Berdasarkan Peraturan Menteri Kesehatan R.I Nomor 62 Tahun 2017 Tentang Izin Edar Alat Kesehatan,
Alat Kesehatan Diagnostik In Vitro Dan Perbekalan Kesehatan Rumah Tangga dengan ini diberikan
persetujuan untuk diedarkan dengan :
ALAT KESEHATAN
Tipe / Ukuran : -
Kemasan : Unit
Nama Produsen / Pabrikan : ELEKTA LIMITED., United Kingdom
Melalui ELEKTA LIMITED., Hong Kong
Nama Pendaftar : PT. BESINDO MEDI PRIMA, DKI Jakarta
Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 31 Desember 2023.
2. Wajib menyampaikan laporan berkala dan laporan jika ada kejadian yang tidak diinginkan akibat
penggunaan Alat Kesehatan tersebut di atas sesuai ketentuan berlaku.
3. Izin edar ini merupakan persetujuan perpanjangan, perubahan penulisan prinsipal dan perbaikan
nama produk dari Nomor Izin Edar Alat Kesehatan KEMENKES RI AKL 21502614109 tanggal 20
Maret 2019. Dengan demikian izin edar sebelumnya dinyatakan tidak berlaku.
4. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk
tersebut, pendaftar bersedia mengembalikan izin edar.
5. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari
persetujuan izin edar ini.
6. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau
kembali.
Catatan:
- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1
Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.
- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
Versa HD™
Providing the flexibility to safely and efficiently deliver the full spectrum of conventional radiotherapy
techniques, Versa HD advances modern cancer care with the added versatility to deliver sophisticated
linear accelerator-based stereotactic treatments – all within a single delivery system.
Table of Contents
Introduction .......................................................... 1
Remote Services.................................................. 22
Introduction
This product data describes the high energy, dual modality Versa HD digital accelerator for radiation therapy. This accelerator has been
designed to deliver therapeutic beams of X-rays and electrons for a wide range of conventional and advanced radiotherapy techniques.
Depth of dose maximum, dmax 1.50 2.10 • MV is the nominal energy, it is intended as guidance and for
identification of the beam quality
Percent dose at 10 cm depth, D10, ±1 % 67.5 73.0
• D10 is the percent absorbed dose along the central axis at the depth of
Penetrative quality, d80, cm, ±0.3 cm 6.4 7.6 10 cm in water in a radiation fieldsize of 10 x 10 cm at SSD = 100 cm,
relative to the maximum dose (Reference BJR Supplement 25)
Quality index, TPR20,10 0.68 0.73
• dmax is the depth of maximum absorbed dose along the central axis in
Dose rate variable in steps between (MU/min.) a radiation fieldsize of 10 x 10 cm at SSD = 90 cm. (Ref. IEC 60976)
Minimum nominal 30 30 • d80 is the depth of 80% of maximum absorbed dose along the central
axis in a radiation fieldsize of 10 x 10 cm at SSD = 90 cm (Ref. IEC
Maximum nominal 500 500 60976)
Table 1 • TPR20,10 is the ratio of the absorbed doses at depths of 20 cm and 10
cm in a water phantom, measured with a constant source-detector
Nominal energy, MV 15 18 distance of 100 cm and a fieldsize of 10 cm x 10 cm at the plane of the
detector (Ref. IAEA TSR 398, IEC 60976).
Depth of dose maximum, dmax 2.60 3.00
Percent dose at 10 cm depth, D10, ±1 % 76.5 78.5
Penetrative quality, d80, cm, ±0.2 cm 8.4 9.0
Quality index, TPR20,10 0.76 0.78
Dose rate variable in steps between (MU/min.)
Minimum nominal 40 40
Maximum nominal 600 600
Table 2
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Versa HD™ Treatment Delivery System
Dose rate
Dose rate in tables 1 and 2 applies at the depth of the dose maximum in water and 100 cm SSD with a 10 cm x 10 cm
fieldsize. The dose rate units of MU/min are equivalent to cGy/min as the accelerator is typically calibrated to provide
1cGy per MU in these conditions.
Spot size
The spot size of the accelerated electron beam at the X-ray target is less than 2 mm at full width half maximum
(FWHM), typically 1 mm.
Fieldsize
• The radiation fieldsize is continuously variable from 0.5 cm x 0.5 cm to 40 cm x 40 cm in the plane containing the
isocenter. Fields larger than 35 cm x 35 cm are limited in the corners by a circle of 50 cm diameter (defined by the
primary collimator).
• Fieldsize is defined as the distance between the 50% dose points on the major axis of the field in the plane of the
isocenter at the depth of 10 cm.
Table 3
Note: 6MV and 10MV High Dose Rate Mode beams have the same beam quality as the flattened 6MV and 10MV described in table 1
(expressed at 10 cm depth).
