Allengers Medical System Mars 15 User Manual
Allengers Medical System Mars 15 User Manual
Allengers Medical System Mars 15 User Manual
User Manual: Mars 15
OPERATION / USER MANUAL
Medical Systems Ltd.
MOTOR DRIVEN MOBILE HF X‐RAY
SERIES: MobilX
MODELS:Mars 15
Catalogue No: 19
Manual No. AMSL/UM/Mars 15/19
Rev. 00 Effective Date 08.02.2011
Page 1 of 40
User Manual: Mars 15
Word of thanks
We very much appreciate your business and now that you are a valuable customer of Allengers
Medical Systems Ltd., we would like to hear from you, because your feedback or suggestions are
important for us. If you have comments, please don’t hesitate to contact us.
ISO 9001:2015 & EN ISO 13485:2016 Company
Head Office, Works,
ALLENGERS MEDICAL SYSTEMS LTD. BHANKHARPUR, MUBARAKPUR ROAD,
S.C.O. 212‐213‐214, SECTOR 34‐A, CHANDIGARH ‐160022 (U.T), INDIA.
CHANDIGARH ‐160022 (U.T), INDIA. DERABASSI, DISTT. MOHALI‐140507 (INDIA)
TEL: +91‐172‐6618081, 6618082
Fax: +91‐1722621912
E‐mail: [email protected]
Website: www.allengers.com
Our EU Authorized Representative,
M/S Michiels SA (Mr. Michiels Christoph),‐2 Luitberg,
1853 Strombeek‐Bever‐Belgique‐Belgium,
Tel: +32 (0) 2 268.45.18 – Direct +32 (0) 2 325.13.65
[email protected]‐www.michiels.be
User Manual: Mars 15
PLEASE GO THROUGH THE ENTIRE INSTRUCTION MANUAL CAREFULLY BEFORE TRYING TO
OPERATE THE DEVICE. THIS MACHINE IS TYPE APPROVED FOR MECHANICAL, ELECTRICAL &
RADIATION SAFETY STANDARDS BY REGULATORY BOARDS. INSTALLATION, ADJUSTMENTS,
CALIBRATION AND REPAIR OF MACHINE MUST BE CARRIED OUT BY PERSON AUTHORIZED BY
ALLENGERS MEDICAL SYSTEM LTD. ONLY.
This manual may not be reproduced, in whole or in part, without the written permission of Allengers
Medical Systems Ltd. (AMSL). The material in this manual is provided for informational purposes
only and due to continuous improvement in product, matter is subject to change without prior
notice.
User Manual: Mars 15
MACHINE COMBINATION: MARS 15 MobilX
CONTENTS ……………………………………………..04
INTRODUCTION ……………………………………………..06
SAFETY HAZARDS ……………………………………………..08
SYSTEM CONFIGURATION & OVERVIEW ……………………………………………..18
OPERATION ……………………………………………..26
MAINTENANCE ……………………………………………..29
LABELS & SYMBOLS …………………………………………....34
TECHNICAL REFERENCE ……………………………………………..36
WARRANTY
Checked by: (QC) ……………………….
Manual No. AMSL/UM/Mars 15/19
Rev. 00 Effective Date 08.02.2011
Page 4 of 40
User Manual: Mars 15
1. MANUAL REVISION HISTORY
Revision Date Change Description
User Manual: Mars 15
2. INTRODUCTION
ABOUT US
Established in 1987, Allengers is a leading Indian name in the realm of medical diagnostic
equipment & IT solutions in more than 70 countries worldwide.
With a vision to develop strategic long term relationships with clients, we are committed to
bringing to life; medical products & solutions and serving the humanity by delivering excellent
patient care.
An Indian market share of more than 35%, ever‐rising exports to foreign governments & clients,
innumerable national & international awards, all bear a testimony to the immense customer
satisfaction our offerings deliver.
Guided by our motto: “Passion for Excellence”, we are an organization fueled by ideas &
innovation.
Our company culture & philosophy is all about creating and fulfilling relationships with clients &
the society by way of meaningful social responsibility.
ALLENGERS PRODUCT PROFILE:‐
Radiology
Cardiology
Urology
Neurology
Orthopaedics
Gastroenterology
IT Solutions
2.1 APPROVALS
2.1.1 Product approvals
This Product complies with the regulatory requirements of the following:
Approved for meeting Radiation Safety Standards by Atomic Energy Regulatory Board (AERB).
Approved for meeting Mechanical & Electrical Safety Standards by Bureau of Indian Standards
(BIS).
CE Certified; Approved for meeting International Safety Standards.
2.1.2 System approvals
ISO 9001:2015 & EN ISO 13485:2016 Approved for meeting Quality Management System
Requirements.
User Manual: Mars 15
2.2 DESCRIPTION
MobilX series X‐ray equipment is intended to be used for routine and special radiographic
examination. This equipment fulfils the requirements of radiologists, physicians and
surgeons with best quality results. X‐Ray equipment provides easy operation with simple
controls. Machine is equipped with special feature known as APR (Anatomical
Programmed Radiography). The Radiography Parameters defined in this machine are based
on Human Anatomy. There is option to select different defined Body Parts to be
exposed and depending on the defined Part by operator, machine it‐self set the parameters
depending on the built of patient. Operator can choose manual mode also and can select
required parameters for exposures.
