X-ray Tube Housing Assembly

◆X-ray tube assembly for all routine diagnostic examinations with conventional or digital radiographic and fluoroscopic workstations ◆The insert features : 16° Rhenium-Tungsten molybdenum target (RTM) ◆Focal spots:        Small 1.0, Large: 2.0 ◆Maximum tube voltage : 125 kV ◆Accommodated with IEC60526 type high-voltage cable receptacles ◆High voltage generator should accord with with IEC60601-2-7 IEC Classification (IEC 60601-1:2005):Class I ME EQUIPMENT

Products Details

Laws,standards and regulations

This product has been manufactured and developed in agreement with the following laws,directives and design regulations: ◆Council Directive 93/42/EEC of 14 June 1993 concerning medical devicesCE marking. ◆EN ISO 13485:2016 Medical device—Quality management systems—Requirements for regulatory purposes.. ◆EN ISO 14971:2012Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) ◆EN ISO15223-1:2012Medical devices——Symbols to  used with medical device labels, labeling and information to be supplied    Part 1: General requirements ◆International Electrotechnical Commission (IEC),the following standards are considered in particular.

Standard Reference

Standard Reference

Titles

EN 60601-2-54:2009 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC60526 High-voltage cable plug and socket connections for medical X-ray equipment
IEC 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
IEC 60613-2010 Electrical, thermal and loading characteristics of rotating anode X-ray tubes for medical diagnosis
IEC60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-3:2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC60601-2-28:2010 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
IEC 60336-2005 Medical electrical equipment-X-ray tube assemblies for medical diagnosis-Characteristics of focal spots

Description 

●The designation is composed as follows:

MWHX7010

Tube

A

High voltage socket with 90 degree direction

MWTX70-1.0/2.0-125

B

High voltage socket with 270 degree direction

Technical Data

Property

Specification

Standard

Nominal input power(s) of the anode

F 1

F 2

IEC 60613

21kW(50/60Hz)

42.5kW(50/60Hz)

 

Anode heat storage capacity

100 kJ  ( 140kHU)

IEC 60613

Maximum cooling capacity of the anode

475W

 
Heat storage capacity

900kJ

 
Max. continuous heat dissipation without Air-circular

180W

 
Anode materialAnode top coating material

Rhenium-Tungsten-TZM(RTM)

Rhenium-Tungsten-(RT)

 
Target angle (Ref: reference axis)

16 °

IEC 60788

X-ray tube assembly inherent filtration

1.5 mm Al / 75kV

IEC 60601-1-3

Focal spot nominal value(s)

F1(small focus)

F2(large focus)

IEC 60336

1.0

2.0

 
X-ray tube nominal voltageRadiographic Fluoroscopic

125kV

100kV

IEC 60613

Data on cathode heating  Max. current Max voltage

≈ /AC, < 20 kHz

 

F1

F 2

 

5.1A

≈5.87.8V

5.1 A

≈7.710.4 V

 
Leakage radiation at 150 kV / 3mA in 1m distance

1.0mGy/h

IEC60601-1-3

Maximum radiation field

573×573mm at  SID 1m

 
X-ray tube assembly weight

Approx. 18 kg

 
 

Conditions for operation,storage and transport

Limits

Operation Limits

Transport and Storage Limits

Ambient temperature

From 10to 40

From- 20to 70

Relative humidity

≤75%

≤93%

Barometric pressure

From 70kPa to 106kPa

From 70kPa to 106kPa

 

Stator key values

1-phase stator
Test point

C-M

C-A

Winding resistance

≈18.0…22.0Ω

≈45.0…55.0Ω

Max.permissible operating voltage(run-up)

230V±10%

Recommend operating voltage(run-up)

160V±10%

Braking voltage

70VDC

Run-on voltage in exposure

80Vrms

Run-on voltage in fluoroscopy

20V-40Vrms

Run-up time(depending on starter system)

1.2s

Warning to interface with X-ray Generator 1.Housing Rupture Never input over rated power to X-ray tube assembly If the input power exceeds tube specification ,it causes the over temperature of anode,insert tube glass shatter and ultimately the following serious problems due to generating over-pressure by oil vaporization inside housing assembly. In such a critical condition causing housing rupture by over load ,the safety thermal switch can not protect X-ray tube even if it work Housing sealing parts rupture. Human injury including burns due to hot oil escape. Fire accident due to flaming anode target. The X- ray generator should have a protective function which manages input power to  be within tube specification.  2.Electric Shock To avoid the risk of electric shock ,this equipment must only be connected to a supply with protective earth.  3.No modification of this equipment is allowed!!

Warning

Cautions

Caution to interface with X-ray Generator 1.Over Rating X-ray tube assembly can be broken with applying just one over rated shot. Please read the technical date sheets carefully and follow the instructions. 2.Permanent Filtration The total filtration and the distance between X-ray focal spot and human body are regulated legally. They should be complied with the regulation. 3.Safety Thermal Switch X-ray tube assembly has safety thermal switch to prohibit further input power when the tube housing reaches to the temperature80 of switch-open. The switch is not recommended connecting stator coil in series circuit. Even if the switch works ,never turn the system power off. The cooling unit should be activated if used with the system. 4.Unexpected Malfunction X-ray tube assembly may have the risk to be unexpectedly malfunctioning due to life termination or failure.If the serious problems caused by the above risk is expected,you are requested to have a contingency plan to avoid such a case. 5.New Application If you use the product with new application not to be mentioned in this specification or with different type of X-ray generator,please contact to us for confirming its availability.

Caution in Operation

1 .X-ray Radiation protection

This product fulfills the requirements of IEC 60601-1-3. This X-ray tube assembly emits X-ray radiation in operation.Only correspondingly qualified and trained personnel are therefore allowed to operate the X-ray tube assembly. Relevant physiologic effects may cause harm to patient,system manufacture should take proper protection to avoid ionization radiation. 2.Dielectric 0il X-ray tube assembly has dielectric 0il contained for high voltage stability. As it is poisonous for human healthif it is exposed to the non-restricted areait should be disposed as following to the local regulation. 3 .Operation Atmosphere X-ray tube assembly is not allowed to be used in the atmosphere of flammable or corrosive gas· 4Adjust the Tube Current Depending on the operating conditionsthe filament characteristics might be changed. This change might Iead to the over rate exposure to X-ray tube assembly. To prevent the X-ray tube assembly from being damagedadjust the tube current  regularly. Besides when the X-ray tube has arcing Problem in a long time useadjustment of the tube current is required. 5.X-ray Tube Housing Temperature Do not touch on X- ray tube housing surface just after operation due to high temperature. Stay X-ray tube to be cooled. 6 .Operating limits Prior to usageplease confirm the environmental condition is within the operating Iimits. 7 .Any Malfunction P1ease contact to SAILRAY immediatelyif any malfunction of the X-ray tube assembly is noticed. 8.Disposal The X-ray tube assembly as well as the tube contain 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.The manufacturer possesses the required technical knowledge and will takes the X-ray tube assembly back for disposal. Please contact customer service for this purpose.

Emission curves of the cathode

                   If(A)                                           Small Focal Spot

                  If(A)                                         Large Focal Spot

Single and series loading

Conditions:Tube Voltage Three-Phase Stator Power Frequency 50Hz/60Hz

Heating and cooling curve of anode

  IEC60613

Heating and cooling curve of X-ray tube assembly

Housing Thermal Characteristics

X-ray tube assembly dimensional drawings

SRMWHX7010ASRMWHX7010BFilter Assembly And Cross Section of PortRotor Connector Wiring

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