Instruction Manual

MTR 108 F - MTR 108 F DHHS

MANUAL RADIOLOGICAL COLLIMATOR

Confidential Information

SERIES R 108 F DHHS

DATE OF ISSUE: REVISION LEVEL: ISSUED BY:

26.02.2010 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 108 F STANDARD VERSION

FDA CERTIFIED VERSION AVAILABLE ON

R 108 F DHHS REQUEST

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 17.03.2010 MRE/10/10
B 22.03.2010 MRD/003/10
C 25.05.2010 VVS/33/10
D 23.09.2010 MRD/011/10
E 15.03.2011 MRE/010/11
F 21.04.2011 MRD/005/11
25.05.2011 MRE/023/11
G
26.05.2011 ACD/008/11
14.07.2011 MRD/013/11
H
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 04.06.2013 MRM/059/13
16.01.2014 MRD/001/14
M
29.01.2014 MRE/006/14
10.02.2014 MRE/002/14
N
12.03.2014 MRD/005/14
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 ADJUSTMENTS
FIELD SIZE INDICATION ADJUSTMENT...............36
SYMBOLS
Shutter Dial Adjustment ................................36
DESCRIPTION CROSSHAIR ADJUSTMENT ...............................36
CHARACTERISTICS ............................................6 Friction Brake Adjustment.............................37
SPECIFICATIONS TROUBLESHOOTING
INSTALLATION SUBSTITUTIONS
X-RAY TUBE COMPATIBILITY ............................11 LED SUBSTITUTION ........................................39
MOUNTING THE COLLIMATOR TO THE X-RAY TUBE Substitution of the Electronic Board for LED 39
11 Mirror Substitution.........................................39
ELECTRICAL CONNECTION ...............................15
SPARE PARTS
Power Supply Connection ............................15
LABELS ..........................................................42
Wiring Diagram .............................................17
Parts Breakdown ..........................................44
GC_LED_5A Board ......................................18
OPTIONAL ITEMS
OPERATION INSTRUCTIONS
RO 002 Iron Spacer......................................45
LIGHT/X-RAY FIELD SETTING ...........................20
RO 041 Mylar Mirror .....................................45
FIELD SIZE SETTING .......................................20
RO 063 Final Control Testing .......................45
Shutter Dial Adjustment ................................20
RO 074 Customized Housing .......................46
CALIBRATION RO 082 Mirror ...............................................46
CENTERING X-RAY BEAM WITH COLLIMATOR RO 096 Customized Wiring ..........................46
LIGHT .............................................................22 RO 107 Customized Knobs ..........................46
LIGHT FIELD TO X-RAY FIELD ALIGNMENT ........23 RO 109 Customized Frame ..........................46
LIGHT FIELD ADJUSTMENTS .............................23 RO 111 Customization of Front Panel ..........46
Vertical Alignment .........................................23 RO 240 Focus-Skin Distance Spacer ...........46
Longitudinal Alignment (Long) ......................23 RO 242/1 Single Laser .................................47
Transversal Calibration (CROSS).................24 RO 258 Additional Variable Filtration - Manual
Selection .......................................................48
COMPLIANCE VERIFICATION
RO 258/1 Additional Variable Filtration - Manual
MINIMUM FILTRATION REQUIREMENT ...............25
Selection .......................................................49
Visual Determination of Half-Value Layer
RO 278 Extra-Focal Shutters........................49
(HVL) ............................................................25
RO 336 Spacer Guides ................................50
Quick-Check of Minimum Filtration
RO 339 Double Laser for Optical SID...........50
Requirement at a Particular kVp ...................26
RO 344 Plastic Spacer Guides .....................51
Standard Absorber Method...........................26
RO 367 Plastic Flange..................................52
VISUAL DEFINITION OF X-RAY VERSUS LIGHT
RO 369 Stop .................................................52
FIELD .............................................................27
RO 370 Stop .................................................53
FIELD SIZE INDICATION....................................27
RO 382 LED on Front Panel.........................53
CROSSHAIR ALIGNMENT ..................................27
RO 395 Single Laser with Cross Projection..55
CHAPTER- ADJUSTMENTS, PARAGRAPH
RO 405 Customized Aluminium Cover .........56
CROSSHAIR ALIGNMENT. .................................27
RO 423 Mounting Plane at 100 mm from the
LIGHT FIELD ILLUMINATION INTENSITY ..............27
Focus ............................................................56
EMC COMPLIANCE .........................................29
RO 441 Plastic Flange, 50° Rotation ............57
Electromagnetic Emissions...........................29
RO 442 Plastic Flange, 90° Rotation ............57
Electromagnetic Immunity for All Equipment
and Systems .................................................29 MAINTENANCE
Electromagnetic Immunity for Non Life- CLEANING RECOMMENDATIONS .......................59
Supporting System .......................................30 DISINFECTION .................................................59
Recommended Separation Distances for Non- RECOMMENDED MAINTENANCE PROGRAM .......59
Life Supporting Equipment ...........................31
GENERAL
COVER REMOVAL WARRANTY.....................................................61
ACCESS TO DIFFERENT COLLIMATOR REPAIRS.........................................................61
COMPONENTS .................................................35 END OF LIFE DISPOSAL ...................................62
DISASSEMBLY .................................................62
TRANSPORT AND STORAGE .............................62

