411-D-102 MRAD3 5 (Non DR) - CE
411-D-102 MRAD3 5 (Non DR) - CE
411-D-102 MRAD3 5 (Non DR) - CE
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Responsibility of the Manufacturer
BPL considers itself responsible for any defects on safety, reliability and
Performance of the equipment as specified only if:
- The electrical, other installation and the environment requirements in the installation room are met as
per the safety, regulatory and statutory requirements mentioned in this manual and
Caution
- Use of accessories other than those recommended by BPL may compromise product performance
Notice
- The information in this document is subject to change without notice.
1
Operating Manual
This user manual has been compiled for the users of BPL MRAD 3.5 in installation, operation and routine
maintenance
Specifications and Operating Characteristics are subject to change without notice for improvements.
Contact Details:
Registered Office:
2
CHAPTER 1 5
PRE INSTALLATION 5
1.1 INFORMATION ON ROOM PLANNING 5
1.2 PACKAGING 5
1.3 UNLOADING 5
1.4 UNPACKING THE UNIT 5
1.5 DEVICE STORAGE 6
1.6 DISPOSAL 6
CHAPTER 2 7
INSTALLATION 7
2.1 ASSEMBLING THE UNIT 7
2.2 TRANSPORT POSITION OF UNIT 8
2.3 SAFETY INFORMATION 8
2.4 PRELIMINARY CHECKS 9
2.5 GENERAL CHECKS 13
Chapter 3 14
Introduction & Safety 14
3.1 Intended Use 15
3.2 User’s Qualification 16
3.3 Cautions & Warnings 16
3.4 Source to Image Distance 18
3.5 Prescribed Uses 18
3.6 Overview 18
3.7 Symbols and Conventions used in the manual 21
3.8 Symbols and Markings 21
3.9 Safety Hazards 24
3.10 Device Identification 27
3.11 Service Life of the Device 27
Chapter 4 28
System Overview 28
4.1 System Components & Description 28
Chapter 5 30
General Installation 30
5.1 General 30
5.2 Installation Procedure 30
Chapter 6 31
System Operation 31
6.1 Frequently Used Functions (FUF): 31
6.2 Control Panel Description 33
3
6.3 Loading Factors 34
6.3.1 APR Chart 36
6.4 Description of Operation 40
6.5 Screen Messages 44
6.6 Error Display 45
6.7 Instructions for Examination 46
6.8 Cassette Holder Operation 47
Chapter 7 49
Room Layout 49
7. Suggested Dark Room Layout 49
Chapter 8 49
Dark Room Film Processing 49
8.1 Dark Room Procedure 49
8.2 X-Ray Film Processing 49
8.3 Dark Room Accessories 50
Chapter 9 53
Maintenance 51
9.1 Inspecting the System 51
9.2 General Maintenance 51
9.3 Preventive Maintenance 52
9.4 Protection Against Ionizing Radiation 52
9.5 Product Disposal Information 53
Chapter 10 54
REGULATORY INFORMATION 54
10.1 Electromagnetic Compatibility (EMC) 54
Chapter 11 58
Key Spare Parts 58
Appendix A. Glossary 63
4
CHAPTER 1
PRE INSTALLATION
This section guides the user through the Pre Installation requirements for the MRAD 3.5.
The Electrical Power Supply: 230 Vac +10%, 50 Hz, with 16 Amp 3 pin Socket. Voltage
between N and G pins should not be more than 2 Volts AC. Maximum Line Resistance that
can give rated output is 0.4 Ohm.
1.2 PACKAGING
The MRAD 3.5 unit is delivered in one wooden box. The completely assembled unit is
packed in one box. The user manual is packed along with the unit.
1.3 UNLOADING
The unloading of the unit from the truck can be carried out using any of the following
ways depending on the site conditions:
1) Using a forklift.
2) Using an overhead travelling crane.
3) Using a chain pulley block and tripod.
4) Using conventional ways i.e. using wedges, wooden planks, pipes or rods and
labour etc.
5
UNPACKING THE CONTROL CONSOLE & OTHER COMPONENTS:
Observe the following steps:
Remove the restraining strips by cutting it. Use a cutting plier for this purpose.
Start removing the wooden planks. For this purpose, the service engineer should
use a claw hammer or nail pulling plier and preferably a crowbar.
First, remove the top planks. Upon opening this plank, you will be able to see the
unit inside. Ensure that there are no transit damages.
Unpack the unit carefully and bring out from the base of the box.
Move the unit on its 3 wheels to the X – Ray room.
This symbol indicates that the waste of electrical and electronic equipment must not
be disposed as unsorted municipal waste and must be collected separately.
The proper differentiated collection for the following start of the unit disused to the
recycle, treatment and disposal, compatible with the environment, aid to prevent
possible negative effects on the environment and health and it favors the recycling of
materials that compose the unit.
The abusive disposal of the product from the user implies the application of
administrative sanctions according to the Standards in force of the unit installation
country.
For information concerning the dismantling modes of the units out of use, stick to the
local provisions or contact a representative authorized by the manufacturer.
6
CHAPTER 2
INSTALLATION
This chapter describes the block diagram along with the theoretical explanation. Refer to
the respective circuit diagrams for better understanding.
7
Control Console
Bring the Mono-Block to its lowermost position by moving the tube arm and lock it.
Hang all the cables on the cable winder.
Loosen the foot brake.
Pay attention that the wheels do not strike against any obstacles.
8
Movement of the X-Ray Tube holding arm is proper. And Tube remains in its desired
position with Lock.
Open the Front Cover of the console cabinet and check for any loose connection or
transport damage.
Check for Mains supply as specified in Technical specification and ensure that
the measured voltage between Earth and Neutral should not be more than
2 Volts.
Make sure all covers are put back to the unit before turning ON the unit.
Unit Movements
The minimum force required to push/pull the unit on a horizontal surface is 3 kg.
Unlock Lock
9
2. Tube Head Horizontal Rotation Lock
Unlock Lock
3. Wheel Lock
Unlock
Lock
Unlock Lock
10
5. Tube Head Horizontal Rotation Lock
Unlock Lock
2.4.2.2 Switching ON
Insert the power plug, turn ON the MCB. ON key LED starts glowing on the console.
