DUNLEE CTR1740 User manual

Table of contents
X-Ray Tube Assemblies 3
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Table of contents
English...................................................................................................... 5
Deutsch, German...................................................................................... 25
Français, French........................................................................................ 45
Español, Spanish....................................................................................... 67
简体中文, Chinese simplified.................................................................... 89
ةيبرعلا, Arabic............................................................................................. 107
Български, Bulgarian................................................................................ 127
Hrvatski, Croatian..................................................................................... 149
Česky, Czech.............................................................................................. 169
Dansk, Danish........................................................................................... 189
Nederlands, Dutch.................................................................................... 209
Eesti, Estonian........................................................................................... 231
Suomi, Finnish........................................................................................... 251
Ελληνικά, Greek........................................................................................ 271
Magyar, Hungarian.................................................................................... 293
Íslenska, Icelandic..................................................................................... 313
Italiano, Italian.......................................................................................... 333
日本語, Japanese...................................................................................... 353
한국어, Korean......................................................................................... 373
Latviešu valodā, Latvian............................................................................ 393
Lietuvių, Lithuanian................................................................................... 413

Table of contents
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Malti, Maltese........................................................................................... 433
Norsk, Norwegian..................................................................................... 453
Polski, Polish............................................................................................. 473
Português, Portuguese.............................................................................. 493
Română, Romanian................................................................................... 513
Русский, Russian....................................................................................... 533
Srpski, Serbian.......................................................................................... 555
Slovensky, Slovak...................................................................................... 575
Slovenščina, Slovenian.............................................................................. 595
Svenska, Swedish...................................................................................... 615
Türkçe, Turkish.......................................................................................... 635
Українська, Ukrainian............................................................................... 655

Table of contents
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Table of contents
1Document Information............................................................................................................................. 6
2Intended Purpose..................................................................................................................................... 7
3Safety Information.................................................................................................................................... 8
Safety Message Used in this Document............................................................................................................ 8
General Safety Information.............................................................................................................................. 8
Limits for Operation, Storage, and Transportation........................................................................................... 9
Electrical Safety............................................................................................................................................... 12
Radiation Protection....................................................................................................................................... 12
Thermal Safety................................................................................................................................................ 12
Cooling / Insulating Media.............................................................................................................................. 13
Electromagnetic Compatibility (EMC)............................................................................................................. 13
Decommissioning............................................................................................................................................ 14
China RoHS Label and Material Declaration Table (China only)..................................................................... 16
Ukraine RoHS Label and Representative (Ukraine only)................................................................................. 17
4Conformity............................................................................................................................................. 18
5Compatibility.......................................................................................................................................... 19
6Maintenance.......................................................................................................................................... 20
Planned Maintenance by the Organization that is Responsible for the Operation........................................ 20
Cleaning and Disinfection.................................................................................................................. 21
Planned Maintenance Schedule........................................................................................................ 22
7Product Identification Label.................................................................................................................... 23
Instructions for Use
X-Ray Tube Assemblies
English

Document Information
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Document Information
Document data
Doc-ID: 300004427481C
Release date: 03/2020
Copyright
© Koninklijke Philips N.V. 2020
Disclaimer
All rights reserved. Koninklijke Philips N.V. reserves the right to make changes in specifications
in accordance with the terms in commercial or other applicable agreements between supplier
and buyer, and will not be liable for any consequences resulting from the use of this publica-
tion. Reproduction in whole or in part is prohibited without the prior written consent of the
copyright owner. The English version of this document is the original version.
Product tradename
The duplicate product identification label which accompanies this Instructions For Use provides
the tradename of the X-ray tube assembly.
Contact information of the manufacturer
Philips Medical Systems DMC GmbH
Röntgenstraße 24
22335 Hamburg / Germany
For further help see different contact options on: www.dunlee.com
1

