Gendex GXDP-700 User Manual Download Page 1

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ENGLISH

Digital Panoramic X-Ray System

User Manual

207723 rev.

GXDP-700™

Approved: Laihonen Tuuli 2016-12-02 16:41

Reviewed: Nieminen Timo Antero 2016-12-02 15:31

Approved

See PDM system to determine the status of this document. Printed out: 2017-03-22 10:54:38

D507729, 7

Summary of Contents for GXDP-700

Page 1: ...v 7 GXDP 700 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 2: ...2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 3: ...mission of Gendex Dental Systems The original language of this manual is English Gendex Dental Systems reserves the right to make changes in specification and features shown herein or discontinue the product described at any time without notice or obligation Contact your Gendex Dental Systems representative for the most current information Manufactured for Gendex Dental Systems 1910 North Penn Roa...

Page 4: ...uuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 5: ...aging programs 23 3 1 Standard Panoramic programs 23 3 2 Advanced Panoramic programs 26 3 3 Default exposure settings 29 3 4 User Configurable Default Program 29 3 5 Cephalometric programs 30 3 6 3D programs 32 3 7 SRT Scatter Reduction Technology 33 3 8 Exposure settings for 3D imaging 34 4 Controlling the unit 35 4 1 Main control panel 35 4 2 Modality section 36 4 3 Exposure settings 36 4 3 2 Pa...

Page 6: ... errors 69 5 6 2 Image transfer errors 69 6 Troubleshooting 71 6 1 Patient positioning 71 6 2 Image appearance 74 6 3 Artifacts 75 6 4 Unit operation 77 7 Maintenance 79 7 1 Maintenance procedure 79 7 1 1 Annual maintenance 79 7 1 2 Calibration intervals 79 7 2 Changing the fuses 80 7 3 Cleaning and decontaminating the unit 80 8 Calibration and adjustment 83 8 1 Introduction 83 8 2 Preparing for c...

Page 7: ...9 7 Scatter radiation measurement 120 9 7 1 Scatter radiation in panoramic program 121 9 7 2 Scatter in cone beam programs 122 9 7 3 Scatter radiation in ceph program 123 10 PC requirements 125 10 1 Minimum PC requirements 125 10 2 The dental imaging software 128 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status ...

Page 8: ...uli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 9: ...projection axially corrected Maxillary sinus Frontal dentition Orthogonal panoramic Cephalometric optional Cephalometric latero lateral LL projection Cephalometric PA AP projection Carpus program optional Not available in USA and Canada 3D H x W optional 61x41 mm Field of View 61x78 mm Field of View NOTICE The FOV heights are maximum values measured at the center of the FOV the measured height at ...

Page 10: ...4 Associated documentation GXDP 700 user manual GXDP 700 installation manual GxPicture Driver software installation manual The user manual supplied with the dental imaging software e g VixWin The installation manual supplied with the dental imaging software e g VixWin The user manual supplied with the 3D imaging software e g InVivo The installation manual supplied with the 3D imaging software e g ...

Page 11: ... are interested to examine FH Frankfort Horizontal H Horizontal DRT Dose Reduction Technology SRT Scatter Reduction Technology reduces the effect of metal and other dense radiopaque objects which typically create artifacts that are seen as stripes and shadows Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of t...

Page 12: ...d for checking that the unit doesn t hit the patient Operator should maintain visible contact with the patient and technical factors This allows immediate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance It is the responsibility of the doctor to decide whether x ray exposure or any additional exposures are justified and necessary The minim...

Page 13: ...onment fulfills the requirements listed in the Installation manual Special attention must be paid to the strength of the floor and wall materials electrical mains and radiation protection It is the responsibility of the customer to ensure that the site is large enough for the patients The unit contains toxic materials that need to be handled properly when disposing the unit Return the unit to the ...

Page 14: ...socket shall not be placed on the floor To avoid the risk of electric shock the unit must only be connected to a supply mains with protective earth The site must fulfill the environmental requirements in the installation manual chapter technical specifications There should be free space around the unit for safe operation The PC Ethernet switch to which the unit is connected should be approved appr...

Page 15: ...nd symptoms 3D imaging examinations must be justified for each patient to demonstrate that the benefits outweigh the risks Where it is likely that evaluation of soft tissues will be required as part of the patient s radiological assessment the imaging should be done using conventional medical CT or MR rather than 3D imaging using Cone Beam technology Cone beam computed tomography images are not ad...

Page 16: ...lead to a reduced level of safety of the resulting system If this device is used with 3rd party imaging application software not supplied by the manufacturer the 3rd party imaging application software must comply with all local laws on patient information software This includes the Medical Device Directive 93 42 EEC and or relevant legal requirements in the USA Do not connect any equipment to the ...