Press ON key on the control panel. After the booting screen appears, the MRAD 3.5 unit will
be initialization condition for a few seconds. Set values of kVp, mA & mAs will display on
the screen, and settings will now respond to the corresponding switches on the panel. The
increment and decrement of kVp, mA and mAs will occur in 1 step for each press.
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2.4.2.3 COLLIMATOR (Light Beam Diaphragm – LBD)
The collimator is used to select the area to be exposed to X-ray Radiation. The user has to
switch ON the collimator power supply by the collimator key available on the keyboard. Then
the collimator bulb can be switched ON by pressing the ON button available on the collimator.
After 35 seconds the light will turn off automatically. Pressing the ON push button will turn
the light on for the next 35 seconds.
The area to be exposed will be shown by light. The Exposure area can be adjusted horizontally
& vertically by rotating the knobs present on the collimator.
Total Filtration : 3.3 mm Al
Collimator Filtration : 0.1 mm Al
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2.4.2.4 BLOCK DIAGRAM
2.4.3 EXPOSURE:
2.4.3.3 Radiography
Set the exposure parameters. pull the Exposure Release Switch and give exposure. The
yellow LED on the console panel will light up for duration equal to the exposure time. An
audible indication by a muffled sound from the buzzer will confirm the working of the
exposure.
Check for the following before handing over the unit to the customer.
Cassette Holder: The box on the front of the console is meant for storing the cassettes.
Check it is clean and 2-3 cassettes can be accommodated in the box.
Tube head arm is moving freely and the Tube head remains in the position during the
exposure.
All the handles shall be of the same color & movement of the unit is smooth.
13
Chapter 3
The devices is designed and manufactured in such a way that, when used under the
conditions and for the purposes intended, they will not compromise the clinical condition
or the safety of patients, users , it is provided that any risks which may be associated with
their intended use when weighed against the benefits to the patient and are compatible
with a high level of protection of health and safety.
The Essential performance of the machine also depends upon the mA& kVp calibration of
the unit. The machine is designed in such a way that calibration can be checked at any time
and can be calibrated (if out of calibration) by our trained service staff. And the connection
signal and signal strength notification are displayed on the screen.
The machine can be isolated from electrical mains by removing the three-pin top plug from
the supply mains.
BPL M-Rad 3.5 is high-frequency mobile X-Ray solution that combines unique design &
superior image quality at low radiation dosage which is ideal for patient wards, intensive
care, operating rooms, etc. The equipment provides Radiography for Diagnostic purpose.
MRAD 3.5 Mobile radiographic units consist of a wheeled cart that transports an x-ray
generator, an x-ray tube and moveable tube stand, collimator, and a film cassette.
MRAD 3.5 has the following major parts:
Control Console: The control panel houses the X-Ray Generator along-with other control &
command circuitry. All parameters related to the 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 are given in the separate
section of this Manual. The control panel uses a soft touch Keyboard.
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feedback signals. The advantages of this configuration are summarized in the speed of HV
rise time at the tube terminals and in its precision. It is also possible to control different X-
ray output power and exposure timing. The max load output power is 3.5 kW.
X-ray monobloc: The X-ray Tube head Monobloc contains a Double Focus Stationary Anode
Tube. Also housed are filament transformers, high voltage transformer & other related parts
and components. The monobloc is filled with Transformer oil for providing Insulation & for
cooling of X-ray Tube. The Tube head is completely sealed to prevent any leakage. The X-ray
Tube head Monobloc emits the X-rays when Exposure is initiated from hand switch.
Light Beam Diaphragm (LBD): The collimator is used to select the area to be exposed to X-
ray Radiation. The user has to switch ON the collimator power supply by the collimator key
available on the keyboard. The collimator bulb can be switched ON by pressing the ON button
available on the collimator. After 35 seconds the light will turn off automatically. Pressing
the ON push button will turn the light on for the next 35 seconds. The area to be exposed will
be shown by light. The Exposure area can be adjusted horizontally & vertically by rotating
the knobs present on the collimator.
Tube Mounting Arm: The Tube mounting arm holds the Monobloc. The Tube-Arm is
mounted on the Vertical Column attached to the control panel. On the end of the Arm, the
Tube head is tube head along with LBD is mounted. The arm is designed with a pair of
gas springs to balance the load of monobloc and collimator. For taking exposure user will
move this Tube arm for setting SID (Source to Image Distance) with the aid of
measuring tape which is provided in the Light Beam Diaphragm (LBD).
Environmental conditions:
Operating temperature in the range of +15°C to 30°C, at non-condensing RH up to 75%.
The MRAD 3.5, a Mobile x-ray machine is used to take pictures of dense tissues such as
bones. This is because bones absorb the radiation more than the less dense soft tissue.
It includes an x-ray generator, x-ray tube, and X-ray film. The Patient body part, of which x-
ray image is to be taken, is placed between X-ray Cassette and X-ray tube at a SID of 1000
mm. X-rays are generated by an X-ray tube, a vacuum tube that uses a high voltage to
accelerate the electrons released by a hot cathode to a high velocity. The high velocity
electrons collide with a metal target, the anode, creating the X-rays. The high energy x-rays
pass through a patient toward the X-ray film. Black areas on an x-ray represent areas
where the x-rays have passed through soft tissues. White areas show where denser
tissues, such as bones, have absorbed the x-rays.
On pressing the ready and exposure key from hand-switch after setting the parameters
(kVp, mA, mAs), the x-ray is being generated toward the X-ray film through the patient.
3.2 Intended Use
Radiography system is intended to be used for obtaining diagnostic quality x-ray image at low
dose to patient by exposing x-rays on patient body. There are preset dose specified for
various patient size and anatomical region (e.g. - Anatomical Programming) and the same can
also be preset by the user.
15
The MRAD 3.5 equipment is a Mobile Radiographic Unit for radiography on X-Ray Film
that may be used in different places and situations: operating theatre, orthopaedics,
intensive care, emergency room & wards in the hospitals.
The MRAD 3.5 is exclusively meant for taking diagnostics X-Ray radiographs.
It is the responsibility of the owner to ensure that properly trained, qualified personnel who
have obtained credentials from the appropriate authorities to operate the system.
