Rev5 (User's Manual)

ARCOVIS 2000 SB/RB
Revision: 5
Version: 31 October 2005
User's Manual
File: [AF30010E00R05.doc]
Code: 6979901903
WARNING: THE INFORMATION THAT IS PRINTED WITHIN THIS MANUAL IS VITAL FOR A
CORRECT USE OF THE EQUIPMENT; PLEASE CAREFULLY READ IT ANY TIME BEFORE USE.
User's Manual ARCOVIS 2000 SB/RB
This page has been left intentionally blank
[File:AF30010E00.doc]
ARCOVIS 2000 SB/RB User's Manual
Table of contents
1. SAFETY AND COMPLIANCE ................................................................

................................................................................................
......................................................................
...................................... 2
1.1. ELECTRICAL SAFETY.................................................................................................................................... 3
1.2. LASER TARGETING DEVICES SAFETY ........................................................................................................... 3
1.3. MECHANICAL SAFETY................................................................................................................................. 3
1.4. ELECTROMAGNETIC COMPATIBILITY (EMC) ............................................................................................... 4
1.5. PROTECTION AGAINST IONIZING RADIATION........................................................................................... 4
1.6. GENERAL DISPOSAL ................................................................................................................................... 5
1.7. INTERFACEABILITY ...................................................................................................................................... 5
1.8. COPYRIGHT............................................................................................................................................... 5
1.9. APPLICATION & FINAL DESTINATION ......................................................................................................... 6
1.10. CLASSIFICATION ........................................................................................................................................ 7
1.11. COMPLIANCE ............................................................................................................................................ 7
2. COMPONENT IDENTIFICATION................................
IDENTIFICATION................................................................
................................................................................................
................................................................ 8
2.1. ASSEMBLY .................................................................................................................................................. 8
2.2. MOBILE IMAGE INTENSIFIER....................................................................................................................... 9
2.3. CONTROL PANEL..................................................................................................................................... 11
2.4. FLUOROSCOPY FOOTSWITCH ................................................................................................................ 12
2.5. RADIOGRAPHY/FLUOROSCOPY CONTROL HANDSWITCH ...................................................................... 12
2.6. MONITOR TROLLEY ................................................................................................................................. 13
2.7. OPERATIONAL MESSAGES........................................................................................................................ 14
2.8. ERROR MESSAGES.................................................................................................................................... 15
2.9. SAFETY DEVICES....................................................................................................................................... 16
3. UNIT USE ................................................................
................................................................................................
..............................................................................................
..............................................................17
.............................. 17
3.1. UNIT MOVEMENT .................................................................................................................................... 17
3.2. CONNECTION BETWEEN MONITOR TROLLEY - MOBILE IMAGE INTENSIFIER........................................... 18
3.3. CONNECTION BETWEEN FOOTSWITCH - MOBILE IMAGE INTENSIFIER ................................................... 19
3.4. POSITIONING.......................................................................................................................................... 19
3.5. UNIT SETUP.............................................................................................................................................. 20
3.6. USE MODE............................................................................................................................................... 20
3.7. SHUTDOWN PROCEDURE........................................................................................................................ 28
4. MAINTENANCE ................................................................
................................................................................................
......................................................................................
......................................................29
...................... 29
4.1. GENERAL WARNINGS............................................................................................................................... 29
4.2. CHECKS AND INSPECTION BY THE USER ................................................................................................. 29
4.3. CLEANING ............................................................................................................................................... 30
4.4. DISINFECTION ......................................................................................................................................... 30
5. TECHNICAL DATA................................
DATA................................................................
................................................................................................
...................................................................................
...................................................31
................... 31
5.1. LABELS AND SYMBOLS ............................................................................................................................. 31
5.2. ENVIRONMENTAL CONDITIONS .............................................................................................................. 36
5.3. ELECTRICAL DATA .................................................................................................................................... 37
5.4. EXPOSURE MODE: FLUOROSCOPY.......................................................................................................... 43
5.5. EXPOSURE MODE: RADIOGRAPHY ........................................................................................................... 44
5.6. IMAGE SYSTEM ........................................................................................................................................ 45
5.7. DIGITAL IMAGES PROCESSOR.................................................................................................................. 47
5.8. ACCESSORIES .......................................................................................................................................... 47
6. MECHANICAL DATA................................
DATA................................................................
................................................................................................
................................................................................
................................................48
................ 48
6.1. C-ARM UNIT DIMENSIONS WITH I.I. TUBE 6”/7”/9”.................................................................................. 48
6.2. “LOW PROFILE”MONITOR TROLLEY DIMENSIONS.................................................................................... 49
6.3. “HIGH PROFILE”MONITOR TROLLEY DIMENSIONS................................................................................... 49
6.4. MECHANICAL DATA, DIMENSIONS AND WEIGHTS................................................................................... 50
7. DOCUMENT STATUS ................................................................
................................................................................................
.................................................................................
.................................................I
................. I
[File:AF30010E00.doc] Rev. 0 - Pag. 1/50

1. SAFETY AND COMPLIANCE

The purpose of this user's manual is to provide a set of easy to use instructions for the proper use
of the system.
All of the information contained herein is based on the current version of the system. Villa Sistemi
Medicali reserves the right to improve and implement changes to the information herein to reflect
any changes necessitated by technological enhancements to the system.
This x-
x-ray unit must be used in strict compliance with the safety instructions contained in
this manual and must not be used for purposes other those for which it w was
as intended.
The x-ray unit may only be operated by skilled, properly trained personnel with the required
knowledge of x-ray safety practices and the proper use of x-ray equipment.
The operator is responsible for the use of the system in compliance with the applicable standards
concerning installation and use.
The system safety circuits and devices must not, for any reason, be moved, modified, or omitted.
The monitor trolley key switch may only be activated by authorized personnel and only during the
use of the system. Once system use has been completed, the key must be removed and stored in a
safe place.
The unit must not be operated when electrical, mechanical, or radiological faults are present or
when any of the indicators or alarm devices are malfunctioning.
When used in conjunction with other apparatus, components, or modules, whose compatibility is
uncertain, it is necessary to ensure the absence of any danger to the patient or operator. Consult
Villa Sistemi Medicali for information.
As with any technical apparatus, this x-ray unit must be used properly with periodic checks and
maintenance as specified in the chapter “Planned maintenance” of the Service Manual.
Villa Sistemi Medicali is responsible for the safety of its products only when maintenance, repairs,
or modifications have been performed by its personnel or by personnel authorized by Villa Sistemi
Medicali in writing.
Villa Sistemi Medicali cannot be held liable for any malfunction, damage, or danger
resulting from improper use of the system or non-
non-compliance with the rules for proper
maintenance
maintenance.
nance.
Pag. 2/50 - Rev. 0 [File:AF30010E00.doc]

1.1. ELECTRICAL SAFETY
Only trained service personnel authorized by Villa Sistemi Medicali may remove the unit
covers and only in accordance with the instructions contained in the Service Manual.
This X-ray unit may only be used in environments or medical rooms in compliance with the
applicable IEC standards.
The X-ray unit must not be used in areas where there exists a danger of explosion.
Cleaning and disinfecting agents, including those used on patients, may create an explosive,
gaseous mixture. Use only those products in compliance with the applicable rules.
1.2. LASER TARGETING DEVICES SAFETY
• Keep always a good lightening on the room.

• Never look through the output window of the laser targeting device.
• Never fix the reflections of the laser targeting devices.
• Before starting any examination, the patient must remove earrings, glasses, necklaces and
whatever could reflect the laser beam and be printed on the image.
• Don't clean the openings of the laser targeting devices with tools that could modify their optics.
Only the service personnel must perform possible cleaning actions.
• The min. distance between the laser source and the patient must not be lower than cm20.
The only purpose of the laser use is to reduce the minimum the patient dose, it doesn’t
be considered as an absolute means of centering.
The activation of procedures other those listed above can cause the emission of
dangerous non-
non-ionizing
ionizing radiations.
1.3. MECHANICAL SAFETY
The unit can be moved only by trained personnel by complying with the following safety conditions:
• Move the unit by considering the conditions for the movement that are indicated in detail in
the paragraph 3.1 "UNIT MOVEMENT".
• Don't move and use the unit on surfaces with inclination higher than 5°
• Only use the proper handles to move the unit.
• Avoid collision with obstacles.
• After positioning the unit, engage the parking brakes.

