User Manual CT PHANTOMS T40016, T40017 and
Contents
1. 9 Medical Device Directive MDD Components measuring system suuussss 6 2 The Council of the European Communities Council Direc D tive 97 A43 EURATOM on health protection of individuals A d r ure nep Disinfectiori oi eterne reiten tutes 9 against the danger of ionizing radiation in relation to medical Disposal prodct eiie e eea 9 exposure 3 IEC 61223 2 6 E Evaluation and routine testing in medical imaging depart Evaluating the results iieii iieii 9 ments G Part 2 6 Constancy tests X ray equipment for computed tomography General information eene 2 4 IEC 60601 2 44 l Medical electrical equipment ee Intended USE ieai e erae aa iare ieat 4 Part 2 44 Particular requirements for the safety of X ray equipment for computed tomography L Literatures coed ince eels ide Rn 12 M Maintenance aeneo eee ieee aie 9 Measurement ccceccceceececeececeeeeeeeneaeeeeeeeseeennaeeeeeeeees 8 Measurement performing seeee 8 Measurement preparing ss 8 Measuring equipment ssssssesseseee 6 O Order information essen 11 P Phantom components ssssssssseseee 6 Phantom description esssssssseeee 6 S Safety information sssssseeeen 4 T Technical specifications sees 10 12 D698 131 0 12. Features hole in the center and four holes off center for accommodation of CT ionization chamber 30009 Includes 4 blind plugs For dose measurements in accordance with IEC 61223 2 6 CT body phantom carrying case Carrying case for CT body phantom T40016 Mounting bracket for CT Phantoms for fixation of the CT head or body measuring phantom to GEMS CT installations CT head measuring phantom 15 cm long acrylic cylinder 16 cm in diameter Features hole in the center and four holes off center for accommodation of CT ionization chamber 30009 Includes 4 blind plugs For dose measurements in accordance with IEC 61223 2 6 CT head phantom carrying case Carrying case for CT head phantom T40017 DIADOS dosemeter CT chamber and ac cessories CT head amp body phantom two 15 cm long acrylic cylinders 16 and 32 cm in diameter The big cylinder can ac commodate the small one Both cylinders feature four holes off center and one central hole for CT chamber 30009 For dose measurements in accordance with IEC 61223 2 6 CT phantom and DIADOS E carrying case carrying case for CT phantom T40027 DIADOS E dosemeter CT chamber and acces sories CT ion chamber 4 73 cc ion chamber for dose length product measurements in CT Length of measuring volume 150mm cable length 2 5 m connecting system M CT ion chamber 3 14 cc ion chamber for dose length product measurements in CT Length of measuring volume 100mm cable length 2 5 m connecting system M DI
3. 1020 33 2 For your Safety The following safety statements are divided into DANGER WARNING CAUTION and NOTE Definitions DANGER Indicates an imminent hazard If not avoided the hazard will result in death or serious injury WARNING Indicates a hazard If not avoided the hazard can result death or serious injury CAUTION Indicates a potential hazard If not avoided the hazard could result in minor injury or product property damage NOTE Provides useful information to assure that you get the most from your equipment D698 131 0 1 CT PHANTOMS T40016 T40017 and T40027 For your Safety P W Safety Information WARNING Shock Hazard Strictly observe the following warnings Failure to do so may endanger the lives of the patient the user and other persons involved Before using the product the operator must ascertain that it is in correct working order and operating condition Liquids must not enter the device If liquids have entered the device it must be thor oughly inspected before being used again Exclusion of operation in the patient envi ronment Neither the product nor any periph eral device may be operated within the patient environment see Figure 1 Exclusion of operation as device with pa tient contact The device is not for use in direct contact with the patient Neither the device nor any peripheral device may have contact to the patient Devices may
4. ADOS diagnostic dosemeter measures dose dose rate dose per pulse and exposure time with semi conductor de tectors Electrometer mode RS232 interface and rechargeable battery included For 115 230V 50 60Hz DIADOS E diagnostic dosemeter complies with IEC 61674 Measures dose dose rate dose per pulse and exposure time with semi conductor detectors Electrometer mode RS232 interface and recharge able battery included Requires power supply L991041 DIADOS CT adapter connecting system M for connection of a CT chamber type TM30009 or TM77336 to the DIADOS Supplies the CT chamber with a voltage of 100V UNIDOS Universal Dosemeter System M secondary standard reference class dosemeter for dose and dose rate measurements in radiotherapy diagnostic radiology mammography and health physics Includes RS232 rechargeable batteries and mains cord for 115 230V 50 60Hz UNIDOS E therapy and diagnostic dosemeter for dose and dose rate measurements Connecting system M Includes RS232 rechargeable batteries and mains cord for 115 230V 50 60Hz T40016 T40016 1 010 T40016 1 020 T40017 T40017 1 010 T40027 T40027 1 050 TM77336 TM30009 T11003 T11035 T16018 T10001 T10008 D698 131 0 1 11 P W CT PHANTOMS T40016 T40017 and T40027 Literature Literature Index 1 The Council of the European Communities Council Direc C tive 93 42 EEC of June 1993 concerning medical devices CIGANING e
