MAM VENUS+ USER MANUAL (1)

You might also like

Download as pdf or txt
Download as pdf or txt
You are on page 1of 28

AN ISO 9001:2015 & EN ISO 13485:2016 COMPANY

+
ALLENGERS MAM-VENUS
Mammography Machine

OPERATION / USER MANUAL

Our EU Authorized Representative: -


MEDICAL SYSTEMS LTD. Mr. Michiels Christoph,
S.C.O. 212-214, SEC. 34-A, Michiels SA,
CHANDIGARH (INDIA) 2 Luitberg, 1853 Strombeek, Bever,
TEL.: +91-172-6618081, 6618082, Belgique, Belgium
FAX: +91-172-2621912, Tel: +32 (0) 2 268.45.18
E-mail: export.service@allengers.net +32 (0) 2 325.13.65
Website: www.allengers.com E-mail: cmi@michiels.be

Catalogue No. 10

Passion for excellence


Approvals

We thank you for purchase of Allengers Mammography Machine. Please go through the User
Manual carefully before operating the machine. This machine is type approved for
Mechanical, Electrical & Radiation Safety Standards by following regulatory boards:

PRODUCT APPROVAL

¾ Bureau of Indian Standards (BIS) – CM/L-9129174:


Approved for meeting Mechanical & Electrical
Safety Standards.

¾ Atomic Energy Regulatory Board (AERB) – 99-TA-


359: Approved for meeting Radiation Safety
Standards.

¾ CE Certified – CE 663857: Approved for meeting


International Safety Standards.

SYSTEM APPROVAL

¾ ISO 9001:2015 & EN ISO 13485:2016 Approved for


meeting Quality Management System Requirements.

Allengers Mammography-User Manual


Rev. ‘0’ Eff. Date: 26.02.2011
Contents

Contents

1. For Your Safety ………………………………………………… 1

2. System Overview………………………………………………… 7
2.1 Features……………………………………………………………….….. 9

3. Technical Specifications ………………………………………... 10


3.1 Electrical Specifications…………………………………………………. 11
3.2 Environmental Conditions…………………………………………….…. 11

4. Description of Control…………………………………………... 12
4.1 Description of Control Keys……………………………………………... 13
4.2 Description of Switches on Mammography Column……………………. 18
4.3 Description of Switch on LBD…………………………….…………….. 19

5. Operating Instructions………………………………………….. 20
5.1 Breast positioning………………………………………………………... 20
5.2 Film loading in cassette…………………………………….……………. 20
5.3 Machine operation………………………………………….…………..... 21
5.4 Technic chart……………………………………………….…………….. 22

6. Dark Room Procedures & Room Layout..…………………….. 23


6.1 Dark room procedure…………………………………………………….. 23
6.2 X-Ray film processing…………………………………………………… 23
6.3 Suggested room layout…………………………………………………… 24

7. Maintenance……………………………………………………... 25
7.1 Overview………………………………………………………………… 25
7.2 Inspecting the system…………………………………………………….. 25
7.3 General maintenance…………………………………………………….. 26

8. Troubleshooting…………………………………………………. 27

9. Warranty……………………………………………………….... 28

Checked By_____________________

Allengers Mammography-User Manual


Rev. ‘0’ Eff. Date: 26.02.2011
For Your Safety

1 For Your Safety


Read these simple guidelines. Not following them may be dangerous or illegal. Read the
complete User Manual for further information.

Warning Symbol
SWITCH ON SAFELY

Switch ON the machine only with dry hands. Please


check the earthing before switching ON the machine

ATTENTION SYMBOL

Please refer User Manual when seen this symbol on your


machine.

USE SENSIBLY

Operate your machine as explained in the User Manual.

QUALIFIED SERVICE

Only qualified personnel may install or repair this


Equipment.

WATER RESISTANCE

Your device is not water resistant. Keep it dry.

Allengers Mammography - User Manual Page 1


Rev. ‘0’ Eff. Date: 26.02.2011
For Your Safety

DANGEROUS VOLTAGE

If seen on your equipment don’t touch that part because


some High Voltage or Dangerous Voltage must be there.

INTERFERENCE

Wireless or Mobile Devices may be susceptible to


interference, which could affect performance.

CONNECTING TO OTHER DEVICES

When connecting to any other device, read its User


Manual for detailed Safety Instructions. Do not
connect incompatible products.

WARNING MESSAGE

Please refer User Manual when seen this symbol on


your machine.

PROTECTIVE EARTH

This symbol is for protective earth. If seen on your


equipment, it indicates the protective earth terminal.

OFF

Indicate that equipment can be switched OFF when


pressed this switch.

ON

Indicate that equipment can be switched ON when pressed


this switch.

