翻译公司资讯

世联翻译公司完成医疗器械英文翻译

发布时间：2018-09-14 14:05　　点击：

世联翻译公司完成医疗器械英文翻译

Product type:

The product is a permanently installed equipment of Class I Type B according to the classification requirements in Section 5 of GB9706.1, which can never be used in positions with flammable anesthetizing gas mixed with air or oxygen or nitrous oxide.

The product is used in continuous operation with intermittent loading.

Product transportation or storage conditions:

In the transport or packing state, the product can be kept for less than 15 weeks in the following environment conditions.

a) Environment temperature: -20℃～+70℃

b) Relative humidity: 10％～93％

c) Atmosphere pressure range: 500hPa～1,060hPa

The product can be used normally in the following environment conditions:

a) Environment temperature: +10℃～+40℃

b) Relative humidity: 30％～75％

c) Atmosphere pressure range: 700hPa～1,060hPa

Manufacturer’s responsibilities:

The manufacturer shall be responsible for the safety, reliability and quality of the product in the following conditions:

The product is transported or stored in accordance with the requirements of the Manual;

The installation, debugging, addition, modification, maintenance and removal of the product are made by the personnel approved by the manufacturer;

The product is used in the environment meeting the requirements of the Manual;

The using and maintenance of the product is made in accordance with the requirements of the Manual.

HF50-R32 medical diagnosis X-ray generator Manual version descriptions

Version Cover date Reason for changing version

01 December, 2003 Original version

02 September, 2006 Re-registration

3.0 ---- Re-registration

3.1 ---- 3.0version registration supplementation

Manual descriptions

Thanks for purchasing the product of the Company.

Please read the Manual carefully before using the product, which can provide correct guidance on how to use the product.

The following signs in the Manual shall be used with the following meanings:

Danger To indicate potential danger, ignoring which may cause the personal injury or serious damage of the product.

Caution To indicate potential danger, ignoring which may cause the personal injury or damage of the product.

Note To indicate important reminder to be followed in the operation.

Section 1 Safety

1 Safety notes

Special attention shall be paid to the following notes in using the product:

Note Attention should be paid to the followings in moving the product:

☆ To avoid unnecessary incline, vibration and impact;

☆ To mover the product in accordance with the requirements in related section of the Manual, avoiding the product damage;

The product should be used and stored with attention paid to the followings:

☆ Please not to use and store in the position with flammable and explosive gases;

☆ Please not to use and store the product in the environment with air pressure, temperature and humidity exceeding the permissible range;

☆ Please pay attention to the voltage, frequency and permissible current of AC power supply;

☆ To keep sound ventilation and avoid the direct sunshine;

Attention should be paid to the followings in using the product:

☆ To read the Manual carefully and to be familiar to the performance and operation of the product as much as possible;

☆ To confirm the connection of the product with the power supply and sound grounding;

☆ To confirm the voltage of the power supply again.

Attention should be paid to the followings in using the product:

☆ To start and shut off the product in the order as required in the Manual;

☆ To operate the product in strict accordance with the requirements of the Manual;

☆ To make maintenance in accordance with the requirements of the Manual;

☆ To make debugging in accordance with the requirements of the Manual before the product is put into operation again after a long time;

☆ To observe the product in the operation; to shut off the product and cut off the network power supply in case of any abnormal condition;

The following measures shall be taken in case of the faults of the product:

☆ To shut off the product immediately and cut off the network power supply;

☆ To stick the note of “In fault!” on the product and contact with the Company or the local maintenance sector appointed by the Company; never to make any disassembly arbitrarily;

Note Notes on environment protection:

☆ Some materials harmful to the environment are used for some required functions of the product. Therefore, the waster of the product shall not be mixed with ordinary industrial and domestic waste;

☆ Please not to pour the transformer oil freely;

☆ The waste of the product shall be treated in accordance with the stipulations of the local environment protection sector.

Caution The installation, debugging, addition, modification, maintenance and removal of the product should be made by the personnel approved by the manufacturer. Otherwise, the Company shall not be liable for the arising product damage or personal injury.

Caution The product must be used only after the installation debugging by the trained professionals. Otherwise, it may cause the product damage or personal injury.

2. Electrical security

The signs of the electrical safety in the Manual shall have the following meanings:

Type B application sign

Neutral wire sign

Dangerous voltage

Protection grounding sign

3. Mechanical safety

Caution To make sure patients’ or your hands within the permissible safe position and clothes not winding with the product in the movable range of the components of the product.

Note Please not to place any other objects within the movable range of the components of the product.

4. Radiation protection

X-ray is harmful for the health. The wrong understanding and operation will cause radiation injuries on the patients, the operator and other persons.

The operator shall receive the training on the radiation protection with corresponding protection knowledge and attention should be paid to the followings:

Note Notes on radiation protection:

☆ The overexposure will not only impact the image quality but cause the radiation injuries as well. Therefore, it’s quite important to select reasonable exposure parameter and dose.

☆ Unnecessary exposure or wrong operation will cause radiation injuries on the patients, the operator and other persons.

☆ The operator should make sure the patient in reasonable posture and use the facilities to prevent or reduce the radiation injury to the patient, making sure the safety of the patient.

☆ The distance between the focus and the skin of the patient shall be kept as far as possible to make sure the absorption dose as low and reasonable as possible.

