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

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.

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• 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.

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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.

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Labeling Summary

Safety Labels

CHASSIS GROUND STUD

ATTEN TIO N: CONSULT ACCOMPANYING DOCUMENTS

CAUTION: IONIZING RADIATION

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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:

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System Overview

Components

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

)

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

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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

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Ceiling-mounted Unit

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

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