It is intended to be used in hospitals, clinics and diagnostic centers and the operator must
be radiologists, radiographers & trained staff.
Observe all cautions and warnings provided on the equipment, accessories and those
provided in this manual.
Cautions:
The unit must not be disposed along with industrial or domestic waste and must be
regarded as hazardous waste.
While transporting the unit on the slope ensure that the slope should not exceed
+10°.If the slope is more than 10°, there is a risk of toppling.
Before opening / closing the covers ensure that the mains is switched off and the plug
is removed from the socket.
Ensure that the protective earth connections of the sub-assemblies are properly
connected.
For taking exposures use hand switch provided with approx. 2.9-metre-long coiled
cable.
Do not remove any accessible cover of the machine. Only service personnel are
authorized to perform maintenance or open the access cover of the machine.
This equipment produces ionizing radiation for medical imaging purposes. Observe
proper safety practices during operation.
For efficient functioning & safe usage of the device, always perform the Periodic
Maintenance of the machine in intervals of 1 year.
Do not dispose the device or its accessories along with the domestic waste. Contact
BPLMTPL personnel for proper disposal.
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Use of accessories and cables other than those specified by BPLMTPL could result in
increased Electromagnetic emission or decrease Electromagnetic immunity of this
equipment which result in improper operation.
Radiation Safety:
Before any x-ray exposure, ensure that all the necessary protective precautions
have been taken.
In the room, wear protective clothing (lead Apron). Monitor radiation received using
the personal TLD- badges.
AERB & BIS details are available on the marking label provided on the equipment.
Warnings:
To avoid the risk of electric shock, the machine must be connected to supply mains
with protective earth.
Do not put any part of your body in the direct line of radiation.
The MRAD-3.5 Unit is not waterproof. Water, soap or other liquids, if allowed to
drip into the equipment, can cause electrical short circuits leading to electric shock.
Any modification in the design of the machine must be done only by BPLMTPL service
personnel.
Always select the exposure area precisely by moving the knobs provided in collimator
before taking exposure to minimize the deterministic effect of the machine.
The essential performance of MRAD 3.5 may be affected due to the following conditions:
Usage of Cellphone or any other Electronic device (which emits Electromagnetic
radiation) near Operating area of the machine is strictly prohibited to minimize or
avoid interference.
17
Portable and Mobile RF communication equipment can affect medical electrical
equipment. Make sure that communication equipment ispowered off before they are
taken near this equipment.
When using this system on a patient, ensure that X-RAYS are not exposed directly on to
the patient's implantable pacemaker, and the exposure time must be kept as short as
possible.
Any auxiliary device connected to the device must be IEC certified (Medical electrical
equipment 60601-1 or data processing equipment IEC 60950)
Deterministic effects generally result from the receipt of relatively high dose over a short
period. Injury in the population of cells characterized by a threshold dose and increase in the
severity of reaction as the dose is increased further which results in Skin erythema(Reddening) and
radiation-induced cataract formation in eyes.
It is recommended to study this user manual before operating the equipment and
operating directions be followed carefully.
This unit is suited for all routine & special radiographic examines of the chest, extremities,
skull, abdomen and pelvis. MRAD3.5 is ideal for all possible radiographic applications
offering ease of patient positioning.
MRAD 3.5 unit has only one mode of operation i.e., Radiography. It is also featured with APR
(Anatomical Programming) and Pre-Select Mode. In APR Mode, the parameters as per the
patient sizes are pre-selected and the Pre-Select mode allows the user to save the most
frequently used radiology parameters (i.e. kVp, mA and mAs).
Observe all cautions and warnings provided on the equipment, accessories and those
provided in this manual.
3.5 Overview
3.5.1 General Description of the Equipment
The equipment is a Diagnostic Medical Equipment of Mobile equipment type intended to be
moved from one location to another between periods of use while supported by its own
wheels without dismantling.
The equipment provides Radiography for Diagnostic purpose. It consists of a Mobile X-Ray
unit that houses an X-Ray generator and control circuitry in a mobile frame and a horizontal
to position the X-Ray source at a convenient position. The equipment does not have any
Table.
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3.5.2 X-Ray Tube head Monobloc
The X-ray Tube head Monobloc contains a Double Focus Stationary Anode Tube. Also housed
a filament transformer & other related parts and components. The X-Ray Tube head
Monobloc emits the X- Rays when Exposure is initiated from hand switch.
3.5.3 Number of Tube
The equipment uses One Dual Focus X-Ray tube of Stationary Anode type.
X-RAY GENERATOR
TYPE HIGH FREQUENCY, 40kHz
OUTPUT 3.5kW
kVp RANGE 40-110kVp
MAXIMUM mAs 200
CONTROL PANEL
MCB 250V, 6 A, 50Hz
KEYPAD ATTRACTIVE AND ERGONOMICALLY
DESIGNED KEYPAD HAVING SOFT TOUCH
CONTROL OF ALL RADIOGRAPHIC
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PARAMETERS i.e. kVp, mA AND mAs AND
ALSO CONTROL OF OPERATING MODES,
COLLIMATOR AND ON/OFF.
DISPLAY 20X4 CHARACTER LCD
FEATURES AND FUNCTIONS 1. Soft feather touch keys for kVp, mA AND
mAs selections.
2. kVp, mA and mAs are displayed on the LCD
3. Audible and visual indication during
exposure
4. LED indications for READY, EXPOSURE,
ON/OFF, COLLIMATOR and PRE-SEL MODE.
