INSTRUCTION MANUAL

MTR105
MANUAL X-RAY COLLIMATOR

Confidential Information

Ralco s.r.l.

SERIES R 104

Date of Issue: Revision Level:

Issued by:
02.03.2006 H
 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).
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.
A 26.03.2007 ACD/006/07
B 15.05.2008 MRM/065/08
C 06.11.2008 MRD/15/08
D 18.01.2010 MRE/04/10
E 22.03.2010 MRD/003/10
F 23.09.2010 MRD/010/10
MRD/011/10
G 14.07.2011 MRD/013/11
24.10.2011 MRD/018/11
H 09.03.2012 MRD/006/12
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 SHUTTER DIAL ADJUSTMENT ..................33

SYMBOLS CROSSHAIR ADJUSTMENT .......................33
FRICTION BRAKE ADJUSTMENT ...............33
DESCRIPTION
CHARACTERISTICS ................................... 6 TROUBLESHOOTING
SPECIFICATIONS SUBSTITUTIONS
SUBSTITUTION OF THE HALOGEN LAMP ...36
INSTALLATION SUBSTITUTION OF THE ELECTRONIC
X-RAY TUBE COMPATIBILITY ................... 10 TIMER ....................................................36
MOUNTING THE COLLIMATOR TO THE X-RAY
TUBE ..................................................... 10 SPARE PARTS
ELECTRICAL CONNECTION ...................... 13 R105 STANDARD ...................................37
Label...........................................................37
Power Supply Connection ..........................13
Parts Breakdown ........................................38
GC 338 Timer .............................................16
OPERATION INSTRUCTIONS OPTIONAL ITEMS
RO 001/A Fixed Mounting Flange ..............39
LIGHT/X-RAY FIELD SETTING .................. 18
RO 002 Iron Spacer....................................40
FIELD SIZE SETTING .............................. 18 RO 012/B Retractable Tape .......................40
CALIBRATION RO 041 Mylar Mirror ...................................41
CENTERING X-RAY BEAM WITH COLLIMATOR RO 051 Rotating Mounting Flange .............41
LIGHT .................................................... 19 RO 058 Rotating Mounting Flange .............42
LIGHT FIELD TO X-RAY FIELD ALIGNMENT20 RO 063 Final Control Testing .....................42
LIGHT FIELD ADJUSTMENT ..................... 20 RO 074 Customized Housing .....................43
RO 082 Mirror .............................................43
Longitudinal Calibration (LONG).................20
RO 096 Customized Wiring ........................43
Transversal Calibration (CROSS)...............21
RO 107 Customized Knobs ........................43
COMPLIANCE VERIFICATION RO 109 Customized Frame ........................43
MINIMUM FILTRATION REQUIREMENT ...... 23 RO 111 Customization of Front Panel ........43
Visual Determination of Half-Value Layer RO 240 Focus-Skin Distance Spacer .........43
(HVL) ..........................................................23 RO 318 Auto Centering Cover with Plastic
Quick-Check of Minimum Filtration Flange.........................................................43
Requirement at a Particular kVp.................24 Mounting Flange .........................................44
Standard Absorber Method.........................24 RO 333 White LED .....................................45
VISUAL DEFINITION OF X-RAY VERSUS LIGHT Transversal Calibration (CROSS) ..............46
FIELD .................................................... 25 RO 441 Plastic Flange, 50° Rotation..........49
FIELD SIZE INDICATION .......................... 25 RO 442 Plastic Flange, 90° Rotation..........50
CROSSHAIR ALIGNMENT ......................... 25 MAINTENANCE
CHAPTER- ADJUSTMENTS, PARAGRAPH CLEANING RECOMMENDATIONS ..............51
CROSSHAIR ALIGNMENT......................... 25 DISINFECTION ........................................51
LIGHT FIELD ILLUMINATION INTENSITY ..... 25 RECOMMENDED MAINTENANCE
EMC COMPLIANCE ................................ 27 PROGRAM ..............................................51
Electromagnetic Emissions.........................27
Electromagnetic Immunity for All Equipment GENERAL
and Systems ...............................................27 REPAIRS ................................................53
Electromagnetic Immunity for Non Life- END OF LIFE DISPOSAL ..........................53
Supporting System .....................................28 WARRANTY ............................................53
Recommended Separation Distances for Non- COMPONENTS NOT COVERED BY THIS
Life Supporting Equipment .........................29 WARRANTY ............................................54
MTR105_ingTOC.fm

COVER REMOVAL DISASSEMBLY ........................................54

ACCESS TO DIFFERENT COLLIMATOR TRANSPORT AND STORAGE.....................54
COMPONENTS ........................................ 32 SAFETY/RESPONSIBILITY ........................55
RESIDUAL RISKS ....................................55
ADJUSTMENTS
FIELD SIZE INDICATION ADJUSTMENT ...... 33

MTR105 i
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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.

