Instruction Manual
Instruction Manual
Confidential Information
25.02.2019
LEGAL WARNING
RALCO SRL WILL PURSUE ANY AND ALL LEGAL REMEDIES AVAILABLE UNDER
THE LAW TO RECOVER DAMAGES INCURRED BASED UPON THE ABOVE
VIOLATION(S).
Model Certifications
Revision Level:
The English version of this manual is a translation of the Italian text which
prevails in case of doubts.
Rev. N Date N
THIS INSTRUCTION MANUAL PROVIDES THE SPECIFICATIONS, DIMENSIONS, AND FUNCTIONS FOR A STANDARD
COLLIMATOR. PERSONALIZATIONS ARE AVAILABLE UPON REQUEST. WITH PERSONALIZED COLLIMATORS, THE CUSTOMER
MUST ENSURE THE FOLLOWING HAS BEEN PROVIDED:
• YOUR SPECIFIC CODE IS CLEARLY VISIBLE ON THE BACK LABEL AFTER “CUSTOMIZATION”, ABOVE THE SERIAL
NUMBER, TO ENSURE THE CORRECT PERSONALIZED COLLIMATOR HAS BEEN PROVIDED (SEE ABOVE).
• THE CHAPTER ENTITLED “PERSONALIZATIONS,” WHICH INCLUDES RELEVANT INFORMATION REGARDING YOUR
PERSONALIZATION.
• OTHER PROVIDED ATTACHMENTS WHICH REFER TO YOUR PERSONALIZATIONS.
CONTENTS
INTRODUCTION ADJUSTMENTS
FIELD SIZE INDICATION ADJUSTMENT...............52
DESCRIPTION
Shutter Dial Adjustment ................................52
CHARACTERISTICS ............................................8
CROSSHAIR ADJUSTMENT ...............................52
SPECIFICATIONS Friction Brake Adjustment.............................53
MECHANICAL MOTION STOP ADJUSTMENT .......53
INSTALLATION
CLOSED Stop Long and Cross Shutters......54
TUBE COMPATIBILITY ......................................15
MOUNTING THE FLANGE TO THE X-RAY TUBE .17 TROUBLESHOOTING
ALIGNMENT OF X-RAY TUBE FOCUS AND INDICATORS GC-LED-4A................................56
COLLIMATOR...................................................19
SUBSTITUTIONS
Alignment Device ..........................................20
LED SUBSTITUTION ........................................57
Mounting the Collimator to the Flange ..........21
Replacing the Previous Version LED............58
Mounting Bracket, Type A ............................22
Replacing the New Version LED ..................59
Mounting Bracket, Type B ............................23
SUBSTITUTION OF THE ELECTRONIC BOARD FOR
INCORRECT INSTALLATIONS OF THE COLLIMATOR
LED...............................................................60
TO MOUNTING FLANGE .....................................26
SUBSTITUTION OF THE MIRROR .......................61
ELECTRICAL CONNECTION ...............................27
Power Supply Connection ............................28 SPARE PARTS
Wiring Diagram .............................................29 LABELS ..........................................................64
GC-LED-4A...................................................30 Parts Breakdown ..........................................67
OPERATION INSTRUCTIONS OPTIONAL ITEMS
LIGHT/X-RAY FIELD SETTING ...........................34 RO 001/A Metal Fixed Mounting Flange.......68
Front Panel ...................................................35 RO 002 Iron Mounting Flange Spacer ..........69
RO 012/B Retractable Measuring Tape........69
CALIBRATION
RO 041 Mylar Mirror .....................................70
CENTERING X-RAY BEAM WITH COLLIMATOR
RO 051 Metal Rotating Mounting Flange .....70
LIGHT .............................................................36
RO 055/B Metal Fixed Mounting Flange.......71
LIGHT FIELD TO X-RAY FIELD ALIGNMENT ........37
RO 063 Final Quality Test Report
LIGHT FIELD CALIBRATION ...............................38
Documentation .............................................72
Longitudinal Calibration (LONG)...................38
RO 074 External housing in customized
Vertical Alignment .........................................38
color ..............................................................72
Transversal Calibration (CROSS).................39
RO 077 Light Centring Device to align
COMPLIANCE VERIFICATION collimator to detector ....................................72
MINIMUM FILTRATION REQUIREMENT ...............40 RO 082 Glass Mirror.....................................72
Visual Determination of Half-Value Layer RO 096 Wiring Customization ......................72
(HVL) ............................................................41 RO 109 Front panel frame color
Quick-Check of Minimum Filtration customization................................................73
Requirement at a Particular kVp ...................41 RO 111 Front panel customization ...............73
Standard Absorber Method...........................41 RO 161 External accessory guide rail
VISUAL DEFINITION OF X-RAY VERSUS LIGHT spacer ...........................................................73
FIELD .............................................................42 RO 185/A Metal Fixed Flange ......................74
FIELD SIZE INDICATION....................................42 RO 202 Self-centering top-cover bracket .....75
CROSSHAIR ALIGNMENT ..................................43 RO 203 Self-centering top-cover bracket for
CHAPTER- ADJUSTMENTS, PARAGRAPH Siemens X-Ray tube.....................................75
CROSSHAIR ALIGNMENT. .................................43 RO 222/A Metal Rotating Mounting Flange ..77
LIGHT FIELD ILLUMINATION INTENSITY ..............43 RO 240 Focal-spot to skin spacer ................77
EMC COMPLIANCE .........................................43 RO 242/1 Single Laser Line .........................78
Electromagnetic Immunity for All Equipment RO 242/2 Second Laser Cross Projection....79
and Systems .................................................45 RO 253 Accessory guide rail spacers...........81
Frequency Range and Level: RF wireless RO 258 Additional Variable Filtration - Manual
communication EQUIPMENT .......................45 Selection .......................................................82
RO 258/1 Additional Variable Filtration - Manual
COVER REMOVAL
Selection .......................................................84
ACCESS TO COLLIMATOR COMPONENTS ..........50
RO 271 Substitution of LED light field ..........84
RO 318 Self-centering top-cover bracket .....85
INTRODUCTION
The collimator electronics supplies a signal defined as READY. The X-ray equipment manufacturer will manage this
signal as the X-ray consent. In the event of a collimator failure, the liability for the correct bypass of this signal, in order to
always ensure the X-ray consent, devolves upon the X-ray equipment manufacturer.
Reporting
Information regarding accidents that have occurred while using this collimator must be reported immediately to Ralco, srl.
Limitation of Liability
Ralco is not liable if the provided instructions are not complied with. Furthermore, Ralco is not liable if one or several of
the following instances apply:
If the unit is specifically designed per client specifications and the certification was the duty of the client;
The collimator complies with current standards for static load, a non-wearing class. This statement is based on
studies and tests performed on the collimator performance and its weight. If the final system, through tilting movements
or other dynamic movements, increases the risk factor other than those studied and tested, it is the responsibility of the
customer to ensure that there are no dangerous situations.
The collimator described here, is used on Radiological systems and is classified as a type IIB according to Attachment IX.
The collimator has been designed and manufactured in compliance to Attachment II of Legislative Decree, 2 February
1997, N. 46, Implementation of Directive 93/42/CEE of 14 June 1993 and successive modifications applying Directive
R302/A - R302/A DHHS - Introduction
2007/47/CE.
List Applicable Standards and to which Ralco adheres to:
IEC 60601-1:2005 + Am1:2012 (ed. 3.1), North American market deflections (US+CA)
IEC 60601-1-2:2014 (ed 4)
IEC 60601-1-3:2008 + Am1:2013 (ed. 2.1)
IEC 60601-2-54:2009 + Am1:2015 (ed. 1.1)
IEC 60601-2-45:2011 + Am1:2015 (ed. 3.1) Applicable in Mammography instead of IEC 60601-2-54:2009
IEC 60601-1-6:2010 + Am1:2010 (ed. 3.1) (Usability)
IEC 62304:2006 + Am1:2015 (ed. 1.1) (Software)
IEC 60825-1:2014 (LASER - if applicable)
IEC 62471:2006 (LED - if applicable)
ISO 9001:2015
ISO 13485:2016
ISO 9001:2008
UNI ESO 13485:2016
21 CFR subchapter J (FDA)
8750 01 & 8750 81 (CSA)
CE
*Ralco can provide documentation regarding its adherence to any of the above standards.
