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MTR221/A - MTR221/A DHHS

MANUALE ISTRUZIONI / INSTRUCTION MANUAL

Modello/Model R221/A - R221/A DHHS

OMPLIANCE

ERIFICATION

R22

1/A

- R221

/A DHHS -

omplia

nce V

erification

Ralco

srl

Electromagnetic Immunity for Non Life-Supporting System

The R221/A - R221/A DHHS collimator is intended for use in the electromagnetic environment specified below. The customer

or the user of the collimator should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test
Level

Compliance
Level

Electromagnetic
Environment

Portable and mobile RF

communications equipment should be

used no closer to any part of the R221/

A - R221/A DHHS, including cables,

then the

recommended separation distance

calculated from the equation

applicable to the frequency of the

transmitter.

Recommended Separation Distance

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2,5 GHz

3 V/m

=1.2

√

80 MHz to 800MHz

=2.3

√

800 MHz to 2.5GHz

Conducted RF
IEC 61000-4-6

3 V/m

150 kHz to 80 GHz

3 V

d= 1.2 x

√

Where

is the maximum output power

rating of the transmitter in watts (W)

according to the transmitter

manufacturer and

is the

recommended separation distance in

metres (m).

Field strengths from fixed RF

transmitters, as determined by an

electromagnetic site survey, should be

less than the compliance level in each

frequency range.

Interference may occur in the vicinity of

equipment marked with the following

symbol:

Содержание MTR 221/A

Страница 1: ...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...

Страница 2: ...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 RALC...

Страница 3: ...on 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...

Страница 4: ...R MUST ENSURE THE FOLLOWING HAS BEEN PROVIDED YOUR SPECIFIC CODE IS CLEARLY VISIBLE ON THE BACK LABEL AFTER CUSTOMIZATION ABOVE THE SERIAL NUMBER TO ENSURE THE CORRECT PERSONALIZED COLLIMATOR HAS BEEN...

Страница 5: ...MATOR 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 S...

Страница 6: ...ISINFECTION 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 RESPO...

Страница 7: ...ES 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 IMMEDI...

Страница 8: ...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 INTE...

Страница 9: ...E 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 AVA...

Страница 10: ...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...

Страница 11: ...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 2...

Страница 12: ...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 CHARACTERIST...

Страница 13: ...02 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 p...

Страница 14: ...equest 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...

Страница 15: ...r 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 MA...

Страница 16: ...nd 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 li...

Страница 17: ...bility in this Chapter For the collimator to rotate to position 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 exc...

Страница 18: ...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...

Страница 19: ...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...

Страница 20: ...and then secure the cable stop THE WIRING DIAGRAM INCLUDED IN THIS CHAPTER REFERS TO THE STANDARD PRODUCT IT IS THE RESPONSIBILITY OF THE CUSTOMER WHO HAS REQUESTED AN ELECTRIC CUSTOMIZATION TO ENSURE...

Страница 21: ...del R221 A R221 A DHHS INSTALLATION 15 R221 A R221 A DHHS Installation Ralco srl Remount the cover INCORRECT POWER SUPPLY COULD DAMAGE THE ELECTRONIC TIMER AND OR THE LIGHT SOURCE SUPPLY MAY BE EITHER...

Страница 22: ...MTR221 A MTR221 A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R221 A R221 A DHHS INSTALLATION 16 R221 A R221 A DHHS Installation Ralco srl Wiring Diagram...

Страница 23: ...the light field is factory set at 30 seconds tol 20 It is adjustable from 30 to 45 seconds via a trimmer on the timer board The normal ON OFF cycle is set at 1 minute followed by an idle time of 4 min...

Страница 24: ...asure in collimators with this feature The type of tape measure used is a standard tape mounted on a radiological unit The tape starts with values that correspond to the focus collimator lower edge di...

Страница 25: ...30 cm 12 x 12 at 1 meter 40 Activate the light field and use it to position 18 coins as shown in the diagram Position each pair of coins touching one another so that the inner coin is lighted as much...

Страница 26: ...ulations Greater precision than this is possible Recommended maximum deviation is one fourth It is important the greatest degree of congruency possible is achieved If misalignment is detected in both...

Страница 27: ...ght Field Adjustment Vertical Alignment If the light field is smaller than the X ray field lower the lamp by adjusting screw C If the light field is bigger than the X ray field raise the lamp by adjus...

