User Manual
NORMI 13 (T42023)
Contents
Operating Manual
Technical Manual
Service Manual
D703.131.00/03 en 2015-09 ext/Bru
General Information
NORMI 13 (T42023)
General Information
– The product bears the CE-mark "CE" in accor-
dance with the Council Directive 93/42/EEC
about Medical Devices and fulfills the essential
requirements of Annex I of this directive. The
product is a class I device without a measuring
function (MDD).
– Product standards
The product fully complies with the requirements of the following standards:
– DIN 6868-13
– The user manual is an integral part of the prod-
uct. It should always be kept near the product.
Observance of the manual is a prerequisite for
proper product performance and correct operation.
– Operator safety, specified measuring accu-
racy, and interference-free operation can
only be guaranteed if original products and
parts are used. Furthermore, only the accessories listed in this manual are approved by
PTW-Freiburg and only they or other accessories whose use has been expressly permitted by PTW-Freiburg may be used in conjunction with the product. Safe operation and
proper product performance are not guaranteed if accessories or consumables from other
manufacturers are used.
– PTW-Freiburg cannot be held liable for dam-
age resulting from the use of accessories
or consumables from other manufacturers or
when the user ignores the instructions and
information given in this manual.
– The warranty period is 1 (one) year and begins
on the day of delivery. It is unaffected by
repairs covered by the warranty regulations.
– PTW-Freiburg only considers itself responsi-
ble for the safety, reliability, and performance
of the product if the assembly, extension, readjustment, modification, or repair is carried out
by PTW-Freiburg or by persons authorized by
PTW-Freiburg, and if the product is used in
compliance with the technical documentation.
– In case of any questions concerning the ser-
vice, support, or warranty, please contact your
supplier.
– This manual is in conformity with the product
specifications and all applicable safety standards that are valid as at the printing date. All
rights are reserved for devices, circuits, techniques, software, and names as referred to in
the manual.
– PTW-Freiburg reserves the right to make mod-
ifications.
Please contact PTW or your local representative for the most current information concerning the products of interest.
– No part of the technical documentation may
be reproduced without written permission from
PTW-Freiburg.
– PTW-Freiburg is a registered manufacturer
according to the ElektroG (Elektro- und Elektronikgeräte-Gesetz).
Elektro-Altgeräte-Register (EAR). Registration
number DE15599992
– PTW-Freiburg works in strict accordance with
a quality management system that is continuously updated according to the national and
international standards.
2 D703.131.00/03 en
PTW-Freiburg
Physikalisch-Technische Werkstätten
Dr. Pychlau GmbH
Lörracher Str. 7
79115 FREIBURG
Germany
Tel.: +49 761 49055-0
Fax: +49 761 49055-70
info@ptw.de
www.ptw.de
NORMI 13 (T42023)
General Information
D703.131.00/03 en 3
NORMI 13 (T42023)
Table of Contents
Table of Contents
General Information........................................................................................................2
Table of Contents........................................................................................................... 4
List of Figures.................................................................................................................6
Intended Use................................................................................................................... 7
Accessories...................................................................................................................................................7
Safety Information.......................................................................................................... 8
Operating Manual...........................................................13
1 Description of the Test Object.................................................................................13
2 Preparing the Constancy Test................................................................................. 15
2.1 Required Test Equipment..................................................................................................................... 15
2.2 Test Conditions.....................................................................................................................................15
2.3 Test Setup............................................................................................................................................ 16
3 Constancy Test..........................................................................................................19
3.1 Purpose of the Constancy Test............................................................................................................19
3.2 Performing the Constancy Test............................................................................................................19
3.3 Verifying the Performance Characteristics...........................................................................................20
3.4 Assessing the Results..........................................................................................................................22
3.5 Constancy Test Report......................................................................................................................... 25
4 Accessories................................................................................................................26
4.1 Use of the Bucky Mounting Device T20005 with a Test Object...........................................................26
4.2 Use of the Wall Stand Holder T20018 with Bucky Mounting Device T20005 and Test Object.............29
Technical Manual........................................................... 33
5 Technical Specifications.......................................................................................... 33
5.1 NORMI 13............................................................................................................................................ 33
5.2 Accessories.......................................................................................................................................... 34
5.3 Rated Range of Use and Ambient Conditions.....................................................................................36
6 Accessories and Spare Parts.................................................................................. 37
4 D703.131.00/03 en
NORMI 13 (T42023)
Table of Contents
Service Manual...............................................................39
7 Cleaning......................................................................................................................39
8 Preventive Maintenance........................................................................................... 40
9 Disposal of the Product........................................................................................... 41
Literature........................................................................................................................42
Index...............................................................................................................................43
D703.131.00/03 en 5
NORMI 13 (T42023)
List of Figures
List of Figures
Figure 1: Definition of the patient environment...............................................................................................10
Figure 2: NORMI 13 test object......................................................................................................................14
Figure 3: Schematic test setup with PMMA absorber (near image receptor).................................................17
Figure 4: Schematic test setup with Al absorber (near tube).........................................................................18
Figure 5: Bucky mounting device T20005...................................................................................................... 27
Figure 6: Bucky mounting device T20005 with test object............................................................................. 28
Figure 7: Wall stand holder T20018................................................................................................................30
Figure 8: Wall stand holder T20018 with bucky mounting device T20005 and test object.............................31
Figure 9: Drawing bucky mounting device T20005 (dimensions in mm)........................................................34
Figure 10: Drawing wall stand holder T20018 (dimensions in mm)................................................................. 35
6 D703.131.00/03 en
Intended Use
NORMI 13 (T42023)
Intended Use - Accessories
NORMI 13 (T42023) is a test object for constancy
tests of digital projection radiography systems
according to DIN 6868-13.
