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MOEXFD01
MOEXFD01
MOEXFD01
MOEXFD01
MANUAL DATA
REVISION MOEXFD01 VALID FOR SERIES FROM 1A ONWARD
INDEX OF REVISIONS
20/10/2006 MOEXFD01 – First release
ATTACHMENTS
DESCRIPTION CODE REVISION
NOTES
SUMMARY
GENERAL NOTES ............................................................................................................................ 4
WARNINGS......................................................................................................................................... 4
ELECTROMAGNETIC COMPATIBILITY ....................................................................................... 5
ENVIRONMENTAL CONDITIONS .................................................................................................. 7
WARRANTY ....................................................................................................................................... 8
MAINTENANCE WARNINGS........................................................................................................... 8
CLEANING WARNINGS ................................................................................................................... 8
TECHNICAL CHARACTERISTICS .................................................................................................. 9
IDENTIFICATION ............................................................................................................................ 10
OPERATOR MANUAL................................................................................................................... 12
GENERAL NOTES
WARNINGS
This manual aims at providing the operator of the medical appliance X-FRAME DR with all the information
needed for a correct use of the device.
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.
The company 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 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.
The company cannot be held liable for the consequences of the actions of unauthorized personnel.
The manufacturing company declines all liabilities related to the good functioning of the machine in case the
installation and maintenance are performed by unauthorized personnel.
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.
The manufacturing company retains the right to change the product described in the present manual at any time
and without notice.
All relevant norms for the disposal of this device shall be complied with. The characteristics of the materials
used in this device and in its packaging are listed below to ensure an environmentally conscious disposal:
Wood and/or 100% disposable plastic bubble film, carbon steel, 100% recyclable elastomers and
polycarbonate , aluminum and lead alloy, to be stocked and disposed according to current norms, vitreous
material and electronic components. The device does not contain toxic or dangerous materials according to
current classification criteria.
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.
ELECTROMAGNETIC COMPATIBILITY
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% UT for 0,5 cycles <5% UT for 0,5 cycles typical commercial or hospital environment. If the
variation on the supply X-FRAME DR operator needs a continuous
input lines <40% UT for 5 cycles <40% UT for 5 cycles functioning during voltage interruptions, we
suggest connecting the system to an uninterruptible
<70% UT for 25 cycles <70% UT for 25 cycles power supply (UPS).
IEC 61000 – 4 – 8
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).
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 X-FRAME is installed and used is above the aforementioned conformity level, the
functions of the X-FRAME DR should be put under observation. Additional measures such as a different orientation or position
of the X-FRAME DR 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.
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.
ENVIRONMENTAL CONDITIONS
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.
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 the consequences deriving from actions performed by unauthorized
personnel.
Programmed maintenance of the equipment shall be performed according to the following schedule:
CLEANING WARNINGS
Products used to clean the external surfaces of the machine should have low alcohol content and contain no
corrosive or abrasive cleansing product, 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.
For a correct functioning of this system the filters ahead of the fans MUST always be kept clean. The
operator is responsible for performing this operation at regular intervals, also determining the relevant minimal
interval (filters saturation varies according to the different locations of the appliances)
A – Open the system while checking that the device has been turned off, by removing the front panel acting on
the spring clamps.
B – Clean the PC filter by opening the panel with a tool or coin as shown in the picture.
C – Clean the fan filters shown in the picture by removing the protection (apply a light pressure on the filter
cover sides).
TECHNICAL CHARACTERISTICS
Multi-image
YES
visualization
Grid controls YES
UPS Yes - Optional
Send to Printer Yes
Dicom 3.0 functionalities Send to PACS Yes
Receive Worklist Yes
Processor* 3.0 GHz Pentium 4
RAM* DDR 1 Gb 400 MHz x 4
SATA 80Gb x 2 (RAID 1)
Personal Computer Hard disks*
+ ATA 40Gb
Operating system* Windows XP PRO
* minimum requirements for the pc
Single-phase voltage 230 V +- 10%, 50/60 Hz
Power supply Main system 340 VA
Detector
Temperature From 10° to 40° C
Humidity From 20% to 80%
Detector
Working environment From 18° to 30° C
Temperature
Detector Humidity
From 20% to 75%
Length 550 mm
Depth 600 mm
Main Unit size
Height 660 mm
Weight 95 kg
STANDARD DISPLAY
Model EZ 1MP
Type 18.1” TFT LCD – monochromatic, high contrast, for radiological use
Contrast 600:1
Brightness 700 cd/m2
Frequencies ( H / V ) VGA: 27-82 kHz / 85 Hz ; DVI-I : 27-64 kHz / 60-70 Hz
Resolution 1,3 Megapixels 1280 x 1024
Viewing angles ( H / V) 170° / 170°
Grey levels 1531 (10,5 bits)
Dimensions (L x H x W) 399 x 404 x 203 mm with holder
Weight 7,8 kg
ITALRAY s.r.l. has the right to modify the product described in this manual at any time and without further notice.
