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15. Technical Specifications

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Summary of Contents for Premium PAX-i3D

Page 1: ......

Page 2: ...PCT 90LH User Manual 3...

Page 3: ...perate the PaX i3D Green Premium system It is recommended that you thoroughly familiarize yourself with this manual in order to make the most effective use of this equipment Observe all cautions safet...

Page 4: ...nes 9 3 2 Electricity related Safety Precautions 13 3 3 Radiation Safety 15 3 4 Warnings 16 4 Imaging System Overview 19 4 1 System Components 19 4 2 Features 19 4 3 Standards and Regulations 20 4 4 I...

Page 5: ...ositioning 105 9 4 Patient Positioning 107 9 5 X ray Exposure 113 9 6 Checking the captured image 115 10 Acquiring ENT CT Images 117 10 1 ENT CT Imaging Program Overview 117 10 2 Configuring Exposure...

Page 6: ...159 16 Appendices 161 16 1 Recommended X ray Exposure Table 161 16 2 X ray Dose Data 166 16 3 Electromagnetic Compatibility EMC Information 175 16 4 Hand wrist Image Evaluation References 180 16 5 Ac...

Page 7: ...ire 2D diagnostic image data in panoramic and cephalometric mode 1 2 Indications for use PaX i3D Green Premium Model PCT 90LH is intended to produce panoramic cephalometric or 3D digital x ray images...

Page 8: ...ntended User Profile Considerations Requirement Description Education Licensed dentists or dental hygienists radiologists and graduates of relevant bachelor s degree national qualifications Knowledge...

Page 9: ...equipment has been used normally in accordance with the User Manual The equipment damage or malfunction is not the result of an error on the part of the owner or the operator 2 2 Owner and Operator s...

Page 10: ...mply with a warning may result in severe damage to the equipment or physical injury to the operator and or patient CAUTION Indicates a situation that demands prompt and careful action a specific remed...

Page 11: ...ower Switch Alternate current Label Type B Applied Equipment IEC 60601 1 Degree of protection against leakage current and or electric shock Class 1 equipment Label Radiation hazard Label Indicates the...

Page 12: ...not be disposed of as unsorted municipal waste and must be collected separately Label Indicates that this equipment is classified as a CLASS 1 LASER PRODUCT in accordance with IEC 60825 1 ED 2 regulat...

Page 13: ...abel Locations No Item 1 PaX i3D Green Premium Model PCT 90LH Main Label 2 X ray GENERATOR Label This part has two types according to the X ray Tube model implemented Type 1 Superior tube SXR 130 15 0...

Page 14: ...m User Manual No Item 4 X ray CAUTION Label X ray Attention X ray on when equipment in operation 5 Wheelchair Height Limit CAUTION Label In case a wheelchair must be used the overall height of the whe...

Page 15: ...and implement appropriate measures to remedy such irregularities General safety precautions Follow the instructions specified in this manual to ensure the safety of both the patient and the operator T...

Page 16: ...tandard e g IEC 60950 for IT equipment and IEC 60601 1series for medical electrical equipment In addition all such combination system shall comply with the standard IEC 60601 1 and or IEC 60601 1 1 ha...

Page 17: ...aned using a soft cloth dampened with a mild cleaning solution New hygiene cover must be provided for each new patient to prevent the transmission of communicable disease Do not use aerosol or spray c...

Page 18: ...y may deteriorate if the equipment is operated outside of this range Always allow the equipment sufficient time to warm up while switched on if it has been exposed to temperatures of below 10 C 50 F O...

Page 19: ...ment with other devices Do not connect this equipment to devices which are not designated as a part of the system Do not connect this equipment to a Multiple Portable Socket Outlet MPSO or extension c...

Page 20: ...D protective measures Electrostatic discharge ESD ESD protective measures include Procedures for preventing electrostatic charge build up e g temperature control humidification conductive floor coveri...

Page 21: ...uring imaging the operator must maintain vocal visual contact with the patient from outside the shielded area The operator should continuously check the status of the patient and the equipment during...

Page 22: ...radiological assessment conventional medical CT or MR should be used instead of dental cone beam imaging PaX i3D Green Premium system like other medical equipments uses high frequency electrical sign...

Page 23: ...place flammable materials near this equipment Do not operate the PC while the equipment is performing an operation Failure to comply with this instruction may result in system malfunction Immediately...

