ASR-3000 User Manual PDF

ASR-3000 Mammography System
ASR-3000
Mammography System

User Manual
Rev 2.0

Shenzhen Anke High-tech Co., Ltd.

Content
Shenzhen Anke High-tech Co., Ltd. ................................................................... 1
Content ....................................................................................................................... 2
1 Safety....................................................................................................................... 4
1.1 Manual Conventions..................................................................................... 4
1.2 Application Scope of ASR3000 Mammography System......................... 5
1.3 Contraindications of ASR3000 Mammography System.......................... 5
1.4 Operation and Storage Shipping Environmental Conditions for
ASR3000 Mammography System.......................................................................... 5
The normal operation room of Mammography System is less than twenty
square meters. No smoking in the control room; Fireproofing is a necessity (making
emergent fire precaution measures according to requirements of the local fire
control department). ................................................................................................... 5
1.6 Conforming Standards of ASR-3000 Mammography System --safety........ 7
1.6.1 China ................................................................................................. 7
1.6.2 Europe ............................................................................................... 7
1.7 Conforming Standards of ASR-3000 Mammography System - EMC......... 8
1.8 Service life of ASR-3000 Mammography System....................................... 8
1.9 Symbols and Labels of ASR-3000 Mammography System......................... 8
1.9.1 Symbols ............................................................................................. 8
1.9.2 labels................................................................................................ 11
1.10 Maximum Permissible Dose (MDP) ........................................................ 13
1.11 Manufacturers responsibility................................................................... 13
2 Introduction to ASR-3000 Mammography System............................................ 15
2.1 Structure Features of ASR-3000 Mammography System.......................... 15
2.1.1 Structure of ASR-3000 Mammography System............................. 15
2.1.2 Features of ASR3000 Mammography System............................ 16
2.2 Operation Principle of ASR-3000 Mammography System........................ 17
3 Technical Data of ASR-3000 Mammography System....................................... 18
3.1 Specifications of ASR-3000 Mammography System................................. 18
3.2 Performance Introduction to ASR-3000 Mammography System.............. 20
3.3 Dimensions and Weight of ASR-3000 Mammography System................. 21
4 Installation and adjustment of ASR3000 Mammography System................. 22
4.1 Installation of ASR3000 Mammography System................................... 22
4.2 Power On Inspection of ASR-3000 Mammography System...................... 25
4.2.1 Console inspection of ASR-3000 Mammography System.............. 26
4.2.2 Power on inspection of ASR-3000 Mammography System - Main
Unit.................................................................................................................... 27
4.2.3 Power on inspection of ASR-3000 Mammography System Head28
4.3 Exposure Test of ASR3000 Mammography System.............................. 31
5 Operation and Application of ASR-3000 Mammography System......................... 33
5.1 Preparations for Patients............................................................................. 33
5.2 Head Adjustment of ASR3000 Mammography System......................... 33
5.3 Pressure Presetting of ASR3000 Mammography System...................... 33
5.4 Operation of Mammary Compressor of ASR-3000 Mammography System
2
.................................................................................................................................. 34
5.5 Radiography of ASR-3000 Mammography System................................... 35
6 Troubleshooting of ASR3000 Mammography System...................................... 37
7 Protection and Maintenance of ASR-3000 Mammography System...................... 39
8 Unpacking Inspection of the ASR-3000 Mammography System...................... 41
9 Company Information ........................................................................................... 43

