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Moonray User Manual - Rev.34 - 2020/01/22
Moonray User Manual - Rev.34 - 2020/01/22
34 - 2020/01/22
USER MANUAL
SIMAD srl reserves the right to modify both this user manual and the device herein described. Technical
specifications of the device are subect to modification without prior notice. No part of the content of this
“USER MANUAL” can be intended as an offer, a guarantee, a promise or contractual condition. All modifica-
tions will conform to updated norms and regulations that govern production of medical devices.
Images and drawings shown are for information purposes only
© Copyright SIMAD Srl 2020
No part of this publication may be reproduced, transmitted, copied, transcribed or stored in a retrieval sy-
stem and cannot be translated in any form or by any means or converted into a different electronic format
than the original for any purpose, without the written consent of SIMAD.
REVISIONS - MODIFICATIONS
rev date note signature
D. Rigotti
23 2011/11/10 Added display cleaning instructions – Page 181
E. Carnevale
Added paragraph “Data Backup” - Page 19
D. Rigotti
24 2011/12/14 Added residual risks notices at pages 46, 124, 125.
E. Carnevale
Added routine check “Check Injector piloting” - Page 179
25 2013/09/26 Updating table values of
tolerances G. Fogliani
26-30 Not edited G. Fogliani
31 2019/10/17 Major Updates G. Fogliani
32 2019/11/27 Update - note “Digital Radiography (optional)” page 58 G. Fogliani
Note added - optional mode in place of boost mode - page 62
33 2020/01/17 G. Fogliani
Update - list of icons - page 189
Note added in “Options - Accessories and Detachable Parts”
34 2020/01/22 Update - notes in “introduction” - “Maintenance” G. Fogliani
Updated label figure in “Labelling”
Contents
1 Overview
1.1 Information regarding this Manual ........................................................................................... 12
1.1.1 Manual Validity . .................................................................................................................................................. 12
1.2 Updates ..................................................................................................................................... 12
1.3 Alerts, Warnings and Information . ........................................................................................... 13
2 Introduction
2.1 The Moonray device and its versions ....................................................................................... 16
2.2 Intended use ............................................................................................................................. 18
2.3 Certifications . ........................................................................................................................... 19
2.4 Authorization of use . ................................................................................................................ 19
2.5 Training ..................................................................................................................................... 19
2.6 Authorization for Maintenance and/or Repairs ....................................................................... 20
2.7 Non-authorized modifications .................................................................................................. 20
2.8 Installation of external devices ............................................................................................... 20
2.9 Data Backup .............................................................................................................................. 20
2.10 Technical Assistance Contacts ................................................................................................. 21
2.11 Technical References . .............................................................................................................. 21
3 Safety
3.1 Electrical Safety . ...................................................................................................................... 25
3.1.1 Equipotential Connection . .................................................................................................................................. 25
3.2 Safe Transporting ...................................................................................................................... 25
3.3 Mechanical Safety .................................................................................................................... 25
3.4 Risk of Explosion ...................................................................................................................... 26
3.5 Fire Safety ................................................................................................................................. 26
3.6 Safety, in the presence of mobile phones and IT products . ..................................................... 26
3.7 Contact Risk of Electronic Parts with Conductive Liquids . ....................................................... 27
3.8 Electromagnetic Compatibility . ................................................................................................ 27
3.9 Risk of Exposure to Ionizing Radiation ..................................................................................... 27
3.9.1 List of personal protective apparatus and accessories . .................................................................................... 28
3.10 Laser Safety . ............................................................................................................................. 29
3.11 Network/Data Coupling and USB port ..................................................................................... 29
3.12 Emergency Shutdown Procedures ............................................................................................ 30
3.12.1 Dual VersionEmergency Shutdown Alternatives ................................................................................................ 30
6 Software Guide
6.1 Organizing Information ............................................................................................................. 72
6.1.1 Series/Sequences ................................................................................................................................................ 72
6.1.2 Anonymous Series .............................................................................................................................................. 72
6.1.3 Locked/Unlocked Series ...................................................................................................................................... 73
6.1.4 Work Planning ..................................................................................................................................................... 73
6.1.5 Apply/Remove a Search Filter .............................................................................................................................. 74