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Versa HD™ Treatment Delivery System
Dose rate
Dose rate in table 3 applies at the depth of the dose maximum in water and 100 cm SSD with a 10 cm x 10 cm fieldsize.
The dose rate units of MU/min are equivalent to cGy/min as the accelerator is typically calibrated to provide 1cGy per
MU in these conditions.
Field size
The radiation fieldsize is continuously variable from 0.5 cm x 0.5 cm to 40 cm x 40 cm in the plane containing the
isocenter. Fields larger than 35 cm x 35 cm are limited in the corners by a circle of 50 cm diameter (defined by the
primary collimator).
Beam profile characteristics of square X-ray fields
The beam profile characteristics of the radiation field are measured in the plane perpendicular to the beam axis at a
distance of 100 cm from the target (SDD) and at the standard measurement depth of:
• 10 cm with an SSD of 90 cm for 6MV High Dose Rate Mode and 10MV High Dose Rate Mode
Beam profile shape
For a 30x30 cm2 field the % dose relative to the central axis is as follows:
6FFF 10FFF
Nominal relative dose (%) Nominal relative dose (%)
Measurement point distance from CAX as a percentage of the half field width
for a 30 x 30 cm field size for a 30 x 30 cm field size
20% 94.8 90.5
50% 79.4 69.2
80% 64.2 53.1
Absolute tolerance (±%) 3 3
Table 4
• Field symmetry – maximum ratio of absorbed doses at points symmetrically displaced from the axis of the beam and
within the central field analysis area*: For fieldsizes greater than or equal to 5 cm x 5 cm: less than or equal to 103%
*The central field analysis area is similar to the IEC flattened area except that the nominal (set) field is used instead of the 50% field edge.
Electron beams
Energy choice
Versa HD can be configured optionally with up to 6 electron energies from those listed in table 5.
Energies – beam quality
The penetrative qualities given in table 5 are measured along the beam axis at SSD = 95 cm and for 10 cm x 10 cm
fieldsize. The parameters listed are (IEC 60976 and BJR-25 definition):
R80 – depth of the 80% relative dose
dmax – depth of the maximum dose
Rp – practical range of electrons
The nominal electron beam energies in table 4 are calculated as:
E(MeV)= 3 x R80 (cm)
The variation of R80 does not exceed ±1 mm from the values listed in table 4.
Table 5 Note:
Only one energy from either 9 or 10 MeV can be included in configuration.
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Versa HD™ Treatment Delivery System
Dose rate
The electron dose rate is adjustable in five fixed steps from 37.5cGy/min up to 600cGy/min for all energies. Dose rate is
measured with a fieldsize of 10 cm x 10 cm as defined at SSD = 95 cm and at the depth of the dose maximum in a water
phantom.
Fieldsizes
The electron fieldsize is defined with electron applicators at SSD = 95. When attached to the radiation head, the electron
applicators do not obscure the light field-indicator:
• standard set of four square electron applicators with fieldsizes of: 6 cm x 6 cm, 10 cm x 10 cm, 14 cm x 14 cm and
20 cm x 20 cm
• optional applicators
– square and rectangular applicators with fieldsizes of: 25 cm x 25 cm, 20 cm x 10 cm, 16 cm x 8 cm, 14 cm x 6 cm and
10 cm x 6 cm
– set of four cone applicators with 2, 3, 4 and 5 cm diameter
– an electron arc therapy applicator
• optional electron beam-shaping mould
All electron applicators have removable end frames, which are coded and interlocked for enhanced patient safety. These
end frames can be replaced by bespoke end frames, custom made with the electron beam-shaping mould to match the
shape of the treatment area.
Field uniformity (IEC 60976/60977)
• Flatness: The maximum distance between the 90% isodose contour (at the standard measurement depth) and the edge
of the geometric field does not exceed
– on the major axes of the field: 10 mm
– on the diagonal axes of the field: 20 mm
The maximum ratio of absorbed dose anywhere in the radiation field at the standard measurement depth to the
absorbed dose on the central axis of the beam at the depth of dose maximum does not exceed 1.03 (103%).
• Field symmetry: The maximum ratio of the maximum to minimum absorbed doses (averaged over less than 1 cm²
of area) at any two points symmetrical about the central axis of the beam and within the area confined by a line 1 cm
inside the 90% isodose contour at the standard measurement depth does not exceed 1.03.
X-ray contamination in the electron beam (IEC 60601-2-1. 1998, + A1:2002 Clause 29.2.1) (IEC60601-2-1,2009 Ed3, Clause
201-10-1-2-102-1)
Defined as the percentage absorbed dose on the central axis at a depth 10 cm beyond the practical range of the electron
beam; the X-ray contamination does not exceed:
Nominal energy (MeV) 4 6 8 9 10 12 15
X-ray contamination (%) ≤0.5 ≤0.5 ≤1.0 ≤1.0 ≤1.0 ≤2.0 ≤3.0
Dosimetry System
Three independent air-vented ionization chambers aligned in series in the beam path. Two of the chambers (channel-1/
primary and channel-2/secondary) provide independent monitoring of the delivered dose. Each dose channel is
connected to a separate high precision digital electrometer with automatic leakage compensation and temperature
and pressure correction.