Allengers Mammography - User Manual Page 2


Rev. ‘0’ Eff. Date: 26.02.2011
For Your Safety

Attention
Please read this Manual thoroughly. Although Allengers devices comply with the related
Safety Requirements. This manual provides all information necessary for a correct use and
the warnings related to danger associated with X-Rays Generating Units.

Allengers, is not to be held responsible for,


• Use of the equipment different from the intended one as described in this Manual;
• Damages to the unit, to the operator, to the patient, caused either by wrong
installation or maintenance procedures, different from those described in this
Manual supplied with the unit, and by wrong operations;
• Mechanical and/or electrical modifications performed during and after the
installation, different from those described in the Manual.

Allengers Qualified Engineers must only perform any technical intervention. If so


required, only the authorized personnel can remove the covers and has access to the
internal circuitry of the equipment.

Warnings:
• This device has not been designed to be used in environments where vapours,
anesthetic mixes flammable with air, or oxygen and nitrous oxide can be detected.

• Before cleaning the device, please disconnect it from the AC Mains supply.

• Wherever necessary, use the suitable accessories, such as the Leaded Aprons, Lead
Goggles, and Thyroid Guards to protect the Patient, User & Support Staff of OT
from radiation exposure.

• While performing the radiography, no one, apart from the Operator and the Patient,
must remain in the room.

• Though this unit has been designed with a quite acceptable protection level from
electromagnetic interference, it is advisable to install it at a certain distance from
electrical energy transformation rooms, from static continuity units, from portable
receiving-transmitting units and for Cellular use. Cellular Telephones are only
admitted at a distance of more than 1.5m from any component of the device. Other
medical instruments and devices that must be used in the same installation area of
the unit must comply with the Electromagnetic Compatibility rules in force. Non-
complying instruments, of which the poor immunity from electromagnetic fields is
well known, must be installed at least 3 m away from the equipment and supplied by
a different electrical line.

• The equipment must be OFF while using devices such as electrical scalpels or
similar instruments. The equipment automatically performs some self-test functions
and therefore is able to detect some anomalous conditions. However, whenever there
are doubts on the performance of the equipment (e.g. images too clear, too dark or
with artifacts), the activity must be suspended and an Allengers Qualified and
Authorized Engineer must be contacted.

Allengers Mammography - User Manual Page 3


Rev. ‘0’ Eff. Date: 26.02.2011
For Your Safety

• During the use of the equipment, the operator must comply with the local work
Safety Regulation, in particular with the ones referring to the use of X-Ray
Equipments.

• Avoid to use the CFL Lamps in O.T. as some of the CFL Lamps generate UV
Spectrum (>700 mm) which some times hamper the performance of electronic
circuits.

Environmental risks and displacement

The equipment contains in some of its parts, materials that at the end of the unit’s life, must
be recycled at an approved location. Particularly the device contains the following materials
and/or components:

• Central Unit and Control Console: Iron, Copper, Aluminum, Non-biodegradable


Plastic Material, Glass-Resin for Printed Circuit Boards (PCB).

• Tube Head Assembly: Tube Head Assembly of this X-Ray Equipment contains
High Voltage Tank, X-Ray Tube and Oil filled alongside, Printed Circuit Board
(PCB) and Lead used for controlling Stray Radiations.

Allengers is not responsible for the disposal of the equipment performed by the user
and for the costs related to this intervention.

It is assumed by the manufacturer and distributors of this equipment that all persons
responsible for the operation of this equipment are aware of danger and excessive exposure
to X-Radiation and this equipment is sold with the understanding that Allengers Medical
Systems Limited, their agents and representatives have no responsibility for injury or
damage which may result from exposure to X-Radiations.

Recommendations to reduce Radiation Exposure


The main objective of radiation protection procedures in an X-Ray Diagnostic Installation is
to limit the Radiation Exposure arising from the use of the Diagnostic Equipment as low as
possible so that the radiation doses received by the radiological personnel and general
public never exceeds the maximum permissible dose limits recommended by ICRP
(International Commission on Radiation Protection).

a) The radiation exposure to the patient should be the minimum exposure required to
produce images of good diagnostic quality. Use radiation with care, caution and at a
rate which is ALARA - ‘As Low As Reasonably Achievable’

b) The speed of the film, or screen and film combinations should be of fastest speed
consistent with the diagnostic objective of the radiographic examination.

c) When a patient or film must be provided with auxiliary support during radiation
exposure:

(i) Mechanical holding devices shall be used when the technique permits.

Allengers Mammography - User Manual Page 4


Rev. ‘0’ Eff. Date: 26.02.2011
For Your Safety

(ii) Individuals may be permitted to hold the patient when absolutely


necessary and no individual shall be used routinely for this purpose to the
exclusion of others who might share the task.

