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AN ISO 9001:2008 & EN ISO 13485:2012 COMPANY

ALLENGERS DSA 20
(MOBILE DIGITAL SUBSTRACTION ANGIOGRAPHY SYSTEM)

OPERATION / USER MANUAL

MEDICAL SYSTEMS LTD. Our EU Authorised Representative: -


S.C.O. 212-214, SEC. 34-A, Michiels SA (Mr. Christoph Michiels),
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 Fax: +32.2.662.29.92
Website: www.allengers.com E-mail: cmi@michiels.be

Catalogue No. 38

We Aim For Your Delight


Contents

Contents
1. Approvals……………………………………………………………… 1

2. For Your Safety..........………………………………………………… 2

3. Introduction…………………………………………………………… 8
3.1 Introduction to Machine…………………………………………… 8
3.2 Safety………………………………………………………………. 8
3.3 Recommendations and Practices…...……………………………… 9

4. Room Plan..........................................................................……………. 10

5. System Overview……………………………………………………… 11
5.1 Prescribed Usage…………………………….…………………….. 11
5.2 System Components……………………………………………….. 11

6. System Specifications……………….………………………………… 13
6.1 Block Diagram……………………………………………………... 13
6.2 Brief description of Principal modules…………………………….. 14
6.3 Technical Specifications…………………………………………… 16
6.4 Control Panel (Names and Functions)……………………………... 17
6.5 Power Supply Requirements………………………………………. 24

7. Operation…………………………………..…………………………... 25
7.1 Fluoroscopy………………………………………………………... 25
7.1.1 Fluoroscopy mode...................................................……………… 26
7.1.2 Cine Acquisition Mode…………………................……………… 26
7.2 Radiography………………………………………...……………… 26
7.3 Using Allengers DSA-20 I.I.T.V System…………..……………… 27

8. Trouble Shooting……………………………………………………… 28

9. Maintenance…………………………………………………………… 30
9.1 Overview…………………………………………………………... 30
9.2 Inspecting the System……………………………………………… 30
9.3 General Maintenance………………………………………………. 31

10. Fluoroscopic Technic Chart………………………………………….. 32

11. Warranty………………………………………………………………. 33

Checked by____________________

Allengers DSA-20 User Manual


Rev. ‘0’ Eff. Date: 22.10.2011
Approvals
___________________________________________________________________________

We thank you for purchase of Allengers DSA 20. Please go through the User Manual are
fully 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) 14-TA-


19223: Approved for meeting Radiation Safety
Standards.

¾ CE Certified – CE 663857: Approved for meeting


International Safety Standards.

SYSTEM APPROVAL

¾ ISO 9001:2008 & EN ISO 13485:2012 Approved for


meeting Quality Management System Requirements.

Allengers DSA-20 User Manual Page 1


Rev. ‘0’ Eff. Date: 22.10.2011
For Your Safety

2. Warning Symbols
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 DSA-20 User Manual Page-2


Rev. ‘0’ Eff. Date: 22.10.2011
For Your Safety

DANGEROUS VOLTAGE

This symbol indicates High Voltage or Dangerous Voltage


at this area of equipment. DO NOT TOUCH this part.

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 if you see this symbol on


your machine.

Allengers DSA-20 User Manual Page-3


Rev. ‘0’ Eff. Date: 22.10.2011
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.
• 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.

Allengers DSA-20 User Manual Page-4


Rev. ‘0’ Eff. Date: 22.10.2011
For Your Safety

• 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 DSA-20 User Manual Page-5


Rev. ‘0’ Eff. Date: 22.10.2011
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) Use exposure factors according to body part to avoid excess radiation to patient.

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 DSA-20 User Manual Page-6


Rev. ‘0’ Eff. Date: 22.10.2011
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 DSA-20 User Manual Page-7


Rev. ‘0’ Eff. Date: 22.10.2011
Introduction

3. Introduction

3.1 Introduction to Machine

Keeping in view the ever-increasing requirements of Surgeons in the field of Cardiology, we at


Allengers continue to develop products and services in line with their needs. Allengers DSA-20 is
such an outcome of our efforts which promises to deliver superior image quality, ease of operation
& position, safety to patient & operator, increased life of vital components of equipment and user
interactive self diagnostic capabilities for increased up-time of equipment.

