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DX-D 600

User Manual

0242F EN 20181218

11

1.6

APPLIED PARTS

Applied Parts refer to parts of the medical equipments that in Normal Use
necessarily comes into physical contact with the patient for the medical
equipment to perform its function. These equipments include the following
Applied Parts:

RAD TABLE



Tabletop of the RAD Table



Hand Grips (optional)



Compression Band (optional)



Other accessories

RAD WALL STAND DR



Front panel of the RAD Wall Stand DR



Hand Grips



Overhead Hands Support (optional)



Other accessories

BEAR IN MIND THAT SOME APPLIED PARTS MAY HEAT UP
TO 48

o

C (118.4

o

F) WHEN THE AMBIENT TEMPERATURE

FOR OPERATION IS ON THE LIMIT. THIS IS COMPLETELY
NORMAL AND DOES NOT MEAN A MALFUNCTION OF THE
EQUIPMENT.

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Summary of Contents for DX-D 600

Page 1: ...DX D 600 User Manual Technical Publication 0242F EN 20181218 ...

Page 2: ......

Page 3: ...s upgrade E MAR 24 2015 New Flat Tabletop of the RAD Table Collimator Mechanical Detents New Overhead Patient Holder Lateral DR Detector 35x43 Holder with Trolley Specifications Update F DEC 18 2018 New DX D 600 System Label IEC Standards update Errors List Upgrade Modification of the name of the Legal Manufacturer Applied Parts Heating Warning 1000 mA Generator option General Upgrades This Docume...

Page 4: ...L INJURY OR DEATH ADVISE OF CONDITIONS OR SITUATIONS THAT IF NOT HEEDED OR AVOIDED COULD CAUSE SERIOUS PERSONAL INJURY OR CATASTROPHIC DAMAGE OF EQUIPMENT OR DATA Advise of conditions or situations that if not heeded or avoided could cause personal injury or damage to equipment or data Note Alert readers to pertinent facts and conditions Notes represent information that is important to know but wh...

Page 5: ...16 2 3 Maximum Permissible Dose MPD 17 2 4 Radiation Protection 18 2 5 Monitoring of Personnel 20 2 6 Safety Symbols 20 2 7 Regulatory 25 2 7 1 Certifications 25 2 7 2 Environmental Statement on the Life Cycle of the Equipment or System 25 2 7 3 Mode of Operation 25 2 7 4 Protection Against Electric Shock Hazards 26 2 7 5 Protection against Harmful Ingress of Water or Particular Matter 26 2 7 6 Pr...

Page 6: ...Suspension Movements 68 4 2 1 Ceiling Suspension Manual Motion 69 4 2 2 Detent Points 70 4 2 3 Automatic movements 72 4 2 3 1 Automatic Positioning Control Box 72 4 2 3 2 Remote Control 73 4 2 3 3 Emergency Stop for Automatic Movements 78 4 2 3 4 Automatic Movements Safety Policy 78 4 2 3 5 X ray Interlock 80 4 2 3 6 Auto Center 81 4 2 3 7 Auto tracking 83 4 2 3 8 Auto positioning 93 4 2 4 Positio...

Page 7: ...tical Movements 122 6 1 2 1 DR Vertical Auto positioning 122 6 1 2 2 DR Vertical Auto tracking 122 6 2 Footswitch Operation 122 6 3 Tilting 123 6 4 DR Detector Rotation 125 6 5 Alignment 127 6 6 Portable DR Detector Loading 128 6 7 Using and Maintaining the DR Detector 128 6 8 Grid Loading and Removal 129 6 9 Accessories 130 6 9 1 Overhead Hands Support 130 6 9 2 Mobile Overhead Patient Support 13...

Page 8: ...o Verify the Proper Functioning of the AEC 161 10 PERIODIC MAINTENANCE 163 10 1 Operator Tasks 163 10 2 Service Tasks 164 11 TECHNICAL SPECIFICATIONS 165 11 1 Environmental Requirements 165 11 2 X ray System Positioners 165 11 2 1 Power Line Requirements 165 11 2 2 Information Related to Radiation 166 11 2 3 Dimensions and Product Weight 166 11 3 X ray Generator 176 11 3 1 Factors 176 11 3 2 Range...

Page 9: ...Control Console but it is just motorized the vertical axis to allow the Auto tracking function Other axis are not motorized so it is not possible to complete fully the Auto position functions G Automatic Ceiling Suspension with the Touchscreen Control Console Auto positioning Auto centering and Auto tracking functions available RAD Elevating Table available in double panel systems RAD Wall Stand D...

Page 10: ...tor Ralco R225ACS Automatic Collimator X Ray Tubes Canon E7252X Canon E7254FX Canon E7869XX Canon E7884X Canon E7252X Canon E7254FX Canon E7869XX Canon E7884X Longitudinal Rails 3 4 4 0 4 6 5 3 6 m 3 4 4 0 4 6 5 3 6 m Transverse Rails 2 0 2 25 2 5 2 75 3 0 3 5 m 2 0 2 25 2 5 2 75 3 0 3 5 m Movements policy Manual movements and motorized movement only in vertical axis Manual movements and motorized...

Page 11: ...ptor Fixed DR Detector Portable DR Detector Fixed DR Detector Portable DR Detector Sensing Tray Grid 132 Lines 10 1 FFD 1 m 132 Lines 10 1 FFD 1 5 m 132 Lines 10 1 FFD 1 8 m 132 Lines 10 1 FFD 1 m 132 Lines 10 1 FFD 1 5 m 132 Lines 10 1 FFD 1 8 m Ion Chamber AEC Claymount SSMC 617 Claymount SSMC 617 Functionalities DR Vertical Auto tracking DR Vertical Auto tracking DR Auto positioning X ray Gener...

Page 12: ...for radiographic operations and X Ray Tube positioning are shown on the Touchscreen Control Console Light weight telescopic column design with four independent parts guided by a high precision alignment mechanism for a smooth and quiet operation This rigid and durable design reduces instability and vibration to the minimum to facilitate precision in positioning Optimal mechanical balancing system ...

Page 13: ...EILING SUSPENSION Fully manual positioning in all axis with Vertical Axis motorized for automatic movement Auto positioning Auto tracking and Auto centering in Vertical Axis AUTOMATIC CEILING SUSPENSION Motorized positioning in all axis for automatic movement Full servo electronics for balancing and positioning Auto positioning Auto tracking and Auto centering in all axes ...

Page 14: ...ing axis Double click action pedalavoiding any incident while patient is unattended DR Detector max 430 x 430 mm Configurable automatic stops at 3 different height levels maximum minimum and intermediate Accessories Handgrips Compression Band and Lateral Cassette Holder The Hand grips must not be positioned in the trajectory of the X Ray beam Equipped with Emergency OFF Switch to stop the whole Sy...

Page 15: ... with internal counterweights DR Detector max 430 x 430 mm Manual Tilting which provides DR Detector angulation from 90o horizontal position to 20o DR Detector Rotation of 90o Optional spacer for Single Panel Systems it means that there is just one DR Detector which can operate vertically and horizontally Accessories Handgrips and Overhead Hands Support ...

Page 16: ...that provides all the advantages of high frequency wave form Generators including lower patient dose shorter exposure times and greater accuracy and consistency Three point control by selecting kVp mA and ms or two point control by selecting kVp and mAs no AEC or one point control by selecting kVp with AEC operations Automatic Exposure Control AEC Fail safe function Receptor detection and exposure...

Page 17: ...me identification labels attached to them which provide the following manufacturer and product information Product Model Volts V Line Phases Frequency Hz and Power kVA kW Date of manufacture Serial number Reference Manufacturer Place of manufacture Certification Illustration 1 6 X ray System Labeling Location ...

Page 18: ...abled disabled immobilized or in a state of shock The DX D 600 X ray System contributes to the metrics of imaging performance ensuring the efficient use of radiation The X ray image receptors used in this system are Digital Detectors 1 5 2 NORMAL USE The Normal Use of this X ray System is defined as the Intended Use plus the Maintenance and Service tasks 1 5 3 CONTRAINDICATIONS Do not use this X r...

Page 19: ...nts include the following Applied Parts RAD TABLE Tabletop of the RAD Table Hand Grips optional Compression Band optional Other accessories RAD WALL STAND DR Front panel of the RAD Wall Stand DR Hand Grips Overhead Hands Support optional Other accessories BEAR IN MIND THAT SOME APPLIED PARTS MAY HEAT UP TO 48 oC 118 4 oF WHEN THE AMBIENT TEMPERATURE FOR OPERATION IS ON THE LIMIT THIS IS COMPLETELY...

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Page 21: ...ANUAL CAREFULLY INSTRUCTIONS HEREIN SHOULD BE THOROUGHLY READ AND UNDERSTOOD BEFORE ATTEMPTING TO PLACE THE EQUIPMENT IN OPERATION ESPECIALLY THE INSTRUCTIONS CONCERNING SAFETY REGULATIONS DOSAGE AND RADIATION PROTECTION KEEP THIS OPERATING MANUAL WITH THE EQUIPMENT AT ALL TIMES AND PERIODICALLY REVIEW THE OPERATING AND SAFETY INSTRUCTIONS TECHNICAL INSTRUCTIONS FOR SERVICE PERSONNEL SUCH AS PRE I...