The third ionization chamber is a multi-electrode system that continuously monitors the radiation beam uniformity.
It provides the signals for a highly responsive beam steering and energy servo.
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Versa HD™ Treatment Delivery System
Accelerating waveguide
Versa HD’s accelerating traveling waveguide is optimized for maximum electron beam throughput and efficient use of
RF power. In the traveling waveguide there is no need for complex energy switches subject to mechanical failure and
the design provides a unique wide and flexible energy choice. Elekta offers a 15-year warranty with the confidence of
knowing that it has never been necessary to replace one of our waveguides in clinical use.
Electron gun
The electron gun used in the accelerator is of diode type. It is a cost effective and easily replaceable component. The
electron gun and magnetron are always pulsed simultaneously avoiding dark current leakage problems and the control
of the dose rate is achieved by adjusting pulse repetition frequency.
Focusing coils
A system of focusing solenoids ensures high electron beam transmission through the accelerator structure resulting in
reduced stray-radiation and efficient use of RF power.
Beam steering system
Two pairs of orthogonal steering coils ensure electron beam alignment on the target in all modes, as well as under
any gantry orientation. In conjunction with a dedicated multi-electrode ion chamber and digitally controlled servo
electronics the steering system minimizes beam symmetry changes under all conditions.
Slalom beam-bending system
Electron beam-bending is achieved using a patented slalom beam-bending system. This three stage bending magnet
system is truly achromatic in both the radial and transverse planes. It ensures the best beam transport control and an
electron spot size of typical 1 mm, full width at half maximum (FWHM), at exit.
The inherent low profile of the bending magnet results in the lowest isocentric height for dual modality machines in the
industry. This feature significantly eases the everyday work of the radiotherapist when setting-up patients for treatment.
Slitless beam energy control
Precise and stable beam energy is ensured with sensitive servo control of the gun thermionic emission from a multi-
electrode ionization chamber in the x-ray beam path. This servo system eliminates the need for energy-defining
mechanical slits in the electron beam path, which would result in increased stray X-radiation.
Isocenter
• Target to isocenter distance: 100 ±0.2 cm
• Isocenter height above floor: 124 cm
• Clearance under radiation head:
– distance from surface of radiation head to isocenter: 45 cm
– horizontal distance from gantry to isocenter: 124 cm
– radiation head size: up to 81.5 cm diameter
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Versa HD™ Treatment Delivery System
• Isocenter accuracy:*
– MV isocenter (Gantry): ≤ 0.7mm radius1,2
– Combined MV isocenter (Gantry), collimator and table isocenter for coplanar and non-coplanar treatments:
≤ 1.0mm radius1,2
– MV isocenter & kV imaging isocenter coincidence: ≤ 1.0mm
[1] Reference: Elekta Isocenter Customer Acceptance Test document.
[2] Reference: W. Lutz, K. R. Winston, and N. Maleki, “A system for stereotactic radiosurgery with a linear accelerator,” Int. J. Radiat. Oncol., Biol.,
Phys. 14, 373–381 (1988).
Gantry rotation
• Range: 365° (±182.5°)
• Accuracy of angle indicators: digital scale ±0.5°
• Resolution of angle indicators: digital scale 0.1°
• Speed of rotation: 0 to 1 rpm continuously adjustable
Collimator rotation
• Range: 365° (±182.5°)
• Accuracy of angle indicators: digital scale ±0.5°
• Resolution of angle indicators: digital scale 0.1°
• Speed of rotation: 0 to 3 rpm continuously adjustable
*Note: The method used for measuring the MV isocenter accuracy as reported in this document is not the same as the method stated in IEC 60976/60977
for measuring the displacement of the radiation beam axis from the isocentre. Therefore, the specifications stated in this document are not a declaration of
machine performance for compliance with IEC 60976.
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Versa HD™ Treatment Delivery System
Anti-collision protection
The head of the digital accelerator is fitted with a positive action touch guard that protects against a collision between
the radiation head and the patient on the table or any other object. If activated the interlock chain will stop and inhibit
any movements of the gantry, head and table. Temporary override action is available to allow removing the collision
conditions.
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Versa HD™ Treatment Delivery System
Couchtop
Connexion™ is a modular couchtop comprising of a baseboard and a number of dedicated modules that can be easily and
efficiently attached or detached from the baseboard.
Attached directly to the patient support system, the Connexion baseboard forms the basis for attaching and detaching
dedicated modules, allowing specific connection of the appropriate couchtop module.
