VD UM KermaX plus DDP 003_nd
Contents
1. Subsequently the following characteristics parameters can be changed t C Settings for LED display 1 DISP 1 Settings for LED display 2 DISP 2 Printer selection COM status settings gt You have the choice of being able to switch the RS232 interface on or off for COM connections Sensitivity Resolution settings gt Itis possible to change the position of the decimal point on the LED display and therefore the sensitivity Warning This change may only be carried out by Iba Dosimetry or its locally approved representative A change is only necessary when the display resolution is altered as a result of using different High Sensitivity chambers see chapter 8 ID Number setting gt The ID number can be read on every label attached to the device so that the user can determine exactly which KermaX plus DDP is in use After the set up process has begun the following announcement appears on the upper display This announcement means the system is ready to configure the LED display 1 KermaX plus DDP User Manual Side 12 of 23 ba Dosimetry rs When the RESET button is pushed the system will show the current setting for the LED display 1 CI Id jo ISIE Dose Channel 1 x When the TEST button is pushed several times in succession the following Si settings which are available for LED2. s 3 3 KermaX plus DDP S ingle KermaX plus DDP D ouble KermaX plus DDP User Manual Side 6 of 23 1 lonisation Chamber Illustrated here is the 120 131 version with integrated electronics and an AKP cable 2 AKP cable and Y Connecter 3 Power Pack 4 Control Display Unit KermaX plus DDP 5 Adapter Frame 6 or Extension Rails KermaX plus DDP User Manual ba Dosimetry Side 7 of 23 ba Dosimetry 2 2 2 Control Display Unit KermaX plus DDP The Control Display Unit is equipped with two identical measuring chamber inputs RJ 45 sockets for the connection of the ionisation chambers described in chapter 2 These inputs are marked CH1 and CH2 Additionally the device is equipped with a 9 pin D Sub socket for the connection of a printer and also an RS 232 socket marked RJ 45 for the serial communication with an external computer Input Input Printer Chamber 1 Chamber 2 output RS 232 CH 1 CH 2 RS 232 Py G E ce cnt hi Proves RDN KermaX plus DDP rear view Das KermaX plus DDP has two LED displays and three push button actuators Their functions are described below E E B RESET PRINT TEST Resets the display to Sends a Print command anaes e DAP Chamber 1 ie a Test of the connected s DAP Chamber 2 ambers Initiates an LED Display Sum of the DAP values of the Test Chambers 1 and 2 Wu the Chambers must return a DAP value of betwe
3. a test should be carried out as previously described in see 2 5 2 The results of this test should be noted down b Now the surface area of the light beam at the level where it is projected orthogonal to the middle beam direction must be determined The measuring point of the reference chamber must also be located within this area Switch on the light beam and measure the length and breadth of the projected light field with a ruler The surface area is determined by the multiplication of the two values Note gt Amore accurate method is to produce an x ray radiograph at the same level as the Reference Chamber and subsequently measure the surface area of the exposed film surface c Photographic parameters should be set at the control console and an X ray emission release made In order to make a valid comparison with the manufacturer s Test Calibration the radiograph must be made using 100KV KermaX plus DDP User Manual Side 19 of 23 ba Dosimetry d After the radiograph emission release has been made read and take note of the results displayed on both measuring devices e g Reference Dosimeter display 26830 wGy Display KermaX plus 281 5 uGy m Note gt If a semi conductor chamber is used as the reference system then the display of the KermaX plus DDP measuring system must be adjusted to compensate for the ambient air pressure and temperature e Reference dose surface product calculation Measu
