User manual Expert
Contents
1. User Manual PEXPERTUM May 2007 GENDEX Gendex expert DC 2 2 Setup Before operating the Gendex expert DC you must make the appropriate selections on the master control touch panel Refer to the Default Exposure Values Anatomical Exposure Time Tables in this chapter Note The default anatomical exposure times shown in the Default Exposure Values Anatomical Exposure Time Tables are the factory designated exposure values Recommended Occlusal image expo sure times are also shown in the tables While there is no setting shown on the master control touch panel for Occlusal images you can manually set exposure values for Occlusal images by pressing the time up or time down Y arrows on the touch panel Setting values on the master control touch panel To set up the master control touch panel follow the procedure 1 Switch the On Off power switch to the On position A green indicator light appears next to the Ready Indicator Lamp on the front of the master control touch panel when the unit is ready for exposure operation Note The anatomical exposure time default the time displayed when the unit is initially turned on automatically appears on the display 2 Select the media type film or digital press the Imaging Type Selector between the film and computer icons to toggle to the desired media A green indicator light appears next to the film or digital icon you selected 3 Select the patient type adult or child2. 22 4 4 Accuracy of technique factors 22 4 5 Intraoral X ray tube housing 22 5 Maintenance 25 51 Equipment maintenance daa dds whose ied ence ace lat abe enact 25 52 Cleaning and disinfecting ie dau uit Odea Dank 25 6 Compliance with Applicable Standards 27 6 1 EC Declaration of Conformity 2242144244 u A eed bea Peewee ha 28 6 25 Identification labels estad Ni naar oser 33 6 3 References sans ea PAR Re A RRR Ra PORE eee 34 64 Contact Information sssr amet se tendre Penn eta wade ede hed RA 34 U EE PEXPERTUM May 2007 ser Manual GENDEX Gendex expert DC Warning X ray equipment may cause injury if used improperly It is extremely important that you be fully acquainted with all 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 Avenue Suite 800 Bethesda MD 20814 Personal radiation monitoring and protective devices are available You are strongly urged to use them to protect against unnecessary X ray exposure oq Note The Gendex expert DC Intraoral X ray unit provides a high degree of protection from unnecessary radiation However no practical design ca
3. Gendex expert DC User Manual Manual del usuario Benutzerhandbuch Manuale d uso Manual de l op rateur User Manual English GENDEX Gendex expert DC Table of contents 1 Overview 3 WI SETS piini E Ae apg D a 3 1 2 ABOUT AMIS manual sasse e er erh 3 1 3 Explanation of symbols on technical labels 4 1 4 System Components 424 ceeds nea ara RER EERE ee 5 1 5 USB Connection u a rs anaes Reed Ra ana 5 A ee RS 6 2 Setup and Operation 7 2 1 Master control function cir eee See da ee Okeke han nee hier 7 2 2 SUD ne ne ne 10 2 3 Operation ais a a a a a a Tea EA pas 11 2 4 Customize master control settings 12 2 5 Default exposure values Anatomical Exposure Setting tables 13 3 Additional Customized Film and Digital Options 17 3 1 Additional film and digital customization 17 3 2 Default exposure values for customized programmable film and digital settings Anatomical Time Setting 18 3 3 Restoring anatomical factory default values 19 3 4 Error CONDITIONS cito a aang ahead Leta nee meen A 19 4 Gendex expert DC Specifications 21 41 Tubeheadspecifications s riene ceive neagh athe hepa hor ein an 21 42 Cone Specifications 8 8 28 secede panha a mets gees ek 21 4 3 Power supply requirements
4. press the Patient Selector between the adult and child icons to toggle to the desired patient type A green indicator light appears next to the adult or child icon you selected 4 Select the anatomical area incisor bicuspid lower molar upper molar or bitewing press the Anatomical Time Selector in the center of the anatomy area to toggle to the desired anatomy you wish to X ray A green indicator light appears next to the anatomical section you selected Bitewing Bicuspid Lower molar Incisor Upper molar 5 Check the Exposure Time Display a lf you require a different exposure setting than the factory default value displayed press the time up or time down Y arrows on the master control touch panel to change override the factory setting b If the factory default value matches the desired anatomical exposure time proceed to the Operation section U Lie PEXPERTUM May 2007 ser Manual GENDEX Gendex expert DC 2 3 Operation Caution If the Cool Down Indicator Lamp illuminates during normal operation then the Gendex expert DC tubehead is heated and needs to cool down before an X ray exposure can be taken 1 Position the tubehead and cone to the patient using standard accepted positioning procedures Warning Use extreme care when adjusting the articulated arm to avoid placing your fingers in areas where they may be potentially pinched while you are moving the arm Also do not allow the tubehead to hit the wall after
5. tions pertaining to radiation protection The operator must remain 6 ft 2m from the focal spot and the X ray beam for operator protection The operator must use all radiation protection devices accessories and procedures available to protect the patient and operator from radiation Electrical Safety Covers on the Gendex expert DC equipment should only be removed by qualified and authorized service personnel The Gendex expert DC must be used in areas that comply with all applicable laws and recommendations pertaining to electrical safety used for medical purposes IEC US National Electrical Code or VDE standards concerning provisions of an additional protective earth ground terminal for power supply connection This equipment must always be electrically disconnected from the mains electrical supply before cleaning or disinfecting The Gendex expert DC equipment is classed as ordinary medical equipment without protection against ingress of liquids Water or any type of liquid cannot leak inside the Gendex expert DC as it may cause cor rosion and short circuit the equipment Explosion Safety The Gendex expert DC must not be used in the presence of flammable or potentially explosive disinfect ing gases or vapors which could ignite causing personal injury and or damage to the equipment If such disinfectants are used the vapor must be allowed to disperse before using the equipment Mechanical Safety If complete safeguarding of