3.2 Safety
X-ray, fluoroscopy & Graphy are indispensable accessories for orthopedic, DSA, Cardiac
procedures. Their use is beneficial to a patient but exposes the surgeon to radiation hazards.
Majority of surgeons consider these hazards insignificant either because of bravado or ignorance.
The primary concern has been possibility of malignancy and infertility. The most worry is about
the thyroid, marrow organs (liver and spleen), gonads, hands (skin) and the eyes (lens). Image
intensifier is becoming popular but standard X-Ray unit is still is the workhorse. Although
fluoroscopy reduces the radiation to far below acceptable limits, no author advocates decreased
protection and cavaliser use of the modality like direct handling of the tube and placement of the
hands directly in the field.

The radiation-induced effects are described as stochastic and non-stochastic. A non-stochastic


effect is one that increases in severity with increasing absorbed dose (e.g., decreased sperm
production, skin erythema, and lens opacification). It occurs only after relatively high exposures to
radiation. In a stochastic effect, the probability of occurrence increases with increasing exposure;
however, the severity is independent of the magnitude of the absorbed dose (e.g. cancers and
genetic effects). This is the principal hazard of exposures to low doses of ionizing radiation.

The objective of a radiation protection program is to prevent the occurrence of non-stochastic


effects and to limit the risk of stochastic effects to a reasonable level. In this issue two experts
have highlighted the ill effects of the Roentgen rays on living tissue and enunciated the safety
principles. All surgeons should use well collimated X-ray machines and make use of intensifiers
in image memory mode in preference to live fluoroscopy, stand as far away from the tube as
possible and protect themselves with lead aprons, lead-lined eyeglasses and thyroid shields.

Allengers DSA-20 User Manual Page 8


Rev. ‘0’ Eff. Date: 22.10.2011
Introduction

3.3 Recommendations & Practices

Recommendations
To reduce Radiation Exposure

Use radiation with care, caution and at a rate, which


is ‘As Low As Reasonably Achievable’
(ALARA)

1. Obey radiation protection rules pertinent to


time, distance and shielding.
2. Utilise pulsed fluoroscopy mode to reduce
exposure by a factor of 3 to 10.
3. Prefer low exposure settings to high and
reduce fluoroscopy exposure by 50%.
4. Use collimator to set minimal useful field
size; keep image intensifier in close
proximity to the patient.
5. Stand on the image intensifier side of the
fluoroscopy (see figure I)
6. Step back during fluoroscopy

It is not possible to quantify the radiation received by


hands which are 50 times less sensitive than rest of
the body. Undue fear of radiation should not hold
back medical care.

Good practices
For optimum radiation protection

• Use equipment certified safe by the


Regulatory Board.
• Maintain equipment in optimal working
condition
• Use good quality radiation protection devices
certified by the Regulatory Board
• Use radiation only when required
• Use it as sparingly as possible
• Use image storage devices during
fluoroscopy
• Stand as far away from the primary beam as
possible (see figure I)
• Use TLD monitoring

Allengers DSA-20 User Manual Page 9


Rev. ‘0’ Eff. Date: 22.10.2011
Room Layout

4. Room Layout

Allengers DSA-20 User Manual Page 10


Rev. ‘0’ Eff. Date: 22.10.2011
System Overview

5. System Overview
5.1 Prescribed Usage
Allengers DSA-20 is a Digital Subtraction Angiography System for Fluoroscopy &
Radiography. This equipment is to be used only by an Orthopaedic Surgeon, Urologist,
Gastroenterologist or a Cardiac Surgeon. Its unauthorized use can cause injury or damage.

