User Manual

RAFALE DR
 User Manual

Identification plates
A facsimile of the Identification Plates applied on the radiological unit is shown below.

Declaration of responsibility
The Manufacturer is only responsible for the safety of its products when their
maintenance, repair and/or modification has been carried out by the manufacturer or by
personnel expressly authorised to do so by the manufacturer itself.
The manufacturer shall not be held responsible in any way for malfunction, damage
and/or danger due to incorrect use of the system or to disregard of the maintenance
Regulations.
The user of the installation where the system is connected is responsible for making sure
that the installation itself is only used by suitably trained and qualified operators.

Compliance and reference address

Mobile Equipment compliance with the national and international standard in force.
Information relevant to the compliance may be required to:

Apelem
Parc Scientifique Georges Besse
175 allée Von Neumann
30035 Nîmes Cédex 1 France
Tel : +33 (0)4 66 29 09 07

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Index
Identification plates ................................................................................................... 2
Declaration of responsibility .................................................................................... 2
1 General Description .................................................................... 6
1.1 Application and destined use ............................................................................. 6
1.2 Key .................................................................................................................... 7
1.2 Overlay .............................................................................................................. 7
1.2.1 Overview ....................................................................................................... 7
1.2.2 Control Console ........................................................................................... 8
1.2.3 Collimator ...................................................................................................... 8
2 Safety and Maintenance ............................................................ 10
2.1 Introduction ......................................................................................................10
2.2 Declaration of conformity and responsibility ......................................................11
2.3 Safety devices of the system ............................................................................11
2.3.1 Mechanical safety devices ............................................................................11
2.3.2 Electrical safety devices ...............................................................................11
2.3.3 Circuit breaker ..............................................................................................11
2.4 Protection against ionising radiation .................................................................12
2.5 Residual Risks..................................................................................................13
2.6 Signals .............................................................................................................13
2.6 Signals .............................................................................................................14
2.6.1 Symbol used.................................................................................................14
2.6.2 Signal and Alarm Messages .........................................................................15
2.6.3 Acoustic Signals ...........................................................................................16
2.7 Electromagnetic Compatibility (EMC) ...............................................................16
2.7.1 List of Cables ................................................................................................17
2.7.2 Performance .................................................................................................17
2.7.3 Elecromagnetic Emission .............................................................................17
2.8 Elimination of the Device ..................................................................................21
3 Using the Unit ............................................................................ 23
3.1 Transport of the Unit .........................................................................................23

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3.2 Positioning ....................................................................................................... 23

3.2.1 Positioning the Arm ...................................................................................... 23
3.2.2 Movements of the Monobloc / Collimator Group ........................................... 24
3.3 Turning on........................................................................................................ 24
3.4 Using the Software........................................................................................... 25
3.4.1 User Interface .............................................................................................. 25
3.4.2 Starting software .......................................................................................... 26
3.4.3 NEW PATIENT NOT PLANNED OVERVIEW ............................................. 27
3.4.4 Overview of the general operating framework .............................................. 28
3.4.5 Macro Exposure Mode ................................................................................. 29
3.5 New exam ........................................................................................................ 30
3.6 Adjustment of the dimensions of the x-ray field ................................................ 33
3.7 RX Exposure.................................................................................................... 34
3.8 X-ray Exposure (kV and mAs) .......................................................................... 36
3.9 Operation After Use ......................................................................................... 37
4 Maintenance .............................................................................. 39
4.1 Ordinary Maintenance ...................................................................................... 39
4.1.1 General Recommendations .......................................................................... 39
4.1.2 Check and Inspection to be Carried Out by the User .................................... 39
4.2 Cleaning and Disinfection ................................................................................ 40
5 Configuration ............................................................................ 43
6 Technical characteristics ......................................................... 45
6.1 Electrical data .................................................................................................. 45
6.2 Operating characteristics ................................................................................. 45
6.3 Enviromental Data ........................................................................................... 46
6.4 Radiological Characteristics ............................................................................. 46
6.5 kV-mA Relationship ......................................................................................... 47
6.6 Mechanical Characteristics .............................................................................. 50
6.7 Collimator......................................................................................................... 51
6.8 Monobloc and Inverter ..................................................................................... 51
6.9 PC Technical Characteristics ........................................................................... 52
7 Revision List.............................................................................. 53

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General Description

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1 General Description
1.1 APPLICATION AND DESTINED USE
The apparatus is a Mobile Radiographic Unit DR for radiography on a digital system
specifically designed for use in the plaster rooms, first aid and directly on the patient's
bed. The unit uses certified software as a support tool for diagnostic activities in the
orthopaedic, vascular and interventional field. Therefore, it is possible to acquire, display,
control, store, process and print images acquired through the mobile unit.
The following pages show all the electrical, mechanical and radiological characteristics of
the mobile stand; detailed information is also present in the equipment's User and
Technical Manuals.
And 'provided that the installation and use of the product is intended for qualified
personnel and properly trained with the necessary knowledge in the field of
radiation protection and with the necessary training in the use of X-ray equipment.

➢ The system is not used in contact with the patient - only accidental contact
with some parts of the device with the patient is possible and is contact with
the operator is foreseen.
➢ Contact with the patient is not of the invasive type.
➢ Contact with the operator is foreseen for reasons strictly linked to the
conditions of use
(Operating Manoeuvres).