1.4. ELECTROMAGNETIC COMPATIBILITY (EMC)
This apparatus is in compliance with the applicable rule regarding EMC, Directive 89/336 (Class
B), that defines the allowed emission levels from electronic devices and the required immunity from
interference caused by externally generated electromagnetic fields.
It is not, however, possible to exclude radio signals coming from transmitters such as mobile
phones or similar mobile radio devices. These and other transmitting devices, including those in
compliance with the EMC standards, may influence the proper functioning of medical apparatus
when used in proximity and with a relatively high transmitting power. Therefore, the use of radio
equipment proximity to electronically controlled systems must be avoided in order to eliminate any
interference risk.
Any transmissions by mobile radio equipment must be avoided.

Mobile phones must be switched off in zones close to the unit.
These rules must be applied when the unit is switched on (that is to say connected to
the mains and ready for use).
1.5. PROTECTION AGAINST IONIZING RADIATION
Before any x-
x-ray exposure, ensure that all the necessary protective precautions have
been taken.
During the use of x-rays, personnel present in the room must comply with the following rules
concerning protection against ionizing radiation:
When necessary, use protective shielding against radiation in addition to the shielding already
provided on the unit.
Use protective aprons containing a material equivalent to 0,35mm of lead. Material of this nature
reduces radiation at 50kV by 99,95% and at 100kV by 94,5%.
The best protection against radiation is distance. It is therefore recommended that you stay as far
as possible from the x-ray source and the exposure target. For this purpose, use all of the cable
length provided for the foot-switch.
Avoid walking or standing directly in the x-ray beam.
Always use the smallest possible field of exposure by closing properly the collimator diaphragms.
The scatter dose produced depends principally on the volume of the irradiated object.
Never modify or disconnect the safety circuits or devices designed to prevent

accidental exposures.
Primary protection barrier in compliance with the

Standard IEC 60601-1-3: 2mt

1.6. GENERAL DISPOSAL
Villa Sistemi Medicali produces radiological systems that are advanced in terms of safety and
environmental protection. Assuming that the unit is properly used, there is no risk to people or the
environment.
In order to comply with applicable safety requirements, it is necessary to use materials that may be
harmful to the environment (for example: monobloc oil, protective lead, monitor kinescope,
boards and electronic components). Therefore, when necessary, it needs dispose of them in a
proper way according to the regulations applied in the country where the unit is installed.
For this reason, the unit may not be disposed of along with industrial or domestic
waste and must be reg
regarded
arded as hazardous waste.
This symbol indicates that the wastes resulting from the electric and electronic units
have not to be disposed as undifferentiated town wastes and they have to be picked up
separately.
The proper differentiated collection for the following start of the unit disused to the
recycle, treatment and disposal, compatible with the environment, aid to prevent
possible negative effects on the environment and health and it favours the recycle of
materials that compose the unit.
The abusive disposal of the product from the user implies the application of
administrative sanctions according to the Standards in force of the unit installation
country.
For information concerning the dismantling modes of the units out of use, stick to the
local provisions or contact an representative authorized by the manufacturer.
For additional information, contact Villa Sistemi Medicali.
1.7. INTERFACEABILITY
The device does not forecast any interaction with devices for medication.
It is possible to interface the unit with certain devices such as VCR (VHS Video-recorder), THERMAL
PRINTER, Network (DICOM System). Such devices must be in full compliance with the safety
requirements specified by 93/42/CEE Directive. The interface responsibility, if it has not been
evaluated and authorized in writing for use by Villa Sistemi Medicali, is of the user and/or of the
person who has performed this interface.
1.8. COPYRIGHT
The original release of this manual is in Italian language (file: AF3001_I00RXX.doc): for further
information, please refer to the Italian version.
The software contained in the unit belongs to Technix S.p.A. Upon receipt of the unit, the user
acquires the right to use the software. This right is neither exclusive nor transferable.
Written authorization to Technix S.p.A. is mandatory prior to any modifications for the unit use with
functions other than the ones foreseen.

1.9. APPLICATION & FINAL DESTINATION
ARCOVIS 2000 SB/RB is a "x-ray mobile unit with image intensifier system" and it has been
designed to be used for diagnosis; it must be operated exclusively by qualified, trained personnel
who have been informed of the risks linked to the use of ionizing radiation.
The system does not belong to the category of equipment usable in continuous operation.
The system is not used in contact with the patient. It is possible the only accidental contact of some
unit parts with the patient and the
the contact with the operator is foreseen.
Contact with the patient is non-

non-invasive.
Contact with the operator is strictly for reasons linked to the use of the equipment (normal
operation).
The unit is suitable to be used for x-ray examinations, and in particular for radioscopy,
radiography and diagnosis dedicated to:
• Traumatology
• Pediatrics
• Simple interventional radiology
• Pace Maker implantation
• Operating theater
• Intensive care
• Respiratory system
• Skeletal structure
On request it is possible to provide a set of sterile drapes for the arm. For further information,
please contact Villa Sistemi Medicali
This x-
x-ray unit must not be used in areas where there exists a danger of explosion.
explosion.
For the use in the operating theater, it is necessary to use a footswitch type IP-
IP-X8 (a
footswitch model ASA type FM2 SU1/SU1 F4 is advisable).

1.10. CLASSIFICATION
Protection against electrical hazards .................Class I

Protection against direct and indirect contact.....Unit, Type B with Type B applied part
Protection against water penetration .................Common protection (IPXO)
Use condition protection..................................Continuous use with temporary load
1.11. COMPLIANCE
This x-ray unit is in compliance with the electromedical devices Directive 93/42 CEE and with the
other national and international standards in force.
For any further information please contact:
VILLA SISTEMI MEDICALI

Via delle Azalee, 3
20090 – Buccinasco – (MI) – Italia
Tel: +39 (0)2-48.859.1
Fax: +39 (0)2-48.81.844
E-mail: vsmservice@villasm.com
The manufacturer producer (according to European Directive 93/42/CEE) of ARCOVIS 2000

SB/RB unit is:
TECHNIX S.p.A.
Via E. Fermi, 26
24050 Grassobbio, BG (ITALY)
Tel: +39 (0)35-33.56.78
Fax: +39 (0)35-33.56.75

2. COMPONENT IDENTIFICATION
This section of the manual describes the component parts of the unit.
2.1. ASSEMBLY
The unit is made up of two different parts:
Mobile Image Intensifier

consisting of: “C” Arm,
Monobloc, Image Intensifier,
Control Panel.
Figure 1
Monitor Trolley consisting of:

Trolley, One or Two Monitors,
Images Processing System and
possible Accessories.
Figure 2

2.2. MOBILE IMAGE INTENSIFIER
1. Image Intensifier
2. Handles for the

C-arm sliding
10. Handle for the

horizontal sliding of
the C-arm group
16. Emergency
Pushbutton
11. Handles for the
mobile image
intensifier movement
12. Control Panel
13.
Radiography/Fluorosco
py Control Push-button
4. Internal Collimator
15. Connector for the cable that
5. Focus Position connects the mobile image
system to the monitor trolley
6. Internal Monobloc
14. Fluoroscopy Footswitch

Connector Outlet
Figure 3
[File:AF30010E00.doc] Rev. 4- Pag. 9/50

2.2.1. Handles position for manual movements
1. Brake for the arm

rotation around the
horizontal axis.
Movement: ±270°
1 2. Brake for horizontal

sliding of the arm group.
Movement: 220mm
Figure 4
1. Brake for the orbital
arm rotation.
Movement: 120° (+90° ÷
- 30°)
2. Brake for the overview

movement of the arm
2 1 group.
Movement: ±12,5°
3. Driving handle and rear

wheels braking
3
Figure 5

2.3. CONTROL PANEL
Figure 6
1. System ON 19. Horizontal image inversion

2. System OFF 20. Counterclockwise image rotation
( version 7”-9”)
3. Vertical upwards C-arm movement
21. Clockwise image rotation
4. Vertical downwards C-arm movement ( version 7”-9”)
5. kV Increase / Decrease 22. Image magnification
If they are pressed with key 24, they display the (version 7”-9”)
stored images
23. Image magnification
6. mA Increase / Decrease in manual fluoroscopy (version 7”-9”)
mAs Increase / Decrease in radiography
24. Stored images scroll
7. Fluoroscopy time reset If key 5 (- / +)is pressed, the stored images are
displayed
8. Reset of the max. fluoroscopy time alarm
25. Direct image storage on the memory monitor
9. Automatic fluoroscopy selection and HDF / LDF
modes 26. Recursive filter selection
10. Pulsed fluoroscopy selection / Break time setting for 27. Display for the indication of the unit status
the x-ray emission
28. Led for X-ray emission signal
11. Manual fluoroscopy selection
29. Display for the indication of the working
12. Radiography selection parameters
13. Counterclockwise rotation of the parallel shutters 30. Laser targeting device ON / OFF
14. Clockwise rotation of the parallel shutters 31. Images filament display (Cine loop)
(function enabled according to the configuration )
15. Parallel shutters opening
32. Smart filter - motion detector / Edges sharpen
16. Parallel shutters closing (functions enabled according to the configuration )
17. Iris diaphragm opening 33. Vertical image inversion
18. Iris diaphragm closing