☆ Adequate measures should be taken to protect the patient, medical staff and other persons from direct exposure of X-ray in any conditions.

☆ Attention should be paid to the secondary radiation protection as stray radiation.

☆ The operator shall pay attention to the individual dose monitoring and regular physical examination.

☆ The product room should meet the related requirements of the national and local environment protection and health and quarantine sectors, to make sure no radiation injuries on the operator and other persons.

☆ No alteration should be made on the radiation protection circuit of the product without the prior content of the Company.

Maximum permissible dose (MPD) of the operator

Many studies have made the foundation for MPD of X-ray, of which achievements have been used in the development of MPD standards by International Commission on Radiological Protection (ICRP). Such restraints are not easy to determine and shall be applicable after tracking the latest achievements from time to time. At present, ICRP stipulates that MPD for the radiation staff shall not exceed the following requirements:

Stochastic effect

Annual dose equivalent 50mSv (5rem)

Non-stochastic effect

Annual dose equivalent for eye crystal 150mSv (15rem)

Annual dose equivalent for other parts 500mSv (50rem)

Stray radiation protection

Any objects in the path of X-ray shall cause secondary (scattering) radiation, whose strength depends on the energy and strength of the original radiation and the atomic numbers of the irradiated objects. The strength of the second radiation may be stronger than that of the radiation reaching the front screen of the image intensifier. Therefore, measures should be taken to protect people from the secondary radiation.

It's an effective measure to reduce the danger to the minimum to use the lead shield, as well as lead gloves, apron and neckerchief for thyroid. The lead shield must be not less than 0.5mm thick or 0.5mm equivalent and personal protection appliance as apron and gloves must be not less than 0.25mm thick or 0.25mm equivalent. Please refer to the basic radiation protection standards provided by the radiation protection sector for the basic protection requirements.

Individual dose monitoring

The individual dose monitoring is made to provide the reliable data to make sure whether the inspected is under a safe radiation dose. It can indicate the incorrect or improper actual radiation protection measures and some positions with radiation leakage. It’s the most effective method to measure the exposure quantity with the devices in the exposure to determine whether the protection measure is applicable. Such devices should be placed at all positions possible for the operator or body parts to expose and the measured block shall not exceed the acceptable dose standards.

A common but not accurate method to determine the exposure quantity is to place the film on the typical positions and develop it after a period to determine the radiation quantity.

The generally used method to test the overexposure under the radiation is the individual dosimeter, where the film or substance sensible to X-ray is sealed and placed on the body. However, such method can only be used to measure the radiation reaching to the wearing part. It still can provide reliable measurement on the radiation dose reaching to the body.

5. Environment protection

The product meets the stipulations of Measures for the Administration of the Control of Pollution by Electronic Information Products and the environment protection sign is used, indicating the product contains some toxic and harmful substances or elements. The product has the environment friendly service life of 50years.

Note: The environment friendly service life does not include that of consumables as the battery or fluorescent screen.

The product can be used normally and safely under the stipulated power supply and environment conditions within the environment friendly service life. The product exceeding the environment service life shall be recycled.

The product contains toxic and harmful substances or elements, as indicated in the following Table 1-1.

Table 1-1 Toxic and harmful substances or elements table

Component name: Toxic and harmful substances or elements

Lead

(Pb) Mercury

(Hg) Cadmium

(Cd) Hexavalentchromium

(Cr(VI)) Polybrominated biphenyls

(PBB) Polybrominated diphenyl ethers

(PBDE)

Electrical component × × × × × ×

Printed circuit board × О × О × ×

Nylon and plastic component × × × × × ×

Component plating and coating × × × × × ×

Lead protection component × О О О О О

O indicates the content of such toxic and harmful substance or element in all homogeneous materials of such component under the limit requirements of SJ/T11363-2006 and x indicates the content of such toxic and harmful substance or element in some homogeneous material of such component exceeding the limit requirements of SJ/T11363-2006.

The components of the product contain toxic and harmful substances or elements because of failing to replace the toxic and harmful substances or elements due to the restraints of the global technical process development. With the continuous improvement of the science and technology, the Company is struggling for alternatives of or reduced design of toxic and harmful substances and elements.

6. Electromagnetic compatibility

The product shall not be used near or overlapped with other equipment. Otherwise, the observation should be made to make sure the normal operation with other configurations.

Portable and moveable RF communication equipment should not be close to the product for it may affect the normal operation of the product.

Section 2 Profile

1. Predicted usages

The product is intended for the medical unit to make X-ray Rad diagnosis as a medical diagnosis X-ray generator. The product is not applicable for X-ray Rad diagnosis for angiocardiography, mammary gland and dentistry and can not be used as the X-ray generator for treatment.

Caution Please not to use the product for any other purposes except the predicted usages.

2. Contraindication: not found at present

3. Features

 The high frequency and voltage generator used in the system features stable waveform, low patient dose, short exposure time, high accuracy and sound repeatability; The whole structure of the system is delicate and beautiful with the console and generator separated and LED display, which is easy and simple for operation;

 The high frequency and voltage generator is controlled with multiple microprocessors, improving the exposure repeatability and operation efficiency and extending the service life of X-ray tube; The high grade self-diagnosis program of the generator makes the product fault identification, diagnosis and maintenance relatively easy, shortening the maintenance time effectively; All technical parameters and functions can be selected with the touch keys and displayed on multi-functional character/digital display screen;

 All operation functions, display and control are easy for operation and identification, avoiding confusion after reasonable arrangement;

 The high frequency and voltage generator is set up with APR as many as 600 positions;

 The SC4-1/SC4-4 Rad couch of the system features light structure and complete functions, equipped with rotatable column for different photography requirements;

 Rad couch is equipped with manual beam applicator and the photography positioning can be made with spot light.

