Linear accelerator for IAEA Specification

Radiotherapy [NAHU]-001
Revision 0.0
Dated [2011-06-09]

SPECIFICATION

Linear accelerator for the Radiotherapy Centre within the

Parirenyatwa Group of Hospitals,
Mazowe Street, Harare, Zimbabwe

Approved

__________________________________________________
Division of NAHU --- Date 08.07.2011 (MTPS)

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Linear accelerator for IAEA Specification
Radiotherapy [NAHU]-001
Revision 0.0
Dated [2011-06-09]

1. Scope

This specification describes the requirements for a medical linear accelerator for the
treatment of patients in radiation oncology.

The radiotherapy centre in Parirenyatwa hospital has 3 high energy treatment rooms,
one of which contains a linear accelerator. The layout of the bunker that previously
housed the Brown-Boveri Dynaray-CH (6 MV) linear accelerator, is included
(Annexure I). This is the bunker in which the linear accelerator specified in this
document, is to be installed.

The accelerator is to operate in conjunction within an infrastructure that consists of

Varian XimatronTM simulator, a Varian ClinacTM 2100C and a XiO Dual 2.5D RTPTM
treatment planning system. Mould room accessories, including a manual hot-wire
block cutter are available for patient preparation.

2. Applicable Documents

The following documents shall be applicable for this Specification to the extent
specified hereinafter:

International Electrotechnical Commission, Medical Electrical Equipment, Part 1: General

requirements for Safety, Rep. IEC 601-1, IEC, Geneva (1998)

International Electrotechnical Commission, Medical Electrical Equipment, Part 2-8, Particular

Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV, Rep.
IEC 601-2-1, IEC, Geneva (1998)

“Setting up a Radiotherapy Programme: Clinical, Medical Physics, Radiation

Protection and Safety Aspects”, IAEA, Vienna (2008) (http://www-
pub.iaea.org/MTCD/publications/PDF/pub1296_web.pdf

“International Basic Safety Standards for Protection against Ionizing Radiation and for
the Safety of Radiation Sources”, IAEA, Vienna (1996) (http://www-
pub.iaea.org/MTCD/publications/PDF/Pub996_EN.pdf)

In the event of conflict between the documents listed above and the content of this
Specification, the content of this Specification shall take precedence to the extent of
the conflict.

3. Definitions, Acronyms, and Abbreviations

The following definitions, acronyms, and abbreviations shall apply throughout this
Specification unless defined otherwise hereinafter:

MV: megavoltage
cm: centimeters
mu: monitor units
Gy: Gray
CCTV: closed circuit television
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Linear accelerator for IAEA Specification
Radiotherapy [NAHU]-001
Revision 0.0
Dated [2011-06-09]

UPS: uninterruptable power supply

MLC: multileaf collimator
BSS: “International Basic Safety Standards for Protection against Ionizing Radiation
and for the Safety of Radiation Sources”, IAEA, Vienna (1996)
IEC-601-2-1: International Electrotechnical Commission, Medical Electrical
Equipment, Part 2-8, Particular Requirements for the Safety of Electron Accelerators
in the Range 1 MeV to 50 MeV, Rep. IEC 601-2-1, IEC, Geneva (1998)

4. Requirements

4.1. Functional and Performance Requirements

The System shall meet the following functional and performance requirements:

A complete single photon energy (4 – 6 MV) linear accelerator system to be delivered

and installed, and undergo full acceptance testing of the technical requirements on site.
The system should include a 2 year warranty and a 5 year fully inclusive maintenance
contract. Safety compliance with the BSS and IEC-601-2-1 documents, including all
interlocks is an essential requirement.

4.2. Technical Requirements

The System shall meet the following technical requirements:

4.2.1. Single high energy photon beam linear accelerator (4 – 6 MV) machine,
consisting of

4.2.2. A range of output from at least 50 mu/min to 200 mu/min providing a dose rate of 1
Gy/100 mu in water at the depth of maximum dose at the isocenter in a field size of 10
cm × 10 cm.
4.2.3. A gantry for treatments at SAD = 100 cm,
4.2.4. A patient table providing motorized or hydraulic vertical movement, longitudinal and
lateral motions with isocentric rotation. It should be equipped with a transparent window
for non-attenuated posterior treatment and a centre spine for posterior oblique portals
4.2.5. Collimators providing a maximum field size of 40 cm x 40 cm with at least one set of
asymmetric collimators capable of shielding half the beam.
4.2.6. A set of wedge filters (or a universal or soft wedge). Note that wedging shall be
possible in the direction of the asymmetric collimation.
4.2.7. A comprehensive set of standard shielding blocks with a set of at least 100 coded
block trays,
4.2.8. An optical backpointer
4.2.9. An in-room monitor
4.2.10. A cassette holder with four cassettes for megavoltage portal imaging, including a
tabletop film processor (alternatively an integrated portal imaging system)
4.2.11. a set of 3 lasers for patient centring,
4.2.12. an audio-visual radiation room monitor,
4.2.13. 2 CCTV systems; one with pan, tilt and zoom capability
4.2.14. A patient intercommunication system,

