Ray14 Series
Ray14 Series
RAY-14 family
Manual – Technical Description
siemens-healthineers.com
Table of contents
1 General data 1
1.1 Validity of this document 1
1.2 Safekeeping of operator manuals 1
1.3 Names and parameters 1
2 Address 2
4 Description 4
4.1 Intended purpose 4
4.2 Functional Characteristic 5
4.2.1 Design 5
4.2.2 Characteristic 5
4.3 Explanation of designation 5
5 Notes 6
5.1 General notes 6
5.2 Safety information 6
5.3 Radiation protection 8
5.4 Operating conditions 8
5.5 Electromagnetic Compatibility (EMC) 9
5.6 Maintenance 9
5.7 Checks 9
5.7.1 Visual check with the generator turned off 10
5.7.2 Mechanical check with the generator turned off 10
5.7.3 Electrical check 10
5.8 Disposal 10
5.9 Installation notes for personnel 10
5.9.1 Radiation outlet block 11
5.9.2 X-ray tube assembly connection plates 12
5.9.3 High-voltage connections 14
5.9.4 Tube assembly filtration 15
5.10 Pictograms 16
5.10.1 Symbol of protective earth conductor 16
5.10.2 Warning symbol of dangerous voltage 16
5.10.3 Symbols to mark cathode and anode of HV-connection horns 16
5.10.4 Symbol of operating instructions 16
5.10.5 Symbol for compliance to UL-standard 17
6 Technical Data 18
6.1 X-ray tube / tube assembly 18
6.2 Conditions for operation, storage and transport 20
7 Curves 21
7.1 Heating and cooling curve of anode 21
7.2 Heating and Cooling Curves of X-ray tube assembly 21
7.2.1 Tube assembly without fan 21
7.2.2 Tube assembly with fan 22
7.3 Emission curves of the cathode 23
7.4 Loading curves 24
1 Technical Description
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Table of contents
8 Connection diagrams 32
9 Dimensional drawings 33
9.1 Maximum radiation field 33
9.2 X-ray tube assembly dimensional drawings 34
10 Label 36
10.1 The type label of the X-ray tube assembly 36
10.2 The type label of the X-ray tube 37
2 Technical Description
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CE Mark
Caution: The sale and placing on the market of the equipment described herein is subject to approval
according to national and international regulations.
This device bears a CE mark in accordance with the provisions of EU Regulation 2017/745 of April 5,
2017 concerning medical devices and the Council Directive 2011/65/EU of June 8, 2011 on the
restriction of the use of certain hazardous substances in electrical and electronic equipment.
The CE marking applies only to Medical Devices which have been put on the market according to the
above-mentioned EU Regulation and EU Directive.
Unauthorized changes to this product are not covered by the CE mark and the related Declaration of
Conformity.
Document Version
Siemens Healthcare GmbH reserves the right to change its products and services at any time.
In addition, manuals are subject to change without notice. The hardcopy documents correspond to
the version at the time of system delivery and/or printout. Versions to hardcopy documentation are
not automatically distributed.
Please contact your local Siemens Healthineers office to order a current version or refer to our website
http://www.siemens-healthineers.com.
Disclaimer
The contents of this document may be published under a system integrator’s/manufacturer’s label,
but it is the sole responsibility of the system integrator of the finished medical device that content
and safety measures described within this document are maintained and clear to the end user. The
system integrator is responsible for translations of this document and to provide the language
versions that might be required under country specific regulations. These components and
configurations are not finished medical devices. The system integrator is responsible for com plying
with all laws and regulations that are applicable to finished medical devices with respect to
marketing, sales and installation.
3 Technical Description
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1 General data
1 General data
1.1 Validity of this document
This operator manual applies only to X-Ray tube assembly of the product RAY-14 family from Siemens
Healthcare and was prepared on the basis of the applicable German and international standards, see
section "Laws, standards and regulations" on page 3.
Always keep the operator manual in an easily accessible place near the medical system.
In the following, the X-ray tube assembly RAY-14 family from Siemens Healthcare is generally referred
to as a medical device (ME device) or X-ray tube assembly.