OPERATING MODES MANUAL MODE, APR MODE AND PRE-SEL
MODE
MECHANICAL CHARACTERISTICS
S.I.D 1000 mm
FIELD OF VIEW
At S.I.D 100cm 53.5cm x 50.5cm
At S.I.D 80cm 42.7cm x 40.1cm
At S.I.D 60cm 31.9cm x 29.7cm
ENVIRONMENTAL CONDITIONS(OPERATION)
TEMPERATURE RANGE +15°C TO +30°C
RELATIVE HUMIDITY UPTO 75% NON-CONDENSING
BAROMETRIC PRESSURE 700hPa TO 1060hPa
Description Radiography
Highest electric power 3.5kW (70mA @ 50 kVp, 0.09s)
Highest X-ray tube voltage 110kVp@ 25mA
Highest X-ray tube current 70mA @ 40-50kVp
Nominal Electrical Power 2.5kW (25mA @ 100 kVp,
2.5mAs)
Nominal X-ray tube voltage 100kVp@ 25mA
Lowest current time product 0.5mAs
40kVp-65kVp, 50mA, 10ms
Accuracy of mA ±20% of the set value
Accuracy of kVp ±10% of the set value
Accuracy of mAs ±10% + 1ms of the set value
Accuracy of dose rate ±35%
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Dosimetric Information:
Corresponding
Set mA
kVp mAs mGy
110 80 25 5.372
90 100 25 5.668
70 160 35 5.755
50 200 50 3.2
Warning labels define potential hazards and advise against misuse that might result in
personal injury. Familiarize yourself with these labels and their meanings in order to
ensure a safe environment for both the patient and yourself. Regulatory labels indicate
that the system meets the requirements of specific governmental, medical and
industrial organizations.
Symbols are provided to visually represent concepts such as locked and unlocked brake
positions or the proper transport position of the MRAD-3.5.
21
SYMBOLS/ MARKINGS ON OUTER PACKAGING
Recyclable
Fragile
This way up
High Voltage
Earthing
Alternating Current
Ionizing Radiation
22
Do not dispose in domestic waste
Serial number
Pushing/Leaning Prohibited
Sitting Prohibited
Stepping Prohibited
23
Transport position of the machine.
Please read and follow all WARNINGS, CAUTIONS and NOTES provided in this manual. To
avoid the possibility of injury, damage to the product or loss of data, observe these safety
precautions while operating the system.
The following pages describe hazardous and potentially hazardous conditions, and how to
adequately protect yourself and others from possible injuries.
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3.8.1 Burns
Continuous Radiography exposure may cause the X-Ray Tube housing to reach
temperatures capable of inflicting burns. Do not touch the housing or place the X-Ray
Tube housing near Patients.
3.8.2 Collision
The System is mounted on wheels. If moved improperly, it could roll out of control.
Two people should maintain control of the X-Ray assembly, when moving the system
up or down on an inclined surface.
Never attempt to move the system up or down or any steps or on an incline greater
than 5 degrees.
Always apply the Foot lock when the system is in its final position.
Do not remove any of the assembly covers. Only trained service representatives
should perform repairs.
Do not place food or beverage containers on any part of the equipment. They may
fall and introduce conductive substances into the electrical circuitry.
Always remove power to the equipment before cleaning. Use a slightly damp cloth
or sponge for cleaning.
General Protection
The owner must designate areas suitable for safe operation and service of the system and
ensure that it is used only in these designated areas. It is the responsibility of the owner
to ensure that all personnel wear protective clothing and radiation protection devices while
using this system.
A visual indicator on top of the Exposure key is provided to alert you that an X-ray switch
has been actuated and the X-ray tube is generating ionizing radiation. An audible alarm
also configured to sound during exposure.
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It is assumed by the manufacturer and distributors of this equipment that all persons
responsible for the operation of this equipment are aware of the danger of excessive
exposure to X-Radiation and this equipment is sold with the understanding that BPLMTPL -
their agents and representatives have no responsibility for injury or damage which may
result from exposure to X-Radiation.
X-Ray equipment, if not properly used, may cause injury. Accordingly, the instructions
herein contained should be thoroughly read and understood before you attempt to place
the equipment in operation. The BPLMTPL X - Ray Division will be glad to assist and co-
operate in placing this equipment to use.
Although this apparatus incorporates a high degree of protection against X-radiation other
than the useful beam, no practical design of equipment can provide complete protection
nor can any practical design compel the operator or his assistant to take adequate
precautions or prevent the possibility of authorized or unauthorized person carelessly,
unwisely, or unknowingly, exposing themselves or others to direct or secondary radiation.
26
3.8.5 Equipment Malfunction
Do not attempt to operate the equipment until it has been checked by a qualified service
engineer.
If any of the MRAD-3.5 controls fail to respond as indicated in this User Manual, the
operator should:
1. Remove power to the MRAD-3.5 by unplugging the power cord from the AC
receptacle.
A b c d
b: Year manufactured
1 – 2011 2 – 2012 3 – 2013
c: Month manufactured
A- January E- May I- September
B- February F- June J- October
C- March G- July K- November
D- April H- August L- December
d: Serial Number
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Chapter 4
System Overview
4.1 System Components & Description
The brief description of various Assemblies is mentioned below:
Pressing the Ready switch from hand switch boosts up the filament supply and then on
pressing the Exposure Switch, X-rays are generated.
28
The Monobloc is filled with Transformer oil for providing Insulation & for cooling of X-
ray Tube. The Tube head is completely sealed to prevent any leakage. The X-ray Tube
head Monobloc emits the X-rays when Exposure is initiated from hand switch.
29
Chapter 5
General Installation
5.1 General
It shall be the duty of the installation personnel and the user to ensure that all the safety
measures concerning the unit operation and installation are adhered to.
The unit must be checked for the status of its safety measures at least every year.
If there are any special regulations of the hospital/institute, to be followed over and above
the general safety regulations pertaining to the installation, the same must be ensured.
Before commencing the operation, the user must convince him/her regarding all safety
aspects and their proper functioning. He should also ascertain that all displays and indicators
are functioning as described.
Any change and/or replacement in the unit must be carried out by the manufacturer or a
person authorized by manufacturer only.
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Chapter 6
System Operation
The 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:
The system is connected to a proper supply source and machine is switched ON.
Select the parameters as per the requirement using the keyboard.
Press ready switch.
Press X-ray Exposure Switch.
Now tube Gets High Voltage across anode & cathode.
X-ray production begins for selected kVp, mA and mAs.
Exposure stops automatically after a set time.
Release hand Switch.
The same procedure follows for APR mode and Pre-Select modes.
Necessary precaution for radiation safety to be taken by all persons in the operating room.
FUF-2: Movement of Unit on Floor Handles required to move the unit is easily
recognizable. The brake has to be released
before moving.
