XFM User Manual

Digital mobile diagnostic X-ray system
OPERATOR MANUAL
Cod. MOEXFM06
APPARECCHI RADIOLOGICI ELETTROMEDICALI

VIA DEL PARLAMENTO EUROPEO 9D - 50018 Scandicci (FI) -Italy TEL. +39-055 7228511 – FAX +39-055 7228512
Web: www.italray.it email: info@italray.it
ITALRAY - XFM MOEXFM06
MANUAL INFORMATION
REVISIONE RELEASE MOEXFM06 VALID FROM S/N 01-127-15
PREPARATO PREPARED SARAH BASSI
VERIFICATO CHECKED RICCARDO SARTI ANDREA CINTI
APPROVATO APPROVED STEFANO BALDINI
DATA DI EMISSIONE DATE OF EMISSION 08/07/2015
REVISION INDEX
02/10/2012 MOEXFM00 – First Emission
12/02/2013 MOEXFM01 – Ups detail
24/04/2014 MOEXFM02 – General revision, obstacle sensor, P3543EZ
30/06/2014 MOEXFM03 – Better explanation for some functions
02/10/2014 MOEXFM04 – General revision, USB key function
06/02/2015 MOEXFM05 – New part recommended use of the system
08/07/2015 MOEXFM06 – New system start up
ENCLOSED DOCUMENTATION
CODE / PART NUMBER REVISION
NOTES
This manual in English is the original version.
OPERATOR MANUAL 2 / 72
INDEX
1 WARNING................................................................................................................................... 5
2 INTRODUCTION .......................................................................................................................... 8
3 DESCRIPTION............................................................................................................................ 8
4 TECHNICAL STANDARD ........................................................................................................... 8
5 TECHNICAL SPECIFICATION.................................................................................................... 9
Environmental Conditions.......................................................................................................12
Identification...........................................................................................................................13
Optional .................................................................................................................................14
Disposal of materials ..............................................................................................................14
Warranty ................................................................................................................................14
6 ELECTROMAGNETIC COMPATIBILITY....................................................................................15
7 OPERATOR MANUAL ...............................................................................................................18

System Composition ..............................................................................................................19
Start-up..................................................................................................................................20
Recommended use of system ................................................................................................21
Re-setting the equipment .......................................................................................................23
Pre-use controls.....................................................................................................................24
Manual moving and positioning the equipment .......................................................................26
Motorised device ....................................................................................................................27
Motor driven exclusion ...........................................................................................................29
Special instruction for battery device ......................................................................................30
Information and instruction about battery package ..................................................................30
Positioning the articulated arm................................................................................................31
Arm Locking system...............................................................................................................31
Arm Locking system...............................................................................................................32
Positioning the collimator........................................................................................................33
Setting the x-ray field..............................................................................................................33
PIXIUM 3543EZ Detector .......................................................................................................34
Battery ...................................................................................................................................37
Backup Cable (BUC) ..............................................................................................................37
Battery Charger......................................................................................................................38
ACQUISITION AND IMAGES ELABORATION SYSTEM.............................................................39
Starting and Turning Off the System.......................................................................................39
Examination Management ......................................................................................................40
Open an Examination from Worklist........................................................................................43
Opening of a New examination...............................................................................................45
Open an Examination from the Local Archive .........................................................................47
Configuration..........................................................................................................................47
Print Spooler ..........................................................................................................................48
Storage Spooler .....................................................................................................................49
Quit........................................................................................................................................49
Examination Acquisition .........................................................................................................50
Examination Images...............................................................................................................52
Automatic Processing of the Image ........................................................................................53
Post-Processing / Function Keys ............................................................................................54
The system inverts the level of grey of image. ........................................................................56
MPPS ....................................................................................................................................56
Send To PACS.......................................................................................................................56
Print The Image......................................................................................................................57
Print All The Examination .......................................................................................................57
Window & Level Area ............................................................................................................ 59

Windows & Level................................................................................................................... 60
Zoom..................................................................................................................................... 61
ROI ....................................................................................................................................... 61
Save...................................................................................................................................... 61
Overlays................................................................................................................................ 62
Panel 3543 EZ Sharing with another device........................................................................... 62
User interface........................................................................................................................ 62
8 ERROR MESSAGES................................................................................................................. 65
9 MAINTENANCE WARNINGS .................................................................................................... 66

Instructions for use the USB KEY Recovery........................................................................... 66
10 CLEANING WARNINGS.......................................................................................................... 68
11 STORAGE AND HANDLING INSTRUCTIONS ........................................................................ 70
12 OVERALL DIMENSION........................................................................................................... 71
SOURCE POSITION ....................................................................................................................... 71
1 WARNING
This manual aims at providing the operator of the medical appliance XFM with all
the information needed for a correct use of the device.
Carefully read this manual before using the appliance.
This medical device is designed for use together with a system for emission of
ionizing radiations for diagnostic purposes. Any X-ray source is always a potential
ranger, in particular when the operator is not properly trained or qualified to use it.
Excessive exposure to X-rays can cause health problems. All precautions must
therefore be implemented in order to avoid that unauthorized or unqualified
personnel may use this appliance, thus determining a possible risk for themselves
or for the others. The device shall never be used for purposes different from the
intended ones.
In case of problems or malfunctioning that cannot be solved following the

indications in this manual, the operator shall contact the device manufacturer to
obtain all necessary instructions form ITALRAY s.r.l technical department.
Before performing any operation, all qualified personnel authorized for the use of
this appliance shall be informed of the protective measures required by the
International Commission for Radiological Protection and on the relevant national
standards.
ITALRAY cannot be held liable for the consequences of the actions of unauthorized
personnel.
ITALRAY declines all liabilities related to the good functioning of the machine in
case the installation and maintenance are performed by unauthorized personnel.
Laws limit the operation of this device to doctors or

authorized people as per law.
The type of X-ray exposure produced with this unit can be divided into two
categories:
 professional, for operators
 diagnostic, for patients subjected to an examination.
Comply with all the necessary safety requirements needed and comply with the
national regulations on protection against radiations, because radiations have
harmful effects on the human body.
While performing X-rays, there is always a dispersion of radiations; this means it is
necessary to provide for protection against these radiations. Before performing the
examination, make sure the doctor knows whether a patient is pregnant or not. If
the patient must be assisted by somebody, this person needs to wear the proper
protection equipment.
It is possible to obtain a further protection against the dispersion of radiations, by
using the manual X-ray switch at a distance of 2 meters from the X-ray beams. The
cable of the manual switch is about 4 meters long when completely stretched out.
If the X-ray equipment is not used properly, it may cause injuries. Consequently,
these instructions must be carefully read before operating the equipment.
ITALRAY will be glad to offer assistance and cooperate to start-up the equipment.
Even though this equipment offers a high level of protection against X-rays, besides
the operating beams, no operating measure can assure a complete protection. The
operator shall be responsible for taking all the necessary safety measures to
prevent risks, personal and to others, resulting from an incorrect or excessive
exposure to radiations.
All the operators must receive proper training and take the appropriate safety
measures to avoid injuries.
The equipment is sold with the following condition: ITALRAY, agents and
representatives cannot be held responsible for damages or injuries that could be
caused by the incorrect use of this equipment.
Various materials and personal protection equipment are available on the market.
We highly recommend using them.
ITALRAY declines all liabilities in case authorized personnel do not comply with the
requirements established in the present manual as for completion of their duties.
To avoid irreparable damages to some of its components, never start the

device repeatedly. When turning off the appliance, always wait a few seconds
before starting it again.
In order to avoid damages to the functions of the device, never perform any action
or technical test without explicit authorization of the manufacturing company or of an
authorized technical assistance service of Italray s.r.l.. The user must use only
qualified personnel (manufacturer’s specialized technicians or technicians of an
assistance service with equivalent training) for all electrical maintenance
interventions on the equipment. The connections between the various parts of the
device, calibration and tests must be performed by the manufacturer’s qualified
technicians.
Only properly trained and qualified personnel can access the internal parts of
the unit or disassembled parts.
ITALRAY retains the right to change the product described in the present manual at
any time and without notice.
Privacy
It is the user responsibility to manage the access to the system and to the
data it contains (also through LAN network) with regards to privacy, data
security and protection from viruses that could represent a danger for the
system. Italray accepts no liability thereupon.
2 INTRODUCTION
 This manual provides the user with instructions for correct equipment use.
 The equipment must not be used for purposes other than those intended. Do
not place objects that may damage the table.
 The user is responsible for fulfilling legal obligations regarding the installation
and the functioning of the equipment itself.
 The manufacturer cannot be considered liable for any breakage, malfunction