MTR108 F - R108 F DHHS 1

SAFETY/RESPONSIBILITY .................................63
RESIDUAL RISKS .............................................63

MTR108 F - R108 F DHHS

2
 Modello/Model R108 F - R108 F DHHS
Ralco srl
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;

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.
R108 F - R108 F DHHS - Advisory

MTR108 F - R108 F DHHS Advisory

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 1
 Modello/Model R108 F - R108 F DHHS
Ralco srl
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 13485:2004
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
R108 F - R108 F DHHS - Advisory

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

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.

MTR108 F - R108 F DHHS Advisory

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 2
 Modello/Model R108 F - R108 F DHHS
Ralco srl

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
R108 F - R108 F DHHS - Advisory

MTR108 F - R108 F DHHS Advisory

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 3
 Modello/Model R108 F - R108 F DHHS
Ralco srl
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
R108 F - R108 F DHHS - Symbols

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

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

MTR108 F - R108 F DHHS Symbols

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 4
 Modello/Model R108 F - R108 F DHHS
Ralco srl
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

ISO 7010-
Follow Instructions for Use
M002
R108 F - R108 F DHHS - Symbols

MTR108 F - R108 F DHHS Symbols

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 5
 Modello/Model R108 F - R108 F DHHS
Ralco srl
DESCRIPTION
Multilayer, square field, manual collimation system with a lightweight, compact design
intended for installation on mobile X-ray equipment. This device has been designed and
manufactured for skeletal investigations and ER applications.
The X-ray field is defined by six pairs of shutters: two pairs are lead-lined and four pairs are in
bronze. The shutters move perpendicularly within the X-ray field.
The four bronze shutters are located near the focus: two pairs are mounted near the entrance
window and two pairs are mounted near X-ray focus. The two lead-lined pairs, mounted at the
collimator X-ray beam exit window, serve to accurately define the X-ray field edges.
Shutter movements are manual and 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.
Accessory Guides are used for accessories and additonal filtration.
Retractable Tape mounted on a radiological unit, measures the distance between the
focus and the patient.
High luminosity provided by a White LED simulating the X-ray field. The light field is con-
trolled by an electronic timer.
Minimum Inherent Filtration 2 mm aluminium equivalent.
Plastic Flange allows the collimator to rotate, 20 mm thickness.
GC-Led-5A timer board for light source supply and operation.
Auto-centering top plate (RO 318) with high resistant resin mounting flange allowing +/-
45° rotation of the collimator, the flange is included.

Fig. R108 F Exterior Cover and Dimensions

R108 F - R108 F DHHS - Description

MTR108 F - R108 F DHHS Description

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 6
 Modello/Model R108 F - R108 F DHHS
Ralco srl
This collimator may have the following optional items; a detailed description is provided in the
chapter OPTIONAL ITEMS.