4. i use with the chambers 120 131 OEM 120 101 120 12X In order to select one of the sensitivity values it is always necessary to push the RESET button After the user has selected the sensitivity factor he she can additionally set the ID number beginning from 0 to 7 for the KermaX plus DDP KermaX plus DDP User Manual Side 16 of 23 ba Dosimetry D 1 D The user can change this configuration by pushing the TEST button D 12 ID Nummer 2 DJ 3 ID Number 3 DI 4 ID Number 4 IDI 5 ID Number 5 IDI 6 ID Number 6 DI 7 ID Number 7 D JO ID Number 0 DI 11 ID Number 1 When the user pushes the RESET button the current ID number will be selected and the set up process is terminated KermaX plus DDP User Manual Side 17 of 23 ba Dosimetry 3 Calibration The following calibration procedure should only be carried out only in exceptional cases when really justified The DAP measuring system is O calibrated by the manufacturer prior to shipment and a copy of the Calibration Test Certificate is included with this documentation As a rule a verification of the calibration normally takes place at the time of installation 3 1 Calibration of the Test Value With the help of the KermaX plus DDP original factory test results Calibration Test Certificate includ
5. measuring systems KermaX plus DDP User Manual Side 4 of 23 ba Dosimetry Are electro technical specialists 2 Before using the KermaX plus DDP the correct connection of the chamber and its component accessories must be established The operator must examine the general functionality and security of the chamber the display unit and its cable connections also for physical damage 3 The KermaX plus DDP must be operated in a fire protected clean dry and if possible air conditioned environment Protect it against excessive mechanical and thermal loads as well as dust and unnecessary humidity Note O If condensation should form in the chamber due to a change of temperature then the system is to be dried completely and may not be operated again until such action has been taken 4 Neither the KermaX plus DDP or its components and or accessories e g the attached chambers are intended to be used directly in contact with the patient 5 Do not remove any labels type identification markings from the KermaX plus DDP or from its accessories If type identification markings become illegible the parts concerned must be returned to the manufacturer for correct identification and in order to be re marked 6 Never open the KermaX plus DDP or the attached measuring chambers There are no user serviceable parts O Caution high voltage Danger of Electrocution 7 The KermaX plus DDP and the attached c
6. ba Dosimetry Kona plus D D P Duo display system User Manual NOTICE ba Dosimetry This Operating Manual is an integral component part of the dose surface product measuring system KermaX plus DDP and should always be kept in the proximity of the actual measuring system This Operating Manual is required in order to ensure the correct function and operation of the KermaX plus DDP system The KermaX plus DDP system together with its accessories may be used for no other purposes other than those specified in this Operating Manual The use of the KermaX plus DDP and every other system described in this document the resulting data as well as the verification of the data before clinical use is the sole responsibility of the user Iba Dosimetry accepts no responsibility for personal injury or damage to devices due to faulty operation neglect of the danger warnings in this Operating Manual or local health and safety regulations No part of this Operating Manual may be translated or reproduced in any way without the express written consent of the company Iba Dosimetry The user must treat this documentation like any other copyright protected material In particular if parts of the enclosed documentation are present in electronic form these may not be modified in any way Iba Dosimetry owns all copyrights in the enclosed documentation both in electronic and written form Several key functions of the KermaX plus DDP a
7. display 1 are shown CII l Ir IA lt E Dose rate Channel 1 Time Indicator CI i jt jl ME Channel 1 Sum value Cl Sju M Channel 1 and 2 C2 l dio SIE Dose Channel 2 Cl2 lr Alt E Dose rate Channel 2 _ Time Indicator C 2 t M E Channel 2 Sum Indicator C S u M Channel 1 and 2 C1 d o S E Dose Channel 1 lt To select one the settings in the display push the RESET button when that setting is displayed KermaX plus DDP User Manual Side 13 of 23 ba Dosimetry When the configuration for the LED display 1 is complete the following announcement appears in the LED display 1 dil SP 2 This announcement means the system is ready to configure the settings of LED display 2 When the RESET button is pushed the system shows the current settings for the LED display 2 CIl j Ir Alt JE as When the TEST button is pushed several times in succession the following lt P settings which are available for LED display 2 are shown CH IMIE Time Indicator l Channel 1 Sum value Channel 1 S u M and Channel 2 2 d 0 S E Dose Channel 2 2 lr Alt JE Dose rate Channel 2 E Time Indicator Channel 2 Sum value Channel S u M 1 and Channel 2 q l d O S E Dose Channel 1 OM OO Q OF OO NO Dose rate 1 jr Ajt JE Channel 1 s T
