Gendex DenOptix QST Operator'S And Service Manual Download Page 23

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User and Service Manual

Doc # M010-004WWE July 2005

Gendex DenOptix® QST

4.4

Computer requirements

4.5

Electrical requirements

Minimum Computer Requirements

Recommended

CPU Speed

800 MHz

Pentium 4 2.4 GHz

Operating system

Microsoft® Windows® 2000 /XP Pro

Microsoft® Windows® XP Pro

SP2

RAM

128 MB

256+ MB

Hard Drive

6 GB

40+ GB

USB port

USB 2.0

Monitor

S-VGA with 0.25mm/0.26mm

dot pitch

Video Display Adapter

4 MB RAM, 800 x 600 display,

8+ MB RAM, 1024x768

true color

Keyboard, Mouse

Standard

Backup Device

Highly recommended

Printer

Recommended (see appendix C)

Voltage

100-240 V AC 50/60 Hz power supply auto-senses the input voltage.

Power

110 watts maximum

Power Cord

Standard line cord provided (Medical Grade for 115V)

4.6

Compliance to standards

The DenOptix QST System conforms to the following standards:

Standard

Title

UL 60601-1

Medical Electrical Equipment, Part 1: General requirements for safety

21 CFR Chapter I

Performance Standard for Light-Emitting Products

Subchapter J

MDD 93/42/ECC

European Medical Device Directive (CE Mark)

CAN/CSA-C22.2

Medical Electrical Equipment, Part 1: General requirements for safety

No. 601.1

IEC 60601-1

Medical Electrical Equipment, Part 1: General requirements for safety

IEC 60601-1-2

Medical Electrical Equipment, Part 1: General requirements for
safety- Collateral standard; Electromagnetic Compatibility

IEC 60825-1

Safety of Laser Products

ISO 13485

Medical devices- Quality management systems

ISO 14971

Risk Analysis

To be evaluated based on the number of images taken, and the image file size used by the imaging software.

Summary of Contents for DenOptix QST

Page 1: ...Operator and Service Manual Manuale dell Operatore e Servizio Manuel de l Opérateur et de Service Gebrauschsanweisung Manual del Usuario y de Servicio DenOptix QST Phosphor Plate Technology ...

Page 2: ...Operator and Service Manual English Inglese Anglais Englisch Inglés ...

Page 3: ...ical description 15 4 4 Computer requirements 21 4 5 Electrical requirements 21 4 6 Compliance to standards 21 4 7 Installation 22 4 8 Site selection 22 4 9 Unpacking the unit 23 4 10 Hardware setup and connections 24 4 11 Network installation 25 5 System operating instructions 27 5 1 Preparing your current X ray equipment 27 5 2 Erasing the imaging plate 29 5 3 Infection control 30 5 4 Taking an ...

Page 4: ...tement 53 10 Technical specifications 55 11 Appendix 57 11 1 Appendix A Storage phosphor technology 57 11 2 Appendix B Lighting conditions for handling or erasing imaging plates 58 11 3 Appendix C Optional printer 61 11 4 Appendix D If you need assistance 62 2005 Gendex Dental Systems Gendex DenOptix QST AcuCam and Orthoralix are registered trademarks of Gendex Dental Systems Rinn XCP is a registe...

Page 5: ...ing plate technology offers the following benefits Diagnostic quality images every time Lowers the price of dental imaging by eliminating the need for costly film chemistry and film processors Imaging plates are reusable Saves critical time vs using processing systems DenOptix QST will process 4 bitewings in under 30 seconds and a FMX will process 20 images in less than 4 seconds per image Panoram...

Page 6: ...y you desire As you enjoy using the new DenOptix QST system you are taking advantage of our 50 years of manufacturing expertise in the dental industry Our motto speaks for itself Gendex Imaging Excellence Technical support Call your local Gendex location For a phone number please refer to page 62 Supplies and replacement parts To order supplies or replacement parts for your DenOptix QST contact yo...

Page 7: ...or imaging plates for radiographic diagnostic intraoral and extraoral exposures providing interactive CRT retrieval viewing and processing of stored computed radiographic images The system includes reusable photostimulable phosphor imaging plates a laser diode scan ner device and optical reader components communications electronics and software and various peripheral accessories 1 ...

Page 8: ...6 User and Service Manual Doc M010 004WWE July 2005 Gendex DenOptix QST ...

