KODAK 2100 User Guide
KODAK 2100 Intraoral
X-ray System
User’s Manual
This document is originally written in English.
Manual Name: KODAK 2100 Intraoral X-ray System, User Guide
Document code: SM700
Revision Number: Rev 3
Printed Date: 9/2007
The brand names and logos reproduced in this guide are copyright.
KODAK is a trademark of KODAK used under License.
RVG, Trophy, are registered trademarks of Carestream Health, Inc. All other names
or products referred to in this document are used only for the purpose of
identification and maybe the trademarks or the registered trademarks of their
respective owners.The RVG technology is the subject of and international patent
registered by Carestream Health, Inc.
Table of Contents
1 Safety and Regulatory Information
Conventions Used in This Manual............................................................................................................1-1
General Safety Guidelines.........................................................................................................................1-1
Warnings and Safety Instructions .............................................................................................................1-2
Labeling Summary....................................................................................................................................1-4
IEC Symbols Used....................................................................................................................................1-5
Regulatory Information.............................................................................................................................1-5
CE Conformity....................................................................................................................................1-5
U.S. Regulations..................................................................................................................................1-5
2 System Overview
Components...............................................................................................................................................2-1
Ceiling-mounted Unit (Optional)........................................................ ......................................................2-3
Mounted on Mobile Stand (Optional)......................................................................................... ..............2-4
Floor-mounted Unit (Optional).................................................................................................................2-5
Control Timer Unit....................................................................................................................................2-6
3 Using the System
Positioning.................................................................................................................................................3-1
Positioning the patient.........................................................................................................................3-1
Positioning the x-ray generator ...........................................................................................................3-1
Positioning the imaging receptor.........................................................................................................3-2
Exposure....................................................................................................................................................3-2
Exposure parameters ...........................................................................................................................3-2
Procedure.............................................................................................................................................3-3
Processing .................................................................................................................................................3-3
Additional Features...................................................................................................................................3-4
4 User Mode
Entering User Mode..................................................................................................................................4-1
Changing Parameters.................................. ..... .... ...................................................... ................................4-1
Exiting User Mode....................................................................................................................................4-1
5 Care and Maintenance
General Maintenance.................................................................................................................................5-1
Cleaning...............................................................................................................................................5-2
Disinfecting.........................................................................................................................................5-2
Error messages ..........................................................................................................................................5-2
Troubleshooting ........................................................................................................................................5-4
iii
Table of Contents
6 Specifications
According to IEC Standard 601-2-7.........................................................................................................6-1
Manufacturer.......................................................................................................................................6-1
X-ray Generator........................................................................................................................................6-3
Equipped X-ray Generator........................................................................................................................6-4
Position of Identification Labels...............................................................................................................6-6
Tables of Exposure Times ........................................................................................................................6-7
Emitted Doses.........................................................................................................................................6-14
iv
1
Safety and Regulatory Information
The information contained in this manual is based on the experience and
knowledge relating to the subject matter gained by Carestream Health Inc.
prior to publication. No patent license is granted by this information.
Carestream Health Inc. reserves the right to change this information without
notice, and makes no warranty, express or implied, with respect to this
information. Carestream Health Inc. shall not be liable for any loss or
damage, including consequential or special damages, resulting from any use
of this information, even if loss or damage is caused by Carestream Health
Inc. negligence or other fault.
Conventions Used in This Manual
CAUTION:
Caution points out procedures that you must follow precisely to avoid
damage to the system or any of its components, yourself or others, loss
of data, or corruption of files in software applications.
Note
Notes provide additional information, such
as expanded explanations, hints, or
reminders.
Important
Important highlights critical policy
information that affects how you use this
manual and this product.
General Safety Guidelines
• This product is designed and manufactured to ensure maximum safety
of operation. Operate and maintain it in strict compliance with the safety
precautions and operating instructions contained in this manual.
• This product meets all the safety requirements applicable to medical
equipment. However, anyone attempting to operate the system must be
fully aware of potential safety hazards.
• There are no user serviceable parts in this system. The product must be
installed, maintained, and serviced by qualified service personnel
according to procedures and preventive maintenance schedules in the
product service manual. If your product does not operate as expected,
contact your Service Representative.
• Do not modify this product in whole or in part without prior written
approval from Carestream Health Inc.
• The assembly, extensions, adjustments, modifications, and repairs must
be performed by an authorized Service Representative. Your radiology
system must be installed in premises that comply with applicable
standards.
• Personnel operating and maintaining this system should receive training
and be familiar with all aspects of operation and maintenance.
9/2007 SM700_K2100_03_en 1-1
• T o ensure safety, read all user manuals carefully before using the system
and observe all Caution, Important, and Note callouts located
throughout the manual.
• Keep this manual with the equipment.
• Reading this manual does not qualify you to operate, test, or calibrate
this system.
• Unauthorized personnel are not allowed access to the system.
• If the product does not operate properly or fails to respond to the
controls as described in this manual:
– Follow the safety precautions as specified in this manual.
– Stop using the equipment and do not make or authorize any changes
to it.
– Immediately contact your Service Representative, report the problem,
and await further instructions.
• X-ray systems manufactured by Carestream Health Inc. comply with
safety standards throughout the world for optimum protection against
radiation risks.
• Be aware of the product specifications and of system accuracy and
stability limitations. Consider these limitations before making any
decision based on quantitative values. If you have any doubts, consult
your Sales Representative.
CAUTION
X-rays can be dangerous if used incorrectly . Take precautions even when
following the instructions in this manual.
