User Manual

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“C” Arm Mobile Unit

Neeo

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IDENTIFICATION PLATES
A facsimile of the Identification Plates applied on the radiological unit is shown below.

M ODELLO / MODEL: NEEO R9

CODICE / CODE:
M ATRICOLA / SERIAL N UMBER:
ALIMENTAZIONE / M AIN V OLTAGE: 230V~ 50/60 Hz
I ASSORBITA / I ABSORPTION: 6A FLUORO - 22A RADIO
IBIS Srl, Via Cascina Bruciata 3,
24068 Seriate (BG) ITALY
2014-04

DECLARATION OF RESPONSIBILITY
The MANUFACTURER is only responsible for the safety of its products when their maintenance,
repair and/or modification has been carried out by the MANUFACTURER or by personnel expressly
authorised to do so by the MANUFACTURER itself.
The manufacturer shall not be held responsible in any way for malfunction, damage and/or
danger due to incorrect use of the system or to disregard of the maintenance Regulations.
The user of the installation where the system is connected is responsible for making sure that
the installation itself is only used by suitably trained and qualified operators.

COMPLIANCE AND REFERENCE ADDRESS

Mobile Equipment is in compliance with the national and international standard in force.
Information relevant to the compliance may be required to:

SL - Via Monte Grappa 7 - I - 24121 Bergamo - ITALY

SO - Via Cascina bruciata 3 - 24068 Seriate (BG) - ITALY
Tel+39 035 42.36.343 Fax +39 035 29.22.079
P. IVA e Codice Fiscale IT 02942850161

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INDEX

Index
IDENTIFICATION PLATES .................................................................................................................... 2
DECLARATION OF RESPONSIBILITY ...................................................................................................... 2

1 General Description ................................................................................... 8

1.1 Applications ...................................................................................................................... 8
1.2 Composition ..................................................................................................................... 8
1.2.1 Stand............................................................................................................................. 9
1.2.2 Pedal unit.................................................................................................................... 11
1.2.3 Control console unit stand......................................................................................... 12
1.2.4 Display station ............................................................................................................ 14
1.3 Accessories ..................................................................................................................... 16
1.4 Operation mode ............................................................................................................. 16
1.5 Stand Movements ........................................................................................................... 17
1.6 Transport ........................................................................................................................ 20
1.6.1 Display Station Transport .......................................................................................... 20
1.6.2 Stand Trasport ............................................................................................................ 21
1.7 Switching ON .................................................................................................................. 24
1.8 Operation on completion of Use.................................................................................... 25
1.9 Technical Data ................................................................................................................ 26
1.9.1 Classification of the Apparatus .................................................................................. 26
1.9.2 Technical Characteristics ........................................................................................... 26
1.9.2.1 Electrical and Mechanical Characteristics ......................................................... 26
1.9.2.2 Exposure modes ................................................................................................ 29
1.9.2.3 Image display system......................................................................................... 30
1.9.2.4 Optional Component ......................................................................................... 32
1.9.2.5 kV-mA Relationship ........................................................................................... 33
1.9.3 Dimension and weights.............................................................................................. 45
1.9.3.1 Display station ................................................................................................... 45
1.9.3.2 Stand .................................................................................................................. 46
1.9.3.3 Stand 12” ........................................................................................................... 47

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2 Safety and maintenance ........................................................................... 49

2.1 Introduction .................................................................................................................... 49
2.2 Compliance and respomsibility declaration ................................................................... 49
2.3 Compliance and reference address ................................................................................ 50
2.4 System Safety Mechanisms ............................................................................................. 50
2.4.1 Mechanical Safety ....................................................................................................... 50
2.4.2 Electrical Safety .......................................................................................................... 50
2.4.3 Laser Localizer Safety ................................................................................................. 51
2.4.4 Equipotential earth connection ................................................................................. 51
2.4.5 Thermomagnetic Circuit-Breaker ............................................................................... 51
2.5 Protection against Ionizing Radiation ............................................................................ 52
2.5.1 Designated Significant zones of Occupancy .............................................................. 53
2.6 Residual Risks ................................................................................................................. 54
2.7 Signals ............................................................................................................................. 55
2.7.1 Symbols used .............................................................................................................. 55
2.7.2 Labelling ..................................................................................................................... 56
2.7.3 Messages on the Stand Display .................................................................................. 57
Maintenance ............................................................................................................................... 59
2.8 Routine Maintenance ...................................................................................................... 59
2.8.1 General Recommendations ........................................................................................ 59
2.8.2 Checks and inspections to be carried out by the user .............................................. 60
2.9 Cleaning and Disinfection............................................................................................... 60
2.10 Electromagnetic Compatibility (EMC) ............................................................................ 61
2.10.1 List of Cable ................................................................................................................ 61
2.10.2 Performance ............................................................................................................... 62
2.10.3 Electromagnetic Emissions ........................................................................................ 62
2.11 Elimination of the Device ............................................................................................... 64

3 Use of the Unit ......................................................................................... 67

3.1 Recommendations .......................................................................................................... 67
3.2 Operating Procedure ...................................................................................................... 68
3.2.1 Continuous Fluoroscopy ............................................................................................ 69
3.2.1.1 Continuous Automatic Radioscopy ................................................................... 70
3.2.1.2 Continuous Manual Radioscopy ........................................................................ 70

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3.2.2 Pulsed Fluoroscopy .................................................................................................... 71

3.2.3 Memorized Fluoroscopy (only with RTP) ................................................................... 71
3.2.4 Radiography ............................................................................................................... 71
3.2.5 Image Controls ........................................................................................................... 72
3.2.6 Collimator Control ..................................................................................................... 73
3.2.7 Zoom Conrol .............................................................................................................. 73
3.2.8 Dosimeter (Optional).................................................................................................. 73
3.2.9 Dosimetric information .............................................................................................. 74
4 Revision List.............................................................................................. 75

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1 GENERAL DESCRIPTION

1.1 APPLICATIONS
The apparatus is a MOBILE X-RAY UNIT with an IMAGE INTENSIFIER specially studied for use in
orthopaedics, abdominal and urological operating theatres, as well as in cardiology and for
routine operating procedures.
The available radiologic technique is:
 Continue fluoroscopy
 High dose fluoroscopy (boosted)
 Pulsed fluoroscopy
 Fluoroscopy “one shot”
 Radiography with standard cassette

The specific characteristics, selectable parameter, kV, mA o mAs and his activation are described
in detail on the user manual. The unit, in his maximum configuration, permit a kind of image
elaborations.

Device life: 10 years with a regular maintenance of the device

1.2 COMPOSITION
The SYSTEM is made up of the following:
 STAND with arc to support the IMAGE INTENSIFIER and X-RAY TUBE HEAD with relative
COLLIMATOR
 DISPLAY STATION for acquisition and display of the image
 PEDAL UNIT for x-ray emission control in the various acquisition modes
 INFRARED REMOTE CONTROL (OPTIONAL) for remote control of the DISPLAY STATION functions
used most often.

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1.2.1 STAND

4
18
2
1

21

15
24 23

16
8
14

9
5
17

10

13 11

12

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18 22
4
1
5
3

21
19

11
20

21 7
3

10

12

STAND
1 Handle for horizontal C-arm movement 14 Radiography control pushbutton
2 Brake for locking C-arm angle 15 Handles for moving stand
3 Steering knob and parking brake 16 Pedal unit connector
4 Brake for locking C-arm flag-wavers 17 Radiography pushbutton connector
5 Brake for C-arm sliding 18 Brake for horizontal C-arm positioning
6 Handle for C-arm sliding 19 Equipotential earth connector
7 Image Intensifier 20 Display Station connector
8 Collimator 21 Emergency pushbutton
9 X-Ray Tube Head 22 Stand Control panel
10 Pivot wheel with cable protection 23 Laser Localizer (Optional)
11 X-Ray unit power supply cable 24 Dosimeter (Optional)
12 ± 90° wheels with cable protection 25 Continues fluoroscopy hand switch control
Pulsed fluoroscopy and one-shot hand switch
13 Radiography control extendible cable 26
control

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1.2.2 PEDAL UNIT

RTP SBFM76/SBFM78
/
25 26

- Pulsed Fluoroscopy
- One Shot Fluoroscopy
- Fluoroscopy with Acquisition
- Fluoroscopy
- Pulsed Fluoroscopy
- One Shot fluoroscopy

Fluoroscopy

Although keeping the basic structure unaltered, the SYSTEM is available in various models,
according to the MEMORY installed in the DISPLAY STATION.
 SBFM76
 SBFM78
 RTP