5.2 System Components


13

14

15
9
12

11
10

8
7

6
3
5

Allengers DSA-20 User Manual Page 11


Rev. ‘0’ Eff. Date: 22.10.2011
System Overview

1. CONTROL KEY PANEL 9. IMAGE INTENSIFIER AND CCD


CAMERA WITH OPTICS
2. C MOVEMENT CONTROL 10. MOBILE TROLLEY
PANEL
3. CONTROL 11. IMAGE MEMORY (SOFTWARE)
4. BRAKE LEVER 12. MEMORY KEY BOARD
5. STEERING HANDLE 13. MONITORS
6. ‘C’ CARRIAGE 14. EXPOSURE INDICATOR
7. X-RAY TUBE HEAD 15. SOFTWARE ON / OFF SWITCH
8. ALUMINUM ‘C’

Allengers DSA-20 User Manual Page 12


Rev. ‘0’ Eff. Date: 22.10.2011
System Specifications

6. System Specifications

6.1 Block Diagram (Allengers-DSA-20 Mobile ‘C’ Image Intensifier)


INPUT 230 VOLTS AC 50 Hz

SERVO
Earth
VOLTAGE
STABILISER

OUTPUT
230 V AC ± 2% STABILISED

CONTROL PANEL
Earth

VARIOUS
SUPPLIES & 12 VOLTS
SIGNALS D.C.
230V AC

IMAGE INTENSIFYING CCD


X-RAY TUBE CAMERA
TUBE HEAD & OPTICS

VIDEO OUT

IMAGING SYSTEM WITH


DSA SOFTWARE
230V AC

V out 2
V out 1 V IN

TROLLEY V IN 230V AC V IN 230V AC

MONITOR 2 MONITOR 1

Allengers DSA-20 User Manual Page 13


Rev. ‘0’ Eff. Date: 22.10.2011
System Specifications

6.2 Brief Description of Principal Modules

Allengers-DSA-20 is a Mobile Image Intensifier X-Ray T.V. System. It consists of the


following Main Assemblies:

1. Control
2. ‘C’
3. Image Intensifier with CCD Camera & Optics
4. X-Ray Tube Head
5. Trolley with 2 Monitors
6. Servo Voltage Stabilizer 5 KVA

The brief description of various Assemblies is mentioned below:

1. Control

The Control houses the Invertor Assembly of the X-Ray Generator alongwith other Control
& Command Circuitry. All parameters related to operation of X-Ray generation can be
selected & regulated from the Control Panel. Various display windows indicate the
parameters. The detailed functions of each Key on the Control Panel is given in the
separate section of this Manual.
The control panel uses a flat Panel Keyboard, which makes it easier to clean & disinfect.

2. ‘C’
The ‘C’ is mounted on the carriage attached to the Control Panel. On one end of the ‘C’,
Image Intensifier with CCD camera & optics is mounted and on the other end the X-Ray
Tube Head is fixed. Both these devices are centrally aligned with each other. The ‘C’ also
carries the electrical wiring in its cavity positioned in the back of ‘C’. This wiring makes
interconnections between Control Panel to I.I. Tube & X-Ray Tube Head.

3. Image Intensifier with CCD camera & optics


The Image Intensifier head consists of Image Intensifying Tube of 9” or 12” Diameter (as
per customers order). The Power Supply of the Image Intensifying Tube is also housed
inside the Projected rectangular portion of the Image head.
On top of Image Intensifying Tube, a CCD camera with suitable optics is mounted. The
camera is covered by a Round Cap on I.I. Tube.

Allengers DSA-20 User Manual Page 14


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System Specifications

4. X-Ray Tube head

The X-Ray Tube Head a Double Focus Rotating Anode X-Ray Tube.
The X-Ray Tube Head emits the X-Rays when Exposure is initiated from Control Panel or
Foot Switch.

5. Trolley with 2 Monitors

This is a Mobile Trolley on which Image Memory (Software), 2 Monitors & other devices
like Keyboard, Mouse in built in trolley key board.
A 5 way Terminal Block is mounted on the back of Trolley from where the Electrical
Supply to Image Memory (Software) & Monitors is provided.
High Resolution 19” LCD medical grade Monitors.

6. Servo Voltage Stabilizer


It is highly recommended that a Servo Voltage Stabilizer of Suitable Rating is used to give
stabilized voltage of 230 volts AC ± 1%.

