Ralco R 221 ACS DHHS Series User manual

Instruction Manual
MTR 221 ACS - MTR 221 ACS DHHS
AUTOMATIC RADIOLOGICAL COLLIMATOR
Confidential Information
SERIES R 221 ACS DHHS
DATE OF ISSUE:
25.05.2019
REVISION LEVEL:
H - 04.10.2021
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 ACS STANDARD VERSION
R 221 ACS DHHS FDA CERTIFIED VERSION AVAILABLE ON
REQUEST
Rev. N Date N
A 29.10.2019 MRD/042/19
B 15.11.2019 MRD/044/19
C 17.04.2020 MRE/006/20
D 01.09.2020 MRM/004/20
MRE/002/20
E 08.04.2021 MRD/001/21
F 29.07.2021 MRM/055/21
G 13.09.2021 MRD/016/21
H 04.10.2021 ACD/012/21

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.

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MTR 221 ACS - MTR 221 ACS DHHS -
CONTENTS
INTRODUCTION
DESCRIPTION
CHARACTERISTICS ..........................................8
SPECIFICATIONS
INSTALLATION
X-RAY TUBE COMPATIBILITY..........................16
MOUNTING THE FLANGE TO THE X-RAY TUBE 17
ALIGNMENT OF X-RAY TUBE FOCUS AND
COLLIMATOR.................................................19
Alignment Device........................................20
Mounting the Collimator to the Flange........20
VERIFICATION OF CORRECT INSTALLATION....23
ELECTRICAL CONNECTION.............................25
Power Supply Connection ..........................26
Wiring Diagram ...........................................27
OPERATION INSTRUCTIONS
RADIOGRAPHY ..............................................32
Automatic Operation of Square Field (Long
and Cross) ..................................................32
TOMOGRAPHY...............................................33
Tomography Mode......................................33
Exposure Hold Mode ..................................33
Inclinometer HOLD Mode ...........................33
Light Field Operation ..................................33
CALIBRATION
CENTERING X-RAY BEAM WITH COLLIMATOR
LIGHT ...........................................................35
LIGHT FIELD TO X-RAY FIELD ALIGNMENT ......36
LIGHT FIELD ADJUSTMENT ............................37
Vertical Alignment.......................................37
Longitudinal Alignment (Long) ....................37
Light Field Adjustment ................................38
Transversal Calibration (CROSS)* .............38
ELECTRONIC SYSTEM
GC 007 BOARD............................................39
Characteristics ............................................39
Characteristics ............................................43
GC-LED-4A.................................................47
GC 24 V Power Supply Converter ..............52
SYSTEM START-UP
DESCRIPTION OF CONFIGURATION CONTROLS54
UPDATING OF FIRMWARE ..............................55
Functional Overview ...................................55
Bill of Material .............................................55
Installation...................................................56
Workflow .....................................................56
HW Setup ...................................................57
Copy ...........................................................57
Install ..........................................................58
Issues List...................................................58
CONFIGURATION VIA SERIAL INTERFACE ........59
POTENTIOMETER POSITIONING ALARMS .........59
CAN BUS MESSAGES
MESSAGE LIST OVERVIEW ............................60
COLLIMATOR CONFIGURATION.......................61
QUICK START GUIDE
BOARD GC 007............................................93
Description..................................................93
COMPLIANCE VERIFICATION
MINIMUM FILTRATION REQUIREMENT .............95
Visual Determination of Half-Value Layer
(HVL) ..........................................................96
Quick-Check of Minimum Filtration
Requirement at a Particular kVp.................96
Standard Absorber Method ........................96
VISUAL DEFINITION OF X-RAY VERSUS LIGHT
FIELD ...........................................................97
FIELD SIZE INDICATION .................................97
CROSSHAIR ALIGNMENT................................98
CHAPTER- ADJUSTMENTS, PARAGRAPH
CROSSHAIR ALIGNMENT................................98
LIGHT FIELD ILLUMINATION INTENSITY............98
EMC COMPLIANCE .......................................98
Electromagnetic Emissions ........................99
Electromagnetic Immunity for All Equipment
and Systems.............................................100
Frequency Range and Level: RF wireless
communication EQUIPMENT ...................100
COVER REMOVAL
ADJUSTMENTS
CROSSHAIR ADJUSTMENT ...........................105
LASER ADJUSTMENT ...................................105
MOTOR ADJUSTMENT..................................106
TROUBLESHOOTING
SUBSTITUTIONS
LED SUBSTITUTION ....................................112
Replacing the Previous Version LED .......113
Replacing the New Version LED ..............114
SUBSTITUTION OF THE ELECTRONIC BOARD
FOR LED....................................................115
SUBSTITUTION OF THE ELECTRONIC BOARD
GC 007 .....................................................116
SUBSTITUTION OF RETRACTABLE TAPE
MEASURE...................................................117
SUBSTITUTION OF THE LASER .....................118
SUBSTITUTION OF THE MIRROR ...................119
PHOTOCELL SUBSTITUTIONS .......................120
SPARE PARTS
LABELS ......................................................121
Parts Breakdown ......................................125
OPTIONAL ITEMS
RO 002 Iron Mounting Flange Spacer......126
RO 054 Square Iron Mounting Flange
Spacer ......................................................127

