Ralco MTR 221/A User manual

Instruction Manual
MTR 221/A - MTR 221/A DHHS
MANUAL RADIOLOGICAL COLLIMATOR
Confidential Information
SERIES R 221/A DHHS
DATE OF ISSUE:
09.05.2006
REVISION LEVEL:
G
ISSUED BY:

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:
Model Certifications
R 221/A STANDARD VERSION
R 221/A DHHS FDA CERTIFIED VERSION AVAILABLE ON
REQUEST
The English version of this manual is a translation of the Italian text which
prevails in case of doubts.
Rev. N Date N
A 26.01.2007 MRM/048/06
B 12.06.2008 MRE/15/08
C 06.11.2008 MRD/015/08
D 28.01.2010 MRD/01/010
E
22.03.2010
14.07.2011
24.10.2011
MRD/003/10
MRD/013/11
MRD/018/11
F 09.03.2012 MRD/006/12
G31.07.2013
31.07.2013
MRD/014/13
MRD/015/13

THIS INSTRUCTION MANUAL PROVIDES THE SPECIFICATIONS, DIMENSIONS, AND FUNCTIONS FOR ASTANDARD
COLLIMATOR. PERSONALIZATIONS ARE AVAILABLE UPON REQUEST. WITH PERSONALIZED COLLIMATORS, THE CUSTOMER
MUST ENSURE THE FOLLOWING HAS BEEN PROVIDED:
•Y
OUR 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.

MTR221/A DHHS
1
MTR221/A DHHS -
CONTENTS
ADVISORY
SYMBOLS
DESCRIPTION
CHARACTERISTICS ..........................................6
SPECIFICATIONS
INSTALLATION
X-RAY TUBE COMPATIBILITY..........................10
MOUNTING THE COLLIMATOR TO THE X-RAY
TUBE............................................................10
Mounting the Flange ...................................10
Mounting the Collimator to the Flange........11
ELECTRICAL CONNECTION.............................14
Power Supply Connection ..........................14
Wiring Diagram ...........................................16
OPERATION INSTRUCTIONS
LIGHT/X-RAY FIELD SETTING .........................17
Front Panel .................................................17
CALIBRATION
CENTERING X-RAY BEAM WITH COLLIMATOR
LIGHT ...........................................................19
LIGHT FIELD TO X-RAY FIELD ALIGNMENT ......20
LIGHT FIELD ADJUSTMENT ............................20
Longitudinal Calibration (LONG).................20
Vertical Alignment.......................................21
Transversal Calibration (CROSS)...............21
COMPLIANCE VERIFICATION
MINIMUM FILTRATION REQUIREMENT .............22
Visual Determination of Half-Value Layer
(HVL) ..........................................................22
Quick-Check of Minimum Filtration
Requirement at a Particular kVp.................23
Standard Absorber Method.........................23
VISUAL DEFINITION OF X-RAY VERSUS LIGHT
FIELD ...........................................................24
FIELD SIZE INDICATION .................................24
CROSSHAIR ALIGNMENT ................................24
CHAPTER- ADJUSTMENTS, PARAGRAPH
CROSSHAIR ALIGNMENT. ...............................24
LIGHT FIELD ILLUMINATION INTENSITY............24
EMC COMPLIANCE .......................................25
Electromagnetic Emissions.........................25
Electromagnetic Immunity for All Equipment
and Systems ...............................................26
Electromagnetic Immunity for Non Life-
Supporting System .....................................27
Recommended Separation Distances for Non-
Life Supporting Equipment .........................28
COVER REMOVAL
ACCESS TO DIFFERENT COLLIMATOR
COMPONENTS...............................................31
ADJUSTMENTS
FIELD SIZE INDICATION ADJUSTMENT.............32
Shutter Dial Adjustment ..............................32
CROSSHAIR ADJUSTMENT .............................32
Friction Brake Adjustment ..........................32
MECHANICAL MOTION STOP ADJUSTMENT .....33
Adjustment of Stops ...................................33
CLOSED Stop Long and Cross Shutters....33
OPEN Stop - Long Shutters .......................33
OPEN Stop - Cross Shutters ......................33
....................................................................34
TROUBLESHOOTING
SUBSTITUTIONS
SUBSTITUTION OF THE HALOGEN LAMP .........36
SUBSTITUTION OF THE ELECTRONIC TIMER ....36
SPARE PARTS
R221/A - R221/A DHHS STANDARD ............37
Labels .........................................................37
OPTIONAL ITEMS
RO 001/A Fixed Mounting Flange ..............38
RO 002 Iron Spacer....................................39
RO 041 Mylar Mirror ...................................39
RO 051 Rotating Mounting Flange .............40
RO 058 Rotating Mounting Flange .............41
RO 063 Final Control Testing .....................41
RO 074 Customized Housing .....................41
RO 077 Centering Device...........................41
RO 082 Mirror.............................................42
RO 096 Customized Wiring ........................42
RO 107 Customized Knobs ........................42
RO 109 Customized Frame ........................42
RO 111 Customization of Front Panel ........42
RO 202 Auto Centering Top Cover ............42
RO 240 Focus-Skin Distance Spacer .........43
RO 242/1 Single Laser ...............................44
RO 253 Plastic Spacer Guides ...................45
RO 258 Additional Variable Filtration - Manual
Selection.....................................................45
RO 258/1 Additional Variable Filtration -
Manual Selection ........................................45
RO 318 Auto Centering Cover with Plastic
Flange.........................................................46
RO 333 White LED .....................................46
Vertical Alignment.......................................47
Longitudinal Alignment (Long)....................47
Transversal Calibration (CROSS) ..............48
RO 336 Spacer Guides ..............................51
RO 339 Double Laser for Optical SID ........51
RO 382 LED on Front Panel.......................52
RO 441 Plastic Flange, 50° Rotation..........53
RO 442 Plastic Flange, 90° Rotation..........53
MAINTENANCE
CLEANING RECOMMENDATIONS .....................54