RO 002 Spacers, iron, 1.5 mm thickness for mounting flange

RO 041 Mylar mirror, inherent filtration 0.3 mm Al equivalent
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 frame
RO 111 Personalized front panel
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
Additional variable filtration through three filters on rotating support 1 mm Al
RO 258
+ (0.1 mm CU O 0.2 mm CU O 2 mm Al), manual selection
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
Upper plate with near port shutters designed for installation on rotating
RO 278
anode X-ray tubes
RO 336 Aluminium accessory guides
RO 339 Device equipped with 2 lasers for optical SID
RO 344 Plastic spacer guides, for DAP assembly
Plastic flange with a mechanical stop mounted on the plastic flange, rotation
RO 367
+/- 120°, 18 mm thickness
R108 F - R108 F DHHS - Description

RO 369 Mechanical stop system +/- 90° for plastic rotating flange, 20 mm thickness
Mechanical stop system +/- 120° for the plastic rotating flange, 20 mm
RO 370
thickness
RO 382 LED on front panel
Laser with cross projection for patient centering; fixed
RO 395
distance
RO 405 Covers, aluminium

MTR108 F - R108 F DHHS Description

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 7
 Modello/Model R108 F - R108 F DHHS
Ralco srl
Mounting plane at 100 mm from the focus, not suitable for the upper plate
RO 423
with the extra-focal shutters
RO 441 Plastic flange with a notch rotating +/- 50°, 20 mm thickness without stop
RO 442 Plastic flange with a notch rotating +/- 90°, 20 mm thickness without stop
R108 F - R108 F DHHS - Description

MTR108 F - R108 F DHHS Description

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 8
 Modello/Model R108 F - R108 F DHHS
Ralco srl
SPECIFICATIONS

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

12 - 45 V DC 30 VA/ 20 - 30 V AC
30 VA - 50/60 Hz
Power Supply
12 V DC + jumper JP1
see Electrical Connection
Fuse for power supply protection collimator. Not
T 3.15 A
supplied by Ralco.
Motor Supplied by Collimator Board n.a.
Fuse for Power Supply Protection Collimator. Not
n.a.
supplied by Ralco.

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 optional
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 (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
> 160 lux
35x35 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
R108 F - R108 F DHHS -

Light Field/X-ray Field Correspondence < 1 % SID>

EN 60601-2-54
Accuracy of X-ray field as shown on the front
n.a.
display versus actual X-ray field dimension.

MTR108 F - R108 F DHHS Specifications

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 9
 Modello/Model R108 F - R108 F DHHS
Ralco srl
X-ray Field Indication Precision
Settings on an Index Scale < 2 % SID
EN 60601-2-54
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
< 40 mRh
mA
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 N (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 6.6 Kg
L: 271 mm
Dimensions W: 222 mm
H: 140 mm
R108 F - R108 F DHHS -

MTR108 F - R108 F DHHS Specifications

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 10
 Modello/Model R108 F - R108 F DHHS
Ralco srl
INSTALLATION

X-RAY TUBE COMPATIBILITY

• Collimator/X-ray tube compatibility is determined by the mechanical possibility of mounting
them, see Fig. Tube Compatibility.
• 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 collimator mounting flange must be provided with the collimator.
• The distance between the X-ray tube focus and the flange mounting plane (collimator
upper plate) must be: 80 mm (3.14"), tolerance +/- 1 mm (0.04”).

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.
R108 F - R108 F DHHS - Installation

• 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 (Please use
flange provided and see section in this manual detailing flange dimensions). Allowable tol-
erance is 1 mm. (0.04").
• 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 screws that must be long enough to
be driven into the tube port face for at least 5 threads.