Page 17: ...its electronic boards inside Sensor covers EMC painted Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 18: ... 7 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 19: ...tch rear of car riage and main fuses 6 Tubehead assembly 7 Touchscreen display 8 Control panel 9 Sensor head 10 Head support 11 Chin rest 12 Handgrips 13 Cephalometric unit 14 Cephalometric sensor 15 Secondary collimator 16 Positioning panel 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 On off switch used to power the unit on and off and main fuses Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Niemin...

Page 20: ...c sensor 1 3D sensor units with 3D option 2 Panoramic sensor 1 2 1 2 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 21: ...etric Horizontal laser 5 TMJ laser 6 Horizontal laser top of FOV 3D option only 7 Horizontal laser bottom of FOV 3D option only Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 22: ...r Frankfort Horizontal 1 Image layer laser 2 TMJ laser Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 23: ...ically on based on selected FOV 1 Midsagittal laser 2 Horizontal H light top of FOV 3 Horizontal H laserlight bottom of FOV Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 24: ...r Control Retrusion 6 Image Layer Control Normal position also use to reset position 7 Image Layer Control Protrusion 8 Chin support UP 9 Chin support DOWN 10 Reset button 1 2 3 4 5 6 7 8 9 10 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 20...

Page 25: ...r keys allow the operator to match the patient s actual anatomy by using the cuspid as a guide When the Image Layer laser is initiated look for its position relative to the cuspid then match it to one of the three Image Layer keys Retrusion Normal Protrusion 2 3 2 Cephalometric unit control panel optional Located in Cephalostat secondary collimator enclosure 1 Carriage UP 2 Carriage DOWN 3 Positio...

Page 26: ...rs for patient positioning devices Bite guide disposable covers Chin support disposable covers Temple support disposable covers Nasion support disposable covers Ear holder disposable covers Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 ...

Page 27: ... check tool option Panoramic quality check tool adapter for ceph option Sensor Pan Ceph Platform for dental model Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 28: ...essed during an exposure the exposure is terminated immediately and the x ray unit is completely stopped An interrupted exposure cannot be continued later but has to be retaken from the beginning after the emergency stop switch is released Press to stop the unit rotate to release Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to dete...

Page 29: ...sal membrane 5 min Handle Skin 5 min Ear rod Skin 5 min Disposable cover for ear rod Skin 5 min Sinus Chin rest Skin 5 min Nose support Skin 5 min Disposable cover for Nose support Skin 5 min Temple support Skin 5 min Disposable cover for Temple support Skin 5 min Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status...

Page 30: ...ev 7 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 31: ...t buttons Retrusion Normal Protrusion Select the patient size from the three icons at the top of the LCD screen From left to right the icons represent large medium and small sized patients The dose is increased towards left and decreased towards right Selecting different size patient settings may also affect some panoramic program trajectories or collimation settings as described in individual pro...

Page 32: ...ed skull The exposure factors are designed for an average skull This program produces a typical panoramic arch trajectory throughout the entire scan Small Panoramic Magnification 1 3 Selecting panoramic and small patient keys gives you a panoramic image that is collimated slightly from the top down and has a shorter trajectory from left to right The exposure factors are reduced as well This progra...

Page 33: ...ected frontal views of the patient s left and right temporomandibular joints Clicking on the same key for the TMJ Programs will alternate between the Frontal and Lateral TMJ Programs as designated by the letter F or the letter L Lateral TMJ Magnification 1 23 The Lateral TMJ program provides wide layer corrected lateral views of the patient s left and right temporomandibular joints Clicking on the...

Page 34: ...ght the icons represent large medium and small sized patients The dose is increased towards left and decreased towards right Selecting different size patient settings may also affect some panoramic program trajectories or collimation settings as described in individual program descriptions Frontal Dentition Magnification 1 25 The Frontal Dentition Program provides a vertically and horizontally col...

Page 35: ...tion 1 3 The Half Panoramic Program gives you a full height half panoramic image selecting either the left or the right half of the patient s jaw only with reduced radiation Clicking on the same key for the Half Panoramic Program will alternate between imaging the patient s left or right sides as designated by the icon and the letters R and L The same technique factors and trajectories that apply ...

Page 36: ...ogonal image will also apply to the half Orthogonal image Maxillary Sinus Magnification 1 3 Anterior 10 mm Start Posterior 10 mm The maxillary Sinus Program produces a pan tomographic layer through the posterior maxillary sinus The layer is flatter than the standard panoramic programs and is moved 18mm backward These images are helpful in visualizing the mid and posterior maxillary sinus You can s...

Page 37: ... current program The default mA level is adjusted by an equal amount also for other panoramic programs 3 4 User Configurable Default Program Default imaging program pan ceph 3D can be set using the touch screen display To change default program 1 Start an exam and select the desired program 2 Press the Settings button on the touch screen 3 Select Imaging program defaults 4 Select Set current progr...

Page 38: ...frontal profile of the soft tissues including the chin and the nose tip as well as the Bolton point and the last vertebrae of the spine should preferably also be visible There are three LL cephalometric programs available The programs can be combined with exposure values for different patient sizes by selecting the appropriate patient size key or adjusting the kV or mA settings manually LL Max 22 ...

