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DX-D 100 Mobile X-ray Unit

User Manual

0188K EN 20201116

15

2.6

SAFETY SYMBOLS

The following safety symbols may appear in the equipment.

Their meaning are described below.

Caution. Consult accompanying documents.

Safety Symbol. Follow instructions for use, especially those
instructions identified with Advisory Symbols to avoid any
risk for the Patient or Operator.

(Only applies to Standard IEC 60601-1:2005 and
IEC 60601-1:2005+AMD1:2012)

Manufacturer.

Date of Manufacture.

Medical Device.

Catalogue Number (Model reference).

Serial Number.

Model Configuration.

Summary of Contents for DX-D 100

Page 1: ...DX D 100 Mobile X Ray Unit User Manual Technical Publication 0188K EN 20201116 ...

Page 2: ......

Page 3: ...tors Advisory Indications in Section 3 8 of Motion Controls Information for Collimator Rotation Configuration for Wireless DR Detectors Options Integrated Battery Charger Weight for Mobile units with Standard Column Illustrations Pictures and General Update G OCT 05 2016 General Update H SEP 20 2018 New Label Intended Use IEC Standards Update General Cautions Removed information for Gel Batteries ...

Page 4: ...US PERSONAL INJURY OR DEATH ADVISE OF CONDITIONS OR SITUATIONS THAT IF NOT HEEDED OR AVOIDED COULD CAUSE SERIOUS PERSONAL INJURY OR CATASTROPHIC DAMAGE TO 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 k...

Page 5: ...7 1 Certifications 20 2 7 2 Environmental Statement on the Life Cycle of the Equipment or System 20 2 7 3 Mode of Operation 20 2 7 4 Protection against Electric Shock Hazards 21 2 7 5 Protection against Harmful Ingress of Water or Particulate Matter 21 2 7 6 Protection against Hazards of Ignition of Flammable Anaesthetic Mixtures 21 2 7 7 Protection against Hazards from Unwanted or Excessive Radia...

Page 6: ...onfiguration with Portable DR Detector 47 3 4 Control Console 47 3 5 X ray Handswitch 48 3 6 Infrared Remote Control optional 49 3 6 1 Operation 50 3 6 2 The Remote Finder Device 50 3 7 LED Beacon Light option 50 3 8 Motion Controls 51 3 8 1 Displacement Controls 53 3 8 2 Parking Position of the Arm 58 3 8 3 Movement Controls of the Column and Telescopic Arm 59 3 9 Collimator Controls 61 3 10 Dosi...

Page 7: ...Maintenance 74 5 1 3 Cleaning and Disinfection 75 5 2 Service Tasks 75 6 TECHNICAL SPECIFICATIONS 77 6 1 Factors 77 6 2 X ray Tubes 79 6 3 Physical Characteristics Mobile with Wireless DR Detector 80 6 3 1 Mobile with Wireless DR Detector and Standard Column 80 6 3 2 Mobile with Wireless DR Detector and Telescopic Column 81 6 4 Physical Characteristics Mobile with Portable DR Detector 82 APPENDIX ...

Page 8: ...DX D 100 Mobile X ray Unit User Manual 0188K EN 20201116 iv ...

Page 9: ...eater accuracy and consistency The Generator is controlled by multiple microprocessors which render a higher exposure consistency efficiency in operation and an extended tube life A high level of self diagnostics streamlines serviceability thereby reducing down time All functions displays and controls are logically arranged easily accessible and identified to prevent confusion Technique factors an...

Page 10: ...imator Assembly gauges and related electronic components Rotating Column and Telescopic Arm holding the Tube Collimator Assembly and allowing its positioning There are three Column types available G Standard Column G Standard Short Column optional G Telescopic Column optional only for Mobile with Wireless DR Detector The Telescopic Column in parking position reduces the height of the DX D 100 Mobi...

Page 11: ...r Manual 0188K EN 20201116 3 Illustration 1 1 DX D 100 Mobile X ray Unit Configuration for Wireless DR Detector with Standard Column 1 with Telescopic Column optional 2 Configuration for Portable DR Detector with Standard Column 1 2 ...

Page 12: ...y for motorized movements of the equipment Controls for lock release of Rotating Column Standard or Telescopic and Telescopic Arm Column rotation in relation to its vertical axis 317o telescopic and vertical motion of the Arm Tube Collimator Assembly rotation in relation to its transverse axis 360o and horizontal axis 120o Collimator rotation in relation to its vertical axis 180o Operation Control...

