page:
This menu contains the following functions:
Save all data in txt format
Print all data on a system printer
Return to the Image Tools menu

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USER MANUAL
4.7 CHANGING THE USER PASSWORD
Login passwords are only valid for 90 days. After this time, the system disables a user until the
password is updated.
If a password has expired, the following message appears during the Login:
• To change the password, touch the key symbol:
• Now enter the old password followed by the new password (twice). Then touch the
acceptance command:

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USER MANUAL
4.8 POTTER BUCKY
The equipment also lets you synchronise X-ray exposures with an external potter bucky.
The potter bucky should be connected to the equipment using connector J1, as shown in the figure
below:
J1
ATTENTION:
This function can only be used when the equipment has been
configured by the installer, as explained in the Technical
Manual for the equipment.
Switch both the equipment and the potter bucky off and then connect the two devices using the
connection cable provided by the installer.
Switch both devices on again and access the application. Create a study and select the anatomical
exam preset by the installer to work with a potter bucky.
The icon below indicates that the selected exam can only be used if a potter bucky is connected.

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USER MANUAL
4.9 DETECTOR SETUP USING THE INFRARED INTERFACE
The PIXIUM 3543EZ detector can be shared by more than one primo or Raybow dR unit.
If the detector comes from another unit, it must be set up using the infrared interface before it can be
used with the Raybow dR.
Touch the ACTIVATE INFRARED button (only when the FPD is not connected); the setup page then
opens. (You can access this page from both the Study-List and the Working Frame).
Quickly place the Flat Panel Detector (side with LEDs) close to the IRDA interface.
Note: Optional function.

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USER MANUAL
Red dots appears until the infrared device connects with the detector.
These become green once the infrared device is connected to the FPD.
The “WI-FI connecting” message then appears... indiccating that the setup data have been transferred
correctly.

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USER MANUAL
Part 3: TECHNICAL DATA
CONTENTS
page rev. date
CONTENTS I-1 B 20/04/14
1 TECHNICAL DATA 1.1 to 1.13 B 20/04/14

1.1 Classification of the EM equipment
1.2 Technical characteristics
1.2.1 Electrical / mechanical data
1.2.2 Image acquisition system
1.2.3 Operating modes
1.2.4 kV – Ma correlation: standard version and
motorized version (mains supply)
1.2.5 kV – mA correlation: motorized version (battery
powered)
1.2.6 Dose emitted at a distance of 1m
1.3 Overall dimensions and weight
1.3.1 Mobile unit
1.3.1.1 Overall dimensions and weight:
standard version
1.3.1.2 Overall dimensions and weight:
motorized version
1.3.1.3 X-ray beam size
1.3.2 DRX-1 detector, battery and battery charger
1.3.3 3543EZ Pixium detector, battery and battery
charger

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USER MANUAL
1 TECHNICAL DATA
1.1 CLASSIFICATION OF THE EM EQUIPMENT
Protection against electrical contact: Class I
Protection against electrical contact (applied part): B
Applied part: Wireless F.P. detector
Degree of protection against water penetration: Common EM equipment
Degree of safety in the presence of flammable gases: EM equipment not suitable for use in
the presence of flammable substances.
EM equipment not suitable for use in

oxygen-rich environments
Conditions of use: Continuous
revision B SECTION 3 pag. 1.1

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USER MANUAL
1.2 TECHNICAL CHARACTERISTICS
The technical characteristics of the EM equipment are listed below, split as follows:
1. electrical / mechanical data
2. image acquisition system
3. operating modes
1.2.1 ELECTRICAL / MECHANICAL DATA
POWER SUPPLY Single-phase voltage 230 V ± 10%, 50/60 Hz, 16 A max

Line resistance 0.4 ohm
Connector (IEC 309 compliant) 16 A
ENVIRONMENTAL Transport and storage temperature 10 - 40 °C

CONDITIONS Transport and storage relative humidity 20 - 70 %
Working temperature 10 - 30 °C
Working relative humidity 20 - 70 %
Atmospheric pressure 70 - 106 kPa
MOBILE UNIT - Model Easy 40 module

