GE Healthcare

OTS Kalos Collimator SM

(Ralco 302)

GE P/N : 5780107-1EN Rev1

 Instruction Manual
MTR 302 F/A
MANUAL RADIOLOGICAL COLLIMATOR

Confidential Information

SERIES R 302/A DHHS

DATE OF ISSUE: REVISION LEVEL: ISSUED BY:

10.05.2007 N
 LEGAL WARNING

THE INFORMATION CONTAINED IN THIS MANUAL

IS CONFIDENTIAL. THE CONTENTS OF THIS
MANUAL, INCLUDING RALCO SRL
SOFTWARE AND THE COLLIMATOR ITSELF CANNOT
BE COPIED NOR REPRODUCED IN ANY WAY.

THE CONTENTS OF THIS MANUAL MUST ONLY BE

USED FOR THE PROPER INTENDED USE, FUNCTION
AND MAINTENANCE OF THE RALCO COLLIMATOR.

RALCO DOES NOT EXPRESSLY OR IMPLICITLY GRANT ANY

PROPRIETARY RIGHTS OVER THE RALCO NAME NOR RIGHTS TO MARKET
THE RALCO COLLIMATOR BY ANY OTHER NAME.

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

R 302 F/A STANDARD VERSION

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
MRM/024/07
A 31.01.2007
MRM/025/07
B 06.09.2007 MRD/012/07
C 12.06.2008 MRE/015/08
D 06.11.2008 MRD/015/08
E 22.03.2010 MRD/003/10
F 23.09.2010 MRD/011/10
G 21.04.2011 MRD/005/11
14.07.2011 MRD/013/11
06.09.2011 MRE/042/11
H
26.09.2011 MRM/251/11
24.10.2011 MRD/018/11
I 09.03.2012 MRD/006/12
J 14.11.2012 MRD/012/12
K 12.03.2013 MRM/031/13
L 25.09.2013 MRD/017/13
16.01.2014 MRD/001/14
29.01.2014 MRE/006/14
M 10.09.2014 ACD/020/14
10.09.2014 ACD/026/14
13.11.2014 MRE/041/14
20.01.2017 MRD/001/17
N
14.09.2017 MRD/034/17
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

ADVISORY MECHANICAL MOTION STOP ADJUSTMENT .......37

CLOSED Stop Long and Cross Shutters......37
SYMBOLS
TROUBLESHOOTING
DESCRIPTION
CHARACTERISTICS ............................................6 SUBSTITUTIONS
SUBSTITUTION OF THE HALOGEN LAMP............39
SPECIFICATIONS SUBSTITUTION OF THE ELECTRONIC TIMER ......39
INSTALLATION SUBSTITUTION OF THE MIRROR .......................40
X-RAY TUBE COMPATIBILITY ............................11 SUBSTITUTION OF THE FILTER .........................42
MOUNTING THE COLLIMATOR TO THE X-RAY TUBE SPARE PARTS
11
LABEL ............................................................44
Power Supply Connection ............................14
R302 F/A STANDARD .....................................46
WIRING DIAGRAM ...........................................15
Parts Breakdown ..........................................47
GC 338 Timer ...............................................16
OPTIONAL ITEMS
OPERATION INSTRUCTIONS RO 001/A Fixed Mounting Flange ................48
LIGHT/X-RAY FIELD SETTING ...........................18 RO 002 Iron Spacer......................................49
Front Panel ...................................................18 RO 012/B Retractable Tape Measure ..........49
CALIBRATION RO 041 Mylar Mirror .....................................50
CENTERING X-RAY BEAM WITH COLLIMATOR LIGHT RO 051 Rotating Mounting Flange ...............50
20 RO 055/B Fixed Mounting Flange ................51
LIGHT FIELD TO X-RAY FIELD ALIGNMENT ........21 RO 063 Final Control Testing .......................52
LIGHT FIELD CALIBRATION ...............................22 RO 074 Customized External Cover Color ...52
Longitudinal Calibration (LONG)...................22 RO 077 Centering Device.............................52
Vertical Alignment.........................................22 RO 082 Mirror ...............................................52
Transversal Calibration (CROSS).................23 RO 096 Customized Wiring ..........................52
RO 107 Customized Knobs ..........................53
COMPLIANCE VERIFICATION RO 109 Customized Front Panel Frame ......53
MINIMUM FILTRATION REQUIREMENT ...............24
RO 111 Customized Front Panel..................53
Visual Determination of Half-Value Layer (HVL)
RO 161 Plastic Spacer Guides .....................53
25
RO 185/A Fixed Mounting Flange ................54
Quick-Check of Minimum Filtration
RO 202 Auto Centering Top Cover...............54
Requirement at a Particular kVp ...................25
RO 203 Auto-Centering Siemens Type Cover..
Standard Absorber Method...........................25
55
VISUAL DEFINITION OF X-RAY VERSUS LIGHT
RO 222/A Rotating Mounting Flange............56
FIELD .............................................................26
RO 240 Focus-Skin Distance Sapcer ...........56
FIELD SIZE INDICATION....................................26
RO 242/1 Single Laser .................................57
CROSSHAIR ALIGNMENT ..................................26
RO 242/2 Second Laser Cross Projection....58
CHAPTER- ADJUSTMENTS, PARAGRAPH
RO 253 Plastic Spacer Guides .....................60
CROSSHAIR ALIGNMENT. .................................26
RO 258/1 Additional Variable Filtration - Manual
LIGHT FIELD ILLUMINATION INTENSITY ..............26
Selection .......................................................61
EMC COMPLIANCE .........................................27
RO 271 Lamp with Cooling...........................61
Electromagnetic Emissions...........................27
RO 318 Auto Centering Cover with Plastic
Electromagnetic Immunity for All Equipment
Flange...........................................................61
and Systems .................................................28
RO 333 White LED .......................................63
Electromagnetic Immunity ...........................29
Transversal Calibration (CROSS).................64
Recommended Separation Distances for Non-
LED SUBSTITUTION ........................................66
Life Supporting Equipment ...........................30
RO 382 LED on Front Panel.........................67
COVER REMOVAL RO 441 Plastic Flange, 50° Rotation ............68
ACCESS TO COLLIMATOR COMPONENTS ..........34 RO 442 Plastic Flange, 90° Rotation ............68
RO 452 Manual-Image Stitching on LONG
ADJUSTMENTS Shutters ........................................................69
FIELD SIZE INDICATION ADJUSTMENT ...............36
TO USE THE COLLIMATOR (WITH 3 KNOBS) IN
Shutter Dial Adjustment ................................36
STANDARD MODE: ...........................................70
CROSSHAIR ADJUSTMENT ...............................36
TO USE THE COLLIMATOR IN STITCHING MODE:.71
Friction Brake Adjustment.............................36

MTR302 F/A 1
MAINTENANCE
CLEANING RECOMMENDATIONS .......................73
DISINFECTION .................................................73
RECOMMENDED MAINTENANCE PROGRAM .......73
GENERAL
WARRANTY .....................................................75
REPAIRS .........................................................75
END OF LIFE DISPOSAL ...................................76
DISASSEMBLY .................................................76
TRANSPORT AND STORAGE .............................76
SAFETY/RESPONSIBILITY .................................77
RESIDUAL RISKS .............................................77

MTR302 F/A
2
 Ralco srl Modello/Model R302 F/A

ADVISORY

THE FOLLOWING INSTRUCTION MANUAL MUST BE READ AND UNDERSTOOD IN ITS ENTIRETY BY THE INSTALLER
AND OPERATOR.

INTENDED USE OF THE COLLIMATOR

THIS COLLIMATOR IS DESIGNED TO BE USED WITH A RADIOLOGICAL SYSTEM PRODUCING IONIZING RADIATION
FOR MEDICAL OR VETERINARY USE.
WHOMEVER IS AUTHORIZED TO OPERATE OR SERVICE THE RADIOLOGICAL EQUIPMENT MUST BE THOROUGHLY
FAMILIAR WITH THE PROCEDURES RELATED TO RADIATION PROTECTION AND EQUIPMENT USE AND MAINTENANCE.
RALCO IS NOT RESPONSIBLE FOR ANY PERSONAL INJURIES OR DAMAGE TO PROPERTY FROM MISUSE OR
UNINTENDED USE OF THIS COLLIMATOR.
THIS MANUAL MUST BE MADE AVAILABLE TO THE INSTALLER AND OPERATOR.

INSTALLER AND OPERATOR RESPONSIBILITY

THE INSTALLER AND OPERATOR MUST VERIFY THAT ALL SAFETY STANDARDS ARE FOLLOWED IMMEDIATELY
AFTER INSTALLATION OF THE COLLIMATOR AND BEFORE ANY SUBSEQUENT USE.
ALL PROCEDURES REGARDING THE INSTALLATION AND SAFE USE OF THIS COLLIMATOR MUST BE STRICTLY FOLLOWED.

X-RAY EQUIPMENT MANUFACTURER RESPONSIBILITY

IF THE X-RAY EQUIPMENT MANUFACTURER DOES NOT USE THE READY SIGNAL, ALLOWING X-RAY EXPOSURES
REGARDLESS OF COLLIMATOR STATE OR STATUS, ALL LIABILITY FALLS UPON THE X-RAY EQUIPMENT MANUFACTURER.
IN THE EVENT OF ANY EMERGENCY AND THE READY OR ERROR SIGNALS ARE BYPASSED ALLOWING X-
RAY EXPOSURES, ALL THE LIABILITY FALLS UPON THE X-RAY EQUIPMENT MANUFACTURER.