Note: Safety Precaution for Monitors.

During Sterilization or Fumigation take out the Machine/Monitors from Operation


Theater or Cover the Monitors.

Trolley View

Keyboard Monitor
UP/DOWN Switch
(on backside of
Trolley)

Software ON/OFF LAN Port CD/DVD Writer USB Port


Switch (on Trolley)

Allengers DSA-20 User Manual Page 15


Rev. ‘0’ Eff. Date: 22.10.2011
System Specifications

6.3 Technical Specifications

1. X-Ray Generator

• Type : 50 KHz High Frequency


• Tube head : Rotating Anode Dual Focus X-Ray Tube
• Max. Power : 20 KW
• Max. KV output : 120 KV
• Flouro mA : 5 to 30 mA
• CINE : 30-80 mA
• Max. Rad. mA : 200 mA
• LCD Display for - KV User Selectable.
- mA.
- Fluoro Time
- Magnification
• Radiography APR (Anatomical Programming)
i.e. pre-selected parameters are programmed in the
machine as per the Body Part selected/to be
exposed.
APR covers Head , Chest , Abdomen and
extremities

2. Image Head : 12” Triple field Image Intensifying Tube

3. CCD Camera : 1k X 1k CCD camera with optics mounted on


output window of Image Intensifying Tube.

4. Monitors (2 Nos.) : High Resolution 19” LCD medical grade Monitors


Mounted on Mobile Trolley (As per demand).

5. Power requirement : 230 volts AC ±10%, 50/60 Hz single phase on 15


Amps 3 Pin Socket with Independent Earthing.

Allengers DSA-20 User Manual Page 16


Rev. ‘0’ Eff. Date: 22.10.2011
System Specifications

6.4 Control Panel


3 21 20 19 17 15 16 14
5 6 7 18

4 13

A 1 2 9 12 10 11
22 B A

Note:- By Default the machine is ON in fluoroscopy mode.

Allengers DSA-20 User Manual Page 17


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System Specifications

OPERATOR CONSOLE

1. Machine ‘ON’ key 13. I.I. Zoom key

2. Machine ‘OFF’ key 14. Buzzer Reset key

3. Fluoro/ Radio mode selection key 15. ABS Key

4. Radiographic Exposure key 16. MODE Key

5. Body part change key 17. Iris Open/Close key

6. View key 18. Clockwise/Anti-clockwise image


rotation key (Not Used)

7. mAs Increase/Decrease key 19. Collimator Shutter Clockwise / Anti-


Clockwise Rotation key

8. Reboot key 20. Image Horizontal/Vertical Invert key


(Not Used)

9. Emergency Exposure key 21. Collimator Parallel Shutter open/close


key

10. Fluoroscopy exposure key 22. Display

11. Hi Definition Exposure Key A. ‘C’ Up/Down key

12. KV Increase/Decrease Key B X-Ray Indicator

Allengers DSA-20 User Manual Page 18


Rev. ‘0’ Eff. Date: 22.10.2011
System Specifications

Control Keys Description


1. MACHINE ‘ON’ KEY:
Pressing this key turns ‘ON’ the machine

2. MACHINE ‘OFF’ KEY:


Pressing this key turns ‘OFF’ the Machine. In ‘OFF’ mode the LED on the “OFF’ Key glows
and when ‘ON’ key is pressed this LED stops glowing.

3. FLUORO/RADIO MODE SELECTION KEY:


Pressing this key enables the operator to select the fluoroscopic or radiographic mode
operation. Respective LED glows when a mode is selected. By default the machine is ON in
fluoroscopy mode.

4. RADIOGRAPHIC EXPOSURE KEY


Pressing this key makes radiographic exposure & buzzer starts beep.

5. BODY PART CHANGE KEY


By pressing this key operator can change the parts of patients body i.e. Head, Skull.

6. View in APR Mode


It is used for APR to change the view (LAT, OBL) in this machine.

7. mAs DECREMENT KEY:


This key is used to increase/decrease the mAs in Radio mode.