For the technical specifications of each model, please SEE SECTION 3

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1.2.3 CONTROL CONSOLE UNIT STAND

7 8

1 5 6 2 9

1  The Supply are signalling by light 7 Radiography modality selection

2  X-ray emission signal 8  Increase button

3  C-arm raising 9  decrease button

 Blade diaphragm clockwise /

4  C-arm lowering 10
anticlockwise rotation(3)

5  Switching the stand on 11  blade diaphragm opening / closing(3)

6  Switching the stand off 12  Image clockwise / anticlockwise

rotation(3)

13  No image magnification(3) 24 Manual technique selection

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14  1° image magnification(3) 25 Laser Localizer

activation/deactivation (1)

15  2° image magnification(3) 26  Fluoroscopy time reset

16  Fluoroscopy Selection 27 Reset dose(1)

17 Pulsed Fluoroscopy Selection (5) 28  Fluoroscopy time alarm reset

18  One Shot Fluoroscopy Selection 29  Image search - back / forward(3

19 30  image horizontal inversion

Iris diaphragm closing / opening(2) (3)
activation / deactivation

20  increase / decrease kV(3) 31  Select / deselect half dose (mA/2)

21  increase / decrease mAs(3) 32  Collimator fully open (only in

Radiography)

22  Memorize on ram(4) 33  Fluoroscopy with acquisition

selection (5) (6)

23  Anatomic technique selection 

(1) Active key only with relevant device installed

(2) In Radiography mode, by pressing the key, the iris diaphragm will be automatically opened to the maximum
format collimation
(3) The icon, when selected, will flash for 10 seconds
(4) Save the current image or the last image
(5) With RTP , the selection must be performed using the key of the visualization station
(6) Only with RTP

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1.2.4 DISPLAY STATION

35

36 34

33
47

37

48

32

46

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35 35

40
33 33

41

39
39

44 44
38
45 38
42
42

46 46
43

DISPLAY STATION
31 N.U. 40 Monitor Signal Cable
32 Handle for moving 41 Cable-winder supports
33 Key for switching on 42 Cable output for stand connection
34 Memory Monitor (in DIM 32/64 only) 43 Power supply cable output
35 X-Ray passage signalling lamp 44 Power supply cable connector
36 Work Monitor 45 Thermomagnetic circuit-breaker
37 Emergency pushbutton 46 Pivot wheels with parking brakes
38 Stand connector 47 Modification contrast and brightness control
39 Connection cable to Stand 48 Printer housing (Optional)

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1.3 ACCESSORIES
The system can be interfaced with the following accessories:
 Printer
 DICOM System for image transmission to network /CD ROM(available in RTP model only)
 Laser Localizer
 Dosimeter.
For a detailed description of the components, please SEE SECTION 3.

1.4 OPERATION MODE

The system has different working techniques according to the memory installed.

SBFM76 RTP

Continuos Digital Fluoroscopy  

Pulsed Fluoroscopy  
One Shot Fluoroscopy  
Continuos Digital Fluoroscopy
 
with acquisition on HD/RAM
Max-Opacification and Road-

Mapping
Subtraction in real time 
Radiography with cassette  

* Working mode optional for RTP memory

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1.5 STAND MOVEMENTS

The STAND movements can be either motorized or manual. In the former case, it is sufficient to
press the dedicated keys and then the system must be powered, whereas in the latter it is
necessary to release the brakes by turning the relative knob anti-clockwise, manually position
the Stand and put the brakes on again by turning the knob clockwise.
The Stand movements are indicated below (for the numerical references, please SEE - § 1.2.1 and
1.2.3).

! Do not try to move the system when the brakes are applied.

VERTICAL MOVEMENT - motorized

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HORIZONTAL MOVEMENT - manual

18

C-ARM ROTATION - manual

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C-ARM SLIDING - manual

LATERAL WING-WANG - manual

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1.6 TRANSPORT

1.6.1 DISPLAY STATION TRANSPORT

To transport the DISPLAY STATION follow what is indicated below. The FIGURE shows the
transport configuration (for the numerical references, SEE - § 1.2.4 PAG.14-15).
 Wind the power supply cable and the connection cable to the STAND over the special
rear cable winding supports (41)
 move the DISPLAY STATION after having released the parking brakes (46)
 to move it, use the special side handles (32)
 once the desired position has been found, put the parking brakes on again

32

41

46

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1.6.2 STAND TRASPORT

To transport the STAND follow what is indicated below. The FIGURE shows the transport
configuration (for the numerical references, SEE SECTION 1 - § 1.2.1).

15

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Wind the PEDAL UNIT cable around this and position it on

the front leg of the STAND

 Turn the arc until the vertical position is reached, indicated

by 0° on the goniometer near the relative knob: this means
the IMAGE INTENSIFIER remains positioned at the top

 Take the sideways movement to a central position in

relation to the machine

Position arc sliding to 0° on the goniometer located on the

arc itself

Position arc traverse in correspondence with the value 0 -

i.e. in a fully retracted position in relation to the slide

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 Completely lower the arc (to carry out this operation, the
system must be on - SEE §1.7)

Release the parking brake by means of the knob (3) and

position the mark of this in correspondence with the
required Stand movement, making reference to the signals
indicated on the label applied under it (See FIGURE at the
side)

 Move the STAND using the special transport handles (15).

Once the desired position has been found:

 Put the parking brakes on by means of the knob (3)
 Position the PEDAL UNIT on the floor.
.

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1.7 SWITCHING ON
Once the system has been positioned, follow the indications given below to make it operational
(for the numerical references - SEE SECTION 1 - § 1.2.1 and 1.2.3):
connect the STAND to the DISPLAY STATION
connect the DISPLAY STATION to the power supply mains

! Only use 16 A sockets with earthing terminal.

 if not already connected, connect the PEDAL UNIT

 if not already connected, connect the RADIOGRAPHY PUSHBUTTON
 connect the PATIENT BED to the equipotential earthing connector
(19) located on the stand
 check that the THERMOMAGNETIC CIRCUIT-BREAKER of the DISPLAY
STATION (45) is in the ON position (small lever turned upwards)
 check that the EMERGENCY PUSHBUTTONS of the DISPLAY STATION (37)
and STAND (21) are released. If this is not so, turn them clockwise
 turn the DISPLAY STATION on by using the key switch on the station
itself (33).
 the ON key LED will light up on the STAND.
 turn the STAND on by using the ON key.

For a detailed description of operation of the system, please SEE SECTION 3.

!
ATTENTION – During the use of the visualization station, check that the connection
! cable of the stand is not connected

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1.8 OPERATION ON COMPLETION OF USE

On completion of use, always proceed as specified below (for the numerical references, SEE
SECTION 1 - § 1.2.2 and 1.2.3):
 put the stand in the parking position (SEE § 1.6.2)

 turn the stand off using the OFF key

 wind the cable of the PEDAL UNIT up and position it on the surface
of the front leg of the STAND
 turn the display station off by putting the ON KEY(33) in the OFF
position
 disconnect the cable between the DISPLAY STATION and the STAND
and wind it up over the special supports on the rear of the
DISPLAY STATION itself (41)
 disconnect the power supply cable and wind it up over the
special supports on the rear of the DISPLAY STATION (41).

Never disconnect the cable between the stand and the DISPLAY STATION unless the
! STAND has been turned off beforehand.

Do not remove the connector from the power supply socket if the DISPLAY STATION
! has not been turned off.