6. Half Value Layer Greater than 1 5 mm Aluminum equivalent Nominal Focal spot size 0 4 mm IEC 336 1993 Anode angle 12 5 degrees Anode heat storage 7 kHU Duty cycle 1 30 4 2 Cone specifications The cone specifications consist of the following X ray Field Size Containable in a 6 cm diameter circle measured at the distal end of the installed cone Distance from the focal spot to the distal end of the cone is 8 or 12 20 or 30 cm U ER PEXPERTUM May 2007 ser Manual GENDEX Gendex expert DC 4 3 Power supply requirements The power supply requirements are presented in the following table Nominal Tolerance Useful Range 120 VAC 10 108 132 VAC 230 VAC 10 14 198 253 VAC Note If the line voltage falls outside the range proper operation may be jeopardized Contact an electri cal contractor in your area 4 4 Accuracy of technique factors The power supply requirements are presented in the following table Tube Potential 65 KV 3 kV Current 7 mA 5 Time 02 50 Seconds 005 Seconds 63 2 00 Seconds 1 4 5 Intraoral X ray tube housing Product Data Sheet Gendex expert DC The Gendex expert DC housing is designed to operate with the Gendex GX 70 10DC insert The housing has been designed to operate on the Gendex expert DC high frequency high voltage control making up the Gendex expert DC Intraoral Dental X ray system Physical Specifications Shockproof Hous
7. an authorized Gendex Dealer Technical Representative Contact your authorized Gendex Dealer Technical Representative to change the 8 20 cm cone to a 12 30 cm cone ser Manual U mm PEXPERTUM May 2007 GENDEX Gendex expert DC 2 5 Default exposure values anatomical exposure setting tables This section presents the default exposure time values for specific anatomy areas bitewing lower molar upper molar incisor and bicuspid Most values have been preset into the Gendex expert DC master control touch panel Occlusal exposure values are also shown in separate tables While there is no setting shown on the mas ter control touch panel for Occlusal exposures you can manually set the exposure values for Occlusal exposures by pressing the time up A or time down W arrows on the touch panel SP1 D Speed Film 8 20cm Cone 12 30cm Cone Anatomy Selected Adult Child Adult Child Bitewing 0 320 second 0 160 second 0 630 second 0 320 second Lower Molar 0 320 second 0 160 second 0 630 second 0 320 second Upper Molar 0 400 second 0 200 second 0 800 second 0 400 second Incisor 0 200 second 0 100 second 0 400 second 0 200 second Bicuspid 0 250 second 0 125 second 0 500 second 0 250 second SP2 E Speed Film 8 20cm Cone 12 30cm Cone Anatomy Selected Adult Child Adult Child Bitewing 0 200 second 0 100 second 0 400 second 0 200 second Lower Molar 0 200 second 0 100 second 0 400 seco
8. anatomy area Incisor Bicuspid Bitewing Lower Molar Upper Molar e Patient type adult or child The values exposure times with associated intraoral anatomy areas are preset at the Gendex factory The factory default settings are indicated an LED light appears next to each default selection on the master control touch panel when the touch panel is initially turned on for normal operation The default settings or standard factory configuration consists of the following standard 8 20cm focal length cone bitewing anatomical section and film media for an adult patient For all other exposure times the Gendex Factory Default Time Tables are provided in this chapter U Ea PEXPERTUM May 2007 ser Manual GENDEX Gendex expert DC The standard factory configuration presets can be changed from D speed film to E speed or F speed film from film to digital from adult to child or to a different type of digital imaging system The standard cone can also be changed to the optional 12 30cm cone Gendex Factory Defaults Default Feature Factory Default Configuration Can the default setting be changed Yes No Comment Cone 8 20cm Yes The 8 20cm cone is the standard cone for the Gendex expert DC The cone can be changed to an optional 12 30cm cone or to the optional rectangular 8 20 cm and 12 30cm cones The optional longer 12 30cm cone is used to sharpen the X ray image if the paral
9. basis Warning To avoid any potential hazard or danger to operators and patients contact your authorized Gendex Technical Representative immediately if you experience any unusual operation mechanical issues or equipment malfunction 5 2 Cleaning and disinfecting The Gendex expert DC can be cleaned and or disinfected using the following list of commonly used solutions Note Verify the contents of any cleaning or disinfecting solution against the list above before applying it to any surface of the Gendex expert DC e Isopropyl alcohol e Phenylphenl e Benzyl P Chlorophenol e lodophor e Disobutyl phenoxethoxycthyl Dimethyl Benzyl Ammonium Chloride Warning Only use bleach or glutaraldehydes occasionally U 25 PEXPERTUM May 2007 ser Manual GENDEX Gendex expert DC This page left intentionally blank U ES PEXPERTUM May 2007 ser Manual Compliance With Applicable Standards os S le C US This chapter presents compliance standards The Gendex expert DC complies with the following standards e General electrical mechanical safety e UL60601 1 File Number E185414 Medical Equipment with respect to electrical shock fire and mechanical hazards only in accordance with UL60601 1 IEC60601 1 CAN CSA C22 2 NO 601 1 M90 and to the following particular standards IEC60601 2 32 IEC60601 2 7 IEC60601 2 28 IEC60601 1 2 e Radiation protection IEC60601 1 3 Radiation protection X ray equipment The cer
10. in a typical com mercial or hospital environment Note Ur is the a c mains voltage prior to application of the test level EN PEXPERTUM May 2007 User Manual GENDEX Gendex expert DC e Table 204 Guidance and Manufacturer s Declaration electromagnetic immunity for all equipment and systems that are not life supporting see 6 8 3 201 b The Gendex expert DC is intended for use in the electromagnetic environment specified below The customer or the user of the Gendex expert DC must ensure that it is used in such an environment Table 204 Guidance and Manufacturer s Declaration Electromagnetic Emissions Immunity Test IEC 60601 Test Compliance Electromagnetic Environment Guidance Level Level Portable and mobile RF communications equipment should be used no closer to any part of the Gendex expert DC including cables than the recommended separation dis tance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3V d 12 P IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 Vim d 1 2VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3 P_ 800 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as deter mined by an electromagnetic