2.4. FLUOROSCOPY FOOTSWITCH
The fluoroscopy footswitch is made up of two double step footswitches. The functions are:
1. Left Footswitch:
Fluoroscopy mode:
1° step: continuous or pulsed fluoroscopy
control,
control as selected on the control panel.
2° step: image storage;
storage in continuous
fluoroscopy the current image is stored.
In pulsed fluoroscopy every image between
the exposures is stored.
Radiography Mode:
Unabled footswitch.
2. Right footswitch:
Fluoroscopy Mode:
1° step: "snap shot" control (exposure at
high contrast with reduced background
noise).
2° step: not used.
used Figure 7
Radiography Mode:
Unabled footswitch.
2.5. RADIOGRAPHY/FLUOROSCOPY CONTROL HANDSWITCH
Fluoroscopy Mode:
1° step: continuous or pulsed fluoroscopy
control,
control as selected on the control panel.
2° step: image storage;
storage in continuous
fluoroscopy the current image is stored.
In pulsed fluoroscopy every image between
the exposures is stored.
Radiography Mode:
1° step: preparation control.
control
2° step:: x-
x-ray emission control.
control
Figure 8

2.6. MONITOR TROLLEY

1.X-ray On Light
2. Emergency 2. Emergency
Pushbutton Pushbutton
3. Safety key
4. Main
Thermomagnetic
Switch
5. Trolley brake
Figure 9
High Profile Trolley
1. X-ray On Light
2. Emergency 2. Emergency
Pushbutton Pushbutton
3. Safety key
4. Main
Thermomagnetic
Switch
5. Trolley brake
2 Monitors Version - 1 monitor Version

Figure 10
Low Profile Trolley

2.7. OPERATIONAL MESSAGES
This section of the manual explains the messages and their meaning of the operational messages
that can appear on the display.
Text Meaning
RAD. Radiography Mode Selected

kV ... mAs ... Operational Radiography Parameters
Delay at the end of an exposure before controlling the next
BUSY (flashing)
Radiography
FLUORO Fluoroscopy Mode Selected
kV … mA … Operational Fluoroscopy Parameters
Manual, Automatic, or Pulsed Fluoroscopy Mode Selected in Low
LDF Only Rotating Anode Version
If selected Dose (Low Dose Fluoroscopy)
Manual, Automatic, or Pulsed Fluoroscopy Mode Selected in High
HDF Only Rotating Anode Version
If selected Dose (High Dose Fluoroscopy)
Low Dose Radiography Mode Selected with power of 2,8kW (Low
LDR Only Rotating Anode Version
If selected Dose Radiography)
High Dose Radiography Mode Selected at 5kW from 1 to 8mAs
HDR Only Rotating Anode Version
and if selected in HDF (High Dose Radiography)
Exposure Minutes that are still available with set kV-mA
min…
Only Rotating Anode Version parameters. This value changes by modifying kV and mA data
K… Filter Selection to reduce the photonic noise
Pulsed Fluoroscopy Mode Selected, Break Time between the
T=...sec
Exposures
ONE SHOT Snap Shot Mode Selected

2.8. ERROR MESSAGES
The table indicates how to proceed in case of faults and anomalies.
Text Meaning Corrective Action
SUPPLY FAULT Electronic Power Fault Contact service

Switch the unit off, wait for some
In radiography the high voltage
seconds, switch the unit on again and
kV FAULT applied to the x-ray tube is 75%
make exposure. If the error persists,
lower than the selected value
contact service
Only Rotating Anode seconds, switch the unit on again and
kV ALARM Errors in the high voltage generator
Version make exposure. If the error persists,
contact service
The high voltage applied to the x-ray
Only Fixed Anode seconds, switch the unit on again and
kV MAX tube is higher than the max.allowed
Version make exposure. If the error persists,
value
contact service
Error in the control circuit of the
FILAMENT Contact service
filament current
THERMIC Monobloc overheating Wait for the x-ray tube cooling
Max.use time with overheated x-ray
THERMIC MAX TIME Wait for the x-ray tube cooling
tube
X-RAY TUBE TOO HOT The thermal capacity of the x-ray
Wait for the thermal units recovery
Only Rotating Anode Version tube is finished
The high voltage applied to the x-ray
LACKING OF X-RAYS Contact service
tube is 75% lower than the set value
The radiography control pushbutton
Value the quality of the film obtained,
(Figure 3 pos. 13) has been
MAN STOP RX xxx mAs in case it is unsatisfactory, repeat the
released before the set mAs
exposure
integration
In order to reset the x-ray emission, it
is necessary:
1. release the fluoroscopy footswitch
The max.exposure time in 2. press the key " alarm reset " (timer
FLUORO MAX TIME
fluoroscopy has been reached of the fluoroscopy time is not reset) or
press the key "fluoroscopy
fluoroscopy time reset"
reset
(timer of the fluoroscopy time is reset)
on the control panel (Figure 6)
The radiography exposure time is
seconds, switch the unit on again and
MAX TIME higher than the allowed value of
make exposure. If the error persists,
5sec
contact service
STARTER FAULT Error in the control circuit of the seconds, switch the unit on again and
Only Rotating Anode Version anode rotation starting make exposure. If the error persists,
contact service
Check that the memory is enabled to
MEMORY OFF LINE Error in the images storage system the operating. If the alarm reappears,
contact service

2.9. SAFETY DEVICES
This section of the manual describes the location and the use of safety devices.
ARCOVIS 2000 SB/RB is protected against excessive variations of the mains by means of a
thermo-magnetic pushbutton circuit breaker on the side of the monitor trolley.
In the event that the thermo-magnetic breaker is tripped, in order to activate the unit working
again, it is normally sufficient to reset its control in "ON" condition.
The unit is equipped with two mushroom-head emergency push-buttons placed on the monitor
trolley to be activated to turn off the unit completely in emergency case.
In order to reset the unit ON, it is enough to rotate clockwise the pushbutton body.
A third mushroom-head emergency push-button is available on request and it is placed on the left
front corner of the control desk. The functioning of the push-button is the same as the one of the
emergency push-buttons placed on the trolley.
An operating key, that is necessary for the unit setup, prevents the unit use from non-authorized
personnel.

3. UNIT USE
3.1. UNIT MOVEMENT
How to move the unit without compromising its good working and by minimizing the risks for the
operator:
• check that the monitor trolley is disconnected from the mains and the mobile image intensifier
and that the cables are coiled around the cable-winding.
Conditions of movement:
Vertical position of the C-arm group. It is all down.
Overview position at 0° and C-arm rotation at 0°.
Horizontal position of the C-arm group. It is all back.
Overview position of the C-arm at 0°.
• check that the C-arm movement brakes are all locked (see Figure 4 Figure 5).
• don't move the unit on surfaces with inclination higher than 5°.
• move the unit only after locking the parking brake and use only the proper handles (see Figure
5 pos.3).
• In order to make the movement easier, use the rotation of the rear wheels of the mobile image
intensifier.

3.2. CONNECTION BETWEEN MONITOR TROLLEY - MOBILE IMAGE

INTENSIFIER
The connection between these parts of ARCOVIS 2000 SB/RB is performed through a multipolar
connector with bayonet coupling.
Handle the connectors with care.

Don't unplug by pulling the cable but grip the plug body.
For a proper connection, it is necessary:

• make sure that the unit is off;
• put the cable with the multipolar connectors into the outlets on the monitor trolley and the
mobile image intensifier.
• make sure that the yellow triangular arrows are aligned: only in this way it will be possible
to perform the connection;
• rotate clockwise the rubber ring nut of the connector till it is fully closed. This condition is
identified by the click in the stop position of the bayonet movement.
In order to remove the connection, it is necessary:

• make sure that the unit is off;
• rotate counterclockwise the rubber ring nut of the connector till it is fully open. In order to
open the ring nut properly, it will be necessary to remove it from the stop position.
• disconnect the cable with the multipolar connectors from the outputs on the monitor
trolley and the mobile image intensifier.