Страница 28: ...less than that shown in the following table The information contained in the above table was extracted from the Code of Federal Regulations FDA 21 1020 30 m Type 100 Aluminium Alloy as given in ALUMIN...

Страница 29: ...ctor of 90 kVp and appropriate mA and time values with no added filtration in the beam record the reading Using the type 1100 Aluminium Alloy tape a total of 2 5 mm of Aluminium to the window of the c...

Страница 30: ...DJUSTMENTS paragraph Field Size Indication CROSSHAIR ALIGNMENT CHAPTER ADJUSTMENTS PARAGRAPH CROSSHAIR ALIGNMENT LIGHT FIELD ILLUMINATION INTENSITY a When a light field simulating the X Ray field is u...

Страница 31: ...ble for use in the specified electromagnetic environment The purchaser or user of the R221 A R221 A DHHS should assure that it is used in an electromagnetic environment as described below Emissions Te...

Страница 32: ...vel Electromagnetic Environment Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air EN 60601 1 2 test level Hospital Electronical fast transient burst IEC 61000 4 4 2 kV for power supply l...

Страница 33: ...any part of the R221 A R221 A DHHS including cables then the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distanc...

Страница 34: ...ications equipment Rated Maximum Output Power of Transmitter W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d 1 2 x P 80 MHz to 800 MHz d 1 2 x P 800 MHz to 2 5 GHz d...

Страница 35: ...EMOVAL 29 R221 A R221 A DHHS Cover Removal Ralco srl COVER REMOVAL 1 REMOVE THE TWO KNOBS BY UNSCREWING THE TWO DOWELS PER KNOB 2 REMOVE THE SNAP FIT FRONT PANEL BY PRISING IT OFF AS SHOW IN THE PHOTO...

Страница 36: ...del R221 A R221 A DHHS COVER REMOVAL 30 R221 A R221 A DHHS Cover Removal Ralco srl GENTLY EASE THE TAPE INTO THE COLLIMATOR REMOVE THE SCREW FROM THE SNAP FIT PLATE REMOVE THE PLATE AND THEN LIFT THE...

Страница 37: ...odel R221 A R221 A DHHS COVER REMOVAL 31 R221 A R221 A DHHS Cover Removal Ralco srl ACCESS TO DIFFERENT COLLIMATOR COMPONENTS a ACCESS THE COLLIMATOR POWER SUPPLY BY REMOVING COLLIMATOR BACK PANEL b A...

Страница 38: ...he edges of the shutters see Fig Cross Line If adjustment is required remove the cover from the sides and bottom of the collimator see Chapter COVER REMOVAL Loosen the four screws securing the plastic...

Страница 39: ...eck that the shutters touch Use the field light to check that shutters are closed Rotate the cam stop to a stand still Tighten the Allen screw Open and close the shutters sev eral times to check that...

Страница 40: ...MTR221 A MTR221 A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R221 A R221 A DHHS ADJUSTMENTS 34 R221 A R221 A DHHS Adjustments Ralco srl Fig Long Shutters Fig Cross Shutters...

Страница 41: ...tters Problem Cause Solution The light source fails to switch ON Collimator supplied incorrectly Check Supply Tension Current Polarity Fuses Faulty light source Check item Replace if necessary see Cha...

Страница 42: ...ess the component see Chapter COVER REMOVAL Remove the two screws holding the electronic timer see Fig Timer GC 338 Identify the cables and their position on the terminal board see Chapter INSTALLATIO...

Страница 43: ...Description RS 006 Lamp 24 V 100W RS 033 Lamp holder ceramic RS 041 Panel anti dust RS 047 Push button up to s n 2762 RS 063 Timer electronic GC 338 24 V RS 112 Frame plastic RS 124 Screws fixing for...

Страница 44: ...eld A definitely indistinct edge indicates that the primary shutter close to the focal spot is the one forming the line rather than the outermost shutter To correct the condition use the four mounting...

Страница 45: ...odello Model R221 A R221 A DHHS OPTIONAL ITEMS 39 R221 A R221 A DHHS Optional Items Ralco srl RO 002 Iron Spacer This accessory is used for the mounting flange 1 5 mm thickness RO 041 Mylar Mirror Myl...