2.3 Intended Use
This Radiographic System is intended for use by a qualified / trained Physician or
technician for use on both adult and pediatric subjects for taking Diagnostic X‐Rays. This
Equipment is specially designed for Radiologists. This machine is best suited for the
Skulls, Abdomen, Chest and Pelvic for all routine & special Radiographic Examines. This
machine contains many advance features over conventional machines like‐
o Off‐site Reading: ‐ Mobile machine is intended to use when it is not practical to move the
patient to a Radiology department. This system enables X‐ray exposures to be taken outside
of the X‐ray examination room, such as wards, operating rooms, ICUs, and emergency
medical sites.
o Power Backup and Easy Movement: ‐ Machine can run in offline mode by using backup
bank of Lead‐acid maintenance free batteries. The motor movements are easy to operate
and noise free.
o Reduction in labor provided by ease of operation.
o Required less area: ‐ Machine requires less area to move, operate and for parking as well.
o Anti‐collision for safety: ‐ This machine provide provides Anti‐collision feature for the safety
of patient and the operator as well.
2.4 CONFIGURATION
Mobile radiography is an easy to operate universal radiography X‐ray system, equipped with
high Frequency X‐Ray Generator that enables sharp, blur‐free images to be obtained
even with small children and emergency patients who are less likely to keep still. Also silent
motor is used which enables noise free transportation of equipment even in night‐time
hospital rounds. It contains,
• Machine ON/OFF Key Switch.
• Display of KV and mAs
• KV & mAs increase and decrease
• APR mode
• Bar Graph display for Storage Level of Battery Banks.
• Display of Interlock Signals.
• Inch Movement Controls for Precise positioning of Patients (On Tube Side)
• Detachable exposure switches with a cord of suitable length.
• Optional IR remote control for making X‐ray Exposures
Manual No. AMSL/UM/Mars 15/19
Rev. 00 Effective Date 08.02.2011
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User Manual: Mars 15
3. SAFETY HAZARDS
CAUTION:
Any kind of service or maintenance of equipment is prohibited while machine is in use
with a patient.
2.2 GENERAL SAFETY
• The operation of the x‐ray unit may only be controlled by skilled, properly trained
personnel with the required knowledge of x‐ray safety practices and the proper use of
x‐ray equipment. The operator is responsible for the use of the system in compliance
with the applicable standards concerning installation and use.
• The system safety circuits and devices must not, for any reason, be moved, modified, or
omitted.
• The unit shall not be operated when electrical, mechanical, or radiological faults are
present or when any of the indicators or alarm devices are malfunctioning.
• When used in conjunction with other apparatus, components, or modules, whose
compatibility is uncertain, it is necessary to ensure the absence of any danger to the
patient or operator. Consult AMSL for information.
WARNING:
AMSL cannot be held liable for any malfunction, damage or danger resulting from
improper use of the system or non‐compliance with the rules for proper maintenance.
2.3 RADIATION HAZARDS
Ionizing radiations can lead to radiation injuries, if handled in correctly. When radiation is
applied, comply with the required protective measure at all times. Any X‐ray unit produces
ionizing radiation, which may be harmful to service personal, operator and other in the
vicinity if not properly controlled. Radiation can produce serious or fatal bodily injuries to
any person in the surrounding area if used by unskilled operator. Adequate precautions
must always be taken to avoid exposure to the useful beam, as well as to leakage radiation
from the source or to scattered radiation resulting from the passage of radiation through
matter. Anti scatter grid is provided with the equipment to achieve maximum signal to
noise ratio and best quality images. Therefore it is recommended that this equipment must
be operated in accordance with guidelines set down by the national council on radiation
protection. Dose received by individual is considered to be over‐exposure if the dose
exceeds 20 mSv in a year.
WARNING:
Before any x‐ray exposure, ensure that all the necessary protective precautions have
been taken.
User Manual: Mars 15
2.3.1 PROTECTION AGAINST IONIZING RADIATION
The main objective of radiation protection 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) During exposure, an auxiliary support must be provided to a patient or detector (portable)
i.e.
i. Mechanical holding devices shall be used when the technique permits.
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 than
0.25 mm lead equivalent.
c) Gonadal shielding of not less than 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.
d) Doors of the Room/OT where X‐ray equipment is installed should be closed before making
exposures.
e) 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.
f) Obey radiation protection rules pertaining to time, distance and shielding.
g) Always prefer low exposure settings.
h) Use Collimator to set minimal useful field size; keep detector in close proximity to the
patient.
Note: radiation dose resulting from the operation of the equipment is measured using a
specified procedure.
WARNING:
The equipment must be used with genuine accessories.
User Manual: Mars 15
2.4 ELECTROMAGNETIC COMPATIBILITY (EMC)
Any transmissions by mobile radio equipment must be avoided. Mobile phones must be
switched off in zones close to the unit. These rules must be applied when the unit is
switched on.