3.3. CONNECTION BETWEEN FOOTSWITCH - MOBILE IMAGE INTENSIFIER
The connection between these parts of ARCOVIS 2000 SB/RB is performed through a connector
with pressure coupling.
For a proper connection, it is necessary:

• put the footswitch connector into the proper outlet that is placed on the mobile image
intensifier;
• make sure that the connector is fully put in.
In order to remove the connection, it is necessary:

• press the pushbutton placed under the connector and pull it.
3.4. POSITIONING
How to place the unit in the operative position:
Don't move the mobile image intensifier or the C-

C-arm when the brakes are activated.
For the movements use the proper handles (see Figure 3).
Connect the mobile image intensifier to the monitor trolley

Connect the monitor trolley to the mains (the switching-on pushbutton led of the
mobile image intensifier control panel will light up)
Press the unit ON pushbutton
Adjust the C-arm height
Use the control keys to change the position
Adjust the horizontal position
Control the possible overview rotation of the C-arm.
Adjust the C-arm rotation around the horizontal axis, the goniometric scale will
indicate the rotation angle.
Adjust the orbital position of the C-arm.
When the positioning has been completed, check that all the braking systems are
activated (see Figure 4, Figure 5).

3.5. UNIT SETUP
How to aperate the unit is indicated in order to make it ready to work.

For the operations described here below, refer to Figure 3, Figure 6, Figure 9 and Figure 10.
1. Connect the mobile image intensifier to the monitor trolley.

2. Connect the monitor trolley to the mains (the switching-on pushbutton led of the mobile
image intensifier will light up).
3. Connect the footswitch.
4. Insert the key and activate the main switch on the monitor trolley.
5. Turn the monitor trolley on by rotating the key in "on mains" position (device ON).
For the operations described here below, refer to Figure 6.

1. Turn on the control panel of the mobile image intensifier by operating on the "unit ON"
pushbutton that is placed in the middle of the control panel. In this way the automatic
initial test is activated:
• For 4 seconds on the two displays the unit name and the control software version will
appear, at the same time the audible alarm and the panel leds will activate, as initial
test.
• The status displays indicate that the unit is ready (on the left display the "FLUORO"
indication appears and the other one displays kV and mA parameters).
2. Activate the intended exposure mode according to what is described in the next pages.
Before performing an exposure, make sure that all the necessary precautions
concerning protection against radiation have been activated.
Before performing any examination, make sure that the indication of the residual
exposure time is enough to perform the complete diagnosis.
After a long idle period (3 months or more) it is very important to proceed to the X-
X-
RAY TUBE SEASONING. This is in order to avoid the discharges in high voltage that
could be harmful for the x-
x-ray tube.
This operation requires the intervention of a skilled technician.
3.6. USE MODE
The unit working in the different operative modes is explained.
The prearranged modes are:
• Automatic and manual continuous fluoroscopy

fluoroscopy
• Automatic and manual pulsed fluoroscopy
• Automatic and manual “Snap shot”
• Radiography
Additional modes for the rotating anode version and if selected are:
• H.D.F. Automatic and manual continuous fluoroscopy

• H.D.F. Automatic and manual pulsed fluoroscopy
fluoroscopy
• H.D.F. Automatic and manual “Snap shot”
• H.D.R. Radiography

AUTOMATIC AND MANUAL CONTINUOUS FLUOROSCOPY
Turn the unit on, after the initial test phase, the unit is prearranged to operate in
automatic fluoroscopy.
Select Automatic Fluoroscopy

Fluoroscopy.
scopy
Press the first step of the footswitch or the handswitch to control the exposure.
The x-ray emission indicators in the middle of the control panel and on the
monitor trolley light up.
When the x-ray control is activated, kV/mA value will be set automatically
according to the subject who is under examination so that the best image is
obtained.
The exposure timer indicates the x-ray emission time with 1sec. frequency
During the examination it is possible…
Change the applied recursive filter value.
Rotate the image position.
Overturn horizontally and vertically the image. This operation can be performed
through the keys on the monitor too.
Select other image intensifier entrance field.
Decrease or increase the irradiated area through iris diaphragm.
Decrease or increase the irradiated area through parallel shutters diaphragm.
Rotate the parallel shutters diaphragm position.
Store the current image. This operation can be performed by pressing the second
step of the footswitch or the handswitch.
Turn on the laser targeting device.
Select the Manual Fluoroscopy mode, kV and mA parameters must be set by the
operator.
The manual change of the parameters allows to modify the image quality at the
discretion of the operator.
The automatic control system of the image is disabled.
Scroll the stored images. It will be necessary to stop x-ray emission; by pressing at
the same time the operation key and the keys kV + or –.

AUTOMATIC AND MANUAL PULSED FLUOROSCOPY
Select Pulsed Fluoroscopy mode, the unit indicates the delay time between
exposures, on the monitor the last image will be held.
Every press of Pulsed Fluoroscopy key, change the delay time, the available
frequencies change in function of the installed memory type.
Perform every operation as already indicated for Continuous Fluoroscopy mode.
By selecting Manual Fluoroscopy mode, kV parameter must be set by the operator,

mA value will be selected automatically by the unit.
In order to exit from the mode…

mode…
Press Automatic Fluoroscopy key.
AUTOMATIC AND MANUAL “SNAP SHOT”
No selection from the control panel must be performed.
Press the right footswitch of the x-ray control, after the balance time, an exposure
of about 1sec, controlled directly by the unit, allows to get an image that is at high
contrast and without background noise.
The image is automatically stored on the monitor.
At the end of the exposure it is possible to store the image on the monitor.
In order to perform a new exposure, release the footswitch and press again.

mA value will be automatically selected by the unit.
Press the right footswitch to control the exposure.

RADIOGRAPHY
Select Radiography.
Radiography
Place the cassette-holder at the I.I. Tube input by hitching the two fixed locks and
block it by operating on the proper knob, insert the x-ray cassette with the film.
Set kV and mAs parameters by operating on the increase and decrease keys
placed under the indication of the selected value on the display.
Press the x-ray handswitch and hold it down till the end of the exposure, use all the
length of the extensible cable in order to keep away as much as possible from the
irradiated area
area.
At the end of the exposure the display indicates, for some seconds, the radiation
time.
IF IN “FLUOROSCOPY" MODE THE AUDIBLE ALARM IS ACTIVATED, IT IS POSSIBLE:
Silence the audible alarm and go on with the examination.

This indication is active after that the timer has integrated 5minutes of exposure, if
it is not reset within 30sec the unit stops the x-ray emission.
Reset the timer of x-ray exposure, the count will restart from 0sec.
To be pressed if the unit has stopped the exposure after 30sec from the audible
alarm.

H.D.F AUTOMATIC AND MANUAL CONTINUOUS FLUOROSCOPY

Only rotating anode version, if it is selected.
Press Automatic Fluoroscopy key, the indication on the display will commutate
from L.D.F. (Low Dose Fluoroscopy) to H.D.F. (High Dose Fluoroscopy).
The indicators of the x-ray emission in the middle of the control panel and on the
monitor trolley light up, a particular audible indication (that cannot be disabled)
advises of the exposure in H.D.F. mode.
When the x-ray control is activated, kV/mA value will be set automatically in
function of the subject who is under examination so that the best image is
obtained.
The exposure timer indicates the x-ray emission time with 1sec frequency.
The exposure in H.D.F. mode is active for 20 sseconds

econds (calculated according to the
real x-
x-ray emission), incremented this time the unit selects automatically the L.D.F.
mode.

Select the H.D.F. mode again also after 20 seconds of exposure without stopping
the x-ray emission.
After 10 continuous selections of H.D.F. mode (about 3 minutes of exposure) the

thermal units of the monobloc
monobloc are finished.
Use with caution the H.D.F. function during long and challenging examinations.
When the fluoroscopy footswitch is released, H.D.F. mode is automatically

deselected.
OR

H.D.F. AUTOMATIC AND MANUAL PULSED FLUOROSCOPY

Select Pulsed Fluoroscopy mode, the unit indicates the delay time between
exposures, on the monitor the last image will be held.
Every press of Pulsed Fluoroscopy key changes the delay time, the available
frequencies change in function of the installed memory type.
The indicators of the x-ray emission in the middle of the control panel and on the
monitor trolley light up, a particular audible indication (that cannot be disabled)
advises of the exposure in H.D.F. mode.
When the x-ray control is activated, kV/mA value will be set automatically in
function of the subject who is under examination so that the best image is
obtained.
The exposure timer indicates the x-ray emission time with 1sec frequency.
The exposure in H.D.F. mode is active for 20 seconds, incremented this time the
unit selects automatically the L.D.F. mode

Select the H.D.F. mode again also after 20 seconds of exposure without stopping
the x-ray emission.
After 10 continuous selectio

selections
ns of H.D.F. mode (about 3 minutes of exposure) the
thermal units of the monobloc are finished.
Use with caution the H.D.F. function during long and challenging examinations.
When the fluoroscopy footswitch is released, H.D.F. mode is automatically

deselected.
OR

H.D.F. AUTOMATIC AND MANUAL “SNAP SHOT”

No selection from the control panel must be performed.
Press the right footswitch of the x-ray control, after the balance time, an exposure
of about 1sec, controlled directly by the unit, allows to get an image that is at high
contrast and without background noise.
The image is automatically stored on the monitor.
At the end of the exposure it is possible to store the image on the monitor.
In order to perform a new exposure, release the footswitch and press it again.

