Manual

Technical Description Operator Manual

KAILONG
This product is provided with a CE mark in accordance with the regulations stated in Council Directive 93/42/EEC of June 14th, 1993, concerning Medical Devices.

X-ray tube assembly

H 1086

Contents
1 2 3 3.1 3.2 3.3 4 4.1 4.2 4.3 4.4 GENERAL DATA ................................................................................................. 1 LAWS, STANDARDS AND REGULATIONS ....................................................... 2 DESCRIPTION ..................................................................................................... 3 INTENDED USE:............................................................................................... 3 SPECIAL FEATURES....................................................................................... 3 EXPLANATION OF DESIGNATION ................................................................. 3 NOTES ................................................................................................................. 4 GENERAL NOTES............................................................................................ 4 SAFETY INFORMATION .................................................................................. 4 RADIATION PROTECTION .............................................................................. 5 OPERATING CONDITIONS.............................................................................. 5
Conditioning of the X-ray tube assembly ........................................................................................... 5 Conditioning program (At start with a cold anode) ............................................................................ 5 After an extended idle time of the X-ray tube assembly (more than 2 weeks) ................................... 5 Perform only for installation of a new tube assembly......................................................................... 5

4.4.1 4.4.2 4.4.3 4.4.4

4.5 4.6 4.7

ELECTROMAGNETIC COMPATIBILITY (EMC) .............................................. 6 MAINTENANCE ................................................................................................ 6 CHECKS ........................................................................................................... 6

Visual check with the generator turned off ......................................................................................... 6 Mechanical check with the generator turned off................................................................................. 6 Electrical check ................................................................................................................................... 6

4.7.1 4.7.2 4.7.3

4.8 4.9

DISPOSAL ........................................................................................................ 6 INSTALLATION NOTES FOR PERSONNEL ................................................... 7

Tube assembly connection plates........................................................................................................ 7 High-voltage connections ................................................................................................................... 8 Tube assembly filtration...................................................................................................................... 8

4.9.1 4.9.2 4.9.3

4.10 PICTOGRAMS .................................................................................................. 9

4.10.1 4.10.2 4.10.3 Symbol of earth conductor .................................................................................................................. 9 Caution symbol of dangerous voltage................................................................................................. 9 Symbols to mark cathode and anode of HV-connection horns ........................................................... 9

5 5.1
I

TECHNICAL DATA ............................................................................................ 10 X-RAY TUBE / TUBE ASSEMBLY ................................................................. 10

5.2 6 6.1 6.2 6.3 6.4 7 7.1 7.2

CONDITIONS FOR OPERATION, STORAGE AND TRANSPORT................ 11 CURVES AND TABLES..................................................................................... 12 HEATING AND COOLING CURVE OF ANODE............................................. 12 HEATING AND COOLING CURVES OF X-RAY TUBE ASSEMBLY............. 13 EMISSION CURVES OF THE CATHODE ...................................................... 14 SINGLE AND SERIES LOADING ................................................................... 15 DIMENSIONAL DRAWINGS.............................................................................. 16 MAXIMUM RADIATION FIELD ....................................................................... 16 X-RAY TUBE ASSEMBLY DIMENSIONAL DRAWINGS ............................... 17

II

General data
Protection class I / Type B

X-ray tube assembly according to IEC 60601-2-28/1993 Type H1086X H1086Y

Address for inquiries

HangZhou Kailong Medical Instrument Co Ltd., No.6, No.6 Road, Dongzhou Industrial Zone, FuYang Hangzhou, Zhejiang, 311401 , China URLhttp://www.kailongx-ray.com E-mailinfo@kailongx-ray.com Tel:0086-571-87195000 Fax:0086-571-87195003

Authorized agent according to MDD 93/42/EEC

Shanghai International Holding Corp.GmbH ADD: Eiffestr.80, 20537 Hamburg, Germany Name: Mr. Liang Jin Tel: 0049-40-2513175 Fax: 0049-40-255726 Email: shholding@hotmail.com HangZhou Kailong Medical Instrument Co Ltd., No.6, No.6 Road, Dongzhou Industrial Zone, FuYang Hangzhou, Zhejiang, 311401 , China Chinese

Manufacturer

Language of the original

Page 1 of 17

Laws, standards and regulations

This product has been manufactured and developed in agreement with the following laws, directives and design regulations Directive 93/42/EEC dated June 14, 1993 for medical devices (CE marking). ISO 13485/2003 Medical devices Quality management systems ISO 14971/2007 Medical devices - Application of risk management to medical devices 21 CRF Part 1020, Performance standard for ionizing radiation emitting products, (USA) 21 CFR Part 820 Quality System Regulation, (USA) International Electrotechnical Commission (IEC), the following standards (Table 1) are considered especially: IEC Title