FUF-3: Application of Foot Lock on the Mobile Foot Lock should be appropriately labelled
unit when the device is in the desired position. or marked
Clear illustrations of foot lock position
should be displayed in the user manual
FUF-4: Proper Positioning and alignment of the The Collimator has to be turned on.
Tube-Arm and the patient to expose the area of The locks for ARM movements should be
interest. labelled appropriately
No additional requirements are necessary.
The machine should be used by trained
technicians only.
FUF-9: Setting the kVp parameter User Interface should have clear, legible and
large labels
No additional requirements are necessary.
31
FUF-10: Setting the mA parameter User Interface should have clear, legible and
large labels
No additional requirements are necessary.
FUF-11: Setting the mAS parameter User Interface should have clear, legible and
large labels
No additional requirements are necessary.
FUF-12: Selecting the mode: MANUAL or APR User Interface should have clear, legible and
large labels
No additional requirements are necessary.
FUF-13: Selecting the Patient type User Interface should have clear, legible and
large labels
No additional requirements are necessary.
FUF-14: Selecting the ANATOMY for the patient User Interface should have clear, legible and
large labels
No additional requirements are necessary.
FUF-15: Selecting the VIEW of the anatomical User Interface should have clear, legible and
part of the patient large labels
No additional requirements are necessary.
FUF-16: Selecting the PRE-SEL mode User Interface should have clear, legible and
large labels
No additional requirements are necessary.
FUF-17: Saving the parameters for PRE-SEL or User Interface should have clear, legible and
APR mode large labels
No additional requirements are necessary.
FUF-18: Turning on the Collimator Supply form User Interface should have clear, legible and
Control large labels
No additional requirements are necessary.
FUF-19: Pressing the hand switch for making an No additional requirements necessary. The
exposure. machine should be used by trained
technicians only.
FUF-20: Capturing the image No additional requirements necessary. The
machine should be used by trained
technicians only.
FUF-24: Switching Off the device User Manual clearly defines the procedure
for Switching off the device.
FUF-25: Cleaning the device Guidelines provided in User Manual.
No additional requirements are necessary
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6.2 Control Panel Description
1. ON SWITCH
On pressing this switch, the equipment gets energized and the LED above the ON
switch starts glowing.
2. OFF SWITCH
3. PRE SET
This switch is used to feed the most frequent parameters used by the radiographer.
PRE SEL parameters can be modified or changed at any time. By pressing this key, the
radiographer can directly access the desired parameters.
4. Save
This switch is used to save pre-select data and APR data. PRE-SET and APR parameters
can be modified or changed at any time and saved in flash memory by pressing this
key.
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LCD DISPLAY WITH SELECTION KEYS
These keys are used to increase or decrease the kVp as per patient size. The kVp can
be increased or decreased in the step of 1kVp.
b) mA Up / Down keys
These keys are used to increase or decrease the mA. For radiography mA steps are 25,
35, 50 and 70.
These keys are used to increase or decrease the exposure time as per the dose
required to be given to the patient.
34
Loading Time (Exposure Time):
The Loading Time is determined as the Time interval between the instant when the timing device
generates the signal to start the irradiation and the instant when it generates the signal to
terminate the irradiation. The loading time will depend upon the mA and mAs selected.
1) Manual Mode
2) APR Mode
1) Child
2) Teenager
3) Adult
4) Adult-L
1) CHEST
2) SKULL
3) C-SPINE
4) T-SPINE
5) L-SPINE
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6) PELVIS
7) SHOULDER
8) WRIST
9) FEMUR
10) TIBIA
g) LCD Display
20X4 Character LCD is used to display the set parameters and mode of operation.
In the event of the occurrence of Inverter Fault, INVERTER FAULT etc. is displayed
on the LCD.
1) AP/PA
2) LATERAL
3) OBLIQUE
BODY
S.NO. PATIENT INFO PART PART VIEW kVp MA MAS SEC
1 CHILD SKULL AP-PA 55 50 13 0.26
2 CHILD SKULL LATERAL 52 50 14 0.28
3 TEENAGERS SKULL AP-PA 60 50 16 0.32
4 TEENAGERS SKULL LATERAL 55 50 14 0.28
5 ADULT SKULL AP-PA 65 35 16 0.457
6 ADULT SKULL LATERAL 60 50 14 0.28
7 ADULT-L SKULL AP-PA 68 35 16 0.457
8 ADULT-L SKULL LATERAL 63 50 14 0.28
9 CHILD C-SPINE AP 45 50 8 0.16
10 CHILD C-SPINE LATERAL 47 50 8 0.16
11 CHILD C-SPINE OBLIQUE 46 50 8 0.16
12 TEENAGERS C-SPINE AP 50 70 9 0.129
36
13 TEENAGERS C-SPINE LATERAL 52 50 9 0.18
14 TEENAGERS C-SPINE OBLIQUE 51 50 9 0.18
15 ADULT C-SPINE AP 55 50 9 0.18
16 ADULT C-SPINE LATERAL 57 50 9 0.18
17 ADULT C-SPINE OBLIQUE 56 50 9 0.18
18 ADULT-L C-SPINE AP 58 50 10 0.2
19 ADULT-L C-SPINE LATERAL 60 50 10 0.2
20 ADULT-L C-SPINE OBLIQUE 59 50 10 0.2
21 CHILD CHEST PA 50 70 7 0.1
22 CHILD CHEST LATERAL 55 50 8 0.16
23 TEENAGERS CHEST PA 55 50 10 0.2
24 TEENAGERS CHEST LATERAL 60 50 11 0.22
25 ADULT CHEST PA 60 50 10 0.2
26 ADULT CHEST LATERAL 65 35 12 0.343