Page 22: ...HODS INCLUDING CLINICAL WORKING EXPERIENCE AND AS PART OF MANY COLLEGE AND UNIVERSITY RADIOLOGIC TECHNOLOGY PROGRAMS IN ACCORDANCE WITH LOCAL LAWS OR REGULATIONS SERVICE PERSONNEL MUST HAVE SUFFICIENT KNOWLEDGE TO COMPETENTLY PERFORM THE SERVICE TASKS RELATED TO X RAY DEVICES AND PARTICULARLY TO THE EQUIPMENT DESCRIBED IN THIS MANUAL THIS KNOWLEDGE IS ACQUIRED THROUGH A VARIETY OF EDUCATIONAL METH...

Page 23: ...1 2 PATIENT SUPPORT movable without articulated joints including stationary layers 1 7 1 7 PATIENT SUPPORT with radiolucent panel having onearticulated joint 1 7 1 7 PATIENT SUPPORT with radiolucent panel having two or more articulated joints 2 3 2 3 PATIENT SUPPORT cantilevered 2 3 2 3 Note 1 Devices such as RADIATION DETECTORS are not included in the item listed in this table Note 2 Requirements...

Page 24: ...PATIENTS OR PERSONNEL TO X RAY RADIATION GENERATED BY THIS EQUIPMENT WHICH IS A RESULT OF POOR OPERATING TECHNIQUES OR PROCEDURES NO RESPONSIBILITY WILL BE ASSUMED FOR ANY EQUIPMENT THAT HAS NOT BEEN SERVICED AND MAINTAINED IN ACCORDANCE WITH THE MANUFACTURER INSTRUCTIONS OR WHICH HAS BEEN MODIFIED OR TAMPERED WITH IN ANY WAY IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE THE SAFETY OF THE PAT...

Page 25: ...D THE OVEREXPOSURE OR THE NEED OF PERFORMING A NEW EXAM TO THE PATIENT MAKE SURE THAT THE X RAY TUBE IS SET IN WORKING POSITION WITH THE REFERENCE AXIS X RAY BEAM POINTING TO THE RECEPTION AREA 2 3 MAXIMUM PERMISSIBLE DOSE MPD Before operation people qualified and authorized to operate this equipment should be familiar with the Recommendations of the International Commission on Radiological Protec...

Page 26: ...tend over a period of months or years The best safety rule for an X ray operator is Avoid exposure to the primary beam at all times Any object in the path of the primary beam produces secondary scattered radiation The intensity of secondary radiation depends on the energy and intensity of the primary beam and the atomic number of the object material struck by the primary beam Secondary radiation m...

Page 27: ...area of interest will be completely exposed and the X ray field does not exceed the area of interest Select a Focal Spot to patient skin distance SID as large as possible to keep the absorbed dose for the patient as low as reasonably possible The radiation dose decreases or increases according to the Focal Spot to patient skin distance SID the greater the SID distance the lower the radiation dose ...

Page 28: ...g the amount of exposure is the placement of film at strategic locations After a specified period of time develop the film to determine the amount of radiation A common method of determining whether personnel have been exposed to excessive radiation is the use of personal radiation dosimeters These consist of X ray sensitive film or thermoluminiscent material enclosed within a holder that may be w...

Page 29: ...armful ingress of water or particulate matter IP Classification Ordinary Ionizing radiation Non ionizing electromagnetic radiation Radiation of Laser apparatus Do not stare into beam Only applicable to equipment with Laser Pointer Dangerous voltage General warning caution risk of danger Warning Ionizing radiation ...

Page 30: ...fingers between mobile and fixed parts of the equipment it may cause serious injuries to patient or operator As well make sure the patient extremities are correctly positioned into limit areas during operation movement of parts may cause serious damages to patient Electrostatic sensitive devices No pushing No sitting No stepping on surface ...

Page 31: ...op ON power OFF power ON OFF push push Each position ON or OFF is a stable position Alternating current Three phase alternating current Three phase alternating current with neutral conductor N Connection point for the neutral conductor on Permanently Installed equipment ...

Page 32: ...with local or country laws The letters below the symbol indicate whether certain elements Li Lithium PB Lead CD Cadmium Hg Mercury are contained in the battery All batteries removed from the equipment must be properly recycled or disposed Please contact an authorized representative of the manufacturer or an authorized waste management company for information concerning the decommissioning of your ...

Page 33: ...nforms to DHHS radiation Standards of 21CFR subchapter J as of the date of manufacture 2 7 2 ENVIRONMENTAL STATEMENT ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM This equipment or system contains environmentally dangerous components and materials such as PCBs electronic components used dielectric oil lead batteries etc which once the life cycle of the equipment or system comes to an end becomes da...

Page 34: ...O THE USER 2 7 5 PROTECTION AGAINST HARMFUL INGRESS OF WATER OR PARTICULAR MATTER Protection against harmful ingress of water or particulate matter Ordinary IPx0 in accordance with Standard IEC 60601 1 1988 2005 and 2012 2 7 6 PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES Degree of Safety in the presence of Flammable Anesthetics Mixture with air or with oxygen or with ni...

Page 35: ...w the following control functions from a Protected Area refer to illustration below Selection and control of modes of operation Selection of loading factors for the exposure Actuation of the exposure controls Other necessary controls for the operator during exposure PATIENT ENVIRONMENT Table Base EXAM ROOM OPERATOR CONTROL PROTECTED AREA NO RADIATION AREA Generator Patient environment center posit...

Page 36: ...ficant Zone of Occupancy for the use of the operator and staff designated as follows Illustration 2 1 Radiographic Examination on the RAD Wall Stand DR SID 100 cm Focal Spot 1400 mm S1 S2 S S SIGNIFICANT ZONE OF OCCUPANCY MINIMUM AREA 60 x 60 cm MINIMUM HEIGHT ABOVE THE FLOOR 200 cm SIGNIFICANT ZONE OF OCCUPANCY AT THE RIGHT SIDE OF THE RAD WALL STAND DR X ray Tube Tube Support Collimator X ray Re...

Page 37: ...DE OF THE RAD TABLE CATHODE SIGNIFICANT ZONE OF OCCUPANCY AT THE LEFT SIDE OF THE RAD TABLE ANODE RAD TABLE S3 S4 S5 Focal Spot X ray Tube S SIGNIFICANT ZONE OF OCCUPANCY MINIMUM AREA 60 x 60 cm MINIMUM HEIGHT ABOVE THE FLOOR 200 cm SID 100 cm Phantom X Ray Receptor Patient Support RAD Table S Focal Spot Focal Spot S 50 cm Dosimeter X ray Tube S6 SIGNIFICANT ZONE OF OCCUPANCY AT BACK SIDE OF THE R...

Page 38: ...y attenuation coefficient Radiation measuring instrument Low Radiation Dosimeter The results have been obtained with a configuration that is representative of the worst case within the different configurations of the unit Refer to Illustration 2 1 for Receptor in Vertical position and refer to Illustration 2 2 for Receptor in Horizontal position The following illustration shown the Distribution of...

Page 39: ... of Stray Radiation with the Receptor in Vertical Left Position S1 HEIGHT cm STRAY RADIATION μGy h 0 20 40 60 80 100 120 140 160 180 200 0 10000 20000 30000 40000 S1 SID 50 cm S1 SID 100 cm S1 Phantom SIGNIFICANT ZONE OF OCCUPANCY ON THE LEFT SIDE OF THE RAD WALL STAND DR ...

Page 40: ...of Stray Radiation with the Receptor in Vertical Right Position S2 HEIGHT cm STRAY RADIATION μGy h 0 20 40 60 80 100 120 140 160 180 200 0 10000 20000 30000 40000 S2 SID 50 cm S2 SID 100 cm S2 Phantom SIGNIFICANT ZONE OF OCCUPANCY ON THE RIGHT SIDE OF THE RAD WALL STAND DR ...

Page 41: ...adiation within the Receptor in Horizontal Front Side Position S3 HEIGHT cm STRAY RADIATION μGy h 0 20 40 60 80 100 120 140 160 180 200 0 10000 20000 30000 40000 S3 SID 50 cm S3 SID 100 cm SIGNIFICANT ZONE OF OCCUPANCY AT THE FRONT OF THE RAD TABLE RAD TABLE S3 Focal Spot X ray Tube ...

Page 42: ...diation with the Receptor in Horizontal Left Side Position S4 HEIGHT cm STRAY RADIATION μGy h 0 20 40 60 80 100 120 140 160 180 200 0 10000 20000 30000 40000 S4 SID 50 cm S4 SID 100 cm SIGNIFICANT ZONE OF OCCUPANCY ON THE LEFT OF THE RAD TABLE ANODE RAD TABLE S4 Focal Spot X ray Tube ...

Page 43: ...ation with the Receptor in Horizontal Right Side Position S5 HEIGHT cm STRAY RADIATION μGy h 0 20 40 60 80 100 120 140 160 180 200 0 10000 20000 30000 40000 S5 SID 50 cm S5 SID 100 cm SIGNIFICANT ZONE OF OCCUPANCY ON THE RIGHT OF THE RAD TABLE CATHODE RAD TABLE S5 Focal Spot X ray Tube ...

Page 44: ...tion with the Receptor in Horizontal Back Side Position S6 HEIGHT cm STRAY RADIATION μGy h 0 20 40 60 80 100 120 140 160 180 200 0 10000 20000 30000 40000 50000 60000 S6 SID 50 cm S6 SID 100 cm RAD TABLE Focal Spot X ray Tube S6 SIGNIFICANT ZONE OF OCCUPANCY AT THE BACK OF THE RAD TABLE ...