Page 24: ...ll the equipment Equipment should only be installed by an authorized technician complying with proper installation procedures Security Capabilities It is recommended to install and operate EzDent i SW...

Page 25: ...d FOV for ENT Diagnosis Multi purpose camera equipped for patient positioning and 3D PHOTO acquisition Optional Touch Screen implemented for easy use Digital Imaging Communication in Medicine DICOM fo...

Page 26: ...601 1 3rd UL 60601 1 1st IEC EN 60601 1 3 IEC 60601 2 63 21 CFR 1020 30 31 33 NEMA Standard publication PS 3 1 3 18 2008 This is Class IIb equipment and obtained CE marking in April 2007 for regulatio...

Page 27: ...4 Imaging System Overview PCT 90LH User Manual 21 ENGLISH 4 4 Imaging System Configuration...

Page 28: ...Signal Input Output No Item 1 USB Camera input USB 3 0 Cable To avoid any connection problem it is highly recommended to install a USB 3 0 PCI card for USB 3 0 cables 2 3D Viewer License Key 3 Video o...

Page 29: ...4 Imaging System Overview PCT 90LH User Manual 23 ENGLISH 4 5 Equipment Overview...

Page 30: ...ponent Storage The place where Bite Blocks Chinrest Ass y and the other components can be stored 8 Headrest Holds the patient s head during i CEPH mode imaging 9 Chinrest The place to rest the chin 10...

Page 31: ...4 Imaging System Overview PCT 90LH User Manual 25 ENGLISH No Item Description 15 Chinrest Up Down Switch Adjusts the height of the Chinrest...

Page 32: ...imaging mode For more information refer to 4 5 2 Touch Screen 2 Laser Beam ON OFF button Turns on off the vertical Laser Beam 3 READY button Indicates that imaging is ready after parameter settings a...

Page 33: ...e Software are interlocked mutually therefore indicate the same environment setting values always i CEPH and 3D PHOTO are Optional modalities Do not allow patient to control Touch Screen Doing so may...

Page 34: ...rthogonal mode press UP DOWN button to scroll through next previous ROI option 2 NEXT button Moves to the next step 3 BACK button Moves back to the modality PANO i CEPH Optional Dental CT ENT CT and 3...

Page 35: ...ng on the circumference of the patient s head X ray intensity may be classified as Hard Normal or Soft Soft Normal Hard 4 Examination type Selects between Normal and Special 5 Imaging type Selects bet...

Page 36: ...vailable i CEPH Examination programs 2 NEXT button Moves to the next step 3 BACK button Moves back to the modality PANO i CEPH Optional Dental CT ENT CT and 3D PHOTO Optional selection screen 4 Settin...

Page 37: ...Adjusts kVp and mA 2 Patient s gender age group Selects patient s gender age group 3 X ray intensity Selects X ray intensity Depending on the circumference of the patient s head X ray intensity may be...

Page 38: ...vailable FOV modes 2 NEXT button Moves to the next step 3 BACK button Moves back to the modality PANO i CEPH Optional Dental CT ENT CT and 3D PHOTO Optional selection screen 4 Settings button Adjusts...

Page 39: ...ge group 3 X ray intensity Selects X ray intensity Depending on the circumference of the patient s head X ray intensity may be classified as Hard Normal or Soft Soft Normal Hard 4 Image Option Selects...

Page 40: ...unction Description 1 TOP LED light Brightness control panel Press UP DOWN button to adjust brightness of the LED lights on the top 2 BOTTOM LED light Brightness control panel Press UP DOWN button to...

Page 41: ...d Physical injury to the patient or damage to the equipment Other emergency situations If a problem occurs during image acquisition press the red Emergency Stop Switch to immediately stop the moving p...

Page 42: ...emature release of the Exposure Switch will abort image acquisition Pressing the Exposure Switch activates the LED indicator to turn yellow This color indicates that the X ray is being emitted The Exp...

Page 43: ...the patient the Bite Block the Chinrest and the Headrest should be cleaned with ethanol and wiped with clean towels Components Name and Function Contact duration Bite Block Skin 24 h TMJ Bite Skin 24...

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Page 45: ...SH 5 Imaging Software Overview Three programs are included in this equipment to acquire process and view the image EzDent i 2D viewer and patient management Ez3D i 3D viewer Console software PANO i CE...