Press the right footswitch to control the exposure.

H.D.R. RADIOGRAPHY
Select Radiography,
Radiography the display will display H.D.R.
If commutated with L.D.F. the indication will L.D.R.
The unit commutates automatically between H.D.R. and L.D.R. when the selected
mAs value is lower or higher than 8.
Place the cassette-holder at the I.I. Tube input by hitching the two fixed locks and
block it by operating on the proper knob, insert the x-ray cassette with the film.
Set kV and mAs parameters by operating on the increase and decrease keys
placed under the indication of the selected value on the display.
Press the x-ray handswitch and hold it down till the end of the exposure, use all the
length of the extensible cable in order to keep away as much as possible from the
irradiated area
area.
At the end of the exposure the display indicates, for some seconds, the radiation
time.

3.7. SHUTDOWN PROCEDURE
This section describes the system shutdown procedure in order to guarantee operators and patients'
safety and a long unit life.
Don't disconnect the cable between the mobile image intensifier and the monitor trolley
if the mobile image intensifier is not off.
Don't
Don't remove the connector from the mains outlet if the unit is not off.
When finished the examination, do the following:
1. Position the mobile image intensifier in parking position (down, with the mechanical brakes
activated).
2. Turn off the mobile image intensifier by operating on the "unit off" key of the control panel.
3. Coil the footswitch cable and put it in the proper place.
4. Turn off the monitor trolley by turning the key to the "Off Mains" position (Device OFF) and
remove the key. Store the key in a safe place.
5. Disconnect the mains cable and coil it again on the proper supports of the monitor trolley.
6. Disconnect the cable of the mobile image intensifier/monitor trolley and coil it on the proper
supports of the monitor trolley (rear part).
7. Park the monitor trolley by engaging the wheels brakes

4. MAINTENANCE
This section describes the standard maintenance procedures necessary to assure the unit reliability.
Villa Sistemi Medicali supplies a programmed maintenance plan to be performed on the unit
yearly, the intervention must be performed by skilled and properly trained personnel.
4.1. GENERAL WARNINGS
As with any medical device, this system requires:
o proper use;
o regular checks by the user;
o maintenance and repairs by the authorized personnel
Operational reliability of the unit is kept by following these precautions.
Villa Sistemi Medicali can provide, on request, circuit drawings, parts list, adjustment instructions
or further information for the unit repair.
As users of x-
x-ray units it is necessary to take these precautions in compliance with the
equipment.
prevention standards formulated by the laws concerning the medical equipm ent.
The unit needs regular checks and maintenances. The purpose of the following warnings is to keep
a good operating and safety level.
The unit includes mechanical parts which are subjected to wear in function of the use. After a long
period of use, it is possible that the safety decreases due to the parts wear.
Regular checks and maintenance are useful also to protect the patient and the operators from
damages due to the mechanical parts breakage.
The correct adjustment of the electromechanical and electronical modules influences directly the
unit working, the image quality, the electrical safety and the exposure level to radiations to which
the medical - nursering personnel is subjected.
The maintenance plan includes checks and prevention measures to be done by expressly
authorized personnel and at the unit owner's charge.
In case of the replacement of some parts that can influence the unit safety, use only
original spare parts.
4.2. CHECKS AND INSPECTION BY THE USER
The user must check the x-ray unit as indicated in the table below. In the event of operational
faults or other deviations in respect of the standard operative behaviour, the user must turn off the
unit. The unit may only be operated after repairs have been made.
If a faulty or malfunctioning unit is used, risks to the operators and patients can
increase.

Summary of the periodical checks
Check the functionality of alarms, displays and indicators.

Daily:
Check the warning and danger labels integrity.
Check for oil leakage from the monobloc

Weekly:
Check unusual noises in the monobloc during x-ray emission
Check the x-ray tube and collimator centering.
Every 6 months: Check the functionality of the limit switches of the C-arm movement
Check the sliding bearings condition.
Yearly: Contact the technical after-sale service to perform the constancy and
reproducibility tests, as indicated by IEC 1223-2 and IEC 1223-11
standards, as well as the other operating tests of the unit, as instructed in
the scheduled maintenance plan.
4.3. CLEANING
Please, always take the following information into consideration before choosing a detergent:
• To clean plastic surfaces, simply use water and soap, and nothing else. If other detergents are
used (e.g. with a high alcoholic content, or corrosive solvents, or abrasive detergents), the
material will tend to break or opacify
• To clean enameled parts and aluminium surfaces, simply rub them with a wet cloth and a
delicate detergent, after that rub them with a dry wool cloth
• As regards, chromium-plated surfaces, only rub them using dry wool clothes; do not use any
detergent.
• To clean the other surfaces of the equipment, never use highly alcoholic products, corrosive or
abrasive detergents and solvents
Before cleaning the unit, please take the following actions:

• Turn off the unit and unplug the mains power supply cable.
• Ensure that no liquid seeps into the unit, so as to avoid short-
short-circuiting or corroding the electrical and
electromechanical parts.
4.4. DISINFECTION
To disinfect the equipment and the sterile drapes, it is advisable to use a common liquid solution
featuring an aldehyde base or disinfectants featuring an ampholytic surface-active agent base (e.g. Tego
103, Korsolin).
Substitute disinfectants releasing chlorine or based on phenols are likely to weaken the materials, hence
they are much to be avoided. The same limitations apply to undiluted solutions featuring a high alcoholic
content.
Do not use disinfectant spray; it might penetrate the system, and its safety would not be
guaranteed any longer (damages possibly affecting electrical and electromechanical parts,
formation of flammable air mixtures and vapour solutions).
In cases when disinfection products forming

forming explosive gaseous mixtures are used,
before re-
re-using the equipment always ensure that these gases have dispersed.

5. TECHNICAL DATA
This section of the manual describes the technical features of the unit and the symbols meaning
5.1. LABELS AND SYMBOLS
5.1.1. POSITION
POSITION AND LABELS OF THE UNIT
Fixed Anode Version Rotating Anode Version
WEEE label
Figure 11
Unit Body Monitor trolley
Figure 12 Figure 13
Position of the Laser Device labels (optional) Position of the laser and x-ray danger labels
(optional)

5.1.2. IMAGE INTENSIFIER LABEL

Applied outside the image intensifier
I.I. Tube type A1234BCD * s/n 12345

Power supply type AB12345 ** s/n 123456
Codes present on the label in relation to the installed I.I.tube type:
Brand THALES TOSHIBA

TOSHIBA
TH 9428 HP2
* I.I. Tube type 9”/6”/4” E5764SDS-T1
H542 VR13
TH 9416 HP2
* I.I. Tube type 7”/4” E58871JS-T1
H532 VR12
TH 9466 HP
* I.I. Tube type 6” E5794SDS-T2
H505 VR10
** Power supply type TH 7195 UP 33350
5.1.3. MONITOR LABEL

Applied on the back of both monitors
B/W MONITOR 220/240V - 50/60Hz - 60W COMPLIES WITH FDA RADIATION

MADE IN ITALY by NICAL S.p.A. PERFORMANCE STANDARDS, 21 CFR.
MODEL: SN: SUBCHAPTER J.
FDA NUMBER : 9010197-00
5.1.4. ANTISCATTERING
ANTISCATTERING GRID LABEL
X-RAY GRID
Focus: 80 cm
Ratio 8:1 36 L/cm

5.1.5. MONOBLOC LABEL
Fixed Anode Version Rotating Anode Version
0051 0051
Monobloc S/N° position
5.1.6. PACKING LABEL

Applied outside the packing, with red writings on white background.
fragile protect from rain higher side of the

packing

5.1.7. UNIT SYMBOLS
On mains (unit ON) Indirect radiography
Sliding brake release / arm rotation

Off mains (unit OFF)
Sliding brake release / slide rotation
Sliding brake lock / arm rotation

Unit off
Sliding brake lock / slide rotation
Unit on C-arm rotation degrees indication

(black inside)
Warning, consult the attached

Clutch of the trolley - unit connection
documentation
(yellow inside)
Footswitch Equipotential node
Main supply Laser
WEEE label (see Chapt.1.6 GENERAL DISPOSAL)
Additional DAP METER filtration
Warning about the hazard of X-ray emission

This x-ray unit can be dangerous for the patient and the operator if all
the safety conditions and the use instructions are not observed.
Warning about laser radiation hazard

Don't fix the beam with the naked eye and don't look through optical
devices. Laser system in class 3A, classif. CEI EN 60825-1 sept.95
wave length 635mm power <5mW CW.