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:
R302 F/A - Advisory

IF THE UNIT IS SPECIFICALLY DESIGNED PER CLIENT SPECIFICATIONS AND THE CERTIFICATION WAS THE DUTY
OF THE CLIENT;

MTR302 F/A ADVISORY

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 1
 Ralco srl Modello/Model R302 F/A

THE COLLIMATOR WAS MODIFIED IN ANY WAY BY THE OEM OR OPERATOR;

THE COLLIMATOR WAS INSTALLED WITHOUT RESPECTING THE INSTRUCTIONS, AS PROVIDED IN THIS MANUAL;
THE COLLIMATOR WAS USED IN A WAY OUTSIDE ITS INTENDED USE;

THE COLLIMATOR WAS NOT INSTALLED BY COMPETENT PERSONNEL;

THE COLLIMATOR WAS NOT OPERATED SAFELY OR IN A WAY CONTRARY TO THE INSTRUCTIONS IN THIS MANUAL;
THE COLLIMATOR WAS NOT SUBJECT TO ROUTINE INSPECTION AND MAINTENANCE BY COMPETENT PERSONNEL;
THE COLLIMATOR WAS REPAIRED WITH NON-RALCO SPARE PARTS;

THE COLLIMATOR WAS USED IN A WAY NOT REASONABLY FORESEEN BY RALCO

RALCO IS NOT LIABLE FOR ANY DIRECT OR INDIRECT DAMAGE CAUSED IF THE PROCEDURES IN THIS MANUAL
ARE NOT FOLLOWED.

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 2007/47/CE.
LIST APPLICABLE STANDARDS AND TO WHICH RALCO ADHERES TO:
EN 60601-1:2006
EN 60601-1-2:2007
EN 60601-1-3:2008
EN 60601-2-45:2012
EN 60601-2-54:2009
EN 60825-1:2007

ISO 9001:2008
UNI ESO 13485:2012
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.
R302 F/A - Advisory

MTR302 F/A ADVISORY

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 2
 Ralco srl Modello/Model R302 F/A

INHERENT DANGER OF X-RAYS

THE COLLIMATOR HAS BEEN CONSTRUCTED TO CURRENT STANDARDS TO MEET THE SAFETY REQUISITES OF
DIRECTIVE 2007/47/CE AND ALL OTHER APPLICABLE STANDARDS. HOWEVER, DUE TO RADIOLOGY BEING AN
INHERENT DANGEROUS ACTIVITY WHICH CANNOT BE COMPLETELY SAFE GUARDED AGAINST, IT IS CRUCIAL THAT
ALL SAFETY PROCEDURES ARE FOLLOWED. THE INSTALLER AND OPERATOR MUST FOLLOW ALL ESTABLISHED
PROCEDURES (INCLUDING THOSE MENTIONED IN THIS MANUAL) TO REDUCE THE INHERENT DANGER OF X-RAYS.

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

SYMBOLS
IN THIS MANUAL THE FOLLOWING SYMBOLS ARE USED:

THE TRIANGLE EMPHASIZES WARNINGS AND CAUTIONARY MESSAGES WHICH ARE IMPORTANT FOR YOUR SAFETY
AND/OR EFFICIENT OPERATION OF THE EQUIPMENT. THESE WARNINGS MUST BE STRICTLY COMPLIED WITH.

INFORMATION PROVIDED WITH THE LAMP IS ADDITIONAL ADVICE FOR THE PROPER CONTROL AND PRACTICAL
USE OF THE UNIT.

RALCO INSTRUCTION MANUALS ARE AVAILABLE IN TWO VERSIONS: ITALIAN AND ENGLISH.
THE ENGLISH VERSION OF THIS MANUAL IS A TRANSLATION OF THE ITALIAN TEXT WHICH PREVAILS IN CASE OF DOUBTS.

FOR ANY INQUIRES OR NOTIFICATIONS, PLEASE CONTACT US AT:

RALCO, SRL
VIA DEI TIGLI 13/G
20853 BIASSONO, (MB) ITALIA
TELEPHONE: +39 039 2497925
FAX: +39 039 2497799
R302 F/A - Advisory

E-MAIL: RALCO@RALCO.IT

MTR302 F/A ADVISORY

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 3
 Ralco srl Modello/Model R302 F/A

SYMBOLS

Description No. Ref. IEC

417-iec
Alternating Current 01-14
503

417-iec
Direct Current 01-18
5031

417-iec
Continuous and Alternating Current 01-19
5033

417-iec
Protective Ground 01-20
5019

417-iec
Plus; Positive Polarity 01-27
5019

417-iec
Minus; Negative Polarity 01-28
5006

417-iec
Input 01-36
5006

417-iec
Output 01-37
5034

Remote Control 01-38

Manual Control 01-45 ISO 7000-096

Automatic Control (Closed Loop) 01-46 iso 7000-0017

Iris Diaphragm: Open 01-69 iso 7000-0017

417-iec
Iris Diaphragm: Closed 01-70
5324

General Warning Sign 03-02 iec 601-1

417-iec
Radiation Filter or Filtration 04-51
5381
R302 F/A - Symbols

417-iec
Light Indicator of Radiation Field 04-51
5381

MTR302 F/A SYMBOLS

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 4
 Ralco srl Modello/Model R302 F/A

Description No. Ref. IEC

417-iec
Beam Limiting Device: Open 04-55
5385

417-iec
Beam Limiting Device: Closed 04-56
5386

Beam Limiting Device: Closed with 417-iec

04-57
Separate Opening of the Shutters 5387

Beam Limiting Device with Separate 417-iec

04-58
Closing of the Shutters 5388

Type B Applied Part 02-02 601-i-iec

Caution: Laser Radiation 60825-1

Electrostatic-Sensitive Device

Cassette Size Sensing Device

Device Requiring Proper Disposal attch.4 2002/95/CE

Follow Instructions for Use ISO 7010-M002

R302 F/A - Symbols

MTR302 F/A SYMBOLS

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 5
 Ralco srl Modello/Model R302 F/A

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 quartz iodide lamp simulating the X-ray field.
Minimum Inherent Filtration: 2 mm aluminium equivalent.
Extra Variable Filtration consists of three filters and an open space for no filtration on an
aluminium disk, 1 mm thickness, with setting:
- no filtration
- 1 mm Al equivalent + 0.1 Cu
- 1 mm Al equivalent + 0.2 mm Cu
- 2 mm Al equivalent
GC 338 timer limiting projection lamp exposure time to 30 seconds thus extending lamp life
by preventing overheating.

Fig. R302 F/A

R302 F/A - Description

MTR302 F/A DESCRIPTION

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 6
 Ralco srl Modello/Model R302 F/A

This collimator may have the following optional items; a detailed description is provided in the
chapter OPTIONAL ITEMS.

RO DESCRIPTION

RO 001/A Fixed lead mounting flange, 20 mm thickness, 136 mm diameter

RO 002 Iron mounting flange spacer, 1.5 mm thickness

RO 012/B Retractable tape measure with knob

RO 041 Mylar mirror, inherent filtration 0.3 mm Al equivalent

RO 051 Rotating mounting flange, 18 mm thickness, 136 mm diameter

RO 055/B Fixed mounting flange, 18 mm thickness

Final control testing (light intensity, light field/radiation field alignment, radiation
RO 063
leakage, light field border contrast ratio, general funcitonality and electronic)

RO 074 Customized external cover color

RO 077 Potter Bucky light centering device (BL)

RO 082 Mirror 0.8 mm thickness, filtration equivalent 1 mm Al

RO 096 Customized wiring

RO 107 Customized knobs

RO 109 Customized frame

RO 111 Personalized front panel

RO 161 Plastic spacer guides to accommodate the DAP

RO 185/A Fixed mounting flange, 20 mm thickness

RO 202 Auto-centering top plate for fixed metal flange

RO 203 Auto-centering Siemens top plate

R302 F/A - Description

RO 222/A Rotating mounting flange, 136 diameter, 18 mm thickness

RO 240 Focus-skin spacers, preventing X-ray exposure too close to the patient

Single laser aligning the collimator to the Potter Bucky with power supply
RO 242/1
included

MTR302 F/A DESCRIPTION

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 7
 Ralco srl Modello/Model R302 F/A

RO DESCRIPTION

RO 242/2 Second laser, cross projection for patient centering

RO 253 Plastic spacer guides to assemble DAP

Additional variable filtration through three filters on rotating support 1 mm Al +

RO 258/1
(0.1 mm CU O 0.2 mm CU O 0.3 mm CU), manual selection

RO 271 Halogen lamp 150 W for high luminosity with cooling system

Auto-centering top plate with plastic flange allowing +/- 45° rotation of the
RO 318
collimator, the plastic flange is included

RO 333 White LED

RO 382 LED on front panel

Plastic flange with a notch rotating +/- 50°, 20 mm thickness without stop
RO 441
(available only for collimators assembled with RO 318)

Plastic flange with a notch rotating +/- 90°, 20 mm thickness without stop
RO 442
(available only for collimators assembled with RO 318)

RO 452 Independent Long shutters

R302 F/A - Description

MTR302 F/A DESCRIPTION

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 8
 Ralco srl Modello/Model R302 F/A

SPECIFICATIONS

Specifications of the basic version of the collimator are described here below.

24 V DC - 50/60 Hz - 6.5 A
Power Supply
Fuse for power supply protection collimator. Not
T8A
supplied by Ralco.
Motor Supplied by Collimator Board n.a.
Fuse for Power Supply Protection Motor. Not supplied
n.a.
by Ralco.

