User Manual

GX600/XX Doc. 009748

GX600/XX

USER MANUAL

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REVISION HISTORY

REVISION DATE REASON FOR CHANGE

1.00 MAY 24, 2016 First edition

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INTRODUCTION 5

INTENDED PURPOSE 6

ELECTROMAGNETIC COMPATIBILITY 6

CLASSIFICATION 7

GENERAL DESCRIPTION 8

MAIN FEATURES 8
POWER FEATURES 8
ENVIRONMENTAL SPECIFICATIONS 8
30 KW VERSION 9
POWER FEATURES 9
TECHNICAL FEATURES 9
X-RAY FEATURES 9
40 KW VERSION 10
POWER FEATURES 10
TECHNICAL FEATURES 10
X-RAY FEATURES 10
50 KW VERSION 11
POWER FEATURES 11
TECHNICAL FEATURES 11
X-RAY FEATURES 11
SUPPORTED ACCESSORIES (NOT PROVIDED) 12

WORK MODE 13

3 POINTS TECHNIQUE 14
FOCUS SELECTION 15
POWER SELECTION 15
ACCESSORY SELECTION 15
WORK TECHNIQUE SELECTION 15
ANATOMICAL AREA SELECTION 16
ALARMS OR MESSAGES 16
RESET BUTTON 17
HEAT UNITS GAUGE BAR 18
AEC (AUTOMATIC EXPOSURE CONTROL) WORK MODE 19
LAMPS 20
2 POINTS TECHNIQUE 21
ANATOMICAL TECHNIQUE 22

X-RAY EXECUTION 24

SETUP 25

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LANGUAGE 26
ENABLE A.T. MODIFYING 26
CLOCK 29

EXPOSURE TABLES 30

3 POINTS TECHNIQUE 30
2 POINTS TECHNIQUE 31

MAINTENANCE 32

CLEANING 32
WASTING 32

USED SYMBOLS 33

LABELLING 34

UNIT LABEL 34

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Introduction

X-RAY GENERATOR COMPATIBLE WITH VARIOUS ACCESSORIES PROPERLY DEVELOPPED FOR

X-RAY SYSTEMS

IN ABSENCE OF STRINGENT SAFETY MEASURES, X-RAY EQUIPMENT CAN BE

DANGEROUS TO BOTH PATIENT’S AND OPERATOR’S HEALTH.

Even if this equipment has been planned and assembled following strict safety measures, X-raying can still
be dangerous for the patient’s and the operator’s health. More specifically, excessive exposures to X-rays
cause damages to one’s health.

Everyone when using this device must protect themselves with apposite X-ray protective wear.

Therefore all the necessary precautions must be taken in order to prevent non-authorized or non-qualified
people from using this equipment.

Authorized and qualified people, before making use of this equipment, must inquire of all the safety
measures provided for by the International Commission and the national rules.

Electromagnetic interference
In accordance with the rule 89-336: “Do not use in presence of mobile phones or other equipments that can
cause electromagnetic interference” so as to endanger the equipment.

A PROPER USE OF THIS EQUIPMENT REQUIRES A PREVIOUS AND ACCURATE

CONSULTATION OF THIS MANUAL.

No modification of this equipment is allowed.

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*This manual has been originally written in Italian language.

Intended purpose

GX-600 is a medical device used with complementary X-ray apparatus in order to emit
radiation intended for diagnostic interventional radiology. It is designed to work in a safe
environment for the patient and the operator.
The generator and operational instructions are to be used by qualified persons having
been trained in radiation protection. The generator must be operated in conformance with
the manufacturer's instructions and within local government regulations.

Electromagnetic compatibility

EMC Instructions

1. When stacking or adjacent positioning of equipment or

accessories is unavoidable,
make sure that the performance of the GX-600 High-Voltage X-
ray generator
and of the stacked equipment is not adversely affected.

2. The performance of the GX-600 High-Voltage X-ray generator

can be affected
by the presence of portable and mobile RF communication
equipment.

3. Do not operate the GX-600 High-Voltage X-ray generator

without all covers
and enclosure perfectly fitted onto the High-Voltage Power
Supply.