3
1 Safety
Breast cancer is a kind of common malignant tumor among women. To detect,
diagnose and treat it in its early stage is the only powerful way to prevent and cure breast
cancer and prolong patients' life. Mammography Machine is an effective measure to
inspect mammary diseases, detect and diagnose nonage breast cancer for the time being.
ASR-3000 Mammography System adopts modern technology which is dedicatedly
developed and produced by Shenzhen Anke High-tech Co., Ltd., China (referred to as
Anke hereinafter) With its high degree of automation and image clarity and pretty
operation conveniency for its human technology in design, it turns into a significant
equipment in image diagnosis of mammary diseases.
1.1 Manual Conventions
The manual stress the relevant information or potential risks on personnel or
equipment in three ways
ATTENTION:
CAUTION:
WARNING:
Definitions of ATTENTION, CAUTION AND WARNING are given as follows:
WARNING--- refers alarm for operations or situations that are likely to result in
injuries or death of persons.
CAUTION --- indicates some operations or situations are likely to result in some
equipment damages, inexact data or ineffective programs.
ATTENTION --- proposes some useful information for some function or program.
4
For the safety of equipment and personnel, please read carefully the relevant
chapters about safety and all warnings, cautions and attentions throughout this manual
before using the equipment.
1.2 Application Scope of ASR3000 Mammography System
ASR3000 Mammography is mainly for the inspection, diagnosis and radiography
of mammary diseases.
1.3 Contraindications of ASR3000 Mammography System
Patients with serious diseases incapable of sitting or standing, or with inflamed
tumor as well as those in breast feeding period, X-ray inspection is a contraindication.
When it goes to male breast anormogenesis disease or male breast cancer, X-ray
inspection also should be used carefully. Persons who were inspected with X-ray no more
than 3 months might as well adopt other checking methods to avoid excessive X-ray in
short periods. Patients implanted with prothesis after operation on breast cancer are not
suitable for X-ray inspection but other image inspection methods.
1.4 Operation and StorageShipping Environmental Conditions for
ASR3000 Mammography System
The normal operation room of Mammography System is less than twenty square
meters. No smoking in the control room; Fireproofing is a necessity (making emergent
fire precaution measures according to requirements of the local fire control department).
Normal Operation environmental conditions:
Temperature range: 1030
Relative humidity: 75%
Atmospheric pressure:70 kPa106 kPa
Power conditions:
Supply voltage: ~230V10%
5
Supply frequency: 50Hz1Hz
Maximum power: 6KVA
Protective ground: 0.1
Radiation Protection Conditions:
Adopting compartment operation;
ATTENTION: Mammography System operation room should be conformed
to the radiation protection measures of the national and local relevant regulations.
Storage/Shipping environmental conditions:
Environment temperature: - 10 + 40
Relative humidity: 80%
Atmospheric pressure: 50 kPa 106 kPa
6
1.5 Chinese Product Registration Number of ASR-3000 Mammography
System
()2004 2300065
1.6 Conforming Standards of ASR-3000 Mammography System --safety
1.6.1 China
Standard Description
GB 9706.1 Medical electrical equipment Part 1: General requirements for safety
GB 9706.11 Medical electrical equipment Part 2: Particular requirements for the
safety of X-ray source assemblies and X-ray tube assemblies for
medical diagnosis
GB 9706.12 Medical electrical equipment Part 1: General requirements for safety 3.
Collateral standard: General requirements for radiation protection in
diagnostic X-ray equipment
GB 9706.14 Medical electrical equipment Part 2: Particular requirements for the
safety of associated equipment of X-ray equipment

1.6.2 Europe
Standard Description
IEC 60601-1
Medical electrical equipment Part 1: General requirements for safety
IEC 60601-1-3 Medical electrical equipment Part 1: General requirements for safety 3.
Collateral standard: General requirements for radiation protection in
diagnostic X-ray equipment
EN 60601-1-4 Medical electrical equipment Part 1-4: General requirements for safety
4. Collateral standard: Programmable medical electrical systems
EN 60601-2-45 Medical electrical equipment Part 2-45: Particular requirements for the
safety of mammographic X-ray equipment and mammographic
stereotactic devices
IEC 60601-2-32
Medical electrical equipment Part 2: Particular requirements for the
safety of associated equipment of X-ray equipment
IEC 60601-2-28 Medical electrical equipment Part 2: Particular requirements for the
safety of X-ray source assemblies and X-ray tube assemblies for
medical diagnosis

7

1.7 Conforming Standards of ASR-3000 Mammography System - EMC
CISPR11 Group 1, Class A Limits and Methods of Measurement of Radio
Disturbance and Characteristics of Industrial Scientific and Medical
Radio-frequency Equipment
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for
Safety Collateral Standard: Electromagnetic Compatibility
Requirements and Tests
IEC 61000-4-2 Electrostatic Discharge Immunity
IEC 61000-4-3 Radiated Field Immunity
IEC 61000-4-4 Electrical Fast Transient/Burst Immunity
IEC 61000-4-5 Voltage Surge Immunity
IEC 61000-4-6 Immunity to Conducted Disturbance, Induced by Radio-frequency
Fields
IEC 61000-4-8 Power Frequency Magnetic Fields
IEC 61000-4-11 Voltage Dips, Shorts and Variations
1.8 Service life of ASR-3000 Mammography System
The service life of the ASR-3000 Mammography System is 10 years.
1.9 Symbols and Labels of ASR-3000 Mammography System
1.9.1 Symbols
1.9.1.1 Safety Symbols