REPORTING
INFORMATION REGARDING ACCIDENTS THAT HAVE OCCURRED WHILE USING THIS COLLIMATOR MUST BE REPORTED
IMMEDIATELY TO RALCO, SRL.

LIMITATION OF LIABILITY
RALCO IS NOT LIABLE IF THE PROVIDED INSTRUCTIONS ARE NOT COMPLIED WITH. FURTHERMORE, RALCO
IS NOT LIABLE IF ONE OR SEVERAL OF THE FOLLOWING INSTANCES APPLY:
IF THE UNIT IS SPECIFICALLY DESIGNED PER CLIENT SPECIFICATIONS AND THE CERTIFICATION WAS THE DUTY
OF THE CLIENT;
THE COLLIMATOR 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;
R105 - Advisory

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.

MTR105 ADVISORY
MANUALE ISTRUZIONI / INSTRUCTION MANUAL 1
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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 60601-2-54:2009
EN 60825-1:2007
ISO 9001:2008
UNI ESO 13485:2004
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.

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
R105 - Advisory

ALL POSSIBLE STEPS ARE FOLLOWED TO ENSURE THE HEALTH AND SAFETY OF THE PATIENT AND OPERATOR.

MTR105 ADVISORY
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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
E-MAIL: RALCO@RALCO.IT
R105 - Advisory

MTR105 ADVISORY
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SYMBOLS

Description No. Ref. IEC

417-iec
Alternating Current 01-14
503

417-iec
Direct Current 01-18
5031

Continuous and Alternating 417-iec

01-19
Current 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

01-46 iso 7000-0017
Loop)

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

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

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

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

Beam Limiting Device: Closed

417-iec
with Separate Opening of the 04-57
5387
Shutters
Beam Limiting Device with 417-iec
04-58
Separate Closing of the Shutters 5388
R105 - Symbols

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

MTR105 SYMBOLS
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Description No. Ref. IEC

Caution: Laser Radiation 60825-1

Electrostatic-Sensitive Device

Cassette Size Sensing Device

Device Requiring Proper

attch.4 2002/95/CE
Disposal

Follow Instructions for Use ISO 7010-M002

R105 - Symbols

MTR105 SYMBOLS
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DESCRIPTION
Square-field, single-layer X-ray collimator. This collimator is light weight and compact,
ideally suited for installation on mobile X-ray equipment. The unit has been designed
and manufactured for clinical skeletal investigtions and ER applications.
The X-ray field is defined by 2 pair of lead-lined shutters located near the exit window of the X-
ray beam from the collimator and, a lead-line disc (near the focus) that limits the X-ray beam
to the larger field size.
The 2 pair of shutters move perpendicularly within the X-ray field; shutter movements are
manual, controlled by two knobs on the collimator front panel.
CHARACTERISTICS
Mounting Plane at 100 mm (3.93") from the focus.
Continuous film coverage from Min: 00 x 00 cm to Max: 43 x 43 cm at 100 cm SID.
Radiation shielding: 125 kVp - 4 A
Accessory guides are used for accessories and additonal filtration.
High luminosity provided by a quartz iodide lamp simulating the X-ray field.
Minimum inherent filtration 2 mm aluminium equivalent.
GC 338 timer limiting projection lamp exposure time to 30 seconds thus extending lamp life
by preventing overheating.

Fig. R105 Front Panel with Exterior Dimensions

R105 - Description

MTR105 DESCRIPTION
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This collimator may have the following optional items; a detailed description is provided in the
chapter OPTIONAL ITEMS.