Inherent Filtration Al. Equivalent

X-ray beam = 75 kV Min. Al Eq. 2 mm
EN 60601-1-3 par. 7.3; 7.4
- no filtration
Filtration, Additional
- 1 mm Al equivalent + 0.1 Cu
X-ray beam = 75 kV
- 1 mm Al equivalent + 0.2 mm Cu
EN 60601-1-3 par. 7.5
- 2 mm Al equivalent
Limitation of Extra Focal Radiation
Set Focus Distance, SID 100 cm (40") < 150 mm
EN 60601-2-54
Square X-ray Field Selection
Min: 00 x 00 cm
100 cm (40") SID - (± 1% SID)
Max: 48 x 48 cm
EN 60601-2-54
Round X-ray Field Selection
1 m SID - (± 1% SID) n.a.
EN 60601-2-54
Light Field Indicator
Luminosity at 1 m from the focus, field size set at 35x35
> 160 lux
cm.
EN 60601-2-54
Light Field Indicator - Contrast
Edge Contrast Setting 35x35 cm at 1 m SID > 4:1
EN 60601-2-54
Light Field Indicator Precision
Light Field/X-ray Field Correspondence < 1 % SID>
R302 F/A - Specifications

EN 60601-2-54
Accuracy of X-ray field as shown on the front display
n.a.
versus actual X-ray field dimension.
X-ray Field Indication Precision
Settings on an Index Scale < 2 % SID
EN 60601-2-54

MTR302 F/A SPECIFICATIONS

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 9
 Ralco srl Modello/Model R302 F/A

SID: (optional)
Precision of Measurement with Retractable Tape < 2% SID
EN 60601-2-54
Maximum Radiation Leakage
Measured at 100 cm with X-ray Beam = 150 kVp - 4 mA < 40 mRh
EN 60601-1-3

Potentiometers
n.a.
Square Field
n.a.
Round Field
Maximum Load for Accessory Guides and Dimensions
for Accessory
GUIDES FOR ACCESSORIES (IF ASSEMBLED): PRIOR TO
INSERTING ACCESSORIES IN THE GUIDES CHECK ON THE
PERFECT ATTACHMENT OF THE SUPPORT WITH THE
MOUNTING SLOT ON THE COLLIMATOR (TOLERANCE MAX.
± 0,5 MM). A FAULTY ATTACHMENT COULD BE DANGER-
OUS AND IT COULD CAUSE THE FALL OF ACCESSORIES.
ATTENTION: Static load: 70 N (about 7.1 Kg)
INTERAXLE SPACING VARIES DEPENDING ON THE COLLIMA-
TOR MODEL:
Dynamic load: 15 Nm (approx.
R 72 - N.A. 3.06 Kg)
R 72 S - 154 MM (+/- 0.5 MM)
R 103 - 133 MM (+/- 0.5 MM)
R 104 - 147 MM (+/- 0.5 MM)
R 105 - 147 MM (+/- 0.5 MM)
R 104/A, 108, R 108 F, R 221 - 152 MM (+/- 0.5 MM)
R 225, R 302 - 177 MM (+/- 0.5 MM)
SEE THE CHAPTER OPTIONAL ITEMS IF THE GUIDES
ARE PROVIDED ON REQUEST.

Operation Environment
10°- 40°C
• Ambient Temperature
0%- 75%
• Relative Humidity
700 - 1060 hPa
• Atmospheric Pressure
Storage
-40° - 70°C
• Temperature
10% - 95%
• Humidity
500 - 1060 hPa
• Atmospheric Pressure
Weight 9.4 Kg
L: 268
Dimensions W: 195.5
H: 206.5
R302 F/A - Specifications

MTR302 F/A SPECIFICATIONS

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 10
 Ralco srl Modello/Model R302 F/A

INSTALLATION
X-RAY TUBE COMPATIBILITY
• Using the dimensions in Fig. Tube Compatibility below, ensure the near port shutters can
be inserted in to the X-ray tube port.
• Check that the tube housing literature indicates congruent minimum inherent filtration (1
mm) and, that maximum radiation leakage is 30 mR/hour measured at 1 m from the source
when operating at its leakage technique factors (150 kVp - 4 mA).
• Source values (tube housing-collimator) must not be less than 3 mm Al for filtration and
must never exceed 100 mR/hr for radiation leakage [21 CFR sub-chapter J, part 1020.30
(m) (1)].
• The distance between the X-ray tube focus and the flange mounting plane (collimator
upper plate) must be: 80 mm (3.14"), tolerance +/- (0.04”).

Fig. Tube Compatibility

MOUNTING THE COLLIMATOR TO THE X-RAY TUBE

CAREFULLY FOLLOW THE MOUNTING INSTRUCTIONS AND MAKE SURE THAT

THE COLLIMATOR IS CORRECTLY ASSEMBLED. INCORRECT MOUNTING COULD
BE DANGEROUS: IT COULD CAUSE THE COLLIMATOR TO FALL OR TO
OPERATE INACCURATELY.

• Use the X-ray tube housing literature to determine the distance from the focal spot to the
tube port face.
• Subtract the resulting distance from 80 mm (3.14") and determine the number of 1.5 mm
(0.06") spacers that, combined with the thickness of the mounting flange, will make up the
difference: (20 mm for the fixed flange; 18 mm for the rotating flange). Allowable tolerance
R302 F/A - Installation

is 1 mm. (0.04").
• Different flange models with their dimensions are listed in the Chapter DESCRIPTION,
paragraph Optional Items.
• Mount the flange and spacers to the tube port with 4 countersunk bolts and 4 countersunk
washers, the bolts must be long enough to be driven into the tube port face for at least 5
threads.

MTR302 F/A INSTALLATION

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• Tighten the bolts.

IMPORTANT
TO SAFEGUARD THE OPERATOR AND PATIENT AGAINST THE HAZARD OF
A FALLING COLLIMATOR, THE FOLLOWING INDICATIONS MUST BE RESPECTED.

• Unscrew the four mounting and centering adjustment Allen screws on the collimator until
the four tabs are withdrawn from the collimator top opening, see Fig. Mounting Flange, in
this Chapter.

WHEN UNSCREWING THE ALLEN SCREWS WHICH CONTROL THE TABS, DO

NOT USE FORCE EXCEEDING 0,55 NM.
UNSCREW WITH CARE SO AS NOT TO DAMAGE THE FIXING TABS.

• Manually adjust the collimator opening to their widest setting.

• Carefully couple the collimator with the tube to determine that the cone/extra focal shutters
have enough clearance to move in the port opening and in the mounting flange, see Fig.
Tube Compatibility in this Chapter.
• Place the collimator on the flange. Tighten the four mounting screws equally until the
collimator holds firmly on the tube housing, see Fig. Mounting Flange in this Chapter.
• The collimator control tabs conform to EN 60601-1. Ralco recommends an appropriate
force which ensures safe locking of the tabs min. 0.75 Nm (± 5 cNm)

MAKE SURE TO TIGHTEN THE ALLEN SCREWS SECURING THE CONTROL TABS.
APPROPRIATE TIGHTENING OF THE 4 ALLEN SCREWS ENSURES SECURE MOUNTING
OF THE COLLIMATOR. TIGHTENING FORCE USED MUST BE GREATER THAN 0.50 NM.

IF THE COLLIMATOR IS TO BE MOUNTED ON A ROTATING FLANGE, USE A TIGHTENING

FORCE BETWEEN MIN. 0,50 NM AND MAX. 0.75 NM.

• Check to see that the distance between the collimator housing and the mounting flange is
equal in all directions and that the collimator face is parallel to the axis of the table.
• Loosen the screws and adjust if required.
R302 F/A - Installation

MTR302 F/A INSTALLATION

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Fig. Mounting Flange

ELECTRICAL CONNECTION

THE WIRING DIAGRAM INCLUDED IN THIS CHAPTER REFERS TO THE STANDARD PRODUCT.
IT IS THE RESPONSIBILITY OF THE CUSTOMER WHO HAS REQUESTED AN ELECTRIC
CUSTOMIZATION, TO ENSURE THAT AN ELECTRIC DIAGRAM RELATING TO THE CUSTOMIZATION
HAS BEEN PROVIDED WITH THE DOCUMENTATION.

THE DEVICE MUST BE EXCLUSIVELY CONNECTED TO POWER NETWORK, WITH EARTH PROTEC-
TION, IN ORDER TO AVOID A RISK OF ELECTRICAL SHOCK.

THE DEVICE IS PROJECTED TO OPERATE WITH A PERMANENT POWER SUPPLY PRESENT

SO THE PROCEDURE OF SWITCHING OFF THE COLLIMATOR IS NOT FORESEEN.
NO RISK OR DEVICE DAMAGE WILL OCCUR IF THE MACHINE IS ACCIDENTLY SWITCHED OFF.

Supply and signals to the collimator must be to 2007/47/CE standards. Devices that supply the
collimator must therefore feature double or reinforced insulation as provided by the General
R302 F/A - Installation

Standard on Electro-medical Equipment CEI62-5 +A2 (EN 60601-1).

MTR302 F/A INSTALLATION

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The device is electrostatic sensitive, consequently all the relating safety standards must
be complied with.

COLLIMATOR MUST BE SUPPLIED AS SPECIFIED, SEE CHAPTER- SPECIFICATIONS. THE SUPPLY

MUST COME FROM A SEPARATE SOURCE FROM THE POWER NETWORK THROUGH DOUBLE
INSULATION OR REINFORCED INSULATION AND WITH LIMITED CURRENT. TRANSFORMER CHAR-
ACTERISTICS MUST CONFORM TO THE REQUIREMENTS OF STANDARD IEC 60601-1.

CABLES AND TERMINALS USED FOR THE INTERNAL CONNECTION OF THE COLLIMATOR MUST
BE SUITABLE FOR OPERATION AT TEMPERATURES OF 70°C AND COLLIMATOR CURRENT
ABSORPTION.

Power Supply Connection

• Remove the part of cover to access the terminal, see Chapter- COVER REMOVAL.
• Connect supply cables to the relative collimator terminals and earth on the screw marked
with the relating symbol: . Use the protective earth cable with green/yellow
insulation.
• In collimators with a free cable stop, remove the cable stop, connect the supply cables,
remount and then secure the cable stop.
• Remount the cover.