This apparatus is in compliance with the standard IEC 60601‐1‐2: 2007 that defines the
maximum allowed emission levels from electronic devices and the required immunity
from interference caused by externally generated electromagnetic fields. It is not,
however, possible to exclude radio signals coming from transmitters such as mobile
phones or similar mobile radio devices. These and other transmitting devices, including
those in compliance with the EMC standards, may influence the proper
functioning of medical apparatus when used in proximity and with a relatively high
transmitting power. Therefore, the use of radio equipment proximity to electronically
controlled systems must be avoided in order to eliminate any interference risk.
2.5 CLEANING & DISINFECTION:
WARNING
Do not use direct water jets for cleaning. The unit protection level for liquids is IPX0.
WARNING
The EQUIPMENT is not waterproof. Water, soap or other liquids, if allowed to drip into
the equipment, can cause electrical short circuits leading to electric shock and fire
hazards. If liquids should accidentally spill into the system, do not apply power or turn
the system on until the liquids have dried or evaporated completely
Cleaning:
Please take the following information into consideration before cleaning the
equipment,
To clean plastic surfaces you must never use anything other than soap and water. If
other detergents are used (e.g. with a high alcohol content) the material will become
matt or tend to crack. Never use any corrosive, solvent or abrasive detergents or
polishes.
When cleaning, please observe the following:
• Before cleaning the X‐ray equipment switch off at the mains.
• Ensure that no water or other liquids can enter the X‐Ray Equipment. This Precaution
prevents electrical short‐circuits and corrosion forming on components.
• You should wipe enameled parts and Aluminum surfaces only with a damp cloth and
mild detergent and then rub with a dry woolen cloth.
Manual No. AMSL/UM/Mars 15/19
Rev. 00 Effective Date 08.02.2011
Page 10 of 40
User Manual: Mars 15
• Rub down chrome parts with a dry woolen cloth only.
WARNING
If you use disinfectants which form explosive mixtures of gases, these must first have
evaporated before you switch the X‐ray equipment on again.
Disinfection
The method of disinfection used must conform to the legal regulations and guidelines
regarding disinfection and explosion protection.
• Before disinfecting the X‐ray equipment switch off at the mains.
• You may disinfect all parts of the X‐ray equipment, including the accessories and
connecting cables, by wiping only.
• Disinfection by spraying is not to be recommended because the disinfectant may enter
the X‐ray equipment.
• If you perform room disinfection with an atomizer, you must switch off the X‐ray
equipment first. When the X‐ray equipment has cooled down, cover it over carefully
with a plastic sheet. When the mist of disinfectant has subsided you can remove the
plastic sheets and disinfect the X‐ray equipment by wiping.
WARNING
Never use any corrosive, solvent or abrasive detergents or polishes.
2.6 ENVIRONMENT PROTECTION
WARNING
The unit may not be disposed of along with industrial domestic waste and must be
regarded as hazardous waste.
AMSL produces radiological systems that are advanced in terms of safety and
environmental protection. Assuming that the unit is properly used there is no risk to
people or the environment.
In order to comply with applicable safety requirements, it is necessary to carefully use
materials that may be harmful to the environment e.g. Mono block oil, protective lead,
monitors kinescope, boards and electronic components. Therefore, when necessary,
proper disposal methods, according to the regulations of the country where the unit is
installed, should be followed. It is advised, equipment must be used within rated
ambient conditions (refer technical reference).
WARNING
Allengers is not responsible for the disposal of the equipment performed by the user
User Manual: Mars 15
and for the costs related to this intervention.
WARNING
This symbol indicates that waste electronic and electrical equipment must not be
disposed of as unsorted municipal waste and must be collected separately. Please
contact an authorized representative of the manufacturer for information concerning
the decommissioning of your equipment.
2.7 ELECTRICAL SAFETY
WARNING
Only trained service personnel authorized by AMSL may remove the unit covers and only
in accordance with the instructions contained in the Service Manual.
WARNING
It is strongly recommended that independent grounding must be available in the socket
from where power is to be supplied to the machine. Proper grounding not only enhances
the performance & reliability of the equipment but increases safety for the operating
staff as well.
WARNING
Integral Multiple Socket‐Out‐let provided in the equipment must not be used with any
other external electrical equipment. Connecting external electrical equipment at MSO may
result in reduced level of safety
WARNING
To avoid electric shock, equipment must be connected to supply mains with protective
earth.
WARNING
Remove batteries if medical equipment is not likely to be used for long time.
2.7.1 Electrical Shock
The following safety procedures must be observed to avoid electric shock or serious
injury to operators and patients and to avoid system malfunction:
• Power supply cord is not detachable. If required, it should be replaced by authorized
service engineer only.
• Make all electrical connections to equipment while outside the patient environment. Do
not touch a connector and the patient at the same time.
• Always remove power to the equipment before cleaning. Use a slightly damp cloth or
sponge for cleaning.
• Do not bypass jumper or otherwise disable the safety interlocks.
Manual No. AMSL/UM/Mars 15/19
Rev. 00 Effective Date 08.02.2011
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• Do not place food or beverage containers on any part of the equipment. If spilled, they
can cause short circuits.
• Do not remove any of the assembly covers. Only trained service representatives should
perform repairs.
• Only qualified service engineers are allowed to service or repair a system.
2.7.2 First Aid In Case of Electrical Shock
• 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.
• 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.
• Place the victim in supine position.