8. o Dose surface product measurement AI Mc ue 0 E with Filter a maintenance reference value inspection Constancy Test of the X ray unit Filters can be test bodies employed in the maintenance inspection Constancy Test of the X ray unit The same Filter must always be used in the same place when a measurement is taken in this way Light field Monthly Note The maintenance checks specified here are only recommendations National amp International laws for the country of use together with local legal regulations must always be observed KermaX plus DDP User Manual Side 22 of 23 6 Customer Relations b Q Dosimetry 6 1 Complaints Product queries and complaints are dealt with according to the established procedures of the Iba Dosimetry quality assurance system Customers should send their query or complaint in writing directly to the following address Iba Dosimetry GmbH Bahnhofstrasse 5 D 90592 Schwarzenbruck Germany Telephone 49 9128 607 0 Fax amp 49 9128 607 10 Email Xx info iba dosimetry com We endeavour to resolve all customer queries or complaints in the shortest time possible Items covered by guarantee warranty will be repaired or replaced within 21 working days 7 Warranty 7 1 Conditions IBA DOSIMETRY GmbH guarantees for a period of 12 months from date of purchase the error free operation of the KermaX plus DDP together with its component accessories In the e
9. and in the lower display the dose surface product of Channel 2 The status of the lower display is indicated by one of three adjacent LEDs In order to use the KermaX plus DDP the supplied power pack must be connected either to the chamber connection CH2 or to the RS 232 socket Additionally the KermaX plus DDP Master allows for the connection of a second device Slave which will always accurately display the same value as the Master DDP The Slave can be connected with an Interface cable to the RS 232 socket In this case power is now supplied through the Master DDP and therefore the system can no longer be connected to a computer 2 8 Setup It is possible to deliver separate results from two individual chambers connected to CH1 and CH2 e Dose surface product in wGym e Dose surface product rate in uGym s KermaX plus DDP User Manual Side 11 of 23 Time indicator in ms bc Dosimetry Data from the two channels can be individually displayed one DDP on the upper LED display the other on the lower LED display The unit of measurement of the displayed value is indicated by one of three LEDs located to the right of the lower display 2 9 Selection of the parameters for each display First of all the user must activate the LED display set up program This is done by depressing the pushbuttons RESET PRINT and TEST simultaneously In this case the pushbutton RESET must be pressed slightly before the other buttons
10. ed with this documentation the original test values can be recreated if required On the right hand side of the housing of the KermaX plus DDP are four access holes Located behind each of these openings is a pushbutton which can enable the user to raise or lower the values measured by the chamber s connected to the measuring device With each push of a button UP increase or Down decrease the value will change by approximately 0 5 assuming that the button is pressed for at least 200ms CH 1 CH2 UP Down UP Down O O O O Right side of the housing of the KermaX plus DDP Example If the test value of the chamber amounts to 1 75 0 7 50 with HS chambers it is necessary to push the UP button of the chamber 1 50 times Afterwards the test value displayed should be approximately 100 0 10 00 in a HS system At any time the change can be viewed by pressing the TEST pushbutton KermaX plus DDP User Manual Side 18 of 23 3 1 1 Preparation for Calibration b Oo In the illustration below the set up for the calibration of the KermaX plus DDP is depicted Focus Collimator shutter KermaX plus DDP Focus F gt reference Reference chamber chamber irradiation surface distance FKA Reference Chamber Reference Dosimeter Set up for the execution of the Calibration 3 1 2 Carrying out the Calibration Routine Procedure a The Display should be reset to Zero 0 by pushing the RESET button Following this