Page 13: ...ment has identification labels attached The labels contain the following information Manufacturer Product Model serial number and date of manufacture Voltage V Input Power kVA Frequency Hz and Output Power kW Inherent Filtration Mass Certifications and Symbols Place and date of manufacture The Label data can vary depending on the DX D 100 Mobile X ray Unit model ...

Page 14: ... can be performed to any kind of patient group Patients may be physically able disabled immobilized or in a state of shock This DX D 100 Mobile X ray Unit contributes to the metrics of imaging performance ensuring the efficient use of radiation The X Ray image receptors used in this unit are Digital Detectors 1 3 2 NORMAL USE The Normal Use of this equipment is defined as the Intended Use plus the...

Page 15: ...RVICE PERSONNEL HAVE TO STUDY THIS 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 KEEPTHIS OPERATING MANUAL WITH THE EQUIPMENT AT ALL TIMES AND PERIODICALLY REVIEW THE OPERATING AND SAFETY INSTRUCTIONS TECHNICAL INSTRUCTIONS ...

Page 16: ...ONAL METHODS 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 EDUCATIO...

Page 17: ...nts 1 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 Req...

Page 18: ...OSURE 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 O...

Page 19: ...R TO AVOID 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 Radiologic...

Page 20: ...d may 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 rad...

Page 21: ...ion Make sure that the 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 Receptor distance SID Source to Image Distance the greater th...

Page 22: ...l locations where the operator or any portion of the body may be exposed Exposure must never exceed the accepted tolerable dose A frequently used but less accurate method of determining 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 be...

Page 23: ...tion Consult accompanying documents Safety Symbol Follow instructions for use especially those instructions identified with Advisory Symbols to avoid any risk for the Patient or Operator Only applies to Standard IEC 60601 1 2005 and IEC 60601 1 2005 AMD1 2012 Manufacturer Date of Manufacture Medical Device Catalogue Number Model reference Serial Number Model Configuration ...

Page 24: ...against 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 25: ...ingers 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 Do not handle ...

Page 26: ...60601 1 2005 and IEC 60601 1 2005 AMD1 2012 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 27: ...cordance 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...

Page 28: ...D 100 Mobile X ray Unit 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 ...

Page 29: ...GAINST 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 IEC 60601 1 2005 and IEC 60601 1 2005 AMD1 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 w...

Page 30: ...r the use of the operator and staff designated as follows Illustration 2 1 Radiographic Examination on the Chest Unit or Front Panel MOBILE X RAY UNIT S SIGNIFICANT ZONE OF OCCUPANCY MINIMUM AREA 60 x 60 cm MINIMUM HEIGHT ABOVE THE FLOOR 200 cm S 140 cm CHEST UNIT MOBILE X RAY UNIT SID 100 cm X Ray Receptor Patient Support Wall Protective Device CHEST UNIT Phantom S1 S2 Focal Spot Focal Spot SIGNI...

Page 31: ...ONE OF OCCUPANCY AT THE LEFT SIDE OF THE MOBILE UNIT ANODE SIGNIFICANT ZONE OF OCCUPANCY AT THE RIGHT SIDE OF THE MOBILE UNIT CATHODE SID 100 cm RAD TABLE Phantom X Ray Receptor Patient Support MOBILE X RAY UNIT RAD TABLE Focal Spot S3 S4 S5 Focal Spot S SIGNIFICANT ZONE OF OCCUPANCY MINIMUM AREA 60 x 60 cm MINIMUM HEIGHT ABOVE THE FLOOR 200 cm S Focal Spot S Dosimeter d d DISTANCE FROM THE AXIS O...

Page 32: ...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 position of the X ray Unit during radiographic examination on the Chest Unit or Front ...

Page 33: ...0 100 120 140 160 180 200 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 5500 6000 6500 S11 S12 S21 S22 d 50 cm d 100 cm d 50 cm d 100 cm d SID 100 cm X Ray Receptor Patient Support Wall Protective Device CHEST UNIT Phantom S1 S2 Focal Spot SIGNIFICANT ZONE OF OCCUPANCY AT THE LEFT SIDE OF THE CHEST UNIT SIGNIFICANT ZONE OF OCCUPANCY AT THE RIGHT SIDE OF THE CHEST UNIT d MOBILE X RAY UNIT ...