• If the jaw is rigid, try to force the mouth open by putting 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.
• Hold the chin up and forward with one hand and pinch the nostril of the victim with
other.
• 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 bend).
• When the chest has moved up, withdraw your mouth and allow the chest to sink back.
User Manual: Mars 15
WARNING
Certain components within the system produce high voltages which can be potentially
Hazardous. To avoid this hazard, only qualified service engineers are allowed to service
or Repair a system.
WARNING
Electrical circuits inside the equipment may use voltages which are capable of causing
serious injury or death from electric shock. To avoid this hazard, never remove any of
the cabinet covers.
2.7.3 ELECTRICAL FIRE
In case of electrical fire, any emergency procedure developed by the owner for the area
in which the system is used, should include these safety measures:
• Remove electrical power to the system by placing the power switch in the off position.
• Unplug the power cord from the AC receptacle.
• Evacuate personnel from the area.
• Only use a fire extinguisher that is approved for use on electrical fires.
• Call your local fire department for help if necessary.
2.8 PROTECTION AGAINST MECHANICAL HAZARDS
2.8.1 Precaution while Handling moving parts
Never service moving machinery parts i.e chains vertical & horizontal carriage etc. when
movements are enabled. Make sure that all movements are switched OFF and that they
cannot be switched ON again accidentally. If necessary, the movement shall be blocked.
Failure to comply may result in equipment damage or serious injury to service
personnel.
In case machine movements are required during installation work or other service
activities, brake must be released by a second person or comply with all relevant service
instruction. Never release the brake manually for longer periods of time. In case the
machinery is in danger of tilting during installation work or other service activities, a
second person has to secure the machinery against tilting.
2.8.2 Precaution while Handling heavy parts
All heavy parts must be lifted while taking all safety precautions. In addition to wearing
the required protective clothing, e.g. safety boots and gloves, take care that heavy
loads are correctly lifted or carried to avoid any physical injury. Mechanical stands,
Tube head and generator must be lifted or transferred carefully. Comply with all
relevant instructions in the documentation. Move heavy or awkward loads by
mechanical means or using several persons.
User Manual: Mars 15
2.8.3 Precaution while Handling spring balance counterweights
Some systems are delivered with inserted spring balance counterweight. For transport,
the counter weight is secured by a screw. Do not remove this screw before all parts and
counter weights are installed. Keep hands off the spring while adjusting it. The parts are
not correctly balanced at this stage. They can move upwards or downwards very fast.
Keep hands off the spring while moving the counter balanced parts.
2.8.4 Precaution while Handling tilting parts
Never service tilting machinery when tilting movements are enabled or brakes are
released. Make sure that the tilting movements are switched OFF and that they cannot
be switched ON again accidentally. If necessary, the movement shall be blocked. Failure
to comply may result in equipment damage or serious injury to service personnel.
In case the machinery needs to be tilted during installation work or other service
activities, the tilting brake must be released by a second person or comply with all
relevant service instruction.
In case the machinery is in danger of tilting during installation work or other service
activities, a second person has to secure the machinery against tilting.
2.9 CONTRAINDICATIONS
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.
Exposure to radiation as a fetus increases the chances of cancer, of developing Tumor
(s) and of leukemia.
Thyroid glands, which are the primary glands of metabolism and energy, are also
known victims of x‐rays. They are particularly sensitive to radiation because of which,
excessive exposure to radiation can lead to various thyroid conditions. Asking for a
thyroid collar when getting your head, neck or collarbone area x‐rayed could be a
preventive measure.
2.9.1 DETERMINISTIC EFFECTS
• Radiation Exposure
– Side effects are limited
– Painless, without sensation
– Very little reaction for most
–
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User Manual: Mars 15
• Long term or high dose exposure (General)
– Nausea
– Vomiting
– Trouble Swallowing
– Fatigue
– Decrease in PLT’s and Lymphocytes
• Decreased Immune Function
• Organ Specific
– Skin
• Erythema – desquamation (reversible)
• Hair loss at
– Mucous Membranes
• Fibrin Plaguing
• Urinary and Bladder Changes
• Visceral Changes (Secretor)
– Reproductive Organs
• Irreversible damage to gametes
• Sterility
– Bone
• Suppress Osteoblast Activity
• Decrease Number of Osteocytes
• Breast Cancer
– Increased dose increases risk
– Age at time of dose is the most significant factor
– Risk does increase equally among different exposure groups
– Followed same temporal pattern as non‐exposed
2.10 Safety checks according to the Medical Device Directive
The safety checks cover operability and operational reliability. They must be performed at
least every 2 years. These tests constitute part of our preventive maintenance under our
service agreements. They cover,
• Visual checking for completeness and apparent damage or defects as well as uncleanliness,
sticking parts and wear and tear which may affect safety.
• Testing the necessary monitoring, safety, display and indicating systems.
• Measuring the safety‐relevant output parameters.
User Manual: Mars 15
• Checking electrical safety as well as the operability of an internal energy supply.
• For the particular product other special technical tests according to the generally accepted
standards of engineering practice.
• Other necessary tests specified by the manufacturer.
• Recording results and filing the test reports in the X‐ray system manual (medical products
logbook).