The standard DIN 6868-13 applies to equipment
working with imaging plates or semiconductor
image receptors and where the diagnosis is carried out using a film at the viewing box or image
display device (diagnosis on a clinical review
monitor). It describes a method that helps to test
the constancy of decisive performance characteristics of X-ray equipment.
NORMI 13 fulfills all requirements of the standard
DIN 6868-13 for constancy tests.
This user manual describes the design of the test
object, the test setup, and the test procedure. The
evaluation of the results is the sole responsibility
of the user.
HINT
WARNING
Hazards originating from other system components.
Hazards to Persons! Equipment Damage!
Observe the safety information provided in the
user manuals of the medical X-ray equipment
and of the measuring devices.
NORMI 13 (T42023) will be referred to as test
object in the following chapters.
Note: In the United States, federal law restricts
this device to sale by or on the order of
a physician.
Accessories
This user manual only describes the use of the
NORMI 13 test object. For detailed information
about constancy tests, please refer to the standard DIN 6868-13.
The following accessories are available for the
test object:
– Bucky mounting device for diagnostic test
object T20005:
for the convenient fixation of NORMI 13 and a
PMMA absorber to the wall bucky
– Wall stand holder T20018:
for the convenient fixation of NORMI 13 to
the wall bucky, with or without an additional,
optional copper plate. The wall stand holder
must always be used in combination with the
bucky mounting device T20005.
For more information about using the accessories, refer to section 4 "Accessories".
D703.131.00/03 en 7
Safety Information
NORMI 13 (T42023)
Safety Information
This is the safety alert symbol. It is used
to alert the user to potential hazards.
Obey all safety messages that follow this
symbol to avoid any possible bodily injury
or equipment damage.
All safety messages consist of the following components:
– Safety alert symbol and signal word
– Type of danger
– Source of danger
– Consequence
– Measures to prevent hazards.
Signal Words
DANGER
Indicates an imminent hazard. If not avoided,
the hazard will result in death or serious injury.
WARNING
Indicates a hazard. If not avoided, the hazard
can result in death or serious injury.
CAUTION
Indicates a potential hazard. If not avoided, the
hazard can result in minor or moderate injury.
NOTICE
Indicates a potential hazard. If not avoided, the
hazard can result in product damage.
HINT
Provides application tips or other useful information to ensure that you get the most from
your equipment.
8 D703.131.00/03 en
NORMI 13 (T42023)
Safety Information
Safety Information
Strictly observe the following safety information
concerning the signal word WARNING. Failure to
do so may endanger the lives of the patient, the
user, and other persons involved.
WARNING
Improper handling.
Hazards to Persons!
The product is a medical device and must
only be handled by persons who are trained
in the use of such equipment and are capable
of applying it properly. The operator must be
trained in the use and operation of the product.
WARNING
Application for uses other than those stated in
the user manual.
Bodily Injury! Equipment Damage!
WARNING
Use of the product when it is not in perfect operating condition.
Bodily Injury! Equipment Damage!
Before using the product, verify that it is in correct working order and operating condition.
Liquids must not enter the product. If liquids
have entered the product, dry the product or
wait for it to dry completely. The product must
be thoroughly inspected by service personnel
before being used again.
WARNING
Hazards originating from other system components.
Hazards to Persons! Equipment Damage!
Observe the safety information provided in the
user manuals of the medical X-ray equipment
and of the measuring devices.
Always apply the product in compliance with
its intended use. Failure to do so may lead to
severe or even fatal injuries and/or equipment
damage and may void the warranty.
Exclusion of operation in the patient environment:
Do not operate the product in the patient environment (refer to Figure 1).
D703.131.00/03 en 9
CAUTION
Use of the product without observing the user
manual.
Bodily Injury! Equipment Damage!
Always use the product in compliance with the
user manual. Otherwise, the provided protection may be impaired.
Use the product only in conjunction with
the products approved by PTW for this purpose and/or the products listed in the section
"Intended Use".
NOTICE
To prevent equipment damage, always employ
the product as instructed in the user manual:
NORMI 13 (T42023)
Safety Information
– Operate the product within the rated ranges
of use indicated in the "Technical Specifications".