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1.9 TECHNICAL DATA

1.9.1 CLASSIFICATION OF THE APPARATUS

CLASSIFICATION – EN 60601 1 § 5
 Type of protection against short circuits: CLASS I
 Degree of protection against and indirect contact: TYPE B
 Use condition: CONTINUOUS WORKING WITH
INTERMITTED LOAD

Unit not to be used in the presence of an inflammable anaesthetic mixture with air
! or nitrous oxide

CLASSIFICATION – 93/42/CEE Directive

 In according with annex IX: CLASS II b

1.9.2 TECHNICAL CHARACTERISTICS

1.9.2.1 ELECTRICAL AND MECHANICAL CHARACTERISTICS

ELECTRICAL FEATURES “S” “R”

Generator power in dc current 3,5 kW 3,5 kW/5Kw(optional)

Single phase voltage 230 Vac ± 10% 230 Vac ± 10%

Frequency 50/60 Hz 50/60 Hz

fluoroscopy working 230 Vac: 6 A 230 Vac: 6 A

Max current absorption
radiography working 230 Vac: 22 A 230 Vac: 22 A

Line compensation Automatic Automatic

Line resistance 0, 4 Ω 0.4 Ω

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RADIOLOGICAL FEATURES “S” “R”

Generator power in dc current 3,5 kW 3,5 kW/5Kw(optional)

Generator operating frequency 40 kHz 40 kHz

Kv range 40 ÷ 110 kV 40 ÷ 120 kV

fluoroscopy working 5 mA 5 mA
Monoblock max current
radiography working 65 mA 65 mA

Max mA with one-shot and fluoroscopy 10 mA 12 mA

mAs range 1 ÷ 250mAS 1 ÷ 250mAS

OPTIONAL: power up to 5kW on the rotating anode version

X-RAY TUBE HEAD “S” “R”

Anode type stationary Rotating (3000 RPM)

0,5x0,5 mm 0,3x0,3 mm
Focal size
1,5x1,5 mm 0,6x0,6 mm

fixed additional filtering 1 mmAl

total filtering > 2.7 mmAl

For all the other information concerning the X-Ray Tube Head and to the X-Ray Insert refer to the X-Ray
Tube Head Technical Data Sheet

COLLIMATOR

Control from stand control console, with continuously adjustable

Iris opening up to the maximum allowed according to the I.I. field
selected

Rotating shutters (optional) 2 parallel leaded shutters with variable opening and rotation

For all the other information concerning Collimator refer to the relative Technical Data Sheet

Virtual collimator with RTP

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MECHANICAL FEATURES “S” “R” “S/R”

Model S-9” R-9” 12”

Motorized vertical run 450 mm 450 mm

Horizontal run 210 mm 210 mm

Wig-wag ± 12° ± 12°

Arc lateral rotation +/- 270° +/- 270°

Arc orbital movement 130° (90°+40°) 130° (90°+40°)

s.i.d. 946 mm 933 mm

Arc depth 659 mm 659 mm

Usable space between x-ray tube head and i.i. 730 mm 730 mm

Min/max length 2018/2463mm 2018/2463mm

Max width 830 mm 830 mm

Min/max height 1827/2277mm 1827/2277mm

Weight 275 kg 275 kg

Manual - Steering back wheels with parking position

Movement
Rotating anterior wheel

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1.9.2.2 EXPOSURE MODES

OPERATING MODES AND FUNCTIONALITY

Display Touch Screen for all the operative parameters and messages
User’s interface
of fault conditions - microprocessor control

radiography 2 points technique (kV and mAs)

Operating
modalities 0 point technique with automatic control for kV and mA
fluoroscopy
1 points technique with manual control of kV
remote control with double step hand switch with extension cable
radiography
(4m)
X-ray command
fluoroscopy remote control with multifunction footswitch (2m)

selection of the Electronic Zoom according to the I.I. fields number.

i.i. field selection In this case the Iris collimator limits the X-Ray Field according to the
selected I.I. field

- filament current
- mAmin and mAmax
- maximum exposure time
- x-ray tube head maximum temperature
SAFETY - x-ray tube head thermal units count
- timer with x-ray stop and reset each 5 min. - maximum counting up to 10 min.
- max kV, min kV, max kV, max I
- anode rotation
- microprocessor self test

TRANSPORT & STORAGE CONDITIONS

Max temperature –10°C ÷ 55°C

Recommended temperature 0°C ÷ 40°C

Relative humidity 20% ÷ 90%

Atmospheric pressure 500 hPa ÷ 1060 hPa

OPERATING CONDITIONS
Max temperature 10°C ÷ 40°C

Relative humidity 30% ÷ 70%

Atmospheric pressure 700 hPa ÷ 1060 hPa

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1.9.2.3 IMAGE DISPLAY SYSTEM

IMAGE INTENSIFIER

For all the information concerning Image Intensifier refer to the relative Technical Data Sheet

IMAGE INTENSIFIER GRID

Ratio 8:1

Shutters 40 L/cm (103 L/”)

Focalizing 90cm

TV CAMERA
ccd sensor ½ “ low persistance yes

Video standard CCIR (625 LINES, 50HZ INTERL)

Bandwidth 14 MHZ

Aspect ratio 4:3

OPTIONAL: 1K x 1K camera see annex

MONITOR
For all the other information concerning the Monitor refer to the its
Standard: LCD monitor 19”
Technical Data Sheet
OPTIONAL: LCD monitor 18” see annex
NEEO 110 DIGITAL VIDEO IMAGE PROCESSOR
image format 576X576X8 BIT
Technical features
NEEO with L.I.H. 110 images memory capacity (2
ram memory
monitors)

Continuous fluoroscopy

Pulsed fluoroscopy with

ACQUISITION FRAME RATE:
Operation modalities RX pulses of 250ms
1 frame/1 sec
each

one-shot fluoroscopy X-RAY TIME: 880ms

Real-time processing - Horizontal/Vertical Inversion

features - Noise Reduction (Recursive Filter)
- Horizontal-Vertical Inversion
Post-processing features
- Printout (Optional)
OPTIONAL: Hard disk memory 300 images

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RTP DIGITAL VIDEO PROCESSOR (OPTIONAL)

image format 576 x 576 x 8 bit

image acquired, stored and displayed

576 x 576 x 12 bit

A/D converter (recursive filter image processing)
10 bit – 15 MHz
(sampling rate)

D/A converter 8 bit

video input standard CCIR 625 lines – 50Hz, 1 Vpp – 75 W
Technical features
video output VGA
video output aux
DVI
(printer and/or vcr)
hard disk memory 160GB (80.000 images)

Acquisition frame rate 1,3,6,12,25 frames/sec.

control panel and alphanumeric keyboard

patiens’ directory
 electronic Rotation
 Horizontal-verthical Inversion
Real time processing
 Contrast and Brightness Adjustment
features  Grey scale Inversion
 Fluoroscopy Acquisition max op.
 Digital Subtracion
 Horizontal-verthical Inversion
 Contrast and Brightness Adjustment
 Grey scale Inversion
 Edge Enhancement
Post processing
 Cine Loop Review
features  Shifting pixels
 Land Marking.
 Digital Subtraction
 Digital zoom 2x
 Overview (Mosaic)

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1.9.2.4 OPTIONAL COMPONENT

LASER LOCALIZER
LASER DIODE Classe II
WAVE LENGTH 655 nm
MAX OUTPUT < 1 mW
CROSS ANGULAR SIZE 20°

LASER LIGHT PRESENCE WARNING

REFERENCE STANDARD IEC 60825-1:1993 + A1:1997 + A2:2001

WARNING Laser Radiation – Do not stare into beam
DOSIMETER
MODEL Kermax 120-122 Vacudap 2002 with optional printer
ACTIVE AREA (Ø) 72 mm 72 mm
MINIMAL DOSE RESOLUTION 1 mGycm2 1 mGycm2
MAXIMAL MEASURABLE DOSE 999.999 mGycm2 99.999.999 mGycm2

