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DX-D 300 U-Arm

User Manual

44

0171F EN 20181009

2.10 DETERMINISTIC EFFECTS

Deterministic effects may occur when the Radiation dose to a certain organ or
tissue exceeds a specific threshold. Particular organs or tissues of such
concern in diagnostic Radiology are the skin and the eye lens. The numerical
value of the threshold dose is in the range between 1 Gy and 3 Gy.

As shown in the Quantitative Information Tables, the radiation dose effects
measured in this equipment are below the threshold in which the severity of
certain effects would take place on human skin or eyes lens.

This mentioned threshold was established by the International Commission on
Radiological Protection (ICRP Publication No 60).

Quantitative Information tables (

Refer to Section 2.9

) illustrate examples of

available 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 health care professional (for example a customer or a user) who has any
complaints or has experienced any dissatisfaction with the quality, durability,
reliability, safety, effectiveness, or performance of this product must notify Agfa.

If the device malfunctions and may have caused or contributed to a serious
injury of a patient, Agfa must be notified immediately by telephone, fax or written
correspondence to the following address:

Agfa Service Support - local support addresses and phone numbers are listed
on www.agfa.com

Agfa - Septestraat 27, 2640 Mortsel, Belgium

Agfa - Fax +32 3 444 7094

Summary of Contents for DX-D 300

Page 1: ...DX D 300 U Arm User Manual Technical Publication 0171F EN 20181009 ...

Page 2: ......

Page 3: ...E APR 27 2015 New Handle and Receptor Overlay New cabinet for Portable Receptor F OCT 9 2018 IEC Fourth Edition Labels Applied Parts Warning Collimator Rotation every 90 degrees 4 information messages added exposure irradiation time 14 ms and Voltage 230 240 V corrected This Document is the English original version edited and supplied by the manufacturer The Revision state of this Document is indi...

Page 4: ...SONAL 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 bu...

Page 5: ... Protection 12 2 5 Monitoring of Personnel 14 2 6 Safety Symbols 14 2 7 Regulatory Information 19 2 7 1 Certifications 19 2 7 2 Environmental Statement on the Life Cycle of the Equipment or System 19 2 7 3 Mode of Operation 19 2 7 4 Protection against Electric Shock Hazards 20 2 7 5 Protection against Harmful Ingress of Water or Particulate Matter 20 2 7 6 Protection against Hazards of Ignition of...

Page 6: ... 1 1 Emergency Stop for Movements 50 4 1 2 Control Panel 52 4 1 3 Touch Screen Console 55 4 2 X Ray Beam Alignment with Respect to Patient 58 4 3 DR Detector Assembly Bumper and Anticrushing System 60 4 4 DR Detector Assembly 62 4 4 1 Portable DR Detector Assembly Usage 63 4 4 1 1 Loading and unloading the Tray 64 4 4 1 2 Rotating the DR Detector 65 4 4 2 Interchangeable Grids 67 4 5 Tube Collimat...

Page 7: ...TENANCE 81 6 1 Operator Tasks 81 6 2 Service Tasks 82 7 TECHNICAL SPECIFICATIONS 83 7 1 Environmental Conditions 83 7 2 U Arm 83 7 2 1 Power Line REquirements 83 7 2 2 Information Related to Radiation 83 7 2 3 Physical Characteristics 84 7 3 X Ray Generator 86 7 3 1 Factors 86 7 3 2 Range of Radiographic Parameters 87 7 3 3 Duty Cycle 87 7 3 4 physical characteristics 88 7 4 X Ray Tubes 89 7 5 Rad...

Page 8: ...DX D 300 U Arm User Manual 0171F EN 20181009 iv ...

Page 9: ...quipped with controls and indicators logically arranged and easily accessible Duplicate of controls are present at the DR Detector Assembly and Remote Control for a better accessibility and handling of the equipment in accordance with the movement to be performed All movements of the Swivel U Arm are motorized A soft thumb pressure on the control buttons allows the linear and rotation movements Un...