Page 34: ... 1000 1500 2000 2500 3000 3500 4000 4500 5000 5500 6000 6500 7000 7500 8000 8500 9000 950010000 S31 S32 S41 S42 d 50 cm d 100 cm d 50 cm d 100 cm S51 S52 d 50 cm d 100 cm d d d MOBILE X RAY UNIT SIGNIFICANT ZONE OF OCCUPANCY AT FRONT SIDE OF THE MOBILE UNIT SIGNIFICANT ZONE OF OCCUPANCY AT THE LEFT SIDE OF THE MOBILE UNIT ANODE SIGNIFICANT ZONE OF OCCUPANCY AT THE RIGHT SIDE OF THE MOBILE UNIT CAT...

Page 35: ...rrect 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 ...

Page 36: ...11 Group 1 This X ray System 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 System is suitable for use in all Harmonic emissions IEC 61000 3 2 Class A This X ray System is suitable for use in all establishments other than domestic and those dir...

Page 37: ...al environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV 2 kV 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 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5s 95 for 0...

Page 38: ...ansmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol d 1 2 P d 2 3 P 800 MHz to 2 5 GHz d 1 2 P 80 MHz to 800 MHz NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electr...

Page 39: ... 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 2400 2500 MHz 0 23 Station transmitter ATSC TV broadcasting 100 kW 54 800 MHz 380 Station tr...

Page 40: ...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 and 315o ...

Page 41: ... FOR RF WIRELESS 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 induced by RF fields IEC 61000 4 6 3 Vrms from 150 kHz to 80 Mhz 6 Vrms in...

Page 42: ...st 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 duty cycle s...

Page 43: ...ity or to the radiation dose rate applied in normal use 2 9 1 FUNCTIONAL TESTS PERFORMED TO OBTAIN THE QUANTITATIVE INFORMATION Equipment These functional tests have been performed with the following configuration DR Detector maximum power X Ray Tube 50kW and Collimator Ralco R221A The results obtained with this configuration are representative of the worst case within the different configurations...

Page 44: ... 0 1 ABDOMEN AP 80 400 0 025 10 Large 100 35 x 43 No 3 5 2 9 59 3 29950 75 87 0 15 HIP AP 75 400 0 04 16 Large 100 35 x 43 No 3 2 2 7 82 5 26270 65 67 0 11 KNEE AP 65 200 0 025 5 Large 100 24 x 30 No 4 1 2 3 9 6 8953 44 56 0 06 ANKLE AP 60 100 0 04 4 Small 100 24 x 30 No 3 8 2 1 4 3973 39 73 0 05 FOOT AP 60 100 0 032 3 2 Small 100 24 x 30 No 3 8 2 1 4 5 3204 32 2 0 094 SHOULDER AP 75 250 0 04 10 L...

Page 45: ...t 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 affectto ...

Page 46: ...DX D 100 Mobile X ray Unit User Manual 38 0188K EN 20201116 This page intentionally left blank ...

Page 47: ...Charging Circuits Controls for Unit motion and controls for Column and Telescopic Arm movements Manual Collimator Panel with controls for opening or closing the Collimator Blades and to switch ON the Collimator Lamp Illustration 3 1 DX D 100 Mobile X ray Unit General Features Control Panel Parking Detent Control Console Handlebar Tube Collimator Handles Line Circuit Breaker Power Line Cable Anti C...

Page 48: ...DX D 100 Mobile X ray Unit User Manual 40 0188K EN 20201116 Illustration 3 2 DX D 100 Mobile X ray Unit Wireless Configuration Options Telescopic Column optional Standard Column ...

Page 49: ...DX D 100 Mobile X ray Unit User Manual 0188K EN 20201116 41 Illustration 3 3 DX D 100 Mobile X ray Unit Portable Configuration Options Standard Column ...

Page 50: ... Unit from mains Position the Unit so that the plug can be easily disconnected For safety reasons and for proper functioning make sure that the Unit is connected to a standard outlet with GND The Line Circuit Breaker in the ON position allows the Charging Circuits to charge batteries when the Unit is connected to the mains Circuit Breaker Power Line Cable Cable Reel Cable Reel with Rollers Rollers...

Page 51: ... start up of the computer SWITCH ON OFF KEY The Key in the ON position is used to start the Unit allowing the Mobile motion and switching ON the Generator and Console for radiographic operation When the key is in ON position the ON symbol is illuminated on the Control Panel The key in the OFF position switches OFF all the equipment functions after a delay to allow the user to shut down the Softwar...