MTR221/A DHHS
MTR221/A DHHS -
2
DISINFECTION ...............................................54
RECOMMENDED MAINTENANCE PROGRAM .....54
GENERAL
REPAIRS.......................................................56
END OF LIFE DISPOSAL.................................56
WARRANTY...................................................56
COMPONENTS NOT COVERED BY THIS
WARRANTY...................................................57
DISASSEMBLY ...............................................57
TRANSPORT AND STORAGE ...........................57
SAFETY/RESPONSIBILITY ...............................58
RESIDUAL RISKS...........................................58

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
ADVISORY
1
R221/A - R221/A DHHS - Advisory
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 ARADIOLOGICAL 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:
IFTHE 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 AWAY OUTSIDE ITS INTENDED USE;
THE COLLIMATOR WAS NOT INSTALLED BY COMPETENT PERSONNEL;
THE COLLIMATOR WAS NOT OPERATED SAFELY OR IN AWAY 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 AWAY 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.

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
ADVISORY
2
R221/A - R221/A DHHS - Advisory
Ralco srl
THE COLLIMATOR DESCRIBED HERE, IS USED ON RADIOLOGICAL SYSTEMS AND IS CLASSIFIED AS ATYPE 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".
•S
AFETY 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.
•O
PERATION 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. ITIS UP TO THE INSTALLER AND OPERATOR TO ENSURE THAT
ALL POSSIBLE STEPS ARE FOLLOWED TO ENSURE THE HEALTH AND SAFETY OF THE PATIENT AND OPERATOR.