4 Product configuration and constitution

The product has the main components as indicated in Table 2-1.

Table 2-1 Unit configuration

Product name Product specification Configuration 1 Configuration 2

High frequency and voltage generator GFS501-1 1 1

X-ray tube unit XD51-20.40/125H-T1F 1 1

Beam applicator XS1-3 1 1

Rad couch SC4-1 1 -

Rad couch SC4-4 - 1

The accompany documents of the product are as follows in Table 2-2.

Table 2-2 Accompanying documents of the product

Document name Configuration 1 Configuration 2 Remark

HF50-R32 medical diagnosis X-ray generator manual One copy The manual

GFS501-1 high frequency and voltage generator manual

GFS501-1 high frequency and voltage generator manual One copy for each manual

XD51-20.40/125H-T1F X-ray tube unit manual One copy

XS1-3 beam applicator manual One copy

SC4-1 Rad couch manual One copy -

SC4-4 Rad couch manual - One copy

Quality certificate 1

Packing list 1

5. Main components functions and usages

5.1 High frequency and voltage generator

The high frequency and voltage generator is designed to meet the requirements of the photography. It can meet the requirements of the ordinary photography and tomography, combined with the Rad couch, vertical RAD stand and tomography accessory. It also can make a single couch single tube X-ray special photography system for the general photography diagnosis.

The high frequency and voltage generator used in the system features stable waveform, low patient dose, short exposure time, high accuracy and sound repeatability; The whole structure of the system is delicate and beautiful with the console and generator separated and LED display, which is easy and simple for operation.

All operation functions, display and control are easy for operation and identification, avoiding confusion after reasonable arrangement;

The high frequency and voltage generator is equipped with the ionization chamber, PMT or photodiode for automatic light photography control, making sure the uniform graying density of the film.

The high frequency and voltage generator is set up with programmable organic Rad (APR) as many as 600 positions;

5.2 X-ray tube unit

The unit consists of X-ray tube and tube sleeve with the high frequency and voltage generator providing high voltage power supply, filament supply and low voltage power supply for rotating anode. The high voltage power supply is transmitted with the high voltage cable with the maximum tube voltage of 125kV and the low voltage power supply is with the starting wire with the phase capacitor of 40μF/630V and starting voltage of 160V.

The XD51-20.40/125H-T1F X-ray tube in the unit has the anode heat capacity of 140kJ, highest rotation speed of 2,700 r/m and focuses of 2.0mm and 1.0mm.

5.3 Beam applicator

The beam applicator in the system can match with the X-ray tube units with the tube voltage of not larger than 150kV, for adjusting and restricting the casting field of X-ray. The lead gate of XS1-3 beam applicator can be opened and closed manually and the spot light is driven with the power supply of AC 24V, suitable for photography. The beam applicator is of multiple-pin structure, reducing the impact of scattered and leaked ray and ray beside the focus effectively. Thus, it can reduce the harmful radiation for the patient and operator.

5.4 Rad couch

The component is accessory to X-ray generator. SC4-1 Rad couch consists of longitudinal couch stand, couch body, beam filter, column and control box, which can be controlled manually with electronic lock. SC4-4 Rad couch consists of longitudinal and horizontal couch stand, couch body, beam filter, column and control box, which can be controlled manually with electronic lock. They can combine with X-ray tube unit and high frequency and voltage generator for ordinary photography, beam filter photography and oblique photography and stretcher photography with optional rotation column.

1 Main technical parameters

1.1 High frequency and voltage generator

Max. tube voltage: 125kV;

Max. tube current: 400mA;

Max. output power: 32 kW;

Nominal power: 32kW

Power supply voltage: 380VAC±38VAC;

Power supply frequency: 50Hz±1Hz;

Power supply internal resistance: ≤0.27;

Whole product input power: Instant 42kVA.

2 Working principle

2.1 High frequency and voltage generator

The generator provides the required high voltage for X-ray tube unit after the rectification, contravariant and double voltage rectification on the grid power supply.

2.2 X-ray tube unit

The focus filament releases electrons after powered with the high frequency and voltage generator and the electrons hit the anode target with the high voltage field, generating required X-ray.

2.3 Beam applicator

The beam applicator can restrict the casting field of X-ray with the lead shield to cover X-ray.

2.4 Rad couch

SC4-1 and SC4-4 Rad couches are of simple structure with integration of column and couch body, easy for installation. The couch is of dual structure with the longitudinally moving couch stand at the upper and the horizontally moving couch stand at the lower. The longitudinal and horizontal couch stands can move, supporting with the rolling bearing, making sure the simple and stable movement and the simultaneous movement of the column and beam filter under the couch. The couch is electromagnetically braked, controlled with normally shut foot switch.

3. Electrical output data and combination

3.1 X-ray tube voltage

The voltage of Rad X-ray tube can be adjusted in different grades within 40 kV～125 kV with each step of not larger than 1kV;

The voltage variation of X-ray tube should be not larger than ±10%;

Rad nominal voltage of X-ray tube is 125kV with permissible maximum tube current of 250mA.