60336/1993 60522/1999 60526/1978 60601-1/1988 including A1:1991 and A2:1995 60601-1-2/2001 60601-1-3/1994 60601-2-7/1998 60601-2-28/1993 60613/1989 60788/2004 60806/1984 62309/2004

X-ray tube assemblies for medical diagnosis Characteristics of focal spots Determination of the permanent filtration of X-ray tube assemblies High-voltage cable plug and socket connections for medical X-ray equipment General requirements for safety Electromagnetic compatibility Requirements and tests General requirements for radiation protection in diagnostic X-ray equipment Medical Electrical Equipment-Part Particular Requirements for SafetySpecification for High Voltage Generators of Diagnostic X-Ray Generators. Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis Electric, thermal and loading characteristics of rotating anode X-ray tubes for medical diagnosis Medical electrical equipment Glossary of defined terms Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis Dependability of products containing reused parts requirements for functionality and tests

Page 2 of 17

Description

3.1 Intended use: X-ray tube assembly with double-focus rotating anode X-ray tube H1086X is intended to be used for all routine diagnostic examinations with conventional or digital radiographic and fluoroscopic workstations of OEM (Original Equipment Manufacturer).

3.2

Special features Long-term high dose yield Focal spots are superimposed Compact tube assembly housing - with optional fan cooling system for high loads

3.3 Explanation of designation The protective tube housing with built-in X-ray tube is called the X-ray tube assembly. The designation is composed as follows:

H1 Housing one

086 KL86 tube

X High voltage socket with 90 degree direction

X-ray tube assembly

H1 Housing one

086 KL86 tube

Y High voltage socket with 270 degree direction

X-ray tube assembly

Page 3 of 17

4
4.1

Notes
General notes In the interest of complying with 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 the 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-asgood-as-new. The requirements of IEC 62309 are fulfilled. Kailong Medical Solution has performed a conformity assessment in accordance with the MDD for this component. The tube assembly is not a sterile product. The housing surfaces are designed for easy cleaning / disinfection (damp cloth). 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. With increased tube assembly load one or two fans can be used in addition. In single fan operation the fan must be provided basically on the anode side. The fans are operated at an alternating voltage of 24 V (50/60 Hz) and a power of approx. 20 W. The installation and the connection of the fans are described in the installation instructions for the fan. Fans must be cleaned once annually. Your customer service can do this correctly. Unless otherwise indicated, all load data specified apply to six-pulse, twelve-pulse, multi-pulse or DC voltage generators.

4.2 Safety information These safety instructions must be strictly observed! Caution! Handle with Care. The tube assembly contains a high-vacuum product that can implode on incorrect handling, such as by impact, striking, dropping down. The generator must guarantee that an overload of the tube assembly is excluded. The X-ray tube assembly may be operated only in agreement with the safety information of this operator manual. The system owner is responsible for compliance with the regulations that apply for the installation and operation of an X-ray system. The use of the X-ray tube assembly is approved only in system(s) of Kailong Medical solutions. It may not be connected with assemblies, components or systems other than those recommended by Kailong Medical solutions. 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. Use of the X-ray tube assembly is forbidden if signs of mechanical, electrical or radiationrelated defects are present. 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 may not be exceeded. For safety reasons the X-ray tube assembly may be replaced only by the service personnel of the manufacturer or by personnel trained by the manufacturer. In extreme modes of operation there is a risk that the temperature of the X-ray tube assembly rises above 85C. For this case the X-ray tube assembly has an overpressure test with temperature sensor ((755)C ) which more safety should block the X-ray generator for safety reasons. An examination in progress can then no longer be continued under radiation control! This case must be avoided by corresponding operating pauses and observing the technical data, especially the maximum continuous heat dissipation of the X-ray tube assembly. The heat storage capacity of the Xray tube assembly may not be exceeded under any circumstances. Page 4 of 17

Caution: At high housing temperature take care to avoid contact when the protective cover is missing. Prior to an examination it is your responsibility as the user to ensure that all safety features are functional and that the product is ready for operation. Caution, operation of the tube assembly only with housing covers fitted! To ensure the safety of both the user and the patient, the customer service must be notified immediately when a defect has been detected, and the operation of the tube assembly concerned must be terminated. Collimators with a weight up to 300N may be fastened to the collimator flange of the X-ray tube assembly. Radiation protection

4.3

This product fulfills the requirements of IEC 60601-1-3, as well as of the American 21 CFR Part 1020. 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. 4.4 Operating conditions

4.4.1 Conditioning of the X-ray tube assembly Before the initial start-up of the X-ray tube assembly or after a longer standstill period proceed for conditioning according to the instructions of the service documents of the system manufacturer. Refer also to section 5.2. 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 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 assembly (more than 2 weeks), it is recommended that the operator perform an abbreviated warm-up procedure as described under item 4.4.2 and 4.4.3. Important: Ensure that adequate radiation safety precautions are taken to protect any existing image intensifier against radiation (e.g. lead apron in the beam path).