11. eeeeeeaneeeeeeees 9 2 4 Measurement iii 10 2 5 System INSPECliolio cosri lea 10 2 5 1 General Information alici 10 2 5 2 EXECUTION sr 10 3 System COMMQUIATION wiv scisiissietentcciuivscssssdeadsnandsatasssieadsanndnadswasisaddeasdaadnmedwacsanss 11 3 1 General Information iccciiiiiriiaiie iii ili 11 3 2 Setup 11 3 3 Selection of the parameters for each display 12 4 Calibrations inaandaa asinasina adidasa iaaiiai 18 4 1 Calibration of the test Valle etere 18 4 1 1 Preparation for Calibration n 19 4 1 2 Execution of the calibration n 19 5 KermaX plus DDP Specification 1rreccazeee eee eee ai zii 21 6 Regular MalNienaNcen cscsrecinicra irrazionale daino 22 7 GUSIOMECRe Rios 23 7 GOMNPRIIE lola 23 8 WarraniV ssciririniianicasionaziasionasonisaalianiianiga lina sia sadssanssaddnbacssssuassiadiadasnadsnasancsanad 23 CECI 23 KermaX plus DDP User Manual Side 3 of 23 Intended Use b A Dosimetry 1 Security and General Information 1 1 General Information Important message The user must ensure that before running the measuring system that this Operating Manual has been read and fully understood The KermaX plus DDP is a medical product of the class Ilb By initial start up and subsequent use of this device and or its associated accessories all applicable National and Internationa
12. en 80 0 and 120 0 when connected With the 120 131HS OEM HS Chamber 8 00 to 12 00 Attention sensitivity settings KermaX plus DDP User Manual Side 8 of 23 ba Dosimetry 2 3 Assembly amp Installation Instructions 2 3 1 KermaX plus DDP S 1 Slide the chamber into the lower accessory rails of the collimator Ensure that even if the collimator shutter is fully open that no shadows from the chamber are visible in the light field 2 Connect the chamber using the 12m long connecting cable AKP cable with the KermaX plus DDP using the socket CH1 3 Connect the RJ 45 plug of the supplied power supply with the socket CH2 4 Connect the power supply to the mains o Carry out a system check in accordance with the following chapter 2 3 2 KermaX plus DDP D 1 Slide the chambers into the lower accessory rails of the collimators Ensure that even if the collimator shutters are fully open that no shadows from the measuring chambers are visible in the light fields 2 Connect the chambers with the KermaX plus DDP by means of two 12m long connecting cables AKP cables using the sockets CH1 and CH2 3 Connect the RJ 45 plug of the power supply to the RS 232 socket gt A Connect the power supply to the mains o Carry out a system check in accordance with the following chapter If a supplemental filter is used behind the measuring chamber then the level indicated must be adjusted according
13. hambers are not waterproof If a risk of immersion or splashing exists then all system components must be sufficiently covered up and protected 8 The KermaX plus DDP requires a power supply within the range of 15 29 V DC For this purpose a power pack is supplied If the chamber should be operated with a different external power supply then this should only take place with the agreement of the X ray unit manufacturer The responsibility lies exclusively with the operator or user of the equipment In any case the power supply should be checked beforehand In the case of any doubt you should contact the manufacturer Iba Dosimetry O Please consider the safety relevant legal regulations KermaX plus DDP User Manual Side 5 of 23 ba Dosimetry 1 3 International Standards Iba Dosimetry GmbH operates a certified quality management system according to EN ISO 13485 07 2003 KermaX plus is a medical device class IIb in accordance with the Medical Device Directive 93 42 EEC 2 Use of the KermaX plus DDP 2 1 Intended use The KermaX plus chambers 120 131 OEM HS 120 131 OEM 120 131 HS 120 12X have been designed for the determination of the level of the dose surface product DAP during an X ray examination The KermaX plus DDP serves to display the levels measured by these chambers and in particular to record the radiation dose received by the patient 2 2 System Components 2 2 1 General System i 1
14. l regulations are to be observed If the KermaX plus DDP is involved in connection with an incident pertaining to local or international Medicine Product Law then the system must immediately be taken out of operation and the manufacturers or the local representative of lba Dosimetry informed about the incident in detail 1 2 Responsibility of the user Data evaluation responsibility Those who use the KermaX plus DDP for the collection of data about dose surface product carry the full and entire responsibility to critically evaluate the results of each measurement Repairs Accessories Enhancements modifications or repairs may only be implemented by Iba Dosimetry or persons who possess sufficient knowledge and expertise and are authorized by lba Dosimetry For repairs only spare parts supplied or authorized by the manufacturer may be used Disregard of the above can lead to a malfunction of the measuring instrument and subsequent errors in the readings Failure to observe any of these conditions will automatically void the manufacturer s warranty Safety Precautions 1 The KermaX plus DDP should only be operated by users who fulfil the following criteria Have an understanding of the functionality and the limitations of the equipment Possesses expert competence concerning current safety regulations about sources of radiation and the relevant legal regulations Have experience in operating dose surface product