RAY-14_1 7037133
RAY-14S_3 7037000
RAY-14S_3F 7037208
RAY-14S_1 7037141
Protection Class
1 Technical Description
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2 Address
2 Address
50,000 exposures
2 Technical Description
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3 Laws, standards and regulations
IEC Title
IEC 60336:2005 + C1:2006 Medical electrical equipment -X-ray tube assemblies for medical
eq EU: EN 60336:2005 diagnosis – Characteristics of focal spots
IEC 60522:2003
Determination of the permanent filtration of X-ray tube assemblies
eq EU: EN 60522:1999
IEC 60526:1978 + C1:2010 High-voltage cable plug and socket connections for medical X-ray
eq EU: EN 60526:2004 equipment
IEC 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for
eq EU: EN 60613:2010 medical diagnosis
3 Technical Description
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4 Description
4 Description
Intended Purpose Statement under the European Medical Device Regulation 2017/745:
X-ray tube assembly intended to be integrated into X-ray imaging systems for medical purposes
This X-ray tube housing assemblies consists of a metallic (e.g. steel, aluminumalloy) case that houses
an X-ray tube to provide appropriate limits for X-ray leakage and adequate insulation to avoid electric
risks during a diagnostic X-ray procedure. It includes sheet lead surrounds at appropriate locations to
shield unwanted X-ray radiation and collimators near the aperture; it is usually filled with oil to prevent
electrical arcs from the high-voltage components of the X-ray tube. The housing also includes
attachment points, cooling means, high-voltage cables, and supports for the tube and cable
receptacles.
This X-ray tube housing assembly is intended to be used in diagnostic X-ray systems for radiographic
and fluoroscopic applications.
Indications
Indication for use of the X-ray tube housing assembly is every clinical indication which requires a
diagnostic X-ray procedure using a diagnostic X-ray system. The specific indications, parts of the body
and the duration of the exposure for which the X-ray tube housing assembly can be used (once or
repeated) are defined by the diagnostic X-ray system in which the X-ray tube housing assembly is inte-
grated.
Contra-indications
For the X-ray tube housing assembly no other contra-indications besides the ones for general
radiologic procedures are currently known. Specific contra-indications might need to be defined by
the system integrator of the diagnostic X-ray system in which the X-ray tube housing assembly is
integrated.
The X-ray tube housing assembly may be used for each patient who is admitted for an X-ray
examination, from newborn to geriatric. The patient population might need to be restricted on system
level as result of the integration of the X-ray tube housing assembly into a diagnostic X-ray system by
the system integrator.
Intended users
X-ray tube housing assemblies are intended to be integrated into diagnostic X-ray systems by a system
integrator, for whom it is required to have specific technical and medical knowledge and skills,
including but not limited to radiation protection, electrical and mechanical safety and cl inical
procedures for which the finalized system is released. Integrated into the diagnostic X-ray system, X-
ray tube housing assembly/ single tank tube assembly are intended to be operated by adequately
trained clinical users. Instructions for use of these devices address exclusively the system integrator
and are not intended being handed over to the clinical operators. All information and advices for the
clinical operator are to be included in the instruction for use and accompanying documents of the
finished diagnostic X-ray system in which the X-ray tube housing assembly is integrated.
4 Technical Description
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4 Description
Undesirable side-effects
Since an X-ray tube housing assembly which is not integrated in a system has no clinical effect, it
consequently has no ide-effects either. Clinical effects and also side-effects are depending on the
design and intended use of the diagnostic X-ray system in which the X-ray tube housing assembly is
integrated and need to be determined on the system level.
4.2.1 Design
· X-ray tube assembly main parts: X-ray tube, housing, stator, insulation oil, X-ray radiation exit
window and collimator flange (“-F” type)
· X-ray tube main parts: cathode, anode(including target), driving system(including bearing system),
glass enclosure
4.2.2 Characteristic
RAY-14_3
RAY-14S_3
Designation of X-ray RAY-14S_3F
tube assembly RAY-14_1
RAY-14S_1
14 X-ray Tube assembly for the OEM market with X-ray tube SV150/33/78R-S Housing
90° reverse model (see dimension drawings)
14S X-ray tube assembly for the OEM market with X-ray tube SV150/33/78R-S housing 90°
version (See dimension drawings)
_3 3-phase drive
_1 1-phase drive
5 Technical Description
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5 Notes
S Siemens adapter
5 Notes
5.1 General notes
In the interest of complying with respected legal requirements concerning the environmental
compatibility of our products (protection of natural resources, avoidance of waste) we endeavor to
reuse components and to return them to the production cycle. We guarantee their reliability and
functionality, quality and life of these components by taking extensive quality assurance measures
including all test procedures, just as for brand new components. Reused parts are “qualified as good
as new”.