4.4.2

Conditioning program (At start with a cold anode) Switch on fluoroscopy at 40 kV. Power up to 110 kV /2mA within approx. 1 minute and hold for 10 minutes. 5 minutes cooling pause.

4.4.3

After an extended idle time of the X-ray tube assembly (more than 2 weeks) Select exposure mode with F2 . (Large focus) 70 kV, 100 mAs, - 2 exposures Pause after each exposure 30 s 90 kV, 300 mAs, - 2 exposures Pause after each exposure 90 s 110 kV, 300 mAs, - 2 exposures Pause after each exposure 110 s

4.4.4

Perform only for installation of a new tube assembly Perform 4.4.1.3 only for installation of a new X-ray tube assembly additionally after you have done 4.4.1.1and 4.4.1.2. Page 5 of 17

125 kV, 50 mAs, - 2 exposures Pause after each exposure 30 s 140 kV, 50 mAs, - 2 exposures Pause after each exposure 30 s * If the tube tends to repeatedly and strongly "arcing", abort the procedure (risk to sensitive parts of the system electronics).

4.5 Electromagnetic Compatibility (EMC) 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. All cables necessary for the connection are provided by Kailong Medical Solutions. No other cables may be used. Correct functioning cannot be guaranteed if accessories other than the components sold by Kailong Medical Solutions are used. This medical electrical component cannot be operated on its own, but only in combination with a generator or a radiological diagnostic system. The proof of compliance with the requirements of IEC 60601-1-2 (2001) with regard to electromagnetic compatibility has been provided by Kailong Medical Solutions as manufacturer. Therefore please refer to the operator manual of the X-ray system for all data, guidelines and manufacturer's declarations on electromagnetic emission. 4.6 Maintenance The X-ray tube assembly is maintenance free. There are no hazards whosesoever for persons and environment in the case of proper use. 4.7 Checks The following checks must be performed at regular intervals. If any announced damage was found dont start any operation with the system. Contact service personnel immediately. 4.7.1 Visual check with the generator turned off 4.7.2 Check the tube assembly for external damage. Check all exposed cables to the tube assembly to ensure that the outer insulation is undamaged do not touch during operation! Check the tube assembly for oil leakages daily.

Mechanical check with the generator turned off Check the fastening of the freely accessible tube assembly. The 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 union nuts.

4.7.3

Electrical check In accordance with IEC 60601-2-7 paragraph 16 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 1 /m. Conformance must be checked by a measurement. If you have concluded a maintenance contract, this measurement will be performed by the service.

4.8 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. The manufacturer possesses the required technical knowledge and will takes the tube assembly back for disposal. Page 6 of 17

4.9 Installation notes for personnel General ESD directives must be complied with when handling the system. Follow instructions for installing, handling, tune-up etc. and/or reference to the operator manual of the X-ray system. 4.9.1 Tube assembly connection plates Caution: 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.

Terminal Markings P (main) 2 S (shift) 3 C(common)1 T (thermal)4 T (thermal)5 E (ground)E

Stator Wire Colors Black Red White

Tube heat shrink

Rotor connection Black Red White

Blue Blue Yellow/Green

Stator key values 1-phase stator

Test point Winding resistance Max.permissible operating voltage(run-up) Recommend operating voltage(run-up) Braking voltage Run-on voltage in exposure Run-on voltage in fluoroscopy Run-up time(depending on starter system) C-P CS 18.0 ... 22,0 45.0 ... 55,0 230V10% 160V10% 70VDC 80 V rms 20V -40V rms 1.2s Page 7 of 17

In 50 Hz or 60 Hz operation of the tube assembly, braking to 25 Hz is recommended Recommended phase-shift capacitor values for 1-phase stators for 50 Hz anode rotation: 43 F for 60 Hz anode rotation: 30 F Different frequency converters can be used for the drive. The phase-shift capacitor depends in this case on the waveform of the frequency converter. 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 100C.

