Page 1
Nuclear Associates
76-414,76-414-4150,76-415
CT Head and Body Dose Phantom
March 2005
Manual No. 76-414-1 Rev. 2
©2004, 2005 Fluke Corporation, All rights reserved. Printed in U.S.A.
All product names are trademarks of their respective companies
Users Manual
Page 2
Fluke Biomedical
Radiation Management Services
6045 Cochran Road
Cleveland, Ohio 44139
440.498.2564
www.flukebiomedical.com/rms
Page 3
Table of Contents
Section 1: General Information................................................................................... 1-1
1.1 Introduction .................................................................................................. 1-1
1.2 Applications ................................................................................................. 1-1
Section 2: Operation.................................................................................................... 2-1
i
Page 4
(Blank Page)
Page 5
General Information
Introduction
1
Section 1
General Information
1.1 Introduction
These phantoms can be used with any computed tomography (CT) system designed to image both head
and body. They can separate dose information for each. When performing dose profile measurements,
the dose phantoms allow the user to collect information for the maximum, minimum and mid-range value
of the nominal tomographic section thickness.
This essential phantom consists of two parts: a body phantom and a head phantom. Both are made of
solid acrylic, 15 cm thick, with diameters of 32 cm and 16 cm, respectively. Each part contains five probe
holes, one in the center and four around the perimeter, 90° apart and 1 cm from the edge. The inside
diameter of the holes is 1.31 cm. Each part includes five acrylic rods for plugging all the holes in the
phantom. A storage and carrying case is available as an option.
1.2 Applications
The CT Dose Phantoms were designed in accordance with the Food and Drug Administration's
performance standard for diagnostic x-ray systems, which includes regulations specifically applicable to
CT systems (21 CFR 1020.33).
1-1
Page 6
Nuclear Associates 76-414-4150
Operators Manual
(Blank Page)
Page 7
Operation
§1020.33 Computed Tomography (CT) Equipment
Section 2
Operation
§1020.33 Computed Tomography (CT) Equipment
Reprinted from: “21CFR 1020.33” pages 535-540.
A. Applicability
1. The provisions of this section, except for paragraphs (b), (c)(1), and (c)(2) are applicable as specified
herein to CT x-ray systems manufactured or remanufactured on or after September 3,1985.
2. The provisions of paragraphs (b), (c)(1), and (c)(2) are applicable to CT x-ray systems manufactured or
remanufactured on or after November 29, 1984.
B. Definitions
2
As used in this section, the following definitions apply:
1) Computed Tomography Dose Index (CTDI) Means
The integral of the dose profile along a line perpendicular to the tomographic plane divided by the
product of the nominal tomographic section thickness and the number of tomograms produced in a
single scan; that is:
Where:
z = position along a line perpendicular to the tomographic plane.
D(z) = Dose at position z.
T = Nominal tomographic section thickness.
n = Number of tomograms produced in a single scan.
This definition assumes that the dose profile is centered around z=0 and that, for a multiple
tomogram system, the scan increment between adjacent scans is nT.
2) Contrast Scale Means
The change in linear attenuation coefficient per CT number relative to water; that is:
2-1
Page 8
Nuclear Associates 76-414-4150
Operators Manual
Where:
Linear attenuation coefficient of water.
μ
w =
= Linear attenuation coefficient of material of interest.
μ
x
= CT number of water.
(CT)
w
(CT)
= CT number of material of interest.
x
3) CT Conditions of Operation Means
All selectable parameters governing the operation of a CT x-ray system including nominal
tomographic section thickness, filtration, and the technique factors as defined in §1020.30(b)(36).
4) CT Number Means
The number used to represent the x-ray attenuation associated with each elemental area of the
CT image.
5) [Reserved]
6) CT Dosimetry Phantom Means
The phantom used for determination of the dose delivered by a CT x-ray system. The phantom
shall be a right circular cylinder of polymethl-methacrylate of density 1.19±0.01 grams per cubic
centimeter. The phantom shall be at least 14 centimeters in length and shall have diameters of
32.0 centimeters for testing any CT system designed to image any section of the body (whole
body scanners) and 16.0 centimeters for any system designed to image the head (head
scanners) or for any whole body scanner operated in the head scanning mode. The phantom
shall provide means for the placement of a dosimeter(s) along its axis of rotation and along a line
parallel to the axis of rotation 1.0 centimeter from the outer surface and within the phantom.
