HF50-R System12.9 PDF

HF50-R HF50-RA
X-ray Unit
for Medical Diagnosis Purpose
Instructions
September 2012
For this unit：
Serial Number of Medical Device Manufacturer License:
JingYaoJianXieShengChanXu No. 20000063
Equipment Type: This Unit is a type of permanently installed stationary equipment which
protection capability against electric shock is Class I, Type B. It has
application parts but no signal input/output parts.
Operation Mode: Continuous operation, intermittent loaded.

Conditions for Transportation and Storage:
(1) Environmental temperature: -20℃～＋70℃；
(2) Relevant humidity: ≤ 93 %；
(3) Atmospheric pressure: 70.0kPa～106.0kPa.
Environmental Conditions for operation:

a) Environmental temperature: 10℃～40℃;
b) Relevant humidity: 30%～75%;
c) Atmospheric Pressure: 70kPa～106kPa.
Manufacturer Responsibility:
The manufacturer is responsible for the security, reliability and performance of this product
in following cases:
a. All Installation, supplementation, commissioning, modification or services are

performed by the personnel approved by the Manufacturer;
b. All electric equipments related to this product accord with the national standards; and
c. This product is operated in line with instructions in the User’s Manual.
NOTE: This Unit shall be used only after proper installation and
commissioning conducted by trained professionals to avoid
unnecessary damage to the Unit or injury to human body.
In case of any conflict in this Manual with the manual of any component, the latter prevails.
In addition to this Manual, other manuals of the components are also provided with the Unit
(different depending on the configuration of the Unit). For the use and maintenance of the
components, refer to the appropriate documentation provided.
Preface
Thank you for purchasing the medical products manufactured by Wandong.
Before using this Unit, be sure to read following precautions carefully for instructions on
how to use it properly.
Safety Precautions:
○ Please read Safety Precautions carefully before using this Unit for proper operation.
○ Be sure to observe the precautions describes in details the important points on safety.
Danger: Advise of conditions or situations that if not heeded or avoided

could cause personal injury or casualty.
Warning: Advise of conditions or situations that if not heeded or avoided

could cause personal injury/casualty or damage to partial or whole
Unit.
NOTE: Advise of conditions or situations that if not heeded or avoided

could cause misoperation or failure.
○ Symbolic marks
This symbol alerts readers of the information on dangers, warnings and

notices, which details are clearly stated in the corresponding sections.
The appearance and technical parameters of this may be alternated

without further notice.
Please carefully read the instructions shown at the ordering interface!

NOTE
In order to avoid dangerousness and ensure safe operation, the following shall be
followed:
◆ Read carefully the following points for proper operation.
◆ Be sure to know the exact operation of the equipment before use.
◆ Following points should be followed when configuring and storing the device:
☆ Do not use or store the device at the places easy to be wet or splashed by water.
☆ Do not use or store this equipment in an environment where air pressure,

temperature or humidity is beyond allowable limits.
☆ Keep ventilated and avoid being exposed directly to sunlight, and prevent from
corrosion of the air containing dust and salt.
☆ Keep this Unit from inclining, unsteadiness, vibration and striking (including
during transportation).
☆ Do not use or store this Unit in a location exposed to chemical corrosion or

