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GENERAL MEDICAL MERATE Spa

Via Partigiani 25 . 24068 Seriate .


BG . ITALIA
Phone 035/4525311
Fax: 0039-035-297787 (Management, Administration, Sales Depts.)
0039-035-299537 (After-sale service Dept.)
General Medical MERATE SpA 06/Nov/07
Via Partigiani, 25 File Opera I 9HR 12HR
24068 Seriate (BG) Italy Tipo Service Manual
e-mail: info@gmmspa.com pag. 2 di 37
Oggetto

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Ver .9
General Medical MERATE SpA 06/Nov/07
Via Partigiani, 25 File Opera I 9HR 12HR
24068 Seriate (BG) Italy Tipo Service Manual
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INDEX
1. GENERAL NOTES ........................................................................................................................5
1.1. Typographic conventions .......................................................................................6
1.1 Symbols of advice positioned on the equipment: ...................................................6
2. INTRODUCTION ...........................................................................................................................7
3. GENERAL INFORMATION ...........................................................................................................8
3.1. The range ...............................................................................................................8
4. POWER SUPPLY..........................................................................................................................8
5. ENVIRONMENTAL CHARACTERISTICS AND FUNCTIONING LIMITS.....................................8
6. RISKS LINKED WITH THE WASTE ELIMINATION .....................................................................9
7. THE PERFORMANCES ..............................................................................................................10
7.1. Image Intensifiers .................................................................................................10
7.2. Dynamic Recursive Filter (DRF)...........................................................................10
7.3. Pulsed fluoroscopy ...............................................................................................10
7.4. Images memorization ...........................................................................................10
9 TV CHAIN CHARACTERISTICS ........................................................................................................11
10 ANALOG TV MONITOR CHARACTERISTICS ................................................................................12
10.1 Dose Control Device ............................................................................................13
10.2 Monitor Support -optional ....................................................................................13
1.2 Dolly .....................................................................................................................13
11 ANALOG TV CHAIN O-I HR 9”, 12”HR CALIBRATION PROCEDURE .....................................14
11.1 Image centering and sizing adjustments ..............................................................14
11.2 Image Direction Adjustment .................................................................................15
11.3 Camera Focus Adjustment...................................................................................16
11.4 Iris /Dose Calibration/ABC calibration ..................................................................17
11.5 Output video signal adjustment ............................................................................18
11.6 Antivignetting........................................................................................................19
11.7 Black level adjustment..........................................................................................20
12 MAINTENANCE ..........................................................................................................................21
12.1 GMM X-ray dose calibration.................................................................................21
12.2 X-ray automatic dose control................................................................................21
13 GENERATOR CONFIGURATION ..............................................................................................22
14. CAMERA INTERFACE................................................................................................................27
15. INTERFACE WITH THE TABLE OPERA T ................................................................................28
INTERFACCIA N33 CON GENERATORE INDICO...............................................................................29
CONNESSIONE CONTROLLO ABS E SYNC ......................................................................................30
CONNESSIONE N33 CON INTENSIFICATORE THALES ...................................................................31
TOSHIBA TUBES ADAPTER 9” 12” ......................................................................................................31
CONNESSIONE N33 CON TELECOMANDATO ..................................................................................32
16. NICAL INTERFACE.....................................................................................................................33
18. TOPOGRAPHIC SCHEME .........................................................................................................35
19. SPARE PARTS ...........................................................................................................................36

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REV DATE NOTE


3 August ‘04 Pag.10: risks linked with waste elimination

4 July ‘05 New topographic and functional schemes


5 March ‘06 Added pulsed fluoro function
Corrigenda: changed ABS levels in the Figure SP
Fluoro Setup (Version 5 date of print 25 May 2006)
6 February ‘07 New electrical schemes: interface scheme and
functional scheme. Replaced old LCD 18” monitor
with a new of 19”. LCD Added the following
chapters: 1) Interface N33 with Indico generator, 2)
ABS and SYNC control connection, 3) Connection
N33 with I.I. Thales , 4)Connection N33with remote
table
7 May ‘07 New O-I 9”/12” HR3, Avoided I I references

8 Sept ‘07 Changed topographic board 56109A


(conector pin J4C-J4D)
9 November ‘07 Avoided TV chain HR3 reference/ Added IB 13”
Note

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1. GENERAL NOTES

WARNING!

