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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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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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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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.

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Precautions Against Mechanical Hazards
SAFE HANDLING OR ROTATING MACHINERY
• Never service rotating machinery, bands or chains when rotational movements are activated.
• Make sure that the rotational movements are switched off.
• Make sure that nobody can switch on the movements accidentally.
• Block the movement, if necessary.
Safe handling of tilting machinery
• Never service tilting machinery when tilting movements are activated or brakes are released.
• Make sure that the tilting movements are switched off.
• Make sure that nobody can switch on the movements accidentally.
• Block the movements, if necessary.
If you tilt the machinery during installation or during other service activities:
• Comply with the specific service instructions.
• Ask a second person to release the brake and to keep the tilting movement under control.
• Avoid uncontrolled tilting movement.
• Never release the brake longer than necessary.
Hazard of physical injury caused by heavy loads
• Wear appropriate protective clothing, such as safety boots an gloves.
• Take care that heavy loads are correctly lifted or carried to avoid any physical injury.
• Ask other persons for help to handle very heavy or awkwardly shaped loads.
• Use mechanical devices whenever it is possible.
• Stick to the installation instructions regarding:
• suitable tools
• lifting devices
• lifting/support points
• particular safety measures
If you do not obey these instructions, there is a risk of property damage.
Safe handling of light source
Light source and adjacent parts can be very hot. They can cause severe burns.
• Never touch the light source, light source socket, or light source bracket with your fingers immediately after use.
• Leave the light source and adjacent parts to cool down before handling them.
Precautions Against Electrical Hazards
Hazard of electrical shock during service tasks
During installation , maintenance, and other service tasks there is a risk of electrical hazards.
• Follow the general instructions provided in this chapter.
If you do not obey these instructions, there is a risk of property damage.
General precautions against electrical hazards
• Switch off the mains supply.
• Make sure that nobody can switch on the system accidentally before you start.
• Make sure that all UPS-powered components are powerless.
• Use a voltmeter to verify that all line disconnects are opened.
• Remove all jewellery, such as bracelets, or rings to prevent short circuits.
Precautions concerning installation and service
Electrical installations of medically used rooms must comply with the requirements of each country.
Follow the instructions provided on the installations sheets for the specific project.
• Always use a separate conductor for ground connection. The neutral conductor is not considered as ground
connection.
• Do not use a three-to-two pins adapter to connect equipment provided with a power cord. Always connect the
equipment to properly grounded, three-pin power outlets.
• Connect the system to the mains as late as possible during installation.
• Make sure that all protective earth conductors are installed and connected before first switching on the system.
• Always be sure that the power is switched off when installing any parts to the equipment.
• Make sure that the large internal capacitors are completely discharged. Discharging can take several minutes.
• Keep away water or other liquids from the inside or the equipment to avoid short-circuits or corrosion.
• After installation or service work on electrical components the following test have to be performed to ensure the
compliance with IEC 62353:
• Touch voltage
• Protective earth conductor resistance
• Earth leakage measuring

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Working when connected to voltages
• Switch off the main power supply when working at the equipment. This rule does not apply for certain measuring and
adjustment procedures that are only possible when the product is switched on.
• Never measure or adjust equipment with power-on unless another person is present.
• Be very careful when working close to live contacts.
• Never perform any work on live parts (> 50 V).
• Prevent unwanted or sudden movements of the system because they are dangerous. If the procedure involves
mechanical movements, take every precaution especially when working with moving and rotating parts. Use the
service switch or the EMERGENCY STOP button before working within the dangerous movement area of a product.
• Check the ground connections before touching conductive system parts.
• Use tools and measuring instruments, which are suitable for the respective procedure only.
• Make sure that est and adjustment points re accessible without any risk of injury. If safe access is not possible,
switch off the system.
• Turn off the power supply immediately after finishing the test or adjustment procedure.
Safe handling of high-voltage cables
• When the mains and auxiliary power supplies are disconnected: Wait at least two minutes before removing the
flexible high-voltage cables from the X-ray tube housing or the generator.
• Discharge any residual charge before touching the contact pins (briefly connect them to ground).
Precaution Against Material Damage
ENVIRONMENTAL CONDITIONS FOR SAFE OPERATION
• The oxygen content of the ambient air during operation must be lover than 25%!
• The X-ray equipment must not be operated along with combustible anaesthesia substances!
• Ensure that the indoor temperature is within +10 - +40°C.
• Ensure that the indoor relative humidity is within 10 - 75%.
• Ensure that the air pressure is within 700 - 1060 hPa
Cleaning and disinfection
• Do not use aggressive cleaning agents to clean the product!
• When you use cleaning agents such as detergents and disinfectants, make sure that they do not contain explosive
substances as they can create explosive gas mixtures!
• Obey the manufacturer’s data of the cleaning agent and disinfectant!
• Obey the manufacturer’s data of the cleaning clothes!
Malfunction through electromagnetic fields
The equipment fulfils all requirements concerning electromagnetic compatibility (EMC).
nevertheless, powerful high frequency transmitters used near the electronic components can cause malfunction of
electronic components under unusual circumstances. This malfunctions causes unwanted risks for patients, operators,
and service personnel.
• Switch off your mobile phone in designated areas.
If you do not obey these instructions, there is a risk of property damage.
Processor overheating
The processor can get damaged within a few seconds.
• Do not operate the processor without cooling.
If you do not obey these instructions, there is a risk of property damage.
Damage by electrostatic discharge (ESD)
ESD can destroy or partially damage electrostatic sensitive devices such as printed circuit boards (PCB). The damage can
lead to instant or later failures of the device.
• Read all the following instructions concerning ESD protection.
• Take all necessary precautions to protect electrostatic sensitive devices.
If you do not obey these instructions, there is a risk of property damage.
The rules concerning ESD protection apply to new devices and old devices and old devices. Old devices are replace and
sent back to the service depot.
Additional symbols on the collimator (if applicable)
or AC Alternating Current No. 01-14 Ref. IEC 417-IEC 503
or DC Direct Current No. 01-18 Ref. IEC 417-IEC 5031