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1.9.2.5 KV-MA RELATIONSHIP

1.9.2.5.1 Version with Rotating Anode X-Ray Tube Head – 2,8 kW

TABLE 1
kV Fluoro mA Fluoro mA/2 Pulsed mA One Shot mA Radio mA kV Fluoro mA Fluoro mA/2 Pulsed mA One Shot mA Radio mA
40 0,2 0,1 0,28 0,48 65 85 4,6 2,3 6,44 11,04 32.94
41 0,24 0,12 0,336 0,576 65 86 4,56 2,28 6,384 10,944 32.55
42 0,28 0,14 0,392 0,672 65 87 4,52 2,26 6,328 10,848 32.18
43 0,32 0,16 0,448 0,768 65 88 4,48 2,24 6,272 10,752 31.81
44 0,36 0,18 0,504 0,864 63,63 89 4,44 2,22 6,216 10,656 31.46
45 0,4 0,2 0,56 0,96 62,22 90 4,4 2,2 6,16 10,56 31.11
46 0,44 0,22 0,616 1,056 60,86 91 4,36 2,18 6,104 10,464 30.76
47 0,48 0,24 0,672 1,152 59,57 92 4,32 2,16 6,048 10,368 30.43
48 0,52 0,26 0,728 1,248 58,33 93 4,28 2,14 5,992 10,272 30.1
49 0,56 0,28 0,784 1,344 57,14 94 4,24 2,12 5,936 10,176 29.78
50 0,6 0,3 0,84 1,44 56 95 4,2 2,1 5,88 10,08 29.47
51 0,82 0,41 1,148 1,968 54,9 96 4,16 2,08 5,824 9,984 29.16
52 1,04 0,52 1,456 2,496 53,84 97 4,12 2,06 5,768 9,888 28.86
53 1,26 0,63 1,764 3,024 52,83 98 4,08 2,04 5,712 9,792 28.57
54 1,48 0,74 2,072 3,552 51,85 99 4,04 2,02 5,656 9,696 28.8
55 1,7 0,85 2,38 4,08 50,9 100 4 2 5,6 9,6 28
56 1,92 0,96 2,688 4,608 50 101 3,96 1,98 5,544 9,504 27.72
57 2,14 1,07 2,996 5,136 49,12 102 3,92 1,96 5,488 9,408 27.45
58 2,36 1,18 3,304 5,664 48,27 103 3,88 1,94 5,432 9,312 27.18
59 2,58 1,29 3,612 6,192 47,45 104 3,84 1,92 5,376 9,216 26.92
60 2,8 1,4 3,92 6,72 46,66 105 3,8 1,9 5,32 9,12 26.66
61 3,02 1,51 4,228 7,248 45,9 106 3,76 1,88 5,264 9,024 26.41
62 3,24 1,62 4,536 7,776 45,16 107 3,72 1,86 5,208 8,928 26.16
63 3,46 1,73 4,844 8,304 44,44 108 3,68 1,84 5,152 8,832 25.92
64 3,68 1,84 5,152 8,832 43,75 109 3,64 1,82 5,096 8,736 25.68
65 3,9 1,95 5,46 9,36 43,07 110 3,6 1,8 5,04 8,64 25.45
66 4,12 2,06 5,768 9,888 42,42 111 3,56 1,78 4,984 8,544 25.22
67 4,34 2,17 6,076 10,416 41,79 112 3,52 1,76 4,928 8,448 25
68 4,56 2,28 6,384 10,944 41,17 113 3,48 1,74 4,872 8,352 24.78
69 4,78 2,39 6,692 11,472 40,57 114 3,44 1,72 4,816 8,256 24.56
70 5 2,5 7 12 40 115 3,4 1,7 4,76 8,16 24.35
71 5 2,5 7 12 39,43 116 3,36 1,68 4,704 8,064 24.14
72 5 2,5 7 12 38,88 117 3,32 1,66 4,648 7,968 23.93
73 5 2,5 7 12 38,35 118 3,28 1,64 4,592 7,872 23.73
74 5 2,5 7 12 37,83 119 3,24 1,62 4,536 7,776 23.53
75 5 2,5 7 12 37,33 120 3,2 1,6 4,48 7,68 23.33
76 4,96 2,48 6,944 11,904 36,84
77 4,92 2,46 6,888 11,808 36,36
78 4,88 2,44 6,832 11,712 35,89
79 4,84 2,42 6,776 11,616 35,44
80 4,8 2,4 6,72 11,52 35
81 4,76 2,38 6,664 11,424 34,56
82 4,72 2,36 6,608 11,328 34,14
83 4,68 2,34 6,552 11,232 33,73
84 4,64 2,32 6,496 11,136 33,33

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1.9.2.5.2 Version with Stationary Anode X-Ray Tube Head – 2,8 kW

TABLE 2
kV Fluoro mA Fluoro mA/2 Pulsed mA One Shot mA Radio mA kV Fluoro mA Fluoro mA/2 Pulsed mA One Shot mA Radio mA
40 0,2 0,1 0,28 0,4 65 85 4,6 2,3 6,44 9,2 32.94
41 0,24 0,12 0,336 0,48 65 86 4,56 2,28 6,384 9,12 32.55
42 0,28 0,14 0,392 0,56 65 87 4,52 2,26 6,328 9,04 32.18
43 0,32 0,16 0,448 0,64 65 88 4,48 2,24 6,272 8,96 31.81
44 0,36 0,18 0,504 0,72 63,63 89 4,44 2,22 6,216 8,88 31.46
45 0,4 0,2 0,56 0,8 62,22 90 4,4 2,2 6,16 8,8 31.11
46 0,44 0,22 0,616 0,88 60,86 91 4,36 2,18 6,104 8,72 30.76
47 0,48 0,24 0,672 0,96 59,57 92 4,32 2,16 6,048 8,64 30.43
48 0,52 0,26 0,728 1,04 58,33 93 4,28 2,14 5,992 8,56 30.1
49 0,56 0,28 0,784 1,12 57,14 94 4,24 2,12 5,936 8,48 29.78
50 0,6 0,3 0,84 1,2 56 95 4,2 2,1 5,88 8,4 29.47
51 0,82 0,41 1,148 1,64 54,9 96 4,16 2,08 5,824 8,32 29.16
52 1,04 0,52 1,456 2,08 53,84 97 4,12 2,06 5,768 8,24 28.86
53 1,26 0,63 1,764 2,52 52,83 98 4,08 2,04 5,712 8,16 28.57
54 1,48 0,74 2,072 2,96 51,85 99 4,04 2,02 5,656 8,08 28.8
55 1,7 0,85 2,38 3,4 50,9 100 4 2 5,6 8 28
56 1,92 0,96 2,688 3,84 50 101 3,96 1,98 5,544 7,92 27.72
57 2,14 1,07 2,996 4,28 49,12 102 3,92 1,96 5,488 7,84 27.45
58 2,36 1,18 3,304 4,72 48,27 103 3,88 1,94 5,432 7,76 27.18
59 2,58 1,29 3,612 5,16 47,45 104 3,84 1,92 5,376 7,68 26.92
60 2,8 1,4 3,92 5,6 46,66 105 3,8 1,9 5,32 7,6 26.66
61 3,02 1,51 4,228 6,04 45,9 106 3,76 1,88 5,264 7,52 26.41
62 3,24 1,62 4,536 6,48 45,16 107 3,72 1,86 5,208 7,44 26.16
63 3,46 1,73 4,844 6,92 44,44 108 3,68 1,84 5,152 7,36 25.92
64 3,68 1,84 5,152 7,36 43,75 109 3,64 1,82 5,096 7,28 25.68
65 3,9 1,95 5,46 7,8 43,07 110 3,6 1,8 5,04 7,2 25.45
66 4,12 2,06 5,768 8,24 42,42
67 4,34 2,17 6,076 8,68 41,79
68 4,56 2,28 6,384 9,12 41,17
69 4,78 2,39 6,692 9,56 40,57
70 5 2,5 7 10 40
71 5 2,5 7 10 39,43
72 5 2,5 7 10 38,88
73 5 2,5 7 10 38,35
74 5 2,5 7 10 37,83
75 5 2,5 7 10 37,33
76 4,96 2,48 6,944 9,92 36,84
77 4,92 2,46 6,888 9,84 36,36
78 4,88 2,44 6,832 9,76 35,89
79 4,84 2,42 6,776 9,68 35,44
80 4,8 2,4 6,72 9,6 35
81 4,76 2,38 6,664 9,52 34,56
82 4,72 2,36 6,608 9,44 34,14
83 4,68 2,34 6,552 9,36 33,73
84 4,64 2,32 6,496 9,28 33,33

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kV – mA/2 Relationship in Continuous Fluoroscopy Mode

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kV – mA Relationship in Pulsed Mode

kV – mA Relationship in One Shot Mode

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1.9.2.5.3 Version with rotating anode x-ray tube head – 5 kW (optional)