IDENTIFICATION
Models
CODE DESCRIPTION
SRD+IR600/A-A BASIC SYSTEM
This manual refers to the system as a whole. Some functions and/or performances are
included only on certain configurations.
OPERATOR MANUAL
X-FRAME DR is a 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.
X-FRAME DR shall be considered as an integral component of a SALA DR system, which
includes:
Multifunctional stand (ex. Tieton) with gurney/table, or bucky stand (ex. BS45) or
radiographic table (ex. BT/BTE);
TELESCOP suspended tube stand for XR tube
X-ray tube
RALCO R309L collimator
CPI INDICO 100 X-ray generator (several power ranges) with AEC, DAP,
MINICONSOLLE
Ionization chamber (compatible with INDICO, size following VACUTEC 70151)
DAP-meter (compatible with INDICO, ex. VACUDAP 2004)
Anti-scatter grid (JPI 438x438mm ratio12 80 L/cm with two DFF 180 cm and 120
cm)
X-FRAME DR
The X-FRAME DR system starts together with the whole SALA DR, that is, it can be
started using the START (marcia) button in the diagnostic appliance.
After the initialization phase, which lasts a few minutes, the system opens the EXAMINATION
MANAGEMENT window (gestione esami) (see EXAMINATION MANAGEMENT section for
details).
X-FRAME DR can be turned off by using the EXIT button on the EXAMINATION
MANAGEMENT window, after confirming the exit request in the relevant pop up
dialogue. The SALA DR can be turned off only after the operating system has come to a
complete shutdown by using the TURN OFF button on the diagnostic device.
If an UPS (optional) is available, the system is turned off directly via the TURN OFF button
on the diagnostic unit.
Note: This turn on/turn off logic does not apply to the PIXIUM 4600 detector and its supply unit. It is of
fundamental importance that this unit is constantly On in order to optimize its performance.
EXAMINATION MANAGEMENT
Opening the examination via the Local archive (archivio locale) containing all the
examination stored in the system
Open it from the Worklist received from the RIS
Open a New examination (nuovo esame)
At every new access, the system automatically selects the last option used. To change
mode, simply move to a different worksheet.
When the 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 X-FRAME DR system.
The results of this query are displayed in a table including the following fields:
Surname
Name
Code
Date of birth
Gender
Examination
Date
The operator can repeat the query to the RIS using the tools included in the table and
selecting different parameters:
*. The search can be performed also 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.
SAfter selecting one or more examinations from the table, it is then possible to import them
in the local archive with the Import button (importa). This action links the imported
examination/s to the operator performing the examination, whose name has to be selected
correctly 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.
The operator can manually add a new examination from the New examination worksheet
(nuovo esame) 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.
Save (salva), to save in the Local archive and reset the fields for new entries (allows
the operator to make batch entries)
Save and open (Salva Ed Apri), to save in the Local archive and immediately open
the examination acquisition window
If you are saving and/or opening a window with incomplete data, a dialogue window will
require you to insert the data and indicates all missing information.
All examinations in the system can be displayed form the Local archive worksheet in the
examination management window.
The fields included in the table are:
Surname
Name
Patient code;
Date of birth
Gender
Type of local examination
Date
Operator
Images
Status
Use classic Windows methods to open one or more examinations on the table (with the
mouse or keyboard).
To open an examination Double click on the examination with the right button of your
mouse.
If the examination record contains no images, opening it will automatically open the
examination acquisition window. Otherwise, the system displays the examination content.
Use the DELETE button to permanently delete the selected examination/s (after confirming
the choice though the dialogue window).
SETUP
The Setup button (configuration) allows access to the system configuration (opens a
dialogue box requiring a password specifically reserved for maintenance operators).
PRINTING QUEUE
The Printing queue functionality (Coda Di Stampa) opens a specific dialogue box to check
the print jobs that have been sent and are being processed.
After selecting one of the printing jobs in the list, the function buttons in this dialogue box
allow canceling, pausing and restarting its execution and clear the printing queue.
ARCHIVE QUEUE
The Archive queue functionality (Coda di archiviazione) opens a specific dialogue box to
check the examinations that have been sent to the SERVER and which are being processed.
After selecting one of the examinations that have been sent to the SERVER, use the button
on this dialogue box to cancel, pause, restart and clear the archive queue.