Material Carbon Fiber, Aluminium & Steel
Size 1304 x 589 x 50 mm
Weight 39.7 kg
Compatibility Compatible with Elekta Precise Table
Accessories
Coded shadow tray assembly short (optional)
The shadow tray assembly for beam-shaping with shielding blocks is supplied as standard with two slots for removable
shadow trays. The outermost tray can be uniquely identified by means of cut-outs at the edge. The digital accelerator
recognizes up to 110 tray codes that can be verified as part of the prescription.
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Versa HD™ Treatment Delivery System
• Maximum fieldsize: 40 cm x 40 cm
• Maximum shielding block height: 94 mm
• Distance shielding block to isocenter: 35.6 cm
• Wedged: Supports delivery of wedged fields using an automatic, integrated wedge with angles continuously variable in
the range 0° to 60° (by combining an open field with a 60° wedged field). The automatic wedge eliminates the need for
manual selection and insertion of individual wedge filters.
• Arc: Gantry rotation during delivery with a fixed field shape and constant gantry speed and dose rate.
• PreciseBEAM™ Segmental: This option enables the digital accelerator to deliver IMRT in segmental (Step-and-Shoot)
mode. Each prescribed segment is delivered accurately and reliably at the highest dose rates for superior patient
throughput. Accurate and stable beam control ensures an accuracy of less than or equal to 1% or 0.1MU (whichever is
greater) which is vital during the sequential delivery of low dose IMRT fields.
• PreciseBEAM™ Dynamic: With the same excellent dose and geometry accuracy and functionalities as segmental, this
option enables continuous dynamic movement of diaphragms and MLC leaves during treatment delivery. Support for
popular techniques such as “sliding windows”.
• PreciseBEAM™ Dynamic Arc: In this arc therapy the linear accelerator delivers a constant number of MU per degree
of movement. During delivery simultaneous gantry rotation and motion of diaphragm and MLC leaves is permitted.
Dose rate and gantry speed can change along the arc and are automatically selected by the control system to achieve
the prescribed dose/deg. Multiple and continuous arcs in CW and CCW direction can be delivered.
• PreciseBEAM™ VMAT: This license enables the Elekta volumetric intensity modulated arc therapy (VMAT) treatment
delivery. VMAT is capable of simultaneous dynamic control of MLC, diaphragms, gantry and collimator. It allows
continuously variable MU per degree along the arc and, as in dynamic arc, the control system automatically adjusts
all linear and angular speeds as well as dose rate. Multiple and continuous arcs in CW and CCW direction can be
delivered.
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Versa HD™
Beam Shaping
Introduction
The Versa HD beam shaping solution, Agility™, provides high resolution beam-shaping across a 40 x 40cm fieldsize.
Leaf Positioning
The robust and reliable Rubicon optical positioning system provides valuable real-time assurance of accurate leaf
positioning. Agility’s Rubicon optical technology offers advanced real-time leaf monitoring and positioning. Ultraviolet
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Versa HD™ Beam Shaping
light from an LED source produces infrared fluorescence when it falls on the ruby tips of the multileaf collimator leaves.
This infrared fluorescence, detected by an infrared camera, is used to reliably monitor and accurately position the leaves
and can be viewed in real-time on the linear accelerator’s display screen.
Integrated Wedge
Wedge angles 0-60°
Wedge field size 40 (XIEC) x 30 (YIEC) cm
Physics Performance
Maximum distance along the major axes between the light field edge and the
X-ray to light coincidence radiation field edge for centred fields at normal treatment distance: 5x5 cm to
20x20 cm = 1 mm; 20x20 cm to maximum square = 1%
• less than 5.5 mm at dmax (flat beams)
• less than 5.5 mm at dmax for field sizes 5 cm x 5 cm to 15 cm x 15 cm
Penumbra (80-20%) for centred fields (6 and 10 MV)
(High Dose Rate Mode)*
• less than 6.0 mm at dmax for field sizes 15 cm x 15 cm to 35 cm x 35 cm
(High Dose Rate Mode)*
Leaf tip penumbra variation for 5x5 cm field over the full travel
< 1 mm
range (for 6 and 10 MV)
1 mm at isocenter
Leaf position accuracy**
0.5 mm RMS
Leaf position repeatability < 0.5 mm
Average transmission through leaves*** <0.375%
Peak transmission through leaves*** <0.5%
X-radiation leakage in patient plane outside primary collimator
<0.2% max, <0.1% avg
cone region ****
X-radiation leakage outside patient plane (at 1 m) ***** <0.5%
* Due to the un-flattened nature of the beam a normalization of the profile is applied by dividing by the largest unflattened open field (40 cm x 40 cm)
** Measured using a stripe test. Maximum error quoted as maximum positional error in any leaf pair abutment and root mean square for any leaf pair
across all abutments.
