Innomed Medical TOP-X 100LC Скачать руководство пользователя

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TOP-X 100LC

HIGH-FREQUENCY X-RAY GENERATOR

USER’S MANUAL

Manufacturer:

Innomed Medical Inc.

H-1146 Budapest
Szabó József u. 12.

Tel.: (36-1) 460-9200
Fax: (36-1) 460-9222

www.innomed.hu

R-4709-EN/G

02.09.2019

Содержание TOP-X 100LC

Страница 1: ...TOP X 100LC HIGH FREQUENCY X RAY GENERATOR USER S MANUAL Manufacturer Innomed Medical Inc H 1146 Budapest Szabó József u 12 Tel 36 1 460 9200 Fax 36 1 460 9222 www innomed hu R 4709 EN G 02 09 2019 ...

Страница 2: ...ow speed 6 1 New labels on the device 6 2 1 revision history added D 11 05 2010 10 kWs min maximum duty cycle for energy storage version generators 6 1 revision history added C 27 04 2010 Modified intended use and operator profile 1 B 13 01 2010 APR selection immediately if only one program is programmed to one bodypart 2 3 Change in saved parameters for APR 2 3 Patient size correction configurabl...

Страница 3: ...2 2 3 Using anatomical programs APR 12 2 3 1 Patient size correction 14 2 4 Manual operating mode 14 2 4 1 Examination device selection 14 2 4 2 Exposure with or without grid 15 2 4 3 X ray tube focal spot selection 15 2 4 4 Exposure X ray tube voltage kV setting 15 2 4 5 2 point mode mAs setting 15 2 4 6 3 point mode mA and exposure time setting 16 2 4 7 Tomography optional 16 2 4 8 Checking X ra...

Страница 4: ...age 26 5 2 The exposure results in too dark or too light image film 26 6 TECHNICAL DATA AND SAFETY 28 6 1 Technical data 28 6 2 Labels on the device 31 6 2 1 Type identification label 31 6 3 Environment 33 Elimination of useless electronic and electrical devices as waste 33 6 4 Electromagnetic compatibility 33 ...

Страница 5: ...10 TOP X 100LC HIGH FREQUENCY X RAY GENERATORS TECHNICAL MANUAL AND INSTALLATION GUIDE Only appropriately qualified person experienced in X ray technology may perform any service activities The user cannot connect any device to the equipment During normal operation the generator does not emit any substance harmful to the environment The oil in the generator s high voltage transformer is harmful to...

Страница 6: ...ay unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed Where Explanation on control panel Never allow an unqualified person to operate the X ray generator Where Explanation on generator on generator parts High voltage is present behind cover at all times when generator power is switched on Where Explanation In documentations of the uni...

Страница 7: ...ator power is switched on Where Explanation on generator s front cover Dangerous voltage remains behind generator cover even if generator mains voltage is switched off Wait at least 10 minutes after switching off generator before removing covers Removal of covers is only allowed to a qualified person Where Explanation On generator s front cover International Protection Marking ...

Страница 8: ...al parameter setting is required In case of AEC option exposures can be made in AEC mode as well the generator stops the exposure when the X ray dosage reaches the preset value in the film plane The TOP X 100LC X ray generator contains the following main units control panel power unit which contains the high voltage transformer power electronics generator controller and device interface and the fo...

Страница 9: ...hnical Manual and Installation Guide The highest available reference air kerma depending on type kW 32kW 150kV 200mA 1 6s 40kW 150kV 250mA 1 3s 50kW 150kV 320mA 1s 65kW 150kV 320mA 1s 80kW 100kV 800mA 0 63s 1 1 4 Instruction for use representative values of reference air kerma The settings of loading factors kV mA mAs s can be found in document TOP X 100LC High Frequency X Ray Generator Technical ...

Страница 10: ...osures possible to mount on collimator and has own display to visualize the dose area product The dosimeter must be calibrated periodically The suggested period is one year The overall uncertainly in the displayed values of the cumulative dose area product above 5μGy m2 does not exceed 35 Suggested dosimeter types KermaX plus 120 131 HS OEM DAP meter IBA KermaX plus 120 IDP DAP meter IBA KermaX pl...