27 ADULT-L CHEST PA 70 35 11 0.314
28 ADULT-L CHEST LATERAL 75 35 13 0.371
29 CHILD T-SPINE AP-PA 55 50 14 0.28
30 CHILD T-SPINE LATERAl 60 50 15 0.3
31 TEENAGERS T-SPINE AP-PA 65 35 15 0.429
32 TEENAGERS T-SPINE LATERAl 70 35 16 0.457
33 ADULT T-SPINE AP-PA 70 35 16 0.457
34 ADULT T-SPINE LATERAl 75 35 16 0.457
35 ADULT-L T-SPINE AP-PA 80 25 17 0.68
36 ADULT-L T-SPINE LATERAl 85 25 18 0.72
37 CHILD PELVIS AP 50 50 14 0.28
38 TEENAGERS PELVIS AP 55 50 15 0.3
39 ADULT PELVIS AP 65 35 16 0.457
40 ADULT-L PELVIS AP 70 35 16 0.457
41 CHILD L-SPINE AP 60 50 16 0.32
42 CHILD L-SPINE LATERAL 65 35 17 0.486
43 CHILD L-SPINE OBLIQUE 63 35 17 0.486
44 TEENAGERS L-SPINE AP 70 35 17 0.486
45 TEENAGERS L-SPINE LATERAL 75 25 18 0.72
46 TEENAGERS L-SPINE OBLIQUE 73 25 18 0.72
47 ADULT L-SPINE AP 75 25 17 0.68
48 ADULT L-SPINE LATERAL 80 25 18 0.72
49 ADULT L-SPINE OBLIQUE 78 25 18 0.72
50 ADULT-L L-SPINE AP 85 25 18 0.72
51 ADULT-L L-SPINE LATERAL 90 25 20 0.8
52 ADULT-L L-SPINE OBLIQUE 88 25 20 0.8
53 CHILD SHOULDER AP/PA 50 50 8 0.16
54 CHILD WRIST AP/PA 44 70 2 0.029
55 CHILD WRIST LATERAL 46 70 3 0.043
56 TEENAGERS SHOULDER AP/PA 60 50 9 0.18
57 TEENAGERS WRIST AP/PA 46 70 4 0.057
58 TEENAGERS WRIST LATERAL 48 70 5 0.071
59 ADULT SHOULDER AP/PA 65 35 10 0.286
60 ADULT WRIST AP/PA 48 70 4 0.057
61 ADULT WRIST LATERAL 50 70 5 0.071
62 ADULT-L SHOULDER AP/PA 68 35 11 0.314
63 ADULT-L WRIST AP/PA 50 70 5 0.071
64 ADULT-L WRIST LATERAL 52 50 6 0.12
37
65 CHILD FEMUR AP/PA 47 50 8 0.16
66 CHILD FEMUR LATERAL 52 50 11 0.22
67 CHILD TIBIA AP/PA 45 70 9 0.129
68 CHILD TIBIA LATERAL 50 50 10 0.2
69 TEENAGERS FEMUR AP/PA 57 50 11 0.22
70 TEENAGERS FEMUR LATERAL 62 50 12 0.24
71 TEENAGERS TIBIA AP/PA 56 50 10 0.2
72 TEENAGERS TIBIA LATERAL 60 50 11 0.22
73 ADULT FEMUR AP/PA 60 50 12 0.24
74 ADULT FEMUR LATERAL 65 35 13 0.371
75 ADULT TIBIA AP/PA 58 50 11 0.22
76 ADULT TIBIA LATERAL 63 50 12 0.24
77 ADULT-L FEMUR AP/PA 63 35 12 0.343
78 ADULT-L FEMUR LATERAL 68 35 13 0.371
79 ADULT-L TIBIA AP/PA 60 50 11 0.22
80 ADULT-L TIBIA LATERAL 65 35 12 0.343
5. ERROR INDICATOR
NOTE: The fault condition is also displayed on the LCD. The exposure will not take place until the
fault condition exists.
The Ready key is disabled. As a result, when this key is pressed, “Key Disabled” message
is displayed on the LCD screen. However, when the ready switch is pressed from the
hand switch, the green LED above the ready key glows.
Bucky Selection Switch is disabled. When this key is pressed, “Key Disabled” message is
displayed on the LCD screen.
38
8. EXPOSURE KEY & ITS INDICATOR
The Exposure key is disabled. When this key is pressed, “Key Disabled” message is
displayed on the LCD screen. However, the yellow LED above the exposure key glows
when the exposure switch is pressed from the hand switch until the exposure ends.
For turning ON the collimator power supply, press the Collimator key once. Blue LED
glows above the collimator key which indicates that collimator supply is ON. Pressing the
same key again will turn it off.
LBD is mounted on the Tube Head having the bulb and lead shutters. Lead shutters are used
for the collimation of the X-ray beam so that the X-ray Beam cannot be scattered and does
not cause any harm to the operator.
The operator has to focus the light beam of the LBD on the area to be exposed and when the
X-ray switch is pressed the X-Ray beam falls exactly at the same area where the light beam
is adjusted.
It is equipped with two Pushbuttons. When the ‘I’ marked button is pressed, the LED gets on.
Similarly, When ‘O’ marked button is pressed, LED will turn off.
39
6.4 Description of Operation
Press the On Switch on the keyboard to switch on the unit. Screen shown in figure
appears on the LCD screen.
Booting screen
Next the window displayed in figure appears which displays the settings of the last
exposure performed.
Final screen
By default, it will always display the settings of the Radiography in manual mode.
For example, as shown in figure, kVp, mAs & mA of the last exposure are displayed on
the screen.
If the user wants to perform the test when screen appears then he can directly press
the Ready key from hand switch. Pressing the Ready key displays the following
screen.
40
When this screen appears press simultaneously the Expose button from hand switch,
another screen appears on the LCD. Once the set time has elapsed, Exposure Off
message is displayed on the screen.
Exposure On
If the user does not want to start the test from the last exposure set values, he / she
can either change the values for that mode or can enter into APR mode by pressing
the Mode key or can enter into Pre- Select Mode by pressing the Pre-Set key as
described below:
APR Screen
41
3. Select the body part of the patient whose X-Ray is to be performed by pressing
the Part key.
4. Once a particular body part is selected then select its corresponding view by
pressing the View key.
The values of kVp, mA and mAs are also displayed on the screen. The values can be
altered as per the desire by using the corresponding selection keys for changing the
values of kVp, mA and mAs and this data can be saved by pressing the Save key. When
the Save key is pressed the following screen appears.
Note: The Radiographic parameters displayed are as per intensifying screen speed selection.