EN 60601-1 par. 5
Protection against electric hazards: "Class I" equipment.
Protection against direct and indirect contacts: Type B equipment with applied parts.
Protection against water see page: "Common equipment".
Safety of operation in the presence of inflammable anaesthetics with air or oxygen or nitrous oxide: Equipment not suited
to application in the presence of inflammable anaesthetic mixtures containing air or oxygen or nitrous oxide.
• Operation conditions: Equipment for continuous operation at intermittent loads - See Chapter Operation Instructions.
• Should label data on the collimator not correspond to the specifications herein, inform Ralco of the non conformity.
• Verifications of the specifications are to be performed according to the indicated equipment standards.
The inherent risk of using collimators in Radiological systems is deemed reasonable as determined by applicable
standards. The use of collimators for Radiological systems is strictly regulated. Ralco follows all applicable standards. It
is up to the installer and operator to ensure that all possible steps are followed to ensure the health and safety of the
patient and operator.
The contact with the moving parts can be considered impossible and may occur only during installation or maintenance
(low hazard). The internal parts are protected by a mechanical safeguard in the form of a metal or plastic sheath which
impedes access. Also motor units are not accessible as knobs are fixed using the Allen screws and can be removed only
by using a tool, in accordance with paragraph 5.92.3 of EN 60601-1 and EN 60601-2-54 par. 201.9.2.2.5. In addition the
collimator has been tested in accordance with EN 60601-1, paragraph 4.8.2
If you do not obey these instructions, there is a risk of death or serious injury.
R302/A - R302/A DHHS - Introduction
• Make sure that all protective earth conductors are installed and connected before first switching on the system.
• Always be sure that the power is switched off when installing any parts to the equipment.
• Make sure that the large internal capacitors are completely discharged. Discharging can take several minutes.
• Keep away water or other liquids from the inside or the equipment to avoid short-circuits or corrosion.
• After installation or service work on electrical components the following test have to be performed to ensure the
compliance with IEC 62353:
• Touch voltage
• Protective earth conductor resistance
• Earth leakage measuring
Processor overheating
The processor can get damaged within a few seconds.
• Do not operate the processor without cooling.
The rules concerning ESD protection apply to new devices and old devices and old devices. Old devices are replace and
sent back to the service depot.
or AC/DC Alternating and Direct Current No. 01-19 Ref. IEC 417-IEC 5033
Beam Limiting Device: Closed with Separate Opening of the Shutters No. 04-57 Ref. 417-IEC 5387
Beam Limiting Device with Separate Closing of the Shutters No. 04-58 Ref. 417-IEC 5388
Follow Instructions for Use Ref. ISO 7010-M002 (see the collimator label)
Disposal
• Dispose any material, batteries and X-ray equipment in accordance with the requirements of national legislation!
• Do not dispose X-ray equipment together with domestic waste!
WARNING
This symbol combined with the signal word WARNING indicates a hazardous situation which, if not avoided, could
result in death or serous injury.
If you do not obey these instructions, there is a risk of death or serious injury.
CAUTION
This symbol combined with the signal word CAUTION indicates a hazardous situation which, if not avoided, could
result in minor or moderate injury.
If you do not obey these instructions, there is a risk of minor or moderate injury.
The shown symbols are sometimes replaced by other symbols which indicate the concrete risk:
Material Damage
NOTICE
This symbol combined with the signal word NOTICE indicates a hazardous situation which, if not avoided, could
result in damages such as material damage. This damage is not related to personal injury.
Other Messages
Important
This symbol combined with the signal word Important indicates an important advice that points out that certain
guidelines, parameters, conditions or restrictions must be observed.
DESCRIPTION
Multilayer, square field, manual collimation system intended for installation on
stationary X-ray equipment. This device has been designed and manufactured for
skeletal and thoracic investigations.
The X-ray field is defined by six pairs of shutters, four of which are lead-lined. The six pairs of
shutters move perpendicularly within the X-ray field. Two pairs of brass shutters are located
near the focus, two are located near the entrance window and two are located near the exit
window of the X-ray beam from the collimator. The latter shutters serve to accurately define the
X-ray field edges.
Shutter movements are manual, controlled by two knobs on the collimator front panel.
CHARACTERISTICS
Mounting Plane at 80 mm (3.14") from the focus.
Continuous Film Coverage from Min: 00 x 00 cm to Max: 48 x 48 cm at 100 cm (40") SID.
Maximum Radiation Leakage: 150 kVp - 4 mA.
High luminosity provided by a White LED simulating the X-ray field. The light field is con-
trolled by an electronic timer.
Minimum Inherent Filtration: 2 mm aluminium equivalent.
Accessory Guides are used for accessories and additonal filtration.
High luminosity provided by a White LED simulating the X-ray field. The light field is con-
trolled by an electronic timer.
GC-LED-4A timer board for light source supply and operation.
This collimator may have the following optional items; a detailed description is provided in the
chapter OPTIONAL ITEMS.
RO DESCRIPTION
Metal fixed mounting flange: 20mm thickness, 136mm diameter (not available
RO 001/A
with RO 318)
RO 041 Mylar mirror with minimum internal inherent filtration: 0.3mm Al equivalent
Metal rotating mounting flange, 18mm thickness, +/- 90° with mechanical stop,
RO 051
136mm diameter (not available with RO 318)
Metal fixed mounting flange: 18mm thickness, 136mm diameter (not available
RO 055/B
with RO 318)
Final quality test report documentation (Light field, luminosity, light to X-ray
RO 063 field correspondence, light field border contrast ratio, x-ray leakage, control of
general functions)
RO 082 Glass mirror with minimum internal inherent filtration: 1mm Al equivalent
Self-centering top-cover bracket for Siemens X-ray tube only (flange provided
RO 203
by Siemens only)
RO DESCRIPTION
RO 242/1 Single laser line to align collimator and detector center: Class 2
RO 242/2 Two lasers forming a crosshair to center the patient to the detector: Class 2
Substitution of LED light field with a 24V 150W halogen lamp, GC338 timer
RO 271
board and cooling fan
RO 586 Single laser line to align collimator and detector center: Class 1
RO DESCRIPTION
RO 587/2 Two lasers forming a crosshair to center the patient to the detector: Class 1
Substitution of LED light field with a 24V 100W halogen lamp and GC338 timer
RO 602
board
R302/A - R302/A DHHS - Description
SPECIFICATIONS
NOTE
POWER SUPPLY
24 V AC/DC - 2 A
Power Supply
Fuse for power supply protection collimator. Not supplied by Ralco. T 2.5 A
Fuse for Power Supply Protection Motor. Not supplied by Ralco n.a.
Potentiometers:
n.a.
Square Field
n.a.
Round Field
ELECTRONIC SPECIFICATIONS
Software n.a.
RADIOLOGICAL SPECIFICATION
Filtration, Additional
X-ray beam = 75 kV n.a.
EN 60601-1-3 par. 7.5
RADIOLOGICAL SPECIFICATION
SID: (optional)
Precision of Measurement with Retractable Tape < 2% SID
EN 60601-2-54
EN 60601-1-3
GENERAL SPECIFICATIONS
Operation Environment
10°- 40°C
Ambient Temperature
10%- 75%
Relative Humidity
700 - 1060 hPa
Atmospheric Pressure
GENERAL SPECIFICATIONS
Storage
-40° - +70°C
Temperature
10% - 95%
Humidity
500 - 1060 hPa
Atmospheric Pressure
Weight 9.4 Kg
L: 268 mm
Dimensions W: 195.5 mm
H: 206.5 mm
**
ATTENTION:
THE DISTANCE BETWEEN TWO RAILS VARIES AND DEPENDS ON THE COLLIMATOR MODEL.