X-RAY EQUIPMENTS CAN BE DANGEROUS TO THE HEALTH OF BOTH PATIENTS AND OPERATORS
UNLESS PROPER SAFETY MEASURES ARE STRICTLY OBSERVED.
Although this equipment was designed and manufactured according to the most up-to-date
safety Standards, the X-ray beam always represents a danger, should not the operator be
properly qualified and trained. Excessive exposures to X-rays cause damages to the human
body: therefore, all the necessary precautions must be taken to prevent unauthorized or
unskilled personnel from operating this equipment, thus jeopardizing themselves and other
people.

Note: This equipment is in compliance with the requirements established by the 89/336/CEE
Directive applying to the Electromagnetic Compatibility.
In order to comply with such requirements, special technical measures were adopted (such as
the application of anti-noise filters and/or ferrites on some circuits) and precise earth
connections were defined. The metallic covers and their clamps are realized and checked by
means of fixing devices or special conductive material-gaskets ensuring both the immunity to
external sources of disturbance and the limitation of possible internal disturbances generated
by the electrical circuits.
Therefore, it is recommended that the technicians executing possible maintenance or
fixing interventions, should not modify the path of the connections and carefully
reconnect all earth connectors of the gaskets (should these be removed during the
maintenance or fault research operations) and restore the protection gaskets with the
utmost attention in the same conditions and with the same fixing devices originally
foreseen.

Note: The original document was drawn up in Italian.

GENERAL MEDICAL MERATE S.p.A. shall decline all responsibility with regard to
the good functioning of the equipment should the installation and/or the maintenance of
if be executed by unauthorized personnel.

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1.1. Typographic conventions


In order to facilitate the reading of the manual, different styles and types were used: please
make reference to the following:

Text identified by one full-stop:


Example:
• Instructions to be executed according to the sequence specified.

Text in ITALICS ACCOMPANIED by the symbol “i” (information):


EXAMPLE:

Important information

Text in italics included within a frame:

Example:

Useful supplementary information

1.1 Symbols of advice positioned on the equipment:


Warning symbol to advise when a possible general danger for the
equipment or the operator may occur.
Invite the operator to check the equipment documentations

Hazard symbol to advise X-ray radiation exposition

Warning symbol to advise for electrical components that are sensitive


to electrostatic discharge

Warning symbol to advise of live electrical parts with a possible risk of


electric shock

Warning symbol to advise of possible fingers squashing

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2. INTRODUCTION

The Analog Tv chain Opera I 9” HR -12” HR identify a “radiological system” consisting in:
a high-resolution camera, Monitor and I. I. The Analog Tv chain aim is to acquire images
through the X ray digital fluoroscopy.

The Analog TV chain Opera I 9HR -12HR is consisting in:

1) OPERA I 9 HR :
¾ Image intensifier 9”
¾ TV chain 1024x1024 (Last Image Hold) with dynamic recursive filter
and with the opportunity to memorize one image at the release of the foot
switch fluoroscopy
¾ Possibility to memorize 99 images in cine loop
¾ Possibility to acquire images in pulsed fluoroscopy mode 1-3-6-12 F/sec
¾ B&W Monitor LCD 19”
Optional: Additional Monitor and monitor dolly

2) OPERA I 12HR:
¾ Image intensifier 12”/13”
¾ TV chain 1024x1024 (Last Image Hold) with dynamic recursive filter
and with the opportunity to memorize one image at the release of the foot
switch fluoroscopy
¾ Possibility to memorize 99 images in cine loop
¾ Possibility to acquire images in pulsed fluoroscopy mode 1-3-6-12 F/sec
¾ B&W Monitor, LCD 19”
Optional: Additional Monitor and monitor dolly

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3. GENERAL INFORMATION

3.1. The range


Noise reduction
Intensifier TV camera Monitor
filter
19 "LCD"
O-I 9” 9" 1024x1024 DRF

19 "LCD"
O-I 12” 12 "/13“ 1024x1024 DRF

4. POWER SUPPLY

Power supply:
Available power supply: 24Vdc ± 20%
Electrical input: 20W
Insulation class:
First class
With applicable parts: no one
For monitor power supply make reference to monitor manual