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RO 063 Final Quality Test Report
Documentation..........................................127
RO 074 External housing and guide rails in
customized color.......................................127
RO 082 Glass Mirror.................................128
RO 096 Wiring Customization ..................128
RO 107 Knob Color Customization...........128
RO 109 Front panel frame color
customization............................................128
RO 111 Front panel customization ...........128
RO 203 Self-centering top-cover bracket for
Siemens X-Ray tube.................................128
RO 210 Aluminium Acessory Guides .......130
RO 240 Focal-spot to skin spacer ............130
RO 242/1 Single laser line to align collimator
and detector center: Class 2.....................131
RO 242/2 Two lasers (one mounted
externally) forming a crosshair to center the
patient to the collimator: Class 2...............133
RO 253 Accessory guide rail spacers in
standard housing color .............................137
RO 278 Fixed Near Focal Shutters...........137
RO 305 Additional Variable Filtration -
Automatic Selection ..................................138
RO 305/1 Additional Variable Filtration.....139
RO 308 External Board ASR003 ..............139
RO 329 Internal Proximity Sensor ............166
RO 330 Connecting cable extension ........168
RO 332/A Resin Rotating Mounting
Flange.......................................................169
RO 336 Aluminium accessory guide rails .169
RO 344 Accessory guide rail spacers with
reinforced support.....................................170
RO 356 Shutter position verified by
potentiometer............................................170
RO 405 Housing Customization ...............170
RO 409 Resin Rotating Mounting Flange .171
RO 441 Resin Rotating Mounting Flange .171
RO 442 Resin Rotating Mounting Flange .172
RO 444 Can Open Protocol......................172
RO 445 Metal Rotating Mounting Flange .173
RO 456 Metal Rotating Mounting Flange .174
RO 476 Asymmetric longitudinal and
transversal shutters ..................................174
RO 484 Infrared Remote Control Box.......176
RO 489 Resin Rotating Mounting Flange .177
RO 490 Metal Rotating Mounting Flange .178
RO 492 Adjustable Top-Cover Bracket ....178
Alignment Device......................................182
Mounting the Collimator to the Flange......183
RO 493 Dual Energy Additional Variable
Filtration ....................................................185
RO 494 Customized Additional Variable
Filtration ....................................................186
RO 495 Camera assembled internally for
patient monitoring .....................................186
RO 496 Software Customization ..............192
RO 510/A Resin Rotating Mounting
Flange.......................................................192
RO 525 Customized Knob design ............193
RO 526 Semiautomatic mode (front panel
with push buttons included) ......................193
MANUAL CONFIGURATION ............................193
Calibration Start-Up ..................................193
Configuration Procedure...........................194
RO 530 Resin Rotating Mounting Flange.203
RO 533 Glass Mirror.................................203
RO 537 Addition of electronics and motorized
shutter movement to render automatic
collimator into manual collimator ..............203
RO 544 7” Touchscreen Display ..............203
RO 556 Measuring Tape Removal ...........212
RO 570 Shutter position verified by
encoders...................................................212
RO 582 Metal Fixed Mounting Flange......213
RO 587/1 Two lasers forming a single line at 1-
meter SID: Class 1 ...................................214
RO 587/2 Two lasers (one mounted external-
ly) forming a crosshair to center the patient to
the collimator: Class 1 ..............................216
RO 597 Asymmetric longitudinal and transver-
sal shutters ...............................................219
RO 609 Self-Centering Top-Cover Bracket
with Zero Position Output Signal ..............219
RO 619 Resin Rotating Mounting Flange with
Position Indicator ......................................229
MAINTENANCE
CLEANING RECOMMENDATIONS ...................230
DISINFECTION.............................................230
RECOMMENDED MAINTENANCE PROGRAM ...230
GENERAL
WARRANTY ................................................232
REPAIRS ....................................................232
END OF LIFE DISPOSAL...............................233
DISASSEMBLY.............................................233
TRANSPORT AND STORAGE .........................233
SAFETY/RESPONSIBILITY.............................234
RESIDUAL RISKS.........................................235

