Skanmobile User Manual

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General Information

Document Number :UMN-000018-0-20


Document Revision :2
Document Part Number : 515-003005-0
Release Date : 14-Mar-2019

User Responsibility
This product is designed to perform its intended function when operated in accordance with the instructions
provided in this manual and other accompanying labels and accessories. A defective unit should not be used.
Parts that are broken, plainly worn, missing, incomplete, distorted or contaminated should be replaced
immediately.

There are no user repairable components / modules used as a part of this product. In case of a defective or
malfunctioning unit the repair should be carried out by a trained technician authorised by Skanray. The user
shall have the sole responsibility of any outcome originating from this product resulting from improper use, faulty
maintenance, damage or use of accessories / replacements parts not approved by Skanray.

Accessories

Use of accessories / replacement parts that are not recommended by Skanray could compromise
the performance of the unit if not compromise operator / patient safety.

Skanray will not be able to honour any warranty claims due to the usage of accessories / replacement parts not
recommended by it. Additionally Skanray shall not be liable for any losses incurred due to the usage of any such
non-recommended accessories/parts. For Continued protection against risk of fire and electric shock, replace
the fuse with type 16A / 250V, Fast blow. Ensure the power inlet to the system is disconnected or mains switch
is switched off before replacing fuse.

Limited Warranty Statement


This warranty does not cover damages caused by any combination of
1 Handling during shipping or
2 Deviation from usage instructions while handling, maintaining or operating the unit as prescribed in this
manual or
3 Alteration or repair attempted by user or by a personnel other than Skanray authorised service personnel or
4 Accidents including natural disasters.
If a product or accessory covered under this warranty is found to be defective because of defective material,
component or workmanship and the warranty claim is made within the warranty period as described above,
Skanray will, at its discretion, repair or replace the product or accessories free of charge.

For improving product quality and customer experience, we at Skanray are dedicated to
upgrading the technology and processes used in our product. The information provided in this
document is subject to change without prior notice. Please contact Skanray for latest updates on
the product and services.

Revision 17 Page I of IV
Revision 17 Page II of IV
Table Of Contents
1 Introduction ............................................................................................................................................... 1
1.1 Your X-Ray Equipment ...................................................................................................................... 1
1.2 Indication for Use .............................................................................................................................. 1
1.3 This Manual ...................................................................................................................................... 1
2 Safety and Precautions ............................................................................................................................. 3
2.1 Patient and Operational Safety .......................................................................................................... 3
2.2 Conventions ...................................................................................................................................... 5
3 Know Your X-Ray Unit............................................................................................................................... 7
3.1 X-Ray System Components – A Checklist ......................................................................................... 7
3.2 Identification of Main Parts ................................................................................................................ 7
3.3 System Labels, Controls and Indicators............................................................................................. 9
3.4 Control and Indicators– Identifications (Integrated Console) ............................................................ 16
3.5 Control and Indicators– Identifications (External Console) ............................................................... 18
3.6 Mechanical Dimensions .................................................................................................................. 20
4 Operating The Unit.................................................................................................................................. 23
4.1 Before You Begin ............................................................................................................................ 23
4.2 Power ON And Initial Checks........................................................................................................... 23
4.3 Positioning of the Tube Head........................................................................................................... 24
4.4 Positioning X-Ray Beam Using Collimator ....................................................................................... 24
4.5 Modifying exposure parameters ...................................................................................................... 25
4.5.1 Parameter Modification Screen: kV.......................................................................................... 25
4.5.2 Parameter Modification Screen: mAs....................................................................................... 25
4.5.3 Mode Selection Screen ........................................................................................................... 25
4.5.3.1 MEDIUM 26
4.5.3.2 THIN 26
4.5.3.3 THICK 26
4.5.4 Exposure History ..................................................................................................................... 27
4.5.5 Sleep Mode ............................................................................................................................. 27
4.6 Delivering an Exposure ................................................................................................................... 27
4.7 User Default Parameter Configuration Settings................................................................................ 29
5 Maintenance ........................................................................................................................................... 31
5.1 Cleaning and Disinfecting................................................................................................................ 31
5.2 Caring for Your Equipment .............................................................................................................. 31
5.3 Shipping and Long Term Storage .................................................................................................... 31
5.4 Preventive Maintenance .................................................................................................................. 32
5.4.1 General Preventive Maintenance Procedure ............................................................................ 32
5.5 Disposal of the Unit ......................................................................................................................... 32
6 Troubleshooting ...................................................................................................................................... 33
6.1 Errors & Warnings........................................................................................................................... 33
7 Technical specifications for Skanmobile and Skanmobile for vet application ............................................. 35
7.1 Tube-head Specifications ................................................................................................................ 35
7.2 X-Ray Tube Insert Specifications ..................................................................................................... 35
7.3 Dimensions and Weight .................................................................................................................. 38
7.4 Mains Power Requirements ............................................................................................................ 39
7.5 Environmental Conditions................................................................................................................ 39
Annex A: Exposure Time & mA List For Selected kV And mAs (230 V /110 V) .............................................. 41
Annex B: Basic X-Ray techniques used for Different Anatomy .................................................................... 45
Annex C: APR Chart – Basic X-ray techniques used for veterinary use........................................................ 73
Annex D: Declaration of Conformity ............................................................................................................ 75
Annex E: Guidance and Manufacturer’s Declaration.................................................................................... 77
Annex F: Contact details ............................................................................................................................. 81
Annex G: Preparation of Detachable Power Cord (Appliance Mains Connector) .......................................... 83

Revision 17 Page III of IV


Revision 17 Page IV of IV
1 Introduction SKANMOBILE‒ High Frequency
Diagnostic X-Ray system

1 Introduction
This manual describes how to use the SKANMOBILE High frequency diagnostic X-Ray system. Read this
manual carefully before using the equipment. Instructions or training to use the system shall be given by an
authorised Skanray personnel.
This manual is applicable to the following variants of SKANMOBILE:

Product Description Part Number

SKANMOBILE – HF diagnostic X-Ray system, 230V AC 303-000018-0


SKANMOBILE – HF diagnostic X-Ray system, 110V AC 303-000018-3
SKANMOBILE – HF diagnostic X-Ray system for veterinary use,
303-000018-17
110V AC
SKANMOBILE – HF diagnostic X-Ray system for veterinary use,
230V AC 303-000018-18

This may be used for veterinary applications.

1.1 Your X-Ray Equipment


SKANMOBILE is an advanced high frequency type X-Ray system designed for superior image quality with
powerful 4KW generator and very low leakage radiation. The system houses two microprocessors, one for
control / supervisory functions and another one dedicated to input power factor correction circuit, without
overloading the primary control functions. For 230 Vac, it can be easily plugged into 16A wall socket. For 110
Vac, it can be easily plugged into NEMA 5-20 wall socket. The technology incorporates feedback circuits that
enable x-rays of accurate and reproducible nature for years of trouble free operation.

1.2 Indication For Use


The SKANMOBILE is indicated for use in generating radiographic images of human anatomy in all general
purpose X-Ray diagnostic procedures. It may be used in radiology departments, emergency rooms, intensive
care units, operating rooms, pediatrics, orthopedics, and clinics.
The system has been designed for indoor usage and used/operated by only trained & qualified Physicians or X-
Ray technologist.

1.3 This Manual


This manual contains information related to normal operation, set-up and safety tips to prevent unwanted X-Ray
exposures. The manual covers description of various components and their functions. Location and meaning of
various labels are provided as well. If the unit does not perform as intended, refer and act as instructed in
Section 6, the “Troubleshooting” section.

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2 Safety and Precautions SKANMOBILE‒ High Frequency
Diagnostic X-Ray system

2 Safety and Precautions


The owner of this Diagnostic X-Ray system shall not modify any components of the system since
this may result in violation of compliance to the standards. Skanray shall not be responsible for
any such modifcation causing violation of compliance, compromise on safety, performance
deterioration or any other adverse efects.

Warranty of this equipment will be void in the event of any modifcation done to the equipment,
misuse of the equipment and opening or servicing by an unauthorized personnel.

2.1 Patient And Operational Safety

This x-ray equipment may give hazardous x-ray to the patient and the operator unless safe
exposure factors and operating instructions are observed.

Follow proper X-Ray radiation safety rules:


RADIATION 1) Do not allow non-prescribed exposures
SAFETY
2) Do not allow unauthorized or untrained personnel to operate the unit.

3) Always focus the collimator light only on to the area to be imaged.

4) Patients should be provided with lead apron and thyroid collar while being exposed.

5) Operator should wear proper X-Ray shielding aprons.

6) Operator should be at a distance of at least 2 meters away from the Tube Head while carrying
out the exposure.

7) Operator should not stand in front of collimator during exposure.

8) Operator should stand behind the Tube head assembly during exposure.

ELECTRICAL 1) This equipment must only be used in rooms or areas that comply with all applicable laws and
SAFETY
recommendations concerning electrical safety in rooms used for medical purposes, e.g., IEC, US
National Electrical code, or VDE standards concerning provisions of an additional protective earth
(ground) terminal for power supply connection.

2) This Equipment is rated IP2X, that is without protection against Ingress of liquids. To protect
against short-circuit and corrosion, no water or any other liquid should be allowed to leak inside the
Equipment.

3) For the User, no serviceable parts are provided inside the Equipment.

4) To avoid the risk of electric shock, this Equipment shall be connected to a mains supply with
protective earth and do not touch patient and accessible conductive parts of the system
simultaneously

5) Always switch OFF the unit and remove the mains plug when cleaning and disinfecting the unit.

6) The unit contains lethally high voltages. Do not attempt to open covers or repair the unit on
yourself or by non certified service personnel.

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SKANMOBILE‒ High Frequency
2 Safety and Precautions
Diagnostic X-Ray system

7) Switch OFF the Equipment after the use to Isolate from the mains.

8) Preventive maintenance and replacement of parts is done by Skanray Authorized Personnel


only.

9) Do not modify this Equipment without written authorization from the manufacturer.

10) Do not try to open or service/clean the Equipment when it is in use.

11) There is No User Serviceable parts in the Equipment. Skanray Europe will make available on
request circuit diagrams, component part lists, descriptions, calibration instructions, or other
information that will assist Skanray Authorised Personnel to repair those parts of ME Equipment that
are designated by the manufacturer as repairable by Skanray Authorised Personnel.

EXPLOSION 1) This equipment must not be used in the presence of flammable or potentially explosive
SAFETY
disinfecting gases or vapours, which could ignite causing personal injury and/or damage to the
equipment. If such disinfectants are used, the vapour must be allowed to disperse before using the
equipment.

2) This equipment is not suitable for use in presence of anaesthetic gases.

ELECTRO 1) Interference between the unit and other sensitive electronics can occur under extreme
MAGNETIC
conditions.
INTERFERENCE
2) Do not use the X-Ray equipment in close conjunction with other sensitive devices or devices
which create high electromagnetic disturbance.

PHYSICAL 1) The Swivel arm lifts up suddenly if the Tube Head assembly is removed from the arm of the
INJURY
trolley.

2) Operator should be at a distance of at least 2 meter away from the Tube Head to avoid any
unintended movement.

INSTALLATION 1) Ensure that your X-Ray unit is assembled and installed inside the Hospital or clinic building, by
AND SERVICE
authorised Skanray personnel.

2) Take the services of authorised Skanray personnel when relocating the unit.

3) The location should be such that it is possible to use the SKANMOBILE X-ray system with ease
for all recommended imaging procedures on the patient with respect to the patient location.

MOBILITY 1) Care must be taken for the movement and positioning of the system.

2) The system must be disconnected from the main power before moving.

3) Before moving system around, the system must be positioned to the parking position to avoid
unnecessary damage to the system.

4) While bringing the Tube Head into parking position, make sure Tube Head is positioned at 90
degrees to the swivel arm to avoid tube-head hitting the lower portion of trolley.

5) Wheels should be unlocked before moving the system.

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SKANMOBILE‒ High Frequency
2 Safety and Precautions
Diagnostic X-Ray system

6) After the system is placed at the desired location, the wheels should be locked.

NOTE: Parking position – Refer Illustration 6

2.2 Conventions
WARNING - Warning statements describe conditions or actions that may result in personal injury or loss
of life.
CAUTION - Caution statements describe conditions or actions that may result in damage to the
equipment or software.
NOTE - Notes contain additional information on the use of the system.

General Caution Symbol

General Warning Symbol

Warning: HOT SURFACE

Warning: Trapping Zone

Refer to the accompanying documents.

Take Note

This symbol points to an important detail / tip in the operation of the unit.

Protective Earth

Mains Earth is required for continued protection against shock hazards.

Warning: Electricity

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SKANMOBILE‒ High Frequency
2 Safety and Precautions
Diagnostic X-Ray system

High Voltage

Dangerous voltage present.

WARNING: X-Ray
X-Ray Source Assembly / Tube Head capable of generating X-Rays. This X-Ray unit may be
dangerous to patient & operators unless safe exposure factors and operating instructions are
observed.

Manufacturing date

Manufacturer’s address

Temperature range

WEEE symbol for disposal.

Requires special disposal methods. Consult local regulatory body for identifying proper disposal
method.