Page 39: ...ingers of the patient in order to evaluate the ossification during the treatment The analysis of the sesamoid bone of the hand is also used for the evaluation of the bone growth The Carpus view program should not be used for imaging a skull as the reduced dose will not be sufficient to achieve good image quality for a Lateral or PA ceph view The Carpus view should only be used where local laws and...

Page 40: ...endodontic imaging 61 x 78 mm FOV optional Standard resolution 200μm voxel size High resolution 133μm voxel size Standard resolution 200μm voxel size Dose Reduction Technology DRT 290μm voxel size Endo program 85μm voxel size Standard resolution 300μm voxel size High resolution 200μm voxel size Dose Reduction Technology DRT 330μm voxel size Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Niemine...

Page 41: ...pically as stripes and shadows from the above mentioned objects To utilize SRT on a CBCT image may have affect to image reconstruction time SRT button is ON SRT button becomes visible on the 3D modality SRT button is OFF Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 ...

Page 42: ...A ranges for each field of view sizes and resolution settings FOV Resolution 3 2 mA 3 6 mA 4 mA 4 5 mA 5 mA 5 6 mA 6 3 mA 7 1 mA 8 mA 9 mA 10 mA 11 mA 12 5 mA 14 mA 61 x 41 mm DRT x x x x x x x x Std Res x x x x x x x High Res x x x x x x x x x x x Endo Res x x x x x x x x x x x 61 x 78 mm optional DRT x x x x x Std Res x x x x x x x High Res x x x x x x x x x Exposure settings for scout imaging d...

Page 43: ...ection 2 Status of the unit 3 Settings 4 Exposure settings 66 66 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 44: ...FOV for 3D imaging can be positioned on the XY plane by selecting the center point of the FOV on the dental arch of the touch screen display The FOV is positioned in the Z direction by using the chin rest movement and positioning lights 4 3 Exposure settings 4 3 1 Exposure indicators and settings kV value mA value Patient name Exposure value and time Dose value DAP Patient size settings Test mode ...

Page 45: ...cremental changes to kV and mA for each program can be made by pressing the keys at the bottom of the LCD screen 4 4 Status section Status field shows when the unit is ready for capturing or any trouble occurs Green or red color indicate the status in question Green means ready to capture and red means not ready During actual exposure a large radiation warning symbol will fill the Touchscreen disp...

Page 46: ...stem crash Please make sure that the retrieved image is as sociated with the correct patient Retrieve With SRT After taking a 3D image with SRT either on or off image can be re reconstructed with different set ting by selecting either Retrieve last image or Retrieve With SRT from the general settings on the touch screen If reconstruction with SRT is un available for the last captured image e g las...

Page 47: ...em IP address and other system related data Quality Assurance Use this to reach the programs for periodical maintenance Languages Use this to select language on the touch screen Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx G...

Page 48: ... rev 7 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 49: ...nged WARNING Handle the sensor with care as instructed in this manual The sensor must not be dropped or exposed to impacts A shock indicator inside the sensor shows if the sensor has been exposed to excess impact 5 1 1 Attaching the sensor NOTICE Normally there is no need to remove the sensor 1 Insert the four slots on the rear of the sensor into the four hooks in the sensor holder Approved Laihon...

Page 50: ...ck ing knob down when the sensor is not in correct posi tion may damage the sensor connectors 5 1 2 Removing the sensor 1 Slide the locking knob upwards on the side of the sensor to unlock the sensor 2 Slide the sensor up and remove it LOCKING UNLOCKING Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this do...

Page 51: ... size Small Panoramic Standard PAN program small patient size Wide arch Panoramic Standard PAN program large patient size Orthogonal programs Bitewing Ortho TMJ axial corrected lateral projection TMJ PA projection Maxillary sinus view 5 3 1 Positioning devices Bite rod with the bite guide Bite rod with the edentulous bite positioner Chin support for edentulous patients Approved Laihonen Tuuli 2016...

Page 52: ...n a patient without the viewing software running for 2D scans You receive an image Sinus rest Chin rest TMJ 66 66 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 53: ...he A buttons on either side and pull ing back Releasing the buttons locks the assembly Have the patient enter the machine at this point standing fully upright and grasping the handgrips Next turn the B knob to close the temple supports 9 Remove eye glasses hearing aids removable dentures jewelry necklaces tongue rings lip rings etc and hair clips and pins Place a protective lead apron on the patie...

Page 54: ...as possible Exposure can also be taken in a sitting position including from a wheelchair Ask the patient to grip the handgrips and bite on the bite guide so that the upper and lower anterior teeth are in the grooves of the bite guide Use the edentulous bite posi tioner or the chin support for an edentulous patient 4 Adjust the unit height to get the Frankfort plane laser passing over the orbitale ...

