User Manual

GX-600/X Doc. :001139

USER MANUAL

1¾ INTRODUCTION
2¾ CLASSIFICATION
3¾ GENERAL DESCRIPTION
4¾ COMMAND CONSOLE
5¾ CONSOLE SETUP
6¾ EXPOSURE TABLES
7¾ MAINTENANCE
8¾ SYMBOLS
9¾ LABELLING

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1. INTRODUCTION

X-RAY GENERATOR TO COUPLE AT VARIOUS TYPE OF ACCESSORIES PROPERLY DEVELOPPED

FOR X-RAY SYSTEMS.

X-RAY EQUIPMENTS CAN BE DANGEROUS FOR PATIENT AND OPERATOR HEALTH IN

ABSENCE OF RIGOROUS PROTECTION MEASURES

Although this equipment is planned and assembled following safety regulations, X-ray sources ever can be
dangerous for the operator and the patient. X-ray excessive exposure causes damages for one’s health.

All people using these devices must protect them with appropriate X-ray shielding..

Consequently must be taken all necessary cautions in order to void the use of this equipment to not
authorized or not qualified people as to represent a danger for himself and for other peoples.

Authorized and qualified people to use this equipment, before to perform any action, must be informed of
protection’s measures as in compliance with X-ray protection rules of International Commission and
nationals rules on the matter.

Electromagnetic interference in conformity to 89-336 rule “don’t use in presence of mobile phones or other
equipments that can cause electromagnetic interferences”, such to endanger the equipment’s

Properly use of this equipment require previous and accurate operator’s

consultation of this user’s manual.

The original version of this manual has been written in Italian language.

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2. CLASSIFICATION

GENERATOR 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:

P.S.M. S.r.l.
Via Orio Al Serio, 14/16
24050 Grassobbio (BG) Italy
Tel: +39 035 4522455
Fax: +39 035 335103
Web: http://www.psmrad.com

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3. GENERAL DESCRIPTION

X-RAY GENERATOR MAIN FEATURES

• Frequency 40 kHz.
• Max Voltage at the Tube 150 kV (depend of the tube).
• Compact and soft design.
• Dosage checking during X-ray emission.
• A 5,7” touch screen display simplifies user’s work.
• User friendly system configuration.
• Integrated anatomical programme.
• Integrated self-diagnosis with alert message storage.
• mA and mAs time selection
• Tube’s thermal units checking.
• Exposure data self-calibration system.

ENVIRONMENTAL SPECIFICATIONS

IN USE
Environment temperature range: 10 – 40 °C.
Relative humidity: 20 – 80%, not condensed
Positioning from sea to 2440 meter above sea level (from 700 to 1100 hPa).

TRANSPORT AND STORAGE

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

The information contained herein is presented only as a guide for the use condition
in respect of operator and x-ray generator safety.
X-ray generator must be used only in respect of safety notice in this section and possible
additional manufacturer’s information and/or safety relevant authorities.

X-RAY FEATURES (*)

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 msec (in 34 Steps)
Current-time factor range from 0,5 to 500 mAs (in 28 Steps)
Power reduction selection 80%

(*) In function of the Model and the X-ray tube installed.

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TECHNICAL FEATURES: 30 kW VERSION

X-ray tube max voltage and X-ray tube max current at this voltage
30 kW 150 kV, 200 mA

X-ray tube max current and X-ray tube max voltage at this current
30 kW 400 mA, 75 kV

X-ray tube current combination and X-ray tube voltage resulting at max power supply
30 kW 250 mA, 120 kV

Maximum constant emission at 100 kV, 0,1 sec.

25 kW 25 kW (250 mA,100 kV, 0.1 s)

TECHNICAL FEATURES: 40 kW VERSION

X-ray tube max voltage and X-ray tube max current at this voltage
37.5 kW 150 kV, 250 mA

X-ray tube max current and X-ray tube max voltage at this current
40 kW 500 mA, 80 kV

X-ray tube current combination and X-ray tube voltage resulting at max power supply
40 kW 400 mA, 100 kV

Maximum constant emission at 100 kV, 0,1 sec.