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or AC/DC Alternating and Direct Current No. 01-19 Ref. IEC 417-IEC 5033
Protective Ground No. 01-20 Ref. IEC 417-IEC 5019
Plus, Positive Polarity No. 01-27 Ref. IEC 417-IEC 5019
Minus, Negative Polarity No. 01-28 Ref. IEC 417-IEC 5006
Input No. 01-36 Ref. IEC 417-IEC 5006
Output No. 01-37 Ref. IEC 417-IEC 5034
Remote Control No. 01-38 Ref.
Manual Control No. 01-45 ISO 7000-096
Automatic Control (Closed Loop) No. 01-46 ISO 7000-0017
Iris Diaphragm: Open No. 01-69 ISO 7000-0017
Iris Diaphragm: Closed No. 01-70 Ref. 417-IEC 5324
Radiation Filter or Filtration No. 04-51 Ref. 417-IEC 5381
Light Indicator of Radiation Field No. 04-51 Ref. 417-IEC 5381
Beam Limiting Device: Open No. 04-55 Ref. 417-IEC 5385
Beam Limiting Device: Closed No. 04-56 Ref. 417-IEC 5386
Beam Limiting Device: Closed with Separate Opening of the Shutters No. 04-57 Ref. 417-IEC 5387
Beam Limiting Device with Separate Closing of the Shutters No. 04-58 Ref. 417-IEC 5388
Cassette Size Sensing Device
Device Requiring Proper Disposal, Attch. 4 Ref. 2002/95/CE

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Type B Applied Part No. 02-02 Ref. 601-I-IEC (Not applicable for R 915, R 915 S and R 915 S DHHS)
Follow Instructions for Use Ref. ISO 7010-M002 (see the collimator label)
General Warning Sign No. 03-02 Ref. IEC 601-1
Caution: Laser Radiation Ref. 60825-1
This symbol identifies electrostatic sensitive devices.
• Always transport electrostatic sensitive devices (such as PCB) in their static shielding bags or
boxes.
• Always use the ESD protection service kit when handling electrostatic sensitive devices.
• Attach the wristband to your wrist (1) and connect the ground cable of the wristband
to the conductive work surface (2).
• Connect the second ground cable (3) to the conductive work surface (2).
• Attach the crocodile clip to a
reliable ground of the cabinet
or console, where the PCB
has to be installed.
• Place the PCB on the conductive work
surface before installing them.
• Place the PCB on the conductive work
surface for hardware settings or
replacement of components.
• Never remove or disconnect the
wristband before all electrostatic
sensitive devices are installed.
• Never remove or disconnect the
wristband before all removed
electrostatic sensitive devices are
safely packed in their static shielding
bags or boxes.
Safety Signs on the Product
• Do not remove or change safety signs!
• Replace illegible safety signs by genuine spare parts!
• Clean soiled safety signs!
Refer to the labelling drawings of the components to see the positions of the labels.
Safety of Personal Protective Equipment
• The collimator does not contain polluting materials or products with the exception of the lead that composes the
shutters and an inner lining of the collimator cover, if properly disposed of at the end of its life cycle.
• Avoid direct contact with lead especially for prolonged periods.
• Gloves must be worn when handling the disassembled collimator, especially the parts mentioned above.
• Do not use for any other work.
• Disposable gloves may also be worn and can be disposed with normal trash.
Disposal
• Dispose any material, batteries and X-ray equipment in accordance with the requirements of national legislation!
• Do not dispose X-ray equipment together with domestic waste!
Fig. 1 ESD protection kit