Siemens Healthcare has performed a conformity assessment in accordance with the MDR for this
component.
The tube assembly is not a sterile product. The housing surfaces are designed for easy
cleaning/disinfection.
Applications with contacts to animal or human tissue or in body cavities are not intended.
Use the original packaging for returning the tube assembly to the manufacturer.
A higher output of the tube assembly can be achieved by optional fan cooling.
Unless otherwise indicated, all load data specified apply to six-pulse, twelve-pulse, multi-pulse or DC
voltage generators.
WARNING
X-ray tube assembly works out of specification.
The X-ray tube assembly must be operated only in agreement with the safety information of this
operator manual. The operator is responsible for compliance with the regulations that apply for the
installation and operation of an X-ray system.
The X-ray tube assembly shall be used only in compliance with its intended use; the instructions of
the operating instructions of the system manufacturer for operation, servicing and care as well as
maintenance of an X-ray system apply. In particular, the tube assembly is not approved for operation
in environments with combustible gas mixtures.
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5 Notes
WARNING
Symbols not legible or damaged may cause wrong installation.
• Use of the X-ray tube assembly is forbidden if signs of mechanical, electrical or radiation-
related are not legible or damaged.
Use of the X-ray tube assembly is forbidden if related signs are not legible or damaged.
The overloading of X-ray tube may cause damage to internal components and take an excess of X-
ray, so user must ensure that X-ray tube assembly is not overloading.
For monitoring certain operating parameters, the X-ray tube assembly is equipped with means for
preventing a possible overload of or damage to the X-ray tube assembly.
Any manipulation to these safety devices is prohibited. The load limit values listed in this manual
shall not be exceeded.Depending on the operating mode, the tube assembly may reach high
temperatures. Please exercise caution when touching the housing surface.
WARNING
Too high temperature may damage this equipment.
• In accordance with the safety concept of the user and this equipment, the 90°C
temperature sensor must be connected.
For the purpose of achieving high continuous output, the tube assembly is designed for operation up
to 90°C. To avoid thermal overload, the tube assembly is equipped with two temperature switches. The
status of the temperature switches must be queried through the system hardware or software, which
generates an error message in the event of an error. The 70°C temperature switch provides information
on the energetic state of the tube assembly and provides a warning to reduce output and terminate
the current examination. Depending on the system configuration, such information can also be
provided by a load computer. The 90°C temperature switch provides the signal to cut off the power
supply to the tube assembly. Any treatment for these safety parts is prohibited.
The maximum electric load capacity of both temperature switches intended by the tube assembly
manufacturer is 230V/0.5A. The connection cables must be designed for a continuous thermal load
capacity of 100°C.
WARNING
Wrong installation may cause death or serious physical injury.
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5 Notes
Prior to an examination as the user’s responsibility to ensure that all safety features are functional and
that the product is ready for operation.
Operation of X-ray tube assembly must be terminated instantly when defect detected and notice
customer service personnel immediately.
Handle with care!
High vacuum pressure parts inside X-ray tube assembly, implosion may be caused by careless treatment
such items as impact, striking, dropping, etc.
Dismounting this equipment without authorization is not permitted.
WARNING
Untrained person may cause person injury or system damage!
• The X-ray tube assembly should be operated only in agreement with the safety instructions
of this operator manual.
CAUTION
Relevant physiologic effects may cause harm to patient.
• Only correspondingly qualified and trained personnel are allowed to operate the X-ray
tube assembly.
The following program must be performed by the customer service during initial startup of the X-ray
tube assembly, or following extended system down time during a service call, as well as when there
are operating malfunctions of the system with a suspicion that there is electrical instability of the X-
ray tube. When the X-ray tube assembly is delivered as a pre-installed system, perform the procedure
once again prior to acceptance of the system by the customer.
