Professional Documents
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OPERATOR'S MANUAL
The original version of this publication was drafted in Italian and will be referred to for any controversy
regarding interpretation of the corresponding versions, translated into several foreign languages.
The contents of this publication may not be reproduced in any manner with any electronic or mechanical
means. It cannot be distributed in any manner without written authorization issued by the manufacturer.
The manufacturer reserves the right to modify/update this document without notice.
REVISION HISTORY
Rev. Date Notes
01 May 2005 New version
02 July 2005 Added T30 section – added labels section / position label
Updated planned maintenance table
03 October 2005 Changed identification labels position picture-added new equipment identification labels
03 November 2005 Changed labels
04 November 2005 Added Peristepping (angiography/phlebography stepping) function to push button (27) and
(28), added function Led 10
05 February 2006 Added Periscanning function – push button (26) – updated maintenance schedule
05 July 2006 Corrigenda for push buttons (22) (29)
06 May 2007 Added warning symbol about fingers squashing, added section : insert the X-ray cassette in
the table cassette holder
07 November 2007 Updated console push buttons (22/63/64/65), updated the infotec
08 January 2008 Updated collimator section/collimator extra focal collimator radiations/added section setting
the patient free from collimator
09 February 2008 Replaced the section setting: “patient free from collimator” with new section “Manually
remove the compressor”.
Paragraph 1.2 “Symbols of advice positioned on the equipment” has been completed, by
adding 3 additional symbols. In the paragraph 22.1 “Mains supply”, the current absorption
10 July 2009 value has been changed from 15A to 20A.
Chapter 20 “Functioning and safety checks” has been revised. General revision of the index,
and of chapter and paragraph numbering.
11 February 2011 New error code 165 entry following positioner software upgrade from V1.6 to V1.6A.
Global revision to update all chapters.
12 April 2014 Modifications and additions for compliance with regulations IEC 60601-1 3rd edition, IEC
60601-2-54, IEC 60601-1-3.
Additions and update of the following sections: applicable standards, labelling, symbols,
13 August 2020 accessories, intended use, dimension drawings, environmental conditions data. Dual Energy
function.
TABLE OF CONTENTS
1. GENERAL NOTES .......................................................................................................... 7
1.1. Typographic conventions.................................................................................................................. 8
1.2. Warning symbols on the equipment ................................................................................................ 9
1.3. Functioning supplementary symbols .............................................................................................10
1.4. Applicable Standards and compliance............................................................................................11
1.5. Classification (IEC 60601-1) ............................................................................................................11
1.6. Electromagnetic compatibility (EMC) .............................................................................................12
2. GENERAL DESCRIPTION.............................................................................................. 15
2.1. Intended use ...................................................................................................................................15
2.2. OPERA T range ................................................................................................................................16
2.3. Components and configuration ......................................................................................................17
2.3.1. Image receptors .......................................................................................................................17
2.3.1.1. Spot Film Device and cassette division program .....................................................................17
2.3.1.2. Image Intensifier and TV chain.................................................................................................18
2.3.1.3. DR flat panel detector ..............................................................................................................19
2.3.1.4. R&F flat panel detector ............................................................................................................19
2.3.2. Collimator .................................................................................................................................19
2.3.3. Compressor ..............................................................................................................................19
2.3.4. Grid ...........................................................................................................................................19
2.3.5. Control console ........................................................................................................................20
2.4. Performance ...................................................................................................................................21
2.4.1. Tilting........................................................................................................................................21
2.4.2. Tabletop ...................................................................................................................................21
2.4.3. X-ray tube stand .......................................................................................................................21
2.4.4. Linear tomography ...................................................................................................................22
2.5. Technical features...........................................................................................................................23
2.6. Dimension drawings .......................................................................................................................26
2.7. Diagnostic room: typical layout ......................................................................................................39
BLANK PAGE
1. GENERAL NOTES
Important Note
X-RAY EQUIPMENT AND DEVICES CAN BE DANGEROUS FOR THE HEALTH OF BOTH PATIENTS AND OPERATORS
UNLESS PROPER SAFETY MEASURES ARE STRICTLY OBSERVED.
Although this equipment was designed and manufactured according to the most up-to-date safety standards,
the source of X-rays is always dangerous when the operator is not properly qualified or trained. Excessive
exposure to X-rays damages the human body.
Therefore, all the necessary precautions must be taken to prevent unauthorized or unskilled personnel from
operating this equipment, thus jeopardizing themselves and other people. Do not use the equipment if you
have not received appropriate training in the correct and safe use of the equipment itself by the manufacturer
or any of his appointed instructor. Before executing any operation, the persons qualified and authorized to
operate this equipment must be informed about the protection and safety measures established by the
International Committee for Radiological Protection, as well as any other relevant national Standards.
For proper use of this equipment, it is necessary that the operator refer preventively and carefully to this
User’s manual. Special attention should be paid to the sections concerning User Interface, Command
Functions, Application Examples, Safety Recommendations and Protection Measures. Incorrect and
inappropriate use of the machine by poorly qualified personnel who are unsuitable and insufficiently
trained can cause fatal accidents.
N.B.
This device is in compliance with the requirements established by the European Directive 2007/47/EC which
amends the Directive 93/42/EEC regarding medical devices, thus it bears the EC mark stating the code number
identifying the notified body responsible for carrying out the procedures foreseen for the compliance
certification.
IMQ S.p.A.
This is a Class IIb device according to Rule 10 of Annex IX to Directive 93/42/EEC and following amendments
and additions.
The manufacturer declines all responsibility with regard to the proper functioning of the equipment, should
the installation or the maintenance of it be executed by unauthorized personnel.
The X-ray system’s installation instructions are included in a service manual, which is a separate item from the
Operator’s manual.
WARNING
Federal law restricts this device to sale by or on the order of a Physician.
According to 21 CFR 801.109
Important information
It is advisable that extra attention be paid in reading the topics identified with this symbol.
WARNING
The topics identified with this icon regard aspects of safety for the patient and/or operator.
Warning symbol that invites operators to follow the instructions for using the device
on which the symbol itself is applied.
Warning symbol that indicates live electrical parts with a possible risk of electric
shock.
Symbol of filtration.
Symbol that indicates electrical and electronic components which must be collected
separately.
Subchapter J label
All the medical devices that interface or integrate with the table for system composition, acquired by the
manufacturer or built with OEM for the manufacturer are individually certified, must meet the requirements
of Annex I of the European Directive 2007/47/EC which amends the Directive 93/42/EEC and must comply
with the following standards regarding electro-medical equipments:
Annex A
The Equipment is suitable for use in the specified electromagnetic environment. The purchaser or user of the
Equipment should assure that it is used in an electromagnetic environment as described below:
RF emissions Group 1 This Equipment uses RF energy only for its internal function.
Therefore, the RF emission is very low and not likely to cause
CISPR 11 any interference in nearby electronic equipment.
RF emissions Class A This Equipment is suitable for use in all establishments other
than domestic and those directly connected to the public low-
CISPR 11 voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions Not Applicable
IEC 61000-3-2
IEC 61000-3-3
Annex B
Electrical fast 2 kV for power IEC 60601-1-2 Mains power quality should be that of a
transient/burst supply lines Test level typical commercial or hospital
IEC 61000-4-4 environment.
1 kV for input/output
lines > 3 m
Surge 0.5/1 kV differential mode IEC 60601-1-2 Mains power quality should be that of a
IEC 61000-4-5 Test level typical commercial or hospital
0.5/1/2 kV common mode environment.
Voltage dips, short 0% Un for 0.5 cycles IEC 60601-1-2 Mains power quality should be that of a
interruptions 0 % Un for 1 cycles Test level typical commercial or hospital
and voltage 70 % Un for 25 cycles environment. If the user of the Equipment
variations on power 0 % Un for 5 s requires continued operation during power
supply input lines mains interruptions, it is recommended that
IEC 61000-4-11 the Equipment be powered from an
uninterruptible power supply or a battery.