(iii) If a human holder is required, the holder shall be positioned such that no
part of body shall be struck by primary X-Ray beam unless protected by
at least 0.5 mm lead equivalent and shall be protected from direct scatter
radiation by protective lead apron of not less then 0.25 mm lead
equivalent.

d) Gonadal shielding of not less then 0.25 mm lead equivalent shall be used for patients
who have not passed their reproductive age during radiographic procedures in which
gonads are under primary beam, except, in cases where shielding would interfere
with diagnostic procedures.

e) Doors of the Room/OT where X-ray equipment is installed should be closed before
making exposures.

f) The X-ray beam should not be directed towards doors or windows of the room, or
towards control panel or darkroom walls unless no other geometry is possible.

g) Obey radiation protection rules pertaining to time, distance and shielding.

h) Prefer low exposure settings to high.

i) Use Collimator to set minimal useful field size; keep Image Intensifier in close
proximity to the patient.

THE EQUIPMENT MUST BE USED WITH GENUINE ALLENGERS


ACCESSORIES

Allengers Mammography - User Manual Page 5


Rev. ‘0’ Eff. Date: 26.02.2011
For Your Safety

First Aid In Case of Electrical Shock

1. Switch OFF the Power Supply: If this is not possible, protect


yourself with dry insulating material and pull the victim clear off
the conductor. Do not touch the victim with your bare hands until
he/she is clear off the conductor.

2. Place the victim in supine position.

3. Keep the air passage clear by turning the head to one side, opening
the patient’s mouth and cleaning it of water, saline, mucus or blood,
a lot of which might have accumulated in the back of the throat.

4. If the jaw is rigid, try to force the mouth open by pressure on the
gum behind the last molar tooth of the lower jaw. When the upper
air passage is cleared, tilt the head backward and force the jaw
forward from the angles of the jaw in front of the ears. This would
prevent mechanical obstructions to the upper air passages.

5. Hold the chin up and forward with one hand and pinch the nostril of
the victim with other.

6. Take a very deep breath and apply your mouth to that of victim and
blow into his mouth until the chest of the victim moves up
indicating filling of the lungs (Never allow the chin to sag).

7. When the chest has moved up, withdraw your mouth and allow the
chest to sink back.

Have someone else sent for a Doctor.

Keep patient warm and loosen his/her clothing.

Do not give liquids until the patient is conscious.

Allengers Mammography - User Manual Page 6


Rev. ‘0’ Eff. Date: 26.02.2011
System Overview

2. System Overview

Allengers MAM-VENUS+ is a Mammography X-Ray System combining flexibility and latest


technology to provide radiologists with an effective diagnostic tool in breast cancer detection.
MAM-VENUS+ mammography machine uses motorized control for precise and comfortable
compression to achieve uniform and high quality images, ease of operation and position, safety
to patient and operator, increased life of vital components of equipment and user interactive self-
diagnostic functions for increased up time of equipment. MAM-VENUS+ mammography
machine comes with Three Chamber Automatic Exposure Control function, which adjusts the
mAs automatically depending upon the breast thickness to achieve optimum quality of image on
radiograph. MAM-VENUS+ mammography machine is also provided with Film Density control
function to select contrast of image on radiograph.

This equipment is Type Approved for Electrical and Mechanical Safety Standards and for the
Radiation Safety (vide IS: 7620) from the Atomic Energy Regulatory Board (AERB), Govt. of
India, thus making it entirely safe from the Radiation Hazards.

In an X-Ray Equipment Stand designed to perform ISO Centric scanning movements and having
three axes of rotation concurrent to the ISO Center O, the ISO Center can be caused to rotate
about a fourth axis (Axis 4) perpendicular to the second axis (Axis 2) and parallel to the third
axis (Axis 3). This permits displacement of the ISO Center in the horizontal plane, especially
along straight lines which are secant with the third axis.