Power supply must be in compliance with the requirements


established by Medical Equipment Directive 93/42 CEE

5. ENVIRONMENTAL CHARACTERISTICS AND FUNCTIONING LIMITS

HUMIDITY TEMPERATURE PRESSURE


In use In stock In use In stock In use In stock
Min. Max. Min. Max. Min. Max. Min. Max. Min. Max. Min. Max.
30% 75% 10% 90% 10°C 40°C -20°C 70°C 700 hPa 1060hPa 700hPa 1060hPa

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6. RISKS LINKED WITH THE WASTE ELIMINATION

The following table gives all information applying to the material composing the equipment,
as well as the relevant quantity and characteristics, so that at the end of its functioning life, it
will be possible to provide for the disposal of the product to be carried out with minimized
risks, according to the specifications established by the provisions of the law about waste
elimination.

COMPONENT MATERIAl QUANTITY CHARACTERISTICS

TROLLEY IRON AND ITS ALLOYS 55 KG MATERIAL THAT CAN BE


SCRAPPED AND RECYCLED

PLASTIC MATERIAL 5 KG MATERIAL THAT CAN BE


SCRAPPED AND RECYCLED

I.I. TUBE IRON AND ITS ALLOYS 40 KG MATERIAL THAT CAN BE


LEAD SCRAPPED AND RECYCLED
MINERAL OIL

CABLES COPPER AND PVC 15 KG MATERIAL THAT CAN BE


AND ELECTRICAL INSULATING SCRAPPED AND RECYCLED
CONNECTIONS MATERIAL MUST BE MANAGED AS A
SPECIAL NOT DANGEROUS
WASTE

ELECTRONIC PCB AND PASSIVE AND 2 KG MATERIAL THAT CAN BE


BOARDS ACTIVE ELECTRONIC SCRAPPED AND RECYCLED
MUST BE MANAGED AS A
SPECIAL NOT DANGEROUS
WASTE

MONITOR PLASTIC MATERIAL 18 KG MATERIAL THAT CAN BE


SCRAPPED AND RECYCLED
MUST BE MANAGED AS A
SPECIAL NOT DANGEROUS
WASTE

In any case, at the end of the functioning life of this equipment, upon the Customer's
request, GMM will be glad to supply a proper assistance for the elimination and/or
scrapping of the product.

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7. THE PERFORMANCES

7.1. Image Intensifiers


The 9" it is especially suitable for general diagnostic examinations with TV fluoroscopy.
The 12"/13” mage intensifier represents the best available solution in this category.

For the 12"/13”version, a particular attention was paid to the magnetic shielding in order to
contain the typical S distortion

7.2. Dynamic Recursive Filter (DRF)


DRF is a particular and innovative recursive filter capable to modify the filter factor
dynamically pixel for pixel which, as well allowing an effective reduction of the noise,
removes the persistence phenomena due to fast movements in the image.

7.3.Pulsed fluoroscopy
The chain system can aquire images in fluoroscopy mode with variable speed of 1-3-6-12
frame for a second

7.4.Images memorization
It is possbile to to memorie until 99 images and review them in in cineloop mode with
variable speed of 12-6-3-1 frame for a second.

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9 TV CHAIN CHARACTERISTICS

Available CCD scanning system : 1024x1024 pixels

Scanning aspect ratio: 1:1 Progressive scanning

CCD Camera Head :


Integrated optical lens system: High resolution with adjustable focus and
Image intensifier output screen: diaphragms
Mounting frames: From 15 to 40mm diameter.
From 6” inch to 16” inch I.I.
CCD / CCU Characteristics :
Gamma correction: 0.35 (for better performance)
Video output A/D converter: 12 bits
Video Bandwidth: 40 MHz ± 3dB
DRF (Dynamic Recursive Filter): Yes
Standard Recursive filter: Factor 2,4,8,16
Memory: 16 bits
Automatic video level compensation: Yes
Automatic x-ray kV/mA compensation: Yes. Analog and digital (up/down)
Dynamic contrast compensation for better image uniformity: Yes (shading)
Very high dynamic video amplifier: Yes
High precision electronic circle: Yes
Video output signal: 1 Vpp (0.3 Vpp Sync)

Video output standards : two channels 1049/60 Hz

Operating conditions :
Working temperature range: -10°C to +45°C
Store temperature range: -40°C to +55°C
Humidity: Operating to 95% relative humidity (non-
condensing)
Mechanical specifications :
Control unit: dimension (WxDxH)/ Weight : 235x192x65mm 1500gr
Camera head: dimension (φ x H)/Weight : (Standard) 127x108mm 1400gr
(with Rotation) 125x95mm 1400gr

Available power supply :


24Vdc ± 20%

Approvals :
Safety: EN 60601-1
EMC: EN 60601-1-2
Others: CE-label according 93/42 CEE directive for
medical devices.