Page 45: ... problem by one or more of the following measures reorient or relocate the affected device increase the separation between the equipment and the affected device power the equipment from a source different from that of the affected device consult the service engineers for further suggestions To comply with the regulations applicable to an electromagnetic interference for a Group 1 Class A Medical D...

Page 46: ...1 Group 1 The DX D 600 Radiographic Room use RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The DX D 600 Radiographic Room is suitable for Harmonic emissions IEC 61000 3 2 Class A The DX D 600 Radiographic Room is suitable for use in all establishments other t...

Page 47: ...l environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV symmetrical coupling 2 kV asymmetrical coupling Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for ...

Page 48: ...ters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol d 1 2 P d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagneti...

Page 49: ...scenario Device Power Frequency Recommended distance m GMRS device Professional Walkie Talkie 5 W 462 467 MHz 2 7 GSM UMTS cell phone 2 W 850 1700 1900 MHz 3 3 FRS device Amateur Walkie Talkie 500 mW 462 467 MHz 0 9 WiFi Bluetooth devices 100 mW 2400 2500 MHz 0 8 DECT devices modern cordless phones 100mW 1880 1900 MHz 0 8 RFID reader 3 10 mW 125 150 KHz 13 56 MHz 0 12 RFID reader 3 10 mW 902 928 M...

Page 50: ...ment Surge IEC 61000 4 5 0 5 kV 1 kV line s to line s 0 5 kV 1 kV 2 kV line s to earth 0 5 kV 1 kV line s to line s 0 5 kV 1 kV 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT for 0 5 cycle at 0o 45o 90o 135o 180o 225o 270o and 315o 0 UT fo...

Page 51: ...TIONS EQUIPMENT Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm to any part of the equipment including cables specified by manufacturer Otherwise degradation of the performance of this equipment could result Conducted disturbances induced by RF fields IEC 61000 4 6 3 Vrms from 150 kHz to 80 Mhz 6 Vrms in IS...

Page 52: ...l V m 380 390 Pulse modulation b 18 Hz 27 430 470 FM c 5 kHz deviation 1 kHz sine 28 704 787 Pulse modulation b 217Hz 9 800 960 Pulse modulation b 18Hz 0 3 28 1700 1990 Pulse modulation b 217Hz 0 3 28 2400 2570 Pulse modulation b 217Hz 28 5100 5800 Pulse modulation b 217Hz 9 a For some services only the uplink frequencies are included b The carrier shall be modulated using a 50 duty cycle square w...

Page 53: ...E QUANTITATIVE INFORMATION Equipment Rad Positioner with Ralco Collimator Instrumentation used Dosimeter Vacudap Dosimeter Unfors Rectangular Phantom made of Polymethyl methacrylate PMMA layers 25 cm x 25 cm x 20 cm Test Details Minimum SID distance from Table 100 cm Maximum SID distance from Wall Stand 180 cm Open Collimator size 13 cm x 13 cm min 43 cm x 43 cm max The measurements were made with...

Page 54: ...23 863 6 629 160 0 012 2 Small 100 2 1 0 016 0 025 7 615 18 691 0 062 100 0 1 10 Small 43 43 11 8 0 090 0 140 5 038 13 354 0 371 200 0 5 100 Large 43x43 107 1 0 862 1 347 9 698 23 798 3 305 40 400 1 400 Large 1 6 391 3 3 166 4 947 17 809 41 228 11 452 40 160 0 012 2 Small 1 6 0 2 0 005 0 006 1 865 4 273 0 014 100 0 1 10 Small 13 13 1 1 0 027 0 034 1 214 3 453 0 096 200 0 5 100 Large 13x13 11 0 257...

Page 55: ... 983 160 0 012 2 Small 100 7 5 0 048 0 074 22 299 233 322 0 778 100 0 1 10 Small 43 43 40 6 0 265 0 414 14 894 161 562 4 488 200 0 5 100 Large 43x43 389 3 2 691 4 205 30 277 320 682 44 539 60 400 1 400 Large 2 2 1491 3 10 435 16 304 58 696 596 348 165 652 60 160 0 012 2 Small 2 2 0 6 0 014 0 018 5 345 53 374 0 178 100 0 1 10 Small 13 13 3 9 0 078 0 098 3 538 36 438 1 012 200 0 5 100 Large 13x13 39...

Page 56: ...160 0 012 2 Small 100 14 3 0 090 0 141 42 391 829 043 2 763 100 0 1 10 Small 43 43 77 0 483 0 754 27 162 553 148 15 365 200 0 5 100 Large 43x43 735 9 4 884 7 632 54 949 1099 409 152 696 80 400 1 400 Large 2 9 2856 2 19 209 30 014 108 049 2111 165 586 435 80 160 0 012 2 Small 2 9 1 4 0 026 0 033 9 931 181 096 0 604 100 0 1 10 Small 13 13 7 2 0 142 0 179 6 462 120 177 3 338 200 0 5 100 Large 13x13 7...

Page 57: ...0 0 012 2 Small 100 21 0 137 0 215 64 362 1829 478 6 098 100 0 1 10 Large 43 43 114 8 0 735 0 140 41 371 1221 809 33 939 200 0 5 100 Large 43x43 1067 6 7 491 1 347 84 277 2346 574 325 913 100 400 1 400 Large 3 6 4373 29 791 4 947 134 061 3901 774 1354 78 100 160 0 012 2 Small 3 6 2 1 0 040 0 006 15 334 396 261 1 321 100 0 1 10 Large 13 13 11 2 0 217 0 034 9 877 263 614 7 323 200 0 5 100 Large 13x1...

Page 58: ...all 100 29 7 0 204 0 319 95 666 3558 261 11 861 100 0 1 10 Large 43 43 163 4 1 090 1 704 61 337 2407 617 66 878 200 0 5 100 Large 43x43 1595 2 11 243 17 568 126 489 4963 617 689 391 125 400 1 400 Large 4 5 5679 6 45 270 70 734 127 321 4418 609 2454 783 125 160 0 012 2 Small 4 5 2 9 0 058 0 073 21 923 776 609 2 589 100 0 1 10 Large 13 13 19 1 0 317 0 401 14 449 520 278 14 452 200 0 5 100 Large 13x1...

Page 59: ...all 100 38 5 0 262 0 409 122 731 5744 348 19 148 100 0 1 10 Large 43 43 210 7 1 444 2 257 81 244 3862 957 107 304 200 0 5 100 Large 43x43 2124 2 15 252 23 832 171 587 8057 739 1119 130 150 400 1 400 Large 5 4 8581 3 62 748 98 043 141 183 6629 009 4603 478 150 160 0 012 2 Small 5 4 3 8 0 077 0 098 29 337 1208 087 4 027 100 0 1 10 Large 13 13 24 4 0 426 0 539 19 410 819 235 22 757 200 0 5 100 Large ...

Page 60: ...lable loading factors for image performance and supply Dose indication which affect to the radiation quality or to the radiation dose rate applied in normal use As indicated in the Quantitative Information Tables the number of exposures needed to reach the previously described maximum radiation values will depend on the selected techniques for each radiographic study 2 11 PRODUCT COMPLAINTS Any he...

Page 61: ...Electrical Cabinet Switch The Emergency OFF Switch must not be activated 2 The RAD Table RAD Wall Stand and Ceiling Suspension turn ON RAD Wall Stand ON OFF Indicator turns ON green lighted 3 Press the X ray Generator Control ON button ON Indicator turns ON green lighted 4 Turn ON the NX Workstation Illustration 3 1 Start Up sequence X ray Control ON Generator RAD Table RAD Wall Stand DR Ceiling S...

Page 62: ...CEDAROUNDTHEROOM FOR GREATER ACCESSIBILITY TO ISOLATE THE EQUIPMENT FROM MAINS TURN OFF THE SWITCH LOCATED AT THE ROOM ELECTRICAL CABINET 3 2 SHUTDOWN ROUTINE TO TURN THE SYSTEM OFF 1 Turn OFF the NX Workstation 2 Press the X ray Generator Control OFF button the Green lamp turns OFF 3 Turn OFF the Room Electrical Cabinet Switch Do not activate the Emergency OFF Switch 4 The RAD Table RAD Wall Stan...

Page 63: ...HE CENTER POSITION THE TABLETOP CAN MOVE FREELY IN LONGITUDINAL AND TRANSVERSE DIRECTION WHEN MINIMAL FORCE IS APPLIED IF THE PATIENT IS STILL ON THE TABLE HE MAY NEED HELP TO STEP DOWN FROM THE RAD TABLE Illustration 3 2 Shutdown sequence NX Workstation X ray Control Room Electrical Cabinet Ceiling Suspension ON OFF Indicator RAD Wall Stand DR RAD Table OFF 1 2 3 4 4 4 r Single Panel Double Panel...

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Page 65: ...ongitudinal Rails or Axis X different lengths extrusion bars which fix the Ceiling Suspension to the ceiling They are marked with green color strips to match the Brakes Buttons of the Control Console Transverse Rails or Axis Y an horizontal structure fixed to the Longitudinal Rails by two bearings assemblies that allow the movement along the Longitudinal Rails The bearings maintain also the alignm...