5.1.8. MONITOR SYMBOLS
Image contrast Up-down image inversion
Image brightness Image rotation
Right-left image inversion On/off
5.1.9. INTERNAL SYMBOLS
Dangerous voltage
Protection ground clamp
5.1.10. FOOTSWITCH SYMBOLS
Snap Shot Control
Fluoroscopy control +
image storage
5.1.11. VARIOUS SYMBOLS
Ionizing radiation Type B equipment
Large focus Total filtration
Small focus Alternate voltage

5.2. ENVIRONMENTAL CONDITIONS
Environmental Factor In normal use Warehouse and transport
Temperature From 10°C to 40°C From -25°C to 70°C
Relative Humidity From 30% to 75% From 10% to 90%
Pressure From 700hPa to 1060hPa From 500hPa to 1060hPa

5.3. ELECTRICAL DATA
Description Fixed Anode Version Rotating Anode Version

Voltage 230 Vac ±10% standard monophase
220 / 240 / 105 / 115 / 125 Vac ±10% monophase on request
Frequency 50 Hz standard - 60 Hz on request
Absorbed current in fluoroscopy 10A @ 230Vac 10A @ 230Vac
20A @ 115Vac 20A @ 115Vac
Absorbed current in radiography 24A @ 230Vac 24A @ 230Vac
48A @ 115Vac 50A @ 115Vac
Line compensation Automatic
Line resistance <0,4Ω @230V
<0,2Ω @115V
Standard mains plug 16A @230Vac
Insulation class Class I with applied parts type B
Use conditions Continuous operating with intermittent load
The unit is not suitable to be used where there exist mixtures inflammable with air or nitrous oxide.
5.3.1. RADIOLOGICAL DATA
Description Fixed Anode Version Rotating Anode Version1

2,8kW @100kV with mAs > 8
Generator in DC current 2,8kW @100kV
5kW @100kV with mAs < 8
Inverter frequency 20kHz
Inverter frequency high voltage 40kHz
Max. ripple <1% @100kV
Rise time <1ms @100kV
Max.high voltage 110kVp 120kVp
Max. current in continuous
4mA 4mA (LDF) / 8mA (HDF)
fluoroscopy
Max. current in “BOOST”
6,5mA 10mA / 12mA with HDF
fluoroscopy
Max. current in radiography 65mA 65mA (LDR) / 90mA (HDR)
Max. mAs in radiography 250mAs
5.3.2. COLLIMATOR
Description Data
Model R601AMP
Fields dimension (DF 100cm):
round field delimitation 5÷23cm
elliptical field delimitation 0÷23cm
Max. protection against the leakage radiation 125kV, 4mA
(EN60601 1.1.3 par.29.204.3)
Inherent filtration (EN60601 1.1.3) 0mm
Motors power supply 12Vdc 0,5mA
Motors fuse delayed 160mA
Potentiometer 1 turn 5kΩ
Dimensions (88,5x86x160,5)mm
Weight 1,4kg
Classification EN60601-1 par.5:
Protection against electrical hazards Class I
Protection against direct and indirect contacts equipment with applied part Type B
Protection against water seepage common protection (IPXO)
1
The system is always configured in LDF mode. During the installation it is possible to change the setting in HDF.
The two modes are available both in fluoroscopy and in radiography.

5.3.3. LASER TARGETING (optional)
General specifications Data
Cross generator with 2 Laser modules

External power supply: 5V
Support mechanics: already available
Laser cable length: 50 cm
Laser targeting device
Optical power: 3,8 mW
Line focusing: at 400mm
Line length: 450mm
Line width: 1mm (-0.2mm)
Line area: 0,00046 mq
Optical power /Area: 8,26 W/mq
Specifications of the diode laser
Glass focusing lens: Plastic
Laser head case material: Aluminum
Wave length: 635nm (+ 10nm)
Output optical power (out collimating lens): < 4 mW
Divergence: < 1.4 mrad
Operating temperature: -10°C - +50°C
Operating current: < 40mA
Operating voltage: 5V
Safety Class: IIIA
5.3.4. X-RAY TUBE AND MONOBLOC
Brand and model of x-ray tube Toshiba DF151SB-T IAE X20P

Anode Fixed Rotating (2850rpm at 50Hz)
Nominal focus dimensions 0,5 mm small focus 0,3 mm small focus
(IEC 336, EN 60336) 1,5 mm large focus 0,6 mm large focus
Nominal anode power (per 1sec.) 680W small focus 5kW small focus
3,2kW large focus 17kW large focus
Thermal anode capacity 30kJ (40kHU) 150kJ = 200kHU
Anode diameter 64mm
Anode angle 16° 10°
Max. continuous anode dissipation 265W (379HU/s) 300W
Max. anode cooling speed 12kJ/min (17kHU/min) 25kJ/min (33kHU/min)
Monobloc model HF1 F/2, HF1 R/2
Power in constant DC current 3,5 kW
Weight 19kg
Min. inherent filtration 1.4mmAl
(IEC 522)
Additional irremovable filtration 1.3mmAl
Total filtration >2.7mm Al
Leakage radiation (IEC 601-1-3) <1mGy/h
Load, heating and cooling curves See the enclosed diagrams
H.V. transformer insulation In oil bath

5.3.5. THERMAL MONOBLOC CAPACITY
Thermal monobloc capacity 600kJ (800kHU)

Max continuous thermal dissipation of
60W
the monobloc
Max. fluoroscopy time at 40W 80kV – 0,5mA: continuous
Max. fluoroscopy time at 64W - 80kV – 0,8mA: 166min
Max. fluoroscopy time at 259W 70kV – 3,7mA: 30min -
Max. fluoroscopy time at 280W 80kV – 3,5min: 25min 80kV – 3,5mA: 33min
Max. fluoroscopy time at 440W 110kV – 4mA: 15min -
Max. time in fluoroscopy H.U. safety after 15min of H.U. safety after 19min of
fluoroscopy @110kV, 4mA fluoroscopy @120kV, 4mA
(440W). (480W).
Cooling at 30° in four hours
Monobloc model MHF833 for Fixed Anode Version

Dimensions

X-RAY TUBE MODEL TOSHIBA DF-

DF-151SB-
151SB-T for Fixed Anode Version
Mechanical dimensions Thermal anode feature
27
24 265W
21
18 150W
15
12
9
6 COOLING
3
0
0 3 6 9 12 15
TIME [min]
Load curves ( - 3~) Load curves ( - 3~)

15 60
50kV 40kV 50kV 40kV
60kV
50
60kV 70kV
10 70kV 40 80kV
80kV 90kV
100kV
90kV 30
100kV 110kV
110kV
5 20
10
0 0
0.1 0.2 0.3 0.5 0.7 1 2 3 5 7 10 0.1 0.2 0.3 0.5 0.7 1 2 3 5 7 10
EXPOSURE TIMES [s] EXPOSURE TIMES [s]

X-RAY TUBE MODEL IAE X20P 0.3 - 0.6 for Rotating Anode Version
Anode heating and cooling curves

Mechanical dimensions
Load curve 0,3mm Focus Load curve 0,6mm Focus

5.3.6. TUBE SEASONING

After a long idle period (3 months or more) it is necessary to proceed to the X-RAY SEASONING.
In case during the procedure some anomalies or operating faults are detected, it is necessary to
interrupt it for at least half an hour and repeat it from the beginning.
1. Set the unit in Manual Fluoroscopy.
2. Perform the following exposures in the order and in the times indicated below in the table.
Operating parameters Exposure

Exposure time
to be repeated
kV mA ON time OFF time
60 3 5' 5' 5 times

80 2 2,5' 2,5' 3 times
100 1 1' 1' twice
5.3.7. TOTAL UNIT HALF-

HALF-VALUE LAYER
Half-value layer @100kV 4,2mmAl -

Half-value layer @110kV 4mmAl 3,9mmAl
Half-value layer @120kV - 3,9mmAl
5.3.8. TOTAL UNIT FILTRATION