RO 001/A Fixed mounting flange, 20 mm thickness

RO 002 Spacers for mounting flange; 1.5 mm thickness
RO 012/B Tape measure, retractable
RO 041 Mylar mirror, inherent filtration 0.3 mm Al equivalent
RO 051 Rotating mounting flange, 18 mm thickness, 136 mm diameter
RO 058 Rotating mounting flange, 18 mm thickness, 140 mm diameter
Final control testing (light intensity, light field/radiation field alignment,
RO 063 radiation leakage, light field border contrast ratio, general
funcitonality and electronic)
RO 074 Customized external cover color
RO 082 Mirror 0.8 mm thickness, filtration equivalent 1 mm Al
RO 096 Customized wiring
RO 107 Customized knobs
RO 109 Customized cover
RO 111 Personalized front panel
Focus-skin spacers, preventing X-ray exposure too close to the
RO 240
patient
Auto-centering top plate with coupling for plastic flange allowing
RO 318
rotation of the collimator, the plastic flange is included
RO 333 White LED
Plastic flange with a notch rotating +/- 50°, 20 mm thickness without
RO 441
stop (available only for collimators assembled with RO 318)
Plastic flange with a notch rotating +/- 90°, 20 mm thickness without
RO 442
stop (available only for collimators assembled with RO 318)
R105 - Description

MTR105 DESCRIPTION
MANUALE ISTRUZIONI / INSTRUCTION MANUAL 7
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SPECIFICATIONS

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

Power Supply 24 V DC/AC - 50/60 Hz - 6.5 A

Fuse for power supply protection collimator. Not
T8A
supplied by Ralco.
Motor Supplied by Collimator Board n.a.

Fuse for Power Supply Protection Collimator n.a.

Inherent Filtration Al. Equivalent

X-ray beam = 75 kV Min. Al 2 mm (1 mm on request)
EN 60601-1-3 par. 7.3; 7.4
Filtration, Additional
X-ray beam = 75 kV n.a.
EN 60601-1-3 par. 7.5
Limitation of Extra Focal Radiation
Set Focus Distance, SID 1 m < 150 mm
EN 60601-2-54
Square X-ray Field Selection
Min: 00 x 00 cm
100 cm SID - (± 1% SID)
Max: 43 x 43 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 > 3:1
EN 60601-2-54
Light Field Indicator Precision
Light Field/X-ray Field Correspondence < 1 % SID>
EN 60601-2-54
Accuracy of X-ray field as shown on the front display
n.a.
versus actual X-ray field dimension.
R105 - Specifications

X-ray Field Indication Precision

Settings on an Index Scale < 2 % SID
EN 60601-2-54

MTR105 SPECIFICATIONS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL 8
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SID: (optional)
Precision of Measurement with Retractable Tape < 2% SID
EN 60601-2-54
Leakage Radiation
Measured at 100 cm with X-ray Beam = 125 kVp - 4 A < 40 mRh
EN 60601-2-54

Potentiometers
n.a.
Square Field
n.a.
Round Field
Maximum Load for Accessory Guides
GUIDES FOR ACCESSORIES (IF ASSEMBLED): PRIOR TO INSERTING Static load: 70 N (about 7.1 Kg)
ACCESSORIES IN THE GUIDES CHECK ON THE PERFECT ATTACHMENT
Dynamic load: 15 Nm (approx.
OF THE SUPPORT WITH THE MOUNTING SLOT ON THE COLLIMATOR
(TOLERANCE MAX. ± 0,5 MM). A FAULTY ATTACHMENT COULD BE 3.06 Kg)
DANGEROUS AND IT COULD CAUSE THE FALL OF ACCESSORIES
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 4.6 Kg
L: 255 mm
Dimensions W: 177 mm
H: 103 mm
R105 - Specifications

MTR105 SPECIFICATIONS
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INSTALLATION
X-RAY TUBE COMPATIBILITY
• Using the dimensions in Fig. Tube Compatibility below, ensure the collimator can be
mounted to the X-ray tube.
• 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 (125 kVp - 4 A).
• 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: 100 mm (3.93"), 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 100 mm (3.93") and determine the number of 1.5 mm
(0,06") spacers that, combined with the thickness of the mounting flange (20 mm for the
fixed flange; 18 mm for the rotating flange). Allowable tolerance is 1 mm. (0.04").
R105 - Installation

• Different flange models with their dimensions are listed in the Chapter - DESCRIPTION, para-
graph Optional Items.
• Mount the flange and spacers to the tube port with 4 bolts that must be long enough to be
driven into the tube port face for at least 5 threads.