Page 66: ...and supports the Telescopic Column L Block Assembly X ray Tube Support with the Tube Collimator and Control Console TELESCOPIC COLUMN It is composed of four different sized hexagonal tubes of steel Fixed to the Carriage the Telescopic Column allows vertical movement of the X ray Tube Assembly in the Vertical Axis Z This motion is controlled by the Vertical Brake The Focal Spot vertical travel is 1...

Page 67: ... Rotation X RAY TUBE SUPPORT It is designed to support the X ray Tube which can rotate around the vertical axis of the Telescopic Column Beta axis 180o from the front position 0o and it can rotate around its transverse axis Alpha axis 135o from 0o position perpendicular to the floor COLLIMATOR The Suspension can be associated with two Collimation options Ralco R225 R225 DHHS Manual Collimator Ralc...

Page 68: ...ns is pressed during an automatic motion it will be stopped immediately Illustration 4 4 Control Console and Brakes Buttons Alpha Axis Brake Angle of the X ray Tube Longitudinal Axis Brake Right Left Transverse Axis Brake Back Front Omni directional Brake Transverse and Longitudinal Vertical and or Alpha will be also activated according to the configuration during installation Vertical Axis Brake ...

Page 69: ...is almost similar with same functions but the movements policy is different Automatic System All axes are motorized and it is possible to move automatically the X ray Tube in all directions Auto positioning Auto centering and Auto tracking functions are available in all axes Semi automatic System Only Vertical Axis is motorized and it is not possible to move automatically the X ray Tube in all dir...

Page 70: ...k the Ceiling Suspension status EXPOSURE CONFIGURATION AREAS Press to select the area to be configured DATA AREA Check and modify according to the available Area Depending on the selected Exposure Configuration Area the displayed parameters change Depending on the Ceiling Suspension Configuration some of the Configuration Areas might not be displayed on the Touchscreen Console Illustration 4 6 Tou...

Page 71: ...T WORKSTATION Press to select Direct exposure when the DR Detector is not required When selected it is possible to execute an exposure at any moment without DR Detector and X ray Tube alignment AEC Controls Auto center and Auto tracking movements are not available in Direct Workstation RAD TABLE WORKSTATION Press to select exposure with the DR Detector of the RAD Table When this option is selected...

Page 72: ...etent Points Skipper No Detent Point is activated when active Active for all Workstations 4 1 3 CEILING SUSPENSION STATUS INDICATOR Current status of Ceiling Suspension are indicated at the right bottom corner of the Touchscreen Console The available status are The Ceiling Suspension is ready to make X ray exposures It is aligned with the DR Detector The Ceiling Suspension and the DR Detector are ...

Page 73: ...osition G SID G ANG or X ray Tube angle G ROT or X ray Tube rotation angle G TILT or RAD Wall Stand DR Detector tilting angle X ray Tube Position and Technique set up depending on the technique 2P or 3P parameters are different kV mAs or kV mA ms AEC set up Illustration 4 7 INFO Display When the position values are in white they indicate the current ones and in black the previously set by default ...

Page 74: ...DX D 600 User Manual 0242F EN 20181218 66 Illustration 4 8 Tube Position Description and Vertical DR Detector Tilting ANG 135o 135o 0o 180o 0o 180o ROT TILT 90o 20o 0o ...

Page 75: ...ed but it is not possible to set it up FOCAL SPOT Small or Large toggle when the Button is pressed OPERATING MODE mAs 2P or mA ms 3P toggle when the Button is pressed Configure the Technique kV and mAs for the 2P kV mA and ms for the 3P PARAMETERS Press on the INCREASE DECREASE Buttons to set up the desired values All new parameters set up modification is automatically transferred to the X ray Gen...

Page 76: ...ANDS MUST BE KEPT AWAY FROM MOBILE COMPONENTS OF THE UNIT INTRAVENOUS TUBING CATHETERS AND OTHER PATIENT CONNECTED LINES SHOULD BE ROUTED AWAY FROM MOVING EQUIPMENT USE THE CONTROL CONSOLE WHEEL TO CONTROL AND DRIVE THE UNIT MOVEMENTS NEVER PUSH DIRECTLY ON THE EQUIPMENT THE TELESCOPIC COLUMN MOVES UP AND DOWN CREATING PINCH POINT AREAS FOLLOWING ILLUSTRATION INDICATES DANGEROUS LOCATIONS WHERE PA...

Page 77: ...PECIAL ACTION IS INDICATED IN THIS MANUAL SIMULTANEITY OF ACTIONS IS ALLOWED IN THE EVENT OF AN EMERGENCY TURN OFF THE CEILING SUSPENSION PRESSING FORCIBLY THE EMERGENCY OFF SWITCH RED MUSHROOM SHAPED SWITCH ON THE X RAY TUBE SUPPORT AUTOMATIC POSITIONING CONTROL BOX OR AT THE ROOM ELECTRICAL CABINET 4 2 1 CEILING SUSPENSION MANUAL MOTION To move the equipment in relation with its axes 1 Press and...

Page 78: ...itudinal and Transverse Axes they are configured for a good alignment with the Receptor according to the direction in which the X ray Tube is pointing or at some specific positions defined by the user On the Vertical Axis defined according to the defined SID Distance On the Alpha and Beta Axes factory set at each 45o But just in the case of the Automatic System they can be modified by the Service ...

Page 79: ...the manual movement is made smoothly when the movement is faster than configured then Detent Point is skipped Mechanical Detents for Semi automatic Ceiling Suspension The Mechanical Detents kit are provided for the Longitudinal and Transverse Axes Install these mechanical detent kit when it is required to improve the Auto tracking detent points performance It is not mandatory their installation wh...

Page 80: ...n Console button will stop the motion 4 2 3 1 AUTOMATIC POSITIONING CONTROL BOX The Automatic Movements Control Console allows the remote control of the Auto center and Parking Auto positions movements instead of using the Ceiling Suspension Console Pressing and holding the PARKING for Auto positioning movements and AUTO CENTER for Auto center and Programmed Positions PP buttons enables the positi...

Page 81: ...rture and light G to move vertically the DR Detector of the RAD Wall Stand DR G to control the automatic movements auto center auto tracking and auto positioning G to move the Ceiling Suspension in all Axes and G to move the DR Detector of the RAD Table Illustration 4 13 Remote Control Collimator Controls RAD Wall Stand DR Controls Automatic Movements Controls Ceiling Suspension Controls RAD Table...

Page 82: ...eiling Suspension IR Detector 2 Hold pressed the desired movement button to move the equipment 3 Release the button to finish with the equipment movement when reached to the desired position or automatic movement is completed The Remote Control must have a direct line of site to the Ceiling Suspension Any people or objects between the both will prevent or stop system movement Note ...

Page 83: ...ss the top of the button to close the Collimator b Press the bottom of the button to open the Collimator DR Detector DOWN Movement Hold pressed to lower the DR Detector of the RAD Wall Stand DR DR Detector UP Movement Hold pressed to raise the DR Detector of the RAD Wall Stand DR PARKING POSITION Hold pressed when executing any Parking Position or Auto position refer to Section 4 2 4 AUTO CENTER H...

Page 84: ...ld pressed the left button to move to the left b Hold pressed the right button to move to the right Transverse displacement of the X ray Tube a Hold pressed the left button to move forwards b Hold pressed the right button to move backwards X Ray Tube Rotation a Hold pressed the left button to move the tube from 0o to 180o b Hold pressed the right button to move the tube from 0o to 180o 0o 45o 90o ...

Page 85: ...owered by an alkaline Nine volt Battery transistor battery type For its replacement 1 Remove the Battery cover 2 Remove the Battery from the snap connector 3 Replace old battery with the new one 4 Insert and fix the cover Illustration 4 15 Remote Control Battery Replacement ...

Page 86: ...row on it Illustration 4 16 X ray System Emergency OFF Switches 4 2 3 4 AUTOMATIC MOVEMENTS SAFETY POLICY When the operation of the equipment is manually controlled by the Operator the risk of collision with other equipments parts of the Room and specially with the other Operators or Patients is very low and totally controllable by the Operator But when the System is Semi Automatic or Automatic it...

Page 87: ...utside to any place inside this area Automatic movement within the virtual safety area is allowed to escape from this area but at a reduced speed In these areas the motion will not continue more than 13 mm 0 5 after the Operator has activated the stop or motion reverse control Minimum SID for automatic movements 950 mm 37 4 Maximum SID for automatic movements 4000 mm 137 5 if Room configuration an...

Page 88: ...get all of them corrected to deactivate the X ray Interlock MESSAGE DESCRIPTION MANUAL MOTION The Suspension is being moved manually AUTO MOTION The Suspension is moving automatically Auto positioning Auto tracking Auto centering etc NO DETECTOR The Detector is not inserted NO SID No SID available The Suspension is not pointing to the Detector or too far from it GEOMETRY No SID available The Suspe...

Page 89: ...sed the motion stops Auto center is paused as soon as the brake of the selected DR Detector is pressed Once the DR Detector brake button is released the auto centering movement continues Auto center is aborted as soon as the brake of the non selected DR Detector is pressed In this case it is necessary to restart auto center If the selected DR Detector position is changed during the auto center mov...

Page 90: ...e correct position as indicated in the Message Illustration 4 19 Position Message for Semi automatic System Final Position Current Position Corrective Movement Direction 5 Press and hold the Auto center button of the Automatic Positioning Control Box to complete the movement or if available in the Remote Control 6 The Collimator Lamp gets lighted to indicate the current position of the X ray tube ...