Power frequency 30 A/m IEC 60601-1-2 Power frequency magnetic fields should be
(50/60 Hz) magnetic Test level at levels characteristic of a typical location
field in a typical commercial or hospital
IEC 61000-4-8 environment.
2. GENERAL DESCRIPTION
OPERA is a system featured by a high degree of integration including a wide range of remote-controlled
tables, generators and digital imaging systems.
The remote-controlled tables of OPERA T range are backed up by an exclusive and advanced concept and
thanks to the high modularity of their structures they can be configured according to the user's specific needs,
thus ensuring the optimization of the performance-cost ratio.
The tabletop is available in carbone fibre or wood stratified version. Both versions can be either
with a flat (A) or concave (B) transversal profile, by simply inverting the tabletop.
The inversion of the tabletop can be executed during the installation or later on by the service
personnel. In addition, a plastic laminate tabletop with flat transversal profile is available.
Configuration with SFD and II-CCD or II-CCD and DR flat panel Configuration with R&F flat panel
OPTIONAL CROSSED
VERTICAL SUBDIVISION
SUBDIVISION (as alternative)
CASSETTE
SIZE* (cm)
1 2 3 4 5 6 4 6
18X24 〇 〇 〇 〇 〇 〇
24X18 〇 〇 〇 〇 〇 〇
18X43 〇 〇 〇 〇 〇 〇
43X18 〇 〇 〇 〇
20X40 〇 〇 〇 〇 〇 〇
40X20 〇 〇 〇 〇
24X24 〇 〇 〇 〇 〇 〇
24X30 〇 〇 〇 〇 〇 〇 〇 〇
30X24 〇 〇 〇 〇 〇 〇
30X30 〇 〇 〇 〇 〇 〇
30X35 〇 〇 〇 〇 〇 〇
35X30 〇 〇 〇 〇 〇 〇
30X40 〇 〇 〇 〇 〇 〇
40X30 〇 〇 〇 〇 〇 〇
35X35 〇 〇 〇 〇 〇 〇
35X43 〇 〇 〇 〇 〇 〇
43X35 〇 〇 〇 〇 〇 〇
40X40 〇 〇 〇 〇 〇 〇
* Cassette size of reference is underlined
Cassette division program
2.3.2. Collimator
Motorized collimator with rectangular field
Motorized collimator with rectangular field and Iris
Motorized collimator with rectangular field, Iris and motorized filters
Motorized collimator with rectangular field and motorized filters
Motorized collimator with rectangular field, Iris and manual filters *
Motorized collimator with rectangular field and manual filters *
* Available in function of the installation Country regulations
For further information, see chapter 11.
2.3.3. Compressor
The remote controlled compressor allows an effective though not traumatic palpation; the compression force
can be adjusted up to 200 N.
A special consideration has been devoted to mechanical and electrical safety, as well as safety against wrong
manoeuvres. The compressor has a parking position from which it automatically moves in and out.
An alternative compression system with three interchangeable cones without automatic parking feature is
available, as optional accessory. For further information, see chapter 12.
2.3.4. Grid
Tables with focal distance (SID) up to 150 cm are equipped with a single grid system.
Tables with focal distance (SID) up to 180 cm can be equipped with a dual grid system to ensure optimal
radiological conditions during any exposure. The system will automatically set the proper grid focalization
based on the selected SID. The grid can be automatically parked to ensure low dose in pediatrics applications
and for extremities examinations.
To use the single grid device is however possible on tables with SID up to 180 cm.
In addition, a high focalization grid is also available.
N.B. The dual grid system is not available for SFD version with crossed subdivisions
Console with touch screen + digital system Secondary in-room console on trolley
This manual contains all the information on operating the examination table and the user interface. For
specific information regarding the single components such as the digital system, the generator and the
collimator, please refer to the respective operator’s manual.
2.4. Performance
2.4.1. Tilting
Tables can be chosen either with 90°/30° tilting system that considerably reduces the overall dimensions of
the equipment or with 90°/90° tilting to make the equipment completely symmetric. Thanks to this
characteristic the footrest can be positioned at either one table extremity or at the other, according to the
user's choice so that the most suitable condition can be defined with respect to the room entrances and the
position of the anti-X-ray booth.
Tabletop‐to‐floor distance is 86 cm both with 90°/30° and 90°/90° tilting.
The elevating 90°/90° tilting allows for setting tabletop‐to‐floor distance from 76 to 100 cm.
2.4.2. Tabletop
Tabletop can be chosen with 210 cm or 240 cm length.
The 210 cm length realizes an extremely compact table without any limitation.
The 240 cm length allows great patient explorations without repositioning.
The tabletop movements are extremely ample:
35 cm in the transversal direction
in longitudinal direction (optional):
- 160 cm (±80 cm ) with 210 cm tabletop length,
- 160 cm (±80 cm ) or 120 cm (+100/‐20 cm) with 240 cm tabletop length.
The table structure allows the operators to move easily towards the patient from any side. The patient gets
on/off easily from the table both in horizontal and in vertical.
When the table is in vertical position, if the tabletop longitudinal movement is available, it is possible to lower
the tabletop in order to ease getting on the footboard for patients with motion difficulties. For safety reasons
this operation can be commanded only from the on‐board console.
Particularly high is the patient's maximum admitted weight: 230kg without any limitations of use, up to 260kg
with limitation of use (static exams).
Due to its special structure, the table placed in vertical position ensures a great diagnostic efficiency:
- extended and easy execution of examinations on charged legs, thanks to the reduced focus‐floor distance
- examinations on stretched patients proves to be very easy since the operator can count on a large focus-
floor distance and wider space for patient positioning, thanks to the ample longitudinal displacement and
long focal distance.
20°/0.6 – 1.2 s
30°/1.2 – 2.5 s
40°/1.2 – 2.5 s
Layer height selection 0 – 330 mm
COLLIMATOR
Type of command Manual
Remote‐controlled
Automatic
Rectangular field Standard
Iris field Optional
Luminous centering device Standard
Optional additional filters 1 mm Al + 0,1 mm Cu
1 mm Al + 0,2 mm Cu
2 mm Al
Inherent filtration 1 mm Al eq. (a 75 kV)
Square field at 1 m Min 00x00 cm Max 48x48 cm
Field light pointer >250 lx (a 100 cm, field 35x35 cm)
Radiation leakage <40 mRh (a 100 cm, 75 kVp – 4 mA)
GRIDS
System with SFD and I.I. SID max 150 cm SID max 180 cm SID max 180 cm with
double grid system*
110 lines/inch 110 lines/inch 110 lines/inch
R = 12:1 F = 120 cm R = 12:1 F = 140 cm R = 12:1 F = 120 cm
150 lines/inch 110 lines/inch
--
R = 13:1 F = 120 cm R = 12:1 F = 180 cm
Grid type Oscillating
Retractable (by push button console)
System with fixed DR flat SID max 150 cm SID max 180 cm SID max 180 cm with
panel detector and I.I. double grid system*
215 lines/inch 215 lines/inch
--
R = 12:1 F = 120 cm R = 12:1 F = 120 cm
215 lines/inch
-- --
R = 12:1 F = 180 cm
Grid type Fixed
Retractable (by push button console)
System with R&F flat panel SID max 150 cm SID max 180 cm SID max 180 cm with
detector double grid system*
215 lines/inch 215 lines/inch
--
R = 12:1 F = 120 cm R = 12:1 F = 120 cm
215 lines/inch
-- --
R = 12:1 F = 180 cm
Grid type Fixed
Retractable (by push button console)
* The dual grid system is not available for SFD version with crossed subdivisions
COMPRESSOR
Compression force Up to 200 N
Travel 55 cm
Parking Automatic
Optional Interchangeable cones without automatic parking
feature
ELECTRICAL CHARACTERISTICS
Nominal line voltage 230 Vac +/- 10 %
Mains frequency 50/60 Hz
Current absorption 15 A
Thermal dissipation 500 W
Type of protection Class I
Degree of protection Type B
Degree of casing protection IPX0
WEIGHTS
2
Equipment 660 - 790 kg - base plate 1.00 / 1,18 m
2
Control console 100 kg - base plate 0,20 m
2
Cabinet 140 kg - base plate 0,21 m
1 control console
2 table
3 digital system cabinet (if
present)
4 generator cabinet
5 monitor
safety area
The manufacturer proposes the layout of a typical diagnostic room, similar to the one seen in the above
picture, which gives the operator complete visual contact with moving tabletop and monitor the patient even
from the remote control station. If it is not possible to use this layout, the manufacturer and clinic engineer
will assess all possible solutions to guarantee a safe working environment, eliminating all possible risks.