Symbol Description

Protective ground

Alternating current
8

Hazardous voltage

High voltage

Attention: refer to accompanying
documents

Type B equipment

Functional ground

Focus position

Ionizing radiation

Manufacturer

Authorized Representative

Date of Manufacture
S
POT
FO
CAL
9

Serial Number
0123

CE certification seal. Number
code beneath the symbol identifies
the notified body code

1.9.1.2 Operation Symbols

Symbol Description

Up or increase

Down or decrease

Right (Head of Main Unit rotates
to the right when press the button)

Left (Head of Main Unit rotates
to the left when press the button)

Protective ground conductor should be connected to the protective ground terminal
on the main unit enclosure marked with protective ground symbol; High Voltage symbol
should be pasted inside console and main unit, on high voltage transformer and X-ray
tube assembly; Group 1 Class B marked on external nameplate of the console; Functional
ground should be connected to inner ground of console, inner ground of main unit and
connect with the protective ground of the enclosure; Focus symbol should be pasted on
X-ray tube assembly; Physiological effect symbol should be pasted on enclosure of the
adapter head; X-ray tube, X-ray tube assembly label should be pasted on enclosure of the
X-ray tube assembly; High voltage transformer(HVT)label should be pasted on enclosure
of the high voltage transformer; external nameplate of the Mammography System should
be pasted on the back side of the console.
10
1.9.1.3 Package and Shipping Symbols
Symbol Prescription

Fragile: handle with care

Keep dry

Humidity storage conditions: Do
not expose contents to environments
exceeding the relative humidity values.

Temperature conditions: Do not
expose contents to temperatures
exceeding the limits shown.

Position: this way up
0%~80% RH
+40
-10
1.9.2 labels
1.9.2.1 Collimator label

11
1.9.2.2 HV generator label

1.9.2.3 Tube assembly label

1.9.2.4 System label

12
1.9.2.5 System Package label

1.10 Maximum Permissible Dose (MDP)
Various studies on the effects of X-ray radiation have provided a foundation for
establishing the maximum permissible dose of X-ray exposure to which an individual
may be exposed. The results of these studies have been used by China national
department on radiation protection and International Commission on Radiological
Protection (ICRP) to develop recommendations for MPD.
WARNING:
1) ICRP Recommends that the MPD to the most critical organs (like heart,
lung, liver, kidney and brain) accumulated at any age shall not exceed the
result of 5rems(age18).
2) In no case shall the exposure exceed three rems in any period of 13
consecutive weeks.
3) For hands, forearms, feet and ankles, the recommended MPD is 75 rems
in any one year.
1.11 Manufacturers responsibility
Although this equipment incorporates protection against X-ray radiation other than
the useful beam, practical design does not provide complete protection. Equipment
design does not compel the operator and assistants to take the necessary precautions; nor
does it prevent the possibility of improper use (authorized or unauthorized persons
13
carelessly, unwisely, or unknowingly exposing themselves or others to direct or
secondary radiation). Allow only authorized, properly trained personnel to operate this
equipment. Be certain that all authorized personnel to use the equipment are aware of the
danger of excessive exposure to X-ray radiation.
The equipment is sold with the following understandings:
1) Manufacturer, its agents and representatives do not accept any responsibility for
overexposure of patients or personnel to X-ray radiation.
2) Manufacturer does not accept any responsibility for overexposure of patients or
personnel to X-ray radiation generated by this equipment as a result of poor
operating techniques or procedures.
3) No responsibility is assumed for any unit that has not been serviced and
maintained by Anke authorized service personnel.

14
2 Introduction to ASR-3000 Mammography System
2.1 Structure Features of ASR-3000 Mammography System
2.1.1 Structure of ASR-3000 Mammography System
ASR-3000 Mammography System, which consists of main unit an console, is a sort
of computer-controlled machine with high frequency (40 KHz) HVT, micro-focus,
molybdenum target, and rotary anode X-ray tube specially for mammography (see
diagram 1). Thereinto:
A) Main unit includes Filter, X-ray tube (invisible), Collimator, Pressure-releasing
switch, Head rotation control button, Bucky, Up/down control and pressure display,
Up/down control button, Mammary compressor, Film cassette, Emergency stop switch,
Head and other accessories;
B) Console includes Numeric display panel, Hand-held exposure switch,
Concentration cable and Power supply switch etc.
15