TABELLA 2
Radio
Pulsed One Radio mA Radio mA Radio mA
kV Fluoro mA Fluoro mA/2 kV Fluoro mA Fluoro mA/2 Pulsed mA One Shot mA mA
mA Shot mA >8mAs <8mAs <8mAs
>8mAs
40 0,2 0,1 0,28 0,4 65 65 85 4,6 2,3 6,44 9,2 32.94 53
41 0,24 0,12 0,336 0,48 65 65 86 4,56 2,28 6,384 9,12 32.55 52.8
42 0,28 0,14 0,392 0,56 65 65 87 4,52 2,26 6,328 9,04 32.18 52.6
43 0,32 0,16 0,448 0,64 65 65 88 4,48 2,24 6,272 8,96 31.81 52.4
44 0,36 0,18 0,504 0,72 63,63 65 89 4,44 2,22 6,216 8,88 31.46 52.2
45 0,4 0,2 0,56 0,8 62,22 64 90 4,4 2,2 6,16 8,8 31.11 52
46 0,44 0,22 0,616 0,88 60,86 63.8 91 4,36 2,18 6,104 8,72 30.76 51.8
47 0,48 0,24 0,672 0,96 59,57 63.6 92 4,32 2,16 6,048 8,64 30.43 51.6
48 0,52 0,26 0,728 1,04 58,33 63.4 93 4,28 2,14 5,992 8,56 30.1 51.4
49 0,56 0,28 0,784 1,12 57,14 63.2 94 4,24 2,12 5,936 8,48 29.78 51.2
50 0,6 0,3 0,84 1,2 56 63 95 4,2 2,1 5,88 8,4 29.47 51
51 0,82 0,41 1,148 1,64 54,9 62.8 96 4,16 2,08 5,824 8,32 29.16 50.8
52 1,04 0,52 1,456 2,08 53,84 62.4 97 4,12 2,06 5,768 8,24 28.86 50.6
53 1,26 0,63 1,764 2,52 52,83 62 98 4,08 2,04 5,712 8,16 28.57 50.4
54 1,48 0,74 2,072 2,96 51,85 61.6 99 4,04 2,02 5,656 8,08 28.8 50.2
55 1,7 0,85 2,38 3,4 50,9 61 100 4 2 5,6 8 28 50
56 1,92 0,96 2,688 3,84 50 60.8 101 3,96 1,98 5,544 7,92 27.72 49.2
57 2,14 1,07 2,996 4,28 49,12 60.6 102 3,92 1,96 5,488 7,84 27.45 48.6
58 2,36 1,18 3,304 4,72 48,27 60.4 103 3,88 1,94 5,432 7,76 27.18 46
59 2,58 1,29 3,612 5,16 47,45 60.2 104 3,84 1,92 5,376 7,68 26.92 45.5
60 2,8 1,4 3,92 5,6 46,66 60 105 3,8 1,9 5,32 7,6 26.66 44
61 3,02 1,51 4,228 6,04 45,9 59.8 106 3,76 1,88 5,264 7,52 26.41 43
62 3,24 1,62 4,536 6,48 45,16 59.6 107 3,72 1,86 5,208 7,44 26.16 42
63 3,46 1,73 4,844 6,92 44,44 59 108 3,68 1,84 5,152 7,36 25.92 40
64 3,68 1,84 5,152 7,36 43,75 58.6 109 3,64 1,82 5,096 7,28 25.68 38
65 3,9 1,95 5,46 7,8 43,07 58 110 3,6 1,8 5,04 7,2 25.45 35
66 4,12 2,06 5,768 8,24 42,42 57.4 111 3,56 1,78 6,44 8,544 25.22 33
67 4,34 2,17 6,076 8,68 41,79 57 112 3,52 1,76 6,384 8,448 25 31
68 4,56 2,28 6,384 9,12 41,17 56.2 113 3,48 1,74 6,328 8,352 24.78 30
69 4,78 2,39 6,692 9,56 40,57 56 114 3,44 1,72 6,272 8,256 24.56 28
70 5 2,5 7 10 40 56 115 3,4 1,7 6,216 8,16 24.35 26
71 5 2,5 7 10 39,43 56 116 3,36 1,68 6,16 8,064 24.14 25.4
72 5 2,5 7 10 38,88 55.8 117 3,32 1,66 6,104 7,968 23.93 25
73 5 2,5 7 10 38,35 55.8 118 3,28 1,64 6,048 7,872 23.73 24.4
74 5 2,5 7 10 37,83 55.6 119 3,24 1,62 5,992 7,776 23.53 24.2
75 5 2,5 7 10 37,33 55 120 3,2 1,6 5,936 7,68 23.33 24
76 4,96 2,48 6,944 9,92 36,84 54.8
77 4,92 2,46 6,888 9,84 36,36 54.6
78 4,88 2,44 6,832 9,76 35,89 54.4
79 4,84 2,42 6,776 9,68 35,44 54.2
80 4,8 2,4 6,72 9,6 35 54
81 4,76 2,38 6,664 9,52 34,56 53.8
82 4,72 2,36 6,608 9,44 34,14 53.6
83 4,68 2,34 6,552 9,36 33,73 53.4
84 4,64 2,32 6,496 9,28 33,33 53.2

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kV – mA Relationship in Continuous Fluoroscopy Mode

kV – mA/2 Relationship in Continuous Fluoroscopy Mode

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kV – mA Relationship in Pulsed Mode

kV – mA Relationship in One Shot Mode

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kV – mA Relationship in Radiography Mode >8mAs

kV – mA Relationship in Radiography Mode <8mAs

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1.9.3 DIMENSION AND WEIGHTS

1.9.3.1 DISPLAY STATION

WEIGHTS: _____kg Drawing N° ____

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1.9.3.2 STAND
MODEL R-9”

WEIGHTS ____kg Drawing N°: ____

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1.9.3.3 STAND 12”

12” MODEL

IN PROGRESS

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Safety and
Maintenance

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2 SAFETY AND MAINTENANCE

2.1 INTRODUCTION
The aim of this USER’S MANUAL is to provide qualified radiology technicians, medical and
paramedical staff with operating instructions to make use of the RADIOLOGY UNIT simple and safe.
This apparatus emits X-RAYS and must only be used in compliance with the safety instructions
indicated in this MANUAL and must not be used for any other purposes than those foreseen.
The system must only be used by personnel with the necessary knowledge in the field of
radiation protection and with the necessary training in use of X-Ray apparatus.
Follow the indications given below very carefully:
 the apparatus must not be used when there are any electrical and/or mechanical faults
 do not use the system when any signalling or alarm device of the system is not working
properly
 any modification to the system must be authorized in writing by the MANUFACTURER
 if you want to use the apparatus in combination with other equipment, components or
modules, and when compatibility with the latter is not certain, it is indispensable to
make sure that there is no danger to the patients and/or operating personnel. In this
case, consult the manufacturer of the apparatus in question or an expert in the sector
 like any other apparatus, the SYSTEM must be used correctly. It also need periodic
checks and maintenance as specified under MAINTENANCE (SEE § 2.8.2 Pag.52).

2.2 COMPLIANCE AND RESPONSIBILITY DECLARATION

The declaration of Product Conformity is always enclosed in the Instruction manual, indicating
the model, code and S/N, as regards the declaration of responsibility refer to the cover of the
User Manual.

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2.3 COMPLIANCE AND REFERENCE ADDRESS

For Information relevant to the compliance make always reference to the cover of the User
Manual.

2.4 SYSTEM SAFETY MECHANISMS

2.4.1 MECHANICAL SAFETY

 Always apply the parking brakes after positioning the unit
 only use the special handles for moving the system
 avoid hitting any obstacles with the unit
 do not remove the protective casing of the apparatus except for maintenance work
expressly foreseen and described in this USER’S MANUAL or in the SERVICE MANUAL.

2.4.2 ELECTRICAL SAFETY

 Make sure that the power supply socket where the apparatus is to be connected is
approved for the foreseen voltage and current for use of the system
 the radiology system must not be used in rooms where there is the risk of explosion
 disconnect the installation from the mains before carrying out any cleaning,
disinfection and/or sterilisation
 the cleaning and disinfection products for the installation can form explosive gaseous
mixtures. It is compulsory to only use products which comply with the corresponding
Standards in force
 take care not to spill conductive liquids on the system components as they would
jeopardise operation and safety were they to penetrate to the inside
 should there be a sudden malfunction of the unit, quickly press one of the two
EMERGENCY PUSHBUTTONS, located on the STAND and on the DISPLAY STATION respectively
(SEE SECTION 1 - § 1.2.1 and 1.2.4), to interrupt operation and avoid any unwarranted
generation of radiation
 always turn the apparatus off after use.

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2.4.3 LASER LOCALIZER SAFETY

 Always keep a good illumination of the room
 never watch into the laser localizer output window
 never watch the laser beam reflections
 before starting an examination, the patient has to remove all objects which could
reflect the laser beam and be exposed on the X-Ray image (ear-rings, glasses, necklace,
etc.)
 never clean the laser localizer output window with tools which could damage or modify
its optics; needed cleaning operations must be carried out only by service authorised
and trained personnel.

2.4.4 EQUIPOTENTIAL EARTH CONNECTION

There is an EQUIPOTENTIAL EARTH CONNECTOR on the STAND. For maximum patient and medical
staff safety, the patient bed must be connected to this connector.

2.4.5 THERMOMAGNETIC CIRCUIT-BREAKER

The system is protected on the power supply circuit by means of a thermomagnetic circuit-
breaker located in the rear of the DISPLAY STATION (SEE SECTION 1 - § 1.2.4).
Should this circuit-breaker trip, to turn the system back on again, simply reset it.

If the thermomagnetic circuit-breaker trips again immediately after resetting, it may

! be an indication of faulty system operation. Immediately contact the technical

service.

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2.5 PROTECTION AGAINST IONIZING RADIATION

Before carrying out any X-Ray exposure, make sure that all the necessary precautions against
radiation have been taken.