If the control console (1) is installed in other positions, (for instance laterally with respect to the tabletop), the
operator and patient are both exposed to risks caused by lack of visibility when the machine is moving.
The next section provides some advice on how to guarantee the operator complete control of all movement
activities:
1. Remove the patient footrest when working in a horizontal direction with the patient on the tabletop.
2. If necessary, arrange some mirrors which ensure the patient can be monitored even in positions where
the tabletop hides the patient from view.
3. ALWAYS watch the machine and the patient when performing all movements.
The same assessments must be made for small diagnostic rooms as the settings of the dedicated software
controlling certain movements of the machine can be adjusted to suit such areas during the installation
phase.
The layout of each of the above listed elements, and the chapter providing relative description, are provided
in the next page.
WARNING
The main control console, remote keyboard, on-board console with joystick and secondary
console (in room) are enabled simultaneously.
DO NOT RUN SIMULTANEOUS CONTROLS FROM DIFFERENT POSITIONS.
Park the secondary console and the double R/F remote foot pedal outside the table
movement area when these devices are not in use.
The layout and presence of the push-buttons may vary according to the type of system
installed.
All possible push-buttons and their related functions can be found in the next chapters.
In order to obtain the best results, we recommend using the maximum allowed magnification
factor based on the area to be examined.
1 2 3 4
Using these push-buttons (1, 2, 3 and 4), the operator can select the most appropriate I.I. (ZOOM) factor
according to the area to be examined.
1 2 3 4
Using these push-buttons (1, 2, 3 and 4), the operator can select the most appropriate image detector factor
(ZOOM) according to the area to be examined.
23
These two push-buttons (5 and 23) allow the operator to select the tomographic layer height, in addition to
the virtual fulcrum around which the X-ray tube - image receptor unit rotation is performed for oblique X-ray
or radioscopy incidences.
The layer height is visualised on the display.
Push-button (5), moves the layer height upwards.
Push-button (23), moves the layer height downwards.
The layer height ranges from 0 to 330 millimetres.
6 7 8 9 10 11 12
24 25 27 28
The tomographic functions can be enabled by pressing one of these push-buttons (7, 8, 9, 10, 11, 12, 24, 25,
27 and 28). Each push-button allows the selection of the angle and scanning time. The LED will flash until the
preparation condition is reached.
Push-button (6) disables the tomographic functions (condition enabled when the equipment is switched
on).
In some integrated systems, the selecting and disabling are performed externally by means of
the APR (Anatomical PRogramming) system. In these cases, the push-buttons (7, 8, 9, 10, 11, 12,
24, 25, 27 and 28) are selected externally. The LED will flash until the selected push-button is
pressed and held and the preparation condition is reached. Similarly, the disabling, push-button
(6) ON, is performed externally, selecting a non-tomographic APR.
If you press and hold one of the following push-buttons (7, 8, 9, 10, 11, 12, 24, 25, 27 and 28) the column
stand and spot film device or detectorwill automatically return to the tomographic area, they will be
centered, and the focal distance will be positioned at 115 cm (note that if the focal distance is at 8° it will
remain in the same position) and the compressor will move to its parking position.
13 14 15 16
These push-buttons allow the operator to select and/or display the image acquisition mode, according to the
following operating modes:
Conventional X-ray on CR or DR film (push-button 13)
Digital fluoroscopy on I.I. or digital exams (RAD/Fluoride) on RF detector (push-button 14).
Exams on bucky stand, stretcher or tabletop, with X-ray housing rotation (push-button 15)
Exams with ceiling stand (push-button 16).
It is possible to alternate the enabled operating modes at any time.
The selected operating mode is indicated by the relative LED.
In case it is necessary to perform exams signalled by the indicator (15), the LED is activated when the X-ray
group is released from its normal position, (aligned on the image receptor).
August 2020 Page 45/135
OPERATOR'S MANUAL OPERA T
GENERAL MEDICAL MERATE S.P.A. CODE 62235 - REVISION 13
In case it is necessary to perform exams with the ceiling stand, the LED (16) is activated when the ceiling stand
has been released from its parking position.
In this condition all the tabletop movements that can cause collision with the stand are inhibited.
WARNING
If the tube is rotated and the “external radiography” accessory is used, the X-ray beam will
extend beyond the primary safety barrier.
5.5. Switching the X-ray room light ON or spot film device programme progress
The X-ray room light ON or spot film device programme progress functions, push-button (17)
can be enabled and configured depending on the system version. The two functions can only
be used alternatively.
The spot film device programme progress function can only be enabled using conventional
spot film devices.
17
Cassette inserted for the first time Same cassette used a second time.
4 4
3 Used cassette size division 3
2 2
Unused cassette size division
1 1
18
A large red button (18) is positioned on the console to start and stop the examination table.
By pulling the button upwards the electrical circuits of the table are enabled, vice-versa by pushing it down
they are disabled.
The symbol placed below this push-button is to remind the operator that before he starts using the
equipment it is necessary to be informed about its functional performance, or carefully read this manual.
There is also another stop button (red button - G1) with the same functions located on the left
side of the spot film device.
19 20 21
Push-buttons (19 and 20) can be used to select the automatic dose level between the two variation curves
preset by the generator. Push-button (21) is used to enable manual fluoroscopy using the generator controls.
22
Push-button (22) in combination with push-button (33) and an appropriate TV system, performs the following
functions:
In acquisition mode (fluoroscopic pedal pressed), push-button (22) starts/stops image sequence
memorization at the speed previously selected by push-button (33).
In review mode, this push-button (22) starts/stops sequence image display previously stored at the speed
selected by push-button (33).
For further information on how to use this function, please refer to the TV system manuals.
24 25 26 27 28
For further information on how to use the Angiographic exercise functions, please refer to the digital system
manuals.
5.10. Stitching
The Stitching function, where available, can be enabled and configured depending on the system
version.
In certain systems, this push-button (26) is used for the angiographic exercise. In this case, the
stitching function cannot be enabled.
In some integrated systems, the selecting and disabling are performed externally by means of the
APR (Anatomical PRogramming) system. In these cases, the push-button (26) is selected
externally. The LED will flash until the selected push-button is pressed and held and the
preparation condition is reached. Similarly, the disabling, push-button (6) ON, is performed
externally, selecting a non Stitching APR.
Push-button (6) disables the Stitching function (condition enabled when the equipment is
switched on).
6
26
Press this push-button (26) to enable the Stitching function. The push-button LED will flash until the
preparation condition is reached.
Hold this button to obtain automatic return of the column stand and the spot film device or detector to
the stitching zone and subsequent centering; the compressor also moves to its parking position.
Stitching can be performed in 0° or ±90° conditions and a focal distance of from 115 to 150 cm; check you
have achieved these conditions before selecting the stitching function.
Inside the stitching area it is possible to perform the patient scan movement using the joystick (65) to
move to the required stitching position.
The number of imaged and the stitching direction are established according to the examination selected
on the relative digital system.
Press this push-button (66) to start the stitching sequence for x-ray exposures. The button must be held
down until the end of the sequence, its release will interrupt the stitching sequence and the digital system
will process the images acquired up until then.
Press this push-button (66) for x-ray exposures:
The X-ray tube unit reaches the start sequence position (step one)
The digital device receives authorisation for acquisition of the first image
When the first acquisition has been completed, the digital device will send the automatic
forward feed command
The tabletop/generator/digital device will move into position for the next step
On reaching the next step, a new acquisition will start as far as the last possible step
On completing the sequence, the system will display the stitching of the acquired images on
the digital monitor.