flammable gasses.
◆ Following points shall be noticed before use:
☆ Confirm correct connections of the Unit and examine if it operates properly.
☆ Ensure that the Unit is well grounded. All yellow/green wires used in the Unit are
protective grounding wires.
◆ Do not disassemble or move the Unit if any failure occurs. Attach a notification with
the word “Malfunction!” on this equipment and contact with Wandong Technical
Service center or local maintenance section authorized by Wandong.
◆ No modification to this Unit is allowed.
◆ Maintenance and Inspection
☆ Examine this Unit and its parts regularly.
☆ Make sure that this Unit works properly and safely when it is reused after a
period of being free from service.
◆ The protective grounding wire must be connected to special protective earth device.
Do not substitute this wire with supply null line.
Type B Equipment
Protective Grounding
Talbe of Content
Section 1 Introduction................................................................................................ 1
1. Anticipate use ................................................................................................... 1
2. Description of the Unit ...................................................................................... 1
3. Documentations for this Unit (see Table 2) ....................................................... 2
Section 2 Product Marks .............................................................................................. 4
1. Classification..................................................................................................... 4
2. Product Certification ......................................................................................... 4
3. Nameplates....................................................................................................... 4
4. Common-used Nameplate ................................................................................ 5
Section 3 Instructions for Use ................................................................................ 6
1 Installation and Commissioning ......................................................................... 6
2. Instructions for Use ........................................................................................ 8
Section 4 Safety and Protection ................................................................................. 10
1 Maximum Permitted Dose (MPD) .................................................................... 10
2 Radiation Protection ...................................................................................... 11
Section 5 Maintenance and Service .................................................................... 12
Table 3 Hazardous Substances or Elements Contained .................................... 13
Figuires ...................................................................................................................... 15
User’ Manual js0114 HF50-R HF50-RA
Section 1 Introduction
1. Anticipate use
HF50-R / HF50-RA X-ray Units are intended to be used by medical or research organizations
for performing radiological diagnosis.
2. Description of the Unit
This User’s Manual provided with the Unit includes all necessary information for
operating/using the Unit, which provides general description about the Unit, instructions for
safe operation, information on adjusting, operating commands and technical parameters.
2.1 Unit Configuration
The Unit is composed of HV generator, X-ray tube assembly and table accessory. Other
optional components may be provided as requested by user. Key optional components are
shown in Table 1.
Table 1 Unit Configuration

HF50-RA HF50-R
Component
Category
Component
Component
Designation Type 1 Type 2 Type 1 Type 2 Type 3 Type 4
HV Generator GFS501-1 1
XD52-30.50
X-ray Generator
1 -
X-ray Tube /125H-T2F
Assembly
E7843X - 1
Beam limiting
XS1-2 1
device
SC4-1 1 - 1
SC4-4 - 1 -
Supporting Devices
Radiography
Table SC3-3 - 1 -
SC3-4 - 1 -
Ceiling rail DJ50-1
- 1 -
Hanger
X-ray Source
1
Assembly ZZ-5 - 1 -
(Opt)
Strut
Wandong Medical 1 Ver. 02

2.2. Key Technical Specifications
Power voltage: three-phase, 380V±38V
Power frequency: 50Hz±1Hz;
Internal Resistance of Power Supply: no more than 0.17Ω;
Safe ground resistance: No more than 4Ω
Rating of the over-current protector: 70A;
Rated leaking current to ground of the leakage protector: 20mA (electromagnetic)
Input Power: no more than 65kVA;
Max output power: 50kW;
Max tube voltage: 150kV (for E7843X) / 125 kV (for XD52-30.50/125H-T2F)；
Adjusting range of tube current: 25mA ~630mA；
Radiography time: 0.02s～5s
Adjusting range of current time product: 0.5mAs－500mAs
The adjusting ranges of the current time product and radiography time are selected from R’10
or R’20 numerical Series.
NOTE: AEC controllable minimum time depends on X-ray tube voltage, tube
current and AEC baseline setting.
For other detail specifications, see corresponding manual for each component.
3. Documentations for this Unit (see Table 2)

Table 2. Documentations for this Unit
HF50-RA HF50-R
Document Title
Type 1 Type 2 Type 1 Type 2 Type 3 Type 4
HF50-R / HF50-RA X-ray

Unit for Medical Diagnosis 1
User’s Manual
Operation Manual of
GFS501-1 HF – HV
Generator
1 suite
Installation, Test and
Maintenance Manual of
GFS501-1 HF - HV Generator
XD52-30, 50 /125H-T2F
User's Manual of Rotating Anode 1 piece -
X-ray Tube Assembly
E7843X List of - 1
Specifications
User’s Manual of SC4-1

1 - - 1
Radiographic Table
User’s Manual of SC4-4 -

- 1 1
Radiographic Table
User’s Manual of SC3-3 1 -

-
Radiographic Table
User’s Manual of ZZ-5 1 if 1

X-ray Source Assembly selected
- as
-
Strut
optional
User’s Manual of SC3-4 - 1 -

Radiographic Table
User’ Manual of DJ50-1 - 1 -

Ceiling Rail Hanger
User’s Manual for XS1-2 1

Beam limiting device
The above are the user’s manuals provided with the components. For specific models, refer
to the marks on the product. These marks should correspond to those in the User’s Manual.