MTR108 F - R108 F DHHS Installation

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 11
 Modello/Model R108 F - R108 F DHHS
Ralco srl
• 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. This ensures the near-port
shutters when fully open, do not contact the side of the X-ray tube housing.
• Carefully couple the collimator with the tube: make sure that the primary near-port shutters
have enough clearance to move in the port opening and in the mounting flange, see Fig.
Tube Compatibility in this Chapter.
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 = tighten, without excessive force;
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.
• 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
R108 F - R108 F DHHS - Installation

all directions and, that the collimator face is parallel to the table axis.
• Loosen the screws and adjust if required.
•

MTR108 F - R108 F DHHS Installation

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 12
 Modello/Model R108 F - R108 F DHHS
Ralco srl
Fig. Mounting Flange
R108 F - R108 F DHHS - Installation

MTR108 F - R108 F DHHS Installation

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 13
 Modello/Model R108 F - R108 F DHHS
R108 F - R108 F DHHS - Installation
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MTR108 F - R108 F DHHS Installation

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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/CE 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
R108 F - R108 F DHHS - Installation

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.

MTR108 F - R108 F DHHS 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.
MAKE CERTAIN THAT POLARITY IS RESPECTED.
R108 F - R108 F DHHS - Installation

MTR108 F - R108 F DHHS Installation

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Wiring Diagram
R108 F - R108 F DHHS - Installation

MTR108 F - R108 F DHHS Installation

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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
R108 F - R108 F DHHS - Installation

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/ OFF: alternate power supply
DIRECT POWER SUPPLY ON: direct power supply (pay attention to polarity)

MTR108 F - R108 F DHHS Installation

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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 OFF: LED and laser are controlled by only push button (on
PUSH-BUTTON NUMBER OUT- J2)
PUT ON: LED is controlled by standard push button (on J2),
laser is controlled independently by push button on JP6.
JP6 - BUTTON INPUT FOR 1. Laser ON button pin 1
LASER ON TIME. 2. Laser OFF button pin 2
JP8 - CONFIGURATION OF LED Laser is controlled independently by the timer, this
ON 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 3.4 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,
R108 F - R108 F DHHS - Installation

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.

MTR108 F - R108 F DHHS 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.

Shutter Dial Adjustment

• Rotate the two control knobs to com-
pletely close both sets of shutters. Use
R108 F - R108 F DHHS - Operation

the field light to check that the shutters

are in fact closed.
• Rotate the knobs and make the knob Fig. Field Size Setting
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.

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Tape Measure

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.
R108 F - R108 F DHHS - Operation

MTR108 F - R108 F DHHS 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.
R108 F - R108 F DHHS - Calibration

• 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.
• 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.

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

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 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.
• 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 ADJUSTMENTS

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.
R108 F - R108 F DHHS - Calibration

• 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

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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 shift it to adjust the posi-
tion 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. Transversal Calibration (CROSS)

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.
R108 F - R108 F DHHS - Calibration

MTR108 F - R108 F DHHS 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
R108 F - R108 F DHHS - Compliance

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:

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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
R108 F - R108 F DHHS - Compliance

in millimetres of aluminium obtained during the test must be greater or equal than the values
listed in the above mentioned table.
a) Direct the central X-ray beam perpendicular and in the center of a RAD-Check instrument.
Determine the exact distance from the X-ray tube focal spot to the window of the collimator
(273 mm - 10.75"). Place the input area of the RAD-CHECK at an equal distance from the
collimator window. Collimate the beam to an area slightly larger than the detector.
b) Select a tube potential of 100 kVp and appropriate mA and seconds, with no added filtration
in the beam make an exposure and record the reading. Using a set of several sheets of 1100
Aluminium Alloy, each having a thickness of 0.5 or 1.0 mm, tape the filtration to the window
of the collimator. Make an exposure for each increments of filtration and record the reading.

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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

R108 F - R108 F DHHS - Compliance

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)].
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.

