Professional Documents
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Revision: 3
Code: 6979901303
ARCOVIS 2000 R - USER’S MANUAL Villa Sistemi Medicali
Summary
SUMMARY 3
SECURITIES AND CONFORMITY 4
ELECTRICAL SECURITIES ................................................................................................................... 5
LASER TARGETING SECURITIES.......................................................................................................... 5
MECHANICAL SECURITIES .................................................................................................................. 5
ELECTROMAGNETIC COMPATIBILITY (EMC) ........................................................................................ 6
IONIZING RADIATION PROTECTION ................................................................................................... 7
GENERAL DISPOSAL ........................................................................................................................... 8
APPLICATION & OPERATION .............................................................................................................. 9
INTERFACEABILITY ............................................................................................................................ 9
CLASSIFICATION.............................................................................................................................. 10
CONFORMITY................................................................................................................................... 10
LEGEND 12
STAND............................................................................................................................................. 12
MOBILE IMAGE INTENSIFIER............................................................................................................ 13
CONTROL PANEL.............................................................................................................................. 14
FOOT SWITCH ................................................................................................................................. 17
MONITOR TROLLEY.......................................................................................................................... 18
MESSAGES AND SIGNALS ................................................................................................................. 19
ALARM MESSAGES............................................................................................................................ 20
MAIN FUSE ...................................................................................................................................... 21
USE 22
UNPACKING AND INSTALLATION ...................................................................................................... 22
TRASPORTATION ............................................................................................................................. 22
INTERCONNECTION ......................................................................................................................... 24
POSITIONING .................................................................................................................................. 26
SETTING TO WORK .......................................................................................................................... 28
EXPOSURES ..................................................................................................................................... 29
END OF USE..................................................................................................................................... 33
MAINTENANCE 34
CHECKS AND INSPECTIONS BY THE USER ......................................................................................... 35
CLEANING: ...................................................................................................................................... 36
DISINFECTION................................................................................................................................. 36
TECHNICAL DATA 38
LABELS AND SIMBOLOGY ................................................................................................................. 38
ENVIRONMENTAL CONDITIONS ........................................................................................................ 42
ELECTRICAL DATA ........................................................................................................................... 43
EXPOSURE MODES: FLUOROSCOPY................................................................................................... 48
EXPOSURE MODE: RADIOGRAPHY .................................................................................................... 49
IMAGE SYSTEM ................................................................................................................................ 50
DIGITAL IMAGES PROCESSOR .......................................................................................................... 51
MECHANICAL DATA .......................................................................................................................... 52
DOCUMENT STATUS 53
• This x-ray unit must be utilized exclusively in compliance with the security
instructions contained in this manual and must not be utilized for purposes other
than the ones foreseen.
• This x-ray unit must be utilized exclusively by personnel with the necessary
knowledge in the x-ray protection field and with the necessary training for the use of
x-ray units.
The operator is responsible for the use of the system in compliance with the applicable
standards concerning installation and use.
• The unit must not be utilized when electrical, mechanical or radiological faults are
present. Besides, the system must not be utilized in case of malfunctioning of any
signaling or alarm device.
• In case of use jointly with other apparatus, components or modules whose
compatibility is not certain, it is necessary to ensure the absence of any danger for
patients or operator personnel. For this purpose consult VILLA SISTEMI MEDICALI.
• VILLA SISTEMI MEDICALI is responsible for the safety of its own products only if
their maintenance, repairing or modification have been performed by VILLA SISTEMI
MEDICALI or by personnel expressively authorized by VILLA SISTEMI MEDICALI
itself by written notice.
• As any technical apparatus, this x-ray unit must be utilized in a proper way with
periodical checks and maintenance as specified in the chapter “Programmed
Maintenance”.
• The safety circuit and devices must not, for any reason, be neither moved, modified,
or omitted.
The key switch positioned on the monitor trolley, must be activated exclusively by
authorized personnel and only during the use of the system. Once the use is
completed, the key must be removed and kept in a safe place.
VILLA SISTEMI MEDICALI won’t be held liable for any malfunctioning, damages or
dangers due to an improper use of the system or non compliant with the maintenance
rules.
ELECTRICAL SECURITIES
• Exclusively trained service personnel and authorized by VILLA SISTEMI MEDICALI
may remove the unit covers, according to the instructions herein contained.
• The x-ray unit may only be used in environments or medical rooms complying with
the applicable IEC standards.
• The x-ray unit must not be utilized in areas where exists danger of explosion.
• The cleaning and disinfection products, including the ones used for patients, may
create explosive and gaseous mixtures. Therefore, use only products in compliance
with the applying rules.
MECHANICAL SECURITIES
• After the positioning of the system, fix the stationary brakes.
• For the unit movement, utilize exclusive the predisposed handles.
