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GENERAL MEDICAL MERATE S.p.A.

Via Partigiani, 25 - 24068 Seriate (BG) ITALIA


tel (0039) 035 4525311 - fax (0039) 035 297787
http: www.gmmspa.com e-mail: info@gmmspa.com
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OPERA RT20
Radiographic Unit
User Manual
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General Medical MERATE SpA
Via Partigiani, 25 25/mag/2007
File OPERA RT20
24068 Seriate (BG) Italy
e-mail: info@gmmspa.com pag.1di 59

OPERA RT20

1. GENERAL NOTES ................................................................................................. 4


1.1. Topographich conventions ......................................................................................................7
1.2. Symbols of advice positioned on the equipment: ..................................................................7

2. DIRECTIVES AND APPLICABLE STANDARDS ............................................ 8

3. GENERAL INFORMATION............................................................................... 12

4. PUSH BUTTONS FUNCTIONS.......................................................................... 19

5. COLLIMATOR ..................................................................................................... 24
5.1. Manual collimation. ...............................................................................................................24

6. ACCESSORIES ..................................................................................................... 27
6.1. Accessory: ...............................................................................................................................27
6.2. Using the accesories ...............................................................................................................28
6.3. Lateral cassette holder...........................................................................................................28

7. CLINICAL USE EXAMPLES – .......................................................................... 29


The X-Ray exposure on Potter Bucky..............................................................................................31
X-Ray in lateral position. ..................................................................................................................31
Use of the radiogenic source with a bucky stand. ...........................................................................32

8. OVERALL DIMENSIONS................................................................................... 34
8.1. Safety recommendations .......................................................................................................41
8.2. Protection measure and safety ..............................................................................................42

9. DANGEROUS AREAS ......................................................................................... 43

10. DANGEROUS POINTS........................................................................................ 44

11. ALLOWED HOLD POINTS................................................................................ 45


11.1. Measures to be taken to avoid damages to things ...............................................................46

12. PROTECTONS AGAINST EXPLOSION.......................................................... 47


12.1. Protection against radiations ................................................................................................47
12.2. Functional checks of the systems ..........................................................................................48

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13. POSSIBILITY OF CONNECTION TO OTHER ACCESSORIES................. 48

14. EMERGENCY PUSH BUTTONS ....................................................................... 48

15. IDENTIFICATION ............................................................................................... 49

16. MAINTENANCE................................................................................................... 51
16.1. General checks .......................................................................................................................52
16.2. Controls of the wire cable and suspension cables ...............................................................53

17. ROOMS DISINFECTION AND CLEANING ................................................... 54


17.1. Risks linked with waste elimination.....................................................................................55
17.2. Environmental characteristics and functioning limits .......................................................57

18. POWER SUPPLY.................................................................................................. 58

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OPERA RT20

Manufacturer General Medical MERATE SpA


Via Partigiani, 25
24068 Seriate (BG) Italy
Tel. (0039) 035 4525311
Fax (0039) 035 297787 / 299537
Equipment type Opera RT20

General Medical MERATE SpA reserves the right to modify/update this document without prior
notice.

This documentation and the related annexes cannot be duplicated or disclosed to any party without the
previous authorization in writing to be issued by General Medical MERATE SpA.

MODIFICATION LIST
01 25 May 2007 Manual release: respect the Preview 11
version added the fingers squashing symbol
02 12
03 13
04 14
05 15
06 16
07 17
08 18
09 19
10 20

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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 MDD 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 - Warning

CAREFULLY READ THIS MANUAL in order to learn how to operate and service this equipment
correctly and to avoid personal injury or unit damage. This manual and the safety labels on the
equipment may also be available in other languages (for information contact the manufacturer). The
complete documentation shipped with the unit, and this manual in particular, must be carefully
preserved for future references or necessities. THIS MANUAL should be considered a permanent part of
the equipment and should remain with it.

MEASURES in this manual are exclusively expressed in the metric system. THE EQUIPMENT
RIGHT AND LEFT SIDES are established by the user, facing the unit. THIS UNIT IS DESIGNED to
be exclusively used during the normal X-Ray operations as pointed out as INTENDED USE. Use in
any other way is considered as contrary to the intended use. The manufacturer refuses all responsibility for
damage or injury caused by a use which differs from the provided one; the user is the only responsible of these
consequences. The careful observance of the functioning, maintenance and repair instructions, which are
pointed out by the manufacturer, are also an essential part of the equipment use.

THE RADIOGRAFIC COMPACT UNIT object of this manual, MUST BE USED, OVERHAULD
AND REPAIRED EXCLUSIVELY BY PERSONNEL that is qualified, familiar with all its
characteristics and acquainted with the relevant safety rules (accident prevention). Laws regarding
accidents prevention and all industrial safety rules must be always observed. The manufacturer is not
responsible for damages or injury caused by any arbitrary modification carried out on this unit.

