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Installation: Melody Ii Technical Manual

This chapter of the Melody II technical manual covers installation of the device. It includes information on device classification, identification labels, precautions for installation, an installation checklist, dimensions and weights, location of internal and C-arm components, and abbreviations. Key points are that the device is a Class IIb medical device according to EU directives, installation must only be done by trained technicians, and safety precautions must be followed regarding X-rays, high voltage, and hot components.
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100% found this document useful (1 vote)
151 views22 pages

Installation: Melody Ii Technical Manual

This chapter of the Melody II technical manual covers installation of the device. It includes information on device classification, identification labels, precautions for installation, an installation checklist, dimensions and weights, location of internal and C-arm components, and abbreviations. Key points are that the device is a Class IIb medical device according to EU directives, installation must only be done by trained technicians, and safety precautions must be followed regarding X-rays, high voltage, and hot components.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 22

MELODY II TECHNICAL MANUAL

CHAPTER 2
INSTALLATION
1 - DEVICE CLASSIFICATION...................................................................................... 2
2- IDENTIFICATION LABELS ....................................................................................... 3
3 – PRECAUTION FOR INSTALLATION ...................................................................... 5
4 - INSTALLATION CHECKLIST ................................................................................... 6
5 – DIMENSIONS AND WEIGHT .................................................................................. 7
6 - MAIN INTERNAL COMPONENTS LOCATION ........................................................ 8
7 - C-ARM COMPONENTS LOCATION ...................................................................... 10
8 - ABBREVIATIONS ..................................................................................................11
9 – POWER LINE CONNECTION ............................................................................... 12
10 – VOLTAGE SELECTOR ....................................................................................... 14
11 – EMERGENCY CUT OFF ..................................................................................... 15
12 – LCD CONTRAST ADJUSTMENT AND LANGUAGE SELECTION ...................... 16
13 – DATE AND TIME SETTING ................................................................................. 17
14- MAXIMUM COMPRESSION FORCE SETTING.................................................... 18
15 – DOOR SAFETY SWITCH .................................................................................... 18
16 – EXTERNAL LAMP ............................................................................................... 19
17 – EXPOSURE COUNTER ...................................................................................... 19
18 –SERVICE MENU ..................................................................................................20
19- DIP SWITCH AND CORRELATED FUNCTIONS .................................................. 21
20 - CALIBRATION .....................................................................................................22
21 – UNIT CLEANING .................................................................................................22
22 – INSTRUCTION FOR USE.................................................................................... 22

VILLA SISTEMI MEDICALI CAP 2 Page 1 of 22


MELODY II TECHNICAL MANUAL

1 - DEVICE CLASSIFICATION

The identification label is placed on the back of the device and a true copy of it is also
placed inside on it.

IEC 601-1 (CEI 62-5) Standard:


MELODY II belongs to Class I type B.

Directive 93/42/EEC for Medical Devices:


MELODY II belongs to Class IIb.

VILLA SISTEMI MEDICALI CAP 2 Page 2 of 22


MELODY II TECHNICAL MANUAL

2- IDENTIFICATION LABELS

VILLA SISTEMI MEDICALI CAP 2 Page 3 of 22


MELODY II TECHNICAL MANUAL

The meaning of symbols appearing on the plate and on some components of the machine
is specified in the following table.

VILLA SISTEMI MEDICALI CAP 2 Page 4 of 22


MELODY II TECHNICAL MANUAL

3 – PRECAUTION FOR INSTALLATION


As for all x-ray units, use of MELODY II must be authorised by the competent authority in
the country of use.
Installation and service of the unit must be carried out by technicians authorised and
trained by Villa Sistemi Medicali.
When performing service and maintenance on the equipment, the following points must
be considered:
 If X-ray emission is required, always use the proper precautions against X-ray
exposure. The technician must remain behind the x-ray glass shield during X-
ray emission.
 Disconnect the mains power supply by means of an external breaker before
removing any cover.
 Even when the equipment is switched off (by means of the on/off push -button,
or emergency switches) there are parts of the equipment that can be at
dangerous voltage.
 Be careful when touching the internal parts: some of them might be very hot.
 Do not leave the equipment unattended after the covers have been removed.
Be aware that improper use and servicing of mammo unit can bring about the following
risks:
 exposure to X-rays, health endangering ionising radiation capable of causing
serious, permanent injuries;
 high voltage can cause serious injuries or death;
 implosion of the vacuum X-ray tube;
 burns resulting from contact with the oil inside the X-ray housing, caused by
tampering or breakage of it
 all risks caused by contact with live components as a consequence of
tampering or interventions carried out on the live equipment without the due
precautions.
 Do not connect to the unit Input/Output serial ports, devices without compliance
to standard EN 60601-1 for electrical safety and EEC directive 89/336
regarding Electromagnetic Compatibility. Connection of Personal Computers
not intended for medical application is not allowed.
 Take care that specified X-ray beam total filtration is not modified by removing
filter or adding other material in the beam.
Ambient storage conditions: (while packed):
-temperature: -10°C/+70°C
-relative humidity: 10%  90%
-pressure: 500 hPa  1060 hPa
Ambient operating conditions:
-temperature: +10°C/+40°C
-relative humidity: 30%  75%
-pressure: 700 hPa  1060 hPa