3.2 X-ray tube current

The current of Rad X-ray tube can be adjusted in different grades within 25 mA～400mA, selected in R′10 numeral system;

The current variation of X-ray tube should be not larger than ±20%;

The maximum current of Rad X-ray tube is 400mA, with obtainable maximum voltage of X-ray tube of 80kV.

3.3 Loading time

The loading time can be adjusted in different grades within 2ms～5,000ms, selected in R′10 numeral system;

The loading time variation of X-ray is not larger than ±(10%+1ms).

3.4 Current time product

The current time product can be adjusted in different grades within 0.5mAs～500mAs, selected in R′10 numeral system;

The current time product variation of X-ray tube is not larger than ±(10%+0.2mAs).

The lowest current time product is 0.5 mAs and the lowest current time product combinations are as follows in Table 3-1.

3.5 Max. output power

Maximum output power combinations and maximum output power are as follows in Table 3-2.

3.6 Nominal power

Nominal power combinations and nominal power are as follows in Table 3-3.

Table 3-1 Lowest current time product combinations

X-ray Tube voltage (kV) X-ray Tube current (mA) Loading time (ms) Current time product (mAs)

80 250 2 0.5

80 25 20 0.5

Table 3-2 Max. output power and combinations

Photography X-ray Tube voltage (kV) 100 80

X-ray Tube current (mA) 320 400

Max. output power(kW) 32 32

Table 3-3 Nominal power and combinations

Nominal power X-ray Tube voltage (kV) 100

X-ray Tube current (mA) 320

Loading time (s) 0.1

Nominal power (kW) 32

3.7 Loading factors combinations are in GFS501-1 high frequency and voltage generator installation and maintenance manual.

3.8 Loading factors in automatic exposure state

Shortest irradiation time in automatic exposure is 2ms;

Largest possible voltage variation of X-ray tube within the irradiation time in automatic exposure is ± 10％;

Largest possible current variation of X-ray tube within the irradiation time in automatic exposure is ± 20％;

4. Loading factors accuracy

The accuracy of the loading factors of the product shall meet the requirements of GB9706.3.

Recommended loading factors for accuracy test are as follows in Table 3-5, according to the requirements of GB9706.3.

Table 3-5 Recommended loading factors for accuracy test

Loading factors for test X-ray Tube voltage (kV) X-ray tube current (mA) Irradiation time (ms)

X-ray tube voltage

(intermittent mode) 40 400 2

40 400 100

125 250 100

X-ray tube current

(intermittent mode) 125 25 20

125 25 100

80 400 100

Irradiation time 125 No limitation 2

100X320 2

Current time product 125 0.5mAs

40 500mAs

5. Linearity and stability in indirect mode

The linearity and stability of the product meet the requirements of GB9706.3.

The setting of air kerma for the test is as follows in Table 3-6, according to GB9706.3.

Table 3-6 Air kerma measurement test setting

Experiment setting Tube voltage Irradiation time Air kerma Tube current or current time product

A 40 0.01~0.32s 400 mA

B 125 0.01~0.32s 50 mA

C 63 0.01~0.32s 1µGy~5µGy To set according to requirements

D 100 0.01~0.32s 1µGy~5µGy To set according to requirements

E 63 0.01~0.32s To set adjacent to C

F 100 0.01~0.32s To set adjacent to D

Note: 1. Settings up from A-D are intended for repeated test and settings up from E-F are to test the linearity and stability.

2. The test program requires resetting to the selected values for each loading factors combination before each one of 10 loadings.

6. Other technical index

6.1 The total filtration is not less than 2.5mmAl.

6.2 The inherent filtration of XS1-3 beam filter is not less than 1.4mmAl/70kV.

1. Transportation and storage

1.1 Storage conditions and period

In the transportation or packing state, the product shall be kept for less than 15 weeks in the following environment conditions:

a) Environment temperature: -20℃～+70℃

b) Relative humidity: 10％～93％

c) Atmosphere pressure: 500hPa～1,060hPa

Note Attention should be paid to the followings in the product using and storage positions:

☆ Not to use and store in the environment with the air pressure, temperature and humidity exceeding the permissible range.

☆ To keep sound ventilation and avoid the direct sunshine.

1.2 Notes in lifting and transportation

The examination should be made whether the package is seriously damaged after the product arrives at the destination. Please keep the site unchanged and notify the distributor in time in case of any damage.

Among the transportation signs outside the package, Figure A means the package should be transported straightly up without any toppling, Figure B means the lifting position and Figure C means the center of gravity, Figure D means it’s fragile and should be handled with care and figure E means the package should be kept from rains. Such requirements indicated in such figures should be implemented strictly in the transportation and moving. The product damages due to improper transportation shall be considered as the transportation accidents.

1.3 Transportation data

All main components of the product are packed separately, totally in three boxes, as indicated in Table 4-1.

The product with packages can be transported by air, rail and water and road of level 3.

Table 4-1 Product packing box checking list

No. Box No. Name Outline dimension (mm) Gross weight (kg)

1 1/2 Host box 2220×1320×1200 504

2 2/2 SC4-1 Rad couch box 2130×1070×1000 420

3 2/2 SC4-4 Rad couch box 2220×1470×1100 550

Note: The product package box should be kept from the weight of more than 100kg on the top, to avoid possible damage.