INCORRECT POWER SUPPLY COULD DAMAGE THE ELECTRONIC BOARDS AND/OR THE
LIGHT SOURCE.
SUPPLY MAY BE EITHER IN ALTERNATE OR DIRECT CURRENT.
MAKE CERTAIN THAT POLARITY IS RESPECTED.
R302 F/A - Installation

MTR302 F/A INSTALLATION

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 Ralco srl Modello/Model R302 F/A

WIRING DIAGRAM
R302 F/A - Installation

MTR302 F/A INSTALLATION

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 Ralco srl Modello/Model R302 F/A

GC 338 Timer
Connectors
1. Lamp output (max 9 A)
2. Push button input
3. Power Supply +12/24 V DC o 12-24 V AC/V DC A
J1 POWER SUPPLY AND OUTPUTS
4. Shared Lamp
5. Power Supply –12/24 V DC o 12-24 V AC/V DC B
6. 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
JUMPERS OFF - no jumper
ON - jumper
JP1, JP2 – LAMP TIME SELECTION JP1 JP2
OFF - 30 s OFF - 30 s
ON - 45 s OFF - 45 s
OFF - 60 s ON - 60 s
ON - 120 s ON - 120 s
JP3, JP4 – OPERATION MODE JP3 JP4
SELECTION
OFF - Timer OFF - Timer
ON - Timer reset by OFF - Timer reset by pressing
pressing the button the button
OFF - Power Supply ON - Power Supply
ON - Fan ON for 90 ON - Fan ON for 90 seconds
seconds longer than the longer than the lamp
lamp
R302 F/A - Installation

MTR302 F/A INSTALLATION

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 16
 Ralco srl Modello/Model R302 F/A

Fig. Timer GC 338

R302 F/A - Installation

MTR302 F/A INSTALLATION

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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.

WARNING:
PROLONGED LIGHTING WITHOUT ALLOWING LIGHT SOURCE TO COOL CAUSES THE
COLLIMATOR TO OVERHEAT IN THE AREA NEAR THE LIGHT SOURCE.
FOR EMERGENCIES: MAXIMUM LIMIT ADIVSED IS 5 SUCCESSIVE LIGHT SOURCE OPER-
ATIONS. ALLOW THE COLLIMATOR TO COOL (ABOUT 10 MIN).

BY INCREASING THE CONSECUTIVE "ON" TIMES, THE SUBSEQUENT REST PERIODS

NEED TO BE EXTENDED ACCORDINGLY. IT IS IMPRUDENT TO PERFORM TWO CONSEC-
UTIVE CYCLES OF 5 ON TIMES.

The collimator has been designed to operate as follows:

• Supply constantly connected during operation of the equipment.
• Light source ON time for the light field is factory set at 30 seconds (tol.20%). It is adjustable
from 30 to 45 seconds via a trimmer on the timer board.
• The normal ON/OFF cycle is set at 1 minute followed by an idle time of 4 minutes to allow
for cooling time (i.e. 1 minute ON/ 4 minutes OFF).
• The field is set by the two knobs on the front panel by following the indications of the scale
with the knob index or visually with the light field.
Front Panel
R302 F/A - Operation Instructions

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).

MTR302 F/A OPERATION INSTRUCTIONS

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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

Fig. Long Aperture

Format Required

Knob Index setting

Fig. Cross Aperture

R302 F/A - Operation Instructions

MTR302 F/A OPERATION INSTRUCTIONS

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CALIBRATION

THE FOLLOWING PROCEDURES REQUIRE THAT X-RADIATION BE PRODUCED. TAKE ADEQUATE

PRECAUTIONS TO MAKE CERTAIN THAT NO PART OF THE HUMAN BODY IS EXPOSED
TO X-RADIATION, DIRECT OR INDIRECT.

CENTERING X-RAY BEAM WITH COLLIMATOR LIGHT

• Select large focus, 60 kV and 5 mAs or equivalent for digital receptor.
• Place a loaded cassette 24 x 30 cm (9.5”x 12”) on the table top and prepare exposure.
• Set SID = 100 cm (40") by using a ruler.

IF THE DISTANCE OF 100 CM (40") SID CANNOT BE DETERMINED, USE THE SID
VALUE CLOSEST TO 100 CM (40") AND CALCULATE THE MEASUREMENT TOLERANCES
AS THE APPROPRIATE PERCENTAGES OF THE DISTANCE.

IF THE X-RAY BEAM CANNOT BE POSITIONED VERTICALLY USE CLAMPS, MASKING TAPE,
OR OTHER MATERIAL AS REQUIRED TO POSITION THE X-RAY TUBE AND IMAGE RECEPTOR.
THE X-RAY TUBE AND THE IMAGE RECEPTOR MUST BE SET OUT AT THE SPECIFIED
SID DISTANCE PERPENDICULARLY TO THE X-RAY TUBE AS DESCRIBED IN THE FOLLOWING
PROCEDURE.

NOTE

FIGURE CHECK LIGHT FIELD/X-RAY FIELD

SHOWS AN EXAMPLE WITH FILM CASSETTE.
THE SAME PRINCIPLE CAN BE USED FOR
A DIGITAL SYSTEM.

• Set field to 24 x 30 cm.

• Centre the X-ray tube on the cassette.
• Switch ON the light and place four metal
strips (c) on the light field edges (a).
• Place a washer (d) on the right hand-top of Light field (a)
the light field. X-Ray field (b)
R302 F/A - Calibration

• Make an exposure. Fig: Check Light Field/X-ray Field

• Develop the film or print exposure scale 1:1.
• Measure the differences L1,L2 W1 and W2
between the outer edge of each copper strips image and the corresponding edge of
the X-ray Field (b).

MTR302 F/A CALIBRATION

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• 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.

SID = 100 cm (40")

2.0% x 100 cm (40") =
LARGE L1+L2 =..........+..........=.......... = ≤ 2.0% SID
FOCUS W1+W2 =..........+..........=.......... = ≤ 2.0% SID
SMALL L1+L2 =..........+..........=.......... = ≤ 2.0% SID
FOCUS W1+W2 =..........+..........=.......... = ≤ 2.0% SID

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.

LIGHT FIELD TO X-RAY FIELD ALIGNMENT

Misalignment of the light field/ X-ray field in either the X (cross table) or Y (long table) direction
must not exceed 2% of the SID. In this case, it would be less than 20 mm (0.80"). If the test film
shows that the light field (shadows of the copper strips) matches the X-ray field (shadow of the
collimator shutters) to within the diameter of one strips and, if the diameter is less than 20 mm
(1.80"), then alignment complies with the regulations.
Greater precision than this is possible. Recommended maximum deviation is one fourth. It is
important the greatest degree of congruency possible is achieved.
If misalignment is detected in both X and Y directions, check the spacing from the focal spot to
the collimator mounting surface is 80 mm (3.14") +/- 1 mm. If spacing needs to be adjusted,
repeat the test film exposure after the adjustment.
If the collimator mount spacing is correct, but adjustment is still necessary proceed as 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
R302 F/A - Calibration

in LIGHT FIELD ADJUSTMENTS in this chapter.

MTR302 F/A CALIBRATION

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LIGHT FIELD CALIBRATION

Longitudinal Calibration (LONG)

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

Fig. Light Field Adjustment

R302 F/A - Calibration

MTR302 F/A CALIBRATION

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Transversal Calibration (CROSS)

If the light-field needs calibration, the
mirror needs to be adjusted as follows:
• Remove the part of the cover
necessary to access the screws, see
Chapter - COVER REMOVAL.
• Loosen the mirror fixing screw A (not
remove) and rotate the cam B to
adjust the position of the mirror, see
Fig. Transversal Calibration
Transversal Calibration (CROSS)
(CROSS).
• Once you have regulated the mirror
tighten the screw A and remount the cover, see Chapter - COVER REMOVAL.
R302 F/A - Calibration

MTR302 F/A CALIBRATION

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COMPLIANCE VERIFICATION

MINIMUM FILTRATION REQUIREMENT

To indicate compliance with 21 CFR, sub-chapter J, part 1020 of Performance Standard it is
necessary for the assembler to perform a series of tests.
Description of test methods are illustrated in this chapter but factors, such as experience,
availability of equipment and tolerance on compliance are referred directly to the Safety
Standards covering Electro-medical equipment.

THE FOLLOWING PROCEDURES REQUIRE THAT X-RADIATION BE

PRODUCED. TAKE ADEQUATE PRECAUTIONS THAT NO PART OF HUMAN
BEING IS EXPOSED TO X-RADIATION, DIRECT OR INDIRECT.

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:

Minimum Filtration Requirement - Beam Quality (HVL)

X-Ray Tube Voltage Minimum HVL
(kilovolt peak) (mm of aluminum)

Designed Measured Specified

I-Other X-Ray II-Other X-Ray
Operating Operating Dental
Systems2 Systems3
Range (kVp) Potential (kVp) System1

30 1.5 0.3 0.3

Below 51 40 1.5 0.4 0.4
50 1.5 0.5 0.5
51 1.5 1.2 1.3
From 51 a70 60 1.5 1.3 1.5
70 1.5 1.5 1.8
71 2.1 2.1 2.5
80 2.3 2.3 2.9
90 2.5 2.5 3.2
100 2.7 2.7 3.6
Above 70 110 3.0 3.0 3.9
120 3.2 3.2 4.3
130 3.5 3.5 4.7
R302 F/A - Compliance Verification

140 3.8 3.8 5.0

150 4.1 4.1 5.4

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.