Page 9: ...7 User and Service Manual Doc M010 004WWE July 2005 Contraindications 2 There are no contraindications for use ...

Page 10: ...8 User and Service Manual Doc M010 004WWE July 2005 Gendex DenOptix QST ...

Page 11: ...long term health hazards to personnel or patients Cautions Any operation procedure or practice which if not strictly observed may result in destruction of equipment or loss of treatment effectiveness Warnings Should be used only by trained professional Federal law restricts the sale of this device to physicians dentists and dental professionals only Use of this device in procedures other than thos...

Page 12: ...t enclosing it first in a completely sealed barrier envelope If a patient swallows an imaging plate contact a physician immedi ately The physician must remove the imaging plate Do not use cracked bent or chipped imaging plates Never open or override the lid lock when the scanner is in use or plugged in The scanner lid will lock during operation In case of power failure unplug the scanner and open ...

Page 13: ...hting will erase the information stored on the imaging plate Do not place scanner on or next to a radiator or water source Excessive heat or small amounts of water may damage the scanner s electrical components Do not use in the presence of flammable anesthetics mixtures Do not autoclave the imaging plates Autoclaving will damage the imaging plate If this happens discard the imaging plate and repl...

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Page 15: ...oftware associated with the scanner can be found in the Imaging Software User Manual and Installation Guide Important instructions for personnel who have been trained in intraoral and panoramic radiography are contained in this manual This manual is not to be used as a replacement for training in dental radiography 4 1 Purpose of the manual AC Alternate current DC Direct current Hz Hertz cycles pe...

Page 16: ... Phosphor D P I Dots per inch CPU Central processing unit your computer IEC International Electrotechnical Commission Power on Power off Green indicator ready Yellow indicator scanning Red indicator error in scanning refer to operators manual High voltage Laser radiation RAM Random access memory MB Mega bytes GB Giga bytes USB Universal serial bus The CE symbol ensures that the product herein spec...

Page 17: ...log shown in the same row The Intraoral FMX and Extraoral EO models are upgradeable to the Combo COMBO system Contact your local Gendex representative for details In addition the Extraoral and Combo systems can be upgraded to Cephalometric by ordering the catalog number listed on the following table Note Buying some components such as imaging plates or carousels may not allow you to use them witho...

Page 18: ...16 User and Service Manual Doc M010 004WWE July 2005 Gendex DenOptix QST Table of models and components ...

Page 19: ...ousel lid must be in the closed position prior to scanning The scanner will not operate with the lid open 2 LED indicator lights with graphic symbols The lights show the current status of the system Green Ready to scan Yellow Blinking Scanning Red Error Figure 4 2 Scanner rear view 1 DenOptix QST scanner power entry module with switch and fuses 2 USB 2 0 connector A USB 2 0 cable provided connects...

Page 20: ...ntraoral imaging plates 1 IP serial number for tracking purposes 2 Date of manufacture 3 Available from Gendex Dental Systems 4 Solid orientation dot 5 IP size indicator Shows the equivalent film size 6 Orientation circle Visibly shows on final radiograph for faster orientation Rear Black Front Blue ...

Page 21: ...ates Panoramic Cephalometric 1 Plastic mounting strips used to hold panoramic imaging plate onto the carousel 2 Active imaging area white color 3 Patient left and right side indicators 4 General information that includes Available from Gendex Date of manufacture Imaging plate size IP serial number Rear Black Front Blue R L ...

Page 22: ...carousel can hold either the 5x12 in or the 15x30 cm imaging plate 4 Cephalometric imaging plate retaining device can hold either 8x10 in or 18x24 cm 5 I O imaging plate holders on the back of the Extraoral EO and Ceph CH carousel The carousel can hold up to four size 2 two size 0 and one size 4 imaging plates Figure 4 6 Disposable barrier envelopes 1 The front of the barrier envelope is blue This...

Page 23: ...maximum Power Cord Standard line cord provided Medical Grade for 115V 4 6 Compliance to standards The DenOptix QST System conforms to the following standards Standard Title UL 60601 1 Medical Electrical Equipment Part 1 General requirements for safety 21 CFR Chapter I Performance Standard for Light Emitting Products Subchapter J MDD 93 42 ECC European Medical Device Directive CE Mark CAN CSA C22 2...

Page 24: ...the light level about 10 20 lux If you need more than one minute refer to appendix B A stable flat countertop large enough to hold the scanner plus provide a working area We suggest a minimum of 189x369 in 46x92 cm The computer does not need to be on the countertop but must be within the length of the USB 2 0 cable 9ft or 3m provided The countertop must be able to hold the weight of the unit or a ...