2. Package opening and inspection

2.1 Notes for opening the package

The careful examination should be made on whether the packing box is sound before opening the box. Please keep the site unchanged and notify the distributer in time in case of any damage.

The packing box should be opened gently, to avoid damaging components and parts. The product unit is packed in different boxes for quantities of components. It’s recommended not to leave about all packing boxes to avoid missing spare parts.

2.2 Inspection content

The checking should be made according to the packing lists of each packing box after opening the package and then the components should be arranged in good order. Then the product will be installed in place according to the requirements of component manuals.

Note: The manuals should be kept properly for further checking.

3. Installation conditions and technical requirements

3.1 Product outline and installation dimension

The product unit consists of various components, of which the outlines and installation dimensions are in corresponding manuals.

The area of the product room should be determined according to the user’s configuration. The Manual provides the requirements on the arrangement and area of the Rad couch and X-ray generator (in attached Figure 1), only for reference of the user.

The floor and walls, doors and windows of the product room should meet related protection requirements for X-ray is harmful to the health.

Related safety facilities as safety switch/emergency switch, alarming light and door interlock switch should be provided, installed and connected according to operation procedures by the user. The safety setting interface of the high voltage generator is described in Table 4-2 and the reference can be made on the high frequency and voltage generator installation and maintenance manual for detailed circuits.

Note The product must be fixed on the floor after the installation positioning to make sure the diagnosis quality and reduce the remaining vibration due to moving in the transportation.

Corresponding measures should be taken to strengthen the installation of the product on the wood floor!

Table 4-2 Safety facility interface descriptions

Interface function Terminal number Connection mode

Door lock switch TB1-15～TB1-16 Connection of insulation terminal of cold pressed tube

Exposure preparation

Alarming door light TB1-13～TB1-14 Connection of insulation terminal of cold pressed tube

3.2 Product power supply requirements

a) Power supply type: three phases four wires;

b) Power supply voltage: 380VAC±38VAC;

c) Power supply frequency: 50Hz±1Hz;

d) Power supply internal resistance: ≤0.27Ω;

e) Power supply capacity: not less than instant 42kVA.

3.3 Grid power supply connection

Besides meeting the power supply requirements of the product, the power supply switch cabinet should be equipped with the power supply switches for the high voltage generator and couch. The power supply for the high voltage generator is three-phase 380VAC and that for the Rad couch is single phase 220VAC.

The product is the permanently installed equipment with the power supply cable connected with the wall switch permanently. Therefore, the grid power supply input terminal still is powered after shutting off the host and couch. The wall switch must be shut off in maintenance or any emergencies.

Note To connect the product with the grid power supply with the power supply cable provided by the manufacturer (meeting CCC requirements) or same type of power supply cable.

The manufacturer shall provide the following power supply cable in specifications indicated in Table 4-3:

Table 4-3 Recommended power supply cable

Components Specification

High frequency and pressure generator YC 450/750V 4X10

Rad couch 60227 IEC 53(RVV) 300/500V 2X1

3.4 Product room and arrangement

a) X-ray protection

X-ray is harmful for the health. Therefore, the radiation protection of X-ray generator room should meet the requirements of the national and local related laws and regulations. Please make inquiry to the local environment protection and health and quarantine sectors.

b) Operations environment conditions

The product can be used normally in the following environment conditions:

Environment temperature: +10℃～+40℃

Relative humidity: 30%～75%

Atmospheric pressure: 700hPa～1,060hPa

Appropriate measures should be taken to make sure the environment conditions for the normal operation of the product.

Note The thermometer and hygrometer should be equipped in the product room for monitoring on the temperature and humidity of the operation environment. If the environment conditions fail to meet the requirements of the product operation, the equipment as the air conditioner and dehumidifier should be equipped to make adjustment on the environmental temperature and humidity for the normal operation of the product.

c) Recommended arrangements in the product room

The arrangement is recommended for the product room, as indicated in attached Figure 1. Please make inquiry to Wandong Technical Service Company in case of any other requirements on the installation.

4. Product moving, examination and installation procedures

4.1 Product moving

The product can be moved to the installation position and installed with at least 6 people. The product is generally moved with the forklift or manual forklift of not less than 1,500mm in the length and 1t in the load capacity. The product should be moved to the package opening position with the fork in the base gap of the packing box. The large scale equipment should not be moved out of the packing box after opening and moved to the installation position with the base.

Note To prevent the large components losing balance in the moving and the product will not be used normally in case of deformation due to falling down or collision.

4.2 Package opening and examination

4.2.1 Box opening tools

Nail hammer and mid-size adjustable spanner

4.2.2 The examination should be made before opening the package whether the independently-packed components are complete. The product provides the standard configurations for the package (in Table 4-1 of Section 1.3), which may be different from the package of the user according to specific ordering contracts.

4.2.3 To examine whether the package is damaged. Please keep the site unchanged and notify the distributer in case of any damages.

4.2.4 To remove the packing boxes of the components to be installed on the ground, such as Rad couch box and then to install in place before removing the host packing box.

4.2.5 To open the packing box from the top or the side, to take out of accessories and to keep the accompanying documents properly. Not to open any package materials, as envelope, paper box or paper bag before checking against the packing list.