16
1. Filter 2. X-ray tube (invisible) 3. Collimator 4. Pressure-releasing switch 5. Head
rotation control button 6. Bucky 7. Up/down control and pressure display 8. Numeric
display panel 9. Up/down control button 10. Power supply switch 11. Mammary
compressor 12. Hand-held exposure switch 13. Film cassette 14. Concentration cable 15.
Emergency stop switch 16. Head
Diagram 1. Outline constructional drawing of ASR3000 Mammography System
2.1.2 Features of ASR3000 Mammography System
High frequency & high voltage generator
40 KHz high-frequency pulse DC power supply, ensures the
stability of X-ray, as well as improves the effectiveness of X-ray, and
decreases the dose that patients adsorb.
X-ray tube:
Molybdenum target micro-focus rotary anode x-ray tube to ensure
image clarity.
Automatic exposure control system:
ASR-3000 adopts advanced solid X-ray detector to compose an
16
automatic exposure control system. With its high sensitivity and quick
response, it ensures X-ray film with optimal exposure for patients of
different ages, or mammary gland with dissimilar thickness and
density.
Three rate flexibility electric drive:
It adopts three autocontrol modes, such as quick up, constant
speed down, automatic decelerating pressing after touching the breast,
automatic stop on reaching the preset pressure, to relieve patients'
pressing pain yet offer convenient operation.
Manual quick pressure-releasing device:
If power fails suddenly when finishing radiography or during
pressing, switch the manual pressure-releasing switch to raise the
compressor automatically to release the pressure on patients breast
immediately.
Bucky with anti-scattering grid:
High efficiency in blocking off scattering X-ray further improves image
quality.
2.2 Operation Principle of ASR-3000 Mammography System
The principle of ASR-3000 is that when heated by filament and electrified with high
voltage, X-ray tube will generate X-ray for radiography.
17
3 Technical Data of ASR-3000 Mammography System
3.1 Specifications of ASR-3000 Mammography System
System parameters
Supply voltage: ~230V10%
Supply frequency: 50 Hz1 Hz
Maximum power: 6 KVA
Supply network apparent resistance: 0.6
Safety grounding: 0.1
Mode of operation: continuous operation with intermitted loading
High frequency & High voltage generator:
Frequency: 40 KHz
MPO: 5 KW
Maximum X-ray tube voltage: 35 KV
Maximum X-ray tube current: 80mA
Weight: 7Kg
X-ray tube:
Anode type: Rotary anode
Anode material: Molybdenum
Anode thermal capacity: 150 KHU
Inherent filtration: 1 mm Be
Added Filtration: 0.3mm Al.
Focus: 0.1mm/0.3mm;
Anode target angle: 12
Tolerance between focus and reference axes: 1cm
Voltage: 22kV-35kV
Maximum current: 80mA (large focus), 20mA (small focus)
Maximum mAs: 120/300mAs (0.1mm/0.3mm);
Multi time loading: Max. duration for every loading is 6s, Interval is 30s, Max. mAs
is 300mAs, Max. loading times per hour is 100 times, Max. mAs is 30000mAs.
Leakage radiation: The average air kerma (kinetic energy released in material) is not
more than 0.25 mGy/h when it is in the range of 1m from the focus and within any 100
cm
2
area (dominant linear dimension is no more than 20cm) under loaded-up condition.
Weight: 16 Kg

18
Mammary compressor:
Mode: Motor driven up/down, manual decompression
Up and down: up, down and flexible compression in 3 rates.
Compressor stroke: 268mm
Pressure range: 018 Kg, regulated step length 0.1 Kg
Pressure display accuracy: 20N thickness indication range: 15-230mm
Mechanical parameters:

maximum up/down range: 10301590 mm
Angle of Head rotation: within 145
SID: fixed 60cm
Filter: Carbon-base microgroove filter
Film cassette: 1824cm
Space between the focus and image receiving surface: 65cm
Range of X-ray field : 1824cm

Automatic exposure control (AEC):

Solid detector X-ray sampling area: 200mm
2
Tube voltage in the mode of automatic exposure:
Density selection contains 9 levels, KV and mAs are auto synchronized.
The corresponding relationship between thickness and tube voltage is as follows:

Serial number
Thickness
mm
High Voltage
KV
1 18-20 22
2 21-30 23
3 31-35 24
4 36-40 25
5 41-45 26
6 46-50 27
7