11. returning the arm to the storage position 2 Use the Quickset Tubehead Control to verify or modify the anatomical exposure settings 3 When you are ready to take an X ray exit the operatory Caution In order to comply with regulations and good safety practices the technique factors must be visible to the operator 4 Press and hold the Coil Cord Switch or Push Button Exposure Switch until the audible signal and X ray exposure indicator light terminates While the X ray is being emitted a yellow indicator light appears next to the Radiation Indicator Lamp on the master control touch panel Radiation Ready indicator lamp indicator lamp Push button exposure switch Cool Down Indicator lamp 65kV 7mA Note If you release the Coil Cord Switch or Push Button Exposure Switch prior to the completion of an exposure the process will immediately terminate with a partial exposure the Exposure Time Display will display an error code ErrO Press any key except the Exposure Switch on the master control panel to clear the error 5 When the audible signal and X ray exposure indicator light terminates return to the operatory and move the tubehead and cone away from the patient 6 Follow local practices to view and read film or digital X ray images U m PEXPERTUM May 2007 ser Manual GENDEX Gendex expert DC 2 4 Customize master control settings The factory default settings can be customized Changing the default settin
12. the On Off power switch to the On position The film or digital icon will be flashing An SP or D setting confirms that the system is in the media output programming menu a If the digital icon indicator is flashing no selection is required b To change to a different media type press the Imaging Type Selector to toggle to the digital icon N Press the time up A or time down W arrows until the LED displays D1 The D1 setting confirms that the system is now set for digital imaging a Press the anatomical time selector again to store the new setting The new time 0 160 seconds will be displayed for the bitewing the default anatomical selection U BER PEXPERTUM May 2007 ser Manual GENDEX Gendex expert DC To change to Digital D2 Press and hold the Anatomical Time Selector then turn the On Off power switch to the On position The film or digital icon will be flashing An SP or D setting confirms that the system is in the media type programming menu a If the digital icon indicator is flashing no selection is required b To change to a different media press the Imaging Type Selector to toggle to the digital icon N Press the time up A or time down W arrows until the LED displays D2 The D2 setting confirms that the system is now set for a CCD or CMOS type digital imaging receptor w Press the anatomical time selector again to store the new setting The new time 0 160 seconds will be dis
13. A Certification Complies with FDA radiation performance standards 21 CFR Subchapter J GendexeXpertDC 65kV 7mA ce M 0 4 IEC336 215mm Al 65 1EC522 0086 6 DTTTTTTTTTTTTTTTTTT 90 70 60 50 030 2 10 Q 10 2 30 40 50 60 70 80 90 A 1 Inside Tube Head under Cone Nr GX 70 10 DC SN REF 110 0210G1 SN Manufactured Des Plaines IL USA FN 7 Inside Cone AY Gendex Dental Systems Des Plaines IL USA Model 112 0951G1 Certification Complies with FDA radiation performance standards 21 CFR sub chapter J SN Manufactured fia N Des Plaines IL USA 8 Inch 20cm Beam Limiting Device FILE NAME 110 0207_2 CDR CA N 4 Under Converter Cover GENDEX ben systems c Des Plaines IL USA 0086 e SSI GENDEX expert oe REF 110 0205G1 Cc us CONTINUOUS OPERATION 16VL 34SL WITH INTERMITTENT LOADING INPUT VOLTAGE REQUIREMENTS lt gt 50 60Hz 115V 12 MAX MOMENTARY RATING 8A 4 en Certification Complies with FDAradiation performance standards 21 CFR Subchapter J Medical Equipment UL60601 1 IEC60601 1 IEC 60601 1 3 IEC 60601 2 7 IEC 60601 2 28 CAN CSA C22 2 No 601 1 ov 05A CLASS 1 LONG TERM RATING 23 es A Manufactured Des Plaines IL USA J am E ir PEXPERTUM May 2007 ser Manual GENDEX Gendex expert DC 6 3 References Gendex expert Installation Manual Gendex Visualix eHD Sensor
14. Manual Gendex expert DC USB Extender Kit Part Number 112 1220G1 6 4 Contact information GENDEX USA Gendex Dental Systems 901 W Oakton Street Des Plaines IL 60018 1884 Tel 888 275 5286 Fax 847 550 1322 European Representative KaVo Dental GmbH Bismarckring 39 Biberach Germany Tel 49 7351 56 0 Fax 49 7351 56 1488 U EN PEXPERTUM May 2007 ser Manual Gendex Dental Systems 901 West Oakton Street Des Plaines IL 60018 Customer Service 1 888 275 5286 Technical Support 1 800 769 2909 European Representative KaVo Dental GmbH Bismarckring 39 Biberach Germany Tel 49 7351 56 0 Fax 49 7351 56 1488 2007 Gendex Dental Systems PEXPERTUM Rev 1 May 2007
15. ar 0 100 second 0 050 second Incisor 0 050 second 0 025 second Bicuspid 0 063 second 0 032 second Note Settings are only applicable until they are changed by user selected values from 0 02s to 2 00s U KI PEXPERTUM May 2007 ser Manual GENDEX 3 3 3 4 Restoring anatomical factory default values To restore the factory default values follow the procedure 1 Turn off the Gendex expert DC Gendex expert DC 2 Press and hold the Anatomical Time Selector the Patient Selector and the Imaging Type Selector then turn the On Off power switch to the On position The LED display and the selector lamps will flash for 5 seconds then function will return to the normal operating mode The unit will be restored to the factory default values Error conditions The Gendex expert DC Master Control Touch Panel provides the user with the capability to manage some error conditions The green Ready lamp amber Cool down lamp and digital Exposure Time Display on the front of Gendex expert Master Control Touch Panel can provide indications that errors have occurred The following chart pro vides an explanation of what the indicators mean and the action that is needed to address the condition Error Condition Table Condition Explanation Action Required The amber Cool down Indicator Lamp comes on and exposure cannot be made Normal operation by design Cool down lamp comes on if too many exposures are made i