STANDARD Arm rotation ± 90°
VERSION Front wheels Castor wheels, anti-static rubber
Rear wheels Ø 43.5 cm
Braking system “Dead man’s”
Focus-plane distance 60 - 202 cm
Rotation of monoblock support +90° to -180°
Rotation of monoblock on its support 0° to +90°
MOBILE UNIT - Model Easy 40 M module

MOTORIZED Arm rotation ± 90°
VERSION Front wheels Castor wheels, anti-static rubber
Rear wheels Ø 43.5 cm - motorized
Max speed 4 km/h
Battery capacity Up to 200 exposures at 50mAs
(80 kVp)
Max battery charging time 5 hours
Braking system “Dead man’s”
Focus-plane distance 60 - 202 cm
Rotation of monoblock support +90° to -180°
Rotation of monoblock on its support 0° to +90°
X-RAY Model CONVERTER OF 7640

GENERATOR Oscillation frequency 40 kHz
Max voltage to X-ray tube 125 kVp
Max power 40 kW @100kV – 400mA – 100ms
Current to X-ray tube 50 - 500 mA
Scale R’10 (see EN60601-2-54)
Max voltage ripple 1%
mAs 1 - 400
Scale R’10 (see EN60601-2-54)

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USER MANUAL
MONOBLOCK Model 125/500 HF/AR

Thermal capacity 825kJ – 1103 kHU
Continuous dissipation 100W
Thermal safety Normally closed at 63°
Inherent filtering 1.5 mm Al @ 80kV
X-RAY TUBE Model IAE – RTM 77H

Anode rotation 3000 RPM
Anode material RTM
Anode target angle 15°
Max anode charge 20 kW / 40 kW
Nominal focus 0.75 mm / 1.25 mm
Thermal capacity of the anode 225kJ- 300kHU
Continuous heat dissipation 750 W max
COLLIMATOR Model R 108

Power supply 24 V – 6.5 A
Class / Type 1/B
Light 100 W – 24 V – 4 A
Light intensity 160 LUX at 1m
Inherent filtering 2 mm Al at 75kVp
Max load capacity of accessory guides Static load 70 N ( c. 7.1 kg)
Dynamic load, 15 Nm (c. 3.06 kg)
DAP (OPTIONAL) Model KermaX Plus

(mod. 120-131 OEM HS / RS485)
Power supply DC: 9 - 29 V (max 65 mA)
Overall dimensions 156 x 180 x 18 mm
Useful area 146 x 146 mm
Sensitivity 0.1 mGy*cm²
GRID Model PDRDRX

(OPTIONAL) Dimension 35 x 43cm
Ratio 6:1
Line pair /inch 215
Focus 67 - 110cm

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USER MANUAL
1.2.2 IMAGE ACQUISITION SYSTEM
DRX-1 Model DRX-1

WIRELESS Dimensions 380 x 460 x 16 mm
DETECTOR Weight 4 kg
Receiver type Amorphous silica
Conversion screen Gd202S:Tb
Acquisition time (typical) 20 seconds
Working dose 0.5 - 5 µGy/image
Pixel size 139 x 139 µm
Dimensions of active area 35.3 x 42.4 cm
Matrix 2544 x 3056 pixel
Resolution (max) 3.6 lp/mm
A/D conversion 14 bits
3543EZ PIXIUM Model Pixium 3543EZ

WIRELESS Dimensions 383 x 460 x 16 mm
DETECTOR Weight 2.8 kg
Receiver type Amorphous silica
Conversion screen Csi
Acquisition time (typical) 12 seconds
Working dose 0.5 - 5 µGy/image
Pixel size 148 x 148 µm
Dimensions of active area 35,5 x 42,6 cm
Matrix 2400 x 2880 pixel
Resolution (max) 3.6 lp/mm
A/D conversion 16 bits
TOUCH SCREEN Model 1938L