MTR105 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 until the four tabs are
withdrawn from the collimator top opening, see Fig. Mounting Flange in this Chapter.

NOTE:
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 shutters 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 colli-
mator 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.

•
R105 - Installation

MTR105 INSTALLATION
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Fig. Mounting Flange
R105 - Installation

MTR105 INSTALLATION
MANUALE ISTRUZIONI / INSTRUCTION MANUAL 12
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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/CEE standards. Devices that supply
to the collimator must therefore feature double or reinforced insulation as provided by the
General Standard on Electro-medical Equipment CEI62-5 +A2 (EN 60601-1).
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 insula-
tion.
• In collimators with a free cable stop, remove the cable stop, connect the supply cables,
remount and then secure the cable stop.
R105 - Installation

MTR105 INSTALLATION
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• Remount the cover.

INCORRECT POWER SUPPLY COULD DAMAGE THE ELECTRONIC TIMER AND/OR THE
LIGHT SOURCE.
SUPPLY MAY BE EITHER IN ALTERNATE OR DIRECT CURRENT.
IN THE CASE OF DIRECT CURRENT SUPPLY INSERT JUMPER JP2 AND MAKE CERTAIN
THAT POLARITY IS RESPECTED.
R105 - Installation

MTR105 INSTALLATION
MANUALE ISTRUZIONI / INSTRUCTION MANUAL 14
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Fig. Wiring Diagram
R105 - Installation

MTR105 INSTALLATION
MANUALE ISTRUZIONI / INSTRUCTION MANUAL 15
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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
R105 - Installation

MTR105 INSTALLATION
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Fig. GC 338 Layout
R105 - Installation

MTR105 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.
FIELD SIZE SETTING
The indicator on the front panel shows the number to be set with the knobs in order to obtain
the required field size, see Fig. Field Size Setting. Should adjustment be necessary, see
Chapter- ADJUSTMENTS.

Fig. Field Size Setting

R105 - Operation Instructions

MTR105 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

• Place a 35 x 43 cm. (14 x 17") cassette on the table top or other flat, horizontal surface.
• Position the X-ray tube/collimator assembly with the focal spot at 1 meter (40") over the
cassette with the X-ray beam perpendicular to the cassette surface. Do not use measure-
ment indicators on the system as reference values, but measure the distance from the
focal spot to the cassette surface with a tape measure of similar device.

IF THE DISTANCE OF 1 M SID CANNOT BE DETERMINED, USE THE SID VALUE CLOSEST
TO ONE METER 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.

• Use the collimator light to center the cassette in the field.

• Mark the location of the cassette with masking tape
or other means so that it may be removed and
replaced in the same position.
• Place white paper on top of the cassette to provide
maximum contrast for the light field.
• Set the collimator to provide a field size of 30 x 30
cm. (12” x 12") at 1 meter (40").
• Activate the light field and use it to position 18 coins
as shown in the diagram.
• Position each pair of coins touching one another so
that the inner coin is lighted as much as possible and
the outer coin is lighted as little as possible.
• The points where the coins contact will define the
edges of the light field.
R105 - Calibration

• The extra two coins are to be set:

• One in a corner to ascertain film position.
• The other at the intersection of the diagonals to define film center.
• Set the X-ray generator to produce a density of about 50 kVp, 5 mAs.

MTR105 CALIBRATION
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• Make an exposure.
• Remove the cassette and process the film.
• Use the test film to check the alignments described below.

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 markers) matches the X-ray field (shadow of the
collimator shutters) to within the diameter of one marker 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 100 mm (3.93") +/- 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.
• Place the cassette in the position originally marked.
• Check the correct position of the film by the shadows cast by the markers.
• Using the images of the collimator shutters as the references for the shape and size of the
X-ray field, adjust the light field to match.
• If adjustment is necessary, adjust the travel of the light source. All procedures can be found
in LIGHT FIELD ADJUSTMENTS in this chapter.
LIGHT FIELD ADJUSTMENT
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 (dissipater) by unscrewing the fixing screws . This
R105 - Calibration

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.

MTR105 CALIBRATION
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See the following Fig. Light Field Adjustment

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 and adjust cam B just enough to be able to rotate the cam
and position the mirror, see Fig. Transversal Calibration (CROSS).
• Once you have regulated the mirror tighten the screw A and remount the cover, see Chap-
ter - COVER REMOVAL.