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MTR 221 ACS - MTR 221 ACS DHHS - Introduction
INTRODUCTION
General Safety Information
Ralco products are designed and manufactured to meet the international safety standards for medical equipment.
However, all medical electrical equipment requires proper installation, operation and servicing, particularly with regard to
human safety.
Read, note, and strictly observe all safety tags on the equipment. Strictly observe all safety directions, all warnings and all
cautions that are mentioned in this chapter and throughout this service documentation. In order to protect the personal
health of service personnel, operators and patients, ensure the safe servicing and operation of the system.
Intended Use of the Collimator
This collimator is designed to be used with a Radiological system producing ionizing radiation for medical or veterinary
use. Whomever is authorized to operate or service the radiological equipment must be thoroughly familiar with the
procedures related to radiation protection and equipment use and maintenance.
Ralco is not responsible for any personal injuries or damage to property from misuse or unintended use of this collimator.
This manual must be made available to the installer and operator.
Installer and Operator Responsibility
The installer and operator must verify that ALL safety standards are followed immediately after installation of the
collimator and before any subsequent use. All procedures regarding the installation and safe use of this collimator must
be strictly followed.
X-ray equipment manufacturer responsibility
If the X-ray equipment manufacturer does not use the READY signal, allowing X-ray exposures regardless of collimator
state or status, all liability falls upon the X-ray equipment manufacturer. In the event of any emergency and the READY or
ERROR signals are bypassed allowing X-ray exposures, all the liability falls upon the X-ray equipment manufacturer.
The collimator electronics supplies a signal defined as READY. The X-ray equipment manufacturer will manage this
signal as the X-ray consent. In the event of a collimator failure, the liability for the correct bypass of this signal, in order to
always ensure the X-ray consent, devolves upon the X-ray equipment manufacturer.
Reporting
Information regarding accidents that have occurred while using this collimator must be reported immediately to Ralco, srl.
Limitation of Liability
Ralco is not liable if the provided instructions are not complied with. Furthermore, Ralco is not liable if one or several of
the following instances apply:
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.
The collimator complies with current standards for static load, a non-wearing class. This statement is based on
studies and tests performed on the collimator performance and its weight. If the final system, through tilting movements
or other dynamic movements, increases the risk factor other than those studied and tested, it is the responsibility of the
customer to ensure that there are no dangerous situations.
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:
IEC 60601-1:2005 + Am1:2012 (ed. 3.1), North American market deflections (US+CA)
IEC 60601-1-2:2014 (ed 4)
IEC 60601-1-3:2008 + Am1:2013 (ed. 2.1)
IEC 60601-2-54:2009 + Am1:2015 (ed. 1.1)
IEC 60601-2-45:2011 + Am1:2015 (ed. 3.1) Applicable in Mammography instead of IEC 60601-2-54:2009
IEC 60601-1-6:2010 + Am1:2010 (ed. 3.1) (Usability)
IEC 62304:2006 + Am1:2015 (ed. 1.1) (Software)
IEC 60825-1:2014 (LASER - if applicable)
IEC 62471:2006 (LED - if applicable)
ISO 9001:2015
ISO 13485:2016

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MTR 221 ACS - MTR 221 ACS DHHS - Introduction
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 all possible steps are followed to ensure the health and safety of the
patient and operator.
The contact with the moving parts can be considered impossible and may occur only during installation or maintenance
(low hazard). The internal parts are protected by a mechanical safeguard in the form of a metal or plastic sheath which
impedes access. Also motor units are not accessible as knobs are fixed using the Allen screws and can be removed only
by using a tool, in accordance with paragraph 5.92.3 of EN 60601-1 and EN 60601-2-54 par. 201.9.2.2.5. In addition the
collimator has been tested in accordance with EN 60601-1, paragraph 4.8.2
Read all information in this chapter carefully.
You are responsible to take safety precautions and to follow the safety instructions. Thus, you can prevent harm
form yourself and other persons.
TECHNICALLY QUALIFIED PERSONNEL ONLY!
• Only technically qualified Field Service Engineers (FSEs) must do the service work. The FSEs must be appropriately
and successfully trained and instructed.
• Perform all service tasks such as installation, maintenance, or repair in strict compliance with the provided safety
instructions!
• Perform all action as for example unpacking, installation, setting to work, testing and replacement according to the
sequence stated in this manual.
• Perform all service tasks in strict compliance with the local regulations concerning safety, health, accident preven-
tion, and medical X-ray devices!
• Never change any system parameters or components that reduce the mechanical safety, electrical safety, radiation
protection properties of the product!
• Do not modify this equipment without authorization of Ralco.
Any unauthorized modification can cause malfunction or deterioration of performance and quality and can therefore
lead to personal injury, clinical misdiagnosis or clinical mistreatment.
• Never leave problems unsolved that may affect the safety of the product!
• Order spare parts via Ralco distribution channel.
• Always perform all relevant safety checks before handing the product over to the customer!
• Keep in mind that certain details or procedures change since you previously installed or serviced a similar product!
If you do not obey these instructions, there is a risk of death or serious injury.
A temperature of the collimator cover, under normal operating conditions and at the maximum ambient operating
temperature (40°C), could exceed 41°C. According to the Table 24 of the General IEC 60601-1 standard, contact with the
collimator cover must be less than 1 minute, both for the operator and for the patient. During the diagnostic test the
operator must pay attention that the patient does not come into contact with the collimator surface for more than 1 minute.
If you do not obey these instructions, there is a risk of serious injury.