Device life: 10 years with a regular maintenance of the device

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1.2 OVERLAY
1.2.1 OVERVIEW
5 1 Pivoting Wheel
3 2 Mechanical support
3 Collimator
4 Handle for positioning monobloc
7 5 Monobloc
6 Key generator ON
7 User interface display
6 15 8 Transport handle “Dead man”
4 9 Electronic control
8 10 UPS location
11 Support for tilting
12 Lateral wheels
13 CD-ROM writer
2
14 Power ON UPS/PC switch
10 16 15 Key generator OFF
1 16 Indicator generator ON
17 LAN connector
18 USB connector

12

9 11

6 15

13

14

17
8

18

16

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1.2.2 Control Console

POWER Power Line Present

ON Key Generator ON

ON Indicator generator ON

ON/OFF UPS/PC Switch ON/OFF

OFF Key generator OFF

The RX emission are signaling

X-RAY
by this light

1.2.3 Collimator

18

17
16
14

14 Rail for accessories and filters

15 Retractable meterstick
16 Adjustment of the transverse
diaphragm
17 Turning collimator light on
18 Adjustment of the longitudinal
15 diaphragm

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Safety and
Maintenance

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2 Safety and Maintenance

2.1 Introduction
The purpose of this Instruction manual is to provide operating instructions for qualified
radiology technicians, medical and paramedical personnel so that use of the Radiographic
unit is simple and safe. The manufacturer reserves the right to integrate and improve this
information when it is available and to update the apparatus in accordance with continual
technological development.
This apparatus emits X Radiation and must only be used in conformity with the safety
instructions indicated in this Manual and must not be used for purposes other than those
foreseen.
The radiological apparatus must only be used by personnel with the necessary knowledge in
the field of protection against radiation and with the required training in use of X-ray
apparatus.
Strictly follow the indications given below:
➢ The apparatus must not be used when there are electrical, mechanical or radiological
faults.
➢ Do not use the system when any signalling or alarm device of the plant is not functioning
correctly
➢ Never use the System in places saturated with flammable or explosive vapors and/or
gases.
➢ All maintenance, modification or repair operations on the System must be carried out by
The manufacturer or by personnel expressly qualified and authorized by the
manufacturer to do this. The latter declines any responsibility for malfunction due to
unauthorized interventions.
➢ If the System is to be used in combination with other pieces of apparatus, components or
modules whose compatibility is not certain, it is necessary to make sure that there is no
danger for either the patients or the operators. In case of need, please consult the
manufacturer.
➢ Like any other apparatus, the System must be used in an appropriate way.
➢ Furthermore, it requires periodic checks and maintenance according to what is specified
in the Maintenance Section of this Instruction manual

The manufacturer declines any responsibility for damage to persons and/or

! things caused by improper use of the same!

The user is always responsible for compliance with standards applicable to the
! installation and use of the equipment!

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2.2 Declaration of conformity and responsibility

The declaration of Product Conformity is always enclosed in the Instruction manual,
indicating the model, code and S/N, as regards the declaration of responsibility refer to the
cover manual.

2.3 Safety devices of the system

2.3.1 Mechanical safety devices
➢ After having positioned the apparatus, put the parking brakes on.
➢ Only use the special handles to move the apparatus
➢ Avoid any impact against obstacles or other structures
➢ Do not remove the protective casing of the apparatus except for maintenance operations
expressly mentioned and described in this Instruction manual or in the Service Manual.

2.3.2 Electrical safety devices

➢ The System can only be used in places or medical rooms which conform with the
applicable IEC Standards.
➢ Make sure that the power supply socket to which the apparatus is connected is approved
for the voltage and current foreseen for use of the system.
➢ The apparatus must not be used in places where there is the risk of explosions
➢ Before proceeding with cleaning, disinfection and/or sterilization of the apparatus,
disconnect the system from the power supply network
➢ The cleaning and disinfection products for the system can form explosive gaseous
mixtures. It is obligatory to only use products which comply with the corresponding
Regulations in force
➢ Be careful not to spill conductive liquids on the components of the system which, by
penetrating inside it, could jeopardise its function and safety
➢ Always turn the apparatus off after use.

2.3.3 Circuit breaker

The system is protected by a power circuit breaker on the front of the equipment. If the
switch intervene, is sufficient restore it to restart the system.

Any shot right after resetting the breaker may indicate bad operation. Contact
! immediately the technical service.

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2.4 Protection against ionising radiation

Before carrying out any x-ray exposure, make sure that all the necessary
precautions against radiation have been taken!.

During emission of radiation, the personnel present in the x-ray room must follow the
instructions in force on the subject of protection against radiation. For this purpose, bear in
mind the following rules:

➢ where necessary, use protective accessories against radiation in addition to the devices
already provided on the apparatus
➢ always use the special radio-protective gowns: a radio-protective material equivalent to
0.35 mm of lead (0.35 mm Pb) attenuates 99.95% of the radiation produced at 50 kV and
94.5% of that produced at 100 kV
➢ the best protection against radiation is distance: therefore, always keep as far away as
possible both from the radiation source and from the object of the exposure, using the
special remote radiography control with extension cable;
➢ avoid moving within or staying in the direct beam of radiation
➢ always use the smallest exposure field possible: the radiation dispersed considerably
depends on the volume of the object radiated
➢ Use always the smallest field of exposure possible, appropriately closing the collimator
diaphragms. The radiation dispersed does, in fact, depend greatly on the volume of the
object radiated.

In no case must the safety circuits provided against accidental exposures be

! modified or de-activated.

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2.5 Residual Risks

The manufacturer produces advanced radiological systems in terms of safety and
protection of the environment. If the apparatus is used correctly, there are no risks for people
or the environment.
With regard to the risks due to improper use of the apparatus, please see the prescriptions
and recommendations provided under the previous points. and it is underlined that:

➢ The Mobile Unit has been designed and constructed to avoid turning over up to an
inclination of 10° from horizontal in its transport position.
➢ It is therefore advisable:
⚫ not to remain, move or place the Apparatus on surfaces with an inclination of more
than 10°.
⚫ not to try to move the Apparatus without working on the special handle for
“releasing the brakes”;
⚫ pay attention, during movement of the Unit, to any obstacles on the floor (cables,
steps and differences in level of any kind)

For the Residual Risks due to any defect in the protection measures used, remember that:
➢ Protection against electric shocks is made by connecting the metal parts of the apparatus
to earth: it is therefore necessary to periodically check correct operation of the whole
earthing circuit - according to the Ordinary Maintenance Programme described in
Section 4 of this manual.