Страница 11: ...ection buttons 3 X ray tube load indicator 12 Bucky enable button 4 Exposure parameter display 13 Anatomical program steps 5 Exposure parameter setting 14 Film speed selection 6 Max tube load selection 15 X ray tube focal spot selection 7 Film density correction AEC 16 Preparation and exposure buttons 8 Automatic exposure control AEC field selection 17 Charge indicator 9 Patient size correction ...

Страница 12: ...chapter 3 2 3 Using anatomical programs APR In the TOP X 100LC generator it is possible to recall the most often used examinations from programs In anatomical program APR operating mode there are 10 buttons available to select the examination An examination or bodypart is assigned to each button The name is indicated next to the button Each bodypart can contain 10 examinations The service staff se...

Страница 13: ... If you do not know the two digit code select the bodypart according to the labels next to the buttons Use the APR SELECT buttons to select the examination Selecting an anatomical program means the automatic setting of the following parameters voltage kV current mA time sec current time product mAs examination device small large focal spot Bucky on off AEC on off selected dominant field filmspeed ...

Страница 14: ...mode as well Correction value for kV in percentage can be changed by service staff if necessary 2 4 Manual operating mode Without the use of anatomical programs all examination related settings must be set manually These are the following examination device selection bucky enable or disable X ray tube focal spot selection X ray tube voltage kV selection X ray tube current mA and exposure time or c...

Страница 15: ...cal spot selection buttons if the specified parameter combination is not allowed the generator will try to recalculate the current and time values by keeping the mAs value unchanged During this process the generator will find the largest mA value for the specified mAs value to create the exposure in as short a time as possible In this case the mAs and kV values do not change The light next to the ...

Страница 16: ...ly the exposure X ray tube current mA changes step by step according to the following 10 12 16 20 25 32 40 50 63 80 100 125 160 200 250 320 400 500 630 mA The minimum and maximum current value depends on the selected focal spot X ray tube capacity and generator power When holding the buttons continuously the exposure time changes step by step according to the following 1 2 3 4 5 6 8 10 12 16 20 25...

Страница 17: ...8 Checking X ray tube load The X ray tube load indicator shows the tube load in percentage in case of specific parameter setting The indicator takes into account the number of exposures made at what energy level and time since This way the indicated value shows the common load from the exposures made so far and the currently set but not yet performed exposure So as time passes with the cooling of ...

Страница 18: ...ccur due to releasing PREP button during preparation interrupted preparation you can make the exposure again If another error occurred the control panel gives a sound at pressing PREP In this case you cannot immediately make the exposure again you have to acknowledge the error with any button except the PREP and EXP on the control panel Before acknowledging read the error message on the anatomical...

Страница 19: ...osure If you reach this exposure time value or mAs value during exposure the generator will terminate the exposure These are the so called backup time or mAs Their goal is protection in cases where the AEC function should fail to operate This can happen if X ray does not reach the detector chamber because perhaps the aperture setting is not correct If the exposure is not stopped by the AEC functio...

Страница 20: ...50 2 1 2 63 2 1 80 1 0 100 0 1 125 1 2 160 2 3 200 1 2 Simultaneously with density correction setting the generator changes the backup mAs value at the same rate 2 5 5 AEC operation monitoring If you have doubts regarding the operation of the exposure automatics or would like to monitor AEC operation for quality control reasons you can do so as follows 1 Fill a container that overhangs the AEC dom...

Страница 21: ...ckup time If it happened in 2 point mode call service CHARGING Energy storage capacitor bank charging in progress Before exposure wait for charging to stop DENSITY MINIMUM Density correction value is at minimum 3 DENSITY MAXIMUM Density correction value is at maximum 3 DOOR OPEN The X ray room door is open preparation cannot proceed DR NOT READY Digital image system is not ready for the exposure E...

Страница 22: ...re mA setting is at the selected focal spot s lower limit If you are at large focal spot try switching to small mA UPPER LIMIT The exposure mA setting is at the selected focal spot s upper limit If you are at small focal spot try switching to large MANUAL 3 POINT You have switched from anatomical program mode to manual 3 point mode kV mA s MANUAL mAs MODE You have switched from anatomical program ...

Страница 23: ...R S MANUAL R 4709 EN G 23 Message on the APR display Message explanation TOMO NOT READY The examination table is not switched to tomography operating mode WAIT FOR COOLING The system has overheated wait until it cools ...