– Handle the product with care.
Figure 1: Definition of the patient environment
10 D703.131.00/03 en
NORMI 13 (T42023)
Symbols on the Nameplate
Symbol Description
Refer to the user manual!
The product bears the CE-mark.
Manufacturer and date of manufacture
Reference number
Serial number
For a description of additional symbols, if
applicable, please refer to the equipment
description.
Safety Information
D703.131.00/03 en 11
NORMI 13 (T42023)
Safety Information
12 D703.131.00/03 en
NORMI 13 (T42023)
Operating Manual - Description of the Test Object
Operating Manual
1 Description of the Test Object
The overall dimensions of the structure plate are
300 mm x 300 mm x 10 mm, and the plate is composed of the following components:
– PMMA plate, 8 mm thick
– grid plate, 0.5 mm thick
– copper plate, 1 mm thick
– front foil, 0.5 mm thick
Absorber
The structure plate is used in combination with an
absorber:
– aluminum absorber, thickness of 25 mm or
– PMMA absorber, thickness of 30 mm
HINT
The standard DIN 6868-13 specifies a
requirement for a 1-mm copper plate for the
PMMA absorber. The PTW structure plate
already includes this copper plate.
– additional, optional copper plate with a thick-
ness of 1.3 mm for measurements at 100 kV
D703.131.00/03 en 13
NORMI 13 (T42023)
5
4
5
6 7
8 5
3
2
1
Operating Manual - Description of the Test Object
Figure 2: NORMI 13 test object
1
Dose measurement area, marking not
radiopaque
2
Crosshairs for central alignment, not
radiopaque
3
X-ray tube axis
4
Dynamic steps
5
Free area for signal normalization
6
X-ray test pattern for spatial resolution
7
Radiation-absorbing line marks for light field
adjustment
8
Low contrast objects for contrast resolution
14 D703.131.00/03 en
NORMI 13 (T42023)
Operating Manual - Preparing the Constancy Test
2 Preparing the Constancy Test
2.1 Required Test Equipment
The following test equipment is needed for performing the constancy test:
– NORMI 13 test object
– PMMA or aluminum absorber
– CONNY II diagnostic dosemeter (T11007) or
NOMEX Dosemeter (L981816) or NOMEX
Multimeter (L981815)
additional equipment for documentation on film:
– densitometer
– ruler
– magnifying lens with a magnification of 4 times
or more
for diagnosis on a clinical review monitor:
– luminance meter
2.2 Test Conditions
To allow the constancy of the X-ray system to be
assessed by comparison with the reference values, it is mandatory to perform all tests under the
same conditions, which are specified below:
– use of the same test equipment
– identical radiographic or fluoroscopic, image
processing, documentation, and viewing conditions
– test object positioned in the same place with
the same spatial orientation and the same
beam geometry; the maximum permitted deviation of the distance between focus and image
receptor compared with the initial state is 1%
max.
– for imaging plate systems:
use of the same plate
– for units with removable anti-scatter grid:
use of the same grid with the same orientation
and the same distance
– for X-ray equipment with light field indicator:
test object positioned such that the edges of
the light field (center of the penumbra region)
coincide with the four line marks of the test
object
These conditions must be defined and recorded
during the acceptance test.
D703.131.00/03 en 15
Operating Manual - Preparing the Constancy Test
2.3 Test Setup
The NORMI 13 test object is intended for tests in
compliance with the standard, employing a PMMA
and copper absorber or an aluminum absorber.
The test setup with a PMMA absorber is shown
in Figure 3. The test setup with an aluminum
absorber is shown in Figure 4.
Position the test object as close to the image
•
receptor of the application device as possible.
The center of the test object should be located
in the middle of the radiation beam.
– Over-couch tubes:
Place the test object on the patient couch
with the measuring plate facing up. The
FOCUS label points upward.
NORMI 13 (T42023)
Center the test object relative to the X-ray tube
•
and adjust the light field indicator to the edge
marks of the test object. During this procedure,
line up the edge of the light field and the four
line marks of the test object.
HINT
If there is no light field indicator, the test
object can be centered relative to the radiation field on the image display device by
means of fluoroscopy control.
Using the supplied reclosable fastener, attach
•
the dose detector to the dose measurement
area (1, Figure 2). Make sure that neither the
dose detector nor the detector cable cover any
of the test elements.
– Under-couch tubes:
Screw the four standoffs to the measuring plate and place the test object on the
patient couch with the measuring plate facing down. The FOCUS label points downward.
– Wall bucky:
Use the bucky mounting device (T20005)
to fasten the test object and the PMMA
absorber (refer to 4.1 "Use of the Bucky
Mounting Device T20005 with a Test
Object"). If the test object is used in com-
bination with the aluminum absorber, the
wall stand holder is needed in addition to
the bucky mounting device (refer to 4.2
"Use of the Wall Stand Holder T20018 with
Bucky Mounting Device T20005 and Test
Object").