Fig. Transversal Calibration (CROSS)

R105 - Calibration

MTR105 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)

Designed Measured Minimum HVL
Operating Range Operating (mm. Of Al) X-ray
(kVp) Potential (kVp) System

30 0.3
Below 50 40 0.4
50 0.5
51 1.2
From 51 a70 60 1.3
70 1.5
71 2.1
80 2.3
90 2.5
100 2.7
Above 71 110 3.0
120 3.2
130 3.5
140 3.8
150 4.1

The information contained in the above table was extracted from the Code of Federal
R105 - Compliance Verification

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:

MTR105 COMPLIANCE VERIFICATION

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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.
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.
R105 - Compliance Verification

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.

MTR105 COMPLIANCE VERIFICATION

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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.

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)].
R105 - Compliance Verification

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.

MTR105 COMPLIANCE VERIFICATION

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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.
R105 - Compliance Verification

MTR105 COMPLIANCE VERIFICATION

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EMC COMPLIANCE
Electromagnetic Emissions

The R105 colimator is suitable for use in the specified electromagnetic environment. The purchaser or user of the R105 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 R105 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 [A] This R105 is suitable for use in all establishments other than
CISPR 11 domestic and those directly connected to the low voltage
power supply network which supplies buildings used for
Harmonic emissions [Not applicable] domestic purposes.
IEC 61000-3-2

Voltage fluctuations/flicker [Not applicable]

emissions
IEC 61000-3-3

CISPR 14 N.A. This Collimator is not suitable for interconnection with other
equipment.

CISPR 15 N.A. This Collimator is not suitable for interconnection with other
equipment.

Electromagnetic Immunity for All Equipment and Systems

Collimator R105 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 Complianc Electromagnetic Environment

Test Level e 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
R105 - Compliance Verification

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

MTR105 COMPLIANCE VERIFICATION

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Electromagnetic Immunity for Non Life-Supporting System

The R105 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 Complian Electromagnetic

Level ce Level Environment
Portable and mobile RF
communications equipment should be
used no closer to any part of the R105,
including cables, then the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended Separation Distance

Radiated RF 3 V/m 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:
R105 - Compliance Verification

MTR105 COMPLIANCE VERIFICATION

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Recommended Separation Distances for Non-Life Supporting Equipment

Collimator R105 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.
R105 - Compliance Verification

MTR105 COMPLIANCE VERIFICATION

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COVER REMOVAL

(1).

REMOVE THE TWO KNOBS BY

UNSCREWING THE KNOB
DOWELS.

(2).

UNSCREW THE SCREWS THAT

FIX THE FRONT PANEL TO THE
COLLIMATOR.

(3).

DISCONNECT THE
CONNECTOR.
R105 - Cover Removal

MTR105 COVER REMOVAL

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(4).

UNSCREW THE 4 SCREWS

FOR THE LOWER COVER AND
4 SCREWS FOR THE UPPER
COVER.

(5).

REMOVE THE COVERS BY

LIFTING THEM OFF THE
COLLIMATOR.
R105 - Cover Removal

MTR105 COVER REMOVAL

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ACCESS TO DIFFERENT COLLIMATOR COMPONENTS
Clutches

ACCESS TO THE CLUTCHES AND THE ELECTRONIC BOARD BY REMOVING THE KNOBS AND THE
FRONT PANEL.

Power Supply

ACCESS TO THE COLLIMATOR POWER SUPPLY BY REMOVING THE SCREW AND THE REAR
PANEL.
R105 - Cover Removal

MTR105 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 cor-
responds 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 and
adjust the cross lines to coincide with the light lines, Fig. Cross Line
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
adjustment point, see Chapter- COVER
REMOVAL.
R105 - Adjustments

• 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.

MTR105 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.
R105 - Adjustments

MTR105 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 collimator is not The mirror or light See Chapter- CALIBRATION,
centered source are not paragraph Light Field to X-ray Field
positioned correctly Alignment

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

Shutters
Problem Cause Solution
R105 - Troubleshooting

Regulate, see Chapter-

Shutters close Friction is loose
ADJUSTMENTS

MTR105 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 termi-
nal board.
• Install the new timer by proceeding in a reverse order; pay particular attention to the con-
R105 - Substitutions

nection of the cables on the 4 or 6-way electric terminal depending in the model.