*** IEC 60601-2-1: 2009, clauses 201.10.1.2.103.2.1a/e and 201.10.1.2.103.2.1b/e for peak and average leakage respectively.
**** IEC 60601-2-1: 2009, clauses 201.10.1.2.103.3a and 201.10.1.2.103.3b for maximum and average leakage respectively.
*****IEC 60601-2-1: 2009, clause 201.10.1.2.104.1a
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Versa HD™
Image Guidance
MV IGRT
iViewGT™ provides 2D MV planar images within a fraction of a second, making on-line patient position correction
possible.
With the increasing demands on departments for improved clinical outcomes and faster workflows, iViewGT helps
achieve this with:
• Excellent clearance and superior field-of-view
• Low patient dose or include as part of the plan
• On-and off-line enhancement and registration of the images
• On-line images for patient positioning verification
• Off-line review and approval of images
• Automatic couch moves and shift trending (via MOSAIQ Image Management Tools)
• Network-ready including DICOM RT and AutoDICOM, with easy connectivity to the MOSAIQ® network
• IMRT quality assurance including MLC verification.
Image Detection
Image detection is by means of a flat panel array detector based on amorphous thin film transistor technology designed
to improve both image quality and ease of use.
This detector is supported by a motorized retractable arm which is controlled from a linear accelerator handheld
controller. The arm is attached to the linear accelerator gantry and can be quickly extended, retracted and placed into
the treatment position enabling imaging at any angle. The fully retracted arm permits unrestricted access by the operator
around the linear accelerator and patient support system.
The image is taken when X-rays passing through the patient activate a fluorescent screen and the amorphous silicon
panel captures the resultant light. The accurate location and extremely stable and rigid mounting of the iViewGT™
detector arm contribute to the accuracy of the positional information, and hence the accuracy of its interpretation.
Image Acquisition
Once a patient is selected on iViewGT single, double, multiple or movie image exposures may be taken during a
treatment using the default settings selected specifically for the patient anatomy. One single exposure up to a movie
sequence may be acquired during one treatment exposure. In addition, more than one movie sequence may be acquired
during one treatment, dependent on the set monitor units (MU) available.
Image acquisition algorithms automatically optimise the raw data prior to image display on the monitor, which can then
be further manipulated before being stored under that patient entry.
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Versa HD™ Image Guidance
Image Display
The single high resolution image monitor combines both patient data and associated images. Each patient has a unique
patient entry under which all associated information and images are stored. Simulator, Multileaf Preparation and DRR
(Digitally Reconstructed Radiograph) planning films may be accessed over a network using DICOM or other network
file format, or via a camera scanner and be assigned as the patient reference images during the course of treatment.
On selection of the patient the reference image is automatically displayed on the screen for comparison and viewing
purposes. All images taken from the linear accelerator and simulator are stored with dimensions to enable accurate
measurements and comparisons to be made. On acquisition, the iViewGT image is automatically displayed alongside
the reference image. This allows for real-time comparison of the actual treatment field with that planned and for
intervention if necessary.
Image Quality
Central to iViewGT is fast, high quality image acquisition and automatic, dose-dependent, control of exposure time.
For each specific patient anatomy, anatomical site and treatment technique, iViewGT optimizes dose delivery for high
image quality.
iViewGT requires typically 1 to 2MU for a 16-bit portal image. iViewGT waits for the linear accelerator to reach optimum
dose rate before triggering image capture. This ensures consistent and repeatable image quality.
The process of dose estimation and, if radiographic film is used, of film processing is eliminated. The low dose required
enables fast image capture and real-time image display.
Image Analysis
iViewGT images may be accessed at the control workstation. Whether operating in stand-alone or in a network, iViewGT
provides versatile, easy-to-use image handling and manipulation tools. The high resolution images are displayed on the
iViewGT single 21” screen.
Editing, printing and annotation are all carried out using the familiar, specifically designed, icon-driven user interface
with associated drop-down lists and help screens.
Multiple images taken during a fraction may be viewed either as a movie loop or tiled in groups of four.
Any displayed image may be zoomed up to maximum full screen width for closer examination.
Images can be displayed in the most appropriate form; window and level gray scale controls, edge enhancement for
anatomical sites with less density differential, and lung and bone inversion for soft tissue identification. Images can be
enlarged, scaled, measured, flipped and rotated for ease of comparison.
Full annotation may be added to an image and stored with it for future reference, just as one would write or draw on
a film.
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Versa HD™ Image Guidance
Image Approval
The clinician can make any additional annotations and, with the appropriate review permission, can approve or
disapprove an image on-line in iViewGT™ at the linear accelerator. Actions required will automatically be presented
to the operator on selection of the patient at the linear accelerator iViewGT workstation. A full audit trail records all
activities on the system. Images may be exported into MOSAIQ® Image Management.