• Avoid collisions with obstacles.
Explanation:
The electronic apparatus which meets the EMC standards has been designed so that, under
normal conditions, any malfunctioning risk, caused by electromagnetic interferences, is avoided.
However, should radio signals be present, coming from high frequency transmitters with a
relatively high transmitting power, used near the electronic apparatus, the risk of electromagnetic
incompatibility, cannot be controlled completely.
During the x-ray use the personnel present in the room must follow the applying rules concerning
the protection against radiation. For this purpose, please comply with the following rules:
• When necessary, utilize protective tools against radiation and in addition at the devices already
foreseen on the unit.
• Use the dedicated protective aprons. A material, protecting against radiation, equivalent to 0,35
mm. lead, lowers of 99,95% a radiation of 50 kV and of 94,5% a radiation of 100 kV.
• The best protection against radiation is distance: therefore keep as far as possible both from
the x-ray source and the exposure target. For this purpose, utilize all the cable length of the
foot-switch controlling x-ray in fluoroscopy, or the extendible cable of the x-ray manual key in
radiography.
• Avoid walking or standing in the direct x-ray beam.
• Always use the smallest exposure field possible, properly closing the collimator diaphragms.
Actually, the scattering radiation mainly depends on the volume of the irradiated object.
GENERAL DISPOSAL
VILLA SISTEMI MEDICALI produces x-ray systems advanced in terms of safety and environmental
protection. Assuming that the unit is properly utilized, then no risk exists for persons and
environment.
In order to fulfill the applying safety rules, it is necessary to utilize materials that may be harmful
for the environment (for example: monobloc oil, protective lead, monitor kinescope, boards and
electronic components), therefore, when necessary, they have to be disposed of in a proper way,
in compliance to the laws of the country where the unit has been installed.
For these reasons the unit cannot be disposed of along with industrial or
domestic waste, and it has to be regarded as special waste.
This system doesn’t come into devices which require continuous use.
The system is not used at contract with the patient, the accidental contact of some
unit parts with the patient is possible and the contact with the operator is foreseen.
The contact with the operator is foreseen for reasons strictly linked to the use
conditions. (use operations).
The unit is suitable for x-ray examinations, and in particular for radioscopy, radiography and
diagnosis dedicated to:
• traumatology;
• paediatrics;
• interventional radiology;
• peace maker implantation;
• operating theater;
• intensive care;
• respiratory system;
• skeleton;
On request, it is possible to provide a set of sterile drapes for the arm. For further information,
please contact Villa Sistemi Medicali.
For the use in the operating theater, it is necessary to use a foot-switch, type
IP-X8, and an ASA foot-switch, type FM2 SU1/SU1 F4 is recommended.
This x-ray unit must not be used in areas where danger of explosion exists.
INTERFACEABILITY
The device does not foresee any interaction with medicine, while the possibility of an interface
with some devices like VCR or THERMAL PRINTER is foreseen; such systems have to be in full
compliance with the safety requirements foreseen by the 93/42/CEE Directive.
Liable is the operator and/or anyone performing any interface, that has not been evaluated and
authorized by VILLA SISTEMI MEDICALI by prior written notice.
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 (IP-X0)
Use condition protection ...................................continuous use with temporary load
CONFORMITY
This x-ray unit is in compliance with the electromedical devices Directive 93/42 CEE and with the
other national and international leading rules.
For any further information please contact:
The producer (according to European Directive 93/42/CEE) of ARCOVIS 2000 R 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
LEGEND
This section of the manual describes the component parts of the unit.
STAND
1. Mobile Image Intensifier
2. Control panel (description at page 15)
3. Foot Switch
4. Monitor Trolley
4 3
1
Picture 1
Picture 2
CONTROL PANEL
1. System ON
2. System OFF
3. Arm vertical upwards motion
4. Arm vertical downwards motion
5. kV increase/kV decrease Only for DFM576 press with 24. for
the up and down images recall
6. Increase / decrease mA in manual fluoroscopy Increase / decrease mAs in radiography
7. Fluoroscopy timer reset
8. Alarm reset (fluoroscopy timer)
9. Automatic fluoroscopy and LDF/HDF *** selection
10. Pulsed fluoroscopy selection/pulsed speed selection
11. Manual fluoroscopy selection
12. Radiography selection
13. Shutters diaphragm anticlockwise rotation
14. Shutters diaphragm clockwise selection
15. Shutters diaphragm opening
16. Shutters diaphragm closing
17. Iris opening
18. Iris closing
19. Horizontal image inversion
20. Anti-clock image rotation
21. Clockwise image rotation
22. 1st.image magnification
23. 2nd image magnification
24. Stored images recall Only for DFM576 press with 5. “+ “or “-“
25. Live image storage
26. Recursive filter
27. Unit status display
28.X-ray emission signal
29.Working parameters display
30.Laser
31.Cine loop review (function enabled only if foreseen on the unit configuration)
32.Smart filter / motion detector (function enabled only if foreseen on the unit configuration)
33.Vertical image inversion (function enabled only if foreseen on the unit configuration)
Picture 3
SUB CONTRAST +
Images subtraction Contrast increase on monitor
MASK CONTRAST -
Mask acquisition Contrast decrease on monitor
6 SEC
Acquisition rate in angio No function
6 images per second
3 SEC
Acquisition rate in angio No function
3 images per second
1SEC ALTERNATIVE LIVE
Acquisition rate in angio Live or alternately stored image
1 image per second on monitor m.