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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.
R108 F - R108 F DHHS - Compliance

MTR108 F - R108 F DHHS Compliance Verification

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EMC COMPLIANCE
Electromagnetic Emissions

The R108 F - R108 F DHHS colimator is suitable for use in the specified electromagnetic environment. The purchaser or user
of the R108 F - R108 F DHHS 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 R108 F - R108 F DHHS uses RF energy only
CISPR 11 for its internal 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 R108 F - R108 F DHHS is suitable for use in all
CISPR 11 establishments other than domestic and those directly
connected to the low voltage power supply network which
Harmonic emissions [Not applicable] supplies buildings used for 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 R108 F - R108 F DHHS 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

R108 F - R108 F DHHS - Compliance

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
70% Un for 25 cycles
on power supply
input lines 0% Un for 5 s
IEC 61000-4-11

Power frequency 3 A/m EN 60601-1-2 Hospital

(50/60 Hz) test level
magnetic field
IEC 61000-4-8

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Electromagnetic Immunity for Non Life-Supporting System

The R108 F - R108 F DHHS 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 R108
F - R108 F DHHS, 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:
R108 F - R108 F DHHS - Compliance

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Recommended Separation Distances for Non-Life Supporting Equipment

Collimator R108 F - R108 F DHHS 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.
R108 F - R108 F DHHS - Compliance

MTR108 F - R108 F DHHS Compliance Verification

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COVER REMOVAL

( 1 ).

REMOVE THE TWO KNOBS

BY UNSCREWING THE TWO
ALLEN SCREWS PER
KNOB.

( 2 ).

REMOVE THE FRONT

PANEL.

( 3 ).

DISCONNECT THE
CONNECTORS.
R108 F - R108 F DHHS - Cover

MTR108 F - R108 F DHHS Cover Removal

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( 4 ).

TURN THE COLLIMATOR

OVER AND UNSCREW THE
FOUR SCREWS ON THE
TWO RAILS.

( 5 ).

GENTLY EASE THE TAPE

INTO THE COLLIMATOR.

( 6 ).

REMOVE THE SCREW FROM

THE SNAP-FIT PLATE.
REMOVE THE PLATE AND
THEN LIFT THE
COLLIMATOR COVER OFF.
R108 F - R108 F DHHS - Cover

MTR108 F - R108 F DHHS Cover Removal

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( 7 ).

REMOVE THE COVER BY

LIFTING IT OFF THE
COLLIMATOR.
R108 F - R108 F DHHS - Cover

MTR108 F - R108 F DHHS Cover Removal

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ACCESS TO DIFFERENT COLLIMATOR COMPONENTS
CLUTCHES

ACCESS THE CLUTCHES BY REMOVING THE

KNOBS AND THE FRONT PANEL.

POWER SUPPLY

ACCESS THE COLLIMATOR POWER SUPPLY

BY REMOVING THE SCREW AND THE REAR
PANEL.
R108 F - R108 F DHHS - Cover

MTR108 F - R108 F DHHS 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 Fig. Cross Line

• Activate the light field.
• Adjust the light field to a narrow line for each pair of shut-
ters 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, see
Chapter - COVER REMOVAL.
• Tighten the screws.
R108 F - R108 F DHHS - Adjustments

MTR108 F - R108 F DHHS Adjustments

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Friction Brake Adjustment
If the shutter movement is too loose or too tight, proceed
as follows: Fig. 1
• Remove the knobs and the parts of the cover to
access the adjustment point, see Chapter- COVER
REMOVAL.
• If a shutter control is too loose and does not hold posi-
tion, tighten one of the two A screws on the U bolt that
frictions the shaft - as illustrated in Fig. 1.
• If a shutter control is too tight, loosen one of the two A
screws on the U bolt that frictions the shaft, see Fig. 1.
Note: Check correct force applied to the friction
brake (0,25 Nm +/-2) by using a torque screwdriver
placed on the knob shaft.
• Before replacing the control knobs close both shut-
ters. Set the indicators in the close position: these
must show correct field size, see Shutter Dial Adjust-
ment in this Chapter.
R108 F - R108 F DHHS - Adjustments

MTR108 F - R108 F DHHS 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
Calibration
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 Setting
Problem Cause Solution
Faulty field size Knobs are not Regulate, see Chapter-
indication regulated ADJUSTMENTS