Intended Purpose
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Intended Purpose
Intended use
The X-ray tube assembly is an X-ray generating tube encased in a radiation-shielded housing.
The X-ray tube assembly is intended to emit X-ray photons to enable the creation of diagnostic
images of human patients. The X-ray tube assembly is only used as integrated part of an X-ray
system and has no medical purpose by its own. The intended treatment, duration and treat-
ment parameters are not defined on X-ray tube assembly level. This is defined by the manufac-
turer of the X-ray system in accordance with the intended use, the intended purpose and the
medical purpose as described in the technical documentation of the X-ray system.
Intended user population
The X-ray tube assembly is remotely controlled by the X-ray system, which itself is operated by
qualified clinical users only. Further details regarding the intended user and patient population
are defined by the manufacturer of the X-ray system in accordance with the intended use, the
intended purpose and the medical purpose as described in the technical documentation of the
X-ray system. The X-ray tube assembly must be installed, repaired and maintained only by tech-
nically qualified field service engineers who have received the appropriate instructions and
training and who are authorized in particular for the installation and commissioning of radiogra-
phy equipment in medical applications.
Intended context
The X-ray tube assembly is intended to be used in a non-condensing, climate controlled, indoor,
clinical environment and is not intended to be used for homecare or by lay persons. The X-ray
tube assembly is intended to be used in permanently installed stationary X-ray systems. The use
frequency is not limited within the expected service lifetime. This X-ray tube assembly is intend-
ed to be re-used. The re-use of this X-ray tube assembly does not require any special treatment.
Additional treatment for re-use may be required and verified by the manufacturer of the X-ray
system for specific applications.
Operating principles
Contraindications are not defined on X-ray tube assembly level, because this is defined by the
manufacturer of the X-ray system in accordance with the intended use, the intended purpose
and the medical purpose as described in the technical documentation of the X-ray system. Spe-
cific warnings are provided within the accompanying documents of the X-ray tube assembly.
The expected service lifetime is referenced in the risk management file and stated in the ac-
companying documents of the X-ray tube assembly.
Essential performance
The X-ray tube assembly does neither have essential performance per se. Nor is any function of
the X-ray tube assembly intended to contribute to the essential performance of the X-ray sys-
tem in which it is integrated.
2

Safety Information Safety Message Used in this Document
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Safety Information
Warning
These Instructions For Use are made to make it possible to work safely with the X-ray
tube assembly. Operate the X-ray tube assembly only in compliance with the instruc-
tions in this document and the operating instructions of the applying X-ray system. Do
not use it for purposes other than for that it is intended.
Read me,
understand me,
and obey me!
Safety Message Used in this Document
This safety-relevant message occur in this instruction for use:
WARNING
shows a hazardous situation for people. If you do not prevent this situation, there is a risk of death or serious
injury.
General Safety Information
The for the operation responsible organization of the applying X-ray system is always responsi-
ble for the compliance with the regulations that apply to the installation and the operation of
this X-ray tube assembly.
• Only technically qualified field service engineers who have received the appropriate instruc-
tions and training for the equipment in medical applications and in particular for the instal-
lation and commissioning of this X-ray tube assembly are allowed to install and repair this
equipment. The installation, calibration and testing of the X-ray tube assembly must be per-
formed in accordance with the respective instructions of the applying X-ray system.
• Only trained and authorized personal are permitted to operate the X-ray tube assembly.
• If the X-ray tube assembly has electrical, mechanical, or functional defects, do not use it.
This fact particularly applies to faulty indicators, displays, warnings, and alarms.
3