MTR105 SUBSTITUTIONS
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SPARE PARTS

NOTE: When ordering spare parts, the customer is requested

to specify the collimator model and serial number.

R105 STANDARD
PN DESCRIPTION
RO 002 Spacer steel, 1.5 mm thickness
RS 006 Lamp, 24 V- 100 W
RS 033 Lamp holder, ceramic
RS 039 Knob with index
RS 041 Panel, anti-dust
RS 047 Push-button up to s.n. 21006
RS 063 Timer, electronic, GC 338 - 24 V
RS 125 Washer
RS 110 Frame, plastic
RS 137 Guide, right
RS 138 Guide, left
RS 146 Screws, for guides, tcm 3x14
RS 155 Panel, rear
RS 199 Cover, upper
RS 239 Plastic, upper cover
RS 463 Cover, lower, 1 mm - group
RS 464 Panel, front 1 mm, group up to sn 21006
RS 465 Mirror, 1.7 mm thickness
RS 720 Cone, lead
RS 725 Tape measure, retractable type
RS 828 Front panel with push-button from s.n. 21007
RS 1171 Screws, cover, TS M3x8
Label
R105 - Spare Parts

MTR105 SPARE PARTS

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Parts Breakdown
R105 - Spare Parts

MTR105 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.
R105 - Optional Items

MTR105 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

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,
• 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.
R105 - Optional Items

MTR105 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.
R105 - Optional Items

MTR105 OPTIONAL ITEMS

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RO 058 Rotating Mounting Flange

This accessory is used to rotate the collimator assembled to the X-ray tube.
• Flange thickness: 18 mm
• Flange diameter: 140 mm

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
R105 - Optional Items

• Light field to X-ray field alignment

• X-ray leakage test
• Edge contrast
• Operation and electronic check up

MTR105 OPTIONAL ITEMS

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RO 074 Customized Housing
The customer can specify a collimator housing color. Ralco’s standard color is RAL9003.
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.
RO 096 Customized Wiring
Customized electrical wiring, if ordered please see Chapter- PERSONALIZATIONS, paragraph
Wiring Diagram.
RO 107 Customized Knobs
The customer can specify the required knob color.
RO 109 Customized Frame
The customer can specify the required frame color.
RO 111 Customization of Front Panel
The customer can customize the front panel adding, for example, the Company Logo and/or
the Company colors.

RO 240 Focus-Skin Distance Spacer

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 INAPPRO-
PRIATE SMALL FOCUS/SKIN DISTANCES
IN ORDER THAT THE DOSE EQUIV-
ALENT TO THE PATIENT BE KEPT AS
LOW AS REASONABLY POSSIBLE.

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

3 - Collimator Cover.

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,
R105 - 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 (tight);
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.

MTR105 OPTIONAL ITEMS

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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
R105 - Optional Items

MTR105 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.
Light Field to X-ray Field Alignment
LONGITUDINAL ALIGNMENT (LONG)

DO NOT TOUCH THE DISSIPATER 1 - Fan, 2 - LED, 3 - GC-LED-5A Board

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
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

Fig. Light Field Adjustment

R105 - Optional Items

MTR105 OPTIONAL ITEMS

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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 and adjust cam B just enough to be able to rotate the cam
and position 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. Transversal Calibration (CROSS)

GC-LED-5A
R105 - Optional Items

MTR105 OPTIONAL ITEMS

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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 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 + EXTER- 1. + External LED
NAL LED 2. - External LED
3. - Photosensor LED Cathode
4. + Photosensor LED Anode
5. Input signal (Photosensor output collector)
6. GND (Photosensor output emitter)
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)
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-BUT- OFF: LED and laser are controlled by only push button (on
TON 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
R105 - Optional Items

MTR105 OPTIONAL ITEMS

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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.
IMPORTANT

JP7 - PROGRAMMING OF OFF - Pic16F526 may be programmed by removing JP8

MICROCONTROLLER PIC16F52 (thermistor input) from Pic
ON - JP8 connected to Pic prevents reprogramming
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 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.
• Remove the cover, see Chapter - COVER REMOVAL.
• Remove the LED protection heatsink.
• Unsolder two wires, see Fig. LED Substitution.
• Unscrew two fixing screws, see Fig. LED Substitution.
• Remove the faulty LED.
• Substitute the LED with an identical item; handle it gently and make sure it doesn’t get dirty.
• Tighten the two fixing screws.
• Solder the two wires.
R105 - Optional Items

• Check on light field/X-ray field correspondence.