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NORMI 13 (T42023)
4
5
6
7
8
2
3
1
Operating Manual - Preparing the Constancy Test
Figure 3: Schematic test setup with PMMA absorber (near image receptor)
1
Additional, optional copper plate, 1.3 mm
thick, for measurements at 100 kV
2
Supporting plate (patient couch)
3
Entrance plane of the image receptor
4
X-ray tube
5
Collimator
6
NORMI 13 test object (consisting of structure
plate and 1 mm copper plate)
7
PMMA absorber, 30 mm
8
Anti-scatter grid
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NORMI 13 (T42023)
1
2
7
3
6
5
4
Operating Manual - Preparing the Constancy Test
Figure 4: Schematic test setup with Al absorber (near tube)
1
X-ray tube
2
Collimator
3
Aluminum absorber, 25 mm
4
NORMI 13 test object (consisting of structure
5
6
7
plate and 1 mm copper plate)
Supporting plate (patient couch)
Anti-scatter grid
Entrance plane of the image receptor
18 D703.131.00/03 en
3 Constancy Test
NORMI 13 (T42023)
Operating Manual - Constancy Test
3.1 Purpose of the Constancy Test
The constancy test is intended to ensure consistent image quality and achieving the required
image quality with the same radiation exposure.
The first constancy test is performed immediately
after the acceptance test of an X-ray system. During this test, the initial state is documented and
the reference values are defined.
In subsequent constancy tests, the measured values of the various performance characteristics are
compared with these reference values.
The following performance characteristics are to
be verified:
– dose
– exposure index
– optical density / luminance or pixel value
– spatial resolution
– contrast resolution
– coincidence of light field and radiation field
– artifacts
3.2 Performing the Constancy Test
In order to take the effects of the X-ray generator,
X-ray tube, application device, and image receptor into account, images with manual exposure
setting and with automatic exposure control and
simultaneous dose measurement are required.
Proceed as follows to obtain the test image:
Adjust the same parameters, voltages, and
•
analysis programs as well as documentation
and display conditions as in the acceptance
test.
HINT
For constancy tests with voltages of 100 kV,
an additional 1.3 mm copper plate can
be attached to obtain adequate switching
times.
Ensure the correct orientation of the plate.
The cut-out must be positioned over the
dose measurement area. On test images
with the copper plate, two spots are visible
next to the X-ray test pattern towards the
center of the image.
Position the test object according to
•
section 2.3 "Test Setup".
D703.131.00/03 en 19
Set the X-ray tube voltage as follows:
•
– Manual setting:
70 kV (100 kV for X-ray tubes that are only
used in the voltage range of about 100 kV)
– Application device with automatic exposure
control:
100 kV (70 kV for X-ray tubes that are only
used in the voltage range of about 70 kV)
Generate a test image with each X-ray tube
•
and each application device with an automatic
exposure control function.
Read the measured value indicated on the
•
detector.
Document and analyze the results according
•
to the standard DIN 6868-13.
NORMI 13 (T42023)
Operating Manual - Constancy Test
3.3 Verifying the Performance Characteristics
The following performance characteristics shall
be verified in the constancy test: The permitted limit deviations of the individual performance characteristics are detailed in section 3.4
"Assessing the Results" .
3.3.1 Dose
Measure the dose always in the same area (1,
Figure 2). Mount the detector with the same ori-
entation on the radiation entrance side of the test
object. Be sure not to exceed the intended range.
It is important to keep the radiation detector of the
dosemeter clear, also when using the additional
copper plate for 100 kV.
3.3.2 Exposure Index
The exposure index is given in data relating to the
test image. Create a test image that is shown on
the image display device or on film. The image
can be taken without a structure plate and with
only the absorber.
3.3.3 Optical Density or Luminance or Pixel Value
Determine either the optical density or the luminance. As an alternative to determining the luminance, you can analyze the pixel values of the digital test image.
20 D703.131.00/03 en
NORMI 13 (T42023)
Operating Manual - Constancy Test
Optical density
Using a densitometer, measure the optical density always in the same place on the test image
that is shown on a film. Choose the step in the
middle of the dynamic steps for the measurement
(4, Figure 2).
Luminance
Using a luminance meter, measure the luminance
always in the same place on the test image that is
shown on the image display device. Choose the
step in the middle of the dynamic steps for the
measurement (4, Figure 2).
Pixel value
The pixel value P indicates the intensity of the
exposure incident on the detector system (e. g.,
imaging plate) at a given pixel.
3.3.4 Spatial Resolution
Determine the spatial resolution by means of the
X-ray test pattern. Use the same image processing parameters for the test image as for the determination of the reference values. Visually evaluate the X-ray test pattern using a magnifying lens
with a 4 to 8 x magnification. The parameter is the
number of line pairs per millimeter (Lp/mm) in the
line group which can be distinguished at the resolution. Compare the parameter with the reference
value and the limit value.
