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Safety measures

INTRABEAM Water Phantom

Version 6.2

Page 16

G-30-1767-en

Symbols and labels

Please observe the warning labels and notices!
If you notice that any of these labels is missing or has become illegible on your
device, please contact ZEISS Service or an authorized representative of ZEISS.
You can obtain replacements.

"Observe the Instructions for Use" label
Observe the instructions for use or accompanying documents.

Equipment marking label
The equipment marking label contains the following information:

The technical data of the INTRABEAM Water Phantom can be found in the
section entitled "Device data" on page 72.

Product and device identification
This label contains the following information:
Date of manufacture

YYYY-MM-DD

UDI (Unique Device Identifier)

Device identification (DI)

(01)04049539101785

Product identification (PI)

(11)YYMMDD(21)663010XXXX

–

Symbol for "manufacturer"

–

Manufacturer (company name) Carl Zeiss Meditec AG

–

Address of the manufacturer

Goeschwitzer Strasse 51-52
07745 Jena, Germany

–

Serial number

663010xxxx

–

Product classification

P30600001

–

Device name

INTRABEAM Water Phantom

–

Reference number

304534-7000-600

–

CE label

with identification num-

ber of the notified body

0297

Содержание INTRABEAM

Страница 1: ...ZEISS INTRABEAM Water Phantom Instructions for Use G 30 1767 en Version 6 2 2022 02 24...

Страница 2: ...Phantom with cat no 304534 7000 600 Manufacturer Original language These Instructions for Use were originally drafted and published in German Copyright Carl Zeiss Meditec AG 2022 All rights reserved...

Страница 3: ...Spherical Applicator Spherical applicator Spherical ball shaped INTRABEAM Flat Applicator Flat applicator Flat applicator INTRABEAM Surface Applicator Surface applicator Surface applicator INTRABEAM 6...

Страница 4: ...INTRABEAM Water Phantom Version 6 2 Page 4 G 30 1767 en Blank page for your notes...

Страница 5: ...ion symbols 9 Target group 10 Field of application 10 Intended use 10 Normal use 10 Notes for the operator 12 Symbols and labels 16 System overview Overview of the modules 18 Water tank module 19 Rota...

Страница 6: ...e water phantom 33 Positioning the probe tip for recording the depth dose curve 35 Positioning the probe tip exactly using the current measurement 36 Measuring the depth dose curve 43 Determining the...

Страница 7: ...rding the depth dose curve with a flat applicator or surface applicator 60 Water phantom procedure for depth dose curve measurements using a flat or surface applicator 62 Care and maintenance Safety i...

Страница 8: ...INTRABEAM Water Phantom Version 6 2 Page 8 G 30 1767 en Regulatory information 73 Ambient conditions 73 Index...

Страница 9: ...corporated into the Instructions for Use Please note this information and be particularly careful in these cases Information symbols The following information symbols are used in these Instructions fo...

Страница 10: ...TRABEAM system to check whether the measured values are within the expected range Normal use The INTRABEAM Water Phantom is used to measure the depth dose curve and the isotropy of your XRS 4 X ray so...

Страница 11: ...e three axial direc tions X Y and Z exactly relative to the measuring chambers For rotation of the XRS 4 X ray source about the Z axis the INTRABEAM Water Phantom features a unit with eight detent pos...

Страница 12: ...edical devices must comply with the relevant standards and guidelines Furthermore any config urations must comply with normative requirements for medical systems see IEC 60601 1 1 2000 or IEC 60601 1...

Страница 13: ...e using the INTRABEAM Water Phantom If you have an INTRABEAM 600 ZEISS Instructions for Use INTRABEAM 600 G 30 1987 UNIDOS Romeo Electrometer Type TN10053 AS Manufacturer PTW Freiburg Instructions for...

Страница 14: ...on only when the XRS 4 is activated The internal radiation monitoring system IRM detects the radiation emitted during the measurement When X ray radiation is generated an audible acoustic signal is em...

Страница 15: ...Version 6 2 G 30 1767 en Page 15 INTRABEAM Water Phantom Safety measures Blank page for your notes...

