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
Pag. 2/76 - Rev. A [File:201175-G-01-01.doc]
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.

Villa Sistemi Medicali ARCOVIS 3000 S/R User's Manual
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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

Villa Sistemi Medicali ARCOVIS 3000 S/R User's Manual
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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.

Villa Sistemi Medicali ARCOVIS 3000 S/R User's Manual
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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]

User's Manual ARCOVIS 3000 S/R Villa Sistemi Medicali
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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