• After extended idle time of the X-ray tube (more than 2 weeks), it is recommended that the
operator perform an abbreviated warm-up procedure as described under item 1 and 3.
Importance: Ensure that adequate radiation safety precautions are taken an protect any
existing image intensifier against radiation (e.g. lead apron in the beam path).
1. Conditioning program
(To be carried out when a new X-ray tube assembly is installed and
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5 Notes
after prolonged downtime (more than 2 weeks) for the start-up with a cold anode)
Switch on fluoroscopy at 40 kV.
Power up to 110 kV/2 mA within 5 minutes and hold for 10 minutes.
5 minutes cooling pause! Continue with exposure mode!
• If the tube tends to repeatedly and strongly "arc", abort the procedure
(risk to sensitive parts of the system electronics). The customer service must be notified.
• If the downtime of X-ray tube assembly is too long, it’s better to do tube-adjust process
according to the tips of 1 & 3.
Radio signals of radio-frequency communication devices such as mobile telephones or other mobile
radio devices can influence the correct functioning of a medical-electrical device.
This X-ray component is subject to special precautionary measures with regard to EMC and may be
installed and put into operation only according to the installation instructions.
This medical electrical component cannot be operated on its own, but only in combination with a
generator or a radiological diagnostic system. According to Chinese and IEC standards, the proof of
compliance with the requirements of IEC 60601-1-2 with regard to electromagnetic compatibility
should be provided by system manufacturer.
5.6 Maintenance
The X-ray tube assembly is maintenance free. There are no hazards whatsoever for persons and
environment in the case of proper use.
5.7 Checks
If any announced damage was found don’t start any operation with the system. Contact service
personnel immediately.
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5 Notes
· Check the fastening of the freely accessible X-ray tube assembly. The X-ray tube assembly must be
firmly seated in the holder - ensure that it is not loose!
· Check the fastening of the freely accessible collimator, the collimator must be firmly seated on the
flange – ensure that it is not loose!
· Check all exposed high-voltage plugs to ensure that they are firmly seated, tighten the mounting
nuts.
· In accordance with IEC 60601-2-28 the shielding of exposed high-voltage cables between the
metal housing of the X-ray generator and the X-ray tube assembly is limited to a maximum of 1Ω
/m. Conformance must be checked by a measurement. If you have concluded a maintenance
contract, this measurement will be performed by the service.
5.8 Disposal
The X-ray tube assembly as well as the tube contains materials such as oil and heavy metals for
which environmentally friendly and proper disposal in accordance with the valid national legal
regulations must be assured. Disposal as domestic or industrial refuse is forbidden.
This equipment manufacturer possesses the required technical knowledge and will takes the tube
assembly back for disposal. Please contact your X-ray tube assembly manufacturer for this purpose.
CAUTION
Improper disposal due to lack of knowledge.
• The manufacturer possesses the required technical knowledge and will take back the X-
ray tube assembly for disposal.
Only qualified staff is permitted to unpack, install and operate the X-ray tube assembly.
Follow instructions for installing, handling, tune-up etc. and/or reference to the operating instruction
of the X-ray system.
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5 Notes
RAY-14_3 RAY-14_1
RAY-14S_3 RAY-14S_1
RAY-14S_3F
The permissible weight for all components that are mounted on the radiation outlet block may together
not exceed 300 N.
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5 Notes
Dimension in mm
WARNING
Breakage of the radiation outlet block may caused by mechanical load too high.
• The permissible weight for all components that are mounted on the radiation outlet block
can not exceed 300 N.
The electrical connections of stator and sensors are located under the decoration cap at anode side
on connection plate (see following views). For connecting cables the decoration cap has to be
removed and follow label as announced under decoration cap. Before operating XTA decoration cap
has to be mounted again in an orientated way to inlet of cables.
RAY-14S_3
RAY-14S_3F
RAY-14S_1
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5 Notes
RAY-14_3
RAY-14_1
• Connection of the signal cable to the temperature switches with a flat plug 6.3x0.8
suitable for the cable cross-section used.
• Connection of the protective conductor cable with a cable lug (closed) suitable for
Note
the cable cross-section used and for M5 screw.