MTR 221 ACS - MTR 221 ACS DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
INTRODUCTION
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Model R 221 ACS - R 221 ACS DHHS
MTR 221 ACS - MTR 221 ACS DHHS - Introduction
• All Ralco’s products conform to RoHS
• All Ralco’s products conform to REACH
Safety Messages Reported Into The Manual
WARNING
This symbol combined with the signal word WARNING indicates a hazardous situation which, if not avoided, could
result in death or serous injury.
If you do not obey these instructions, there is a risk of death or serious injury.
CAUTION
This symbol combined with the signal word CAUTION indicates a hazardous situation which, if not avoided, could
result in minor or moderate injury.
If you do not obey these instructions, there is a risk of minor or moderate injury.
The shown symbols are sometimes replaced by other symbols which indicate the concrete risk:
Material Damage
NOTICE
This symbol combined with the signal word NOTICE indicates a hazardous situation which, if not avoided, could
result in damages such as material damage. This damage is not related to personal injury.
If you do not obey these instructions, there is a risk of property damage.
Other Messages
Important
This symbol combined with the signal word Important indicates an important advice that points out that certain
guidelines, parameters, conditions or restrictions must be observed.
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: [email protected]

MTR 221 ACS - MTR 221 ACS DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
DESCRIPTION
8
Model R 221 ACS - R 221 ACS DHHS
MTR 221 ACS - MTR 221 ACS DHHS - Description
DESCRIPTION
Multilayer, square field, automatic 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 motorized, controlled by stepper motors. Shutters may be adjusted
manually with the two knobs on the collimato front panel or remotely via CanBus controls.
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
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.
Internal Accessory Guides used for DAP chamber, if present.
Retractable Tape mounted on the radiological unit, measures the distance between the
focus and the patient.
Resin Rotating Mounting Flange allows the collimator to rotate, 20mm thickness, 0°
detent, 140mm diameter.
Single Laser for the alignment of the collimator to the receptor (Class 1).
GC 007 electronic board which controls the two stepper motors of square field and one
motor for filter positioning.
GC 009 electronic board which controls the display, inclinometer and 2 encoders.
GC-LED-4A timer board for light source supply and operation.
Power Cable 10 m.
Fig. R 221 ACS - R 221 ACS DHHS Front Panel with Exterior Dimensions

MTR 221 ACS - MTR 221 ACS DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
DESCRIPTION
9
Model R 221 ACS - R 221 ACS DHHS
MTR 221 ACS - MTR 221 ACS DHHS - Description
This collimator may have the following optional items; a detailed description is provided in the
chapter OPTIONAL ITEMS.
RO DESCRIPTION
RO 002 Iron mounting flange spacer: 1.5mm thickness
RO 054 Square iron mounting flange spacer: 1.5mm thickness
RO 063
Final quality test report documentation (Light field, luminosity, light to X-ray field
correspondence, light field border contrast ratio, x-ray leakage, control of general
functions)
RO 074 External housing and guide rails in customized color
RO 082 Glass mirror with minimum internal inherent filtration: 1mm Al equivalent
RO 096 Wiring customization
RO 107 Knob color customization
RO 109 Front panel frame color customization
RO 111 Front panel customization
RO 203 Self-centering top-cover bracket for Siemens X-ray tube only (mounting flange
provided by Siemens only)
RO 210 Aluminium accessory guide rails painted in standard housing color (unless RO
074 selected)
RO 240 Focal-spot to skin spacer
RO 242/1 Single laser line to align collimator and detector center: Class 2
RO 242/2 Two lasers (one mounted externally) forming a crosshair to center the patient to
the detector: Class 2
RO 253 Accessory guide rail spacers painted in standard housing color (unless RO 074
selected)
RO 278 Fixed near focal shutters (single layer collimation) for use with a mounting plane
of 80mm from the X-ray focus
RO 305
Additional variable filtration - automatic selection. 4 position rotating wheel with
selectable filters (clockwise): (1) empty or (2) 0.1mm Cu+1mm Al or (3) 0.2mm
Cu+1mm Al or (4) 2mm Al