ROAD MAP
Mask acquisition No function
max. opacity
SNAP SHOT CLEAR BUFFER RAM
Single exposure activation, Cancellation of images stored in
high contrast RAM
MODE PULSE HOLD
Pulse rate selection One image in RAM
1 each Sec ÷ 6 each Sec memorization
FILTER SEARCH FORWARD
K2 ÷ K16 recursive filter Memory number increase for
image search
HORIZONTAL INVERSION SEARCH BACK
Images horizontal inversion Memory number decrease for
image search
SMART FILTER CINELOOP
Photonic noise reduction Displaying of all images present
Moving images in one RUN
INFRARED RECEIVER LUM +
Infrared receiver for radio Brightness increase on monitor
control
EDGE LUM -
Images edge underlining or Brightness decrease on monitor
attenuation
NEG
In negative image displaying
FOOT SWITCH
1. 1st step: fluoroscopy (continuous or pulsed)
2nd step: (it’s function is not enabled in all versions) live imagine storage; in continuous
fluoroscopy it stores the last image, on the contrary in pulsed fluoroscopy it stores images as
long as the 2nd step is pressed
2. Boosted snap shot control
3. Stand connection cable
Picture 4
MONITOR TROLLEY
1. Reference monitor
2. Work monitor
3. Safety key for setting to work
4. Emergency push button
5. Stand connection cable
6. Power supply cable
7. Cable-coiler
8. Handle for monitor trolley motion
9. x-ray emission lamp
10. Magneto-thermic safety button
11. Control keyboard digital images processor
Picture 5
Meaning
Text
RAD. Radiography mode selected
WAIT (lighting ) wait before another exposure (duty cycle)
kV ... mAs ... operational radiography parameters
FLUORO fluoroscopy mode selected only low dose; high dose
is not selectable
LDF manual, automatic or low dose pulsed fluoroscopy selected
ALARM MESSAGES
This section of the manual explains how to proceed when either faults or anomalies are signaled.
kV FAULT the x-ray tube power voltage in switch the unit off, wait for some
fluoroscopy decreases 85% under seconds, switch it on again and
the set value control exposure. If the alarm is
displayed again, contact the service.
kV MAX the max. high voltage of the x-ray switch the unit off, wait for some
tube is > than 120kV seconds, switch it on again and
control exposure. If the alarm is
displayed again, contact service.
FILAMENT the filament current of the x-ray contact service
tube is < at the minimum value
THERMAL monobloc overheating (>60°C) cool the x-ray tube down
THERMIC MAX. TIME it is displayed 30 sec.s after the cool the x-ray tube down
thermal safety message, and x-ray
emission is stopped
X-RAY TUBE the tube thermal capacity cool the x-ray tube down
TOO HOT decreased 5% under its capacity,
exposure is interrupted
LACKING OF X-RAYS the high voltage of the x-ray tube contact service
is lower then 85% of the set value
MAN STOP RX the radiography control switch has check the image quality and, if
been released before the set mAs necessary, repeat exposure
have been reached (Picture 2)
FLUORO the exposure timer has reached to reset x-ray emission, perform the
MAX.TIME the max. allowed value (5 following:
minutes), after 30s emission is 1. release fluoroscopy footswitch
interrupted 2. either press "alarm reset " key
(the total fluoroscopy timer is not
reset) or press "fluoroscopy timer
reset” key (the total fluoroscopy
timer is reset) on the main control
panel (Picture 3)
MAX. TIME emission has been interrupted switch the unit off, wait for some
before the correct mAs values has seconds, switch it on again and
been reached control exposure.
If the alarm is displayed again,
contact service.
STARTER FAULT the starter hasn’t properly set out switch the unit off, wait for some
seconds, switch it on again and
control exposure. If the alarm is
displayed again, contact service.
MEMORY OFF LINE the memory hasn’t sent to the switch the unit off, wait for some
generator the x-ray control seconds, switch it on again and
control exposure. If the alarm is
displayed again, contact service.
MAIN FUSE
This section of the manual describes devices position and explains how to proceed when the main
power safeties intervene.