4.2.6 To take out of the transportation fillings in the packing box and components and parts with care.

4.2.7 Examination after opening box

a) To check whether the type on the nameplate of the component is consistent with that of the contract;

b) To check the components and parts against the packing lists in the component packing boxes and notify the Company or the distributor in time in case of any missing.

c) To examine whether the components are sound in the packing boxes. Please keep the site unchanged and notify the Company or the distributor in time in case of any damage.

4.3 Installation procedures

 The cable connection of the high frequency and voltage generator and couch accessories can be made with reference to the high frequency and voltage generator technical manual.

 The protection grounding must be connected firmly according to the requirements. The grounding of components should be made with yellow-green wires. The grounding resistance of the general grounding terminal should be not larger than4Ω. The grounding connection of the system is indicated in attached Figure 3.

5. Debugging procedures and notes

5.1 Preparations and notes before powering

Caution The contents in this part shall only be operated by the professional technicians approved by the Company. The wrong operation may cause the product damage!

Note The interactive debugging is made before delivery of the product. All state setting and parameter verification are completed. Please make examination and record according to the requirements of the form by the installation engineer.

Caution The parameters of the high frequency and voltage generator must be set up and calibrated again in case of X-ray tube needing replacement. Please contact the technical service center of the Company.

Note The operator must read all contents of the Manual carefully before the operation of the product, learn about and master all signs, operation procedures and notes of the product for correct and safety operation.

To make sure all components are installed and cables are connected correctly with the reference to the component manual; to make operation after powering to verify all functions of the couch.

The debugging and adjustment of large components as high frequency and voltage generator, Rad couch and beam applicator are described in the product manual.

5.2. Debugging procedures and notes

a) The debugging of the system will be made with 1-2 technicians approved by the Company.

b) Debugging tools:

 Digital multimeter

 Oscilloscope

 Densimeter

 Radiation dosemeter

 A set of metric system internal hexagonal wrench

 A set of tool kit

The technical parameters can be calibrated with reference to GFS501-1 High frequency and voltage installation and maintenance manual.

c) AEC calibration

The AEC calibration can be made with reference to GFS501-1 High frequency and voltage installation and maintenance manual.

5.3 Solutions for abnormal conditions after powering

★ Failing to start and Rad couch brake failing to shut on after powering: to examine whether the power supply is normal and the fuse of the generator and Rad couch is sound;

★ The buzzer keeps alarming after starting the high frequency and voltage generator: to observe the fault code on LED screen of the control panel of high frequency and voltage generator; to find the fault descriptions and solutions according to the fault codes in GFS501-1 High frequency and voltage installation and maintenance manual

6. Trial running preparations, trial running and notes

6.1 Trial running preparations

To pull out the braking positioning pin on the column of the Rad couch and to examine whether all brakes are reliable and effective.

6.2 Trial running notes

To read the high frequency and voltage generator operation manual and Rad couch manual carefully and to operate the system for exposure, AEC and Rad moving in different directions according to the guidance of the manual.

Caution Attention should be paid to the radiation protection in the operation of the high frequency and voltage generator to avoid any damages for the operator and adjacent persons.

Caution The operator should always keep observation on system components and related components of the product to avoid the collision with the patient and adjacent objects.

6.3 Pre-treatment of X-ray tube unit

Note The treatment shall be made in the following methods in case of the first operation and the operation after longer period (more than two weeks) suspension:

To observe kVp and mA values with the oscilloscope;

To make following exposure serials (span of 20sec) with allowable minimum mA of the larger focus:

80kVp,0.1sec for three times；

100kVp,0.1sec for three times；

125kVp,0.1sec for three times；

To make extra three exposures respectively at 140kVp and 150kVp for the X-ray tube with the rated voltage of 150kVp.

To lower the voltage by a grade (to lower the grade 80kVp by 10kV) in case of unstable waveform of kV and mA (Tubuloglomerular discharging) in raising the voltage; to repeat the exposure until the tube works stably.

Note In the training or using, it should not exceed the maximum working voltage and not increase the rated rotation speed. The highest temperature should not exceed 70℃. Meanwhile, attention should be paid to making sure not to exceeding the rated value permissible by the focus rated curve.

7. Acceptance inspection test item, method and criteria after installation and adjustment (or debugging)

The product is intended for special photography unit, with only configuration of photography function:

a Ordinary Rad

In ordinary Rad mode, kV and mA can be operated normally. To shut on the grade I, II of the hand switch on the console, the ordinary Rad should be made with the exposure light shining on the console. To measure mA of Rad with oscillo probe, the value should be within the range required by the standard.

b AEC (automatic exposure control)Rad

To enter AEC state after starting; to select appropriate screen speed and graying density and to shut on the hand switch, the exposure light shins on the console, indicating the automatic Rad of the Rad couch.

Caution Attention should be paid to the radiation protection in the loading operation of the high frequency and voltage generator, avoiding damage on the operator and adjacent persons.

1 Preparations and examination before operation

Please read the Manual and component manuals carefully before the operation, trying to learn about the performance and operation method of the product.

The following examinations should be made:

1.1 To examine the connection between the product and the power supply, making sure the sound connection between the product and the power supply and grounding, normal operation of the power supply system and the voltage within the working voltage range stipulated in the system;

1.2 To make sure the normal temperature and humidity of the product room (to start air conditioner, if necessary);

1.3 To examine whether the operation components are on nonworking positions;

1.4 To remove unnecessary objects and equipment in the operation region of the system;

1.5 To clean the product.

In the operation of the system, Rad couch, X-ray source unit and high voltage cable can make medical diagnosis in the environment of the patient. To protect the health of the patient and operator and to meet the environment requirements, attention should be paid to examining the electrical connection of the system and related accompanying documents should be read carefully to make sure the safe and reliable operation of the components of the system.

