ASR-3000 User Manual.pdf

8/11/2019 ASR-3000 User Manual.pdf

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ASR-3000 Mammography System

ASR-3000

Mammography System

User ManualRev 2.0

Shenzhen Anke High-tech Co., Ltd.


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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 twentysquare 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 Structureof 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

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.................................................................................................................................. 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

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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 toinspect 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 significantequipment in image diagnosis of mammary diseases.

1.1 Manual Conventions

The manual stress the relevant information or potential risks on personnel orequipment 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.

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For the safety of equipment and personnel, please read carefully the relevant

chapters about safety and all warnings, cautions and attentions throughout this manualbefore 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-rayinspection also should be used carefully. Persons who were inspected with X-ray no morethan 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 notsuitable 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 emergentfire 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%

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Supply frequency: 50Hz1Hz

Maximum power: 6KVA

Protective ground: 0.1Radiation 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

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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 formedical 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 60601-1Medical 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 mammographicstereotactic 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

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1.7 Conforming Standards of ASR-3000 Mammography System - EMC

CISPR11 Group 1, Class A Limits and Methods of Measurement of RadioDisturbance 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-frequencyFields

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

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Hazardous voltage

High voltage

Attention: refer to accompanying

documents

Type B equipment

Functional ground

Focus position

Ionizing radiation

Manufacturer

Authorized Representative

Date of Manufacture

SPOT

FO

CAL

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Serial Number

0123

CE certification seal. Numbercode beneath the symbol identifiesthe notified body code

1.9.1.2 Operation Symbols

Symbol Description

Up or increase

Down or decrease

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

Left (Head of Main Unit rotatesto 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 symbolshould 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 andconnect 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 theadapter 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 shouldbe pasted on the back side of the console.

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1.9.1.3 Package and Shipping Symbols

Symbol Prescription

Fragile: handle with care

Keep dry

Humidity storage conditions: Donot expose contents to environments

exceeding the relative humidity values.

Temperature conditions: Do notexpose 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

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1.9.2.2 HV generator label

1.9.2.3 Tube assembly label

1.9.2.4 System label

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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 nationaldepartment 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 13consecutive 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 thanthe useful beam, practical design does not provide complete protection. Equipment

design does not compel the operator and assistants to take the necessary precautions; nordoes it prevent the possibility of improper use (authorized or unauthorized persons

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carelessly, unwisely, or unknowingly exposing themselves or others to direct or

secondary radiation). Allow only authorized, properly trained personnel to operate thisequipment. 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 foroverexposure of patients or personnel to X-ray radiation.

2) Manufacturer does not accept any responsibility for overexposure of patients orpersonnel 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 andmaintained by Anke authorized service personnel.

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2 Introduction to ASR-3000 Mammography System

2.1 Structure Features of ASR-3000 Mammography System

2.1.1 Structureof 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-releasingswitch, 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.

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automatic exposure control system. With its high sensitivity and quick

response, it ensures X-ray film with optimal exposure for patients ofdifferent 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 duringpressing, 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 imagequality.

2.2 Operation Principle of ASR-3000 Mammography System

The principle of ASR-3000 is that when heated by filament and electrified with highvoltage, X-ray tube will generate X-ray for radiography.

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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 KVASupply 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 KWMaximum X-ray tube voltage: 35 KV

Maximum X-ray tube current: 80mA

Weight: 7Kg

X-ray tube:

Anode type: Rotary anodeAnode material: Molybdenum

Anode thermal capacity: 150 KHU

Inherent filtration: 1 mm BeAdded Filtration: 0.3mm Al.

