Zeiss INTRABEAM User manual

ZEISS
INTRABEAM®
Water Phantom
Instructions for Use
G-30-1767-en
Version 6.2
2022-02-24

INTRABEAM Water Phantom
Version 6.2
Page 2 G-30-1767-en
About this manual These Instructions for Use are part of the delivery package.
• Carefully read them before using the device.
• Keep them at the site of use of the device.
• Store them for the entire service life of the device.
• Pass them on to every subsequent owner or user of the device.
Trademark INTRABEAM is a registered trademark of Carl Zeiss Meditec AG or of another
company of the ZEISS Group in Germany and/or other countries.
Trademark UNIDOS®
is a registered trademark of PTW.
Applicable area This user manual applies to the INTRABEAM Water 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. Reprints and reproductions - including excerpts - are not
permitted. However, this user manual may be digitized and archived for
internal use. Access to this data by third parties is not permitted and must be
prevented.
Change note Subject to change in design and scope of delivery and as a result of ongoing
technical development.
The illustrations in this document serve as an example only and do not
necessarily correspond to the setup that you have.
Printed in Germany.
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena
Germany
Email: [email protected]
Internet: www.meditec.zeiss.com

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INTRABEAM Water Phantom
Designations and abbreviations
Several official (English) product names have been abbreviated in the respective
national language in order to enhance the clarity and readability of these
Instructions for Use. In cases where variants of individual devices and products are
explained, these are clearly identified in the text.
Product name
(English) Designation in these Instructions
for Use
Explanation
INTRABEAM
Water Phantom
Water phantom Water phantom:
Used to measure the XRS 4
INTRABEAM
Spherical Applicator
Spherical applicator Spherical = ball-shaped
INTRABEAM
Flat Applicator
Flat applicator Flat applicator
INTRABEAM
Surface Applicator
Surface applicator Surface applicator
INTRABEAM 600 INTRABEAM 600 INTRABEAM 600 refers to the
complete product, workplace and
software.
UNIDOS Romeo Type
TN10053-AS
Electrometer UNIDOS Romeo electrometer Type
TN10053-AS from PTW-Freiburg.
Permanently installed in the
Workplace.
XRS 4 X-ray Source XRS 4 XRS X-ray source
(X-Ray Source), functional principle:
Linear accelerator
Control Console 600 CC 600 Control unit and power supply for
the XRS 4
IORT IORT IntraOperative RadiationTherapy
NC32 INTRABEAM
Floor Stand
Stand Currently:
NC32 INTRABEAM floor stand
INTRABEAM Drape Drape Sterile cover

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Contents
Designations and abbreviations ...................................................................3
Safety measures
Key to symbols ..................................................................................9
Hazard symbols ...........................................................................................9
Information 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
Rotary feedthrough module.......................................................................20
Positioning unit module.............................................................................21
Ionization chamber and ionization chamber holder....................................22
Preparations for use
Technical conditions of use .............................................................23

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Preparatory workflow .....................................................................24
Setting up the water phantom.................................................................. 25
Filling the water tank ................................................................................ 25
Insert the IC ionization chamber in the measuring chamber. ..................... 25
Close the measuring chamber again. ........................................................ 26
Reattach the covers of the water tank properly......................................... 27
Water phantom, fully equipped, acclimatizing .......................................... 27
Operation
Measurement workflow ..................................................................29
Checklist..........................................................................................32
Measuring the depth dose curve without
spherical applicator .........................................................................33
Inserting the XRS 4 in the 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 temperature of the IC ionization chamber....................... 44
INTRABEAM 600....................................................................................... 46
Measuring the depth dose with the INTRABEAM 600 ............................... 46
Calculating the dose rate .......................................................................... 50
Important information on dose rate values ............................................... 51
Measuring the depth dose curve with spherical applicator..............53
Inserting the spherical applicator in the INTRABEAM Water Phantom ....... 53
Positioning the spherical applicator with the XRS probe in the
Z direction ................................................................................................ 55
Measuring the depth dose curve, with spherical applicator and
XRS probe................................................................................................. 55

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Measuring isotropy without spherical applicator.............................56
Positioning the probe tip for isotropy measurement ..................................56
Positioning the rotary feedthrough ............................................................57
Measuring isotropy....................................................................................58
Measuring isotropy with spherical applicator..................................58
Positioning the applicator with the XRS probe for isotropy
measurement ............................................................................................58
Recording 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 inspection.............................................................................67
Calibration of the IC ionization chamber .........................................67
Transporting the water phantom ....................................................68
Care of the water phantom .............................................................68
Calibration and maintenance of the positioning unit.......................69
Calibrating the positioning unit..................................................................69
Maintenance of the positioning unit..........................................................70
Relubricating the positioning unit ..............................................................70
Disposal...........................................................................................71
System data
Ordering data..................................................................................72
Technical data .................................................................................72

