Villa Sistemi Medicali Arcovis 3000 User manual

Revision: G
Version: May 26, 2010
File: [201175-F-01-01.doc]
U
Us se er r’ ’s s M Ma an nu ua al l
WARNING: The information that is printed within this manual is vital for the correct use of the
equipment; please read it carefully before use.

User's Manual ARCOVIS 3000 S/R Villa Sistemi Medicali
[File:201175-G-01-01.doc]
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Villa Sistemi Medicali ARCOVIS 3000 S/R User's Manual
[File:201175-G-01-01.doc] Rev. A - Pag. 1/76
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 and final destination.................................................................................................................... 6
1.10. Classification ................................................................................................................................................. 7
1.11. List of the Standards for the evaluation of the product compliance .............................................................. 7
1.12. Compliance ................................................................................................................................................... 7
2. COMPONENT IDENTIFICATION ......................................................................................................8
2.1. Overview ....................................................................................................................................................... 8
2.2. Mobile Stand ............................................................................................................................................... 10
2.3. Keyboard..................................................................................................................................................... 12
2.4. Fluoroscopy control footswitch.................................................................................................................... 18
2.5. Handswitch for radiography / fluoroscopy control ....................................................................................... 18
2.6. Monitor Trolley ............................................................................................................................................ 19
2.7. Operative messages ................................................................................................................................... 20
2.8. Alarm messages ......................................................................................................................................... 21
2.9. Safety devices............................................................................................................................................. 23
3. UNIT USE.........................................................................................................................................24
3.1. Transport..................................................................................................................................................... 24
3.2. Connection between monitor trolley – mobile stand ................................................................................... 25
3.3. Connection between Footswitch – Mobile Stand ........................................................................................ 26
3.4. Unit ON / OFF ............................................................................................................................................. 27
3.5. Positioning................................................................................................................................................... 29
3.6. Use mode.................................................................................................................................................... 30
3.7. Shutdown procedure ................................................................................................................................... 40
4. MAINTENANCE...............................................................................................................................41
4.1. General warnings ........................................................................................................................................ 41
4.2. Checks and inspection by the user ............................................................................................................. 41
4.3. Cleaning ...................................................................................................................................................... 42
4.4. Disinfection.................................................................................................................................................. 42
5. TECHNICAL DATA..........................................................................................................................43
5.1. Labels and symbols .................................................................................................................................... 43
5.2. Environmental conditions ............................................................................................................................ 47
5.3. Electrical data.............................................................................................................................................. 48
5.4. Exposure mode: fluoroscopy....................................................................................................................... 58
5.5. Exposure mode: radiography ...................................................................................................................... 61
5.6. Image system.............................................................................................................................................. 62
5.7. Digital image processor............................................................................................................................... 65
5.8. Accessories................................................................................................................................................. 70
6. MECHANICAL DATA ......................................................................................................................73
6.1. C-arm unit dimensions with I.I. 9”............................................................................................................... 73
6.2. Axis and interventionist reference point ...................................................................................................... 73
6.3. “Base Trolley” monitor trolley dimensions ................................................................................................... 74
6.4. Dimensions of “High Configuration” monitor trolley..................................................................................... 75
6.5. Mechanical data, dimensions and weights.................................................................................................. 76
7. DOCUMENT STATUS ........................................................................................................................I

User's Manual ARCOVIS 3000 S/R Villa Sistemi Medicali
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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-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 was 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-compliance with
the rules for proper maintenance.

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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 patient dose to a
minimum, 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-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.
• 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.

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1.4. Electromagnetic compatibility (EMC)
This apparatus is in compliance with the standard IEC 60601-1-2 that defines the max.
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-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.
Collimation system adjusted to a field of 30 x
30 cm2 at 1 m from the x-ray tube focus.
Exposure parameters: 100 kVp and 1 mA.
Values normalized to 1 min. of fluoroscopy
(µGy/min).
Equivalent water phantom 30x30x20cm.
The complete isodose measures are included
into the report 035-07 ISO KERMA MAPPING
(cod.200394) attached to the unit
documentation

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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, proper disposal
methods, according to the regulations of the country where the unit is installed, should be
followed.
For this reason, the unit may not be disposed of along with industrial or
domestic waste and must be regarded as hazardous waste.
This symbol indicates that the waste of electrical and electronic equipment must
not be disposed as unsorted municipal waste and must be collected 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 a 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 DVD Recorder, thermal printer,
Network (DICOM System). Such devices must be in full compliance with the safety
requirements specified by 93/42/EEC Directive. The liability of the interface, if it has not been
evaluated and authorized by Villa Sistemi Medicali in writing, is of the operator and/or of the
person who has performed this interface.
1.8. Copyright
The original release of this manual is in Italian language (file: 201175-C-01-00.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.