Limits for Operation, Storage, and Transportation Safety Information
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• If functional defects or other deviations from the normal operational behavior occur, set
the X-ray system to OFF. Tell the company that puts the X-ray system that includes this X-
ray tube assembly on the market about the defects or deviations immediately. Continue the
operation of the X-ray system only after it is repaired. An operation with defective compo-
nents increases safety risks.
• Do not install the X-ray tube assembly to other medical devices than this X-ray tube assem-
bly is made for.
• The manufacturer of the X-ray tube assembly is responsible for the safety features of this X-
ray tube assembly. The manufacturer rejects the responsibility for the safety features of the
X-ray tube assembly if modifications are made.
• For the X-ray tube assembly correct operation and regular, competent maintenance are
necessary.
• Operate the X-ray tube assembly correctly. Maintain or let maintain the X-ray tube assem-
bly correctly. In other cases, the manufacturer of the X-ray tube assembly is not responsible
for incorrect operation, damages, or injuries that occur.
• Do not make or let make service or maintenance at the X-ray tube assembly while the X-ray
tube assembly is in use.
• Any serious incident that occurs in relation to the X-ray tube assembly, must be reported to
the manufacturer and the competent authority of the Member State in which the user
and/or patient is established.
Limits for Operation, Storage, and Transportation
Safe operation of the X-ray tube assembly is only made sure when you use the X-ray tube as-
sembly within the limits of its specifications.
If you ignore the operation limits, there is the danger of coolant that flows out. The X-ray tube
assembly becomes too hot. Component parts that are too hot can blow up as a result of an
implosion or explosion. Refer to the respective operation limits of the applying X-ray system.
• Do not operate the X-ray tube assembly in presence of a flammable anesthetic mixture with
air or oxygen or a nitrous oxide.
• Do not use detergents and disinfectants, also the detergents and disinfectants used on the
patient, that can create explosive gas mixtures.
• The oxygen content of the ambient air during operation must be less than 25 %.

Safety Information Limits for Operation, Storage, and Transportation
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• Obey the specified environmental limits for the X-ray tube assembly:
Environmental limits
X-ray tube assembly
Standard
values
Specific values
Type A Type B Type C
In operation
Ambient temperature [°C]
Minimum +5 +5 +10 +15
Maximum +35 +30 --- +35
Maximum with reduced performance --- --- +40 ---
Ambient humidity [%]
non-condensing
Minimum +10 +10 +20 +20
Maximum +90 +90 +80 +80
Ambient atmospheric pressure [kPa]
Minimum
about 3,000 m above the sea level
+70 +70 +70 +70
Maximum
about ‑750 m below the sea level
+110 +110 +110 +110
For storage and transportation
Temperature limits [°C]
Minimum -30 -30 -25 -25
Maximum +70 +70 +70 +70
Humidity limits [%]
Minimum +5 +5 +5 +5
Maximum +95 +95 +95 +95

Limits for Operation, Storage, and Transportation Safety Information
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Specific
values X-ray tube assembly Number Number Number Number
Type A CTR1740 9890 000 8687x
Type B DA 1094 DU 694
DU 1750 DA 90
DU 2550 DA 90 HS
DU 33100 DA 90 HS
DU 33100-E
DU 2550-E
DU 1750-E
Type C CTR1725 9890 000 8703x 9890 000 8704x 9890 000 8705x 9890 000 8706x
CTR1725CSBS /
CTR1725GSBS
CTR1725S
CTR1740 9890 000 8697x 9890 000 8698x 9890 000 8699x 9890 000 8700x
9890 000 8701x 9890 000 8702x
CTR2150 4598 012 2188x 4598 012 2189x 4598 013 0155x 4598 013 0159x
4598 013 0161x 4598 013 0168x 9890 000 8691x 9890 000 8692x
9890 000 8693x 9890 000 8694x 9890 000 8695x 9890 000 8696x
CTR2250 4598 013 2542x 4598 013 2544x 9890 000 8711x 9890 000 8712x
9890 000 8713x 9890 000 8714x
CTR2280KANG
CTR2280 4598 013 1433x 4598 013 1434x 4598 013 1437x 4598 013 1438x
9890 000 8709x 9890 000 8710x