During radiation emission, the personnel in the X-Ray room must respect the regulations in force
regarding protection against radiation. For this, bear in mind the following rules:

 where necessary, use protective accessories against radiation

 always use the special x-ray protective coats: an x-ray protective material equivalent to
0.35 mm of lead (0.35 mm Pb) attenuates the radiation produced at 50 kV by 99.95%
and at 100 kV by 94.5%
 the best protection against radiation is distance: therefore keep as far away as possible
both from the source of radiation and from the exposure object
 avoid moving or standing in the path of the rays
 always use the smallest exposure range possible: the radiation dispersed largely
depends on the volume of the object x-rayed
 keep the patient’s examination area the furthest away as possible from X Ray source.

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2.5.1 DESIGNATED SIGNIFICANT ZONES OF OCCUPANCY

During radiation emission, the operator and/or the personnel in the X-Ray room that requires be
close to the PATIENT during NORMAL USE, shall use SIGNIFICANT ZONE OF OCCUPANCY showed
in picture, to protection against x-ray radiation.

200 cm

60 cm

80 cm

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2.6 RESIDUAL RISKS

The system is designed and constructed according to the strictest principles of compliance
with safety requirements. However, there are residual risks due either to incorrect use of the
apparatus or to deficiencies in the protective measures taken.
With regard to the risks due to incorrect use of the apparatus, please see the instructions and
recommendations given in the points above.
It must also be underlined that:
 The DISPLAY STATION and the STAND have been designed and constructed to guarantee
stability during normal use, according to the Standards in force, therefore:
 under conditions of use the apparatus is stable on surfaces with inclination up to 5°
 in the transport position (SEE SECTION 1 - § 1.6.2) the apparatus is stable on surfaces
with inclination up to 10°
 not to try to move the DISPLAY STATION and/or the STAND with the brakes on
 to take care to avoid any obstacles on the floor when moving the DISPLAY STATION
and/or the STAND (cables, steps and uneven levels of all kinds).
For the RESIDUAL RISKS due to any defect in the protection measures taken, it must be
remembered that:
 Protection against electric shocks is carried out by means connecting the metallic
covering parts of the apparatus to earth: it is therefore necessary to periodically check –
according to the NORMAL MAINTENANCE PLAN described under § 2.8 of this section – correct
operation of the whole earthing circuit.

Not taking notice of the unit alarms could cause overheating of the X-RAY TUBE HEAD:

! this overload could lead to loss of the means of insulation in the TUBE HEAD itself at
very high temperatures.

During C-arm movements and in particular during UP/DOWN motorised movements,

!
take care that the parts do not hit the patient or the operator.

Avoid very fast movements: the kinetic energy accumulated could be a hazard for
! personnel near the unit.

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2.7 SIGNALS

2.7.1 SYMBOLS USED

Apart from the symbols present on the CONSOLE, REMOTE CONTROL and PEDAL UNIT (SEE SECTION
1 - § 1.2.2 E §1.2.3), others have been used on the STAND and DISPLAY STATION, as shown below.

SYMBOL MEANING LOCATION

DISPLAY STATION

SWITCHING THE SYSTEM ON Display Station Key for switching on

SWITCHING THE SYSTEM OFF Display Station Key for switching on

FOLLOW INSTRUCTIONS FOR USE Unit label

PHYSIOLOGICAL EFFECTS Unit label, control panel

CLASS B EQUIPMENT (IEC-601-1

Unit label
STANDARD)

EQUIPMENT THAT REQUIRES A CORRECT

Unit label
DISPOSAL (2012/19/EC)
STAND

MANUFACTURER Unit label

RADIOGRAPHY Radiography Pushbutton / Connector

FLUOROSCOPY Fluoroscopy Pedal Unit connector

EQUIPOTENTIAL NODE Patient bed connector

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SYMBOL MEANING LOCATION

X-RAY FOCUS POSITION X-Ray Tube Head covering

CAUTION LASER RADIATION X-Ray Tube Head covering

LASER CHARACTERISTICS AND

RADIAZIONE LASE R NON FISSARE I L FASCIO
APPARE CCHI O LASE R DI CLASSE 2

X-Ray Tube Head covering

Pma x< 1 mW
l = 655 nm

WARNINGS
IEC 608 25-1:1 993 + A1: 1997 + A2:20 01

MOVEMENT LOCKED In correspondence of each knob

STAND

MOVEMENT UNLOCKED In correspondence of each knob

STAND MOVEMENT/LOCKING
Stand steering knob
DIRECTION

2.7.2 LABELLING
A sample of the identifying labels stuck on the X-Ray unit is attached to the present USER’S
MANUAL (SEE COVER).

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2.7.3 MESSAGES ON THE STAND DISPLAY

The X-ray exposure is interrupted when the following alarms are on, except further
indications, and the red led lights. If the alarm lights again after the advised technical
intervention has been made, get in touch with the service staff.

MESSAGE MEANING INTERVENCTION

SUPPLIER FAULT Supplier fault Contact service
Put a jumper between 1and 2 on the
TOTAL EMERGENCY Contact service
connector XT2 - IB02 board
Max fluoroscopy time exceeded without
WHATCH DOG Contact service
max fluoroscopy time intervention
X-RAY COMMAND ON Footswitch / handswitch fault Contact service
Switch off and on the unit.
ALARM FILAMENT Filament current not present
If the problem still persist contact service
Switch off and on the unit.
ALARM INVERTER Inverter fault
If the problem still persist contact service
Switch off the unit and wait for monobloc
THERMIC MONOBLOC ALARM Max working temperature exceeded
cooling
Push the DAP button to stop the alarm.
DAP FAULT, RESET DAP DAP fault
If the problem still persist contact service
Check the image quality. If the case repeat
MAX FLUOROSCOPY TIME Max radiography time exceeded
the exposure.
CAN BUS OFFLINE CAN BUS circuit open Contact service
COLLIMATOR OFF LINE Failure into the collimator supply circiut Contact service
X – RAY LEAKAGE Failure on the x-ray circuit Contact service
If you are at the 5° minute reset the alarm
Total flouroscopy time exceeded at 5 or 10
MAX FLUOROSCOPY TIME pushing , if you are at 10° minute, push
minutes
on button
During radiography the real kV are Switch off and on the unit.
ERROR KV
lower then 85% of setted KV If the problem still persist contact service

ERROR MA
During radiography the mA value is lower Switch off and on the unit.
then 10 mA If the problem still persist contact service
Failure of the x-ray insert stator supplier
STARTER FAULT Contact service
circuit
MEMORY OFF LINE No feedback from memory Contact service
The x-ray insert is next to consume the
residual thermal units, will be allow use
X-RAY WARM Wait for x-ray insert cooling
fluoroscopy mode with mA/2, won’t be
allow use radiography mode

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ALLARM MESSAGE

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MAINTENANCE
This USER’S MANUAL only refers to routine maintenance. For special maintenance operations,
interventions in the case of faults and/or replacement of components, the SERVICE MANUAL must
be consulted

2.8 ROUTINE MAINTENANCE

2.8.1 GENERAL RECOMMENDATIONS

The radiological system requires regular checks and maintenance. The recommendations
given below are aimed at maintaining good operation and service safety.
The apparatus contains mechanical parts subject to wear according to the use they are put to:
after a long period of use, the degree of safety may decline due to wear on parts. Regular
inspections and maintenance serve, above all, to protect the patient and operator from hazards
due to any eventual breakage of mechanical parts.
Correct regulation of the electromechanical and electronic modules affects operation, image
quality, electrical safety and the level of exposure to radiation both the medical and paramedical
personnel as well as the patients are subjected to.
The maintenance program includes checks and preventive interventions to be seen to by the
owner of the apparatus and must be carried out by expressly authorised personnel.

CAUTION - In the case of necessary replacement of parts which may affect the safety of the
machine adversely, only use original spare parts.

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2.8.2 CHECKS AND INSPECTIONS TO BE CARRIED OUT BY THE USER

The user must see to training the operating personnel so that they are able to carry out the
daily checks. These checks are listed in TABLE here below. The weekly and 6-monthly checks must
only be carried out by qualified personnel authorised by the technical service.