16. cond 0 063 second 0 250 second 0 125 second D2 Digital CCD or CMOS Type Receptors 8 20cm Cone 12 30cm Cone Anatomy Selected Adult Child Adult Child Bitewing 0 080 second 0 040 second 0 160 second 0 080 second Lower Molar 0 080 second 0 040 second 0 160 second 0 080 second Upper Molar 0 100 second 0 050 second 0 200 second 0 100 second Incisor 0 050 second 0 025 second 0 100 second 0 050 second Bicuspid 0 063 second 0 032 second 0 125 second 0 063 second Recommended Occlusal Image Exposure Times for Digital Receptors 8 20cm Cone 12 30cm Cone Digital Receptor Adult Child Adult Child D1 PSP Plate Receptors D2 CCD or CMOS Type Receptors 0 250 second 0 125 second 0 125 second 0 063 second 0 500 second 0 250 second 0 250 second 0 125 second eee EXPERTUM May 2007 Additional Customized Film and Digital Options 3 1 The Gendex expert DC Master Control Touch Panel provides the user with the capability to expand film and digital options The user can set and maintain custom anatomical presets for film and for digital imaging This chapter presents the following sections e Additional Film and Digital Customization e Default Exposure Values for Customized Film and Digital Settings Anatomical Time Setting e Restoring Customized Anatomical Exposure Times to Factory Default Values e Error Cond
17. d patient Depending on the selection made the unit auto matically modifies the anatomical exposure time Imaging Type Selector A toggle function that allows the user to select between the use of film or a digital imaging receptor Depending on the selection made the unit automatically modifies the anatomical exposure time 6 Gendex expert DC Ready Indicator Lamp Indicates that the On switch has been pushed and the unit is ready for operation Cool Down Indicator Lamp Warning light This lamp will illuminate when the tubehead becomes heated indicating that the tubehead needs to cool before the next exposure can be taken Radiation Indicator Lamp Warning light This lamp will illuminate when the exposure button is pressed and X ray radiation is being produced Push Button Exposure Switch Allows the user to activate an exposure on the master control touch panel 10 Coil Cord Exposure Switch Not Shown 11 12 Allows the user to exit the operatory and then activate an exposure Quickset Tubehead Control Allows the user to select the anatomical exposure times directly at the tubehead Also allows the user to select the patient type The selections are indicated according to the corresponding LED light On Off Power Switch Switching to the On position supplies power to the unit The Ready Indicator Lamp on the master control touch panel indicates that the unit is ready for use
18. e to Cathode 65 kV Voltage Anode to Ground 70 kV Thermal Characteristics e Housing Heat Storage Capacity 250 kHU s 177J see graph for more detail e Maximum Cooling Rate 3 3 kHU s Min Heat Units kV mA time in seconds 1 4 Gendex expert DC Housing Heating amp Cooling Chart 45 7 300 O 40 250 3 ine Heabng 100 Duty Cycle x 35 A bien H 200 Y 5 a 150 2 amp 30 E Sej ES pro 5 204 0 SPP E PL PPS E PP PFEFFER time mun U EN PEXPERTUM May 2007 ser Manual GENDEX Gendex expert DC This page left intentionally blank U EJ PEXPERTUM May 2007 ser Manual Maintenance To ensure a safe and functional Gendex expert DC product a maintenance program must be established It is the owner s responsibility to arrange for maintenance service and to ensure that the personnel performing the maintenance are fully qualified to service Gendex expert DC equipment This chapter presents the following sections e Equipment Maintenance e Cleaning and Disinfecting 5 1 Equipment maintenance Calibration and function checks must be performed on the Gendex expert DC at installation and on a yearly basis The calibration and function checks are listed in the System and Function Checks section of the Gendex expert DC Installation manual supplied with the product Gendex recommends that cleaning and general maintenance be performed on the Gendex expert DC on a routine
19. est Compliance Electromagnetic Environment Guidance RF emissions Group 1 The Gendex expert DC uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The Gendex expert DC is suitable for use in all CISPR 11 establishments including domestic establishments Harmoni emissions and those directly connected to the public low voltage IEC 61000 3 2 Class A power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions Complies IEC 61000 3 3 EJ PEXPERTUM May 2007 User Manual GENDEX Gendex expert DC e Table 202 Guidance and Manufacturer s Declaration electromagnetic immunity for all equipment and systems see 6 8 3 201 a 6 The Gendex expert DC is intended for use in the electromagnetic environment specified below The customer or the user of the Gendex expert DC must ensure that it is used in such an environment Table 202 Guidance and Manufacturer s Declaration Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the rela
20. fication labels The Gendex expert DC Tubehead Master Control and Cone have identification labels that specify the model number serial number and applicable product approval listings On specified components subject to U S Government Radiation Performance Standards 21 CFR Subchapter J a certification statement is included with other required information LT ig 9 I Under Center Joint REF 112 1194G1 SN e lt a 3 GE 4 z 2 NDEX CAUTION X RAYS TO BE OPERATED ONLY BY AUTHORIZED PERSONNEL SEE OPERATOR S INSTRUCTIONS ATTENTION RAYONS X OPERATION SEULEMENT PAR DU PERSONNEL AUTORISE VOIR MANUEL DE L OPERATEUR WARNING THIS X RAY UNIT MAT BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED ON PON 2 Under End Cap SS eee Certification Complies with FDA radiation REF 112 1192G1 performance standards 21 CFR Subchapter J C SN Gendex Dental Systems Des Plaines IL USA 0086 faa Medical Equipment REF 110 0205G1 te A UL60601 1 IEC60601 1 IEC 60601 1 3 c us IEC 60601 2 7 IEC 60601 2 28 CAN CSA C22 2 No 601 1 AVES es CONTINUOUS OPERATION WITH INTERMITTENT LOADING INPUT VOLTAGE REQUIREMENTS CLASS 1 TYPE b WZ 50 60Hz 15V 230v LONG TERM RATING OSA 03A A x MAX MOMENTARY RATING BA 4A 2 Under Yoke EY Gendex Dental Systems Des Plaines IL US