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
ADVISORY
3
R221/A - R221/A DHHS - Advisory
Ralco srl
SYMBOLS
INTHIS 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 ATRANSLATION 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: [phone]
FAX: [phone]
E-MAIL: [e-mail]

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
SYMBOLS
4
R221/A - R221/A DHHS - Symbols
Ralco srl
SYMBOLS
Description No. Ref. IEC
Alternating Current 01-14 417-iec
503
Direct Current 01-18 417-iec
5031
Continuous and Alternating
Current 01-19 417-iec
5033
Protective Ground 01-20 417-iec
5019
Plus; Positive Polarity 01-27 417-iec
5019
Minus; Negative Polarity 01-28 417-iec
5006
Input 01-36 417-iec
5006
Output 01-37 417-iec
5034
Remote Control 01-38
Manual Control 01-45 ISO 7000-096
Automatic Control (Closed
Loop) 01-46 iso 7000-0017
Iris Diaphragm: Open 01-69 iso 7000-0017
Iris Diaphragm: Closed 01-70 417-iec
5324
General Warning Sign 03-02 iec 601-1
Radiation Filter or Filtration 04-51 417-iec
5381
Light Indicator of Radiation Field 04-51 417-iec
5381
Beam Limiting Device: Open 04-55 417-iec
5385
Beam Limiting Device: Closed 04-56 417-iec
5386
Beam Limiting Device: Closed
with Separate Opening of the
Shutters 04-57 417-iec
5387
Beam Limiting Device with
Separate Closing of the Shutters 04-58 417-iec
5388
Type B Applied Part 02-02 601-i-iec

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
SYMBOLS
5
R221/A - R221/A DHHS - Symbols
Ralco srl
Caution: Laser Radiation 60825-1
Electrostatic-Sensitive Device
Cassette Size Sensing Device
Device Requiring Proper
Disposal attch.4 2002/95/CE
Follow Instructions for Use ISO 7010-M002
Description No. Ref. IEC

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
DESCRIPTION
6
R221/A - R221/A DHHS - Description
Ralco srl
DESCRIPTION
Multilayer, square field, manual collimation system with a lightweight and compact
design intended for installation on mobile and stationary 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, four of which are lead-lined. The six pairs of
shutters move perpendicularly within the X-ray field. Two pairs of brass shutters are located
near the focus, two are located near the entrance window and two are located near the exit
window of the X-ray beam from the collimator. The latter shutters serve to accurately define the
X-ray field edges.
Shutter movements are manual, controlled by two knobs on the collimator front panel.
CHARACTERISTICS
Mounting Plane at 80 mm (3.14") from the focus.
Continuous Film Coverage from Min: 00 x 00 cm to Max: 48 x 48 cm at 100 cm (40") SID.
Maximum Radiation Leakage: 150 kVp - 4 mA.
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.
Halogen Lamp providing high luminosity for the X-ray field projection.
Minimum Inherent Filtration 2 mm aluminium equivalent.
GC-Led-5A timer board for light source supply and operation.
Fig. R221/A- R221/A DHHS Front Panel with Exterior Dimensions
This collimator may have the following optional items; a detailed description is provided in the
chapter OPTIONAL ITEMS.

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
DESCRIPTION
7
R221/A - R221/A DHHS - Description
Ralco srl
RO 001/A Fixed mounting flange, 20 mm thickness
RO 002 Spacers for mounting flange; 1.5 mm thickness
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
RO 063
Final control testing (light intensity, light field/radiation field alignment,
radiation leakage, light field border contrast ratio, general funcitonality and
electronic)
RO 074 Customized external cover color
RO 077 Potter Bucky light centering device (BL)
RO 082 Mirror 0.8 mm thickness, filtration equivalent 1 mm Al
RO 096 Customized wiring
RO 107 Customized knobs
RO 109 Customized cover
RO 111 Personalized front panel
RO 202 Top auto-centering plate for fixed metal flange
RO 240 Focus-skin spacers, preventing X-ray exposure too close to the patient
RO 242/1 Single laser aligning the collimator to the Potter Bucky with power supply
included
RO 253 Plastic spacer guides to assemble DAP
RO 258 Additional variable filtration through three filters on rotating support 1 mm Al +
(0.1 mm CU O 0.2 mm CU O 2 mm Al), manual selection
RO 258/1 Additional variable filtration through three filters on rotating support 1 mm Al +
(0.1 mm CU O 0.2 mm CU O 0.3 mm CU), manual selection
RO 318 Auto-centering top plate with coupling for plastic flange allowing rotation of the
collimator, the plastic flange is included
RO 333 White LED
RO 336 Aluminium accessory guides
RO 339 Device equipped with 2 lasers for optical SID
RO 382 LED on front panel
RO 441 Plastic flange with a notch rotating +/- 50°, 20 mm thickness without stop
(available only for collimators assembled with RO 318)
RO 442 Plastic flange with a notch rotating +/- 90°, 20 mm thickness without stop
(available only for collimators assembled with RO 318)