MTR302 F/A COMPLIANCE VERIFICATION

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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:

Total Filtration Of Primary Beam In Aluminium Equivalence

Total Filtration (mm Al

Operating Voltage (kVp)
Equivalent)

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.
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.
R302 F/A - Compliance Verification

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.

MTR302 F/A COMPLIANCE VERIFICATION

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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

VISUAL DEFINITION OF X-RAY VERSUS LIGHT FIELD

Chapter - COLLIMATOR CALIBRATION - paragraph - Light-Field to X-ray Field Alignment.
R302 F/A - Compliance Verification

FIELD SIZE INDICATION

Chapter- ADJUSTMENTS, paragraph Field Size Indication.

CROSSHAIR ALIGNMENT
CHAPTER- ADJUSTMENTS, PARAGRAPH CROSSHAIR ALIGNMENT.

LIGHT FIELD ILLUMINATION INTENSITY

a) When a light field simulating the X-Ray field is used the illumination provided at 100 cm.
cannot be less than: 160 lux [(21 CFR 1020.31 (d) (2) (ii)].

MTR302 F/A COMPLIANCE VERIFICATION

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b) Place the Focus of the X-Ray tube at 100 cm. from the table top were the light field as been
projected. Open the collimator's shutters to assure that each quadrant of the light field is
larger than the measuring area of the photometer.
c) Check that the voltage specified by the manufacturer is applied to the lamp, make certain
that all surfaces in the light beam are clean and unobstructed.
d) Place a photometer capable of reading up to 160 lux in the centre of each of the four
quadrants of the light field.
e) Turn on the light beam and read the light intensity, subtract to it the ambient lighting,
previously determined.
f) Verify that the average illumination is higher than 160 lux.
g) Verify that the contrast ratio is performed between two points:
• The first point at 3 mm outside the edge of the light field.
• The second point at 3 mm inside the edge of the light field.
These measurements are to be performed with the probe of the lux metre set at 1 mm
aperture.
h) Record the measured values including all data regarding the instrument and voltage
employed.

EMC COMPLIANCE
Electromagnetic Emissions

The R302 F/A colimator is suitable for use in the specified electromagnetic environment. The purchaser or user of the R302
F/A should assure that it is used in an electromagnetic environment as described below:

Emissions Test Compliance Electromagnetic Environment- Guidance

RF emissions Group 1 The Collimator R302 F/A uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.

RF emissions Class B
CISPR 11
This R302 F/A is suitable for use in all establishments, including
Harmonic emissions Class A
domestic establishments and those directly connected to the
IEC 61000-3-2
public low-voltage power supply network that supplies buildings
Voltage fluctuations/flicker Complies used for domestic purposes.
emissions
IEC 61000-3-3
R302 F/A - Compliance Verification

MTR302 F/A COMPLIANCE VERIFICATION

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Electromagnetic Immunity for All Equipment and Systems

Collimator R302 F/A is intended for use in the electromagnetic environmenmt specified below. The customer or the user should
assure that it is used in such an environment.
Immunity IEC 60601 Test Compliance Electromagnetic Environment
Test Level Level
Electrostatic 6 kV contact EN 60601-1-2 Hospital
discharge (ESD) 8 kV air test level
IEC 61000-4-2
Electronical fast 2 kV for power EN 60601-1-2 Hospital
transient/burst supply lines test level
IEC 61000-4-4 1 kV for input/output lines
>3m
Surge 1 kV differential mode EN 60601-1-2 Hospital
IEC 61000-4-5 2 kV common mode test level
Voltage dips, short 0% Un for 0.5 cycles. EN 60601-1-2 Hospital
interruptions and 40% Unfor 5 cycles test level
voltage variations on
70% Un for 25 cycles
power supply input
lines 0% Un for 5 s
IEC 61000-4-11
Power frequency (50/ 3 A/m EN 60601-1-2 Hospital
60 Hz) test level
magnetic field
IEC 61000-4-8
R302 F/A - Compliance Verification

MTR302 F/A COMPLIANCE VERIFICATION

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Electromagnetic Immunity

The R302 F/A collimator is intended for use in the electromagnetic environment specified below. The customer or the user
of the collimator should assure that it is used in such an environment.

Immunity Test IEC 60601 Test Compliance Electromagnetic

Level Level Environment
Portable and mobile RF
communications equipment should be
used no closer to any part of the R302
F/A, including cables, then the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended Separation Distance

Radiated RF 3V 3 V/m d=1.2 √P 80 MHz to 800MHz d=2.3

IEC 61000-4-3 80 MHz to 2,5 GHz √P 800 MHz to 2.5GHz

Conducted RF 3 V/m 3V d= 1.2 x √P

IEC 61000-4-6 150 kHz to 80 GHz

Where P is the maximum output power

rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
metres (m).

Field strengths from fixed RF

transmitters, as determined by an
electromagnetic site survey, should be
less than the compliance level in each
frequency range.
Interference may occur
in the vicinity of
equipment marked with
the following symbol:
R302 F/A - Compliance Verification

MTR302 F/A COMPLIANCE VERIFICATION

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Recommended Separation Distances for Non-Life Supporting Equipment

Collimator R302 F/A is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the collimator can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the collimator as recommended below,
according to the maximum output power of the communications equipment.

Separation Distance According to Frequency of Transmitter

Rated Maximum Output (m)
Power of Transmitter
W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
d= 1.2 x √P d = 1.2 x √P d 0 2.3 x √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
R302 F/A - Compliance Verification

MTR302 F/A COMPLIANCE VERIFICATION

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COVER REMOVAL

(1).

TIGHTEN THE FOUR ALLEN

SCREWS TO ALLOW REMOVAL
OF THE COVER.

(2).

REMOVE THE FRONT PANEL

BY UNSCREWING THE TWO
DOWELS PER KNOB.

(3).

REMOVE THE SNAP-FIT

FRONT PANEL BY PRISING IT
OFF AS SHOW IN THE
PHOTOGRAPH.
R302 F/A - Cover Removal

MTR302 F/A COVER REMOVAL

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(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).

TURN THE COLLIMATOR OVER

AND UNSCREW THE FOUR
SCREWS.
R302 F/A - Cover Removal

MTR302 F/A COVER REMOVAL

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(7).

REMOVE THE REAR COVER

BY UNSCREWING THE THREE
SCREWS.

(8).

PLACE THE COLLIMATOR

LOWER SIDE DOWN AND
SLIGHTLY RAISE.
SLIP THE SEMI-CIRCLE OUT.

(9).

EASE THE COVER UPWARDS

GENTLY.
THIS WILL ALSO RELEASE
THE SMALL PANEL.
R302 F/A - Cover Removal

MTR302 F/A COVER REMOVAL

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ACCESS TO COLLIMATOR COMPONENTS

Friction

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 F/A - Cover Removal

MTR302 F/A COVER REMOVAL

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Power Supply

ACCESS THE COLLIMATOR POWER SUPPLY BY REMOVING COLLIMATOR BACK PANEL.

Longitudinal Movement

ACCESS THE TRANSVERSAL ADJUSTMENT PARTS BY REMOVING THE LATERAL PLATE.

R302 F/A - Cover Removal

MTR302 F/A COVER REMOVAL

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ADJUSTMENTS

WARNING:
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.

FIELD SIZE INDICATION ADJUSTMENT

EN60601-1-3- par. 29.201.8
Regulations state that collimators must indicate the size of the X-Ray field at the SID in use to
within 2% of that SID.
Shutter Dial Adjustment
• Rotate the two control knobs to completely close both sets of shutters. Use the field light to
check that the shutters are in fact closed.
• Rotate the knobs and make the knob index coincide exactly with the scale reading that
corresponds to size 30x30 cm at 1 m SID.
• Measure the X-ray field of the test image.
• If the reading is not correct, adjust the indicator using the screws on the sides of each knob.
CROSSHAIR ADJUSTMENT
• Activate the light field.
• Adjust the light field to a narrow line for each pair of
shutters by turning the two knobs alternately.
• Check that the project cross line is exact halfway
between the edges of the shutters, see Fig. Cross
Line.
• If adjustment is required, remove the cover from the
sides and bottom of the collimator, see Chapter -
COVER REMOVAL.
• Loosen the four screws securing the plastic panel Fig. Cross Line
and adjust the cross lines to coincide with the light
lines, see Chapter - COVER REMOVAL.
• Tighten the screws.
FRICTION BRAKE ADJUSTMENT Fig. Friction Brake
If the shutter movement is too loose or too tight,
proceed as follows:
• Remove the parts of the cover to access the
R302 F/A - Adjustments

adjustment point, see Chapter- COVER

REMOVAL.
• If a shutter control is too loose and does not
hold position, tighten one of the two screws
A on the U bolt that frictions the shaft, see
Fig. Friction Brake.

MTR302 F/A ADJUSTMENTS

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• If a shutter control is too tight, loosen one of the two screws A on the U bolt that frictions
the shaft, see Fig. Friction Brake.
• Before replacing the knobs, close both shutters and mount/fix the knobs so that the field
index is set at “0” (completely closed), see paragraph Shutter Dial Adjustment in this
Chapter.
MECHANICAL MOTION STOP ADJUSTMENT
The purpose of these stops is to prevent stressing the control shafts of the shutters at the two
limits of travel. This is done by limiting rotation of the control shafts.
• Adjustment of these stops will not be required unless:
• The shutters can not be completely closed or opened to the largest size.
• Torsion is felt at one or both ends of the travel.
• The shutters themselves appear to limit the motion rather than the stops.

Fig. Long and Cross Shutters

CLOSED Stop Long and Cross Fig. Closed Stop

Shutters
The stop is effected by a cam
• Loosen the Allen screw placed on the
side of the stop. See Fig. Closed
Stop
• Use the knob to close the shutters.
Take care not to apply excessive
force to check that the shutters touch.
• Use the field light to check that
shutters are closed.
• Rotate the cam stop to a stand still.
R302 F/A - Adjustments

• Tighten the Allen screw.