21. ges will not be saved and the unit will return to normal operation 2 Press the time up or time down arrows until the LED displays SP2 The SP2 setting confirms that the unit is now set for E speed film 3 Press the Anatomical Time Selector again to store the new setting The new time 0 200 seconds will be displayed for the bitewing the default anatomical selection Orr rr ser Manual PEXPERTUM May 2007 GENDEX Gendex expert DC To change to F Speed 1 Press and hold the Anatomical Time Selector then turn the On Off power switch to the On position The film or digital icon will be flashing An SP or D setting confirms that the unit is in the media output programming menu a If the film icon indicator is flashing no selection is required b To change to a different media type press the Imaging Type Selector to toggle to the film icon Time selectors Anatomical time selector Imaging type selector 2 Press the time up A or time down W arrows until the LED displays SP3 The SP3 setting confirms that the system is now set for F speed film 3 Press the Anatomical Time Selector again to store the new setting The new time 0 125 seconds will be displayed for the bitewing the default anatomical selection To change to Digital D1 Note When the digital icon is selected the system automatically uses exposure times associated with digital D1 or D2 Press and hold the Anatomical Time Selector then turn
22. gs for film or digital speed You can change the default D speed film SP1 to E speed SP2 or F speed SP3 film or to digital PSP digital receptor DI or CCD or CMOS digital receptor D2 The following table captures the film and digital choices to produce quality X ray images Displayed on LED Speed Media Output Film and Digital Exposure Times for the Bitewing Default SP1 D 0 320 SP2 E Film 0 200 SP3 F 0 125 D1 PSP Sen 0 160 D2 CCD or CMOS 9 0 080 Note Refer to the Default Exposure Values Anatomical Exposure Settings Table in this chapter When a different film or digital speed is selected the unit automatically uses exposure times associated with the new selection Prerequisite Before you change film or digital speed make sure the unit is turned off To change to E Speed 1 Press and hold the Anatomical Time Selector then turn the On Off power switch to the On position The film or digital icon will be flashing and the LED will display SP1 SP2 SP3 D1 or D2 An SP or D setting confirms that the unit is in the media type programming menu a If the film icon indicator is flashing no selection is required b To change to a different media type press the Imaging Type Selector to toggle to the film icon Note When changing the media type you must quickly press the Imaging Type Selector If there is no keypad activity for 30 seconds the unit will not remain in the programming mode chan
23. ing Zinc hermetically sealed under vacuum with high dielectric insulating oil Inherent to the housing is an expansion chamber designed to provide adequate compensation for the full temperature range Operating Temperature 50 F to 100 F 10 C to 40 C Storage Temperature 40 F to 160 F 40 C to 70 C U EN PEXPERTUM May 2007 ser Manual GENDEX Gendex expert DC Inherent Filtration Thickness mm AHE mm Al Equivalent Material Min Max 65 kV Min Max Glass 1 27 1 91 0 51 0 65 0 97 Insulating Oil 6 5 7 7 0 08 0 52 0 62 Polycarbonate 16 4 16 7 0 09 1 48 1 50 Total 2 64 3 09 Radiation Output Technique 65kV 7mA 0 50sec Source to Detector Distance 229mm 9 410mR 125mR 3 55 mGy 1 05 mGy Typical Half Layer At 65kV 1 9mm Aluminum Leakage Radiation Complies to IEC 60601 1 3 IEC Section 29 204 Leakage Radiation Maximum continuous power input equals 1 400 heat units per min HU Min tube is the limiting factor HU Min kV x mA x 1 4 x Exp Time sec 60 1 400 HU Min 65 kV x 0 27mA x 1 4 x 60 sec X ray Coverage The insert target angle is 12 5 e Circular cone at 8 inches 200 mm SSD 60 mm Dia 0 3mm e Circular cone at 12 inches 300 mm SSD 60 mm Dia 0 3mm e Rectangular cone at 8 inches 200 mm SSD 36mm x 46mm 1 AHE Aluminum Half value Equivalent correlation 2 SSD Source to Skin Distance Weight 13 0 lbs 5 9 kg Maximum Head Anod
24. itions Additional Film and Digital Customization To customize the preset film or digital options follow the procedure Note You will need to refer to the Default Exposure Values for Customized Programmable Film and Digital Settings Anatomical Time Setting in this section in order to input the recommended custom settings Prerequisite Before you change film or digital speed make sure the unit is turned off 1 Press and hold the Anatomical Time Selector and the Imaging Type Selector then turn the On Off power switch to the On position 2 Release the Anatomical Time Time Selector and the Imaging Type selectors Selector switches The LED display will show the current exposure time and you will see Anatomical the flashing lamps next to the time selector Anatomical Time Selector Imaging Type Selector and the Patient Selector The flashing Imaging type lights indicate that the unit is mea m in the customized program ming mode Patient selector U DA PEXPERTUM May 2007 ser Manual GENDEX Gendex expert DC 3 The film or digital icon will be flashing a If the correct film or digital icon is illuminated or flashing no selection is required b To change to a different media press the Imaging Type Selector to toggle to the film or digital icon Note If there is no keypad activity for 30 seconds the unit will not remain in the programming mode changes will not be saved and the unit will return to normal operati
25. l images to film or digital receptors Note If training is needed a Gendex expert DC dealer will provide training This chapter presents the following sections e Users e About this Manual e Explanation of Symbols e System Components e Safety 1 1 Users This manual is intended for trained dental professionals and authorized Gendex Dealer Technical Representatives 1 2 About this manual This manual provides information and instructions to enable users to operate the Gendex expert DC in a safe and effective manner Before operating the Gendex expert DC users must read this manual completely and adhere to all warnings and cautions described in this manual ser Manual U El PEXPERTUM May 2007 GENDEX Gendex expert DC 1 3 Explanation of symbols on technical labels Type B Protection against electric shock UL60601 1 2003 Consult written instructions in this User Manual X ray Source Assembly Warning X ray This X ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed X ray Emission Mains Hot Wire Mains Neutral Wire Earth Ground Electronic Equipment Do not recycle into normal trash x Oz E e Op User Manual PEXPERTUM May 2007 GENDEX Gendex expert DC 1 4 System components The Gendex expert DC consists of the following components Articulated Arm The tubehead can be positioned with an extended reach The 8 20cm co