Page 55: ...er position on the patient s actual canine Image Layer Adjustment button A Retrusion If the light is behind the canine on the patient click this button to have the unit compensate during image capture The unit will automatically make a 3 mm anterior adjustment B Normal occlusion default Leave at this setting if the laser hits the center of the canine C Protrusion If the light is in front of the ca...

Page 56: ...umn The patient is slightly leaning backwards during the imaging while maintaining a secure hold of the handgrips If the patient s neck is slumped forward gen tly stretch up the patient s neck from the base of the skull 9 Ask the patient to swallow place their tongue firmly against the roof of their mouth and remain still for the du ration of the exposure Approved Laihonen Tuuli 2016 12 02 16 41 R...

Page 57: ...er than the patient s chin 3 Guide the patient to the unit and instruct to stand as straight and tall as possible Ask the patient to take grip of the handgrips and set the nose against the TMJ nose support 4 Adjust the unit height to get the Frankfort plane laser passing over the orbitale and porion Nose support Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 3...

Page 58: ...J laser until it aligns with the middle of the condyle by using the Image Layer Adjust ment laser buttons In this case the light will reposition on the patient s TMJ area Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy...

Page 59: ... tient to swallow place their tongue firmly against the roof of their mouth and remain still for the duration of the ex posure b TMJ open Ask the patient to open their mouth to the fullest extent possible and remain still for the duration of the exposure Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this d...

Page 60: ...o the unit and instruct to stand as straight and tall as possible Ask the patient to grip the handgrips and bite on the bite guide 4 Adjust the unit height to get the Frankfort plane laser passing over the orbitale and porion 5 Check the position of the midsagittal laser If it is not on the midsagittal plane of the patient gently adjust the pa tient s head Approved Laihonen Tuuli 2016 12 02 16 41 ...

Page 61: ...from radiation by standing behind a suit able x ray radiation shield and clearing the area Make sure that you can see and hear the patient during the ex posure NOTICE In all examinations the user of the x ray equip ment should wear protective clothing The operator does not need to be close to the patient during normal use The protection against stray radiation can be achieved by using the hand swi...

Page 62: ...op During the expo sure you will hear an audible signal and the exposure warning symbol is displayed on the touchscreen 3 After the exposure release the temple supports and move the head support assembly away from the patient Carefully guide the patient out of the unit Remove hy gienic barriers and decontaminate the necessary parts of the unit with approved methods and products 4 PC The image can ...

Page 63: ... 1 Move the ceph sensor to the ceph sensor holder 2 PC Open the viewing software select a patient and schedule acquisition 3 Select CEPH tab at the touchscreen display 4 Select the imaging program 5 Set the kV and mA or select the patient size small medium large Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status o...

Page 64: ...vable dentures jewelry necklaces tongue rings lip rings etc and hair clips and pins Place a protective lead apron on the patient Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 65: ...er 1 ear holder brake 2 NOTICE Use a new hygienic barrier for every patient 2 Adjust the unit height 3 Guide the patient to the unit Instruct the patient to stand as straight and tall as possible under the cepha lostat head Slide the ear plugs in the patient s ears Tall patients can also sit on a chair Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved...

Page 66: ...the nasion support aside Place the hygienic barriers NOTICE Use a new hygienic barrier for every patient 2 Adjust the unit height 3 Guide the patient to the unit facing the sensor Instruct the patient to stand as straight and tall as possible un der the cephalostat head Slide the ear rods towards patient s ears Tall patients can also sit on a chair Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed...

Page 67: ...ies of your country 1 Unlock the lever and turn the ear rods to the PA projec tion position Lock the position Tilt the nasion support aside Place the carpus holder to the nasion support holder 2 Adjust the unit height if needed 3 Ask the patient to remove rings and metal objects and to place hand on the carpus holder Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02...

Page 68: ...ee the imaging software user manual NOTICE In all examinations the user of the x ray equipment should wear protective clothing The opera tor does not need to be close to the patient during nor mal use The protection against stray radiation can be achieved by using the hand switch not less than 2 m 7 ft from the focal spot and the x ray beam Operator should maintain visible contact with the patient...

Page 69: ...t the touch screen display 3 Select the FOV size 61 x 41 mm 61 x 78 mm optional 4 Select scout or resolution selection DRT Standard High Endo Chin support Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights rese...

Page 70: ... support Place the hygienic barrier NOTICE Use a new hygienic barrier for every patient 2 Select patient size and adjust mA if needed 3 Select the area of interest dragging the target on the dental arch display while centering the crosshairs on the region of interest The 3D FOV is positioned more accu rately by using the scout image mode The area of inter est can be adjusted on the touch screen di...

Page 71: ...the midsagittal plane of the patient gently adjust the pa tient s head 8 Adjust the unit height and chin rest height to get the Re gion of Interest between the top and bottom FOV lasers Position the patient so that the occlusal plane is horizon tal A horizontal line from the superior border of the tra gus to the inferior border of the ala is a close approximation for occlusal plane horizontal Appr...