Page 52: ...nnected to the mains power supply for battery charging whenever the Line Circuit Breaker for Charging Circuits is in the ON position and the Emergency Switch Off is not pressed IF THIS INDICATOR IS OFF DURING THE BATTERIES CHARGING PROCESS AND THE VOLTAGE IS PRESENT IN THE MAINS IT MAY BE DUE TO A DEFECTIVE BATTERY IN THIS CASE THE UNIT TURNS OFF AUTOMATICALLY TO AVOID OVERHEATING THE REMAINING BA...

Page 53: ... charge level Indicators on both columns stop scrolling and only the Upper Green Indicators remain illuminated Whenunpluggedfrommains theBatteriesdischargeindependentlydepending on their use X ray exposures or motors since the Mobile is provided with two independent battery modules Upon disconnecting the Unit from the mains if the Unit has been connected for a short period of time after several ex...

Page 54: ...e batteries charge level is 80 of the total charge When the upper Green Indicators light steady normal operation is allowed After charging during approximately 1 5 to 2 5 hours Indicators are scrolling up from the upper half of the lower Green Indicators and the rest of the Indicators below are lighting steady When the lower Green Indicators light steady normal operation is allowed although it is ...

Page 55: ...urther information refer to section 3 11 1 4 Handswitch HS connector 5 USB Ports Keyboard and Mouse connections for Technical Service 6 WI FI Connection internal 7 Bluetooth Connection option internal in order to connect other accessories Mouse Keyboard Barcode Reader Touchpad etc 8 Ethernet Cable Reel 3 1 2 5 4 3 3 2 CONFIGURATION WITH PORTABLE DR DETECTOR The Mobile Unit is provided with 1 CD DV...

Page 56: ...rrent switches from stand by to the selected mA X RAY EXPOSURE After pressing the Handswitch completely the X ray exposure is made the X ray On indicator on the Console will light and an audible signal sounds during the length of exposure The unit cannot perform exposures when the Arm is secured in the parking position Depending on the configuration the unit cannot perform exposures when the Arm w...

Page 57: ... Indicator Batteries Compartment Remote Finder Compartment Before starting the exposure ensure that there are no other equipment operating with an Infrared Remote Control at the same time neither close to nor behind windows or lead glass screens in the room Before carrying out an exposure with this device turn off any other units operating with an Infrared Remote Control that might be affected by ...

Page 58: ...F Return the Control Remote device back to its cradle on the Mobile Unit The preparation cycle automatically aborts and returns to Stand by Mode if an exposure is not initiated within 15 seconds after the Prep command or if the Collimator Lamp is turned ON during this cycle The exposure aborts if the Exposure button is released 3 6 2 THE REMOTE FINDER DEVICE The Remote Exposure Control has a built...

Page 59: ...SITION 10o WITH THE ARM OUT OF PARKING POSITION 5o IF FOR ANY REASON THE UNIT EXCEEDS THE INDICATED INCLINATION ANGLES AND LOSES THE VERTICALITY THE ARM COULD RISE SHARPLY TO THE TOP OF THE COLUMN THIS COULD CAUSE PERSONAL INJURY AND OR DAMAGE TO THE EQUIPMENT MONITOR THE SYSTEM MOVEMENTS WITH SPECIAL CARE AVOID ANY IMPACT OF THE UNIT WITH WALLS FURNITURE OR OTHER ELEMENTS IN THE ROOM THAT MAY CAU...

Page 60: ... PATIENT CONNECTED LINES SHOULD BE ROUTED AWAY FROM MOVING EQUIPMENT Motion Controls are only enabledwhen the Switch Key onthe Control Panel is in the ON position Always place the Unit in Parking position before turning the Generator and Console off even though lock controls will remain enabled for 15 seconds after turning off both the Generator and Console in order to place the Unit in Parking po...

Page 61: ...ot in Parking Position approx 1 6 km h 1 mph Velocity can be configured by service personnel DUE TO THE WEIGHT OF THE MOBILE UNIT THE BRAKING DISTANCE AT FULL SPEED ON A SMOOTH SURFACE IS 1 METER MAXIMUM Displacement cannot be performed when the Unit is connected to the mains In order to avoid uncontrolled displacement of the Unit during the Start up due to a failure of the displacement controls H...