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1.9. Application and final destination
ARCOVIS 3000 S/R is a "mobile x-ray 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 designed for continuous
operation.
The system is not used in contact with the patient; however, accidental contact of
some unit parts with the patient and the operator is possible.
Contact with the patient is 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
This x-ray unit must not be used in areas where danger of explosion
exists.
For use in operating theater, it is necessary to use a sterile coverings to
protect the arm-monobloc-intensifier group from liquids seepage and a
footswitch type IP-X8 (like the standard one).
The patient support must not have an equivalent filtration higher than
2mmAl.
The patient must be placed as close as possible to the image intensifier.
The unit is available in two versions:
ARCOVIS 3000 S with stationary anode monobloc, successively named
“Stationary anode version”,
ARCOVIS 3000 R with rotating anode monobloc, successively named “Rotating
anode version”.
If not else specified, the technical characteristics are intended available for
both versions.

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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)
Fluoroscopy footswitch protected against the
submersion effects (IPX8)
Use condition protection................................. Continuous working with temporary load
1.11.List of the Standards for the evaluation of the product compliance
Reference Description
MDD 93/42/EEC class IIB according to
Annex IX rule 10.
Medical Devices Directive (EC mark)
IEC 60601-1 1st edition Medical devices safety
IEC 60601-1-2 1st edition Electromagnetic compatibility
IEC 60601-1-3 1st edition Protection against ionizing radiation
IEC 60601-2-7 2nd edition HV generators
IEC 60601-2-28 1st edition Tube-housing groups
IEC 60601-2-32 1st edition Mechanical safety aspects
ISO 14971:2000 Risk analysis
CEI EN 60825-1 2nd edition Laser equipment safety
ARCOVIS 3000 S/R with radio-protection according to the Standard CEI EN 60601-1-3 (1995)
Gruppo Inverter-monoblocco:
(IN-9040-5 HF + I-40S 3,5 RF, IN-9040-5 HF + I-40R 5 RF) EN60601-2-7:1998
X-ray group for diagnostics ARCOVIS 3000 S/R IEC 601-2-28 (1993)
Complementary unit ARCOVIS 3000 S/R IEC 601-2-32
1.12.Compliance
This x-ray unit is in compliance with the Electromedical Devices Directive
93/42 EEC class IIb and with the Annex IX rule 10.
For any further information concerning the
compliance please contact:
The manufacturer (according to the European
Directive 93/42/EEC) of the unit ARCOVIS
3000 S/R is:
Villa Sistemi Medicali
Via delle Azalee, 3
20090 Buccinasco, MI (ITALY)
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
Technix S.p.A.
Via E. Fermi, 45
24050 Grassobbio, BG (ITALY)
Tel: [phone]
Fax: [phone]

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2. COMPONENT IDENTIFICATION
2.1. Overview
The unit ARCOVIS 3000 S/R is made up of two different parts: Mobile Stand and Display
Station.
Mobile stand consisting of:
“C” Arm, Monobloc, Image
Intensifier, Control Panel (Fig. 1).
Fig. 1

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Display Station consisting of:
• nr.1 orientable LCD monitor
17”, directly on mobile stand for
digital systems with CCD 0,5K x
0,5K (Fig. 2). *
• “Low Profile Base Trolley” with
two LCD monitors 19” for video
systems 0,5K2(Fig. 3).
• “High Profile Base Trolley” with
two monitors 18” for video
systems 1K2 (Fig. 4).
• “High Configuration” trolley with
two monitors 19”/18” for video
systems 0,5K2 / 1k2(Fig. 5).
Fig. 2
Fig. 3
Fig. 4 Fig. 5
* Note: the number of the monitors and the
monitor trolley change according to the
image system choice.