Page 46: ...Intel Xeon E5 1620v3 3 5GHz 2133 10MB cache CPU RAM 32GB DDR4 2133 ECC RAM HDD 1TB SATA 1 st HDD Graphics board NVIDIA GEFORCE GTX980 Ti OC D5 6GB or greater Ethernet interface Broadcom 5761 Gigabit P...

Page 47: ...Patient Records and EzDent i User Manual for more information Security Capabilities It is recommended to install and operate EzDent i SW within a secure operating environment that allows only authoriz...

Page 48: ...ging parameters on either the Touch Screen or the Console Software running on the PC They are synched and display the same environmental settings For more details on the Touch Screen refer to 3 3 2 To...

Page 49: ...and Current Adjustment If the patient is selected in EzDent i the default kVp mA according to the patient s information gender age is displayed This tool adjusts the kVp and mA values and controls the...

Page 50: ...n imaging mode without 3D PHOTO After selecting an imaging mode and exposure parameters After completing patient positioning 11 Imaging parameters configuration panel Selects the imaging parameters fo...

Page 51: ...econstruct Click Reconstruction button 15 Laser Beam ON OFF button Turns the Laser Beam on or off for patient positioning Enabled when NEXT button is clicked after the imaging conditions are configure...

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Page 53: ...nds before turning it on again Warm up the equipment for at least 5 minutes before the operation For the best image quality it is recommended to have worm up phase for more than 30 minutes If the equi...

Page 54: ...uipped with Windows built in firewall Windows Defender antispyware tools and other commonly used 3 rd party security tools and application systems The latest updates for anti virus software and a fire...

Page 55: ...ator to set up a unique user ID and Password to prevent any unauthorized access to patients confidential information User ID and Password can be assigned to give permission to register add delete and...

Page 56: ...nt Records You can search through the patient database using a patient s Chart Number First Name or Last Name 1 Enter the Name or Chart Number of the patient to be searched on the Patient Search panel...

Page 57: ...elect the patient to be captured 2 Click ACQUISITION tab and select the imaging mode CT Panorama or Cephalo 3 The Main Screen for the selected mode appears Refer to 4 3 Console Software From the Main...

Page 58: ...6 Getting Started 52 PaX i3D Green Premium User Manual Left blank intentionally...

Page 59: ...structs U shaped arch data to a single 2D image utilizing multiple images taken with the X ray beam scanning specific oral maxillofacial regions at different angles Examination Programs It is classifi...

Page 60: ...een Premium User Manual Examination Type Arch Selection ROI Example Bitewing Left SPECIAL Examination N A TMJ LAT Open TMJ LAT Close Sinus LAT Sinus PA Bitewing imaging mode is activated only when Ort...

Page 61: ...nts with a V shaped arch trajectory Typically for some females Normal Standard A panoramic imaging mode for adult patients with a normal arch trajectory Wide Standard A panoramic imaging mode for the...

Page 62: ...ing mode to minimize the overlapped region of the teeth from the X ray exposure which is beamed perpendicularly between teeth Bitewing A panoramic imaging mode to acquire an image only for the region...

Page 63: ...e X ray beam is directed on the lateral TMJ region TMJ Open and Close Sinus LAT A special imaging mode to acquire a Sinus image in which X ray beam is directed on the lateral region of the maxillary s...

Page 64: ...ust be completed first If not you must return to the 6 Getting Started and finish the step first You can set the imaging parameters either on the Touch Screen or through the Console Software running o...

Page 65: ...Screen Mode Description Normal Normal option Magic PAN Optional Reconstructs the image with optimized focus autofocus from the entire panorama to acquire high quality images Any errors caused by issue...

Page 66: ...activate three Bitewing examination options Bitewing Bitewing Right and Bitewing Left select Orthogonal Arch in the Arch Selection panel For more information about PANO Examination Program refer to 7...

Page 67: ...intensity Click Arrow button to zoom in The dose is adjustable by the 1 kVp and 0 5 mA respectively 9 When the exposure parameter setting is completed guide the patient to the equipment for positionin...

Page 68: ...ust keep holding the Headrest until the Handle Frame is opened and take it out after the Handle Frame is opened When the Chinrest Ass y is attached Take out the Chinrest and the Chinrest Base in turn...