or bodily damage if the equipment is not operated correctly, or is not suitably
maintained.
3 DESCRIPTION
XFM scope of application:
Digital general-purpose mobile diagnostic X-ray system
XFM digital mobile x-ray unit is designed to perform radiologic examinations and
diagnostic investigations both in the department (Operating room, Sports Medicine,
Emergency Department, Paediatrics, Orthopaedics) and in the ward.
4 TECHNICAL STANDARD
The device has been designed and manufactured in compliance with the following
directives and product standards:
European directive 93/42/CEE, medical device equipment, and upgrades
Classification: CLASS II b.
EN 60601-1 Medical electrical equipment. General requirements for safety
Classification: CLASS 1; TYPE B
EN 60601-1-2 Medical electrical equipment. General requirements for safety -
Collateral standard: Electromagnetic compatibility – requirements and
test
EN 60601-1-3 General requirement for radiation protection in diagnostic X-Ray
EN 60601-1-6 Medical electrical equipment. General requirement for basic safety
and essential performance
EN 60601-2-28 Medical Electrical Equipment Part 2: Particular Requirements for the
Safety of X-Ray Source Assemblies and X-Ray Tube Assemblies for
Medical Diagnosis
EN 62304:2006 Medical device software; software life cycle processes
5 TECHNICAL SPECIFICATION
Acquisition Resolution Pixium 3543EZ: 2880x2400x16 bits
Field Pixium 3543EZ: 432x345 mm

IMAGES
Dimension 14 MB
N. of recordable images More then 20.000
Communication / image
Wi-Fi or BUC cable
download
Automatic LUT Linear or logarithmic LUT
Hierarchic enhancement YES (EVEREST -X) - Auto
Generator Control In-built management
Anatomic tables YES - customisable
R.O.I. YES
Other functions Zoom YES
Exposure Index YES
Level of grey min-max YES
Multi-image
YES
visualization
UPS YES
Send to Printer YES
Dicom 3.0
Send to PACS YES
functionalities
Receive Worklist YES
Processor Intel
RAM 2GB DDRII type
Personal Computer Hard disks 2,5” SATA interface 500 GB
Operating system Windows Embedded standard 7
Single-phase voltage 230 V +/- 10%, 50/60 Hz
230 Vac (110Vac optional)

Main system
+/-10% 50/60 Hz
Power supply Standby current 0,5 A
Max instant current 16 A
Depth x Length x Height 120 x 67 x 161 cm

Weight ~ 273 kg + 5 kg of detector
Height (column folded) 1610 mm
Height (column extended) source 2023 mm
Max SID to floor 2023 mm
Min SID to floor 610mm, 604mm parked
Device
characteristics Rotation of harm x-ray tube holder +/- 90°
Inclination of harm x-ray tube
holder (rotation of monoblock -90° +180°
around Y axis)
Collimator rotation +/- 90°
Braking system Dead man system
Max frontal extension 1125 mm
Max lateral extension 860 mm
Max power: 40kW
kVp from 40 kVp to 125 kVp
Current from 50 mA to 500 mA
X-ray generator Exposure time 1 – 250 ms (battery mode)
1 – 6300ms (power supplied)
monoblock
mAs values: 0,5 - 400 mAs (27 steps)
2 points technique (variation
of kV and mAs)
Operating modes:
3 points technique (variation
of kV, mA and Seconds)
More than 1000 anatomic
Anatomic techniques
techniques stored
Rotating anode, 3000 rpm
Model
Model: I.A.E: RTM 77 H
Anode material RTM
Anode inclination 15°
Focal spots 0,75mm / 1,25mm
X-ray tube
Filament Power 20 kW / 40 kW
Total: 3,7mm Al (0,7 mm +
Filtration
add. 1mm + 2mm collimator)
Thermal capacity 224kJ – 300kHU
Thermal dissipation continue Max anode 750W
Model Pixium Portable 3543 EZ

Dimensions 38,3 x 45,95 x 1,5 cm
Weigh 2,8 kg (FE)
min: 80cm; max: 300 cm;
Source-Image distance (SID)
typical: 135 cm
Detector
Angle between x-ray beam axis and min: - 45°,max: + 45°;
axis perpendicular to FE typical: 0°
Max weight uniformly distributed on 135 kg (operating conditions)
the surface
3 hours typical at 180
Battery operating images/hours, till 5 hours in
non operative conditions.
Model Ralco R 108, manual
Lead Shutters 6 pairs
Light type Halogen Lamp 100 W
Collimator
Dimensions 271x222x140mm
Square field, up to 48x48cm
Field Type
@ 100cm Sid
Minimum inherent filtration 2mm Al eq.
STANDARD DISPLAY TOUCH SCREEN (*)
Model AUO, LCD 19” touch screen CAPACITIVE technology
Type 5:4
Contrast 2000:1
Brightness 600cd/mq LED
Resolution 1280x1024
Viewing angles 178 degrees
(*) ITALRAY s.r.l. has the right to modify the product described in this manual at any time and without further notice.
Battery Kit Optional (40 Ah)

Type Li-ion
Recharging time Max. 5 hours
Battery 24 V
Battery capacity 40 Ah (upgradeable on request)
Motorization kit optional
Max speed [km/h] 5Km/h
Max. way incline [°] 10°
Max. step height [cm] 2cm
Total XFM weight with flat panel 286kg
detector and motorization kit.
Battery Kit 40 Ah performance
More then 350
Exposition n°
with parameters: 80kV, 200mA 12mAs
Exposition power Up to 40kW, with less 10% battery too
Standby time More then 6 h
Battery capacity 40 Ah (upgradeable on request 60Ah e 90Ah)
ENVIRONMENTAL CONDITIONS
For the digital detector :

TRANSPORT AND STORAGE WORK ENVIRONMENT
Temperature: +18°C ÷ +30 °C (full performance)
During the normal use maintain the temperature
Temperature: -10°C ÷ +55 °C
within a range of + / - 4 ° C from the calibration
Humidity: 5 ÷ 95% N.C.
temperature of the detector.
Pressure: 500mbar ÷ 1100mbar
Humidity: 20 ÷ 75 % N.C.
Drop: 55cm max height (packaged)
Pressure: 700mbar ÷ 1100mbar
Drop: 70cm max height
For the rest of the system:
TRANSPORT AND STORAGE WORK ENVIRONMENT
Temperature: -25°C ÷ +70 °C Temperature: +10°C ÷ +40 °C
Humidity: 20 ÷ 80 % N.C. Humidity: 20 ÷ 80 % N.C.
IDENTIFICATION
Always indicate the code and serial number for enquiries on repair actions and
spare parts.
Device label
monoblock Label
OPTIONAL
There are three main versions that differ in the following ways:
Code AMR+IR101/*-* : XFM Mobile DR standard model
Code AMR+IR201/*-* : same functions of XFM Mobile DR standard model but able
to perform X-ray examinations without power supply connection.
Code AMR+IR301/*-* : same functions of XFM Mobile DR standard model but

motorized movement and able to perform X-ray examinations without power supply
connection.
Each models use Pixium 3543 EZ digital radiography flat panel.
Available optional: DAP meter, different battery capacity (60Ah, 90Ah).
DISPOSAL OF MATERIALS
The device comply with the directives ROHS-RAEE 2011/65/EC and 2012/19/EC
Waste from Electrical and Electronic Equipment Directive and Reduction of
Hazardous Substances.
- Packing:
Wood and bubble sheet 100% recyclable
- Assembly materials :
Carbon steel 100% recyclable
Elastomers and plastic materials 100% recyclable
Cables and other electrical materials
For DR flat panel read the Trixell recommendations
The equipment must not be disposed of as normal urban solid waste.
It must be taken to an expert waste disposal centre and in conform with the local
laws in force.
WARRANTY
All medical devices manufactured by ITALRAY are covered with a 1 year warranty
from the date of delivery. This warranty period can be extended by signing a
technical support contract according to the needs of the client.
ITALRAY ensures availability of spare parts and maintenance for a period of 10

years from the date of installation.
6 ELECTROMAGNETIC COMPATIBILITY
Requirement of EN 60601-1-2
5.2.1.1 All equipments and systems:
a) A statements that medical electrical equipment needs special precautions regarding EMC and
needs to be installed according to EMC information
b) A statement that mobile RF communications equipment can effect medical electrical equipment
MANUFACTURER’S GUIDE AND DECLARATIONS. ELECTROMAGNETIC EMISSIONS

