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OPERA RT20
3. GENERAL INFORMATION............................................................................... 12
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
8. OVERALL DIMENSIONS................................................................................... 34
8.1. Safety recommendations .......................................................................................................41
8.2. Protection measure and safety ..............................................................................................42
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16. MAINTENANCE................................................................................................... 51
16.1. General checks .......................................................................................................................52
16.2. Controls of the wire cable and suspension cables ...............................................................53
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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
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
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.
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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.
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In order to facilitate the reading of the manual, different styles and types were used: please make
reference to the following:
Important information
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CEI EN 60601-1-3/IEC 60601-1-3: Medical Devices. Collateral rule. General regulations for
radiation protection with diagnostic radiological
equipments
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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.
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).
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.
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.
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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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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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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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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 .
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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.
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.
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POTTER BUCKY
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
Please for further collimator information make reference to the Ralco collimator
Manual
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Collimator
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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.
6.1. Accessory:
1) Lateral cassette holding
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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.
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:
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;
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
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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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1) rotate the radiogenic system, so that the radiant beam is addressed transversally towards the
examination tabletop and the lateral cassette holder;
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
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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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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ACCESSORIES
Lateral cassette holder
Back tabletop horizontal handle
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8. OVERALL DIMENSIONS
FRONTAL VIEW
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PLAN VIEW
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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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• 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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The arrows marked on the drawings indicate possible dangerous points as follows: white arrows:
crushing; black arrows: crash.
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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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)
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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
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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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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.
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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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:
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.
In addition there are the following manufacture labels, placed on the various equipment components:
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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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Via Partigiani, 25 25/mag/2007
File OPERA RT20
24068 Seriate (BG) Italy
e-mail: info@gmmspa.com pag.52di 59
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File OPERA RT20
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e-mail: info@gmmspa.com pag.53di 59
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.
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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Via Partigiani, 25 25/mag/2007
File OPERA RT20
24068 Seriate (BG) Italy
e-mail: info@gmmspa.com pag.54di 59
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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24068 Seriate (BG) Italy
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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
File OPERA RT20
24068 Seriate (BG) Italy
e-mail: info@gmmspa.com pag.56di 59
Figura 11
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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.57di 59
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Via Partigiani, 25 25/mag/2007
File OPERA RT20
24068 Seriate (BG) Italy
e-mail: info@gmmspa.com pag.58di 59
Current absorption: 6A
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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Via Partigiani, 25 25/mag/2007
File OPERA RT20
24068 Seriate (BG) Italy
e-mail: info@gmmspa.com pag.59di 59
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