Options :
360° Continuous rotating camera head (with slip
ring)
Neutral density filter

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10 ANALOG TV MONITOR CHARACTERISTICS

Model
MOLVL 1964C/MED
Specifications

Panel LCD Display TFT LCD IPS Gray scale

Characteristics Active screen size 48cm(19.0 inches)


Pixel Pitch 0.294(H)×0.294(V)mm

Pixel Format 1280(H)×1024(V)

Viewing Angle (Horizontal) 170degrees@CR>=10


Viewing Angle (Vertical) 170degrees@CR>=10
Display Colors Truth 8-bit and can simulate to 10-bit
Power Supply Input Voltage Range 100 – 240 V AC
Input Frequency Range 50 – 60 Hertz
Fuse Internal and not user replaceable
Power Output 55W (Max)
Max Input AC Current 1.5Arms @ 90V AC, 0.75Arms @180V AC

Environment Operating Temperature +10℃ ~ +40℃

Conditions Storage Temperature -10℃ ~ +60℃

Operation Relative Humidity 30% ~75% Non-Condensing

Storage Relative Humidity 10% ~95% Non-Condensing

Atmospheric pressure 500~1060 hPa

Mechanical Width 418 mm


Dimensions Height 424 mm
Depth 226.5 mm
Monitor Weight 9.7kg
The “Top Level Assembly” shall meet the
Packaging Packaging Specification
Packaging Specification.
The ink shall not rub off after a suitable drying
Ink
time.
The carton shall withstand 10 trips by any
Multiple Trips combination of air, rail, land, or sea
transportation.

Shipping Carton Type One Piece Construction

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10.1 Dose Control Device


The system is completed of an automatic device for fluoroscopy dose control with Kv/mA
variation.

10.2Monitor Support -optional


Three types of TV monitor supports are available:
Dolly
Desk monitor support
Console support

1.2 Dolly
The dolly is the most common and simple sytem in order to support the TV monitor . It has
cartwheels and accessories shelves

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11 ANALOG TV CHAIN O-I HR 9”, 12”HR CALIBRATION PROCEDURE

11.1Image centering and sizing adjustments


For image adjustment and centering, please follow these instructions carefully:
¾ Loosen the three screws that are fastening the camera to the image intensifier.
¾ Loosen the Allen screw positioned on the head camera.
¾ Loosen the ring nut positioned on the head camera (Fig.1 CCD Camera)
¾ Disconnect the blanking circle by moving JP3 (X0 and X8) on gearcase assembly
interface
¾ Start the X ray beams at a low dose, with no phantom in the beam.
¾ Move the visible image to the monitor center, (in case it is necessary to make smaller
the image size, loosen the ring nut positioned on the head camera, on the other hand, if
it’s necessary to increase the image size, please tighten the ring nut located on the
head camera)
¾ Make the Horizontal and Vertical image size around 280 millimeters/11inches ( Fig.2
¾ Tighten the three screws and the ring nut positioned on the head camera.
¾ Replace the JP3 (X4 manifacturing setting)
ALUMINIUM
COVER

ALLEN SCREW

ADJUSTABLE
DISTANCE RING

CCD
ADAPTER

Fig. 1 CCD camera

Fig. 2 Blanking circle

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11.2 Image Direction Adjustment


¾ To adjust the image direction, place at the Image Intensifier center entrance field, (Fig
3.1 Allen screw at the Image Intensifier center field), an Allen screw.
¾ The Allen screw head side (HEAD) will identify the top image side, the short right
Allen screw side will identify the right image hand side (RIGHT),

Fig 3.1 Allen screw at the I. I. center field Fig. 3.2 MonitorImage adjustment direction

¾ Loosen the Allen screw positioned on the head camera side and turn it around until
you will reach the right position in the monitor (Fig. 3.2 Monitor image adjustment
direction)
¾ Fasten the Allen screw.
¾ In case you will not reach the right image direction, please move the jumpers
positioned on the interface board as follows:

1) JP1 (Inversion V.)