Not respecting the unit alarms could lead to overheating of the

! X-RAY MONOBLOC: this overload could result in loss, by the MONOBLOC itself,
of the insulating medium at very high temperatures.

During movements of the apparatus, take care that the parts do not hit the
! patient or the operator.

Avoid excessively fast movements: the kinetic energy accumulated

! could be a hazard for personnel close to the unit.

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2.6 SIGNALS
2.6.1 Symbol used
Apart from those on the Control Console (Cfr. Section 1 - §1.2.2), other symbols have been
used on the unit which are illustrated below.

Symbol Mean Placing

Key ON Carter display Touch screen

Key OFF Carter display Touch screen

UPS/PC Switch ON/OFF Front of the unit

Indicator generator ON Front of the unit

Operating Instruction Label of the inverter

See attached documentation Label of the unit

Label of the unit

Physiological Effects
Control panel

Apparatus in B class (standard EN601-

Label of the unit
1)

Device that requires proper

Label of the unit
disposal(2012/19/EC)

Pushbutton
Radiography
Radiography connector

Earthing protection Unit earth bar

Position of X-ray focus Monobloc cover

Presence of high voltage Unit’s electronic cco

Label of the unit,

! Warning
Annex documentation

Large focus Annex documentation

Small focus Annex documentation

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2.6.2 Signal and Alarm Messages

In the presence of the following alarm message the exposure is interrupted. If the alarm
reappear after You perform the recommended action, please contact the service.

Table 2.6.2 – Messages of the control console

Message Meaning Intervention
Possible alarm in stand-by
SUPPLY OF UNIT FAULT Error in the electronic system Call the technical service
Connect the jumper, if the alarm come back it is
TOTAL SAFETY ACTIVE Absence of the jumper on the IB02
necessary to contact the technical service
Turn the unit OFF and ON again.
The time of exposition is more long then
ACTIVATION OF WATCH DOG If the alarm comes back it is necessary to contact
the set
the technical service
Turn the unit OFF and ON again.
X-RAY COMMAND ALREADY
Error in the X-ray pushbutton If the alarm comes back it is necessary to contact
ACTIVE
the technical service
Turn the unit OFF and ON again. If the alarm
ALARM FILAMENT FAULT No current in the filament comes back it is necessary to contact the technical
service
The voltage to the X-ray tube exceeds Turn the unit OFF and ON again. If the alarm
ALARM INVERTER FAULT 110% of the Rated Value; error in the comes back it is necessary to contact the technical
high voltage generation circuit service
ALARM SET KV FAULT The set Kv is not correct Contact the technical service
ALARM THERMIC SAFETY Monobloc temperature too high Wait that the monobloc comes back cold
Connect the pushbutton connector, If the alarm
The pushbutton connector are not
X-RAY COMMAND DISABLED comes back it is necessary to contact the technical
connect
service
Turn the unit OFF and ON again. If the alarm
The capacitor bank is not charged or
CAPACITOR BANK FAULT comes back it is necessary to contact the technical
discharged correctly by the device
service
Turn the unit OFF and ON again. If the alarm
CHARGE CAPACITOR FAULT Error in the charge capacitor circuit comes back it is necessary to contact the technical
service
Turn the unit OFF and ON again. If the alarm
DAP FAULT. PRESS RESET Error of the measure of the dose area
comes back it is necessary to contact the technical
DAP (if present) patient device (DAP)
service
Possible alarm during the RX-exposure
The radiography control pushbutton has
Assess whether the image obtained is good and, if
MAN X-RAY STOP been released before the end of the
necessary, repeat the exposure.
exposure
Repeat the exposure. Turn the unit off and on
The exposure is not done, the KV value again and repeat the exposure. If the alarm comes
X-RAY LACKING
is 80% less than the set back, it is necessary to contact the technical
service
The unit has interrupted the radiography Assess whether the image obtained is good and, if
MAX TIME exposure since the maximum admissible necessary, repeat the exposure increasing the
exposure time has been reached value of the kV.
During radiography, the voltage at the X- Turn the unit off and on again and repeat the
KV FAULT ray tube is lower than 85% of the set exposure. If the alarm comes back, it is necessary
value to contact the technical service.
Turn the unit off and on again and repeat the
During radiography the value of the mA is
mA FAULT exposure. If the alarm comes back, it is necessary
less than 10 mA
to contact the technical service.
Error in Power supply circuit of the
STARTER FAULT Contact the technical service
Monobloc stator
Wait that the monobloc comes back cold, If the
X-RAY TUBE HOT The temperature of the tube is too hot alarm comes back, it is necessary to contact the
technical service
PREP.TIME TOO LONG The time of the preparation was too long Repeat the exposition

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2.6.3 Acoustic Signals

Here is the list of the most important acoustic signals

3 BEEP Exposure has taken place correctly

1 BEEP The X-ray pushbutton has been released before completion of the exposure - the
exposure has therefore been interrupted

2.7 Electromagnetic Compatibility (EMC)

According to the foreseen use, this electronic apparatus conforms with the 2004/108/EC
Directive, which defines the maximum permitted emission levels for electronic apparatus and
immunity from electromagnetic fields.
In any case, it is not possible to absolutely exclude the possibility that radio signals coming
from transmitters, such as mobile phones or similar mobile radio systems, themselves
conforming to the EMC standard, may influence correct operation of the electro medical
apparatus if they are used near the systems and have a relatively high transmission power.
Consequently the use of this type of radio apparatus in the immediate vicinity of medical
systems controlled electronically must be avoided, to eliminate any risk of interference.
EXPLANATION
Electronic apparatus which satisfies the EMC standard is designed so that, under normal
conditions, there is no risk of electromagnetic interference. However, in the case where
radio signals coming from high frequency transmitters with a relatively high transmission
power are used near the electronic apparatus, the risk of electromagnetic incompatibility
cannot be totally kept under control.

WARNING!
All types of transmission with mobile radio apparatus must be avoided.
Mobile telephones must be turned off in rooms near the apparatus.
These rules must be applied when the unit is active.