• Open and close the shutters several
times to check that they close/open
fully and that, when they close, the
cam touches the stop.

MTR302 F/A ADJUSTMENTS

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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.
Light Source
Problem Cause Solution
Collimator supplied Check: Supply/Tension/Current/
incorrectly Polarity/Fuses
Check item
Faulty light source Replace if necessary, see
Chapter- SUBSTITUTIONS
The light source fails to
switch ON Check timer supply
Faulty timer Substitute if necessary, see
Chapter- SUBSTITUTIONS

Faulty ON/OFF push- Check contact

button Substitute if necessary
Faulty timer Substitute timer
Light source fails to
switch OFF Push-button is
Substitute push-button
shorted

Centering
Problem Cause Solution
The light field of the The mirror or light See Chapter- CALIBRATION,
collimator is not source are not paragraph Light Field to X-ray Field
centered positioned correctly Alignment

Field Size
Problem Cause Solution
Faulty field size Knobs are not Regulate, see Chapter-
indication regulated ADJUSTMENTS

Shutters
R302 F/A - Troubleshooting

Problem Cause Solution

Regulate, see Chapter-
Shutters close Friction is loose
ADJUSTMENTS

MTR302 F/A TROUBLESHOOTING

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SUBSTITUTIONS
SUBSTITUTION OF THE HALOGEN LAMP

WARNING: NOT IMMEDIATELY TOUCH THE DISSIPATER WITH YOUR FINGERS

IT COULD BE HOT AND CAUSE SEVERE BURNS.

WARNING: DO NOT TOUCH THE LAMP, THE SOCKET, OR THE LAMP BRACKET
WITH YOUR FINGER. THEY CAN BE VERY HOT AND CAUSE SEVERE BURNS.

WARNING: 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.

• Disconnect power supply.

• Remove the part of the cover and/or the knobs to access the component, see Chapter-
COVER REMOVAL.
• Remove the lamp protection heat sink.
• Carefully remove the faulty lamp.
• Substitute the lamp with an identical lamp.
• Make sure that the lamp pins are completely inserted in the lamp-holder.
• Check on light field/X-ray field correspondence, see Chapter- ADJUSTMENTS.
• If necessary remove the lamp, rotate it 180° axially and reinsert.
SUBSTITUTION OF THE ELECTRONIC TIMER
• Disconnect power supply.
• Remove part of the cover to access
the component, see Chapter - COVER
REMOVAL.
• Remove the two screws holding the
electronic timer, see Fig. Timer GC
338.
• Identify the cables and their position
on the terminal board, see Chapter-
INSTALLATION, paragraph Electrical
Connection.
Fig. Timer GC 338
• Disconnect the cables from the
terminal board.
R302 F/A - Substitutions

MTR302 F/A SUBSTITUTIONS

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• Install the new timer by proceeding in a reverse order; pay particular attention to the
connection of the cables on the 4 or 6-way electric terminal depending in the model.

SUBSTITUTION OF THE MIRROR

• Remove the collimator cover, front

panel and rear cover, see Chapter-
COVER REMOVAL.
• Remove the collimator lateral
protection walls.
• Remove the mirror shaft stop on the
left side of the collimator.

• Remove the three screws on the

upper left partition.

• Remove the two screws on the

cable stops.
R302 F/A - Substitutions

MTR302 F/A SUBSTITUTIONS

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• Remove the cable stop located on

the front partition of the collimator
on the upper right hand side.

• Remove the screw on the rear

partition of the collimator on the
upper left hand side.

• Lift off the upper part of the right

hand partition.
R302 F/A - Substitutions

MTR302 F/A SUBSTITUTIONS

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 Ralco srl Modello/Model R302 F/A

• Substitute the mirror and remount in

reversed order.

SUBSTITUTION OF THE FILTER

• Disconnect the power supply.
• Remove the knobs and the front panel, see Fig. 1/Fig. 2 and Chapter - COVER REMOVAL.

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.
R302 F/A - Substitutions

MTR302 F/A SUBSTITUTIONS

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 42
 Ralco srl Modello/Model R302 F/A

Fig. 3 Fig. 4
R302 F/A - Substitutions

MTR302 F/A SUBSTITUTIONS

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SPARE PARTS

WHEN ORDERING SPARE PARTS, THE CUSTOMER IS REQUESTED TO SPECIFY THE

COLLIMATOR MODEL AND SERIAL NUMBER.

THE SPARE PARTS LISTED BELOW REFER TO THE STANDARD MODEL ONLY.

PLEASE CONSULT YOUR PERSONALIZATION PAGE TO VERIFY WHICH SPARE PARTS

MAKE UP YOUR CUSTOMIZED MODEL.

LABEL
LABEL 1A

LABEL 3A LABEL 4 LABEL 5

LABEL 7

LABEL 6
R302 F/A - Spare Parts

MTR302 F/A SPARE PARTS

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Fig. Standard Model Labels, LED (RO 333) and/or Laser

(Red Laser Line - RO 242/1)

Fig. Standard Label

Fig. Standard Model Labels, LED (RO 333) and/or Laser

(Red Laser Lines - RO 242/2)
R302 F/A - Spare Parts

MTR302 F/A SPARE PARTS

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R302 F/A STANDARD

Cod. Description
RS 006 Halogen lamp, 24 V-100 W
RS 033 Lamp holder
RS 063 Timer board, 24 V
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 403 Upper semicircular cover
RS 408 Front panel, up to SN 13360
RS 423 Rear cover
RS 424 Frame
RS 578 Lamp holder support
RS 596 Screw, TS M3x25 mm
RS 788 Front panel, from SN 13361
RS 1107 Antidust panel
R302 F/A - Spare Parts

MTR302 F/A SPARE PARTS

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 46
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Parts Breakdown
R302 F/A - Spare Parts

MTR302 F/A SPARE PARTS

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OPTIONAL ITEMS
This collimator may have the following optional items; a detailed description is provided in this
chapter.

RO 001/A Fixed Mounting Flange

Thickness of this mounting flange is 20 mm.
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
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.
R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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RO 002 Iron Spacer

This accessory is used for the mounting

flange; 1.5 mm thickness.

RO 012/B Retractable Tape Measure

Mounted on a radiological unit, measures the distance between the focus and the patient.

Use of the retractable tape measure in collimators with this feature:

The type of tape measure used is a standard tape mounted on a radiological
unit. The tape starts with values that correspond to the focus/collimator lower
edge distance; maximum radiological measurement with the tape is 2 m max
even though, for purely mechanical reasons, maximum tape extension is 3 m
max. STOP is evident immediately after the maximum mechanical value.
Forcing and/or extending the tape beyond this point will cause the following
inconveniences:
• Breakage of the tape or,
• Distortion of the tape or,
R302 F/A - Optional Items

• 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.

MTR302 F/A OPTIONAL ITEMS

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RO 041 Mylar Mirror

Mylar mirror, internal filtration equivalent at

minimum 0.3 mm Al.

RO 051 Rotating Mounting Flange

This accessory is used to rotate the collimator assembled to the X-ray tube.
• Flange thickness: 18 mm
• Flange diameter: 136 mm
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
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.
R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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RO 055/B Fixed Mounting Flange

Thickness of this mounting flange is 18 mm.

R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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RO 063 Final Control Testing

This test provides higher control to check 100% of the production lot to verify product quality
from beginning to end of the production cycle.
Final tests include:
• Light field illumination intensity (if applicable),
• Light field to X-ray field alignment (if applicable),
• X-ray leakage test,
• Edge contrast (if applicable),
• Operation and electronic check up.

RO 074 Customized External Cover Color

The customer can specify a collimator cover color. Ralco’s standard color is RAL9003.

RO 077 Centering Device

Centering device of the Potter Bucky (BL).
Reflects the lamp light to form a bright line to align
collimator to Potter Bucky.
Adjustment
• Remove the collimator rear cover to gain
access to the point of adjustment, see
Chapter COVER REMOVAL.
• The line is to fall on a perpendicular bisector
line constructed against the anti-dust plastic
panel toward the control face of the collimator.
• To adjust the position of the line, shift the light
support group as required. Note that the
support group and bracket are inside the
collimator frame and cannot be seen, but may
be controlled by the two securing screws A, Fig. Centering Device Adjustment
see Fig. Centering Device Adjustment.

RO 082 Mirror
Glass mirror, 0.8 mm thickness, inherent filtration 1 mm Al equivalent. With this mirror, the
collimator equivalent filtration value of 2 mm Al is reduced to 1 mm Al.
R302 F/A - Optional Items

RO 096 Customized Wiring

Customized electrical wiring, if ordered please see Chapter- PERSONALIZATIONS, paragraph
Wiring Diagram.

MTR302 F/A OPTIONAL ITEMS

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RO 107 Customized Knobs

The customer can specify the required knob color.

RO 109 Customized Front Panel Frame

The customer can specify the required frame color.

RO 111 Customized Front Panel

The customer can customize the front panel adding, for example, the Company Logo and/or
the Company colors.

RO 161 Plastic Spacer Guides

Pair of plastic rail guides designed to protect
the ionization chamber and allow the
insertion of other accessories.
CAUTION
PAY ATTENTION TO THE DISTANCE OF LOWER
GUIDES THAT COULD BE GREATER THAN THE
DISTANCE OF UPPER GUIDES.
R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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RO 185/A Fixed Mounting Flange

This accessory is used to install the

collimator to the X-ray tube.
• 20 mm thickness

RO 202 Auto Centering Top Cover

This accessory is designed to precisely
install the collimator to the X-ray tube with a
metal flange and without any additional
adjustment of light field to X-ray field.
R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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RO 203 Auto-Centering Siemens Type Cover

This cover is designed to allow the attachment of
the collimator to a Siemens X-ray tube.