Allengers Mammography - User Manual Page 7


Rev. ‘0’ Eff. Date: 26.02.2011
System Overview

Tube Head

Compression Paddle
UP/DOWN Switches

Emergency OFF
LBD
Switch

Column Rotation & Column


UP/DOWN Switch

Manual Compression Paddle


UP/DOWN Knob
Compression Paddle
UP/DOWN Switches
Bucky

Protection Screen

LCD Panel for Compression


Parameter Display

Allengers Mammography - User Manual Page 8


Rev. ‘0’ Eff. Date: 26.02.2011
System Overview

2.1 SALIENT FEATURES MAMMOGRAPHY MACHINE

o High Frequency X-Ray Generator


o Rotating Anode X-Ray Tube with 0.1/0.3 mm focal spot & Molybdenum target
o Collimator with Auto OFF of Halogen Lamp
o Feather Touch Control Panel with LCD Display of selected parameters
o Actuator Operated Compression with LCD Display of Compression Force,
Degree, Breast Thickness
o User selectable Compression Force
o Bucky with fine grid (Reciprocating) 5:1, 31 lines/cm
o Motor Operated UP/DOWN Movement
o Motor Operated ‘C’ Rotation.
¾ Automatic Filter Selection*
ƒ Molybdenum Filter (Mo)
ƒ Aluminum Filter (Al) or Rhodium Filter (Rh) (OPTIONAL)
o Three Chamber Automatic Exposure Control
o Anatomical Programming
o Film Density Adjustment Function
o Protection Screen with Lead Glass for Operator Protection
o Auto Compression Release after exposure.
o Auto Release of Compression in case of Power Failure.

‘*’ OPTIONAL ITEM

Allengers Mammography - User Manual Page 9


Rev. ‘0’ Eff. Date: 26.02.2011
Technical Specification

3. Technical Specifications
PARAMETERS SPECIFICATIONS
Radiography KV 20 to 39 KV in steps of 0.5 KV
Radiography Timer Variable mAs from 1 to 700 mAs, mA output: 150mA
X-Ray Generator High Frequency 50 KHz., 5 KW X-Ray generator
X-Ray Tube Head -Double focus Rotating Anode, 9600 R.P.M. X-Ray Tube of focal spot 0.1 mm
(Small) and 0.3 mm (Large)
-Collimator with Auto Shut OFF after 45 Seconds ±15 Seconds.
-Target Material: Molybdenum
-Inherent Filtration: 0.5 mm Be
-Additional filter 1.0 mm Al or 0.035 mm Mo, (Rh*)
Control -Manual Two Point Technique Selector (kV and mAs)
-Automatic Exposure Control (3 Chamber)
-Anatomical Programming Mode & Manual Mode
-Automatic Filter Change
-Auto Stop Angular Movement
-Filter is automatic selected as per kV selection (Molybdenum & Rhodium)
-Film Density Control Functions (7 Step Density Control)
-LCD Display of kV/mAs, Molybdenum/Aluminium/Rhodium Filter* Selection.
-Indicators of Ready & X-Ray ON, Large/Small Focus Selection, APR/AEC,
Density Control & Self Diagnostic Functions
-Machine ON/OFF Switch, Focus Selection Switch, Ready & X-Ray Exposure
Switch, kV Increase/Decrease Switch & mAs Increase/Decrease Switch
Automatic collimation for size of bucky 24x30cm & 18x24cm with cassette size
24X30 & 18x24cm.
Automatic Focal Spot selection with insertion of Magnification stand is
provided.
Stand Assembly -Motorize ISO Centric Gantry UP/DOWN Movement: 70 to 140 cms.
-Angular Rotation: ±90°.
-Focus Film Distance: 650 mm
-Actuator based Breast Compression up to 20 Kg with Compression
Increase/Decrease Switches in steps, Compression Release Switch
-Automatic Decompression after Exposure.
-LCD Display of Compression Force in Kg (Preset of Compression force as per
user requirement – 3 to 20 KG), Degree, Breast Thickness
-Compression System is Motorise in such a way that paddel speed progressively
reduce as it contact with breast.
-Manual & Dual Speed Compression
-Compression Paddles for Normal & Magnification Mode
-Magnification Device: 1.8X, 1.5X (Optional).
-18 x 24 cm Bucky.
-Motor Operated Oscillating Grid of size 18 x 26 cm, 5:1, 31 lines/cm
-Molybdenum & Rhodium / Aluminum Filter
-Cone for Localization and Radiation Protection
-Column UP/DOWN Movement Foot Switches.
-Column rotation Switches on both side of Column.
Additional Features -Hand Switch with retractable cord for initiation of exposure
-Film Marking Device
-Protection Screen with fully transparent Lead Glass for Operator Protection

‘*’ OPTIONAL ITEM.

Allengers Mammography-User Manual Page 10


Rev. ‘0’ Eff. Date: 26.02.2011
Technical Specification

3.1 ELECTRICAL SPECIFICATIONS:

Main Supply: 220V AC ± 10% Single Phase

Power: 5 KW

Current: 15 Amps.

Frequency: 50/60 Hz.

EARTHING: It is strongly recommended that independent earthing (at zero potential) is available in
the power socket in the Room where the machine is to be used. Proper earthing not only enhances
the performance & reliability of the equipment but increases safety for the operating staff as well.