Page 10: ...e Generator is controlled by multiple microprocessors providing increased exposure consistency efficient operation and extended Tube life A high level of self diagnosis greatly increases serviceability and reduces down time 1 1 GENERAL FEATURES The main features of the U Arm are A solid and ergonomic design Rotation and vertical motorized movements of U Arm and motorized SID adjustment of the Tube...

Page 11: ...oop control of X ray Tube current kVp and filaments which minimizes potential errors and the need for readjustments Automatic line compensation due to closed loop operation of X ray Tube current and kVp 1 2 OPTIONS Radiographic Mobile Table with Carbon Fiber Table Top Radiographic Mobile Table with Laminated Table Top Arm Rest 1 3 PRODUCT IDENTIFICATION The major items in the equipment have some i...

Page 12: ...DX D 300 U Arm User Manual 4 0171F EN 20181009 Illustration 1 2 Identification Labels Laminated Table Optional Carbon Fibre Table Optional U Arm Control Box Label at bottom right side ...

Page 13: ...ay be physically abled disabled immobilized or shocked This DX D 300 U Arm contributes to the metrics of imaging performance ensuring the efficient use of radiation The X Ray image receptor used in this equipment is a DR Detector fixed or portable 1 4 2 NORMAL USE The Normal Use of this equipment is defined as the Intended Use plus the Maintenance and Service tasks 1 4 3 CONTRAINDICATIONS Do not u...

Page 14: ...e medical equipment to perform its function This RAD equipment includes the following Applied Parts Tabletop of the Radiographic Mobile Table Tabletop of the Positioner Arm Rest optional Other accessories BEAR IN MIND THAT SOME APPLIED PARTS MAY HEAT UP TO 48oC 118 4oF WHEN THE AMBIENT TEMPERATURE FOR OPERATION IS ON THE LIMIT THIS IS COMPLETELY NORMAL AND DOES NOT MEAN A MALFUNCTION OF THE EQUIPM...

Page 15: ...S MANUAL 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 PR...

Page 16: ...ETHODS 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 ME...

Page 17: ...2 1 2 PATIENT SUPPORT movable without articulated joints including stationary layers 1 7 1 7 PATIENT SUPPORT with radiolucent panel having one articulated 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 Requireme...

Page 18: ...OF 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 ...

Page 19: ...VOID 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 Pro...

Page 20: ... extend 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 radiatio...

Page 21: ...he 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 do...

Page 22: ...ning 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 b...

Page 23: ...t harmful 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 24: ...ce 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 25: ... stop 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 26: ...ce 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 yo...

Page 27: ...DX D300 U Arm conforms 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 a...

Page 28: ...K TO THE USER 2 7 5 PROTECTION AGAINST HARMFUL INGRESS OF WATER OR PARTICULATE 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 wit...

Page 29: ...th means to allow 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 ROOM ELECTRICAL CABINET EXAM ROOM Generator and Control Box POSITIONER PATIENT ENVIRONMENT PATIENT MOBILE TABLE OPERA...

Page 30: ...ne Significant Zone of Occupancy for the use of the operator and staff designated as follows Illustration 2 1 Radiographic Examination in Thorax Position Receptor in Vertical Position SID 100 cm 40 S1 SIGNIFICANT ZONE OF OCCUPANCY AT THE LEFT SIDE OF THE RECEPTOR UNIT IN VERTICAL POSITION Phantom Focal Spot Patient Support X Ray Receptor 50 cm S SIGNIFICANT ZONE OF OCCUPANCY MINIMUM AREA 60 x 60 c...

Page 31: ...200 cm S Focal Spot S 50 cm Dosimeter Phantom X Ray Receptor Patient Support Focal Spot X RAY TUBE SID 100 cm SIGNIFICANT ZONE OF OCCUPANCY AT FRONT SIDE OF THE RECEPTOR PATIENT ON A RAD TABLE WITH WHEELS RAD TABLE S2 Focal Spot X RAY TUBE S3 S4 SIGNIFICANT ZONE OF OCCUPANCY AT RIGHT SIDE OF THE RECEPTOR PATIENT ON A RAD TABLE WITH WHEELS SIGNIFICANT ZONE OF OCCUPANCY AT LEFT SIDE OF THE RECEPTOR ...