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2.7.1 List of Cables

The system integrator must take care of the kind of cables used for connection of the mobile
unit are listed below:

Cable Recommended length

Monobloc cable 4m
X-ray hand switch cable 4m
Power supply cable 7.5 m

The use of accessories, transducers and cables other than those specified may
! result in increased emission or decreased immunity of the equipment

2.7.2 Performance
The essential performances of the mobile unit with regard to EMC are:
• High quality digital X-ray images
• Software robustness
• Robustness of the communication link with the system
• No image lost
• Artefacts on the image can occur but without any risk of wrong diagnostic

2.7.3 Elecromagnetic Emission

The mobile unit needs special precautions regarding EMC and needs to be
! installed and put into service according to the EMC information provided below

Guidance and manufacturer’s declaration – electromagnetic emission

The mobile unit is intended for use in the electromagnetic environment specified below. The customer or the user
of the mobile unit should assure that is used in such an environment.
Emission test Compliance Electromagnetic environment - guidance
The mobile unit uses RF energy only for its
RF Emission CISPR 11 internal function. Therefore, its RF emission are
Group 1
very low and are not likely to cause any
interference in nearly electronic equipments.
RF Emission CISPR 11 Class A The mobile unit is suitable for use in all
Harmonic emissions IEC 61000-3-2 Not applicable establishments other than domestic and those
directly connected to the public low-voltage
Voltage fluctuations/flicker emissions
Not applicable power supply network that supplies buildings
IEC 61000-3-3 used for domestic purposes.

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Guidance and manufacturer’s declaration – electromagnetic immunity
The model mobile unitis intended for use in the electromagnetic environment specified below. The customer or
the user of the mobile unit should assure that is used in such an environment.
Electromagnetic
IEC 60601-1-2
Immunity test Compliance level environmental -
test level
guidance
Electrostatic discharge +/- 8kV contact +/- 8kV contact Floors should be
(ESD) +/- 15kV air +/- 15kV air wood, concrete or
IEC 61000-4-2 ceramic tile. If floor
are covered with
synthetic material, the
relative humidity
should be at least
30%.
Electric fast transient / +/- 2kV for power supply +/- 2kV for power supply Mains power quality
burst +/- 1kV for input / output lines +/- 1kV for input / output should be that of a
IEC 61000-4-4 lines typical commercial or
hospital environment.
Surge +/- 1kV differential mode +/- 1kV differential mode Mains power quality
IEC 61000-4-5 +/- 2kV common mode +/- 2kV common mode should be that of a
typical commercial or
hospital environment.
Voltage dips, short <5% Ut <5% Ut Mains power quality
interruptions and voltage (> 95% dip in Ut) for 0,5 cycle (> 95% dip in Ut) for 0,5 should be that of a
variation on power supply ---------------------------------------- cycle typical commercial or
input lines ------ ------------------------------------- hospital environment.
IEC 61000-4-11 40% of Ut --------40% of Ut If the user of the
(60% dip in Ut) for 5 cycle (60% dip in Ut) for 5 cycle Mobile unit requires
---------------------------------------- ------------------------------------- continued operation
------ -------- during power main
70% of Ut 70% of Ut interruption, it is
(30% dip in Ut) for 25 cycle (30% dip in Ut) for 25 cycle recommended that
---------------------------------------- ------------------------------------- the
------<5% Ut -------- Mobile unit be
(> 95% dip in Ut) for 5 s <5% Ut powered from an
(> 95% dip in Ut) for 5 s uninterruptible power
supply or a battery.
Power frequency 30 A/m 30 A/m
(50/60 Hz) magnetic field
IEC 61000-4-8

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Guidance and manufacturer’s declaration – electromagnetic immunity
The model mobile unit is intended for use in the electromagnetic environment specified below. The customer
or the user of the mobile unit should assure that is used in such an environment.
Electromagnetic
EN 60601-1-2
Immunity test Compliance level environmental –
test level
guidance
Conducted RF 3 Vrms 3 V rms Portable and mobile RF
EN 61000-4-6 150 kHz to 80 MHz communications
equipment should be
used no closer to any
parts of the mobile unit,
included cables, than the
recommended
separation distance
calculated from the
equation applicable to
the frequency of the
transmitter.
---------------------------------
---
Recommended
separation distance:
d= 1,2√P 150kHz to 80
Radiated RF 3 V/m 3 V/m MHz
EN 61000-4-3 80 MHz 2,7GHz Recommended
separation distance:
d= 1,2√P 80MHz to 800
MHz
Recommended
separation distance:
d= 2,3√P 800MHz to
2,5GHz
---------------------------------
---
Where P is the maximum
output power rating of
the transmitter in watts
(W) according to the
transmitter manufacture
and d is the
recommended
separation distance in
meters (m).
Field strengths from fixed
transmitter, as
determined by an
electromagnetic site
survey, should be less
than the compliance
level in each frequency
range.
Interference may occur
in the vicinity of
equipment marked whit
the symbol:

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Recommended separation distances between

portable and mobile RF communications equipment and the mobile unit
The mobile unit is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the mobile unit can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the mobile unit as recommended below, according to the maximum output power of the communications
equipment.
Separation distance according to frequency of transmitter m
Rated maximum output
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
power of transmitter
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 rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
The mobile unit is compliance with RED2014/53/UE

Par. 5.2.1.1 punto f)

RF communications equipment may cause interference on electromedical devices.
In connection with the mobile unit device, do not use this equipment at a distance less than
30 cm (12 inches) from any part of the device in question.

Par 5.2.1.2 – Par 5.2.2.1

The mobile unit device is classified (according to CISPR 11) as class A group 1.
The characteristics of this device make it suitable for use in industrial and hospital areas.
Any deviation from IEC 60601-1-2 and from instructions necessary to maintain basic safety,
with reference to electromagnetic disturbances, must not compromise the life expectancy of
the device's services.