4.9.2

High-voltage connections

The tube assemblies. are provided with a 3-pin high-voltage socket on the cathode side. 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.

L / II

S/I

C/0

S, I = Small focal spot L, II = Larger focal spot C, 0 = Neutral conductor

Guide groove

4.9.3

Tube assembly filtration

The total tube assembly filtration is 2.5mm Al equivalent and it is including additional filtration. The added filters consist of two filter disks (2 x 0,5 mm Al).

Page 8 of 17

4.10 Pictograms

4.10.1 Symbol of earth conductor A earth conductor symbol is cast on metal surface near connection point on the connecting plate at anode side of the tube assembly.

4.10.2 Caution symbol of dangerous voltage Caution symbol of dangerous voltage is affixed twice, 1x on the cover plate at anode side of the Xtube assembly and 1x on the cover plate at cathode side of the X-ray tube assembly.

4.10.3 Symbols to mark cathode and anode of HV-connection horns 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. HV-connection horn anode side HV-connection horn cathode side

Page 9 of 17

Technical Data

Data corresponding to IEC 60601-2-28 5.1 X-ray tube / tube assembly Specification F1 F2 Standard IEC 60613

Property Nominal input power(s) of the anode

20 kW(50HZ) 22 kW(60HZ) Anode heat storage capacity Maximum cooling capacity of the anode Heating curve, cooling curve of the anode Single and series loading Heat storage capacity of the X-ray tube assembly Heating and cooling curve of the X-ray tube assembly Max. continuous heat dissipation of the tube assembly (without Air-circular ) Maximum (symmetrical) radiation field Anode top coating material Reference axis of the X-ray tube Reference axis of the X-ray tube assembly Target angle (Ref: reference axis) X-ray tube and X-ray tube assembly F1 (small focus ) Focal spot nominal value(s) Ref: Reference axis 0.6

50kW(50HZ) 54kW(60HZ) IEC 60613

111kJ(150kHU) 475W See table in section 6.1 See table in section 6.4. 900kJ See figure in section 6.2. 180W See figure in section 7.1. Rhenium-Tungsten Perpendicular to the tube axis Perpendicular to the tube axis 12

IEC 60613 IEC 60613 IEC 60613 IEC 60613 IEC 60613 IEC 60806

IEC 60788

F2 ( large focus ) 1.2

IEC 60336

Total filtration of the X-ray tube assembly= inherent filtration + additional filtration X-ray tube nominal voltage

2.5 mm Al / 75 kV 1.5 mm + (2x 0.5) mm Al 150 kV

IEC 60601-1-3 IEC 60522

IEC 60613

Page 10 of 17

Property Data on cathode heating F1

Specification /AC, < 20 kHz F2

Standard

Max. current Max voltage Emission characteristics of the cathode Data on anode drive Anode rotary frequency Maximum anode frequency Main dimensions and interfaces X-ray tube assembly weight Leakage radiation at X kV / YmA in 1m distance Information on auxiliaries

5.4 A 7V

5.4 A 12 V IEC 60613

See curve(s) section 6.3 50/60 Hz 60 Hz See dimension drawings section 7.2 Approx. 18 kg 0,8 mGy/h at nominal voltage 150kV 3.4mA n.a. There are no auxiliaries Trunnion rings belong to system

IEC 60601-1-3

High-voltage connection

+ -

3-pin IEC 60526 3-pin Cream white

Housing color 5.2 Conditions for operation, storage and transport Operation Ambient temperature Relative humidity Barometric pressure From 10 C to 40 C From 30 % to 75 % From 700 hPa to 1060hPA

Transport and storage From - 20C to + 70C From 5% to 95% From 500 hPa to 1060 hPA

Page 11 of 17

6
6.1

Curves and tables

Heating and cooling curve of anode IEC 60613

Page 12 of 17

6.2

Heating and cooling curves of X-ray tube assembly IEC 60613

Page 13 of 17

6.3

Emission curves of the cathode IEC 60613

IEC 60613

Page 14 of 17

6.4 6.4.1

Single and series loading Single Loading Curves

Anode drive

60/50 Hz Conditions: Tube Voltage Three-Phase

Stator Power Frequency 60Hz

Conditions:

Tube Voltage

Three-Phase

Stator Power Frequency 50Hz

Page 15 of 17

7
7.1

Dimensional drawings
Maximum radiation field The field coverage depends on the source-image distance (SID) and the anode angle. For example, field coverage of 40cm x 40cm can be achieved at 1 m SID with this tube assembly (12 anode angle)

Page 16 of 17

7.2

X-ray tube assembly dimensional drawings

Page 17 of 17