Page 72: ...sing the buttons locks the assembly Next turn the C knob to close the temple supports 1 Horizontal laser top of FOV 2 Horizontal laser bottom of FOV Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 73: ...ble signal and the exposure warning symbol on the touch screen display appears Continue to hold down the exposure button until the au dible signal ends and the machine has come to a com plete stop 3 Two scout preview images appear on the touchscreen display A B C A 66 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the st...

Page 74: ...l allow you to see higher into the upper arch and raising the Chin Support will allow you to see lower into the lower arch An additional Scout View may be needed for a major adjust ment to Patient positioning 6 Trigger the exposure button to capture the 3D image or if needed take a new scout by pressing the Scout button B and trigger the exposure button Use the Back button C to return to the previ...

Page 75: ...appears 4 Select SRT ON or OFF based on your estimation of the need See chapter 3 7 SRT Scatter Reduction Technology Reduction DRT 3D image quality Standard 3D image quality High resolution 3D image quality Endo program Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 5...

Page 76: ...model NOTICE It is recommended to use a sponge or a foam under radiographic guide during the scan 3 Take scout image with default values Correct position if needed 4 Select same resolution and parameters as in patient scan NOTICE Position the radiographic guide in similar way Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determin...

Page 77: ... unit fails to operate as described in the user s manual switch the unit off wait a few seconds and switch the unit on again 5 6 2 Image transfer errors If an image is not transferred successfully to the PC close and then reopen the dental imaging software and or restart the PC DO NOT restart the unit as this will erase any image that is stored in the unit memory and this retrievable image will be...

Page 78: ...v 7 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 79: ...ble cause Remedy Incisors and canines wide and unsharp Rows of teeth widened 1 Patient is too far back or posterior 2 Image Layer laser instruc tion was not followed 1 Check patient positioning with Image Layer laser and Adjust ment buttons 2 Insert bite guide ABACK Problem Possible cause Remedy Teeth appear wider on one side and narrower on the opposite Ramus widths are different on opposite side...

Page 80: ...nts exposed high and are often cut off from the image Image has an exaggerated smiling shape Patient head tilted forward Check FH plane using the hori zontal laser Problem Possible cause Remedy Middle area of the image too bright and unsharp Spine shadow Patient s neck was not stretched Stretch patient s neck by having him or her step forward while maintaining a secure hold of the handgrips ANECK ...

Page 81: ...ed correctly 1 Check midsagittal plane and center patient s head Problem Possible cause Remedy Rows of teeth exposed too high TMJs are cut off 1 Chin was not resting on chin support 2 Patient positioned too high Check patient positioning Problem Possible cause Remedy Rows of teeth exposed too low Mandible not exposed completely in the image Chin rest was not used with bite rod Install chin rest Ap...

Page 82: ...ftware Con trast and brightness not optimum 2 Manual technique factors used too high 1 Adjust contrast and densi ty 2 Decrease technique fac tors Problem Possible cause Remedy Lack of image contrast 1 Imaging software Con trast and brightness not optimum 2 kV used is too high 3 Gamma value is not cor rect for the monitor being used 1 Adjust contrast and bright ness 2 Lower the kV setting 3 Adjust ...

Page 83: ...image Patient has moved during the exposure Retake the image Problem Possible cause Remedy Vertical dark lines on image Patient s shoulder in contact with machine parts Check patient positioning Problem Possible cause Remedy Patient s right side teeth are not exposed Exposure button released pre maturely Retake the image Problem Possible cause Remedy Right and left image sides are incomplete TMJs ...

Page 84: ...nes on image Sensor problem Consult the dealer Problem Possible cause Remedy CEPH Lateral view has 2 ear plugs 1 Cephalostat lock not locked 2 Ear plugs misaligned 1 Lock it 2 Call service Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 b...

Page 85: ...ave patient take step for ward so they are leaning back during scan Problem Possible cause Remedy Patient s shoulders are touching the x ray tube or sensor Patient is too big for the unit Wide and high shoulders Shoulders tensed unit is posi tioned too low Reverse patient s hands on Handgrips left to right side han dle and vice versa to pull the shoulders in Alternately ask the patient to round th...

Page 86: ...v 7 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 87: ...stributor for details 7 1 2 Calibration intervals To keep the image quality at best possible level calibrations and quality checks shall be carried out at regular intervals according to the table below NOTICE The calibrations mentioned in this manual can be done by the user or qualified service personnel Modality Minimum requirement Recommendation 3D Two 2 times annually Four 4 times annually Pano...

Page 88: ...cleaner do not spray into any ventilation grills Do not allow water or other cleaning liquids to enter the unit interior since these may cause short circuits or corrosion The unit should be cleaned after every usage CAUTION Clean the dust off the unit regularly The unit might overheat if excess dust is gathered on the cooling grilles Unit surfaces All surfaces can be wiped clean with a soft cloth ...