Alternating current

Focal Spot

N1=2 Protected against solid foreign objects of 12.5 mm Ø and greater.


IP2X N2=X Non-protected against Liquid Droplets.

L Mains Line Connection

N Mains Neutral Connection

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3 Know Your X-Ray Unit SKANMOBILE‒ High Frequency
Diagnostic X-Ray system

3 Know Your X-Ray Unit


3.1 X-Ray System Components – A Checklist
SKANMOBILE X-Ray system consists of the following major components.
 Tube Head Assembly (including Collimator)
 Trolley
 External Console
 This user manual 1 number (UMN-000018-0-20)

3.2 Identification Of Main Parts

Illustration 1: TUBE HEAD ASSEMBLY

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Illustration 2: INTEGRATED SKANMOBILE GENERATOR

Illustration 3: INTEGRATED SKANMOBILE GENERATOR

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3 Know Your X-Ray Unit
Diagnostic X-Ray system

3.3 System Labels, Controls And Indicators


This section lists the labels, controls and indicators that are affixed on the unit. Please refer Illustration 4 and
Illustration 5 for the location where they are affixed. The mark number is given against each label below.

FUSE RATING LABEL (L2)

SKANMOBILE STICKER (L3)


DANGER LABEL (L1)

FOCAL SPOT LABEL (L4)

SKANMOBILE TUBEHEAD RATING LABEL


(L5)

INPUT SPECIFICATION LABEL 110 V(L6)


INPUT SPECIFICATION LABEL 230 V(L6)

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HOT SURFACE CAUTION LABEL (L8)

COLLIMATOR FIELD INDICATION LABEL (L7)

SYSTEM LABEL SKANMOBILE- 230V (L9) SYSTEM LABEL SKANMOBILE- 110V (L9)

CE MARK LABEL (L11A)

[COUNTRY SPECIFIC]

TUBE HEAD ARM POSITIONING LABEL (L12)

TUBE HEAD POSITIONING LABEL (L13)

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TRAPPING ZONE CAUTION LABEL (L14)

COLLIMATOR SERIAL NUMBER LABEL (L16)

SKAN MOBILE CONSOLE LABEL (L15)

WARNING LABEL (L17)

COLLIMATOR REAR SHUTTER TAPE (L19)


COLLIMATOR FRONT SHUTTER TAPE (L18)

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X-RAY TUBE (L20) TUBE HOUSING SERIAL NUMBER (L21)

TROLLEY SERIAL NUMBER (L22)

MEMBRANE KEYPAD CONSOLE (L24)

DOME LABEL
(L25) SKANMOBILE DECORATIVE STICKER (L26)

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Diagnostic X-Ray system

SLS CAUTION LABEL (L28)

SLS UNLOCK LABEL (L27)

CUSTOMER SUPPORT LABEL (L29)

EXTERNAL CONSOLE LABEL (L30)

CONTROLS and INDICATORS


1) Mains ON/OFF Switch (C1)
2) Exposure Hand Switch (C2)
3) Collimator Rear Shutter Control Knob (C3)
4) Collimator Front Shutter Control Knob (C4)

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Illustration 4: Label Location

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Illustration 5: Label Location

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3.4 Control And Indicators– Identifications (Integrated Console)


FAULT LED
PREP / READY LED

kV INCREMENT KEY
X-RAY ON LED

mAs INCREMENT KEY


mAs DECREMENT KEY
mAs DISPLAY
RESET KEY
kV DECREMENT KEY
kV DISPLAY
LAMP ON / OFF KEY
Label 15 (L15): Control Console – Identification

LED Indications
PREP / READY LED • Yellow colour indicates system is getting prepared to take X-Ray by
preheating filament.

• Green colour indicates system is ready to take X-Ray.

X-RAY ON LED X-Ray on Indication

FAULT LED When there is a fault in the system, FAULT LED will glow in Red colour.

KEY Functions
kV INCREMENT KEY • Increments the set kV in steps of 1 and jumps to steps of 5 for continuous
pressing.
• Inactive if kV is preset at 100.

kV DECREMENT KEY • Decrements the set kV in steps of 1 and jumps to steps of 5 for continuous
pressing.

• Inactive if kV is preset at 40.

mAs INCREMENT KEY mAs range shall increment from 0.1 to 250mAs (@ 40kV) as per the
following:
0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.3, 1.4, 1.6, 1.8, 2, 2.2, 2.5,

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2.8, 3.2, 3.6, 4, 4.5, 5, 5.6, 6.3, 7.1, 8, 9, 10, 11, 12.5, 14, 16, 18, 20, 22, 25,
28, 32, 36, 40, 45, 50, 56, 63, 71, 80, 90, 100, 110, 125, 140, 160, 180, 200,
220, 250
mAs range is limited to maximum power.
Inactive if mAs is preset at maximum setting.

mAs DECREMENT KEY mAs range shall decrement from 250 (@ 40kV) to 0.1mAs as per the
following:
250, 220, 200, 180, 160, 140, 125, 110, 100, 90, 80, 71, 63, 56, 50, 45, 40,
36, 32, 28, 25, 22, 20, 18, 16, 14, 12.5, 11, 10, 9, 8, 7.1, 6.3, 5.6, 5, 4.5, 4,
3.6, 3.2, 2.8, 2.5, 2.2, 2, 1.8, 1.6, 1.4, 1.3, 1.1, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4,
0.3, 0.2, 0.1

mAs range is limited to maximum power.


Inactive if mAs is preset at 0.1.

RESET KEY • In fault state, this key resets the generator to standby mode. Some faults
cannot be reset by this key. They are reset only by switching off the power
once and switching on again. These are called as “Power on reset faults”
and list is given in generator fault list Section 6.1.

• In standby mode, displays Input voltage as Uin. Press KV INCREMENT


KEY for scrolling through other system parameters, DC bus voltage BUS,
heat sink temperature HSt, tank oil temperature Olt, PFC software version
PFC and Exposure count(number exposures delivered by tube)

LAMP KEY • Switches on and off the collimator lamp. Internal timer switches off the light
after 30seconds.

DISPLAY Indications
KV DISPLAY • Displays default/set KV value in standby mode.
• Displays Error message Exx(where xx stands for code) in fault mode

mAs DISPLAY • Displays default/set mAs value in standby mode.


• Displays Error code in fault mode. Refer generator fault list section for list
of faults.

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3 Know Your X-Ray Unit
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3.5 Control And Indicators– Identifications (External Console)


MODE Key
LCD Display
kV Increment Key
SET Key
PREP / READY / X-RAY ON LED
mAs Increment Key
mAs Decrement Key
kV Decrement Key
RESET Key
FAULT LED
LAMP ON LED
LAMP ON Key
Label (L24)- External Console- Identification

LED Indications
PREP / READY / X-RAY • Yellow colour indicates system is getting prepared to take X-Ray by
ON LED preheating filament.
• Green colour indicates system is ready to take X-Ray.

• X-Ray on Indication

FAULT LED When there is a fault in the system, FAULT LED will glow in Red colour.

LAMP ON LED When the lamp is switched ON, LAMP ON LED will glow in yellow colour

KEY Functions

kV INCREMENT KEY • Increments the set kV in steps of 1 and jumps to steps of 5 for continuous
pressing.
• Inactive if kV is preset at 100.
• When MODE key is pressed, kV increment key is used to scroll various
program modes

kV DECREMENT KEY • Decrements the set kV in steps of 1 and jumps to steps of 5 for continuous
pressing.

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• Inactive if kV is preset at 40.


• When MODE key is pressed, kV decrement key is used to scroll various
program modes

mAs INCREMENT KEY mAs range shall increment from 0.1 to 250mAs (@ 40kV) as per the following:
0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.3, 1.4, 1.6, 1.8, 2, 2.2, 2.5,
2.8, 3.2, 3.6, 4, 4.5, 5, 5.6, 6.3, 7.1, 8, 9, 10, 11, 12.5, 14, 16, 18, 20, 22, 25,
28, 32, 36, 40, 45, 50, 56, 63, 71, 80, 90, 100, 110, 125, 140, 160, 180, 200,
220, 250
mAs range is limited to maximum power.
Inactive if mAs is preset at maximum setting.

mAs DECREMENT mAs range shall decrement from 250 (@ 40kV) to 0.1mAs as per the
KEY following:
250, 220, 200, 180, 160, 140, 125, 110, 100, 90, 80, 71, 63, 56, 50, 45, 40, 36,
32, 28, 25, 22, 20, 18, 16, 14, 12.5, 11, 10, 9, 8, 7.1, 6.3, 5.6, 5, 4.5, 4, 3.6,
3.2, 2.8, 2.5, 2.2, 2, 1.8, 1.6, 1.4, 1.3, 1.1, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3,
0.2, 0.1

mAs range is limited to maximum power.


Inactive if mAs is preset at 0.1.

RESET KEY In fault state, this key resets the generator to standby mode. Some faults
cannot be reset by this key. They are reset only by switching off the power
once and switching on again. These are called as “Power on reset faults” and
list is given in generator fault list Section 6.1.

LAMP KEY Switches on and off the collimator lamp. Internal timer switches off the light
after 30 seconds.

MODE KEY Used to enter various programming Modes

DISPLAY Indications

LCD DISPLAY • Displays default/set kV & mAs value in standby mode.


• Displays Error message in fault mode

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3.6 Mechanical Dimensions

+4º
Illustration 6: Overall Dimension (Min position at 23° ): 1344×1188×716 (±50mm)
−1º

(Parking Position)
All dimensions are in mm

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Illustration 7: Overall dimension (Max position at 139° ±4°): 2050×1110×716 (±50 mm)

All dimensions are in mm

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4 Operating The Unit SKANMOBILE‒ High Frequency
Diagnostic X-Ray system

4 Operating The Unit


4.1 Before You Begin

Ensure that the operator has read and understood this manual regarding
operation of the system. Government regulators may require a licensed operator
to use this equipment. Check with your local seller regarding this.

REGULATORY Installation and use of radiation generating equipment is regulated by the


APPROVAL government or its authorized agencies in most countries. Check with your local
seller regarding site approvals or usage.

You should be well acquainted with the radiation protection methods for both the
operator and patient before attempting to use this equipment.

FILM DEVELOPMENT Majority of repeat exposures and inferior X-Ray images are attributed to the
storage, handling, use and developing of X-Ray films rather than the equipment
itself. Ensure that the image capture films are stored and used as per
instructions.

Let the patient know that he/she is going to be X-Rayed. Avoid X-Rays or take
necessary precautions when X-Raying pregnant patients.

4.2 Power ON And Initial Checks


• Make sure that the unit is fully integrated and commissioned for use by Skanray Authorized personnel.

• Turn OFF the supply mains switch before connecting the equipment to wall socket.

• Ensure that the supply mains has the protective earth connection to avoid risk of electric shock.

• Ensure proper illuminated environmental conditions before operating the device.

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SKANMOBILE‒ High Frequency
4 Operating The Unit
Diagnostic X-Ray system

• Position the Equipment such that the appliance coupler and mains switch are easily accessible to turn
off in case of Emergency.

• Ensure that during the use keep the User Manual handy to know about the reference dose as per Annex
B.

• Switch ON the mains power and POWER button provided in unit.

• On power up, integrated console will initially display the firmware version and then displays default kV
and mAs values. Default values will be 40 KV and 0.1 mAs or the previously configured value.

• External console shows a screen as SKANRAY SKANMOBILE on power up as shown below.

• While this is displayed the console goes through a state of self test for making sure that all the internal
and external components of the console are working fine.
During this stage please do not press any keys on the keypad for they will be treated as a
keyboard error.

• Immediately following a successful self test the console displays a screen similar to the one as shown
below. All the processes in this console starts from the home screen.

• Default KV and mAs values will be displayed once the generator is ready to take X-Ray. Default values
will be 40 KV and 0.1 mAs or the previously configured value.

4.3 Positioning Of The Tube Head


• Unlock the gas spring using the handle provided in the SLS assembly.

• Rotate the handle anticlockwise to release the movement of the gas spring.

• The arm can be positioned anywhere within the working limits.

• Rotate the handle clockwise to arrest the movement of the gas spring.

4.4 Positioning X-Ray Beam Using Collimator


• Open collimator shutters using the knob provided in collimator.

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Diagnostic X-Ray system

• Press LAMP KEY to turn on the light field.

• Adjust the light field using the 2 knobs(Dials) provided in collimator, as per the table below. The light
field adjusted will be the X-Ray field while taking X-Ray. Align the centre of the grid to centre of the
Image receptor. Grid is indicating centre of the X-Ray beam axis.

• There is an automatic timer of 30 seconds for collimator light. This will switch off the light after 30
seconds. If the light field adjustment is still required, press the LAMP KEY again.

• Press LAMP KEY or the preparation button in the Exposure Hand Switch to switch off the collimator
lamp, if it is on.

4.5 Modifying Exposure Parameters


4.5.1 Parameter Modification Screen: kV
• Use the kV INCREMENT/ DECREMENT keys to modify the kV to the desired value.
• The kV value displayed on the parameters pane (on the left side) will be updated with the new value.