To repeat the sequence, it is necessary to run the stitching sequence again starting by re-selecting the
examination.
For further information on how to use the Stitching function, please refer to the digital system manuals.
The Automatic sequence during tomography, if available, is linked to the tomographic functions.
29
Push-button (29) allows you to automatically increase the height of the tomographic layer set during the
installation procedure, from 1 to 10 mm.
30
Pressing this push-button (30) it is possible to park the grid outside the X-ray beam field:
LED ON and flashinggrid parked, outside the X-ray beam field
LED OFFgrid inside the X-ray beam field
31
Press this push-button (31) to enable the mixed programming function and the division execution sequence
available is selected automatically.
It is possible to change the type of division within a program.
According to the cassette size and the type of SFD (with or without crossed-division) some push-buttons (43,
44, 45, 46, 47 and 48) are disabled, while the remaining ones can be selected in order to select the division
execution sequence. The selected sequence is indicated by the fixed LED for the program that is first executed
and will flash for the program executed later on.
32
If you simultaneously press this push-button (32) and the X-ray exposure push-button a series of exposures
will automatically be executed according to the chosen size division.
This function will be disabled at the end of the exposure of the last section of the film or as soon as the
exposure push-button is released.
33
This push-button (33) allows you to set the image review or memorization frequency.
The value associated to the image review or memorization frequency is displayed on the display screen.
For further information on how to use the Pulsed fluoroscopy function, please refer to the TV system
manuals.
34 35
These push-buttons (34 and 35)can be used to select image inversion:
Right-left (push-button 34)
Up-down (push-button 35)
The function of the Focal distance Selector push-buttons, in particular push-button (38), varies according to
the configuration, as illustrated below:
3 push-button system
36 37 38
Systems with max FFD = 180 optional
4 push-button system 3 push-button system
36 37 38 38A 36 37 38
It is possible to select from three (or four) different focal distances by pressing the relative push-button (36,
37and 38 or38A), using one of the two procedures below:
39 40 41 42
Press the push-buttons (39, 40, 41 and 42) to enable the selected sensitive areas. Enabling is confirmed when
the LED is ON.
These push-buttons are only enabled in versions with a single console separated from the
generator.
When integrated consoles are used, selection takes place in the section of the console dedicated
to the generator.
39 40 41 42
Press the push-buttons (39, 40, 41 and 42) to select the filter inserted in the collimator. Enabling is confirmed
when the LED is ON.
The push-buttons are paired in the following order:
Push-button (39) = no filter inserted
Push-button (40) = 1Al+0,1cu filter
Push-button (41) = 1Al+0,2cu filter
Push-button (42) = 2Al filter
These push-buttons are only enabled if the collimator with automatic filters is fitted and if the
filters are controlled from the table console. When the filters are controlled externally, (e.g. APR
digital system) the console selectors are not enabled.
43 44 45 46 47 48 47 48
These push-buttons (43, 44, 45, 46, 47 and 48) allow the operator to program the transversal or crossed
division of the film.
The spot film device with 2,3,4 bands or stripes allow the division of any size in the transversal direction;
The division in 5, 6 bands or stripes is only possible for sizes over 24cm or 10 inches.
The crossed spot film device in addition to the division of any size in a transversal direction, also allows
the crossed subdivision in 4 and 6 for the 18x24, 24x24, 24x30 sizes.
This push-button (43) foresees the use of the film on the entire size (panoramic).
It is enabled at startup.
43
This push-button (44) allows the transversal division of the film size into two.
44
This push-button (45) allows the transversal division of the film size into three.
45
This push-button (46) allows the transversal division of the film size into four.
46
A B This push-button (47) allows the transversal division of the film into five (A) or the crossed
division of the film size into four (B)
Push-button (A) is optional: installed on 5 and 6 division band spot film device systems
only.
47 Push-button (B) is optional: installed on crossed spot film device systems only.
A B This push-button (48) allows the transversal division of the film into six (A) or the crossed
division of the film size into six (B)
Push-button (A) is optional: installed on 5 and 6 division band spot film device systems
only.
48 Push-button (B) is optional: installed on crossed spot film device systems only.
The LED placed on each push-button indicates the division currently selected.
The number of available exposures is always displayed according to the selected program. In addition, when
the cassette holder is in the parked position in the spot film device, it is possible to read the dimension of the
cassette inserted in the spot film device by pressing the selected cassette division button.
The selected film size division automatically determines the automatic collimation of the X-ray beam, with the
command: "Radiography preparation".
At each "Radiography" command, the division program advances one step while the number of available
exposures shown on the display decreases. After exposing the final section of the film, the cassette is
automatically sent to its parking position. The display will indicate that the division program is over (0
radiographs available) and it is not possible to perform any further radiographic exposures.
It is always possible to insert a radioscopy between one radiographic exposure and another by pressing the
radioscopic foot pedal. The following radiographic exposure will be executed by turning back to the point
where the division program was last interrupted.
When the radiographic exposure series is over, you can only perform other exposures after replacing the
radiographic cassette. When you replace the radiographic cassette, the division program last selected will
remain active.
49
This push-button (49) is used to switch on or off the lamp of the luminous centring device in order to carry out
a visual check of the collimation. The lamp will automatically switch off after 30 seconds.
50 51
These push-buttons (50 and 51) are provided to control a iris diaphragm, if available:
The left push-button (50) causes the diaphragm to open
The right push-button (51) causes the diaphragm to close
52
This push-button (52), can be used to select whether to perform fluoroscopy exams with the I.I. placed at the
minimum distance from the tabletop (normal condition) or with the I.I. left at the same distance that it
assumes when spot film device cassette-holder is in the field (condition indicated with LED on).
The normal condition is the best possible condition for geometrical magnification and resolution.
In other conditions, the fluoroscopy-radiography transition time is minimal.
The Collimation mode selectors, where available, depend on the system version.
53 54
These push-buttons are used to select the collimation mode:
This push-button (53) selects collimation in automatic or semi-automatic mode
This push-button (54) selects collimation in Bucky mode
When neither of the two push-buttons are selected (the LED on push-button (53) is flashing), the system is set
to semi-automatic mode.
In all operating modes, it is always possible to execute collimation in reduction mode using the joystick (61) or
directly on the collimator using its knobs.
Setting 002
COLLIMATION APERTURE PERPENDICULAR SIDE AT THE FILM SIZE SELECTED IN RADIOGRAPHIC MODE (the
perpendicular diaphragm and iris always open in radiographic mode at the film size).
In Radiographic mode:
- The parallel side remains stationary in the previously selected position.
- The perpendicular side and iris, if present, always open on the film size (maximum allowed aperture)
even if previously collimated.
Setting 003
COLLIMATION APERTURE PERPENDICULAR SIDE AT THE FILM SIZE SELECTED IN RADIOGRAPHIC MODE IF
NOT COLLIMATED (the perpendicular diaphragm and iris open in radiographic mode at the film size if they
were not collimated in fluoroscopic mode).
In Radiographic mode:
If the size of the perpendicular side is not reduced using the joystick (61) before the radiographic phase:
The parallel side remains stationary in the previously selected position.
The perpendicular side remains on the film size (maximum allowed aperture)
The iris, if present, opens on the film size (maximum allowed aperture) even if previously collimated.
If the size of the perpendicular side is reduced using the joystick (61) before the radiographic phase:
The parallel side remains stationary in the previously selected position.
The perpendicular side remains stationary in the previously selected position.
The iris, if present, remains stationary in the previously selected position.
Setting 004
COLLIMATION APERTURE WITH THE IRIS SHUTTERS ON THE FILM SIZE SELECTED IN RADIOGRAPHIC MODE,
AND COLLIMATION APERTURE WITH THE PERPENDICULAR SHUTTERS AT THE FILM SIZE SELECTED IN
RADIOGRAPHIC MODE IF NOT COLLIMATED (the iris always opens in radiographic mode at the film size whilst
the perpendicular diaphragm opens in radiographic mode at the film size only if it was not collimated in
fluoroscopic mode)
In Radiographic mode:
If the size of the perpendicular side is not reduced using the joystick (61) before the radiographic phase:
The parallel side remains stationary in the previously selected position.