28
8 51-55 29
9

30
10 55-60 31
11

32
12 61-70 33
13

34
14 71 35
19
Explanations of other application parameters:
Minimum current time product with loading factors:10mAs at 20mA, 20kV and
0.5s
Min. exposure time in the mode of automatic exposure: 0.32s
Tube voltage range in the mode of automatic exposure: 22kV- 35kV
Tube current in maximal tube voltage: 50mA
Tube voltage in maximal tube current: 30kV
X-ray tube nominal electric power: 2.4kW
mAs range: meet the required range of R'20 of ISO497
3.2 Performance Introduction to ASR-3000 Mammography System
(1) Computerized technology of the machine, numeric displays of various
parameters, easy and intuitive operation.
(2) High quality X-ray imaging system made up of bifocus rotary anode tube
with micro-focus, high frequency high-voltage power supply and bucky with
carbon-base microgroove filter improves image definition in a large degree.
(3) 3 rates motor-driven mammary compressor and manual quick
pressure-releasing device;
Fast escalation rate helps to shorten operating time;
Rate of descent is 1/2 of the escalation rate which ensures safety in operation;
Decelerating flexible compression makes the mammary compressor
automatically decelerates when it touches the patients breast tissues thus soothe the
patient's suffering;
Manual quick pressure-releasing device, just switch the pressure-releasing key
after exposure, the mammary compressor will raise immediately. This device still
functions during pressing or in accidental power failure to ensure safe operation.
(4) AEC system:
200mm
2
X-ray sampling area of solid detector ensures reliable sampling. The
control mode adopts methods of initial value comparing with final value of
restriction, automatically adjust the values of KV and mAs to carry out automatic
exposure control. In order to ensure radiography quality, regulates KV value mainly
on mammary tissues with different density; regulates mAs value mainly on breast
with dissimilar thickness. The machine specially contains 5 levels density
presetting according to different films, film processing (photographic developing)
state and diagnose demands for users' selection in practical operation.
20
3.3 Dimensions and Weight of ASR-3000 Mammography System
ASR-3000 Mammography System is packed in two cases, the package cases sizes
are:
Main unit case: 900mm(L)1100mm(W)2150mm(H),
Console case: 600mm(L)520mm(W)1200mm(H),
Total weight of ASR3000 Mammography System is about 200 Kg
21
4 Installation and adjustment of ASR3000 Mammography
System
4.1 Installation of ASR3000 Mammography System
(1) Place the main unit and the console in the operation position.
(2) Mammography System is an equipment of permanent installation. After
removing the wheels under the base plate, fasten the machine with fixing bolts
on the ground.
(3) Adjust the balance of the machine.
(4) Installation of X-ray tube.
a) Fix the tube on the Head according to diagram 2a
Step 1: Place the tube on the installation board
Step 2: Screw down the four allen screws (attached with the machine)

Diagram 2a. Installation of X-ray tube
22
b) Insert the HV cable plug and connect the aero-plug of junction cable (see diagram
2b.)
ATTENTION: Clean the high voltage plug with clean silky
fabric first (cleanings solvent with aether or xylene etc. are forbidden), dry
it with blower, apply high voltage coupler in full dose. Then insert it (the
above stuff are attached with the machine).

Step 1: Insert High Voltage plug, screw down blind nut
Step 2: Insert aero-plug of cable
Step 3: Connect protective ground

Diagram 2b. Installation of X-ray tube
c) Fix X-ray tube enclosure according to diagram 2c
Step 1: Place X-ray tube enclosure;
Step 2: Tightening up;
Step 3: Fix back cover
23

Diagram 2c. Installation of X-ray tube
(5) Fix collimator according to diagram 3
Step 1: Aim the collimator at the hole site;
Step 2: Screw in 4 allen screws (attached with the machine)

24
Diagram3. Installation of Collimator

(6) Connect the protective ground terminal of main unit to the protective ground
conductor in the operation room; Connect the console to the main unit (refer to
diagram 4), installation finished.
Step 1: Connection of the protective ground terminal;
Step 2: Connection of the console and the main unit

Diagram 4. Connection of protective ground terminal and Mammography System
4.2 Power On Inspection of ASR-3000 Mammography System
ASR-3000 Mammography System has been adjusted strictly before it leaves factory.
Its specifications already reach the relevant standards. What the users should do is just
switching on the machine to see whether it functions normally or not.
ATTENTION: Before switching on the machine, connection
between protective ground terminal of the machine and protective ground
conductor of the operation room must be checked.
25
4.2.1 Console inspection of ASR-3000 Mammography System
After plugging in the local power, press " Power " switch on the console panel (refer
to diagram 5), machine is switched on. When it is powered on, the initial state of the
console panel shows as follows:
(1) Green indicator light turns on in Power switch;