Compliance to any EMC standard does not guarantee that a device will not interfere with
or will not be affected by the operation of another electrical medical equipment placed in
the nearby environment. Therefore, the GX-600 High-Voltage X-ray generator is not
designed to work in close vicinity with other electrical equipment or in the presence of
portable and mobile RF communication equipment. Stacking and adjacent positioning of
equipment should be avoided.

The GX-600 High-Voltage X-ray generator is intended for use in the electromagnetic
environment in
which radiated RF disturbances are controlled. The customer or the user of the GX-600
High-Voltage Xray generator can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment
(transmitters) and the GX-600 High-Voltage X-ray generator.

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CLASSIFICATION

93/42 EEC, Class II b, Annex IX, rule 10

Class I Equipment (IEC 60601-1)
Applied rule Type B (IEC 60601-1)
Protection Degree IP X0
Use Requirements “Equipment planned for continuous working with discontinuous charge”
Safety Degree “Equipment not suitable for use in presence of antiseptic mixture with air, oxygen or
with nitrous oxide”

Manufactured According MDD 93/42 CEE by:

I.M.D.Generators s.r.l.
Via G.Matteotti 28/a
24050 Grassobbio (BG) Italy
tel: +39 035 526344
fax: +39 035 528088
web site: www.imdxray.com

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GENERAL DESCRIPTION

MAIN FEATURES
Frequency: 40 kHz.
Max tube voltage: 150 kV (depending on the tube model).
mA and mAs selection modes.
System automatic calibration.
Dose check during the X-ray emission.
Anatomical technique.
Self diagnostics with error messages storage.
Heat units check.
5,7” touch screen.
User friendly system configuration.
Compact and soft design.

POWER FEATURES

400 Vac three-phase power supply.

50 / 60 Hz frequency.
Absorbed current in continuous working: 1 A.
Absorbed current in discontinuous working: 12 A.
Line resistance < 0,5 Ohm.

ENVIRONMENTAL SPECIFICATIONS
IN USE
Temperature range: 10 – 40 °C.
Relative humidity: 20 – 80%, not condensed.
Positioning: from 0m to 2440m ASL (from 700 to 1100 hPa).

TRANSPORT AND STORAGE

Temperature range: -25 – 70°C.
Relative humidity: 5 – 95%, not condensed.
Atmospheric pressure range: 500 – 1060 hPa (375 – 795 mm Hg).

THE INFORMATION HEREIN INCLUDED REPRESENT A GUIDE FOR USING THIS

EQUIPMENT IN RESPECT OF THE OPERATOR’S HEALTH AND THE X-RAY
GENERATOR’S SAFETY.

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30 KW VERSION

POWER FEATURES

Power supply: three-phase 400 Vac.

Frequency: 50/60 Hz.
Absorbed power:
o continuous: 1A
o discontinuous: 50 A
Line resistance: <0,3 Ohm.
Power supply cables:
o max length: 5 m
o min section: 16 mm2 (Line) and 25 mm2 (Ground).

TECHNICAL FEATURES

X-ray tube max voltage and max current at this voltage:

150 kV, 200 mA, 30 kW.
X-ray tube max current and max voltage at this current:
75 kV, 400 mA, 30 kW.
X-ray tube max power and max voltage, current at this power:
120 kV, 250 mA, 30 kW.
Max constant emission at 100 kV and 0,1 ms:
100 kV, 250 mA, 25 kW.

X-RAY FEATURES
(depending on the X-ray tube)

Voltage range: from 40 to 150 kVp (in 110 steps).

Current range: from 32 to 400 mA (in 13 steps).
Time range: from 2 to 5000 ms (in 34 steps).
Current*time range: from 0,5 to 500 mAs (in 28 steps).
Cut power: 80% of full power

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40 KW VERSION

POWER FEATURES

Power supply: three-phase 400 Vac.

Frequency: 50/60 Hz.
Absorbed power:
o continuous: 1A
o discontinuous: 63 A
Line resistance: <0,25 Ohm.
Power supply cables:
o max length: 5 m
o min section: 16 mm2 (Line) and 25 mm2 (Ground).