1.2 – Documentation rights


This instruction manual, including technical drawings, tables and photos, are a manufacturer’s freehold
property. These information can be used only for the purpose for which they have been produced. It is
excluded from any other form of use, even partial, without explicit authorization by the manufacturer.

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1.3 - Testing
The equipment testing has been performed by the manufacturer with procedures that are to verify that the
equipment, subject of this manual, is without faults and that its working features comply to the ones foreseen for
this type of use. This kind of test is exclusively carried out by qualified personnel and its result is specified on
the inspection report. The manufacturer keeps, in conformity with law, the only report copy every unit has.

1.4 - Guarantee
Guarantees are supplied only in accordance with the contract conditions. Damages which are caused by
incorrect equipment use or by non-observance of the rules in this manual will not be considered under
guarantee. Damages from not a proper equipment uses or inobservance of the rules relevant this equipment will
not in any case be considered under guarantee.

ATTENTION! The guarantee is automatically voided if interventions on


the unit are made by non-authorized personnel

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1.1. Topographich 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
1.2. Symbols of advice positioned on the equipment:

Warning symbol in order 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 in order to advise X-ray radiation exposition

Warning symbol in order to advise for electrical components that are


sensitive to electrostatic discharge

Warning symbol in order to advise of live electrical parts with a


possible risk of electrical shock

Warning symbol in order to advise of possible fingers squashing

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2. DIRECTIVES AND APPLICABLE STANDARDS


The Table OPERA RT20 complies with the following regulatory requirements and design
standards:

CEI EN 60601-1/IEC 60601-1+A1: Medical devices. General regulations for safety

CEI EN 60601-1-2/IEC 6061-1-2: Medical Devices. Collateral rule. Electromagnetic


compatibility

CEI EN 60601-1-3/IEC 60601-1-3: Medical Devices. Collateral rule. General regulations for
radiation protection with diagnostic radiological
equipments

CEI EN 60601-1-4/IEC 60601-1-4: Medical devices. Collateral rule. Medical devices


programmable systems.

CEI EN 60601-2-32/IEC 60601-2-32: Medical Devices. Peculiar regulations for equipments


safety complementary to radiological equipments

• Type of protection against electric shock: Class I equipment. (IEC 60601-1)


• Degree of protection against electric shock: Type B (60601-1)
• Degree of protection against harmful ingress of water: Ordinary equipment.
• Mode of operation: Continuous operation with intermittent loading (standby – exposure X
ray).
• Equipment not suitable for use in presence of a flammable anaesthetic mixture with air or
with oxygen or nitrous oxide.

NOTE: All referenced standards are considered to be at the latest revision

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EMC (IEC 60601-1-2:2001/ EN 60601-1-2:2001 / CEI EN 60601-1-2:2003)

GUIDA E DICHIARAZIONE DI FABBRICA – EMISSIONE ELETTROMAGNETICA


This manufacture declaration is suitable for all the RT 20 tables models and based on the
RT20 test results. All the RT20 models are manufactured in the same way, by following the
same production and using the same components related to electromagnetic emission

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ELECTROMAGNETIC COMPATIBILITY (EMC)

In accordance with the intended use, this radiographic table equipment complies with the European
Council Directive concerning Medical Devices. The CE marking affixed to this product signifies this.
The reference standard EMC89/336/CEE of this Directive defines the permitted levels of
electromagnetic emission from this equipment and its required immunity from the electromagnetic
emissions of other devices.
WARNING: It is not possible, however, to exclude with absolute certainty the possibility that other
high frequency electronic equipment, which is fully compliant to the EMC regulations, will not
adversely, affect the operation of this system. If the other equipment has a comparatively high level of
transmission power and is in close proximity to the system, these EMC concerns (the risk of
interference) may be more pronounced. It is therefore recommended that the operation of equipment of
this type such as mobile telephones, cordless microphones and other similar mobile radio equipment
be restricted from the vicinity of the device.

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3. GENERAL INFORMATION
OPERA RT20
The OPERA RT20 is an extremely compact radiographic unit with innovative characteristics able to
improve all aspects concerning:

1. use versatility,
2. operating speed,
3. patient's comfort,
4. small encumbrance.

OPERA RT20 structure is characterized by a stand fixed on floor which entirely supports the
examination table.

This particular structure allows:

Floor completely free from elements like rails, stirrups, cables which can hamper
operations of exam preparation and stretchers placement.

Examination table able to get down to an especially reduced distance from the floor.

Easy and quick X-ray tube positioning for lateral and oblique projections (the second
one is motor driven).

Optimization of all the exams on wall bucky stand or patients on stretcher.

The unity is arranged to join on the stand the touch screen commands of the high frequency generator.

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MAIN CHARACTERISTICS

X-ray tube stand, fix on floor, joined with examination table support structure.

Examination table support structure with motorized adjustable height and mobile in the four horizontal
directions.

Manual movements with mechanically balanced mobile parts, electromagnetic brakes.