4.5.2 Parameter Modification Screen: mAs


• Use the mAs INCREMENT/ DECREMENT keys to modify mAs.
• The mAs value on the parameters pane (on the right side) will be updated with the new value.

4.5.3 Mode Selection Screen


• Press the MODE button from the home screen to display the Mode selection list.
• A screen similar to the one shown below appears on the display.
• Use the kV INCREMENT/ DECREMENT keys to navigate within the list. Press these buttons until the
desired mode is highlighted.
• Press the SET key to use the highlighted mode.

Page 25 of 83
SKANMOBILE‒ High Frequency
4 Operating The Unit
Diagnostic X-Ray system

4.5.3.1 MEDIUM
• Under this there is a list of 23 different Anatomy that the User can configure for each anatomy for a
particular image receptor.
S/N Anatomy S/N Anatomy S/N Anatomy S/N Anatomy S/N Anatomy S/N Anatomy
1 Chest AP 5 Hip 9 Ankle 13 Humerus 17 Hand 21 L-Spine Lat
2 Chest Lat 6 Femur 10 Foot 14 Elbow 18 T-Spine AP 22 C-Spine AP
3 Abdomen 7 Knee 11 Shoulder 15 Forearm 19 T-Spine Lat 23 C-Spine Lat
4 Pelvis 8 Tibia 12 Swimmers 16 Wrist 20 L-Spine AP

• Use the kV INCREMENT / DECREMENT keys to navigate within the list. Press these buttons until the
desired setting is highlighted.
• Press the SET key to use the highlighted mode. The default values are displayed. Pressing the MODE
key without saving returns to home screen without any changes.
• Now set kV and mAs parameters and press SET key, automatically save the parameters into particular
anatomy.

4.5.3.2 THIN
• Under this there is a list of 23 different Anatomy that the User can configure for each anatomy for a
particular image receptor.
S/N Anatomy S/N Anatomy S/N Anatomy S/N Anatomy S/N Anatomy S/N Anatomy
1 Chest AP 5 Hip 9 Ankle 13 Humerus 17 Hand 21 L-Spine Lat
2 Chest Lat 6 Femur 10 Foot 14 Elbow 18 T-Spine AP 22 C-Spine AP
3 Abdomen 7 Knee 11 Shoulder 15 Forearm 19 T-Spine Lat 23 C-Spine Lat
4 Pelvis 8 Tibia 12 Swimmers 16 Wrist 20 L-Spine AP

• Use the kV INCREMENT/DECREMENT keys to navigate within the list. Press these buttons until the
desired desired setting is highlighted.
• Press the SET key to use the highlighted mode. The default values are displayed. Pressing the MODE
key without saving returns to home screen without any changes.
• Now set kV and mAs parameters and press SET key, automatically save the parameters into particular
anatomy.

4.5.3.3 THICK
• Under this there is a list of 23 different Anatomy that the User can configure for each anatomy for a
particular image receptor.

Page 26 of 83
SKANMOBILE‒ High Frequency
4 Operating The Unit
Diagnostic X-Ray system

S/N Anatomy S/N Anatomy S/N Anatomy S/N Anatomy S/N Anatomy S/N Anatomy
1 Chest AP 5 Hip 9 Ankle 13 Humerus 17 Hand 21 L-Spine Lat
2 Chest Lat 6 Femur 10 Foot 14 Elbow 18 T-Spine AP 22 C-Spine AP
3 Abdomen 7 Knee 11 Shoulder 15 Forearm 19 T-Spine Lat 23 C-Spine Lat
4 Pelvis 8 Tibia 12 Swimmers 16 Wrist 20 L-Spine AP

• Use the kV INCREMENT/DECREMENT keys to navigate within the list. Press these buttons until the
desired desired setting is highlighted.
• Press the SET key to use the highlighted mode. The default values are displayed. Pressing the MODE
key without saving returns to home screen without any changes.
• Now set kV and mAs parameters and press SET key, automatically save the parameters into particular
anatomy.

4.5.4 Exposure History


• The console stores the last 30 exposures in its internal memory and is not erased by a power down. You
may use one of these exposure details to deliver a new exposure.
• By default the most recent exposure appears at the top of the list followed by the older ones. Now use
the kV INCREMENT/DECREMENT keys to select one from the list and press SET key to load into
home screen.

4.5.5 Sleep Mode


• When left unattended for 10 minutes, the external console goes to sleep mode as shown below.

4.6 Delivering An Exposure


• Set the kV and mAs to required values.

• Press the actuator of the exposure handswitch to level I prep (preparation) as shown in Illustration 8.
PREP/READY LED will glow in yellow colour and the buzzer will beep audibly in periodic fashion. This
indicates system is getting prepared to take X-Ray.

Page 27 of 83
SKANMOBILE‒ High Frequency
4 Operating The Unit
Diagnostic X-Ray system

Illustration 8: Exposure Handswitch

Do not extend the cable of the exposure handswitch beyond 4 meters.

• The external console displays the screen as shown below

• When the generator is ready to take X-Ray, PREP/READY LED will turn to green and buzzer will beep
audibly in periodic fashion at twice the rate of the beep during preparation mode. The external console
displays as shown below

• Press the actuator of the exposure handswitch to level II exposure as shown in Illustration 8 to take X-
Ray and hold till the buzzer stops or X-RAY ON LED goes off. Buzzer and X-RAY ON LED will be
continuously ON throughout the exposure time. During exposure the external console displays as
shown below

• Feed back kV and mAs values will be displayed after exposures for few seconds.

Page 28 of 83
SKANMOBILE‒ High Frequency
4 Operating The Unit
Diagnostic X-Ray system

• Generator enters cooling mode after taking each X-Ray. Generator cooling mode is indicated in display
as “CLG Prd”. Cooling period depends on the exposure time. The external console displays as shown
below.

Do not switch of the generator while generator is in cooling mode.


There is a fan provided inside the generator for cooling, which needs specifc time
to cool the generator electronics before taking next X- Ray. Power OFF/ON reset X- Ray exposures
taken before elapsing cooling period may lead to malfunctioning of generator.

• Generator will display previously set kV and mAs values after the completion of cooling period and is
ready to take next exposure.

4.7 User Default Parameter Configuration Setngs


Please follow the procedure below sequentially without break. If any wrong key is pressed, repeat
the procedure from the beginning. Setting Default parameters can be done only with internal
console.

• Press RESET KEY once to take the Generator to parameter display mode.

• After one second delay, press RESET KEY once more to take the generator to standby mode (Shows
default kV and mAs) followed by mAs DECREMENT KEY immediately.

• The generator enters into Default Parameter Configuration mode (It shows last configured parameters if
set, if not, then it shows 40 kV, 0.1 mAs).

• Change the kV and mAs values to suit the operator's requirements.

• After the values are set, press RESET KEY once followed by mAs DECREMENT KEY immediately.

• The unit enters into standby mode with the previously configured parameters.

• The configuration will be retained once the unit is switched OFF and ON and will be displayed as default
value henceforth.

• If the operator wants to change the default values, repeat the above procedure

Page 29 of 83
5 Maintenance SKANMOBILE‒ High Frequency
Diagnostic X-Ray system

5 Maintenance
5.1 Cleaning And Disinfecting
CAUTION: Switch off the device and disconnect from supply mains prior to cleaning. Preventive Maintenance
and Replacement of spares are to be done only by Authorized Personnel.

1) Use a soft cloth damped in a mild soap solution for cleaning the outside
surfaces of the unit.

2) Do not spray or let the cleaning fluid enter the unit.

3) Periodic disinfecting of the unit is required for hygiene. Disinfect with a


compatible low or intermediate level instrument grade disinfectant after
cleaning.

4) Use a non-acetone based disinfectant liquid. Very mild detergent is


recommended for cleaning the equipment.

5.2 Caring For Your Equipment


• Do not allow the unit to impact with any hard surfaces.

• Switch off the unit when leaving for the day or when not used for a long time.

• Ensure that the unit is not subject to direct sunlight.

• Do not force the arm mechanisms or Tube Head into a position it is not designed for. There are
movement stoppers provided.

• Do not hang external loads or weights on the Tube Head or extension arm. The arm and base units are
designed for its own weight and may not hold an additional weight.

• Schedule and carry out periodic maintenance checks.

• Place the Tube Head assembly to the parking position (23º angle of swivel arm) when not in use- Refer
Illustration 6.

5.3 Shipping And Long Term Storage


• Use the original packing box for shipping / transporting the unit.

• When not using for a long time, cover the unit with dust proof covers and ensure the unit is not exposed
to harsh environments

• When re-starting after long (more than 3 months) storage, take the unit through a ‘seasoning’ procedure
to ensure the Tube Head operates at its optimum. Following procedure explains the seasoning process.

• Set the kV and mAs to the minimum value

• Give 5 exposures

• Increase kV in steps of 10 kV and repeat the above step.

• Repeat the above step till the maximum kV is reached

Page 31 of 83
SKANMOBILE‒ High Frequency
5 Maintenance
Diagnostic X-Ray system

5.4 Preventive Maintenance


Like all electrical Equipment, this unit requires not only correct use, but also Maintenance and checks at regular
intervals. This precaution will guarantee that the Equipment works safely and efficiently.

• For the continued safety of the Equipment/Operator, the preventive maintenance should be performed
by Skanray Authorized Personnel. It is recommended to subject the equipment to preventive
maintenance schedule of once in every year after the first year of operation

• In case of long storage or non usage of the equipment more than 3 months user can perform quality
control tests.

• Set the kV and mAs to the minimum value (40kV and 0.1mAs)

• Give 5 Exposures.

• Increase kV in steps of 10 kV and repeat the above step.

• Repeat the above step till the maximum kV (100kV) is reached.

5.4.1 General Preventive Maintenance Procedure


• Check if all the labels are intact and well attached, if not, then they should be replaced.

• Check if there are oil marks on the Tube Head, if yes, then it should be replaced.

• Check if the exposure handswitch is damaged or broken, if yes, then it should be replaced.

• Check if the swivel arm is balanced, if not, then the adjustment for balancing the arm needs to be
performed.

• Check if the X-Ray beam is centred, if not, then the Collimator needs to be adjusted to centralise the
Light field and X-Ray field.

• Check for the proper functioning of X-Ray Exposure LED and Exposure buzzer.

• Check if there are any external damages to the equipment which could make it unsafe in terms of
protection from radiation.

• Adjustment of the rotation, friction mechanism parts needs to be performed whenever found loose.

5.5 Disposal Of The Unit


• Do not dispose this unit as general waste. It contains elements that could be toxic.

• Do not attempt to dispose this unit as scrap.

• Do not open the unit. The unit can be refurbished only by a Skanray qualified technician.

• Local governments would have rules and regulations on waste disposal of electronic goods. Please
follow the local guidelines.

• Your distributor could also buy back the unit to be disposed off.

• Contact the factory for shipping back units for disposal against relevant disposal charges.

Page 32 of 83
6 Troubleshooting SKANMOBILE‒ High Frequency
Diagnostic X-Ray system

6 Troubleshooting
6.1 Errors & Warnings
When generator is in fault mode, fault code and fault description will be displayed as “E” followed by 2 digit fault
code in kV DISPLAY and 3 digit fault description in mAs DISPLAY. Refer table below for complete list.

S/N ERROR CODE ERROR DESCRIPTION DISPLAY ERROR DESCRIPTION


01 E03 bAL kV Unbalance
02 E22 FIL Filament Open
03 E24 PrP Preparation Error
04 E25 oN X-RAY ON switch ON
05 E26 CAL No calibration
06 E27 Abt Exposure abort
07 E29 noP PFC not ON by Prep
08 E30 nod PFC not received Power
09 E33,E35 noC No PFC Communication
10 E42 CAP Calibration Problem (wrong data)
11 E16,E43 oCC Over Current Cathode
12 E17,E44 oCA Over Current Anode
13 E18,E45 FoC Filament Over Current
14 E14,E46 AoU Anode Over Voltage
15 E13,E47 CoU Cathode Over Voltage
16 E10,E48,E52 ASP Anode Spit
17 E12,E51 IoC Inverter Over Current
18 E11,E49,E53 CSP Cathode Spit
19 E50,E54 ArC Tube ARC
20 E15,E57 bSC DC Bus Short Circuit
21 E01 oPn Cable Open
22 E04 oUU Output under Voltage (kV)
23 E05 OOU Output Over Voltage (kV)
24 E36 PoC PFC Over Current
25 E37 PoU PFC Over Voltage (DC Bus)
26 E38 bUL DC Bus OFF
27 E40 IUU Input Under Voltage
28 E41 IoU Input Over Voltage
29 E02 OLt OIL Hot
30 E06 HSt Heat Sink Hot
31 E34 CAN Communication Error

Page 33 of 83
SKANMOBILE‒ High Frequency
6 Troubleshooting
Diagnostic X-Ray system

Listed below are the troubleshooting tips to help you recover from an error condition.

S/N OBSERVED PROBLEM RECOMMENDED ACTION

Error state with error code from S / N 1 Press RESET KEY. Generator will return to standby state.
1.
to S / N 20 If the problem persists, request service call

Error state with error code from S / N Switch off mains power. Wait for 2 minutes. Switch on mains power.
2.
21 to S / N 24 If the problem persists, request service call.