Page 69: ...earrings hair pins braces false teeth etc Metal objects may induce ghost images and lower the image quality 2 Let the patient wear a lead apron to protect themselves from residual radiation 3 Push th...

Page 70: ...g process Sit close against the chair Hold the handle See front Close the mouth Breathe through the nose Keep both shoulders parallel Relax the body Straighten the Cervical Vertebra 2 Adjust the heigh...

Page 71: ...before the next patient 5 Let the patient bite the Bite Block along its grooves with his her front teeth 6 On the Console Software Click NEXT button when the exposure parameter setting is completed O...

Page 72: ...f the vertical line or between the other two vertical lines 8 Let the patient maintain the posture as follows Close the mouth Place the tongue to the roof of the mouth Close the eyes Before conduct th...

Page 73: ...7 Acquiring PANO Images PCT 90LH User Manual 67 ENGLISH 10 Press READY button No X ray will be emitted at this point Console Software Touch Screen 11 Go to 7 5 X ray Exposure to start the exposure...

Page 74: ...the chair Hold the handle See front Close the mouth Breathe through the nose Keep both shoulders parallel Relax the body Straighten the Cervical Vertebra 2 Adjust the height of the Chinrest by using t...

Page 75: ...h Screen a confirmation window will appear after NEXT button is clicked Click OK button if the setting is correct In case NEXT button has been already clicked you will see pop up window directly Conso...

Page 76: ...the tongue to the roof of the mouth Close the eyes Before conduct the next step be sure to let the patient know that the Rotating Unit will be lower to the exposure location and instruct him or her to...

Page 77: ...dle in comfortable posture and see front Patients need to keep the following poses during imaging process Sit close against the chair Hold the handle See front Close the mouth Breathe through the nose...

Page 78: ...ment with their jaw Doing so may cause difficulty to maintain the proper position to get images of good quality 5 Align the Vertical Beam to the center of the patient s face It can prevent the acquire...

Page 79: ...allowing once open your mouth as wide as possible Close the eyes Before conduct the next step be sure to let the patient know that the Rotating Unit will be lower to the exposure location and instruct...

Page 80: ...ign the Vertical Beam to the center of the patient s face 4 You can see the patient through the Touch Screen Make sure that the patient s Frankfurt line is tilted about 5 from the horizontal lines of...

Page 81: ...handle See front Close the mouth Breathe through the nose Keep both shoulders parallel Relax the body Straighten the Cervical Vertebra 2 Adjust the height of the Chinrest by using the Chinrest UP DOWN...

Page 82: ...ompleted On the Touch Screen a confirmation window will appear after NEXT button is clicked Click OK button if the setting is correct In case NEXT button has been already clicked you will see pop up w...

Page 83: ...down 9 Click NEXT button when the patient positioning is completed The Rotating Unit will come down to the exposure location Then READY button will be activated on the Touch Screen and the Console Sof...

Page 84: ...ing in normal situation Doing so may lead the patient to be unsafe The operator must keep vocal visual contact with the patient at all times during image acquisition process Do not operate the PC duri...

Page 85: ...ently underway The X ray Indicator icon of the Console Software turns yellow 3 Release the Exposure Switch when Image capturing is complete message appears on the screen 4 The Rotating Unit will move...

Page 86: ...ed images can be confirmed in EzDent i Refer to the EzDent i User Manual for more information 1 The images are transferred to EzDent i automatically 2 The images are automatically saved if automatic s...

Page 87: ...ss the growth of lateral side of the face It is also used to examine the ramus mandibulae the posterior region of the third largest molar in the lower jaw the sidewall of the maxillary sinus the front...

Page 88: ...ure of the lower jaw the side wall of the maxillary sinus and zygomatic arch fractures Also used to study the inner and outer alar plates and holes at base of the skull Waters view Used to study the f...

Page 89: ...be completed first You can set the imaging parameters on either the Touch Screen or the Console Software running on the PC They are synched and display the same environmental settings 1 Click i CEPH...

Page 90: ...i CEPH examination refer to 7 1 i CEPH Imaging Program 3 The gender age group of the patient is selected automatically based on the patient information If necessary you can select the gender age grou...