2) JP2 (Inversion H.)

These jumpers enable the image to be inverted to 180°

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11.3 Camera Focus Adjustment

¾ Place on the patient tabletop a “MIRA FUNK TEST or CONVERGIN LINE PAIR”
¾ Loosen the head camera cover
¾ Find on the printed circuit board the focus hole place (Fig. 4CCD head camera focus
adjustment)
Insert the screwdriver inside the focus hole place and turn it around to the right or to the left
side until you will obtain the maximum resolution

Fig. 4 Camera focus a djustment

After having set the image focus it could be necessary to


adjust the image size

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11.4 Iris /Dose Calibration/ABC calibration

¾ Cover the X-ray output collimator area with a copper sheet of 1millimetre thick.
¾ Make sure that the grid is in
¾ Select 70 kV on the X ray generator and adjust the mA to obtain 35 µR/s (±10%).
¾ Loosen the camera head cover.
¾ Find the hole for Iris adjustment (Fig.5 Iris CCD camera) on the printed circuit
¾ While performing fluoroscopy, insert the screwdriver into the regulation diaphragms
hole and set the Iris screw in order to obtain the two LEDS (red and green) turned off
on N30 PWR20 board.
¾ Check if J8 and J7 on N30 PWR20 board, are both positioned in 2-3 position

Fig. 5 Iris CCD camer a (printed circuit)

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11.5 Output video signal adjustment


The sequences of actions to be executed in order to adjust output video signal are as follow:
¾ Cover with at least 2millimetres lead plate half Image Intensifier entrance field (Fig. 6
Output video signal adjustment)
¾ Cover the X-ray output collimator area with a copper sheet of 1 millimeter thick
¾ Select to 70 kV the X- ray generator and set the mA in order to obtain 35 µR/s
(±10%).
¾ Check if J5 (Fig.9 Trimmers adjustment) is in position pin 1-2
¾ Set the Trimmer R84 on board PWR20 in order to obtain a video signal of about
300mV (±10%)
¾ Check if the jumper J4, positioned on N30 PWR20 board (Fig.9 Trimmers adjustment)
are in pin position 2-3

Fig. 6 Video signal adjustment

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11.6 Antivignetting

¾ Connect an oscilloscope to the out camera video signal


¾ Cover the X- ray out put collimator area with a copper sheet of 1 millimeter thick.
¾ Select 70 kV on the X – Generator function and adjust mA in order to obtain 35 µR/s
(±10%)
¾ Adjust the Trimmer for horizontal line (Fig. 7 Antivegnitting) and Trimmer for
vertical square (Fig. 7 Antivegnitting) in order to obtain the oscilloscope signal
illustrated in the fig.7 (Fig. 8 Vignetting)

Adjustment Trimmers Timing on


oscilloscope
H. Tilt P 52 10 µS/DIV
V. Tilt P 47 5 mS/DIV
H. Vign. P 61 10 µS/DIV
V. Vign P 48 5 mS/DIV

Fig. 7 Antivegnitting

Fig. 8 Vignetting

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N30 PWR20
NDR_ADV0

1 1
J8
2 2 1 2
3 3 J7
J5 J6 1 2

R61 R52 R47 R48

J4

R R R84 R79 R
101 100 106

Fig. 9 Trimmers adjustment

11.7 Black level adjustment


The sequences of actions to be executed in order to control the black level are as follows:

¾ Check if the Auto control black level function is inserted (J6 pin position 1-2
(Fig.9 Trimmers adjustments)
¾ Adjust the black level to 30mV by moving theTrimmer R101, but without starting the
X- ray function
¾ Place the PHILIPS phantom on the patient tabletop and start the X- ray function
¾ Adjust the Trimmer R100 to reach the black level to 50 mV

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12 MAINTENANCE

Every 6/12 months it is advise to control if the x-ray beams dose is in compliance with the
requirements established by the country low directive where the Tv chain equipment is
installed.