26. leling technique is used The rectangular cone is used to reduce the X ray field size to that of the film Also the rectangular cone helps reduce radiation to the patient Film D speed Yes The default D speed film can be changed to E or F speed film If film will not be used the digital option is available Patient Type Adult Yes The default adult type patient can be changed to the child patient type Anatomy Setting Anatomical Exposure Time Bitewing Yes The default bitewing setting can be changed to one of the following selections e Incisor e Bicuspid e Bitewing e Lower Molar e Upper Molar am ee ser Manual PEXPERTUM May 2007 Master control touch panel The master control touch panel consists of the following features and functionality 1 Exposure Time Display Allows the user to view the anatomical exposure time and system infor mation Time Selector Allows the user to adjust the anatomical exposure time up or down W toa specific value The time up arrow and the time down arrow W allow the user to override the anatomical exposure time Anatomy Selection Anatomical Time Selector Allows the user to select the desired tooth area When the tooth area is selected the unit auto matically displays the anatomical exposure time for the desired area Patient Selector A toggle function that allows the user to select an adult or a chil
27. n a short period of time This feature protects and extends the life of the tubehead Wait until lamp goes out indicates that the tube has properly cooled down ErrO flashes on the Exposure Time Display The exposure has been terminated prematurely This can be caused by an equipment malfunction or the operator releasing the exposure switch prior to the end of the exposure time selected Pressing any key except the exposure switch on the master control touch panel will clear the display and restore normal operation Care must be taken to press and hold the exposure button until the exposure is finished Err1 flashes on the Exposure Time Display Power Supply voltage was outside of required range 108V 132V 198V 253V Wait until line voltage returns to nor mal indicated by the return to normal display rather than error indication or have a qualified electrician check the power line Err2 is displayed on the Exposure Time Display Power Supply voltage dropped below the minimum requirement 108V or 198V during the exposure The exposure is not terminated but X ray output may be low Pressing any key on the master control touch panel will clear the flashing and restore normal operation If the problem persists it is strongly recommended that a qualified electrician check the power line User Manual LE PEXPERTUM May 2007 GENDEX Gendex expert DC Condition Err3 fla
28. n provide complete protection nor prevent operators from expos ing themselves or others to unnecessary radiation Service Any user maintaining or servicing the Gendex expert DC unit will void the warranty Gendex strongly recommends that only authorized Gendex dealers maintain and service the Gendex expert DC Classification The Gendex expert DC is UL Class Type B equipment UL60601 1 2003 Authorized Representative Your Gendex dealer will assist you in placing the Gendex expert DC in operation For dealer opportunities or customer service contact the following European Representative GENDEX Dental Systems C KaVo Dental GmbH 901 West Oakton Street 0086 Bismarckring 39 Des Plaines IL 60018 1884 Biberach Germany Tel 888 275 5286 Tel 49 7351 56 0 Fax 847 550 1322 Fax 49 7351 56 1488 Copyright Documentation for Gendex expert DC and the operating software are copyrighted with all rights reserved Under the copyright laws this documentation may not be copied photocopied reproduced translated or reduced to any electronic medium or machine readable form in whole or part without the prior written permission of Gendex Dental Systems Gendex and Gendex expert DC are registered trademarks of Gendex Language The original language of this manual is English U 2 PEXPERTUM May 2007 ser Manual Overview The Gendex expert DC is a high frequency X ray system designed to produce gray scale intraora
29. nd 0 200 second Upper Molar 0 250 second 0 125 second 0 500 second 0 250 second Incisor 0 125 second 0 063 second 0 250 second 0 125 second Bicuspid 0 160 second 0 080 second 0 320 second 0 160 second SP3 F Speed Film 8 20cm Cone 12 30cm Cone Anatomy Selected Adult Child Adult Child Bitewing 0 125 second 0 063 second 0 250 second 0 125 second Lower Molar 0 125 second 0 063 second 0 250 second 0 125 second Upper Molar 0 160 second 0 080 second 0 320 second 0 160 second Incisor 0 080 second 0 040 second 0 160 second 0 080 second Bicuspid 0 100 second 0 050 second 0 200 second 0 100 second ey PEXPERTUM May 2007 User Manual GENDEX Gendex expert DC Recommended Occlusal Image Exposure Times For Film Receptors 8 20cm Cone 12 30cm Cone Film Speed Adult Child Adult Child SP1 D Speed 0 500 second 0 250 second 1 00 second 0 500 second SP2 E Speed 0 320 second 0 160 second 0 630 second 0 320 second SP3 F Speed 0 200 second 0 100 second 0 400 second 0 200 second D1 Digital PSP Plate Receptors 8 20cm Cone 12 30cm Cone Anatomy Selected Adult Child Adult Child Bitewing 0 160 second 0 080 second 0 320 second 0 160 second Lower Molar 0 160 second 0 080 second 0 320 second 0 160 second Upper Molar 0 200 second 0 100 second 0 400 second 0 200 second Incisor 0 100 second 0 050 second 0 200 second 0 100 second Bicuspid 0 125 se