TECHNICAL FEATURES

X-ray tube max voltage and max current at this voltage:

150 kV, 250 mA, 37,5 kW.
X-ray tube max current and max voltage at this current:
80 kV, 500 mA, 40 kW.
X-ray tube max power and max voltage, current at this power:
100 kV, 400 mA, 40 kW.
Max constant emission at 100 kV and 0,1 ms:
100 kV, 400 mA, 40 kW.

X-RAY FEATURES
(depending on the X-ray tube)

Voltage range: from 40 to 150 kVp (in 110 steps).

Current range: from 32 to 500 mA (in 13 steps).
Time range: from 2 to 5000 ms (in 34 steps).
Current*time range: from 0,5 to 500 mAs (in 28 steps).
Cut power: 80% of full power

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50 KW VERSION

POWER FEATURES

Power supply: three-phase 400 Vac.

Frequency: 50/60 Hz.
Absorbed power:
o continuous: 1A
o discontinuous: 80 A
Line resistance: <0,2 Ohm.
Power supply cables:
o max length: 5 m
o min section: 16 mm2 (Line) and 25 mm2 (Ground).

TECHNICAL FEATURES

X-ray tube max voltage and max current at this voltage:

150 kV, 320 mA, 48 kW.
X-ray tube max current and max voltage at this current:
100 kV, 500 mA, 50 kW.
X-ray tube max power and max voltage, current at this power:
100 kV, 500 mA, 50 kW.
Max constant emission at 100 kV and 0,1 ms:
100 kV, 500 mA, 50 kW.

X-RAY FEATURES
(depending on the X-ray tube)

Voltage range: from 40 to 150 kVp (in 110 steps).

Current range: from 32 to 500 mA (in 13 steps).
Time range: from 2 to 5000 ms (in 34 steps).
Current*time range: from 0,5 to 500 mAs (in 28 steps).
Cut power: 80% of full power

FIRMWARE VERSION
Code: 1726
Version: 4.00

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OPERATING MODES

3 points technique:
o kV, mA, ms selection;
o mAs automatically calculated and displayed;
o AEC (optional).

2 points technique:
o kV, mAs selection;
o max mA calculated, used and displayed;
o AEC (optional).

Anatomical technique:
o 5 anatomical areas per installed accessory;
o 8 available tests per area (120 tests in total);
o 3 patient sizes per test;
o memorizable data:
accessory (table bucky, wall bucky, free technique);
work tecnique (3 points, 2 points);
X-ray data (kV, mA, ms for 3 points tech; kV, mAs for 2 points tech.);
Focus (large, small)

SUPPORTED ACCESSORIES (not provided)

X-ray tube with HT Federal Standard ANIE 150 kV cable;

vertical column with bucky;
ceiling suspension;
operation and catheters table.

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WORK MODE

Press the switch in the middle of the screen to start up the X-ray generator and enter the
work page.

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3 POINTS TECHNIQUE

2
1

3 4 9

5 6 7

01 Anatomical area selection

02 kV, mA and ms selection
03 Power selection
04 Work technique selection
05 Accessory selection
06 AEC activation
07 Error reset
08 Focus selection
09 Anode and Housing Heat Units gauge bar

NB: press to return to the first screen (standby mode).

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FOCUS SELECTION

The large focus is active; press the button to select the small focus.

The small focus is active; press the button to select the large focus.

POWER SELECTION

Cut power is active; only the 80% of full power is available. Press this
Button to enable the full power.

Full power is active; the whole amount of power ia available. Press this
Button to cut down the available power to 80%.

ACCESSORY SELECTION

Each button corresponds to one accessory:

table bucky

free technique

wall bucky

When you select an accessory, the corrsponding button turns color; in the example the
free technique is active.

WORK TECHNIQUE SELECTION

The 3 points technique is active; you can set kV, mA and ms. Press this
button to switch to the 2 points technique.

The 2 points technique is active; you can set kV and mAs. Press this
button to switch to the 3 points technique.