PRIOR TO INSERTING ACCESSORIES IN THE RAILS MAKE SURE THAT THE DIMENSIONS OF THE
ACCESSORY MATCHES WITH THE DISTANCE BETWEEN TWO RAILS SLOTS (TOLERANCE MAX.
± 0,5 MM).
THE INCORRECT DIMENSION CAN LEAD TO DANGEROUS SITUATIONS AND/OR TO THE ACCESSORY
FALLING.
SEE THE CHAPTER OPTIONAL ITEMS IF THE RAILS DIFFER FROM THE STANDARD ONES OR ARE PRO-
VIDED ON REQUEST.
R302/A - R302/A DHHS - Specifications
INSTALLATION
WARNINGS
EACH FLANGE WHICH IS PROVIDED WITH THE COLLIMATOR BEARS A SERIAL NUMBER
MATCHING THE COLLIMATOR. THIS ENSURE THE CORRECT FLANGE IS ALWAYS USED.
IT IS MANDATORY TO ALWAYS USE THE PROVIDED FLANGE.
WARNING
TUBE COMPATIBILITY
1. Using the dimensions in Fig. Tube Compatibility below, ensure the near port shutters of
the collimator are placed in the X-Ray tube port correctly.
• Assembly values (X-Ray tube housing and collimator) must comply with a minimum
value of inherent filtration and a maximum value of radiation leakage.
2. The distance between the X-Ray tube focus and the flange mounting plane (collimator
upper plate) must be: 80 mm (3.14"), tolerance +/- 1 mm (0.04 “).
R302/A - R302/A DHHS - Installation
WARNING
CAUTION
CAUTION
2. Mount the mounting flange and spacers (optional) to the X-Ray tube port using 4 screws
long enough to be driven for at least 5 threads.
CAUTION
ENSURE THE SCREW HEAD IS INDEED CORRECT FOR THE FLANGE SELECTED.
IT IS THE RESPONSIBILITY OF THE END-USER TO ENSURE ALL SAFETY MEASURES
ARE IMPLEMENTED TO ENSURE THE SCREWS ARE OPTIMALLY TIGHTENED INCLUDING
THE USE OF APPROPRIATE LOCKTITE.
TIGHTEN THE 4 SCREWS TO THE X-RAY TUBE HEAD SECURELY, STRICTLY ACCORDING
TO THE INSTRUCTIONS OF THE X-RAY TUBE MANUFACTURER.
R302/A - R302/A DHHS - Installation
CAUTION
Alignment Device
This device is used to ensure the collimator
mounting flange is correctly aligned to X-Ray beam.
The X-Ray tube manufacturer provides a tolerance
for the placement of X-Ray tube focus.
Ralco recommends to use the Focal Alignment
Device (jig) to ensure the correct flange alignment
with the centre of the X-Ray beam, see Fig. Focal
Alignment Device. By making an exposure, it is
possible to check the perpendicularity and
concentricity using fixed references on the X-Ray
image.
Once the mounting flange is aligned the collimator
light/X-ray field should also be aligned (within
specific tolerances).
Please consult the technical specifications of your X-
Ray tube to find the maximum tolerance for the
A - X-Ray Tube, B - Focal Adjustment Device
position of the focus. Should the use of an alignment C - Mounting Flange, D - Screw, E - Washer
device not be possible, Ralco collimators allow for
the regulation of the light field.
Fig. Focal Alignment Device
R302/A - R302/A DHHS - Installation
NOTE
WARNINGS
WARNINGS
WARNING
WARNING
R302/A - R302/A DHHS - Installation
RALCO PRODUCES MANY FLANGE TYPES WITH VARIOUS DIMENSIONS. BELOW, PLEASE
FIND 2 MAIN FLANGE TYPES WITH THEIR FUNCTIONAL MODES. THE DIMENSIONS
ARE FOR ILLUSTRATIVE PURPOSES ONLY. IT IS THE RESPONSIBILITY OF THE END-
USER TO ENSURE THE SAFE COUPLING OF THE COLLIMATOR AND FLANGE.
• Flange B1 (WITH rotation): With the tabs fully retracted, tighten tabs in the following
sequence:
-> tabs 1 and 3 - at least 7 turns
-> tabs 2 and 4 – 5 ½ turns exactly
(if you are not able to respect the turns something is incorrect).
Flange B1 Troubleshooting:
The collimator tabs glide on the flange outer ring and the collimator rotates towards the X- Ray
tube axis. If, however:
-> the release force from the position 0° and the collimator rotation towards the X-Ray tube
axis is too low, the two tabs of the tab 2 and 4 need to be tighten ½ turn.
-> the release force from the position 0° and the collimator rotation towards
the X-Ray tube axis is too high, the two tabs of the tab 2 and 4 need to be loosened
½ turn.
Fig. Mounting Bracket, Type B + Flange B1 Fig. Mounting Bracket, Type B + Flange B1
(NO rotation) (WITH rotation)
R302/A - R302/A DHHS - Installation
5. Ensure the mounting flange is indeed coupled flat against the top mounting plane of the
collimator and the 4 tabs overlap the flange outer ring to guarantee the collimator does not
fall. See Fig. Correct overlap of the tab.
R302/A - R302/A DHHS - Installation
6. Check that the distance between the collimator housing and the mounting flange is equal in
all directions. See Fig. Correct overlap of the tab.
7. Loosen the screws and adjust if required.
WARNING
1. The 4 tabs overlap the flange outer ring - see Fig. Correct Overlap.
2. Ensure the Mounting flange is flat against the collimator mounting plane - see Fig. Flat Mounting Plane.
3. Ensure the 4 tabs are not in contact with only the Mounting Flange Edge - see Fig. Incorrect Overlap.
4. Ensure the 4 tabs do not lock the Flange Outer Ring instead of overlapping it - see Fig. Flange Edge.
R302/A - R302/A DHHS - Installation
ELECTRICAL CONNECTION
NOTE
WARNING
CABLES AND TERMINALS USED FOR THE INTERNAL CONNECTION OF THE COLLIMATOR
MUST BE SUITABLE FOR OPERATION AT TEMPERATURES OF 80°C AND COLLIMATOR
CURRENT ABSORPTION.
R302/A - R302/A DHHS - Installation
WARNINGS
Wiring Diagram
R302/A - R302/A DHHS - Installation
GC-LED-4A
CONNECTORS
1. 24 V AC/DC or 12 V DC
2. +5 V Fan
3. GND Fan
J2 - SUPPLY AND OUTPUTS 4. +5 V Laser
5. GND Laser
6. + Power-up/Power down external push-button
7. GND Power-up external push-button
1. + LED 5 A positive output
J1 - LED OUTPUT
2. - GND Led 5A
1. Vpp
2. +5 V
J3 - PROGRAMMING 3. GND
CONNECTORS 4. PGD
5. PGC
6. NC
1. + External LED
R302/A - R302/A DHHS - Installation
2. - External LED
J4 - HOME SENSOR INPUT + 3. - Photosensor LED Cathode
EXTERNAL LED 4. + Photosensor LED Anode
5. Input signal (Photosensor output collector)
6. GND (Photosensor output emitter)
1. NTC LED input
J5 - PUSH BUTTON INPUT + NTC 2. NTC LED input
EXTERNAL LED 3. Laser input, pin 1
4. Laser input, pin 2
1. +5 V
J6 - OPEN-COLLECTOR OUTPUT
1. GND
J7 - OPEN-COLLECTOR (ABNORMAL 1. +
OPERATION MANAGEMENT) 2. -
J8 - J9 - ENCODER
(By connecting an opto-switch it is 1. +LED
possible to switch ON the light when 2. IN
the shutter move) 3. GND
**The encoder reading is available 4. GND
for s.w. 2.00 and 5.00
JP5 - LED POWER SUPPLY UP TO 6.2 OFF: LED power supply is adjustable through trimmer to max. 4.8 A
A (STANDARD SETTING 4 A) ON: LED power supply is adjustable through trimmer to max. 6.2 A
OFF: Standard
JP9 - LASER CONTROLLED
ON: When the button, placed on J5, is pressed the laser switches ON
INDEPENDENTLY
independently from the light.