Страница 46: ...istinct edge indicates that the primary shutter close to the focal spot is the one forming the line rather than the outermost shutter To correct the condition use the four mounting centering adjustmen...

Страница 47: ...O 077 Centering Device Centering device of the Potter Bucky BL Reflects the lamp light to form a bright line to align collimator to Potter Bucky Adjustment Remove the collimator rear cover to gain acc...

Страница 48: ...rical wiring if ordered please see Chapter PERSONALIZATIONS paragraph Wiring Diagram RO 107 Customized Knobs The customer can specify the required knob color RO 109 Customized Frame The customer can s...

Страница 49: ...Skin Distance Spacer This accessory ensures a minimum safety distance 309 5 mm between the X ray focus and the patient THIS ACCESSORY DEALS WITH PREVENTING THE USE OF INAPPRO PRIATE SMALL FOCUS SKIN...

Страница 50: ...llen screw when the laser beam falls on or is parallel to the bisector line drawn on the anti dust panel Shift the laser system by loosening the two B screws holding the laser system base to the beam...

Страница 51: ...ays and accommodates the following three filters 0 no filtration 0 1 mm copper 1 mm Al Al eq 2 8 mm 0 2 mm copper 1 mm Al Al eq 5 6 mm 1 mm aluminum 1 mm Al support Setup of Filters Rotate the alumini...

Страница 52: ...ntersink screws For the collimator to rotate to position two of the four tabs retract to allow to rotation Adjust and tighten the four Allen screws as follows screws 1 and 3 7 turns until the tongue t...

Страница 53: ...ew D If the light field is bigger than the X ray field raise the light source by adjusting screws D Tighten the two screws C See Fig Light Field Adjustment Longitudinal Alignment Long Remove part of t...

Страница 54: ...REMOVAL Loosen the mirror fixing screw A not remove and shift it to adjust the posi tion of the mirror see Fig Transver sal Calibration CROSS Once you have regulated the mirror tighten the screw A an...

Страница 55: ...ON NUMBER OUTPUT OFF LED and laser are controlled by only push button on J2 ON LED is controlled by standard push button on J2 laser is controlled independently by push button on JP6 JP6 BUTTON INPUT...

Страница 56: ...wo fixing screws Solder the two wires Check on light field X ray field correspondence Fig LED Substitution Trimmers TR1 CURRENT CONTROL Adjust the output current intensity to the LED Step less current...

Страница 57: ...el near the collimator controls see Fig Laser Line Adjust the position of the line by rotating or moving the base of the laser system To rotate the laser system loosen the Allen screw A see Fig Laser...

Страница 58: ...imer cables from the terminal board white 0 V red 5 V Remove the laser and substitute with an identical item Tighten the screws Check the laser alignment see Chapter ADJUSTMENTS Remount the cover see...

Страница 59: ...nge 50 Rotation Plastic flange with notch allowing 50 rotation of the collimator without stop 20 mm thickness Available only if collimator is assembled with optional item RO 318 RO 442 Plastic Flange...

Страница 60: ...rectives covering disinfection and protection against explosion hazards Disconnect supply Disinfect the unit including accessories and cables with a dampened cloth Do not spray the unit with the disin...

Страница 61: ...st window Do not use abrasive or inflammable cleaning products Wipe away all excess oil and remount the cover MAKE SURE TO TIGHTEN THE ALLEN SCREWS SECURING THE COLLIMATOR OR THE CONTROL TABS APPROPRI...

Страница 62: ...13 G 20853 BIASSONO MB ITALIA FAX 39 039 2497 799 EMAIL RALCO RALCO IT END OF LIFE DISPOSAL Your collimator contains materials which can be recycled and reused Specialised companies can recycle your...

Страница 63: ...accessories In warranty spares will be available only upon return to Ralco at the customer s expense of the parts considered to be faulty to allow Ralco to assess the cause of the fault COMPONENTS NO...

Страница 64: ...in this manual The unit has not been subject to routine functional inspection The unit has not been subject to routine maintenance The unit has been repaired with unoriginal spare parts Ralco shall de...

Страница 65: ...s and or suggestions to p vescera ralco it Date Customer Information regarding possible accidents that may have occurred while using the collimator Directive 2007 47 CE states that accidents such as d...

Страница 66: ...info_cl fm...

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