The XFM system is designed to be operated in the electromagnetic environment described below. The client and/or user of
the XFM system must ensure that the working environment corresponds to these indications.
Emission check Conformity Electromagnetic environment - Guide
RF XFM uses RF energy only for its internal functions. Therefore, RF
CISPR 11 - CEI EN 55011 Group 1 emissions are very low and are not likely to interfere with nearby
Emissions electronic devices.
RF
CISPR 11 - CEI EN 55011 Class B XFM is suitable for use in all buildings, including homes and
emissions buildings with connections to the low tension public supply
Harmonic emission network that supplies buildings aimed at domestic use.
Class A
IEC 61000 - 3 - 2
Voltage variation
emissions/flicker Conforming
IEC 61000 - 3 - 3
MANUFACTURER’S GUIDE AND DECLARATIONS - ELECTROMAGNETIC IMMUNITIES

The XFM system is designed to be operated in the electromagnetic environment described below. The client and/or user of the
XFM system must censure that such an environment is actually in use.
Test level
Immunity check Conformity level Electromagnetic environment - Guide
IEC 60601
Electrostatic shock ± 6 kV with contact ± 6 kV with contact Floors must be wooden, in piling or ceramics. If
(ESD) ± 8 kV air ± 8 kV air floors are coated in synthetic materials, relative
humidity must be at least 30%.
IEC 61000 – 4 – 2
Transient/fast power ± 2 kV for power supply ± 2 kV for power supply Line voltage quality shall be the one used for a
trains lines lines typical commercial or hospital environment.
± 1 kV for input/output ± 1 kV for input/output
lines lines
IEC 61000 – 4 – 4
Overvoltage ± 1 kV differential mode ± 1 kV differential mode Line voltage quality shall be the one used for a
± 2 kV common mode ± 2 kV common mode typical commercial or hospital environment.
IEC 61000 – 4 – 5
Loss of voltage, short Line voltage quality shall be the one used for a
voltage interruption or <5% U T for 0,5 cycles <5% U T for 0,5 cycles typical commercial or hospital environment. If
variation on the supply the XFM operator needs a continuous
input lines <40% U T for 5 cycles <40% U T for 5 cycles functioning during voltage interruptions, we
suggest connecting the system to an
<70% U T for 25 cycles <70% U T for 25 cycles uninterruptible power supply (UPS).
IEC 61000 – 4 – 11 <5% U T for 5 seconds <5% U T for 5 seconds

Magnetic field with 3 A/m 3 A/m Magnetic fields with net frequency should have
mains frequency the characteristic levels used for commercial or
(50/60 Hz) hospital environments.
IEC 61000 – 4 – 8
MANUFACTURER’S GUIDE AND DECLARATIONS - ELECTROMAGNETIC IMMUNITIES

The XFM system is designed for work in the electromagnetic environment described below. . The client and/or user of the
XFM system must ensure that the working environment corresponds to these indications.
Test level
Immunity check Conformity level Electromagnetic environment - Guide
IEC 60601
RF communication devices, both portable and
mobile, should not be used near any of the
components of the XFM system, including
cables, unless they comply with all
recommended separation distances
computed according to the equation that
Conduced RF 3 Vrms applies to the transmitter frequency.
A
IEC 61000 – 4 – 6 from 150 kHz to 80 MHz Recommended separation distances
d  1 .2 P
from 80 MHz to 800 MHz
Radiated RF 3 V/m A
from 800 kHz to 2.5 MHz
IEC 61000 – 4 – 3 from 80 kHz to 2.5 MHz
Where P is the maximum nominal output
power of the transmitter in Watt (W)
according to the transmitter manufacturer and
d is the recommended separation distance in
meters (m).
The intensity of the transmitter field with fixed

RF, as determined by an electromagnetic
a
survey on site, could be lower than the
b
conformity level in each frequency interval .
Interference phenomena are possible in the

presence of appliances bearing the following
symbol:
Note:
(1) At 80 MHz and 800 MHz, the maximum frequency interval applies.
(2) These guidelines do not apply to all conditions. Electromagnetic propagation is influenced by absorption and reflection
properties of structures, objects and persons.
a
B The field intensity for fixed transmitters as the base stations for radiophones (mobile phones, cordless phones) and land
mobile devices, CB hams, AM and FM and TV transmitters can be provided for both in theory and exactly. If the field
intensity measured in the installation where the XFM is installed and used is above the aforementioned conformity level,
the functions of the XFM should be put under observation. Additional measures such as a different orientation or
position of the XFM could be necessary in case of abnormal operations.
The field intensity in the frequency interval from 150 kHz to 80 MHz should be lower than 3 V/m.
RECOMMENDED SEPARATION DISTANCES BETWEEN MOBILE AD PORTABLE RADIO COMMUNICATION DEVICES

AND THE X-FRAME DR SYSTEM
The XFM system is designed for work in an electromagnetic environment where irradiated RF interference is kept under
control. The client or final user of the XFM can contribute to preventing all electromagnetic interference by ensuring a minimum
distance between the portable and mobile RF communication devices (transmitters) and the XFM as recommended with
regards to the maximum output power of radio communication devices.
Separation distance based on the frequency of the transmitter
Maximum output power
of the transmitter [m]
from 150 kHz to 80 MHz from 80 MHz to 800 MHz from 800 kHz to 2.5 MHz
[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
For transmitters with a maximum output nominal power not included among those presented in this table, the recommended
separation distance in meters (m) can be computed using the equation that applies to the transmitter frequency, with P being
the maximum output power of the transmitter in Watts (W) according to the indications given by the transmitter manufacturer.
Note:
(1) At 80 MHz and 800 MHz the maximum frequency interval applies.
(2) These guidelines could not be applicable in all situations. Electromagnetic propagation is influenced by absorption and
reflection properties of structures, objects and persons.
This manual refers to the system as a whole. Some functions and/or

performances are included only on certain configurations.
7 OPERATOR MANUAL
Keep the device connected to the external power supply, in order

to use it with full performances (with battery charged).
The complete discharge of battery and the long period of time

without supply cause serious damage to Pixium 3543EZ detector.
To avoid the damage to panel and monoblock, keep the system
supplied also during long periods of inactivity.
Keep the detector in Docking Station always.
SYSTEM COMPOSITION
The system is composed by:

1. Monoblock with rotating anode X-ray tube;
2. collimator
3. Transportation handle (with joystick if XFM is motorized)
4. Control desk panel touch screen console with interface software and digital
acquiring system;
5. ON/OFF Switch
6. manual preparation/Xray switch
7. Panel charge position
8. Arm unlock handle
9. DAP (optional) connector
10. step for tilt device
11. DVD writer on the right, LAN connection on the left
12. rotating and mobile stand
13. Pixium 3543 EZ detector
Internally; digital system, motor driven (optional), battery package for cordless
exposition (optional).
12
6 5
1
3
2 11
9 13
10
8
START-UP
Following the Start-up procedure:

1) Arm the main circuit breaker.
WARNING: set the overload switch to ON always.
2) Connect the power cable to the power supply
The system is turn on, PC power on will start approximately 10 seconds after the
system switch on.
System switch off
XFM DR Mobile system can be completely switched off by pressing the dedicated
button on the right side of the unit (circled in red in picture below)
RECOMMENDED USE OF SYSTEM
When system is not in use
To keep battery package for motorization & exposures always fully charged it’s
recommendable to keep XFM DR Mobile always plugged into wall supply, when
system is not in use.
Note:
For a correct battery charge, plug device into wall power supply and turn off PC by
pressing the dedicated button on the right side of the unit (after the device plugged
into wall power supply). Monitor is turned off.
When system is plugged into wall power supply, motorization commands are
disabled for safety reasons.
Restart the system
From the previous state to turn on the system again, disconnect the power plug and
connect it again. The system will turn on completely in about 10 seconds.
Disconnect the power plug to move the device manually or motorized.
Moving the system with the motorization package
Rotate the black transport bar to release the brakes and move the joystick
forwards/reverse in order to drive the system towards the exam location.
For safety reasons reverse speed is half of the forward speed. Forward/Reverse
speed can be adjusted as per end user requests during system installation.
Joystick can finely regulate the speed of the system from 0 m/s when in rest
position to a max speed of 1,38 m/s when completely bended forward.
Note: During the movement arm needs to be kept folded and fixed in place.
Anti-collision system
For safety reasons, system is integrated with an anti-collision sensor placed on the
front side of the machine. Anti-collision sensor detects the presence of obstacles in
front of the system during its motorized movement. Sensor field is 45° with a
distance of 2/3 meters and can be adjusted.
Whenever the system detects an obstacle, it slows down progressively until it stops,
informing the end user of the obstacle presence with visual alerts (leds flashing at
monitor sides).
Anti-collision detection and the consequent system slow down when detecting
obstacles, is very useful also when entering lifts or getting next to the patient bed
side.
Note: Anti-collision functionality can be disabled, simply pressing one of the 2

buttons placed right under the joystick assemble.
Note: In case of any problem with the system motorization, a switch placed on the
front side of the unit (see picture below circled in red) permits to disable the motor
inertia. This feature together with the light weight of XFM unit permits to easily move
around the system with very lttle effort for the driver.
Exposures
Thanks to the Lithium battery package for the exposures, system is capable of
performing exams while disconnected from power supply. In case of low battery
charge, system can equally be connected to wall power supply in order to proceed
with the examination.
Exposure and Motorization Battery recharging
The lithium battery package for Exposures and for Motorization completely
recharges in less than 5 hours.
Flat Panel Battery recommended use
XFM DR Mobile system is delivered with 35x43 cm (or with 24x30 cm or both)
wireless flat panel with 2 Lithium rechargeable batteries and 1 external battery
recharger.
System is provided with a dedicated flat panel compartment that keeps the flat
panel battery always in charge while panel is inserted and system is all turn on.
If the system is turn off, the flat panel is NOT in charge.
Recommendations: For workflow continuity and for long batteries life, ITALRAY
recommends to always keep a second battery in charge with the external charger
in case of power down of the first battery. Battery exchange is instantaneous and
very easy to perform. Please refer to page 33 of the manual for this task.
External USB port

External USB port placed on the left side of XFM DR Mobile is mainly useful to
export images onto USB pen drives and for service activities.
Note: ITALRAY recommends, before inserting the pen drive, to previously check its
integrity and the total absence of viruses.
Note: ITALRAY recommends to use the external USB port only for the above
reasons and not to install any external software nor additional driver through this
port or through the CD/DVD. Any fault occurring on the OS due to this un-
observance, will void the system warranty condition.
RE-SETTING THE EQUIPMENT
In case of error message OVL or OVC, it is necessary to stop and start the
equipment. If after this procedure the error message shows up again, contact
assistance service.
PRE-USE CONTROLS
WARNING: Before using the equipment, verify if it is necessary to

perform the exposure cycles indicated below.
Non-compliance with the instructions could damage the monobloc.
Before using the equipment, if the unit hasn’t been used for a number of days
higher than what is indicated below, it is necessary to run this exposure cycle.
If during the operation discharge sounds can be heard from the X-ray group or other
unusual noises, interrupt the procedure and start again after an hour.
During the exposure cycle indicated below, we suggest closing the collimator, to
limit the emission of radiation in the room.
If the equipment hasn’t been used for more than 15 days, run the pre-heating cycle
indicated below.
Select the large focus and perform 6 exposures in the sequence indicated below
(total time 2 minutes):
kVp mAs Exp Time

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 unit hasn’t been used for more than 3 months, run the formation cycle
indicated below.
(total time 1h and 10min): If the unit hasn’t been used for more than 3 months, run
the formation cycle indicated below.
(total time 1h and 10min):
kVp mAs Exp Time

40 6.3 3 20 sec
stop 120 sec
50 6.3 3 20 sec
stop 120 sec
60 6.3 3 20 sec
stop 120 sec
70 6.3 3 20 sec
stop 120 sec
80 6.3 3 20 sec
stop 120 sec
90 6.3 3 20 sec
stop 120 sec
100 6.3 3 20 sec
stop 120 sec
110 6.3 3 20 sec
stop 120 sec
120 6.3 3 20 sec
stop 120 sec
125 6.3 3 20 sec
stop 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 3 - Monoblock formation cycle
If there are no errors the equipment is ready for ordinary operation.
MANUAL MOVING AND POSITIONING THE EQUIPMENT
The compact design, the limited weight and the front swiveling wheels make the
equipment easy to move.
Before moving the equipment make

sure the power cable is disconnected
from the equipment.
Before moving the equipment put it in

transportation position with arm fixed.
Locking the arm

Put arm in transportation position and lock with lever.
Arm lock Arm unlock
Unlocking the brake system
To move the unit press the transportation

level downwards to unlock the brakes; keep
lever pressed and move in desired direction.
Moving and obstacles overcoming
To overcome any small obstacles (ex. in/out of

elevators) put foot on lifting platform, the front
part of the unit lifts up and the obstacles can
easily be overcome. Max step height 2 cm.
WARNING : Do not open doors pushing them open with the front part of the
equipment.
MOTORISED DEVICE
If the device is motorised, use it in the following way:
1. Unplug the power supply from the power point: only without external power, the
engine of the device will be powered by the 24V of battery.
2. Release the brakes: turning the handle the brakes are released and the drives
are enabled.
3. Starting the engine: move the lever that is located in the centre of the handle to
start the engine. To advance, the lever must be moved in front direction. It is
possible to adjust the speed of XFM, tilting more the lever the device increases
the speed, tilt less the lever the device decrease the speed. To activate the
reverse, move the lever toward the operator. The adjustment of the reversing
speed follows the same philosophy of the start, but the maximum reverse speed
is 40% of the maximum reachable by default (adjustable during installation).
Reverse
Starting
4. Releasing the handle the brakes are activated and drives are turning off.
Moving on a horizontal floor, the speed can reach 5Km/h as previously indicated its
regulation is obtained by the use of a joystick located in the central part of the
control handle.
When motion is selected and the direction is FORWARD, automatically starts

working a security system, able to adjust the travel speed in relation to the
obstacles on the path.
In the front cover of the machine, is positioned a sensor, able to detect any object or
person to a distance of about 3 meters.
If an obstacle comes within range of the control system, automatically, the machine,
decreases its speed very quickly, to obtain the arrest of the movement.
At the same time, the action of automatic braking, is shown to the operator, by a
pair of indicator lights of white colour, positioned at the top of the monitor frame.
Warning Light OFF Warning light ON
In some cases, however, this safety system, can create problems for the operator, if
the route includes the passage of the machine along crowded hallways or the use of
elevators.
In both cases, however, the system can create a kind of problem, opposing to any
movement.
The operator in this case, in a voluntary manner, has the ability to inhibit the anti-
collision system, using the buttons on the lower side of the control handle.
view of the lower part of the handle
To disable the anti-collision system, simply press one of two buttons;
Two buttons are located, one on the right and the other to the left of the joystick, to
facilitate the operation using the thumb of the hand that does not operate the speed
control.
The use of one of the buttons while driving in the presence of obstacles, inhibits the
anti-collision system, and avoids any reduction in speed is not desired.
By removing the pressure on the buttons the anti-collision system begins to operate
regularly.
Pressing one of the buttons in the presence of obstacles, the machine continues to
move at the programmed speed.
The warning lights placed on the frame of the monitor is lit to warn, however, that
the device is working properly anyway.
The anti-collision system, is not active while the machine is moving in REVERSE.
MOTOR DRIVEN EXCLUSION
When the operator considers unnecessary to use motorized movement on the

device, he can exclude it by pressing the button in the front of the device.
If the button light is OFF, the motorized function is able;
if the button light is ON, the motorized function is disable.
Motor driven ON/OFF

button.
proximity sensor
Special instruction for battery device
If XFM has special battery package for exposition without power connection or
motor driven, the battery level is shown on the lower right of the touch screen.
When XFM is not connected to the external power line, the battery level is shown on
the display by the charging percentage together the symbol:
Information and instruction about battery package
XFM use lithium-ion battery, it allows a constant power output up to a minimum

charge, is possible to perform 40 kW exposure until charge level less then 10%.
For a fully battery charge and equalization, 5 hours are sufficient.
With full charged battery, the standby time is 6 hours.
This battery type, allows a high number of charging cycles (> 3000).
Charging cycle means full charge of the battery pack from 0% to 100%.
The partial refills, are not counted.
For this reason it is recommended therefore, do not fully discharge the battery pack
POSITIONING THE ARTICULATED ARM
Unlock the articulated arm using the unlock

lever.
Grab the handle, and push the

arm upwards and position the
monobloc – x-ray tube as
desired.
ARM LOCKING SYSTEM
Activation of the Locking system in normal utilization
If the arm is lifted upper to 170cm the block system is engaged that don’t permit at
the arm to go down under 170cm: form make this operation is necessary to operate
un the leverage positioned near the monobloc (see lateral picture). To unlock the
arm follow the under
instructions:
1. lift a little the arm