The perpendicular side remains on the film size (maximum allowed aperture)
The iris, if present, even if collimated, opens on the film size (maximum allowed aperture).
If the size of the perpendicular side is reduced using the joystick (61) before the radiographic phase:
The parallel side remains stationary in the previously selected position.
The perpendicular side remains stationary in the previously selected position.
The iris, if present, opens on the film size (maximum allowed aperture) even if previously collimated.
Fluoroscopy (004) Radiography (004)
55
Normal condition: during tilting, the table stops automatically in a horizontal position and the push-button
(55) is OFF and disabled.
It is possible to press the push-button (55) to select whether or not to disable the automatic stop function: the
LED will come ON.
56
Press this push-button (56) to restore the vertical position of the stand after the execution of oblique
incidences, the LED will come ON as soon as it reaches the vertical position.
With table tilting wider than ±85° and X-ray group rotated (not centred on the SFD or detector ),
controlling the vertical position of the stand (centering), if this occurs with the stand moving
downwards the movement will stop at 140cm from the floor. It is necessary to release it and
repeat the command to continue with the movement. The movement will be enabled again at
minimum speed.
WARNING
If longitudinal displacement of the tabletop is performed to the right or left, it is prohibited to
allow the patient to get on/off the tabletop from the overhanging side (see figure below).
57 58 59
The lateral push-buttons (57 and 59) control the tabletop longitudinal displacement:
The lateral push button (57) moves the table top towards the left.
The lateral push button (59) moves the table top towards the side.
The central push-button (58) is used to place the tabletop in its original centered position. As soon as the
tabletop reaches the central position, the push button LED will come ON.
60
This push-button (60) alternately controls the cassette holder IN-OUT function in the spot film device; the LED
will come ON to indicate the cassette holder OUT condition.
The display indicates the number of available exposures and will switch off if the radiographic cassette is
not inserted or the relative cassette holder is in the OUT position.
61
Using the joystick (61), it is possible to open and close the internal collimator diaphragms.
Push the joystick forwards to open the longitudinal diaphragms.
Push the joystick backwards to close them.
Push the joystick to the left to open the transversal diaphragms.
Push the joystick to the right to close them.
5.29. Compressor
62
The tabletop is equipped with a motorized compressor, enabling the pre-adjustment of the compression
pressure. The compressor movement is enabled using a joystick type lever (62):
Tip the lever forwards to lower the compressor and enable compression.
Tip the lever backwards to raise the compressor again.
When the compressor device is in compression there will be an inhibition of the following movements:
tabletop transversal displacement
tabletop longitudinal displacement
spot film device stand unit inclination and transversal displacement
focal distance decrease
Enabling the tomography or stitching command will automatically raise the compressor.
63
In order to use the joystick (63) to control the movements, it is necessary to move the lever and
simultaneously press the “enable movements” button, which is positioned on the lever itself.
The Footrest rotation function, where installed, is paired to tables with this option.
64
In order to use the joystick (64) to control the movements, it is necessary to move the lever and
simultaneously press the “enable movements” button, which is positioned on the lever itself.
It is possible to enable the stand incidence command and the longitudinal patient scanning
command simultaneously.
With the table tilting wider than ±85° and X-ray group rotated (not centered on SFD or detector),
by driving the oblique incidence downwards, the movement will stop at 140 cm from the floor. It is
necessary to release it and repeat the command to continue the movement. The movement will
be enabled again at minimum speed.
65
In order to use the joystick (65) to control the movements, it is necessary to move the lever and
simultaneously press the “enable movements” button, which is positioned on the lever itself.
The movement speed varies according to the inclination degree of the control lever. This allows the operator
to change the scanning speed according to the operational needs, i.e. it will be possible to increase the speed
if long movements are to be executed and then decrease the speed when approaching the area to be
diagnosed in order to achieve accurate centering.
The movements have been programmed to achieve a “topographic” correspondence with the image
displayed on the monitor.
Pushing the joystick to the right will achieve lateral displacement of the tabletop towards the internal
side, corresponding to screen image shifting to the right.
Pushing the joystick to the left will achieve lateral displacement of the tabletop towards the external side,
corresponding to screen image shifting to the left.
Pushing the joystick forwards will achieve the displacement of the I.I intensifier X-ray tube stand group
towards the left side of the longitudinal axis, corresponding to screen image shifting upwards.
Pushing the joystick towards the operator (backwards) will achieve the displacement of the I.I.-X-ray tube
stand group towards the right side of the longitudinal axis, corresponding to screen image shifting
downwards.
When the movements approach their maximum extensions, the tilting speed automatically and gradually
decreases in order to prevent them coming to an abrupt stop.
With the table tilting wider than ±85° and X-ray group rotated (not centred on the SFD or
detector ), by driving the oblique incidence downwards, the movement will stop at 140 cm from
the floor. It is necessary to release it and repeat the command to continue the movement. The
movement will be enabled again at minimum speed.
66
The X-Ray exposure command is executed by means of a double-click push-button (66).
The first click of the push-button enables the Radiography Preparation, while the second click (deeper)
enables the X-Ray, tomographic or stitching exposure.
67
The fluoroscopic exposure command is executed by means of the pedal (67).
Normal visualization on the display is inhibited when an error code or power off occur.
The display (11) is only available on systems equipped with conventional or hybrid spot film
device.
WARNING
The main console, the keyboard and secondary console (in room) are enabled simultaneously.
DO NOT RUN SIMULTANEOUS CONTROLS FROM DIFFERENT POSITIONS.
Park the secondary console outside the table displacement area when not in use.
Push-button
Secondary console (in room) control function description
group
18 Emergency STOP push-button
30 Grid parking
36-37-38-38A Focal distance selector
49 Collimator lamp
50-51 Iris diaphragms
55 Stop in the horizontal position
56 Stand vertical position
57-58-59 Tabletop longitudinal displacement
60 Cassette holder in - out
61 Diaphragm collimation
62 Compressor
63 Tabletop elevation and tilting
64 X-ray tube stand incidences
65 Control of the patient scanning movements
66 X-Ray exposure
In order to enable control the movements via the remote keyboard (onboard machine control
panel) it is necessary to press the desired movement push-button and simultaneously the
“enable movements” push-button (G2), which is positioned to the remote keyboard.
The only movement for which the simultaneous pressing of the "enable movements" push-
button is not required is the cassette holder IN/OUT function.
Please refer to the “Command functions of the main control console” chapter for the description of the
push-buttons and relative functions.
(G6)
The two remaining push-buttons control the longitudinal displacement of the tabletop. The displacement will
come to a halt each time the examination table reaches the central position. It is necessary to release the
push-button and press it again to continue the scan.
When the examination table is tilted, press the left or right push-button to lower the tabletop towards the
floor (step by step mode), in order to make it easier for patients with motor difficulties to climb onto the
patient footrest.
With the table tilting wider than ±85° and X-ray group rotated (not centered on SFD or detector),
by driving the oblique incidence downwards, the stand centering, longitudinal scan and table
displacement will stop at 140 cm from the floor. It is necessary to release it and repeat the
command to continue the movement. The movement will be enabled again at minimum speed.
31
Select conventional radiography (if available and/or enabled) and/or select the generator receptor
associated to the conventional radiography selection.
Cassette
INSERT/EJECT
Position the cassette on the tray when it has exceeded the external tray guide.
External guide
Slot the cassette into the external guide paying attention to the position of the fingers.
Adjust the "right-left" indicator where necessary.
“Right-Left” indicator
WARNING
Inserting the cassette incorrectly could lead to squashing of fingers!
Please refer to the “Using the accessories” chapter for installation instructions of the on-board console with
joystick.