Use conventional commercially available equipment to protect yourself
and your patients against scattered radiation risks.
• If you fail to comply with these instructions, Carestream Health Inc. will
not be responsible for the safety reliability, and characteristics of the
equipment.
:
Warnings and Safety Instructions
CAUTION:
Do not operate the equipment in the presence of explosive liquids,
vapors, or gases. Do not plug in or turn on the system if hazardous
substances are detected in the environment. If these substances are
detected after the system has been turned on, do not attempt to turn off
the unit or unplug it. Evacuate and ventilate the area before turning off
the system.
DANGER: THIS IS AN ELECTRICAL UNIT. DO NOT EXPOSE IT
TO WATER SPRAY. SUCH ACTION MAY CAUSE AN
ELECTRICAL SHOCK OR A MALFUNCTION OF THE
UNIT.
1-2 SM700_K2100_03_en 9/2007
WARNING
The user is responsible for the operation and maintenance of this unit.
This unit must only be operated by legally qualified persons.
The cover of the unit must not be opened by the operator.
Inspection and maintenance operations should only be carried out by an
approved technician.
WARNING
This unit must be installed in an x-ray room that complies with current
installation standards. From this location, visual or audio communication
must be maintained with the patient, together with access to the control
interface during exposure.
WARNING
Do not operate the unit if there is the threat of an earthquake.
Following an earthquake, ensure that the unit is operating properly before
using it again.
Failure to observe this precaution may expose patients to hazards.
WARNING
X-ray equipment can be hazardous to patients and the operator if the
exposure safety factors and operating instructions are not observed.
WARNING
Do not place objects within the field of operation of the unit.
WARNING
We recommend that the patient and the operator wear protective lead-lined
aprons, unless other Radiation Protection Protocols apply locally.
Ensure that any parts of the unit that may come into contact with the patient
and the operator have been disinfected after each patient has been exposed to
x-rays.
If the unit develops a fault, turn it off (O) and display a sign that states “Out
of Service.”
WARNING
The operator must ask the patient to refrain from moving during the entire
period of exposure.
In the European Union, this symbol indicates that
when the last user wishes to discard this product,
it must be sent to appropriate facilities for
recovery and recycling.
Contact your local sales representative for
additional information on the collection and
recovery programs available for this product.
9/2007 SM700_K2100_03_en 1-3
Labeling Summary
Safety Labels
CHASSIS GROUND STUD
ATTEN TIO N: CONSULT ACCOMPANYING DOCUMENTS
CAUTION: IONIZING RADIATION
1-4 SM700_K2100_03_en 9/2007
IEC Symbols Used
The system may have labels with one or more of the following symbols.
These symbols indicate the IEC standards to which the system conforms.
Caution — consult accompanying documents
Protective earth
Power ON
Power OFF
Regulatory Information
The product conforms to the following safety standards: IEC/EN 60 601-1
Medical Electrical Equipment General Requirements for Safety, IEC/EN 60
601-2 Medical Electrical Equipment Electro-Magnetic Compatibility
Requirements and Tests.
CE Conformity
This product conforms to the requirements of EU Council Directive
93/42/EEC. The Kodak intraoral x-ray system is a Class II b medical device,
which bears the following mark of conformity: .
U.S. Regulations
U.S federal law restricts this device to sale by or on the order of a
dentist.
CAUTION:
9/2007 SM700_K2100_03_en 1-5
2
System Overview
Components
d
c
e
b
Figure 1. KODAK 2100 Intraoral X-ray System
a. High-frequency x-ray generator
• Transformer and associated electronics, and an oil-bathed x-ray tube
• Beam-limiting device
• Radiation diameter – 6 cm (2 3/8 in.)
•
Distance from x-ray tube focal spot to skin – 20 cm
(7 7/8 in.
• Handle to facilitate positioning
b. Wall framework
• Contains the high-frequency generator’s control electronics designed to
support its mechanical stand
)
a
f
c. Control timer unit
• Selection of exposure times
• Self-test of the microprocessor each time the unit is activated
• Alarm during incorrect operation
• Digital icon that reduces the exposure time range if you are using a
Kodak RVG sensor
9/2007 SM700_K2100_03_en 2-1
d. Scissor arm
• Allow you to position the generator precisely and easily
• Wall-mounted with a choice of extensions
Figure 2. Side view of KODAK 2100 Intraoral X-ray System
Table 3. Types of Scissor Arms
Extension R Span A
CG 645 47.0 cm
(18.5 in.)
CG 646 64.8 cm
(25.5 in.)
CG 648 82.5 cm
(32.5 in.)
170.0 cm
(66 15/16 in.)
188.0 cm
(74 in.)
205.0 cm
(80 11/16 in.)
e. On/off switch
• Contains built-in light
f. Rectangular collimator (optional)
• Different sizes adapted to films and RVG sensors
Additional options
• Separate exposure switch (if the control panel is attached to the wall
framework)
• Ceiling-mounted unit
• Floor-mounted unit
• Unit mounted on mobile stand
2-2 SM700_K2100_03_en 9/2007
Ceiling-mounted Unit
d
b
c
f
Figure 4. KODAK 2100 Intraoral X-ray System ceiling-mounted unit
a. High-frequency x-ray generator
b. Ceiling-mounted unit containing the high-frequency x-ray
generator’s control electronics
c. Separate timer/control unit for the x-ray generator
d. Scissor arm
e. On/off switch with built-in light
f. Rectangular collimator
e
a
9/2007 SM700_K2100_03_en 2-3
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