Page 91: ...always slower than the Master s speed Auto tracking function activation Manually press the Auto tracking Control in the Control Console or Remote Control if available The SID is set at the current distance When the Programmed Position PP is configured to have the Auto tracking function activated It will remain ON automatically after reaching the demanded Programmed Position Refer to Section 4 2 6 ...

Page 92: ...on becomes inactive After this time activate again the Auto tracking function It is not necessary to center the X ray Tube with the DR Detector but both pieces of equipment must be aligned that is the X ray tube must be pointing to the DR Detector The Slave equipment will reach the final position once the X ray beam is pointing to the same spot of the DR Detector that it was pointing to before sta...

Page 93: ...iontracks itsmovement in the same direction The SID remains constant c The Ceiling Suspension is the Master and is moved along its Alpha Axis Press and hold the Alpha Brake button of the Control Console and angle the X ray Tube The DR Detector tracks its movement longitudinally The SID is modified d The RAD Table is the Master and is moved longitudinally while the Ceiling Suspension is angled Pres...

Page 94: ...0181218 86 Illustration 4 23 Auto tracking Movement Policy for Automatic System with RAD Table Raise Lower Master Slave Master Slave Slave Master Master Slave Master Slave Slave Master Slave Master A B C D E Master Slave Slave Master ...

Page 95: ...in the same direction The SID remains constant It is not valid when the Receptor is tilted at 90o b The Ceiling Suspension is the Master and is moved in the Alpha Axis Press and hold the Alpha Brake Button and angle the X ray Tube The DR Detector tracks its movement vertically so the SID is modified c The RAD Wall Stand DR is the Master and is moved vertically The DR Detector can be tilted at any ...

Page 96: ... D 600 User Manual 0242F EN 20181218 88 Illustration 4 24 Auto tracking Movement Policy for Automatic System with RAD Wall Stand DR Slave Slave Slave Master Master Master Slave Master B A Slave Master C D ...

Page 97: ...ontrol of the Console or Remote Control if available to activate the function the background is in yellow when activated 2 Move manually the Table refer to Illustration 4 25 Step and hold the RAISE or LOWER Control Pedal to move UP DOWN the DR Detector The Ceiling Suspension tracks vertically its movement in all cases The SID remains constant in all cases 3 Step and hold the pedal until the Slave ...

Page 98: ...DX D 600 User Manual 0242F EN 20181218 90 Illustration 4 25 Auto tracking Movement Policy for Semi automatic System with RAD Table Raise Lower Master Slave Master Slave Slave Master ...

Page 99: ...and hold the Vertical Lock or step on the UP DOWN Pedal of the Footswitch The Ceiling Suspension tracks its movement in the same direction in all cases The SID remains constant b The Ceiling Suspension is the Master and is moved vertically The DR Detector must be at 0o Press and hold the Vertical Brake button of the Control Console and move up down the X ray Tube The DR Detector moves in the same ...

Page 100: ...DX D 600 User Manual 0242F EN 20181218 92 Illustration 4 26 Auto tracking Movement PolIcy for Semi automatic System with RAD Wall Stand DR Slave Slave Slave Master Master Master Slave Master B A ...

Page 101: ...st PP which has been performed If the Programmed position was set to have the Auto tracking ON it remains on once this position is performed If the position was configured to have the Auto tracking off it must be activated on the Console to turn it on 4 2 3 8 AUTO POSITIONING Auto positioning assists the Operator with the Ceiling Suspension movements and also with the RAD Table and RAD Wall Stand ...

Page 102: ...ith the Auto position the Tube position is not referenced to any specific Workstation so all or just some of the available axes of the X ray Tube and DR Detectors can be configured on each Auto position Auto positions are intended to be used as parking positions or to work with Direct Workstation For a complete positioning of the Ceiling Suspension use the Programmed Positions The Auto positions a...

Page 103: ... AUTO POSITIONS Select the Workstation Select the Auto position with the INCREASE DECREASE Buttons Press the VALIDATE AUTO POSITION Button to activate the position Press and hold the PARKING Button on the Automatic Positioning Control Box to execute the movement Once the new position is reached the PARKING POSITION Indicator lights up DUE TO SAFETY REASONS WHEN A NEW AUTO POSITION IS SELECTED IF T...

Page 104: ...cific Workstation so all or just some of the available axes of the X ray Tube and DR Detectors can be configured on each Auto position taking into account that only the vertical axes of the X ray Tube and RAD Wall Stand are motorized so any position configured in any other axis must be completed manually Auto positions are intended to be used as parking positions or to work with Direct Workstation...

Page 105: ...INCREASE DECREASE Buttons to modify the SID Source Image Distance value from 800 to 2000 mm 31 5 to 78 7 If necessary configure manually the new Rotation or Angulation angles when working with the RAD Wall Stand Press the VALIDATE AUTO POSITION Button to activate the position Press and hold the PARKING Button on the Automatic Positioning Control Box or Remote Control if available to execute the mo...

Page 106: ...o in the PP In the Semi automatic System this function allows to configure automatic movements in the Vertical Axis only It is important that the RAD Wall Stand and RAD Table were configured correctly before executing the Programmed Position In case the last PP was configured with the Auto tracking On it remains ON until it is deactivated manually or selecting other PP configured with the Auto tra...

Page 107: ... a message will be displayed in the console explaining the corrective action to be completed It is also indicated first the Current Position and the Final Position Illustration 4 31 Position Message for Semi automatic System Final Position Current Position Corrective Movement Direction 3 Press the VALIDATE PP Button to activate the Programmed Position 4 Press and hold the AUTO CENTER Button of the...

Page 108: ...eptor or tube collimator assembly to assure that the X Ray beam is correctly positioned ALWAYS SELECT THE CORRECT FIELD SIZE TO AVOID EXCESSIVE RADIATION THE X RAY BEAM AXIS AND THE REFERENCE AXIS OF THE PLANE OF INTEREST COINCIDE AND ARE ORTHOGONAL WITH RESPECT TO THE PLANE OF INTEREST IN EXAMS PERFORMED WITH THE IMAGE RECEPTOR PERPENDICULARLY POSITIONED WITH RESPECT TO THE TUBE COLLIMATOR ASSEMB...

Page 109: ...0 User Manual 0242F EN 20181218 101 Illustration 4 32 Patient Positioning In Double Panel Systems X Ray Beam Collimator Light Collimator Knobs Laser Line Laser Line X Ray Beam Collimator Light Collimator Knobs ...

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Page 111: ... DR Detector in horizontal position Illustration 5 1 RAD Table Tabletop Control Pedals Base Base Covers DR Detector Emergency OFF Switch Active Workstation Indicator DR Detector Handle BASE COVERS The RAD Table elevating system mechanism Power Supply and all electronics are located in the Base It supports also the Tabletop and the DR Detector Box Covers are in charge of protecting the electronics ...

Page 112: ...is composed by a sheet of laminated melamine Its attenuation is 1 2 mm eq Al at 100 kV Illustration 5 2 Tabletops Standard Tabletop Flat Tabletop CONTROL PEDALS The Control Pedals are used to release the brakes and let the Tabletop free movement for its longitudinal and transverse positioning and vertical motion There are four different Control Pedals that allow all vertical and horizontal movemen...

Page 113: ...d It is located under the top Cover of the RAD Table EMERGENCY OFF SWITCH The RAD Table is equipped with an Emergency OFF Switch placed below the front right end of the Tabletop To release the Emergency OFF Switch just press and turn it to the same direction indicated with an arrow Clockwise IN THE EVENT OF AN EMERGENCY TURN OFF THE RAD TABLE PRESSING FORCIBLY THE EMERGENCY OFF SWITCH RED MUSHROOM...

Page 114: ...WHILE GETTING ON OR OFF THE TABLE THIS COULD RESULT IN A RISK OF FALLING OFF TO EXCEED THESE LIMITS MAY CAUSE DAMAGES TO THE EQUIPMENT AND OR INJURIES TO THE PATIENT When Tabletop horizontal movements reach their maximum limits the Tabletop and patient are in a cantilever situation The operator must be careful when manipulating the equipment to avoid getting the patient injured Get the patient cor...

Page 115: ...se position of the Tabletop with respect to the DR Detector 1 Press and hold down one of both TABLETOP MOTION Pedals 2 Move the Tabletop in all directions while the Control Pedal remains held down 3 Release the Control Pedal when the Tabletop is at the desired position It will get locked in that position The total Transverse travel of the Tabletop is 240 mm 9 4 and the default total Longitudinal t...

Page 116: ...ABLETOP MOVEMENT DRIVE THE TABLETOP WITH THE HANDS ON TOP OF THE TABLETOP HANDS MUST BE KEPT AWAY FROM THE BOTTOM OF THE TABLETOP EDGES AT ALL TIMES WHEN THE RAD TABLE IS POWERED OFF THE BRAKES FOR THE LONGITUDINAL AND TRANSVERSE MOVEMENT OF THE TABLETOP ARE RELEASED AND IT CAN BE MOVED FREELY WATCH OVER THE MOVEMENT OF THE TABLETOP TO AVOID DAMAGES AND INJURIES THE FOLLOWING ILLUSTRATION INDICATE...

