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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