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 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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RO 222/A Rotating Mounting Flange

This customized accessory is used to rotate

the collimator assembled to the X-ray tube.
• 136 mm diameter
• 18 mm thickness

RO 240 Focus-Skin Distance Sapcer

This accessory ensures a minimum safety
distance (309.5 mm) between the X-ray
focus and the patient.

THIS ACCESSORY DEALS WITH

PREVENTING THE USE OF INAP-
PROPRIATE SMALL FOCUS/SKIN
DISTANCES IN ORDER THAT THE
DOSE EQUIVALENT TO THE
PATIENT BE KEPT AS LOW AS
REASONABLY POSSIBLE.

1 - Countersunk Screws, 2 - Focus-Skin Distance Spacers,

3 - Collimator Cover.
R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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RO 242/1 Single Laser

The collimator laser is classified as Class 2 Fig. Laser Line
(1 m W - wavelength = 645 mm, +/- 10 nm);
used for collimator/image receptor center
alignment, see Fig. Laser Line.
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.
• To rotate the laser system, loosen
the Allen screw A, see Fig. Laser
Adjustment.
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
bisector line on the anti-dust panel,
see Fig. Laser Alignment.
• Tighten the two B screws.
DO NOT APPLY EXCESSIVE Fig. Laser Alignment
FORCE TO THE SCREW. THE
LASER SHELL IS IN PLASTIC AND
EXCESSIVE PRESSURE COULD
CRACK THE PLASTIC AND POSSI-
BLY SHORT-CIRCUIT THE LASER.
R302 F/A - Optional Items

Substitution
• Disconnect supply.
• Remove the cover, see Chapter- COVER
REMOVAL.
• Unscrew the fixing Allen screws A, see
Fig. Laser Adjustment.

MTR302 F/A OPTIONAL ITEMS

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• 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 Second Laser Cross Projection

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.

CAUTION: CLASS 2 LASER

SYSTEM DO NOT STARE INTO
THE BEAM.

CALIBRATION CONTROL
• Draw a cross (two lines at 90°) on a
sheet of paper and use this as reference.
• 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

R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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• Examine the laser projections on the paper: the laser is

correctly calibrated when the projections coincide with the
lines drawn on the paper, otherwise an adjustment will be
necessary.
ADJUSTMENT
Horizontal
• Disconnect power supply. Collimator
• Remove the laser cover located on the collimator cover by crosshair
unscrewing the two screws A, see Fig. Horizontal Laser. projection
• To correct horizontal misalignment, loosen the screws B,
see Fig. Horizontal Laser and move the laser support
Laser line
until the projected laser line coincides with the cross on
projection
the sheet of paper. Tighten screws B.
Vertical
• Disconnect power supply. Fig. Laser Projections
• Remove the knobs and front panel, see Chapter- COVER
REMOVAL.
• To correct vertical misalignment, loosen the Allen screw A, see Fig. Vertical Laser on the
laser support; rotate the laser and align the laser line over the cross on the sheet of paper.
• To move laterally the laser loosen the screws B and shift the laser support until the
projected laser line coincides with the cross on the sheet of paper.
• Tighten B screw s.

DO NOT APPLY EXCESSIVE FORCE TO THE SCREW. THE LASER SHELL IS IN PLASTIC AND EXCESSIVE
PRESSURE COULD CRACK THE PLASTIC AND POSSIBLY SHORT-CIRCUIT THE LASER.

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.
• Tighten the screws.
• Check the laser alignment, see paragraph ADJUSTMENT.
• Remount the laser cover.
Vertical
• Disconnect supply.
• Remove the knobs and front panel, see Chapter- COVER REMOVAL.
• Loosen the Allen screw A, see Fig. Vertical Laser on the laser support.
• Disconnect the timer cables from the terminal board - white 0 V, red 5 V.
R302 F/A - Optional Items

• Remove the laser and substitute with an identical item.

• Tighten the Allen screw.
• Check the laser alignment, see paragraph ADJUSTMENT.
• Remount the laser cover.

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Classification EN 60825-1 par. 1 -5: Class 2 laser product => Red laser line.

Fig. Horizontal Laser Fig. Vertical Laser

RO 253 Plastic Spacer Guides

Pair of plastic rail guides

complete with support designed
to accommodate the ionization
chamber and ensure its lateral
protection.
R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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RO 258/1 Additional Variable Filtration - Manual Selection

Additional variable filtration with manual

settings may be optionally added to the
minimum collimator filtration in the form of a
disk, 1 mm thickness, controlled manually from
the front panel. The disk features a hole for the
passage of X-rays and accommodates the
following three filters:
• 0: no filtration
• 0,1 mm Cu (Al eq. 2,5 mm)
• 0,2 mm Cu (Al eq. 5 mm) Fig. RO 258/1
0,3 mm Cu (Al eq. 7.5 mm)
To adjust and/or to change the filter see RO 258
Additional Variable Filtration description in this Chapter.

RO 271 Lamp with Cooling

System lamp for high luminosity. This Lamp is

complete with a cooler system kit which includes:
fan, thermo probe, and timer board to limit lamp ON
cycles.
Power Supply: 24 V 150 W - 8 A
Fuse for power supply protection collimator: T 10 A
(not supplied by Ralco).

1 - Fan, 2 - Heat sink

RO 318 Auto Centering Cover with Plastic Flange

This accessory is designed to allow rotation and precisely install the collimator to the X-ray tube
through the plastic flange.
The mounting flange is provided with the collimator top plate. Place the flange with the letter F
(front/knob) turned toward the X-ray tube front using countersink screws.
R302 F/A - Optional Items

For the collimator to rotate to position "Ø", two of the four tabs retract to allow to rotation. Adjust
and tighten the four Allen screws as follows:
screws 1 and 3 = 7 turns until the tongue touches slightly the flange;
screws 2 and 4 = 5½ turns exactly;
See Fig. Mounting Flange in this chapter. Please Note: If Allen screws "2" and "4" are
tightened more than 5 ½ turns, the collimator will not rotate.

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The collimator control tabs conform to EN60601-1. Secure the tabs along the edge of the
mounting flange but do not lock them. Excessive tightening of the tabs prevents collimator
rotation.

Check that the distance between the collimator housing and the mounting flange is equal in all
directions and, that the collimator face is parallel to the table axis.
Loosen the screws and adjust if required.
Mounting Flange
R302 F/A - Optional Items

Screws 1 e 3= Tighten fully.

Screws 2 e 4= from position completely open, tighten 5½ turns to ensure
collimator rotation. Tighten these screws to stop collimator rotation.

MTR302 F/A OPTIONAL ITEMS

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RO 333 White LED

The white LED which substitutes the halogen lamp

has a higher luminosity (>250 lux a SID of 1 m) and a
longer life (60,000 hours). The board GC-Led-5A
supplies the LED and a fan for cooling is supplied by a
12-45 V DC 30 CA/20 - 30 V AC 30 V A - 50/60 Hz.
The white LED can be adjusted vertically,
longitudinally and laterally.

1 - Fan, 2 - LED, 3 - GC-LED-5A Board

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, lower the light source by adjusting screw D.
• If the light-field is bigger than the X-ray field, raise the light source by adjusting screws D.
• Tighten the two screws C.
See Fig. Light Field Adjustment
Longitudinal Alignment (Long)

DO NOT TOUCH THE DISSIPATER WITH YOUR HANDS; IT COULD BE HOT AND
CAUSE SEVERE BURNS.

• Remove part of the cover, see Chapter - COVER REMOVAL.

• If the light-field needs to be moved laterally, loosen (not remove) the fixing screws A.
• Use screw B to adjust transversely.
• When calibration is terminated, lock the screws A.
See Fig. Light Field Adjustment
R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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Fig. Light Field Adjustment

Transversal Calibration (CROSS)

If the light-field needs calibration, the mirror needs to be adjusted as follows:
• Remove the part of the cover necessary to access the screws, see Chapter - COVER
REMOVAL.
• Loosen the mirror fixing screw A (not remove) and rotate the cam B to adjust the position of
the mirror, see Fig. Transversal Calibration (CROSS).
• Once you have regulated the mirror tighten the screw A and remount the cover, see
Chapter - COVER REMOVAL.