2. operate on the
leverage on the
arrow direction and
arrive at the system
unlock
3. push down the arm
to 10cm with the
leverage in unlock
position
4. now is possible to
release the unlock
leverage and put the
arm in a position
lower than 170cm.
Locking system action in fault case
If a fault occurs on the suspension system the locking system is engaged which
does not allow the arm to go below the minimum height of 170cm.
In this case the machine lose its security features and has not to be used until the
restoration of the spring group.
The replacement of the gas spring group have to be performed only by
authorized personnel
Use the positioning handle to fix the

collimator monobloc unit. Remember
that the rotation of the monobloc group
on the horizontal axis is +90°/-180° ,
and 0° ÷ +90° on the vertical axis
POSITIONING THE COLLIMATOR
Before rotating the collimator, unlock the anti-

rotation lever.
The collimator can rotate +/- 90° around the axis
of the x-ray beam. The collimator rotation travel is
limited by a mechanical stopper.
SETTING THE X-RAY FIELD
This paragraph is valid with the standard RALCO collimator supplied by Italray. For
more information refer to the specific manual of the product.
The collimator limits the X-ray field to the working area.
Press the ON/OFF button of the field indicator to display through light the width of
the field to irradiate; the button is located both on the control desk panel and the
collimator itself. The light switches off automatically when the button X-RAY
PREPARATION is pressed, or after the maximum switch on time (set at 30
seconds) has passed.
To avoid over-heating in the area around the collimator

light, after enabling the light field five times in a row, wait
about 10 minutes before switching back on.
Position the monoblock collimator group using as reference the field marked by the
light tracer and the cross trace, which indicates the axis of the X-ray beam and its
entrance point on the patient.
Adjust the size of the field by using

the control knobs on the front
panel of the collimator. The right
knob commands the longitudinal
plates, the left knob the lateral
ones.
It is possible to obtain fields from 0 x 0 to 43 x 43 cm (17”x17”) at a focus distance

of 100 cm (40 ”).
The scales under the knobs indicate the field covered at a distance of 100 cm (40”).
The table on the front panel allow the operator to calculate the number to set on the
scale under the knob, to light up the desired cassette size with Source Image
Distance from 100 to 200 cm; this number is obtained by matching the SID being
used with the column on the line of the cassette size.
Cassette size (cm)
cm 13 18 24 30 35 40 43 Inch
100 13 18 24 30 35 40 43 40”
SID SID
150 10 12 16 20 23.5 26.5 28 60”
(cm) (inch)
200 6.5 9 12 15 17.8 20 21.6 78”
5” 7” 9.5” 12” 14” 16” 17”
Cassette size (inch)
Example: setting field with cassette of 30 at SID 150
PIXIUM 3543EZ DETECTOR
The Pixium 3543EZ is the sensor device capable of absorbing the X-rays and
converting them into an electrical signal that is spatially sampled by the matrix of
pixels and digitised by the ADC. The image that is formed is transmitted to the host
computer.
The communication to the host computer is insured either through Wifi antennas or
through the backup cable.
The powering of the Pixium 3543EZ is insured either by the battery in free cassette
wireless mode or through the back-up cable.
The Pixium 3543EZ is portable, which means that the technologist can carry it with
hands. The mechanics of the Pixium
3543EZ has been designed according to
following criteria:
 Mechanical compatibility with film
cassette standard;
 Cleanability;
 Mechanical robustness;
 Ergonomics for manual handling
(including reduced weight);
 Contact with the patient;
 Aesthetics (including possible customisation).
The FE must be handled with care. In case of falling

down on the foot of someone, the FE can cause injuries
to the person.
Meaning of LEDs configurations

3 LEDs are provided for maintenance on the Pixium 3543EZ to give basic
information on the detector behaviour.
LED name logo Colour Description

No battery or OFF state or during
OFF
boot
Orange
Battery capacity below 10%
Blinking fast
Battery
Battery capacity between 15% and
Orange
10%
Battery capacity between 100% and
Green
15%
Wifi disabled by software or OFF
OFF
state or during boot
Wifi not ready (detector not
Wi-Fi Orange
connected to an Access Point)
Wifi available (detector connected to
Green
an Access Point)
OFF OFF State

Orange
Error state
Blinking slow
Status Orange OFFLINE or download state
Green Blinking
Listen state
slow
Green Operation state and ONLINE
BATTERY
The battery can be charger either:

 using the back-up cable, while it is placed into the Pixium 3543EZ ;
 using the battery charger.
Battery Installation : place the battery
and turn the latch (clock wise)
Battery removal: after the Pixium

3543EZ has been switched off, turn
the latch counter-clockwise and
remove the battery.
BACKUP CABLE (BUC)
The connector of the BUC is positioned in the upper part of the Pixium 3543EZ
detector, close to status LEDs. It recharges the battery when it is depleted, allowing
to perform examinations while the battery is charging, and if connected to the
access point, it allows to download images by disabling the wifi. The back up cable
pinout is symmetrical and thus the cable can be plugged in both directions as
shown on the figure bellow:.
When detector is parking inside XFM, the BUC is connected to detector and the
battery is in charge.
BATTERY CHARGER
To charge the battery use the battery charger follow the input mode shown in the
figure below:
The charger provides leds for the user:

1 green led on the back side indicating the presence of input power
2 leds per slot indicating the status of each battery.
Green blinking The battery is charging,
- Green static The battery is fully charged
- Red: the battery charging is stopped - error state.
Inside the compartment Pixium 3543EZ

detector is charging when system is
turn on. If the system is turned off the
panel battery is not in charge
It is recommended to always keep the

panel in the compartment of XFM when
it is not in use.
Warning: Turn off the panel BEFORE the battery removal even when
the panel is connected to the BUC cable.
ACQUISITION AND IMAGES ELABORATION SYSTEM
Portable XFM has an internal system designed for the acquisition and processing of
high resolution digital images for static radiology and it is based on the use of a
digital detector and a computer-based acquisition system. The user interface of the
device appears as a Personal Computer, so the proper use of the device requires a
basic level of computer literacy.
In particular, the acquisition system is composed by:
 Trixell PIXIUM 3543EZ detector with Docking Station for the charge of
battery and the manage of communication between detector and PC;
 Central Unit (power supply of system, logical unit (PC), software, interface);
 Operator’s interface: monitor touch screen;
 DAP optional.
STARTING AND TURNING OFF THE SYSTEM
The initialisation phase takes some minutes, so it is recommended to turn on the

system before reaching the patient room. When the system hasn’t external power
supply, the batteries and the UPS take it on. In this condition the system emits
an acoustic signal every 4 seconds. The battery must be used only for a
limited period (only for short movements from storage to patient’s room).
During the exam the device must be power supplied.
The monitor is touch screen and it is the unique interface for the operator.
The switching off of the system takes place through the Quit button, that enables
the shutting down of all the system.
It is recommended to power the system when the computer is off, in order to

avoid dangers to the detector, created by humidity.
EXAMINATION MANAGEMENT
The Examination management window opens as soon as the initialisation is

complete and allows the operator to access an examination in three different
modes:
 Opening the examination via the Local Database containing all the
examination stored in the system
 Opening from the Dicom Worklist acquired from the RIS
 Opening of a Insert New Examination
At every new start the system automatically sets to the last used mode. To
change mode, simply move to a different worksheet.
Figure 1: the figure shows the list of examinations on the first window that it is opened
at the start of XFM software.
Besides the three worksheets, the EXAMINATION MANAGEMENT window also

includes the following buttons:
 Configuration - generates a confirmation dialogue with access password