12.1GMM X-ray dose calibration


The GMM calibration dose is: 35 µR/s (±10%), and it is obtain thanks to the following steps:
¾ Set the Image Intensifier to Nominal FOV
¾ Put the dosimeter probe at the top of the Image Intensifier entrance field, just below
the grid place
¾ Set the TV chain system with the FLOUROSCOPY modality onto ON and set to
70kV the generator, the mA must be regulated in order to obtain in the dosimeter the
following values: 35 µR/s (±10%)
¾ Set the focal distance to 115 centimeters
¾ Put a copper sheet 1millimeter thick at the collimator entrance field

Following this previous sequence of commands it gives the opportunity to


obtain a video signal at 300 mV. The video signal can be measured by an
oscilloscope

12.2X-ray automatic dose control


The sequences of actions to be executed in order to obtain the X-ray AUTO dose control are
as follows:
¾ Please put at the collimator X- ray output field a copper sheet 1millimeter thick
¾ Please insert the AUTO dose control function
¾ Please start FLUOROSCOPY function and check if the nominal field of the output
video signal, measured by an oscilloscope, remains at the 300 mV (±10%) value.
¾ Change the magnifying mode and control if the video signal will stay at 300 mV
(±10%) value

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13 GENERATOR CONFIGURATION

The following sequence of values are an example and must be


regulated during the equipment adjustment in the examination room
In order to obtain the right Tv chain system functioning, install on your PC system the
GenWare programme.
Set up the GenWare generator programme as follows:
¾ Select from the GenWare main menu programme the SET UP function
¾ Select FLUORO SETUP
¾ Insert the following data into the window fluoro FLUORO ABS:

Make reference to the following figure (Fig. 10 GenWare Utilities):

Fig. 10 GenWare Utilities

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Fig . 11 GenWare PF Setup

Fig. 12 GenWare Utilities PF ABS

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After it, select from GenWare programme tool bar:

¾ RECEPTOR SET UP function


The RECEPTOR SET-UP window will open
¾ Select RECEPTOR 1
¾ Insert at the INTERFACE options the number 13
¾ Select RECEPTOR 6
¾ Insert at the INTERFACE options the number 19
¾ Disable the Receptor Enable

Make reference to the following figure (Fig. 11 RECEPTOR SET-UP):

Fig. 11 RECEPTOR SET-UP

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Fig. 12 RECEPTOR SET-UP

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On the generator set the JW22 on the position 2-3

Fig. 13 JW22

Warning!
Check if the internal monitor switch is positioned onto ON, make reference
to the following figure

Fig. 14 GDS monitor label

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14. CAMERA INTERFACE

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15. INTERFACE WITH THE TABLE OPERA T

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INTERFACCIA N33 CON GENERATORE INDICO

J2

N33 J4D to TDI J4D

J4C
N33 J2 to TDI J2

N33 J4D to TDI J4C J4D

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CONNESSIONE CONTROLLO ABS E SYNC

0V24

ABS

SYNC

TV chain SC1 ABS to


TDI J7 pins 1-2

TV chain SC1 24 VDC power


supply to Room Interf. Board
TB7/TB8

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CONNESSIONE N33 CON INTENSIFICATORE THALES

N33 AMP2 to I.I connector

TOSHIBA TUBES ADAPTER 9” 12”

DIN 5 male poles Canon 15 male poles


Pin 1 +24V Pin 15
Pin 2 NC
Pin 3 GND Pin 5
Pin 4 M1 Pin 14
Pin 5 M2 Pin 6
Fig. 15 Adapter cable tube Toshiba

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CONNESSIONE N33 CON TELECOMANDATO

N33 AMP3 interface to


Positioner 25S3 board AMP10A

N33 AMP1 interface to


Positioner 25S3 board AMP10

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16. NICAL INTERFACE

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17. FUNCTIONAL SCHEME

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18. TOPOGRAPHIC SCHEME

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19. SPARE PARTS

CCD N33 SPARE PARTS

MODEL DESCRIPTION

CCD Head CCD Camera Head N331 without rotation


N33 w/o rotation
N30_PWR20 Analogic board including NDR_ADV0 block

N33_DIG3 Digital board with output blocks

N33_MEM1 Frame board

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