6.1.6 Eliminating a Series/Sequence ............................................................................................................................. 74
6.1.7 Recuperating a Series/ Sequence . ...................................................................................................................... 75
4 Contents
© Copyright SIMAD srl 2020
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MOONRAY User Manual - Rev.34 - 2020/01/22 Contents
6 Contents
© Copyright SIMAD srl 2020
Total pages: 218
MOONRAY User Manual - Rev.34 - 2020/01/22 Contents
8 Troubleshooting
8.1 Proposed solutions ................................................................................................................. 164
9 Maintenance
9.1 Introduction ............................................................................................................................ 166
9.2 Scheduled Maintenance ......................................................................................................... 166
9.2.1 Scheduled Maintenance for motorized version . ............................................................................................. 167
9.3 Routine Check by User ............................................................................................................ 167
9.4 Cleaning & Disinfection ........................................................................................................... 169
9.4.1 Cleaning ............................................................................................................................................................. 169
9.4.2 Disinfection . ...................................................................................................................................................... 169
9.5 Cleaning and disinfection the motorization console .............................................................. 170
9.6 Cleaning the motorization console cable ................................................................................ 170
9.6.1 Printer ................................................................................................................................................................. 170
11 Technical Data
11.1 Functionality - Ambient Conditions ....................................................................................... 176
11.2 Power Supply .......................................................................................................................... 176
11.3 Generator . .............................................................................................................................. 176
11.4 Maximum Ratings .................................................................................................................. 176
11.5 Radiation Leakage Factors ...................................................................................................... 178
11.6 Grid ......................................................................................................................................... 178
11.7 Options - Accessories and Detachable Parts . ......................................................................... 179
11.8 X-Ray Scattering ...................................................................................................................... 180
11.9 Interventional Reference Point ............................................................................................... 181
11.10 Leakage radiation . .................................................................................................................. 183
11.11 Labeling .................................................................................................................................. 184
13 Motorized Version
13.1 Specific warnings .................................................................................................................... 192
15 MENU ITEMS
15.1 Accessing Menu Items ............................................................................................................ 206
15.2 Save . ....................................................................................................................................... 206
15.3 Memory Recall ........................................................................................................................ 207
15.4 Manual Positioning ................................................................................................................. 207
15.5 Select Language ...................................................................................................................... 208
16 ISOCENTRIC FUNCTION
8 Contents
© Copyright SIMAD srl 2020
Total pages: 218
MOONRAY User Manual - Rev.34 - 2020/01/22 Contents
10 Contents
© Copyright SIMAD srl 2020
Total pages: 218
1 Overview
1
1.2 Updates
Changes to the functions of the system are possible after the publication of
this manual, therefore operators must consult the “Updates” chapter found
in the addendum if present. If there are no diverse indications, the functions
of the system must be utilized according to the indications in this manual.
Ch.
“NOTE”: Informs the operator to pay special attention to certain conditions
or settings in order to avoid malfunctions and to help avoid problems. 1
DUAL Version
Which is composed of a Workstation and a mobile “C” arm unit.
Compact Version
A sole Compact device with an integrated workstation.
Ch.
Figure 2: Moonray System Compact version examples 2
500 Version
The different versions available allow to satisfy the particular requests for
diagnostic procedures.
2.3 Certifications
SIMAD adheres to national and international laws and norms and to the
EMC standards for these types of devices. These norms and standards
define the admissible electromagnetic levels by the device and the relative
immunity to electromagnetic interference from external sources. For details
and for the declaration of conformity please contact SIMAD.
The Moonray Systems are compliant to IEC 60601-1:2005/A1:2012 and is
classified as a Class I type B (electrical).
The Moonray Systems are compliant to 93/42/CEE directives and subse-
quent modifications and is classified as a Risk Class II b (active device desti-
ned to emit ionizing radiation).
According to the 2007/47 EEC directives, SIMAD guarantees that the devices
is not manufactured utilising tissues of animal and human origin.
Ch.
2
2.4 Authorization of use
The installation and use of these devices are subject to the national laws
of the country in which it is installed and to which the users/operators are
obligated to adhere.
The use of the device for other aims other than those expressly declared by
the manufacturer as well as its wrongful use, can release the manufactu-
rer (or his agent) of all or part of the responsibility due to non-conformity,
damages or injury resulting from improper use. The radiological system
must be exclusively used by qualified personnel for the use of radiological
apparatus, as per the national norms in force.