Page 62: ... the unit using the Handlebar If the problem persists restart the unit If the handlebar is still blocked or any of the displacement controls does not respond contact Technical Service 4 beeps Fine Positioning Controls on the Handgrips activated during startup Mobile movements are only allowed using the Handlebar Ensure that the Fine Positioning Controls are not pressed and restart the unit Try to ...

Page 63: ... OF THE X RAY MOBILE UNIT THE USER MUST HAVE DRY HANDS WHEN WORKING WITH THE SYSTEM DO NOT USE OR DRIVE THE SYSTEM WITH WET HANDS OR IMPREGNATED WITH DISINFECTANT GEL OR ANY OTHER SUBSTANCE OR LIQUID SPECIALLY WHEN USING THE MOVEMENT CONTROLS HANDLEBAR HEAD ASSEMBLY HANDGRIPS OTHERWISE THESE SUBSTANCES COULD CAUSE SYSTEM MALFUNCTION AND OR AN INCORRECT OPERATION OF THE MOTION CONTROLS IN THIS CASE...

Page 64: ...116 The illustration below details the corresponding movements The buttons correspond to each motor and do not change when the Unit is in Parking Position RB LB LF RF RB RB LB LB LF RF RF LF LF RB RF LB RB Right Back RF Right Front LF Left Front LB Left Back ...

Page 65: ...et dismount the Support from the lower side of the Mobile Unit Clutch Screws Clutch Screws Wheels with Screwed Hubcap Wheels with Magnetic Hubcap Support for Key Sets DRIVE THE UNIT MANUALLY ONLY WHEN MOTORIZED MOTIONS CANNOT BE PERFORMED DUE TO MALFUNCTIONING OR MOTOR BATTERY DISCHARGE IN THIS CASE NEVER DRIVE THE UNIT ALONG A RAMP OR INCLINED SURFACES DRIVE IT ONLY IN FLAT SURFACES TO AVOID PERS...

Page 66: ...ase the Arm from Parking Position push down the Arm while pressing on the Brake Control at the Tube Collimator Assembly or Blocking Lever Parking Detent Catch ALWAYS KEEP THE ARM IN PARKING POSITION EXCEPT WHEN PERFORMING RADIOGRAPHIC EXAMS THIS WILL PREVENT INJURIES OR UNIT DAMAGE DURING DISPLACEMENT The unit cannot perform exposures when the Arm is secured in the parking position Depending on th...

Page 67: ...llows a vertical travel of 1470 mm for Standard Column 1340 mm for Short Column or 1490 mm for Telescopic Column and a telescopic travel of 540 mm for Standard Column or for Telescopic Column These Hand grips are also used without having to press the Brake Control to rotate the Tube Collimator Assembly from its vertical position 180_ on its transversal axis A This movement has detents every 90_ bu...

Page 68: ...full image size of the Detector depending on the Collimator position X Ray Tube Anode Angle Detector Size Required SID with Collimator rotated at Anode Angle Detector Size 0 or 90 45 24X30 30X24 SID 65 cm SID 85 cm 12 35X43 43X35 SID 90 cm SID 125 cm 43X43 SID 90 cm SID 125 cm 24X30 30X24 SID 55 cm SID 65 cm 16 35X43 43X35 SID 75 cm SID 90 cm 43X43 SID 75 cm SID 90 cm Note ...

Page 69: ...t with the knobs to open the blades 3 Rail System with two guides in order to install the external additional filters used for pediatric examinations 0 1 mm Cu or 3 5 mm Al in the upper guide and the Radiation Meter in the lower one 4 SID Guard Source Image Distance 5 Measuring tape to measure the SID 6 Variable Filtration optional with the following filtration options 0 mm AL 1 mm Al 0 1 mm Cu J ...

Page 70: ...tion Meter Do not install any accessories between the Radiation Meter and the patient This will disturb the radiation reading Radiation Meter optional The Radiation Meter can be removed from the rail system to be cleaned or serviced To remove the Radiation Meter pull back on the two tabs which lock the Radiation Meter to the rails and pull out the Radiation Meter The cable connection to the PC is ...

Page 71: ...etectors are placed in the Storage Bin at the Back Cover for Detectors Grid and Accessories Wireless DR Detectors communicate with the Mobile Unit through an internal Wireless Access Point Storage Bin for Wireless DR Detectors Grid and Accessories Font Cover Support for optional Battery Charger and Grid Wireless DR Detector 1 2 3 1 2 3 2 ...