2.11 Owner’s Responsibilities:
The owner has the responsibility to ensure equipment compatibility, operator
qualifications and the continued compliance of equipment and operating specifications.
Equipment should only be used in designated use areas with approved AC receptacles.
Unauthorized changes or modifications to any part of the system could have hazardous
consequences. Changes or modifications must not be made unless specifically authorized
by Allengers Medical Systems ltd. If in any case modification has been done by service
engineer appropriate inspection and testing must be conducted to ensure continued safe
use of equipment.
User Manual: Mars 15
4. SYSTEM OVERVIEW
This Machine inherits the "outstanding maneuverability and high operability" and it is equipped with
High Frequency X‐Ray Generator that enables sharp, blur‐free images to be obtained even with small
children and emergency patients who are less likely to keep still. Adopting a new silent motor for
producing less noise.
Counter Balanced Mobile Stand (Using Spring Tension) with Electromagnetic Locking is designed
keeping in view the stringent requirements of Mobility, Parking Position locking for tube head for a
jerk free and reliable operation. The Unit has Two Separate Battery Banks to power X‐Ray Generator
and Motors for movements. Hence the machine can work even when power is not available.
Machine has also speed control for exam mode and parking mode. MobilX system consists of
X‐ray Generator –
X‐ray generator consists of high frequency inverter and integrated filament control section to
deliver consistent output. In APR mode, equipment automatically selects parameters as per the
anatomy of the patient.
Collimator –
Collimator with either manual or motorized movements has available. Helps in dose reduction and
better image quality by provides control area for X‐rays
X‐ray tube assembly‐
Dual focus rotating anode X –ray tube has provision of rotation by ±90º.
Battery banks‐
Two battery banks available one for power backup 4 nos. batteries (12V\24Ah) and another for
motorization 5 batteries (12V\12Ah).
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Rev. 00 Effective Date 08.02.2011
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4.1 Description of control
Apron Hanger
X-Ray Tube
with LBD
Push Bar
Parking Lock
Column
Anti- collision
User Manual: Mars 15
Description of Control Functions: 4
1 2
Sr. Description Image
No.
1 EMERGENCY STOP:
Emergency STOP switch is provided
on control panel to Switch OFF the
Machine when any emergency occurs
during Machine Operation.
Note: Machine will not get ON when
emergency switch is pressed . To get
back in normal position, rotate the
switch In clockwise direction.
2 KEY SWITCH
Key selector switch is provided for
limited access of the X‐ray
equipment. Machine switches ON
when key is operated in clockwise
direction.
Note: Emergency stop switch must
not be in pressed condition.
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4 BATTERY CHARING INDICATION
When Input Supply given to machine Low Full
the Battery Charging Indicator (Bar
Graph Indicator) starts blinking from
Low side to Full side this mean
batteries are charging. When input
supply disconnected then Battery
Charging Indicator shows actual
charging level of batteries. Movements Battery Bank It displays the status of
Status
Battery charging of Power
Pack Module.
5 HAND SWITCH
This is used to press Ready switch Exposure
and Exposure switch using
Ready
retractable type cord.
AUDIBLE ALARM: Continuous Beep
tone is heard during the emission of
X‐Rays.
1 2
3 3
4 4
6 6 5
Sr. Description Image
No.
1 This Switch is for the left side movement of
the Machine
2 This switch is for the right side movement of
the Machine.
5 This is to release the electromagnetic locking
of Column and Horizontal Arm.
6 These knobs are used to open/close the
shutters of LBD.
7 This Switch is to energize the LBD.
8 Measuring Tape for check the Table Top &
Tube Head Distance.
9 Push Bar (on Handle): By pressing this bar we
can move the Machine.
Manual No. AMSL/UM/Mars 15/19
Rev. 00 Effective Date 08.02.2011
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4.2 How to start
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 by operating it with half of the maximum working tube
voltage and then increase maximum working tube voltage by incrementing it by 5KV per minute
and keep it there for three minutes.
Mobil e Radiography is a universal machine which can be used direct on mains when it is installed at X‐
ray room or when it is convenient to shift the patient near the x‐ray machine. On the other way machine
can be used on battery backup by transporting the machine near the patient bed when it is not easy to
shift the patient at x‐ray room.
Machine must be put on charging by plug in it on mains when it is not being used for exposures.
And tube head must be in parking position.
When machine is to be shifted near the patient bed, First
unplug the machine from mains thereby release battery
bank from getting charged.
Switch ON main MCB (16A) and drive MCB (16A) before
shifting the machine.
Note: Before shifting the machine near patient bed, be
ensure that tube head must be in parking position and
should be properly locked.
When machine is shifted near the patient bed, release the
tube head from parking position by un lock the mechanical
lock.
Now switch ON inverter MCB (63A) and backup MCB
(63A).
Machine is ready for exposure. Select different parameters
as per requirement. And position the patient.
Switch ON the LBD and readjust/refine the tube head
position by using inch movement switches provided on
handle as shown. After final positioning, make exposure
using exposure switch.
To make the exposure, first press the READY SWITCH and
then after a brief delay (1 sec.) press the exposure switch.
Do not release both the Switches until timer terminates
exposure automatically. LBD ON Switch
NOTE: Since X‐RAYS are harmful; so keep the maximum
safe distance from the primary beam.