TABLE 2

INTERVAL CHECK
DAILY  Operation of the signals, display touch screen and LEDs
CHECKS  The warning and danger labels are intact
WEEKLY  Absence of oil leaks from the X-Ray Tube Head
CHECKS  Absence of unusual noise in the X-Ray Tube Head during X-Ray emission
 Proper operation of the automatic Fluoroscopy
6-MONTHLY  The earthing value of the whole system
CHECKS  The power supply voltage value
 The value of the continuous voltages generated inside the system
 Fixing and general state (dust and corrosion) of the cards
 Correct operation of the limit micro-switches
 The state of the sliding bearings
 Centring of the tube and collimator

2.9 CLEANING AND DISINFECTION

Products with a high content of alcohol, corrosive and/or abrasive detergents or solvents
must not be used to clean the surfaces of the apparatus. To disinfect the system, only use
methods in compliance with the laws in force regarding disinfection and protection procedures
against explosion.
To carry out the cleaning and disinfection operations, take the following precautions:
 turn the system off and disconnect the mains power supply cable
 make sure that no liquid gets into the apparatus so as to avoid any short-circuits or
corrosion of the electrical and electromechanical parts.
CAUTION - The unit has not to be used in presence of anaesthetic and/or inflammable disinfectant
and cleaning products.
CAUTION – If, producing explosive gaseous, mixture, are used, make sure that gases are dispersed
before switching on the unit.

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2.10 ELECTROMAGNETIC COMPATIBILITY (EMC)

According to the foreseen use, this electronic apparatus conforms with the IEC 60601-1-2
Directive, which defines the maximum permitted emission levels for electronic apparatus and
immunity from electromagnetic fields.
In any case, it is not possible to absolutely exclude the possibility that radio signals coming
from transmitters, such as mobile phones or similar mobile radio systems, themselves
conforming to the EMC standard, may influence correct operation of the electro medical
apparatus if they are used near the systems and have a relatively high transmission power.
Consequently the use of this type of radio apparatus in the immediate vicinity of medical
systems controlled electronically must be avoided, to eliminate any risk of interference.

WARNING!
All types of transmission with mobile radio apparatus must be avoided.
Mobile telephones must be turned off in rooms near the apparatus.
These rules must be applied when the unit is active.
.

2.10.1 LIST OF CABLE

The system integrator must take care of the kind of cables used for connection of the mobile
unit are listed below:
Cable Recommended length
Monoblock cable 4m

X-ray hand switch cable 4m

Power supply cable 7.5 m

The use of accessories, transducers and cables other than those specified may result
! in increased emission or decreased immunity of the equipment

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2.10.2 PERFORMANCE
The essential performances of the mobile unit with regard to EMC are:
 High quality digital X-ray images
 Robustness of the user interface and communication with the system

2.10.3 ELECTROMAGNETIC EMISSIONS

The mobile unit needs special precautions regarding EMC and needs to be installed
! and put into service according to the EMC information provided below

Guidance and manufacturer’s declaration – electromagnetic emission

The mobile unit is intended for use in the electromagnetic environment specified below. The customer or the user of
the mobile unit should assure that is used in such an environment.
Emission test Compliance Electromagnetic environment - guidance
RF Emission CISPR 11 Group 1 The mobile unit uses RF energy only for its internal
function. Therefore, its RF emission are very low and are
not likely to cause any interference in nearly electronic
equipments.
RF Emission CISPR 11 Class A
The mobile unit is suitable for use in all establishments
Harmonic emissions IEC 61000-3-2 Not applicable other than domestic and those directly connected to the
Voltage fluctuations/flicker emissions Not applicable public low-voltage power supply network that supplies
IEC 61000-3-3 buildings used for domestic purposes.

Guidance and manufacturer’s declaration – electromagnetic immunity

The mobile unit is intended for use in the electromagnetic environment specified below. The customer or the user of
the mobile unit should assure that is used in such an environment.
IEC 60601-1-2 Electromagnetic
Immunity test Compliance level
test level environmental
Electrostatic discharge (ESD) +/- 6kV contact EN 60601-1-2
Hospital
IEC 61000-4-2 +/- 8kV air Test Level
Electric fast transient / burst +/- 2kV for power supply EN 60601-1-2
IEC 61000-4-4 +/- 1kV for input / output Test Level Hospital
lines > 3 m
Surge +/- 1kV differential mode EN 60601-1-2
Hospital
IEC 61000-4-5 +/- 2kV common mode Test Level
Voltage dips, short interruptions 0% Un for 0.5 cycles EN 60601-1-2
and voltage variation on power 40% Un for 5 cycles Test Level
Hospital
supply input lines 70% Un for 25 cycles
IEC 61000-4-11 0% Un for 5 s
Power frequency 3 A/m EN 60601-1-2
(50/60 Hz) magnetic field Test Level Hospital
IEC 61000-4-8

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Guidance and manufacturer’s declaration – electromagnetic immunity

The mobile unit is intended for use in the electromagnetic environment specified below. The customer or the user of
the mobile unit should assure that is used in such an environment.
Electromagnetic
Immunity test test level IEC 60601 Compliance level
environmental
Non-life-supporting
equipment
3V
Da 150 kHz a 80 MHz
Conducted RF
EN 60601-1-2 Test Level
EN 61000-4-6 Life-supporting equipment
3V
outside ISM band
10 V
Inside ISM band Hospital
Non-life-supporting
equipment
3 V/m
Da 80 MHz a 2,5GHz
Radiated RF
EN 60601-1-2 Test Level
EN 61000-4-3 Life-supporting equipment
10 V/m
Da 80 MHz a 2,5GHz

Recommended separation distances between portable and mobile RF communications equipment and the mobile unit
The mobile unit is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the mobile unit can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the mobile unit
as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power Separation distance according to frequency of transmitter m
From 150 KHz to 80 MHz From 80 MHz to 800 MHz From 800 MHz to 2.5 GHz
of transmitter (W)
d=1.2x√P d=1.2x√P d=2.3x√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
below 800MHz d=1.2√P between 800MHz and 2GHz d=2.3√P
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

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2.11 ELIMINATION OF THE DEVICE

Once the product is at the end of its use it must be disposed following the enforced rules
concerning the separate collection of waste and it cannot be treated as a simple urban waste.

The symbol:

Indicates that the product has the requirements requested by new directives introduced for the
environmental protection (2011/65/EC, 2012/19/EC) and it must be disposed properly once its life
cycle is ended.
When the device has reached the end of its life it must be disposed at the proper centres for the
separate collection of electrical and electrical wastes, or it must be returned to the reseller or to
the manufacturer in case you want to replace the product with another equivalent new one.
The proper separate collection helps to avoid possible negative effect on the environment and
on health and it facilitates the second use and the re-cycle of materials of which the device is
composed of. Ask for further information to the local authorities about the areas dedicated to
the wastes disposal.
Who does not dispose the product following what here above mentioned will be responsible for
the enforced rules.

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3 USE OF THE UNIT

3.1 RECOMMENDATIONS
 ATTENTION: THIS APPARATUS EMITS IONISING RADIATION WHEN THE RADIOSCOPY PEDAL OR THE
RADIOGRAPHY PUSHBUTTON ARE ACTIVATED. FOLLOW THE GENERAL METRICAL PROTECTION
REGULATIONS IN FORCE AND THE ADVICE OF THE OF THE PHYSICS PHYSICIAN IN CHARGE OF
SECURITY.
 CARRY OUT SHORT FLUOROSCOPY EXAMINATIONS, using the stored images as much as
possible. This allows the patient and operator to be exposed to the least possible
radiation.
 Keep the part of the patient being examined AS FAR AWAY AS POSSIBLE FROM THE FOCAL
SPOT of the x-ray tube. (Minimum distance between focal point - output cone = 20
cm).
 During Radiography, MOVE AS FAR AWAY AS POSSIBLE FROM THE X-RAY SOURCE, using the
special extension Cable. Check that you are never exposed towards the ray output
cone, but keep behind it.
 ALWAYS CONNECT the patient support point (e.g. operating table) to the equipotential
earthing point which comes out of the Stand.
 Before accessing any internal part (either electrical or mechanical) of the apparatus,
make sure that the Power Supply Connector of the unit is DISCONNECTED FROM THE
POWER SUPPLY NETWORK.
 When the Stand is in the stopped position, do not try to move the Stand by getting
hold of it at the ends of the arm. To move it, always release the stop (3) first and only
work using the special handles (1), (6) and (15).
 For the kind of use of the apparatus, it is advisable to have REGULAR MAINTENANCE of
the electrical and mechanical parts of the unit carried out by the manufacturer's.
 Use the unit in low doses when possible

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3.2 OPERATING PROCEDURE

 Upon ignition (Cfr. § 1.7), the unit automatically prearranges for operating in
Automatic CONTINUOUS SCOPY.

 Select MANUAL OR AUTOMATIC SCOPY by operating on icon or .

 Select PULSED SCOPY by operating on icon ; if the device is fitted with RTP, the
selection is performed from the visualization station
 Select low-dose or normal-dose using icons or

 Select ONE SHOT SCOPY by operating on icon .

 Select SCOPY and GRAPHY by operating on the pushbutton .