Diagram5. Initial state of the machine when power on
(2) mA (current) displays 000
(3) X-Ray(X-ray exposure) indicator light remains off;
(4) Alarm (Alarm) red light remains off;
(5) Ready (Preparation) indicator light remains off;
(6) Filter, Bucky indictor light turns on;
(7) Mode (operating mode) is on M (manual);
(8) Focus is on L (larger focus);
(9) Density displays 3;
(10) KV (high voltage) displays 28;
(11) mAs (current time product) displays 100;
(12) S (second) displays 2;
(13) Both Force and Thickness on the control panel of main unit display some
values. If the above initial state is displayed normally, the machine functions
26
well.
WARNING: No smoking or fire in operation room!
4.2.2 Power on inspection of ASR-3000 Mammography System - Main Unit
(1) Up/down movement of Head and automatic limiting check (refer to diagram 6)
Press " " button on the control panel of main unit to raise Head, press " " button
to descent it.

Diagram6.Head movement and automatic limiting
(2) Emergency power off inspection (refer to diagram 7)
Press the red emergency stop button at the bottom of main unit to check the switch
off function.
27

Diagram 7. Emergency power off inspection
4.2.3 Power on inspection of ASR-3000 Mammography System Head
(Refer to diagram 8)
(1) Thickness display is OK or not;
(2) Force presetting is OK or not;
(3) Simulated pressure test: Place the left fist between mammary compressor and
bucky to test (refer to diagram 9);
WARNING: Before pressure test, insert a film cassette into
bucky first!
a. Pressure is set as 5 Kg;
b. Operator holds his left fist and put it on between mammary compressor and
bucky from front of mammary compressor;
c. Press paddle descending button, it displays pressure increase gradually;
d. When the pressure reaches 5 Kg, the compressor automatically stops," OK "
green indicator light turns on;
e. Press up button or switch pressure-releasing switch to release the pressure.
28

Diagram 8. Power on inspection of c-arm

29

Diagram 9: Simulated pressure test
(4) Head rotating and location limit test
Press the Head rotating button on the control panel of main unit, the Head should be
able to rotate left and right 145 (refer to diagram 10).
30

Daigram10. Head rotating and location limit test
4.3 Exposure Test of ASR3000 Mammography System
(1) Press " power " switch on console panel, the initial display of the console panel
shall be as explained in item 5.2.1;
(2) Mode is set on M (manual);
(3) Focus is set on L (lager focus);
(4) KV(high voltage) is set to 22 KV;
(5) mAs (current time product) is set to 50 mAs;
(6) Press hand-held exposure switch (do not release without abnormal situation) to
process an exposure:
Press hand-held exposure switch, Ready(preparation) indicator light
turns on;
Start the rotary anode of X-ray tube;
After 0.8 second time delay," X - ray " (X-ray emitting) indicator light
turns on, " Alarm " (alarm) beepers buzzes to remind the processing of X-ray
tube exposure
One second later, the exposure automatically stops, then X-Ray
(X-ray emitting) indicator light turns off;
31
Release the hand-held exposure switch at this time;
mA(current) automatically displays the tube current value of this
radiation, exposure ends.
CAUTION: Before taking formal exposure for patients, 38
times exposure test(increase KV from 22KV to 35 KV gradually) depending
on the storage period of the machine. The purposes are:
a. Tube aging;
b. To check if the machine works stably when loaded with high voltage;
c. If the data display normally.

4.4 Switch off ASR3000 Mammography System
If no radiography for a short time, shut off the power switch on the console panel to
switch off the machine.
ATTENTION: After Mammography inspection, if no
radiography for a long time, unplug the main power supply from the outlet
after switching off the machine for the purpose of safety.
32
5 Operation and Application of ASR-3000 Mammography System
5.1 Preparations for Patients
Patient should take off their jupe (including necklace and others) lest false image
affect diagnose during breast radiography.
WARNING:
1. Check the patients breast before taking a radiography, if there is wound or serious
inflammation, compression is prohibited.
2. Women within 5 months pregnancy should not take Mammography radiography.