1. Tube arm with

2. Motorized rotation for oblique incidences

3. Rotation around vertical axis for lateral projections and external accessories

4. Hinged joint of the X-ray tube for projections on wall bucky stand.

Under table bucky mobile in longitudinal sense with handle and unlock brake button.

Push buttons on tube front for electromagnetic brakes and oblique incidence motorized rotation
command. Goniometer for incidences value reading.

Coupling with wall bucky stand OPERA RS10 complete with support base for focal distances
adjustment.

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OPERATING CHARACTERISTICS
Examination table elevation
The examination table has an excursion in height from a minimum of 41 up to 85 cm from the floor.
Therefore positioning of patients with reduced mobility is especially made easy.

Examination table movements


Total table displacements are 142 cm in longitudinal sense and 20 cm in transverse sense.
Bucky moves under the table for 131 cm.

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ƒ Lateral projections
Lateral projections may be performed simply with tube arm rotation both for right and left side. A 126
cm focal distance from centerline of the examination table is obtained.

Examinations on stretchers
In this position it is possible to easily perform examinations on stretchers having a floor completely
without obstacles and a high focus-film distance (maximum distance from floor 228 cm).

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Examinations with wall bucky stand


Coupling with wall bucky stand was especially pleasant to give the possibility of executing
examinations with great versatility and swiftness. Wall bucky stand is equipped with a special support
base to adjust focus-film distance in several elements configurations. In this first configuration it is
possible to execute examinations with 180 and 200 cm focus-film distances ideal for the thorax and
spine.

In this configuration the X-ray beam can get down up to 7 cm from floor.

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In the examinations of inferior extremities the shown configuration is used. in order to reach 133 cm
focus-film distance.

This configuration allows whole vertical excursion of the wall bucky stand (the X-ray beam can get
down up to 40 cm from floor)

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Add-on X-ray generator

The unit can be completed with a very compact high frequency generator equipped with touch screen
command arranged on the stand. This solution allows an easy examinations management reducing the
number of elements which constitute the plant.

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4. PUSH BUTTONS FUNCTIONS

5
5A

1 1
2 2
3 4 3
Figura 1

9
8 7
Figura 2

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6
Figura 3

Keys:
1 Focal distance
2 X-ray tube Hunting (rotation around the horizontal axis)
3 X-ray tube rotation (rotation around the vertical axis)
4 Table elevation
5 Collimation
6 Transveral longitudinal tabletop
7 Potter
8 Emergency stop push button
9 Equipment power switched on signal

1) Focal Distance
Near the collimator there are two symmetrical push buttons in order to move the focal device distance
manually (1). By pushing one of these buttons you will be able to release the focal brake and as a
result to be able to move the focal device .

2) X-ray tube hunting


Near the collimator there are two symmetrical switches for the motorized X-ray tube hunting
movement (2). By pushing one of these two switches toward the direction indicated of the symbols
you will obtain the tube rotation toward counterclockwise/clockwise movement around the vertical
axis direction. The equipment movement will stop as soon as the far end of travels are reached.

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WARNING!
In order to rotate the X ray housing in the position shown in (A/Figure
4). it is necessary to position the X ray tube to +/- 90°. Only when this
previous position is reached it will be possible to release, thanks to its
hand lever (B/Figure 4), the X ray tube housing and rotated it towards
the wallstand.

B
Figure 4

In the position shown by (Figure 4) it is not possible any X ray housing support hunting movement .

In order to proceed with X ray housing movement is necessary to follow the written below procedure:

1) bring back again the X ray housing in its central position (C/Figure 5)
2) only after X ray central positioning it is possible to start again the X ray housing hunting
movement (D/Figure 5)

C Figure 5 D
3) X-ray tube rotation
Near the collimator there are two symmetrical push buttons for the X-ray manual tube rotation
movement around the vertical axis (3). By pushing one of these buttons you will obtain the parking
solenoid release and as a result you will be able to move it.

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4) Table elevation
Near the collimator there is a switch rocker in order to make table motorized movement (4). By
pushing the switch rocker toward the symbol direction you will obtain the up/down table movement.
The equipment movement will automatically stop when the end of travels are reached.

5) Collimator
On the front cover of the collimator there are two knobs (5) for the manual blades collimator
movements. The collimator blades are free and it is possible to make a collimation in over
size/reduction by the knobs until the mechanical blades opening are covered. The push button (5A)
lights/switches off the lamp of the center square in order to be able to make a visual check of the
collimation; the lamp will light off automatically after 30s.

6) Transversal and Longitudinal tabletop


On the table frame there are some symmetrical buttons for the manual table translation in the
longitudinal and transversal direction (6). By pushing one of these buttons you will release the parking
tabletop brakes in order to be able to move it.

7) Potter
Outside the potter support there is a handle for the potter manual movement (7). By pushing the handle
you will have the release of the potter parking brake and as a result you will be able to move it.