Page 32: ... Phantom Rectangular water phantom of 25 x 25 x 15 cm or a material having a similar X Ray 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 Thorax position and refer to Illustration 2 2 f...

Page 33: ... cm STRAY RADIATION μGy h SID 100 cm 40 S1 SIGNIFICANT ZONE OF OCCUPANCY AT THE LEFT SIDE OF THE RECEPTOR UNIT IN VERTICAL POSITION Phantom Focal Spot Patient Support X Ray Receptor d S11 S12 d 50 cm d 100 cm S11 S12 0 20 40 60 80 100 120 140 160 180 200 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 5500 6000 6500 7000 7500 8000 8500 9000 950010000 ...

Page 34: ...UPANCY AT FRONT SIDE OF THE RECEPTOR PATIENT ON A RAD TABLE WITH WHEELS RAD TABLE Focal Spot X RAY TUBE S3 S4 SIGNIFICANT ZONE OF OCCUPANCY AT RIGHT SIDE OF THE RECEPTOR PATIENT ON A RAD TABLE WITH WHEELS SIGNIFICANT ZONE OF OCCUPANCY AT LEFT SIDE OF THE RECEPTOR PATIENT ON A RAD TABLE WITH WHEELS 0 20 40 60 80 100 120 140 160 180 200 0 2000 4000 6000 8000 10000 12000 14000 S21 S22 d 50 cm d 100 c...

Page 35: ...UPANCY AT FRONT SIDE OF THE RECEPTOR PATIENT ON A RAD TABLE WITH WHEELS RAD TABLE Focal Spot X RAY TUBE S2 S4 SIGNIFICANT ZONE OF OCCUPANCY AT RIGHT SIDE OF THE RECEPTOR PATIENT ON A RAD TABLE WITH WHEELS SIGNIFICANT ZONE OF OCCUPANCY AT LEFT SIDE OF THE RECEPTOR PATIENT ON A RAD TABLE WITH WHEELS 0 20 40 60 80 100 120 140 160 180 200 0 2000 4000 6000 8000 10000 12000 14000 S31 S32 d 50 cm d 100 c...

Page 36: ... AT FRONT SIDE OF THE RECEPTOR PATIENT ON A RAD TABLE WITH WHEELS RAD TABLE Focal Spot X RAY TUBE S2 S3 SIGNIFICANT ZONE OF OCCUPANCY AT RIGHT SIDE OF THE RECEPTOR PATIENT ON A RAD TABLE WITH WHEELS SIGNIFICANT ZONE OF OCCUPANCY AT LEFT SIDE OF THE RECEPTOR PATIENT ON A RAD TABLE WITH WHEELS 0 20 40 60 80 100 120 140 160 180 200 0 2000 4000 6000 8000 10000 12000 14000 16000 18000 S41 S42 d 50 cm d...

Page 37: ...the 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 Medica...

Page 38: ...F emissions CISPR 11 Group 1 This X ray Unit uses 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 This X ray Unit is suitable for use in all Harmonic emissions IEC 61000 3 2 Class A This X ray Unit is suitable for use in all establishments other than domestic a...

Page 39: ...ypical commercial or hospital environment Surge IEC 61000 4 5 1kV line s to line s 2kV line s to earth 1kV symmetrical coupling 2kV 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 cycle 40 UT 60 dip in UT for 5 cycles ...

Page 40: ...xed RF transmitters 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...

Page 41: ...rio 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 MHz 24...

Page 42: ...ospital environment 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 a...

Page 43: ...ELESS COMMUNICATIONS 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 M...

Page 44: ...munity Test Level 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 dut...