FUSE DETAILS:

FUSE NO. FUNCTION RATING


F1 LINE 20 A
F2 NEUTRAL 20 A
F3 DELTA TRANSFORMER (COLUMN UP/DN, 04 A
COMPRESSION UP/DN, LBD, ROTOR,)
F4 KVP DISPLAY TRANSFORMER 0.5 A
F5 ROTOR ASSEMBLY 02 A
F6 FILAMENT SUPPLY 06 A

3.2 ENVIRONMENTAL CONDITIONS:

Storage:

Temperature 00 to 400 C

Humidity Maximum 90 % at 300 C

Operating Conditions:

Temperature: 10 to 40o C
Humidity: 0 to 75% RH Non Condensing
Atmospheric pressure: 70KPa…110KPa

Allengers Mammography-User Manual Page 11


Rev. ‘0’ Eff. Date: 26.02.2011
Description of Control

4. Description of Control
Operator Console of Allengers MAM Venus+ consists of following keys:

12

10 8

11 9

1 2 3 5 6 4 7 13 14

Allengers Mammography - User Manual Page 12


Rev. ‘0’ Eff. Date: 26.02.2011
Description of Control

4.1 DESCRIPTION OF CONTROL KEYS

1. MACHINE ON SWITCH
Pressing this Switch causes the machine to become ‘ON’. The Display has shown the unit
warming up for approx. 35 seconds. During this period of time machine performs the
internal checks.

2. MACHINE OFF SWITCH

Pressing this Switch turns OFF the machine. If the 15 Amps. Mains Switch on wall socket
is ‘ON’ & 230 V AC supply is available to the machine, this Indicator will glow. Glowing
of indicates that power is available to machine.

3. DENSITY CONTROL SWITCH (Applicable only in AEC Mode)

When machine is made ON, density control is selected to level 0 by default. Pressing this
switch increases the level to +1 so that darkness of image on film is increased. Again
pressing this switch further increases the level to +2 & +3 so that darkness increases further.
Similarly to reduce the darkness, pressing this switch again will decrease the level to -2 & -
3 so that darkness of image on film is reduced. Again pressing this switch will increase the
level to -1 so that darkness of image gets increased. (Selection of density control level may
require experience of few examinations).

When we increase the film density the mAs are increase 12.5% automatically and
when we decrease the film density the mAs are decrease 12.5% automatically.

4. DENSITY SELECTION INDICATORS – Density


Selection Indication on LCD display (Applicable in AEC
Mode)
Each indicator indicates the level of density selected by Density control switch. These
Indicators are not glowing but display of density are shown on LCD at Panel. (-3, -2, -1, 0,
+1, +2, +3)

5. FILM SCREEN COMBINATION SELECTION SWITCH (OPTIONAL)

This switch is used to compensate film density for different combination of Film and
intensifying screens available in particular country.

Allengers Mammography - User Manual Page 13


Rev. ‘0’ Eff. Date: 26.02.2011
Description of Control

6. FILM SCREEN COMBINATION SELECTION INDICATORS

These indicators glow to indicate the level of selection selected by Film Screen
Combination Selection Switch. The Indicator at higher level indicates low factors as
required by high-speed film screen combination and vice-versa.

7. APR/AEC/AUTO MODE SELECTION SWITCH

When machine is switched ON, ANATOMICAL PROGRAMMING mode is selected by


default, in this mode select pre-programmed factors for doing radiography of different sizes
of breasts. When we press this switch the machine is gone to AEC (automatic exposure)
mode. When this mode is selected machine automatically selects mAs depending upon the
breast size when exposure switch is pressed. However, KV is to be selected manually
depending upon breast size. Factors can be selected for three different sizes of breasts i.e.
Small, Medium & Large. Pressing this switch selects the three sizes as displayed on LCD.
In Auto Mode, KV will automatically change as per breast thickness and mAs selects
automatically depends upon the breast size when exposure switch is pressed.

8. SIZE SELECTION OF BREAST (SMALL/MEDIUM/LARGE)

This Switch is used for selection of small/medium/large size breast in Anatomical


Programming/AEC mode. In APR mode kV selected are 23 & mAs is 160, 25 & mAs is
240 & 26 & mAs is 300 respectively as per size of breast is selected. However, the operator
can still vary kV & mAs by switches (- & +) provided on control panel.

In AEC mode kV selected are 23, 25 & 26 respectively as per size of breast is selected.
However, the operator can still vary kV by switches (- & +) provided on control panel and
mAs are selected by AEC Chamber automatically as per Breast Size.

AEC Chamber is selected by default as per breast size is selected by operator i.e. Chanel-1
to Chanel-3 as per breast size.

Note:- In AEC mode before exposure mAs are 000 shown on LCD Display. When
exposure terminate given mAs are shown on LCD display.