These faults are generated when defined operating


Error state with error code from S / N specification/conditions are not met. These faults will be
3.
25 to S / N 30 automatically cleared if operating conditions comes back to defined
specifications.

Check if switch illuminates.

If not, there may be a loose contact at the wall socket end.

Or the wall outlet is not receiving power. Check local electrical circuit
for trips.
The unit does not power on when
4. If switch is illuminating, then check the following.
mains is switched on.
Ensure that the mains cable connection to the power socket in
system is proper.

Switch off mains power. Wait for 2 minutes. Switch on mains power.

If the problem persists, request service call.

Verify film development and storage method. The films could be


No X-Ray image even through the unit
5. damaged or the chemicals could be contaminated
indicates normal exposure
Log a service call to validate exposure quality.

This can be due to normal wear and tear or using excess force on
Tube Head generator assembly drifting
6. the Tube Head generator during its rotation.
with respect to swivel arm axis.
Tighten the Nylock nut as described in the integration procedure.

7. Collimator light not working Request a service call.

Page 34 of 83
7 Technical specifications for Skanmobile and Skanmobile for vet SKANMOBILE‒ High Frequency
application Diagnostic X-Ray system

7 Technical specifications for Skanmobile and Skanmobile for vet application


7.1 Tube-head Specifications
Generator Type : High Frequency, DSP Controlled, Constant Potential (DC)
Control of High Voltage : Closed Loop
High Voltage Range : 40 kV – 100 kV Settable (Step size 1 kV)
Accuracy of High Voltage : < ± 5%
Generator Frequency : Upto 200kHz
High Voltage Ripple : Low frequency ripple (Measured at ≤ 10kHz) < 4%

High frequency ripple (Measured at ≤ 50kHz) < 10%


High Voltage Rise Time : < 3 mS
Control of Tube Current : Closed Loop
Tube-head current range : 10 mA – 100 mA
Maximum Exposure Time : 5 seconds @ 230 Vac / 110 Vac input.
Minimum Exposure Time : 10 mS
mAs range : 0.1mAs to 250mAs @ 230 Vac / 110 Vac input, limited to maximum
power.
mAs accuracy : < ± (5%+0.2mAs) for >1mAs and < ± (10%+0.2mAs) for ≤ 1mAs
Duty Cycle : 1:30 Duty cycle for exposure ≥ 1 sec and minimum of 30sec off / rest
time & auto limit based on temperature.
Mode of Operation : Continuous operation with intermittent loading with rest time of
minimum 30sec and 1:30 duty cycle (for exposures ≥1sec) adaptive
and auto limit based on temperature.
Type of cooling : Forced cooling, 8200RPM,10.8CFM
Additional X-Ray filtration : Minimum 2.0 mm Al equivalent
Total X-Ray filtration : ~ 2.5mm AL equivalent @ 100kV
Minimum focus to skin distance : 300 mm
Maximum X-Ray field : 480 mm X 480 mm at 1 meter from focal spot.
Leakage radiation @ 1meter : < 50 mR / Hour
Leakage radiation technique : 100 kV, 4 mAs (40 mA, 100 mSec)
Ingress Protection Classification : IP2X

7.2 X-Ray Tube Insert Specifications


Tube Insert Model : OX105-2
Focal Spot (IEC60336) : 1.8 mm
Anode material : Tungsten
Anode angle : 19°
Insert Inherent filtration : 0.5 mm Al equivalent
Anode thermal capacity : 30 kJ
Nominal anode input power at 0.1s(DC) : 4200 W

Page 35 of 83
7 Technical specifications for Skanmobile and Skanmobile for vet SKANMOBILE‒ High Frequency
application Diagnostic X-Ray system

Illustration 9: X-Ray Tube Insert Thermal Data-OX/105-2

Illustration 10: X-Ray Tube Insert Rating Chart-OX/105-2

Page 36 of 83
7 Technical specifications for Skanmobile and Skanmobile for vet SKANMOBILE‒ High Frequency
application Diagnostic X-Ray system

Illustration 11 Heating and cooling curves of tube insert

Illustration 12 Tube anode target angle

Page 37 of 83
7 Technical specifications for Skanmobile and Skanmobile for vet SKANMOBILE‒ High Frequency
application Diagnostic X-Ray system

Illustration 13 Focal Spot with tolerance

Illustration 14: Indication of angle between X-Ray beam axis & image receptor plane.

7.3 Dimensions And Weight


Total Weight of System : ~ 85 kgs for 230 Vac unit and ~ 97 kgs for 110 Vac unit
Weight of Tube Head including collimator : ~ 25 kgs
Weight of collimator : ~ 5 kgs
Weight of trolley including SLS and Gas spring : ~ 60 kgs for 230 V unit and ~ 62 kgs for 110 V unit

Page 38 of 83
7 Technical specifications for Skanmobile and Skanmobile for vet SKANMOBILE‒ High Frequency
application Diagnostic X-Ray system

Type of painting
: Semi Glossy

+30 +4º
Vertical travel at minimum position : 384 mm @ 23º
− 10 − 1º

Vertical travel at maximum position : 2050 ± 50 mm @ 139º ± 4°


Horizontal Reach with Tube Head : 1344 ± 50 mm
Rotation of Tube Head on horizontal arm : 360°
Swivel angle of Tube Head on horizontal arm : < 290°

7.4 Mains Power Requirements


Line voltage range : 230 Vac ± 10% or 100-110Vac ± 10%
Line frequency : 50 Hz ± 5% / 60 Hz ± 5%
Maximum / Momentary Input current : ~ 16 Amps for 230 Vac / ~ 35 Amps for 100-110 Vac
Standby input current : ~ 0.6 Amps for 230 Vac / ~ 2.5 Amps for 100-110 Vac
Electrical Connection : Line, Neutral and Earth (Earth is Mandatory)

7.5 Environmental Conditions


Operating conditions Conditions for transport and storage
Temperature : +10°C to +40°C Temperature : -30°C to +70°C
Humidity : 25% to 75% Humidity : 95 % non condensing
Altitude : 1500m Altitude : 3500m

Page 39 of 83
Annex A: Exposure Time & mA List For Selected kV And mAs (230 V / SKANMOBILE‒ High Frequency
110 V) Diagnostic X-Ray system

Annex A: Exposure Time & mA List For Selected kV And mAs (230 V /110 V)
Definitions:
kV Set kV
mAs Set mAs
Exp-Time(mSec) Calculated X-Ray ON time for set mAs, in milliseconds
mA Calculated mA for set mAs

S/ kV mAs Exp- mA S/ kV mAs Exp- mA


N Time(mSec) N Time(mSec)

1 40 0.1 10 10 29 40 160 3020 50

2 40 0.2 10 20 30 40 200 4000 50

3 40 0.3 10 30 31 40 250 5000 50

4 40 0.4 10 40 32 50 0.1 10 10

5 40 0.5 10 50 33 50 0.2 10 20

6 40 0.6 10 60 34 50 0.3 10 30

7 40 0.7 10 70 35 50 0.4 10 40

8 40 0.8 10 80 36 50 0.5 10 50

9 40 0.9 10 90 37 50 0.6 10 60

10 40 1 10 100 38 50 0.7 10 70

11 40 2 20 100 39 50 0.8 10 80

12 40 3.2 32 100 40 50 0.9 11.25 80

13 40 4 40 100 41 50 1 12.50 80

14 40 5 50 100 42 50 2 25 80

15 40 6.3 63 100 43 50 3.2 38 80

16 40 7.1 71 100 44 50 4 50 80

17 40 8 80 100 45 50 5 62.50 80

18 40 9 90 100 46 50 6.3 78 80

19 40 10 100 100 47 50 7.1 88 80

20 40 20 320 62.5 48 50 8 100 80

21 40 32 500 62.5 49 50 9 128.57 70

22 40 40 800 50 50 50 10 142.86 70

23 40 50 1000 50 51 50 20 400 50

24 40 63 1260 50 52 50 32 780 40

25 40 71 1420 50 53 50 40 1000 40

26 40 80 1600 50 54 50 50 1250 40

27 40 90 1800 50 55 50 63 1550 40

28 40 100 2000 50 56 50 71 1760 40

Page 41 of 83
Annex A: Exposure Time & mA List For Selected kV And mAs (230 V /110 SKANMOBILE‒ High Frequency
V) Diagnostic X-Ray system

S/ kV mAs Exp- mA S/ kV mAs Exp- mA


N Time(mSec) N Time(mSec)

57 50 80 2000 40 92 70 0.2 10 20

58 50 90 2250 40 93 70 0.3 10 30

59 50 100 2500 40 94 70 0.4 10 40

60 50 160 3800 40 95 70 0.5 10 50

61 50 200 5000 40 96 70 0.6 10.50 57.14

62 60 0.1 10 10 97 70 0.7 12.25 57.14

63 60 0.2 10 20 98 70 0.8 14 57.14

64 60 0.3 10 30 99 70 0.9 15.75 57.14

65 60 0.4 10 40 100 70 1 17.50 57.14

66 60 0.5 10 50 101 70 2 35 57.14

67 60 0.6 10 60 102 70 3.2 53 57.14

68 60 0.7 10.50 66.66 103 70 4 70 57.14

69 60 0.8 12 66.66 104 70 5 87.50 57.14

70 60 0.9 13.50 66.66 105 70 6.3 122 50

71 60 1 15 66.66 106 70 7.1 142 50

72 60 2 30 66.66 107 70 8 186.70 42.85

73 60 3.2 48 66.66 108 70 9 210.04 42.85

74 60 4 60.01 66.66 109 70 10 233.37 42.85

75 60 5 75.01 66.66 110 70 20 701.75 28.5

76 60 6.3 92.01 66.66 111 70 32 1055.26 28.5

77 60 7.1 121.01 58.33 112 70 40 1403.51 28.5

78 60 8 137.15 58.33 113 70 50 1754.39 28.5

79 60 9 180 50 114 70 63 2109.25 28.5

80 60 10 200 50 115 70 71 2458.29 28.5

81 60 20 480.08 41.66 116 70 80 2807.02 28.5

82 60 32 909.90 33.3 117 70 90 3157.89 28.5

83 60 40 1201.20 33.3 118 70 100 3508.77 28.5

84 60 50 1501.50 33.3 119 70 140 4980.32 28.5

85 60 63 1821.80 33.3 120 80 0.1 10 10

86 60 71 2122.10 33.3 121 80 0.2 10 20

87 60 80 2402.40 33.3 122 80 0.3 10 30

88 60 90 2702.70 33.3 123 80 0.4 10 40

89 60 100 3003 33.3 124 80 0.5 10 50

90 60 160 4554.50 33.3 125 80 0.6 12 50

91 70 0.1 10 10 126 80 0.7 14 50

Page 42 of 83
Annex A: Exposure Time & mA List For Selected kV And mAs (230 V /110 SKANMOBILE‒ High Frequency
V) Diagnostic X-Ray system

S/ kV mAs Exp- mA S/ kV mAs Exp- mA


N Time(mSec) N Time(mSec)

127 80 0.8 16 50 162 90 5 128.60 38.88

128 80 0.9 18 50 163 90 6.3 182.02 33.33

129 80 1 20 50 164 90 7.1 211.05 33.33

130 80 2 40 50 165 90 8 240.02 33.33

131 80 3.2 62 50 166 90 9 324.09 27.77

132 80 4 80 50 167 90 10 360.10 27.77

133 80 5 100 50 168 90 20 900.09 22.22

134 80 6.3 139.26 43.75 169 90 32 1353.19 22.22

135 80 7.1 187.28 37.5 170 90 40 1800.18 22.22

136 80 8 213.33 37.5 171 90 50 2250.23 22.22

137 80 9 240 37.5 172 90 63 2703.68 22.22

138 80 10 320 31.25 173 90 71 3151.65 22.22

139 80 20 800 25 174 90 80 3600.36 22.22

140 80 32 1220 25 175 90 90 4050.41 22.22

141 80 40 1600 25 176 90 100 4500.45 22.22

142 80 50 2000 25 177 90 110 4993.58 22.22

143 80 63 2460 25 178 100 0.1 10 10

144 80 71 2820 25 179 100 0.2 10 20

145 80 80 3200 25 180 100 0.3 10 30

146 80 90 3600 25 181 100 0.4 10 40

147 80 100 4000 25 182 100 0.5 12.50 40

148 80 125 5000 25 183 100 0.6 15 40

149 90 0.1 10 10 184 100 0.7 17.50 40

150 90 0.2 10 20 185 100 0.8 20 40

151 90 0.3 10 30 186 100 0.9 22.50 40

152 90 0.4 10 40 187 100 1 25 40

153 90 0.5 11.25 44.44 188 100 2 50 40

154 90 0.6 13.50 44.44 189 100 3.2 78 40

155 90 0.7 15.75 44.44 190 100 4 100 40

156 90 0.8 18 44.44 191 100 5 142.86 35

157 90 0.9 20.25 44.44 192 100 6.3 208 30

158 90 1 22.50 44.44 193 100 7.1 234.58 30

159 90 2 45 44.44 194 100 8 320 25

160 90 3.2 67.51 44.44 195 100 9 360 25

161 90 4 90.01 44.44 196 100 10 400 25

Page 43 of 83
Annex A: Exposure Time & mA List For Selected kV And mAs (230 V /110 SKANMOBILE‒ High Frequency
V) Diagnostic X-Ray system

S/ kV mAs Exp- mA S/ kV mAs Exp- mA


N Time(mSec) N Time(mSec)

197 100 20 1000 20 202 100 71 3550 20

198 100 32 1520 20 203 100 80 4000 20

199 100 40 2000 20 204 100 90 4500 20

200 100 50 2500 20 205 100 100 5000 20

201 100 63 3150 20

Note:
• The above indicated mA and exposure time are valid for nominal input voltage of 230 Vac / 110 Vac

• If the input voltage goes above 230 Vac / 110 Vac, mA increases and exposure time decreases for
corresponding mAs.