3.3.5 Contrast Resolution
Determine the number of low contrast elements
that are discernible on the test image. Prerequisite: all steps of the dynamic range must be discernible on the same test image. Use the same
image processing parameters for the test image
as for the determination of the reference values.
The pixel value is determined at the output of
the imaging system or on the images stored in
the PACS (Picture Archiving and Communication
System).
The preferred spot for determining the pixel value
is the step in the middle of the dynamic steps
(4, Figure 2). The measuring field should comprise no less than 1000 pixels. It has proven useful to utilize the area of the steps minus a border.
The measured pixel value P depends on the dose
value that might be measured behind the step.
The mean of all pixel values of this measurement
area is calculated as the characteristic pixel value
and is defined as the reference value for the constancy test.
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NORMI 13 (T42023)
Operating Manual - Constancy Test
3.3.6 Coincidence of the light field and the radiation field
Using a test image, determine the deviation
between the light field and the radiation field.
Compare the irradiated field with the field outlined
by the line marks of the test object (to which the
light field indicator has been adjusted). Add the
marks missing on the test image. Determine the
deviations in both horizontal and vertical direction. Use the measurement tools of the program
installed at the workplace. Only in exceptional situations should rulers be used for measurements.
HINT
This test cannot be performed on facilities without a light field indicator.
3.3.7 Artifacts
Check the test image for artifacts that may affect
the quality of the diagnosis.
3.4 Assessing the Results
The evaluation of the results is based on the following maximum deviations from the reference
values determined in the initial state.
If the deviations exceed the permitted ranges,
measures must be taken to eliminate the causes,
i. e., to restore the initial state.
3.4.1 Dose
– Measurements with PMMA absorber:
With automatic exposure control, the dose values shall not deviate by more than ±30% at 70
kV (±25% at 100 kV), and with manual exposure setting, by not more than ±30% at 70 kV
and 100 kV from the reference value.
– Measurements with aluminum absorber:
With automatic exposure control, the dose values shall not deviate by more than ±25% at 70
kV (±20% at 100 kV), and with manual exposure setting, by not more than ±30% at 70 kV
and 100 kV from the reference value.
3.4.2 Exposure Index
The exposure index and the maximum permitted
deviations are manufacturer-specific parameters
and usually indicated in the test image data.
The maximum permitted deviation of the exposure index from the image receptor dose is ±50%.
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NORMI 13 (T42023)
Operating Manual - Constancy Test
3.4.3 Optical Density
For both, automatic exposure control and manual exposure setting, the measured optical density shall not deviate more than ±30% from the
reference value.
3.4.4 Luminance
For both, automatic exposure control and manual exposure setting, the maximum deviation ΔL
of the measured luminance shall not exceed
+100% / -50%.
3.4.5 Pixel Value
Perform three ROI measurements for determining
the permitted deviations from the reference value:
– at the reference step (field in the middle, mea-
sured behind 1 mm of copper) P
– at the adjoining step (measured behind
0.65 mm of copper) P
dose+step
– at the adjoining step (measured behind
1.4 mm of copper) P
dose+step
Calculate the maximum (P+1) and the minimum
(P-1) deviation from the reference value according
to the following formula:
– P+1 = P
– P-1 = P
reference
reference
+ factor × (P
+ factor × (P
The factor used in the calculation depends on the
voltage, it is 0.45 for 70 kV and 0.7 for 100 kV (see
Table 1).
reference
dose+step-Preference
dose+step-Preference
)
)
70 kV 100 kV
Limit of the pixel value towards a
lower dose: P
-1
Limit of the pixel value towards a
higher dose: P
+1
P1 + 0.45 × (P
P1 + 0.45 × (P
- P1) P1 + 0.7× (P
1.4
- P1) P1 + 0.7× (P
0.65
P1 = pixel value behind the 1-mm Cu step (reference value)
P
= pixel value behind the 0.65-mm Cu step
0.65
P
= pixel value behind the 1.4-mm Cu step
1.4
Table 1: Formulas for calculation of the permitted deviations
1.4
0.65
- P1)
- P1)
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NORMI 13 (T42023)
Operating Manual - Constancy Test
Model calculation
The following pixel values were determined by the
ROI measurement of the reference step P1 and
the adjoining steps P
– P1 or P
– P
dose+step
– P
dose+step
reference
(P
0.65
(P
1.4
: 13483
): 16603
): 10645
0.65
and P
for 70 kV:
1.4
For the calculation of the limit values P-1 and P+1,
these pixel values are entered in the appropriate
formula.
– Minimum deviation P-1:
13483 + 0.45 × (10645-13483) = 12206
– Maximum deviation P
+1
13483 + 0.45 × (16603-13483) = 14887
3.4.6 Spatial Resolution
The image of the X-ray test pattern should not be
of poorer quality compared with the initial state.
The measured values, in particular, should not
drop below the reference values determined in the
acceptance test. The limit value for spatial resolution valid in the last acceptance test must not
be exceeded by any of the X-ray images obtained
with the test object.