30. ne has a reach of e 59 149cm e 69 175cm e 79 200cm The optional 12 30cm cone has a reach of e 55 140cm e 65 165cm e 75 191cm Master Control Touch Panel Allows the user to set specific exposure values based on the anatomical area and view system conditions Tubehead e Focal spot indicated by raised features on cover e Secondary operator controls Cone e Standard 8 20cm focal length e Optional 12 30cm e Optional Rectangular 8 20cm or 12 30cm 1 5 USB connection The Gendex expert DC features an integrated universal serial bus USB connection The USB is a pass though connection designed to work with the Gendex expert DC USB Extender Kit and the VisualiX eHD sensor system The Gendex expert DC USB Extender Kit is the only reliable way to implement the USB option No other USB cables USB active extensions or USB hubs are supported with this system For more information about the USB connection refer to the Gendex expert DC USB Extender Kit Part Number 112 1220G1 ser Manual U Le PEXPERTUM May 2007 GENDEX Gendex expert DC 1 6 Safety Prior to operating the Gendex expert DC all laws regulations and preventative measures must be carefully read and addressed for the following conditions e Radiation e Electrical e Explosion e Mechanical Radiation Safety Only qualified and authorized personnel may operate the equipment while observing all laws and regula
31. nvironment in which radiated RF disturbances are controlled The customer or the user of the Gendex expert DC can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Gendex expert DC as recommended below according to the maximum output power of the communications equipment Table 206 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Equipment or System Rated Maximum Separation Distance according to Frequency of Transmitter Output Power m of Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz W d 1 24P d 1 24P d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 78 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies J User Manual PEXPERTUM May 2007 GENDEX Gendex expert DC 6 2 Identi
32. ody No 0086 Signed Date 3 lel 007 ser Manual Mari Lambert Manager of Regulatory Affairs U ER PEXPERTUM May 2007 GENDEX Gendex expert DC The Gendex expert DC classified as Medical Electrical Equipment requires special precautions regarding EMC and must be installed and put into service according to the EMC information provided in the accompanying product documentation Portable and mobile RF communications equipment can effect Medical Electrical Equipment The Gendex expert DC complies with EMC requirements when used with the cables and accessories supplied with the product The use of accessories and cables other than those sold by Gendex Imaging and specified as replacement parts for internal components may result in increased emissions or decreased immunity of the Gendex expert DC The Gendex expert DC should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the Gendex expert DC should be observed to verify normal operation in the configuration in which it will be used e Table 201 Guidance and Manufacturer s Declaration electromagnetic emissions for all equipment and systems see 6 8 3 201 a 3 The Gendex expert DC is intended for use in the electromagnetic environment The customer or the user of the Gendex expert DC must ensure that it is used in such an environment Table 201 Guidance and Manufacturer s Declaration Electromagnetic Emissions Emissions T
33. on 4 Select the anatomical type and the patient type you wish to set 5 Using the time up or time down arrows set the exposure value until the desired value is displayed for the anatomical setting the patient type and the imaging type you selected 6 To set additional custom values for anatomical patient and imaging values repeat steps 1 5 7 To exit the programming mode press the Anatomical Time Selector and then the Imaging Type Selector together to exit and return the unit to operation Note The imaging type startup default will be the last selected media output when the programming mode was exited The patient type default will be the last selected patient type 32 Default Exposure Values for Customized Programmable Film and Digital Settings Anatomical Time Setting This section presents the default values for specific anatomical areas bitewing lower molar upper molar incisor and bicuspid using custom film and digital imaging options Customized Film Factory Setting Any Size Cone Adult Child Anatomy Selected Bitewing 0 125 second 0 063 second Lower Molar 0 125 second 0 063 second Upper Molar 0 160 second 0 080 second Incisor 0 080 second 0 040 second Bicuspid 0 100 second 0 050 second Customized Digital Factory Setting Any Size Cone Anatomy Selected Adult Child Bitewing 0 080 second 0 040 second Lower Molar 0 080 second 0 040 second Upper Mol
34. played for the default bitewing the default anatomical selection Changing the default Power On option from Adult Patient to Child Patient When the Gendex expert DC is first turned on the adult patient is the default patient type If desired the unit can be modified to automatically select the child patient as the default patient type To change the factory default follow the procedure Note When a patient type Is specified by the user the unit automatically uses the corresponding exposure time value for the selected patient 1 Switch the On Off power switch to the On position The Ready Indicator Lamp on the front of the master control touch panel will be lit 2 Press the Patient Selector until the green light is lit next to the child option 3 Turn off the Gendex expert DC The unit will automatically select the child patient option when it is turned on again Note The last patient type selected during normal operation will be the default selection at the next startup Modifying the Unit for the Optional 12 30 cm Cone The Gendex expert DC uses the 8 20 cm cone The 12 30 cm long cone is recommended when using the paralleling film positioning technique with X ray positioning devices Gendex recommends using the 12 30 cm cone when longer exposure times are needed The exposure times for the 12 30 cm cone can be selected by changing an internal electrical setting However the modification can only be performed by