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Regulatory information....................................................................73
Ambient conditions..........................................................................73
Index

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INTRABEAM Water Phantom Safety measures
Safety measures
Key to symbols
We would like to inform you about safety aspects which must be observed
when handling this device. This chapter contains a summary of the most
important information concerning matters relevant to instrument safety.
Hazard symbols
The following safety information has been incorporated 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 for Use:
Additional information and tips
WARNING Indicates a hazard which can lead to death or severe injury if it is not
prevented.
CAUTION Indicates a hazard which can cause minor to moderate injury if it is not
prevented.
NOTE Indicates a hazard which can cause damage to material if it is not
prevented.
–Listing Prerequisite for an action
• Prompt for action Result of an action

Safety measures INTRABEAM Water Phantom
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Target group
These Instructions for Use are intended for qualified specialist staff who have
been trained and briefed in preparing and handling the medical device on the
basis of these Instructions for Use.
Certain fields of application of the INTRABEAM system may require advanced
qualification of users in the particular special field.
Field of application
Intended use
The INTRABEAM Water Phantom is used to measure the depth dose curve and
the isotropy of the XRS 4 X-ray source of the INTRABEAM 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 source to check whether the measured values
are within the expected range.
Using the depth dose curve, a characteristic curve is recorded from the dose
rate [Gy/min] in relation to the penetration depth [mm] in water of the respec-
tive XRS 4 X-ray source at 40 kV and at 50 kV.
The geometry of the spherical radiation emission of the probe tip is checked
when measuring the isotropy. The isotropy check is performed at maximum
beam current and the beam voltage selected for the respective XRS 4 X-ray
source.
The INTRABEAM Water Phantom is an accessory to the INTRABEAM 600.

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INTRABEAM Water Phantom Safety measures
The INTRABEAM Water Phantom is to be used exclusively in conjunction with
the INTRABEAM system.
You can measure the XRS 4 X-ray source alone or with an applicator attached.
In order to accommodate the X-ray beam detector and the IC ionization
chamber, the INTRABEAM Water Phantom has been designed with two meas-
uring chambers with different orientation. Each of the measuring chambers
contains an adapter element for the IC ionization chamber.
The INTRABEAM Water Phantom essentially comprises a radiation-shielded
water tank, inside which you can position the tip of the XRS 4 X-ray source
exactly.
The water tank contains two plastic holders for the IC ionization chamber.
Using micrometer screws, you position the probe tip in the 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 positions which are displaced at
45° intervals.
You perform the measurements using the INTRABEAM software. The control
unit (CC 600) controls the XRS 4 X-ray source. The IC ionization chamber
detects the X-ray radiation and sends its measured values to the electrometer.
You operate the electrometer in "stand alone mode" when measuring with
the INTRABEAM Water Phantom, i.e. it is not controlled by the user terminal
and must be operated manually.
Applied part The INTRABEAM Water Phantom has no applied parts as defined by
IEC 60601-1.
Product life cycle The product life cycle is 7 years.
Essential
performance features Sufficient radiation protection.
Equivalent safety The principles of equivalent safety are not applied.
PEMS The INTRABEAM Water Phantom contains no programmable electronic medical
system (PEMS).

Safety measures INTRABEAM Water Phantom
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Notes for the operator
The correct use of the system is absolutely vital for safe operation. Therefore,
please thoroughly familiarize yourself with the contents of these Instructions
for Use before starting up the system. Please also observe the respective In-
structions for Use of any additional equipment.
Duties of the operator This device must be used by properly instructed and trained personnel only. It
is the responsibility of the customer or the company operating the device to
train and instruct all operating personnel.
• Only operate the device within the scope of its intended use.
• Please keep these Instructions for Use where they are easily accessible at
all times for the persons operating the system.
• Please follow the symbols and labels on the packaging and on the device,
see Page 16.
Legal regulations • Observe the legal regulations for accident prevention and occupational
health and safety applicable in the country concerned.
Precondition for
additional equipment Additional devices that are connected to electronic medical 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 60601-1:2005, chapter 16). Anyone connecting additional equipment to
medical electrical devices is a system configurer and as such responsible for
compliance of the system with the normative requirements for systems.
Please note that local legislation takes priority over the above-mentioned nor-
mative requirements. Please contact ZEISS Service if you have any questions.
• Only use original accessories or consumables approved by Carl Zeiss. If you
wish to use other accessories ensure that Carl Zeiss or the manufacturer
of the accessories have verified and confirmed that these accessories meet
the respective safety standards and can be used without risk.
Warranty and liability Warranty and liability depend on the applicable contractual stipulations.
The manufacturer is not liable for damages caused by unauthorized use of the
device. Furthermore, this will forfeit any rights to claim under warranty.
• Do not modify this device without the manufacturer's approval.
If the system is modified after consultation with the manufacturer, suita-
ble inspections and testing must be completed to ensure subsequent safe
use.