Page 25: ...DenOptix QST system as they re listed in the Table If any items are damaged or missing contact your dental dealer immediately Figure 4 7 Scanner 1 each Figure 4 10 Disposable Barrier Envelopes 500 Size 2 FMX and Combo units 200 Size 2 EO units Figure 4 8 Intraoral Carousel 1 each FMX and Combo units Figure 4 9 EO CH Carousel 1 each EO Combo units and Ceph upgrade Figure 4 11a Size 0 Imaging Plates...

Page 26: ...e power on to the monitor and computer Step 4 Connect the device end of the USB 2 0 cable to the USB 2 0 connector on the back of the DenOptix QST scanner Connect the scanner to a grounded power outlet Make sure the other end of the USB 2 0 cable is connected to the USB 2 0 port on the computer Step 5 Connect the computer to a network if desired Refer to your Imaging Software User Manual and Insta...

Page 27: ... QST 4 11 Network installation Refer to your network computer professional for network installation configuration and maintenance Refer to your Imaging Software User Manual and Installation Guide for more information on how to configure the Imaging Software in a network ...

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Page 29: ...es produce excellent diagnostic images over a wide range of exposures With the DenOptix QST system it is possible to get diagnostic images at the same exposure time you use for X ray film or as much as 80 reduction of the dose required for D speed film This means that it is more difficult to over or under expose an image We recommend how ever that you start with the exposure times outlined in the ...

Page 30: ... Total inherent filtration 2 mm Al equip Unless the image is grossly over or under exposed image density can be corrected by sub sequent software processing contrast brightness see Imaging Software User Manual and Installation Guide 1 One impulse is equal to 017 sec at 60 Hz The recommended number of impulses can be adjusted as necessary for proper exposure resulting in adequate image density and ...

Page 31: ...e blue or white in color to direct intense light for 2 minutes Fluorescent light is highly recommended An effective way to erase the imaging plate is to use a lightbox such as the RINN Universal Viewer We recommend fixing the lightbox under a cabinet Make sure to lay the imaging plate down with the ACTIVE SIDE UP blue or white face facing the lightbox shining down Expose the plates to light for 2 ...

Page 32: ...old sterilize the imaging plates After erasing the imaging plates follow these directions Figure 5 1 Insert the imaging plate into the barrier envelope ensuring that the black side of the imaging plate can be seen through the clear side of the barrier envelope Pay careful attention to the location of the orientation dot Figure 5 2 With the imaging plate completely inserted seal the envelope by rem...

Page 33: ...position in the patient s mouth Make sure that the blue side front of the barrier envelope and therefore front of the imaging plate is toward the X ray source Wear appropriate gloves and protective attire We recommend the use of a positioning device The orientation dot should be posi tioned toward the occlusal surface for peri apical projections Fold back the barrier prior to inserting it into the...

Page 34: ... intraoral examination remove and dispose of gloves and move to a semi darkened room or area see Section 4 8 Remove lid and begin the process of loading the imaging plates Do not touch the transfer container with contaminated gloves Figure 5 7 Remove your gloves and wash any powder from your hands Mount the I O imaging plates onto the carousel by sliding the right side of the imag ing plate into t...

Page 35: ...reviously outlined for intraoral imaging but mount the I O imaging plates on the panoramic carousel When scanning a Pan or Ceph plate rotate the knob in the direction of Pan or Ceph When no pan or ceph is loaded rotate the knob in the direction of NO PAN or CEPH Figure 5 11 In a semi darkened room see Section 4 8 open the cassettes With the white surface pointed away from the carousel insert one s...

Page 36: ...late around the carousel and push the free end under the edge of the other clip Push until you hear a click Panoramic shown Figure 5 13 Open the carousel well cover on the DenOptix QST scanner and insert the carousel Close the cover You are now ready to scan your panoramic or cephalometric imaging plate ...

Page 37: ...in black will be skipped not acquired You can choose between 150 300 and 600 dpi Scan time will be longer as you chose high er dpi Make the appropriate choice by clicking on one of the combinations and then click ing on scan NOTE The more specific you are the faster the scan time will be For example scanning the top row takes less than 30 seconds at 300 dpi Scanning 20 imaging plates at 300 dpi ta...

