Innomed Medical TOP-X 100LC User Manual

High-frequency x-ray generator

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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
R-4709-EN/G
www.innomed.hu
02.09.2019

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  • Page 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 R-4709-EN/G www.innomed.hu 02.09.2019...
  • Page 2 USER’S MANUAL TOP-X 100LC REVISION HISTORY Revision Release date List of changes, new or modified chapters 02.09.2019  Revision 20.02.2016  New labels and symbols  Technical data added ambient parameters: 6.1  New ID labels on the device: 6.2.1 ...
  • Page 3: Table Of Contents

    TOP-X 100LC USER’S MANUAL TABLE OF CONTENTS WARNING LABELS AND SYMBOLS ..............5 1. INTRODUCTION ....................8 General instructions, informations for use of X-RAY........9 1.1.1 Repetition of exposures ..............9 1.1.2 Reference air kerma ................9 1.1.3 Highest available reference air kerma ..........9 1.1.4...
  • Page 4 USER’S MANUAL TOP-X 100LC 5. TROUBLESHOOTING ..................26 Exposure terminated with “INTERRUPTED EXP.” message ......26 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...
  • Page 5 TOP-X 100LC USER’S MANUAL NOTICE! Innomed Medical Inc. presents the following information according to effective European normative and related international standards. Generator operation requires thorough preparation in the field of X-ray diagnostics. There is lethal voltage in the high-voltage cables and X-ray tubes within the generator, even after shutdown.
  • Page 6: Warning Labels And Symbols

    USER’S MANUAL TOP-X 100LC WARNING LABELS AND SYMBOLS Descriptions of warning labels and symbols on the generator and the control panel: Symbol Where? Why? Where: on generator’s front cover,type identification label, documentation This symbol is used to indicate a potential...
  • Page 7 TOP-X 100LC USER’S MANUAL Symbol Where? Why? Where: on generator’s front cover Explanation: Dangerous voltage present behind generator covers times when generator power is switched on. Where: on generator’s front cover Explanation: Dangerous voltage remains behind generator cover even if generator mains voltage is switched off.
  • Page 8: Introduction

    X-ray radiation. Manufacturer of the X-ray equipment is not responsible for any harms resulting from wrong X-ray parameter setting. The main feature of the TOP-X 100LC X-ray generator is its ease of operation. You can select the parameter settings from 100 pre-programmed automatic exposure modes.
  • Page 9: General Instructions, Informations For Use Of X-Ray

    TOP-X 100LC USER’S MANUAL General instructions, informations for use of X-RAY 1.1.1 Repetition of exposures Pay attention to local skin dose levels that causes tissue reactions under intended use in case of repetitive or prolonged exposure! 1.1.2 Reference air kerma The amount of X-Ray radiation, such as the value of reference air kerma is directly proportional to the current –...
  • Page 10: Information On The Configuration Of Test Geometries For Dosimetric Test

    USER’S MANUAL TOP-X 100LC Depending on the type of tube, and depending on the usage time of the tube “aging” the values may change (10-30%), but the relative values do not change. 1.1.5 Information on the configuration of test geometries for dosimetric test focal –...
  • Page 11: Generator Operation

    TOP-X 100LC USER’S MANUAL 2. GENERATOR OPERATION 2.1 Controls on the control panel Anatomical program (APR) On and off buttons selection Anatomical program display Device selection buttons X-ray tube load indicator Bucky enable button Exposure parameter display Anatomical program steps...
  • Page 12: Turning The Generator On

    (over 80% load) exposures in the first 10 minutes after power on! 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.
  • Page 13 TOP-X 100LC USER’S MANUAL You can select the anatomical program as follows: If only one examination is assigned to a button:  Push the button next to the required examination name. If bodyparts are assigned to the buttons:  If you know the two-digit examination code, enter it. After pressing the button for the first digit (bodypart), the light next to it will begin to flash: this indicates that the control panel is waiting for the second digit.
  • Page 14: Patient Size Correction

    USER’S MANUAL TOP-X 100LC 2.3.1 Patient size correction The anatomical programs contain parameters for average-size patients. If the patient is fatter, or in fact thinner than average, or maybe you would like to create exposures of a child, use one of the buttons in the patient field:...
  • Page 15: Exposure With Or Without Grid

    TOP-X 100LC USER’S MANUAL 2.4.2 Exposure with or without grid Use this button to select whether to use the specified device with or without grid. The light next to the button indicates the enabled grid movement. In case of exposures without a grid, lower kV and lower mAs is needed due to the decreased filtering –...
  • Page 16: 3-Point Mode: Ma And Exposure Time Setting

    USER’S MANUAL TOP-X 100LC When continuously holding the buttons, the mAs changes step-by-step according to the following: 0.5, 0.6, 0.8, 1, 1.2, 1.6, 2, 2.5, 3.2, 4, 5, 6.3, 8, 10, 12, 16, 20, 25, 32, 40, 50, 63, 80, 100, 125, 160, 200, 250, 320, 400, 500, 630 mAs...
  • Page 17: Checking X-Ray Tube Load

    TOP-X 100LC USER’S MANUAL Tomography exposures can be made as follows: 1. Select and set tomography operating mode on the examination table. Select the tomography examination device on the generator, and set the exposure parameters (or select the appropriate anatomical program).
  • Page 18: Automatic Exposure Control (Aec, Optional)