8) Emergency stop push button


On the left potter there is a red button in order to stop the equipment (8).
By pulling the red button toward out, the electrical equipment circuits are powered, on the other hand
by pushing it down they are de energized

9) Electrical power switched ON signal


Position on the left side of the equipment near the emergency push button there is a green light signal
that will light on when the equipment power is activated.

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POTTER BUCKY

The Potter Bucky is available in the following version.


• Bucky LRE: type with manual collimation

Figure 6 Potter Bucky

The potter Bucky is powered electrically

For further information about the potter Bucky and its electrical power
supply make reference to the Potter Bucky manuals

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5. COLLIMATOR

5.1. Manual collimation.


The manual collimator has two knobs in order to adjust the position of collimator radiant beam output.
CHECK THE SET COLLIMATED SIDE
The measure of the collimated side is found out by putting into relation the value set by the collimator
knob and the overlay table placed on the collimator front panel.
Around the collimator knob there is a special graduated scale, at each segment it corresponds a
collimator aperture.
By putting into relation the segment set by the collimator knob with the front panel collimator overlay
table it will be possible to check the collimated side measure
The DFF measure (Distance Focus to Film) in use has to be determinate by the retractable meter
positioned under the collimator.
SET THE CASSETTE SIZE
In order to set the cassette size make reference to the following procedure:
1) measure the DFF (Distance Focus to Film) by the retractable meter positioned under the collimator
2) in function of the cassette dimension find out in the overlay table the point of intersection with the
DFF measure
3) The value obtained from the overlay table will have to be set by the collimator knobs.

Please for further collimator information make reference to the Ralco collimator
Manual

OPERATOR VISUAL CHECK OF THE IRRADATED FIELD AND X-RAY BEAM


ADJUSTMENT
The operator can illuminate and visually verify the irradiated field size by the collimator timed lamp
lightening (~30s). In order to switch on the collimator lamp press for a little the push button positioned
on the collimator. With the lamp on, a second luminous beam will simulate the radiant beam. The line
beam will be direct towards the cassette holder (partially extracted from the bucky) and will allow the
operator to align in longitudinal way the potter bucky with the collimator

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Collimator

Extra focal collimator radiation field (longitudinal blades)

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Extra focal collimator radiation field (transversal blades)

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6. ACCESSORIES
The utmost suppleness of application and universality of the “radiographic table”are further enhanced
by the availability of a wide range of accessories.

Note: The accessories used must be the original ones by GMM:

6.1. Accessory:
1) Lateral cassette holding

2) Horizontal handle for back patient table top (optional)

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6.2. Using the accesories

IMPORTANT INFORMATION
Please find in the next pages important information applying to the use of the standard accessories.
In order to ensure the product reliability it is allowed to use accessories exclusively manufactured by
GMM or accessories made by other manufacturers provided with GMM’s authorization.
The user is held responsible for the use of other possible accessories that are not authorized by GMM.

6.3. Lateral cassette holder

This accessory is used in order to make lateral radiography outside the potter bucky:
I order to use this accessory make reference to the following procedure:

1) put the cassette holding on the patient tabletop

2) insert the needed cassette size in the cassette holding

3) do position the cassette holding on the back of the patient in function of the are you need to
radiograph
4) rotate the radiogenic system, so that the radiant beam is addressed transversally towards the
examination tabletop and the lateral cassette holder;

5) insert the cassette in the cassette holder;

6)center and collimate the patient’s part to be X-ray;

7) select the radiographic exam and the type of patient, the direct exposition, the radiographic
constants and the exposure technique; on the generator

8) press the preparation button and, when the generator is ready for the exposure, press the

X ray exposition button.

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7. CLINICAL USE EXAMPLES –

1 2 3

4 5 6

7 8 9

10 11 12

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13 14 15

16 17 18

19 20 21

22 23 24

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The X-Ray exposure on Potter Bucky


To take a radiography it is necessary to act in the following way:
1) center the radiant beam towards the bucky;
2) insert the cassette into the bucky;
3) center and adjust the irradiate area on the patient;
4) select on the generator the radiographic exam, the kind of exam end the type of patient (for
instance indirect on bucky, constant radiographic) and technique;
5) press the preparation button and when the generator is ready for the exposure, press the X ray
exposure one.
Warnings!
All patient’s parts which are at risk, must be always protected by additional
shielding devices according to the radiation safety law.

X-Ray in lateral position.


To take X-Rays laterally, as accessory is available the spot cassette holder to be positioned on
patient table top. To this aim, do as follows:

1) rotate the radiogenic system, so that the radiant beam is addressed transversally towards the
examination tabletop and the lateral cassette holder;

2) insert the cassette in the cassette holder;

3) center and collimate the patient’s part to be X-ray;

4)select the radiographic exam and the type of patient, the direct exposition, the radiographic
constants and the exposure technique; on the generator

5) press the preparation button and, when the generator is ready for the exposure, press the

X ray exposition button.

Warnings!
All patient’s parts which are at risk, must be always protected by additional
shielding devices according to the radiation safety law.