Section 2 Product Marks
1. Classification
 Anti-electric shock: Class I -- Type B, with application parts.
 Anti-harmful fluid: Common Type
 Safety level when operating in the environment of mixture of combustible narcotic gas
and air or mixture of combustible narcotic gas and nitrous oxide: This Unit is a device
that cannot be used under the existences of mixtures of combustible narcotic gas and
air or mixtures of combustible narcotic gas and nitrous oxide.
 Operation Mode: Continuous operation, intermittent loaded.
2. Product Certification
Manufacturer / Product obtained following certification:
 ISO9001
 ISO13485
 CCC Safety Certification
3. Nameplates
This Unit is labeled with a nameplate for whole Unit and nameplates for all components. The
nameplate for whole Unit is shown as follows:

4. Common-used Nameplate

Section 3 Instructions for Use
1 Installation and Commissioning
1.1 Requirements for Installation
1.1.1 Room Conditions
The area of the operation room should be determined according to the Unit configuration
requested by user. The room layout provided in this Manual is only for user's reference
(see Figure 1, 2 and 3).
1.1.2 X-ray is harmful to human bodies. Therefore, the arrangement of the operation room
where the Unit it is installed, including storey, walls, doors and windows, shall accord with
concerning protective requirements.
WARNING: Temperature and humidity testers shall be installed in the room

where this Unit is installed, in order to monitor the environmental
temperature and humidity. In case the environmental condition
does not meet the requirements for using this Unit, air-conditioner
or humidity-conditioner should be installed to secure proper
operation of the Unit.
NOTE: In order to avoid X-ray radiation to the operating doctor during

exposure, the doctor often needs to perform operation in a protected
zone. Therefore, an intercom device should be installed for patient to
hear clearly the instructions from the doctor.
1.2 Installation Procedures
1.2.1 Check the parts against the packing list first, and then place them in order and carefully
read the Manuals for each component before installing them according to the Manuals. As
there are multiple components that are packed separately in different boxes, it is suggested
to arrange these boxes orderly to avoid missing any component.
NOTE: Pease keep the Manuals properly for later use.

1.2.2 Other safety devices, such as safety/emergency switches, alarming lamp and door
interlocking switch, are to be provided and installed by user. All these shall be installed
according to the specified procedures.
1.2.3 Power Line Connection

The Power Supply should satisfy the requirement of this Unit. In addition, a main power
switch for the whole Unit and a separate power switch for table accessory should be set in
the power cabinet. The wall switch must meet with the requirements for the creepage and
electric clearance specified in IEC328, Switches for Electric Appliances.
The power line of HV generator should be connected to wall switch via power cabinet. The
power lines of table accessories may be determined based on specific configuration. (Please
refer to Figure 4.)
This Unit is a type of permanently installed and the power line is permanently connected to
the wall switch. The mains input terminals of both mainframe and the table will still be
electriferous. Disconnect the wall switch before repairing the Unit or at an emergency.
The power lines accord with CCC requirements.
1.2.4 For the cable connections between HV Generator to all table accessories, refer to the
Entire Unit Connection Diagram in this Manual (Figure 4).
1.2.5 Grounding wires should be connected firmly according to the requirement. All grounding
wires are green/yellow ones. The grounding resistance of the main grounding terminals
should be no more than 4Ω. For connections of grounding wires, see attached Figure 4.
1.2.6 For the alignment of the Table, Ceiling-rail Hanger (if selected as optional) and X-ray
Source Assembly Strut (if selected as optional), refer to the manuals for these components.
1.2.7. See Beam limiting device Manual for installation of the Beam limiting device.
1.3. Overall Combined-Commissioning
WARNING: The procedures described in this Section must be performed only by

qualified personnel approved by our Company. Any improper
operation may result in damage to the Unit!
1.3.1 Examining each component by starting them.
Before commissioning the Unit, assemble each component, power on them separately and
examine them against the component manuals respectively, such as HV generator and
diagnostic table.
1.3.2 Separately commissioning each component

After installation of mechanical parts is completed, perform electrical connection. After

confirming that all connections are correct, power on the components such as HV Generator
and Diagnostic Table, and then test and adjust them accordingly.
1.3.2.1 For commissioning of HV Generator, refer to Installation, Test and Maintenance