SIMAD declines responsibility tied to the malfunction of the Moonray
Systems and any possible damages caused to people or things derived from
the use by non-qualified personnel.
2.5 Training
Personnel must receive sufficient training on safety and use before activa-
ting the device as described in this manual. Training requirements for this
type of device vary from country to country. The operators must receive
training in accordance with the laws and norms of binding character.
SIMAD can supply necessary training for the correct use of the device and
can supply the relative informative material upon request.
SIMAD Srl
Tel: + 39 051 686 08 11
Fax: +39 051 686 12 46
Maintenance & Defects: do not use the Moonray Systems for applications
until the internal auto-check procedure has terminated and the main-
tenance program has been updated. If a part of the device should be
defective or not correctly repaired, do not use it until the repair has been
terminated. Using the device with defects or with repairs that have not
been carried out correctly can expose the operators and the patient to
danger (injuries, death or wrong diagnosis/treatments).
Get to know the safety features: do not use the Moonray Systems until
you have read and understood and become familiar with all the safety
information, safety and emergency procedures contained in this section.
Use, without adequate knowledge can result in injury/death or in incorrect
diagnosis/treatments.
Adequate Training: do not use the Moonray Systems for applications until
you have received adequate and sufficient training relative to the safe and
efficient operation of the device. If you are not sure of your capabilities in
the use of the device DO NOT USE IT. Operating the device without ade-
quate training can result in injury/death or incorrect diagnosis/treatments.
External Connections: Make sure the device is not connected to any type of
information network during use on a patient. Connect to networks only for
post-processing or to execute a backup.
Safety Mechanisms: do not try to remove, edit or exclude the safety me-
chanisms, it can result in injury or death.
Use & Compatibility: do not use the Moonray Systems for other than what
it was intended.
Do not use the Image Intensifier grid as a workbench or as a shelf for
objects or to place anatomical parts of the patient.
Use products recognized as compatible by SIMAD. Operation and uses
other than those intended or with incompatible devices can cause injury/
death or incorrect diagnosis/treatment.
Residual risks
SIMAD has taken the necessary actions to reduce risks tied to the use of the
device; however risks cannot be eliminated totally. Following, you will find
warnings to inform the operators of possible risks.
Do not remove cover or wires from the device if not indicated in this
manual. High voltage is present and failure to comply can cause injury or
death. Only qualified and authorized personnel can remove the cover and
wires.
Use the device only in places and areas that satisfy the requirements called
for by laws for this type of device.
Always unplug the device from the power panel when cleaning and disin-
fecting.
Only qualified and authorized personnel can remove the protective covers
and all other covers.
Do not allow the use of radio devices in the area allocated for the Moonray
Systems even if they are turned off. If their emissions go above the EMC
standards, malfunctions and in severe cases injury/death or incorrect
diagnosis can occur.
During use, the skin/focal spot spacer, supplied with the device, must be
mounted. The spacer maintains the minimum distance of 20 centimeters
between the focal spot and the patient’s skin.
Increasing the distance between the patient and the II (Image Intensifier)
obtains less visual field, less definition of the images and major skin doses.
Diffused radiation results to be higher as opposed to the correct position
(CEI EN 60601-1-3 9.2).
Higher doses than expected can occur due to objects that are found
between the X-Ray and the patient, for example the operating table. See
device documentation to discover the attenuation equivalent (CEI EN
60601-1-10.2)
Only qualified and authorized personnel can operate this device. Personnel
who operate the device and personnel in the workplace must observe all
the laws and regulations in force in the country in which they are found. If in
doubt do not use the device. Users are invited to follow the current recom-
mendations of the International Commission of Radiology and the United
States National Council on Radiation Protection and Measurements.
Utilize only the necessary doses for each treatment or specific exam. Guide-
lines for radiation:
• Produce rays only if necessary and for the least amount of time possible.
• Use the pulsating rays technique and, when possible, use the automatic
exposure control.
• Stay as far away as possible from the X-Ray source and from the subject
it hits.
• Wear personal protective apparatus and a dosimeter to detect the
absorbed values.