MONITOR Type 19” colour, TFT
Touch screen IntelliTouch superficial acoustic wave
Pixel size 0.284 x 0.2842 mm
Resolution 1440 x 900 at 60 Hz
Contrast ratio 1000 : 1
Brightness 230 cd/m²
Colours 16.7 million
Viewing angle 178° vertical – 178° horizontal
Overall dimensions 408 x 255 mm

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USER MANUAL
VIDEO PROCESSOR Image format (*) Matrix : see detector matrix

UNIT 16 bits, unsigned
Dynamic saving 4 GB RAM
Acquisition Digital, 16 bits, Ethernet via LAN
Post-processing (*) Dedicated LUT for each exam type
Spatial filters
ATH (Anatomic Tissue Harmonization)
Image flip: V / H
Continuous image rotation
Electronic shutters (rectangular and polygonal)
Reverse polarity (grey scale)
Image previews (thumbnails)
Zoom, with variable enlargement
Brightness and contrast control
Graphic functions Distance calculation
Angle calculation
Overlay of text and markers on image
System HD SATA2, standard capacity 320 GB,
guaranteed 24/24 operation
Archive HD SATA2, standard capacity 320 GB,
guaranteed 24/24 operation
N° images that can be saved 60 images / GB
N° exams Unlimited: depends on HD capacity
Operating system Windows XP Professional 32 bits
Processor INTEL Pentium dual core
Ethernet 10/100/1000MBits Standard DICOM 3 - Ethernet TCP/IP
Support for PENDRIVE USB 2.0 interface
Media CD/ DVD recorder drive
1.2.3 OPERATING MODES
RADIOGRAPHY Techniques 2-point: kV, mAs

3-point: kV, mA, msec
Patient sizes 4 sizes: Paediatric, Small, Medium, Large
kV selection Continuous: 40 - 125 kV
(*):
The image is saved in RAW format on the equipment archive disk (D).
The parameters for the digital image processing used to display the image on the monitor are saved in
the equipment DATABASE.
The type of digital processing applied to the image is indicated by the name of the projection in
question, which appears together with the image itself.

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USER MANUAL
1.2.4 kV – mA CORRELATION: STANDARD VERSION AND MOTORIZED VERSION (MAINS

SUPPLY)
40kV 46kV 51kV 56kV 61kV 66kV 71kV 76Kv 81kV 86kV 91kV 96kV 101Kv 106kV 111kV 116kV 121kV
÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷
45kV 50kV 55kV 60kV 65kV 70kV 75kV 80kV 85kV 90kV 95kV 100kV 105kV 110kV 115kV 120kV 125kV
0,5mAs 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA
0.6mAs 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA
1mAs 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA 100mA
50mAs 200mA 250mA 500mA 500mA 500mA 500mA 500mA 500mA 400mA 400mA 320mA 320mA 125mA 125mA 50mA
63mAs 200mA 250mA 500mA 500mA 400mA 400mA 400mA 320mA 200mA 200mA 100mA 100mA 63mA
80mAs 200mA 250mA 500mA 500mA 400mA 400mA 320mA 250mA 100mA 100mA 50mA 50mA
100mAs 200mA 250mA 400mA 400mA 250mA 200mA 125mA 100mA 63mA 50mA
125mAs 200mA 200mA 125mA 125mA 100mA 80mA 63mA 63mA
160mAs 125mA 100mA 80mA 80mA 50mA 50mA 50mA 50mA
200mAs 80mA 80mA 63mA 63mA 50mA 50mA
250mAs 80mA 50mA 63mA 50mA
320mAs 63mA 63mA
400mAs 63mA
÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷
50mA 6,3s 6,3s 6,3s 5s 4s 4s 3.2s 3.2s 2s 2s 1.6s 1.6s 1.25s 1s 1s 0.8s 0.8s
63mA 6,3s 5s 4s 3.2s 2.5s 2.5s 2s 2s 1.6s 1.25s 1.25s 1s 1s 0.8s 0.63s 0.63s 0.63s
80mA 3.2s 2.5s 2s 2s 1.6s 1.6s 1.25s 1.25s 1s 1s 0.8s 0.8s 0.63s 0.63s 0.5s 0.5s 0.4s
100mA 1.6s 1.6s 1.25s 1.25s 1.25s 1s 1s 1s 0.8s 0.8s 0.63s 0.63s 0.5s 0.5s 0.4s 0.4s 0.32s
125mA 1.25s 1s 1s 1s 0.8s 0.8s 0.8s 0.63s 0.63s 0.63s 0.5s 0.4s 0.4s 0.4s 0.32s 0.32s 0.25s
0.125s 0.08s
160mA 0.8s 0.8s 0.63s 0.63s 0.63s 0.63s 0.5s 0.5s 0.4s 0.4s 0.32s 0.32s 0.25s 0.25s 0.2s
0.2s 0.2s
0.2s 0.16s 0.08s
200mA 0.63s 0.63s 0.5s 0.5s 0.5s 0.5s 0.4s 0.4s 0.32s 0.2s 0.2s 0.16s 0.16s 0.16s
0.32s 0.25s 0.25s
0.2s 0.08s
250mA 0.4s 0.4s 0.4s 0.4s 0.32s 0.25s 0.25s 0.2s 0.2s 0.16s 0.16s 0.125s 0,125s 0,1
0.32s 0.32s
320mA 0.32s 0.32s 0.32s 0.25s 0.25s 0.25s 0.2s 0.2s 0.16s 0.16s 0.16s 0.125s 0.125s 0,1s 0,1s 0,08s
400mA 0.25s 0.25s 0.25s 0.2s 0.2s 0,16s 0,16s 0,125s 0,125s 0,1s 0,1s
500mA 0.2s 0.16s 0,16s 0,125s 0,125s 0,1s 0,1s
Key:
SMALL FOCUS
LARGE FOCUS