EXIT
The EXIT button (Uscita) is used to turn off the X-FRAME DR system (requires
confirmation through dialogue box). It is not available if the system is equipped with an
UPS (optional): In this case the system turns off together with the diagnostic appliance.
EXAMINATION ACQUISITION
The examination acquisition window (acquisizione esame) represents the interface with the
X-ray generator.
The access to the exam acquisition window is automatic upon opening a new examination
containing no images. Moreover, the window can also be accessed by pressing the F2 key on
the computer keyboard, but if another examination with other images is already open.
N.B.: choosing the examination/projection together with the patient body build implies:
The X-RAY button enables the acquisition that shall be performed by pressing the remote
button PREPARATION/RAYS (preparazione/raggi). The x-ray emission button in the
miniconsolle of the x-ray generator is blocked.
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.
The examination acquisition (using the relevant functions) also allows to :
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 presents no command areas.
The acquired images are pre-processed also according to the type of examination, following
this sequence:
Other functions that are available to the operator after acquiring the images can be managed
through the context menu tool, which appears when clicking on the image right clicking on
the image with the mouse.
CLOSE EXAMINATION
Selecting the checkbox close examination (chiudi esame) from the Context Menu the
system opens a dialogue window to confirm the choice and then closes the examination.
Closing the examination is an operation provided for in the DICOM standard in order to
differentiate an examination which has already been sent to a printer or an archive server
from an examination which only underwent the acquisition phase.
PRINT LAYOUT
Selecting the Print layout (componi stampa) checkbox in the Context menu the system
starts the setup tool for the printing operation you wish to perform by using the images
previously sent to the print buffer (see section Print/Roi print).
The print layout tool allows to compose the images on the print preview dragging them with
the mouse, to select the number of copies to be printed, to associate a priority with regards to
other printing jobs, to display more previews in case of multiple page documents, to send the
print, to cancel the print buffer or to go back to the examination.
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 moving the mouse cursor while
holding the left mouse button :
Increase
LEVEL
(average grey level)
×
Decrease Increase
WINDOWS
(number of grey levers
displayed)
Õ Ö WINDOWS
(number of grey levers
displayed)
Ø
Decrease
LEVEL
(average grey level)
If you select the AUTOMATIC WINDOWS & LEVEL checkbox in the CONTEXT
MENU the system will reset the initial view optimized for the predefined ROI.
ZOOM
The zoom factor can be easily managed using them mouse wheel. However, the ZOOM
sub-menu in the CONTEXT MENU offers some predefined functions:
*. The real time view is a typical function of reports workstations. On this system we provide a purely
informative tool.
PROCESSING
The PROCESSING submenu in the CONTEXT MENU offers the following functions:
INVERSION
To have the system invert the grey level display of the image, select the INVERSION
checkbox (inversione) in the CONTEXT MENU.
ROI
By selecting the ROI checkbox on the CONTACT MENU you enable the post-processing
function that will be executed using the mouse (also disabling the PAN function).
A new AREA OF INTEREST can be traced moving the mouse squared cursor while
holding the left mouse button. The WINDOWS & LEVEL for the selected area will be
optimized.
CUT
By selecting the CUT checkbox (taglia) on the CONTEXT MENU you enable the post-
processing function that will be executed using the mouse (also disabling the PAN
function).
A new AREA OF INTEREST can be traced moving the mouse squared cursor while
holding the left mouse button. Deselecting the checkbox CUT after confirming the
dialogue window, you will cut out the portion of the image which is outside the AREA OF
INTEREST. This operation cannot be undone.
SAVE
If you select the SAVE checkbox (salva) in the CONTEXT MENU an identical copy of the
image is saved as last image of the examination.
SEND
Selecting the SEND checkbox in the CONTEXT MENU the image is sent to the
ARCHIVE QUEUE on the predefined server.
PRINT/PRINT ROI
If you select the PRINT checkbox (stampa) or the PRINT ROI checkbox (stampa ROI) in
the CONTEXT MENU, or the corresponding AREA OF INTEREST, this is sent to the
print buffer.
If the print buffer is empty, a dialogue window will ask to select the PRINTER and the
PRINT FORMAT.
DELETE
Selecting the DELETE checkbox (cancella) in the CONTEXT MENU you delete the
displayed image (the system open a dialogue window to confirm this action).
BUTTONS
 Close the program Exit and stop the system (disabled with UPS)
v Patients Examination
list. EXAMINATION MANAGEMENT window
b Single patient
examinations
Show the dialogue window displaying the list of examinations for the same
patient of an open exam
crop
multi
Image
Show all the images of an open exam in a single image
± Close
Examination Closes the examination
# Service Set up