Shutters
R108 F - R108 F DHHS -

Problem Cause Solution

Regulate, see Chapter-
Shutters close Friction is loose
ADJUSTMENTS

MTR108 F - R108 F DHHS Troubleshooting

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SUBSTITUTIONS

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

Fig. LED Substitution

A - LED Fixing Screws

B - Electronic Board

Substitution of the Electronic

Board for LED
• Disconnect Supply.
• Remove part of the cover to
access the component, see
Chapter- COVER REMOVAL.
• Remove the two screws holding
the electronic timer.
• Identify the cables and their posi-
tion on the terminal board, see
Chapter- ELECTRICAL CONNEC-
Fig. Electronic Board for LED
R108 F - R108 F DHHS - Substitutions

TION.
• Disconnect the cables from the
terminal board.
• Install the new timer by proceeding in a reverse order; pay particular attention to the con-
nection of the cables on the 2 or 8-way electric terminal.

Mirror Substitution
• Remove the mirror fixing screw (right side), see Fig.1.
• Remove the mirror rotation cylinder (right side), see Fig.2.
• Unscrew the fixing screws of the mirror-group panel (left side), see Fig. 3.
• Slide the panel with mirror group out (left side), see Fig. 4.

MTR108 F - R108 F DHHS Substitutions

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.

Fig. 1 Fig. 2

Fig. 3 Fig. 4
R108 F - R108 F DHHS - Substitutions

MTR108 F - R108 F DHHS Substitutions

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SPARE PARTS

NOTE: When ordering spare parts, the customer is requested

to specify the collimator model and serial number.

R108 F- R108 F DHHS STANDARD

PN DESCRIPTION
RS 124 Flathead Screw
RS 596 Screws, cover
RS 754 Guide, right
RS 755 Guide, left
RS 893 Upper cover
RS 1012 Flange, mounting, plastic
RS 1054 Lower cover, leaded
RS 1055 Panel, rear
RS 1064 Timer power LED
RS 1065 White LED
RS 1066 Knob, left, with index
RS 1106 Fan LED
RS 1116 Anti dust panel
RS 1167 Tape measure, retractable type
RS 1284 Removable mirror
RS 1285 Panel, front, with push-button
R108 F - R108 F DHHS - Spare Parts

MTR108 F - R108 F DHHS Spare Parts

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LABELS

Laser Labels (Red Laser Line)

R108 F - R108 F DHHS - Spare Parts

MTR108 F - R108 F DHHS Spare Parts

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LED Labels (White Laser Line)
R108 F - R108 F DHHS - Spare Parts

MTR108 F - R108 F DHHS Spare Parts

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 43
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Parts Breakdown
R108 F - R108 F DHHS - Spare Parts

MTR108 F - R108 F DHHS 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 002 Iron Spacer

This accessory is used for the mounting
flange; 1.5 mm thickness.

RO 041 Mylar Mirror

Mylar mirror, internal filtration equivalent at
minimum 0.3 mm Al.
R108 F - R108 F DHHS - Optional

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:

MTR108 F - R108 F DHHS Optional Items

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• 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 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.
R108 F - R108 F DHHS - Optional

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

3 - Collimator Cover.

MTR108 F - R108 F DHHS Optional Items

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RO 242/1 Single Laser Fig. Laser Line
The collimator laser is classified as Class 2 (1 m W
- wavelength = 645 mm); 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 Fig. Laser Adjustment
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 FORCE

TO THE SCREW.THE LASER SHELL
IS IN PLASTIC AND EXCESSIVE Fig. Laser
PRESSURE COULD CRACK THE Alignment
PLASTIC AND POSSIBLY SHORT-
R108 F - R108 F DHHS - Optional

CIRCUIT THE LASER.

Substitution
• Disconnect supply.
• Remove the cover, see Chapter- COVER
REMOVAL.
• Unscrew the fixing Allen screws A, see Fig.
Laser Adjustment.
• Disconnect the timer cables from the terminal
board - white 0 V, red 5 V.