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2.2. Mobile Stand
Fig. 6
Fig. 7
Handswitch for radiography /
fluoroscopy control
Control panel
Connector for the connecting
cable between mobile image
intensifier and monitor trolley
Image intensifier
Focus position
Collimator
Monobloc
Outlet for the
fluoroscopy footswitch
connector
Handles for the
arm sliding Handle for the horizontal
arm group sliding
Handles for the movement
of the mobile image
intensifier.
Emergency push-button for
the UP/DOWN movement
Printer for dosimeter
(optional)
Mains cable
Cable reel
ON key
Outlet for External
Interblocks (optional)

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2.2.1. Handles and brakes position for manual movements
1. Brake for the arm
rotation around the
horizontal axis.
Movement:±270°
2. Brake for horizontal
sliding of the arm group.
Movement: 220mm
3. Brake for the orbital
arm rotation.
Movement:123°
(+90°÷-33°)
Fig. 8
4. Brake for the overview
movement of the arm
group.
Movement: ±12,5°
1. Driving handle and rear wheels
braking
Fig. 9
Pos.1: brake ON
Pos.2: oblique movement
Pos.3: free movement
Pos. 4: oblique movement
Pos.5: right-left movement
3
1
1
2 4
5
2
1
4
3
The brake handle is take-up type. In order to avoid
collision dangers with the unit or the user, always put the
handle again in horizontal position.

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2.3. Keyboard
2.3.1. Unit
All keys are membrane type. The keyboard group can rotate ±45° in respect of the central position
for its simpler use.
Fig. 10
Area 1
Vertical arm movement
Laser targeting device
OFF/ON
System OFF
Led for x-ray emission
signal
System ON Alarm signal
Area 2
Digital image rotation 1
Shutters diaphragm rotation
Image enlargement
Shutters diaphragm
closing/opening
Horizontal image reversal
Iris diaphragm
closing/opening
Image edges enhancement
Motion Detector
(unavailable function)
ENTER + F1: “Utility Mode”
selection
Stored images scrolling
Commutation between
LIVE image and MEM
image on single monitor.
Image transfer from the live
monitor to the memory
monitor
kV decrease / increase
mA/mAs decrease /
increase
1For SBFM78, DIP and HRC memories series: by pressing at the same time the two rotation push-buttons for four seconds, there is the
digital image rotation resetting.

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2.3.2. “Base Monitor Trolley”
Memories series SBFM /HRC
The memory series SBFM76 has not the keyboard.
The memories series SBFM78 have only the alphanumeric keyboard for the patient data input.
F1 allows PATIENT NAME (max 63 characters) to be inserted
F10 allows DATE and TIME to be inserted
F5 allows activation of NEGATIVE function on Memory Monitor
HOME shows last image recently memorized
END shows last image in the memory buffer
PG UP scan of memorized images in increasing order
PG DN scan of memorized images in decreasing order
The SBFM device is equipped with the possibility of completely clearing all memorized images.
To use this function, press “PG UP” and “PG DN” commands at the same time for approximately 4
seconds (clearing time: from 10 sec to 2 min)
The keyboard can be placed under the unit keyboard (unit with monitor aboard) or on the highest
shelf of the “Base Trolley” in “Low Profile” configuration.
The memories series HRC have the alphanumeric keyboard and mouse for the patient data input.
Keyboard and mouse are placed on the highest shelf of the “Base Trolley” in “High Profile”
configuration.
2.3.3. High Configuration trolley
On the High Configuration trolleys, there is always a small remote keyboard that duplicates some
controls present on the unit keyboard.
All keys are membrane type.
F11 F12 LINE
Fig. 11
1^ line 2^ line
Image enlargement Digital image rotation
Image edges enhancement Stored images scrolling
Motion Detector
(unavailable function)
Image transfer from the live
monitor to the memory monitor
Image reversal on vertical
axis
n.u.
Shutters diaphragm
closing/opening
Shutters diaphragm rotation
Iris diaphragm
closing/opening
n.u.