Technical Specifications
Amorphous Silicon (a-Si) Radiation Image Detector
Retractable System:
• Retractable to 25 cm
• Clearance from gantry face to isocentre, 124 cm
• Motorised movement from second handheld controller
• Manual movement longditudinal
• Offset field 11.5 cm in any direction
• Fixed SSD at 60 cm from isocenter
Weight:
• Detector – 22 Kg
• Detector + arm 143 Kg
Isocentric accuracy:
• Stability 2 mm at isocenter
Safety:
Mechanical collision detection coupled with couch/gantry movement interlock
Panel Dimensions:
Length x width 410 x 410 mm
Scintillator:
DRZ-Plus
Field of View:
Image size referred to isocenter: 26 x 26 cm (long. x lat.) with head at 0°
Image Resolution:
• 1024 x 1024
• 16 bit grey scale
• pixel size at isocenter: 0.25 mm
• pixel size at detector: 0.4 mm
Image Acquisition Rate:
7.7 frames per second
Image Quality
Specifications applicable to X-rays in the energy range 4 to 18MV (25MV optional).
Contrast-to-Noise Ratio
Energy (MV) Dose CNR
6MV 1 >90
6MV 3 >110
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Versa HD™ Image Guidance
Measured with Standard Imaging QC3 phantom (PIPSPro) Maximum frame averaging
16
Versa HD™ Image Guidance
Contrast Optimization:
• Adjust brightness and contrast
• Noise correction function
• Display equalisation (automatic edge/contrast enhancement) algorithm
• CLAHE display optimization
• Invert black on white (air and bone display inversion)
kV IGRT
X-ray Volume Imaging (XVI)
XVI provides a kV imaging solution optimized for advanced image guided radiation therapy (IGRT), including 2D,
3D (& 4D) imaging modalities. XVI has a suite of sophisticated imaging tools, providing the technology to acquire and
utilize kV images for accurate patient positioning.
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Versa HD™ Image Guidance
The reconstruction engine that is included in the VolumeView option is based on a FeldKamp backprojection algorithm
specifically optimized for X-ray volume (cone-beam CT) acquisition.
Patient Aperture
The patient clearance aperture is 90 cm for both imaging and treatment delivery. The XVI hardware folds away against
the gantry when not required. This enables techniques such as non-coplanar treatment techniques to be achieved with
high efficiency.
Field-of-View
Field-of-view is determined as the visible reconstructed VolumeView image. The available field-of-view options are as
follows:
• Small: 27 cm x 26 cm
• Medium: 41 cm x 26 cm
• Large: 50 cm x 26 cm
Typical File Sizes for Reconstructed Images
Registration Workflows
VolumeView™ Regsitration
Specific anatomy for registration can be selected by utilising a clipbox (cube) volume or a 3D shaped region of interest.
The shaped registration region of interest allows structures imported from the treatment planning system to be utilized
for generation of the registration volume.
The following optimized registration workflows are available for efficient, intuitive image guidance:
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Versa HD™ Image Guidance
Product Performance
3D VolumeView™ Image Quality
The 3D image quality has been determined using the Phantom Laboratories CATPhan 503 Phantom with contrast
resolution module, spatial resolution module and uniformity resolution module. Example parameters used for image
acquisition are:
Parameter Value
kV 120
ms 40
Field-of-view 27 cm (small)
No. of projections 650
Gantry sweep (arc) 360 degrees
Reconstruction in-line
Slice thickness 1.5 mm
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Versa HD™ Image Guidance
kV Imaging System
Peak power 40kw, iso spec.
Radiographic kv range 70kVp – 150kVp
X-ray Tube
– Fan cooled
– X-ray tube housing assembly: total heat storage capacity: 1200kHU
– Cooling rates for anode and housing with additional ventilator (HU/min.) 705HU/s
– Added filtration 2.6 mm Al and 0.1mm Cu
Duty Factor
– Nominally two VolumeView™ scans in 15 mins
Amorphous Silicon Detector
– 41 cm x 41 cm
– Nominally 5.5FPS
– Image matrix 1024 x 1024 x 16 bits
DICOM
• DICOM CT import
• DICOM RT plan import
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Versa HD™ Image Guidance
Calibration Phantoms
Flexmap phantom
The single ball bearing phantom and table mount and associated software tools are used for routine QA checks, MV
isoccenter determination and kV system calibration.
Water calibration phantom
Water phantom used for multiple level gain calibration. (optional)
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Versa HD™
Remote Services
Elekta Remote Services is dedicated to ensuring that customers derive on-going value from their cancer management
solutions, and allows them to use their assets efficiently and effectively to treat patients by maintaining peak operational
performance to optimize clinical availability.
Elekta Remote Services to Versa HD is provided via Elekta IntelliMax™ a technology platform that allows data to be
transferred between Elekta and the Clinic as well as allowing Elekta to remotely access the Linear Accelerator.