40 kW 40 kW (400 mA,100 kV, 0.1 s)

TECHNICAL FEATURES: 50 kW VERSION

X-ray tube max voltage and X-ray tube max current at this voltage
48 kW 150 kV, 320 mA

X-ray tube max current and X-ray tube max voltage at this current
50 kW 500 mA, 100 kV

X-ray tube current combination and X-ray tube voltage resulting at max power supply
50 kW 500 mA, 100 kV

Maximum constant emission at 100 kV, 0,1 sec.

50 kW 50 kW (500 mA,100 kV, 0.1 s)

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Operating mode

3 (three ) parameters setting technique:

• kV – mA – msec selection
• mAs automatically calculated and visualized in function of the parameters setted.
• Automatic Exposure Control AEC (Option)

2 (two) parameters setting technique:

• kV e mAs selection
• mA maximum automatically calculated and visualized in function of the parameters
setted.
• Automatic Exposure Control AEC (Option)

Anatomical Technique setted mode :

• 5 anatomical areas
• 8 tests for each selecting area
• 3 patient size selecting

Parameters that can be admitted to Anatomical technique:

accessory choice ( table’s Bucky– wall’s bucky– free accessory )
X-ray parameters (kV – mA – mAs – ms)
Focus selection
work technique (3 points – 2 points)

X-RAY GENERATOR ACCESSORIES

(not supplied by P.S.M.)

- 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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4. CONSOLE

Press switch-on symbol to start up the X-ray generator and to enter the work page.

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• 3 points work technique

2 1

7
5

10 3 4 9

1. kV - mA - msec. manual setting.

2. mAs setted visualization
3. accessories selection button
4. work mode choice
5. focus selection
6. maximum charge selection
7. anatomical region selection
8. Reset
9. A.E.C. selection
10. unit used indicator

N.B. PRESS “F5” KEY TO RETURN TO STAND-BY MODE.

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ACCESSORIES SELECTION

The selected accessory is shown with white colour.

Table Bucky

Free accessory

Wall Bucky

WORK SELECTION MODE

Press the shown button to change the required work mode.

3 points work technique mode - Kv - Ma - ms -

2 points work technique mode - Kv - mAs -

FOCUS SPOT SELECTION

Press the shown button to change the selection of focus spot

Large focus

Small focus

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MAXIMUM CHARGE SELECTION

Press the shown button to change X-ray generator maximum charge

X-ray parameters of the filament reduced at 80%

X-ray parameters of the filament at full power 100%

ANATOMICAL REGIO SELECTION

As to enter to the test planned technique, select directly one of the five anatomical areas in
which has been shared the human body.
The number visualized in each area shows the number of tests planned for that particular
zone.

SKULL

THORAX

UPPER LIMBS

PELVIS

LOWER LIMBS

For each anatomical area it is possible to plan till a maximum of 8 tests.

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RESET BUTTON

Out of order or alarm signal appears on the display through proper message, at the same
time reset button lights up, and after the restoration of the optimum condition of working,
push reset button to cancel the signalling.

Reset button off – no signalling

Reset button on – signalling on the panel, press the button after the
resolution of the problem

X-RAY TUBE THERMAL UNITS INDICATOR

Graphic representation, through coloured bar, of X-ray tube thermal heating.

White area represents residual thermal units, coloured area used units.
When is reached X-ray tube thermal capacity appears a message signalling on the panel
and further X-ray exposition is not enable until X-ray tube cooling come back into allowed
limits.

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Automatic Exposure Control (AEC) Work Mode

AEC Left Area Selection

AEC Center Area Selection

AEC Right Area Selection

AEC Density

AEC Film / Screen Selection

AEC Post mAs Display

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• indications of light

Exposure ready

X-ray emission

Waiting for focus change (5 seconds)

Waiting for further exposure, after emission. (minimum 10 seconds
maximum in function of emitted quantity.)

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• 2 points technique work

Operative procedure is like the 3 points technique, the variation is located only on the
buttons for mAs choice.
X-ray generator, in this mode, searches automatically mA maximum value possible , in
function of the charge setted on the display.