Страница 16: ...wing information The technical data of the INTRABEAM Water Phantom can be found in the section entitled Device data on page 72 1 Product and device identification This label contains the following inf...

Страница 17: ...Version 6 2 G 30 1767 en Page 17 INTRABEAM Water Phantom Safety measures Fig 1 Symbols and labels 1 2 3...

Страница 18: ...iew INTRABEAM Water Phantom Version 6 2 Page 18 G 30 1767 en System overview Overview of the modules 1 Water tank 2 Rotary feedthrough with mount for the XRS 4 3 Cable holder swiveling 4 Positioning u...

Страница 19: ...leeves between tank and positioning device 4 Water tank wall 5 Water tank viewing window 6 Measuring chamber for isotropy measurement 7 Measuring chamber for depth dose measurement 8 IC ionization cha...

Страница 20: ...gh module 1 Rotary feedthrough with eight detent positions in steps of 45 each 2 Rotary feedthrough clamping screw This clamping screw can be used to fix the rotary feedthrough in any de tent position...

Страница 21: ...ing lever The indicator has its zero position at the highest point It shows the travel path in 1 mm steps with 2 decimal places 2 Positioning in the Y direction depth Micrometer adjustment knob with l...

Страница 22: ...older 1 Ionization chamber IC 2 Measuring window of the IC ionization chamber 3 Ionization chamber holder 4 Measuring chamber closed with cover 5 Inserting the IC ionization chamber with the ionizatio...

Страница 23: ...correct measured values Use the water phantom only in connection with original ZEISS compo nents CAUTION If not appropriately transported on site the water phantom may fall down and cause injury or be...

Страница 24: ...lder from the open measuring cham ber Insert the IC ionization chamber in the ionization chamber holder Insert the ionization chamber holder in the measuring chamber Screw the cover of the measuring c...

Страница 25: ...illing the water tank You may fill the water tank only with deionized water Any other fluid would falsify the measurement result Remove one of the cover plates from the top of the water tank and set i...

Страница 26: ...ring chamber as a cable feedthrough In order to prevent the cable of the IC ionization chamber from being crushed when screwing on the measuring chamber cover you must sure that the IC ionization cham...

Страница 27: ...ed from X rays while the XRS 4 is in operation you must properly insert both covers of the water tank in their guides and the respective covers of the measuring chambers must be screwed on Water phant...

Страница 28: ...Preparations for use INTRABEAM Water Phantom Version 6 2 Page 28 G 30 1767 en Blank page for your notes...

Страница 29: ...rotary feedthrough Tighten both fastening screws of the XRS mount evenly by hand Tighten the clamping screw by hand to fix the rotary feedthrough in one of its other seven detent positions Insert the...

Страница 30: ...d Switch on the INTRABEAM and let it warm up Record the depth dose curve Place the probe tip in the optimum position see page 35 in relation to the IC ionization chamber in the measuring chamber for t...

Страница 31: ...do this use the rotary feedthrough to rotate the XRS 4 to the 8 detent positions fixing it in the detent posi tion with the clamping screw in each case Calculate the deviation from the ideal isotropy...

Страница 32: ...r phantom with the IC ionization chamber has been adapted to room temperature The IC ionization chamber is located in the correct measuring chamber The XRS 4 is seated in the rotary feedthrough withou...

Страница 33: ...er tank NOTE If while being inserted in the INTRABEAM Water Phantom the probe tip is placed too deep in the water tank it may collide with the measuring cham ber and thus be bent to a point where it i...

Страница 34: ...100 You will find detailed explanations on how to operate the measuring functions in the Instructions for Use of your INTRABEAM Instructions for Use INTRABEAM 600 You can interrupt X ray emission by p...

Страница 35: ...at the measuring window of the IC ionization chamber is always located exactly in the center and the ver tical distance in the Z axis from the measuring chamber wall always remains the same Since the...

Страница 36: ...shutter of the Workplace so that the electrometer is accessible for operation No other action is required the electrometer is automatically switched to manual operation Warning If the shielding provid...

Страница 37: ...Phantom Operation Set the electrometer to current measurement Set the appropriate current measuring range for the electrometer Set the probe tip to a distance of several millimeters away from the mea...