In order to use the on-board joystick to control the table displacement, it is necessary to
move the lever and simultaneously press the “enable movements” push-button which is
positioned near the remote keyboard (on-board control panel).
Pushing the joystick to the right will achieve lateral displacement of the tabletop towards the
internal side, corresponding to screen image shifting to the right.
Pushing the joystick to the left will achieve lateral displacement of the tabletop towards the
external side, corresponding to screen image shifting to the left.
Pushing the joystick forwards will achieve the displacement of the I.I.-X-ray tube stand group
towards the left side of the longitudinal axis, corresponding to screen image shifting
upwards.
Pushing the joystick towards the operator (backwards) will achieve the displacement of the
I.I.-X-ray tube stand group towards the right side of the longitudinal axis, corresponding to
screen image shifting downwards.
With table tilting wider than ±85° and X-ray group rotated (not centred on the SFD or
detector), by driving the oblique incidence lower the movement will stop at 140 cm from the
floor. It is necessary to release it and repeat the command to continue the displacement
operations. Displacement will be enabled again at minimum speed.
11. COLLIMATOR
11.1. Lighting up of the luminous beam
Press push button (A) on the collimator.
The luminous beam will remain lit on for about 30 seconds simulating the dimension of the X-ray field. It
will switch off automatically.
The cross (G) indicates the position of the central radiation.
Average illumination is not less than 160 LUX; edge contrast ratio is minimum four to one (4:1)
The field size at various Focus-Film Distances (FFD) is shown by the dial indicators on the front of the
collimator.
L R
G
C
Collimator provided with control devices for the manual limitation of the X-ray field
+90° +180°
Follow the same above-specified procedure. You can modify the X-ray field up to the mechanical limits of the
adjustment area of the collimator
WARNING
If you rotate the tube or use the accessory provided for external radiographs the radiation
beam will extend beyond the primary protective shielding.
Collimator rotated to the left Centred collimator Collimator rotated to the right
The collimator, provided with luminous centering device, allows three adjustment modes:
- manual
- remote‐controlled from the control panel
- automatic, according to the cassette division, I.I. field, focus‐to‐film distance..
The collimator can be a rectangular field type or a rectangular‐iris fields type very useful with
digital system applications.
- Besides, as an option, are available a series of additional filters:
position 1: 1 mm Al + 0,1 mm Cu
position 2: 1 mm Al + 0,2 mm Cu
position 3: 2 mm Al
position 4: empty
- rotation feature for easy collimation of contact radiographies with cassette out of SFD (eg.:
extremities);
- more powerful lamp for brightness compensation of the luminous field due to the DAP
meter presence.
For further information on the collimator types, make reference to the relevant manuals.
F = Focus
A = Extra focal shutters
B = R302 collimator
C = Maximum field
D = Maximum stray radiation
E = Lead limitation
G = Upper cover
R302 LONG
F = Focus
A = Extra focal shutters
B = R 302 collimator
C = Maximum field
D = Maximum stray radiation
E = Lead limitation
G = Upper cover
F = Focus
A = Extra focal shutters
B = R 503 collimator
C = Maximum field 430 mm
D = Maximum stray radiation
E = Lead limitation
G = Upper cover
F = Focus
A = Extra focal shutters
B = R 503 collimator
C = Maximum field 430 mm
D = Maximum stray radiation
E = Lead limitation
G = Upper cover
12. COMPRESSOR
The remote-controlled compressor allows an effective though not traumatic palpation; the compression force
can be adjusted from 50 to 200 N.
A special consideration has been devoted to mechanical and electrical safeties, as well as safety against wrong
manoeuvres.
Thanks to this function, to remove the compressor manually will not be necessary in
(62)
case it is an obstacle to equipment functions.
Compressor display
H
L
B
B M
Lift the compressor by means of the lever [B] (Fig. 3) as shown in Fig. 4 e Fig. 5, by turning the lever
counter clockwise if you are standing behind the back side of the equipment.
Fig. 4 Fig. 5
Distance scale
For tables equipped with continuous variable focal distance, a distance scale is positioned on the compressor
column which allows for measuring the exact focal distance, upon releasing the related push button.
In addition the X- ray maximum fluoro dose value will be compensated related to focal distance choice.
1 With longitudinal tabletop option, the alarm code 022 may occur also in case of malfunction of the tabletop circuit.
August 2020 Page 85/135
OPERATOR'S MANUAL OPERA T
GENERAL MEDICAL MERATE S.P.A. CODE 62235 - REVISION 13
14. ACCESSORIES
The utmost suppleness of application and universality of the table are further enhanced by the availability of a
wide range of accessories.
13x18 and 15x40 cassette adapters Intercommunication system Photocell for low ceilings
Double R/F remote foot pedal On-board console joystick Rotating footrest
Stitching bar
Secondary console (in room))
Please find in the next pages important information regarding use of the standard accessories
and use of a few optional accessories.
In order to ensure product safety, accessories exclusively made by the manufacturer or accessories made by
other suppliers but authorized by the manufacturer may only be used.
The user is held responsible for the use of other possible accessories that are not authorized by the
manufacturer.
WARNING
Make sure all accessories are fitted correctly on their guides or support fixtures! If this is not
the case, they could fall and cause injuries to persons or damage to equipment during
machine tilting or movement phases.
C
A
B C
A B
The footrest can also be fastened in a more advanced position compared with the center of the tabletop.
Normally this position is used when the operator wishes to seat the patient on the footrest (seat mode).
To mount the footrest in seat mode:
press the locking buttons so as to release the locking device
push the footrest some centimetres onwards and release the blocking buttons A-Fig. 8
keep on pushing the footrest slowly onwards until the new blocking position is reached C-Fig. 8
make sure that the footrest is firmly secured to the guides by bearing down on the longitudinal axis
onwards and backwards
WARNING
Make sure the footrest is correctly assembled on its support fixtures! If this is not the case,
they could come loose and cause injuries to persons and objects during machine tilting or
movement phases.
Do not execute any adjustment of the footrest when the table is in the vertical position: you
would take the risk to make the patient fall or hurt your feet.
Mounting of the rotating footrest is done in the same manner as for standard footrest.
To mount the rotating footrest onto the tabletop, follow instructions provided in this section.
(150kg is the maximum patient weight allowed on the rotating footrest).
Upon fixing the footrest to the tabletop guides, connect the cable.
B
A
C
Fig. 9 – Rotating footrest Fig. 10 – Cable connection
If the footrest is mounted on the foot side, the cable must be connected to point A-Fig. 10. If the footrest
is mounted on the head side, the cable must be connected to point B-Fig. 10.
Connect the second end of the cable to point C-Fig. 10, with the equipment switched off.
Switch the equipment on.
14.3.2. Handgrips
The handgrips ensure the patient a safe and firm holding position as well as an increased sensation of safety.
The handgrips can be fixed in any position of the tabletop guides.
14.3.3. Shoulder-rests
The shoulder-rests ensure complete safety to the patient when, during the examination, it is necessary to
place him in the trendelenburg position (e.g. myelography).
Since it is possible to use the shoulder-rests together with the handgrips, before mounting the shoulder-rests
it will be necessary to fix the hadgrips (if they are not already mounted on the guides):
Attention
Always place the tabletop in the horizontal
position first.
WARNING
Both the mounting and the use of the support for cassette / wifi detector are allowed only with
the table in the horizontal position.
In no case is the operator allowed to use this accessory with the table in vertical position!
The image-receptors, available in various formats, can be used both vertically and horizontally
(portrait/landscape). The anti-scatter grid is available in two versions: with or without handle.
Below are shown, by way of example, some types of image receptors that can be used with this accessory.
The lateral support for wireless detector/CR cassette can be mounted anywhere on the side rails of the
patient tabletop, on both sides of the table.
WARNING
Both mounting and use of the lateral support for wireless detector is only permitted with the
table in a horizontal position and the accessory positioned on the patient table top.
Under no circumstances may the user use this accessory with the table in a vertical or
tilted position outside the patient tabletop!
(B)
WARNING
This adjustment must always be made using one hand to operate the knob and the other
hand to hold the rod.