Page 38: ...h and metric click IN or CM Choose your imaging plates by click ing on each of the imaging plate boxes you want to acquire and then clicking on scan The plates in black will be skipped not acquired To save the template click on the template menu choice and save When the scan is complete the I O images will appear on the screen Note if an error occurs during the scan the scanner will stop Follow th...

Page 39: ...the outside of the DenOptix QST scanner has been touched by a contaminated surface it must be cleaned BEFORE PROCEEDING TURN THE SCANNER OFF AND DISCONNECT FROM THE POWER OUTLET The outside of the scanner can now be wiped with a towel dampened with cold sterilizing solution and then allowed to air dry DO NOT SPRAY OR SOAK THE SCAN NER If necessary wipe the inside of the carousel well with a cloth ...

Page 40: ...ogress is complete and the green light is on 2 Save any changes you have made and close down the imaging software for example VixWin Pro software To protect your data frequently back up your files 3 Turn the power switch in the back of the scanner to the Off position 4 Turn off all computer components following any instructions from the manufacturer If you live in an area of frequent thunderstorms...

Page 41: ...6 The DenOptix QST imaging systems can operate with different imaging software For example VixWin imaging software from Gendex optimizes digital X ray images from the DenOptix QST systems Please refer to your Imaging Software User Manual and Installation Guide for detailed instructions ...

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Page 43: ... well DO NOT SPRAY OR SOAK THE SCANNER Wipe the inside of the carousel well with a very slightly damp cloth Be careful not to allow running or dripping solvents into the DenOptix QST scanner This could cause damage to the electronics inside Allow to air dry before plugging in or turning back on Cleaning imaging plates Imaging plates should be handled carefully For the best images take care not to ...

Page 44: ...e carousel Figure 7 2 Spray the soiled surfaces of the imaging plate holder and carousel with a general household non abrasive cleaner or soap and water Do not use strong alkaline or ammonia based cleaners Wipe clean and allow to air dry Figure 7 3 Insert the dry imaging plate holder under the vertical plastic retention piece on the carousel Slightly tighten the screws to hold the first side in pl...

Page 45: ...on Do not use strong alkaline or ammonia based cleaners Wipe clean and allow to air dry If the intraoral imag ing plate holder is soiled remove it by removing both vertical plastic retention pieces by removing the three screws on each side and following the same instruc tions as for the intraoral image plate holder cleaning Clean with the general household non abrasive spray or soap and water Allo...

Page 46: ...ff as per Section 5 7 Unplug the power cord and USB 2 0 cable WARNING To avoid possible electrical shock ensure that the power cord is unplugged Figure 7 6 Insert a small flat tipped screwdriver into the top of the fuse cover on the back of the scanner Pry the top of the connector open Figure 7 7 Remove the fuse holder Change both fuses Ensure that new fuses meet the following spec ifications 250 ...

Page 47: ...local Gendex dealer The damaged holder can be removed and the new holder mounted as described in Section 7 1 Imaging plate maintenance The DenOptix QST imaging plates have no operator serviceable parts Lubrication The DenOptix QST Digital System might occasionally require lubrication If the scanner should start to squeak during scanning please contact your local Gendex dealer Do not position the D...

Page 48: ...ice representative Ensure that the outlet is grounded and has power 7 3 Troubleshooting Gendex DenOptix QST Lid is Locked System is scanning Power Failure or lack of power Wait for scanning to end before attempting to open the lid DO NOT OVERIDE THE LOCKING MECHANISM DURING SCAN NING Unplug the scanner from the power source Slide a thin tool or credit card into the gap between the lid and the scan...

Page 49: ... lid Reconnect the cable Check for tightness Swap with a known good cable if possible Turn off the scanner and re install the DenOptix QST systems software driver Turn the unit on Call your service representative After scanning no image appears on the monitor There are no imaging plates on the carousel The imaging plate is mounted backwards on the carousel The imaging plate was erased prior to sca...

Page 50: ...dling of the imaging plates Increase the amount of time that is used to erase plates Alternatively increase the inten sity of the light source To test if an imaging plate is completely erased simply mount an erased plate on a carousel and scan it If no image is obtained your procedure is effective at com pletely erasing imaging plates Insure the imaging plates are inserted properly into the barri ...

Page 51: ...e barrier envelope did not seal properly After the protective strip covering the adhesive on the barrier envelope was removed the adhesive was touched or picked up dirt Immediately seal the barrier envelopes after removing the adhesive strip Imaging plates fall out into the DenOptix QST scanner carousel well The imaging plates have not been loaded properly See Section 5 4 for more information Prac...