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
SPECIFICATIONS
8
R221/A - R221/A DHHS - Specifications
Ralco srl
SPECIFICATIONS
Specifications of the basic version of the collimator are described here below.
Power Supply 24 V AC/ DC - 50/60 Hz - 6.5 A
Fuse for power supply protection collimator. Not
supplied by Ralco. T 8 A
Motor Supplied by Collimator Board n.a.
Fuse for Power Supply Protection Collimator. Not
supplied by Ralco. n.a.
Inherent Filtration Al. Equivalent
X-ray beam = 75 kV
EN 60601-1-3 par. 7.3; 7.4
Min. Al 2 mm (1 mm on request)
Filtration, Additional
X-ray beam = 75 kV
EN 60601-1-3 par. 7.5
n.a.
Limitation of Extra Focal Radiation
Set Focus Distance, SID 1 m
EN 60601-2-54
< 150 mm
Square X-ray Field Selection
100 cm (40") SID - (± 1% SID)
EN 60601-2-54
Min: 00 x 00 cm
Max: 48 x 48 cm
Round X-ray Field Selection
1 m SID - (± 1% SID)
EN 60601-2-54
n.a.
Light Field Indicator
Luminosity at 1 m from the focus, field size set at 35x35
cm.
EN 60601-2-54
> 160 lx
Light Field Indicator - Contrast
Edge Contrast Setting 35x35 cm at 1 m SID
EN 60601-2-54
> 4:1
Light Field Indicator Precision
Light Field/X-ray Field Correspondence
EN 60601-2-54
< 1 % SID>
Accuracy of X-ray field as shown on the front display
versus actual X-ray field dimension. n.a.
X-ray Field Indication Precision
Settings on an Index Scale
EN 60601-2-54
< 2% SID>

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
SPECIFICATIONS
9
R221/A - R221/A DHHS - Specifications
Ralco srl
SID: (optional)
Precision of Measurement with Retractable Tape
EN 60601-2-54
< 2% SID
Maximum Radiation Leakage
Measured at 100 cm with X-ray Beam = 150 kVp - 4 mA
EN 60601-2-54
< 40 mRh
Potentiometers
Square Field
Round Field
n.a.
n.a.
Maximum Load for Accessory Guides
GUIDES FOR ACCESSORIES (IF ASSEMBLED): PRIOR TO INSERTING
ACCESSORIES IN THE GUIDES CHECK ON THE PERFECT ATTACHMENT
OF THE SUPPORT WITH THE MOUNTING SLOT ON THE COLLIMATOR
(TOLERANCE MAX. ± 0,5 MM). AFAULTY ATTACHMENT COULD BE
DANGEROUS AND IT COULD CAUSE THE FALL OF ACCESSORIES
Static load: 70 N (about 7.1 Kg)
Dynamic load: 15 Nm (approx.
3.06 Kg)
Operation Environment
• Ambient Temperature
• Relative Humidity
• Atmospheric Pressure
10°- 40°C
0%- 75%
700 - 1060 hPa
Storage
• Temperature
•Humidity
• Atmospheric Pressure
-40° - 70°C
10% - 95%
500 - 1060 hPa
Weight 7.7 Kg
Dimensions
L: 270.5 mm
W: 183 mm
H: 168 mm