3.4.7 Contrast Resolution
The number of discernible low contrast elements
in the test object shall not deviate from the reference value determined in the acceptance test.
The limit value for contrast resolution valid in the
last acceptance test shall not be exceeded.
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NORMI 13 (T42023)
Operating Manual - Constancy Test
3.4.8 Coincidence of the light field and the radiation field
The deviations referred to the image receptor
plane shall not exceed 2% of the distance (r)
between focus and image receptor in each case.
and
and
V Imaging scale according to DIN
Magnitude of the horizontal deviations between light field and radiation field
Magnitude of the vertical deviations between light field and radiation field
6868-150 that was defined and
documented during the acceptance test as a criterion for the
constancy test
3.4.9 Artifacts
The X-ray image must be free from structures
whose size, shape, edge sharpness, and difference in optical density or luminance relative to the
surrounding area could affect the diagnosis.
3.5 Constancy Test Report
The test report shall include the following minimum information:
– Indication that the test was performed accord-
ing to DIN 6868-13
– Operator of the X-ray installation
– Tested installation
– Imaging system (image receptor type, analysis
software)
– Test equipment
– Exposure parameters (e. g., distance between
focus and image receptor, distance between
focus and test object, tube voltage)
– Reference values, maximum deviations and
current parameter readings
– Date and name of the person performing the
test
We recommend using a standardized protocol
where the test results can be entered in tabular
form. This makes it easier to compare them to the
initial values. The standard DIN 6868-13 provides
a model form sheet.
D703.131.00/03 en 25
4 Accessories
NORMI 13 (T42023)
Operating Manual - Accessories
4.1 Use of the Bucky Mounting Device T20005 with a Test Object
Assembly
Place the test object with the PMMA absorber
•
(30 mm) and the bucky mounting device
T20005 on a suitable table.
Place the NORMI 13 test object on the PMMA
•
absorber. Join both components by means of
four knurled screws.
Undo the screws of the bucky mounting
•
device.
Then use the two star knob bolts (4, Figure 5)
•
to fix the PMMA absorber (threaded bores
on the sides) on the bucky mounting device
T20005.
Disassembly
Holding the assembled bucky mounting device
•
with both hands, lift it off the wall bucky. To further disassemble the bucky mounting device,
place it on a suitable table.
Unscrew the star knob bolts (4, Figure 5) and
•
remove the test object.
Using a ruler or the edge of the table, align the
•
height of the test object in the bucky mounting
device.
Set the angle bracket for fitting the bucky
•
mounting device to the thickness of the wall
bucky.
Tighten the star knob bolts on the bucky
•
mounting device.
Holding the assembled bucky mounting device
•
with both hands, suspend it in the wall bucky.
It may prove necessary to adjust the position
of the bucky mounting device.
26 D703.131.00/03 en
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3
2
1
4
Operating Manual - Accessories
Figure 5: Bucky mounting device T20005
1
Star knob bolt for adjusting the angle bracket
to the thickness of the wall bucky
2
Adjustment range for thickness of the wall
bucky
3
Adjustment range for position of the test
object
4
Star knob bolt for fixing the PMMA absorber
or the wall stand holder T20018
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NORMI 13 (T42023)
1
2
Operating Manual - Accessories
Figure 6: Bucky mounting device T20005 with test object
1
Bucky mounting device
2
PMMA absorber (with test object)
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Operating Manual - Accessories
4.2 Use of the Wall Stand Holder T20018 with Bucky Mounting Device T20005 and Test Object
Assembly
Place the wall stand holder T20018, the test
•
object, and the bucky mounting device T20005
on a suitable table.
Fasten the rails of the wall stand holder
•
T20018 to the bucky mounting device T20005
(refer to Figure 8).
Set the angle bracket for fitting the bucky
•
mounting device to the thickness of the wall
bucky.
Insert the test object in the wall stand holder.
•
Using the set screws (3, Figure 7), press the
test object against the rails.
HINT
For further use, please remember that the test
object and the holder are not firmly joined.
Disassembly
Holding the assembled holder with both
•
hands, lift it off the wall bucky. To further disassemble the holder, place it on a suitable table.
Undo the set screws (3, Figure 7) and remove
•
the test object.
Using a ruler or the edge of the table, align the
•
height of the test object in the mounted holder.
Holding the assembled holder with both
•
hands, suspend it in the wall bucky. It may
prove necessary to adjust the position of the
bucky mounting device.
D703.131.00/03 en 29
NORMI 13 (T42023)
1
4
3
2
Operating Manual - Accessories
Figure 7: Wall stand holder T20018
1
Rail
2
Attachment point
3
Set screw
4
Nameplate
30 D703.131.00/03 en
NORMI 13 (T42023)
1
3
2
Operating Manual - Accessories
Figure 8: Wall stand holder T20018 with bucky mounting device T20005 and test object
1
Bucky mounting device
2
Wall stand holder
3
Test object
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Operating Manual - Accessories
32 D703.131.00/03 en
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Technical Manual - Technical Specifications
Technical Manual
5 Technical Specifications
Only values with specified tolerances or limits are guaranteed. Values without tolerances are for informational purposes only.