5.2 Head Adjustment of ASR3000 Mammography System
Press Head up/down button and rotating button on the control panel of main unit to
adjust the Head height position and projection angle according to the patient's height.
WARNING: Operating personnel or patients should never approach the Head
during adjusting the Head height and inclination lest bruising.
5.3 Pressure Presetting of ASR3000 Mammography System
The pressure adjustable range of the mammary compressor is 018 Kg, and the
practical application pressure range is 515 Kg, and it can be preset according to the
breast size and density of patients' breast tissues.
33
ATTENTION:
Do not press the mammary compressor before loading the film cassette
to avoid damage the bucky.
ASR-3000 Mammography Systems pressure range is safe to human
body, in order to obtain sharply focused image, doctors usually like to get the
patient's mammary as thin as they can. If the patient has distinct tumor or
distinct pressing pain etc., the pressure should be set as light as possible
depending on patients feel of pain.
In the course of radiography, the operator should look after the patient's
situation all the time. If there is abnormity, stop filming immediately.
In order to reduce unwanted over dosage radiation on the patient to the
least, focus-to-skin distance as large as possible is recommended.
5.4 Operation of Mammary Compressor of ASR-3000 Mammography
System
(1) Press mammary compressor ascending button to raise the mammary compressor
to a proper height;
(2) Position the patient's breast above the film cassette, the front edge of the film
cassette should tightly close to the patient's breast root in case breast tissues be omitted.
(3) Press mammary compressor descending button, mammary compressor descents,
when mammary compressor touches the breast, the descending speed of the mammary
compressor will automatically slowdown, meanwhile the pressure will ascend,"
Thickness " automatically displays the actual value after compression. When pressure
reaches the preset value, mammary compressor automatically stops," OK" green
indicator light turns on, showing that compressing finishes and radiography is ready.
ATTENTION:
There is some relationship between the thickness of the pressured
breast and the filming quality, the thinner the breast thickness, the better the
image quality, which is favorable to diagnose.
34
In order to decrease thickness, increase the pressure and keep on
pressing. When the patient breast feel painful and can not bear it, operator
should switch pressure-releasing key immediately to stop compressor; When
radiography finishes or the patient feels painful intensively during compressing,
or sudden power failure occurs, operator should switch pressure-releasing key
immediately (refer to diagram1) to release the pressure promptly and ease the
patient's pain as soon as possible.
(4) Mammary compressors disinfection
In order to avoid cross infection among patients during Mammography radiography,
the manufacturer requests that the mammary compressor surface must be disinfected
with 75% alcohol after inspecting each patient (or adopt other surface sterilization
methods), then examine the next patient.
5.5 Radiography of ASR-3000 Mammography System
(1) Radiography mode setting (refer to diagram 5) ASR3000 owns two operating
modes in radiography, i.e. A (automatic) and M (manual).
"A" (automatic) mode: While operator chooses this mode in radiography,
radiography conditions (KV, mAs) are not adjustable, after the operator sets "density",
nothing remains but to press hand-held exposure switch, radiography will be performed
automatically.
Note: Condition of automatic radiography is that the computer self-regulating KV
and mAs values to reach the due blacken degree of a film according to patients' breast
thickness and X-ray penetration rate after being pressed. The operator can set " Density"
to adjust film's blacken degree.
"M" (manual) mode: The operator set KV and mAs values by themselves, "
Density" is unadjustable then.
Note: KV and mAs can be set by operator, but there are Max. Limitation set by the
manufacturer, (refer to table 1) for the safety of X-ray tube.
Table 1:ASR3000 KVmAs limit value list
35
KV mAs
80mA 30 300 L(large
focus)
50mA 35 300
S(small
focus)
20mA 30 120
(2) Exposure
When finishing the above operations, make sure that there is no mistake, then press
hand-held exposure switch to start an exposure. When pressing hand-held exposure
switch, "Ready" indicator light on control panel turns on, then the anode rotates for about
0.8 second, "X-ray" (X-ray emitting) indicator light turns on, X-ray starts to radiate.
When it reaches the end of exposure time, exposure ends automatically; "X-ray" (X-ray
emitting) and " Ready " (preparation) indicator lights turn off," mA " (current) displays
the tube current of this exposure, then the operator can release the hand-held exposure
switch.
Note: In the course of normal exposure, hand-held exposure switch should not be
released until the exposure ends, otherwise the exposure stop swiftly. But if there is
unexpected situation happening during the exposure, one can release the hand brake to
stop exposure. After an exposure finishes, release the mammary compressor, and take out
the film cassette.
CAUTION: In order to protect the molybdenum target rotary
anode tube, the equipment is fixed with a 30 second time delay protective
circuit, that is to say next exposure must be processed 30 second after the
previous one.
ATTENTION: In order to protect the patient against the
accidents and make sure that the operator can keep in touch with the patient
all the time during taking an exposure, user must install a voice
communication system between the operation room and the shielded room.