Descrizione Dati
Monoblocco 1,4 mmAl

Addizionale su collimatore (1 piastra) 1 mmAl
Carteratura monoblocco 0,3 mmAl
Totale filtrazione unità 2,7 mmAl
Filtrazione richiesta
2,7 mmAl
In accordo alla IEC 60601-1-3 par. 28.201.5

5.4. EXPOSURE MODE: FLUOROSCOPY
5.4.1. CONTINUOUS FLUOROSCOPY

Automatic brightness control (kV - mA)
Small focus (IEC 336) 0,5mm 0,3mm

kVp range 40÷110kV 40÷120kV
mA range in LDF1 0,2÷4mA 0,2÷4mA
mA range in HDF Not available 0,4÷8mA
kV – mA ratio 40kV / 0,2mA
70kV / 3,5mA LDF
40kV / 0,2mA
120kV / 4mA
70kV / 3,5mA
40kV / 0,4mA
110kV / 4mA
70kV / 7mA HDF
120kV / 8mA
Safety timer Audible alarm after 5’
X-ray interruption after 5’30”
Max.time 10’
Single exposure with Last Image Hold (LIH) storage
5.4.2. PULSED FLUOROSCOPY

Automatic parameters control (kV, mA, t)

Exposure rate From 2 images/sec to 1 image every 13 sec.
(it can be selected on the control panel) (memory DIP...)
From 1 image/sec to 1 image every 5 sec.
(other memories)
Exposure time range From 6 to 19 steps that last 40/33ms for DIP...
From 200 to 800 ms for other memories
(default 400ms)
Other specifications as per continuous fluoroscopy
5.4.3. SNAP SHOT

Automatic exposure control (kV, mA, t)

mA range 0,5÷6,5 mA 1÷10 mA
1÷12 mA with HDF1
X-ray flash time < 1,5 sec
Acquisition obtained through the integration of 16 consecutive
readings
Automatic image storage in RAM or Hard Disk, in function of
the memory.
Other specifications as per continuous fluoroscopy
1
Only rotating anode version, if it is selected

5.5. EXPOSURE MODE: RADIOGRAPHY

Two points technique, kV and mAs selection
Large Focus (IEC 336) 1,5mm 0,6mm

kVp range 40÷110kV 40÷120kV
mA range 23 ÷ 65 mA LDR
25 ÷ 65 mA
40 ÷ 90 mA HDR
mAs range 1 ÷ 250 mAs
Exposure times range 0,015÷5 sec 0,011÷5 sec
Duty cycle 1:40
Anodic mA–
mA– kV association (with power supply 115V-
115V-230V)
kV mA LDR mA HDR mA
40 65 65 90
50 56 56 80
60 46 46 75
70 40 40 70
80 35 35 60
90 31 31 55
100 28 28 50
110 25 25 45
120 - 23 40
Current - reference time at 0,1s product

Fixed Anode Rotating Anode
Version Version
at 70kV 4mAs 8mAs

at 100kV 3,2mAs 5mAs
at 110 kV 2,5mAs -
at 120 kV - 4mAs
mAs range 1 - 250 mAs in 25 selections
Possible kVp / mAs settings

kVp values Possible mAs values
from 40 to 49 1 - 1,3 - 1,6 - 2 - 2,5 - 3,2 - 4 - 5 - 6,3 - 8 - 10 - 13 - 16 - 20

25 - 32 - 40 - 50 - 63 - 80 - 100 - 130 - 160 - 200 - 250
from 50 to 64 1 - 1,3 - 1,6 - 2 - 2,5 - 3,2 - 4 - 5 - 6,3 - 8 - 10 - 13 - 16 - 20
25 - 32 - 40 - 50 - 63 - 80 - 100 - 130 - 160 - 200
from 65 to 79 1 - 1,3 - 1,6 - 2 - 2,5 - 3,2 - 4 - 5 - 6,3 - 8 - 10 - 13 - 16 - 20
25 - 32 - 40 - 50 - 63 - 80 - 100 - 130 - 160
from 80 to 99 1 - 1,3 - 1,6 - 2 - 2,5 - 3,2 - 4 - 5 - 6,3 - 8 - 10 - 13 - 16 - 20
25 - 32 - 40 - 50 - 63 - 80 - 100 - 130
from 100 to 1 - 1,3 - 1,6 - 2 - 2,5 - 3,2 - 4 - 5 - 6,3 - 8 - 10 - 13 - 16 - 20
110 25 - 32 - 40 - 50 - 63 - 80 - 100

5.6. IMAGE SYSTEM
5.6.1. IMAGE INTENSIFIER
Description Double field 7/4” Triple field 9/6/4”
Brand Thales Toshiba Thales

Model TH 9416 HP2 E5764SDS – T1 TH 9428 HP2
H532 VR12 H542 VR13
Fields Number 2 3 3
Nominal Input Diameter 170 mm 230 mm 230 mm
Output Image Diameter 20 mm 20 mm
Output Window Thickness 3,6 mm 3,6 mm
Useful Input Field Size 160/105 mm 215/153/116 mm 215/160/120 mm
Typical Resolution (Central) 50/54 lp/cm 48/56/66 lp/cm 48/56/64 lp/cm
Conversion Factor (Cd/m-2/mR/s-1) 150/65 240 (on9”) 240/120/60
Contrast Ratio 22:1 / 30:1 25:1 23:1/25:1/30:1
Integral Image Distortion 4% / 2% 6% standard 4% / 2% / 1%
Differential Distortion at 90% radius 17% / 5% 15% / 6% / 3%
DQE at 59.5 kV 65% 65% 65%
"All metal" Technology Yes Yes Yes
Input Screen "Hi-Res." Yes Yes Yes
MTF at 10 Lp/cm 55/65% n.a. 60/65/70%
MTF at 20 Lp/cm 22/30% n.a. 25/30/40%
Low Frequency Drop LDF 7/6% n.a. 7/6/5%
Fixed Antiscatter Grid Ratio 8:1, 36 shutters/cm, focus 80 cm, material aluminum
(1) According to IEC standard 1262-1 to 1262-6

n.a. = not available

5.6.2. TV CHAIN AND MONITOR
Description Data
Camera
Camera Technology CCD at low persistence of ½”
Video standard Standard CCIR 625/50Hz interconnected with matrix 752(H) x 582(V) pixels
Standard EIA 525/60Hz interconnected with matrix 768(H) x 494(V) pixels
Aspect ratio 4:3
Resolution 20 lines-pairs (on 6” image intensifier)
Gamma correction 0,4
Video output A/D converter 10 bit
Band width 20 MHz ± 3dB
Signal-noise ratio 50 dB
Automatic video level Yes
compensation
Dynamic contrast Shading Yes
Image rotation Continuous camera rotation 360° (the effect is visible only during the x-ray
(optional) emission).
Power supply 24Vdc ±20% 20W
Control unit dimensions 226x120x46 mm, 0550Kg
Camera head dimensions Ø85x87mm, 0.460Kg (standard) Ø101x87 mm, 1.1Kg (rotation)
CRT TV Monitor NF17F2Axx MSD201L

Size 17” flat square 17” flat profile
Aspect ratio 4:3 landscape 4:3 landscape
Deflection angle 110° 110° diagonale
Phosphor type White - P45 P45
Light trasmission 46 % 42 %
Geometry Geometric error < 1,5 % Linearity <5%
H/V linearity <1,5% Centering <2mm
Max Luminance 480 Cd/m2 450 Cd/m2
Controls Contrast, Brightness, H/V inversion, Four push-buttons for contrast and
image rotation. brightness, On-Screen-Display
Scanning Standard 625 lines 50Hz/60 Hz 50 to 120Hz autoscan
(on request: 625 lines 100 Hz/120 hZ
anti-flickering)
Automatic Brightness Control Yes Yes
Video input signal 0,15 to 1,5Vpp, 75 Ohm 0,714Vpp, 75 Ohm
Dimensions (HxWxD) 326x452x337mm 360x405x363mm
Power Supply 115, 220Vac ±15% 90 to 264Vac, 47÷63Hz
Power Consumption 48W <110W
Memory
Last image hold Standard
Digital filter for the noise Selectable by the operator with k=0, 2, 4, 8, 16 (memories SBFM).
reduction on image Selectable by operator with k=0, 2, 4, 8 (memories DFM).
Selectable by the operator with k=2, 4, 8 ,16 (memories DIP).
“Smart Filter” Automatic de-selection of the filter with live images. Available with some
models of memory. For further details consult the Par. 5.7
Image matrix and memory 576x576 pixel, 8 bits, 256 gray levels
A/D converter 10 bits on DIP2000