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
INSTALLATION
10
R221/A - R221/A DHHS - Installation
Ralco srl
INSTALLATION
X-RAY TUBE COMPATIBILITY
• Using the dimensions in Fig. Tube Compatibility below, ensure the near port limiter can
be inserted in to the X-ray tube port.
• Check that the tube housing literature indicates congruent minimum inherent filtration (1
mm) and, that maximum radiation leakage is 30 mR/hour measured at 1 m from the source
when operating at its leakage technique factors (150 kVp - 4 mA).
• Source values (tube housing-collimator) must not be less than 3 mm Al for filtration and
must never exceed 100 mR/hr for radiation leakage [21 CFR sub-chapter J, part 1020.30
(m) (1)].
• The distance between the X-ray tube focus and the flange mounting plane (collimator
upper plate) must be: 80 mm (3.14"), tolerance +/- (0.04”).
Fig. Tube Compatibility
MOUNTING THE COLLIMATOR TO THE X-RAY TUBE
Mounting the Flange
• Use the X-ray tube housing literature to determine the distance from the focal spot to the
tube port face.
• Subtract the resulting distance from 80 mm (3.14") and determine the number of 1.5 mm
(0,06") spacers that, combined with the thickness of the mounting flange , will make up the
difference. Allowable tolerance is 1 mm. (0.04"), see Fig. Mounting Flange in this Chapter.
• Make sure that the flange is supplied with collimator.
• The collimator/X-ray tube mounting flange shows the letter F "front/knob". Place the flange
with the letter turned toward the X-ray tube front, see Fig. Mounting Flange in this
Chapter.
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.

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
INSTALLATION
11
R221/A - R221/A DHHS - Installation
Ralco srl
• 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.
• Tighten the screws.
Mounting the Collimator to the Flange
• Unscrew the four mounting Allen screws until the four tabs are withdrawn from the
collimator top opening, see Fig. Mounting Flange in this Chapter.
• 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
all directions and, that the collimator face is parallel to the table axis.
• Loosen the screws and adjust if required.
•
IMPORTANT
TO SAFEGUARD THE OPERATOR AND PATIENT AGAINST THE HAZARD OF AFALLING
COLLIMATOR, THE FOLLOWING INDICATIONS MUST BE RESPECTED.
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.

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
INSTALLATION
12
R221/A - R221/A DHHS - Installation
Ralco srl
Fig. Mounting Flange

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
INSTALLATION
13
R221/A - R221/A DHHS - Installation
Ralco srl

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
INSTALLATION
14
R221/A - R221/A DHHS - Installation
Ralco srl
ELECTRICAL CONNECTION
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 therelating safety standards must
be complied with.
Power Supply Connection
• Remove the part of cover to access the terminal, see Chapter- COVER REMOVAL.
• Connect supply cables to the relative collimator terminals and earth on the screw marked
with the relating symbol: . Use the protective earth cable with green/yellow
insulation.
• In collimators with a free cable stop, remove the cable stop, connect the supply cables,
remount and then secure the cable stop.
THE WIRING DIAGRAM INCLUDED IN THIS CHAPTER REFERS TO THE STANDARD PRODUCT.
ITIS 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 ARISK OF ELECTRICAL SHOCK.
THE DEVICE IS PROJECTED TO OPERATE WITH APERMANENT POWER SUPPLY PRESENT
SO THE PROCEDURE OF SWITCHING OFF THE COLLIMATOR IS NOT FORESEEN.
NORISK OR DEVICE DAMAGE WILL OCCUR IF THE MACHINE IS ACCIDENTLY SWITCHED OFF.
COLLIMATOR MUST BE SUPPLIED AS SPECIFIED, SEE CHAPTER- SPECIFICATIONS. THE SUPPLY
MUST COME FROM ASEPARATE 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°CAND COLLIMATOR CURRENT
ABSORPTION.