Manual of GFS501-1 HF - HV Generator.
1.3.2.2 For the commissioning of Radiographic Table, refer to the manual of Radiographic
Table.
1.3.2.3 For Commissioning of Beam limiting device, see the Manual of Beam limiting device.
1.3.2.4 For Commissioning of X-ray Source Assembly Strut, see the Manual of X-ray Source
Assembly Strut.
1.3.2.5 For Commissioning of Ceiling-Rail Hanger, see the Manual of Ceiling-Rail Hanger.
1.3.3 Powering on the Unit (refer to the powering-on sequence).
1.3.4 Function verification
After powering on the unit, operate the buttons on the panel of H-V Generator and observe if
the indications on the LCD display properly. After confirming all indications are in proper
conditions, examine the functions of Normal Radiography, Anatomic Programmer
Radiography and Bucky Radiography, by referring the manuals of the components.
1.3.5 System commissioning
Conduct commissioning according to the manuals of specific components to confirm all

technical specifications are met.
2. Instructions for Use
2.1 Please conduct following examinations before starting the Unit:
2.1.1 Confirm that the power supply system works properly and keep the room at appropriate
temperature and humidity (air conditioning unit can be used if necessary).
2.1.2 Confirm that all controls are at non-operating status.
2.1.3 Confirm that all emergency switches are released.
2.2. Precautions
In order to protect the patient, operator and the environment, please ensure the proper
electric connections and carefully read the documentation provided with the Unit. Be careful
to ensure the Unit to work in a safe and reliable manner.
2.3 Starting Sequences

Close the wall switch for main Unit first and then the wall switch for HV Generator. Press
down the Power-On button on the console of HV Generator. After the HV self tests successful,
close the wall switch for the Table.
2.4 Shutting down
Cut off the wall switch for the Table first, Then, Press down the Power-Off button on the
console of HV Generator. After the HV Generator is powered off, cut off the wall switch for HV
Generator. Finally, cut off the wall switch for main Unit.

Section 4 Safety and Protection
Failure to comply with the protection requirements might result in injury to the patient
and operator.
Each person involved in X-ray operation must read all the safety and adjustment
requirements, in particularly the parts marked with “Important! ...... X-ray Protection”.
This is of critical importance. Carefully read and understand these requirements before
operating the Unit.
Though X-ray is harmful to human health, no danger will be brought by X-ray equipment as
long as proper procedures have been performed. Ensure that the maintenance and operation
personnel have received proper training and know that the radiation is harmful. Those in
charge of this Unit must know the safety requirements on operating X-ray unit. Carefully read
all the manuals for each component to fully understand safety and operation requirements.
Warning: Operators should observe the components from time to time to

secure that the patient will not be hit by any component.
Warning: Failure to follow Manufacturer’s requirements on repairing and

maintenance or any change to the Unit without approval may
result in injury to patient or operator due to excessive X-ray
exposure. Wandong assumes no liability for such injury.
1 Maximum Permitted Dose (MPD)
Many studies on X-rays have provided the basis for X-ray MPD. These study results have
been adopted by ICRP in the development of MPD standards. Of course these limits are not
easy to determine, so new achievements must be tracked and turned into actual applications.
For the professionals engaged in X-ray work, the maximum accumulative total exposure dose
recommended by ICRP should be no more than following:

* Average effective dose within 5 successive years 20 mSv
* Average effective dose within a year 50mSv
* Annual equivalent dose to eye lens 150mSv
* Annual equivalent dose to hands, feet and skins 500mSv
2 Radiation Protection
Many measures have been taken to prevent direct exposure to harmful X-ray. It might take
months or years before symptom appears due to cumulative effect of X-ray’s impact. For an
operator, the principle of safety is to “avoid being directly exposed under X-ray at any time”.
Any object in the way of X-ray may produce secondary (scattered) radiation, which intensity
depends on the energy and intensity of initial radiation as well as the atomic number of the
irradiated object. which intensity might be higher than the ray to the film. Measures should be
taken against such radiation.
Lead screen is an effective way to reduce secondary radiation. To minimize the risk, please
use lead screen, lead gloves, lead apron, and lead thyroid collar during operation. Lead
screen should be no less than 2mm or 2mm lead equivalent. Personnel safety wares such as
lead gloves and lead apron, should be no thinner than 0.25mm or 0.25mm lead equivalent.
To secure fundamental protection, refer to the Basic Standards for Radiological Protection
provided by your radiological protection department.
Warning: Do not expose hands, wrists, arms or other body parts directly to
radiations when operating or servicing X-ray Unit.