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INTRABEAM Water Phantom Safety measures
• Modifications and repairs of this device or any equipment operated to-
gether with this device may only be performed by ZEISS SERVICE or other
specialists authorized by Carl Zeiss.
Required additional
information These Instructions for Use (G-30-1767) titled "INTRABEAM Water Phantom"
contain detailed explanations on use of the water phantom and information
on the functions of the INTRABEAM which are relevant for the water
phantom.
For further explanations on the use your INTRABEAM, please refer to the re-
spective instructions for use or the product information attached to your
INTRABEAM and its accessories.
• Read through the following Instructions for Use thoroughly before 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 Use: D970.131.01
– "INTRABEAM Spherical Applicators"
ZEISS Instructions for Use: G-30-1478
– "INTRABEAM Surface Applicator Set"
ZEISS Instructions for Use: G-30-1856
– "INTRABEAM Flat Applicator Set"
ZEISS Instructions for Use: G-30-1880
Requirements for
the user The INTRABEAM (INTRABEAM 600) may only be used by qualified specialists
who have been trained in the operation of the INTRABEAM. Other persons are
prohibited from operating or using the INTRABEAM.
Every facility that operates an INTRABEAM must appoint suitable and qualified
specialists who have been trained in operation of the INTRABEAM and are re-
sponsible for the tasks associated with the INTRABEAM.
The manufacturer, Carl Zeiss Meditec AG, offers training courses on the
INTRABEAM (INTRABEAM 600).

Safety measures INTRABEAM Water Phantom
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Safety during
the measurement • Above all, please observe the safety instructions on radiation protection in
the Instructions for Use of your INTRABEAM (INTRABEAM 600).
If the XRS 4 is properly seated in the XRS mount of the rotary feedthrough (for
rotary feedthrough, see page 20), the optical interlock system closes and
permits the generation of X-rays. The INTRABEAM generates X-radiation 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 emitted from the loudspeaker of the control unit (CC 600)
and the external warning lamp lights up.
The status of the interlock system is always displayed in the "Treatment"
window, see the "Interlock Status" display.
Appropriate radiation protection is required:
Before performing a measurement, you must ensure that the XRS 4 is properly
seated in the rotary feedthrough and that all covers and radiation protection
shields of the water tank are properly attached.

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INTRABEAM Water Phantom Safety measures
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Safety measures INTRABEAM Water Phantom
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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.
2"Observe the Instructions for Use" label
Observe the instructions for use or accompanying documents.
3Equipment 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.
1Product 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

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INTRABEAM Water Phantom Safety measures
Fig. 1: Symbols and labels
12 3

System overview INTRABEAM Water Phantom
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System overview
Overview of the modules
1Water tank
2Rotary feedthrough with mount for the XRS 4
3Cable holder, swiveling
4Positioning unit
1
2
4
3

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INTRABEAM Water Phantom System overview
Water tank module
1Cover of filler opening
2Rotary feedthrough with mount for the XRS 4
3Radiation protection sleeves between tank and positioning device
4Water tank wall
5Water tank viewing window
6Measuring chamber for isotropy measurement
7Measuring chamber for depth dose measurement
8IC ionization chamber in the measuring chamber
9Covers of measuring chambers
10 Drain cock with hose connection
11 Cable connection between IC ionization chamber and electrometer
1
3
4
5
6
8
9
10
11
7
2

System overview INTRABEAM Water Phantom
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Rotary feedthrough module
1Rotary feedthrough
with eight detent positions in steps of 45° each
2Rotary feedthrough clamping screw
This clamping screw can be used to fix the rotary feedthrough in any de-
tent position.
3XRS mount,
mounting plate for the XRS 4
4Fastening screws for the XRS mount
132
4
4