8. REBOOT KEY
This key is used for reboot the machine. (this function not used in this machine)

9. EMERGENCY EXPOSURE KEY


This key is used for making an emergency exposure.
This key is used to do fluoroscopic exposure in case of emergency i.e. in case of an interlock is
glowing on display during exposure but still fluoroscopic exposure is required. To do
emergency exposure, press the emergency exposure key.

Allengers DSA-20 User Manual Page 19


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System Specifications

10. FLUORO EXPOSURE KEY:


This key is used to make a fluoroscopic exposure, it is parallel to the foot switch and function is
same as foot switch.

11. HIGH DEFINITION EXPOSURE KEY:


When high definition mode is enabled; this key initiates the High definition (CINE)
fluoroscopic exposure.

12. KV INCREASE/DECREASE KEY:


This key is used to increase/decrease the KV.

13. I.I. ZOOM KEY):


This key enables the operator to select the Image field of a 12” I.I. Pressing repeatedly selects
the 12”, 9” and 6” fields in sequence.

14. BUZZER RESET KEY


This key is used for reset the buzzer after 300 seconds of time.

This key Resets the 300-second cumulative timer to zero after 300 seconds of total fluoroscopic
exposure time. After 300-second fluoro exposure, a buzzer sounds and exposure is terminated.
By pressing this key fluoro time is reset and fluoroscopy can be resumed.

15. AUTOMATIC BRIGHTNESS STABILIZATION KEY (ABS):


This key enables the automatic brightness control mode. In this mode, the machine selects the
most optimum factors of fluoroscopic KV & mA automatically depending upon the thickness of
area under observation. When ABS is ON the indicator with this key is glowing.

16. FLUOROSCOPY MODE KEY:


Pressing this key selects the desired mode of fluoroscopy. There are three different modes of
fluoroscopy available. By default continuous mode of fluoroscopy is selected. Pressing this key
once selects single pulse fluoroscopy mode in which exposure takes place for single pulse of
short duration. Again pressing this key selects pulsed mode of fluoroscopy in which exposure
takes place in pulses instead of continuously so that exposure dose to patient is less.

17. IRIS OPEN/CLOSE KEY (OPTIONAL):


Pressing this key opens/closes the Iris of collimator.

Allengers DSA-20 User Manual Page 20


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System Specifications

18. CLOCK WISE / ANTI CLOCK WISE IMAGE ROTATION KEY: (Not Used)
This key rotates the image on Monitor in Clock Wise / Anti Clock Wise direction

19. COLLIMATOR SHUTTER CLOCKWISE / ANTI-CLOCKWISE ROATION KEY


(OPTIONAL):
Pressing this key rotates the collimator shutter in Clockwise / Anti-clockwise direction.

20. IMAGE HORIZONTAL / VERTICAL INVERT KEY (Not Used):


Pressing this key, the image orientation is Invert Horizontal/Vertical and vice versa indicated
with LED

21. COLLIMATOR PARALLEL SHUTTER OPEN/CLOSE KEY (OPTIONAL):


Pressing this key open/closes the shutter of collimator

22. DISPLAY:
This is a dual display module. At the time of fluoroscopy exposure it displays active
fluoroscopy mA and once you have selected Radiography the same display will display
Radiographic mAs.

Allengers DSA-20 User Manual Page 21


Rev. ‘0’ Eff. Date: 22.10.2011
System Specifications

A. ‘C’ UP/DOWN KEY

Pressing this key starts upward/downward movement of ‘C’.

B X-RAY INDICATOR

This indicator glows when X-Rays are emitted.

In case any one of these Interlock remain ‘ON’ & doesn’t become ‘Off’ during fluoro 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.
To indicate Thermal Key activation due to Excessive
heating of Tube head. Wait for tube head to cool
down to normal temperature.

Allengers DSA-20 User Manual Page 22


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System Specifications

C-Movement Control Panel

4 1
3 2

5 6 7

1. Horizontal Release: This switch is used for Horizontal lock release for to move the C-
Arm Carriage in Horizontal Position.