Page 89: ...th all laws and regulations within the local jurisdiction Examples of cleaning agents that can be found in disinfectant products which are allowed or prohibited when cleaning the unit Allowed Methanol metyl alcohol Soap Isopropyl alcohol distilled water Not allowed Bentzene Chlorine bentzene Acetone Acetic ether agents containing phenol paracetic acid peroxide and other oxygen cleaving agents sodi...

Page 90: ...sterilization Flash sterilization Temperature 270 F 132 C Exposure time 3 minutes Steam flush pressure pulse steam sterilization Temperature 270 F to 275 F 132 C to 135 C Exposure time 3 to 4 minutes Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyr...

Page 91: ...alibration program is suc cessfully done Move on to next calibration Not passed means that adjustment is still needed Follow the instructions the image if any and take another exposure Some calibration programs are iterative and demand a few repetitions Failed means that the system could not decide what adjustment should be done in order for the calibration to succeed This calibration status is al...

Page 92: ...he user s manual supplied with the dental imaging software for more information 4 PC Click the image acquisition button to activate image capture 5 Touch the settings button on the touch screen display 6 Select the Quality assurance button The calibration display appears Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the...

Page 93: ...stall the double cone calibration tool 4 Take an exposure 5 Repeat the calibration until calibration result passed is achieved Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 94: ... versa NOTICE Re do panoramic pixel calibration if cephalostat sensor is moved to panoramic side or the sensor is changed 1 Remove the double cone calibration tool 2 Select the program 3 Press Patient In 4 Take an exposure Touch screen display informs when the calibration is passed Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to de...

Page 95: ...panoramic Quality Check Tool optional to the chin support 2 Select the Pan QC program 3 Press Patient In 4 Take an exposure Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 96: ...rom both pins to center should be equal length NOTICE The panoramic QC collimator is equipped with a 0 8 mm copper filter If more filtration is required additional filtration may be attached to the tubehead cover The unit may be configured to use higher exposure values to compensate for an additional 1 mm copper filter Ask Technical Support to adjust the copper thickness setting as required 1 2 3 ...

Page 97: ...for both 3D imaging modes standard and high resolution Standard geometry calibration has to be done first 3 Press Patient In 4 Install the 3D calibration phantom 5 Take an exposure 6 Repeat the calibration until calibration result passed is achieved This calibration is only needed with 3D units Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM...

Page 98: ...gram 3 Press Patient In 4 Take an exposure The result image informs when the calibration is passed Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 99: ...information and pass fail re sult can be found in the reconstructed volume from axial view Use 3D viewing software from to find the axial slic es containing the information If quality check is not passed unit may need recalibration Please redo 3d ge ometry and 3d pixel calibrations If the quality check is still not passed contact service Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen T...

Page 100: ...723 rev 7 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 101: ...o panoramic pixel calibration if cephalostat sensor is moved to panoramic side or the sensor is changed 1 Rotate the ear holders into PA view position and move them completely apart Turn nasion support up out of the way 2 Select Ceph Pix program 3 Press Patient In 4 Take an exposure 5 This calibration should always be a pass Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 20...

Page 102: ...it and ensure that it s leveled from the spirit level 2 Select the Ceph QC program 3 Press Patient In 4 Take an exposure 5 Visually evaluate the result using the installed imaging software Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 b...

Page 103: ...2 High contrast resolution minimum 3 1LP mm must be distinguishable 3 All four low contrast holes must be visible 1 2 3 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 104: ...723 rev 7 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 105: ...21 CFR Chapter I Subchapter J at the date of manufacture GXDP 700 is in conformity with the provisions of Council Directive 93 42 EEC as amended by the Directive 2007 47 EC concerning medical devices Performance Standards and European Union Directive 93 42 EEC Medical Devices Directive Product name GXDP 700 Model GXDP 700 Product type Digital dental imaging system with panoramic cephalometric and ...

Page 106: ... THA 300 Tube type Toshiba D 052SB D 054SB C Stationary W anode Tube voltage 57 90 kV In some countries min kV limited to 60 kV Max tube current 16 mA In some countries max mA limited to 15 mA Max electric output 1 44 kW Target angle 5 degrees Focal spot 0 5 x 0 5 mm according to IEC 60336 2005 Nominal anode input 1750 W Reference axis In the middle of the panoramic sensor s active area Max anode ...

Page 107: ...w 15A Cooper Bussman time delay MDA 15 Power consumption 2 3 kVA 230 VAC 1 65 kVA 110 VAC Maximum impedance of main 0 2 Table 1 100 VAC mA 16 14 12 5 x x 11 x x x x x 10 x x x x x x x 9 x x x x x x x x x 8 x x x x x x x x x x 7 1 x x x x x x x x x x 6 3 x x x x x x x x x x 5 6 x x x x x x x x x x 5 x x x x x x x x x x 4 5 x x x x x x x x x x 4 x x x x x x x x x x 3 6 x x x x x x x x x x 3 2 x x x ...