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USER MANUAL
1.2.5 kV – mA CORRELATION: MOTORIZED VERSION (BATTERY OPERATED)
÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷
50mAs 200mA 250mA 500mA 500mA 500mA 500mA 500mA 500mA 400mA 400mA 320mA 320mA 125mA 125mA 50mA
÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷ ÷
50mA 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s
0.125s 0.08s
160mA 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.2s
0.2s 0.2s
0.2s 0.16s 0.08s
200mA 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.25s 0.2s 0.2s 0.16s 0.16s 0.16s
0.25s 0.25s 0.25s
0.08s
250mA 0.2s 0.2s 0.2s 0.2s 0.2s 0.2s 0.2s 0.2s 0.2s 0.2s 0.16s 0.16s 0.125s 0.125s 0.1
0.2s
320mA 0.125s 0.125s 0.125s 0.125s 0.125s 0.125s 0.125s 0.125s 0.125s 0.125s 0.125s 0.125s 0.1s 0.1s 0.08s 0.08s
400mA 0.1s 0.1s 0.1s 0.1s 0.1s 0.1s 0.1s 0.1s 0.1s 0.1s 0.1s
500mA 0.1s 0.1s 0.1s 0.1s 0.1s 0.1s 0.1s
Key:
SMALL FOCUS
LARGE FOCUS

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USER MANUAL
1.2.6 DOSE EMITTED AT A DISTANCE OF 1m
The dose emitted for each mAs has been measured at a distance of 1m from the focal spot of the X-
ray tube.
kV uGy/mAs
40 7.01
50 15.16
60 24.62
70 35.14
80 46.45
90 59.32
100 72.83
110 86.94
120 102.40
125 109.80
Dose/mAs [uGy/mAs] at 1m
120,00
110,00
100,00
90,00
80,00
uGy/mAs
70,00
60,00
50,00
40,00
30,00
20,00
10,00
0,00
40 50 60 70 80 90 100 110 120 130
Rx Tube Voltage [kV]

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USER MANUAL
1.3 OVERALL DIMENSIONS AND WEIGHT
1.3.1 MOBILE UNIT
1.3.1.1 OVERALL DIMENSIONS AND WEIGHT: STANDARD VERSION
revision B PART
Weight: 2603 kg
page 1.9
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USER MANUAL
1.3.1.2 OVERALL DIMENSIONS AND WEIGHT: MOTORIZED VERSION
Weight : 280 kg