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Figura 7- X-Ray in lateral position.

Use of the radiogenic source with a bucky stand.


The radiogenic source is designed to be used with a bucky stand too. Exploiting totally the vertical
travel of the radiogenic unit and a bucky stand, it is possible to take not only the thorax radiography,
but also the lower limbs (under load) ones.
To take a radiography with a bucky stand, do as follows:
1) insert the cassette in the bucky wallstand of the required size

2) center and collimate the patient to part to be radio graphed


3) select on the generator the radiographic exam and the kind of patienty ( indirect exposition on
wallstand, radiographic constants end exposition technique)
4) push the preparation push button and as soon as the generator is ready for exposition push
exposition push button

Figura 8 Use of the X-ray with bucky to the wall

Warnings!
All patient’s parts which are at risk, must be always protected by additional
shielding devices according to the radiation safety law.

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X-ray tube stand


Focal distance from floor Up to 228 cm
Rotation about vertical axis +/- 90°
Rotation about horizontal axis +/- 110° motor driven
Hinged joint of x-ray tube + 90°
Vertical movement balancing Counterbalanced
Movement enabling Buttons
Type of movements/brakes Manual/electromagnetic
Collimator
Diaphragm regulation Manual
Light control Electronic Timer
Focal distance control Metric tape line
Table
Plastic laminate (stratified wood
Examination table material
optional)
Absorption 0.7 mm Al eq
Longitudinal displacement 142 cm
Lateral displacement 20 cm
Electromagnetic brake control Buttons on handgrip
Distance patient-film 9.3cm
Height from floor From 41 to 85 cm motorized
Elevation speed 4 cm/s
Patient maximum weight 180 kg
Bucky
Longitudinal displacement 131 cm
103 lines/inch R = 10:1
Grid
F= 100 cm
Cassette formats From 13x18 to 35x43 cm
Supply
Voltage 230 V single phase
Maximum absorbed power 1 kVA

ACCESSORIES
Lateral cassette holder
Back tabletop horizontal handle

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8. OVERALL DIMENSIONS

FRONTAL VIEW

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LEFT LATERAL VIEW

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PLAN VIEW

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FRONTAL VIEW WITH A STRETCHER

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Via Partigiani, 25 25/mag/2007
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24068 Seriate (BG) Italy
e-mail: info@gmmspa.com pag.38di 59

RT20 WITH WALLSTAND

FRONTAL VIEW WITH WALLSTAND

PLAN VIEW WITH WALLSTAND IN LATERAL POSITION

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Via Partigiani, 25 25/mag/2007
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24068 Seriate (BG) Italy
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FRONTAL VIEW WITH INCIDENCE ANGLE ON WALLSTAND

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Via Partigiani, 25 25/mag/2007
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24068 Seriate (BG) Italy
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PLAN VIEW WITH WALLSTAND IN FRONTAL POSITION

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8.1. Safety recommendations


It is the installer and/or operator's responsibility to observe all the governmental obligations and
regulations in force applying to the installation and/or use of this equipment.
All the parts of this product must be checked and inspected at least every 12 months in order to ensure
the proper working of the product as well as the necessary safety for patients, personnel and third
parties.
Additional checks and inspections should be carried out more often if the product is meant for working
more hard than the standard average use.
Please get in touch with Service Department or authorized distributors for executing the system
inspection.
Every 12 months the servicing technicians should inspect the unit and, if necessary, replace the
components that could involve situations of danger due to wear.
These inspections should be foreseen within the annual maintenance program executed by Service
Department.
Should possible national standards require more inspections or checks, please make sure that these are
carried out.
Before any control, the operating personnel must make sure that all the signals and safety devices work
properly and the equipment is properly set for the use.
The lamp signals the X-ray exposure should light on only after the command for exposure is activated
and keep lit on only for the time strictly required by the X-ray exposure. Should this lamp lights on
when no exposure command was given, you shall immediately switch off the generator and call
GMM's Service Department.
Any modification or implementation of the system must be carried out in compliance with the national
and international standards and regulations.
As manufacturers and installers of this product we can not be held responsible with regard to the
equipment safety, performance, efficiency if:
− the installation, implementation, resetting, modifications, fixings are executed by unqualified
personnel and/or personnel not authorized by Service Department;
− components being important for the safety of the product are not replaced by original spare parts
by GMM;
− the electrical cabling inside the rooms where the system is to be installed is not in compliance
with the specifications established by IEC 364 series Standards or relevant national standards;
− the system is used in a different manner compared with the specifications stated in the manual
applying to its use.
Upon request, GMM will be glad to let you have the technical documentation applying to the servicing
of the system at the relevant cost.
The availability of this documentation does not represent any authorization to execute possible repairs
by technicians being not employed by GMM.
GMM is not responsible for repairs executed by technical personnel outside GMM's Servicing
Organization without a specific written consent.