Page 45: ...O OBTAIN THE 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 100 cm Maximum SID 180 cm Open Collimator size 13 cm x 13 cm min 43 cm x 43 cm max The measurements were made with the exposure parameters shown on ...

Page 46: ... 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 25...

Page 47: ...1 983 160 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 3...

Page 48: ... 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 ...

Page 49: ...60 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 13x...

Page 50: ...mall 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 13x...

Page 51: ...mall 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 52: ...vailable 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...

Page 53: ...cal Cabinet To turn the System ON 1 Turn ON Room Electrical Cabinet Switch the Emergency Stop not activated 2 Press the X Ray Control ON Button the Green lamp turns ON 3 Press ON OFF Switch located at the Control Box Door the Emergency Stop not activated the Green lamp turns ON 4 Turn ON the NX Workstation Illustration 3 1 Start Up sequence U Arm Power Room Electrical Cabinet 4 NX Workstation 3 Co...

Page 54: ...E LOCATED ON OR NEAR THE X RAY ROOM ELECTRICAL CABINET USUALLY PLACED NEAR THE GENERATOR CONTROL CONSOLE MORE THAN ONE OF THESE SWITCHES MAY BE PLACED AROUND THE ROOM FOR GREATER ACCESSIBILITY TO ISOLATE THE EQUIPMENT FROM MAINS TURN OFF THE SWITCH LOCATED AT THE ROOM ELECTRICAL CABINET BEFORE POWERING ON THE UNIT CHECK THAT THERE IS NOTHING ON THE DR DETECTOR ASSEMBLY SURFACE OR ON THE U ARM IN T...

Page 55: ...ntrol Box Door the Emergency Stop not activated the Green lamp turns OFF 3 Press the X Ray Control OFF Button the Green lamp turns OFF 4 Turn OFF Room Electrical Cabinet Switch the Emergency Stop not activated Illustration 3 2 Shutdown sequence U Arm Power Room Electrical Cabinet 1 NX Workstation 2 Control Box X Ray Generator 4 X Ray Generator Control 3 ON OFF ...

Page 56: ...DX D 300 U Arm User Manual 48 0171F EN 20181009 This page intentionally left blank ...

Page 57: ...rol Panel are duplicated on the DR Detector Assembly Handle Illustration 4 1 DX D 300 U Arm DR Detector Assembly DR Detector Assembly Handle Control Buttons Proximity Sensor 1 Mobile Table Vertical Column U Arm DR Detector Assembly Rotation Indicator Tube Collimator Assembly Proximity Sensor 2 U Arm Control Panel Touch Screen Control Buttons U Arm Power X Ray Generator Control ON OFF Fixed or Port...

Page 58: ...PATIENT HANDS 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 4 1 1 EMERGENCY STOP FOR MOVEMENTS The Unit includes a Emergency Stop located at the DR Detector Assembly that disables all movements of the U Arm in case of emergency Press the red mushroom shaped switch to block movements To...

Page 59: ... 3 Motorized Vertical Movement of Swivel Arm 4 Motorized SID Adjustment 5 Motorized Rotation Movement of Swivel Arm 6 Automatic Undertable Positioning 7 Automatic Thorax Positioning 8 Safety Lock 9 Low Speed 10 Motorized Rotation of DR Detector Assembly 11 Remote Control Sensor 12 Collimator Control Button At Remote Control 13 Tube Rotation Not Available 14 Pre programmed Functions Not Available R...

Page 60: ...ical adjustment of the U Arm Release them to lock in position When the Central Carriage has reached to the highest or lowest vertical position a message appears on the Screen SW LIMIT MIN HEIGHT or SW LIMIT MAX HEIGHT The U Arm height from the Center of the Detector axis to the floor is continuously indicated in the Touch Screen Console Height U ARM ROTATION Press and hold the respective button to...