In case of risk of dew, once the equipment has been unpacked, wait for at least 24 hours
before applying voltage, thus enabling it to reach a thermal equilibrium with the
surrounding environment.

VILLA SISTEMI MEDICALI CAP 2 Page 5 of 22


MELODY II TECHNICAL MANUAL

4 - INSTALLATION CHECKLIST

Please make sure to fill in this form during installation.


MELODY  II  /B II Type S/N
Installation place Installation date
Installed by

Mains Voltage: Frequency:

Item to check OK ?
External damage
Glass shield locked
H.T. tank overpressure valve opening
H.T. tank oil leakage
X-ray tube assembly oil leakage
Check for connectors properly inserted
Mains voltage check (Vac ) and eventual voltage selector
configuration
Mains wiring and phase/neutral/earth connections check
Emergency push buttons in operating position
Mains connection and emergency breaker function
Switch ON unit and check for:
C-ARM UP/DOWN movement to end of travel switches
C-ARM rotation brake
Compression movement UP/DOWN
Collimator lamp
Compression force
Compressor release when pressing both pedals
Collimator plate detector switch (if installed)
Cassette detector switch
External lamps (equipment on/ X-ray on)
Door interlock
Display contrast and language
Calendar clock set
Rotating anode starter safety circuit re-calibration (60 Hz only)
AEC detector offset calibration [o]
AEC detector gain calibration [r] with phantom
Automatic filter changer operation (if installed)
Collimator mirror “out of field” during x-ray
Standard film darkness calibration
PC Advanced film darkness calibration
Reset exposure memory

