PTW NORMI 13 User manual

D703.131.00/03 en 2015-09ext/Bru
User Manual
NORMI 13 (T42023)
Contents
Operating Manual
Technical Manual
Service Manual

NORMI 13 (T42023)
General Information
2 D703.131.00/03 en
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 require-
ments 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 oper-
ation.
– Operator safety, specified measuring accu-
racy, and interference-free operation can
only be guaranteed if original products and
parts are used. Furthermore, only the acces-
sories listed in this manual are approved by
PTW-Freiburg and only they or other acces-
sories whose use has been expressly permit-
ted by PTW-Freiburg may be used in con-
junction with the product. Safe operation and
proper product performance are not guaran-
teed 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, read-
justment, 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 stan-
dards that are valid as at the printing date. All
rights are reserved for devices, circuits, tech-
niques, software, and names as referred to in
the manual.
– PTW-Freiburg reserves the right to make mod-
ifications.
Please contact PTW or your local representa-
tive for the most current information concern-
ing 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 Elek-
tronikgeräte-Gesetz).
Elektro-Altgeräte-Register (EAR). Registration
number DE15599992
– PTW-Freiburg works in strict accordance with
a quality management system that is contin-
uously updated according to the national and
international standards.

NORMI 13 (T42023)
General Information
D703.131.00/03 en 3
PTW-Freiburg
Physikalisch-Technische Werkstätten
Dr. Pychlau GmbH
Lörracher Str. 7
79115 FREIBURG
Germany
Tel.: [phone]
Fax: [phone]
[e-mail]
www.ptw.de

NORMI 13 (T42023)
Table of Contents
4 D703.131.00/03 en
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

NORMI 13 (T42023)
Table of Contents
D703.131.00/03 en 5
Service Manual...............................................................39
7 Cleaning......................................................................................................................39
8 Preventive Maintenance........................................................................................... 40
9 Disposal of the Product........................................................................................... 41
Literature........................................................................................................................42
Index...............................................................................................................................43

NORMI 13 (T42023)
List of Figures
6 D703.131.00/03 en
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

NORMI 13 (T42023)
Intended Use - Accessories
D703.131.00/03 en 7
Intended Use
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 car-
ried 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 character-
istics 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
This user manual only describes the use of the
NORMI 13 test object. For detailed information
about constancy tests, please refer to the stan-
dard DIN 6868-13.
WARNING
Hazards originating from other system compo-
nents.
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
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 acces-
sories, refer to section 4 "Accessories".

NORMI 13 (T42023)
Safety Information
8 D703.131.00/03 en
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 com-
ponents:
– 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 infor-
mation to ensure that you get the most from
your equipment.

NORMI 13 (T42023)
Safety Information
D703.131.00/03 en 9
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!
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 envi-
ronment:
Do not operate the product in the patient envi-
ronment (refer to Figure 1).
WARNING
Use of the product when it is not in perfect oper-
ating condition.
Bodily Injury! Equipment Damage!
Before using the product, verify that it is in cor-
rect 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 compo-
nents.
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)
Safety Information
10 D703.131.00/03 en
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 protec-
tion may be impaired.
Use the product only in conjunction with
the products approved by PTW for this pur-
pose 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:
– Operate the product within the rated ranges
of use indicated in the "Technical Specifica-
tions".
– Handle the product with care. Figure 1: Definition of the patient environment

NORMI 13 (T42023)
Safety Information
D703.131.00/03 en 11
Symbols on the Nameplate
Symbol Description
Refer to the user manual!
The product bears the CE-mark.
Manufacturer and date of manu-
facture
Reference number
Serial number
For a description of additional symbols, if
applicable, please refer to the equipment
description.

NORMI 13 (T42023)
Safety Information
12 D703.131.00/03 en

NORMI 13 (T42023)
Operating Manual - Description of the Test Object
D703.131.00/03 en 13
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 com-
posed 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

NORMI 13 (T42023)
Operating Manual - Description of the Test Object
14 D703.131.00/03 en
5
4
5
6 7 85
3
2
1
Figure 2: NORMI 13 test object
1Dose measurement area, marking not
radiopaque
2Crosshairs for central alignment, not
radiopaque
3X-ray tube axis
4Dynamic steps
5Free area for signal normalization
6X-ray test pattern for spatial resolution
7Radiation-absorbing line marks for light field
adjustment
8Low contrast objects for contrast resolution

NORMI 13 (T42023)
Operating Manual - Preparing the Constancy Test
D703.131.00/03 en 15
2 Preparing the Constancy Test
2.1 Required Test Equipment
The following test equipment is needed for per-
forming 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 val-
ues, 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 con-
ditions
– test object positioned in the same place with
the same spatial orientation and the same
beam geometry; the maximum permitted devi-
ation 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.

NORMI 13 (T42023)
Operating Manual - Preparing the Constancy Test
16 D703.131.00/03 en
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.
– Under-couch tubes:
Screw the four standoffs to the measur-
ing plate and place the test object on the
patient couch with the measuring plate fac-
ing down. The FOCUS label points down-
ward.
– 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").
•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 radi-
ation 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.

NORMI 13 (T42023)
Operating Manual - Preparing the Constancy Test
D703.131.00/03 en 17
4
5
6
7
8
2
3
1
Figure 3: Schematic test setup with PMMA absorber (near image receptor)
1Additional, optional copper plate, 1.3 mm
thick, for measurements at 100 kV
2Supporting plate (patient couch)
3Entrance plane of the image receptor
4X-ray tube
5Collimator
6NORMI 13 test object (consisting of structure
plate and 1 mm copper plate)
7PMMA absorber, 30 mm
8Anti-scatter grid

NORMI 13 (T42023)
Operating Manual - Preparing the Constancy Test
18 D703.131.00/03 en
1
2
7
3
6
5
4
Figure 4: Schematic test setup with Al absorber (near tube)
1X-ray tube
2Collimator
3Aluminum absorber, 25 mm
4NORMI 13 test object (consisting of structure
plate and 1 mm copper plate)
5Supporting plate (patient couch)
6Anti-scatter grid
7Entrance plane of the image receptor

NORMI 13 (T42023)
Operating Manual - Constancy Test
D703.131.00/03 en 19
3 Constancy Test
3.1 Purpose of the Constancy
Test
The constancy test is intended to ensure con-
sistent 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. Dur-
ing this test, the initial state is documented and
the reference values are defined.
In subsequent constancy tests, the measured val-
ues 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 recep-
tor 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".

NORMI 13 (T42023)
Operating Manual - Constancy Test
20 D703.131.00/03 en
•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.
3.3 Verifying the Performance
Characteristics
The following performance characteristics shall
be verified in the constancy test: The per-
mitted limit deviations of the individual perfor-
mance 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 lumi-
nance. As an alternative to determining the lumi-
nance, you can analyze the pixel values of the dig-
ital test image.