ON, ON: s.w.4.00 (following the button, the switching on of the board is
controlled by closing the contact)
If the board is configured as JP8 standard:
OFF:( pushing the button the status will change) (if on will switch off and
the other way around)
ON: The board works in renewal time mode. In this mode, each time the
button is pressed, the ignition time is renewed without switching off the
light.
If the light is already on, it continues to stay on but with renewed time.
Also applies to the laser if independent
The fan switches ON together with the LED, and operates 15 seconds
FAN
longer after the LED OFF.
Trimmers
LEDs
ALARM DIAGNOSTIC
The timer identifies anomalies/errors/malfunctions. The outgoing messages from J7 are managed and
interpreted by “intelligent board”
bit = 10 ms
byte:
1 bit sync (1)
8 bit data - transmission bit L....H
1 bit stop (0)
Output status:
0 = output disabled
1 = output enabled
BYTE 4: alarms:
bit7:
bit6: High LED temperature
bit5: High timer temperature
bit4: Push button pressed more than 5 seconds
bit3: Laser error
bit2: Fan error
bit1: LED short-circuited
bit0: LED disconnected or faulty driver
R302/A - R302/A DHHS - Installation
OPERATION INSTRUCTIONS
LIGHT/X-RAY FIELD SETTING
• Set the collimator at 100 cm SID.
• By rotating the knobs and with the knob index on the front panel, follow the tags of the
scale.
• Do not force the knobs.
• Activate the light field by pressing the related push-button on the collimator front panel.
• The collimator is ready to operate.
WARNINGS
CAUTION
Front Panel
The X-ray field is set through the knobs that control the shutter movement. The table provides
the readout of the values which must be set with the knobs. The exact value to be set is
obtained by crossing the SID in use (the value indicated by vertical axis), with the cassette size
value in cm or inches (horizontal axis).
E.g.
To obtain the X-ray field 24 cm (LONG) x 35 cm (CROSS) at SID 150 cm, with reference to
the chart, set the Long knob indicator to 16.5 cm and the Cross knob indicator to 24 cm. See
Fig. Long Aperture and Fig. Cross Aperture.
SID in use
CALIBRATION
WARNINGS
NOTE
NOTE
• For required values is referred to the System Reference Manual. However, the values L1 +
L2 and W1 + W2 shall NEVER exceed 2 cm (representing 2% of the SID).
• Note the measured values in Chart below.
• Repeat preceding steps with small focus selected.
CAUTION
THE HEEL EFFECT WILL CAUSE THE FIELD TOWARD THE CATHODE TO BE SLIGHTLY
LESS SHARP THAN ON THE OTHER THREE SIDES. THIS IS NORMAL AND CANNOT
BE CORRECTED BY ADJUSTMENT. IN ADDITION, AN X-RAY TUBE OF 12° OR LESS
TARGET ANGLE WILL PRODUCE AN ASYMMETRICALLY SHAPED FIELD WHEN A LARGE
FIELD SIZE IS USED AT SHORT SID, BECAUSE OF ANODE CUT-OFF EFFECT. THIS
IS NORMAL AND MAY NOT BE CORRECTED BY ADJUSTMENT.
follows:
• Place the test film on the face of the cassette over the white paper or repeat exposure on
the flat panel.
• Place the cassette in the position originally marked.
• Check the correct position of the film or the X-ray field on the flat panel by the shadows
cast by the copper strips.
• Using the images of the collimator shutters as the references for the shape and size of the
X-ray field, adjust the light field to match.
• If adjustment is necessary, adjust the travel of the light source. All procedures can be found
in LIGHT FIELD ADJUSTMENTS in this chapter.
WARNINGS
DO NOT TOUCH THE DISSIPATER WITH YOUR HANDS; IT COULD BE HOT AND
CAUSE SEVERE BURNS.
• Remove the part of the cover necessary to access the screws, see Chapter - COVER
REMOVAL
• Remove the light source protection heatsink by unscrewing the fixing screws . This allows
you to access the light source.
• If the light-field needs to be moved laterally, loosen (not remove) the fixing screws A.
• Adjust through screw B.
• When calibration is terminated, lock the screws A.
See the following Fig. Light Field Adjustment
Vertical Alignment
• If the light field is smaller than the X-ray field, lower the lamp by adjusting screw C.
• If the light field is bigger than the X-ray field, raise the lamp by adjusting screw C.
See Fig. Light Field Adjustment.
COMPLIANCE VERIFICATION
WARNINGS
The above HVL requirements can be met if it is demonstrated that the aluminium equivalent in
the primary beam is not less than that shown in the following table:
1
Dental X-ray Systems designed for use with intraoral image receptors and manufactured after
December 1, 1980.
2 Dental X-ray Systems designed for use with intraoral image receptors and manufactured before
or on December 1, 1980, and all other X-ray systems subjected to this section and manufac-
tured before June 10, 2006.
3
All X-ray systems, except dental X-ray systems designed for use with intraoral image receptors
subjected to this section and manufactured on or after June 10, 2006.
The information contained in the above table was extracted from the Code of Federal
Regulations FDA 21 1020.30 (m).
Type 100 Aluminium Alloy (as given in “ALUMINUM STANDARDS AND DATA” verification of
compliance).
Visual Determination of Half-Value Layer (HVL)
The above HVL requirements can be met if it is demonstrated that the aluminium equivalent in
the primary beam is not less than that shown in the following Total Filtration table:
Below 50 0.5
From 51 to 70 1.5
Over 70 2.2
The Aluminium equivalence of each component in the primary beam (X-ray tube and housing,
beam limiting device and any additional filtration in the system) is specified on the component,
in the technical data attached to the component or can be measured. Determine the total
aluminium equivalence in the primary beam and make sure that it is equal or greater than those
specified in the above Table Total Filtration of Primary Beam in Aluminium Equivalence.
Quick-Check of Minimum Filtration Requirement at a Particular kVp
If the total inherent filtration cannot be seen, then the HVL must be obtained with the following
procedures:
The HVL in millimetres of aluminium in the system under test must be compared with those
specified in Table Minimum Filtration Requirement - Beam Quality (HVL) and must be
greater than or equal to the values shown in the table.
a) Direct the central X-ray beam perpendicular and in the center of a RAD-Check instrument.
R302/A - R302/A DHHS - Compliance Verification
Determine the exact distance from the X-ray tube focal spot to the window of the collimator
(273 mm - 10.75"). Place the input area of the RAD-CHECK at an equal distance from the
collimator window. Collimate the beam to an area slightly larger than the detector.
b) Make an exposure at a pre-selected technique factor of 90 kVp and appropriate mA and time
values with no added filtration in the beam; record the reading.
Using the type 1100 Aluminium Alloy, tape a total of 2.5 mm of Aluminium to the window of
the collimator. Make an exposure using the same technique factors; record the reading.
c) Verify that the radiation read with the 2.5 mm Al in the beam is greater or equal to 50% of
the radiation read with no filtration in the beam.
Standard Absorber Method
The HVL determination obtained from the following procedures are to be compared with those
illustrated in the Table - Minimum Filtration Requirement - Beam Quality (HVL). The HVL
in millimetres of aluminium obtained during the test must be greater or equal than the values
listed in the above mentioned table.
a) Direct the central X-ray beam perpendicular and in the center of a RAD-Check instrument.
Determine the exact distance from the X-ray tube focal spot to the window of the collimator
(273 mm - 10.75"). Place the input area of the RAD-CHECK at an equal distance from the
collimator window. Collimate the beam to an area slightly larger than the detector.
b) Select a tube potential of 100 kVp and appropriate mA and seconds, with no added filtration
in the beam make an exposure and record the reading. Using a set of several sheets of 1100
Aluminium Alloy, each having a thickness of 0.5 or 1.0 mm, tape the filtration to the window
of the collimator. Make an exposure for each increments of filtration and record the reading.
c) Plot the exposure readings (log scale) versus the total added filtration thickness on semi-log
paper; see the sample hereunder.
d) Verify that HLV values in the useful beam for the above specific tube potential is not less
than the values shown in Table - Minimum Filtration Requirement - Beam Quality (HVL).
generale\12_verif_conf_graph.gif
R302/A - R302/A DHHS - Compliance Verification
CROSSHAIR ALIGNMENT
CHAPTER- ADJUSTMENTS, PARAGRAPH CROSSHAIR ALIGNMENT.