Page 117: ...nts raise and lower of the Tabletop can be performed by both central Control Pedals RAISING and LOWERING 1 To raise lower the RAD TABLE press and hold the RAISING LOWERING Control Pedal 2 Raise lower the Tabletop up to the desired position If the maximum minimum heights have not been reached continue pressing it 3 Release the Control Pedal the Tabletop will get locked automatically 4 The Tabletop ...

Page 118: ...uting any Auto position or Programmed Position that has been configured with a DR Detector horizontal displacement It is important to have the X ray Tube exactly centered with the DR Detector A density drop at the image edges may appear indicating an inaccurate alignment The Longitudinal center of the Grid and the DR Detector matches with the mark of the Grid Handle The X ray tube can be aligned w...

Page 119: ...3 Push in the tray using the Handle Check that the DR Detector is correctly inserted A click sound means that the Grid is in place 5 5 GRID LOADING AND REMOVAL Grids are intended to reduce scattered radiation and significantly enhance image quality The RAD Table holds a removable grid focalized and labelled 100 cm 40 The Grid is provided with a label indicating its features Follow the procedure be...

Page 120: ...he Tabletop edges and make the patient feel secure when it is moving They do not support patients weight but give patients a feeling of security and to avoid injuries For safety reasons Hand grips must be used in all radiological examinations They can be installed along the Tabletop rails fit them to the rails and locked at any position with the thumbscrews USE ALWAYS THE HAND GRIPS TO AVOID INJUR...

Page 121: ...r is used for Table lateral work including knee shoulder skull etc This Lateral Cassette Holder is placed directly on the Tabletop It can be adjusted to hold all standard Cassette sizes and to perform X ray exams at different heights Its adjustable rails are used to easily insert or remove the Cassette and at the same time to hold it tight while the X ray examination is taking place Adjust the hei...

Page 122: ...5x43 cm 14 x17 Illustration 5 8 Mobile Detector Holder Insert the portable DR Detector in the Support It must be always in landscape orientation Illustration 5 9 Detector Installation Vertical Lock Lever Make sure that the Vertical Lock is locked when mounting the DR Detector to keep it from falling down unexpectedly which could cause damages to the DR Detector and Support Note ...

Page 123: ... Hold the Support during this procedure to avoid unexpected falls Illustration 5 10 Vertical Lock Lever Release the Lock Activate the Lock 2 Place the Support at the desired height 3 Tighten CW the Lever to fix again the Support at its new position The DR Detector Holder is also mobile it is provided with four wheels and each with its own brake pedal To lock the wheel step on the brake pedal Illus...

Page 124: ... OR OTHER ELEMENTS IN THE ROOM THAT MAY CAUSE DAMAGE TO THE UNIT AND OR THE OTHER ROOM ELEMENTS DRIVE THE UNIT IN FLAT SURFACES IF IT IS NOT POSSIBLE TRAVEL SURFACES SHOULD NOT EXCEED 5o INCLINATION RAMPS EXCEEDING THIS ANGLE COULD CAUSE SERIOUS DAMAGE TO THE UNIT AND BY USING IT UNDER THESE CONDITIONS COULD EVENTUALLY REPRESENT A DANGER FOR THE USER HOLD ALLWAYS SECURELY THE VERTICAL BAR TO DRIVE...

Page 125: ...st be mounted in the field as it is shipped splitted Refer to the image below for graphical information about its assembly procedure 1 Tighten the Column to the Trolley 2 Mount the DR Detector Support and lock it with the Vertical Lock Lever Illustration 5 12 DR Detector Holder Assembly Procedure ...

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Page 127: ...t Bracket Covers COLUMN The Column Assembly is formed by the following elements DR Detector Support Assembly This assembly comprises the Vertical Carriage that moves along the Column guides the Vertical Lock Handle with the DR Detector Brake Control and the Tilting and Rotation Controls Vertical Lock Handle It enables the DR Detector Support movement along the Column stand It can be left or right ...

Page 128: ...des the DR Detector the Detector Container Box and the Front Panel The Front panel Attenuation 0 70 mm eq Al at 60 kV The DR Detector can be Fixed or Portable ACTIVE WORKSTATION INDICATOR When the RAD Wall Stand is selected as the current active Workstation on the system the Active Workstation Indicator gets lighted It is located in the Top Cover of the Column PATIENT HAND GRIPS The RAD Wall Stand...

Page 129: ...Detector assembly can be moved automatically when executing any Auto position or Programmed Position that has been configured with a DR Detector vertical displacement 1 Press the Brake Control on the Vertical Lock Handle it is indicated by a label near the handle Illustration 6 2 Press Vertical Lock Handle to release the DR Detector Brake DR Detector Brake 2 Check that the brakes are released and ...

Page 130: ...Refer to Sections 4 2 4 Position Automatic System Auto positioning 4 2 5 Position Semi automatic System Auto positioning and 4 2 6 Programmed Positions PP 6 1 2 2 DR VERTICAL AUTO TRACKING This functionality allows the X ray Tube or the DR Detector to be tracked by the other one when one of them initiates the vertical movement whenever they are previously aligned The relative distance and the SID ...

Page 131: ...O PATIENT Illustration 6 4 Potential Pinch Points The DR Detector position is locked using The Tilting Brakes There are two Tilting Brake Control buttons one at each lateral DR Detector Support Press and hold any of them to release the Tilting Brake The DR Detector is locked at any angle between 20o and 90o The 0o 90o Detents located on the DR Detector Support left side These mechanical detents lo...

Page 132: ...0o 90o Detent 2 Press and hold one of the Tilting Brake pushbuttons located on the DR Detector Support 3 Tilt manually the DR Detector up to the desired position 4 The angle is indicated on the Tilting Goniometer on the right lateral 5 Release the pushbutton to get the DR Detector position locked 6 If final position is 0o or 90o insert the Lock Detent ...

Page 133: ...erformed in another range position 1 Release the Rotation Lock lever Lower it to release the Rotation Lock 2 Unlock the Rotation Detent located at the right of the DR Detector Support It reinforces the DR Detector Rotation Lock performance and locks the DR Detector at 0o position Illustration 6 6 DR Detector Rotation Lock Lever and Rotation Detent Rotation Lock Lever Rotation Detent 1 2 3 Rotate D...

Page 134: ...load configuration of the DR Detector or counter clockwise for the right load Illustration 6 8 Right load configuration of the Wall Stand for Double Panel System 1 2 3 For Single Panel Systems Tilt always the DR Detector before rotating it The rotation will be downwards counter clockwise for the left load configuration of the DR Detector or clockwise for the right load Illustration 6 9 Left load c...

Page 135: ... X ray Tube is accurately centered with the DR Detector transversely If the alignment is not accurate density cut off at the edges of the image and appearance of grid patterns may be found To assure that the DR Detector is aligned with the X ray beam move the DR Detector or the X ray Tube in order that the collimator light is aligned with this center mark of the Front Panel Illustration 6 10 DR De...

Page 136: ... the Air conditioning or Heating may produce condensation in the equipment wait until the condensation evaporates before performing an exposure As a general rule raise or lower the room temperature gradually to avoid condensation During exposure do not use the DR Detector near devices generating a strong magnetic field For Wireless DR Detectors do not cover the IR Data Port with hands or other par...

Page 137: ...according to the SID Source Image Distance The Grid is provided with a label indicating its features Illustration 6 12 RAD Wall Stand DR Grid Removable Grid SID Label Grid Handle Grid Slot Follow the procedure below for Grid loading For grid removal follow the procedure below in reverse order Handle the Grid with care and place it in the accessories holder when not in use Dropping the Grid could c...

Page 138: ...t must be placed at each lateral of the DR Detector Support It can support a maximum load of 15 kg It can be installed at both sides of the DR Detector To install it 1 Loosen the locking knob 2 Install the Overhead Arm Support in the holder 3 Fix it with the locking knob Illustration 6 13 Overhead Hands Support The Support can be used in two different positions Working position at 0o and Parking a...

Page 139: ... two Locking Pins for its use It can support a maximum load of 15 kg The Support is already factory installed when required by the customer and can be installed at both sides of the DR Detector Illustration 6 15 Mobile Overhead Patient Support Patient Holder Holder Support Parking Locking Pin Tilting Locking Pin To install it 1 Pull out the Parking Locking Pin at the center of the Support 2 Instal...

Page 140: ...ration 6 16 Overhead Hands Support Working and Parking Position Working Position Parking Position To tilt down the Patient Support pull out the Tilting Locking Pin and then rotate the Holder Support Use the Locking Pin to fix it There are two different tilting positions available at 30o and 50o when the Holder is at the left and at 30o and 50o when the Holder is at the right Illustration 6 17 Over...

Page 141: ...so it is not possible to tilt the DR Detector with it installed It is necessary to remove it from the Cabinet and then tilt It is also recommendable in all cases to rotate the DR Detector with the Patient Support removed and never tilted as the Support can crash with the carriage Illustration 6 18 Correct Tilting and Rotation Procedures ...

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Page 143: ...hnical description needed to maintain compliance with Standard IEC 60601 1 3 2008 Collimator controls consist of the following buttons and knobs 1 COLLIMATOR DISPLAY 6 CHANGE OF FILTER 2 MANUAL BLADE CONTROLS 7 COLLIMATOR LAMP CONTROL LED ON 3 AUTOMATIC MODE INDICATOR GREEN 8 RETRACTABLE METRIC TAPE 4 BUSY MODE INDICATOR RED 9 LASER POINTER WINDOW 5 MANUAL MODE INDICATOR YELLOW 10 LASER POINTER ON...