ARCOVIS 2000 R is protected against excessive fluctuation of the mains line by means of a
magnetothermic push-button, placed on the monitor trolley. In case the magnetothermic switch
intervene, it’s enough to restore it.
Picture 6
1. emergency stop switches (red color): they switch the unit off in case of emergency; to restore
them the switch has to be clockwise rotated.
2. setting to work key: without this key, the unit cannot be switched on.
3. main switch (magneto-thermic type)
USE
UNPACKING AND INSTALLATION
Before the use, the unit has to be unpacked. (ref. to chap. ”Installation”, Service Manual)
TRASPORTATION
This section of the manual explains how to handle the unit assuring a proper functioning and
limiting risks to the operator.
(ref. to Picture 8 pg.24, and 9 page 24).
• Check that the monitor trolley is disconnected from the mains and from the stand, then check
out that the cables are wrapped up in the cable-coiler.
• Check that the arm is completely lowered, in vertical position, with slide completely clown,
monobloc and Image Intensifier on the horizontal axis.
• Check that the arm movement brakes are all activated.
• Never move the unit on inclination planes higher than 10°.
Picture 7
Perform the movement only after having released the parking brake and using
exclusively the proper handles.
If necessary, carry out a 90° rotation of the stand rear wheels.
Picture 8
1. Handle for trolley movement
2. Trolley wheels brake
3. Handles for stand movement
4. Stand Parking brake
6 7 9 5 8
Picture 9
5. Handle for rear wheels ±90° rotation
6. Arm sliding brake
7. Arm rotation brake
8. Arm angulation brake
9. Arm horizontal position brake
INTERCONNECTION
This section of the manual describes how to connect the various parts of the unit.
The connection between these parts has to be done by means of a multipolar connector with
bayonet coupling.
The connection between these parts has to be done by means of a connector with pressure
coupling.
POSITIONING
This section of the manual describes how to move the unit into the required position.
Do not try to move the stand or the arm while brakes are activated.
For any movement, utilize the proper handles.
1. Disconnect the parking brake.
Picture 10
2. Connect the stand to the monitor trolley.
3. Connect the trolley to the mains (the ignition led of the stand panel will light on).
4. Switch the trolley on (Picture 5, page19) by the safety key on it.
5. Press the button for “stand ignition control” on the control panel.
6. Adjust the arm height.
Picture 11
7. Adjust the horizontal arm position.
Picture 12
Picture13
9. Adjust the arm rotation (the goniometric scale will indicate the rotation angle).
Picture 14
10. Adjust the arm orbital motion
Picture 15
11. Once the positioning is done, verify that all the braking systems are activated.
SETTING TO WORK
This section of the manual describes how to proceed with the activation of the unit to make it
ready for functioning.
1. Connect the stand to the monitor trolley.
2. Connect the monitor trolley to the mains (the ignition led of the stand panel will light on).
3. Connect the foot-switch.
4. Insert the key and activate the main switch on the monitor trolley.
5. Switch the monitor trolley on rotating the key in “on mains" position (unit switched on).
6. Switch the control table of the stand on, acting on the "unit ignition” key located in the
middle of the keyboard.
This way the stand initial automatic test will be activated:
For 4 seconds the 2 displays will visualize the name of the unit and the control software
version. At the same time the acoustic signals and the panel leds are activated.
The status display visualizes:
“FLUORO”: the unit is ready for the low dose functioning. The high dose commutation is not
possible.
“LDF”: The unit is predisposed for the low dose functioning. The HDF high dose commutation
is possible by the corresponding key. (ref. to pict.3, key n°9).
kV and mA data in automatic fluoroscopy are visualized on the working parameters display.
7. Activate the selected exposure mode according to what’s described in the following pages.
The foreseen modes are:
a) Manual and automatic continuous fluoroscopy both in LDF low dose and in HDF high dos
b) Manual and automatic pulsed fluoroscopy both in LDF low dose and in HDF high dose
c) Manual and automatic "Snap shot" both in LDF low dose and in HDF high dose
d) Radiography, the 24x30 cassette holder has to be assembled at the IB tube input.
EXPOSURES
This section of the manual explains the functioning of the unit and the selection of the different
exposure modes.
Before any exposure, check out that all the necessary precautions against
radiation have been taken.
Please ref. to chapter LEGENDA (PAG. 13, pict.3) for nomenclature and position of the controls; in
particular, ref. to par. CONTROL CONSOLE to identify the control buttons.
a) CONTINUOUS FLUOROSCOPY
1. Once the unit is switched on, the unit is predisposed to function with automatic dose control.
kV/mA value will be automatically set according to the patient under examination. “FLUORO”
is visualized on the left display, if the unit is predisposed only for the low dose functioning.