• Use the iris collimator (beam reduction)
• Keep the focal point as far away as possible (at least 200 mm) to reduce
the absorbed dose as much as possible.
• Eliminate all objects along the beam and place the source of the X-Rays
under the table to reduce scattering.
The USB connection to the computer is reserved for use by technicians for
maintenance purposes.
Do not connect devices to the USB port of the Moonray during use of the
device on patients.
When a part of the device is not shutdown, electrical power is present in parts of the
circuits until total shutdown and until the plug is removed from the power panel. If
a UPS (uninterruptible power source) is present (limited to the Moonray Dual ver-
sion) the Workstation has sufficient power only to guarantee switching off the PC.
Total shutdown
Option C Workstation monitor cart magneto thermal circuit breaker set to 0
or:
Option D Remove plug from the power panel
D
B
60601-2-43
Non-Projecting Version
C-Arm Shutdown
Option A
Turn the key towards the OFF position
Total shutdown
Set to 0 the magneto thermal circuit breaker located on fuses
Ch.
Option B
panel
3
or:
Option C Remove plug from the power panel
4.1 Safety
The operator must learn and become familiar with the information and the
emergency procedures indicated in the relative safety chapter.
Safety: do not use the Moonray Systems without having first read and un-
derstood the information on safety and emergency procedures indicated.
Use without having first become familiar with the safety and emergency
procedures can cause injury/death or incorrect diagnosis.
Maintenance: use the Moonray Systems after having carried out the equip-
ment check procedure making sure that maintenance has been completed.
If the user finds defects DO NOT USE the device until it has been repaired.
Using the device in these cases can expose the user and the patient to
radiation and other dangers. For information regarding maintenance see
relative chapter.
Knowledge by the operator: become familiar with the Moonray Systems
before using.
4.2 Transporting
The device has a limited grade of stability. Comply with the indications
relative to transport and movement.
Figure A – The areas which present a risk of entrapment are numbered. See
the following paragraphs for detailed description.
Ch.
4
Figure B – The areas that present an entrapment risk are numbered. See the
following paragraphs for detailed description.
Grip the device using only the handles and pay attention to points number
1 and 2 indicated in Figure A so as to avoid harming hands or arms.
To move the Workstation Cart grip the handles on the sides as per the C-
Arm. The handles come in either white or yellow depending on the version
of the device.
Ch.
4
During movement of the C-Arm and the workstation cart, do not pull but
push it forward. Keep feet away from the bottom of the device while it is
moving, see points 4 in Figures A and B.
Warning – Danger of getting hands and wrists caught in the steering wheel
(point 5 in Figure A)
Warning, do not insert foot between the two pedals when the C-Arm is in a
locked position.
Ch.
4
Do not rotate over +/- 360°, going over this limit can cause damages to the
cable and malfunction to the device.
Danger of getting parts of the body caught or crushed while carrying out
the movement. Pay particular attention to fingers, hands, feet, arms and
head. See figure A at points 12 (fingers) and 13 (hands, arms), 14 (arms,
wrists), 15 (body, head), 16 (fingers, hands) and 18 (feet).
Danger of getting parts of the body caught or crushed while carrying out
the orbital movement. Pay particular attention to fingers, hands, feet,
arms and head. See figure A at points 12 (fingers) and 13 (hands, arms), 14
(arms, wrists), 15 (body, head), 16 (fingers, hands) and 18 (feet).
Move the support bracket horizontally to the desired position using the
graduated scale found on the side of the bracket itself if necessary.
To lock the corresponding brake, turn the command towards the “closed
padlock” symbol anti-clockwise.
Danger of getting parts of the body caught or crushed while carrying out
the longitudinal slide movement. Pay particular attention to fingers, hands
and arms. See figure A at points 7 (hands, wrists) and 8 and 9 (fingers).
Ch.
4
Danger of getting parts of the body caught or crushed while carrying out
the motorized movement. Pay particular attention to arms. See figure A at
point 6.
Power
supply
C-arm cable.
Model
Serial
number
C-arm to
Workstation
Cart cable.
Detail A
MODEL CODE
Pedal
Detail B
Hand-held
radiography
SERIAL N. command
Ch.
4
Disconnecting the C-Arm from the Workstation
Rotate the ferrule anticlockwise and extract the connector.