Press again the button for work mode choice to return to the page of 3 points
work.

N.B. PRESS “F5” KEY TO RETURN TO STAND-BY MODE.

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• Anatomical Technique work mode.

Press the interested anatomical area to enter to the planned tests.

Es. After to have pressed the skull area the panel shown the following image:

selection buttons for patient size:

SMALL MEDIUM LARGE

The patient size change involves a variation of 10% of setted kV for medium patient.

Es. SMALL MEDIUM LARGE

Kv 72 80 88

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Buttons for the scrolling of planned tests on selected anatomical zone.

Ex. For selected anatomical zone has been planned 3 tests.

Use the showed buttons to scroll, at the inside of selected zone, the planned tests.
The test visualized upon the buttons shows the particular name coupled to the test
on the panel.

Settled focal spot indication with selected test.

N.B. It is not possible to change this planned selection.

Reset button signalling for alert or warning.

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SKULL

THORAX

UPPER LIMBS

PELVIS

LOWER LIMBS

To select a different anatomical area, press the interested zone defined in broken line on
the picture.
N.B. The number visualized in anatomical areas shows the planned tests.

N.B. PRESS THE KEY FUNCTION “F5” TO RETURN TO PREVIOUS WORK

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WARNING : If during normal generator’s working comes displayed the following page,
execute the procedure described below the image.

NOT turn-off the generator for any reason.

Inform immediately servicing, as to provide to replace the PLC buffer battery.

To take again the work press the function key F5.

N.B. In all work pages is displayed the symbol shown below as to remember to the
operator that the generator is in anomalous condition.

Every 5 minutes is proposed again the warning display.

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5. CONSOLE SETUP
As to enter to console SETUP page, from stand-by display, press the function key “F1”
shown by the arrow

It is displayed the password page that allows the access to qualified operator only.

Enter the password " 00 " ( zero zero ) and press "ENT" button

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Now it is displayed the page where the operator can execute personalized layout and
setting.

LANGUAGE SELECTION

Message visualization language choice.

Press the key “ITA” to select all panel texts in Italian language.
Press the key “ENG” to select all panel texts in English language.
Press the key “DEU” to select all panel texts in German language.
Press the key “SPA” to select all panel texts in Spanish language.

RESET

Press this button to manually reset the waiting time.

N.B. The operation must be executed ONLY with the authorization of servicing,

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ANATOMICAL TEST MODIFICATION

Press the key at the side e visualize “ON”.

In this condition is enabled the possibility to modify the parameters of planned tests in
Anatomical Technique.

After to have positioned the switching on in “ON” condition, press the function key “F5” to
return to stand-by page

Press in the centre of the panel to turn on the unit and to visualize the 3 points technique
mode.

“T.A. modify enable” enable command.

On the panel, just next the function key “F3” key function, is visualized a new arrow that
shows the activation of modification mode of anatomical test parameters.

To modify the parameters of planned tests, it is necessary to execute the following

instructions:
• select the anatomical region. ( es SKULL )
• select the test to modify ( ex. test 1 of 3 )
• return to work page pressing the button “F5” Esc
• modify the required radiographic parameters ( ex kV value from 78 to 70. )
• Press the key “F3”, showed by the arrow, to store the new data.

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To modify or to insert the name coupled to the test selected, proceed as follow:
Select the test to be modified or inserted the name.

Press the function key “F1” to enter the keyboard

digit the name to couple to the selected test and

press
“enter” to confirm

Press “F5” key to return to the previous display.

Press function key “F5” again to return at starting page, then press the function key “F3” to
store the new setting.

N.B.: To activate new data, switch off and then switch on the X-ray generator.

If it is required the modification of other tests already planned, repeat the described
sequence.

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DATE – TIME SETTING

From the page “user setting” press the key “ HOUR-DATE” to enter the page of date-time
setting used by the X-ray generator.

choice of the page for date and/or time modification.