• If the input voltage goes below 230 Vac / 110 Vac, mA decreases and exposure time increases for
corresponding mAs.

Page 44 of 83
Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

Annex B: Basic X-Ray techniques used for Different Anatomy


Note:

1) The below mentioned X-Ray protocol and methods are for recommendation only. Operator is solely responsible for deciding the protocol and method of taking
X-Ray. Final results depend on many factors.

2) Image quality can get affected due to chemical degradation over a period of time or wrong film developing techniques. Please check with chemical
manufacturer for proper usage of the developing chemicals.

3) This table is applicable to average 70 kg patient.

4) For a patient of average of more than 70 kgs, increase kV and mAs as required.

5) For a patient of average of less than 70 kgs, decrease kV and mAs as required.

6) These parameters are based on 400 speed film.

7) If images are too dark (Over Exposed), decrease mAs; if images are too light (Underexposed), Increase mAs. Adjust the kV and mAs accordingly using a
different FFD or varying the kV or settings.

8) The Reference dose is for FFD of 100 cm and can change ± 20 % depending upon Accuracy of Dose meter and Accuracy of the kV and mAs delivered.

9) The Dose will Significantly increase with Decrease in FFD and dose will Significantly reduce with Increase in FFD.

CAUTION: Always position the Equipment such that minimum FFD (100cm) is met.

Page 45 of 83
Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The patient stands erect AP median saggital plane 90
Direct lead rubber gonad
degrees to the film coronal plane parallel to the film. The arm
Shoulder protection using a "half
is placed in normal anatomical position palm forwards with the
1 survey apron". Avoid irradiating the 65 8 28.43 100
distal humeral epicondyles equidistant from the film, with
AP thyroid and breast tissue as
slight (15 degree) abduction. Take care to prevent the patient
much as possible.
leaning backwards and hunching up the shoulder
The patient stands erect AP median saggital plane 90
degrees to the film coronal plane parallel to the film, the
Direct lead rubber gonad patient is then rotated 35 to 45 degrees to the affected side
protection using a "half until the dorsal surface of the scapula is parallel to the film.
Shoulder
2 apron". Avoid irradiating the 55 10 23.42 100 The arm is placed in normal anatomical position palm
joint AP
thyroid and breast tissue as forwards with the distal humeral epicondyles equidistant from
much as possible. the film, with slight (15 degree) abduction. Take care to
prevent the patient leaning backwards and hunching up the
shoulder.
The patient lies supine with the shoulder raised up on a small
pad about 2 inches and the head supported, the trunk and
Direct lead rubber gonad legs are angled away from the side to be imaged which is
Infro – protection using a "half placed safely near the edge of the trolley or couch top. The
3 superior apron". Avoid irradiating the 55 12.5 28.65 100 arm of the affected side is abducted 90 degrees and the
Supine thyroid and breast tissue as elbow flexed to aid external rotation and supported (a drip
much as possible. stand can be a useful aid). A small cassette is placed using a
small sandbag above the skin surface of the shoulder well into
the root of the neck which is fixed towards the opposite side

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Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The patient is seated with their back to the couch or horizontal
Direct lead rubber gonad
Modified bucky, the trunk is rotated 30 degrees to the affected side so
protection using a "half
axial that the blade of the scapula is parallel to the edge of the
4 apron". Avoid irradiating the 65 8 28.43 150
(Wallace table, if possible the tip of the elbow rests on the edge of the
thyroid and breast tissue as
) table top. The cassette is placed horizontally behind the
much as possible
humerus and in contact with the arm.
The patient stands erect facing the cassette and is rotated into
the 60 degree anterior oblique position, of the side under
Direct lead rubber gonad
investigation, the radiographers hand placed on the posterior
protection using a "half
Scapula skin surface should be at right angles to the film, the median
5 apron". Avoid irradiating the 65 9 31.93 100
Lateral saggital plane at approximately 60 degrees to the cassette.
thyroid and breast tissue as
The arm of the affected side should be brought posterior to
much as possible
the elbow flexed slightly and the back of the hand placed on
the buttock of the affected side.
Direct lead rubber gonad The patient stands erect facing the film, leans forward to bring
protection using a "half the clavicle as close as possible and parallel to the film,
Clavicle
6 apron". Avoid irradiating the 65 6.3 21.35 100 coronal plane approximately 20 degree anterior angle, median
PA
thyroid and breast tissue as saggital plane 10 degrees forward into the anterior oblique
much as possible position of the side under investigation.
7 Acromio Direct lead rubber gonad 65 8 28.43 100 The patient stands erect AP median saggital plane 90
clavicula protection using a "half degrees to the film coronal plane parallel to the film. Take care
r Joints apron". Avoid irradiating the to prevent the patient leaning backwards and hunching up the
AP thyroid and breast tissue as shoulder. Two exposure one each side / both sides are made,
much as possible. Rather the first pair in the normal relaxed position and the second
than irradiating the whole with the patient holding a 1.5 kg wt in each hand to stress the
width of the chest some joint and accentuate any subuxation or an unstable joint.

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S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
centres prefer individually
centred collimated images of
each area. However this does Weights suspended from wrist band rather than being held
not demonstrate the medial reduces shoulder hunching.
end of clavicles which may be
involved in an injury
The patient stands erect AP; the position of the film is
Direct lead rubber gonad adjusted to include the shoulder and elbow joints. The
protection using a "half patients arm is abducted approximately 20 degrees and
Humerus
8 apron". Avoid irradiating the 65 7.1 24.98 100 externally rotated to bring the distal epicondyles equidistant
AP
thyroid and breast tissue as from the film, the patient may need to be rotated to the
much as possible affected side. The humerus may need to be positioned
diagonally across the film to include the full length.
The patient stands erect PA, the position of the film is
adjusted to include the shoulder and elbow joints, with the
humerus in contact with the cassette, i.e. rotated into the
Direct lead rubber gonad
anterior oblique position approximately 20 degrees. The arm
protection using a "half
Humerus is abducted approximately 35 degrees away from the trunk
9 apron". Avoid irradiating the 48 6.3 9.513 100
Lateral and the palm of the hand placed on the iliac crest to bring an
thyroid and breast tissue as
imaginary line through distal humeral epicondyles at 90
much as possible
degrees to the film, elbow in true lateral position. The
humerus may need to be positioned diagonally across the film
to include the full length

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S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The patient sits alongside the end of the table with the
affected arm fully extended and the hand supinated, the table
Direct lead rubber gonad top should be raised to the level of the lower border of the
protection using a "half axilla so the whole arm is supported and parallel to the
Forearm
10 apron". Ensure lower limbs 50 6.3 10.86 100 cassette. The patient should lean externally to bring the
AP
and torso are not below table humeral epicondyles equidistant from the film, in this position
top in primary beam the wrist will be externally rotated from AP. It is not possible to
view proximal and distal ends in true AP position, it is best to
ensure that the area of most interest is projected correctly
The patient sits alongside the end of the table with the
Direct lead rubber gonad
affected elbow flexed at 90 degrees and the hand rotated
protection using a "half
externally into the true lateral position, the table top should be
Forearm apron".
11 50 6.3 10.86 100 raised to the level of the lower border of the axilla so the
Lateral Ensure the lower limbs and
whole arm is supported and parallel to the cassette. The hand
torso is not below the table
may need to be supported on a small pad to bring to
top in the primary beam.
superimpose the humeral epicondyles.
The patient sits alongside the end of the table with the
Direct lead rubber gonad affected arm fully extended and the hand supinated, the table
protection using a "half top should be raised to the level of the lower border of the
Elbow
12 apron". Ensure lower limbs 48 6.3 9.51 100 axilla so the whole arm is supported and parallel to the
AP
and torso are not below table cassette. The patient should lean externally to bring the
top in primary beam humeral epicondyles equidistant from the film, in this position
the wrist will be externally rotated from AP

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S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The patient sits alongside the end of the table with the
Direct lead rubber gonad affected elbow flexed at 90 degrees and the hand rotated
protection using a "half externally into the true lateral position, the table top should be
Elbow
13 apron". Ensure lower limbs 50 7.1 12.46 100 raised to the level of the lower border of the axilla so the
Lateral
and torso are not below table whole arm is supported and parallel to the cassette. The hand
top in primary beam may need to be supported on a small pad to bring to
superimpose the humeral epicondyles
The patient sits alongside the end of the table with the
Direct lead rubber gonad affected elbow flexed at 90 degrees and the hand rotated
Elbow protection using a "half externally into the true lateral position, the table top should be
14 head of apron". Ensure lower limbs 55 6.3 14.56 100 raised to the level of the lower border of the axilla so the
radius and torso are not below table whole arm is supported and parallel to the cassette. The hand
top in primary beam may need to be supported on a small pad to bring to
superimpose the humeral epicondyles

Direct lead rubber gonad


protection using a "half
Elbow From the AP position the patients elbow is flexed maximally,
15 apron". Ensure lower limbs 55 6.3 14.56 100
Axial ensure that the humeral epicondyles are equidistant to the film
and torso are not below table
top in primary beam

Direct lead rubber gonad The patient sits alongside the long edge of the table arm
protection using a "half extended palm downwards, or at the end of the table with the
16 Wrist PA apron". Ensure lower limbs 46 3.2 4.01 100 elbow flexed at 90 degrees, hand and wrist flat on the
and torso are not below table cassette with the fingers flexed to maximize contact of the
top in primary beam wrist with the cassette

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Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation

Direct lead rubber gonad The patient sits alongside the long edge of the table arm
protection using a "half extended palm downwards, or at the end of the table with he
Wrist
17 apron". Ensure lower limbs 48 4 6.12 100 elbow flexed at 90 degrees, hand and wrist flat rotated
Lateral
and torso are not below table external to bring the radio and ulna styloid processes in
top in primary beam vertical alignment
The patient sits alongside the long edge of the table arm
Direct lead rubber gonad
extended palm downwards, or at the end of the table with he
protection using a "half
Wrist elbow flexed at 90 degrees, hand and wrist flat on the
18 apron". Ensure lower limbs 45 5 6.23 100
Oblique cassette with the fingers flexed to maximize contact of the
and torso are not below table
wrist with the cassette. The wrist and forearm are then
top in primary beam
externally rotated 45 degrees and supported on a foam pad.
Wrist The patient sits alongside the long edge of the table arm
Direct lead rubber gonad
Angled extended palm downwards, or at the end of the table with he
protection using a "half
for elbow flexed at 90 degrees, hand and wrist flat on the
19 apron". Ensure lower limbs 50 5 8.71 100
Scaphoi cassette with the fingers flexed to maximize contact of the
and torso are not below table
d + Ulnar wrist with the cassette. The hand and fingers are then
top in primary beam
deviation maximally deviated laterally (ulna deviation).