Section 5 Maintenance and Service
This Unit is of precious medical equipment. Users should not only understand its technical
performance, structure and operation procedures, but also perform routine maintenance and
regular safety examinations to it, in order to make it work sufficiently, extend its service life
and secure the safety of both human and the Unit. The safety examinations include:
Note: Safety examinations should be performed annually or once half a year.

The examiners must be the trained and qualified professional
technicians.
 Examine if there is any mechanical or functional damage to the Unit and its accessories.
 Regularly examine if there is any change to the voltage of the power supply to secure that
it meets the Unit requirement.
 Regularly examine the protective grounding wires and terminals for all components to
check for any loose or displacement. If any, tighten or fix it immediately.
Carefully read the requirements for maintenance/service in the Manual for each component.

All hazardous substances or elements contained in this Unit are listed below.
Table 3 Hazardous Substances or Elements Contained
Hazardous Substances/Elements
Component/ Lead Mercury Cadmium Chrome Polybrominat Polybrominated

Element VI ed Biphenyls Diphenyl Ether
(Pb) (Hg) (Cd)
(Cr(VI)) (PBB) (PBDE)
Electronic
× × × × × ×
Device/Element
PCB × О × О × ×
Nylon/Plastic × ×
× × × ×
Parts
Part Coating × × × × × ×
Lead
Protective × О О О О О
Parts
О: means that the content of hazardous substances or elements in all homogeneous

materials is below the limit of specified in SJ/T11363-2006.
X: means that the content of hazardous substances or elements in at leas one

homogeneous material is over the limit of specified in SJ/T11363-2006.
Containment of hazardous substance/element is because of incapability of using an

alternative for hazardous substance/element due to limited technical process level in the
world at present. As technical improvements, the Manufacturer will actively seeking for the
designs using alternatives of hazardous substance/element or reducing the use of them.
50
This mark is the marking for control of pollution caused by electronic information products. It
indicates that this product contains certain hazardous substance/element. The duration of
environment-friendly use of this product is 50 years.
Note: This duration does not cover consumable parts such as batteries and luminescent
screens.

It is safe for use of this Unit if it is properly used under required environmental conditions
with required power supply. Any Unit beyond the environment-friendly use period shall be
recovered through recycling procedures.

Figuires
Figure 1 Installation Schematic of HF-50R Units together with SC3-3 table and
ZZ-5 Stand

Figure 2 Installation Schematic of HF-50R HF-50RA Units together with SC4-1

table and SC4-4 table

Figure 3 Installation Schematic of HF-50R Units together with SC3-3 table and
SC3-4 table and ceiling rail hanger

Mains power Total switch

Power voltage：380V A B C N Wall switch
X-ray tube assembly
Power frequency ：50Hz

XD52-30.50/125 or
HV socket GFS501-1 HV generator device Power Internal Resistance：≤0.17Ω
Sampling board
Wall switch capability：≥70A
E7843X
TB 2 A B C
Filament board
HV transformer assembly
6mm ×10m
6mm ×13m
6mm2 ×16m
6mm2 ×12m
6mm2 ×20m
6mm2 ×10m
2
HTCPU Board
Anode、cathode
HV generator device switch
Radiography table switch

V1 V 2 Main athwart change circuit
Ano de sta rtup、
tem pe rature co dtro l
PP 2
TP2
PC 3 PT 9 U V W N
A B C A B C
2
6 mm × 0.8 m
2
6 mm × 10 m
X-ray source assembly stand
Radiography table
XZ
Power supply box

LC 3 LC 4 JX 81 Light spot lamp XZ DZ 1A XZ
Power supply box
XZ
ZZ -5
Operation console
JX 82 CZ 10 1
XZ
Brake power DJ50-1
GFS501-1
SC3-4
SC3-3
Ceiling rail hanger Radiography table

JX L
Vibrational grid
SC4-4
SC4-1 Radiogrphy table
Radiogrphy table
Figure4 HF50-R HF50-RA Entire Unit Connection Diagram Ver:a