Page 61: ... again to deselect Low Speed SAFETY LOCK This button lights up in the Touch Screen Console when Undertable or Thorax positioning is reached Also when any other safety device is activated for example the DR Detector Assembly Safety Band or the U Arm Gauges The Operator must press it before performing any other motion The Safety Lock stops any motion of the U Arm Also this button resets all recovera...

Page 62: ...3 MOVE ANY MOVEMENT BUTTON In case the Unit remains continuously blocked the Safety Lock button is activated it can be moved by pressing and holding the Move button and then pressing the movement button required ROTATION DISPLAY This Display shows the angle performed by the U Arm and the angle performed by the Detector It also displays some error messages PROXIMITY SENSOR 1 The U Arm is provided w...

Page 63: ...reen Select Program number The screen goes to Positioning Programs Screen Position number selection Auto positioning Data Enable Manual or viceversa Auto Access to Positioning Screen Reference picture of program number selected Access to Programs Screen press and hold for 5 seconds 1 Select the program number with the Up and Down arrow buttons 2 Press Select the screen changes to Positioning scree...

Page 64: ...position Save new position Data Picture for Reference Press and hold for 5 seconds Insert Password 1111 1 Press and hold Programs for 5 seconds 2 Insert the password 1111 and press OK 3 Select the Program position number to be modified and Press Modify 4 Then press the Positioning button and press on the different motion buttons in order to place the U Arm at the desired position 5 Then go back to...

Page 65: ...0181009 57 Illustration 4 7 Touch Screen Console Generator Parameters Screen Generator Parameters Screen Selection of Large Small Focus AEC Selections Access to Positioning Screen Selection of Generator Parameters Access to Programs Screen ...

Page 66: ...e Position Button or Thorax Position Button The Unit automatically moves to the specified position The Collimator Lamp automatically turns on 2 Center the Collimator light which corresponds to the X Ray beam with respect to DR Detector Adjust the field size with the Collimator Lamp knobs only for Manual Collimators 3 Position the patient for the examination Illustration 4 8 Patient Positioning X R...

Page 67: ...F INTEREST IN EXAMS PERFORMED WITH THE DR DETECTOR ASSEMBLY PERPENDICULARLY POSITIONED WITH RESPECT TO THE TUBE COLLIMATOR ASSEMBLY IN CASE OF EXAMS WHERE THE DR DETECTOR ASSEMBLY IS NOT PERPENDICULARLY POSITIONED WITH RESPECT TO THE TUBE COLLIMATOR ASSEMBLY THE X RAY BEAM AXIS DOES NOT COINCIDE WITH THE REFERENCE AXIS OF THE PLANE OF INTEREST AND IT IS NOT ORTHOGONAL WITH RESPECT TO THE PLANE OF ...

Page 68: ...3 seconds in up or down movement the following is an explanation of when the unit stops or reverses Detector Assembly Bumper When the U Arm is moving down or when it rotates it will always reverse the movement if the Detector Assembly Bumper is activated to avoid something kept between the detector and the floor 1 2 3 1 2 3 When the U Arm is moving up and the Detector Bumper is activated it will m...

Page 69: ... reverse movement or stop depending on the following situations The system only reverses down automatically when the Anticrushing System is activated and the angle is between 30o and 50o the angle interval where the Detector Assembly could be under the table In any other case it stops 1 2 3 30o 50o In the rest of the angle ranges from 51o to 120o and in horizontal position the system just stops 51...

Page 70: ...le Detector Ion Chamber Housing Front Panel with AEC Detector Areas and very low absorption level Removable Grid Chin Rest Handle with movement buttons Emercency Stop Bumper Portable Detectors include a Tray to conveniently load the Detector in portrait or landscape position Fixed DR Detector Assembly Portable DR Detector Assembly ...

Page 71: ...gned to conveniently house a Portable DR Detector an Ion Chamber and a removable Grid The Operator may load manually the DR Detector in Portrait or Landscape position The Handle of the Tray includes a Brake Bar for extracting the Tray Illustration 4 9 Portable DR Detector Assembly Removable Grid Tray Brake Bar Handle DR Portable Detector ...