5.1 NORMI 13
Device designation NORMI 13 (T42023)
Manufacturer PTW-Freiburg
Application test object for constancy tests of digital projection radiography sys-
tems according to DIN 6868-13
Structures – dynamic steps:
7 steps with heigths of
0 mm; 0.30 mm; 0.65 mm; 1.00 mm; 1.40 mm; 1.85 mm, 2.30 mm
– radiation-absorbing line marks for light field adjustment
– X-ray test pattern for spatial resolution
– low contrast objects for contrast resolution
– free area for signal normalization
– area for dose measurement, marks not radiopaque
– crosshairs for central alignment, marks not radiopaque
Material – PMMA plate, 8 mm thick
– grid plate, 0.5 mm thick
– copper plate, 1 mm thick
– front foil, 0.5 mm thick
Dimensions test object: 300 mm x 300 mm x 10 mm
PMMA absorber: 300 mm x 300 mm x 30 mm
aluminum absorber: 163 mm x 163 mm x 25 mm
Weight (test object only) approx. 2.0 kg
D703.131.00/03 en 33
NORMI 13 (T42023)
47-144
150
393
373
117,5
117,5
Technical Manual - Technical Specifications
5.2 Accessories
5.2.1 Bucky Mounting Device T20005
Device designation Bucky mounting device for diagnostic test object, T20005
Manufacturer PTW-Freiburg
Intended use mechanical accessory for test objects (e.g., NORMI 13 with
PMMA absorber for fixing the test objects to the wall bucky)
Dimensions refer to Figure 9 / clamping range for wall (47...144) mm
Material angle bracket: aluminum
star knob bolts: steel, plastic handle
Weight approx. 0.8 kg
Figure 9: Drawing bucky mounting device T20005 (dimensions in mm)
34 D703.131.00/03 en
NORMI 13 (T42023)
245
245
50 4050
Technical Manual - Technical Specifications
5.2.2 Wall Stand Holder T20018
Device designation Wall stand holder, T20018
Manufacturer PTW-Freiburg
Intended use mechanical accessory for bucky mounting device T20005
for fixing the test objects (e.g., NORMI RAD/FLU or NORMI 13) to
the wall bucky
Dimensions refer to Figure 10
clamping range for test object 25 mm
Material rails: PVC (polyvinyl chloride)
screws: POM (polyoxymethylene)
Weight approx. 0.6 kg
Figure 10: Drawing wall stand holder T20018 (dimensions in mm)
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NORMI 13 (T42023)
Technical Manual - Technical Specifications
5.3 Rated Range of Use and Ambient Conditions
Rated range of use
Temperature
Relative humidity
Atmospheric pressure
Maximum operating altitude
Transport and storage conditions
Temperature
Relative humidity
Atmospheric pressure
(+10 ... +40) °C, (+50 ... +104) °F
(10 ... 80) %, no condensation
(max. 20 g/m³ absolute humidity)
(700 ... 1060) hPa
3000 m above sea level
(-20 ... +60) °C, (-4 ... +140) °F
(10 ... 85) %, no condensation
(max. 20 g/m³ absolute humidity)
(600 ... 1200) hPa
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NORMI 13 (T42023)
Technical Manual - Accessories and Spare Parts
6 Accessories and Spare Parts
NORMI 13 Set PMMA
set for quality control of digital X-ray installations acc. to DIN 6868 part 13. Includes
structure plate, PMMA absorber, bucky mounting device, Velcro tape and carrying case
NORMI 13 Set Al
set for quality control of X-ray installations acc. to DIN 6868 part 13. Includes structure
plate, Al absorber (to be fixed directly to the collimator), bucky mounting device, Velcro
tape and carrying case
99.5% Cu Absorber, (300 x 300 x 1.3) mm
for measurements at tube voltage of 100 kV
NORMI holder for bucky wall stand
for fixation of the test object NORMI 13 or NORMI RAD/FLU on a bucky wall stand.
Includes bucky mounting device T20005 and accessory T20018
Bucky mounting device
for mounting the diagnostic test objects X-Check FLU, NORMI 13 and the REX phantom
to a bucky wall stand
Wall stand holder
accessory for T20005 for mounting the NORMI RAD/FLU or NORMI 13 test object at a
bucky wall stand
CONNY II diagnostic dosemeter
battery operated, with semi-conductor detector for constancy tests of conventional and
mammography X-ray installations
L981247
L981246
T42023.1.006
L981473
T20005
T20018
T11007
NOMEX Set
incl. NOMEX Dosemeter and Multimeter, software, BT adapter, 2 x 2 m and 5 m USB
cable, power supply, transport case, box. Measures dose, dose rate, dose/pulse,
pulses, time, kV, TF, HVL. Semiconductor detectors or ICs can be connected.