Page 72: ...or 2 Wireless DR Detector Large format 5 Notepad 3 One slot for DR Detector Batteries Slot for positioning the DR Detector to cover it with Protective Bags Figure 1 Storage Bin 1 Position the DR Detector tilted forward in the front slot of the Storage Bin 2 Take a Protective Bag from slot 1 3 Slide the Protective Bag over the DR Detector Figure 2 To cover the DR Detector in a Protective Bag 4 Wire...

Page 73: ...e Wireless DR Detectors 24X30 35X43 43X43 24X30 35X43 Wireless DR Detectors with optional Back up Cable The unit is provided with a Grid Support at the Front Cover and for some Wireless DR Detectors with a Battery Charger Support For further information about supported Batteries and DR Detector models refer to the DR Detector manuals 1 Battery Charger optional it depends on the Wireless DR Detecto...

Page 74: ...e for some Wireless DR Detectors With the optional Back up Cable connected to the Detector it is possible to expand from a wireless configuration to a wired configuration This cable has to be plugged to connector RJ45 ETH at the Peripheral Connections Panel of the Mobile Unit RJ45 ETH Detector Back up Cable Optional Wired Configuration for some Wireless DR Detectors Some wireless DR Detectors can ...

Page 75: ...R Detector DX D10 It can be provided an optional Anti Scatter Grid Support designed to fit the Portable DR Detector inside It is placed inside the DR Detector Grid Holder The Portable DR Detector is placed in the DR Detector Grid Holder at the Back Cover Detector Grid Holder Front Cover Detector Cable Tether Portable DR Detector Grid 1 2 3 1 2 3 ...

Page 76: ... cloth slightly damped the patient contact surfaces as well as the handle and Grid with disinfectants such as ethanol For cleaning wipe with a cloth damped in neutral detergent For further information on the DR Detector Handling and Maintenance refer to the DR Detector manuals Grids are intended to reduce scattered radiation and significantly enhance image quality Each Grid has an attached label t...

Page 77: ...e 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 a conflict with this procedure comply with the Tube manufacturer s instructions Perform X ray Tube warm up as fo...

Page 78: ...or 2 Center the Collimator light which corresponds to the X Ray beam with respect to receptor For that use the Collimator Light centering marks and the laser line on the receptor handle if applicable 3 Position the patient for the examination 4 Turn ON the Collimator Lamp and adjust the field size with the Collimator controls 5 Perform any adjustment on the patient position receptor or tube collim...

Page 79: ... IMAGE RECEPTOR 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 INTEREST THEREFORE THE RESULTING IMAGE WILL BE DEFORMED IT IS THE OPERATOR RESPONSIBILITY THE PROPER POSITIONING OF THE PATIENT AND EQUIPMENT BEFORE PERFORMING AN E...

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Page 81: ...lity to have available spare parts for this equipment for at least ten 10 years from the date of manufacturing NEVER ATTEMPT TO PERFORM MAINTENANCE TASKS WHILE THE ME EQUIPMENT IS IN USE WITH A PATIENT 5 1 OPERATOR TASKS 5 1 1 BATTERIES MAINTENANCE If the unit has not been used or it has been stored for two months it should be energized to prevent deep discharge of the batteries A deepdischarge wi...

Page 82: ...enance tasks shall include the following items DO NOT REMOVE ANY COVER DISASSEMBLE OR MANIPULATE INTERNAL COMPONENTS IN THE UNIT THESE ACTIONS COULD CAUSE SERIOUS PERSONAL INJURIES AND OR EQUIPMENT DAMAGE 1 With the Unit OFF plug it in and leave it sufficient time to completely charge The recommended time is approximately 9 hours until the Battery Charge Level Indicators on both columns stop scrol...

Page 83: ... a cloth moistened in clean water When it is needed to disinfect the Control Console clean it with a cloth impregnated with isopropyl alcohol DO NOT APPLY DIRECTLY ANY LIQUID ON THE SCREEN OR OTHER SURFACES NOR USE CLEANERS CONTAINING BLEACH AMMONIA OR ANY OTHER ABRASIVE OR SOLVENT LIQUID IT COULD CAUSE DAMAGE TO THE EQUIPMENT 5 2 SERVICE TASKS Only service personnel specifically trained on this m...