WARNING
Electromagnetic Emissions
The R302/A - R302/A DHHS colimator is suitable for use in the specified electromagnetic environment. The purchaser or user
of the R302/A - R302/A DHHS should assure that it is used in an electromagnetic environment as described below:
RF emissions Class [A] This R302/A - R302/A DHHS is suitable for use in all
CISPR 11 establishments other than domestic and those directly connected
to the low voltage power supply network which supplies buildings
Harmonic emissions [Not applicable] used for domestic purposes.
IEC 61000-3-2 The EMISSIONS characteristics of this equipment make it suit-
able for use in industrial areas and hospitals (CISPR 11 class A).
Voltage fluctuations/flicker [Not applicable] If it is used in a residential environment (for which CISPR 11 class
emissions B is normally required) this equipment might not offer adequate
IEC 61000-3-3 protection to radio-frequency communication services. The user
might need to take mitigation measures, such as relocating or re-
orienting the equipment
R302/A - R302/A DHHS - Compliance Verification
Electrostatic 8 kV contact EN 60601-1-2 Floors should be wood. concrete or ceramic tile. If floors
discharge (ESD) 2/4/8/15 kV air test level are covered with synthetic material. the relative humidity
IEC 61000-4-2 should be at least 30%.
Electronical fast 2 kV for power EN 60601-1-2 Mains power quality should be that of a typical commer-
transient/burst supply lines test level cial or hospital environment.
IEC 61000-4-4 1 kV for input/output
lines >3m
Surge 0.5/1 kV differential EN 60601-1-2 Mains power quality should be that of a typical commer-
IEC 61000-4-5 mode test level cial or hospital environment.
0.5/1/2 kV common
mode
Voltage dips, short 10 ms – 0% a 0°, 45°, EN 60601-1-2 Mains power quality should be that of a typical commer-
interruptions and 90°, 135°, 180°. 225°, test level cial or hospital environment. If the user of the collimator
voltage variations 270°, 315° R302/A - R302/A DHHS requires continued operation
on power supply 20 ms – 0% a 0° during power mains interruptions. it is recommended
input lines 500 ms – 70% a 0° that the collimator R302/A - R302/A DHHS be powered
IEC 61000-4-11 5 s – 0% from an uninterruptible power supply or a battery.
Power frequency 30 A/m EN 60601-1-2 Power frequency magnetic fields should be at levels
(50/60 Hz) test level characteristic of a typical location in a typical commercial
magnetic field or hospital environment.
IEC 61000-4-8
R302/A - R302/A DHHS - Compliance Verification
**Pulse Modulation: 18 Hz
COVER REMOVAL
(1).
(2).
(3).
(4).
DISCONNECT THE
CONNECTOR.
(5).
IN COLLIMATORS WITH
MEASURING TAPES, REMOVE
THE TAPE STOP BY LIFTING IT
OFF WITH A SCREW DRIVER.
GENTLY EASE THE TAPE INTO
ITS CONTAINER WITHIN THE
COLLIMATOR.
(6).
(7).
(8).
(9).
ACCESS THE CLUTCHES BY REMOVING THE TWO KNOBS AND/OR THE FRONT PANEL DEPENDING
ON THE COLLIMATOR MODEL.
Timer Board
ACCESS THE TIMER BOARD BY REMOVING THE TWO KNOBS AND/OR THE FRONT PANEL
DEPENDING ON THE COLLIMATOR MODEL.
R302/A - R302/A DHHS - Cover Removal
Power Supply
Longitudinal Movement
ADJUSTMENTS
WARNINGS
THIS IS PROVIDED AS AN AID TO THE END USER. RALCO IS NOT LIABLE FOR
ANY DAMAGES RESULTING FROM THE ALTERING OF PRESET FACTORY
CONFIGURATIONS.
ADJUSTMENTS HAVE BEEN PRESET AT THE FACTORY PRIOR TO SHIPMENT OF
THE COLLIMATOR. SHOULD ANY PROBLEM ARISE REQUIRING THE NEED TO
RECALIBRATE, PLEASE CONTACT RALCO FOR ASSISTANCE BEFORE PROCEEDING
WITH THE ADJUSTMENT.
TROUBLESHOOTING
A faulty Collimator must not be used until it is repaired and checked.
The use of a faulty collimator might impair the safety of the operator and patient.
Before returning the collimator to Ralco for repair, please make sure that the fault is not caused
by one of the problems listed below. If the indications provided fail to solve your fault, please
make sure that you obtain a Return number (RMA) from Ralco for the collimator, see
Chapter - GENERAL, paragraph Repairs.
GENERAL FAULT FINDING
Function Fault Description Fault finding and solutions
Area defined by Light • Check if source flange distance is correct (see chapter INSTALLATION)
Field not (completely) on • Check if mirror or light source are positioned correctly (see chapter CALIBRA-
film TION)
• If still NOK, exchange the collimator.
• Check if mirror or light source are correctly positioned (see chapter CALIBRA-
Collimator The light field of the colli-
TION, paragraph Light Field to X-Ray Field Alignment)
calibration mator is not centered
• If still NOK, replace collimator
INDICATORS GC-LED-4A
Number Color Description Fault finding and solutions
SUBSTITUTIONS
LED SUBSTITUTION
WARNING
NOT IMMEDIATELY TOUCH THE DISSIPATER WITH YOUR FINGERS IT COULD BE HOT
AND CAUSE SEVERE BURNS.
DO NOT TOUCH THE LIGHT SOURCE, THE SOCKET, OR THE LIGHT BRACKET WITH
YOUR FINGER. THEY CAN BE VERY HOT AND CAUSE SEVERE BURNS.
DO NOT TOUCH THE LED LENS WITH YOUR FINGERS DIRECTLY, EVEN WHEN
IT IS COLD. OIL FROM YOUR SKIN WILL LOWER THE LED PERFORMANCE.
IF YOU HAVE TOUCHED THE LED, WIPE THE LED SURFACE WITH A SOFT
CLOTH IN CASE OF CONTACT.
The LED Substitution Kit is composed of the following components: the LED (A), and an
extension cable (B), pictured in Fig. LED Substitution Kit. This Kit is designed to substitute
any LED Ralco provides.
Prior to replacing the LED, confirm which version of LED is installed on your collimator which
will ensure the substitution is performed correctly.
• The previous version LED is connected to the board via 2 cables (red and black), see Fig.
Previous Version LED below.
• The new LED is connected to the board via the connector, see Fig. New Version LED
below.
on the terminal board, see Chapter INSTALLATION, paragraph Wiring Diagram in the
Instruction Manual for your specific model.
• Carefully remove the LED and the extension cable from their packaging.
• Make sure that the extension cable (B) is firmly connected to the LED (A), see Fig. LED
kit.
• Adjust the length of the extension (B) cable by cutting the 2 cables (red/black).
• Connect both cables to the board.
• Remount the heat sink protection by tightening the two fixing screws (C), see Fig. LED
Substitution below.
• Remount the covers in reverse order, see Chapter COVER REMOVAL.
• Verify the Light Field/X-Ray field correspondence, see Chapter CALIBRATION.
SPARE PARTS
NOTE
THE SPARE PARTS LISTED BELOW REFER TO THE STANDARD MODEL ONLY.
LABELS
Fig. Standard Model Labels, LED and Laser (Red Laser Line - Fig. DHHS Model Labels, LED and Laser (Red
optional RO 586) Laser Line - optional RO 586)
Fig. Standard Model Labels, LED and Laser Fig. DHHS Model Labels, LED and Laser
(2 Red Laser Lines - optional RO 587) (2 Red Laser Lines - optional RO 587)
PN Description
RS 047 Push button
RS 093 Mirror with support
RS 178 Knob
RS 390 Cover
RS 394 Right accessory guide
RS 395 Left accessory guide
RS 402 Lateral access panel
RS 424 Frame
RS 596 Screws, TC M3x25 mm
RS 796 Front panel, up to SN 13771
RS 798 Front panel, from SN 13772
RS 1106 Fan
RS 1150 Antidust panel
R302/A - R302/A DHHS - Spare Parts
Parts Breakdown
R 302/A
R302/A - R302/A DHHS - Spare Parts
OPTIONAL ITEMS
This collimator may have the following optional items; a detailed description is provided in this
chapter.