Confidentiality and system security are maintained at all times as remote access can only be undertaken with an
approved customer representative present at the site during the connection.
By having Remote Services support in place customers enjoy enhanced clinical availability, quicker response times,
speedier trouble shooting and access to the global Elekta team of technical experts and engineers throughout the
working week regardless of linear accelerator location.
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Versa HD™
Site Requirements
This list includes only some relevant site requirements in general terms. For detailed site planning information please refer to Site
Planning Reference documentation.
Electrical
Electrical supply for linear accelerator: Peak power 30 kVA, Radiating 18kVA. Three-phase, neutral and earth. Nominal
voltage 380 to 420V, Nominal frequency 50 or 60Hz.
Water cooling
A supply of cooling water is required that can be configured as a one-pass system or a closed loop. If the hospital is
not ordering an Elekta water cooler then the client is required to supply the linear accelerator with cooled water to the
following specification:
• temperature of water at input to the linear accelerator between 12° and 20°C
• maximum flow – 30 liters/minute
• maximum (absolute) pressure at the input to the linear accelerator should not exceed 4 bar
Maximum heat input into the hospital water is approximately 12kW, thus temperature gain of hospital water at 30 liters/
minute flow is approximately 6°C.
Lighting
There should be no lighting on the ceiling or walls within 500 mm either side of the isocenter.
Cable Ducting
Cable ducts are required to run from the rear of the accelerator to the control room. Ducting should be set into the
concrete floor for this. Smaller ducts are required to run from the linear accelerator gantry to the water cooler (if used)
and to the Client Interface Terminal.
Lifting Equipment
An I-section girder with a safe working load (SWL) of 2200kg should be mounted on to the concrete ceiling directly
above and parallel to the rotation axis of the gantry (end stops must be fitted if girder is open-ended).
23
Versa HD™
Art. nr. 4513 371 1111 03:16 © Elekta AB (publ). All mentioned trademarks and registered trademarks are the property of the Elekta Group. All rights reserved. No part of this document may be reproduced in any form without written permission from the copyright holder.
Description
Elekta Versa HD™ Elekta Versa HD™
Provides:
- Elekta's high end digital accelerator, providing a range of both x-ray and electron energies
to satisfy the requirements of external beam radiotherapy. Up to 3 FF Photon, 2 FFF
Photon, 9 electron energies, and 2 HDRE energies can be configured.
- Digital accelerator with exclusive cover set design;
- Agility™ world fastest MLC, Elekta's integrated multi-leaf collimator that provides full field
high resolution beam shaping (5mm at isocentre), a 40 x 40cm treatment
field and effective leaf tip speed of up to 6.5cm/sec, capable of covering
multiple targets with interdigitation and island shapes;
- 6MV and 10MV flattened energies delivered as standard;
- A broad spectrum of delivery techniques from 3D Conformal Radiotherapy to IMRT,
VMAT SRS, and SBRT techniques;
- Equipped with Hexapod with 6 degree of freedom for easier set up
Photon Beams
FF Energy (MV) 6 and 10 MV
FF Energy Dose Rate 30 - 500 MU/Min
FFF Energy (MV) 6 and 10 MV FFF
FFF Energy Dose Rate 200 - 1400 MU/ Min for 6 MV FFF and 400 - 2200 MU/ Min for 10 MV FFF
Wedge Motorized wedge
Continuosly variable in the range 0° to 60°
Accelerator System
RF Power Source The RF power is derived from the compact, high-efficiency, fast-tuning MG 6370E Magnetron. The
MG 6370E was specifically designed for radiotherapy linear accelerators and features a built-in
electromagnetic frequency tuner ensuring precise and responsive AFC.
This magnetron is able to operate under a wide range of temperature and humidity conditions. It is
completely powered off when the linear accelerator is not in operation and will be at operating
temperature in less than 10min after power on.
The magnetron is mounted on the gantry and rotates with it giving very convenient access for
rapid maintenance allowing replacements to be completed in just 30mins.
High efficiency due to Power Consumption up to 30% lower
Type of wave accelerator accelerating traveling waveguide is optimized for maximum electron beam throughput and
efficient use of RF power. In the traveling waveguide there is no need for complex energy switches
subject to mechanical failure and the design provides a unique wide and flexible energy choice.
Elekta offers a 20-year warranty with the confidence of knowing that it has never been necessary
to replace one of our waveguides in clinical use.
Page 1 of 5
TECHNICAL SPECIFICATION
Description
Electron gun The electron gun used in the accelerator is of diode type. It is a cost effective and easily replaceable
component. The electron gun and magnetron are always pulsed simultaneously avoiding dark
current leakage problems and the control of the dose rate is achieved by adjusting pulse repetition
frequency
Focusing coils A system of focusing solenoids ensures high electron beam transmission through the accelerator
structure resulting in reduced stray-radiation and efficient use of RF power.
