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