9. FILAMENT SELECT SWITCH

When machine is switched ON, Large focus of Tube is selected by default. Pressing this
Switch changes the focus selection from large to small and vice-versa. When Magnification
Stand instead in Bucky assembly machine will automatically select small focal spot.
Selected focal spot will display on LCD.

Allengers Mammography - User Manual Page 14


Rev. ‘0’ Eff. Date: 26.02.2011
Description of Control

10. mAs DECREASE/INCREASE SWITCH

Pressing (-/+) these Switches enables the user to decrease/increase the mAs. At Large focus
mAs can be selected from 1 to 700 mAs and at small focus mAs can be varied from 1 to
230 mAs.

11. KV DECREASE/INCREASE SWITCH

Pressing (-/+) these Switches enables the user to decrease/increase the KV; it can be
increase from 20 to 39 KV. KV can be decreased/increased in steps of 0.5 kV.

12. LCD DISPLAY

Shows kV, mAS, Mode i.e. AEC, APR size of breast (Small/Medium/Large), filter (Mo,
Rh*/Al*) and Tube Filament (large/small) selected by user.

13. READY SWITCH WITH INDICATOR

This Switch is used to boost the filament. When this Switch is pressed, Indicator along this
Switch glows.

14. EXPOSURE SWITCH WITH INDICATOR

This Switch is used to make an exposure. For exposure, first press the Ready Switch and
then Exposure Switch. Exposure Indicator above this Switch glows to indicate that
exposure is takes place.

Allengers Mammography - User Manual Page 15


Rev. ‘0’ Eff. Date: 26.02.2011
Description of Control

INTERLOCKS
In case any one of these Interlock remain ‘ON’ & doesn’t become ‘OFF’ during exposure, it
is an indication of fault.

Interlocks Purpose
To indicate KV fault. Call for Allengers Service
Engineer if this Interlock Display.

To indicate filament. Supply to X-Ray Tube not


O.K. Call for Allengers Service Engineer if this
Interlock Display.

No-Cass: This interlock will appear on the


screen when cassette not inserted in bucky
assembly

ERTH_INT: This interlock will appear on the


screen when Earth is not coming to Machine.
Call for Allengers Service Engineer if this
Interlock Display

Exposure

A. Ready HAND SWITCH

This is used to press Ready switch and Exposure switch using retractable type cord.

B. FOOT SWITCH for ‘C’ UP/DOWN and Compression UP /


DOWN

The Foot Switch is used for ‘C’ UP/DOWN and for Compression UP & DOWN.

Pressing UP Switch decreases the compression. Again pressing this key will decrease the
compression further. This way compression can be decreased. This key does not work when
compression display is 000.

Pressing DOWN initiates the movement of compression paddle downwards & compresses
the breast with force of 3 Kg initially. Again pressing this key will increase the compression
further 3 Kg. Compression can be increase in this way up to 20 kg. Compression force of 10
Kg is recommended. Compression releases automatically after exposure.

Manually release / compress feature is also provided for compression.

Allengers Mammography - User Manual Page 16


Rev. ‘0’ Eff. Date: 26.02.2011
Description of Control

SWITCH PANEL AVAILABLE ON BOTH SIDE OF COLUMN

2 1

4
5

DIGITAL DISPLAY OF COMPRESSION PARAMETERS

Weight Compressed Degree Scale


Breast thickness

Allengers Mammography - User Manual Page 17


Rev. ‘0’ Eff. Date: 26.02.2011
Description of Control

4.2 DESCRIPTION OF SWITCHES ON COLUMN:


These switch panels are provided on both sides of Column for convenience to the operator.

1. COMPRESSION INCREASE KEY

Pressing this key initiates the movement of compression paddle downwards & compresses
the breast with Selected force. Speed progressively reduces as it gets contact with the
Breast. Again pressing this key will increase the compression further of 3 Kg. Compression
can be increase in this way up to 20 kg.

2. COMPRESSION DECREASE KEY

Pressing this key decreases the compression. Again pressing this key will decrease the
compression further.

3. COMPRESSION RELEASE KEY

Pressing this key releases the compression and paddle moves upwards continuously & stops
at its home position.

4. COLUMN UP/DOWN SWITCH

Pressing this Switch Column moves in Upward / Downward direction.

5. COLUMN ROTATION SWITCH

Pressing this Switch Column Rotate in Clockwise / Anticlockwise direction. Auto Stop of
Angular Movement at ±90°.

6. COMPRESSION PARAMETER DISPLAY

Displays the value of compression force in KGs, Compress Brest thickness in CMs & Deg
for Angulations. Also Set Weight, Pre Compression, Dual Mode Full Compression
displayed on LCD.