2 Patient environment

The high frequency and voltage generator, X-ray tube unit, beam applicator and Rad couch are suitable for the operation in the patient environment.

3 Operation method and notes

3.1 Starting procedures of the system:

3.1.1 To switch on the general wall switch of the power supply system;

3.1.2 To switch on the wall switch of the high frequency and voltage generator;

3.1.3 To press the ON button on the console of the high frequency and voltage generator and the high frequency and voltage generator should make self-examination without any fault information;

3.1.4 To switch on the wall switch of Rad couch, the brake can be operated reliably and effectively, moving in free direction for normal operation.

3.2 Shutting off procedures of the system:

After making sure there are no patient or objects blocking the couch movement, to shut off the wall switch of the power supply of the couch at first, to press the OFF button on the console of the high frequency and voltage generator, to shut off the wall switch of the high frequency and voltage generator after the high frequency and voltage generator is powered off; to shut off the general switch of the power supply system at last.

3.3 Descriptions on starting and shutting off of the high frequency and voltage generator

ON: to enter the starting procedure by pressing down the button of the high frequency and voltage generator. After the starting, the system will make self-examination smoothly and will automatically select the ordinary photography at the tube II.

OFF: to press the button to shut off the product and all indicators go out.

Caution The transformer in the product is not shut off the power supply. The general switch should be cut off in case of the product not in operation any longer.

Danger If the cover of the console of the generator requires opening after shutting off, please to make sure remaining energy in each energy storage components is discharged completely and the red shining diode on the power supply plate go out.

Note Please make reference to corresponding manuals for detained operation methods and notes of main components.

Caution If the X-ray tube unit requires replacement, the parameters of the high frequency and voltage generator must be reset and calibrated. Please contact the technical service center of the Company.

Note The operator must, before the product in operation, read all contents of the manual carefully and master all signs, operation procedures and notes for correct and safe operation.

4 Notes and restarting procedures in case of grid fault

The Rad couch is powered separately and the power supply is controlled with the wall switch, so it is not connected with the starting and shutting off of the high frequency and voltage generator.

Note The Rad couch is braked electromagnetically. Attention should be paid to making sure the patient safety in case of any fault of the power supply in the operation.

To restart the system according to the starting procedures after the power supply restoration; to make reference to the fault descriptions and solutions in components manuals for corresponding treatment.

Section 6 Maintenance

1. Daily maintenance and examination

The product is one of precise and valuable medical equipment. It requires the user to learn about the technical performance, structure principle and operation procedures and to make daily maintenance and regular safety examination to make sure the efficiency, to extend the service life and to guarantee the product and personal safety.

Safety examination contains the followings:

*To examine whether there is any mechanical and functional damages on the product and accessories;

*To make regular learning about the power supply and to examine whether the power supply resistance (or voltage) is changing and to make sure the requirements of the product;

*To make regular examination whether the protection grounding and connection terminals of components are loosed or moved. To fasten from time to time, if any.

1.1 Regular maintenance

The regular maintenance must be made to make sure the safe and continuous operation of X-ray high frequency and voltage generator.

The regular maintenance should be made in two methods, of which the first is made by the user or the operator and the second is made by the professional maintenance personnel.

The first regular maintenance should be made after six month when completing the installation. The further maintenance is made every 12 months.

1.2 Operator’s duties

The regular maintenance should contain the followings:

Caution Not to move any cover of the high frequency and voltage generator; not to disassembly or alter any components in the control cabinet of the high frequency and voltage generator, which will cause serious personal injuries and equipment damage!

Note Not to clean any part of the system with the power on. To shut off the generator and couch and make sure the insulation of the electrical equipment before the cleaning.

1.2.1 To shut off the high frequency and voltage generator and cut off the wall switch;

1.2.2 To make regular sterilization with common ultraviolet method according to the actual requirements of the hospital, generally every week. The extra sterilization may be made in case of larger outpatient.

1.2.3 To examine the cable connection of main parts of the high frequency and voltage generator (with control cabinet, console and high voltage transformer unit).

1.2.4 To clean the product regularly, with clean water with little soap for shell and surface in case of any chemical corrosion; to clean with the damp cloth of clean water, without any detergent or solvent.

1.3 Maintenance personnel’s duties

Caution The maintenance personnel must pass the related professional training of the system. Otherwise, the Company shall not be responsible for any equipment damage in the maintenance and personal injuries after the maintenance.

Note The filament value must be reset in case of replacing any main components as X-ray tube unit, high voltage transformer or main circuit plate (HTCPU and filament plate).

Note The electrical connection of components must be checked against the electrical connection drawing.

Note To examine whether the grounding is connected soundly and grounding nail is loose or rust according to the protection grounding diagram and to fasten or replace screw, if any.

It’s forbidden to disassembly any protection grounding wire arbitrarily and grounding terminals should not be used for other purpose.

To examine whether the switch is contacted soundly and the brake strength is adequate of the accessory equipment of the couch.

The maintenance should be made in accordance with the specific requirements on the regular maintenance in component manuals.