2. C-UP: This switch is used for moving the C-Arm to Up Ward.

3. Caudal: This switch is used for moving the C-Arm to make Caudal view.

4. Cranial: This switch is used for moving the C-Arm to make Cranial view.

5. Left Anterior Oblique: This switch is used for moving the C-Arm to make
LAO view.

6. Right Anterior Oblique: This switch is used for moving the C-Arm to make
RAO view.

7. C-Down: This switch is used for moving the C-Arm to Down Ward.

Note: When machine is in ±90° LAO/RAO position don’t move the CRA/CAU movement
of machine.

Allengers DSA-20 User Manual Page 23


Rev. ‘0’ Eff. Date: 22.10.2011
System Specifications

6.5 Power Supply requirements


The electrical power requirements for Allengers DSA-20 Mobile image intensifier is given
below:
Voltage: 230 volts A.C., 50Hz, 15 Amps. Single phase
Regulation: ±1%
It is recommended that a single phase, 5 KVA Servo Stabilizer or 5 KVA UPS will be used
with the equipment having output of 230 V AC ±1%
The wiring Electrician must ensure that at the power socket, the right pin socket is connected to
phase (line) & left pin socket to neutral. With a multimeter, the following should also be
checked.
- Voltage between Phase & Neutral = 230 V AC
- Between Neutral & Earth = 5 V AC
- Between Phase & Earth = 230 V AC

EARTHING

It is strongly recommended that independent EARTHING (at zero


potential) is available in the power socket in the Operation Theatre
where the machine is to be installed. Improper EARTHING can result
in poor image quality (i.e. snow in image can be there).

Proper EARTHING not only enhances the performance & reliability of


the equipment, it is safe for the operating staff as well.

Allengers DSA-20 User Manual Page 24


Rev. ‘0’ Eff. Date: 22.10.2011
Operation

7. Operation

WARNING: If X-ray Tube is being operated for the first time or re-operating the X-
ray tube after more than four weeks, the tube should be warmed-up as
follows:

Operate it with half of the max. working tube voltage and then increase
to max. working tube voltage with the speed of more than 5kV per
minute and keep it there for three minutes.

7.1 Fluoroscopy

This machine has two Modes of operation

Normal Mode: In this mode, KV is to be selected manually from the control Panel according
to Patient’s Physique. The user can refer to the Technic chart given in this manual for
selection of the Parameters. This mode can be selected by pressing the switch on the control
panel.

ABS Mode: (Automatic Brightness Stabilization Mode): This mode is selected by default.
A small LED lights up next to ABS key.
In this mode the machine automatically selects the fluoroscopic KV & mA depending upon
the Patient’s Physique. For the thicker part, the machine automatically selects higher
KV/mA for effective penetration & optimum Image quality.

Appropriate section of the User Manual may be referred depending upon the requirement.

Before attempting to make an exposure, it is assumed that the following steps have already
been completed.
1. The system is connected to a proper supply source and the Machine switched ON.
2. Imaging System/ Monitors & others options switched ON.
3. Patient is positioned on the Table.
4. C-Arm is positioned, aligned & height of C-Arm is adjusted properly to expose
area of interest.
5. The F/R selector on C-Arm Control Panel to be selected at FLR mode.
6. The fluoroscopic parameters viz, KVP & FmA adjusted according to patient’s
physique, (Please refer to enclosed technique chart for optimum selection of
parameters.)
7. The brightness & contrast of Monitors adjusted.
Allengers DSA-20 User Manual Page 25
Rev. ‘0’ Eff. Date: 22.10.2011
Operation

8. Necessary precaution for radiation safety to be taken by all persons in the


operating room.

7.1.1 Fluoroscopy Mode

By pressing the fluoroscopy F/S the unit release the exposures in pulses & not continuously.
In this mode, pressing the foot switch continuously would release the exposures to become
‘ON’ for a very short time & then becomes ‘OFF’ automatically. The Image thus formed
keeps on getting held on the Monitors & the moment next pulse of exposure comes, the old
image vanishes. This way, the radiation to the operating staff & patient is minimized. After
releasing the F/S last image is hold on FLR monitor

7.1.2 Cine Acquisition Mode

By pressing the cine F/S the unit release the exposure and image memory software starts
capturing the image and adding to make a loop. In this mode full loop saved in imaging
software.

