PTW NORMI 13 Manuale utente
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.: +49 761 49055-0
Fax: +49 761 49055-70
info@ptw.de
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
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