Par. 5.2.2.4
The frequencies of transmission of the WI-FI signal from the device to the outside are:
5.18-5.24 Ghz
5.745-5.805 Ghz

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2.8 Disposal of the Device

Once the product is at the end of its use it must be disposed following the enforced rules
concerning the separate collection of waste and it cannot be treated as a simple urban
waste.
The symbol:

Indicates that the product has the requirements requested by new directives introduced for
the environmental protection (2011/65/EC, 2012/19/EC) and it must be disposed properly
once its life cycle is ended.
When the device has reached the end of its life it must be disposed at the proper centres for
the separate collection of electrical and electrical wastes, or it must be returned to the
reseller or to the manufacturer in case you want to replace the product with another
equivalent new one.
The proper separate collection helps to avoid possible negative effect on the environment
and on health and it facilitates the second use and the re-cycle of materials of which the
device is composed of. Ask for further information to the local authorities about the areas
dedicated to the wastes disposal.
Who does not dispose the product following what here above mentioned will be responsible
for the enforced rules.

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Using
the Unit

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3 Using the Unit

3.1 Transport of the Unit
➢ The transport position of the Unit must be the one shown in the following figure (with the
pantograph arm brake on).
➢ The power supply cable must be wound over the special cable-winding support.
➢ To get over small differences in level, use a foot to press on the Tilting Support (11).
➢ Movement of the Unit must only be made after releasing the parking brakes using the
special handle (8).

The Mobile Unit is Braked and cannot Move unless the “dead man Brake” is
! Released (8)

3.2 Positioning
➢ Do not try to move the system when the brakes are on.
➢ For movements, use the special handles.
➢ To connect the apparatus to the power supply network, only use 16A sockets with
earth terminal.
➢ To turn the Unit on, proceed as indicated in Paragraph 3.3.

3.2.1 Positioning the Arm

➢ Using the Monobloc Handle Positioning (4) lift the monobloc / Collimator group up
to the desired height. By released the Handle, the system remains in the position it
was taken to thanks to a Clutch Device integrated in the apparatus.

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3.2.2 Movements of the Monobloc / Collimator Group

The Monobloc / Collimator group can rotate in all directions, as shown in the figures below.
To position it, use the Monobloc positioning handle (4).
The inclination of the X-ray unit is indicated by the Goniometer placed in the front (F)

3.3 Turning on
To make the system operational:
➢ Connect the Unit to the power supply mains
➢ Switch on the flat panel(follow the specific VXvue user manual)
➢ Turn on the unit using the key and the relative pushbutton present on the unit(6)
➢ Switch on the UPS/PC unit pressing the relative push button
➢ The initial automatic Test of the unit will start immediately
➢ Wait for the completely start of the software

! Wait for the complete start of the system before carrying out any other
operation!

To connect the apparatus to the power supply mains, only use 16A sockets

! with earth terminal

Do not continually turn the unit on and off

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3.4 Using the Software

3.4.1 User Interface
The user interface consists of an LCD monitor with a touch screen.

Take care to avoid any damage to the surface of the LCD monitor when
! using the system.

The buttons displayed on the monitor can be touch-selected by the operator. Entering text or
characters is done by means of a virtual keyboard which can be called up using the special
icon.

DISPLAY/HIDE VIRTUAL KEYBOARD

The following image shows a normal screen where the virtual keyboard has been called up.

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3.4.2 Starting software

At the start of the device, will automatically appear on the monitor, the login window.
User : Operator
Password: 1234
Insert login password

For full features please refer to operator manual of VxVue Software

!

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3.4.3 NEW PATIENT NOT PLANNED OVERVIEW

! (for detailed description please refer to VxVue operator manual)

The following menu is used to manually enter a new patient to be examined.
Activate, if not yet active, the virtual keyboard using the appropriate button

Standard fields
Patient ID Number of identification of patient
Last Name Surname of the patient
First Name Name of the patient
Sex Gender of the patient
Birth Date Date of birth of the patient
Acc. No. Accession Number
Procedure Type of procedure
Performing Physician User

Click on “Start study” to start examination

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3.4.4 Overview of the general operating framework

The operating panel is the screen that appears when a new exam is opened.
It is divided into two sections: the Frame Area and the Command Area.

1 Study Tab Area

In the Study tab area, you can select the study registered for shooting.

• Click Button, you can automatically save and close the study tab being shot.

2 Detector and Patient Size Selection Area

You can select the detector to be shot and the size of the patient to prepare for shooting.

• The detector icon to be used for shooting can be selected.

• The patient size icon can be selected.

3 Shooting Step Selection Area

You can select the category and the shooting area and direction to prepare for shooting.

• The category can be selected.

• You can select shortcut icon of shooting area registered in human figure.
• After selecting the shooting area, you can select the shooting direction buttons located
on the left and right of the human figure.

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4 Quick Access Tool

You can adjust the recorded image with the image adjustment tool button that you registered.

• The tools registered in the user image adjustment tool can be registered in the Setting
mode.

5 Go to Macro-Exposure Mode

You can switch to the close-up shooting mode screen by clicking the Maximum button.

6 Image View Area

You can check the images shot in the image view area.

7 Thumbnail Area

You can check the thumbnails of the images shot in the thumbnail area. When you select the
thumbnail image, the selected image appears in the image view area.

3.4.5 Macro Exposure Mode

You can enlarge the image view area to shoot and adjust the image.

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3.5 New exam

1- Input patient information (information in green are mandatory)

2- Click on “Start Study”

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This page will appear.

3- Select the anatomical part and relative projection that you intend to examine
4- At this point it is possible to perform the RX display.
5- Follow the procedure for adjusting the spoke field size and Rx exposure (§.3.6 - 3.7 -
3.8)

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6- Make the first simple adjustments if necessary

7- Close or send the exam to the PACS.
8- When the exam is closed, the changes made to the image will be saved automatically

For detailed features, refer to the VxVue operator manual

!