For each technical intervention executed by our Service Department's personnel, we suggest you
should request for a copy of the relevant Testing Minutes where the following is always specified: kind
of the intervention executed, modifications of the rated parameters or value range, date, name,
signature of the technician who carried out the intervention.

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Via Partigiani, 25 25/mag/2007
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8.2. Protection measure and safety


Before switching on the equipment, the operator shall verify:

• dangerous areas on the equipment, where possible risks may exist with reference to crashes or
crushings;
• dangerous areas on the equipment where the patient or the operator may get injured;
• dangerous movements that may determine a damage to the equipment.

Warning!
It is the operator’s responsibility to command movements of the equipment
only after making sure that these do not involve any risks of damage to the
patient or third parties.

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9. DANGEROUS AREAS
The dashed areas indicated on the drawings show the areas within which possible risks of crash or
crushing may occur.

Danger of crash:
In these areas it exists a risk of crash during the movement with stretchers, beds, chairs, mobile table
with medical instruments, baskets, stands, etc.
Therefore, you shall verify that the relevant area is free from any obstacles before commanding any
movements of the equipment.

Danger of crushing
In these areas it exists a possible danger of crushing for the operator, the patient or third parties when a
movement of the equipment is commanded:

• Before commanding any movements, you shall verify that nobody else but the patient is
present within the area and that the patient is properly secured on the tabletop as described
here below.

The following pages must be read carefully in order to avoid other possible problems with dangerous
areas related to the equipment.

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10. DANGEROUS POINTS

The arrows marked on the drawings indicate possible dangerous points as follows: white arrows:
crushing; black arrows: crash.

Dangerous points for the hold:


The white arrows indicate the points/zones where a possible crushing of the patient/operator’s feet and
hands may occur.

Dangerous crash points


The dark arrows show the points/equipments parts where the patient may crash against:

Warning!
In no case use part of the equipment in a different way as shown from this
manual

Warning!
During the movements of the equipment or the patient positioning, it is
only and exclusively allowed to lean/to hold the points provided for the
relevant purpose

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11. ALLOWED HOLD POINTS

The operator’s hold points are the following:

1) push buttons control device bar which is positioned in front of the collimator

2) A push button handles fixed on the frontal side of patient table top (handles for manual tabletop
translations)

3) A push button handle fixed on right and left table top side
(handle for manual tabletop translation)

The patient’s hold point is the following:

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1) Horizontal handle for back tabletop position

Warning!
In case the hold point upon described can not be used you shall make sure
to avoid any possibility of crushing with mobile parts or other objects.
The operator has to make sure, before starting the equipment movement
that in no case the patient hold/lean on to the edge of the tabletop

Warning!
Patient arms, legs and hair have not to stick out from patient table top

11.1. Measures to be taken to avoid damages to things


Before commanding any movements, make sure that no obstacle is present within the movement area.
The dangerous areas of your equipment have already been indicated as “areas of crash”. No object or
expendable supplies must be placed on the equipment. As a matter of fact, during the movements of
the X ray tube or the tabletop, these could crush such objects. Do not place any objects on any other
surface; In case of tilting, these objects could fall, thus involving possible damages. Do not climb up
any point of the tabletop cover or the SFD. The covers could get damaged and cause failures or bad
functions of the equipment. In no case you shall put glasses for liquids (or other objects) on the
equipment, the cabinet or the control panel.
The liquid could penetrate inside some components of the equipment causing damages to the
equipment itself or wrong interpretations of the films. We suggest you should immediately eliminate
possible liquid stains.

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12. PROTECTONS AGAINST EXPLOSION


This equipment is not meant for working in areas subject to risks of explosions.

12.1. Protection against radiations


Although the collimation system considerably reduces the exposure of the patient to X-ray, the
following recommendations must be followed:

a) You shall collimate the radiated field to the minimum possible value.
b) You shall provide the patient with the best possible protection by using specific screens in
plumbed rubber (in compliance with the requirements established by IEC 61331-3), if
exposures are to be executed next to the patient's genital organs.
c) If it is necessary the presence of a doctor or auxiliary personal near the patient during the X-ray
exams, they must wear the specific protective garments (lead aprons, gloves/mittens, collar
ext)in compliance with the requirements established by IEC 61331-3.

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12.2. Functional checks of the systems

Warning!
During the execution of all the functioning tests requiring the activation of the X-ray generator, you
shall always wear your protective garments (lead aprons), you shall keep an adequate distance from the
X-ray beam and, if necessary, you shall wear your pen dosimeter for the individual control to the X-
ray exposure.

13. POSSIBILITY OF CONNECTION TO OTHER ACCESSORIES


This equipment to other accessories can sometimes result not so clear and from the instructions
applying to these accessories, the operator should always ask the relevant manufacturer or an expert in
order to ensure that the connection does not affect the necessary safety against dangers to users and
environment.