Direct lead rubber gonad The patient sits alongside the end of the table elbow flexed
Hand protection using a "half palm downwards, or at the end of the table with he elbow
20 Dorsi- apron". Ensure lower limbs 45 5 6.23 100 flexed at 90 degrees, hand and wrist flat on the cassette the
Palmar and torso are not below table elbow may need a small pad to promote contact of the hand
top in primary beam with the cassette. The fingers can be spread slightly

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Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation

Direct lead rubber gonad The patient sits alongside the end of the table elbow flexed
protection using a "half palm downwards, or at the end of the table with he elbow
Hand DP
21 apron". Ensure lower limbs 45 5 6.23 100 flexed at 90 degrees, hand and wrist flat on the cassette the
Oblique
and torso are not below table hand is then rotated laterally 35 to 45 degrees laterally and
top in primary beam supported so that the fingers are parallel to the film
The patient sits alongside the end of the table elbow flexed
Direct lead rubber gonad and the hand in true lateral position the fingers are then flexed
protection using a "half and the finger in question extended parallel to the film, a radio
Finger
22 apron". Ensure lower limbs 50 5 8.71 100 lucent pointer may aid maintenance of the extension. For
Lateral
and torso are not below table fingers other than the middle the hand is rotated to the lateral
top in primary beam position bringing the finger in question nearest the film or in
contact with it for the 2nd and 5th
The PA position is easiest for the patient however the AP
projection produces less magnification and better detail as the
thumb is in contact with the cassette. PA Position, The patient
sits alongside the end of the table elbow flexed palm
Direct lead rubber gonad
downwards, or at the end of the table with he elbow flexed at
protection using a "half
Thumb 90 degrees, the hand is rotated into the true later position
23 apron". Ensure lower limbs 45 5 6.23 100
PA/AP projecting the thumb clear of superimposition with the fifth
and torso are not below table
metacarpal. AP Position, The patient stand with their back to
top in primary beam
the table and the arm is extended and internally rotted to bring
the palmar aspect of the thumb facing upwards, adjust the
table height to a comfortable position, adjust the rotation of
the arm to bring the thumb into true AP position

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S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The patient sits alongside the end of the table elbow flexed
palm downwards, or at the end of the table with he elbow
Direct lead rubber gonad
flexed at 90 degrees, hand and wrist flat on the cassette the
protection using a "half
Thumb elbow may need a small pad to promote contact of the hand
24 apron". Ensure lower limbs 50 5 8.71 100
Lateral with the cassette. The fingers can be spread slightly. The
and torso are not below table
thumb is abducted and the hand internally rotated and
top in primary beam
supported in position such that the thumb is lateral and in
contact with the cassette.
The patient lies supine on the table with the femur under
examination aligned to the midline of the table. The femur is
Femur Direct lead rubber gonad
25 50 8 14.19 100 aligned in slight internal rotation to bring the distal femoral
AP protection
condyles equidistant from the film, ensure the knee joint is
projected onto the film
(Non Trauma)The patient lies on the affected side and the
upper limb is flexed maximally and drawn up over and in front
of the affected limb and supported suitably. the knee of the
affected side is flexed 20 degrees to aid stability, and the long
Femur Direct lead rubber gonad axis of the femur is aligned to the long axis of the table.
26 52 10 19.95 100
Lateral protection (Trauma cases require a horizontal ray lateral)With the patient
supine on the table and the affected limb aligned to the long
axis of the table. A small support is placed under the knee to
raise the knee off the table, the unaffected leg is flexed 90
degrees at the hip and knee and supported

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S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation

The patient lies supine on the table legs extended and the
affected limb aligned to the long axis of the table. The leg is
Direct lead rubber gonad
27 Knee AP 48 6.3 9.51 100 rotated inwards until the femoral condyles are equidistant from
protection
the film or the patella is midway between the femoral
condyles. The tibia should be parallel to the film

(Non Trauma)The patient lies on the affected side and the


upper limb is flexed maximally and drawn up over and in front
of the affected limb and supported suitably. The knee of the
affected side is flexed 45 degrees. The femoral condyles
Knee Direct lead rubber gonad should be in vertical alignment and the tibia parallel to the
28 50 7.1 12.46 100
Lateral protection table. (Trauma cases require a horizontal ray lateral)With the
patient supine on the table and the affected limb aligned to the
long axis of the table. A small support is placed under the
knee to raise the knee and support it in approximately 25
degrees of flexion
Patient Prone, The patient lies prone on the table with the
Knee long axis of the leg aligned to the long axis of the table. The
Intercon Direct lead rubber gonad knee is flexed 45 degrees and the ankle supported. Patient
29 55 7.1 16.42 100
dylar protection supine, The patient sits on the table with the long axis of the
notch leg aligned to the long axis of the table, the knee is flexed 45
degrees

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Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation

The patient lies prone on the table with the leg aligned to the
Direct lead rubber gonad long axis of the table, and supported so that the femoral
Knee PA
30 protection using a "half 55 7.1 16.42 100 condyles are equidistant from the film and the patella centred
Patella
apron". midway between the condyles. Note this position may note be
possible on an injured patient

The patient sits on the table with the long axis of the leg in line
with the long axis of the table, the affected limb is flexed to
Knee bring the internal angle to 45 degrees, the tibia and fibula are
Direct lead rubber gonad
Axial in line with the femur There are several variations to this
31 protection using a "half 55 7.1 16.42 100
Patella projection in position of the patient for minimizing radiation
apron".
"Skyline" dose to the gonads by avoiding directing the central ray in line
with the rest of the body and comfort and ease of performing
the examination.
The patient lies supine on the table with the long axis of the
tibia and fibula in line with the long axis of the table. If the leg
is positioned in true anatomical normal position with neither
Tibia & Direct lead rubber gonad
the knee or ankle joint will be projected in the "normal " AP
32 Fibula protection using a "half 48 7.1 10.99 100
position, therefore it is probably best to position the joint
AP apron".
nearest the suspected anomaly in correct AP position, i.e.
when the knee is in true AP position the ankle will be internally
rotated more than normal

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S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The patient lies supine on the table with the long axis of the
tibia and fibula in line with the long axis of the table and then
rotates externally to the affected side. If the leg is positioned
Tibia & Direct lead rubber gonad in true anatomical normal position with neither the knee or
33 Fibula protection using a "half 50 7.1 12.46 100 ankle joint will be projected in the "normal " lateral position,
Lateral apron". therefore it is probably best to position the joint nearest the
suspected anomaly in correct lateral position, i.e. when the
knee is in true lateral position the ankle will be externally
rotated more than normal
The patient lies supine on the table legs extended, long axis
of the limb in line with the long axis of the table, the foot is
dorsi flexed to bring the plantar aspect 90 to the film. The
patient then rotates externally onto the affected side and
flexes the knee slightly to aid stability; a small pad under the
Direct lead rubber gonad
Ankle knee will aid correct positioning. The position is correct when
34 protection using a "half 50 8 14.19 100
Lateral the tibial and fibula malleoli are not in vertical alignment but
apron".
with the tibial malleolus approximately one centimetre anterior
to the fibula malleolus approximately. Note that the foot is
extremely mobile and rotating the foot externally may not
rotate the tibia and fibula, when rotating the ankle the whole
leg has to be rotated.

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S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The patient lies supine on the table legs extended, long axis
of the limb in line with the long axis of the table, the foot is
dorsi flexed to bring the plantar aspect 90 to the film. The
patient then rotates externally onto the affected side and
Ankle flexes the knee slightly to aid stability; a small pad under the
Direct lead rubber gonad
AP & knee will aid correct positioning. The position is correct when
35 protection using a "half 48 6.3 9.51 100
Oblique the tibial and fibula malleoli are not in vertical alignment but
apron".
(mortice) with the tibial malleolus approximately one centimetre anterior
to the fibula malleolus approximately. Note that the foot is
extremely mobile and rotating the foot externally may not
rotate the tibia and fibula, when rotating the ankle the whole
leg has to be rotated.
The patient sits on the table legs extended, long axis of the
Ankle limb in line with the long axis of the table, the foot is dorsi
Direct lead rubber gonad
Axial for flexed to bring the plantar aspect 90 to the film, a bandage
36 protection using a "half 50 7.1 12.47 100
Calcane round the foot held by the patient may help to maintain this
apron".
um dorsi-flexion of the foot. the long axis of the foot is positioned
vertically

Direct lead rubber gonad The patients lies or sits on the table legs extended, the
37 Foot DP protection using a "half 45 6.3 8.26 100 affected limb is flexed at the knee to bring the plantar aspect
apron". of the foot in flat contact with the cassette

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S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation

The patients lies or sits on the table legs extended, the


Direct lead rubber gonad affected limb is flexed at the knee to bring the plantar aspect
Foot DP
38 protection using a "half 48 7.1 10.99 100 of the foot in flat contact with the cassette, the foot is then
Oblique
apron". rotated medially until the dorsal skin surface is parallel to the
cassette

The patient lies supine on the table legs extended, long axis
of the limb in line with the long axis of the table, the foot is
Direct lead rubber gonad
Foot dorsi flexed to bring the plantar aspect 90 to the film. The
39 protection using a "half 48 7.1 10.99 100
Lateral patient then rotates externally onto the affected side and
apron".
flexes the knee slightly to aid stability; a small pad under the
knee will aid correct positioning.

Axial Skeleton
S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The 28 day rule should be applied for female
patients. In males direct lead rubber gonad
The patient lies supine on the table with the mid-
protection can be applied at all times In females
saggital line in the center of the table. The legs
direct lead rubber gonad protection is generally
Pelvis are internally rotated approximately ten degrees
1 not advised on the first examination, however if 70 71 296.54 100
AP by separating the heels 5 cm and bring the toes
the patient is subsequently examined gonad
together in order to bring the femoral necks
protection may be used if the area of interest is
parallel to the film to reduce foreshortening
not obscured. On small patients the omission of
a grid will reduced the exposure

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S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The 28 day rule should be applied for female
patients. In males direct lead rubber gonad
The patient lies supine on the table with the mid-
protection can be applied at all times In females
saggital line in the center of the table. The legs
Hip joint direct lead rubber gonad protection is generally
are internally rotated approximately ten degrees
2 AP not advised on the first examination, however if 60 50 146.90 100
by separating the heels 5 cm and bring the toes
(implant) the patient is subsequently examined gonad
together in order to bring the femoral necks
protection may be used if the area of interest is
parallel to the film to reduce foreshortening
not obscured. On small patients the omission of
a grid will reduced the exposure
The patient lies supine on the table, A.S.I.S.s
The 28 day rule should be applied for female equidistant from the table top with the
patients. In males direct lead rubber gonad midsaggital line in the center of the table, the
protection can be applied at all times In females affected limb is turned inwards 10 degrees and
direct lead rubber gonad protection is generally supported using a sandbag or similar. The
Pelvis
not advised on the first examination, however if 70 63 256.69 100 unaffected limb is flexed 90 degrees at the hip
3 Hip
the patient is subsequently examined gonad and knee and supported. A 24×30 cm grid is
lateral
protection may be used if the area of interest is placed upright with the medial side well into the
not obscured. On small patients the omission of waist and parallel to the neck of the femur. A
a grid will reduced the exposure small pad under the patients buttocks raising the
of the table may ease positioning

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S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The 28 day rule should be applied for female
patients. In males direct lead rubber gonad The patient lies supine on the table, A.S.I.S.s
protection can be applied at all times In females equidistant from the table top with the
Pelvis
direct lead rubber gonad protection is generally midsaggital line in the center of the table. The
Hips
4 not advised on the first examination, however if 70 63 256.69 100 hips and knees are flexed and the soles of the
"Frogs"
the patient is subsequently examined gonad feet placed together in the midline, the knees
Lateral
protection may be used if the area of interest is are forced down towards the table top as far as
not obscured. On small patients the omission of possible. Ensure leg positioning is symmetrical
a grid will reduced the exposure
The patient lies supine on the table with the
The 28 day rule should be applied for female
midsaggital line in the centre of the table. The
patients. In males direct lead rubber gonad
Pelvis affected side is raised 45 degrees and
protection can be applied at all times In females
Hip supported on pads with the legs extended or
direct lead rubber gonad protection is generally
Judets minimally flexed to aid support. A second
5 not advised on the first examination, however if 80 50 283.45 100
view of projection may be made with the patient rotated
the patient is subsequently examined gonad
Acetabul 45 degrees onto the affected side and the
protection may be used if the area of interest is
um(1) central ray directed to a point midway along an
not obscured. On small patients the omission of
imaginary line from the ASIS to the symphysis
a grid will reduced the exposure
on the affected side

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S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The 28 day rule should be applied for female
patients. In males direct lead rubber gonad
The patient lies on the table with the mid
Pelvis protection can be applied at all times In females
saggital plane parallel to the table, support
Leonard direct lead rubber gonad protection is generally
under the waist may be required. The long axis
6 George not advised on the first examination, however if 80 50 283.45 100
of the patient should be in line with the long axis
lateral the patient is subsequently examined gonad
of the table, the hips and knees flexed to aid
protection may be used if the area of interest is
comfort and stability
not obscured. On small patients the omission of
a grid will reduced the exposure
The patient lies supine on the table with the long
The 28 day rule should be applied for female
axis of the body in line with the centre of the
patients. In males direct lead rubber gonad
Sacrum table, legs and knees extended. The anterior
7 protection can be applied at all times On small 70 63 256.69 100
AP superior iliac spines should be equidistant from
patients the omission of a grid will reduced the
the table ensuring there is no rotation of the mid
exposure.
saggital plane
The patient lies on the table with the mid
The 28 day rule should be applied for female
Sacrum saggital plane parallel to the table, support
patients. In males direct lead rubber gonad
& under the waist may be required. The long axis
8 protection can be applied at all times On small 85 80 496.35 100
Coccyx of the patient should be in line with the long axis
patients the omission of a grid will reduce the
Lateral of the table, the hips and knees flexed to aid
exposure.
comfort and stability
The 28 day rule should be applied for female
Sacro The patient lies prone on the table midline
patients. In males direct lead rubber gonad
Iliac aligned to the midline of the table coronal plane
9 protection can be applied at all times On small 75 40 196.55 100
Joints parallel to the table, a support under the ankles
patients the omission of a grid will reduced the
PA to aid comfort
exposure.