15. ly If the O KermaX plus DDP is installed in a below table X ray Unit then generally speaking a re calibration and or verification of the calibration must be carried out see chapter recalibration Do not exceed the maximum dose surface product rate The size of the radiation field at the surface of the centred chamber may not exceed 146 mm X 146 mm KermaX plus DDP User Manual Side 9 of 23 ba Dosimetry 2 4 Taking Measurements After switching on the system is ready for use after 10 s However in order to achieve thermal equilibrium it is essential that a warm up time of 15 minutes will have elapsed in order that the attached chambers can operate to within the tolerances given in the Technical Specification Immediately before each measurement is made it is necessary to push the RESET button once After pressing the RESET button the KermaX plus DDP is ready for use The operator is now able to measure the dose surface product and or the dose surface rate 2 5 Environmental Conditions The following environmental conditions must be observed in order for the measuring device to operate to within the specified tolerances 2 5 1 Working Temperature between 10 and 50 Air humidity between 30 and 75 without condensation Air pressure between 700 hPa and 1060 hPa 2 5 2 Storage Transportation Temperature between 10 and 50 Air humidity between 30 and 75 without condensation Air press
16. nd its component accessories are protected by International Patents Iba Dosimetry GmbH Bahnhofstrasse 5 D 90592 Schwarzenbruck Germany Phone 49 9128 607 0 Fax 49 9128 607 10 www iba dosimetry com Copyright 2005 by Iba Dosimetry GmbH CE 0124 Please take note of this important symbol Emphasized notes in this manual are important for the correct operation of the device and should be read carefully KermaX is a registered trade mark of the company IBA DOSIMETRY GmbH All other Brands Trademarks and Trade Names mentioned in this documentation are the property of the applicable manufacturers and companies IBA DOSIMETRY GmbH renounces all claims of possession to rights in Brands Trademarks and Trade Names mentioned in this documentation which are not their property KermaX plus DDP User Manual Side 2 of 23 ba Dosimetry Index 1 Security and general information 1 cririeezazizie eine 4 1 1 General INFOFMABION ccicici irrita aiinbine lenire 4 1 2 Responsibility of the Useless leale 4 Safety precautions riali 4 2 Aplication of the KermaX plus DDP cccccccessseseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 6 ZA MGSO USC xs needs 6 2 2 System COMPONMGING lore 6 22 1 Generale 6 2 2 2 Indicator KermaX plus DDP 8 2 3 Assembly ciali aa 9 2 3 1 KermaX plus DDPS rsa 9 2 3 2 KermaX plus DDP D o oo eee cece ee eeeeeeeeeeeeeeeeeee
17. o select one the settings in the display push the RESET button when that setting is displayed KermaX plus DDP User Manual Side 14 of 23 ba Boat When the configuration for the LED display 2 is complete the activated printer setting is shown D The user can change this configuration by pushing the TEST button Pir i nit 2 Printer 2 Pir i nit Printer 1 Si A printer will selected when the RESET button is pushed Note If the user selects Printer 1 standard setting the system will support the label printer Star DP8340S In this case the DIP switches on the printer must be configured as follows ON HME OFF When a printer has been selected the current setting for the RS 232 interface is displayed as either on or off KermaX plus DDP User Manual Side 15 of 23 Da ba Dosimetry D The user can change this configuration by pushing the TEST button C O M lo f f Interface off C O M JON Interface on When the RESET button is pushed the following text appears in the display e g D The user can change this configuration by pushing the TEST button Display Resolution 10 for S E N S E 1 0 use with the chambers 120 131 HS OEM HS S E N S E 0 1 Display Resolution 1 for