“LDF” appears if the unit is predisposed both for the low dose and for the high dose
functioning. “HDF” high dose selection has to be performed by the relating key (ref. to
pict.3, pos.9).
2. In order to operate with manual kV/mA mode, it’s necessary to press “manual fluoroscopy
selection” button and operate on the kV and mA increase / decrease buttons.
3. Exposure is controlled by the left footswitch, 1st step.
4. The x-ray emission is signalized by the lightening of the led located in the middle of the
control panel ( ref. to pict.3, pos.28) and by the luminous lamp placed on the monitor trolley.
5. During x-ray emission the following information are on the two displays:
left display: Indicating the x-ray tube heating capacity available in HU ...%. X-ray emission
is always possible between 1% and 100% of its capacity.
The alarm “ X-RAY TUBE TOO HOT” is displayed under 5%, in order to warn the doctor
that the heating capacity is worn out. The x-ray emission is interrupted under 1%, and it will
not be available anymore until 5% will be obtained at least. The tube cooling can happen
also with the unit switched off.
The thermal unit decrease depends on the selected radiological data.
right display; Indicating the effective working radiological parameters (Kv and mA), and the
exposure counting time (timer).
6. By the "recursive filter" key, the filter weight is selectable (K2 ÷ K16); if foreseen by the unit
the value is indicated on the console display, if not it is only displayed on the monitor.
7. Once the pedal is released, the monitor ML will visualize the last image hold.(LIH)
8. To store the live image of the ML monitor, on the MM memory monitor, it’s necessary to push
the “reference image storage” key, placed on the control panel (ref. to pict.3, pos.25) or,
while emitting, press the left footswitch 2nd step The number of memorizable frames depends
on the unit version, anyway, once the max. memory capacity is achieved, the first stored
image will be the first one to be eliminated and replaced by a new frame (frames memory
handling, type F.I.F.O.).
9. To recall the stored images, press the “stored images recall” key. (ref. to pict.3, pos.24).
The timer purpose is to avoid an excessive x-ray dose to the patient and/or operator; the control
panel display indicates the values of the minutes and seconds of the accumulated emission in the
format : "MINUTI : SECONDI"
Each 5' the alarm gives a continuous warning signal that can be turned off acting on the “alarm
reset” button on the control console within 30 seconds, otherwise the x-ray emission will be
interrupted.
To restore the x-ray emission, it’s necessary to:
1. release the fluoroscopy footswitch;
2. push the “alarm reset” button (this way the emission time will remain accumulated) or, press
“fluoroscopy time reset” button (this way the emission time will start from zero).
Once the max. value of 99' is reached, x-ray emission will be interrupted; in this case, the
emission will be restored only resetting the emission timer pushing the “fluoroscopy time reset
key” of the control panel.
b) PULSED FLUOROSCOPY
1. The use of the pulsed fluoroscopy function can be performed both in automatic mode and in
manual one.
• Automatic: Press the “ Automatic selection” key ( ref. to pict.3, pos.9). kV and mA
radiological parameters will change according to the patient under examination.
• Manual: Press the “Manual selection” key (ref. to pict.3, pos.11). Kv and mA radiological
parameters have to be manually selected by the control keyboard.
2. Select pulsed fluoroscopy mode, pressing the “pulsed fluoroscopy selection” (ref. to pict.3,
pos.10) on the control panel. On the left display will appear “T=...sec” indicating the selected
rate. To modify the pulsed rate, push the “pulsed rate” key (ref. to pict.3, pos.10). The
pulsed rate increases every key pushing, changing the time frame between two flashes, it is
not possible to modify the x-ray time duration, which is of 400ms. The pulse rate varies from
one exposure per second, to one exposure per 6 seconds.
3. To control exposure, press the fluoroscopy foot-switch 1st step. X-ray emission is signalized
by the lighting of the led placed in the middle of the control panel (ref. to pict.3, pos.28) and
by the luminous lamp on the monitor trolley. (ref. to pict.5 pos.9)
On the ML reference monitor, the frame is updated every x-ray flash, while in the stand- by
time frame, the last image remains memorized.
4. To store the ML working monitor image on the MM memory monitor, press the “Image
storaging“ key, placed on the control console (ref. to pict.3, pos.25) or, while emitting, press
the left foot-switch 2nd step (it will store images as long as the 2nd step is pressed).
The number of memorizable images depends on the memory available on the unit, anyway
once the maximum storage capacity is achieved, the first stored image will be the first one to
be eliminated, and replaced by a new frame (F.I.F.O /First in-First out).
5. To recall the stored images press the “ stored images recall” key ( ref. to pict.3. pos.24).
C)”SNAP SHOT"
1. The snap shot function allows a high contrasted and no noisy image. mA values are always
associated to kV automatically, in order to guarantee the best result in any operating status.