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ANATOMICAL AREA SELECTION

If you press one of the areas placed on the human figure, you automatically activate the
anatomical technique. The number displayed at the center of each zone stands for how
many exams (linked to that area) are saved.

SKULL

THORAX

UPPER LIMBS

PELVIS

LOWER LIMBS

NB: for each anatomical area it is possible to save a maximum of 8 tests.

ALARMS OR MESSAGES

Here is a list of the displayable messages:

starter not ok
release X-ray button
85% kV not present
mA too high
mA too low
inverter fault
filament fault
thermal safety
door safety
bucky fault
max time of prep rad
AEC error
I fil max
Contact fault

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DOOR SAFETY
A microswitch is connected to the PSM45 Interface Board, which signals the status of the
X-ray room door.
The open contact disables any X-ray emission and is notified by a warning message on
the panel.

RESET BUTTON

Any failures or critical conditions are recognized by the system and notified through
warnings or error messages. When this happens, the reset button lights up, allowing you
to delete the message.

The reset button is inactive; no message is present.

The reset button is active; a message is displayed, press this button to

delete it.

NB: the deletion of an error message shall be done only after you solved the problem that
generated the message. If you press the button without doing this, nothing will happen.
If the problem can not be resolved, contact service.

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HEAT UNITS GAUGE BAR

Anode HU

Housing HU

This is a representation of the heat conditions.

The gray area stands for the residual heat units, while the painted area shows the used
heat units. When the X-ray thermal capacity is reached, a message pops up and no more
emissions are available until the X-ray tube cools down within the limit.

Warning : If Thermal Units of the insert are maximum load, with exposure values higher
this indication is displayed

The exposure is inhibited, wait for the restoration of the thermal capacity of the insert, or
decrease the workload set.

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AEC (Automatic Exposure Control) WORK MODE

Left area selection

Center area selection

Right area selection

Density

Film selection

mAs display

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LAMPS

RX preparation is complete, the system is ready to X-ray

X-ray emission is on

The system is in waiting; this always happens after focus change (waiting
time = 5 seconds) and when the emission has ended (waiting
time = max time between 10 seconds and the last exposure time).
While in waiting, the system cannot X-ray.

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2 POINTS TECHNIQUE

This page is pretty similar to the 3-P technique page. The only difference is the mAs
selection button.
In this mode, the system automatically loads the max possible mA value, based on the
mAs and the power selected.

Press this button to switch back to the 3 points technique.

NB: press to return to the first screen (standby mode).

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ANATOMICAL TECHNIQUE

When you press one of the five areas marked on the human figure, you automatically
activate the Anatomical Technique.
As an example, if you press the ‘head area’ the following screen will appear.

Use these 3 buttons to select the patient size

SMALL MEDIUM LARGE

When the MEDIUM size is selected, the system loads 100% of the set kV value. You may
consider it a neutral size. Instead, if you select a different size, you automatically vary the
kV value by 10% of the set value.
Here is an easy example, assuming that in medium size you selected 80 kV:

SMALL MEDIUM LARGE

Kv 72 80 88

90% 100% 110%

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Use these buttons to scroll the exams linked to the active

area. In this example you have 2 exams saved for the
‘skull’ area. The first exam is the one selected.
On the display you can also read the name of the test
(‘name exam 1’ in the example).

NB: The exams planned stored are advices deriving from market surveys.

In this page this object is not a switch, but simply a lamp, indicating which
Focus,power, mode, accessory is active. This parameter has been saved when
planning the exams,
so it is strictly linked to the exam selected, and you cannot change it.

To select a different anatomical area, just press the corresponding circled zone on the
human figure.

NB: press to return to the first screen (standby mode).

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X-RAY EXECUTION

BUTTON A BUTTON B

After setting the radiological parameters, you can perform x-rays through the console.

PROCEDURE

• Press and hold preparation button (button A) until the symbol lights up;
• Press button B to emit x-rays.

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SETUP

In order to enter the setup, from the standby page press the key .

The password page appears;

you need to type in the right password to proceed.

Enter the password “0001" (zero zero zero one) and press the ENT button.