5. To make the exposure, first press the READY switch as shown in figure and then after
a brief delay (1 sec) press the EXPOSURE switch. Do not release both the
switches until exposure is terminated by timer or the “Exposure ON” is displayed
on the LCD or the beep sound is terminated. Once the set time has elapsed,
Exposure Off message is displayed on the screen.
42
Note: When Ready and Exposure switch is pressed corresponding LEDs of Ready and Exposure
also glows.
6. Switch OFF the unit by pressing the OFF switch. This step should be taken on
termination of the exposure, unless another exposure is to be made on the next
patient.
7. If instead of APR mode the user wants to perform the radiography in Pre- select mode
then press the Pre–Set key, the following screen appears.
Pre-Select screen
The values of kVp, mA and mAs are also displayed on the screen. The values can be
altered as per the desire by using the corresponding selection keys for changing the
43
values of kVp, mA and mAs and this data can be saved by pressing the Save key. When
the Save key is pressed, the following screen appears.
8. 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 exposure is
terminated by timer or the “Exposure ON” is displayed on the LCD or the beep sound
is terminated.
44
machine is in initializing mode for
Capacitor charging.
45
Inverter Fault screen
Initial Position-OFF
Ready
1st Step-READY
2nd Step-EXPOSE
46
Position Description
4. Plugin the 2 Pin Male connector of cassette holder to the socket provided at the
bottom of the mounting cover back of the table.
5. Select desired Rad. Time as per the body part of the patient.
6. Select desired kVp on the control panel as per the penetration required for the
body part of the patient.
7. After all parameters are selected and patient/ MRAD-3.5 Cassette in position &
aligned, Press RAD. Exp. Switch on the control panel. The exposure is released &
X-Ray indicator glows.
8. Take out the cassette from the holder & develop the film in the darkroom.
47
Chapter 7
Room Layout
48
Chapter 8
Dark Room Film Processing
Dark Room Procedure
To obtain the best results from the X-Ray Machine, the following should be observed
in Dark Room: -
1. Dark Room should be totally dark and no light should enter the room.
2. Loading and unloading of films in the cassette should be done only in Dark Room
under standard safe light.
3. A qualified and trained Radiographer should only be allowed to operate the X-Ray
Equipment.
5. The Intensifying screens should be handled with care and touching the screens with
fingers should be avoided.
6. The Developer and the Fixer solutions should always be covered and preferably new
solutions to be prepared after every 30-40 days or after 250 films whichever is
earlier.
8. Solutions should be stirred with a wooden stick each time films are dipped. Separate
wooden sticks, each for developer and fixer should be used.
2. Take out the exposed film and fix it in the hanger of a suitable size.
49
3. Dip the film in the Developer. After about 15 seconds take out the film from the
Developer to visually observe the Developing status. Dip it again and take out to
monitor the development as frequently as possible.
4. Take out the film from the Developer tank after it is fully developed.
5. Dip the film in water to rinse all traces of developer on the film.
6. After proper rinsing, dip the film in the fixer. Let it be dipped in fixer for 5 Minutes.
7. Dip the film in running water to rinse and remove all the fixer from the film.
The Darkroom should preferably be of size 6’X6’ with only one door for entry & exit.
ACCESSORIES OF DARKROOM
7. Safe Light.
50
Chapter 9
Maintenance
Regular Maintenance of the x-ray 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.
b) User should confine only to preserve the exterior 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.
c) BPLMTPL maintains a Nation Wide network of Service Centres from which the
assistance of skilled service personnel may be obtained. You are requested to
contact any of the centres near you for all your service related problems. Telephone
no. of our Service Centre are mentioned in this Menu.
51
from the proper values, the tube current must be readjusted. This should be done
by qualified Service personnel specially trained in servicing the equipment.
Acceptance Criteria:
Set loading parameter of the machine shall be under the limits as specified in the
AERB quality checklist by verifying with the aid of RaySafe Xi meter.
52
Ensure the quality inspection including calibration of the machine
shall be performed once in 2 years as per AERB norms.
BPLMTPL 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.
53
Chapter 10
REGULATORY INFORMATION
10.1 Electromagnetic Compatibility (EMC)
EMISSION TESTS
54
Electromagnetic Interference immunity
55
< 5 % UT (>95 % dip in UT) interruptions, it is recommended
for 5 s that the system be powered from
an uninterruptible power supply.
Power frequency 30 A/m Measurements were made on a
magnetic field IEC ground plane that extends 1-
61000-4-8 meter minimum beyond all sides
of the system under test. The
indicated field was pre-calibrated
prior to placement of the system
under test.
Conducted RF Application Points : 230V, 50 Measurements were made on a
IEC61000-4-6 Hz AC, ground plane. The EUT was
0.150-80MHz – 3Vrms (80% located 10cm above the reference
AM, 1kHz) ground plane and any associated
ISM Band – 6Vrms (80% AM, I/O cables attached to the EUT
1kHz) were located between 30mm and
50mm above the ground plane.
The indicated field was pre
calibrated prior to placement of
the system under test.
Radiated 80-2700 MHz: 3 V/m (80% Measurements were made in a
Susceptibility AM, 1kHz) shielded semi-anechoic chamber
IEC61000-4-3 380-390 MHz: 27V/m (Pulse and the indicated field strength
Modulation 18 Hz) was pre-calibrated prior to
430-470 MHz: 28V/m (FM placement of the system under
±5kHz deviation 1 kHz Sine test. Tests were performed in both
Wave) the horizontal and vertical
704-787 MHz: 9V/m (Pulse polarities, where applicable. The
Modulation 217 Hz) antenna was placed 3 meters from
800-960 MHz: 28V/m (Pulse the product under test. All four
Modulation 18 Hz) sides of the EUT were investigated
1700-1990 MHz: 28V/m for anomalies.
(Pulse Modulation 217 Hz)
2400-2570 MHz: 28V/m
(Pulse Modulation 217 Hz)
5100-5800 MHz: 9V/m (Pulse
Modulation 217 Hz)
56
SupplementaryInformation:
The functions to be tested and the specific, detailed IMMUNITY pass/fail criteria should be
derived from one or more sources. For ME EQUIPMENT and ME SYSTEMS with multiple
functions, the pass/fail criteria should be applied to each function, parameter and channel.