 Print Spooler - shows all printing jobs queuing for processing.
 Storage Spooler - shows the queue of all data to be sent to the SERVER
 Generator Only to enter the direct examination mode, opens a window for
setting the radiological parameters and allows x-rays in order to carry out the
examinations with the CR cassette.
 Remote Service allows the request remote assistance by entering a
password.
 Quit - turns off the system (generates a confirmation dialogue with
password)
And the following function keys:
 Delete: for deleting of one or more selected examinations. Attention: before

carrying out this operation ensure that the examination was sent to the PACS
and/or is saved on a digital support.
 Edit: to modify the examination parameters: anatomic region, type of test, user
name, Accession Number, surname and name of patient, code, gender, date of
birth.
 Open: in order to open the selected examination.
 Images Received: only available in case images can be received
 Query Archive: opens the dialogue window to import the examinations list in
the queue at the RIS (see in figure 2)
 Read CD: starts the examination import procedure from the CD/DVD
 Create CD: initiates the procedure of creating the CD/DVD after selecting at
least one test from the Examination Manager window. To select more than one
test, hold down the SHIFT key (for tests that are listed in sequence) or the CTRL
key (for tests not in sequence).
 Send: to send one or more examinations to the archive, after selecting the
archive from the control box shown in figure 6.
OPEN AN EXAMINATION FROM WORKLIST
When the Dicom Worklist worksheet is displayed in the Examination

management window, the system queries the RIS and takes into account only the
examinations entered in the system that same day and that have not been imported
locally by the system. Pay attention that the LAN cable is connected and working to
download the examination from RIS.
Figure 2: Dicom Worklist window, to import the patients and the examinations from RIS.
The results of this query are displayed in a table including the following fields:
 Surname (of patient)
 Name (of patient)
 Code (patient ID)
 Date of birth (of patient)
 Gender (M/F)
 Examination (study description e.g. routine exam)
 Date (exam date)
The operator can repeat the query to the RIS using the tools included in the table
and selecting different parameters:
 Input time frame.
 Patient Name*
 Patient Surname *
 Examination code (internal code used by the site)
*. Searching is also possible by inserting a part of the name or surname or using some wild card
characters. To search in the surname field, i.e. for the surname ROSSI, the operator can insert ROS
or *SSI.
By selecting one or more examinations from the table it is then possible to import
them in the local archive with the Import button. This action links the imported
examination/s to the operator performing the examination, whose name has to be
selected prior to this operation.
After the import operation, if importing a single examination, the system shows the
Examination Acquisition window.
If the import action involves several examinations, the system displays the Local
archive worksheet of the Examination management window.
OPENING OF A NEW EXAMINATION
The operator can manually add a new examination from the New examination
worksheet in the Examination management window. This is the only available
examination entering mode for premises having no RIS. Below we give a list of the
data that can be entered in the system. None of them is mandatory.
 Exam - Body part (select from the list)
 Exam - Name (select from the list it is the exam projection)
 Operator (select from the list)
 Accession Number (RIS code from hospital RIS)
 Patient - Surname
 Patient - Name
 Patient - Code
 Patient - Sex (M, F)
 Patient - Birth Day (dd/mm/yyyy)
 Free Disk Space available
Figure 3: Insert New Exam window, to insert a new patient, that is not allow on
the Worklist or on RIS.
To enter patient data

(name, surname, birth
day, ...) select the desired
field and type the
information via the virtual
keyboard that appears on
the bottom of the image.
Figure 4: hidden virtual keyboard.
Data can be entered using one of the following functions:

 Add, to save in the Local archive and reset the fields for new entries (allows
the operator to make batch entries)
 Add and open, to save in the Local archive and immediately open the
examination acquisition window
When saving and/or opening a window with incomplete data, a dialogue box asks
for confirmation before carrying out the operation and indicates all missing
information.
OPEN AN EXAMINATION FROM THE LOCAL ARCHIVE
All examinations in the system can be displayed form the Local Database
worksheet in the Examination management window.
The fields included in the table are:
 Surname
 Name
 Patient code (from hospital RIS)
 Birth day
 Sex
 Exam, type of examination
 Date
 Operator
 Images
 Status
Use classical Windows methods to open one or more examinations from the table
(with the virtual keyboard, where it needs). To open the exam, select the field with
patient's name and press the Open button.
If the examination record contains no images, the opening will flash-cut to the
Examination acquisition window. Otherwise, the system displays the examination
content.
Use the DELETE button for permanent deletion (with confirmation dialog window) of
the examination/s selected.
CONFIGURATION
The Setup button (configuration) allows access to the system configuration (it
generates a confirmation dialog with password access reserved for maintenance
technicians).
PRINT SPOOLER
The Print Spooler function opens a specific dialogue box that allows you to verify
the prints sent and still in the process of execution.
After selecting one of the printing jobs in the list, the function buttons in this dialogue
box allow to delete, pause and restart it or to empty the print queue.
Figure 5: the figure shows the Dicom Pint Spooler, that is available from the first
window of X-Frame DR software.
STORAGE SPOOLER
The Storage Spooler function opens a specific dialogue box to check the
examinations that have been sent to the SERVER and are being processed.
After selecting one of the examinations sent to the SERVER, use the function keys
of this dialogue box to cancel, pause, restart and clear the archive queue.
Figure 6: the figure shows the Dicom Storage Spooler, that is available from
the first window of software.
QUIT
The QUIT button is used to turn off the system (requires confirmation through
dialogue box).
EXAMINATION ACQUISITION
The Examination acquisition window is the interface to the X-ray generator.

The Examination acquisition is accessed automatically when opening a new
examination containing no images. You can also access the window through the
console CAPTURE function key, but only when an examination containing other
images is already open.
Figure 7: Examination Acquisition Window. It is possible change the type examination

and define the radiological parameters.
These are the functions in this window:

 Window Name: Patient’s Surname and Name (Code) - Examination
 Target Exam: Allows you to choose in which patient examination to acquire
the image (a polytraumatised patient may have been inserted into the RIS
and then locally imported once for each type of test)
 Body Part: allows the selection of the anatomical part concerning the testing
to be carried out (abdomen, legs, upper limbs, pelvis, skull, spine, chest)
 Exam: allows the selection of the test to be carried out between those
associated with the preselected part of the body.
 Projection: selects the projection of the exam
 Detector charge: allows to check the status of charge of battery and if the
BUC cable needs to perform the examination.
 Patient Size: the radiological parameters are changed automatically whilst
selecting the size of the patient. Allow to select among four typical body
builds
 Operator: associates the name of an operator to the image that will be
acquired
 X-RAY generator: shows the parameters associated with the x-ray
generator, which are re-set according to the selected examination/projection
and to the body build. The operator may change them. See also the x-ray
generator manual for information.
 back to exam: when you press this button, the "Examination management
window" automatically opens
 new exam: when you press this button, the "insert new exam window"
automatically opens
Note: choosing the examination/projection together with the patient body build
implies:
 Saving the selected image parameters
 Suggesting the settings for the x-ray generator,
 The application of a suitable processing to the image that will be acquired.
Note: The system displays all error messages form the x-ray generator through
dialogue windows.
Once the image exposure is completed, it will be sent to the monitor in a few
seconds.
EXAMINATION IMAGES
After acquiring a new image or opening an examination that contains previously

acquired images, the system presents the image (or the first of several images of
the same examination) on the screen at the maximum available zoom rate so as to
display the entire image on the screen. The monitor has no command areas.
The image also show the following information:

 On the top left side the Patient information: NAME, SURNAME, GENDER,
DATE OF BIRTH, ID CODE
 In the top right side: type of Examination/Projection and radiological
parameters such as kV, mA and ms (or mAs), dose/area output expressed in
mGy cm2 or μGy*m²;
 Bottom left: Utility information such as Identification No. of the image within
the examination, Exposure Index IE: (E.I.) is a parameter that helps the
operator to understand if an examination was performed with the correct
dose, Zoom rate and Windows and Level;
 Bottom centre: Italray and XFM logos;
 Bottom right: Name of the operator and acquisition time of the image, name
of the health care facility where the image was taken
AUTOMATIC PROCESSING OF THE IMAGE
The acquired images are pre-processed also according to the type of examination,
following this sequence:
 Image correction to compensate detector defects and environmental
variables
 Logarithmic LUT
 EVEREST-X: Hierarchy enhancement
 Electronic collimation (ROI)
 Windows & Level on the non-collimated area
POST-PROCESSING / FUNCTION KEYS
Opening the exam with at least one image, on the right of image there are the
function keys, that enable some utility and post-processing functions.
Patients
Link to EXAMINATION MANAGEMENT window
Examination list
Acquire Link to EXAMINATION ACQUISITION window
Prints all the images available for a single

Print All examination, previously selected, following the
Examination procedure described under PRINT ALL
EXAMINATION
Image scroll Horizontal arrows scroll the images back and forth.
Delete the current image, visualised on the monitor,

Delete Image
with a confirmation button.
Selecting the SEND checkbox, the image is sent to

the archive on the PACS. More PACS are
Send to PACS
configurable and the operator can choose the PACS
or can send the image to a default PACS.
The image is sent to a print buffer. If the buffer is

Print the image empty, a dialog window will open and it will possible
chose the PRINTER and the SIZE OF PRINT.
Allows to change the status of exam (OPEN/CLOSE)

Send MPPS
sending a message MPPS to the server.
PAN function Drags the image in all direction (top-bottom, right-left)
ZOOM Increases or decreases the zoom of image.
Actives a post-processing function that acts to the

Window & Level brightness and contrast ton the image, described in
Window and Level section.
Pressing the monitor in a point on the image and drag

ROI the pointer, it selects a new Region Of Interest. The
areas of images out from the ROI will became black.
Selecting a particular area of the image (pressing the

Area Window & monitor and drag the pointer), the minimum and
Level maximum level of grey inside the selection are used
as references for all the image.
Mirror Rotate the image around the central vertical axis.
Flip Rotate the image around the central horizontal axis.
Rotation +90° Rotate the image of 90° clockwise.
Undo Undo Processing
Redo Redo Processing cancelled
Saves the same image visualised on monitor, as a

Save
new image of exam (for presentation).
Inversion The system inverts the level of grey of image.
Inserts a new overlay. Pressing the screen in a point

of image where a new label needs, the virtual
Insert overlay
keyboard will appear. Inserted the new label, press the
confirm button.
Change / shift Pressing the screen, in the point where there is the
overlay overlay, it is possible to change or shift it.
Pressing the screen, in the point where there is the

Delete overlay
overlay, it will be deleted.
Following some functions will be individually described.
MPPS
This feature, if enabled, allows you to change the status of the examination
(OPEN/CLOSED) sending a MPPS message to the server. The sending of these
messages is normally automatic on the opening and closing of the examination.
SEND TO PACS
By selecting the Send To PACS checkbox from the Context Menu the system
opens a dialog box in which the operator can select the archive to send the
examination to.
Figure 8: Send Image box.
By opening the dropdown menu you’ll find the possible destination archives.
PRINT THE IMAGE
When selecting Print The Image, the image is sent

to a buffer of print. If the buffer is empty, the
system initiates a composition tool that allows to
chose the printer, the size of print and the image
disposal. Using this feature, it is possible sent
different image to the buffer of print. The selected
images of the examination are collected for
printing. The picture on the side shows the first
dialogue box that is opened.
From here you can choose: the printer, the print
size, layout and images of the type of orientation of the printing sheet. These
parameters are defined and confirmed by pressing the "OK" key. Chose the images
to print, select “Print All Examination” and the window preview will be opened.
PRINT ALL THE EXAMINATION
When selecting Print All The Examination from a Context Menu, the system
initiates a composition tool for the selected printing operation. Using this function,
the images previously selected with the Print the Image function, will be collected
for the printing.
A new window for
the print preview is
opened:
From this window you can: change back the format of the image, choose the
number of copies to print and print priority, scroll through the pages, print a single
page or the entire examination, cancel the printing or close the preview in case you
want to add more images. If you want to enlarge or shrink an image, you can do this
by placing the cursor on the image and scroll up and down with the mouse wheel.
Figure 9: Print Composer Window. The window shows the print preview and
allows to change size and position of image before printing.
Priority: is a Dicom field, if the printer handles priority, it is possible to assign a

higher priority to pass the examination the print queue.
Cancel: back to the main menu keeping the composition settings to print
Abort: close print menu and cancel the print composition
WINDOW & LEVEL AREA
By selecting the WINDOWS & LEVEL AREA checkbox in the CONTEXT MENU
you enable the post-processing function, which acts on the WINDOW & LEVEL
(brightness and contrast) of the image by optimising the display of an image area
selected by the operator. Enabling this feature will disable the PAN and the pointer
becomes a square with central cross. If the operator now selects a particular area of
the image, values from the minimum and maximum levels of grey in this area are
taken as reference for the entire image. In this way the area chosen by the operator
will have the best display.
WINDOWS & LEVEL
By selecting the WINDOWS & LEVEL checkbox in the CONTEXT MENU you
enable the post-processing function, which can be performed by using the mouse
(the PAN function is disabled).
Brightness and contrast of the image can be modified, pressing the screen on the
image and drop the pointer in this way:
Increase
LEVEL
(level of grey mean)

Decrease Increase
WINDOWS WINDOWS
(number of grey level   (number of grey level
visualised) visualised)

Decrease
LEVEL
(level of grey mean)
ZOOM
Select the ZOOM function, an increasing or decreasing zoom is activated on the

image. Pressing the screen and moving the pointer in the directions up - down the
size of image increase or decrease.
Increase
ZOOM

Decrease
ZOOM
Use the function key PAN to move the image.
ROI
By selecting the ROI checkbox on the CONTEXT MENU, the post-processing

function is enabled and the PAN function is disabled.
A new AREA OF INTEREST can be traced, pressing the screen and moving the
squared cursor. Everything that is outside the area will be blackened (collimation
software). To remove the collimation it is sufficient to double pression outside the
image.
Note: collimated images are sent to PACS with the active ROI and as an overlay.
You can then retrieve the information out of the ROI by removing the collimation at
any time.
SAVE
If you select the SAVE checkbox in the CONTEXT MENU an identical copy of the
image is saved as last image of the examination.
OVERLAYS
By selecting OVERLAYS from the CONTEXT MENU, the system opens a new
window for note entering with four options: insert the last record entered, insert a
new note (ADD), modify an existing note (EDIT), move a pre-existing note (MOVE).
ATTENTION: when an image is sent with notes, these notes are saved on the
image and you cannot remove them. Notes can be removed at any time from the
local image with no data loss.
PANEL 3543 EZ SHARING WITH ANOTHER DEVICE
Thanks to the Pixium 3543 EZ high sharing capacity, the operator can share the
same panel with two different devices, for example the mobile unit XFM and a fixed
location device such as X-Frame DR EZ or X-Frame DR.
The operation of XFM and another fixed device is based on the principle that the
two systems are independent of one another. Both of the two systems have the
same features as download exams from PACS sending Dicom images to the PACS
or printer.
They have in common the detector Pixium 3543 EZ which can only be used on one
system at a time. For this reason, the user must enable the panel on the system
that wants to use causing the automatic disabling from the previous device.
USER INTERFACE
The user who wants to use one of the two systems must enable the panel on the
system chosen. The procedure is the same in both cases.
Push the button “Connect Detector” and approach the Infra Red configuration
module to the panel receiver that is located near the battery LED. Wait until the
system will not give the message of connection.
Panel Infra
Red receiver
The message is received by the infrared module involves the flashing of the LED
panel. If you do not receive the message, move the module slightly, bringing it
closer or further away to the receiver, will not happen until the LED flash. Then stop
the movement and hold the module until the operation is complete (end of LED
flashing, turn on the green light).
Panel Infra Red configuration with fixed device (X-Frame DR EZ or X-Frame DR)
Infra Red
configuration module
Pixium 3543 EZ Infra

Red receiver
Panel Infra Red configuration with mobile unit XFM. The procedure is the same of
the fixed unit, the IR module is located inside the compartment immediately below
the carrying handle.
Open special compartment Inside is present the Infra Red