MTR 221 ACS - MTR 221 ACS DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
DESCRIPTION
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Model R 221 ACS - R 221 ACS DHHS
MTR 221 ACS - MTR 221 ACS DHHS - Description
RO 305/1
Additional variable filtration - automatic selection. 4 position rotating wheel with
selectable filters (clockwise): (1) empty or (2) 0.1mm Cu or (3) 0.2mm Cu or (4)
0.3mm Cu
RO 308 External analogic/digital interface in metal housing with 10 meter connecting
cable
RO 329 Internal proximity sensor
RO 330 Connecting cable extension
RO 332/A Resin rotating mounting flange: 15mm thickness, 0° detent/stop, 140mm
diameter including fixing screws (not available with RO 492 or RO 498)
RO 336 Aluminium accessory guide rails (rail distance 150mm and 176mm)
RO 344 Accessory guide rail spacers with support painted in standard housing color
(unless RO 074 selected)
RO 356 Shutter position verified by potentiometer: Output signal managed by customer
RO 405 Housing customization: Aluminum
RO 409
Resin rotating mounting flange milled to form a square: 20mm thickness, +/-0°
detent, 140mm diameter + three iron mounting flange spacers milled to form a
square: 1.5mm thickness (not available with RO 492 or RO 498)
RO 441 Resin rotating mounting flange: 20mm thickness, +/-50° detent, 140mm diameter
(not available with RO 492 or RO 498)
RO 442 Resin rotating mounting flange: 20mm thickness, +/-90° detent, 140mm diameter
(not available with RO 492 or RO 498)
RO 444 Collimator control protocol: CANopen (CiA 412-2)
RO 445 Metal rotating mounting flange, 20mm thickness, +/-90° mechanical stop, 140mm
diameter (not available with RO 492 or RO 498)
RO 456 Metal rotating mounting flange: 20mm thickness, +/-90° mechanical stop, 136mm
diameter (only available with RO 492)
RO 476 Asymmetric longitudinal and transversal shutters (increased housing
dimensions: 244x282x216cm - R 225 ACS housing)
RO 484 Infrared control box to command collimator functions (only available with RO 476)
RO DESCRIPTION

MTR 221 ACS - MTR 221 ACS DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
DESCRIPTION
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Model R 221 ACS - R 221 ACS DHHS
MTR 221 ACS - MTR 221 ACS DHHS - Description
RO 489 Resin rotating mounting flange: 20mm thickness, +/-45° detent, 140mm diameter
(not available with RO 492 or RO 498)
RO 490 Metal rotating mounting flange, 18mm thickness, +/-90° mechanical stop, 140mm
diameter with countersunk mounts (only available with RO 492)
RO 492 Adjustable top-cover bracket for use with metal mounting flange (mounting flange
not included)
RO 493 Dual energy additional variable filtration: 200ms per 90° movement (filters not
included- only available with RO 494)
RO 494 Customized additional variable filtration
RO 495 Camera assembled internally for patient monitoring: IP ethernet interface
RO 496 Software customization
RO 510/A Resin rotating mounting flange: 18mm thickness, +/-90° detent, 140mm
diameter (not available with RO 492 or RO 498)
RO 525 Knob customization
RO 526 Semiautomatic mode (front panel with push buttons included)
RO 530 Resin rotating mounting flange: 17mm thickness, +/-0° detent, 140mm diameter
(not available with RO 492 or RO 498)
RO 533 Glass mirror + aluminum plate with minimum internal inherent filtration: 2.3mm Al
equivalent
RO 537 Addition of electronics and motorized shutter movement to render automatic
collimator into manual collimator
RO 544 7" touchscreen display
RO 556 Measuring tape removal
RO 570 Shutter position verified by encoders
RO 582 Metal fixed mounting flange: 16mm thickness, 136mm diameter (only available
with RO 492)
RO 587/1 Two lasers forming a single line at 1-meter SID: Class 1
RO DESCRIPTION

MTR 221 ACS - MTR 221 ACS DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
DESCRIPTION
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Model R 221 ACS - R 221 ACS DHHS
MTR 221 ACS - MTR 221 ACS DHHS - Description
RO 587/2 Two lasers (one mounted externally) forming a crosshair to center the patient to
the detector: Class 1
RO 597 Asymmetric longitudinal and transversal shutters
RO 609 Self-centering top-cover bracket with zero position output signal using a
microswitch (resin mounting flange not included)
RO 619
Resin rotating mounting flange: 15mm thickness, +/-90° detent, 140mm
diameter, 0° position tolerance +/-3° with fixing screws (only available with RO
609)
RO DESCRIPTION