Page 108: ... 240 VAC mA 16 x x x x x x x 14 x x x x x x x x x 12 5 x x x x x x x x x x 11 x x x x x x x x x x 10 x x x x x x x x x x 9 x x x x x x x x x x 8 x x x x x x x x x x 7 1 x x x x x x x x x x 6 3 x x x x x x x x x x 5 6 x x x x x x x x x x 5 x x x x x x x x x x 4 5 x x x x x x x x x x 4 x x x x x x x x x x 3 6 x x x x x x x x x x 3 2 x x x x x x x x x x 57 60 63 66 70 73 77 81 85 90 kV Approved Laiho...

Page 109: ...halostat FH light 3D imaging programs laser light CLASS 1 LASER PRODUCT max output 100µW Warning symbols are placed next to the laser lights and the label describing the laser light classification is placed inside the carriage side cabinet USA Canada models have different types of laser light stickers according to local requirements Caution use of controls or adjustments or performance of procedur...

Page 110: ...2 16 mA 2 5 16 4 s 30 Small Panoramic 57 90 kV 3 2 16 mA 2 5 14 4 s 30 Orthogonal Panoramic 57 90 kV 3 2 16 mA 2 0 12 9 s 30 Lateral TMJ 57 90 kV 3 2 16 mA 5 3 10 6 s 23 PA TMJ View 57 90 kV 3 2 16 mA 5 6 10 6 s 55 Maxillary Sinus 57 90 kV 3 2 16 mA 12 5 s 30 Bitewing 57 90 kV 3 2 16 mA 2 4 11 9 s 30 Panoramic QC 57 90 kV 3 2 12 6 mA 16 4 s 66 kV 3 2 mA with 0 8 mm Cu filter 70 kV 8 mA with 1 8 mm...

Page 111: ...grams 61 x 41 mm FOV Low Dose resolution 90 kV 3 2 7 1 mA 1 2 s 61 x 41 mm FOV standard resolution 90 kV 6 3 12 5 mA 2 3 s 61 x 41 mm FOV high resolution and Endo program 90 kV 4 12 5 mA 6 1 s 61 x 41 mm FOV scout 90 kV 4 12 5 mA 0 02 s 61 x 78 mm FOV Low Dose resolution 90 kV 3 2 5 mA 2 4 s 61 x 78 mm FOV standard resolution 90 kV 6 3 12 5 mA 4 9 s 61 x 78 mm FOV high resolution 90 kV 4 10 mA 12 ...

Page 112: ...tient positioning Operation Arm mounts on left or right side of the unit Interlocked pan ceph sensor Motorised carriage buttons at cephalostat head assembly Positioning aids Ear holders Nasion support with vertical mm scale Frankfort plane laser light Contact plate Carpus program 3D imaging patient positioning Operation Left or right side of unit Motorised carriage movement Positioning aids Chin r...

Page 113: ... and depth 100 x 100 m and 14 bits Active area height 223 2 mm 2232 pixels Image field width in lateral view 9 4 inches 240 mm maximum 7 1 inches 180 mm minimum Image field width in PA view 9 4 inches 240 mm maximum 7 1 inches 180 mm minimum Resolution 4 LP mm cephalometric max height 223 mm max height 223 mm 3D image receptor Sensor unit 3D sensor Technology Sensor type CMOS Image pixel size and ...

Page 114: ... 60 inches Installation Standard wall mount with 45 angled joint Optional base for free standing unit unit height is increased 25 mm Height x Width x Depth inches mm 2440 x 2065 x 1210 mm 96 x 81 3 x 47 6 inches Weight 240 kg 529 lbs Cephalometric Ambient temperatures Transportation and Storage 10 50 C Operation Temperature 10 35 C RH max 85 700 1060 mbar Ceph ready option Ordered separately Optio...

Page 115: ...t your local distributor for more information 3D Imaging Kit Add 3D imaging capability to GXDP 700 digital pan or pan and ceph FOV 61 x 41 mm 3D Large Field Of View Capability Add optional 3D Large Field Of View 61 x 78mm imaging to existing Standard 3D Field Of View 61 x 41mm Must already have 3D capability Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Ap...

Page 116: ... arm and the touchscreen can be on either side L R Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 117: ...109 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 118: ...n can be on either side L R Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 119: ...mation The operating instructions can be supplied electronically or in paper format Collision warning Unit can collide with a seated patient when driving the carriage downwards Pay attention on the unit movement Laser radiation yellow label Attention consult accompanying documents Ground Functional Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See...

Page 120: ...r This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment Type B Applied part CE 0537 symbol MDD 93 42 EEC ETL symbol Conforms to UL STD 60601 1 Certified to CSA Approve...

Page 121: ...s suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 IEC 61000 3 2 Class A GXDP 700 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage pow...

Page 122: ...V common mode Mains power quality is that of a typical commercial and or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cy...

