AJEX 240H User manual

Operating Instructions for Portable X-ray Unit
Model : AJEX240H
FOR VETERINARY MEDICINE ONLY
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AXR-240H-MN01 (E) / Rev. 03 AJEX Meditech, Ltd.

Table of contents
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1. General information
1-1. Manufacturer and EC authorized representative information
1-2. Symbols and Terms
1-3. Reference Standards
1-4. Warranty
2. Safety note
2-1. Radiation protection
2-2. Explosion protection
2-3. Mechanical safety
2-4. Electromagnetic protection
3. Product information
3-1. Description
3-2. Intended use and application
3-3. Accessory
3-4. Operating & storage condition
3-5. Overview of operating elements
4. Operation procedure
4-1. Overview
4-2. Transporting the unit
4-3. Start-Up
4-4. Positioning the unit
4-5. Collimating to the object
4-6. Setting the exposure parameters
4-7. Releasing an exposure
4-8. Switching the unit OFF
5. Cool-Down Periods
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16
12
8
3

6. Maintenance
6.1 Daily/monthly test and annual maintenance
6.2 Cleaning
6.3 Service
6.4 Disposal
7. ERROR code
8. Technical data
8.1 Specifications
8.2 Dimensions
8.3 Label
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1. General information
1-1. Manufacturer and EC authorized representative information
1) Manufacturer :
AJEX Meditech, Ltd.
- Address : 38-1, Mangpo-dong, Yeongtong-ku, Suwon-city, Kyunggi-do,
KOREA
- Head office ; Tel : + 82-31-204-4200∼2, Fax : + 82-31-204-4203
e-mail : [email protected]
- Seoul office ; Tel : + 82-2-3462-8170∼2, Fax : + 82-2-3462-1812
2) EC authorized representative :
Peter Blach Rontgen systeme
- Address :
Wolfener Str. 32-34, Haus i, 12681, Berlin, Germany
Tel: + 49 30 50 01 60 55, Fax: + 49 30 50 01 60 56,
e-mai:[e-mail]
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1-2. Symbols and Terms
The following symbols will be used in this manual : their meaning and
applications are described further below.
WARNING
CAUTION
NOTE
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Warning :
Caution :
Note :
It warns the conditions and situations which,
if not taken over or avoided, could
cause heavy damages to people or cause
fatal damages to the equipment.
It warns of the conditions and situations
which, if not taken over or avoided,
could cause damages to people or to the
equipment.
They inform the reader about the relevant
facts and conditions.

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Identify the point where the system safety
ground is fastened to the chassis.
Protective earth that is connected to
conductive parts of Class Ⅰ equipment
for safety purposes.
(This symbol is used inside the unit.)
Protective earth (ground) :
Ionized Radiation :
The ionized radiation is dangerous for the
patient and the operator.
Therefore, the operator and his assistants
must take adequate precautions, to prevent
the possibility of authorized or unauthorized
persons carelessly or unknowingly exposing
themselves or others to direct or secondary
radiation.
Dangerous high voltage :
Dangerous high voltage over 1,000VAC or
1,500VDC.
(This symbol is attached inside the unit.)