MTR108 F - R108 F DHHS Optional Items

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• 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 258 Additional Variable Filtration - Man-

ual Selection
Additional variable filtration with manual settings may
be optionally added to the minimum collimator
filtration in the form of an aluminium 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 copper + 1 mm Al (Al eq. 2.8 mm)
0,2 mm copper + 1 mm Al (Al eq. 5.6 mm) Fig. RO 258
1 mm aluminum + 1 mm Al support.
Setup of Filters
• Rotate the aluminium disc that protrudes from the filter opening on the front panel.
• Indication of the filtration value is provided on the upper part and lower rim of the disc; this
value refers to the additional filtration in the X-ray beam.
R108 F - R108 F DHHS - Optional

MTR108 F - R108 F DHHS 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 an aluminium
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. Fig. RO 258/1
0,1 mm Cu (Al eq. 2.8 mm) Fig. RO 258/1
0,2 mm Cu (Al eq. 5.5 mm)
0,3 mm Cu (Al eq. 8.0 mm)
Setup of Filters
• Rotate the aluminium disc that protrudes
from the filter opening on the front panel.
• Indication of the filtration value is provided on
the upper part and lower rim of the disc; this
value refers to the additional filtration in the
X-ray beam.
Substitution of Filter group
• Disconnect supply. Fig. Filter substitution
• Remove the front panel. See Chapter -
COVER REMOVAL.
• Remove the filter support by unscrewing the 2 screw A. See Fig. Filter substitution.
• Substitute the support with an identical part.
• Remount the support with a new filter - do not tighten the screws.
• Check that disc rotation is uniform: play must be reduced to a minimum.
• Tighten the 2 screws A.
• Remount the front panel.

RO 278 Extra-Focal Shutters

Upper cover with extra-focal shutters to allow
the use of the collimator with rotating anode
X-ray tubes; brass extra-focal.
R108 F - R108 F DHHS - Optional

MTR108 F - R108 F DHHS Optional Items

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 49
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RO 336 Spacer Guides

Pair of aluminium rail guides designed for an
ionisation chamber with different dimensions
to standard chamber and to allow the
insertion of other accessories.

RO 339 Double Laser for Optical SID

The collimator has two lasers which serve for the optical
definition of the prefixed SID. The lasers are mounted
behind the front panel. Two laser lines must measure 60
cm (+/-1) at 1 m (+/- 0.5 cm) and projected at 10 cm (+/-1)
from the centre of the light/X-ray field. The projection of a
single line signifies that the two lines overlap and
consequently the lasers are correctly focussed at the SID
set. The projection of two laser lines signifies the SID
value has not be entered correctly. See fig. Laser Line.

CAUTION: CLASS II LASER SYSTEM DO NOT STARE

INTO THE BEAM.

Laser Adjustment
• Remove part of the cover to access the point of Fig. Laser Line
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.
R108 F - R108 F DHHS - Optional

• 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 Fig. Laser Adjustment
device front plate.
• Move the base until the laser beam falls over the
perpendicular bisector line on the anti-dust panel, see Fig. Laser Adjustment.

MTR108 F - R108 F DHHS Optional Items

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• Tighten the screws B.

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
• Disconnect supply.
• Remove the cover, see Chapter- COVER REMOVAL.
• Unscrew the fixing Allen screws A, see Fig. Laser Adjustment.
• Disconnect the timer cables from the terminal board - white 0 V, red 5 V.
• Remove the laser and substitute with an identical item.
• Tighten the screws.
• Check the laser alignment, see Chapter- ADJUSTMENTS.
• Remount the cover, see Chapter- COVER REMOVAL.

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

RO 344 Plastic Spacer Guides

Pair of plastic rail guides complete with
support designed to accommodate the
ionization chamber and ensure its protection.
R108 F - R108 F DHHS - Optional

MTR108 F - R108 F DHHS Optional Items

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 51
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RO 367 Plastic Flange

Plastic flange with spot facing, 18 mm
thickness, for the collimators with the
mounting plane at 80 mm (3.14") from the X-
ray focus.