Allengers Mammography - User Manual Page 18


Rev. ‘0’ Eff. Date: 26.02.2011
Description of Control

7. EMERGENCY OFF

Emergency OFF is provided above ‘C’ Rotation Switch Panel on both side of Control for
Switch OFF the Machine & releases the compression when any emergency occurs during
X-Ray procedure.

Note:- If Emergency Switch is pressed machine is not getting ON. In that case rotate
the Switch in Clockwise direction.
8. COMPRESSION FORCE SELECTION SWITCH

Preset of Compression force is provided in the Machine with which user can select the
compression force as per user requirement. It can be selected from 3 Kg to 20 Kg with
these switches.

4.3 DESCRIPTION OF SWITCHES ON LBD

LBD ON/OFF
SWITCH
LBD

LBD CONE

ON/OFF SWITCH

Pressing this switch turns ON/OFF the LBD Bulb. LBD Bulb switches OFF automatically after 50
seconds.

AUTOMATIC FILTER CHANGE*

As the kV is increased the filter will be automatically changed (After 29.5 KV Filter will change to
Rhodium/Aluminium).
‘*’ OPTIONAL ITEM
Allengers Mammography - User Manual Page 19
Rev. ‘0’ Eff. Date: 26.02.2011
Dark Room Procedures & Room Layout

6. Dark Room Procedures & Room Layout

6.1 Dark Room Procedure:


To obtain the best results from the X-Ray Machine, following should be observed generally
in Dark Room: -
1. Dark Room should be totally dark and no light should enter in the room.
2. Loading and unloading of films in the cassette should be done only in Dark Room
under standard safe light.
3. A qualified and trained Radiographer should only be allowed to operate the
X-Ray Equipment.
4. Films should be stored in Dry and Dark place.
5. The Intensifying screens should be handled with care and wet finger marks of any
chemicals should not touch the screens.
6. The Developer and the Fixer solutions should always be covered and preferably new
solutions to be prepared after 2 Months or 250 films whichever is earlier.
7. The Temperature of Developer and Fixer to be maintained between 25 to 30 Degrees.
8. Solutions should be stirred with wooden stick each time films are dipped. Separate
wooden sticks, each for developer and fixer should be used.

6.2 X-Ray Film Processing:

1. Open the exposed cassette in the Dark Room.


2. Take out the exposed film and fix it in the hanger of suitable size.
3. Dip the film in the Developer. After about 15 seconds take out the film from the
Developer to visually observe the Developing status. Dip it again and take out to
monitor the development as frequently as possible.
4. Take out the film from the Developer tank after it is fully developed.
5. Dip the film in water to rinse all traces of developer on the film.
6. After proper rinsing, dip the film in the fixer. Let it be dipped in fixer for 5 Minutes.
7. Dip the film in running water to rinse and remove all the fixer from the film.
8. Dry film either in open place or in film drier.

Allengers Mammography - User Manual Page 23


Rev. ‘0’ Eff. Date: 26.02.2011
Dark Room Procedures & Room Layout

6.3 Suggested Room Plan

LAYOUT OF MAMMOGRPAHY INSTALLATION

MAMMOGRAPHY
UNIT

Room Size: Min 11 ft x 10 ft

DOOR DOOR

CHANGE
ROOM

Room Size: 5 ft. x 4 ft. Room Size: 5 ft. x 4 ft.

Note: We are providing Lead Glass as a protective device with the machine.

Allengers Mammography - User Manual Page 24


Rev. ‘0’ Eff. Date: 26.02.2011
Maintenance

7. Maintenance

7.1 Overview
Regular maintenance of system is necessary for safe and trouble free use. Periodic maintenance
helps in reducing equipment downtime, service cost and operational hazards.

Contact the local service representative for spares or preventive maintenance inspections. It is
recommended that preventive maintenance be performed every three months.

7.2 Inspecting the System

Daily Checklist

√ After each use, remove the power cord from Power outlet and cover the machine
properly.
√ Clean the Tube Head and external surface of the unit by dry cloth.

Weekly Checklist

√ Check system power cord for any cracks or damages.


√ Check all connectors outside the machine for their firmness.

Monthly Checklist

√ Visually inspect the unit every month for any physical damage to different parts.
√ Check that panel covers are properly tight with screws from all sides.
√ Check the electrical and power cables for any crack, cuts etc.
√ Check the equipment for any loose connection or loose hardware.
√ Check the Tube Head for any leakage.
√ Check for any abnormal noise or sparking in the machine.

Allengers Mammography - User Manual Page 25


Rev. ‘0’ Eff. Date: 26.02.2011
Maintenance

7.3 General Maintenance


1. Since only trained & qualified personnel should be permitted access to the internal
portion of the X-ray unit, it is recommended that service and maintenance be performed
by our local Service Engineer.