MTR105 OPTIONAL ITEMS

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Fig. LED Substitution

1 - LED protection heatsink 2 - Fixing screws

RO 441 Plastic Flange, 50° Rotation

Plastic flange with notch allowing +/- 50°
rotation of the collimator without stop, 20 mm
thickness.
R105 - Optional Items

MTR105 OPTIONAL ITEMS

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RO 442 Plastic Flange, 90° Rotation

Plastic flange with notch allowing +/- 90°
rotation of the collimator without stop, 20 mm
thickness.
R105 - Optional Items

MTR105 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 colli-
mator cover is not watertight.
• Do not reapply power if inflammable liquids have leaked into the collimator.
See the following Maintenance Instructions.
• Clean the varnished and aluminium surfaces with a damp cloth only, using a neutral
cleansing agent then dry the surfaces with a soft cloth.
• Clean chrome surfaces with a dry soft cloth.

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 lamp used to simulate the light 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
R105 - Maintenance

or damage.
• Check the electric system and substitute parts that show wear.
• 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 win-
dow. Do not use abrasive or inflammable cleaning products.

MTR105 MAINTENANCE
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• Wipe away all excess oil and remount the cover.

MAKE SURE TO TIGHTEN THE ALLEN SCREWS SECURING THE COLLIMATOR OR THE CONTROL TABS.
APPROPRIATE TIGHTENING OF THE 4 ALLEN SCREWS ENSURES SECURE MOUNTING OF THE
COLLIMATOR. TIGHTENING FORCE USED MUST NOT EXCEED 0.50 NM.

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.
R105 - Maintenance

MTR105 MAINTENANCE
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GENERAL
REPAIRS
In the event the customer finds any noncompliance or malfunctions of the collimator, contact
Ralco via e-mail at the address: p.vescera@ralco.it (Ralco Assistance).
The information must include:
• The model and serial number of the collimator found on the label.
• A detailed description of the problem (in Italian or English).
• It is important to specify if you want a repair or a total refurbishment of the product.
Ralco will resolve the problem by either providing directions, and/or field service or by sending
replacement parts.
In the event the collimator needs to be repaired at Ralco, customer service will immediately
provide the customer with a RMA (Return Merchandise Authorization) number as your consent
to the return and provide all necessary additional information.
The shipping of the unit is at the customer’s expense if the unit is out of warranty, see
paragraph WARRANTY in this chapter.
Ralco reserves the right to decide if the collimator is to be repaired or substituted.
Defective material is to be sent to:
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.
WARRANTY
Ralco undertakes to replace and repair any collimator part during a period of 24 months from
R105 - General

the date of invoice and cover the labour costs involved, not including the exemptions below.
The warranty applies provided the product has been handled properly in accordance with its
operating instructions; presentation is required of the original invoice indicating the date of

MTR105 GENERAL
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purchase, the model and serial number as well as other documents originally supplied with the
set.
Exemptions:
• If unit documents have been altered in any way or made illegible;
• If the model or production number on the product has been altered, deleted, removed or
made illegible;
• If repairs or product modifications and alterations have been performed by unauthorized
and unqualified persons;
• If unauthorized repairs and/or modifications have been performed;
• To damage caused by misuse or neglect, incorrect installation or accidental damage
including but not limited to lighting, water or fire;
• To use of unoriginal spare parts and accessories.
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 lamps.
Items not produced by Ralco; these items will be accorded to warranty granted by the
constructor:
• Motors: 1 year
• Potentiometers: 1 year
• Electronic Boards: 1 year
• Laser: 1 year
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%
• Atm. Pressure = from 500 a 1060 hPa.
images\collimatori\fig
R105 - General

MTR105 GENERAL
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SAFETY/RESPONSIBILITY
Ralco adheres to the directives governing manufacturers of electro-medical equipment:
Directive 2007/47/CEE 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/CEE. 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.
R105 - General

MTR105 GENERAL
MANUALE ISTRUZIONI / INSTRUCTION MANUAL 55
 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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