Страница 38: ...e measuring window in the X and Y coordinate axes in succession 1 2 NOTE If the probe tip is bent out of tolerance while being inserted in the water phantom the XRS 4 will no longer be able to emit ra...

Страница 39: ...osition The probe tip has been centered above the measuring window of the IC ion ization chamber Release the locking lever on the Z direction adjustment knob Move the probe tip downward until it almos...

Страница 40: ...e probe tip and the measuring chamber If you keep adjusting the probe tip further downwards after touching the measuring chamber you will notice that the effort required to adjust the Z mi crometer sc...

Страница 41: ...ater Phantom Operation Recording the Z position value Once the probe tip is in the optimum Z position you can record this Z value Note down the Z position reading of the positioning unit as Z1 mm You...

Страница 42: ...chamber from the upper surface of the ionization chamber housing You can take this value from the PTW calibration certificate where it is designated as Distance between entrance foil and chamber top d...

Страница 43: ...he user may un intentionally come into contact with emitted X ray radiation Ensure that the XRS mount is properly seated in the rotary unit that the XRS 4 is properly seated in the XRS mount and that...

Страница 44: ...e measured value NOTE If the measurements are performed outside of the specified ambient condi tions you may obtain falsified measurement data Ensure that the ambient conditions specified on page 73 a...

Страница 45: ...Version 6 2 G 30 1767 en Page 45 INTRABEAM Water Phantom Operation Blank page for your notes...

Страница 46: ...of your INTRABEAM 600 You may already have performed the following adjustments in order to ex actly position the probe tip vertically by checking its position via current meas urement Open the Treatm...

Страница 47: ...Version 6 2 G 30 1767 en Page 47 INTRABEAM Water Phantom Operation...

Страница 48: ...al measurements yields the depth dose curve of the current XRS 4 Actuate the Fortsetzen button to reactivate the emission of X ray radi ation Measure the depth dose in the Z position Z1 or for r1 Star...

Страница 49: ...Version 6 2 G 30 1767 en Page 49 INTRABEAM Water Phantom Operation Blank page for your notes...

Страница 50: ...a different algorithm than the one specified by ZEISS significant deviations from the ZEISS calibra tion data may occur Always use the algorithm specified by ZEISS for calculating the depth dose curv...

Страница 51: ...s been implemented Both of these requests were discussed and implemented in close cooperation with the TARGIT Physics Group which is internationally staffed by qualified physi cists TARGIT measuring m...

Страница 52: ...is approx 5 2 mm in contrast to only 2 9 mm for the TN34013 This leads to different angular resolutions and to different true distances r typical geometric and absorption prob lem for point sources Th...

Страница 53: ...he applicator with the probe tip is a precondition for accurate and meaningful measuring results Do not adjust the positioning unit in the X and Y axes Unless this has already been done Note down the...

Страница 54: ...erly Reinsert the XRS mount with the applicator in the rotary feedthrough The exact position is determined by locating pins Retighten the screws for fixing the XRS mount in the rotary feedthrough secu...

Страница 55: ...the locking lever on the Z direc tion adjustment knob Measuring the depth dose curve with spherical applicator and XRS probe Measure the depth dose curve of the XRS probe with the applicator at tached...

Страница 56: ...made Leave the positioning in the X and Y axes previously performed for the measurement of the depth dose curve unchanged Move the probe tip upwards in the Z axis until it is positioned roughly cente...

Страница 57: ...g the XRS 4 through one full revolution while measuring the emitted X ray radiation In order to achieve exact positioning and repeatability of the rotary table the latter must be equipped with 8 deten...

Страница 58: ...an XRS 4 when measuring the isotropy The isotropy check is performed at maximum beam current and the beam voltage selected for the respective XRS 4 Positioning the applicator with the XRS probe for is...

Страница 59: ...made Leave the positioning in the X and Y axes previously performed for the measurement of the depth dose curve unchanged Move the spherical applicator with the X ray probe upwards in the Z axis until...

Страница 60: ...lever on the adjusting knob for the Z axis The isotropy measurement is performed by rotating the XRS 4 through one full revolution while measuring the emitted X ray radiation Position the rotary feedt...