Rewind the cable loosely to avoid damage and place on the reel.
C-arm cable
Power
supply
Model
Serial
number
Detail A
Pedal
MODEL CODE
Hand-held
radiography
command
SERIAL N.
Main
switch
If the Moonray Systems is already on, do not turn it off by using the same
switch but carry out the correct shutdown procedure; not doing so can
cause damages or data loss.
Before starting up the device, make sure that removable disks (CD or DVD)
4
are not still inserted because they can cause errors to the PC’s booting
procedure.
4.4.4 Shutting-Down
5.1 Description
The C-Arm control panel/console provides access to X-Ray production nee-
ded to obtain images with the digital imaging system.
Figure 11: Traditional (on the left) and new Touch Screen Consoles (on the right)
For easy access to the control panel, please orient so that it is visible from
each side of the C-Arm. To turn the panel to the other side, just slip it out
towards the back of the mobile unit and turn it in the desired position (the
panel is in a fixed position in the Compact version).
In the following pages you will find descriptions of the icons present on the
control panel and how to select and regulate for various scenarios.
The touch screen console has commands that are activated directly by tap-
ping the command icons on the screen with your finger.
When you try to activate a command that is not permitted, the following
icon will be visualized in the center of the control panel:
50 Description
© Copyright SIMAD srl 2020
Total pages: 218
MOONRAY User Manual - Rev.34 - 2020/01/22 5 C-Arm Control and Command Console
Exposure in radiography
Hand held mode is accessible
exclusively through
radiography
the hand-held manual
command command located on the
left side of the X-Ray unit:
Preparation to exposure
The icon indicates that the automatic settings of the exposure parameters
are in progress. It will appear off, when the X-Rays are not being emitted
and on, when the values of the exposure have been determined.
Preparation to exposure
Rotating state
Ch.
Anode Heating Status
Producing X-Rays causes the consequential heating of the anode. The ther-
5
mal level is indicated in the following icons:
To enable camera rotation, press the key relative to the “Camera Rotation”
icon and use the control knob to rotate.
Camera rotation
If using the touch screen console, the two command keys for rotation will
appear next to the icon just selected.
Rotation Keys
To deactivate the camera rotation, press the “Camera Rotation” icon again.
The system will hide the two rotation keys.
If the camera is activated it will always rotate and will stop only when it
reaches its travel limit.
The “Monitor A” will visualize the actual rotation of the camera during its
movement; it could result to be different from the direction indicated by
the icon of the selected command, depending on if it is activated or not
and if the horizontal or vertical flip imagine positioning is being used.
Ch.
For deactivating diaphragm movement icon touch on other part of the
screen . 5
Regulating the opening of the iris collimator is not possible in the “radio-
graphy” mode, due to the fact that it must be completely open.
The maximum and minimum aperture of the iris diaphragm depends on
the “level of the zoom” (input field) activated.
The aperture dimension will never surpass the allowed value for the zoom
level selected.
To activate position regulation, press the relative icon. When on, the filter
movement is enabled and the following icons will appear.
Aperture/Closure icons
To open or close the filter compensator, select the corresponding icons, the
aperture regulation will last as long as the command is active.
To enable rotation regulation, select and hold the corresponding icon. The
same rotating icons seen before will appear.
For deactivating diaphragm movement icon touch on other part of the
screen.
Image Flipping
To obtain a specular flip of the image present in monitor A, press the key
next to the icon. Each time you press you obtain a new flip.
Horizontal Flip
Vertical Flip
The flip image commands are visible only in the absence of X-Ray emission.
Ch.
Field of View 5
The on icon indicates which field of view has been selected. Upon start-
up, the device positions itself on the maximum field available. To select a
diverse input field and therefore a different magnifying factor of acquisition,
press on desidered fied of view icon.
Maximum field
Medium field
Small field
Minimum field
Maximum field
Medium field
Minimum field
When the “Radiographic” mode is activated, the system opens the dia-
phragm compensators completely, the iris collimator blocks the comman-
ds that can be activated through the icons on the right hand side of the
screen and “turns off” the icon corresponding to fluoroscopy.
The system also disables the movement commands of the camera, of the
collimator diaphragms, horizontal and vertical image flipping and the II
visual field selection.