7.2 Radiography
The Allengers DSA-20 is set for an output of 200 mA on Radiographic Mode. To obtain
desired ‘mAs’ in Radiography Mode, select the Radiographic time (in seconds) from mAS +,
- (Keys No. : 7) User can change the mAS from 1mAS to 100mAS.
Appropriate mAS values as indicated in the Radiographic Technique chart may be selected
for various Body Parts.

NOTE: Radiography can be performed on the machine subject to availability of a suitable


power line having line resistance of 0.4 ohms as per IS:7620 (I) Table 3.

Satisfactory Radiographic operation cannot be performed on Power lines having line


resistance of more than 0.4 ohms (Ref. IS: 7620(I)).

The Allengers DSA-20 I.I.T.V. system is capable of performing Radiographic functions.


Following precautions must be taken before attempting to make a radiographic exposure: -

a) Use only lead backed X-Ray Cassettes in the Universal cassette holder.
b) Never give a direct radiographic exposure without the X-Ray Cassette in place.

Allengers DSA-20 User Manual Page 26


Rev. ‘0’ Eff. Date: 22.10.2011
Operation

Proceed as given below to take an exposure:

1. Align Al. ‘C’ to patient.


2. Quickly assemble the universal cassette holder on the input screen of image
intensifier.
3. Slide the loaded X-Ray Cassette into cassette holder.
4. Plug in the 2 Pin Male connector of cassette holder to the socket provided at the
bottom of mounting cover near the I.I. tube.
5. On the control panel of machine press F/R switch (3) to ‘R’ position.
6. Select desired Rad. Time as per the body part of patient with the help of seconds +, -
(7). The selected time is indicated by respective LED.
7. Select desired KV on the control panel as per the penetration required for the body
part of the patient.
8. After all parameters are selected and patient/ C-Arm/ Cassette in position & aligned,
Press RAD. Exp. Switch (4) on control panel. The exposure is released & X-Ray
indicator (B) Glows.
9. Take out the cassette from the holder & develop the film in the dark room.
10. Remove cassette holder from the I.I. & keep at safe place.

Allengers DSA-20 User Manual Page 27


Rev. ‘0’ Eff. Date: 22.10.2011
Trouble Shooting

8. Trouble Shooting

S.NO. FAULT SYMPTOMS SUGGESTED ACTION

1. Machine does not get ON ƒ Check wall socket with a multimeter. It


should read 230 volts. In case voltage
stabilizer is connected, check output of
servo stabilizer.
ƒ Check sequence of Phase & Neutral.
Check Earth wire present & connected.

2. No exposure when foot switch ƒ Check foot switch connector’s proper


is pressed. insertion.

3. Image quality poor ƒ Check parameters selection on Control


Panel. They must correspond to patient’s
physique. 2 frames for DSA and 15
frames for FLR & CINE. Check
Brightness/Contrast on monitors.
ƒ Check the earth fault indicator if glowing
get the proper earthing done. As
improper EARTHING can lead to
snow in image (ie. poor image quality).

4. Image quality & memory ƒ Switch OFF the Memory (Sofware) Unit
function erratic & Switch ON again.
ƒ Check for any loose connection at the
rear panel off memory/ monitors.

5. Audible Alarm sounds on ƒ Press Reset Button on Control Panel.


pressing foot switch & No
generation of X-rays.

6. X-Rays are generating but no ƒ Check for any loose connection at the
image (FmA reading present) rear of Memory (Software) & monitors.

Allengers DSA-20 User Manual Page 28


Rev. ‘0’ Eff. Date: 22.10.2011
Trouble Shooting

S.NO. FAULT SYMPTOMS SUGGESTED ACTION

7. Monitor Power ON LED is ƒ Check the input mode selected on


glowing but no display on Monitor. It should be according to the
Monitor. (Dtd. 22.08.2017) Input Cable used (HDMI, DVI or VGA).
ƒ Check loose connections of input source
cable (HDMI, DVI or VGA Cable).