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S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation

The examination may be performed either prone


or supine, supine will be described here prone is
shown by way of comparative example) In the
Sacro The 28 day rule should be applied for female
supine position the joint space on the raised
Iliac patients. In males direct lead rubber gonad
side is visualised. The patient lies supine on the
10 Joints protection can be applied at all times On small 75 40 196.55 100
table midline in line with the midline of the table,
AP patients the omission of a grid will reduced the
from this position the patient is rotated so the
Oblique exposure.
affected side is raised and the midsaggital plane
is at an angle of 30 degrees from horizontal, and
the patient supported on radio lucent pads

The patient lies on the table with the mid


Lumbar saggital plane parallel to the table, support
The 28 day rule should be applied for female
Sacral under the waist and a pad between the knees
patients. In males and females direct lead
11 articulati 75 45 221.20 100 may be required. The long axis of the patient
rubber gonad protection can be applied at all
on should be in line with the long axis of the table,
times
Lateral the hips and knees flexed to aid comfort and
stability.
The patient lies supine on the table midline
The 28 day rule should be applied for female aligned to the midline of the table, the hips and
Lumbar
patients. In males and females direct lead knees flexed 45 degrees to reduce the lumbar
12 Spine 70 63 256.69 100
rubber gonad protection can be applied at all curve, the ASISs are equidistant from the table
AP
times ensuring the midsaggital plane is at 90 degrees
to the table

Page 62 of 83
Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The patient lies on the table with their long axis
in line with the long axis of the table, a line at a
tangent to the third lumbar vertebra should be in
The 28 day rule should be applied for female
Lumbar line with the midline of the table. The hips and
patients. In males and females direct lead
13 Spine 75 80 392.55 100 knees are flexed for stability and the hands are
rubber gonad protection can be applied at all
Lateral placed on a pillow in front of the patients face.
times
Ensure the line of the spinous processes are
parallel to the table if not use pads to adjust the
position

Lumbar The 28 day rule should be applied for female From the supine position the patient is rotated
Spine patients. In males and females direct lead 45 degrees with the side to be imaged raised,
14 80 80 453.20 100
Posterior rubber gonad protection can be applied at all and supported on pads, with the hips and knees
oblique times slightly flexed to aid stability.

The patient lies supine on the table midline


aligned to the midline of the table, the ASISs
The 28 day rule should be applied for female and the Acromio clavicular joints are equidistant
Thoracic
patients. In males and females direct lead from the table ensuring the midsaggital plane is
15 Spine 66 32 113.54 100
rubber gonad protection can be applied at all at 90 degrees to the table. The neck is extended
AP
times to avoid superimposition of the mandible on the
upper thoracic spine, flexion of the hips and
knees may help reduce the thoracic curve

Page 63 of 83
Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The patient lies on one side on the table, mid-
saggital plane parallel to the table top and mid
The 28 day rule should be applied for female coronal plane midline aligned to the midline of
Thoracic
16 patients. In males and females direct lead 75 50 245.75 100 the table, the hips and knees flexed 45 degrees
Spine
rubber gonad protection can be applied at all to support the patient and minimise movement,
Lateral
times raising the arms well above the head maximises
visualisation of the upper vertebrae
The patient stands erect with the median
saggital plane parallel to the bucky face, the arm
Thoracic The 28 day rule should be applied for female
nearest the bucky is raised the elbow flexed and
Spine patients. In males and females direct lead
17 75 50 245.75 100 the forearm rested on the top of the head. The
Upper rubber gonad protection can be applied at all
other arm is positioned hanging loosely at the
Lateral times
patients side, a weight may help lower the
shoulder
The patient stands erect in the AP position
median saggital plane at 90 degrees to the film
In males and females direct lead rubber gonad with the patient’s midline in line with the center
Cervical
protection can be applied at all times, avoid the of the bucky, feet slightly apart to aid stability,
18 spine 1- 65 12.5 42.98 100
breast tissue particularly in young females; coronal plane parallel to the film. The mouth is
2 AP
collimate to prevent irradiation of the eyes. opened wide, chin is raised until an imaginary
line from the center of the mouth to a point level
with the mastoid tips is horizontal

Page 64 of 83
Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
The patient stands erect in the AP position
Cervical median saggital plane at 90 degrees to the film
spine 3- In males and females direct lead rubber gonad with the patient’s midline in line with the center
7 AP protection can be applied at all times, avoid the of the bucky, feet slightly apart to aid stability,
19 65 12.5 42.98 100
(Swimm breast tissue particularly in young females; coronal plane parallel to the film. The chin is
er's collimate to prevent irradiation of the eyes. raised until an imaginary line from the upper lip
View) to the external occipital protuberance is
horizontal

The patient stands or sits erect with the median


In males and females direct lead rubber gonad saggital plane parallel to the bucky, the chin is
Cervical
protection can be applied at all times, avoid the raised to prevent superimposition of the
20 spine 68 14 55.40 100
breast tissue particularly in young females; mandible, the arms internally rotated to project
Lateral
collimate to prevent irradiation of the eyes. the heads of the humeri away from the vertebral
bodies

The patient stands or sits facing the bucky then


In males and females direct lead rubber gonad
Cervical turns 45 degrees to bring the median saggital
protection can be applied at all times, avoid the
21 Anterior 68 14 55.40 100 plane at 45 degrees to the bucky, the head is
breast tissue particularly in young females;
Oblique then rotated parallel to the film, with chin is
collimate to prevent irradiation of the eyes.
raised slightly.

The patient lies supine on the table. Median


Abdome
saggital plane aligned to the center. The knees
n AP Direct lead rubber gonad protection in males.
22 60 50 146.90 100 can be flexed at 45 degrees and supported for
Supine / 28 day rule for females where appropriate
comfort. The arms placed alongside the trunk or
KUB
above the head

Page 65 of 83
Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

SKULL: Supine Trolley Technique


S/ FFD Pictorial
Image Radiation Protection kV mAs mR Patient position
N cm Representation

The patient lies supine on the trolley or X-Ray table, the


midsaggital plane central. The patients head is positioned so
Skull Avoid irradiation of the thyroid that the inter-pupilary line is parallel to the film. The neck is
1 20FO region, direct lead rubber 70 32 134.5 100 flexed depressing the chin until the radiographic baseline
(Trolley) protection my be used (RBL) is at 90 degrees to the film, Not possible if there is a
possible cervical injury) A small pad may be needed under
the occiput or beneath the cassette

The patient lies supine on the trolley or X-Ray table, the


midsaggital plane central. The patients head is positioned so
Skull FO Avoid irradiation of the thyroid that the interpupilary line is parallel to the film. The neck is
2 30 region, direct lead rubber 70 32 134.5 100 flexed depressing the chin until the radiographic baseline
(Trolley) protection my be used (OMBL) is at 90 degrees to the film, Not possible if there is a
possible cervical injury) A small pad may be needed under
the occiput or beneath the cassette

The patient lies supine on the table midsaggital plane aligned


Skull
central to the table, the head is supported on a small pad,
Lateral Collimate to limit irradiation of the
3 75 32 157.10 75 side of interest nearest the film. the median saggital plane
(Horizont thyroid gland
must be parallel to the film which is placed along side the
al Ray)
head

Page 66 of 83
Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

S/ FFD Pictorial
Image Radiation Protection kV mAs mR Patient position
N cm Representation
The patient lies supine on the table midsaggital plane aligned
central to the top, the chin is depressed until the orbital
Skull
meatal line is at 90 degrees to the trolley top, a small pad may
Mental- Collimate to limit irradiation of the
4 75 32 157.10 100 be needed below the occiput to achieve this comfortably. The
occipito- thyroid gland
interpupilary line should be parallel to the trolley top. The film
Modified
(grid cassette) is place vertical above the vertex as in the
picture below

Skull The patient lies supine on the trolley the midsaggital plane
Facial- aligned to the long axis of the trolley, interpupilary line parallel
Collimate to limit irradiation of the
5 bones 65 45 160.25 100 to the floor. The cassette is supported alongside the affected
thyroid gland
Lateral / side of the face parallel to the midsaggital plane. the chin is
Mastoid raised to bring the orbital meatal line vertical

Erect Bucky Technique


S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
Dentures and oral jewellery should be removed. The patient
Avoid irradiation of the thyroid sits erect facing the bucky, midsagittal plane in the midline of
Skull PA
1 region, direct lead rubber protection 75 40 196.55 100 the film, coronal plane parallel to the film interpupillary line
20
my be used parallel to the floor. The chin is lowered to bring the orbital
meatal line at 90 degrees to the film

Page 67 of 83
Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation

The patient sits erect facing the bucky, midsaggital plane in


Skull Avoid irradiation of the thyroid
the midline of the film,interpupilary line parallel to the floor.
2 Reverse region, direct lead rubber protection 75 40 196.55 100
The chin is lowered 30 degrees from the PA position to bring
Townes my be used
the orbital meatal line at 60 degrees to the film

Take care with this technique, the patient may suffer vaso
vagal reactions or vertigo, it is not suitable for trauma
patients. The patient sits erect with their back to the erect
Skull Direct lead rubber thyroid
3 75 45 221.20 100 bucky, a small pillow is placed behind the shoulders and the
SMV protection advisable
patient extends the neck until the orbital meatal baseline is
parallel to the film, the interpupilary line parallel to the floor
and the median saggital plane at 90 degrees to the film
Take care with this technique, the patient may suffer vaso
vagal reactions or vertigo, it is not suitable for trauma
PNS patients. The patient sits erect with their back to the erect
Direct lead rubber thyroid
4 water's 60 56 149.84 100 bucky, a small pillow is placed behind the shoulders and the
protection advisable
view patient extends the neck until the orbital meatal baseline is
parallel to the film, the interpupilary line parallel to the floor
and the median saggital plane at 90 degrees to the film

Page 68 of 83
Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
Dentures and oral jewellery should be removed. The patient
sits erect facing the erect film, the head is then turned so that
the side of the face is in contact with the bucky, median
saggital plane parallel to the film and interpupillary line
Skull Direct lead rubber thyroid
5 70 25 105.50 100 parallel to the floor. This position requires the patient to sit
Lateral protection advisable
upright as close as possible to the bucky. A grid cassette in
an erect film holder which sits away from the bucky face may
permit the patient's shoulder to be positioned below the lower
border of the film holder if the are unable to turn the head
Dentures and oral jewellery should be removed. The patient
Facial Direct lead rubber thyroid sits erect facing the bucky, midsaggital plane in the midline of
Bones protection advisable. A beam the film, coronal plane parallel to the film interpupillary line
6 OM/ delineating cone / diaphragm will 65 40 142.40 100 parallel to the floor. The chin is raised to bring the orbital
Water's limit the area irradiated reducing meatal line at 45 degrees to the film. In some centers the
view the scatter to the thyroid region patient is imaged mouth open to demonstrate the sphenoid
sinuses

Dentures and oral jewellery should be removed. The patient


Direct lead rubber thyroid sits erect facing the bucky, mid-saggital plane in the midline
Facial protection advisable. A beam of the film, coronal plane parallel to the film interpupillary line
7 Bones delineating cone / diaphragm will 70 32 134.5 100 parallel to the floor. The chin is raised to bring the orbital
OM 30 limit the area irradiated reducing meatal line at 45 degrees to the film. In some centers the
the scatter to the thyroid region patient is imaged mouth open to demonstrate the sphenoid
sinuses

Page 69 of 83
Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

S/ Pictorial
Image Radiation Protection kV mAs mR FFD cm Patient position
N Representation
Dentures and oral jewellery should be removed. The patient
sits erect facing the erect film, the head is then turned so that
Facial
Direct lead rubber thyroid the side of the face is in contact with the bucky, median
8 Bones 65 28 100.01 100
protection advisable. saggital plane parallel to the film and interpupillary line
Lateral
parallel to the floor. This position requires the patient to sit
upright as close as possible to the bucky.
The patient sits erect facing the erect film, the head is then
turned so that the side of the face is in contact with the bucky,
Nose Direct lead rubber thyroid
9 55 2 5.64 100 median saggital plane parallel to the film and interpupillary
Lateral protection advisable.
line parallel to the floor. This position requires the patient to
sit upright as close as possible to the bucky.
Dentures and oral jewellery should be removed. The patient
Facial sits erect facing the bucky, mid-sagittal plane in the midline of
Direct lead rubber thyroid
10 Mandible 70 20 84.57 100 the film, coronal plane parallel to the film interpupillary line
protection advisable.
PA parallel to the floor. The chin is lowered to bring the orbital
meatal line at 90 degrees to the film
Dentures and oral jewellery should be removed. The patient
sits erect facing the erect film, the head is then turned so that
the side of the face is in contact with the bucky, median
saggital plane parallel to the film and interpupillary line
Mandible Direct lead rubber thyroid
11 60 12.5 35.87 100 parallel to the floor, from this position the head is then tilted
Oblique protection advisable.
20 degrees to bring the skin surface over the body of the
mandible in contact with the bucky. The chin is raised to
prevent superimposition of the mandibular structures on the
cervical spine. The jaw is closed and teeth occluded
Chest