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Memories series DIP
The memories series DIP have a keyboard dedicated to the post processing.
All keys are membrane type.
ACQUISITION
ANGIOGRAPHY
VIEW
DICOM
OVERVIEW
KEYBOARD
ON
I.R.
M
L
! @ # $ % ^ & * ( ) _ +~ 1 2 3 4 5 6 7 8 9 0 =
`
W E R T Y U I O P { }Q [ ]
A S D F G H J K L "
'
Enter
:
;
Z X C V B N M < > ?
Shift Ctrl Space Alt
=
.,
Shift
Esc F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 Del
DOSE
¦
Fig. 12
For an easier understanding they have been divided into 7 different groups: KEYBOARD,
ACQUISITION, PROCESSING, ANGIOGRAPHY, DICOM, VIEW, OVERVIEW
KEYBOARD
New exam Patients list
DOSE
Dose information VCR prearrangement
Search start backwards Search start onwards
Rotation +
Rotation -
ACQUISITION
SNAPSHOT control prearrangement Image reversal on vertical axis
PULSED FLUOROSCOPY control
prearrangement
Image rotation resetting
Recursive filter selection
L
MEM image and FLUOROSCOPY
alternation
SMART filter activation / deactivation
L
Image storage key

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PROCESSING
It allows the images visualization in
negative
SHARP / SMOOTH / OFF edges
processing
Key to increase the brightness Key to increase the contrast
Key to decrease the brightness Key to decrease the contrast
ANGIOGRAPHY
Angiographic acquisition rate selection
1 image per second
Key for the mode activation of the
subtraction between images
Angiographic acquisition rate selection
3 images per second
Mask acquisition key
Angiographic acquisition rate selection
6 images per second
SHIFTING PIXEL function activation
MAX OP control activation / deactivation
LAND MARK control activation
DICOM
Single image sending to DTU Whole exam sending to DTU
Current RUN sending to DTU DTU monitor commutation
VIEW
Memory number decrease Memory number increase
ALTERNATE MEMORY procedure
control
Key to delete the images stored in the
buffer (active only in DISKLESS mode)
OVERVIEW
Stored image zoom Stored images overview

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Memories series HRP
The memories series HRP have the alphanumeric keyboard and the mouse for the patient data
input.
All keys are membrane type.
,
>
.
\
:
;
"
'
/
[]
+
=
|
Pause Screen
Print
Del
Lock
Num
*
.
Enter
CtrlCtrl
F1
Scroll
Lock
Alt
0
123
45 6
789
+
123456789
A
ZXCVBNM
SDFGHJ K
QWE R T Y U I O
L
F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12
0
P
)
(
*
&
<
%
$
#
@
!
Home Pag
Pag
End
Ins
-
Enter
Alt Gr
}{
-
_
?
`
Esc
Caps-lock

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2.3.4. Display
Alphanumeric touch-screen display 5” for x-ray parameters and warning/error messages.
The keys, so-called at “retention”, are displayed:
in positive on white background for the non-active function
in negative on black background for the active function
Note: the box with the dose indication is displayed only if the dosimeter is installed and in working
condition.
2.3.5. Audible signals
1 BEEP2Sound signal when any key is pressed.
2 BEEPS Storage OK.
A LONG BEEP
(about 1sec)
Alarm, malfunction.
2It is possible to deactivate the audible signals or modify the volume (§3.6.10 Utility Mode).

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2.4. Fluoroscopy control footswitch
The footswitch is enabled only in fluoroscopy mode.
The fluoroscopy control footswitch consists of a double-step pedal and two single-step ones.
The functions in the different modes are:
1. Left pedal (two steps):
Fluoroscopy Mode:
1° step: fluoroscopy control.
2° step: image storage; in continuous
fluoroscopy the current image is stored.
2. Right pedal (a step):
Pulsed fluoroscopy mode.
3. Third pedal (a step):
Fluoroscopy mode:
"snapshot" control (high-contrast
exposure with reduced background noise).
Fig. 13
2.5. Handswitch for radiography / fluoroscopy control
The control handswitch is made of a two-
steps switch.
Radiography mode:
1° step: preparation control.
2° step: emission control.
In radiography mode it is possible to press
immediately the exposure control (2° step),
with an emission delay due to the anode
starting phase (only for rotating anode version).
It is possible to control Fluoroscopy and
Storage even with the radiography
handswitch.
Fluoroscopy mode:
1° step: fluoroscopy control.
2° step: image storage.
Normally the function is enabled. In order
to disable it, it is necessary Service
intervention.
Fig. 14
1
3
2