Means for the placement of a dosimeter(s) or alignment device at other locations may be
provided for convenience. The means used for placement of a dosimeter(s) (i.e., hole size) and
the type of dosimeter(s) used is at the discretion of the manufacturer. Any effect on the doses
measured due to the removal of phantom material to accommodate dosimeters shall be
accounted for through appropriate corrections to the reported data or included in the statement of
maximum deviation for the values obtained using the phantom.
7) Dose Profile Means
The dose as a function of position along a line.
8) Modulation Transfer Function Means
The modulus of the Fourier transform of the impulse response of the system.
9) Multiple Tomogram System Means
A CT x-ray system which obtains x-ray transmission data simultaneously during a single scan to
produce more than one tomogram.
10) Noise Means
The standard deviation of the fluctuations in CT number expressed as a percent of the
attenuation coefficient of water. Its estimate (S
following expression:
2-2
) is calculated using the
n
Page 9
§1020.33 Computed Tomography (CT) Equipment
Where:
CS = Contrast scale.
= Linear attenuation coefficient of water.
μ
w
s = Estimated standard deviation of the CT numbers of picture elements in a specified area of the
CT image.
11) Nominal Tomographic Section Thickness Means
The full-width at half-maximum of the sensitivity profile taken at the center of the cross-sectional
volume over which x-ray transmission data are collected.
12) Picture Element Means
An elemental area of a tomogram.
13) Remanufacturing Means
Modifying a CT system in such a way that the resulting dose and imaging performance become
substantially equivalent to any CT x-ray system manufactured by the original manufacturer on or
after November 29, 1984. Any reference in this section to "manufacture", "manufacturer", or
"manufacturing" includes remanufacture, remanufacturer, or remanufacturing, respectively.
14) Scan Increment Means
The amount of relative displacement of the patient with respect to the CT x-ray system between
successive scans measured along the direction of such displacement.
Operation
2
15) Scan Sequence Means
A preselected set of -two or more scans performed consecutively under preselected CT
conditions of operations.
16) Sensitivity Profile Means
The relative response of the CT x-ray system as a function of position along a line perpendicular
to the tomographic plane.
17) Single Tomogram System Means
A CT x-ray system which obtains x-ray transmission data during a scan to produce a single
tomogram.
18) Tomographic Plane Means
That geometric plane which the manufacturer identifies as corresponding to the output tomogram.
19) Tomographic Section Means
The volume of an object whose x-ray attenuation properties are imaged in a tomogram.
C. Information to be Provided for Users
Each manufacturer of a CT x-ray system shall provide the following technical and safety information, in
addition to that required under § 1020.30(h), to purchasers and, upon request, to others at a cost not to
exceed the cost of publication and distribution of such information. This information shall be identified and
provided in a separate section of the user's instruction manual or in a separate manual devoted only to
this information.
1) Conditions of Operation. A statement of the CT conditions of operation used to provide the
information required by paragraph (c) (2) and (3) of this section.
2-3
Page 10
Nuclear Associates 76-414-4150
Operators Manual
2) Dose information. The following dose information obtained by using the CT dosimetry phantom.
For any CT x-ray system designed to image both the head and body, separate dose information shall
be provided for each application. All dose measurements shall be performed with the CT dosimetry
phantom placed on the patient couch or support device without additional attenuating materials
present.
(i) The CTDI at the following locations in the dosimetry phantom:
(a) Along the axis of rotation of the phantom.
(b) Along a line parallel to the axis of rotation and 1.0 centimeter interior to the surface of the
phantom with the phantom positioned so that CTDI is the maximum obtainable at this depth.
(c) Along lines parallel to the axis of rotation and 1.0 centimeter interior to the surface of the
phantom at positions 90, 180, and 270 degrees from the position in paragraph (c)(2)(i)(b) of
this section. The CT conditions of operation shall be the typical values suggested by the
manufacturer for CT of the head or body. The location of the position where the CTDI is
maximum as specified in paragraph (c)(2)(i)(b) of this section shall be given by the
manufacturer with respect to the housing of the scanning mechanism or other readily
identifiable feature of the CT x-ray system in such a manner as to permit placement of the
dosimetry phantom in this orientation.