Exiting the “Radiographic” mode, all the controls will be reactivated and
the iris diaphragm will be brought back to the position it was in before
entering the radiographic mode.
The Moonray System equipped with a Digital Detector can acquire and
display the image also using a three-point configuration as a radiological
power setting mode. The image will be presented on a monitor with the
typical resolution of fluoroscopy.
Exposure time
In all the other working modes except “Radiographic”, the amount indicates
the total duration of X-Ray emission executed, starting from start-up of the
device or from the last reset of this parameter.
In the “Radiographic” work mode, the amount indicates the duration of the
impulse that will be emitted in correspondence to the activating command
of the X-Rays.
To regulate the duration of emission, press the key next to the icon. Modifi-
cations can be made using the following command icons: Ch.
Increase/Decrease icons
5
To disable the modification of these values, press the key on the left of the
icon till it “turns off”. The system will hide the variation keys.
The device is equipped with a double safety feature that works as follows:
Pulsed low energy X-Ray emission: every time the sum of the duration of
emission surpasses 4’:30”, an acoustic warning signal is sounded which can
turned off by touching the time exposure icon for not more than 1 second.
If you do not stopped, the acoustic warning signal will sound every time one
of the X-Ray emission commands is activated.
X-Ray boost emission: Following is a table of the duration of X-Ray emis-
sions, which correspond to the frequency pulsed emission boost:
• Boost 0.5: 240 sec
• Boost 1: 120 sec
• Boost 2: 60 sec
• Boost 4: 30 sec
• Boost 6: 20 sec
• Boost 12: 20 sec
The image on the video shows the duration of the X-Ray emission and not
the duration of the activation of the command.
For example, activating the fluoroscopic command for 10 seconds with a
Boost emission of 12 will produce a 5 second value on the screen.
To reset the chronometer from the total emission value, select and hold the
icon till the system visualizes the value: “0:0”.
To reset the timer to 5 minutes of X-Ray emission, press and hold Exposure
time icon.
To set voltage:
1 Touch the icon Voltage setting visualization. Two variation icons will appear
on the right of the value.
Holding down the “+” and “-“ icons will increase or decrease the value one
unit at a time for the first 1.5 seconds then the system will vary the units
10 at a time.
To disable the value setting, select the icon till it turns off.
In the radiographic and manual fluoroscopy work modes, you must set the
value of the filament current to generate X-Rays. In the “DSA”, “Cine” or
“Road Mapping” modes you can specify a maximum current table.
To activate the mA value setting:
1 Touch the icon Current setting/visualization and exposure tables. The sy-
stem will visualize the two variation icons on the right of the value.
Setting the values of the current tables for Boost, DR, DSA, Cine and Road-
map work modes can be done only in the absence of X-Ray emission.
5.3.1 Fluoroscopy
Touch the desired icon till it lights and then touch the icon relative to the
desired mode. If the boost or pulsed mode is chosen, the system predispo-
ses for the selected mode and visualizes the increase/decrease keys. The
user can select a diverse mode or accept the current one. To exit selection,
touch the same icon till it turns off. The fluoroscopy manual commands and
pedal command are activated with the left pedal (in the two pedal versions).
Fluoroscopy
X-Rays are emitted in a pulsed mode. The user can manually or automatical-
ly set the current and voltage parameters. The maximum supply current is 3 Ch.
mA.
This emission mode is defined NORMAL FUNCTION MODE (CEI EN 60601-2- 5
43 - § 51.101.4)
The Pulsed fluoroscopy value that generates the highest Air Kerma Rate is
120 kV, 20mA. (CEI EN 60601-2-43)
Fluoroscopy
Boost
Pulsed rays are emitted with frequency indicated in the upper part of the lit
icon. The voltage and current values are established automatically. The user
can indicate the full scale current. The initial current value is 6 mA and can
reach up to 10 mA,
The Boost value that generates the highest Air Kerma Rate is 120 kV, 10 mA,
12 impulses/sec (CEI EN 60601-2-43)
12 impulses/sec.
6 impulses/sec.
4 impulses/sec.
2 impulses/sec.
1 impulses/sec.
The boost mode can be optionally replaced by a mode having the maxi-
mum current values comparable to those of radioscopy. Times and pulse
frequencies remain typical of the boost mode.