Page 91: ...button to zoom in The dose is adjustable by the 1 kVp and 0 5 mA respectively 6 When the exposure parameter setting is completed guide the patient to the equipment for positioning the patient Go to 8...

Page 92: ...rest is attached Detach it The operator or the patient must keep holding the Headrest until the Handle Frame is opened and take it out after the Handle Frame is opened When the Chinrest Ass y is attac...

Page 93: ...s hair pins braces false teeth etc Metal objects may induce ghost images and lower the image quality 2 Let the patient wear a lead apron to protect themselves from residual radiation 3 Push the Handle...

Page 94: ...keep the following poses during imaging process Sit close against the chair Hold the handle See front Close the mouth Breathe through the nose Keep both shoulders parallel Relax the body Straighten t...

Page 95: ...creen a confirmation window will appear after NEXT button is clicked Click OK button if the setting is correct In case NEXT button has been already clicked you will see pop up window directly Console...

Page 96: ...r to the exposure location and instruct him or her to relax down 9 Click NEXT button when the patient positioning is completed The Rotating Unit will come down to the exposure location Then READY butt...

Page 97: ...Control Panel 2 Let the patient put the right hand splaying on the inner side of the Rotating Unit as shown below Make sure that the patient does not bend his her fingers 3 On the Console Software Cli...

Page 98: ...ck NEXT button when the patient positioning is completed Then READY button will be activated on the Touch Screen and the Console Software 5 Press READY button No X ray will be emitted at this point Co...

Page 99: ...ioning in normal situation Doing so may lead the patient to be unsafe The operator must keep vocal visual contact with the patient at all times during image acquisition process Do not operate the PC d...

Page 100: ...alert sound comes out to indicate that X ray emission is currently underway The X ray Indicator icon of the Console Software turns yellow 3 Release the Exposure Switch when Image capturing is complete...

Page 101: ...orted images can be confirmed in EzDent i Refer to the EzDent i User Manual for more information 1 The images are transferred to EzDent i automatically 2 The images are automatically saved if automati...

Page 102: ...8 Acquiring i CEPH Images Optional 96 PaX i3D Green Premium User Manual Left blank intentionally...

Page 103: ...It is classified as below based on the FOV FOV cm Description ROI 21x19 For entire maxillofacial region diagnostics including frontal bone frontal sinus nasal ethmoid zygomatic maxillary bones and ma...

Page 104: ...al CT 3D PHOTO 3D PHOTO images can be acquired as well as Dental CT images at one time Special Option Auto Pano Auto Ceph 2D images of conventional panoramic cephalometric view are available with the...

Page 105: ...o acquire Dental CT Images 6 Getting Started must be completed first You can set the imaging parameters on either the Touch Screen or the Console Software running on the PC They are synched and displa...

Page 106: ...hen each imaging program is included in the equipment To acquire 3D PHOTO with CT images click DENTAL CT CT 3D PHOTO button 2 Select FOV size You can configure Auto Pano and Auto Ceph options when 21x...

Page 107: ...se Auto Pano Auto Ceph option window Console Software Touch Screen You can configure Horizontal options when 8x8 is selected Console Software Touch Screen Auto Pano Auto Pano is a feature used to acqu...

Page 108: ...red and can be seen on the EzDent i Viewer 3 Select an Image Option On Touch Screen click Settings button before selecting options Console Software Touch Screen The Green mode produces approximately 2...

Page 109: ...p of the patient is selected automatically based on the patient information If necessary you can select the option manually Console Software Touch Screen 6 Select X ray intensity Console Software Touc...

Page 110: ...A respectively 8 When the exposure parameter setting is completed guide the patient to the equipment for positioning the patient Go to 9 3 Getting Prepared for Patient Positioning On the Console Softw...

Page 111: ...t When the Headrest is attached Detach it The operator or the patient must keep holding the Headrest until the Handle Frame is opened and take it out after the Handle Frame is opened When the Chinrest...

Page 112: ...sses earrings hair pins braces false teeth etc Metal objects may induce ghost images and lower the image quality 2 Let the patient to wear a lead apron to protect themselves from residual radiation 3...

Page 113: ...lowing poses during imaging process Sit close against the chair Hold the handle See front Close the mouth Breathe through the nose Keep both shoulders parallel Relax the body Straighten the Cervical V...