5.7. DIGITAL IMAGES PROCESSOR
- no available ; • available
Specifications SBFM34/0 SBFM34/4 SBFM36/110

SBFM36/110 SBFM78/330 DIP2000 S DIP2000 A
Model SBFM34/0 SBFM34/4 SBFM36/110 SBFM78 DIP 2000 S DIP 2000 A

Images Number 1+4 1+110 1+330 1+48 Max 6x8000
L.I.H
buffer ram buffer ram non volatile mem. buffer ram on hard disk
Monitor Number 1 2 2 2 2 2
Digital Rotation - - - • - -
100 Hz anti-flickering Optional Optional • • • •
Smart Filter - - - • •
Recursive Filter, Noise Reduction, • • • • • •
OFF,2,4,8,16
Left - Right Image Inversion • • • • • •
Up - Down Image Inversion • • • • - -
Hard Disk - - - - - •
Remote Control - - - Optional Optional
Road-mapping, Max Opac. - - - - - •
Real Time Subtraction (DSA) - - - - - •
Cine Loop Review - - - - • •
Frame Acquisition Rate fps - - - - - 1-3-6 per sec.
Zoom - - - - • for 2 •, for 2
Overview - - - - • for 4/16 • for 4/16
Contrast Enhancement - - - • • •
Edges Enhancement
• • • • • Log. Exp. • Log. Exp.
Smooth, Normal, Sharp
Digital Adjustment for - - - - • •
Contrast/Brightness
Positive/Negative Image - - - - • •
Text Writing - - - • • •
Directory Patients' Memory - - - • - •
Infrared Remote Control - - - - • •
Virtual Shutter - - - - - -
Video Signal CCIR625/50 EIA 525/60 1Vpp 75ohm CCIR625/50 CCIR625/50 EIA 525/60 1Vpp
75ohm
Image Format 576x576 x12 bit 576x576 x8bit
A/D Converter 8 bit 8 bit 8 bit 10 bit 10 bit 10 bit
D/A Converter 8 bit 8 bit 8 bit 8 bit 8 bit 8 bit
Sampling Rate 15 MHZ 15 MHZ 15 MHZ 15 MHZ 15 MHZ 15 MHZ
5.8. ACCESSORIES
Description Standard Optional
X-ray handswitch with extensible cable •

Fluoroscopy control by double footswitch •
Cassette-holder •
Cassette-holder for radiography on cassette •
Sterile drapes set •
Thermal dry film printer Sony UP 960 / UP 980 or equivalent •
Video-recorder Super-VHS Mitsubishi HS-MD3000 •
Scan Converter from 50Hz to 100Hz •
Laser Targeting Device •
Dose meter with ionization chamber (DAPMeter) •
Printer for dose meter •
DICOM3 Protocol, only for Image Processor DIP2000 •
CD Rom for storing the images in Dicom format (only with Dicom) •
Floppy Disk for storing 4 images in BMP format (only with Dicom) •
Cavo nodo equipotenziale lg.300 •

6. MECHANICAL DATA
6.1. C-ARM UNIT DIMENSIONS WITH I.I. TUBE 6”/7”/9”

6.2. “LOW PROFILE”MONITOR TROLLEY DIMENSIONS
6.3. “HIGH PROFILE”MONITOR TROLLEY DIMENSIONS

6.4. MECHANICAL DATA, DIMENSIONS AND WEIGHTS
Monitor Trolley Monitor Trolley

Description C-arm unit
“Low Profile” “High Profile”
Weight 293kg (unit with fixed 125 kg 145 kg 160 kg 190 kg (max
anode) (standard (standard (standard config. with 2
config. with 1 config. with 2 config. with 2 monitors and
monitor) monitors) monitors) all
300kg (unit with
accessories)
rotating anode)
Width 798 mm 815 mm 830 mm

Depth in movement 1900 mm (with I.I. 9”) 620 mm 580 mm
position 1876 mm (with I.I. 7”)
Height in movement 1844 mm (with I.I. 9”) 1690 mm 1668 mm
position 1908 mm (with I.I. 7”)
Vertical motion Motorized, 500mm in 60 sec
Horizontal motion Manual, 220mm
C-arm rotation around the

Manual, ±270°
horizontal axis
Orbital rotation Manual, 120° (+90° ÷ - 30°)
C-arm group overview Manual, ±12,5°
740 mm (with I.I. 9”)

Useful space
790 mm (with I.I. 7”)
666 mm (with I.I. 9”)

C-arm depth
700 mm (with I.I. 7”)
950 mm (with I.I. 9”)

S.I.D.
1000 mm (with I.I. 7”)
Focus-Skin Distance 210 mm
C-arm unit:
Rear driving wheels with manual control by the
operator, front castor.
Unit movement Manual parking brake.
Monitor trolley:
Front and rear castors.
Brake on the front wheels.
Rear 125 x 40 mm
Wheels Diameter Front 80 x 30 mm
Trolley 125 x 30 mm
Protection against the cables squashing Semirigid rubber core hitch on all the unit wheels

7. DOCUMENT STATUS
Rev. Date Page/s Modification description
0 02.12.02 - Document approval
1 15.09.03 33-38-39-48 Introduction of a new monobloc
Monobloc label updating, new monitors, CCD camera and memory SBFM
32,33
2 12.02.04 version introduction; removed the unit configuration with 6” I.I. and 7/5”
45÷48
Toshiba I.I.
4,34, Introduction of the laser device technical data and updating of some
3 28.06.04
37,38,39 technical data.
Introduction of the optional emergency push-button on units and updating
3, 9,16, 32,
4 14.06.05 warnings laser device. Introduction of the new SBFM78 memory. Image
45, 47
Intensifier technical data update.
Introduced position of WEEE label.
5 31.10.05 5, 31, 34
Introduced explanation note of the WEEE symbol.
[File: AF30010E00R05.doc] Pag. I/I

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ARCOVIS 2000 SB/RB

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1. SAFETY AND COMPLIANCE ................................................................

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1. SAFETY AND COMPLIANCE

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1.1. ELECTRICAL SAFETY

1.2. LASER TARGETING DEVICES SAFETY

• Keep always a good lightening on the room.

1.3. MECHANICAL SAFETY

[File:AF30010E00.doc] Rev. 4 - Pag. 3/50

1.4. ELECTROMAGNETIC COMPATIBILITY (EMC)

Any transmissions by mobile radio equipment must be avoided.

1.5. PROTECTION AGAINST IONIZING RADIATION

Never modify or disconnect the safety circuits or devices designed to prevent

Primary protection barrier in compliance with the

Pag. 4/50 - Rev. 3 [File:AF30010E00.doc]

1.6. GENERAL DISPOSAL

For additional information, contact Villa Sistemi Medicali.

[File:AF30010E00.doc] Rev. 5 - Pag. 5/50

1.9. APPLICATION & FINAL DESTINATION

Contact with the patient is non-

Pag. 6/50 - Rev. 0 [File:AF30010E00.doc]

Protection against electrical hazards .................Class I

For any further information please contact:

VILLA SISTEMI MEDICALI

The manufacturer producer (according to European Directive 93/42/CEE) of ARCOVIS 2000

[File:AF30010E00.doc] Rev. 0 - Pag. 7/50

The unit is made up of two different parts:

Mobile Image Intensifier

Monitor Trolley consisting of:

Pag. 8/50 - Rev. 0 [File:AF30010E00.doc]

2.2. MOBILE IMAGE INTENSIFIER

2. Handles for the

10. Handle for the

12. Control Panel

14. Fluoroscopy Footswitch

[File:AF30010E00.doc] Rev. 4- Pag. 9/50

2.2.1. Handles position for manual movements

1. Brake for the arm

1 2. Brake for horizontal

2. Brake for the overview

3. Driving handle and rear

Pag. 10/50 - Rev. 0 [File:AF30010E00.doc]

2.3. CONTROL PANEL

1. System ON 19. Horizontal image inversion

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2.4. FLUOROSCOPY FOOTSWITCH

2.5. RADIOGRAPHY/FLUOROSCOPY CONTROL HANDSWITCH

Pag. 12/50 - Rev. 0 [File:AF30010E00.doc]

2.6. MONITOR TROLLEY

2 Monitors Version - 1 monitor Version

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2.7. OPERATIONAL MESSAGES

RAD. Radiography Mode Selected

Pag. 14/50 - Rev. 0 [File:AF30010E00.doc]

2.8. ERROR MESSAGES

The table indicates how to proceed in case of faults and anomalies.

Text Meaning Corrective Action

SUPPLY FAULT Electronic Power Fault Contact service

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2.9. SAFETY DEVICES

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