USER MANUAL
1.3.1.3 X-RAY BEAM SIZE
Anode angle
Focal spot
Fixed beam limitation (*)
Reference axis
(*) = with X-ray collimator plates fully open

USER MANUAL
1.3.2 DRX-1 DETECTOR, BATTERY AND BATTERY CHARGER
BATTERY
Thickness: 6.7 mm
Weight: 0.5 Kg
DETECTOR
Thickness : 16 mm
wEIGHT: 3.5 Kg
The battery charger is not a medical device and so must not be placed in the vicinity of the patient.
It should simply be placed on a workbench close to a mains socket (100-240V AC, 50/60Hz - max
consumption 1A).
BATTERY CHARGER
Weight: 2 kg

USER MANUAL
1.3.3 3543EZ PIXIUM DETECTOR, BATTERY AND BATTERY CHARGER
DETECTOR
Thickness : 16 mm
Weight: 2.6 Kg
BATTERY
Thickness : 7 mm
Weight: 0.2 Kg
The battery charger is not a medical device and so must not be placed in the vicinity of the patient.
It should simply be placed on a workbench close to a mains socket (100-240V AC, 50/60Hz - max
consumption 1A).
BATTERY CHARGER
Weight: 0.5 kg


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EN

series 01 Mobile X-ray device with digital detector

NOTE : This manual is also valid for these systems :

pages rev. date

0.1 to 0.9 B 20/03/14

1 DESCRIPTION OF THE EM EQUIPMENT

revision B PART 0 page 0.1

XX XXX 67 XX Follow instructions

ATS Applicazione Tecnologie Speciali s.r.l.

Fig. 1 – Position of the Raybow

SN XX XXX 88 XX Follow instructions

ATS Applicazione Tecnologie Speciali s.r.l.

Fig. 2– Position of the primo-mR serial n° label

revision B PART 0 page 0.2

SN XX XXX 67 XX Follow instructions

ATS Applicazione Tecnologie Speciali s.r.l.

Fig. 3 – Position of the Raybow dR-M

SN XX XXX 88 XX Follow instructions

ATS Applicazione Tecnologie Speciali s.r.l.

Fig. 4 – Position of the primo-mR-M serial n° label

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Component Serial n° Position Figure

X-ray monoblock Supplier’s Visible, on device Fig. 6

DRX-1 wireless detector Supplier’s Visible, on device

3543EZ PIXIUM wireless detector Supplier’s Visible, on device

DAP (optional) Supplier’s Visible, on device Fig. 8

The figures below show the positions of the serial n° labels:

Collimator serial n° label

Easy 40 / Easy 40M module

Fig. 5 - Position of serial n° labels: X-ray collimator, Easy 40 / Easy 40M

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Monoblock serial n° label

Fig. 6 - Position of serial n° labels: monoblock , anti-scatter grid (optional).

Battery serial n° Battery charger serial n°

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Fig. 8 - Position of serial n° labels –DAP (optional)

Battery charger serial n°

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This X-ray device is produced by:

Applicazione Tecnologie Speciali srl

The following harmonised standards apply to the EM equipment:

EN 62366 1st edition Medical devices – Application of engineering characteristics used

EN ISO 14971:2009 Medical devices. Application of risk management to medical devices

EN 980:2008 Symbols used for labelling medical devices

EN ISO 780:1999 Graphic markings for moving goods

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Part 1: GENERAL DESCRIPTION

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CONTENTS I-1 B 20/03/14

1 DESCRIPTION OF THE EM EQUIPMENT 1.1 to 1.15 B 20/03/14

2 SAFETY 2.1 to 2.31 B 20/03/14

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1 DESCRIPTION OF THE EM EQUIPMENT

1.1.1 COMPLETE SYSTEM

The EM equipment consists of:

5 Anti-scatter grid 4 Battery charger

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1.1.2 MOBILE UNIT - STANDARD VERSION

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1.1.3 MOBILE UNIT - MOTORIZED VERSION