35. ray System provides a high degree of protection from unneces sary radiation However no practical design can provide complete protection nor prevent operators from exposing themselves or others to unnecessary radiation U EN PEXPERTUM May 2007 ser Manual GENDEX Gendex expert DC 6 1 EC Declaration of Conformity GENDEX DENTAL SYSTEMS 901 West Oakton Street Des Plaines IL 60018 1884 Phone 847 364 3931 Fax 847 718 0601 Authorized Representative Kavo Dental GmbH Bismarckring 39 Biberach Germany EC Declaration of Conformity Name Description of product Gendex eXpert DC REF Model s 110 0207G1 110 0207G2 110 0207G3 110 0207G4 110 0207G5 110 0207G6 Class IIb Reference Standards under which conformity is declared IEC 60601 1 W Al A2 IEC 60601 1 1 IEC 60601 1 2 IEC 60601 1 3 IEC 60601 1 4 IEC 60601 2 7 IEC 60601 2 28 IEC 60601 2 32 IEC 60336 TEC 60417 IEC 60552 IEC 60878 EN 1041 EN 980 ISO 13485 GENDEX Dental Systems declares that the products described herein meet all the applicable Essential Requirements of the EC Medical Device Directive 93 42 EEC in Annex I For Class IIb products described herein the product is manufactured inspected tested and released in accordance with the approved quality assurance system established in accordance with ISO 13485 and Annex Il of the EC Medical Device Directive under the supervision of the British Standards Institution a Notified Body carrying the Notified B
36. shes on Exposure Time Display Explanation A hardware fault has occurred Action Required Reset the unit by turning Off the power switch for 30 seconds and then turning On the power switch If the problem persists contact your authorized Gendex Dealer Technical Representative Err4 flashes on the Exposure Time Display A fault has occurred and terminated the exposure Pressing any key except the exposure switch on the master control touch panel may clear the Error and restore normal operation If the problem per sists contact your authorized Gendex Dealer Technical Representative U EN PEXPERTUM May 2007 ser Manual Gendex expert DC Specifications This chapter presents specifications for the Gendex expert DC Cooling and duty rating specification apply at altitudes up to 12 000 ft 3 600 m average relative humidity not exceeding 90 percent and maximum ambient temperature not exceeding 104 degrees F 40 degrees C This chapter presents the following sections e Tubehead Specifications e Cone Specifications e Power Supply Requirements e Accuracy of Technique Factors e Intraoral X Ray Tube Housing Product Data Sheet 4 1 Tubehead specifications The tubehead specifications consist of the following Maximum Rated Tube Potential 65 kV at 7 mA tube current Leakage radiation in the loading state Less than 250 micro Gy h at 1 meter from the focal spot Minimum permissible first
37. site sur vey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Gendex expert DC is used exceeds the applicable RF compliance level above the Gendex expert DC should be observed to verify normal operation If abnormal performance is observed addi tional measures may be necessary such as re orienting or relocating the Gendex expert DC gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than V V m EN PEXPERTUM May 2007 User Manual GENDEX Gendex expert DC Table 206 Recommended separation distances between portable and mobile RF communications equipment and the equipment or system The Gendex expert DC is intended for use in an electromagnetic e
38. the Gendex expert DC is not possible extreme care must be taken to ensure that no body part especially fingers or clothing of the operator or the patient can be trapped or injured by any part of the equipment Make sure that fingers are not caught or pinched in the articulated arm when closing it Le PEXPERTUM May 2007 User Manual Setup and Operation The Gendex expert DC Master Control Touch Panel contains a microprocessor The microprocessor enables and controls exposure values for film and digital imaging receptors This chapter presents the following sections e Master Control Function e Setup e Operation e Customize Master Control Settings e Default Exposure Values Anatomical Exposure Times Tables 2 1 Master control function The Gendex expert DC Master Control Touch Panel provides the following function e Preset anatomical time settings e Single button selection for patient type e Single button selection for film or digital imaging receptor e Customization capability Preset anatomical time settings allow the user to choose technique values corresponding to imaging type anatomical area or patient type selections The anatomical time settings are based on the following criteria e Media type exposure time Film speed SP D E F or digital imaging PhotoStimulable Phosphor System PSP digital D 1 Charged Coupled Device CCD or Complementary Metal Oxide Semiconductor CMOS Systems D2 e Intraoral
39. tified components of the Gendex expert DC system comply with Radiation Performance Standards 21 CFR Subchapter J at the time of manufacture Warning The equipment must be installed and operated in accordance with the safety procedures and oper ating instructions given in this User Manual and in the Gendex Installation Manual for the purposes and applications for which it was designed Modifications 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 regula tions regarding installation of the equipment with respect to the building are observed X ray equipment may cause injury if used improperly It is extremely important that you be fully acquainted with all 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 Avenue Suite 800 Bethesda MD 20814 Personal radiation monitoring and protective devices are available You are strongly urged to use them to protect against unnecessary X ray exposure Note The Gendex expert DC Intraoral X
40. tive humidity should be at least 30 Electrical fast 2 kV for power 2 kV for power Mains power quality should be that transient burst supply lines supply lines of a typical commercial or hospital environment IEC 61000 4 4 1 kV for 1 kV for input output lines input output lines Surge 1 kV differential 1 kV differential Mains power quality should be that mode mode of a typical commercial or hospital IEC 61000 4 5 environment 2 kV common mode 2 kV common mode Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ur gt 95 dip in Uy for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Uy for 5 sec lt 5 Ur gt 95 dip in Uy for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Uy for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the Gendex expert DC requires continued operation during power mains interruptions it is recom mended that the Gendex expert DC be powered from an uninter ruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels characteristic of a typical location
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