VILLA SISTEMI MEDICALI CAP 2 Page 6 of 22


MELODY II TECHNICAL MANUAL

5 – DIMENSIONS AND WEIGHT

780 mm

SUPERFICIE

mm
445 mm

D'APPOGGIO

532
0,39 m 2

Peso stativo : kg 275

Peso paratia anti-X : kg 75


Peso paratia anti-X incernierata: kg 75

Hinged X-Ray glass shield weight: kg 75

Peso paratia anti-X trasparente: kg 130

Transparent X-Ray glass shield weight: kg 130

Peso paratia anti-X semitrasparente: kg 105

Semitransparent X-Ray glass shield weight: kg 105

VILLA SISTEMI MEDICALI CAP 2 Page 7 of 22


MELODY II TECHNICAL MANUAL

6 - MAIN INTERNAL COMPONENTS LOCATION

BACKSIDE VIEW

VILLA SISTEMI MEDICALI CAP 2 Page 8 of 22


MELODY II TECHNICAL MANUAL

FRONTSIDE VIEW

VILLA SISTEMI MEDICALI CAP 2 Page 9 of 22


MELODY II TECHNICAL MANUAL

7 - C-ARM COMPONENTS LOCATION


SENSORE DI TEMPERATURA 02-171

Standard C Arm
SENSORE DI TEMPERATURA 02-171

For biopsy C Arm

VILLA SISTEMI MEDICALI CAP 2 Page 10 of 22


MELODY II TECHNICAL MANUAL

8 - ABBREVIATIONS

Abbreviation Description
C1, C2 Anode starter capacitors (16 µF 450V)
C3, C4, C5, C6 Inverter capacitors (2200 µF 350V)
M1 General terminal block (contacts number 1...17)
LA1 Collimator lamp, halogen 24V-100W
PL1 Collimator lamp holder
EM 4 Compressor clutch
MT 1 C-arm vertical movement motor
MT 2 Compressor motor
MT 3 Bucky grid linear actuator
MT 5 C-arm rotation brake motor
MSW3 C-arm rotation handle microswitch
MW 1 Vertical C-arm movement emergency switch down
MW 2 Vertical C-arm movement emergency switch up
MW 3 Vertical C-arm movement limit switch down
MW 4 Vertical C-arm movement limit switch up
MW 5 Cassette detector microswitch
MW 7 Brake locked microswitch
MW 8 Brake unlocked microswitch
MW 9 Collimator detector microswitch
MW 10 Rh filter microswitch
MW 11 Mo filter microswitch
MW 12 Filter OK microswitch
PB 1 ON/OFF push-button
PB 12 X-ray push-button
PB 11A, PB 11B Emergency shutdown pushbuttons
PB 2, PB 3 Vertical C-arm movement pushbuttons
PE 1 + PE 2 Compressor footpedals
PCB/92-072 CPU board
PCB/92-073 Filament supply board
PCB/92-074 Anode starter board
PCB/92-076 COM1 - COM2 serial ports board
PCB/92-077 Analog input board
PCB/92-078 AEC interface board
PCB/92-079 Inverter, filament, anode starter interface board
PCB/92-080 Console and display interface board
PCB/92-082 Motherboard
PCB/92-083 Keyboard
PCB/93-107 Potter driver board
PCB/96-153 Mirror magnet board
PHTM6000 AEC detector
KTFLA0206 MOSFET inverter assembly
KTFLI0009 HT transformer
DS 1 Display board
RY 1, RY 2 Static relay
R1 82 50W resistor (inverter capacitor pre-charge)
T1 (TF 203) Power transformer
T2 (TF 205) Services transformer
TLR1 Mains breaker
PD1, PD2 Inverter supply bridge rectifier
Z1 Mains filter

VILLA SISTEMI MEDICALI CAP 2 Page 11 of 22


MELODY II TECHNICAL MANUAL

9 – POWER LINE CONNECTION


Before powering the equipment, it is important to get a clear view of the internal parts
subject to dangerous voltages for the operator to avoid any accidental contact.

Voltage higher than 60 Vac is present on:


Terminal and fuses of power line connection
Contact breaker and emergency cut off buttons PB11A and PB11B
Line filter
Terminals M2, M2, M15
Fuses F1,2,3,4,5,6,7,8
Static Relays RY1, RY2 and resistor R1
Transformers TF205, TF203 and their connected parts
C-arm driving gear motor MT1 and travel-ends MW1, MW2
Motherboard CPU 92-082
Starting Rotating anode 92-074 and capacitors C5, C6
Tube Rotating Anode Cable and supply connections

Inverter Power supply > 500 Vdc is present on:


Rectifier bridges PD1, PD2
Capacitors block C1,2,3,4
Inverter block
High Voltage generator

High-voltage 20÷35 kV is present on:


High Voltage generator
High voltage cable
X-ray Tube

Mains power shall be connected to the unit by means of the terminal block (labelled L, N,
gnd) located in the lower, left corner of the rear component board. Please note that the
live wire (L) will be connected directly to the fuse holder (F1). The mains cable shall pass
through the suitable cable holder provided in the posterior plate.
When preparing the room for connection, observe the following indication:
 Mains voltage must be single phase 220, 230 or 240 V~, 50 or 60 Hz. Some
settings in the equipment must be made to allow for the different voltages and
/or frequencies. See the relevant paragraph.
 The mains cables must have a section of not less than 4 mm2.
 The mains line apparent resistance must be less than 0.2 
 The mains line must be permanently connected.
 A mains breaker must be provided according to local and international
regulations. We suggest the installation of a circuit breaker (thermal + earth
leakage) with the following characteristics: I N=30A, IN=30mA

Before powering the equipment, check that the internal settings for voltage and frequency
match the available power supply. (see next paragraph)

VILLA SISTEMI MEDICALI CAP 2 Page 12 of 22


MELODY II TECHNICAL MANUAL

WARNING:
the unit is supplied in configuration A for phase / neutral / earth single phase line.
If available mains is phase / phase / earth, one additional 20AT fuse must be
installed on the neutral wire as sketched in configuration B.

L
F1
Neutral

Ground
Phase

Configuration A: connection to Phase/neutral mains line

N
Additional fuse
20AT
L
F1
Phase 2
Phase 1

Ground

Configuration B: connection to a Phase/Phase mains line with additional fuse

VILLA SISTEMI MEDICALI CAP 2 Page 13 of 22


MELODY II TECHNICAL MANUAL

10 – VOLTAGE SELECTOR
Set the connections on transformers TF 203, TF 205 and on connector CN 11 according
to the available voltage.

Note:
if the unit is operated with 60Hz line frequency, readjust rotating anode safety circuit
calibration. Refer to section 12.1 for details.