Safety Information Electrical Safety
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Electrical Safety
Use this X-ray tube assembly only in medical rooms that obey the requirements of relevant
local or transregional standards and laws.
Warning:
Electricity
Radiation Protection
Before you make an X-ray exposure, put all necessary radiation precautions into effect. You
can find information about radiation precautions in the instructions for use of the applying X-
ray system.
• Before you start with radiation, make sure that the X-ray system supplies sufficient proof
of a correct image quality.
• To stop radiation, use the emergency stop switch of the X-ray system! Warning:
Ionizing radiation
Thermal Safety
To prevent damage due to thermal overloading, make sure that you do not operate the X-ray
tube assembly outside its specified load parameters. This prevention decreases the risks to the
patient, operating staff, third parties, and the environment.
Warning:
Explosive material

Cooling / Insulating Media Safety Information
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Cooling / Insulating Media
• Do not swallow media that spills.
• Do not let media or its vapors to go into your sewerage system.
• Do not breathe the media vapors.
• Make sure to supply closed rooms with fresh air.
• Do not cause vomiting.
• Remove spilled media. Use a liquid-absorbent material.
• Discard the cleaning materials. Obey the local environmental laws and regulations.
Warning:
General
Electromagnetic Compatibility (EMC)
In accordance with its intended use, this electronic product obeys the law that controls EMC.
This law gives the permitted emission levels from electronic equipment and its necessary sta-
bility against electromagnetic fields.
Electronic products that obey the EMC requirements have a design so that under normal con-
ditions there is no risk of incorrect operation because of electromagnetic interference. If radio
signals from high-frequency transmitters with a high transmitting power occur, the risk of
electromagnetic incompatibility when operated closely to medical devices can occur.
In unusual circumstances, unintended functions of the electronic product can occur. Possibly
undesirable risks for the patient, operating staff, or third parties occur. For this reason, pre-
vent all kinds of transmission with mobile devices. The risks also apply when the medical de-
vice is in STANDBY mode.
The X-ray tube assembly is suitable for professional healthcare facility environment.
Too high EMC disturbances can lead to unwanted X-ray, interrupted X-ray, wrong X-ray, unex-
pected status changes, error messages, component defects, or loss of installation parameters.
Portable RF communications equipment (including peripherals such as antenna cables and ex-
ternal antennas) should be used no closer than 30 cm (12 inches) to any part of the X-ray tube
assembly. Otherwise, degradation of the performance of this equipment could result.
The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11
class B is normally required) this equipment might not offer adequate protection to radio-fre-
quency communication services. The for the operation responsible organization might need to
take mitigation measures, such as relocating or re-orienting the equipment.
Warning:
Non-ionizing radia-
tion

Safety Information Decommissioning
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Decommissioning
The take-back obligation, correct disposal, and recovery of the X-ray tube assembly refer to
the European Waste Electrical and Electronic Equipment (WEEE) directive. It also refers to the
requirements of local and transregional legal requirements.
The manufacturer of the X-ray tube assembly assembles state-of-the- art X-ray tube assem-
blies in terms of safety and environmental protection. If no parts of the X-ray tube assembly
are opened and if the X-ray tube assembly is used correctly there are no risks to persons or
the environment.
To obey regulations, sometimes it is necessary to use materials that are harmful to the envi-
ronment. Discard these materials in a correct manner.
This X-ray tube assembly contains materials that are toxic. Do not discard the X-ray tube as-
sembly together with industrial or domestic waste.
Obey the disposal
regulations!
The manufacturer
• supports you in the disposal of the X-ray tube assembly in accordance with valid legal requirements.
• takes back the X-ray tube assembly.
• returns re-usable parts to the production cycle via certified disposal companies. Extensive test and quality
assurance procedures as well as detailed checks of the components guarantee the same high level con-
cerning quality and functionality that is expected from new materials.
• makes a contribution to the protection of the environment.
In case you have questions concerning safe disposal, please consult the manufacturer in full confidence.