Configuration module
On touch screen, push

the button “Connect
Detector”, approach
the Infra Red
configuration module
to the panel receiver
that is located near the
battery LED.
Wait until the system
will not give the
message of
connection.
8 ERROR MESSAGES
If there is an error, the system warns the operator by showing the error message on
the display. Below is an explanation of:
 The error messages
 Description of the possible cause that generated the error.
 Actions needed to restore the operating conditions of the equipment
If the equipment continues to show the error after the corrective action (for those
errors that do not require the intervention of the technical Assistance office) write
down the code and the serial number of the equipment and contact the Technical
Assistance office.
MESSAGE CAUSE and SOLUTION

Situation the operator cannot redress. Refer to service
Calibration not performed
manual.
Loading of capacitors in progress. If after 90 sec the
Loading in progress loading has not been completed, restart the system.
Refer to service manual.
kVp, mA parameters or times too long; reduce load
Maximum load
values to tube.
Released 1st step before performing the 2nd X-ray step.
Release 1st step
Repeat the exposure.
Released 2nd step before the X-ray time. Repeat the
Release 2nd step
exposure.
Situation the operator cannot redress. Refer to service
Generator Fault
manual.
9 MAINTENANCE WARNINGS
Maintenance shall be performed only by the manufacturer or by personnel
authorized by ITALRAY s.r.l. The company cannot be held liable for any
consequences arising from actions performed by unauthorised personnel.
Programmed maintenance of this equipment shall be performed according to the
following schedule:
 DARK and X-RAY CALIBRATION with TEST_AT every 3 months whenever
there is evidence of an artifact can not be removed by repeated exposure to high
uniform dose to the panel,
 replacement of the Hard Disk: whenever defects appear (eg excessive
slowness of the system in daily operations.
The system automatically sends a warning when quarterly maintenance is needed.
The device living time is defined in 10 year.
INSTRUCTIONS FOR USE THE USB KEY RECOVERY
In case that the operating system of the generator XFM has crashed and is not able
to start a USB key is present in the rear drawer of the machine this key will allow
you to restore the operating system, bringing it back to the factory settings.
WARNING!!!
The use of the USB key will
cause the loss of the exams
archive.
To make this operation is necessary to have a powered USB HUB and a USB
keyboard. The recovery process is as follows:
 Remove the USB key from the drawer
 Insert the external USB HUB into the USB connector on the left side of the
machine and connect the USB key and the keyboard.
 Turn on the machine...will starts the recovery program with a screen like this:
 do not perform any operation, wait until the machine switches to the next
screen.
 In folliwing screens the recovery program will make you twice time this
question:
"Are you sure you want to continue? (y / n) "
answer yes to both by pressing "Y" and "Enter".
 Now, the program will make the recovery operations (format the hard disk of the
machine in order to install the operating system present on the USB key, which
is the same one that was on the machine at the time of the first switch ON),This
operation will take a few minutes.
 After the recovery the program will show the following dialog window
using the arrow keys on your keyboard select the option "power off" and press
“enter."
 After the switch off of the computer unplug the USB HUB whit the keyboard and
the USB key, then restart your PC.
The operation is completed, at the switch of the PC the program xframe.exe will
restart as the first turn on of the machine.
10 CLEANING WARNINGS
Products used to clean the external surfaces of the machine should have low
alcohol content and contain no corrosive or abrasive detergent, no solvents
(gasoline, alcohol, acetone, etc). Cleaning external surfaces shall therefore be
performed only with a wet cloth and neutral detergent and the surface shall be dried
with a soft dry cloth. To perform cleaning operations always respect the following
indications:
 Turn off the device
 Check that no liquid can penetrate into the device so as to avoid short-circuit
and corrosion of the components
The material used to clean, sterilise, and disinfect a PIXIUM 3543 EZ, such as
towelettes and dust clothes, must be processed using dedicated waste recycling
procedures. The detector remains functional under limited exposure to the liquids
defined in the table here below.
The column “clean” means that neither discoloration nor aesthetic (nor functional) damage
occurs due to a limited exposure of the corresponding part to the corresponding liquid.
For each part indicated in the first line, a quote “+” means a perfect cleanness even
after several hours exposure, a “0” means that slight discoloration might occur
especially for several minutes to hours exposure, a “no“ means that the surface
might be seriously affected and thus is not guaranteed by specification. Values into
brackets are to be confirmed.
11 Storage and Handling Instructions

Pixium Portable 3543EZ detector:
 Refer to the Unpacking Instruction Label attached to the outer cardboard box for
the storage and handling conditions of the incoming shipment (stacking
limitations, environmental temperature and humidity, pressure, etc...).
 The detector must be stored and handled within its original larger outer
cardboard box. Do not open this outer box if there is no need.
 While not used nor powered, the detector should be stored within the inner
protective bag resealed or closed with adhesive tape, and using desiccant
material inside the bag to avoid any humidity on the detector
12 Overall dimension
Source Position
The location of the source in the monoblock is shown in the following figure:
Via Del Parlamento Europeo 9/D 50018 Scandicci (FI) Italy

tel. +39/055/7228511 fax. +39/055/7228512
web: www.italray.it email: info@italray.it

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Digital mobile diagnostic X-ray system

APPARECCHI RADIOLOGICI ELETTROMEDICALI

This manual in English is the original version.

4 TECHNICAL STANDARD ........................................................................................................... 8

7 OPERATOR MANUAL ...............................................................................................................18

Window & Level Area ............................................................................................................ 59

9 MAINTENANCE WARNINGS .................................................................................................... 66

11 STORAGE AND HANDLING INSTRUCTIONS ........................................................................ 70

Carefully read this manual before using the appliance.

In case of problems or malfunctioning that cannot be solved following the

Laws limit the operation of this device to doctors or

To avoid irreparable damages to some of its components, never start the

 The manufacturer cannot be considered liable for any breakage, malfunction

Field Pixium 3543EZ: 432x345 mm

230 Vac (110Vac optional)

Depth x Length x Height 120 x 67 x 161 cm

Model Pixium Portable 3543 EZ

Battery Kit Optional (40 Ah)

For the digital detector :

Code AMR+IR301/*-* : same functions of XFM Mobile DR standard model but

Each models use Pixium 3543 EZ digital radiography flat panel.

Available optional: DAP meter, different battery capacity (60Ah, 90Ah).

For DR flat panel read the Trixell recommendations

The equipment must not be disposed of as normal urban solid waste.

ITALRAY ensures availability of spare parts and maintenance for a period of 10

MANUFACTURER’S GUIDE AND DECLARATIONS. ELECTROMAGNETIC EMISSIONS

MANUFACTURER’S GUIDE AND DECLARATIONS - ELECTROMAGNETIC IMMUNITIES

IEC 61000 – 4 – 11 <5% U T for 5 seconds <5% U T for 5 seconds

MANUFACTURER’S GUIDE AND DECLARATIONS - ELECTROMAGNETIC IMMUNITIES

The intensity of the transmitter field with fixed

Interference phenomena are possible in the

RECOMMENDED SEPARATION DISTANCES BETWEEN MOBILE AD PORTABLE RADIO COMMUNICATION DEVICES

This manual refers to the system as a whole. Some functions and/or

Keep the device connected to the external power supply, in order

The complete discharge of battery and the long period of time

Keep the detector in Docking Station always.

The system is composed by:

Following the Start-up procedure:

WARNING: set the overload switch to ON always.

2) Connect the power cable to the power supply

System switch off

RECOMMENDED USE OF SYSTEM

When system is not in use

Restart the system

Moving the system with the motorization package

Note: Anti-collision functionality can be disabled, simply pressing one of the 2

Exposure and Motorization Battery recharging

Flat Panel Battery recommended use

External USB port

RE-SETTING THE EQUIPMENT

WARNING: Before using the equipment, verify if it is necessary to

kVp mAs Exp Time

kVp mAs Exp Time

If there are no errors the equipment is ready for ordinary operation.

MANUAL MOVING AND POSITIONING THE EQUIPMENT

Before moving the equipment make

Before moving the equipment put it in

Locking the arm

Arm lock Arm unlock

Unlocking the brake system

To move the unit press the transportation

Moving and obstacles overcoming

To overcome any small obstacles (ex. in/out of

If the device is motorised, use it in the following way:

Code AMR+IR301/- : same functions of XFM Mobile DR standard model but