NOTE
THE HEEL EFFECT WILL CAUSE THE FIELD TOWARD THE CATHODE TO BE SLIGHTLY
LESS SHARP THAN ON THE OTHER THREE SIDES. THIS IS NORMAL AND CANNOT
BE CORRECTED BY ADJUSTMENT. IN ADDITION, AN X-RAY TUBE OF 12° OR LESS
TARGET ANGLE WILL PRODUCE AN ASYMMETRICALLY SHAPED FIELD WHEN A LARGE
FIELD SIZE IS USED AT SHORT SID, BECAUSE OF ANODE CUT-OFF EFFECT. THIS
IS NORMAL AND MAY NOT BE CORRECTED BY ADJUSTMENT.
R302/A - R302/A DHHS - Optional Items
NOTE
FORCING AND/OR EXTENDING THE TAPE BEYOND THIS POINT WILL CAUSE THE
FOLLOWING INCONVENIENCES:
BREAKAGE OF THE TAPE OR,
DISTORTION OF THE TAPE OR,
IMPOSSIBILITY OF RETRACTING THE TAPE INTO ITS LODGING BECAUSE THE GRIP
OF THE SPRING HAS BEEN FORCED AND HOOK-UP IS CONSEQUENTLY DISTORTED.
NOTE: DO NOT EXTEND THE TAPE BEYOND THE INDICATION OF STOP.
NOTE
THE HEEL EFFECT WILL CAUSE THE FIELD TOWARD THE CATHODE TO BE SLIGHTLY
R302/A - R302/A DHHS - Optional Items
LESS SHARP THAN ON THE OTHER THREE SIDES. THIS IS NORMAL AND CANNOT
BE CORRECTED BY ADJUSTMENT. IN ADDITION, AN X-RAY TUBE OF 12° OR LESS
TARGET ANGLE WILL PRODUCE AN ASYMMETRICALLY SHAPED FIELD WHEN A LARGE
FIELD SIZE IS USED AT SHORT SID, BECAUSE OF ANODE CUT-OFF EFFECT. THIS
IS NORMAL AND MAY NOT BE CORRECTED BY ADJUSTMENT.
CAUTION
PAY ATTENTION TO THE DISTANCE OF
LOWER GUIDES THAT COULD BE GREATER
THAN THE DISTANCE OF UPPER GUIDES.
R302/A - R302/A DHHS - Optional Items
NOTE
RALCO RECOMMENDS FOLLOWING THE BELOW PROCEDURE, DURING THE INSTALLATION OF THE COLLIMATOR
EQUIPPED WITH THE SIEMENS TOP COVER TO THE X-RAY TUBE. THE CORRECTLY PERFORMED PROCEDURE
ALLOWS THE COLLIMATOR TO ROTATE FREELY.
PROCEDURE:
1. REMOVE THE COLLIMATOR FROM ITS PACKAGING AND PLACE IT ON A FLAT SURFACE,
2. UNSCREW ALL 3 FIXING SCREWS OF THE COLLIMATOR, SEE FIG. 1,
3. INSTALL THE COLLIMATOR ONTO THE FLANGE PREVIOUSLY MOUNTED TO
THE X-RAY TUBE.
4. TIGHTEN ALL 3 SCREWS COMPLETELY, SO THAT THE TABS WILL TOUCH
THE FLANGE SLIGHTLY,
5. ONCE THE SCREWS ARE COMPLETELY TIGHTENED LOOSEN ONE BY ONE ABOUT
1/2 TURN (180°) TO ALLOW THE COLLIMATOR TO ROTATE FREELY. SEE FIG. 2.
Fig. 1 Fig. 2
R302/A - R302/A DHHS - Optional Items
RO 242/1 Single Laser Line to align collimator and detector center: Class 2
The collimator laser is classified as Class 2
(1 m W - wavelength = 645 nm, +/- 10 nm);
used for collimator/image receptor center
alignment, see Fig. Laser Line.
WARNING
CAUTION: CLASS 2
LASER SYSTEM DO NOT
STARE INTO THE BEAM
Laser Adjustment
• Remove part of the cover to access the
point of adjustment, see Chapter-
COVER REMOVAL.
• The line is to fall on a perpendicular
cross-line on the plastic anti-dust panel
near the collimator controls, see Fig.
Laser Line.
• Adjust the position of the line by rotating
or moving the base of the laser system. Fig. Laser Line
• To rotate the laser system, loosen
the Allen screw A, see Fig. Laser
Adjustment.
• Tighten the Allen screw when the
laser beam falls on or is parallel to
the bisector line drawn on the
anti-dust panel.
• Shift the laser system by loosening the
two B screws holding the laser system
base to the beam limiting device front
plate.
• Move the base until the laser
beam falls over the perpendicular
Fig. Laser Adjustment
bisector line on the anti-dust
panel, see Fig. Laser Alignment.
R302/A - R302/A DHHS - Optional Items
Substitution
• Disconnect supply.
• Remove the cover, see Chapter- COVER REMOVAL.
• Unscrew the fixing Allen screws A, see Fig. Laser Adjustment.
• Disconnect the timer cables from the terminal board - white 0 V, red 5 V.
• Remove the laser and substitute with an identical item.
• Tighten the screws.
• Check the laser alignment, see Chapter- ADJUSTMENTS.
• Remount the cover, see Chapter- COVER REMOVAL.
Classification EN 60825-1 par. 1 -5: Class 2 laser product => Red laser line.
RO 242/2 Two lasers forming a crosshair to center the patien to the detector: Class 2
Second laser which serves to center the
patient using the cross projection.
The collimator lasers are classified as Class
2 (1 m W - wavelength = 645 mm, +/- 10 nm)
and are used for collimator/image receptor
center alignment.
CALIBRATION CONTROL
• Draw a cross (two lines at 90°) on a
R302/A - R302/A DHHS - Optional Items
WARNINGS
SUBSTITUTION
Horizontal
• Disconnect supply.
• Remove the laser cover located on the collimator cover by unscrewing the two screws A,
see Fig. Horizontal Laser.
• Disconnect the timer cables from the terminal board - white 0 V, red 5 V.
• Remove the laser and substitute with an identical item.
R302/A - R302/A DHHS - Optional Items
Fig. 1 Fig. 2
• Unscrew the 2 screws A holding the filter system on the front plate, see Fig. 3 and Fig. 4.
• Slide the filter system out from the collimator body.
• Substitute with an identical filter group.
• Check that disc rotation is uniform.
• Insert the filter system into the collimator body.
• Tighten the 2 screws A.
• Remount in reverse order.
Fig. 3 Fig. 4
R302/A - R302/A DHHS - Optional Items
WARNINGS
Laser Adjustment
• Remove part of the cover to access the point of
adjustment, see Chapter- COVER REMOVAL.
• The line is to fall on a perpendicular cross-line on
the plastic anti-dust panel near the collimator
controls, see Fig. Laser Line.
• Adjust the position of the line by rotating or moving
the base of the laser system.
• To rotate the laser system, loosen the Allen
screw A, see Fig. Laser Adjustment.
• Tighten the Allen screw when the laser beam
falls on or is parallel to the bisector line drawn
on the anti-dust panel. Fig. Laser Adjustment
R302/A - R302/A DHHS - Optional Items
WARNINGS
• Adjust the length of the laser line by screwing or unscrewing the screws B. See Fig. Laser
Adjustment.
• Shift the laser system by loosening the two C screws holding the laser system base to the
beam limiting device front plate.
• Move the base until the laser beam falls over the perpendicular bisector line on the
anti-dust panel, see Fig. Laser Adjustment.