18. red field size for the reference chamber e g Reference Dose 0 01 m 26830 uGy 0 10m length x 0 10m width Reference dose surface product 268 30 pGy m f Comparison of the reference dose surface product and the KermaX plus DDP dose surface product 100 x 281 5 pGy m _ _ _ _ __ _ 100 4 92 268 30 pGy m g Result The KermaX plus DDP shows in this case a value of 4 92 more In order to correct this deviation the DOWN button for the appropriate channel on the side of the KermaX plus DDP must be pushed approx x10 times See 3 1 in order to re adjust the measuring instrument each depression of the key results in an approx 0 5 change h Check that the test value is within the given tolerances 100 0 5 10 00 with a 120 131 HS chamber when the TEST button is pressed on the KermaX plus DDP i If the test values are ok press the RESET button and the KermaX plus DDP is now ready to start taking measurement readings KermaX plus DDP User Manual Side 20 of 23 4 KermaX plus DDP Technical Specification Number of chamber inputs Display Resolution gt Dose surface product display in combination with the chambers 120 1310EM 120 12X in combination with the chambers 120 131 HS 120 131 OEM HS gt Dose surface product display in combination with the chambers 120 131 120 12X in combination with the chambers 120 131 HS 120 131 OEM HS gt Irradia
19. tion time Measuring range gt Minimum measurable dose surface product in combination with the chambers 120 131 120 131 OEM 120 12X in combination with the chambers 120 131 HS 120 131 OEM HS gt Maximum measurable dose surface product in combination with the chambers 120 131 120 131 OEM 120 12X in combination with the chambers 120 131 HS 120 131 OEM HS gt Minimum measurable dose surface product rate in combination with the chambers 120 131 120 12X 120 131 OEM in combination with the chambers 120 131 HS 120 131 OEM HS gt Maximum measurable dose surface product rate in combination with the chambers 120 131 in combination with the chambers 120 131 HS 120 131 OEM HS in combination with the chambers 120 101 120 12X ba Dosimetry 0 1 uGy m 0 01 Gy m 0 1 uGy m s 0 01 uGy m s 50 ms 0 1 uGy m 0 01 Gy m 999999 9 uGy m 99999 99 uGy m 0 1 uGy m s 0 01 uGy m s 30000 0 uGy m s 3000 00 uGy m s 1000 0 Gy m s KermaX plus DDP User Manual Side 21 of 23 5 Regular Maintenance b A The following routine maintenance checks should be carried out as specified below in order to ensure the trouble free operation of the measuring device Test Frequency Tolerance Automatic Self Test Monthly 8 00 12 00 at 120 XXX HS chambers 80 0 120 0 15 Absolutely accuracy Instrumentation Control Every 5 years i t
20. ure between 700 hPa and 1060 hPa 2 6 System Inspection 2 6 1 General Information After the initial installation Acceptance Test and thereafter once a month the operator should carry out an inspection of the KermaX plus DDP 2 6 2 Execution Press the TEST button ED The KermaX plus DDP resets itself automatically and generates a test signal in the amplifier of the connected chambers Afterwards the connected chambers should show a DAP value between 80 0 and 120 0 With 120 131 HS chambers 8 00 12 00 scythe 10 adjust KermaX plus DDP User Manual Side 10 of 23 lha Press the RESET butt on J gt Briefly all LED display elements must Y light up and reset all indicator values to 0 Zero In the event that a test returns a value outside of the given tolerances you will have to carry out a recalibration of the system System configuration 2 7 General Information The system can be configured to operate with a one or two channel display e One 1 channel on only one chamber attached corresponds to KermaX plus DDP S The KermaX plus DDP shows in the upper display the dose surface product of Channel 1 and in its lower display either the dose surface product rate or the exposure time measured with Chamber 1 e Two 2 channels on two chambers attached corresponds to KermaX plus DDP D The KermaX plus DDP indicates in the upper display the dose surface product of Channel 1
21. vent of a defect IBA DOSIMETRY GmbH shall decide whether the system will be replaced or repaired free of charge The following data must be included for a possible claim under warranty Description of the defect error The date of purchase The model number of the device The serial number of the chamber Postage and packaging costs will be paid for by the owner unless otherwise first agreed in writing with IBA DOSIMETRY GmbH Costs incurred as a result of damage to the equipment caused during transit will be the responsibility of the owner Subject to change VD UM KermaX plus DDP 003 KermaX plus DDP User Manual Side 23 of 23
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