GENERAL MEDICAL MERATE S.

pA
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.)
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INDEX
1. GENERAL NOTES.............................................................................................................................5
1.1. Typographic conventions .......................................................................................6
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. Fluroscopy pulsed mode ............................................................................................10
7.4 Memorizzazione Immagini...........................................................................................10
8. TV CHAIN CHARACTERISTICS .....................................................................................................11
9. ANALOG TV MONITOR CHARACTERISTICS ...............................................................................12
10.1 Dose Control Device..................................................................................................13
10.2 Monitor Support –optional ........................................................................................13
10.3 Dolly ..........................................................................................................................13
10. IDENTIFICATION LABELS .........................................................................................................14
11.1. Labelling identification ..........................................................................................15
11. User interface ................................................................................................................................16
12. Continuous or pulsed fluoroscopy mode ..........................................................................................17
13.1. Continuous fluoroscopy........................................................................................17
13.2. Pulsed fluoroscopy ...............................................................................................18
13. Cine loop function (review speed) ...................................................................................................19
14. MAINTENANCE AND CLEANING..............................................................................................20
15.1. Maintenance.........................................................................................................20
15.2. Maintenance guide ...............................................................................................20
15.3. Cleaning ....................................................................................................................................20

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REV DATE Revisions Hisotry

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

4 March ‘06 Added pulsed fluoro function

5 Febuary‘07 Updated only from the graphic point of view the
console push buttons
Replaced the old LCD 18” monitor with the new
monitor 19” LCD; replaced the Monitor trolley
with a new one and added the new trolley
identification label, added new camera label
6 May ‘07 New O-I 9”/12” HR3, Avoided I.I references

7 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.

Before executing any operation, the person being qualified and authorized to operate this
equipment, must be informed about the protection and safety measures established by the
International Committee for the Radiological Protection, as well as any other relevant national
Standards.

For a proper use of this equipment, it is required that the operator should previously and
carefully refer to the present User’s manual.
A special attention should be paid to the sections “Safety Recommendations”, “Protection
Measures”, “Functioning and Safety Controls”.
Note: This equipment is in compliance with the requirements established by the 93/42/CEE
European Directive applying to medical devices and bears the EC Compliance mark complete
with the code number identifying the Notified Body being responsible for the application of
the procedures required for the compliance certification

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
it 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

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 -12H3 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 store one image at the release of the foot switch
fluoroscopy
¾ Possibility to store 99 images in cine loop
¾ Possibility to aqcuire in fluoroscopy pulse mode 1-3-12- frame per a second
¾ B&W Monitor, LCD 19”
Optional: Additional Monitor and monitor dolly

2) Opera I 12 HR:

¾ Image intensifier 12”/13”

¾ TV chain 1024x1024 (Last Image Hold) with dynamic recursive filter
and with the opportunity to store one image at the release of the foot switch
fluoroscopy
¾ Possibility to store 99 images in cine loop
¾ Possibility to aqcuire in fluoroscopy pulse mode 1-3-12- frame per a second
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 monitors power supply make reference to monitors 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” image 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. Fluroscopy pulsed mode

The chain system can acquire images in pulsed fluoroscopy with variable speed from 1-3-6-12
images per a second

7.4 Memorizzazione Immagini

It is possible to store until 99 immages and review them in cineloop mode with variable speed
from 12-6-3-1 images per a second.

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8. 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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9. 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.

10.2 Monitor Support –optional

Three types of TV monitor supports are available:
-dolly
-desk support
-consolle support

10.3 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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10. IDENTIFICATION LABELS

CABINET REMOTE CONTROLLED TABLE

The Cabinet of the remote controlled table and the gearcase assembly with board are
identified by the following label:

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11.1. Labelling identification

IMAGE INTENSIFIER 12” IMAGE INTENSIFIER 9”

MONITOR

TROLLEY
MONITOR SUPPORT

The Trolley Monitor support is identified by the following label:

For the remaning TV chain equipments make

reference to their manuals

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11. User interface

Choice of the I.I. magnification factors

1 2 3 Not available
By means of these push-buttons (1, 2 and 3) on the positioner console, the operator can select
the most adequate I.I. field. Remember the magnification fields available are only 3, from 0
to 2 (the field n.3 is not available).

Image inversion on the monitor

34 35
By means of these push-buttons (34 and 35) it is possible to select image inversion:
• Right-to-left image inversion (34)
• Up-to-down image inversion (35)

Receptor selection

13 14

The push-button 14 is disabled with this analog version of the system.

The push-button 13 allows the acquisition of the images on the film or in fluoroscopy mode
(SFD).