Decommissioning Safety Information
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Safety Information China RoHS Label and Material Declaration Table (China only)
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China RoHS Label and Material Declaration Table (China
only)
50
中国 RoHS
China RoHS

Ukraine RoHS Label and Representative (Ukraine only) Safety Information
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Ukraine RoHS Label and Representative (Ukraine only)
Address of the legal manufacturer:
Філіпс Медікал Системс ДМС ГмбХ
Ронтгенштрассе 24, 22335 Гамбург, Німеччина
Philips Medical Systems DMC GmbH
Röntgenstraße 24, 22335 Hamburg, Germany
Ukraine representative for X-ray tubes, which are marked with the conformity mark of Ukraine RoHS Technical
Regulation:
Уповноважений представник в Україні:
ТОВ «КРАТІЯ МЕДТЕХНІКА»,
вул. Багговутівська, буд.17-21, м. Київ, 04107, Україна.
Тeл.: 0 800 21-52-32
Електронна пошта: [email protected]
Дата останнього перегляду інструкції зі застосування: 03/2020

Conformity
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Conformity
The X-ray tube assembly that is shown in these instructions for use puts the provisions of the
• European CE Marking of Conformity, and
Identification num-
ber of the notified
body
• FDA 21 CFR 1020.30
into effect.
If you have further questions that refer to local or transregional legal requirements,
make a contact to:
Philips Medical Systems DMC GmbH
Röntgenstraße 24
22335 Hamburg / Germany
For further help see different contact options on: http://www.dunlee.com
4

Compatibility
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Compatibility
Only technically qualified field service engineers who have received the appropriate instruc-
tions and training for the equipment in medical applications and in particular for the installation
and commissioning of this X-ray tube assembly are allowed to install and repair this equipment.
The installation, calibration and testing of the X-ray tube assembly must be performed in ac-
cordance with the respective instructions of the applying X-ray system.
To make sure that the X-ray tube assembly and the X-ray system are compatible, refer to the
technical instructions of the X-ray system.
If necessary, speak to the manufacturer of the applying X-ray system.
The company that puts the X-ray system that includes this X-ray tube assembly on the market is
responsible for the installation of the X-ray tube assembly to the X-ray system. The installation
must agree with all local and transregional legal requirements.
5

Maintenance
Planned Maintenance by the Organization that is Responsible for
the Operation
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Maintenance
Only technically qualified field service engineers who have received the appropriate instruc-
tions and training for the equipment in medical applications and in particular for the mainte-
nance of this X-ray tube assembly are allowed to do planned and corrective maintenance on
this equipment. The maintenance inclusive calibration and testing of the X-ray tube assembly
must be performed in accordance with the respective instructions of the applying X-ray system.
The manufacturer of this X-ray tube assembly recommends measures for planned maintenance.
The recommended measures must agree with the local and transregional legal requirements.
The expected service life time is 10 years. This requires that the X-ray tube assembly is subject
to service maintenance according to the requirements of this service instructions and the serv-
ice instructions of the applying X-ray system.
Planned Maintenance by the Organization that is
Responsible for the Operation
The for the operation responsible organization of medical devices is committed to do planned
maintenance. This planned maintenance must refer to the regulations for the prevention of in-
dustrial accidents, local or transregional medical product laws, and further regulations.
This X-ray tube assembly requires regular planned maintenance:
Make sure that service personnel do planned maintenance on this X-ray tube assembly regular-
ly.
Precautionary planned maintenance measures prevent personal injury and make sure that the
for the operation responsible organization puts all commitments into effect.
If functional defects or other deviations from the normal operational behavior occur, set the X-
ray system to OFF. Tell the company that puts the X-ray system that includes this X-ray tube
assembly on the market about the defects or deviations immediately. Continue the operation
of the X-ray system only after it is repaired. An operation with defective components increases
safety risks.
Regular maintenance cycles decrease the probability of a spontaneous failure. You cannot pre-
vent spontaneous failures completely. If it is necessary to have the guaranteed availability of
the X-ray system, make sure that a redundant standby X-ray system is available.
The structural integrity of the X-ray tube assembly does not wear.
6