Fig. Calibrazione Trasversale (CROSS)

R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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GC-LED-5A Board

CONNECTORS
J2 - SUPPLY AND OUTPUTS 1. 20-30 V AC or 12-45 V DC
2. 20-30 V AC or 0 V DC
3. +5 V Fan
4. GND Fan
5. +5 V Laser
6. GND Laser
7. + Power-up/Power down external push-button
8. GND Power-up external push-button
J1 - LED OUTPUT + LED 5 A positive output
- GND Led 5A
J3 - PROGRAMMING 1. Vpp
CONNECTORS 2. +5 V
3. GND
4. PGD
5. PGC
6. NC
J4 - HOME SENSOR INPUT + 1. + External LED
EXTERNAL LED 2. - External LED
3. - Photosensor LED Cathode
4. + Photosensor LED Anode
5. Input signal (Photosensor output collector)
6. GND (Photosensor output emitter)
R302 F/A - Optional Items

Jumpers OFF: without jumper

ON: with jumper
JP1, JP2 - ALTERNATE/DIRECT OFF: alternate power supply
POWER SUPPLY ON: direct power supply (pay attention to polarity)

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JP3 - FAN POWER SUPPLY OFF: fan is operated by micro controller according to
settings made with LED
ON: fan is always supplied
JP4 - LASER POWER SUPPLY OFF: Laser is micro controller operated
ON: Laser is always supplied
JP5 - CONFIGURATION OF PUSH- OFF: LED and laser are controlled by only push button (on
BUTTON NUMBER OUTPUT J2)
ON: LED is controlled by standard push button (on J2),
laser is controlled independently by push button on JP6.
JP6 - BUTTON INPUT FOR LASER ON 1. Laser ON button pin 1
TIME. 2. Laser OFF button pin 2
JP8 - CONFIGURATION OF LED ON Laser is controlled independently by the timer, this
TIME configuration is applicable in the same manner for both
push buttons.
OFF: output status is changed by pressing button (if the
light is OFF will be ON and vice versa).
ON: the timer operates in the time renew mode. When the
button is pressed the time is renewed without the LED OFF
(if the LED is ON it will stay ON but with the time reset). The
same is applicable for the laser if is independent.
FAN The fan switches ON together with the LED, and operates
15 seconds longer after the LED OFF.
Trimmers

TR1- CURRENT CONTROL Adjust the output current intensity to the LED.
Step-less current adjustment from 0 to 5.1 A. Adjusting
current to approximately 4.7 A (+/- 5%) will increase LED
life without a significant loss of luminosity.
TR2 - TIME ADJUSTMENT Adjusts the time from 30s to 120s up to 90% of run,
maximum light ON time is 15 min. for safety reasons.
When the timer is regulated at over 120s (i.e. 100% of its
adjustment), the timer performs as power supply: it starts
by powering-up the LED and other features such as laser
and fan. In this case, maximum light ON time is 15 min. for
safety reasons.
LED SUBSTITUTION
• Disconnect supply.
R302 F/A - Optional Items

• Remove the cover, see Chapter - COVER REMOVAL.

• Disconnect the LED wires from the board.
• Remove the LED protection heatsink by unscrewing the 2 screws C, see Fig. LED
Substitution.
• Substitute the LED with an identical item; handle it gently and make sure it doesn’t get dirty.
• Remount the protection heatsink by tightening the two fixing screws C.
• Connect the two wires to the board.
• Check on light field/X-ray field correspondence. See Chapter CALIBRATION.

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Fig. LED Substitution

Heatsink protection screws

RO 382 LED on Front Panel

LED on the front panel indicates that one of

the three additional filters has been
introduced in the X-ray beam.
R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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RO 441 Plastic Flange, 50° Rotation

Plastic flange with notch allowing +/- 50°

rotation of the collimator without stop, 20 mm
thickness.
Available only if collimator is assembled with
optional item RO 318.

RO 442 Plastic Flange, 90° Rotation

Plastic flange with a notch allowing +/- 90°

rotation of the collimator without stopping,
20 mm thickness.
Available only if collimator is assembled with
optional item RO 318.
Characteristics:
• type: rotating flange, +/- 90°
• material: PA 66, PTFE, Glass fibres
• thickness: 20 mm
• diameter: 140 mm
R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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RO 452 Manual-Image Stitching on LONG Shutters

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 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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TO USE THE COLLIMATOR (WITH 3 KNOBS) IN STANDARD MODE:

At the desired SID the operator has to select the
proper field using the references in the silk screen
board on the front panel.
e.g., if the operator wants to set an X-ray field of 35
x 43 cm where 35 cm is given by the Cross shutter
and 43 cm is given by the Long shutters, at SID 100
cm, the operator has to position the Cross knob (the
knob on the left) on the value of the scale that
indicates 35 and both the two Long knobs (the knob
in the middle and the knob on the right) on the value
of the scale that indicates 43. See Fig. Index scale
35 x 43 cm.

Fig. Index scale 35 x 43 cm

DO NOT USE A SINGLE LONG KNOB. YOU
MUST ALWAYS USE BOTH LONG KNOBS
TOGETHER, AND BOTH LONG KNOBS POSI-
TIONED ON THE SAME DESIRED APERTURE
(FIELD).

A single Long knob gets half the aperture selected. If

you select the two Long knobs with different
aperture, long field is misaligned with respect to the
centre of the field (the centre of the cassette). To get
an aligned field you must always use both Long
knobs positioned on the same aperture (field)
desired.
Fig. Index scale 43 x 15 cm
e.g., at SID 100 cm, to have an X-ray field 43 cm
(Cross) x 15cm (Long), the Cross knob must be
positioned at 43 and both the 2 Long knobs must be
positioned at 15. See Fig. Index scale 43 x 15 cm.

e.g., at SID 100 cm, to have an X-ray field 35 cm

(Cross) x 20 cm (Long), the Cross knob must be
positioned on 35 and both the 2 Long knobs must be
positioned on 20. See Fig. Index scale 43 x 20 cm
R302 F/A - Optional Items

Fig. Index scale 43 x 20 cm

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TO USE THE COLLIMATOR IN STITCHING MODE:

The maximum aperture of the X-ray field is 43 x 43 cm
at SID 100 cm.
The stitching mode can be used at different SID.
This mode permits to subdivide the X-ray field in 3
sections and to make 3 exposures, one for each
section.
To set the stitching mode at the desired SID, the Cross
knob (the knob on the left) has to be positioned on the
value of the scale in reference to the silk screen board
on the front panel. The two Long knobs (the knob in the
middle and the knob on the right) both have to be
positioned on the setting 1, 2 or 3 indicated on the
scale following the stitching desired field.
Fig. Field 1
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 F/A - Optional Items

Fig. Field 3

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Fig. Stitching process

R302 F/A - Optional Items

MTR302 F/A OPTIONAL ITEMS

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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
collimator 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.

Do not spray water or detergent directly over the collimator. The unit’s liquid
protection level is IPx0.

DISINFECTION
The disinfection method use must conform with the currently applicable norms and directives
covering disinfection and protection against explosion hazards.
.
Never use caustic substances, solvents or abrasive detergents.

If products that could form explosive gas mixtures are used, allow the gas to
evaporate before starting the system.
• 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.

RECOMMENDED MAINTENANCE PROGRAM

Ralco suggests a yearly servicing program, however shorter intervals are advisable when the
collimator is subject to heavy workloads.
• Re-calibration of the collimator will be necessary whenever the X-ray tube is changed or at
each substitution of the source light (lamp or LED, if assembled) used to simulate the light
R302 F/A - Maintenance

field.
• Calibration procedures must be performed as described in this manual.
• Check once a week that the screws and tabs which serve to secure the collimator to the
flange/tube adapter are correctly tightened.
• Remove the covers and panels from collimator. Inspect the moving parts for signs of wear
or damage.
• Check the electric system and substitute parts that show wear.

MTR302 F/A MAINTENANCE

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• Check the plastic anti-dust window and substitute it if necessary.

• Clean the collimator with a soft cloth paying particular attention to the plastic anti-dust
window. Do not use abrasive or inflammable cleaning products.
• Wipe away all excess oil and remount the cover.

MAKE SURE TO TIGHTEN THEALLEN 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.

IF THE COLLIMATOR IS TO BE MOUNTED ON A ROTATING FLANGE, USE A TIGHTENING FORCE

BETWEEN MIN. 0,50 NM AND MAX. 0.75 NM.
R302 F/A - Maintenance

MTR302 F/A MAINTENANCE

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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
customer;
• 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;
• 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: repairs@ralco.it (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
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.
R302 F/A - General

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.

MTR302 F/A GENERAL

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Please send defective material to the following address:

RALCO SRL
VIA DEI TIGLI 13/G
20853 BIASSONO (MB) - ITALIA
FAX: ++39-039-2497.799
EMAIL: RALCO@RALCO.IT

END OF LIFE DISPOSAL

Your collimator contains materials which can be recycled and reused. Specialised companies
can recycle your product to increase the amount of reusable materials and to minimize the
amount of materials to be disposed of.
The product contains lead which can be highly contaminating if dispersed
incorrectly. The following symbol signifies that the product conforms to the
environmental requirements of directives 202/95/EC, 2002/96/EC, 2003/108/EC;
it must be disposed of correctly at the end of its life-cycle.
The collimator does not contain polluting materials or products with the exception
of the lead that composes the shutters - avoid direct contact with lead especially for prolonged
periods.
It is required that you observe Local Laws regulating the disposal of the collimator using
certified environmental management entities. Should this prove impossible, return the
collimator to Ralco at the purchaser's expense and Ralco will undertake its correct disposal.
If you are replacing the unit with new equipment, you may return the old collimator to Ralco.
Please contact us if you require further information.
DISASSEMBLY

CARE MUST BE TAKEN NOT TO LET THE COLLIMATOR FALL.

• Disconnect supply to the collimator.

• Remove the cover and disconnect the supply cables.
• Loosen the fixing Allen screws on the upper part of the collimator connected to the flange
mounted to the X-ray tube.
TRANSPORT AND STORAGE
• Suitable packing must be provided for the collimator.
• Place the collimator in a plastic bag to avoid packing material from entering the collimator.
• Use an appropriate packing for transport, shipment or storage; the collimator must be
protected from rough handling. This will avoid damage to the collimator during transport,
shipment or storage.
• Limit Storage conditions:
• Ambient Temperature = from -40°C to +70°C
• Relative Humidity = from 10% to 95%
R302 F/A - General

MTR302 F/A GENERAL

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• Atm. Pressure = from 500 a 1060 hPa.

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.

INFORMATION REGARDING ACCIDENTS THAT HAVE OCCURRED WHILE USING THE RADIOLOGICAL
COLLIMATOR MUST BE REPORTED IMMEDIATELY TO RALCO SRL.

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.
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.
R302 F/A - General

MTR302 F/A GENERAL

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 77
 Information For The Manufacturer
The following form is provided for your comments and suggestions with regards to the collimator so that we
may ensure and improve the quality of our production.
Please e-mail comments and/or suggestions to: p.vescera@ralco.it

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:
info_cl.fm
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