Page 114: ...ameter setting is completed On the Touch Screen a confirmation window will appear after NEXT button is clicked Click OK button if the setting is correct In case NEXT button has been already clicked yo...

Page 115: ...Click NEXT button when the patient positioning is completed The Rotating Unit will come down to the exposure location Then READY button will be activated on the Touch Screen and the Console Software W...

Page 116: ...th shoulders parallel Relax the body Straighten the Cervical Vertebra 2 Adjust the height of the Chinrest by using the Chinrest UP DOWN button on the Control Panel until the patient s chin is placed c...

Page 117: ...llel to the patient s nasal base If necessary click or press LED light UP DOWN button to adjust LED light brightness to have proper lighting for the photograph Console Software Touch Screen 6 Click 3D...

Page 118: ...nual 9 Let the patient see the Eye mark 3 when you hear the beep sound 10 Put the Chinrest into the unit when 3D photography is completed 11 Click Press NEXT button to continue with Dental CT Imaging...

Page 119: ...ing in normal situation Doing so may lead the patient to be unsafe The operator must keep vocal visual contact with the patient at all times during image acquisition process Do not operate the PC duri...

Page 120: ...ntly underway The X ray Indicator icon of the Console Software turns yellow 3 Release the Exposure Switch when Image capturing is complete message appears on the screen 4 The Rotating Unit will move u...

Page 121: ...d in EzDent i Refer to the EzDent i User Manual for more information 1 The images are transferred to EzDent i automatically 2 The images are automatically saved if automatic save option is configured...

Page 122: ...9 Acquiring Dental CT Images 116 PaX i3D Green Premium User Manual Left blank intentionally...

Page 123: ...h the X ray beam scanning specific oral maxillofacial regions and reconstructs them to 3D sliced images Examination Programs It is classified as below based on the FOV FOV cm Description ROI 21x19 For...

Page 124: ...TO 3D PHOTO images can be acquired as well as ENT CT images at one time Special Option Auto Pano Auto Ceph 2D images of conventional panoramic cephalometric view are available with the specific FOV Fo...

Page 125: ...s To acquire ENT CT Images 6 Getting Started must be completed first You can set the imaging parameters on either the Touch Screen or the Console Software running on the PC They are synched and displa...

Page 126: ...n each imaging program is included in the equipment To acquire 3D PHOTO with ENT CT images click ENT CT CT 3D PHOTO button 2 Select FOV size You can configure Auto Pano and Auto Ceph options when 21x1...

Page 127: ...e reconstructed 2D images during 3D CT scans without additional X ray exposure It has the same region that conventional cephalometric images offer It provides images for PA Lateral SMV and Waters view...

Page 128: ...High Resolution 2010 FOV 21x19 cm 108 kVp 6 5 mA 18 0 sec 1130 FOV 17x11 cm 108 kVp 6 5 mA 16 6 sec Green 1610 FOV 21x19 cm 95 kVp 6 5 mA 18 0 sec 770 FOV 17x11 cm 90 kVp 6 5 mA 16 6 sec 4 Select a Vo...

Page 129: ...y intensity Click Arrow button to zoom in The dose is adjustable by the 1 kVp and 0 1 mA respectively 8 When the exposure parameter setting is completed guide the patient to the equipment for position...

Page 130: ...bit When the Headrest is attached Detach it The operator or the patient must keep holding the Headrest until the Handle Frame is opened and take it out after the Handle Frame is opened When the Chinre...

Page 131: ...es earrings hair pins braces false teeth etc Metal objects may induce ghost images and lower the image quality 2 Let the patient wear a lead apron to protect themselves from residual radiation 3 Push...

Page 132: ...llowing poses during imaging process Sit close against the chair Hold the handle See front Close the mouth Breathe through the nose Keep both shoulders parallel Relax the body Straighten the Cervical...

Page 133: ...ter setting is completed On the Touch Screen a confirmation window will appear after NEXT button is clicked Click OK button if the setting is correct In case NEXT button has been already clicked you w...

Page 134: ...Click NEXT button when the patient positioning is completed The Rotating Unit will come down to the exposure location Then READY button will be activated on the Touch Screen and the Console Software...

Page 135: ...oulders parallel Relax the body Straighten the Cervical Vertebra 2 Adjust the height of the Chinrest by using the Chinrest UP DOWN button on the Control Panel until the patient s chin is placed comfor...