2. User should confine only to preserve the external appearance of the unit by cleaning the
unit with dry cloth. It is recommended to take suitable precautions against accumulation
of dust etc. on the control panel, tube head and fluoroscopy etc. Dust covers may be used.

3. Allengers Medical Systems Ltd. maintains a network of Service Centres through which
the assistance of skilled service personnel may be obtained. You are requested to contact
any of the centre near you for all your service related problems. Contact details alongwith
Telephone Numbers of our Service Centres are mentioned in this manual.

4. Tube current adjustments:


• Following the installation, occasional readjustments of tube current will be
required because of changes in electron emission of the filament of X-Ray tubes
brought out by evaporation of Tungsten.

• When mA values are more than 10% off from the proper values, the tube current
must be readjusted. This should be done by qualified Service Engineer specially
trained in servicing the equipment.

Safe use & Adequate Maintenance of Rechargeable Batteries:

The battery is provided for emergency release of compression tray in case of power
failure. Therefore, it must be ensured that battery is fully charged in normal use. If
battery is to be replaced only approved battery with same ratings as the original one
should be used.

Paint Shade Used in Machine


Sr. No. Colour Shade

1. WHITE PANTONE 11-4201 TPX


CLOUD DANCER

2. GREEN PANTONE 366 C

3. SILVER PANTONE 421 C

Allengers Mammography - User Manual Page 26


Rev. ‘0’ Eff. Date: 26.02.2011
Troubleshooting

8. Troubleshooting

Sr. FAULT SYMPTOMS POSSIBLE REASONS FOR FAULTS


No.
1 Machine does not get ‘ON’ 230 Volts between Phase & Neutral at wall socket not
coming.
Loose connections inside plug of Machine.
Potential between Earth and Neutral not 0 V.

F1 20 Amps. Line Fuse blown.


F2 20 Amps. Neutral Fuse blown.

2 Exposure Does not take place Check Interlock on LCD.


3 Column not moving UP/DOWN F3 4 Amps Fuse for Column UP/DOWN Movement
blown.

4 X-Ray film comes out Black X-Ray film may be exposed to Light accidentally.
with No Image
Too long developing time.
Machine needs recalibration. Ask for Allengers
Service Engineer.
5 Radiograph is not up to the Software/firmware parameters need to be re-validated.
mark Call Allengers Engineer for re-calibration of the
equipment.

Allengers Mammography - User Manual Page 27


Rev. ‘0’ Eff. Date: 26.02.2011
Warranty

Warranty Card Customer Copy

HEAD OFF.: S.C.O. 212-214, SECTOR 34-A, CHANDIGARH- INDIA,


EPBAX NO.: +91-172-6618081, 6618082, FAX:+ 91-172-2621912,
MEDICAL SYSTEMS LTD. SERVICE SUPPORT: +91-9316523117,
An ISO 9001:2015 & E-mail: : export.service@allengers.net
Website: www.allengers.com
EN ISO 13485:2016 Company

Customer Name & Address : _________________________________________________


_________________________________________________
Equipment Description : _________________________________________________
Model : _________________________________________________
Serial No. of Unit : _________________________________________________
Date of Dispatch : _________________________________________________
Date of Installation : _________________________________________________
Date of Warranty Expiry : _________________________________________________

The equipment supplied is warranted against defective workmanship & material for a period of 12 months from the
date of Installation or 15 months from the date of dispatch which ever is earlier. Equipment & parts proved defective
within the warranty period shall be replaced or repaired free of material & labour cost.

This warranty will not apply in the following cases:

1. Breakages of any item due to misuse / mishandling.


2. Any defect occurring in machine due to service taken from third party/freelancer. Alteration or
modification carried out in the machine without any written permission from the Company.
3. If machine operated on an electrical supply which is differ from the power ratings specified for the
machine.
4. If changes occur in the operational condition of the equipment due to humidity or any other influence
outside the control of the Company.
5. When damage is caused directly due to lack of user care or damage is due to operator error.

All Vacumatic items (X-Ray Tubes & Image Intensifying Tubes) are subject to pro-rata warranty and these items
going defective during the warranty period shall be replaced as per following replacements policy.

a) Price of the X-Ray Tube or I.I. Tube “A” = Rs. X


b) Un-expired portion of the warranty = Y Months
c) Pro-Rata Credit to be allowed to customer “B” = XxY
12
d) Replacement cost to be borne by customer = A-B

For ALLENGERS MEDICAL SYSTEMS LTD. Customer Sign & Seal

(AUTHORIZED SIGNATORY)

Allengers Mammography-User Manual Page 28


Rev. ‘0’ Eff. Date: 26.02.2011

You might also like