Page 52: ...cycle Comments Plastic Barrier Envelopes No Dispose of with other Carousel Latches No non recyclable plastic items Holders for I O Plates No Aluminum Housing Optic Module Yes Remove all non aluminum Carousels Yes parts before recycling Scan Engine Frame Yes Carriage Optic Module Yes Storage Phosphors I O Imaging Plates No Contain barium which may be Panoramic Imaging Plates No regulated Contact yo...

Page 53: ... the scanner to come back to room temperature Then follow the guidelines outlined in Section 5 8 1 Storage The DenOptix QST System is designed to be shipped in its original shipping container by normal commercial carriers Ensure that the carousel has been removed from the scanner and that the carousel well is empty If the system is to be moved long distances or under adverse conditions it should b...

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Page 55: ... repaired or replaced at our option The DenOptix QST Scanner and Carousels must be installed and operated in accordance with the Gendex written instruc tions furnished with the unit DenOptix QST imaging plates The DenOptix QST Imaging Plates are designed expressly for use with the DenOptix QST scan ner DenOptix QST Imaging Plates will be replaced if defective in manufacturing or packaging only Wit...

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Page 57: ...5 Class 1 Laser Device Operating Conditions 15 to 35 C 59 to 95 F 5 95 RH NC Storage and Shipping 40 to 70 C 40 to 158 F Temperatures Class I Grounded For Indoor Use Only Suitable for continuous operation DenOptix QST intraoral imaging plates Size 0 Size 1 Size 2 Size 3 Size 4 I O dimensions 22x35 mm 24x40 mm 31x41 mm 27x54 mm 57x76 mm Recommended Dose Significant reduction in relation to typical ...

Page 58: ...metric imaging plates Dimensions Pan 5x12 in 15x30 cm Ceph 8x10 in 18x24 cm Recommended Dose Equal to standard panoramic systems equipped with rare earth intensifying screens 400 speed Storage Store in their clear plastic shipping envelope Operating and 18 to 35 C 64 to 95 F 5 80 RH NC Storage Conditions ...

Page 59: ...at the timer on your intraoral X ray source can be turned down to a very low level without affecting the image quality How storage phosphor imaging plates work Each DenOptix QST Imaging Plate is made up of a very thin layer of tiny storage phosphor crystals that are bonded together and coated on a flexible sheet of plastic These storage phosphor crystals have the ability to capture the energy of X...

Page 60: ...erprets the blue light and changes it into a digital image light is used to erase the residual information from the imaging plate Between X ray exposure and scanning however one must be careful handling the imaging plates An imaging plate should never be removed from its protective barrier and exposed to a strong source of light This act would erase the latent image from the plate Therefore you mu...

Page 61: ...g plates for periods of time longer than suggested does not harm them A good place to store your imaging plates is under the erasing light source Fluorescent lights We recommend using fluorescent lights for erasing imaging plates A lightbox typically gives off between 1000 and 5000 lux Measure your lightbox and use the lowest value to deter mine the erasing time At 1000 lux an imaging plate will b...

Page 62: ... Record the erasing time that resulted in no image This is the time required to erase an unscanned imaging plate 8 Repeat steps 1 4 This time under low light conditions remove the imaging plates from the barrier envelopes and mount them on a carousel Scan the imaging plates 9 Remove the scanned imaging plates and place them in the dark into a light protected area such as a light tight drawer 10 No...

Page 63: ...esolution and pseudo randomic dithering We recommend using the photographic quality glossy paper and printing on the highest resolution setting available Thermal printers Thermal printers print in shades of grey with at least 64 levels Thermal printers use a special type of paper which guarantees a print life of about 3 years Dye sublimation printers Suitable for high printing quality whenever the...

Page 64: ...Fax 1 847 640 5310 www gendex com Europe Italia European Headquarters KaVo Dental Gendex Dental Systems Via A Manzoni 44 20095 Cusano Milanino MI Tel 39 02 618008 1 Fax 39 02 618008 09 www gendex dental com Deutschland KaVo Dental Gendex Dental Systems GmbH Albert Einstein Ring 15 22761 Hamburg Tel 49 40 899688 0 Fax 49 40 899688 19 www gendex de France KaVo Dental Division Imagerie Gendex ZAC Par...

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