In case of the disassembly of X-ray source unit (including X-ray tube unit and beam applicator) in the maintenance of the system, the field should be examined again to make sure whether there is any excursion and the adjustment should be made, if any.

2 Maintenance in operation

The high voltage generator of the system has the function of self-examination. Please inquiry fault code table to determine the problem or contact the maintenance personnel in case of any fault of the product.

3 Maintenance period and method

Table 6-1 Component maintenance period and contents

Maintenance component Maintenance period Maintenance contents

Whole unit Half a year to one year Safety maintenance of the whole unit

High frequency and voltage generator Half a year to one year Protection grounding, connection terminal, examination function, kV, mA curve

Rad couch Half a year to one year Protection grounding, connection terminal, steel wire

Beam applicator Half a year to one year Protection grounding, connection terminal, spot light

X-ray tube unit Half a year to one year Protection grounding, connection terminal, target surface

To pay attention to whether the movable parts work normally and special attention should be paid to the wearing of the steel wire and make regular cleaning and lubricating. To examine whether the bearing is worn, rust and corrosive and lack of lubricant; to apply clean lubricant after the cleaning, if necessary.

The common ultraviolet sterilization method is suitable for the components touching with the patient as the couch surface. It’s not proper to make cleaning on the metal surface of painting with alcohol for a long time to avoid impacting the appearance of the product due to chemical reaction of the alcohol with the painting layer.

4 Maintenance for long time storage

If the product in idle for a long time, please cut off the connection with the grid power supply, to cover the high frequency and voltage generator, console and Rad couch well with the tarpaulin and to make regular cleaning and wiping on the room and the product.

To make anti-damp treatment to avoid the oxidation and rust corrosion of the product.

Some preparations should be made before using again the high frequency and voltage generator after a long time idle to make sure the normal operation of the high frequency and voltage generator.

To make warm up for a period of time;

To make tube unit training (referring to GFS501-1 high frequency and high voltage generator installation maintenance manual

To install the limit block of Rad couch and cover the dust cover for the long time idle of Rad couch; After a long time idle, to pay attention to whether the movable parts work normally and special attention should be paid to the wearing of the steel wire and make examination on whether the bearing is worn, rust and corrosive and lack of lubricant; to apply clean lubricant after the cleaning, if necessary

5 Environment protection requirements

The X-ray product is designed according to the latest environment protection standards. The product will make no harm to the people and environment in case of correct operation of the product without disassembly of the product.

Some materials harmful to the environment are used for some required functions of the product. Therefore, the waster of the X-ray product shall not be mixed with ordinary industrial and domestic waste;

The waste of the X-ray product shall be treated in accordance with the stipulations of the local environment protection sector.

1) The waste transformer oil should be recycled according to the requirements of the environment protection sector;

2) The replaced components in the maintenance should be recycled.

Section 7 Sign and symbol

1 Product nameplate

The nameplate of the product is indicated in Figure 7-1. Figure 7-2 shows the general nameplate, used on the cover of the electrical cabinet of the generator.

Figure 7-1 Product nameplate

Figure 7-2 General nameplate

Other component nameplates of the product are stick to corresponding components, with reference to the component manuals.

2. External signs and related descriptions

The product has the following external signs, as indicated in Table 7-1.

Table 7-1 External signs and related descriptions

Sign Position Description:

On product name plate Type B application part

High frequency and voltage generator’s electrical cabinet side Environment protection sign

High frequency and voltage generator’s electrical cabinet façade and side High voltage bus warning sign

3. Internal signs and related descriptions

The product has the following internal signs, as indicated in Table 7-2.

Table 7-2 Internal signs and related descriptions

Sign Position Description:

Grounding Protection grounding sign

N wire connection Neural wire

At 380VAC power supply inlet terminal in the control cabinet of GFS501-1 high frequency and voltage generator 380VAC power supply fuse sign

4. Warning signs and related descriptions

The product has the following warning signs, as indicated in Table 7-3.

Table 7-3 Warning signs and related descriptions

Sign Position Description:

Contravariant unit side

High voltage oil tank top cover High voltage danger

Couch To make sure the safety of hands in the operation of the product

Figure 1 Product room arrangement

Chinese English

操作间 Operation room

铅玻璃窗 Lead glass window

控制台 Console

电源闸 Power supply switch

电器柜 Electrical cabinet

摄影床中心 Rad couch center

Figure 2 System principle block diagram

Chinese English

摄影床 Rad couch

限束器 Beam applicator

控制盒 Control box

高频高压发生装置 High frequency and voltage generator

高压油箱 High voltage oil tank

启动线 Starting line

温控线 Temperature control line

高压电缆 High voltage cable

X射线管组件 X-ray tube unit

Manufacturer: China Resources Wandong Medical Equipment Co., Ltd.

Registered address: Building 3 Yard 9 Jiuxianqiao East Road Chaoyang District Beijing

Production address: Building 3 Yard 9 Jiuxianqiao East Road Chaoyang District Beijing

No. 7 Sanjianfang Nanli Chaoyang District Beijing

After-sales service provider: Manufacturer: China Resources Wandong Medical Equipment Co., Ltd. Technical Service Branch

Address: Building 3 Yard 9 Jiuxianqiao East Road Chaoyang District Beijing

Postcode: 100015

Service Tel: 400 815 8800

Fax: 010-5885 7466

E-mail：infor@wdjf.com

Website：www.wdjf.com

(The product parameters may change without prior notice)

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