36
6 Troubleshooting of ASR3000 Mammography System
ASR-3000 Mammography System functions safely and reliably with quite low
failure rate. Our company will take the responsibility of repairing the equipment if there
is trouble in its service. Refer to table 2 for the disposal of common faults.

Table 2 common faults disposal list of ASR-3000 Mammography System
Faults Causes Disposal
a. no main power
a. check the main power
supply
1. Power supply
indicator light remains
off when switched the
machine is on.
b. power supply main
switch is not on
b. turn on the main
switch of the machine
a. computer error a. restart the computer
2. ALARM beeps
b. grounding wire failure
connection
b. connect the
grounding wire correctly
a. it does not reach the 30
seconds time delay after the
former exposure
a. wait for 30 seconds,
then press hand brake again
b. the working circuit error
makes rotary anode can not
rotate or start
b. contact our company
3. Ready
indicator light does not
turn on when pressing
hand brake
c. filament heating circuit
error

4. Difference
between the display and
actual thickness of
mammary gland
b. measuring device error b. contact our company
5. No X-ray, no
mA display, film cant
be exposed
b. HV circuit error b. contact our company
CAUTION: When users can not eliminate the troubles after
handling according to the above list, please contact with our company
37
instead of check it by themselves.

38
7 Protection and Maintenance of ASR-3000 Mammography System
ASR-3000 Mammography System shares the same principle with other medical
diagnosis Machine, it generates to process radiography when the X-ray tube is electrified
with high voltage.
Because X-ray and high voltage electric shock are both tremendous potential hazard
to patients and operators, the equipment is specially contrived several protective
measures to decrease X-ray radiation jury and High Voltage electric shock accidents. In
order to avoid those accidents, users must take regular protection and maintenance every
half a year according to the relevant regulations of this manual during operation.
WARNING: High voltage compartment cant be opened and replaced at
hazard!
There must be air-conditioning in the operation room, and the relevant
fire control regulations of the nation must be conformed.

WARNING: No smoking and other fireworks inside the machine room!

The operation room must be kept clean and neat. When operation is
over, routine surface cleaning and ultraviolet air sterilization must be done.

X-ray protection
(1) During radiography, patients should wear lead-rubber apron (lower abdomen);
(2) Operator can use lead shield or operate in another room.
39
Safety inspection on the equipment should be done semiannually.
(1) Make sure each display on the console panel is normal;
(2) Make sure each operation button works well;
(3) Make sure each operation button on the control panel of main unit works well.

ATTENTION: Directly measure the mammary gland thickness
with ruler to see if the displays accord with the actual thickness, the normal
error is 2mm.
Open the back cover of the main unit to check if the steel wires get
worn or not, if yes, please inform our company to replace them in time.
ATTENTION: The steel wires are the loading part of suspending
the Head. The machine is contrived double steel wires suspending system to
prevent accidents caused by broken steel wires. Even if one of the steel
wires breaks, the c-arm still keeps safe, but our company should be informed
of replacing the steel wires in time.
External power check
(1) Make sure the protective ground is connected;
(2) Check if there is abrasion on the power supply inlet wire surface.

40
8 Unpacking Inspection of the ASR-3000 Mammography System
(1) Check the external package to make sure no damage before unpacking. If there
is damage, contact relative department and take a picture as a proof. You must get
permission from relative department before unpacking. If the equipment is damaged,
claim for compensation from shipping unit.
(2) Unpacking orders
The machine is packed in two cases, case for the main unit:
900mm(L)1100mm(W)2150mm(H), case for the console:
600mm(L)520mm(W)1200mm(H)
First open the console case, read the packing list and manual in it then open the
main unit case.
Orders of opening the main unit case:
1. Remove top board;
2. Remove front board;
3. Take out all the accessories and fillers;
4. Remove left and right boards;
5. Remove backboard;
6. Take out the two inclined benches for future use;
7. Remove the Head anticollision cover and main unit top section cover;
8. Adjust the four stubs on the base with adjustable wrench to raise the
machine 25mm, remove the fixing flitch;
9. Check the positions of the four trundles, if necessary, turn them to make
them move in the direction of back and forth, then adjust the stubs with the
wrench to lay the trundles on the base board;
10. Place two incline boards in front of the mammography system, wheel it
slightly along the incline board to the floor;
41
11. Wheel the mammography system to the installation position

42
43
9 Company Information
Manufacturer: Shenzhen Anke High-Tech Co., Ltd
Address: 26 Yanshan Road, Shekou, Shenzhen, Guangdong 518067, China
Zip code: 518067
Telephone: 86 755-26688889
Fax: 86 755-26695307

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