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button to confirm the inserted data

button to clear the inserted data

scrolling buttons to select the field to modify

Procedure of insertion of new date-hour:

• digit the number of the hours to insert using numerical keyboard

• press the key “ENT” to confirm
• use the scrolling buttons to select the following field.
• digit the number of the minutes
• press the key “ENT” to confirm
• use the scrolling buttons to select the following field
• digit the number of the seconds.
• press the key “ENT” to confirm
• use the scrolling buttons to select the following field
• digit the number of the day
• press the key “ENT” to confirm
• use the scrolling buttons to select the following field
• digit the number of the month
• press the key “ENT” to confirm
• use the scrolling buttons to select the following field
• digit the number of the year ( 4 figures).
• press the key “ENT” to confirm

N.B. WARNING All fields must be inserted

When is completed the insertion of all fields press the button on the side,
to enable the transfer of the data to the processor.

N.B. PRESS THE FUNCTION KEY“F5” TO VISUALIZE THE

PREVIOUS DISPLAY

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ALARM

From the page “user setting” press the key “ ALARM” to enter the page of alarm message
visualization stored on the panel.

During normal functioning the X-ray generator console visualizes the status message on
the panel.
This chapter relates on the message table and suggests how to solve the problems.

Press the button to reset the message

The alarm is recorded on a panel page with the description on the type of alarm, start and
end hour of the alarm.

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Error message

STARTER NOT READY FILAMENT SAFETY

>85% Kv INVERTER SAFETY

RADIOGRAPHIC INTERRUPTION X-RAY TUBE THERMIC CONTACT

DOOR SAFETY MAX. TIME OF PREPARATION

MAXIMUM mA MINIMUM mA

From alarm storage page press function key “F4” to visualize the alarm statistics panel ,
this function allows to have the immediate check of alarm numbers and of the statistics of
intervention on X-ray generator.

Stored alarm statistics page:

N.B. PRESS FUNCTION KEY “F5” TO VISUALIZE PREVIOUS PAGE.

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6. EXPOSURE TABLES

3 points technique, selection parameters

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, selection parameters

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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7. MAINTENANCE
Installer and/or operator of the unit described in this document has to know all safety rules
and regulations.
All X-ray generator parts must be controlled and inspected at least once a year, to ensure
unit correct functioning and operator and patient safety.
Every 12 (twelve) months an engineer must inspect and, if necessary, replace those parts
that could represent danger for wear and tear effect.
Verify panel and all visual and sound signals, pay particular attention to X-ray emission
indicator that must be visible during the effective X-ray emission only,
otherwise immediately interrupt the maintenance and contact service
department.

N.B. : During X-ray emission functioning test put the protective wearing (lead-covered),
keep properly distance and carry an exposure control film – badge or personal pen
dosimeter.

CLEANING

Switch off and disconnect the system from power supply before to start the cleaning.

• Clean plastic areas with water and mild soap.

Other substance can damage plastic parts.
• Don’t utilize cleaning agent or corrosive cream, solvent or abrasive.
• Be sure that water or other liquid substance don’t penetrate the unit
These cautions prevent short-circuits and components corrosion.
• It isn’t recommended the spry disinfection, as the disinfectant can penetrate
the X-ray unit.

WASTE

Unit out of use must be wasted following current regulation

of special waste.

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8. SYMBOLS

USED SYMBOLS

• Annex “D” ( IEC 60601-1 )

• Small focus

• Large focus

• Warning

• Radiation

• CE marking 0051

• Earthing

• Waste

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9. LABELLING

UNIT POSITIONING LABEL

P.S.M. S.r.l.
Via Orio al Serio, Grassobbio - BG - ITALY

Generator : MX 350/S7.5
S.N. : 00/05-0000 0051
Supply : 230V~ 50/60Hz ± 10%
Power : 16A~ (Operation Mode )
Classification : I IEC60601-1
Ionizing Radiation Max : 120 kVp
Phisiological Effects :
Code: XRE.28.M07.001 Doc:000456

CONSOLE POSITIONING LABEL

P.S.M. S.r.l.
Via Orio al Serio, Grassobbio - BG - ITALY

Console : MX 7.7” COLOR

S.N. : 10/05-0783
Supply : 24Vdc ± 10%
Power : 1A
Display : V708 C
S.N. : 5080435
Code: XRE.28.M07.006 Doc:000481

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