Page 72: ...ut 2 Place the DR Detector centered in the Tray and push slightly the end stops with the Detector until it is fitted in the four stops of the Tray Illustration 4 10 DR Detector Loading End Stops 3 If applicable guide the DR Detector Cable out through the Cable Clips to avoid damages in the Cable when inserting the Tray and fully insert the Tray Detector Cable Cable Clip ...

Page 73: ...s and raise the DR Detector with both hands 2 1 Cable Clip 4 4 1 2 ROTATING THE DR DETECTOR The shape of the end stops is designed to house the Detector in both positions Landscape and Portrait With the Detector inserted in the Tray in Portrait position and the Tray inserted in the DR Detector Assembly 1 Pull out the Tray to the end of its travel and pick up the DR Detector with both hands 2 Turn ...

Page 74: ...tor centered in the Tray and push slightly the end stops until it is fitted in the four stops of the Tray 4 Guide the Detector Cable out through the Cable Clips if applicable to avoid damages in the Cable when inserting the Tray and fully insert the Tray Cable Clips ...

Page 75: ...ed with a Slot for exposure Grid and two Slots for the replacing Grid Slot for exposure Grid Slots for replacing Grid Slot for exposure Grid Slots for replacing Grid Fixed DR Detector Assembly Portable DR Detector Assembly Before making an exposure using a Grid check that the focus distance of the Grid matches the actual SID the Tube side of the Grid faces the X Ray Tube the Grid is fully inserted...

Page 76: ...sembly in relation to its transverse axis loose the lock lever and lift the ratchet Ratchet has position detents every 45o As well when the operator rotates the Tube Collimator Assembly the message Tube Rot appears in the U Arm Software Console whenever the Detector workstation is selected The Tube Collimator Assembly can be clockwise rotated up to 180o and counterclockwise rotated up to 90o Rotat...

Page 77: ...ndow 10 Laser Pointer On Off Button 6 2 3 4 5 7 Transverse Field Size Source to Image Distance 1 Manual Blade Knobs 2 8 9 10 Longitudinal Field Size 1 When pressing the Collimator Lamp push button the Collimator light and an optional Laser light turn on They remain lighting for 30 seconds before they switch Off automatically lighting time can be configured Exposure field on the DR Detector is auto...

Page 78: ...th Standard IEC 60601 1 3 2008 4 7 DOSEMETER DEVICE OPTIONAL The Dosemeter device Iba Kermax Plus is optional and compatible with the Collimator installed in the equipment Refer to the corresponding Dosemeter Manual for extended information about operation or technical description needed to maintain compliance with Standard IEC 60601 1 3 2008 4 8 ARM REST OPTIONAL U Arms equipped with this option ...

Page 79: ...tive actions prior to arriving in site Table 4 1 Error and Warning Messages Error No DESCRIPTION IN SCREEN WHAT TO DO 1 Initialize EEPROM in Service Mode 2 EEPROM could not be initialized 3 Move without Order Call Service Turn the Unit OFF ON if error remains call field service 4 Fatal RAM ERROR Call Service 5 Movement Order active during Start up 6 Security Call Service Turn the Unit OFF and call...

Page 80: ...site Move An opposite movement button has been pressed while other movement was in progress Release the opposite movement button 19 Calibration Warning Turn the Unit OFF ON if error remains call field service 20 Program not Selected Move button has been pressed without having selected a auto position Move button has been pressed again after the target position has been reached U arm position param...

Page 81: ...r Broken Cable Call Service Refer to Section 4 9 Gauge Active Communication lost with Control Board Collimator not communicating Control Board not communicating Interface Board not communicating Interface Board not communicating RCC not communicating CAN BUS COMMUNICATION LOST Physical Limit Column Rotation Left Physical Limit Column Rotation Right Physical Limit Detector Left Physical Limit Detec...