The rod is not equipped with mechanical stops: if it is not held manually, it may cause the
detector support to fall onto the patient tabletop!
WARNING
When adjusting the clamps (D), make sure to hold them externally so as not to risk crushing
your hands.
Please refer to "User interface" chapter for instructions on how to use the joystick.
WARNING
Whether a footswitch for the exam room is present on the system, it is possible that its use
has been limited and that it is disabled for radiographic exams.
WARNING
Do no step on the footswitch top cover.
A wireless pedal is also available for use in the examination room. The wireless pedal is powered by three
standard batteries. It is the operator's responsibility to check the state of charge of the batteries and replace
them if necessary.
There are two LEDs on the wireless pedal, whose functions are explained below.
Symbol State Description
Off (and Battery LED on) No pairing partner found (receiver out of range, switched off)
Battery LED Orange Battery capacity between 20% and 50% (<= 3.75 … 3.3 V)
Blinking orange (slowly) Battery capacity < 20% (<= 3.3 … 3.0 V)
Blinking orange (fast) Battery level below limit value = 5%, <3.0 V (Deep Sleep Mode)
WARNING
Park the wireless pedal, when not in use, in a safe area that excludes the risk of accidental
activation. Do not take the device out of the examination room.
WARNING
In order to ensure proper hygienic conditions the medical staff must make sure the parts of the
device that come into contact with the patient (such as examination tabletop, tabletop and
stretcher cushions) are protected using the relative bio-compatible material sheet.
Mounting of these handgrips is done in the same manner as for those provided as standard accessory.
To mount these special handgrips, follow instructions provided in section 14.3.2.
The handgrips must be positioned on the tabletop so that the knobs A-Fig. 17 are perfectly aligned.
The accessory is composed of a support with fittings B-Fig. 17 and a contention structure B-Fig. 19. The
accessory must be assembled with the table in horizontal position.
Position the support B-Fig. 17 on the tabletop and fasten the two ends C-Fig. 17 to the tube supports of
the knobs A-Fig. 17.
Tighten the belts A-Fig. 18, on both sides, keeping the support in the middle and tighten the safety
buckles B-Fig. 18.
Ensure it is firmly fastened, lifting the support a few centimetres from the tabletop surface.
WARNING
16kg is the maximum weight allowed on the paediatric cradle for small patients.
To assemble the compressor cone A-Fig. 22 simply insert the holder in the relative seat and apply a light
pressure B-Fig. 22, making sure the lever is positioned as indicated in Fig. 23. Pull in the opposite direction to
remove the cone.
Should it be necessary release the compressor manually, follow the instructions given below to remove the
cone:
pull the lever towards the exterior A-Fig. 23;
rotate the lever upwards B-Fig. 23;
slide out the compressor cone C-Fig. 23.
WARNING
The system can present one or two grids focused according to the focal distance.
If the exam selected does not require the use of the grid, remove it from the detector using the
appropriate handle. If the grid is not removed, the system will not allow the transfer of the X-
rays.
When the grids have been removed, ensure that they are stored in a secure place.
If the second grid option is enabled, the system will show a warning message for the operator. According to
the focal distance, one of the two following messages will be displayed:
- Make sure you have inserted the first grid for DFF ≤ 150 focusing
- Make sure you have inserted the second grid for DFF ≥ 150 focusing
16.1. Thorax
With the option "variable focal
distance" the radiography of the
thorax can be executed with a
focus-film distance of 150 cm or
180 cm (depending on the table
version).
(A) (B)
16.7. Skeleton
The ample examination field that can be obtained thanks to the movement of the "Image Intensifier/Stand"
group, allows the operator to execute the most thorough analysis of the patient.
Examinations of the skull (C), back spine and lumbar column (D) can be executed with any incidences, as well
as examinations of the legs (E).
16.8. Arms
It is also possible to execute examinations with free
cassette, with the patient both laying in the horizontal
position and standing or sitting in an external position with
respect to the table.
16.9. Hysterosalpingography
The possibility of moving the "Image Intensifier/X-ray tube
column" group towards the front end (or the back end) of
the table, allows the operator to easily execute any
radioscopic examinations and radiographs of the female
genital apparatus.
16.10. Phlebography
If you command a light inclination of the tabletop, the
patient can be positioned as shown on the left. In this case
you will be able to execute a phlebography under the
radioscopic control.You shall pay your attention in order to
keep the "Image Intensifier/X-ray tube column" group in
the lowest position and fix the footrest at about 10 cm
from the lower end of the mobile plan. After centring the
patient as shown on the left, you will execute the
examination by moving the "Image Intensifier/X-ray tube
column" group upwards. Normally a 60 cm displacement
is sufficient. In this case the variable speed of the group
displacement proves to be very useful.
As manufacturers and installers of this product we cannot be held responsible with regard to equipment
safety, reliability and performance in situations where:
- installation, amplifications, resetting, modifications, repair work are performed by unqualified and/or
personnel not authorized by GMM's Service Department to perform such activities;
- in the event of breakage, components that are deemed important for proper system operation are not
replaced by original spare parts;
- the electrical wiring system in the X-ray room does not comply with the specifications established by
IEC 364 series Standards or relevant national standards;
- the equipment is not used according to the relative user instructions.
Upon request, we will be happy to place the technical documentation at your disposal at the relative nominal
cost, with the understanding that this documentation is not an authorization for technical interventions on
the equipment. The manufacturer is not responsible for any repair work done without its specific
authorization in writing, demonstrating its consent.
For each technical intervention effected by our Service Department's personnel, we recommend that you
request a copy of the relevant testing report with the following specifications: type of the intervention,
modifications of the rated parameters or value range, date, name, signature of the technician who carried out
the intervention.
WARNING
It is the operator’s responsibility to activate equipment movements only after making sure
that the patient or third parties cannot be harmed by these movements.
WARNING
Do not remove covers or cables from the system. High electrical voltages are present within
this system. Removing covers or cables could lead to serious or fatal personal injury.
WARNING
The operator must not touch any part of the console or X-ray generator and the patient
simultaneously.
WARNING
An additional MULTIPLE-SOCKET OUTLET or extension cord shall not be connected to the
ME (Medical Electrical) SYSTEM.
WARNING
Do not connect unapproved equipment to the console.
Do not attempt to make any unauthorized connections to these or any other ports on the
system.
Incorrect connections or use of unapproved equipment may result in injury or equipment
damage. Consult your service representative if external equipment is to be connected to
this system.
WARNING
The movement stop button must be unlocked (pull the red button) only after the cause of
the hazard has been clearly identified and eliminated.
18.3.5. Microswitches
The equipment is fitted with one microswitch (1) positioned as shown in Fig. 30.
This microswitch serves as additional safety device on the end of stroke of the tilting mechanical transmission.
Two additional microswitches (2) in Fig. 30, guarantee that the machine will never collide with the floor of the
examination room in which it is installed. These microswitches get enabled in case that the software for floor
limits fails to work.
MICROSWITCHES
(1) Tilting
(2) I.I. safety (on tables equipped with I.I.)
WARNING
Before commanding any equipment movement make sure that the relative area is free of
obstacles.
WARNINGS
Before commanding any movement of the equipment, verify that no one but the patient is
present within the machine moving area and that the patient is properly positioned and
secured on the tabletop, as described further on.
While commanding the equipment, do not remain standing close to the machine.
While commanding the equipment, do not assume a working position seated directly on the
equipment.
• Be particularly wary of the risk of crushing feet when the equipment tilts.
The following pictures show and better explain which dangerous areas must be particularly paid attention to.
The cross-hatched parts shown in the pictures identify the areas where dangers of collision or crushing exist.
Dangerous areas are shown in front and side views, in the 3 main functioning positions of the equipment:
horizontal table (0°), vertical table (+90°), vertical table (-90°).
In Fig. 35 the points where danger of collision exists are shown by the black arrows, while points where
danger of crushing exists are shown by white arrows.
Some warning labels are placed on the machine, close to the points where danger of crushing exists, as
illustrated in chapter 21.