• Connection of the stator cable with cable lugs (open or closed) suitable for the cable
cross-section used and for M4 screw.
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5 Notes
3-phase stator
RAY-14_3 RAY-14S_3 RAY-14S_3F
Test point 0-I 0 - II I - II
Winding resistance 22.8...24.8 22.8...24.8 22.8...24.8
Max. permissible operating voltage (run-up) 400V +10%
Braking voltage 70 V DC
Run-up time (depending on starter system) approx. 1.0 s
1-phase stator
RAY-14S_1 RAY-14_1
In 150Hz or 180Hz operation of the tube assembly it is mandatory to brake the anode to at least
25Hz after loading. In 50 Hz or 60 Hz operation of the tube assembly, braking to 25 Hz is
recommended.
The stated values must be viewed only as reference values. Check the run -up time and the speed at
the first start-up. Exposure release is permitted only after the nominal speed is reached.
To avoid unnecessary development of heat from the stator, the electrical maximum values must be
used for as short a time as possible.
The stator connection cables must be designed for a continuous thermal load capacity of 100°C.
The X-ray tube assembly is provided with a 3-pin high-voltage socket on the anode and the cathode
sides.
This requires appropriate high-voltage cables. 30 m cable length should not be exceeded. The
enclosed corona disks must be covered with silicone oil and slipped over the plug contacts.
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5 Notes
L / II S/I
S / I = Small focal spot
C/0
L / II = Large focal spot
C / 0 = Neutral conductor
Guide groove
The total tube assembly filtration is 2.5mm Al equivalent and it is including additional filtration.
Guide
The added filters consist of three filter groove
disks (3x 0.5mm Al).
Note Lead cone must be remounted again after removing filter disks for fitting the
collimator.
The filter disks and the lead cone for image intensifier adaptation are replaced as follows:
Lead cone
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5 Notes
CAUTION
A contact with unprotected lead is possible during the replacement of the filter plates. The inside
of the protection cone in the radiate exit window is unpainted.
5.10 Pictograms
A protective earth conductor symbol is cast on metal surface near connection point on the
connecting plate at anode side of the tube assembly.
A pictogram as symbol to mark the HV-connecting horns concerning anode with plus sign and
cathode with minus sign on the horns of the X-ray tube assembly. Symbols are located on respective
horn.
Symbol remark operator referring to operating instructions before operation is needed. Symbol
locate on surface of this equipment nearby cathode socket.
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5 Notes
CAUTION
Misunderstanding of those symbols may cause wrong installation.
Medical –Applied electromagnetic radiation equipment as to electric shock, fire and mechanical
hazards only in accordance with ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), CAN/CSA-C22.2
No. 60601-1 (2014), IEC 60601-1-3:2008 + A1:2013, CSA CAN/CSA-C22.2 NO.60601-1-3-09
(2011) + AMD1 (2015), IEC 60601-1-6:2010 + A1:2013, CAN/CSA-C22.2 NO. 60601-1-6A:11 +
AMD1 (2015), IEC 60601-2-28:2017, CAN/CSA-C22.2 NO. 60601-2-28:18; E347424
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6 Technical Data
6 Technical Data
6.1 X-ray tube / tube assembly
F1 F2
Anode rotary
Nominal input power(s) of the anode at
frequency
thermal anode reference power 300 W
IEC 60613:1989
For anode rotary frequency 50/60 Hz 22 kW 54 kW
50 Hz / 60 Hz / 150 Hz / 180 Hz
150/180 Hz 33 kW 78 kW
F1 F2
Anode rotary
frequency
Nominal input power(s) of the anode at
IEC 60613:1989
thermal anode reference power 130 W
50/60 Hz 22kW 54 kW
150/180 Hz 34 kW 80 kW
F1 F2
Anode rotary
Nominal input power(s) of the anode at frequency
thermal anode reference power 0 W IEC 60613:1989
50/60 Hz 29kW 73kW
150/180 Hz 45 kW 107 kW
F1 F2
Anode rotary
frequency
Nominal radiographic anode input power
IEC 60613:2010
50/60 Hz 22 kW 54 kW
150/180 Hz 34 kW 80 kW
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6 Technical Data
F1 F2
Focal spot nominal value(s)
0.6 1.2 IEC 60336
Ref: Reference axis
Total filtration of the X-ray tube assembly= 2,5 mm Al / 75 kV= IEC 60522
inherent filtration + additional filtration IEC 60601-1-3
1,0 mm Al/75 + (3x 0,5) mm Al
X-ray tube nominal voltage 150 kV IEC 60613:2010
F1 F2
n.a.