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12. Continuous or pulsed fluoroscopy mode

To select continuous or pulsed fluoroscopy mode push the button. on the generator

13.1. Continuous fluoroscopy

With this mode the generator produce a continuous X-Ray beam.
The user can see live images on the screen and the Last Image Hold function is present.

The TV chain 1K*1K has also the opportunity to store and visualize on the monitor 99
images in cineloop modality. The images memorization speed can be changed among 12, 6,
3, 1, image/s using the button 33. The beginning of the memorization can be defined pressing
the button (22).

33 22

The console display n.1 visualizes the number shown in the following column table (*), that
correspond to the values shown in each column table line (see following table):

Number visualized on
Img/s Maximum time
the console (*)
0 NOT-AVAILABLE
1 12 8 sec
2 6 17 sec
3 3 33 sec
4 1 99 sec
Images memorization speed during continuous fluoroscopy

To determine the images acquisition maximum time make reference to the previous table.

To store images, push the foot fluoroscopy pedal to activate Xray beam and press the button
(22) on table console when the properly images are present on the screen.
The memorization of the images will take place till the button (22) on table console is
pressed.

The images memorization will stop in one of these cases:

1) releasing the fluoroscopy foot pedal;
2) releasing the button (22) on table console, it should be possible to store multiple
fluoro sequence;
3) at the 99th image
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13.2. Pulsed fluoroscopy

With this modality the generator produce a pulsed X-Ray beam. The pulses frequency is
defined by the generator panel buttons.
The user can see live images on the screen and the Last Image Hold function is present.
The TV chain 1K*1K has also the opportunity to store and visualize on the monitor 99
images in cineloop modality. The images memorization speed is the same defined by means
of the generator panel.

Generator pulse/s Img/s Maximum time

12 12 8 sec
6 6 17 sec
3 3 33 sec
1 1 99 sec
Generator pulses and images memorization speed during pulsed fluoroscopy

To determine the images acquisition maximum time make reference to the previous table.

22

To store images, push the foot fluoroscopy pedal to activate Xray beam and press the button
(22) on table console when the properly images are present on the screen.
The memorization of the images will take place till the button (22) on table console is
pressed.

The images memorization will stop in one of these cases:

1) releasing the fluoroscopy foot pedal;
2) releasing the button (22) on table console;
3) at the 99th image

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13. Cine loop function (review speed)

3) Adjustable tabletop 4) Stand 5) Available
1) Acquisition 2) Layer height height angle exposures
frequency or review Tilting angle
image function

1 2 3 4 5 6 7 8 9 10 11
It is possible to review the images with different speeds using the following push-buttons on
the table control panel console:

33 22
The console display n.1 visualizes the number shown in the following table, column (*).

Number visualized on
Img/s Maximum time
the console (*)
0 IMAGES DELETING
1 12 8 sec
2 6 17 sec
3 3 33 sec
4 1 99 sec
Images visualization speed during fluoroscopy review

To visualize the images stored you must push the button (22) on table console.
The visualization of the images will take place till the button (22) on table console is pressed.
It is possible to change the images visualization speed by pushing button (33).
The images visualization will be stopped in one of these cases:
1) pressing the fluoroscopy foot pedal;
2) releasing the button (22) on table console;

To delete stored images make reference to the following procedure:

1) Do select on Table console display 0
2 Press for at least 3 seconds the push button (22) on the table console
3) Thanks to the above procedure all the stored images will be deleted

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14. MAINTENANCE AND CLEANING

15.1. Maintenance
The system will serve you well if you take care of it.

¾ Do not expose the system to direct sunlight. Do not place near sources of heat, such as a
radiator.
¾ Do not expose the system to temperature do not mention in the service manual.
¾ Do not subject the system to magnetic fields.
¾ Do not expose the system to rain or moisture.
¾ Do not spill water or any liquid on the system.
¾ Do not subject the system to heavy shock and vibration.
¾ Do not expose the device to dust and dirt.
¾ Never place objects on top of the system to avoid damaging it.
¾ Never place the system on uneven surfaces.

All electrical equipment should be used according to the instruction provided. It is advised
to control all connections and the image quality on a regular basis. Is will guarantee an
efficient
function and long product life.

15.2. Maintenance guide

Frequency Description
2 years Cable connection and condition inspection
6 months Image quality check

15.3. Cleaning
When cleaning the system, follow these steps:
¾ Power off the system and disconnec it from the power line
¾ Use a soft cloth moistened with water, remember after it use a dry cloth to dry these
equipment parts
¾ Do not use liquid or solvents.
¾ Liquid and detergent fluid must not penetrate inside the equipment in order to avoid
short ciucuit or corrosion

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