Page 82: ...on Left Limit Tube Rotation Right Collimator Rot Tube Rot Proximity Sensor activated Informative Message Photocell 1 activated g Photocell 2 activated Limit SID minimum Limit SID maximum Limit Height minimum Limit Height maximum Inverters Powering Up Emergency Move Press and Hold MOVE button any Movement button Position Adjusted by User Position Reached Press and Hold MOVE button MOVE button relea...

Page 83: ...t Up Stitching target positions not reachable Press Height Down Stitching Setup Height and SID modified Stitching Setup SID modified Informative Message Moving to Stitching Setup position Press Move button to Stitching position Stitching Setup position reached Stitching Setup Height modified Stitching Aborted Incorrect button pressed Stitching Setup error invalid parameters Stitching Setup error n...

Page 84: ...n for Stitching Initial setup Press Move button for Stitching Initial setup Press Move button to extra image position Press Move button Detector Orientation Stitching is not possible with Detector in landscape position Turn the Detector to Portrait position Tray Out Insert the Detector Tray Tube Rotated and Detector inside X Rays inhibited until the Tube is pointing the Detector Turn the Tube towa...

Page 85: ...or X ray Tube warm up at the start of each day and when the 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 actual Tube in use comparing its recommendations with this procedure If there is conflict with this procedure comply with the Tube manufacturer s instructions Perform...

Page 86: ... Exposure workstation and technique parameters using the Generator controls on the software Console 4 Instruct patient to maintain the required position Prepare the X ray Tube by pressing the Handswitch push button to the Prep position and maintain it until the Prep indicator is illuminated 5 Instruct patient to remain still and to hold his breath as required then make the X ray exposure by pressi...

Page 87: ...rs using the Generator controls on the Console 6 Continue with the radiographic operation Refer to Section 5 3 step 4 5 4 1 HOW TO VERIFY THE PROPER FUNCTIONING OF THE AUTOMATIC EXPOSURE CONTROL This procedure is not mandatory it is only a method so that the operator can verify the proper functioning of the Automatic Exposure Control 1 Ensure that X ray Tube has been properly warmed up 2 Align and...

Page 88: ...must 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 m...

Page 89: ...th intervals Heavy duty installations more than 125 patients per day require a regular six 6 month maintenance The manufacturer undertakes to have available spare parts for this equipment at least for ten 10 years after the unit manufacturing NEVER ATTEMPT TO PERFORM MAINTENANCE TASKS WHILE THE ME EQUIPMENT IS IN USE WITH A PATIENT 6 1 OPERATOR TASKS The tasks of this periodic maintenance shall in...

Page 90: ... kind When it is needed to disinfect any surface clean it with a cloth impregnated with isopropyl alcohol Do not apply directly any liquid on the surfaces nor use cleaners containing bleach ammonia or any other abrasive or solvent liquid it could cause damage to the equipment 6 2 SERVICE TASKS Only service personnel specifically trained on this medical X ray equipment should work on service tasks ...

Page 91: ...r to the Digital Detector Documentation 7 2 U ARM 7 2 1 POWER LINE REQUIREMENTS VOLTAGE FREQUENCY MINIMUM INPUT POWER REQUIRED POWER CONSUMPTION IN STAND BY 230 240 V Single Phase 50 60 Hz 2 5 kVA 80 W 7 2 2 INFORMATION RELATED TO RADIATION Radiation Output Accuracy C V Coefficient of Variation 0 05 Reproducibility related to loading factors Maximum Symmetrical Radiation Field Measured at 75 kVp 1...

Page 92: ...ximum Source Image Distance SID 1800 mm 70 8 SID adjustment speed 87 mm s 3 4 s Rotation of U Arm 120o 30o rotation may be limited by cables Rotation of Tube Collimator Assembly 180o 90o rotation may be limited by cables Rotation of DR Detector Assembly 45o Table Top Detector distance 40 7 mm 1 6 Table Top Attenuation 0 9 mm Al eq Maximum Patient weight on DR Detector Assy 18 kg 39 68 lb Grids 1 m...