Focus: 0.1mm/0.3mm;Anode target angle: 12

Tolerance between focus and reference axes: 1cm

Voltage: 22kV-35kVMaximum 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 100cm

2area (dominant linear dimension is no more than 20cm) under loaded-up condition.Weight: 16 Kg

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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: 0

18 Kg, regulated step length 0.1 KgPressure display accuracy: 20N thickness indication range: 15-230mm

Mechanical parameters:

maximum up/down range: 10301590 mm

Angle of Head rotation: within 145

SID: fixed 60cmFilter: 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: 200mm2

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

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Explanations of other application parameters:

Minimum currenttime product with loading factors:10mAs at 20mA, 20kV and0.5s

Min. exposure time in the mode of automatic exposure: 0.32s

Tube voltage range in the mode of automatic exposure: 22kV- 35kVTube current in maximal tube voltage: 50mA

Tube voltage in maximal tube current: 30kV

X-ray tube nominal electric power: 2.4kWmAs 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 thepatient's suffering;

Manual quick pressure-releasing device, just switch the pressure-releasing keyafter 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:

200mm2X-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 mainlyon mammary tissues with different density; regulates mAs value mainly on breastwith 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.

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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

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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 2aStep 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

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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 silkyfabric first (cleanings solvent with aether or xylene etc. are forbidden), dry

it with blower, apply high voltage coupler in full dose. Then insert it (theabove stuff are attached with the machine).

Step 1: Insert High Voltage plug, screw down blind nut

Step 2: Insert aero-plug of cableStep 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

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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)

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Diagram3. Installation of Collimator

(6) Connect the protective ground terminal of main unit to the protective groundconductor 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 justswitching 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 groundconductor of the operation room must be checked.

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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

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well.

WARNING: No smoking or fire in operation room!

4.2.2 Power on inspection of ASR-3000 Mammography System - ain 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.

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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 andbucky 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.

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Diagram 8. Power on inspection of c-arm

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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 beable to rotate left and right 145 (refer to diagram 10).

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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 panelshall 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-raytube exposure

One second later, the exposure automatically stops, then X-Ray

(X-ray emitting) indicator light turns off;

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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 noradiography for a long time, unplug the main power supply from the outlet

after switching off the machine for the purpose of safety.

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5 Operation and pplication 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 seriousinflammation, 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 toadjust 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.

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ATTENTION:

Do not press the mammary compressor before loading the film cassetteto 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 ordistinct 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'ssituation 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 compressorto a proper height;

(2) Position the patient's breast above the film cassette, the front edge of the filmcassette 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 mammarycompressor will automatically slowdown, meanwhile the pressure will ascend,"

Thickness " automatically displays the actual value after compression. When pressurereaches 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.

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In order to decrease thickness, increase the pressure and keep on

pressing. When the patient breast feel painful and can not bear it, operatorshould 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 thepatient'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 sterilizationmethods), 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' breastthickness 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

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KV mAs

80mA 30 300L(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 exposureswitch, "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-rayemitting) and " Ready " (preparation) indicator lights turn off," mA " (current) displays

the tube current of this exposure, then the operator can release the hand-held exposureswitch.

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 tostop exposure. After an exposure finishes, release the mammary compressor, and take outthe film cassette.

CAUTION: In order to protect the molybdenum target rotary

anode tube, the equipment is fixed with a 30 second time delay protectivecircuit, that is to say next exposure must be processed 30 second after the

previous one.

ATTENTION: In order to protect the patient against theaccidents 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.

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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 powera. 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 computer2. 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 pressinghand brake

c. filament heating circuit

error

a. computer error a. restart the computer4. Difference

between the display and

actual thickness of

mammary gland

b. measuring device error b. contact our company

a. computer error a. restart the computer5. No X-ray, nomA display, film cant

be exposedb. HV circuit error b. contact our company

CAUTION: When users can not eliminate the troubles afterhandling according to the above list, please contact with our company

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instead of check it by themselves.

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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 hazardto 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 athazard!

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 isover, 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.

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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 normalerror 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 suspendingthe 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 informedof 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.

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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 themain 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 themachine 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 thewrench 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;

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11. Wheel the mammography system to the installation position

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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

ASR-3000 User Manual.pdf

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