Страница 61: ...s clean Once the telescope like radiation protection rings have been removed from flat or surface applicators with large diameters they must be at tached between the applicator and the XRS mount befor...

Страница 62: ...plicators cannot be placed flat directly in the ionization chamber This is a problem similar to that of spherical applicators when the dose rate has to be measured there on the applicator surface For...

Страница 63: ...state see illustration below but cannot be measured at an air water interface which as previously described is more difficult to implement A comparison of the applicator values recorded with the ioniz...

Страница 64: ...d the IC ionization chamber on page 42 r1 dH dA dIC Note As was the case with the spherical applicators the user must make a correc tion regarding the actual distance between the reference point of th...

Страница 65: ...ximum distance along the Z axis that can be reached on the central axis with these applicators is 22 mm The depth dose measurements should therefore be performed in 0 5 mm steps from 0 to 15 mm and th...

Страница 66: ...the applicator too deep in the Z axis as there is a risk of it colliding with the ionization chamber holder Secure the Z positioning using the locking lever on the adjusting knob for the Z axis Applic...

Страница 67: ...only by the manufacturer or qualified personnel The scope of the safety checks of the system should include at least the fol lowing points Availability of the Instructions for Use Visual inspection o...

Страница 68: ...site the water phantom may fall down and cause injury or be damaged Always carry the water phantom together with a second person and hold it by the handles attached to its sides Avoid collisions and h...

Страница 69: ...e downward so that the gage block is slightly clamped and can no longer be moved The indicator should now read zero Otherwise you need to readjust the counter see below Move the slide upward again Rem...

Страница 70: ...ase and any contamination from the guideways and from the threads of the spindle and ball screw drive Cleaning agents such as benzine or petroleum ether are generally not required Evenly apply a thin...

Страница 71: ...ge 71 INTRABEAM Water Phantom Care and maintenance Disposal If you have any questions please contact the manufacturer or your sup plier NOTE Dispose of the water phantom in compliance with your pertai...

Страница 72: ...hamber 304534 7000 610 IC ionization chamber type 34013 304534 7000 620 Water phantom Properties Weight Approx 40 kg Dimensions Length x Width x Height Approx 580 mm x 400 mm x 520 mm Water tank Conte...

Страница 73: ...E mark The medical device complies with the essential re quirements stipulated in Appendix I of the Medical Device Directive 93 42 EEC In line with appendix XII of the Medical Device Di rective 93 42...

Страница 74: ...System data INTRABEAM Water Phantom Version 6 2 Page 74 G 30 1767 en Blank page for your notes...

Страница 75: ...18 Calculating deviations 58 Cat No 72 Characteristic curve 10 Checking the Z position via effort and air gap 40 Checklist 32 Conditions of use technical 23 Configurations 12 Control console 10 Cover...

Страница 76: ...device 10 Hazard symbols 9 J IC ionization chamber 10 24 25 43 IC ionization chamber in the measuring chamber 19 Information symbols 9 Instructions for Use for the INTRABEAM 600 13 Instructions for Us...

Страница 77: ...g chambers 10 Measuring window of IC ionization chamber 22 Micrometer screws 10 Modifications not permitted 12 Module overview 18 N Normal use 10 O Operation 29 Ordering data 72 P Penetration depth 33...

Страница 78: ...of users advanced 10 R Radiation emission spherical 10 56 58 Radiation therapy 13 Radiation generation of 33 Registered trademark of PTW 2 Regulatory information 73 Requirements for the user 13 Rotar...

Страница 79: ...tom 10 Water phantom acclimatizing 27 Water phantom care of 68 Water phantom ordering data 72 Water phantom set up 25 Water phantom transporting 68 Water tank 18 Water tank module 19 Water tank wall 1...

Страница 80: ...Index INTRABEAM Water Phantom Version 6 2 Page 80 G 30 1767 en Blank page for your notes...

Страница 81: ...Version 6 2 G 30 1767 en Page 81 INTRABEAM Water Phantom Blank page for your notes...

Страница 82: ...Carl Zeiss Meditec AG Goeschwitzer Strasse 51 52 07745 Jena Germany Email info meditec zeiss com Internet www zeiss com med...

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