VILLA SISTEMI MEDICALI CAP 2 Page 14 of 22


MELODY II TECHNICAL MANUAL

11 – EMERGENCY CUT OFF


On the front side of the unit, two emergency pushbuttons are located t o be used for total
and instantaneous Switch OFF.
This control is only intended for operator's use in a condition of real or presumed danger.
In such a circumstance, the unit is totally disconnected from the mains, x -ray emission is
blocked, every motorised movement is blocked and compression paddle automatically
releases letting the patient free.
This control cannot be used for normal Switch OFF of the unit.
Pushbuttons are provided of self-lock function to prevent any self-release.
If you can't switch ON the unit, please inspect emergency pushbuttons for any lock on of
one or both of them.

VILLA SISTEMI MEDICALI CAP 2 Page 15 of 22


MELODY II TECHNICAL MANUAL

12 – LCD CONTRAST ADJUSTMENT AND LANGUAGE SELECTION


Display contrast depends on ambient temperature.
Its adjustment may be set only using the RV1 trimmer on the PCB 92 -083 board, which
can be reached opening lateral panel.
To select the desired language for the error message, use the dip switches located on the
same PCB 92-083 board.

DIPSW1 PCB 92-083 KEYBOARD/CONTROL PANEL

1 2 3 4 Language
OFF OFF OFF X Italian
ON OFF OFF X French
OFF ON OFF X English
ON ON OFF X German
OFF OFF ON X Spanish
ON OFF ON X Polish
OFF ON ON X Turkish
ON ON ON X Portuguese

DIPSW1

RV1

PCB 92-083

VILLA SISTEMI MEDICALI CAP 2 Page 16 of 22


MELODY II TECHNICAL MANUAL

13 – DATE AND TIME SETTING


The following steps must be carried out when adjusting the disp lay date and time:

Activate the regulation mode by simultaneously pressing the acoustic error signal button
(12) and the decompression mode selection button (10). Keep these buttons pressed
during regulation.

The date and time can be selected using the following buttons:
day KV regulation button 3
month mAs regulation button 4
year film screen selection button 7 +
AEC selection button 8
minutes compression force regulation button 11
hour optical density regulation button 9

VILLA SISTEMI MEDICALI CAP 2 Page 17 of 22


MELODY II TECHNICAL MANUAL

14- MAXIMUM COMPRESSION FORCE SETTING


The maximum compression force can be set, depending on local regulation, at 15 or 20kg.
The force is calibrated till 20 kg as explained in the related chapter of this manual, and the
index can vary between 1 and 20 on display. But it is possible to limit the range of the
index between 1 and 15 by means of Jumper 18 on PCB 92 -082-6. If the jumper is closed,
the index range is 1-15 and the force is limited accordingly.

15 – DOOR SAFETY SWITCH

An input is provided to allow the connection of a contact detecting the state of the
entrance door of the room where the unit is located. Any attempt to take a shot while the
door is open will cause the warning:

DOOR OPEN

to show up, and radiation emission will be inhibited.

On the other hand, opening the door during exposure will have no effect and no need to
repeat the exposure, thus delivering an extra dose to the patient.

SICPORTA
DOOR SAFETY
+5 +5

R41 R42

I7

IC15
CN18
1 1 M2 5
2 2 M2 4

DOOR SAFETY SWITCH

CONTATTO SICUREZZA PORTA

IF PROTECTION CONTACT IS NOT USED, INPUT TERMINALS SHALL BE SHORT


CIRCUITED.

METALTRONICA
Title
SICUREZZA PORTA
Size Document Number REV
A PORTA.SCH
Date: April 17, 1995 Sheet of

VILLA SISTEMI MEDICALI CAP 2 Page 18 of 22


MELODY II TECHNICAL MANUAL

16 – EXTERNAL LAMP
An output is provided to connect an external mains voltage lamp.
A set of two signals allows the state of the unit to be recognised (POWER ON /
RADIATION ON).

The lamp control circuit is located on the motherboard CPU 92-082.


The circuit is protected by fuse F6, and the lamps are connected to terminal board M2.

DO NOT USE LAMPS EXCEEDING 25W.

Different external lamp


If you want to control different external lamps, you can use the Normally Open contact
which refers to terminals 2 and 3 of M2 terminal board. Before this operation, 220Vac
power supply must be disconnected from CN13.

17 – EXPOSURE COUNTER
The unit contains an electromechanical pulse counter to count all the shots taken. The
pulse counter is located on PCB 92-082.