(ii) The CTDI in the center location of the dosimetry phantom for each selectable CT condition of
operation that varies either the rate or duration of x-ray exposure. This CTDI shall be presented
as a value that is normalized to the CTDI in the center location of the dosimetry phantom from
paragraph (c)(2)(i) of this section, with the CTDI of paragraph (c)(2)(i) of this section having a
value of one. As each individual CT condition of operation is changed, all other independent
CT conditions of operation shall be maintained at the typical values described in paragraph
(c)(2)(i) of this section. These data shall encompass the range of each CT condition of operation
stated by the manufacturer as appropriate for CT of the head or body. When more than three
selections of a CT condition of operation are available, the normalized CTDI shall be provided, at
least, for the minimum, maximum, and mid-range value of the CT condition of operation.
(iii) The CTDI at the location coincident with the maximum CTDI at 1 centimeter interior to the surface
of the dosimetry phantom for each selectable peak tube potential. When more than three
selections of peak tube potential are available, the normalized CTDI shall be provided, at least,
for the minimum, maximum, and a typical value of peak tube potential. The CTDI shall be
presented as a value that is normalized to the maximum CTDI located at 1 centimeter interior to
the surface of the dosimetry phantom from paragraph (c)(2)(i) of this section, with the CTDI of
paragraph (c)(2)(i) of this section having a value of one.
(iv) The dose profile in the center location of the dosimetry phantom for each selectable nominal
tomographic section thickness. When more than three selections of nominal tomographic section
thicknesses are available, the information shall be provided, at least, for the minimum, maximum,
and midrange value of nominal tomographic section thickness. The dose profile shall be
presented on the same graph and to the same scale as the corresponding sensitivity profile
required by paragraph (c)(3)(iv) of this section.
(v) A statement of the maximum deviation from the values given in the information provided
according to paragraph (c)(2) (i), (ii), (iii), and (iv) of this section. Deviation of actual values may
not exceed these limits.
2-4
Page 11
Operation
§1020.33 Computed Tomography (CT) Equipment
2
3) Imaging Performance Information. The following performance data shall be provided for the CT
conditions of operation used to provide the information required by paragraph (c)(2)(i) of this section.
All other aspects of data collection, including the x-ray attenuation properties of the material in the
tomographic section, shall be similar to those used to provide the dose information required by
paragraph (c)(2)(i) of this section. For any CT x-ray system designed to image both the head and
body, separate imaging performance information shall be provided for each application.
(i) A statement of the noise.
(ii) A graphical presentation of the modulation transfer function for the same image processing and
display mode as that used in the statement of the noise.
(iii) A statement of the nominal tomographic section thickness(es).
(iv) A graphical presentation of the sensitivity profile, at the location corresponding to the center
location of the dosimetry phantom, for each selectable nominal tomographic section thickness for
which the dose profile is given according to paragraph (c)(2)(iv) of this section.
(v) A description of the phantom or device and test protocol or procedure used to determine the
specifications and a statement of the maximum deviation from the specifications provided in
accordance with paragraphs (c)(3)(i),(ii),(iii), and (iv) of this section. Deviation of actual values
may not exceed these limits.
D. Quality Assurance
The manufacturer of any CT x-ray system shall provide the following with each system. All information required
by this subsection shall be provided in a separate section of the user's instructional manual.
1) A phantom(s) capable of providing an indication of contrast scale, noise, nominal tomographic
section thickness, the spatial resolution capability of the system for low and high contrast objects,
and measuring the mean CT number of water or a reference material.
2) Instructions on the use of the phantom(s) including a schedule of testing appropriate for the system,
allowable variations for the indicated parameters, and a method to store as records, quality
assurance data.
3) Representative images obtained with the phantom(s) using the same processing mode and CT
conditions of operation as in paragraph (c)(3) of this section for a properly functioning system of the
same model. The representative images shall be of two forms as follows:
(i) Photographic copies of the images obtained from the image display device
(ii) Images stored in digital form on a storage medium compatible with the CT x-ray system. The
CT x-ray system shall be provided with the means to display these images on the image display
device.
E. [Reserved]
F. Control and Indication of Conditions of Operation
1) The CT conditions of operation to be used during a scan or a scan sequence shall be indicated
prior to initiation of a scan or a scan sequence. On equipment having all or some of these
conditions of operation at fixed values, this requirement may be met by permanent markings.