Beam steering system Two pairs of orthogonal steering coils ensure electron beam alignment on the target in all modes,
as well as under any gantry orientation. In conjunction with a dedicated multi-electrode ion
chamber and digitally controlled servo electronics the steering system minimizes beam symmetry
changes under all conditions.
Slitless beam energy control Precise and stable beam energy is ensured with sensitive servo control of the gun thermionic
emission from a multielectrode ionization chamber in the x-ray beam path. This servo system
eliminates the need for energy-defining mechanical slits in the electron beam path, which would
result in increased stray X-radiation.
Touchguard System Elekta's touchguard system to prevent collision for pasient safety
MLC
Agility™, Elekta's (160 leaves) and world's fastest integrated multi-leaf collimator that provides
full field high resolution beam shaping (5mm at isocentre), a 40 x 40cm treatment field and
effective leaf tip speed of up to 6.5cm/sec, and diapghgram up 9 cm/s with average transmission <
0.375% capable of covering multiple targets with interdigitation and island shapes
Fraxion Fraxion
Mechanical Features
Gantry rotation 365°
Target to axis distance 100 ±0.2 cm
Isocentre high 124 cm
Collimator rotation range 365° (±182.5°)
Isocentre clearance 45 cm
Page 2 of 5
TECHNICAL SPECIFICATION
Description
Field size collimator 0.5 cm x 0.5 cm to 40 cm x 40 cm
Couch
Type Couch iBeam Evo
The iBEAMevoCouchtop has no metallic components apart from the rails.
The table top comes with a fixed rail at the foot end of the couch and a removable, light weight rail
for the superior couch end.
HexaPod
HexaPOD evo RT Couchtop with homogeneous carbon fiber couchtop tih 6 Degrees of Motion
Movement
Size Length : 2300 mm
Width : 570 mm
Height : 87 mm
Couch lift capacity 200 kg
Couch lift range Longitudinal Movement range : 0 to 100 cm
Lateral Movement range : +/- 25cm
Vertical Movement range : 66 to 176 cm (using C-Arm top)
Column rotation range : +/- 360 degrees with indent 0 degree
IMRT Planning
• Monte Carlo Algorithm for MLC based planning
• Step and Shoot delivery mode, supported for Elekta
• Dynamic MLC (Sweeping Window) delivery mode, supported for Elekta
• Dynamic conformal Arc with MLC shaping based on the view
of the target. Supported for Elekta
Contouring
Atlas-Based Autosegmentation software
Atlas-Based Autosegmentation is an automated contouring application that deforms atlases of
anatomy previously defined on a reference image onto any new patient image, creating an entire
new structure set fit to the patient anatomy.
Virtual Simulation
Page 3 of 5
TECHNICAL SPECIFICATION
Description
- Contouring
- CT Simulation
- Fusion
- 4D Support
- Plan Review and Approval
- DICOM Import and Export Capabilities
- Use with Treatment Planning Systems for dose calculation
Monaco VMAT
• Fully dynamic gantry and MLC movement
• Variable dose rate delivery, controlled by varying gantry speed, leaf speed, and
dose rate Supported for Elekta
SBRT/ SRS
Equipment Requirement
Electrical requirement 50 Hz, 380 to 420 V, peak power 30 kVA, three-phase
Prasarana Ruangan
In room display Flat screen 19" monitor
CCTV/camera Color CCTV monitoring system with pan, zoom, and tilt functions
Patient Intercom System Intercom for patient and radiographer communication
Room Laser Set of 3 Room lasers
Water Chiller Water Chiller 50 Hz
Stabilizer Automatic Voltage Stabilizer
Keterangan Tambahan
Delivery Time Indent 4-5 bulan
Hardware OIS Sudah termasuk
Rigging Sudah termasuk
Dehumidifier Sudah termasuk
Pekerjaan Pra Instalasi Sudah termasuk Fascia Wall, Pit, Ducting
Patient Fixation Patient Fixation termasuk SBRT/ SRS Set
Garansi 2 tahun setelah tanggal Uji Fungsi Alat (Customer Acceptance Test)
Training On Site Training Dokter, Fisika Medis, Radioterapis, dan Teknisi di Rumah Sakit / On Site
Training Overseas/ Luar Negeri 2 Orang di Pusat Training ELEKTA, pelaksanaanya bergantung pada jadwal / kelas yang diberikan
oleh pusat training Elekta
Page 4 of 5
TECHNICAL SPECIFICATION
Description
Paket Pembelian Tidak • Dosimetry System
Termasuk • Biaya Pembuatan Bunker
• Biaya instalasi kabel power dan panel listrik
• Uninterruptible Power Supply (UPS)
Page 5 of 5