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Page 85: ...0 250 320 400 500 Depending on the Generator model Exposure Time Range From 1 millisecond to 10 seconds through the following Time stations Milliseconds 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 Seconds 1 1 25 1 6 2 2 5 3 2 4 5 6 4 8 10 Power Output 0 1s 125 kVp 160 mA 100 kVp 200 mA 80 kVp 250 mA 62 kVp 320 mA 150 kVp 200 mA 128 kVp 250 mA 100 kVp 320 mA ...

Page 86: ...ains will be 100 discharged from full charge in approximately 9 hours for Lead Crystal Batteries Battery Capacity for the Motors Batteries fully charged float voltage of approx 112 Volts at nominal of approx 102 Volts Charge Capacity 9 Ah The required time for the Batteries to be fully charged is 6 hours With the Batteries fully charged and disconnected from the mains the Mobile Unit can be in con...

Page 87: ...Spots 0 3 mm 1 0 mm Anode kHU kVp 140 kHU 150 kVp Target Angle 12 Maximum Specified Energy Input in 1 hour 150 kVp 1440 mAs Inherent Filtration of X ray Source Tube Collimator refer to Identification Label E7884X Low Speed Rotating Anode Focal Spots 0 6 mm 1 2 mm Anode kHU kVp 300 kHU 150 kVp Target Angle 12 Maximum Specified Energy Input in 1 hour 150 kVp 3408 mAs Inherent Filtration of X ray Sou...

Page 88: ...imum 1980 mm maximum 2125 mm 560 kg without Detectors and or Accessories Note There is an optional Short Column that reduces in 130 mm the Column height the maximum SID and the Vertical Travelling of the Arm Reception Area Focal Spot min 702 max 1242 min 510 max 1050 192 530 max SID 2020 2125 Travel 1470 120o Focal Spot 317o 670 1980 Reference Axis 1330 Focal Spot 180o 1150 1313 2358 max 2508 Dime...

Page 89: ...313 mm maximum 2560 mm 670 mm minimum 1340 mm maximum 2150 mm 580 kg without Detectors and or Accessories 180o Reception Area Focal Spot min 702 max 1242 min 510 max 1050 192 1275 1340 1150 1313 2410 max 2560 530 max SID 2020 2150 Travel 1490 120o 317o Focal Spot Focal Spot 670 600 1340 Reference Axis Dimensions in mm Tolerance in Dimensions 1 180o 90o 120o ...

Page 90: ...60 kg without Detectors and or Accessories Note There is an optional Short Column that reduces in 130 mm the Column height the maximum SID and the Vertical Travelling of the Arm 180o 317o Reception Area Focal Spot min 702 max 1242 min 510 max 1050 192 530 max SID 2020 2125 Travel 1470 120o Focal Spot 670 1980 Reference Axis 1330 Focal Spot 1360 max 2555 Dimensions in mm Tolerance in Dimensions 1 1...

Page 91: ...adiographic procedures while maintaining acceptable clinical image quality will benefit patients Please review the following link and reduce pediatric technique factors accordingly http www pedrad org associations 5364 ig As a general rule next recommendations shall be observed in pediatrics X Ray Generator must have short exposures times AEC must be used carefully preferably use manual technique ...

Page 92: ...lowing scientific literature regarding pediatric radiosensitivity GROSSMAN Herman Radiation Protection in Diagnostic Radiography of Children Pediatric Radiology Vol 51 No 1 141 144 January 1973 http pediatrics aappublications org cgi reprint 51 1 141 Technique factors You should take steps to reduce technique factors to the lowest possible levels consistent with good image acquisition For example ...

Page 93: ... medical images secure The medical devices security is a shared responsibility between manufacturer and responsible organization Use only materials supplied by Official Support Technical Service for your Image Management software updates REQUIRED STRATEGIES BY THE OWNER OPERATOR Antivirus protection Use antivirus programs such as Total AV ScanGuard Security Suite Norton by Symantec PC Protect Mcaf...

Page 94: ...ded by us and never use image management software supplied by anyone else Our development process utilizes the CISCO AMP protection We are constantly scanning our development computers for malware We hope you are doing the same A summary of our integrity controls Our development computers are constantly being scanned for malware and our supplier for anti virus software automatically updates the so...

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Page 96: ...at 27 B 2640 Mortsel Belgium 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 Published by Agfa N V B 2640 Mortsel Belgium 0413 ...

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