    USER’S MANUAL TOP-X 100LC Pushing the PREP button or the hand-held exposure switch to the first stop starts the generator preparation (revs up X-ray tube anode and heats up the filament), indicated by the “PREPARATION…” message on the anatomical program display and a continuous sound.
  • Page 19: Turning Aec Operating Mode On And Off

    TOP-X 100LC USER’S MANUAL AEC may be used in both manual and anatomical program mode. In anatomical program mode, depending on the examination programming, the program starts with or without AEC. 2.5.1 Turning AEC operating mode on and off AEC operating mode may be turned on by selecting the appropriate dominant field.
  • Page 20: Density Correction

    USER’S MANUAL TOP-X 100LC The operator selects what foil and film to use based on the nature of the examination and other circumstances. H, M or D must be selected on the control panel accordingly. According to film / foil combination sensitivity the generator automatically corrects the mAs value in both anatomical program and manual operating modes.
  • Page 21: Messages On The Anatomical Program Display

    TOP-X 100LC USER’S MANUAL 3. MESSAGES ON THE ANATOMICAL PROGRAM DISPLAY 3.1 Operation messages The following messages appear on the anatomical program display during normal operation. These messages do not require service intervention. Message on the APR display Message explanation BACKUP mAs ERR.
  • Page 22 USER’S MANUAL TOP-X 100LC Message on the APR display Message explanation KEY INHIBITED You have pressed a button that is disabled in the configuration you are using (for example, you have selected tomography but the table does not support it; or selected AEC but there is no dosage measurement chamber built into the table).
  • Page 23 TOP-X 100LC USER’S MANUAL Message on the APR display Message explanation TOMO NOT READY examination table switched tomography operating mode. WAIT FOR COOLING The system has overheated, wait until it cools. R-4709-EN/G <23>...
  • Page 24: Error Messages

    USER’S MANUAL TOP-X 100LC 3.2 Error messages The following messages indicate setting errors, or generator or system failure. If you see any of the following messages or messages not listed in Chapter 3 on the anatomical program display, call service!
  • Page 25: Cleaning And Maintenance

    TOP-X 100LC USER’S MANUAL 4. CLEANING AND MAINTENANCE If necessary, the generator and the control panel cover may be cleaned as follows. Before cleaning turn the generator completely off, including power input as well, and all other devices in electrical connection with the generator.
  • Page 26: Troubleshooting

    USER’S MANUAL TOP-X 100LC 5. TROUBLESHOOTING The following section contains a list of common simple problems and their solutions. Exposure terminated with “INTERRUPTED EXP.” message The generator terminated the exposure because you have released the exposure button during X-ray switching. The button must be pressed during X-ray switching (indicated by sound and X-ray symbol), unless you want to terminate the exposure.
  • Page 27 TOP-X 100LC USER’S MANUAL When using the automatics, take care that the dosage detector chamber’s selected field is covered by the examined patient body part, because the part of the image in the selected field will have the appropriate density. Make 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).
  • Page 28: Technical Data And Safety

    USER’S MANUAL TOP-X 100LC 6. TECHNICAL DATA AND SAFETY 6.1 Technical data Nominal output power 32 kW 40 kW 50 kW (0.1 s): (100 kV, 320 mA) (100 kV, 400 mA) (100 kV, 500 mA) Max. output voltage: 150 kV...
  • Page 29 TOP-X 100LC USER’S MANUAL Nominal output power 65 kW 80 kW (0,1 s): (100 kV, 650 mA) (100 kV, 800 mA) Current-time product: line powered: 0.5 – 630 mAs 0.5 – 630 mAs 0.5 – 630 mAs Max. output average...
  • Page 30 USER’S MANUAL TOP-X 100LC basic safety and essential performance 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.
  • Page 31: Labels On The Device

    TOP-X 100LC USER’S MANUAL 6.2 Labels on the device 6.2.1 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:...
  • Page 32 USER’S MANUAL TOP-X 100LC Structure of the type identifier in the label’s “REF” section: TOP-X 100LC ab - c – defghij-k where: Generator mA and power limit: 400 mA (32 kW) 500 mA (40 kW) 630 mA (50 kW) 800 mA (65-80 kW)
  • Page 33: Environment

    TOP-X 100LC USER’S MANUAL 6.3 Environment Elimination of useless electronic and electrical devices as waste (It is applicable in the selective waste collection system of the European Union and other European countries.) This symbol on the product or on its packaging indicates that this product should not be treated as household waste.
  • Page 34 The following declarations should be observed during installation and use of the unit: Guidance and manufacturer’s declaration – electromagnetic emissions Line powered versions of TOP-X 100LC generator family are intended for use inelectromagnetic environment specified below. The customer or the user of TOP- X100LC generator should assure that it is used in such an environment.
  • Page 35 USER’S MANUAL Guidance and manufacturer’s declaration – electromagnetic immunity The TOP-X 100LC X-ray generator family are intended for use inelectromagnetic environment specified below. The customer or the user of TOP-X100LC generator should assure that it is used in such an environment.
  • Page 36 USER’S MANUAL TOP-X 100LC The TOP-X 100LC X-ray generator family are intended for use inelectromagnetic environment specified below. The customer or the user of TOP-X100LC generator should assure that it is used in such an environment. Immunity IEC 60601 Compliance...
  • Page 37 TOP-X 100LC X-ray generator unit TOP-X 100LC X-ray generator family is intended for use in electromagnetic environment where electromagnetic disturbances are under control. Customer and user of TOP-X 100LC X-ray generator family can help on preventing electromagnetic influence between portable...

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