The x-ray emission duration is approximately 1 second long.
The snap shot function use can be performed both in automatic mode and in manual one.
Automatic: press the “automatic selection” key (ref. to pict.3, pos.9).
kV and mA radiological parameters will change according to the patient under examination.
Manual: press the “manual selection” key (ref. to pict.3, pos.11)
kV radiological parameters have to be manually selected by the control keyboard. mA value is
always automatically connected in function of the selected kV.
2. No exposure mode pre-selection is required, as SS mode is immediately available by pushing
the corresponding footswitch.(ref. to pict.4. pos.2) The x-ray emission is signalized by the
lightening of the led placed in the middle of the control console (ref. to pict.3, pos.28)., by
the luminous lamp located on the monitor trolley.(ref. to pict.5, pos.9).
3. To store the image it’s necessary to push the “reference image storage” key, placed on the
control panel. The number of memorizable frames depends on the memory available on the
unit, anyway once the max. memory capacity is achieved, the first stored image will be the
first one to be eliminated and replaced by the new frame. (F.I.F.O. First in First out).
4. To recall stored images, press the “stored images recall” key. (ref. to pict.3, pos.24).
NOTE:
Keep it pushed until the end of exposure. If the radiography foot switch is released before the
required time, the x-ray emission is interrupted and the message “ MAN STOP RX" is displayed.
Emission is signalized by the acoustic signal of the Image Intensifier. (ref. to pict.3, pos.28)
5. At the end of exposure the control panel display indicates the time of the performed
exposures.
END OF USE
This part of the manual explains the procedures to be followed at the end of the use, in order to
guarantee the user’s safety and a long duration of the unit .
Never disconnect the cable between stand and trolley if the unit is not
turned off.
Never take the connector out from the plug, if the unit is not turned off.
1. Place the stand in “parking” position (lowered, with mechanical brakes activated).
2. Turn the stand off, by the “unit stopping” button on the control panel.
3. Wrap the pedal cable and position it in the foreseen space.
4. Switch the monitor trolley off turning the key in the “off main” position (unit off) then take the
key out and place it in a safe place. Disconnect the main power switch.
5. Disconnect the power supply cable and wrap it in on the proper hooks on the monitor trolley.
6. Disconnect the stand/trolley cable and wrap it on the corresponding hooks on the trolley (rear
side).
7. Park the monitor trolley acting on the wheel brakes.
MAINTENANCE
This part of the manual explains the standard maintenance procedures required to assure the unit
reliability in the future.
In the Chapter 10 “Additional Information” of TECHNICAL MANUAL, VILLA SISTEMI MEDICALI
provides a Programmed Maintenance to be performed on the unit.
GENERAL WARNINGS
As any unit this system needs the following:
• a proper use;
• regular checks by the user;
• maintenance and repairings by the authorized staff.
Operational reliability of the unit is kept following these precautions.
VILLA SISTEMI MEDICALI S.p.A. can provide, on request, circuit drawings, parts list, adjustment
instructions or further information for the unit reparation.
As users of a x-ray unit it’s compulsory , according to the laws ruling the
medical devices, to follow these precautions.
The unit needs regular checks and maintenance. Aim of the following warnings is to keep a good
functioning and safety level.
The unit includes mechanical parts which are subject to wear in function of the use. After a long
period of use, safety may decrease due the parts wear.
Regular inspections and maintenance also protect operators and patient from damages caused by
the breaking of mechanical parts.
A correct adjustment of the electromechanical and electronical modules directly influence the
functioning, the image quality, the electrical safety, and the exposure level to radiation to which
both medical personnel and patients are subjected.
The maintenance program includes controls and preventional measures to be done by the
customer and to be performed exclusively by authorized personnel.
In case of parts replacement that are linked to the unit safety, use only
original spare parts.
CLEANING:
Please consider the following information before choosing a detergent:
• Use only soap and water to clean plastic surfaces. In case of use of other detergents (for ex.
detergents with a high alcohol rate, corrosive lotions, abrasives and solvents), the material can
break or opacize.
• Brush with a humid cloth and with a soft cleaner to clean aluminum surfaces, then brush with a
dry wool cloth.
• For chromate surfaces, brush exclusively with dry wool cloth and don’t use any detergent.
• Never use high alcohol rate products, corrosive detergents, abrasives and solvents, to clean the
other surfaces of the unit.
DISINFECTION
For the unit and sterilizable drapes, the use of a liquid solution with aldehydical base or based on
ampholitical surface active agent (ex: TEGO 103,Korsolin) is recommended.
Substitutive disinfectants releasing chlorine or based on phenols must be avoided as they can
cause the material stuff weakening. The same restrictions are valid for non-dilute solutions with a
high alcohol rate. Don’t use disinfectant spray; this can pass through the unit damaging its safety.