5. PIWFREIBURG User Manual CT PHANTOMS T40016 T40017 and T40027 D698 131 0 1 2005 01 Sa P W CT PHANTOMS T40016 T40017 and T40027 General Information General Information The product bears the CE mark CE in accor dance with the Council Directive 93 42 EEC about Medical Devices and fulfills the essential requirements of Annex 1 of this directive The product is a class device without meas uring function MDD The user manual is an integral part of the product It should always be kept near the product Observance of the manual is a pre requisite for proper product performance and correct operation Operator safety specified measuring accuracy and interference free operation can be guar anteed only if original products and parts are used Furthermore only the accessories listed in this manual are approved by PTW Freiburg and may be used in conjunction with the prod uct or else accessories whose use has been expressly permitted by PTW Freiburg Safe operation and proper product performance are not guaranteed if accessories or consumables from other manufacturers are used PTW Freiburg cannot be held liable for dam ages resulting from the use of accessories consumables from other manufacturers or when the user ignores the instructions and in formation given in this manual The warranty period is 1 one year and begins on the day of delivery It is unaffected by re pairs cov
6. ad the values from the measuring device and enter the data into the protocol For the determination of the weighted Computed Tomography Dose Index CTDlw the DLP has to be measured corresponding step 1 to 13 in all four outer holes and the center hole D698 131 0 1 CT PHANTOMS T40016 T40017 and T40027 Evaluating the Results P W 5 Evaluating the Results The evaluation and interpretation of the results are in the responsibility of the user CTDI Determine the CTDI Computed Tomography Dose Index from the measured DLP Compare the determined CTDI with the baseline value Compare the deviation with the allowed de viation from the standard If the deviation is too high take steps to eliminate the errors CTDlw Determine the CTDly Computed Tomography Dose Index from the measured DLP values Compare the determined CTDlw with the baseline value Compare the deviation with the allowed de viation from the standard If the deviation is too high take steps to eliminate the errors 6 Cleaning Preventive Main tenance and Disposal 6 1 Cleaning and Disinfection Wipe off the phantom only with a moist cloth Do not immerse the phantom into water Use only the following disinfectants with the given concentrations 296 solution of KORSOLIN 1 aqueous solution SOKRENA 5 96 solution Sagrotan 5 96 solution Gigasept 6 2 Preventive Maintenance Check the phantom before using for mechanical dama
7. ance Disposal of the Product TECHNICAL SPECIFICATIONS ORDER INFORMATION LITERATURE INDEX P W O CO Xo co co qq 10 11 12 12 D698 131 0 1 P W CT PHANTOMS T40016 T40017 and T40027 Intended Use 1 Intended Use The CT phantoms are PMMA cylinders represent ing the head or the body to be CT scanned T40016 is a CT head measuring phantom T40017 is a CT body measuring phantom T40027 is a CT head and body measuring phantom consisting of a smaller and a larger cylinder The smaller cylinder is used as a head measuring phantom In order to get a body measuring phantom the smaller cylinder has to be inserted into the larger one CT phantoms are used to determine the Computed Tomography Dose Index CTDI in acceptance and constancy tests according to the standards IEC 61223 2 6 IEC 60601 2 44 and FDA 1020 33 For constancy checks the CTDI must be measured at least after a period of six months or after major maintenance and service activities The CTDI must comply with the reference value within a tolerance of 20 The user manual describes the use of the test ob ject in acceptance and constancy tests of CT equipment based on the standard IEC 61223 2 6 NOTE This manual only describes the use of the CT phantoms For detailed information about ac ceptance and constancy tests of CT systems please refer to the standard IEC 61223 2 6 IEC 60601 2 44 and FDA
8. be connected to other devices or to parts of systems only if it has been ascer tained that this connection does not impair the safety of the patient the operator or the envi ronment WARNING Suffocation Hazard Dispose of the packag ing material observing the applicable waste control regulations Keep the packaging mate rial out of children s reach Patient Hazard The product is a medical electrical device and must only be handled by persons who are trained in the use of such equipment and are capable of applying it prop erly The operator must be trained in the use of the device NOTE Please observe the user manuals of all con nected devices This symbol stands for Please observe the manual Figure 1 Definition of patient environment D698 131 0 1 PTW CT PHANTOMS 140016 T40017 and T40027 Components of the Measuring System 3 Components of the Measuring System Phantom Description of the phantoms head T40017 and or body measuring phan tom T40016 4 acrylic dummy plugs The phantoms provide holes to insert a chamber or an acrylic dummy plug for the measurements Support screw rubber gisk head T40017 and body measuring phantom head and body measuring phantom T40027 T40016 each with 4 holes off center and one 8 acrylic dummy plugs hole in the center support screw rubber disk both cylinders of the head and body measuring Measuri