DR (Digital Radiography)
A single pulse is emitted. The voltage and current values are established
automatically. The user can indicate the full scale current: the initial setting
is 6 mA and by accessing the mA setting mode 10 mA can be set.
DR (Digital Radiography)
Pulsed Fluoroscopy
Pulsed X-Rays are emitted and frequency is indicated in the upper part of
the lit icon. The voltage and current values are established automatically.
The maximum current available is 3mA.
The Pulsed Fluoroscopy value that generates the highest Air Kerma Rate is
120 kV, 3 mA, 12 impulses/sec (CEI EN 60601-2-43)
12 impulses/sec.
6 impulses/sec.
4 impulses/sec.
Ch.
5
2 impulses/sec.
1 impulses/sec.
5.3.2 Cine/DSA
The Cine or DSA modes can be selected only through the PC by clicking on
the desired work mode.
• The Cine work mode is available only in GSE+ and VE version.
• The DSA function is available only in the double pedal and vascular/en-
dovascular software versions. It is not available on the Compact models.
When you select the Cine or DSA modes, the system disables (by hiding
them) the selection icons “Boost”, “DR” and “Pulsed”; the Fluoroscopy
mode icons (described above) disappear on the control panel and the fol-
lowing icons appear:
Fluoroscopy
The operator can set diverse types of reference tables, according to necessi-
ty, through the mA setting procedure. (See Setting current values (mA)).
Pulsed or pulsed exposure tables are available:
• In the 12 imp./sec. version, the only available frequency is 12 impulses
per second;
• In the 25 imp./sec. version, the user can select either 12 or 25 imp./sec.
To set the desired frequency, touch the icon corresponding to the diverse
pulsed frequencies:
The numerical value on the right of the icon has two diverse meanings, ac-
cording to the activation / deactivation of the X-Ray emission commands:
• Deactivated X-Ray emission command: the numerical value indicates
the current table set for emission with a “fluoroscopy +” command.
• Activated X-Ray emission command: the numerical value indicates the
existing current value of the filament current.
The Fluoroscopy+ Pulsed value that generates the highest Air Kerma Rate is
120 kV, 80 mA, 12 imp/sec (or 25 imp/sec in the versions in which this value
is available). (CEI EN 60601-2-43)
1 Max 1 mA Pulsed
2 Max 2 mA
3 Max 3 mA
30 Max 30 mA
40 Max 40 mA Pulsed 25 imp./sec Pulsed 12 imp./sec
50 Max 50 mA
60 Max 60 mA
70 Max 70 mA
80 Max 80 mA
5.3.3 Roadmap
Selection of the roadmap mode is activated from the workstation by clicking
on the desired work mode (see Setting current values (mA)). The Roadmap
function is available only in GSE+ and VE version and with vascular and
endovascular software.
When using the Roadmap mode, the command and control console visuali-
zes only the Pulsed Fluoroscopy icon:
Fluoroscopy
1 Max 1 mA
2 Max 2 mA
Pulsed
3 Max 3 mA
20 Max 20 mA
1 Max 1 mA
2 Max 2 mA Pulsed
3 Max 3 mA
Fluoroscopy
Fluoroscopy AUTO : 120 kV, 3 mA 0.37
Boost : 120 kV, 10 mA, 12 impulses/sec 0.6
Pulsed Fluoroscopy : 120 kV, 3 mA, 12 impulses/sec 0.26
Cine/DSA
Pulsed Fluoroscopy : 120 kV, 1 (3) [6] mA 0.16 (0.37) [0.6]
120 kV, 30 mA, 12 (25)
Pulsed Fluoroscopy : 0.84 (2)
impulses/sec
120 kV, 80 mA, 12 (25)
Pulsed Fluoroscopy : 1.6 (3.6)
impulses/sec
Maximum levels of AIR KERMA RATE IN Radiography for image:
A specific trial object representing an average patient can be indicated in a
PMMA dummy in a square form that is 20 cm thick and 25 cm. side base (CEI
EN 60601-1-3 - § 5.2.4.2).
The CPU card power supply battery is not charged to the optimum
Discharged Battery
level. Call customer service.
Filament Error The Filament or its control function has generated an error.