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3.6 Adjustment of the dimensions of the x-ray field

➢ Adjust the Focus / Film distance - which can be measured using the
Retractable Meter (15) - moving the X-ray unit .
➢ Turn the Collimator light on by using the Turn collimator light on
pushbutton on the Touch Screen or using the Turn collimator light on (17)
pushbutton located on the Collimator itself.
➢ At this point, adjust the luminous field (which coincides with the X-ray Field)
to centre the area to be x-rayed, by means of the Longitudinal Diaphragm
Adjustment (18) and Transverse Diaphragm Adjustment (16) knobs.

18

17
16
14

15

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3.7 RX Exposure
Before carrying out any exposure, make sure that all necessary radiation
! precautions have been activated.

After a long period of inactivity (3 or more months) it is very important to

proceed with the seasoning of the rx tube. This is to avoid high voltage
! discharges that could damage the RX pipe; the procedure is described in the
Service Manual.

X-Ray emission are indicated by

the RX exposure LED lighting up.

3.7.1 EXPOSURE RX KV AND MAS

If you have selected an anatomical technique, the unit is immediately ready for Rx
exposure and the preset kV and mAs values appear on the screen.
If you want to change the preset values, manually change the values from the control
console.

➢ Use the KVp and mAs buttons to set the desired values for these parameters.
➢ Position the panel.
➢ Pull out the Control button from the Control Support. This device is a double-stage button
(Trip A and Trip B - see figure below) and must be used as shown below.
➢ Press the X Ray Control button and take the first shot (A). Hold the button in
this position for at least 3 seconds. When you are ready, take the second shot
(B) accordingly with the beam command button and hold it in that position. At
this moment the X-ray emission starts and the Emission LED lights up.
➢ At the end of the X-ray emission the LED turns off and the acoustic signal ends. At this
point it is possible to release both clicks of the Control button. After a few seconds the
screen will display the acquired image.

It is not possible to acquire images until the generator and the detector are ready for
the emission and acquisition of X-rays. Status of the generator and detector are
shown in the appropriate boxes.

At the first click of the exposure button the radiological system is brought into x-ray
preparation. The second click enables X-ray emission for the set time. After a few
seconds the image will be shown on the monitor.

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Before making any exposure, make sure that all the necessary precautions

! against radiation have been taken.

Releasing the first click (A) early does not have any consequences.
Early release of the second click (B) interrupts x-ray radiation emission.
! The Display will show the wording “Man X-ray Stop” for about 10 seconds
and the Unit will emit an intermittent sound.

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3.8 X-ray Exposure (kV and mAs)

N° Exam kV mAs kV mAs kV mAs

1 SKULL LATERAL 74 2,5 78 3,2 82 4
2 SKULL AP 68 2,5 70 2,8 72 3,2
3 SKULL SINUSES AP 73 2,8 75 3,2 77 3,6
SKULL SINUSES
4 73 2,5 75 2,8 77 3,2
LATERAL
5 THORAX 80 5,6 85 8 90 8
6 THORAX AP 80 5,6 82 6,3 84 7,1
7 THORAX LATERAL 75 5,6 77 6,3 79 7,1
8 SPINE 65 4 68 5 72 6,3
9 SPINE LATERAL 63 4 66 5 69 6,3
10 LOMBO AP 75 6,3 80 8 85 10
11 LOMBO LATERAL 78 7,1 83 9 88 11
12 PELVIS AP 72 5,6 75 6,3 78 7,1
13 HAND AP 43 3,6 44 4 45 4,5
14 WRIST AP 50 3,2 52 3,6 54 5
15 WRIST LATERAL 51 3,2 53 3,6 55 4
16 ELBOW AP 53 3,6 56 4 59 4,5
17 SHOULDER AP 60 10 63 12,5 66 16
18 FOOT AP 48 4,5 50 5 52 5,6
19 FOOT LATERAL 49 4,5 51 5 53 5,6
20 ANKLE AP 49 5 52 6,3 55 8
21 ANKLE LATERAL 57 5 50 6,3 53 8
22 KNEE AP 55 3,2 58 4 62 4,5
23 KNEE LATERAL 57 3,2 60 4 64 4,5

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3.9 Operation After Use

After use, always proceed according to what is specified below:
➢ Put the stand into the parking position.

➢ Turn the unit off using the relative icon. Exit -> ShutDown

➢ Please wait until PC is OFF

➢ Shut down UPS/PC trough the push button
➢ Shut down the generator trough the push button
➢ Shut down flat panel detector
➢ Disconnect the power cord and wind it on the appropriate supports.
Do not remove the connector from the power supply socket
! unless the Unit has been turned off !

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Maintenance

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4 Maintenance
In this Instruction manual reference is only made to ordinary maintenance. For
extraordinary maintenance operations, interventions in the case of faults and/or replacement
of components, it is necessary to refer to the Service Manual.

4.1 Ordinary Maintenance

4.1.1 General Recommendations
The radiological system needs checks and maintenance operations carried out regularly.
The following recommendations have the aim of keeping good operating conditions and
service safety.
The apparatus contains mechanical parts subject to wear according to use: after a prolonged
period of use the degree of safety may decrease due to wear of parts.
Regular inspections and maintenance serve above all to protect the patient and operator
from hazards caused by any breakage of mechanical parts.
Correct adjustment of the electro-mechanical and electronic modules affects operation,
electrical safety and the level of exposure to radiation both medical and paramedical
personnel and the patients are subjected too. The maintenance programme includes checks
and preventive interventions which are the responsibility of the owner of the apparatus, and
which must be carried out by expressly authorized personnel.

Should it be necessary to replace parts which could jeopardise safety of

! the machine, only use original spare parts

4.1.2 Check and Inspection to be Carried Out by the User

The user must see to training the operating personnel so that they are able to make the daily
checks. These checks are listed in Table 4.1.2.

The weekly, six-monthly and annual checks are reserved for qualified
! and authorized personnel of the technical service.