C
+
N
1
5 T
U 2 D
P
1 1
9 5
R 1
5
3 T
R
1
2

Pulse counters DO NOT necessarily record the same values, and cannot be
synchronised.
Software data counters are stored into the non -volatile RAM located on PCB 01-170.
Replacing this RAM will cause all data therein contained to be lost.

M
E
T T
i A
C
t L
O T
S
l D o R
R
N
ei A c u
O
T C E
0
z m O V
eD e n N
A I S o
a C
M N
t A T
h 2 f 2
t N p ur A
P e
e U A
mi l . S
e
VILLA SISTEMI MEDICALI : b 1 e6 L
C
t CAP 2 Page 19 of 22
MELODY II TECHNICAL MANUAL

18 –SERVICE MENU
If buttons 7 and 12 are held down together, the Service Menu is displayed:

12

VILLA SISTEMI MEDICALI MELODY II MAMMO


CPU
F2=OK F4=OK
INVERTER
POWER = GOOD SERVICE = OK
FILAMENT POWER SUPPLY
>>GOOD<<
ROTOR SUPPLY
>>GOOD<<
SOFTWARE XX TUBO
Tube Housing kJ 25°C
n. .............. ../../.. ..................

Enabling to obtain the following information:


a) software revision;
b) type of tube installed;
c) total number of JOULES, by focus, supplied to the tube from its installation to present;
d) total number of exposure made from large focus and small focus;
e) time and date of last exposure made.

Normal display function is restored pressing pushbutton 12 for few seconds.

VILLA SISTEMI MEDICALI CAP 2 Page 20 of 22


MELODY II TECHNICAL MANUAL

19- DIP SWITCH AND CORRELATED FUNCTIONS

01-170 Board
SW1
DIP1 ON = anode current calibration mAH
DIP2 ON = anode current calibration mAL
DIP3 ON = DEMO mode
DIP4 ON = BYM C-arm
DIP5 ON = Reduced DEATA PLUS
DIP6 ON = Calibration % Reduced Deata Plus
DIP7 ON = Compression force calibration
DIP8 ON = FILTROMAMM enabled

SW2
DIP1 ON = C-arm location for Digital Bym controlled from control panel
DIP2 ON = PHTM9000 three fields detector enabled
DIP3 ON = mirror magnet OFF = 96-153
DIP4 ON = C-Arm brake for MELODY II
DIP5 ON = Printer S’PRINT I-LP1 for adhesive labels

SW1, DIP1 & DIP2: To enter Anode current calibration. See dedicated section in Chapter
3, Filament.
SW1, DIP3: In DEMO mode all functions are active, except for the X-ray output, whose
sequence is simulated (only manual mode)
Demo mode can be used during an exhibition and during safety rotating anode calibration.
SW1, DIP4: For isocentric C-arm this dip switch must be ON, for normal C-arm must be
OFF, because it influences the breast thickness value and the AGD values.
SW1, DIP5: Reduced Deata Plus with only one film/screen and one technique. It is only
intended for manual calibration when PC densitometer, sensitometer ar e not available.
Optical density linearity is not guaranteed as well fulfilment of applicable standard and Q.A
protocols.
SW1, DIP6: To enable manual adjustment of O.D. for Reduced Deata Plus. Dip 6 is active
only if DIP 5 is ON. Refer to related chapter of the manual.
SW1, DIP7: Calibration of compression system.
SW1, DIP8: ON to enable FILTROMAMM functionality. If FILTROMAMM is installed later,
as upgrade, dip 8 must be switched ON and Mo/Rh curves of AEC must be calibrated.

SW2, DIP1: When the device is configured with bym C-arm and digital bym, two detectors
placed on c-arm detect c-arm position.
If the device has no detectors, c-arm position can be detected from control panel after
switching DIP1 SW2 = ON on PCB/01-170 board.
SW2, DIP2: must be set OFF only for PHTM6000.
SW2, DIP3: The configuration of this DIP Switch depends on the hardware of the
mammography unit.
SW2, DIP4: For the proper functionality of the disk brake, must remain ON .
SW2, DIP5: OFF for Easylabel protocol ON for S’PRINT protocol

VILLA SISTEMI MEDICALI CAP 2 Page 21 of 22


MELODY II TECHNICAL MANUAL

20 - CALIBRATION
Automatic exposure meter calibration (AEC) is the only necessary operation to do before
use.
See chapter 3 of this manual.

21 – UNIT CLEANING
The unit can be cleaned using a soft cloth with neutral detergent.

22 – INSTRUCTION FOR USE


For any instruction or warnings see the Operator’s manual.

VILLA SISTEMI MEDICALI CAP 2 Page 22 of 22

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