WARNING
When the equipment is moving or the patient is being positioned, personnel and patient may
only grasp the grips that have been provided specifically for this purpose.
For patient weights higher than 230 kg (up to max. 260 kg) it is necessary to place the table at
its minimum height, to position the mobile area based on the area to be examined and, only
later, to load the patient on the tabletop.
WARNING
With a patient weighing more than 230 kg (up to max. 260 kg) on board, no movements are
allowed (static exam).
We suggest that you immediately eliminate contrast liquid stains. Before the examination, carry out an overall
inspection without any object with the largest possible format.
18.9. Protection against explosions
This equipment is not designed to operate in areas where there are explosion risks.
WARNING
Repetitive or prolonged exposures may result in local skin dose levels that cause adverse tissue
reactions.
In various load, filtration and collimation conditions which are typical of intended uses as defined in the
relevant paragraph, dosimetric information were detected by using:
FFD
115/180 cm
DOSIMETER
20 cm
PMMA
20 cm
The measured values have been recalculated by relating them to the patient entrance reference point (30 cm
above patient support).
The values thus obtained have been then compared with those measured by the system in the same
operating conditions.
The variance between the values measured by the system and the values obtained with the test is included
within the limit range defined by the standard.
Upon customer request the company can provide further dosimetric information referred to specific and
peculiar work techniques.
The following table summarizes doses expressed as Air kerma rate (Ak rate, mGy / min) or Air kerma (AK mGy)
considering a set of typical modes of operation.
ADDED FILTERS
0Al 1Al - 0,1 Cu 1Al - 0,2 Cu 2 Al
Ak rate Ak rate Ak rate Ak rate
RADIOSCOPY (*) Dose level kV mA mGy/min kV mA mGy/min kV mA mGy/min kV mA mGy/min
maximum field size Level 1 58 1,5 7,89 61 1,7 3,21 62 1,8 2,10 59 1,6 4,44
zoom 20x20 Level 1 67 2,3 15,54 70 2,6 6,91 71 2,7 4,93 69 2,5 9,62
maximum field size Level 2 62 1,8 11,59 65 2,1 4,98 66 2,2 3,29 64 2,0 6,91
zoom 20x20 Level 2 73 3,0 24,67 75 3,3 11,22 77 2,8 8,16 74 3,1 14,80
maximum field size Level 3 68 2,4 17,32 67 2,3 7,67 72 2,8 5,55 69 2,5 10,69
zoom 20x20 Level 3 73 3,0 37,00 79 3,8 18,13 85 4,2 13,44 81 4,0 23,68
ADDED FILTERS
0Al 1Al - 0,1 Cu 1Al - 0,2 Cu 2 Al
PULSED
RADIOSCOPY Ak rate Ak rate Ak rate Ak rate
4 frame/sec (*) Dose level kV mA mGy/min kV mA mGy/min kV mA mGy/min kV mA mGy/min
maximum field size Level 1 49 37,7 10,44 53 38,9 3,74 55 39,5 1,88 51 38,3 4,15
zoom 20x20 Level 1 56 40,0 16,06 60 41,0 5,24 63 42,4 3,49 59 40,7 7,61
maximum field size Level 2 54 39,2 12,34 58 40,4 4,88 60 41,0 3,37 56 39,8 5,82
zoom 20x20 Level 2 63 43,1 20,11 67 45,2 8,04 69 47,3 5,24 66 44,5 11,00
maximum field size Level 3 60 41,0 18,92 64 43,8 4,98 66 45,2 3,57 62 42,4 7,10
zoom 20x20 Level 3 71 48,8 28,34 75 50,0 8,21 78 50,8 5,42 73 49,2 11,19
* Radioscopy (continuous and pulsed) used in dynamic examinations (e.g., urography, cistography, clisma
barium, digestive and alimentary tract)
** Values typical of skeleton examinations (e.g., skull, upper and lower extremities, spine, pelvis)
*** Values typical of abdomen and thorax examination
It is common knowledge that the ionization process can cause damages to cellular DNA. See following
information about deterministic effects on human body after localised and whole body irradiation by X-ray
(data source: ICRP, International Commission on Radiological Protection):
WARNING
Do not attempt to install unauthorized software onto any system component.
19.1. Cleaning
Clean the equipment by means of a soft cloth or a cotton pad. Dampen the cloth or pad with a solution of
tepid water and normal household liquid detergent.
Do not use any abrasive detergents, organic solvents, or cleansers containing solvents (alcohol, ether).
WARNING
Do not use liquid sprays! Fluid cleansers must not under any circumstance penetrate the
equipment!
19.2. Disinfection
For disinfecting the surfaces we recommend using a liquid solution with aldehyde or amphoteric based water
solution for disinfecting surfaces such as Tego 103, Korsolin (not available in Canada. For Canadian market we
recommend using tb Minuteman or hx2).
The following disinfectants have been found compatible with the cover material of the equipment and can be
used on the outer surface of the devices, as well.
- WIP’ ANIOS Excel
- Sani-Cloth AF3
- Microzid Sensitive Wipes
- Meliseptol Rapid
- Acrylan
- Lysoformin 3000
WARNING
It is generally known that disinfectants can be hazardous to health. Concentrations of
disinfectants in air that is breathed must not exceed specific legal limits. For this reason, it is
important to follow instructions supplied by the manufacturer regarding their usage.
This medical equipment must be carefully used and needs periodical maintenance as specified
in the technical documentation.
General Medical Merate S.p.A. is responsible for the safety of its products only in case their
maintenance, repairing or modification are carried out by General Medical Merate S.p.A. or by
personnel authorized by General Medical Merate S.p.A.
General Medical Merate S.p.A. denies any responsibility for improper operation, damages or
dangerous situations caused directly or indirectly by non-respect of maintenance schedules.
Note Spare parts used for maintenance or technical service must be original GMM parts.
21. LABELLING
21.1. Identification and compliance labels
Labels are applied to identify the product from a commercial point of view and to meet the requirements of
the standards currently in force.
Pos. Description
1 Brand or distributor logo
2 Name and address of the brand or distributor
3 Name and address of the manufacturer
4 Product name (as per the CE Certificate)
5 Code or reference name for internal use
6 Serial number
7 Production Data
8 Electric power supply data
9 Additional power supply data and/or product features
10 Space reserved for product certifications
11 Additional power supply data and/or product features
WARNING
Do not remove adhesive labels applied to the machine, they are an integral part of the
documentation accompanying the equipment.
The content of the labels shown must be considered as example, valid only for their position.
Collimator (8)
Grid (5)
IP21
2 1 I. I. group (9) 4 3
In addition the following manufacture labels are supplied, placed on the following equipment components:
The identification of the product from a commercial point of view is ensured by the application of adhesive
labels on the front of the Spot Film Device, of the collimator and of the control console.
Adhesive label on the front of SFD GMM logo + full equipment and model trade name
Adhesive label on the front of collimator GMM logo
Adhesive label on control panel GMM logo + OPERA trade name
N.B. Normally the power supply of the remote-controlled table is picked up by a 16A, delayed 400Vac
nominal bipolar sectioning automatic switch, placed in the mains supply panel board of the exam room,
with intervention differential protection not higher than 30mA in compliance with IEC/CEI standards.
The ground terminal of the equipment must be connected in a visible manner to the earth equipotential
node of the diagnostic system by means of a protection conductor, with the minimum section of 10 mm 2.
The power cable from the mains supply panel board to the equipment electrical cabinet must have a
minimum section of 2.5 mm2.
All the power connections and earth cables must be in compliance with the national rules related or
equivalent.
WARNING
To avoid risk of an electric shock, this equipment must only be connected to a grounded
electrical network.
Please contact General Medical Merate S.p.A. or other firms authorized by the national authorities for the
disposal of electrical and electronic equipment.
In order to minimize risks, the following chart and table supply information regarding the materials used to
manufacture the equipment, relative quantities, characteristics and disposal methods.
8 7
7
4
5
1 10 1 6 2 1
00
00