9. e top of the patient treatment couch 4 Set up the phantom Use the support screw and rubber disk of the phantom Turn the phantom so that one of the outer holes is in the twelve o clock position Tighten the screw NOTE If you do not use the rubber disk and the screw is not tighten strong enough the support can displace because of the high weight 5 Insert the chamber into the hole in twelve o clock position or in the position with maxi mum exposition Insert the acrylic dummy plugs into the holes not used NOTE For CT equipment performing scans with less or more than 360 the selected position has to represent the area of maximum patient dose 6 Align the phantom with respect to the CT plane and rotational axis using the crosshairs of the phantom 4 3 Performing a Measurement 7 Set up the CT for the scan 8 Start the measurement of DLP dose length product at the measuring device Perform the Scan 9 Stop the measurement Read the values from the measuring device and enter the data into the protocol 10 Change the chamber position Insert the chamber into the center hole and the acrylic dummy plugs into the not used holes CAUTION Change the chamber and dummy plugs care fully If the phantom is moved the alignment has to be repeated 11 Set up the CT for the scan 12 Start the measurement of DLP at the measur ing device Perform the scan 13 Stop the measurement Re
10. ered by the warranty regulations PTW Freiburg considers itself responsible for safety reliability and performance of the prod uct only if assembly extension readjustment modification or repair is carried out by PTW Freiburg or by persons authorized by PTW Freiburg and if the product is used in compli ance with the technical documentation This manual is in conformity with the product specifications and all applicable safety stan dards valid at printing date All rights are re served for devices circuits techniques soft ware and names referred to in the manual No part of the technical documentation may be reproduced without written permission from PTW Freiburg PTW Freiburg works in strict accordance with a quality management system which is con tinuously updated according to national and international standards PTW FREIBURG Physikalisch Technische Werkstatten Dr Pychlau GmbH L rracher Str 7 79115 FREIBURG GERMANY Phone 49 761 49055 0 Fax 49 761 49055 70 info ptw de www ptw de D698 131 0 1 CT PHANTOMS T40016 T40017 and T40027 Contents Contents GENERAL INFORMATION 1 2 4 1 4 2 4 3 8 INTENDED USE FOR YOUR SAFETY COMPONENTS OF THE MEASURING SYSTEM MEASUREMENT General Preparing for a Measurement Performing a Measurement EVALUATING THE RESULTS CLEANING PREVENTIVE MAINTENANCE AND DISPOSAL Cleaning and Disinfection Preventive Mainten
11. ges 6 3 Disposal of the Product At the end of the life time of the phantom you have to dispose the components in accordance with legal local requirements Ensure a careful separation of the materials The phantom does not contain any hazardous goods The cost for an eventual return at the end of the product life time is to be borne by the customer D698 131 0 1 PTW CT PHANTOMS T40016 T40017 and T40027 Technical Specifications 7 Technical Specifications Only values for which tolerances or limits are specified are guaranteed Values for which no tolerances are specified are for information only Device designation CT head measuring phantom CT body measuring phantom CT head and body measuring phantom Manufacturer PTW Freiburg Intended Use Determination of the Computed Tomography Dose Index CTDI in accep tance and constancy tests Dimensions and Weight Dimensions Weight CT head measuring phantom Cylinder with 16 cm and 15 cm length 3 6 kg CT body measuring phantom Cylinder with 32 cm and 15 cm length 14 4 kg CT head and body measuring Cylinder with 16 cm and 15 cm length and 14 4 kg phantom Cylinder with 32 cm and 15 cm length The smaller cylinder can be inserted into the larger one 10 D698 131 0 1 CT PHANTOMS T40016 T40017 and T40027 Order Information P W 8 Order Information CT body measuring phantom 15 cm long acrylic cylinder 32 cm in diameter
12. ng equipment phantom T40027 each with 4 holes off center and the smaller cylinder one hole in th t dosemeter DIADOS DIADOS E UNIDOS or y SAM RIOT UNIDOS E Etched crosshairs on the phantom allow exact CT chamber alignment A support keeps the phantom in its posi tion on the CT couch for DIADOS and DIADOS E CT adapter for chamber HV connection cables CAUTION Pay attention to use the correct connecting system at chamber and measuring device UNIDOS or UNIDOS E BNT TNC or PTW M connector DIADOS or DIADOS E M connector Figure 1 CT chamber CT body measuring phantom T40016 and CT head measuring phantom T40016 6 D698 131 0 1 CT PHANTOMS T40016 T40017 and T40027 PTW Components of the Measuring System Figure 2 CT chamber and CT body and head measuring phantom T40027 D698 131 0 1 7 P W CT PHANTOMS T40016 T40017 and T40027 Measurement 4 Measurement 4 1 General The phantoms are distinguished only by the di ameter body measuring phantom 32 cm with phantom T40027 the smaller cylinder inserted into the larger one and head measuring phantom 16 cm The assembly of the measuring system and the measurement is the same for all phantoms 4 2 Preparing for a Measurement 1 Prepare the protocol Enter necessary data according to the standard 2 Set up the measuring device and the chamber according to their user manuals 3 Put the phantom on the tabl
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