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Table 4.1.2

Daily checks
Check operation of the signals, the touch-screen monitor and the luminous LEDs.
Check operation of the parking brake.
Check integrity of the warning and danger labels.
Weekly checks
Check that there are no oil leaks from the Monobloc.
Check there are no unusual noises in the Monobloc during X-ray emission.
six-monthly checks
Check correct operation and the relative value of the whole earthing circuit.
Check the power supply voltage value.
Check the value of the direct voltages generated inside the system.
Check fixing and general state (dust and corrosion) of the cards.
Check centring of the monobloc-collimator group.
Annual checks
Check kV and mAs (*)
Safety Check leakage current
Test Check electric strength
Check earth resistance
(*) Call the Service to carry out the safety and reproducibility tests, as indicated in the IEC 1223-2 and IEC
1223-11 standards, the other functional checks of the apparatus, as described in the programmed maintenance
plan (Service manual)

4.2 Cleaning and Disinfection

To clean the surfaces of the apparatus, products with a high content of alcohol, corrosive
and/or abrasive detergents and solvents must not be used.
To disinfect the system, only use methods in accordance with the regulations in force
regarding disinfection procedures and protection against explosions.
To carry out the cleaning and disinfection operations, follow the precautions indicated below:

➢ Turn the system off and disconnect the mains power supply cable.
➢ Make sure that no liquid enters the apparatus, in order to prevent short-circuits and
corrosion of the electrical and electro-mechanical components.

The apparatus is not suitable for use in the presence of anesthetics and/or
! flammable disinfection and cleaning products. Should products which form
explosive gaseous mixtures be used, make sure that the gases are dispersed
before turning the unit on again.
For any replacements of the unit components (Monobloc, collimator), please
! refer to the Service Manual– Section 3 – Maintenance.

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White Page

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Configuration

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5 Configuration

Please refer to VxVue operator manual

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Technical
Characteristics

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6 Technical characteristics
6.1 Electrical data
The information regarding the Technical data of the System is given in table 6.1.
Table 6.1

Description Data
Voltage 230 Vac
Frequency 50 Hz
Continuous operation <1A
Max absorbed current
Intermitted operation 12A
Line compensation Automatic
Line resistance < 2.5 Ω

Power supply socket 16A Power supply at 230 Vac

Class I
Classification EN60601-1
With type B part applied
Conditions of use EN60601-1 Continuous operation with intermitted load
Directive classification 2007/47/CE Class II b (annex IX norm 10)

6.2 Operating characteristics

The information regarding the Technical data of the System is given in table 6.2.
Table 6.2

Description Data

Rear-lit Touch Screen for all the operating parameters and messages for
Operator interface
any possible anomalous conditions. Managed by Microcontroller.
Selectable languages Italian, English, French, German, Spanish, Russian, Japanese
Radiography exposure
Remote control with double click and extension cable
control
Radiography with free
Technique with 2/3 points (kV, mAs/KV, mAs, mS).
technique
– mAmin and mAmax Safety device
– Maximum X-ray tube load safety device
– Maximum exposure time safety device
– Temperature and Monobloc
Safety devices
– Max kV, min kV, max I
– Capacitor Faulty
– Starter Anode Faulty
– Microprocessor auto-test with display of the diagnostic messages..

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6.3 Enviromental Data

The information regarding the environmental transport and operating data of the System is
given in Table 6.3.

Table 6.3
Transport and storage Operation
Description Data Data
Maximum Temperature From –10 °C to 55°C From 10 °C to 40 °C
Recommended
From 0 °C to 40 °C From 10 °C to 40 °C
temperature
Relative humidity From 20% to 90% From 30% to 75%
Pressure From 500 to 1060 hPa From 700 to 1060 hPa

6.4 Radiological Characteristics

The information regarding the environmental transport and operating data of the System is
given in Table 6.4.
Table 6.4

Maximum power 32 kW

Inverter Frequency 100 kHz

Ripple ≤ 3%
Total filtration > 2.7mm Al
Inverter model HF1 100
Monobloc model E 100 R HF
Maximum voltage at the monobloc 125 kV
Maximum current at the monobloc 425 mA

Monobloc heat capacity 600 KJ

Monobloc continuous heat dissipation 60W
Rx-tube double focus 0.6 mm - 1.3 mm
Kv variation steps 1KV
220 mAs (28 steps):
0,2 / 0,5 / 0,8 / 1 / 1,3 / 1,6 / 2 / 2,5 / 3,2 / 4 / 5 / 6,3 / 8
Maximum mAs
/ 10 / 13 / 16 / 20 / 25 / 32 / 40 / 50 / 63 / 80 / 100 /
130 / 160 /200 /220

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6.5 kV-mA Relationship

The information regarding the mA-Kv relationship of the System is given in Table 6.5A and
6.5B, Respectively for large and small focus and it’s graph

Large Focus

mAs Table 6.5A

220 100 / / / / / / / / / / / / / /
200 125 125 / / / / / / / / / / / / /
160 125 125 / / / / / / / / / / / / /
130 125 125 125 125 / / / / / / / / / / /
100 200 200 200 200 200 200 / / / / / / / / /
80 320 320 320 400 400 200 200 200 125 / / / / / /
63 320 320 320 400 400 320 320 320 200 200 100 100 / / /
50 320 320 320 400 400 320 320 320 320 320 200 100 100 100 100
40 320 320 320 400 400 400 400 320 320 320 250 200 200 200 200
32 320 320 320 400 400 400 400 320 320 320 320 250 250 200 200
25 320 320 320 400 400 400 400 320 320 320 320 250 250 200 200
20 320 320 320 400 400 400 400 400 320 320 320 250 250 200 200
16 320 320 320 400 400 400 400 400 320 320 320 250 250 250 200
13 320 320 320 400 400 400 400 400 320 320 320 250 250 250 200
10 320 320 320 400 400 400 400 400 320 320 320 250 250 250 200
8 320 320 320 400 400 400 400 400 320 320 320 250 250 250 200
6.3 320 320 320 400 400 400 400 400 320 320 320 250 250 250 200
5 320 320 320 400 400 400 400 400 320 320 302 250 250 250 200
4 320 320 320 400 400 400 400 400 320 320 302 250 250 250 200
3.2 320 320 320 400 400 400 400 400 320 320 320 250 250 250 200
2.5 320 320 320 320 320 320 320 320 320 320 320 250 250 250 250
2 320 320 320 320 320 320 320 320 320 320 320 250 250 250 250
1.6 320 320 320 320 320 320 320 320 320 320 320 250 250 250 250
1.3 250 250 250 250 250 250 250 250 250 250 250 250 250 250 250
1 250 250 250 250 250 250 250 250 250 250 250 250 250 250 250
0.8 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200
0.5 160 160 160 160 160 160 160 160 160 160 160 160 160 160 160
0.2 63 63 63 63 63 63 63 63 63 63 63 63 63 63 63
40- 43- 46- 51- 61- 66- 71- 82- 91- 101- 104- 111- 121-
kV 50 81
42 45 49 60 65 70 80 90 100 103 110 120 125