Press the “User menu”

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LANGUAGE

By using these buttons you can change the text visualization language.

ENABLE A.T. MODIFYING

If you set this switch to ON position, you will enable the

possibility to modify the parameters of the saved exams in
Anatomical Technique.
Here below is described the whole procedure you need to follow
in order to do this.

I. After setting the ‘enable AT mod’ button to ON position, return to the standby page.
Here, press the start button.

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II. You can now notice a new button.

III. Select the anatomical area, then select the exam that you want to modify.
Es. Thorax Es.2

IV. Now you are back to the 3 points technique page; here set the new data ( Es kV =
95 ), then press “modification A.T.” button to save them.

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I. select the number of examination to be saved, in this case nr. 2

II. if you want to edit the text, select the dedicated area and write the new text
III. press "ENTER" to store the new data

The modification is done; this means that when you’ll next start the system again, the new
data will be used.

NB: press to return.

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CLOCK

select the field, enter the time and date you want. press "ENTER"

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EXPOSURE TABLES
3 POINTS TECHNIQUE

mA
ms 32 40 50 63 80 100 125 160 200 250 320 400 500

2 0,5 0,6 0,8 1

3 0,6 0,8 1,0 1,2 1,5
4 0,5 0,6 0,8 1,0 1,3 1,6 2
5 0,5 0,6 0,8 1,0 1,3 1,6 2,0 2,5
6 0,6 0,8 1,0 1,2 1,5 1,9 2,4 3
8 0,6 0,8 1,0 1,3 1,6 2,0 2,6 3,2 4
10 0,5 0,6 0,8 1,0 1,3 1,6 2,0 2,5 3,2 4,0 5
12 0,6 0,8 1,0 1,2 1,5 1,9 2,4 3,0 3,8 4,8 6
16 0,5 0,6 0,8 1,0 1,3 1,6 2,0 2,6 3,2 4,0 5,1 6,4 8
20 0,6 0,8 1,0 1,3 1,6 2,0 2,5 3,2 4,0 5,0 6,4 8,0 10
25 0,8 1,0 1,3 1,6 2,0 2,5 3,1 4,0 5,0 6,3 8,0 10,0 12,5
32 1,0 1,3 1,6 2,0 2,6 3,2 4,0 5,1 6,4 8,0 10,2 12,8 16
40 1,3 1,6 2,0 2,5 3,2 4,0 5,0 6,4 8,0 10,0 12,8 16,0 20
50 1,6 2,0 2,5 3,2 4,0 5,0 6,3 8,0 10,0 12,5 16,0 20,0 25
63 2,0 2,5 3,2 4,0 5,0 6,3 7,9 10,1 12,6 15,8 20,2 25,2 31,5
80 2,6 3,2 4,0 5,0 6,4 8,0 10,0 12,8 16,0 20,0 25,6 32,0 40
100 3,2 4,0 5,0 6,3 8,0 10,0 12,5 16,0 20,0 25,0 32,0 40,0 50
125 4,0 5,0 6,3 7,9 10,0 12,5 15,6 20,0 25,0 31,3 40,0 50,0 62,5
160 5,1 6,4 8,0 10,1 12,8 16,0 20,0 25,6 32,0 40,0 51,2 64,0 80
200 6,4 8,0 10,0 12,6 16,0 20,0 25,0 32,0 40,0 50,0 64,0 80,0 100
250 8,0 10,0 12,5 15,8 20,0 25,0 31,3 40,0 50,0 62,5 80,0 100,0 125
320 10,2 12,8 16,0 20,2 25,6 32,0 40,0 51,2 64,0 80,0 102,4 128,0 160
400 12,8 16,0 20,0 25,2 32,0 40,0 50,0 64,0 80,0 100,0 128,0 160,0 200
500 16,0 20,0 25,0 31,5 40,0 50,0 62,5 80,0 100,0 125,0 160,0 200,0 250
630 20,2 25,2 31,5 39,7 50,4 63,0 78,8 100,8 126,0 157,5 201,6 252,0 315
800 25,6 32,0 40,0 50,4 64,0 80,0 100,0 128,0 160,0 200,0 256 320 400
1000 32,0 40,0 50,0 63,0 80,0 100,0 125,0 160,0 200,0 250,0 320 400 500
1250 40,0 50,0 62,5 78,8 100,0 125,0 156,3 200,0 250,0 312 400 500
1600 51,2 64,0 80,0 100,8 128,0 160,0 200,0 256 320 400
2000 64,0 80,0 100,0 126,0 160,0 200,0 250,0 320 400 500
2500 80,0 100,0 125,0 157,5 200,0 250,0 312 400 500
3200 102,4 128,0 160,0 201,6 256 320 400
4000 128,0 160,0 200,0 252,0 320 400 500
5000 160,0 200,0 250,0 315 400 500