Page 144: ...han the DR Detector Size Collimator mode is indicated in the Touchscreen Console under the Patient Information The modes are AUTOMATIC MANUAL BUSY Illustration 7 2 Press on Collimator Status Data to display the status reason Press to know the reason of Busy or Manual modes When the Mode is Manual or Busy press on the Collimator Status Data on the Touchscreen Console to know the reason why the Auto...

Page 145: ...tus and pointing to the DR Detector If any of this conditions is not complied with the collimator automatically is in Manual or Busy mode After selecting the Automatic mode from the Manual Mode check if it is necessary to change the FOV It already remains as configured for the Manual Mode 7 1 2 BUSY MODE This mode activates the X RAY INTERLOCK so it is not possible to do any exposure In Status Are...

Page 146: ...entered with the DR Detector center MODALITY The System is currently on STITCHING Mode 7 1 4 COLLIMATION LIGHT CONTROL Collimator Light activates in two different modes MANUALLY Press on the MANUAL CONTROL Button AUTOMATICALLY The collimator is controlled by the Ceiling Suspension The light will switch on when G Collimator Blades change their configuration G Collimator is rotated G DIRECT Workstat...

Page 147: ...two knobs The table on the Front Panel shows the number to set with the knobs to open the blades according to the SID and X ray field to be used Use the retractable Metric Tape to read the SID measure Illustration 7 3 Collimator Controls Collimator Lamp Push button Knobs to open or close the Collimator blades Retractable Metric Tape Refer to the corresponding Collimator Manual for extended informa...

Page 148: ...stalled in the equipment The usual compatible Dosimeter devices are Vacudap 2000 2004 Series with Manual Collimator Iba Kermax Plus with Automatic Collimator Refer to the corresponding Dosimeter Manual for extended information about operation or technical description needed to maintain compliance with Standard IEC 60601 1 3 2008 Note ...

Page 149: ...le MOVEMENT IS NOT POSSIBLE It is locked In case that Vertical lock is broken contact Service THE DR DETECTOR DOES NOT TILT Power supply is OFF Switch on the System AUTO TRACKING FUNCTIONALITY DOES NOT WORK Check the Ceiling Suspension Control Console Error Message Complete the recommended Action by the Ceiling Suspension Control Console 8 2 RAD TABLE PROBLEM CHECK IF ACTION Emergency Stop Switch ...

Page 150: ...ce CEILING SUSPENSION ON CONTROL CONSOLE OFF Check Control Console Cables connections Contact Service WRONG DISPLAY MEASURES Wrong calibration Contact Service 8 4 SOFTWARE ERROR MESSAGES 8 4 1 ERROR DISPLAY The ERROR MESSAGE is displayed in the Control Console 1 Error Message 2 Cause of the Error 3 Action to be completed to avoid the Error This last Level is not displayed with all errors 4 Press t...

Page 151: ...799 8 Auto centering 11800 to 11899 9 Auto tracking 11900 to 11999 Table 8 1 System Miscellaneous CODE USER ERROR MESSAGE ERROR DESCRIPTION ACTION 9 Collimator cause Click on Collimator Information to know the reason 10 Interlock cause Check if Interlock is activated Click on Interlock icon to know the reason 11 Collimator Mode Click on Collimator Information to know the reason 12 Collimator Error...

Page 152: ...n Calibration File File not present or opened by other application Try again 11002 Write Error in Calibration File File not present or locked Try again 11003 Position Demand Error Not possible to reach to the configured position Modify position configuration 11004 Workstation not available Invalid Workstation Configure correct Workstation 11005 Tomography Parameters not Configured Tomography not c...

Page 153: ... not calibrated calibration file corrupted Calibrate once again If message persists change SBC CF 11107 Invalid Calibration Data CS Vertical Axis not calibrated calibration file corrupted Calibrate once again If message persists change SBC CF 11108 Invalid Calibration Data CS Angular Axis not calibrated calibration file corrupted Calibrate once again If message persists change SBC CF 11109 Invalid...

Page 154: ...ck End Switch Limit range 11117 Operative rejected CS Vertical position out of calibrated range Right there only MANUAL movement allowed Axis moved out of defined range manually Axis not calibrated Potentiometer misaligned Potentiometer or Potentiometer Circuitry defective A D converter problem Check position feedback Contact Service 11118 Board Failure CS Vertical No motor power or motor driver d...

Page 155: ...rative rejected CS Rotational position out of calibrated range Right there only MANUAL movement allowed Axis moved out of defined range manually Axis not calibrated Potentiometer misaligned Potentiometer or Potentiometer Circuitry defective A D converter problem Check position feedback Contact Service 11124 Board Failure CS Rotational No motor power or motor driver defective Potentiometer Tachomet...

Page 156: ...ry defective Coupling did not engage Replace the Control Driver Board 11204 Invalid calibration data Wall Stand Vertical Check Vertical Axis calibration 11205 Invalid calibration data Wall Stand Tilting Check Calibration 11210 Position out of range Wall Stand Vertical Axis moved out of defined range manually Axis not calibrated Potentiometer misaligned Potentiometer or Potentiometer Circuitry defe...

Page 157: ...and Tilting Axis moved out of defined range manually Axis not calibrated Potentiometer misaligned Potentiometer or Potentiometer Circuitry defective A D converter problem Check Axis calibration 11214 Control Board Error Wall Stand Tilting No motor power or motor driver defective Potentiometer Tachometer or circuitry defective Coupling did not engage Replace Control Driver Board 11215 End switch li...

Page 158: ...able Longitudinal No motor power or motor driver defective Potentiometer Tachometer or circuitry defective Coupling did not engage Replace the Control Driver Board 11312 End Switch Limit Table Longitudinal Axis moved out of defined range manually Axis not calibrated Potentiometer misaligned Potentiometer or Potentiometer Circuitry defective A D converter problem Check End Switch Limit position act...

Page 159: ... tilting geometry Get aligned the Bucky Detector 11511 Detector GRID Rotation Please get the Detector aligned Bucky Detector and Tube not aligned Get aligned the Bucky Detector 11512 Operative rejected Please fix the Table height geometry state Invalid Table height configuration Get the Table at the correct height 11513 Operative rejected Table Safety distance is crossed Auto movement Safety Polic...

Page 160: ...n Wait for system stop 11528 Operative rejected Please release the MANUAL activators to proceed All brakes activated Press any Control Console brake button 11529 Operative rejected The Detector and the Tube crane are misaligned Please get set a valid SID The Bucky Detector and the Tube are misaligned Align X ray Tube and Bucky Detector 11530 Auto tracking skipped Function already activated Auto tr...

Page 161: ... Longitudinal pre tomo target out of specifications Please adjust site parameters 11610 Safety Issue Abnormal Velocity detected on CS Longitudinal Velocity upper limit detected on Suspension Longitudinal Axis In Manual motion move smoothly In automatic motion calibrate the speed 11611 Safety Issue Abnormal Velocity detected on CS Transversal Velocity upper limit detected on Suspension Transversal ...

Page 162: ...S Transversal target out of specifications Please check POSITION parameters Configure POSITION 11732 Auto movement aborted CS Transversal target Configure POSITION 11733 Manual mode aborted CS Transversal timeout Please try again Auto position not completed movement on Ceiling Suspension Transversal Axis timed out Try again 11741 Parking rejected CS Vertical target out of specifications Please che...

Page 163: ...l Stand Vertical target out of specifications Please check POSITION parameters Configure POSITION 11781 Parking rejected Wall Stand Rail target out of specifications Please check POSITION parameters Configure POSITION 11791 Parking rejected Table Longitudinal target out of specifications Please check POSITION parameters Configure POSITION 11792 Auto movement aborted Table Longitudinal target Confi...

Page 164: ...ve Bucky Detector and try again 11822 Auto movement aborted The CS Longitudinal Axis is blocked Please try again Auto centering does not start because final position for the Ceiling Suspension slave Longitudinal Axis timed out Try again 11831 Operative rejected CS Transversal Target is out of calibrated range Please check POSITION parameters Auto centering does not start because final position for...

Page 165: ...ing does not start because final position for the Ceiling Suspension slave Beta Axis timed out Try again 11871 Operative rejected Wall Stand Vertical Target out of calibrated range Please check POSITION parameters Wall Stand Vertical Target out of calibrated range Move Bucky Detector and try again 11881 Operative rejected Wall Stand Tilting Target out of calibrated range Please check POSITION para...

Page 166: ...al Axis 11922 Auto tracking paused CS Longitudinal limit Target position out of limits on Longitudinal Axis of the Ceiling Suspension Do not exceed the longitudinal limit 11931 Auto tracking aborted CS Transversal limit Target position out of calibrated limits on Transversal Axis of the Ceiling Suspension Calibrate the Ceiling Suspension transversal Axis 11932 Auto tracking paused CS Transversal l...

Page 167: ...Tube warm up at the start of each day and when the X ray Tube selected has not been in use for approximately one hour This warm up procedure is used for a typical X ray Tube Consult the X ray Tube manufacturer instructions for the current X ray Tube in use comparing its recommendations with this procedure If there is conflict with this procedure comply with the X ray Tube manufacturer s instructio...