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Small Focus

mAs Tabella 6.5B

220 100 / / / / / / / / / / / / / /
200 100 100 / / / / / / / / / / / / /
160 125 125 / / / / / / / / / / / / /
130 125 125 125 125 / / / / / / / / / / /
100 160 160 160 160 125 100 / / / / / / / / /
80 160 160 160 160 125 100 100 80 80 / / / / / /
63 160 160 160 160 125 100 100 100 80 80 80 63 / / /
50 160 160 160 160 125 125 125 100 80 80 80 63 63 50 50
40 160 160 160 160 125 125 125 100 80 80 80 63 63 63 50
32 160 160 160 160 160 125 125 100 100 100 80 80 80 63 50
25 160 160 160 200 160 125 125 100 100 100 80 80 80 63 50
20 160 160 160 200 160 125 125 100 100 100 80 80 80 63 50
16 160 160 160 200 160 125 125 100 100 100 80 80 80 80 63
13 160 160 160 200 160 125 125 125 100 100 80 80 80 80 63
10 160 160 160 200 160 125 125 125 100 100 100 80 80 80 63
8 160 160 160 200 160 160 160 125 100 100 100 80 80 80 80
6.3 160 160 160 200 160 160 160 125 100 100 100 80 80 80 80
5 160 160 160 200 160 160 160 125 100 100 100 100 100 80 80
4 160 160 160 200 160 160 160 125 100 100 100 100 100 80 80
3.2 160 160 160 200 160 160 160 125 100 100 100 100 100 80 80
2.5 160 160 160 200 160 160 160 125 100 100 100 100 100 80 80
2 160 160 160 200 160 160 160 125 100 100 100 100 100 80 80
1.6 160 160 160 200 160 160 160 125 100 100 100 100 100 80 80
1.3 160 160 160 200 160 160 160 125 125 100 100 100 100 80 80
1 160 160 160 200 160 160 160 125 125 100 100 100 100 80 80
0.8 160 160 160 200 160 160 160 125 125 100 100 100 100 80 80
0.5 160 160 160 160 160 160 160 125 125 100 100 100 100 80 80
0.2 63 63 63 63 63 63 63 63 63 63 63 63 63 36 63
40- 43- 46- 51- 61- 66- 71- 82- 91- 101- 104- 111- 121-
kV 50 81
42 45 49 60 65 70 80 90 100 103 110 120 125

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Max kV-mA ratio in radiography mode - 32 kW

440,00

400,00

360,00

320,00 49
81
mA Grafia

280,00

240,00
101
200,00
51 121
160,00

120,00 111
80,00 81 125
40,00
35 45 55 65 75 85 95 105 115 120 125
kV

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6.6 Mechanical Characteristics

The information regarding the mechanical transport and operating characteristics of the System is
given in Table 6.6.

TABLE 6.5

Description 32 kW

Width 620 mm
Length 1181 mm
Height 1466 mm
Focus’s Height max, with outreach 1989 mm
Diameter of rear wheels 200 mm
Weight ≈ 200 kg
Handling Dead man brake
Cassette holder 35x45

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6.7 Collimator
The information regarding the information relative to the collimator characteristics is given in Table
6.7.

Tabella 6.7
Description Data
Multiple level blades parallel and perpendicular
Blade handling Manual
Dimensions of radiated field with focus-film distance of di 1 m: 43 x 43
cm
Focus-film distance indication with retractable tape measure (2m)
Light brightness (lux) >160 lux a 1 m
Inherent collimator filtration 2 mm Al
All the other information regarding the collimator are present in its relative manual.

6.8 Monobloc and Inverter

The technical characteristics of the Monobloc and inverter are shown in Table 6.8A and 6.8B.

Table 6.8A Monobloc

Description Data
Min. Inherent Filtration 1.8 mm Al
Total filtration >2.7 mm Al
All the other information regarding the collimator are present in its relative manuals.

Table 6.8B Inverter

Description Data
Model HF1 100 / 2
Maximum power 32 kW
Power supply voltage 230 Vac ± 10%
Power supply frequency 50/60 Hz
Maximum current 12A
Digital outputs High active
Digital inputs High active
Logic circuit power supply ± 15Vdc

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6.9 PC Technical Characteristics

Hardware and Software recommendations.

OS Microsoft Windows 10 Professional 64bit

LAN Card 1000BASE-T Gigabit Ethernet card

Intel® PRO 1000 Series (Gigabit LAN Card for
network interface)
WLAN Card Embedded wireless LAN card Supports IEEE
802.11nDual Band: 2.4𝐺𝐻𝑧, 5𝐺𝐻𝑧Supports Max
300Mbps
CPU Intel Core i5 or higher (or comparable CPU)
Memory 8GB or higher
HDD or SDD 1TB or higher
Monitor 1280 X 768 or higher
CD-ROM CD or DVD R/W

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7 Revision List
Revisions are handled with the change in the document number that is indicated by the
corporate management software.

DOCUMENT REVIEW DATE MODIFIED

NUMBER
003145 REV 00 11/Sept/2020 1st Release

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