Page 123: ...an the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Field strengths from fixed transmitters such as base stations for cellular telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be estimated accurately To assess the electromagnetic environment due to fixed RF transmitters...

Page 124: ...ded ELECTROMAGNETIC COMPATIBILITY of the EQUIPMENT and or SYSTEM Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601 1 2 Frequency of Transmitter Equation Rated Maximum Output Power of Transmitter watts 150KHz to 80 MHz Separation Distance meters 80 MHz to 800 MHz Separation Distance meters 800 MHz to 2 5 GHz Separation Distance meters 0 01 0 12 0 12 0 23...

Page 125: ...ble Relative humidity must be maintained above 30 percent Stacked components equipment The GXDP 700 should not be used adjacent to or stacked with other equipment if adjacent or stacked use is necessary the GXDP 700 should be observed to verify normal operation in the configuration in which it will be used Interference may occur in the vicinity of equipment marked with the following symbol No port...

Page 126: ...mal Characteristics 5 10 15 20 25 1 10 TUBE CURRENT mA EXPOSURE TIME s 2 3 5 7 20 80kV 90kV 100kV 50kV 60kV 70kV Maximum Rating Charts Absolute maximum rating charts DC Center Grounded Focal Spot 0 5 mm 5 10 15 20 25 1 10 TUBE CURRENT mA EXPOSURE TIME s 2 3 5 7 20 80kV 90kV 100kV 50kV 60kV 70kV Maximum Rating Charts Absolute maximum rating charts DC Center Grounded Focal Spot 0 5 mm Approved Laiho...

Page 127: ...igure 1 6 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 128: ...he skull The measurements in cone beam programs were performed in CT PIO position with the movement of rotation unit using hi resolution option maximum exposure time Exposure values were 90kV 13mA and 6 1 sec with small FOV and 90kV 10mA and 13 sec with large FOV The measurements in cephalometric program were performed in ceph PIO position with the movement of the ceph head Exposure values were 90...

Page 129: ...levels measured with the test instrument Height Left ear 45deg Nose 45deg Right ear central beam 0 187mR 0 246mR 0 417mR 0 335mR 0 227mR 15cm up from central beam 0 158mR 0 134mR 0 161mR 0 144mR 0 158mR 15cm down from central beam 0 171mR 0 202mR 0 275mR 0 248mR 0 204mR Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the ...

Page 130: ...al beam 0 531mR 0 406mR 0 241mR 0 409mR 0 462 15cm down from central beam 0 531mR 0 577mR 0 448mR 0 713mR 1 083 Height L ear 45deg Nose Skull 45deg R ear central beam 0 826mR 0 661mR 0 603mR 0 735mR 0 861 15cm up from central beam 0 878mR 0 662mR 0 490mR 0 747mR 0 911 15cm down from central beam 1 285mR 0 944mR 0 800mR 1 019mR 1 380 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo A...

Page 131: ...re taken with 90kV 13mA 10sec scanning exposure time and scatter radiation was measured at 50 cm distance from the head The following table shows the scatter radiation levels measured with the test instrument Height Right ear Nose Left ear central beam 0 025mR 0 034mR 0 066mR 15cm up from central beam 0 021mR 0 022mR 0 059mR 15cm down from central beam 0 038mR 0 029mR 0 081mR Approved Laihonen Tuu...

Page 132: ...v 7 Approved Laihonen Tuuli 2016 12 02 16 41 Reviewed Nieminen Timo Antero 2016 12 02 15 31 Approved See PDM system to determine the status of this document Printed out 2017 03 22 10 54 38 D507729 7 Copyright 2016 by PaloDEx Group Oy All rights reserved ...

Page 133: ... used graphics board and graphics driver of the reconstruction worksta tion Consult technical support for information on the sup ported boards and drivers Examples of supported boards NVidia Quadro 4000 NVidia GeForce GTX 660 The compatible graphics driver versions are found on the driver update DVD 2 GB dedicated display memory is required PCI board connection Full length PCIe x16 slot for GPU bo...

Page 134: ...rated graphics are not supported Power supply 500 watt minimum Network Gigabit Ethernet 1000Base T Operating system Windows 7 Windows 8 8 1 or Windows 10 Display 20 LCD display 1600 x 1200 or 22 LCD wide screen display 1680 x 1050 or better Standard The PC must meet the IEC 60950 standard minimum re quirements Mouse Mouse with scroll wheel OpenCL support OpenCL 1 1 supported by either processor or...

Page 135: ...in the PC in order to connect also to the site network Position the PC and any other external device at least 1 5 m 60 from the x ray unit so that the patient cannot touch the PC or any other external device while being x rayed The PC and any other external devices shall not be connected to an extension cable Multiple extension cables shall not be used Do not position the PC where it could be spla...

Page 136: ...ese possible risks The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system Consideration relating to the choice shall include Use of the accessory in the PATIENT VICINITY The safety certification of the accessory has been performed in accordance to the appropriate IEC 601 1 and or IEC 601 1...

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