Note: After exposure if machine needs to be shifted at its designated location, it must be shifted with
tube head in parking position. Machine must be put at charging mode after switching off all MCBs.
4.3 Power off procedure
Powering Down the X‐ray Generator
Power off the machine from panel then Powering down the inverter MCB and backup MCB typically
does power down the other parts, such as X‐ray tube, collimator etc.
Manual No. AMSL/UM/Mars 15/19
Rev. 00 Effective Date 08.02.2011
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5. OPERATION
5.1 How to start
NOTE: When the equipment has to be used after remained switched “OFF” for overnight or four
hours or more, it is recommended that control should be turned “ON” 10‐15 minutes prior to
exposure. It will provide consistency of radiographic results and ensure proper warm up of tube
filament.
CAUTION
X‐Rays may be harmful if proper Radiation Protection Measures are not taken. So, it is assumed
that proper radiation protection measures are taken in the room where X‐Rays machine is going to
be operated.
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 maximum working tube voltage and then increase to maximum working
tube voltage with the speed of more than 5kV per minute and keep it there for three minutes.
5.1.1 Machine Operation
The operating instructions mentioned below are prepared so that the operation of the equipment is
carried out in proper sequence. It is assumed that before an exposure is made, the patient will be
positioned, Tube Head aligned and cassette loaded & placed at the desired position:
• Make control ON by pressing “ON” Push Button. Allow the unit to warm up for 60 Seconds. This
interval may be used for positioning patient & other equipments etc.
Note: If the unit is OFF for considerable time (4 hours or more) it is recommended that the unit
be turned “ON” 5 minutes before exposures are made. This will provide greater consistency of
Radiographic Results.
• Check Voltage on Voltmeter and adjust it to 230 Volts (red line) with the help of coarse or fine
voltage compensators.
• Ensure Mode Switch is in Radiography Mode.
• Determine the Technic to be used from Technic Chart and select the desired mA station.
Select Time (seconds) from Timer Knob.
• Observe mAs reading on mAs digital display and confirm that the required mAs value is indicated.
• Select KVP to the desired value by turning the major or minor Tap Switches. If the indicated
value on KVP Display is less or more by a large difference use major KVP Switch, otherwise adjust
with minor KVP Switch.
• Observe that the selected parameters are within the tube Rating limits (Check that O/L indicator
doesn’t glow).
• Select Bucky either “IN” or “OUT” of the circuit as desired.
• Observe the Patient & other devices.
• To make the exposure, first press the ready switch and keep it pressed for couple of seconds &
then press the X‐Ray Switch. Do not release these switches until exposure starts & terminates
automatically as per the selected time. The X‐Ray “ON" indicator will glow during the exposure
and mA meter needle would indicate the tube Current as selected on Technic Selector.
• If at all the selected combination of mA, KVP and time exceeds the tube Rating limits the
exposure will not initiate on pressing Ready & X‐Ray Switch. In this condition the over load lamp
will glow.
• The unit can now be switched OFF if no immediate exposure is to be made.
5.2 Radiographic Parameters
With the factors, given in the table, radiographs are taken and films developed with conventional
standard processing procedures. KVP values given in the chart are minimum & maximum values for
different anatomical parts.
With the experience gathered, the finally selected mAs, (mA x sec.) are entered in the columns provided
in the chart and are reliably used for producing consistent & satisfactory radiographs
+
-
X-RAY TUBE
LBD
PATIENT
GRID
IMAGE RECEPTOR TABLE TOP
6. MAINTENANCE
X‐ray unit contains mechanical components such as drive chains, ropes, steel strips and gears which
are subjected to wear and tear due to operation. They include means of suspension for heavy
components (X‐ray tube assembly etc.). After a lengthy period of operation the safety of the
suspension may be impaired by wear and tear (e.g. rope break). The correct setting of the
electromechanical and electronic assemblies affects the functioning, image quality, electrical safety
and exposure of the patient and medical personnel to radiation.
WARNING
Faulty components which affect the safety of the X‐ray equipment must be replaced by genuine
spare parts.
Allengers recommends you to
• Perform the tests indicated in the section 6.1 on regular basis.
• Have the X‐ray unit serviced by the Allengers Service personnel at least once a year. You must have
heavily used X‐ray equipment subjected to maintenance more frequently.
In this way you avoid endangering the patient and you meet your obligations. By entering into a
service agreement with Allengers, you retain the value and safety of your X‐ray equipment. All the
necessary maintenance, including the safety tests for the purpose of preventive avoidance of danger
and the necessary settings for optimum image quality and minimum exposure to radiation, are
performed at regular intervals. Allengers agrees on these intervals with you, taking the legal
requirements into account.
Manual No. AMSL/UM/Mars 15/19
Rev. 00 Effective Date 08.02.2011
Page 29 of 40
User Manual: Mars 15
6.1. Inspecting the System
Daily Checklist
√ Before closing the x‐ray room or when the machine is not to be used for long time switch off the
main supply and cover the machine properly.
√ Clean the external surface of the unit by damp cloth only.
Weekly Checklist
√ Check system power cables and H.V. cables for any cracks or damages.