Page 168: ...ion THIS EQUIPMENT CAN BE MOVED IN DIFFERENT AXES PLEASE TAKE CARE THAT NEITHER THE PATIENT NOR THE OPERATOR STAFF ARE IN THE MOVEMENT AREA OF THE EQUIPMENT ALWAYS WATCH WHERE YOU STAND REMOVE ALL OBJECTS FROM THE COLLISION AREA IT IS MANDATORY TO POSITION FIRST THE EQUIPMENT AT THE INITIAL POSITION OF THE EXAMINATION AND THEN WITH THE SYSTEM ALREADY STOPPED POSITION THE PATIENT 3 Position the pat...

Page 169: ...0 is the normal setting on the NX Station 5 Select the technique parameters back up time mAs using the RAD controls on the NX Station or on the Ceiling Suspension Control Console 6 Continue with the radiographic operation Refer to Section 9 3 step 4 9 4 1 HOW TO VERIFY THE PROPER FUNCTIONING OF THE AEC This procedure is not mandatory it is only a method so that the operator can verify the proper f...

Page 170: ...t not be aborted by the AEC back up timer 10 The noted Exposure mAs and time have to be equal 10 between all three Ion Chambers If not contact Service 11 Repeat the above steps changing the Density and or the homogeneous phantom e g a bucket with 5 cm of water Compare the Exposure mAs and time between each Ion Chamber and between the values noted before for a lower density or less water lower mAs ...

Page 171: ...anufacturer undertakes to have available spare parts for this equipment for at least ten 10 years after the unit s manufacturing date NEVER ATTEMPT TO PERFORM MAINTENANCE TASKS WHILE THE EQUIPMENT IS IN USE WITH A PATIENT 10 1 OPERATOR TASKS The tasks of this periodic maintenance shall include the following items DO NOT REMOVE ANY COVER DISASSEMBLE OR MANIPULATE INTERNAL COMPONENTS OF THE EQUIPMEN...

Page 172: ...with a cloth moistened in warm water with mild soap Wipe with a cloth moistened in clean water Do not use cleaners or solvents of any kind 10 2 SERVICE TASKS Only service personnel specifically trained on this medical X ray equipment should work on service tasks installation calibration or maintenance of the equipment Refer to the respective chapters of the Service Manual provided with this equipm...

Page 173: ...oF TRANSPORT STORAGE 500 hPa 1060 hPa 10 90 20 oC 4 oF 70 oC 158 oF 11 2 X RAY SYSTEM POSITIONERS 11 2 1 POWER LINE REQUIREMENTS EQUIPMENT FREQUENCY VOLTAGE MAX PERMANENT CURRENT CEILING SUSPENSION 50 60 Hz 115 240 VAC 3 5 1 6 A RAD TABLE 50 60 Hz 115 240 VAC 4 2 A RAD WALL STAND DR 50 60 Hz 24 VDC 4 A NOTE Power Line for the RAD Wall Stand DR is supplied by the RAD Table in Double Panel Systems a...

Page 174: ...he Focal Spot of 1200 mm in accordance with IEC 60806 1984 11 2 3 DIMENSIONS AND PRODUCT WEIGHT EQUIPMENT DIMENSIONS WEIGHT EQUIPMENT DEPTH WIDTH HEIGHT WEIGHT RAD TABLE 868 mm 34 17 2200 mm 86 61 580 mm 22 83 min 920 mm 36 22 max 261 Kg 575 4 lbs RAD WALL STAND w o DR Detector 637 mm 25 518 mm 20 39 2240 mm 88 1 193 Kg 425 48 lbs CEILING SUSPENSION WEIGHT Kg lbs TOTAL WITHOUT CEILING RAILS SYSTEM...

Page 175: ... RAD TABLE Illustration 11 1 RAD Table Dimensions and Travels with Fixed DR Detector Tabletop travel is set by default at 490 10 mm 19 2 0 4 on both sides It is possible to enlarge the Tabletop displacement on the left side to 600 mm 23 6 Note ...

Page 176: ... 168 Illustration 11 2 RAD Table Dimensions and Travels with Portable DR Detector Tabletop travel is set by default at 490 10 mm 19 2 0 4 on both sides It is possible to enlarge the Tabletop displacement on the left side to 600 mm 23 6 Note ...

Page 177: ...R Illustration 11 3 RAD Wall Stand DR Dimensions and Travels for Double Panel System 382 15 405 15 9 305 12 243 9 6 130 408 16 1 5 1 330 13 479 18 9 1979 77 9 1500 59 1 522 20 6 2240 88 2 137 5 3 729 28 7 905 35 1 Fixed DR Detector 955 37 5 Portable DR Detector ...

Page 178: ...all Stand DR Dimensions and Travels for Single Panel Systems 610 24 1500 59 1 522 20 6 400 default 15 7 723 28 5 587 23 1 1500 59 1 1979 77 9 479 18 9 250 9 8 361 min 14 2 933 36 7 1110 43 7 Fixed DR Detector 1160 45 6 Portable DR Detector 130 613 24 13 5 12 330 12 99 ...

Page 179: ...tration 11 5 RAD Wall Stand DR Rotation and Tilting Specifications 90o 180o 0o Left Load for Double Panel System Right Load for Double Panel System 90o 20o 90o Tilting Rotation 90o Left Load for Single Panel System Right Load for Single Panel System ...

Page 180: ...OMETRY DR Detector A B C D E Xd Yd FIXED 579 mm 22 80 137 mm 5 39 45 1 mm 1 78 185 1 mm 7 29 PORTABLE 657 mm 25 87 655 mm 136 mm 0 0 mm 0 0 54 mm 2 13 176 2 mm 6 94 190 mm 7 48 PORTABLE 655 mm 25 79 136 mm 5 35 51 2 mm 2 02 179 mm 7 05 D E Xd Yd C Receptor Center Cabinet Center Portable DR Detector 559 22 556 21 8 A B Fixed DR Detector 559 22 485 19 A B ...

Page 181: ...DR LEFT LOAD RIGHT LOAD 874 34 41 506 4 19 94 Same travel specification for both load configurations right or left GRIDS RAD Table 1 m 132 lines inch 10 1 Carbon Fibre RAD Wall Stand DR 1 m 132 lines inch 10 1 Carbon Fibre 1 5 m 132 lines inch 10 1 Carbon Fibre 1 8 m 132 lines inch 10 1 Carbon Fibre Note ...

Page 182: ... Longitudinal Travel for LongitudinalRails of6000 mm 236 2 maximum 4866 10 mm 191 5 0 39 max for Automatic and Semi automatic Suspension with default End Stops Configuration 5166 10 mm 203 38 0 39 max for Semi automatic Suspension with modified End Stops Configuration Transverse Travel for Transverse Rails of 3000 mm 118 1 maximum 1895 10 mm 74 6 0 39 maximum ...

Page 183: ...DX D 600 User Manual 0242F EN 20181218 175 Illustration 11 9 Ceiling Suspension Specifications Front View ...

Page 184: ...omatic compensation 10 Maximum line regulation for maximum kVA demand 5 NOTE For 1000 mA Generators operating with lines at 400 415 440 480 V an auxiliary boost transformer is required to adequate the line voltage to 530 V 11 3 2 RANGE OF RADIOGRAPHIC PARAMETERS PARAMETER RANGE kVp From 40 kVp to 150 kVp in 1 kV steps mA From 10 mA to 1000 mA through the following mA stations 10 12 5 16 20 25 32 4...

Page 185: ...its should be set during installation depending on the capacity of the X ray Tube 11 3 4 PHYSICAL CHARACTERISTICS COMPONENT DIMENSIONS WEIGHT COMPONENT LENGTH WIDTH HEIGHT WEIGHT X ray Generator 592 mm 23 3 360 mm 14 2 690 mm 27 2 95 Kg 209 lb Illustration 11 10 Generator Dimensions Cable Access 592 360 690 ...

Page 186: ... in 1 hour 150 kVp 4800 mAs Inherent Filtration of X ray Source Tube Collimator refer to Identification Label CANON E7869XX High Speed Rotating Anode Focal Spots 0 6 mm 1 2 mm Anode kHU kVp 600 kHU 150 kVp Target Angle 12 Maximum Specified Energy Input in 1 hour 150 kVp 5189 mAs Inherent Filtration of X ray Source Tube Collimator refer to Identification Label 11 5 COLLIMATORS Model R225 R225 DHHS ...

Page 187: ...ched pediatric exams can not performed using this device Positioning the pediatric patient Pediatric patients are not as likely as adults to understand the need to remain still during the procedure Therefore it makes sense to provide aids to maintaining stable positioning It is strongly recommended the use of immobilizing devices such as bean bags and restraint systems foam wedges adhesive tapes e...

Page 188: ...mA 2 5 10 mAs for a pediatric patient Whenever possible use high kVp techniques and large SID Source Image Distance Summary Image only when there is a clear medical benefit Image only the indicated area Use the lowest amount of radiation for adequate imaging based on size of the child reducing tube output kVp and mAs Try to use always short exposure times large SID values and immobilizing devices ...

Page 189: ......

Page 190: ...at 27 B 2640 Mortsel Belgium Published by Agfa N V B 2640 Mortsel Belgium 0413 This product bears a CE marking in accordance with the provisions of the 93 42 EEC MDD dated June 14 1993 as amended by 2007 47 EC dated September 5 2007 ...

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