14. EMERGENCY PUSH BUTTONS


In case of a possible emergency situation causing risks of danger to the patient or the operator, the
equipment's functioning can be stopped immediately by pressing the EMERGENCY STOP push-
button.
The emergency stop push-button is red so as to ensure an easy and immediate identification.
If you press this push-button all the controls of the equipments will be deactivated immediately

Attention!
The EMERGENCY STOP push-button can be released (by pulling it)
only after identifying and eliminating the problem that determined the
emergency situation. Should the foreseen stop not be activated, you shall
press the GENERAL EMERGENCY STOP push-button that is provided
for stopping the electrical supply to the whole installation.In this case, the
equipment must not be reactivated anymore and Service Department must
be informed immediately.

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Via Partigiani, 25 25/mag/2007
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15. IDENTIFICATION
The OPERA RT20 table is identified by a series of adhesive labels placed on the column in vertical
position. These labels ( Figura 9: ) are applied in order to ensure both the proper identification of the
product from the commercial point of view and the compliance with the requirements established by
the Standards in force.
Besides the brand mark, the company’s address and the manufacturing place, the Identification label
includes the following information:

• model and reference Standards


• Serial Number and production lot
• The date of production (month and year)
• Rated voltage, number of the phases, absorbed current and mains frequency.

TABLE COLUMN

1 2
Figura 9: Identification labels

The identification labels are positioned Le targhette di identificazione vengono poste sulle singole parti
come raffigurato in.

1 Table Table right side of table frame


2 Column On Left bottom column side

In addition there are the following manufacture labels, placed on the various equipment components:

3 Grid Label printed on the grid


4 AEC chamber On the AEC chamber
5 X-ray tube housing On the internal side of the X-ray assembly cover
6 Collimator On the rear side of the collimator

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X ray housing

Collimator

Grid
AEC chamber

Column
Table

Figura 10

The commercial equipment identification is done by the adhesive labels on the lest front side of the
elevation table top carriage. GMM’s symbol-label is placed on X ray housing cover and on the front
left elevation tabletop carriage

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16. MAINTENANCE
The equipment includes mechanical and electrical parts, which need to be regularly subjected to
checks and maintenance in order to guarantee a unit efficient and enduring working. As suggested by
the manufacturer, the main controls typology and frequency to do regularly are listed below.
The operator and in other words the person that is responsible of the equipment must ask for technical
support at the foreseen dates and hold all the unit documentation, that means this manual and the
technical one. The operator must always addressed to the technical personnel for the equipment
maintenance and repairing; these operations must never be done by the operator.
For any possible technical problem, it is mandatory to immediately contact the technical assistance
and stop the use of the equipment until the system has been restored to its normal and optimal
working conditions. This is to avoid damage to the unit and to avoid exposure of patients and users to
needless risks.
For any possible technical problem, it is mandatory to immediately contact the technical assistance
and stop the use of the equipment until the system has been restored to its normal and optimal
working conditions. This is to avoid damage to the unit and to avoid exposure of patients and users to
needless risks.
The equipment maintenance can not be done by the customer. The manufacturer has no responsibility
in case of bad working, which can be caused by negligence or elusion of the basic maintenance rules
listed below.
Warning!
the preventive maintenance must be exclusively done by qualified and
authorized personnel.

If it is necessary to contact the manufacturer for technical problems or the Subject to agreement with
our administration department, we are at full disposal to supply the necessary technical support
equipment maintenance, it should be better to take note in advance of the unit serial number and test in
order to quicken and focus the technical support intervention. This information can be easily obtained
from the identification label, which is on the equipment.
A general check of the unit and its functioning conditions must be done at intervals no longer then 12
months. More frequent controls must be done if the unit is subjected to heavy use or in case of
restarting after a long stop. Changes, up-dating and extraordinary maintenance must be done by the
manufacturer or technical personnel authorized by him. Every ordinary and extraordinary operation on
the equipment must be supported by documents; these must be findable.

Warning!
Maintenance and documentation duties must be observed; in contrary case,
the equipment manufacturer’s responsibilities decay automatically.

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16.1. General checks


Before the maintenance operations, it should be better to read carefully the safety instructions which
are in Maintenance chapter (Chapter 16)
It is very important to repair as soon as possible the unit damages. In particular, remember that every
scratch to the protective paint must be touched up with specific paints supplied by the manufacturer; if
this operation is done well, it prevents a dangerous oxidizing phenomenon, which could compromise
the integrity and the strength of the system metal structure.

GENERAL CHECKS INTERVAL


Cleaning of the ball bearings sliding guides 12 months
Cleaning and lubrication of bearings and pins 12 months
Check and regulation of the bearing functions and play 12 months
Efficiency of the centring and alignment devices 12 months
Tightening of the screwed parts 12 months
Efficacy of the braking devices 12 months
Efficiency of the control and signal devices 12 months
Condition of sheaths and electrical cables 12 months

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16.2.Controls of the wire cable and suspension cables


The stand carriage is balanced by two counterweights (inside the column) and it is suspended by a four
of independent metallic cables. Careful maintenance of the suspended parts is required in order to
avoid potential dangers for the operators/patients and to guarantee the correct functioning of the
equipment itself. The steel ropes controls must be planned following the table indications, that means
every year. It is very important that during the check operations the metallic cables are greased by
common grease. The checks must be done on all the metallic cables lenght. You must check that there
aren’t metallic cables squashing or any twist strands breaking. In addition check the right wind up of
the metallic cables on the pulleys and the wear condition of them.