F5
XZ-3
L
A5 5A Beam limiting device light
2 9 V/3 .5 A
XZ-1 spot lamp Power supply
L F4
XZ-4
4A A1 L0
220V Power supply
A3 D1 XZ-5
F3 CZ101-8
1 3
A2 AC + C1 R1
2 2 V/4 A 5A
AC220V 2 K/2 W DC24V Brake
2 4
AC - 2 2 0 0 μ /5 0 V XZ-6
B1 CZ101-10
6 A/1 0 0 0 V
Vibrational grid
B4 XZ-9 JXL -2 JXL -7
F2 D2
N XZ-2 1 3
B2 AC + R2
C2
2 4 V/5 A 5A 2 K/2 W
2 4
AC -
2 2 0 0 μ /5 0 V XZ-10
B5 JXL -3 JXL -8 ZL
6 A/1 0 0 0 V
JXL -6
JXL -5 EXP .fe ed b ac k
SC4-1
Radiography table brake
XZ-2
XZ-7 PT9-1
KMA1-2
XZ-11 PT9-2
XZ-12 PT9-3
XZ-13 PT9-4 GFS501-1

HV generator device
Figure5 Power box connection diagram for SC4-1 together with GFS501-1generator Ver:a

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HF50-R HF50-RA

Operation Mode: Continuous operation, intermittent loaded.

(2) Relevant humidity: ≤ 93 %；

(3) Atmospheric pressure: 70.0kPa～106.0kPa.

Environmental Conditions for operation:

b) Relevant humidity: 30%～75%;

c) Atmospheric Pressure: 70kPa～106kPa.

a. All Installation, supplementation, commissioning, modification or services are

c. This product is operated in line with instructions in the User’s Manual.

Thank you for purchasing the medical products manufactured by Wandong.

Danger: Advise of conditions or situations that if not heeded or avoided

Warning: Advise of conditions or situations that if not heeded or avoided

NOTE: Advise of conditions or situations that if not heeded or avoided

This symbol alerts readers of the information on dangers, warnings and

The appearance and technical parameters of this may be alternated

Please carefully read the instructions shown at the ordering interface!

◆ Read carefully the following points for proper operation.

◆ Be sure to know the exact operation of the equipment before use.

☆ Do not use or store this equipment in an environment where air pressure,

☆ Do not use or store this Unit in a location exposed to chemical corrosion or

◆ Following points shall be noticed before use:

☆ Confirm correct connections of the Unit and examine if it operates properly.

◆ No modification to this Unit is allowed.

◆ Maintenance and Inspection

☆ Examine this Unit and its parts regularly.

2. Description of the Unit

Table 1 Unit Configuration

Wandong Medical 1 Ver. 02

2.2. Key Technical Specifications

Power voltage: three-phase, 380V±38V

Power frequency: 50Hz±1Hz;

Internal Resistance of Power Supply: no more than 0.17Ω;

Safe ground resistance: No more than 4Ω

Rating of the over-current protector: 70A;

Rated leaking current to ground of the leakage protector: 20mA (electromagnetic)

Input Power: no more than 65kVA;

Max output power: 50kW;

Max tube voltage: 150kV (for E7843X) / 125 kV (for XD52-30.50/125H-T2F)；

Adjusting range of tube current: 25mA ~630mA；

Radiography time: 0.02s～5s

Adjusting range of current time product: 0.5mAs－500mAs

3. Documentations for this Unit (see Table 2)

Wandong Medical 2 Ver. 02

Table 2. Documentations for this Unit

HF50-R / HF50-RA X-ray

User’s Manual of SC4-1

User’s Manual of SC4-4 -

User’s Manual of SC3-3 1 -

User’s Manual of ZZ-5 1 if 1

User’s Manual of SC3-4 - 1 -

User’ Manual of DJ50-1 - 1 -

User’s Manual for XS1-2 1

Wandong Medical 3 Ver. 02

Section 2 Product Marks

 Anti-electric shock: Class I -- Type B, with application parts.

 Anti-harmful fluid: Common Type

 Operation Mode: Continuous operation, intermittent loaded.

Manufacturer / Product obtained following certification:

 CCC Safety Certification

Wandong Medical 4 Ver. 02

Wandong Medical 5 Ver. 02

Section 3 Instructions for Use