This includes identification of:
– the HAZARDS;
– the functions to be tested for IMMUNITY to verify freedom from unacceptable RISK;
– the criteria on which to base the pass/fail decision;
– operating modes;
– characteristics of simulated PATIENT physiological signals;
– specification of locations of INTENDED USE;
– the characteristics of the test, where these are at the discretion of the MANUFACTURER.
For Example:
Malfunction
Deviation from normal operation that poses an unacceptable RISK to the PATIENT or
OPERATOR
Artefact or distortion in an image in which the artefact would interfere with diagnosis,
treatment or monitoring
Cessation or interruption of any intended operation, even if accompanied by an ALARM
SIGNAL
Mobile Diagnostic X-Ray equipment for radiography MRAD 3.5 is complying to IEC 60601-2-
54;2009+A1-2015
57
Chapter 11
1
2
3
7
4
58
2
11
13
14
10 15
16
17
18
19
20
12
21
22
23
59
No. Spare Part Code Description
8 386TILTMETAY TILTOMETER ASSEMBLY
9 386COLLIMET MANUAL COLLIMATOR 24 VAC PN:LBD 9
10 411LBL001 CONTROL DEC SHEET-M-RAD 3.5–BASIC
11 411RELAYPCBAY MRAD 3.5 RELAY PCB AY
12 382INVERTORIMD IMD INVERTER
13 PCB382IRRES PCB C-RAY PRIME IR RES X-RAY-02 VER 1.0
14 382CONCTR3P20A230V CONTACTOR 3 POLE+1 AUX POLE, 230VAC 20A
15 411CONTROLPCBAY MRAD 3.5 CONTROL PCB AY
16 382CIRBRKRDP CIRCUIT BREAKER DOUBLE POLE P/N:BB20060D
17 382SMPSECM100UQ44 SMPS 100-240V XP POWER:ECM100UQ44
18 382FILMNTBRDIMD X-RAY FILAMENT BOARD IMD S15
19 382LINEFILTR001 LINE FILTER 250VAC 20A CHASS MNT
20 FUSB1A6250V20MMCE FUSE SB 1.6A, 250Vac, 5x20 mm
21 FUSB1A25250V20MM FUSE SB 1.25A 250V 5x20mm
22 FUSB1A25250V20MM FUSE SB 1.25A 250V 5x20mm
23 TFR411FILMNT FILAMENT TRANSFORMER 322 VA PN:MELE-0313
ARM ASSEMBLY
26
27
28
24
Section A
25
FORK HOLDER WELDMENT
29
60 30
31
No. Spare Part Code Description
24 386UPARMAY UPPER ARM ASSEMBLY
25 386ARMCLP1WELD ARM CLAMP 1 WELDMENT
26 386FRKHLDWELDAY FORK HOLDER WELDMENT ASSEMBLY
27 386LWARMAY LOWER ARM ASSEMBLY
28 386ARMPVTPIN ARM PIVOT PIN
29 386FRKSFTPBBS2 FORK SHAFT PB BUSH 2
30 386FRKSFTPBBS1 FORK SHAFT PB BUSH 1
31 386ARMLNKWELD ARM LINK WELDMENT
Section A
32 34
33 35
36
38
37
61
No. Spare Part Code Description
32 386ARMLKSC ARM LOCK SCREW
33 386ARMLKWS ARM LOCK WASHER
34 386ARMLKSLDWELD ARM LOCK SLIDER WELDMENT
35 386ARMLKFRICWS ARM LOCK FRICTION WASHER
36 386ARMLKSLDNUTWELD ARM LOCK SLIDE NUT WELDMENT
37 386KYCVRSUWELD KEY COVER SUPPORT WELDMENT
38 411KEYCVRAY KEY COVER ASSEMBLY
44
39
40
45
41
46
42
43 47
48
62
Appendix A. Glossary
Terms Description
A Ampere
V Voltage
W Watt
kW Kilo Watt
inch Inches
cm Centimetre
m Metre
Hz Hertz
mA Milli Ampere
UI User Interface
63
Revision History
This document is the private property of BPL Medical Technologies Private Limited (BPLMTPL). It must not be reproduced,
disclosed to any third parties without permission in writing from M/s. BPL Medical Technologies Private Limited , Bangalore
64
BPL MEDICAL TECHNOLOGIES PVT. LTD.
INSTALLATION REPORT
! CUSTOMER NAME fr ADORES~ -
- - -
Supplied by
(Dealer Name/Code)
--
Invoice /Bill No.
Model Number
-
-
--r- ----
-----
- -
Date
Serial Number
-
-
-
INSPECTION REPORT:
·---- - ---- --- -- --- -
PARAMETER REMARKS
---
AC Mains
--
L- N Voltage Volts
L-GND Voltage Volts
Volts
N-GND Voltage
----
Stabilizer/any other
regulating device connected _
-- - -- - ------ - - - -
Generator availability
Working condition of all the YES NO
functions - --- - --- - - -- - -
. -·--·- --
YES NO
Accessories availability as
per list
YES NO
Demonscrati ~ -~:l!_s~ mer___ ·--· -· -
YES NO
- Tips on user maintenance to
the product - -
-- NO
Details provided on after YES
sales service fr consumables
-
availability ~
.
The equ1pmen tis working satisfactorily
Name Et S1gnature of the Customer
----
CUSTOMr:t~ SATl ~f-ACl ION !»UHVr Y
Pun:;lt,fl,P
Serial No.
fo l. I Cell fo l I Cell
-
4 DELIVERY 30%
'
Rated By Rate On Date (dd/mm/yy)
- -
Name
Signature
1.
2.
Total Rating
For 5
____________
,__ -
For 100 l
Remarks (by BPL):
Product Invoi ce No .:
Model Date of
0
Happier Living Everyday
Purchase
Serial No.
1 APPEARANCE 10%
3 FEATURES 30%
4 RELIABILITY 30%
Name
Signature
1.
2.
Bangalore : BPL Medical Technologies Pvt. Limited, 11th KM, Bannerghatta Road,
Arakere, Bangalore - 560 076, PH : 080-26484388 / 26484314 / 26484350
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Bhopal(M.P.) 462011, PH : 0755 - 4059311
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