8. Some abnormal sounds when Call your local Service Engineer.


X-ray ON & no image.

9. No Image on the Monitor when ƒ This problem could be because of supply


exposing. to camera missing or the Video signal
missing/ Loose connection of signal wire
set Camera or Memory (Software) unit.
Please note that the square will appear on
the 1st Monitor only when the Monitor is
switched “ON” for the first time.
ƒ Check Memory (Software). It should be
‘ON’.
ƒ Video signal wire either from Memory
(Software) or Monitor loose connection or
disconnected. Set it right.

10. C-Arm movements hard ƒ Check that locks are open.

In case that fault cannot be solved by suggested actions, please call your local Allengers Service
outlet for assistance.

Allengers DSA-20 User Manual Page 29


Rev. ‘0’ Eff. Date: 22.10.2011
Maintenance

9. Maintenance

9.1 Overview
Regular Maintenance of the Allengers DSA-20 Mobile 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 representatives for parts or planned maintenance inspections. It is
recommended that maintenance be performed on the system every three months.

9.2 Inspecting the System


Daily checklist.
• After each use, remove the Power Cord from the Power outlet and cover the machine
properly.
• Clean the Tube Head and exterior appearance of the unit by soft dry cloth.

Weekly checklist
• Check system power cord for any cracks or damages.
• Check all the connectors outside the machine for their firmness
• Clean the foot switch with a soft dry cloth.

Monthly checklist
• Visually inspect the unit every month.
• Check for mechanical problems or keyboard problems.
• Check the electrical and power cables for cracks, cuts.
• Check the equipment for loose or missing hardware.
• Check for any leakage from the Tube Head
• Check for any abnormal noise or sparking in the machine.

Allengers DSA-20 User Manual Page 30


Rev. ‘0’ Eff. Date: 22.10.2011
Maintenance

9.3 General Maintenance


1. 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 ALLENGERS Service Engineer.

2. User should confine only to preserve the exterior appearance of the unit by cleaning the
unit with soft 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


from 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.
Telephone no. of our Service Centre are mentioned in this Manual.

4. Tube Current Adjustments:


Following the installation, occasional readjustment of Tube current will be required
because of changes in electron emission of the filament of X-Ray Tubes brought about by
evaporation of Tungsten.

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

Sr. No. Colour Shade

1. WHITE PANTONE 11-4201 TPX


CLOUD DANCER

2. GREEN PANTONE 366 C

3. SILVER PANTONE 421 C

Allengers DSA-20 User Manual Page 31


Rev. ‘0’ Eff. Date: 22.10.2011
Fluoroscopic Technic Chart

10. Fluoroscopic Technic Chart

S.NO. PART VIEW KVP

1. WRIST AP 40-45

2. ELBOW AP/LAT 40-45

3. SHOULDER AP 45-50

4. LEG AP/LAT 45-50

5. KNEE AP/LAT 50-52

6. FEMUR AP/LAT 45-55

7. HIP JOINT AP 55-65

8. HIP JOINT LAT 60-70

9. CHEST AP 50-55

10. ABDOMEN AP 60-65

11. SPINE AP 65-70

12. SPINE LAT 70-80

13. SKULL AP/LAT 60-70

Above are only suggested parameters. In practice these may vary according to the physique
of the patient. The operator may adjust the parameters to get a better video image quality.

Allengers DSA-20 User Manual Page 32


Rev. ‘0’ Eff. Date: 22.10.2011
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 9001:2008 & E-mail: export.service@allengers.net
Website: www.allengers.com
EN ISO 13485:2012 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 DSA-20 User Manual Page 33


Rev ‘0’, Eff. Date: 12.10.2011
Warranty

Warranty Card Office 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 9001:2008 & E-mail: export.service@allengers.net
Website: www.allengers.com
EN ISO 13485:2012 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 DSA-20 User Manual Page 33


Rev ‘0’, Eff. Date: 12.10.2011

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