√ Check all connectors outside the machine for their firmness.
√ Clean the Hand Switch with a Soft Dry Cloth.
Monthly Checklist
√ Visually inspect the unit every month for any physical damage to different parts.
√ Check for machine covers. These should be firm & tight properly.
√ Check the electrical and power cables for any crack, cuts etc.
√ Check the equipment for any loose connection or loose hardware.
√ Check the Tube for any leakage.
√ Check for any abnormal noise or sparking in the machine.
√ Check for any virus threat at PC.
6.2 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 etc. Dust covers may be used.
3. Allengers Medical Systems Ltd. maintains a network of Service Centers through which the assistance
of skilled service personnel may be obtained. You are requested to contact any of the centers near
you for all your service related problems.
WARNING
Always disconnect the equipment from its electrical supply before cleaning or performing non‐
electrical tests and maintenance.
Recording results
Service and repairs must be entered in the medical products logbook, including the following data:
• Type and scope of work.
• If necessary, details of any changes to ratings or the working zone.
• Date, person performing the work, signature.
Formaldehyde (HCHO)
Note: - Always disconnect the equipment from its electrical supply before cleaning or
performing non-electrical tests and maintenance.
3. SILVER PANTONE 421 C
Manual No. AMSL/UM/Mars 15/19
Rev. 00 Effective Date 08.02.2011
Page 32 of 40
User Manual: Mars 15
6.3 TROUBLE SHOOTING
Sr. FAULT SYMPTOMS POSSIBLE REASONS FOR FAULTS
No.
1 Machine not getting on Check the Line Fuses.
Check the Key Switch. It should be properly On.
Check the MCBs. It should be in upward direction.
2 The light beam doesn’t Get ON. Check the collimator Bulb. It may be fused. Replace with a
New one of the similar rating.
Check the F4 Fuse. If blown replace the fuse. It should be
4Amp.
3 The Machine Exposes but no Collimators lead shutters may be closed.
Image Light & X‐Ray beam not aligned. (Call for Allengers Service
Engineer)
Check the 63 Amp. MCB. It should be on upward.
Machine needs recalibration by Allengers Service Engineer.
4 Machine charging not done Check the line Fuse F 1 & F 2. It should be 30Amp.
Check the Line Voltage in the Wall socket.
Check the three Pin Top For main supply.
CAUTION
7. LABELS AND SYMBOLS
Following labels and symbols are used to identify different parts and processes at the machine.
User/operator is advised to read these symbols carefully.
SWITCH ON SAFELY
Switch ON the machine only with dry hands. Please
check for proper grounding before switching ON the
machine.
ATTENTION SYMBOL
Warning, Caution or Danger
(Please refer to User/Installation Manual when seen this
symbol on your machine)
USE SENSIBLY
INTERFERENCE
8. TECHNICAL REFERENCE
8.1 Classification Type
Type of protection against electrical shock: Class 1
Protection against direct and indirect contact: Type B applied part
Degree of protection against water penetration: Common protection (IP 30)
Mode of Operation: Intermittent (Non‐continuous)
8.1.1 Compliance
This X‐ Ray unit is in compliance with Medical Device Directive 93/42/EEC, classified as Class IIb
(according to annex IX rule 10), List of standards for the evaluation of product compliance.
REFERENCE DESCRIPTION
MDD 93/42/EEC Medical Device Directive
EN 60601‐1:2006 Medical Electrical Equipment Part 1: General requirements for basic
Safety & essential performance
EN 60601‐1‐2:2007 Medical Electrical Equipment Part 2: General requirements for basic
safety and essential performance‐Collateral Standard:
Electromagnetic compatibility‐Requirements and tests
EN 60601‐1‐3:2008/AC:2010 Medical electrical equipment‐part 1‐3: General requirements for the
basic safety and essential performance‐Collateral standard: Radiation
protection in diagnostic X‐ray equipment.
ISO 15223‐1:2012 Medical Devices‐ Symbols to be used with Medical device labels,
labeling and information to be supplied – Part 1: General
Requirements
EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
EN 60601‐2‐54:2009 Basic safety & essential performance of OPG for Radiography and
Radioscopy
Guidance and Manufacturer’s declaration, according to EN 60601‐1‐2:2007
(Group 1, Class A, for use in Hospitals, not Life‐supporting)
Table 1 – Guidance and manufacturer’s declaration – electromagnetic emissions – for all EQUIPMENT
and SYSTEMS (see 5.2.2.1 C)
Guidance and Manufacturer’s declaration – electromagnetic emissions
The OPG is intended for use in the electromagnetic environment specified below. The customer or the
user of the OPG should assure that it is used in such in such an environment.
Emission Test Compliance Electromagnetic environment – guidance
RF emissions Group 1 OPG uses RF energy only for its internal function. Therefore, its RF
CISPER 11 emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions Class A The OPG is suitable for use in all establishments other than domestic
CISPER 11 and those directly connected to the public low‐voltage power supply
Harmonic Class A network that supplies buildings used for domestic purposes.
emissions
IEC 61000‐3‐2
Voltage Complies
fluctuation
/flicker
emissions
EN 61000‐3‐3
Table 2 – Guidance and manufacturer’s declaration – electromagnetic immunity – for all EQUIPMENT
and SYSTEMS (see clause 5.2.2.1 f)
Guidance and manufacturer’s declaration – electromagnetic immunity
The OPG is intended for use in the electromagnetic environment specified below. The customer or the
user of the OPG should assure that it is used in such an environment.