(possible damages to electrical and electromechanical components, formation of inflammable
gaseous mixes and steam solutions.).
TECHNICAL DATA
This part of the manual explains the unit technical specifications and the meaning of the
symbology.
ETICHETTATURA UNITÀ
MONITOR LABEL
Stuck on the back of both monitors.
B/W MONITOR 220/240V - 50/60Hz - 60W COMPLIES WITH FDA RADIATION
PERFORMANCE STANDARDS, 21 CFR.
MADE IN ITALY by NICAL S.p.A.
SUBCHAPTER J.
MODEL: SN: FDA NUMBER : 9010197-00
MONOBLOC LABEL
PACKING LABEL
Stuck outside the packing with red inscriptions on white back -ground.
superior edge of
fragile protect from rain
the packing
UNIT SIMBOLOGY
on mains (unit on)
unit off
unit on
foot switch
main supply
radiography selection
equipotential knot
Laser
MONITOR SIMBOLOGY
image contrast image up/down inversion
INTERNAL SIMBOLOGY
dangerous voltage
FOOT-SWITCH SIMBOLOGY
snap shot
image storage
fluoroscopy
image storage
VARIOUS SIMBOLOGY
ionizing radiation type B equipment
ENVIRONMENTAL CONDITIONS
Warehouse and
Environmental element Normal use
transportation
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
ELECTRICAL DATA
POWER SUPPLY
Power supply........................................................ Monophase, 230V+10%-5%, 50/60Hz, 16A
Line resistance...................................................... < 0,4Ω
Standard plug....................................................... 16A
Fluoroscopy max. absorption ................................. 10A
Radiography max. absorption ................................ 26A
ARM MOTOR
Typology.............................................................. Asynchronous monophase bipolar motor
Use cycle.............................................................. max. 2 minutes ON - min. 15 minutes OFF
COLLIMATOR
R601 AMP Model
Field size with a 100cm. focal distance, and collimator assembled 80cm from the radiogen beam:
Inherent filtration
EN60601-1-3 par. 29.201.2 / 29.201.6............................ 0mm
LASER TARGETING
Wavelength .................................................................. 635nm
Optical power of laser diode .......................................... < 4mW
Optical power of the collimated beam............................. < 3,5mW
Divergence ................................................................... 6,67mRad
Optical power on the working plane ............................... < 3mW
GENERATOR
Generator power in DC current (IEC 601-1)............. 5kW
Max. voltage......................................................... 120kVp
Max. ripple at 100kVp ........................................... <1%
Rise time at 100kVp .............................................. <1ms
Maximum rates
Current in radiography with large focus .................. 90mA
Current in fluoroscopy with small focus................... 10mA
Current in fluoroscopy with small focus (***).......... 12mA
Housing characteristics
Half-value layer without S.E.V ................................ 2,0mmAI
Minimum inherent filtration at 0kV.......................... 1,8mmAI
Approximated weight ............................................ 19,6kg
Thermal characteristics
Thermal capacity .................................................. 600kJ=800KHU
Thermal safety ( NC thermal switch)....................... 57°C±3°C
Rubber lung ......................................................... 0,4dm3
Continuous thermal dissipation .............................. 60W
Maximum housing temperature.............................. 60°C
MONOBLOC
Weight................................................................. 19.6 Kg
TUBE SETTING IN
After a long inactivity period (3 months or more) it’s necessary to proceed with the X-RAY TUBE
SETTING IN; if anomalies or functioning faults are detected during the process, the whole
procedure has to be interrupted for at least half an hour; then start again from the beginning.
1. Select manual fluoroscopy.
2. Perform the following exposures according to the sequences and times indicated herebelow.
X-RAY TUBE
Typology............................................................................... Rotating Anode
Model .................................................................................. IAE, X20P 0.3-0.6
Rotation speed ...................................................................... 3000 turns/min.
Building characteristics
Small focus (IEC 336)............................................................. 0,3mm
Big focus (IEC 336) ................................................................ 0,6mm
Anodic diameter..................................................................... 64mm
Anodic angle ......................................................................... 10°
Target material...................................................................... Rhenium, Tungsten, Molybdenum
Focal distance 70 cm.............................................................. 25cm
Focal distance 100 cm ............................................................ 35cm
Min. Inherent filtration ........................................................... 0,5mm AI equal
Tube material ........................................................................ Glass
Thermal characteristics
Anodic thermal capacity ......................................................... 150kJ=200kHU
Anodic thermal dissipation ...................................................... 300W
Max. power in thermal balance ............................................... 100W
Max. speed anode cooling ...................................................... 25kJ/min.