NOMEX Dosemeter
incl. software, USB cable, BT adapter, power supply and a transport case. Measures
(depending on the detector) dose, dose rate, dose/pulse, pulses, time, kV, TF and HVL.
NOMEX Multimeter, external semiconductor detectors or ion chambers can be connected.
NOMEX Multimeter
incl. NOMEX Multimeter, NOMEX Software, 2 m USB cable, 5 m active ext. cable and
a transport case/box. Measures dose, dose rate, dose/pulse, pulses, time, kV, TF and
HVL. Requires connection to a PC or NOMEX Dosemeter
L981814
L981816
L981815
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NORMI 13 (T42023)
Technical Manual - Accessories and Spare Parts
38 D703.131.00/03 en
NORMI 13 (T42023)
Service Manual - Cleaning
Service Manual
WARNING
Improper execution of service tasks.
Hazards to Persons! Equipment Damage!
Ensure that the service tasks described below
are only performed by specialized staff.
In addition, ensure that all other service tasks
are only performed by PTW-Freiburg or by a
person authorized by PTW-Freiburg.
7 Cleaning
General Information on Cleaning
NOTICE
To avoid surface damage, do not use disinfectants on a phenol base or peroxide compounds
to disinfect the surface.
The product cannot be sterilized or completely
disinfected.
The product must not be treated or come in contact with fat, oil, alcohol, or substances containing
solvents.
Cleaning agents and solvents contained in disinfectants (alcohols) have proved to be particularly
harmful.
D703.131.00/03 en 39
NORMI 13 (T42023)
Service Manual - Preventive Maintenance
Clean the product simply by wiping it down with
a dry or slightly moistened cloth. Use water or a
mild soap solution.
Alternatively, you can use a common disinfection
agent for medical instruments which is specified
in the list of disinfectants of your national hygiene
institute (e.g., VAH in Germany). If your country
does not provide such a list, we recommend either
a solution on an aldehyde base or a solution with
a quaternary ammonium compound.
Surfaces
Clean the surfaces as follows:
Only wipe the product down. Liquids must
•
not be allowed to enter the product. Do not
immerse the product in water or other liquids.
Do not apply spray to the product.
8 Preventive Maintenance
Below, you will find a list of the maintenance measures and inspections necessary for the product.
Check before each use
Before each use, visually inspect the product
•
for signs of mechanical damage.
If damage or malfunctions are identified, the
•
product must be repaired before it is used
again.
Repair
Repairs may only be carried out by PTW-Freiburg
or by persons/companies authorized by PTWFreiburg.
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NORMI 13 (T42023)
Service Manual - Disposal of the Product
9 Disposal of the Product
The typical lifetime of the product is approx.
10 years.
At the end of the product lifetime, the components
of the product must be disposed of in compliance
with the applicable waste control regulations. The
different materials must be separated and recycled as appropriate.
The product contains components made of lead
which must be disposed of in compliance with the
legal provisions.
D703.131.00/03 en 41
Literature
[1] Council Directive 93/42/EEC concerning medical devices
(Medical Device Directive - MDD)
[2] Council Directive 97/43/EURATOM on health protection
of individuals against the dangers of ionizing radiation in
relation to medical exposure
[3] DIN 6868-13
Image quality assurance in diagnostic X-ray departments
-
Part 13: RöV constancy test of projection radiography
systems with digital image receptors
NORMI 13 (T42023)
Literature
42 D703.131.00/03 en
Index
NORMI 13 (T42023)
Index
A
Accessories....................................................... 26, 34
Artifacts.............................................................. 22, 25
B
Bucky mounting device T20005........................ 26, 29
C
Cleaning................................................................... 39
Coincidence of light field and radiation field....... 22, 25
Constancy test......................................................... 19
performance......................................................... 19
preparation........................................................... 15
purpose................................................................ 19
test conditions...................................................... 15
test report............................................................ 25
Contrast resolution............................................ 21, 24
D
Description............................................................... 13
Disposal................................................................... 41
Dose.................................................................. 20, 22
E
P
Performance characteristics, verification................. 20
Pixel value......................................................... 20, 23
R
Rated range of use................................................. 36
Repair...................................................................... 40
S
Safety information...................................................... 8
Spatial resolution............................................... 21, 24
Symbols................................................................... 11
T
Technical specifications........................................... 33
T20005................................................................. 34
T20018................................................................. 35
Test equipment........................................................ 15
Test setup................................................................ 16
W
Wall stand holder T20018....................................... 29
Exposure index.................................................. 20, 22
G
General information................................................... 2
I
Intended use.............................................................. 7
L
List of figures............................................................. 6
Literature.................................................................. 42
Luminance......................................................... 20, 23
M
Maintenance............................................................ 40
Maximum deviations................................................ 22
O
Optical density................................................... 20, 23
D703.131.00/03 en 43
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