Immunity Test EN 60601 test level Compliance level Electromagnetic environment –
guidance
Electrostatic discharge ±2 kV, ±4 kV, ±6 kV ±2 kV, ±4 kV, ±6 kV Floors should be wood, concrete
(ESD) contact contact or ceramic tile. If floors are
EN 61000‐4‐2 ±2 kV, ±4 kV, ±8 kV ±2 kV, ±4 kV, ±8 kV covered with synthetic material
air air the relative humidity should be
at least 30%.
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be
transient/burst supply lines supply lines that of a typical hospital
EN 61000‐4‐4 ± 1 kV for ± 1 kV for environment.
input/output lines input/output lines
Surge ± 1 kV line(s) to ± 1 kV line(s) to Mains power quality should be
line(s) line(s) that of a typical hospital
EN 61000‐4‐5 ± 2 kV line(s) to ± 2 kV line(s) to environment.
earth earth
Voltage dips, short <5 % UT <5 % UT Mains power quality should be
interruptions and (>95 % dip in UT) (>95 % dip in UT) that of a typical commercial
voltage variations on for 0,5 cycle for 0,5 cycle hospital environment. If the user
power supply input 40 % UT 40 % UT of OPG requires continued
lines (60 % dip in UT) (60 % dip in UT) operation during power mains
Manual No. AMSL/UM/Mars 15/19
Rev. 00 Effective Date 08.02.2011
Page 37 of 40
User Manual: Mars 15
The OPG is intended for use in the electromagnetic environment specified below. The customer or the
user of the OPG should assure that it is used in such an environment
Immunity test EN 60601 test Compliance Electromagnetic environment‐guidance
level level
Portable and mobile RF communications
equipment should be used no closer to any
part of the OPG, including cables, than the
recommended separation distance calculated
from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1,2√P
Conducted RF 3 Vrms 3 Vrms d = 1,2√P 80 MHz to 800MHz
EN 61000‐4‐6 150 kHz to 80MHz 150kHz to 80 d = 2,3√P 800 MHz to 2.5 GHz
MHz
Where p is the maximum output power rating
of the transmitter in watts (W) according to
the recommended separation distance in
meters (m).
Radiated RF EN
61000‐4‐3 Field strength from fixed RF transmitters, as
3 V/m determined by an electromagnetic site survey
80MHz to 2.5 GHz 3V/m should be less than the compliance level in
80 MHz to 2.5 each frequency range.
GHz Interference may occur in the vicinity of
equipment marked with the following
symbol.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
A. Field strength from transmitters such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitter s, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the X‐Ray Machine is used exceeds the applicable RF
compliance level above the X‐Ray Machine should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the X‐Ray Machine.
B.
C. Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3V/m.
8.2. Technical Specification
Technical Specification
PARAMETERS SPECIFICATIONS
X‐RAY GENERATOR High Frequency 50 KHz, 15 KW X‐Ray Generator
POWER BACK UP Individual Battery Backup for MobilX operations & X‐ray Generator Unit.
KV RANGE 40 to 125 with a step of 1KV each.
mAs 1‐200mAs (250mA Max.)
X‐RAY TUBE • Dual Focus, Rotating Anode Tube, of focal spot 1.0 Sq. mm (Small) & 2.0
Sq. mm (Large)
• Collimator with Auto Shut OFF
CONTROL • Machine ON/OFF key Switch.
• Digital display of KV and mAs
• APR Mode selection with Following proceeding
o Patient Type
o Body Part
o Patient Size
• To Increase/Decrease KV/ mAs.
• Indication of Ready & X‐Ray ON
• Bar‐Graph Indications for Storage Level of Power Backups.
• Easy to Troubleshoot as provisions for Fault Indication on the Control
Panel.
• Hand Switch with Retractable Cord for initiation of Exposure.
• X‐Ray Tube Head Temperature Sensor for Thermal cut‐off.
LBD With auto shut OFF light & retractable measuring for SID measurement.
STAND a) Spring Balanced Mobile Stand with Electromagnetic Locking.
b) Parking position for the Tube head as a safety measure.
c) Spring Action Locking for Tube Head Rotation
MOBILE OPERATIONS • Highly Versatile Battery controlled Mobile operations.
• Smooth & Jerk free operations.
Operating Temperature Temperature: 100‐400C
Relative Humidity: 0 to 75% RH Non Condensing
Atmospheric pressure: 70KPa…106KPa
Storage Temperature Temperature: 00‐400C
Relative Humidity: Maximum 90% at 300C
POWER BACKUP • Independent batteries for X‐Ray generator and motorized movements.
• Lead‐acid maintenance free batteries
• Machine can run on both Mains and Backup mode
POWER SUPPLY 230V AC ± 10%, 15A (Single Phase Supply), 50/60 Hz with Proper Earthing.
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.
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.
(AUTHORIZED SIGNATORY)
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.
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.
(AUTHORIZED SIGNATORY)