• Tighten the screws C.
Substitution
• Disconnect supply.
• Remove the cover, see Chapter- COVER REMOVAL.
• Unscrew the fixing Allen screws A, see Fig. Laser Adjustment.
• Disconnect the timer cables from the terminal board - white 0 V, red 5 V.
• Remove the laser and substitute with an identical item.
• Tighten the screws.
• Check the laser alignment, see Chapter- ADJUSTMENTS.
• Remount the cover, see Chapter- COVER REMOVAL.
Classification EN 60825-1 par. 1 -5: Class 2 laser product => Red laser line.
This accessory is used to rotate the collimator assembled to the X-Ray tube: 20 mm
thickness, +/-90° mechanical stop, 140 mm diameter (not available with RO 492)
See Chapter INSTALLATION for the correct flange/collimator mounting.
When the collimator is assembled check the collimator to Focal Spot Alignment
(Primary Shutter Cut-Off).
Inspect the four images of the four collimator shutters which form the edges of the X-ray
field. A definitely indistinct edge indicates that the primary shutter, close to the focal spot, is
the one forming the line, rather than the outermost shutter.
To correct the condition, use the four mounting/centering adjustment screws to shift the
R302/A - R302/A DHHS - Optional Items
collimator in the direction of the indistinct line. Repeat the test film exposure after making
the adjustment.
THE HEEL EFFECT WILL CAUSE THE FIELD TOWARD THE CATHODE TO BE SLIGHTLY LESS SHARP THAN ON
THE OTHER THREE SIDES. THIS IS NORMAL AND CANNOT BE CORRECTED BY ADJUSTMENT. IN ADDITION,
AN X-RAY TUBE OF 12° OR LESS TARGET ANGLE WILL PRODUCE AN ASYMMETRICALLY SHAPED FIELD WHEN
A LARGE FIELD SIZE IS USED AT SHORT SID, BECAUSE OF ANODE CUT-OFF EFFECT. THIS IS NORMAL AND
MAY NOT BE CORRECTED BY ADJUSTMENT.
Each single Long shutter is moving through a knob on the front panel.
This specialized system allows the user to manually adjust and fine-tune the stitch position.
During the manual-stitching process, alignment of the Potter Bucky with the X-Ray beam is
manually performed for each exposure.
The X-Ray tube remains stationary throughout the entire process. The acquired number of
exposures is 3 at 100 cm SID. See Fig. Stitching process.
THE FRONT PANEL SHOWS THE 2 INDEX SCALES THAT ALLOWS THE COLLIMATOR TO OPERATE
EITHER IN THE STANDARD OR STITCHING MODE. SEE FIG. INDEX SCALE - STANDARD MODE
AND FIG. INDEX SCALE - STITCHING MODE.
THE MAXIMUM COLLIMATOR APERTURE IN THE STITCHING MODE IS 43 X 43 CM AT 100 CM SID.
R302/A - R302/A DHHS - Optional Items
Field 1
Cross left knob - aperture 35 cm
Long central knob - position 1
Long right knob - position 1
See Fig. Field 1.
Field 2
Cross left knob - aperture 35 cm
Long central knob - position 2
Long right knob - position 2
See Fig. Field 2.
Fig. Field 2
Field 3
Cross left knob - aperture 35 cm
Long central knob - position 3
Long right knob - position 3
See Fig. Field 3.
R302/A - R302/A DHHS - Optional Items
Fig. Field 3
RO 586 Single laser line to align collimator and detector center: Class 1
Laser Adjustment
• Remove part of the cover to access the
point of adjustment, see Chapter-
COVER REMOVAL.
• The line is to fall on a perpendicular
cross-line on the plastic anti-dust panel
near the collimator controls, see Fig.
Laser Line.
• Adjust the position of the line by rotating
Fig. Laser Line
or moving the base of the laser system.
• To rotate the laser system, loosen
the Allen screw A, see Fig. Laser
Adjustment.
• Tighten the Allen screw when the
laser beam falls on or is parallel to
the bisector line drawn on the
anti-dust panel.
• Shift the laser system by loosening the
two B screws holding the laser system
base to the beam limiting device front
plate.
• Move the base until the laser
Fig. Laser Adjustment
beam falls over the perpendicular
bisector line on the anti-dust
R302/A - R302/A DHHS - Optional Items
Substitution
The Laser Substitution Kit is composed of the following components: the lase (A), the extension
cable (B) and the laser label (C) pictured below in Fig. Laser Substitution Kit. This Kit is
designed to substitute any laser Ralco provides.
Prior to replacing the laser, confirm which version of laser is installed on your collimator which
will ensure the substitution is performed correctly.
• The previous laser version is connected to the board via 2 cables (red and white), see Fig.
Previous Laser Version below.
• The new laser is connected to the board via the connector, see Fig. New Laser Version
below..
R302/A - R302/A DHHS - Optional Items
Laser Adjustment
• Remove part of the cover to access the point
of adjustment, see Chapter- COVER
REMOVAL.
• The line is to fall on a perpendicular cross-
line on the plastic anti-dust panel near the
collimator controls, see Fig. Laser Line.
• Adjust the position of the line by rotating or
moving the base of the laser system.
• To rotate the laser system, loosen the
Allen screw A, see Fig. Laser
Adjustment.
• Tighten the Allen screw when the laser
beam falls on or is parallel to the Fig. Laser Adjustment
bisector line drawn on the anti-dust
panel.
R302/A - R302/A DHHS - Optional Items
• Move the base until the laser beam falls over the perpendicular bisector line on the
anti-dust panel, see Fig. Laser Adjustment.
• Tighten the screws C.
Substitution
• Disconnect supply.
• Remove the cover, see Chapter- COVER REMOVAL.
• Unscrew the fixing Allen screws A, see Fig. Laser Adjustment.
• Disconnect the timer cables from the terminal board - white 0 V, red 5 V.
• Remove the laser and substitute with an identical item.
• Tighten the screws.
• Check the laser alignment, see Chapter- ADJUSTMENTS.
• Remount the cover, see Chapter- COVER REMOVAL.
Classification EN 60825-1 par. 1 -5: Class 1 laser product => Red laser line.
RO 587/2 Two lasers forming a crosshair to center the patient to the detector: Class 1
Second laser which serves to center the
patient using the cross projection.
The collimator lasers are classified as
Class 1 (1 m W - wavelength = 645 mm,
+/- 10 nm) and are used for collimator/
image receptor center alignment.
CALIBRATION CONTROL
• Draw a cross (two lines at 90°) on a
sheet of paper and use this as refer-
ence.
• Switch the light ON and set the sheet
of paper at 1 m from the focus.
• Make sure the cross on the paper
coincides exactly with the two lines
silk-screened on the plastic window. Fig. Laser Line
WARNINGS
SUBSTITUTION
The Laser Substitution Kit is composed of the following components: the lase (A), the extension
cable (B) and the laser label (C) pictured below in Fig. Laser Substitution Kit. This Kit is
designed to substitute any laser Ralco provides.
R302/A - R302/A DHHS - Optional Items
Prior to replacing the laser, confirm which version of laser is installed on your collimator which
will ensure the substitution is performed correctly.
• The previous laser version is connected to the board via 2 cables (red and white), see Fig.
Previous Laser Version below.
• The new laser is connected to the board via the connector, see Fig. New Laser Version
below.
14.Carefully remove the laser, the extension cable and the label from their packaging.
15.Ensure the extension cable (B) is firmly connected to the laser (A), see Fig. Laser Substi-
tution Kit above.
16.Substitute the laser with the identical item using component (A) of the Laser Substitution
Kit, see Fig. Laser Substitution Kit above.
17.Adjust the length of the extension (B) cable by cutting the 2 cables (red/white).
18.Connect both cables to the board.
19.Apply the new laser label (C) to the collimator cover, see Chapter SPARE PARTS in the
Instruction Manual for your specific mode.
20.Verify the Laser alignment, see Chapter ADJUSTMENT or OPTIONAL ITEMS in the Instruction
Manual for your specific model.