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Linear accelerator for IAEA Specification
Radiotherapy [NAHU]-001
Revision 0.0
Dated [2011-06-09]

4.2.15. an Uninterruptable Power Supply (UPS) to maintain consol information during a

power outage
4.2.16. A dual ionization chamber system with independently monitored high voltage supply
4.2.17. A closed chiller system to ensure adequate continuous cooling of the linear accelerator
4.2.18. A power conditioner to ensure adequate stability of the power of the linear accelerator
4.2.19. All required radiation alarm monitors, anti-collision devices, emergency switches,
warning lights, access and safety interlocks.
4.2.20. The pricing should include an extended warranty of at least 2 years, which
commences on completion of acceptance testing.
4.2.21. Furthermore a 5 year fully-inclusive maintenance contract agreement post-warranty
should be included. A comprehensive spare parts kit should be available locally and it
should be re-stocked as parts are used (please provide a list of the spares that will be
provided).
4.2.22. Installation and delivery to site should be included
4.2.23. Any room alterations should be stated and quoted.
4.2.24. Training of all relevant staff should be included.
4.2.25. Additional technical requirements will apply (see Appendix VI of IAEA publication
“Setting up a Radiotherapy Programme: Clinical, Medical Physics, Radiation Protection
and Safety Aspects”, IAEA, Vienna (2008) (http://www-
pub.iaea.org/MTCD/publications/PDF/pub1296_web.pdf)

4.3. The following options should be quoted for separately:

4.3.1. The supply of a record and verify system should be quoted as an option:
4.3.2. The record and verify system should be networked to the treatment unit offered and
to the existing treatment planning system (XiO Dual 2.5D RTPTM) and should consist of
at least 2 workstations.
4.3.3. The pricing should include an extended warranty of at least 2 years, which
commences on completion of acceptance testing.
4.3.4. Furthermore a 5 year fully-inclusive hardware and software maintenance contract
agreement post-warranty should be included.
4.4. The supply of a dual photon linear accelerator with a range of electron energies. Please note
that this unit would replace the existing linear accelerator (6/10 MV photons) and that removal
and preparation of the bunker would be the responsibility of the end-user.
4.4.1. The unit must furthermore comply with all other specifications listed under item 1 (a –
x) above.
4.4.2. The pricing should include an extended warranty of at least 2 years, which
commences on completion of acceptance testing.
4.4.3. Furthermore a 5 year fully-inclusive maintenance contract agreement post-warranty
should be included.
4.5. The supply of a linear accelerator including a conventional, i.e. non-demountable multi-leaf
collimator (MLC) capable of conformal radiotherapy:
4.5.1. The unit must furthermore comply with all other specifications listed under item 1 (a –
x) above.
4.5.2. The pricing should include an extended warranty of at least 2 years, which
commences on completion of acceptance testing.

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Linear accelerator for IAEA Specification
Radiotherapy [NAHU]-001
Revision 0.0
Dated [2011-06-09]

4.5.3. Furthermore a 5 year fully-inclusive maintenance contract agreement post-warranty

should be included.
4.5.4. A comprehensive spare parts kit for the MLC should be available locally and it should
be re-stocked as parts are used (please provide a list of the spares that will be provided).

5. Marking

The System shall have all safety markings in the English language.

6. Packing

The System, for the shipment by air to the End-User, shall be packed in accordance
with international standards that are applicable for the shipment by air of this kind of
equipment.

7. Quality Requirements

7.1. The System shall be manufactured, shipped and installed in accordance with the ISO
9000 quality assurance system or an equivalent quality assurance system.

7.2. The Contractor shall document the compliance with this quality assurance system.

8. Testing and Acceptance

The System, prior to shipment, shall be tested for conformance of the System with
manufacturer’s performance specifications and the minimum requirements specified
herein.

The System, after installation, shall be tested by the Contractor together with the
hospital medical physicist to demonstrate that the performance meets the
manufacturer’s performance specifications and the minimum requirements specified
herein as determined by the IAEA and the End-User.

The results of the testing of the System shall be documented by the Contractor in an
acceptance protocol that shall be signed by the hospital medical physicist.

9. Installation and Training

The Contractor shall install the System at the Radiotherapy Centre within the
Parirenyatwa Group of Hospitals, Mazowe Street, Harare, Zimbabwe. Training of a
local hospital service engineer in front-line maintenance shall be included, preferably during
the installation and acceptance testing process.

The Contractor shall provide three days’ training for up to three staff of the End-User
in the operation of the System at the End-User’s location immediately after the
installation and acceptance testing of the System.

10. Deliverable Data Items

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Linear accelerator for IAEA Specification
Radiotherapy [NAHU]-001
Revision 0.0
Dated [2011-06-09]

The Contractor shall provide two complete sets of operation and servicing manuals
and technical drawings in the English language.

ANNEXURE I

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