Page 70 of 83
Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

S/ FFD Pictorial
Image Radiation Protection kV mAs mR Patient position
N cm Representation
The patient stands ERECT facing the cassette, the cassette
is raised so the top is 3cm above the skin margins above the
Direct lead rubber waist level
apices, the patient's chin is rested on the top of the cassette
protection, posterior at low kV,
1 Chest PA 65 7.1 24.98 100 holder, the patient is asked to place the backs of the hands
anteriorly at higher kV. Avoid
on the waist at the sides. The shoulders and arms are rolled
irradiation of the eyes and thyroid
forward to bring the scapulae towards the side of the chest.
Exposure is made on deep suspended inspiration
The patient stands (feet slightly apart for stability) erect left
(normally unless right lateral is indicated) side to the film /
bucky, median saggital plane parallel to the film. The patient
Direct lead rubber protection using
may need to flex forward from the waist to ensure the limits
Chest a half apron around the waist.
2 70 10 41.98 100 of the examination fit on the film. The patients arms are
Lateral Correct centering should avoid
folded across the top of the head and the elbows gripped
irradiation of the thyroid gland
with the hand of the opposite side. The chin is raised up. The
top of the film should be positioned about 3 cm above the
tops of the shoulders
The patient stands erect facing the bucky, from here the
patient is rotated 45degrees with the affected side away from
the film, the arm of the affected side is raised and placed
Chest
across the head which may need to be turned towards the
Anterior Direct lead rubber waist level
affected side for comfort and ease of positioning. Ensure the
3 oblique, protection, posterior at low kV, 70 10 41.98 100
opposite site anterior chest wall is in contact with the bucky
Ribs anteriorly at higher kV
to aid immobilization. The erect anterior oblique position
(Axillary)
reduces the dose to breast tissue compared with the
posterior oblique, however the ribs are further from the film
which may compromise image quality

Page 71 of 83
Annex B: Basic X-Ray techniques used for Different Anatomy SKANMOBILE‒ High Frequency Diagnostic X-Ray system

S/ FFD Pictorial
Image Radiation Protection kV mAs mR Patient position
N cm Representation
Sternum
Direct lead rubber waist level The patient lies prone on the table with the left side raised
PA Rt
4 protection, avoid irradiation of 70 32 134.5 100 (RAO) approximately 15 degrees, arm and knee of the raised
Anterior
thyroid side to aid stability
Oblique
The patient stands erect median sagittal plane parallel to the
Direct lead rubber waist level erect bucky, the hands are clasped together behind the
Sternum
5 protection, avoid irradiation of 66 25 92.46 100 patients back, the patient projects the chest forward on
Lateral
thyroid suspended inspiration

The patient stands erect median sagittal plane parallel to the


Direct lead rubber waist level erect bucky, the hands are clasped together behind the
6 Chest AP protection, avoid irradiation of 65 7.1 24.98 100 patients back, the patient projects the chest forward on
thyroid suspended inspiration

Page 72 of 83
SKANMOBILE‒ High Frequency
Annex C: APR Chart – Basic X-ray techniques used for veterinary use
Diagnostic X-Ray system

Annex C: APR Chart – Basic X-ray techniques used for veterinary use
SL# Anatomy KV mAs Dose in mR

1 Dog Full Body 100 14 130.2

2 Dog Head 100 14 130.2

3 Dog Spine 100 14 130.2

4 Dog Thorax 100 3.6 34.03

5 Dog Abdomen 100 5.6 49.2

6 Dog tail 100 12.5 120.8

7 Dog Extremeties 100 12.5 120.8

8 Cat Full Body 100 14 130.2

9 Cat Head 100 14 130.2

10 Cat spine 100 14 130.2

11 Cat Thorax 100 3.6 34.03

12 Cat Abdomen 100 5.6 49.2

13 Cat extremeties 100 12.5 120.8

14 Cat tail 100 12.5 120.8

15 Reptile Full Body 90 14 100.4

16 Bird 95 14 115.2

17 Turtle 100 14 130.2

Page 73 of 83
SKANMOBILE‒ High Frequency
Annex D: Declaration of Conformity
Diagnostic X-Ray system

Annex D: Declaration of Conformity


D1 : Name and Description of Product

Medical device name : High frequency Diagnostic X-Ray system

Medical device model : SKANMOBILE-XXX

Device Variants : 303-000018-0 SKANMOBILE HF diagnostic X-Ray system, 230 Vac

: 303-000018-3 SKANMOBILE HF diagnostic X-Ray system, 110 Vac

D2: Following Standards under which conformity is declared:

Standard, Regulations & Directives Title

ANSI / AAMI ES 60601-1: 2005 / (R) Medical electrical equipment- Part 1: General requirements for basic
2012 safety and essential performance.

IEC 60601-1: 2012 + CORR. 1 (2006) + Medical electrical equipment – Part 1: General requirements for
CORR. 2 (2007) basic safety and essential performance

Medical electrical equipment -Part 1: General requirements for


EN 60601-1-3: Ed 2.1 (2013-14) safety -3. Collateral standard: General requirements for radiation
protection in diagnostic X-Ray equipment

Medical electrical equipment – Part 2-28: Particular requirements for


IEC60601-2-28: Ed 2.0 (2017) the basic safety and essential performance of X-Ray tube
assemblies for medical diagnosis

Medical electrical equipment – Part 2-54: Particular requirements for


EN/IEC 60601-2-54 ed1.0:2009
the basic safety and essential performance of X-Ray equipment for
Amendment- 2 -2018
radiography and radioscopy

Page 75 of 83
SKANMOBILE‒ High Frequency
Annex D: Declaration of Conformity
Diagnostic X-Ray system

D3: Marking:
The products described herein are conform to the following regulatory markings

A) CE marking.

D4: Declaration
Skanray Europe SRL declares that the products described herein meet all the applicable Essential
Requirements of the EC Medical Device Directive 93/42/EEC in Annex I, For Class IIb products
described herein, the product is manufactured, inspected, tested, and released in accordance with the
approved quality assurance system established in accordance with ISO 13485:2016 Annex II of the EC
Medical Device Directive under the supervision of the IMQ, a Notified Body carrying the Notified Body No.
0051.

D5: Authorized Representative & Notified body

Europe Authorized Representative Notified Body


Skanray Europe s.r.l IMQ S.p.A.
Via Quintiliano 43 - 20138 Milan - Italy
Via Della Tecnica, Tel: +39 02 50 73 1
Fax: +39 02 50 99 15 00
3- San Lazzaro di Savena (40068),
Bologna, Italy.
E mail: [email protected]

Page 76 of 83
SKANMOBILE‒ High Frequency
Annex E: Guidance and Manufacturer’s Declaration
Diagnostic X-Ray system

Annex E: Guidance and Manufacturer’s Declaration


According to: IEC 60601-1-2: 2014(4th Edition)

(Group 1, class A, for use in Hospitals) (Not LIFE-SUPPORTING)

SKANMOBILE-XXX is tested as per applicable IEC standards, to be used under electromagnetic environment
specified below. The customer or the user of SKANMOBILE-XXX should assure that it is used in such an
environment. Where XXX Variants = 230 Vac, 110 Vac

Emissions test Compliance Electromagnetic environment – guidance


SKANMOBILE-XXX uses RF energy only for its
RF emissions
internal function. Therefore, its RF emissions are
IEC 60601-1-2:2014 Group 1
very low and are not likely to cause any interference
CISPR 11:2010
in nearby electronic equipment.
RF emissions
IEC 60601-1-2:2014 Class A
CISPR 11:2010 SKANMOBILE-XXX is suitable for use in all
Harmonic emissions establishments, other than domestic establishments
IEC 60601-1-2:2014 Class A and those directly connected to the public low-
IEC 61000-3-2:2009 voltage power supply network that supplies
Voltage fluctuations / flicker emissions buildings used for domestic purposes.
IEC 60601-1-2:2014 Complies
IEC 61000-3-3:2013
Table 1: Guidance and Manufacturer’s Declaration – Electromagnetic Emissions – For all EQUIPMENT and SYSTEMS

Electromagnetic
Immunity test EN 60601 test level Compliance level
environment – guidance

Electrostatic Floors should be wood,


± 8 kV contact-Direct ± 8 kV contact-Direct concrete or ceramic tile. If the
discharge (ESD)
± 8 kV contact-Indirect ± 8 kV contact-Indirect floor is covered with synthetic
IEC 60601-1-2:2014
± (2, 4, 8, 15) kV air ± (2, 4, 8, 15) kV air material, the relative humidity
IEC 61000-4-2:2008 should be at least 30 %.

± 2 kV for power supply


Electrical fast ± 2 kV for power supply
lines 100kHz repetition
lines 100kHz repetition Mains power quality should be
transient/burst frequency
frequency that of a typical commercial or
IEC 60601-1-2:2014 ± 1 kV for Signal lines
± 1 kV for Signal lines hospital environment.
IEC61000-4-4:2012 100kHz repetition
100kHz repetition frequency
frequency
Surge Mains power quality should be
± 1 kV Differential mode ± 1 kV Differential mode
IEC 60601-1-2:2014 that of a typical commercial or
± 2 kV Common mode ± 2 kV Common mode
IEC 61000-4-5:2005 hospital environment.

Page 77 of 83
SKANMOBILE‒ High Frequency
Annex E: Guidance and Manufacturer’s Declaration
Diagnostic X-Ray system

Electromagnetic
Immunity test EN 60601 test level Compliance level
environment – guidance

0% UT for 0,5 cycle Mains power quality should be


Voltage dips, short 0% UT for 0,5 cycle
At 0°, 45°, 90°, 135°, that of a typical commercial or
interruptions and At 0°, 45°, 90°, 135°, 180°,
180°, 225°, 270° and hospital environment. If the
voltage variations 225°, 270° and 315°
315° user of the SKANMOBILE-XXX
on power supply 0% UT for 1 cycle requires continued operation
0% UT for 1 cycle
input lines At 0° during power mains
At 0°
IEC 60601-1-2:2014 70% UT for 25/30 cycle interruptions, it is
70% UT for 25/30 cycle
At 0° recommended that the
IEC 61000-4-
At 0° SKANMOBILE-XXX be
11:2004 0% UT for 250/300 cycle
0% UT for 250/300 cycle powered from an
uninterruptible power supply.

Power frequency
(50/60 Hz) Power frequency magnetic
fields should be at levels
magnetic field 3 A/m 3 A/m
characteristic of a typical
IEC 60601-1-2:2014 50Hz OR 60Hz 50Hz OR 60Hz
location in a typical commercial
IEC 61000-4-8:2009 or hospital environment.

Table 2: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity – For all EQUIPMENT and SYSTEMS

EN 60601 Compliance Electromagnetic


Immunity test
test level level environment – guidance
Portable and mobile RF communications equipment should
be used no closer to any part of the SKANMOBILE-XXX ,
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Conducted RF Recommended separation distance
IEC 60601-1- 3 V, 6V 3 V, 6V
d  1,2 P
2:2014 150 kHz to 80 150 kHz to 80
IEC 61000-4- MHz MHz d  1,2 P 80 MHz to 800 MHz
6:2013
d  2,3 P 800 MHz to 2,5 GHz

Where P is the maximum output power rating of the


transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance
in meters (m).

Page 78 of 83
SKANMOBILE‒ High Frequency
Annex E: Guidance and Manufacturer’s Declaration
Diagnostic X-Ray system

Field strengths from fixed RF transmitters, as determined by


Radiated RF an electromagnetic site survey, a) should be less than the
IEC 60601-1- 3 V/m 3 V/m compliance level in each frequency range.
2:2014 80 MHz to 2.7 80 MHz to 2.7 Interference may occur in the vicinity of equipment marked
IEC 61000-4- GHz GHz with the following symbol b):

3:2010

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 strengths from fixed 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 transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
SKANMOBILE-XXX is used exceeds the applicable RF compliance level above, the SKANMOBILE-XXX
should be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the SKANMOBILE-XXX.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 3: Guidance and manufacturer’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS that are
not LIFE-SUPPORTING

Page 79 of 83
Annex F: Contact details SKANMOBILE‒ High Frequency
Diagnostic X-Ray system

Annex F: Contact details

Manufactured at registered office & Radiology Skanray Europe s.r.l.


Division Via Cicogna 36, 38,
40068 San Lazzaro di Savena,
Bologna Italy.
Phone : +39 051 628 5800
Customer Support Email : [email protected]

Page 81 of 83
Annex G: Preparation of Detachable Power Cord (Appliance Mains SKANMOBILE‒ High Frequency
Connector) Diagnostic X-Ray system

Annex G: Preparation of Detachable Power Cord (Appliance Mains Connector)

Note:
Country Specific Power Cord,
North American Power Cord- AWG 14 minimum, ROJ, 4.5 meters minimum
International Power Cord- 1.5 sqmm minimum, ROJ, 4.5 meters minimum
Hospital Grade Power Cord- AWG 14 minimum, ROJ, 4.5 meters minimum
or any other country specific power cord can be used.
Item # Description Qty MFR1 MFR1 Part # MFR2 MFR2 Part #

1 AC Power cord 3 Core, 1 No Longwell 3P16A / 4.5M


1.5 sqmm 16A
Pakistan Plug, ROJ
4.5 meters
2 Power Outlet Re Wireable 1 No Schurter 4790.1200 International 57090-RA
Female C19, R/A 16A / Config
250 Vac

3 Ring Terminal Non 3 Nos Tyco 32186 MOLEX 19069-0101


Insulated M3.5 14-16
AWG

Page 83 of 83
2

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