Page 93: ...Arm Dimensions SID 1000 40 SID 1800 70 8 1250 49 2 2135 84 1680 66 450 17 7 2240 88 Max Travel 1265 49 8 45o 45o 310 25 2650 104 3 Maximum height in Undertable position 700 27 5 Reference Axis Reception Area 12 2 1 2775 109 25 Maximum height of the Positioner 180o 90o ...

Page 94: ...0 mA 150 kVp Compatible X Ray Tubes E7884X E7252X E7254FX E7869XX E7252X E7254FX E7869XX E7884X E7252X E7254FX E7869XX E7252X E7254FX E7869XX E7252X E7254FX E7869XX E7254FX E7869XX POWER LINE AND NOMINAL WORKING FREQUENCY A C D 230 240 VAC Single Phase 50 60 Hz 400 415 440 VAC Three Phase 50 60 Hz 480 VAC Three Phase 50 60 Hz Line voltage automatic compensation 10 Maximum line regulation for maxim...

Page 95: ...Product of mA x Time values from 0 1 mAs to 500 mAs ms From 1 to 10000 milliseconds through the following Time stations 1 2 3 4 5 6 8 10 12 16 20 25 32 40 50 64 80 100 125 160 200 250 320 400 500 640 800 1000 1250 1600 2000 2500 3200 4000 5000 6400 8000 and 10000 AEC mAs 0 1 mAs to 500 mAs AEC Exposure Time Nominal shortest irradiation Time 14 ms Max ms with DR Detector 550 1000 7 3 3 DUTY CYCLE T...

Page 96: ... mm 23 3 360 mm 14 2 690 mm 27 2 95 kg 209 lb Control Box 592 mm 23 3 422 mm 16 6 600 mm 23 6 63 kg 138 lb X ray Generator Control Box 592 mm 23 3 422 mm 16 6 1290 mm 50 78 158 kg 348 lb Illustration 7 2 Generator Control Box Dimensions CONTROL BOX Upper Cable Entrance COMPACT GENERATOR BACK COVER Lateral Cable Entrance HV Cables Stator Cable 690 27 16 600 23 62 ...

Page 97: ...Specified Energy Input in 1 hour 150 kVp 5760 mAs Inherent Filtration of X ray Source Tube Collimator refer to Identification Label E7254X High Speed Rotating Anode Focal Spots 0 6 mm 1 2 mm Anode kHU kVp 400 kHU 150 kVp Target Angle 12 Maximum Specified Energy Input in 1 hour 150 kVp 4800 mAs Inherent Filtration of X ray Source Tube Collimator refer to Identification Label E7869XX High Speed Rota...

Page 98: ...D MOBILE TABLE Height x Length x Width 700 x 2000 x 650 mm 27 5 x 78 7 x 25 5 Weight 40 kg 70 5 lb Maximum Patient weight 200 kg 440 lb X ray Transparency Area L x W 1880 x 528 mm 74 x 20 8 X ray Absorption Factor 1 05 mm Al equivalent Illustration 7 3 Dimensions of Laminated Mobile Table 700 mm 27 5 650 mm 25 6 2000 mm 78 7 ...

Page 99: ...dth 700 x 2200 x 650 mm 27 5 x 86 6 x 25 5 Weight 32 kg 70 5 lb Maximum Patient weight 200 kg 440 lb X ray Transparency Area L x W 1940 x 650 mm 76 4 x 25 5 X ray Absorption Factor 1 mm Al equivalent Illustration 7 4 Dimensions of Carbon Fiber Mobile Table 700 mm 27 5 650 mm 25 6 2200 mm 86 6 USEFUL X RAY AREA 1940 mm 76 4 ...

Page 100: ...DX D 300 U Arm User Manual 92 0171F EN 20181009 This page intentionally left blank ...

Page 101: ...ed pediatric exams can not be 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 ...

Page 102: ...A 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 A...

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Page 104: ...ptestraat 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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