WARNINGS
DO NOT TOUCH THE DISSIPATER WITH YOUR HANDS; IT COULD BE HOT AND
CAUSE SEVERE BURNS.
• Remove the part of the cover necessary to access the screws, see Chapter - COVER
REMOVAL
• Remove the light source protection heatsink by unscrewing the fixing screws . This allows
you to access the light source.
• If the light-field needs to be moved laterally, loosen (not remove) the fixing screws A.
• Adjust through screw B.
• When calibration is terminated, lock the screws A.
See the following Fig. Light Field Adjustment
Vertical Alignment
• Remove the part of the cover necessary to access the screws, see Chapter - COVER
REMOVAL.
• If adjustment is required loosen the two screws C holding the light support.
• If the light-field is smaller than the X-ray field, move away the light source by adjusting
screw D.
• If the light-field is bigger than the X-ray field, move the light source closer by adjusting
screws D.
• Tighten the two screws C. See Fig. Light Field Adjustment
R302/A - R302/A DHHS - Optional Items
WARNINGS
DO NOT TOUCH THE DISSIPATER WITH YOUR HANDS; IT COULD BE HOT AND
CAUSE SEVERE BURNS.
DO NOT TOUCH THE LAMP, THE SOCKET, OR THE LAMP BRACKET WITH YOUR
FINGER. THEY CAN BE VERY HOT AND CAUSE SEVERE BURNS.
DO NOT TOUCH THE LAMP WITH YOUR FINGERS, EVEN WHEN IT IS COLD. OIL
FROM YOUR SKIN WILL CAUSE THE LAMP TO CRACK AND POSSIBLY EXPLODE.
IF YOU HAVE TOUCHED THE LAMP, WIPE THE SURFACE WITH ALCOHOL, THEN
HANDLE THE LAMP WITH A PIECE OF PAPER.
GC 338 Timer
Connectors
21.Lamp output (max 9 A)
22.Push button input
23.Power Supply +12/24 V DC o 12-24 V AC/V DC A
J1 POWER SUPPLY AND OUTPUTS
24.Shared Lamp
25.Power Supply –12/24 V DC o 12-24 V AC/V DC B
26.Shared push button
1. +Laser Power Supply (5 V)
J2 LASER POWER SUPPLY 5VDC 2. GND Laser
1. V pp
2. +5 V
3. GND
J3 PROGRAMING CONNECTOR
4. PGD
5. PGC
6. NC
1. +Fan Power Supply (max 200 mA)
J4 – FAN POWER SUPPLY 12V DC
2. – Fan Power Supply
R302/A - R302/A DHHS - Optional Items
MAINTENANCE
To ensure constantly safe performance of the collimator and its compliance with applicable
regulations, a maintenance program is indispensable.
It is the Owner's responsibility to supply or arrange for this service.
CLEANING RECOMMENDATIONS
• The collimator housing must be cleaned as prescribed by the sanitary regulations followed
by the operator.
• Disconnect supply.
• Use non abrasive cleaning products.
Care must be taken to prevent liquid from entering the collimator. Please Note: The colli-
mator cover is not watertight.
• Do not reapply power if inflammable liquids have leaked into the collimator.
See the following Maintenance Instructions.
• Clean the varnished and aluminium surfaces with a damp cloth only, using a neutral
cleansing agent then dry the surfaces with a soft cloth.
• Clean chrome surfaces with a dry soft cloth.
CAUTION
DISINFECTION
The disinfection method use must conform with the currently applicable norms and directives
covering disinfection and protection against explosion hazards.
CAUTION
• Disconnect supply.
• Disinfect the unit including accessories and cables with a dampened cloth.
• Do not spray the unit with the disinfectant because it could leak into the collimator.
CAUTION
MAKE SURE TO TIGHTEN THE ALLEN SCREWS SECURING THE COLLIMATOR OR THE
CONTROL TABS.
APPROPRIATE TIGHTENING OF THE 4 ALLEN SCREWS ENSURES SECURE MOUNTING
OF THE COLLIMATOR. TIGHTENING FORCE USED MUST NOT EXCEED 0.50 NM.
NOTE
GENERAL
WARRANTY
This product has been manufactured and tested to the highest quality standards by Ralco, srl.
Ralco undertakes to replace and repair any collimator during a period of 24 months for
mechanical and 12 months for electrical parts (motors, potentiometers, electrical boards,
lasers) from the date of invoice (shipment date from Ralco).
The warranty applies provided the product has been handled properly in accordance with its
operating instructions and its intended use.
Warranty covers cost of all components and labor involved, unless:
• Product documents have been altered in any way or made illegible;
• The model or production number on the product has been altered, deleted, removed or
made illegible;
• Repairs or product modifications and alterations have been performed by unauthorized and
unqualified persons;
• Unauthorized repairs and/or modifications have been performed;
• Damage caused by misuse or neglect, incorrect installation or accidental damage;
• Damage occurred during transit due to shipping company, or incorrect packing by cus-
tomer;
• Unoriginal spare parts and accessories have been used.
In-warranty spares will be available only upon return to Ralco, at the customer's expense, of
the parts considered to be faulty to allow Ralco to assess the cause of the fault.
Components Not Covered by this Warranty:
• Consumable items such as lamp bulbs, lexan panels and mirrors (if applicable);
• Cosmetic damage such as scratches;
• Any missing components when product arrives for repair.
REPAIRS
In the event the customer finds any Non Conformity in the product, please contact Ralco via e-
mail at the address: [email protected] (Ralco Repair Assistance).
To successfully resolve any Non Conformity, the following information must be provided:
• The model and serial number of the collimator found on the label;
• A detailed description of the problem (in Italian or English);
• Whether you want a repair, refurbishment, or model upgrade of the product.
Ralco and the customer will work together to resolve the problem by either providing
instructions, and/or field service or by sending replacement parts.
In the event the collimator needs to be repaired at Ralco, you will be provided with a RMA
(Return Merchandise Authorization) number as your consent to the return. If a product is
R302/A - R302/A DHHS - General
returned to Ralco without a RMA or without a description of the problem, the customer will incur
a €100 processing fee.
If the product is returned under warranty and no defect is found, the customer incurs the cost
of evaluation, testing and shipping.
The shipping of the unit is at the customer’s expense if the unit is out of warranty.
The warranty period resets only on replaced parts once repairs are completed (shipment date
from Ralco back to customer), see paragraph, WARRANTY.
Ralco reserves the right to decide if the product is to be repaired or substituted.
WARNINGS
SAFETY/RESPONSIBILITY
Ralco adheres to the directives governing manufacturers of electro-medical equipment:
Directive 2007/47/CE para.10 -Legislative Decree n° 46 para.10
Ralco shall not be held responsible when instructions provided in the present manual are not
complied with. Ralco shall not be held responsible if the collimator relates to one or several of
the following instances:
• The unit is of Ralco construction, built to client specifications with no CE marking.
• The unit has been modified by the OEM or end user.
• The unit has been installed without respecting the instructions provided in this manual.
• The unit is used without respecting the instructions provided in this manual.
• The unit has not been subject to routine functional inspection.
• The unit has not been subject to routine maintenance.
• The unit has been repaired with unoriginal spare parts.
• Ralco shall decline all responsibility for any damage, direct or indirect, caused to persons
or things by inappropriate accessories.
WARNINGS
RESIDUAL RISKS
The collimator has been constructed to current standards to meet the safety requisites of
directive 2007/47/CE. However, due to the presence of x-rays, the type of application implies
a residual risk derived from possible faults that could occur during operation of the unit.
R302/A - R302/A DHHS - General
The Instructions contained in the this Manual will ensure the correct use of the device and
reduce the causes of possible hazards.
The residual risks of the device are reasonable; they have been assessed and approved in the
related Risk Management Plan contained the Technical Report.
Date:
Customer:
Information regarding possible accidents that may have occurred while using the collimator.
Directive 2007/47/CE states that accidents (such as death or grievous injury to a patient) that involve the
collimator described herein, must be reported to the Ministry of Health and to the Manufacturer.
The present form is provided to report to Ralco srl post-free.
Date:
Customer:
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