Indication of the CT conditions of operation shall be visible from any position from which scan
initiation is possible.
2) Timers, (i) Means shall be provided to terminate the x-ray exposure automatically by either de-
energizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting
data collection. Such termination shall occur within an interval that limits the total scan time to no
2-5
Page 12
Nuclear Associates 76-414-4150
Operators Manual
more than 110 percent of its preset value through the use of either a backup timer or devices which
monitor equipment function. A visible signal shall indicate when the x-ray exposure has been
terminated through these means and manual resetting of the CT conditions of operation shall be
required prior to the initiation of another scan.
(ii) Means shall be provided so that the operator can terminate the x-ray exposure at any time
during a scan, or series of scans under x-ray system control, of greater than one-half second
duration. Termination of the x-ray exposure shall necessitate resetting of the CT conditions of
operation prior to the initiation of another scan.
G. Tomographic Plane Indication and Alignment
1) For any single tomogram system, means shall be provided to permit visual determination of the
tomographic plane or a reference plane offset from the tomographic plane.
2) For any multiple tomogram system, means shall be provided to permit visual determination of the
location of a reference plane. The relationship of the reference plane to the planes of the
tomograms shall be provided to the user in addition to other information provided according to
§1020.30(h). This reference plane can be offset from the location of the tomographic planes.
3) The distance between the indicated location of the tomographic plane or reference plane and its
actual location may not exceed 5 millimeters.
4) For any offset alignment system, the manufacturer shall provide specific instructions with respect to
the use of this system for patient positioning, in addition to other information provided according to
§1020.30(h).
5) If a mechanism using a light source is used to satisfy the requirements of paragraphs (g) (1) and (2)
of this section, the light source shall allow visual determination of the location of the tomographic
plane or reference plane under ambient light conditions of up to 500 lux.
H. Beam-On and Shutter Status Indicators
1) Means shall be provided on the control and on or near the housing of the scanning mechanism to
provide visual indication when and only when x rays are produced and, if applicable, whether the
shutter is open or closed. If the x-ray production period is less than one-half second, the indication
of x-ray production shall be actuated for one-half second. Indicators at or near the housing of the
scanning mechanism shall be discernible from any point external to the patient opening where
insertion of any part of the human body into the primary beam is possible.
2) For systems that allow high voltage to be applied to the x-ray tube continuously and that control the
emission of x rays with a shutter, the radiation emitted may not exceed 100 milliroentgens (2.58 x
-5
coulomb/kilogram) in 1 hour at any point 5 centimeters outside the external surface of the
10
housing of the scanning mechanism when the shutter is closed. Compliance shall be determined by
measurements averaged over an area of 100 square centimeters with no linear dimensions greater
than 20 centimeters.
I. Scan Increment Accuracy
The deviation of indicated scan increment from actual scan increment may not exceed 1 millimeter.
Compliance shall be measured as follows: The determination of the deviation of indicated versus actual
scan increment shall be based on measurements taken with a mass 100 kilograms or less, on the patient
support device. The patient support device shall be incremented from a typical starting position to the
maximum incrementation distance or 30 centimeters, whichever is less, and then returned to the starting
position. Measurement of actual versus indicated scan increment may be taken anywhere along this
travel.
2-6
Page 13
Operation
§1020.33 Computed Tomography (CT) Equipment
2
J. CT Number Mean and Standard Deviation
1) A method shall be provided to calculate the mean and standard deviation of CT numbers for an
array of picture elements about any location in the image. The number of elements in this array
shall be under user control.
2) The manufacturer shall provide specific instructions concerning the use of the method provided for
calculation of CT number mean and standard deviation in addition to other information provided
according to § 1020.30(h).
(The information collection requirements in paragraphs (c), (d), (g), and (j) were approved by the Office
of Management and Budget under control number 0910-0025)
[49 FR 34712, Aug. 31, 1984; 49 37381, Sept. 24, 1984, as amended at 49 FR 47388, Dec. 4, 1984; 56
FR 36098. Aug. 1,1991]
2-7
Page 14
Fluke Biomedical
Radiation Management Services
6045 Cochran Road
Cleveland, Ohio 44139
440.498.2564
www.flukebiomedical.com/rms
Loading...