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6 Technical Data
Atmospheric pressure From 700 hPa to 1060 hPa From 500 hPa to 1060 hPa
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7 Curves
7 Curves
7.1 Heating and cooling curve of anode
IEC 60613:1989
A B
X-ray tube assembly in horizontal position X-ray tube assembly only in vertical position
Position changed during operation
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7 Curves
IEC 60613:1989
The heating curves include the power loss of the cathode and the stator, e.g. 150/180 Hz
anode drive 5000J/start-up and deceleration, 25 Hz anode drive for fluoroscopy 75 J/s.
Tube assembly with fan horizontal or tube assembly vertical with fan on top
IEC 60613:1989
The heating curves include the power loss of the cathode and the stator, e.g. 150/180 Hz
anode drive ≈5000 J/start-up and deceleration, 25 Hz anode drive for fluoroscopy ≈ 75 J/s.
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7 Curves
IEC 60613:2010
IEC 60613:2010
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7 Curves
IEC 60613:1989
IEC 60613:2010
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7 Curves
IEC 60613:1989
IEC 60613:2010
25 Technical Description
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7 Curves
IEC 60613:1989
IEC 60613:2010
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7 Curves
IEC 60613:1989
IEC 60613:2010
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7 Curves
IEC 60613:2010
Series duration
IEC 60613:1989
Series duration
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7 Curves
IEC 60613:2010
Series duration
IEC 60613:1989
Series duration
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7 Curves
IEC 60613:2010
Series duration
IEC 60613:1989
Series duration
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7 Curves
IEC 60613:2010
Series duration
IEC 60613:1989
Series duration
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8 Connection diagrams
8 Connection diagrams
RAY-14_3 RAY-14S_3 RAY-14S_3F
RAY-14S_1 RAY-14_1
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9 Dimensional drawings
9 Dimensional drawings
9.1 Maximum radiation field
The field coverage depends on the source-image distance (SID) and the anode angle.
For example, field coverage of 42cm x 42cm can be achieved at 1 m SID with this tube assembly (12°
anode angle)
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9 Dimensional drawings
RAY-14_3 RAY-14_1
RAY-14S_3 RAY-14S_1
RAY-14S_3F
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9 Dimensional drawings
F = focus position
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10 Label
10 Label
10.1 The type label of the X-ray tube assembly
The type label of the X-ray tube assembly is described in the following figure:
(11)
1. Product name
2. Global Trade Identification Number
3. Model number
4. Country of Origin code
5. Serial number
6. UDI (Unique Device Identification)
7. MD (Medical Devices)
8. CE-conformity mark
9. Date of manufacture symbol with the date below
10. Identifier of selected system components or parts for product traceability
11. Minimum specified permanent filtration
12. Nominal input voltage
13. EC Representative
14. Legal manufacturer
15. Manufacturer’s country
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10 Label
The type label of the X-ray tube is described in the following figure:
1. Product name
2. Global Trade Identification Number
3. Model number
4. Country of Origin code
5. Serial number
6. Nominal focal spot size, small focus
7. Nominal focal spot size, large focus
8. Norm according to which the focal spot sizes were determined
9. Legal manufacturer
10. Manufacturer’s country
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Siemens Healthineers Headquarters Legal Manufacturer
Siemens Healthcare GmbH Siemens X-Ray Vacuum
Henkestr. 127 TechnologyLtd., Wuxi
91052 Erlangen, Germany No.112, Meiyu Road
Phone: +49 9131 84-0 214028 Wuxi, Jiangsu
siemens-healthineers.com P.R. China
Published by Siemens Healthcare GmbH · Doc.Gen.Date: Dec 2020 · Print No. R76-020.140.96.15.02 · © Siemens Healthcare GmbH, 2020