Warning!
The main cable breakage is a consequence of missed periodical checks and
maintenance of the ceiling suspension; hanging from the ceiling, the
telescopic stand needs a scrupulous maintenance of its hanging parts in
order to avoid possible dangerous situations for operators/patients, or other
persons in the working vicinity, and to guarantee the correct functioning of
the unit as well.

WIRE ROPES CHECKS INTERVAL


Condition of the steel wire ropes (gear) 12 months
Condition of the ropes pulleys 12 months
PARTS THAT MUST BE REPLACED AT INTERVALS INTERVAL
Steel ropes 10 years

It is possible to ask for spare parts or updating to the manufacturer. They are at full disposal for
maintenance or extraordinary renovation interventions as well.
Do not use in any case the stand when one of the two wire ropes show signs of change or
damage. Contact the technical support and replace the broken ropes.

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17. ROOMS DISINFECTION AND CLEANING

Warning!
The power supply must be disconnected before the cleaning. Do not use
water, to avoid corrosive phenomenon on the steel parts

The unit does not require particular cleaning operations; however, pay attention not to damage it. For
painted parts do not use abrasive substances, but products like those for car body cleaning. For
disinfection use commercial products whose effects are tested. Do not use gaseous disinfectants,
formalin and spray products which could generate dangerous and damaging infiltrations inside the
equipment. Further information and advices can be read in manuals and instructions concerning
disinfections and protections against explosions

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17.1. Risks linked with waste elimination

At the end of the working equipment components life, equipment and accessories waste and
elimination must be done in accordance with waste and elimination rules.

This symbol indicates that the equipment has electrical and electronic components. In accordance
with the requirements DIRECTIVE 2002/96/EC on waste electrical and electronic equipment (WEEE),
equipment and accessories waste cannot be treated as rubbish bins or similar means of municipal waste
collection

Please keep in contact with GENERAL MEDICAL MERATE SpA or another waste electrical and
electronic equipment qualified firm authorized from local country authority,
in order 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.

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Via Partigiani, 25 25/mag/2007
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Figura 11

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os Component Material Quantity Characteristics


1 General Iron and its alloys 390 kg Material that can be scrapped
structure and recycled
2 Aluminium 124 kg Material that can be scrapped
and recycled
3 counterweights Lead 110 kg Material that can be scrapped
and recycled
4 Covers ABS 7 kg Recyclable material
5 Printed circuit Epoxidic laminatic >10 cm2 Inside the equipment recyclable
0.5 kg material to be treated as WEEE
Boards Electrolytic condenser >25x25mm Assembled inside the equipment
recyclable material to be treated as
WEEE
6 Connection Copper conductor + 20 kg Material that can be recycled
cables PvC insulting material but to be treated as special
waste WEEE

17.2. Environmental characteristics and functioning limits

HUMIDITY NON TEMPERATURE ALTITUDE


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

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18. POWER SUPPLY


All the equipments of any X-ray installation must be connected to the electrical mains by means of a
contact or another multipolar sectioning device that has to be installed by the Customer. The room of
the installation must be in compliance with the IEC/CEI or UL/CSA prescriptions in force.
The national regulations applying to X-ray installations must be carried out in all the relevant
countries. Anyway, the compliance with the above-mentioned Standards is strongly recommended, of
course where these are not contradictory compared with the national regulations established in order to
ensure safety for the operator, the patient and third parties.

Rated voltage 230 V

Voltage change 220 V

Allowed fluctuation of mains voltage +/-10%

Mains frequency 50/60 Hz

Current absorption: 6A

Thermal dissipation 300W

Type of protection: Class I

Degree of protection Type B

Electromagnetic compatibility Equipment in compliance with EN 606001-1-2

Important Note
Normally the power supply of the table is taken by a 6A, delayed 400Vac nominal, placed in the mains
supply panel board of the exam room, with intervention differential current not higher than 30mA in
compliance with IEC/CEI Standards.

In case the electrical distribution panel isn’t preset with an ON/OFF switch, the switch must be
accessible to the operator, to make him able to switch ON/OFF. the table In compliance with UL/CSA
the equipment must be supplied by two delayed fuse of 6A – 400Vac with an ON/OFF switch placed
on the exam room, The iron terminal of the equipment must be connected in a visible manner to the
earth equipotential node of the diagnostic system by means of a protection conductor, with the minim
section of 10mmq. The supply cable from the mains supply panel board to the equipment electrical
cabinet must have a minim section of 2.5mmq.
All the conductors must be made in copper. All the supply connections and earth cables must be in
compliance with the national rules or equivalent.

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