 The emission of rays is engaged with RTP, only if office is opened from visualization
station. If it’s not so, the message “open office” is displayed.

Figure 3.1 – CONTROL PANEL – SELECTION OF WORKING MODE

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3.2.1 CONTINUOUS FLUOROSCOPY

 Upon ignition, UNIT prearranges in AUTOMATIC CONTINUOUS SCOPY
 The RX emission can be activated from the PEDAL CONTROL RX (Cfr. § 1.2.2).
 You can choose to leave the automatic adjustment mode of the dose and pass to manual

mode by operating on .
 SCOPY TIME appears on the touch screen display and indicates minutes and seconds of
effective scopy from the beginning of the exam. After 4.5 minutes the stand starts to
emit an acoustical signal and proceeds with the emission of rays. At the 5th minute, the
machine automatically interrupts the emission of rays; it is possible to continue the
exam for another 5 minutes by operating on the icon ALARM RESET FLUOROSCOPY TIME

represented by icon .
 The alarm also activates when the totalizer reaches 10 minutes. The totalizer can also be

zeroed at any time by operating on icon .

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3.2.1.1 CONTINUOUS AUTOMATIC RADIOSCOPY

 It’s possible to pass from MANUAL to AUTOMATIC mode by operating on icon .

 If the icon appears on the touch screen display, it means that the automatic mode is
already active
 With this mode, the kV and mA values automatically sets in order to visualize an optimal
image on the monitor.
 ATTENTION: THE mA VALUES ARE AUTOMATICALLY ASSOCIATED WITH THE kV VALUES DISPLAYED
(you can choose between mA or mA/2 by operating on the icon ).
 mA values appear on the touch screen display during the passage of rays.
 Give the RX emission command with the RX pedal (Cfr. § 1.2.2).
 If necessary, adjust CONTRAST and BRIGHTNESS of monitor with commands 47 (Cfr. § 1.2.4).

3.2.1.2 CONTINUOUS MANUAL RADIOSCOPY

 You can pass from AUTOMATIC to MANUAL MODE by operating on icon .

 If the icon is present on the touch screen display, it means that the automatic mode
is already active
 Select kV VALUE operating on kV icon, it’s possible to increase or decrease the value with
increase (+) and decrease (-) pushbuttons. This value appears on the touch screen
display.
 Give the RX emission command with the RX pedal (Cfr. § 1.2.2).
 Adjust the kV value with the pushbuttons until you get an optimal image on monitor.
 If necessary, adjust CONTRAST and BRIGHTNESS of monitor with commands 47 (Cfr. §
1.2.4).

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3.2.2 PULSED FLUOROSCOPY

 This technique allows to DRASTICALLY REDUCE the dose-exam.
 In order to work with the Pulsed FLUOROSCOPY (with equipment prearranged on scopy)

press the icon .

 The x-ray emission frequency is fixed (with RTP you can choose the emission frequency
of the visualization station)
 Give the scopy command with the RX pedal (Cfr. § 1.2.2) to activate the RX Pulsed
EMISSION .
 With this technique, the video image on monitor is updated at every RX FLASH, while it is
stored during the entire pause period.

3.2.3 MEMORIZED FLUOROSCOPY (ONLY WITH RTP)

 Select the memorized fluoroscopy from the visualization station
 Select the interval at which you want to memorize the images

 The icon is displayed

 Give the RX emission command with RX pedal

In scopy mode, when possible, use mA/2 mode ; this allows to drastically reduce the
! exam dose and use the device longer. mA/2 mode is already selected upon ignition.

3.2.4 RADIOGRAPHY

 Select the functioning mode in GRAPHY by pressing the key .

 Couple the CASSETTE-HOLDER FOR RADIOGRAPHY on the intensifier tube input.
 THE COUPLING IS FACILITATED BY THE RAPID SELF-COUPLING SUPPORT.
 Insert the cassette for radiography into the cassette holder.
 Select icon kV and by operating on increase (+) and decrease (-) pushbuttons. Select the
value desired.
 Select the mAs icon and by operating on increase (+) and decrease (-) pushbuttons.
Select the value desired.

 Select the icon; the collimater moves to a position of maximum opening.

 Give the graphy command using the REMOTE CONTROL 14 (Cfr. § 1.2.1).

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3.2.5 IMAGE CONTROLS

 When you release continuous or pulsed scopy pedal, the last memorized image is
displayed (L.I.H.) on the work monitor 36 (Cfr. § 1.2.4).

 Press the icon on the touch screen display to save the L.I.H. image of memory
monitor 34 (Cfr. § 1.2.4). During the emission of X-ray, a light pressure on the icon is

sufficient to save work monitor image on memory monitor

 In order to browse images (from lowest to greatest number) on the memory monitor

(110 images max), press icon and then the increase (+) pushbutton to go
forward, or the decrease (-) pushbutton to go backward

 By operating on icon and on the increase (+) or decrease pushbutton (-) the
image can be continuously rotated on the work monitor. Rotation is also possible on
LIH image.

 By operating on icon image can be inversed horizontally on work monitor.

Image inversion is also possible on LIH image.

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3.2.6 COLLIMATOR CONTROL

 By operating on icon and on increase and decrease pushbuttons, it is possible to

adjust iris opening and closing on the collimator

 By operating on icon and on increase and decrease pushbuttons, it is possible to

adjust opening and closing of collimator shutters

 By operating on icon and on increase and decrease pushbuttons, it is possible to

adjust clockwise and anticlockwise rotation of collumator shutters
 In presence of RTP it is possible to know collimator positions by the virtual collimator
displayed on the monitor (the virtual collimator is displayed during its control, without
RX emissions)

A good collimation of the anatomic part allows to reduce the dose adsorbed by the
! patient

3.2.7 ZOOM CONROL

 By operating on icon and on the increase and decrease pushbuttons, it is possible to

command the zoom.
 There are two zoom intervals; both cover a circular surface. The first zoom diameter is 6”
and the second is 4”

3.2.8 DOSIMETER (OPTIONAL)

 Before starting the exam, reset the dosimeter by operating on icon

 The display will show the dose adsorbed by the patient.

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3.2.9 DOSIMETRIC INFORMATION

FOCAL SPOT to IMAGE RECEPTOR Fixed distance at 948 mm Pass
Distance…………………………………...
Position of the measuring 514 mm Pass
detector…..:
Loading factors Measured AIR Factors (3)
(KV) (mA) (s) (mAs) KERMA RATE
(radioscopy)
(µG/sec)
40 0,2 — — 11 Manual; zoom 0; 1mmAl
50 0.6 — — 50 Manual; zoom 0; 1mmAl
60 2,8 — — 313 Manual; zoom 0; 1mmAl
70 5 — — 756 Manual; zoom 0; 1mmAl
80 4,8 — — 911 Manual; zoom 0; 1mmAl
90 4,4 — — 1024 Manual; zoom 0; 1mmAl
100 4 — — 1101 Manual; zoom 0; 1mmAl
110 3,6 — — 1152 Manual; zoom 0; 1mmAl
120 3,2 — — 1181 Manual; zoom 0; 1mmAl
40 0,1 — — 5,6 Manual; zoom 0; 1mmA; curve ½ mA
50 0,3 — — 24 Manual; zoom 0; 1mmA; curve ½ mA
60 1,4 — — 156 Manual; zoom 0; 1mmA; curve ½ mA
70 2,5 — — 372 Manual; zoom 0; 1mmA; curve ½ mA
80 2,4 — — 462 Manual; zoom 0; 1mmA; curve ½ mA
90 2,2 — — 520 Manual; zoom 0; 1mmA; curve ½ mA
100 2 — — 551 Manual; zoom 0; 1mmA; curve ½ mA
110 1,8 — — 571 Manual; zoom 0; 1mmA; curve ½ mA
120 1.6 — — 585 Manual; zoom 0; 1mmA; curve ½ mA
78 4,8 — — 894 Automatic; zoom 0
98 4 — — 1097 Automatic; zoom 1
120 3,2 — — 1162 Automatic; zoom 2
91 2,2 — — 520 Automatic; zoom 0 curve ½ mA
120 1.5 — — 577 Automatic; zoom 1 curve ½ mA
120 1,5 — — 576 Automatic; zoom 2 curve ½ mA

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4 REVISION LIST
Revisions are handled with the change in the document number that is indicated by the IRIS
corporate management

DOCUMENT NUMBER REVIEW DATE MODIFIED

001929 REV 00 26/05/2014 I° emission
002569 REV 01 09/03/2017 CE Addition an revision
002773 REV02 02/11/2017 Destination use, 5Kw,
I.I.12”

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