RO 369 Stop
Mechanical stop ± 90° to be mounted on the high resistant resin mounting flange, 20 mm
thickness. This accessory includes also the modification of the collimator cover.
R108 F - R108 F DHHS - Optional

MTR108 F - R108 F DHHS Optional Items

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RO 370 Stop
Mechanical stop ± 120° to be mounted on the high resistant resin mounting flange; 20 mm
thickness. This accessory includes also the modification of the collimator cover.

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.
R108 F - R108 F DHHS - Optional

MTR108 F - R108 F DHHS Optional Items

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Classification EN 60825-1 par. 1 -5: Class 2 laser product => Red laser line.
R108 F - R108 F DHHS - Optional

MTR108 F - R108 F DHHS Optional Items

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RO 395 Single Laser with Cross Projection
The collimator laser is classified as Class 2 (1 m W
- wavelength = 645 mm); used for collimator/image
receptor center alignment and operates at a fixed
distance, see Fig. Laser Line.

CAUTION: CLASS II 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 lines are 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
Fig. Laser Line
moving the base of the laser system.
• To rotate the laser system, loosen the
Allen screw A, see Fig. Laser
Adjustment.
• Tighten the Allen screw when the laser
beam falls on or is parallel to the bisector
line drawn on the anti-dust panel.
• Shift the laser system by loosening the screws
B 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.
Fig. Laser Adjustment
• Tighten the screws B.

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
R108 F - R108 F DHHS - Optional

THE LASER.

Substitution
• Disconnect supply.
• Remove the cover, see Chapter- COVER
REMOVAL.
• Unscrew the fixing Allen screw A, see Fig.
Laser Adjustment.
• Disconnect the timer cables from the terminal Fig. Laser Alignment
board - white 0 V, red 5 V.

MTR108 F - R108 F DHHS Optional Items

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• 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 405 Customized Aluminium Cover

Customized covers in aluminium to customer design.

RO 423 Mounting Plane at 100 mm from the

Focus
The accessory is available only with the cone version.
R108 F - R108 F DHHS - Optional

MTR108 F - R108 F DHHS 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 notch allowing +/- 90°
rotation of the collimator without stop, 20 mm
thickness.
Available only if collimator is assembled with
optional item RO 318.
R108 F - R108 F DHHS - Optional

MTR108 F - R108 F DHHS Optional Items

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R108 F - R108 F DHHS - Optional
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MTR108 F - R108 F DHHS 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
R108 F - R108 F DHHS - Maintenance

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
or damage.
• Check the electric system and substitute parts that show wear.
• Check the plastic anti-dust window and substitute it if necessary.

MTR108 F - R108 F DHHS Maintenance

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• 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.
• 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.
R108 F - R108 F DHHS - Maintenance

MTR108 F - R108 F DHHS 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 cus-
tomer;
• Unoriginal spare parts and accessories have been used.
In-warranty spares will be available only upon return to Ralco, at the customer's expense, of
the parts considered to be faulty to allow Ralco to assess the cause of the fault.
Components Not Covered by this Warranty:
• Consumable items such as lamp bulbs, lexan panels and mirrors;
• 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
R108 F - R108 F DHHS - General

a €100 processing fee.

If the product is returned under warranty and no defect is found, the customer incurs the cost
of evaluation, testing and shipping.
The shipping of the unit is at the customer’s expense if the unit is out of warranty.
The warranty period resets only on replaced parts once repairs are completed (shipment date
from Ralco back to customer), see paragraph, WARRANTY.
Ralco reserves the right to decide if the product is to be repaired or substituted.
Please send defective material to the following address:

MTR108 F - R108 F DHHS General

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 61
 Modello/Model R108 F - R108 F DHHS
Ralco srl
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.
R108 F - R108 F DHHS - General

• 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

MTR108 F - R108 F DHHS General

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 Modello/Model R108 F - R108 F DHHS
Ralco srl
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.
R108 F - R108 F DHHS - General

MTR108 F - R108 F DHHS General

MANUALE ISTRUZIONI / INSTRUCTION MANUAL 63
 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