Electric characteristics
Max. voltage.......................................................................... 130kV
Max. filament current ............................................................. 5,4A
Small focus 0,3 max. power.................................................... 5kW
Large focus 0,6 max. power.................................................... 17kW
CONTINUOUS FLUOROSCOPY
Automatic brightness control (kV - mA)
Small focus (IEC 336)............................................ 0,3mm
kVp variation range .............................................. 40÷ 120kV
mA in LDF variation range .................................... 0,2÷ 4mA
mA in HDF variation range(***)............................. 0,4÷ 8mA
120kV - 4mA thermal units check ........................... H.U. 100% ÷ < 1% in 16 min.
120kV - 8mA thermal units check(***) ................... H.U. 100% ÷ < 1% in 7 min.
Cooling with natural ventilation .............................. H.U. <1% ÷ 100% in 3 hours
PULSED FLUOROSCOPY
Automatic parameters check (kV, mA, t)
Small focus........................................................... 0,3mm
kVp variation range............................................... 40÷ 120kV
mA in LDF variation range ..................................... 0,2÷ 4mA
mA in HDF variation range(***)............................. 0,4÷ 8mA
Exposure rate ....................................................... 1i/1s, 1i/2s, 1i/3s, 1i/5s
SNAP SHOT
Automatic exposure control (kV, mA, t)
Small focus (IEC 336)............................................ 0,3mm
kVp variation range............................................... 40÷ 120kV
mA in LDF variation range ..................................... 1÷ 10mA
mA in HDF variation range(***)............................. 1÷ 12mA
Anti noise filter applied.......................................... K16
Single exposure with LIH memory
ANTISCATTERING GRID
Ratio.................................................................... 8:1
Lines/cm .............................................................. 36
Grid focus ............................................................ 80cm
At 70-100-120 kV 1mAs nominal voltages, the linearity measure towards the current-reference time product, results higher then 20%.
Measures for the other data comply with the IEC 601.2.7 standard, par. 50.101 and 50.102.
IMAGE SYSTEM
9”IMAGE INTENSIFIER
“All metal” technology
High Res input phosphor screen
Image size ........................................................... 9" / 6" / 4"
Real image size..................................................... 215mm / 160mm / 120mm
Typical central resolution for 4".............................. 64lp/cm
Typical central resolution for 6".............................. 56lp/cm
Typical central resolution for 9".............................. 48lp/cm
Contrast ratio ....................................................... 23:1, 25:1, 30:1
DQE at 59,5kV...................................................... 65% (IEC standard)
Conversion factor.................................................. 240/120/60Cd⋅ m-2/mR⋅ s-1
7” IMAGE INTENSIFIER
"All metal" technology
High Res input phosphor screen
Image size ........................................................... 7" / 5"
Real image size..................................................... 160mm / 120mm
Typical central resolution for 5".............................. 50lp/cm
Typical central resolution for 7".............................. 46lp/cm
Contrast ratio ....................................................... 22:1
DQE at 59,5kV...................................................... 65% (IEC standard)
Conversion factor.................................................. 140/70Cd⋅ m-2/mR⋅ s-1
CCD CAMERA
TV camera with a CCD sensor
Integrated optical system
Video level automatic compensation
360°rotation of the CCD camera with automatic return to 0°
Dynamic contrast compensation (SHADING)
Scanning system................................................... CCIR 625/50 or EIA 525/60
High resolution CCD sensor .................................. 470000 pixel
Band width........................................................... 20MHz±3dB
Aspect ratio.......................................................... 4:3
TV MONITO
Power supply........................................................ monophase, 220/240V, 50/60Hz, 60W
Scanning system................................................... CCIR 625/50, EIA 525/60,
........................................................................... CCIR 1249/50, EIA 1023/60
Video entrance high impedance ............................. 2 connector BNC
Video band (525/625 line) ..................................... >15Mhz±3dB
Video band (1023/1249 line).................................. >25Mhz±3dB
Input video signal ..................................................... CCIR 625/50, EIA 525/60 1Vpp on 75Ω
Output video signal ................................................... CCIR 625/50, EIA 525/60 1Vpp on 75Ω
Working memory ...................................................... 576x576x12 bits
Image size ............................................................... 576x576x8 bits
AD/DA converter....................................................... 8 bits
Sampling frequency .................................................. 15Mhz
Brightness and contrast curve.(Look up table)............. 8 bits on 256 grey levels
Recursive filter for photonic noise reduction ................ K2 weight=4,77dB
K4 weight=8,45dB
K8 weight=11,80dB
K16 weight=14,90dB
Environmental characteristics
MECHANICAL DATA
Document Status
Rev. Date Page/s Modification description
0 - - Document approval
1 - - General revision
2 10.04.00 5,38,40,41,43 Laser targeting introduction
3 15.09.00 17,29,31,41 Double step foot-switch
4
5