1-3. Reference Standards
The AJEX240H is manufactured according to the following standard.
- Related Korea Government Regulations & Standards
- 2007/47/EC ; Medical Device Directive
- EN 60601-1+A1+A2 : 1995
(Part 1:General requirements for safety)
- EN 60601-1-1 : 2000
(Collateral standard:Safety requirements for medical electrical systems)
- EN 60601-1-2 : 2007
(Collateral standard:Electromagnetic compatibility-Requirements and tests)
- EN 60601-1-3 : 2008
(Collateral standard:General requirements for radiation protection in diagnostic
X-ray equipment)
- EN 60601-1-4 : 2004
(Collateral standard:Programmable electrical medical system)
- EN 60601-2-7 : 1998
(Part 2-7:Particular requirement for the safety of high-voltage generators of
diagnostic X-ray generators)
- EN 60601-2-28 : 1993
(Part 2:Particular requirement for the safety of X-ray source assemblies and
X-ray tube assemblies of medical diagnosis)
- ISO 14971:2007 ; Risk management
- Others : Related standards (Government regulations, IEC, ISO etc. ) for the
graphic symbols, risk management, quality system, etc.
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1-4. Warranty
AJEX warrants the product for a period 12 months from date of shipment.
The warranty is valid only when the unit is used in the proper environment
as specified in this operation instructions.
Make sure to use the unit as instructed in this operating instructions.
The warranty provided hereunder is limited to the furnishing or replacement
parts only by AJEX without charge, FOB KOREA.
The warranty does not cover the damage and loss caused by outside factors
such as a natural disaster. ( for example ; fire, flood, storm, lightening etc. )
The warranty does not cover the damage and loss caused by operation
under abnormal conditions, upgrades, modifications or repairs are performed
by personnel not authorized by AJEX.
AJEX does not take responsibility for damages or loss which appear after
the warranty period.
Service may be requested by sending a letter, fax or e-mail to AJEX.
The product name, serial number, date of purchase and details of the
problem should be contained in the letter, fax or e-mail.
If necessary, the defective unit should be packed in a carrying box and
send to AJEX.
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2. Safety note
CAUTION
Personnel operating the unit described in this document must comply with
government safety regulations and guidelines.
We will not be held liable for the safety features, reliability and performance of
the unit, when :
- Upgrades, modifications or repairs are performed by personnel not authorized
by AJEX.
- The unit be used in a manner other than specified on this operating
instructions.
2.1 Radiation protection
WARNING
The ionized radiation is dangerous for the patient and the operator.
Ensure maximum radiation protection for the patient when taking exposures
near reproductive organs.
Also, persons who are near the patient during the exposure must wear
protective clothing. ( e.g. lead-rubber aprons )
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One of the main considerations in X-ray work is protection against the
hazards of X-ray radiation. Proper use of the X-ray unit does not pose
any danger; however, Careless or improper usage can be dangerous.
Therefore, it is essential that all service or operating personnel be properly
informed of this subject.
Although this unit incorporates protection against X-ray radiation other
than the useful beam, practical design can't guarantee the complete
protection.
Therefore, the operator and his assistants must take adequate precautions,
to prevent the possibility of authorized or unauthorized persons carelessly
or unknowingly exposing themselves or others to direct or secondary
radiation.
Ensure maximum radiation protection for the patient when taking exposures
near reproductive organs.
- Collimate the radiation beam field as small as possible.
- Persons who are near the patient during the exposure must wear
protective clothing ( e.g. lead-rubber apron, gloves etc. ).
- When releasing the exposure, the operator must keep away sufficient
protective distance between yourself and the radiation source.
( more than 2m from radiation source. )
- Wear the radiation monitor badge or pen dosimeter.
It is very important that all the operators must understand the ICRP (the
International Commission of Radiological Protection) rules and all the
advice which are listed on the NCRP (the National Council on Radiological
Protection and measurement) report.
☞ Refer to ICRP publications No. 60, 84, 87, 90, 93, 103
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2-2. Explosion protection
WARNING
This unit is not intended for use in explosion-prone areas.
2-3. Mechanical safety
WARNING
The operator is responsible for ensuring the safety of the patient and third
parties prior to unit movement and positioning the unit
Extreme care must be taken when positioning the unit in close proximity to
the patient.
If use stand unit for AJEX240H, extreme care must be taken when installing
or separating the unit to stand unit.
If not locking safety lock, unit support arm ( and/or guide ) lift up rapidly,
when the AJEX240H is separated from stand unit, at some weight balancing
type stand unit.
CAUTION
No protection against water or any liquid.
Do not place objects on the X-ray unit, for example, cassettes, aprons, etc.
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2-4. Electromagnetic protection
The electromagnetic disturbance it generates does not exceed a level allowing
other apparatus to operate as intended.
The apparatus has an adequate level of intrinsic immunity of electromagnetic
disturbance to enable it to operate as intended.
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3. Product information
3-1. Description
AJEX240H is a portable X-ray unit designed for ease usage. Applying high
frequency inverter type X-ray generator, AJEX240H provide improved image
quality and reduced radiation dosage compare with the same rank different
type X-ray generators. ( self-rectification or full-wave rectification type )
3-2. Intended use and application
This equipment is used for generating X-ray to get the X-ray image for the
purpose of diagnosis of patient.
This equipment is possible to move the place for patient because it is designed
for portable type.
This equipment is possible to combine with the mobile stand unit for
convenience for patient positioning according to user's needs.
AJEX240H is designed for the following application :
- Physician with general practice for veterinary medicine only
- Beside exposures in hospital ward for veterinary medicine only
- Surgery and orthopedics for veterinary medicine only
- Veterinary medicine only
3-3. Accessory
If you unpack the unit, verify X-ray unit and accessories as shown belows.
Portable X-ray unit ; AJEX240H 1 set
Accessories ; - Carrying case 1 ea
- Exposure switch 1 ea
- Wire jack for mAs (or mA) measurement 1ea
- Operating instructions (AXR-240H-MN01 (E)) 1ea
- Inspection sheets by manufacturer 1ea
Option ; Bucky unit interface kit (Model : 240H-BIK-01)
If Bucky unit is used, this kit must be connected between AJEX240H
and Bucky unit.
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3-4. Operating & storage condition
1) Operating conditions
- Temperature : 5 ∼ 40 ℃
- Humidity : 30 ∼ 85 %
- Atmospheric pressure : 600 ∼ 1060 hPa
2) Storage conditions
- Temperature : -40 ∼ 70 ℃
- Humidity : 10 ∼ 95 %
- Atmospheric pressure : 50 ∼ 1060 hPa
WARNING
This product is not intended for use in explosion-prone areas.
CAUTION
Avoid the following environments for operation or storage ;
- where the ambient temperature falls below -40℃ or exceed 70℃.
( Normal operating & storage temperature range is 5℃ ∼ 40℃ )
- where the ambient relative humidity fall below 10% or exceed 95%.
( Normal operating & storage relative humidity is 30 ∼ 85 % )
- Where the atmospheric pressure fall below 50 hPa or exceed 1060 hPa.
( Normal operating & storage atmospheric pressure is 600 ∼ 1060 hPa )
- where the unit is expose to toxic gas or explosion-prone areas.
- where the unit is expose to water vapor, spray or splashing water.
- where the unit is expose to salty atmosphere.
- where the unit is expose to excessive shocks or vibrations.
- where the unit is expose to dust.
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3-5. Overview of operating elements
1) Error indicator ; Yellow color
2) X-ray exposure indicator ; Yellow color
3) Ready indicator ; Green color
4) Power indicator ; Green color
5) kV display & up, down key ; 3 digit 7-segment display
Key : △ - increment kV steps, ▽ - decrement kV steps
6) mAs display & up, down key ; 3 digit 7-segment display
Key : △ - increment mAs steps, ▽ - decrement mAs steps
7) X-ray exposure time display
Display : 3 digit 7-segment
8) APR size selection key :
'APR (Anatomical Programmed Radiography)' means the function which
is stored frequently used exposure conditions in this unit.
3 sizes are available. ( small, middle, large )
☞ Refer to '4-6. Setting the exposure parameters' on the page 21.
9) Wall Bucky Unit selection key
☞ If Bucky unit is used, interface kit is connected between AJEX240H and
Bucky unit. ; Bucky unit interface kit (Model : 240H-BIK-01)
10) Table Bucky Unit selection key
☞ If Bucky unit is used, interface kit is connected between AJEX240H and
Bucky unit. ; Bucky unit interface kit (Model : 240H-BIK-01)
11) SET key ; APR exposure conditions storage mode selection.
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1)
2)
3)
4)
5) 6) 7) 8)
9)
10)
11)
12)
13) 14) 15) 16)