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2 POINTS TECHNIQUE

mA
mAs 125 160 200 250 320 400 500
0,5 3,1 2,5 2,0
1 6,3 5,0 4,0 3,1 2,5 2
1,6 10,0 8,0 6,4 5,0 4,0 3,2
2 12,5 10,0 8,0 6,3 5,0 4
2,8 17,5 14,0 11,2 8,8 7,0 5,6
3,2 20,0 16,0 12,8 10,0 8,0 6,4
4 25,0 20,0 16,0 12,5 10,0 8
5 31,3 25,0 20,0 15,6 12,5 10
6,3 39,4 31,5 25,2 19,7 15,8 12,6
8 50,0 40,0 32,0 25,0 20,0 16
10 62,5 50,0 40,0 31,3 25,0 20
13 81,3 65,0 52,0 40,6 32,5 26
16 100,0 80,0 64,0 50,0 40,0 32
20 160,0 125,0 100,0 80,0 62,5 50,0 40
25 200,0 156,3 125,0 100,0 78,1 62,5 50
32 256,0 200,0 160,0 128,0 100,0 80,0 64
40 320,0 250,0 200,0 160,0 125,0 100,0 80
50 400,0 312,5 250,0 200,0 156,3 125,0 100
63 504,0 393,8 315,0 252,0 196,9 157,5 126
80 640,0 500,0 400,0 320,0 250,0 200,0 160
100 800 625,0 500,0 400,0 312,5 250,0 200
125 1000 781,2 625,0 500,0 390,6 312,5 250
160 1280 1000 800,0 640,0 500,0 400,0 320
200 1600 1250 1000 800.0 625,0 500,0 400
250 2000 1562 1250 1000 781,2 625,0 500
320 2560 2000 1600 1280 1000 800 640
400 3200 2500 2000 1600 1250 1000 800
500 4000 3125 2500 2000 1562 1250 1000

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MAINTENANCE
The installers and operators of this equipment must be acquainted with all the current
safety rules and regulations.
All the X-ray generator parts must be checked and inspected at least once a year, as to
guarantee correct working and safe conditions for both the patient and the operator.
Every 12 (twelve) month must make an inspection and, if necessary, replace those parts
that could represent a danger due to wear and tear.

Please constantly check the control panel and verify all the visual and sound signals. Pay
particular attention to the X-ray indicating lamp, which must be visible throughout the X-ray
emission only. Failing this, please immediately contact the servicing.

NB: before any operating test be sure to put on the protective lead-covered wear; also
keep at a safe distance from the X-ray tube and make use of an exposure control film or a
dosimeter.

This model does not require a daily maintenance.

CLEANING
Switch off and completely disconnect the machine from the main line before
cleaning.
Clean the plastic parts with water and mild soap; other substances may be harmful.
Do not ever use any corrosive, solvent, abrasive cleansing or polishing
agents.
Do not let water nor any other liquid substances seep through the unit; this prevents
from short circuits, corrosion and oxidation. Disinfectant sprays are not
recommended, as they may seep through the unit as well.

WASTING
Unserviceable units must be wasted observing the current regulations
about special waste.

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USED SYMBOLS
Annex D (IEC 60601-1)

Small focus

Large focus

Warning

Radiation

CE marking
0051

Earthing

Waste

Technical Documentation

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LABELLING

UNIT LABEL

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