Страница 24: ...e system DATA BASE ERROR Control panel failure DEV RDY TIMEOUT No ready signal from the bucky DEVICE CONFLICT Examination device is not installed DEVICE INTERRUPT Bucky ready signal terminated during exposure EEPROM ERROR Control panel failure EXP TIMEOUT X ray did not start or exposure stopped by backup time FILAMENT ERROR X ray tube focal spot heating error GEN NOT READY Generator standby signal...

Страница 25: ...r splash inside the device and no detergent remains on the covers Beware that the labels on the covers remain intact visible and legible Let covers dry completetly but wait at least 15 minutes after cleaning before turning the generator on The generator requires regular maintenance performed by the professional service staff annually according to the installation manual Maintenance includes X ray ...

Страница 26: ...ation does not have exposure time requirements for example short time for movement freezing or tomography If you do not use exposure automatics AEC the exposure parameters must be selected according to the following aspects film and screen properties patient radial size shape examined tissue type X ray tube focal spot film distance the extent type of other filters between X ray tube focal spot and...

Страница 27: ... sure you only limit the beam with the aperture so the entire selected field is completely inside otherwise the image will be overexposed the film will be too dark The automatics takes into consideration the sensitivity and characteristics provided for the selected film speed H M D during installation so it is important to always use the film speed appropriate for the applied film and screen Densi...

Страница 28: ... Max output energy line powered energy storage 50 kWs 6 3 kWs 20 50 kWs 10 kWs 20 50 kWs 10 kWs 20 20 kWs 20 30 kWs 20 Current time product line powered energy storage 0 5 630 mAs 0 5 200 mAs 0 5 630 mAs 0 5 250 mAs 0 5 630 mAs 0 5 250 mAs Max output average power 50 kWs min line powered 30 kWs min energy storage Nominal output power 0 1 s 65 kW 100 kV 650 mA 80 kW 100 kV 800 mA Max output voltage...

Страница 29: ... time accuracy 10 1 ms Current time product accuracy 10 0 2mAs Device lifetime 10 years with regular maintenance Classification Protection against electric shock Class I electric shock protection Applied part type no patient part Protection against water penetration IP 20 Sterilization disinfection not a sterile device Operating mode continuous operation The device may not be used in the presence ...

Страница 30: ...formance Electromagnetic disturbances Requirements and tests EN 60601 2 54 2009 Medical electrical equipment Part 2 54 Particular requirements for the basic safety and essential performance of X ray equipment for radiography and radioscopy We reserve the right for changes ...

Страница 31: ...2 1 Type identification label The desktop console is optional part of the generator its type identifier label is always as follows sample The generator may be identified with the type identification label on the side as follows Standard version sample UL version sample ...

Страница 32: ... 24C20 230 240 VAC 1 phase 16 A with 20 kWs energy storage unit 24C30 230 240 VAC 1 phase 16 A with 30 kWs energy storage unit 403 380 400 VAC 3 phase line powered d 1 generator capable of serving one X ray tube e R only radiography operating mode f L 50 Hz anode rotation H 150 180 Hz optional highspeed anode rotation g A with automatic exposure control AEC N without AEC option h C with built in c...

Страница 33: ...user might need to take mitigation measures such as relocating or re orienting the equipment Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the TOP X 100 LC X ray generator including cables specified by the manufacturer Otherwise degradation of the performance of this equipment cou...

Страница 34: ...n nearby electronic equipment RF emissions CISPR 11 Class A TOP X 100LC generator is suitable for use in all establishments other than domestic and these directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic current emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker IEC 61000 3 3 Not applicable Certain parts o...

Страница 35: ...ential mode 2 kV common mode 1 kV differential mode 2 kV common mode 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 0 UT 100 dip in UT for 1 cycle 70 UT 30 dip in UT for 25 cycle 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 ...

Страница 36: ...F transmitters 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 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and refle...

Страница 37: ...unit and telecommunication equipment that calculated from maximum output power of transmitter the following way Maximum output power of transmitter W Separation distance as a function of transmitter frequency m 150 kHz 80 MHz d P 2 1 80 MHz 800 MHz d P 2 1 800 MHz 2 5 GHz d P 3 2 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 If the transmitter power is not in the...

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