12) APR position selection key :
'APR (Anatomical Programmed Radiography)' means the function which
is stored frequently used exposure conditions in this unit.
9 positions are available.
Refer to '4-6. Setting the exposure parameters' on the page 21.
13) kV up, down key ;
Display : 3 digit 7-segment
Key : △ - increment kV steps, ▽ - decrement kV steps
Refer to '4-6. Setting the exposure parameters' on the page 21.
14) mAs display & up, down key
Display : 3 digit 7-segment
Key : △ - increment mAs steps, ▽ - decrement mAs steps
Refer to '4-6. Setting the exposure parameters' on the page 21.
15) Beam limiting device lamp ON/OFF key
16) Enter key ; Error reset.
CAUTION
The equipment has been factory-adjusted for optimum performance.
Do not attempt to adjust any preset controls or switches except those
specified in this operating instructions.
NOTE
If you want to use bucky device, prepare the bucky interface kit (option).
This kit must be connected between AJEX240H and Bucky unit. ; Bucky unit
interface kit (Model : 240H-BIK-01). Please contact to AJEX Meditech, Ltd.
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4. Operation procedure
4-1. Overview
Refer to pages 17
4-2. Transporting the unit
Refer to pages 19
4-3. Start-up
Refer to pages 20
4-4. Positioning the unit
Refer to pages 20
4-4. Positioning the unit
Refer to pages 20
4-4. Positioning the unit
Refer to pages 20
4-5. Collimating to the object
Refer to pages 21
4-6. Setting the exposure
parameters
Refer to pages 23
4-7. Releasing an exposure
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Move AJEX240H
to the location desired
Connect the exposure switch,
Plug the unit in and switch ON.
Position the unit
for the examination
Position the patient or the object
for the examination
Position the cassette
Set the SID,
switch ON the Beam limiting device light,
collimate to the cassette format
Set the kV and mAs
Release the exposure

4-2. Transporting the unit
Get the unit into a carrying box and move the carrying box to the
location desired.
NOTE
AJEX240H is a portable X-ray unit designed for easy moving.
In case of using the mobile stand, refer to the mobile stand operating
instructions for proper use of the mobile stand.
( Refer to below fig1, fig 2, fig 3 )
fig 1. An example of J-type mobile stand ( Manufacturer : AJEX Meditech, Ltd.)
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fig 2. An example of M-type mobile stand ( Manufacturer : AJEX Meditech, Ltd. )
fig 3. An example of V-type mobile stand ( Manufacturer : AJEX Meditech, Ltd. )
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4-3. Start-up
1) Connecting of the unit
a) Connect the exposure switch into a female connector marked 'exposure
switch' on the rear cover.
b) Insert the line voltage input plug into a grounded wall socket.
WARNING
Verify the power switch is OFF before inserting of the plug.
Do not touch the plug with wet hands to prevent electric shock when
power is activated.
2) Switching the unit ON
Turn on the power switch on the rear cover.
After a few seconds, the initialization routine will run and display initial
data.
Initial display data : 80 kV, 3.0 mAs, 0.1sec.
NOTE
If initial display data is not displayed after power switch ON, turn off
the power switch and turn on it again after a few seconds.
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