Gendex ORTHORALIX 8500 Bedienungsanleitung

Operator Manual

Panoramic X-ray

Operator’s Manual 032-0176-EN Rev. 4

IMPORTANT! . . . X-RAY PROTECTION

X-ray equipment may cause injury if used improperly. The instructions contained in this manual must be read and followed

when operating the ORTHORALIX® 8500. GENDEX dealers will assist you in placing the ORTHORALIX 8500 in operation.

The ORTHORALIX 8500 provides a high degree of protection from unnecessary X-radiation. However, no practical design

can provide complete protection, nor prevent operators from exposing themselves or others to unnecessary radiation. It is

important that you become fully acquainted with applicable government radiation protection regulations. Many provisions

of these regulations are based on the recommendations of the National Council on Radiation Protection and Measurements.

Recommendations for dental X-ray protection are published in NCRP Report Number 35 available from NCRP Publications,

7910 Woodmont Ave., Suite 800, Bethesda, MD 20814, or at www.ncrp.com. Personal radiation monitoring and protective

devices are available. You are urged to use them to protect against unnecessary X-radiation exposure.

Gendex Orthoralix®8500

Operator’s Manual 032-0176-EN Rev. 4

General 7

Compliance with Applicable Standards 9

Symbols and Labels 11

3.1 Symbols 11

3.2 Location of identication labels 12

Safety 13

Product Description 15

Control Keys and Indicators 17

Preliminary Procedures 19

7.1 Film selection 19

7.2 Darkroom requirements 19

7.3 Film and cassette handling 19

Table of contents

Operator’s Manual 032-0176-EN Rev. 4

Gendex Orthoralix®8500

General Operating Procedures 21

8.1 Equipment preparation 21

8.2 Program selection 22

Standard Panoramic Program 25

Panoramic Projection Factors 29

Common Positioning Errors 31

11.1 Panoramic image quality 35

Hygienic Procedures and Cleaning 35

12.1 Hygienic procedures 35

12.2 Cleaning procedures 35

System Conguration Program 37

13.1 Pan sensitivity (Film Speed) 37

Error Messages 39

Technical Data 41

Gendex Orthoralix®8500

Operator’s Manual 032-0176-EN Rev. 4

Recommended maintenance 43

Manufacturer's Declaration 45

Operator’s Manual 032-0176-EN Rev. 4

Gendex Orthoralix®8500

Operator’s Manual 032-0176-EN Rev. 4

General

This Operator’s Manual is intended to assist the Operator in the safe, and effective operation of the

lm-based ORTHORALIX 8500 high frequency Panoramic X-ray system.

It contains the information necessary to operate the equipment, the technical specications, and

the procedures to perform its simple maintenance.

Before attempting to operate the equipment, read this manual thoroughly. Pay particular attention

to all Warnings and Cautions incorporated in it.

Operator’s Manual 032-0176-EN Rev. 4

Gendex Orthoralix®8500

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Operator’s Manual 032-0176-EN Rev. 4

Compliance with

Applicable Standards

Class and Type of Certied equipment: ORTHORALIX 8500 belongs to the Class I Type B equipment

per IEC 60601.1 – 1990 / A2 - 1995 and Class IIb per European MDD 93/42/EEC.

The ORTHORALIX 8500 complies with the following standards:

General (electrical/mechanical) safety:

• UL60601-1FileNumber:E185414

• CAN/CSAC22.2No.601.1-M90

• IEC60601-2-32

• ElectromagneticInterference:IEC60601-1-2:

• Radiationprotection:IEC60601-1-3Radiationprotection/X-RayEquipment

• Lasers:IEC60825-1(2001)

The ORTHORALIX 8500 Tubehead complies with the following standards:

• IEC60601-2-7

• IEC60601-2-28

The certied components of the ORTHORALIX 8500 system comply with Radiation Performance

Standards21CFR,SubchapterJ,attimeofmanufacture.

The equipment must only be installed and operated in accordance with the safety

procedures and operating instructions given in this Operator’s Manual and in the

Installation/ Maintenance Manual for the purposes and applications for which it was

designed.

Modications and/or additions to the equipment may only be carried out by Gendex or

by third parties expressly authorized by Gendex to do so. Such changes must comply with

legal requirements as well as with the generally accepted technical rules.

It is the responsibility of the user to ensure that existing legal regulations regarding

installation of the equipment with respect to the building are observed.

Operator’s Manual 032-0176-EN Rev. 4

Gendex Orthoralix®8500

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