Page 136: ...allel to the patient s nasal base If necessary click or press LED light UP DOWN button to adjust LED light brightness to have proper lighting for the photograph Console Software Touch Screen 6 Click 3...

Page 137: ...ISH 9 Let the patient see the Eye mark 3 when you hear the beep sound 10 Put the Chinrest into the unit when 3D photography is completed 11 Click Press NEXT button to continue with ENT CT Imaging For...

Page 138: ...oning in normal situation Doing so may lead the patient to be unsafe The operator must keep vocal visual contact with the patient at all times during image acquisition process Do not operate the PC du...

Page 139: ...y underway The X ray Indicator icon of the Console Software turns yellow 3 Release the Exposure Switch when Image capturing is complete message appears on the screen 4 The Rotating Unit will move up a...

Page 140: ...med in EzDent i Refer to the EzDent i User Manual for more information 1 The images are transferred to EzDent i automatically 2 The images are automatically saved if automatic save option is configure...

Page 141: ...des 3D PHOTO images Image Acquisition Module A separate Intel Sense SDK module utilizing a 3D PHOTO camera is used Scan Area It covers the surface of the face 3D PHOTO images themselves have no diagno...

Page 142: ...e Handle Frame 4 Let the patient sit on the chair and close the Handle Frame 5 Let the patient hold the handle in comfortable posture and see front 6 Adjust the height of the Chinrest by using the Chi...

Page 143: ...arallel to the patient s nasal base If necessary click or press LED lamp UP DOWN button to adjust the brightness to have proper lighting for the photograph Console Software Touch Screen 10 Click 3D Sc...

Page 144: ...Manual 13 Let the patient see the Eye mark 3 when you hear the beep sound 14 Put the Chinrest into the unit when 3D photography is completed 15 Push the Handle Frame s Open Close button inward and op...

Page 145: ...pturing is completed 2 Double click the image to confirm on the Patient list 3 You can check the captured image OBJ file with a 3rd party 3D PHOTO viewer after exporting the image from EzDent i You ca...

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Page 147: ...ther the Console Software is ready for imaging If imaging cannot be performed Cause Actions to be taken Failure of initialization Wait until the equipment is initialized and then try again If this pro...

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Page 149: ...corrosion on the surface of the equipment Do not use any cleaning products which contain silicon They could potentially damage the equipment s electrical components The following table summarizes the...

Page 150: ...are the input fuses which must comply with the manufacturer s specifications As a precaution against fire the replacement should be the one in the same type and range There are no user serviceable pa...

Page 151: ...are not heated abnormally Daily Confirm that the LED indicator turns yellow when the Exposure Switch is pressed Ensure that the LED indicator remains yellow for the entire duration of the exposure Da...

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Page 153: ...ed of in accordance with disposal regulations IEC 60601 1 6 8 2 j Parts Materials Recyclable To the special disposal site Hazardous waste Needs Separate Collection Frame and Covers Aluminum and plasti...

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Page 155: ...ion Mode FDD mm FOD mm ODD mm Magnification CT 672 72 384 12 288 60 1 75 PANO 672 72 446 13 226 59 1 51 i CEPH PA and Lateral 672 72 384 12 288 60 1 75 Virtual 1 i CEPH Carpus 672 72 626 20 46 50 1 07...

Page 156: ...unit mm Item Description Weight 321 kg 708 lbs with the Base Total Height Max 2185 mm 86 0 inch Rotating Unit Vertical Movement Max 680 mm 26 8 inch Dimensions Length L x Width W x Height H 1575 L x 1...

Page 157: ...0 kV 1 kV increment 10 mA 4 10 mA 1 mA increment 20 PANO i CEPH 0 5 mA increment CT 0 1 mA increment 10 Cooling Cooling Protect Optional fan cooling 60 Total filtration Min 2 5 mm Al Added filtration...

Page 158: ...15 Technical Specifications 152 PaX i3D Green Premium User Manual Maximum Rating Charts Emission Filament Characteristics...

Page 159: ...15 Technical Specifications PCT 90LH User Manual 153 ENGLISH Anode Thermal Characteristics Tube Housing Assembly Thermal Characteristics...

Page 160: ...increment 10 mA 4 10 mA 1 mA increment 20 PANO i CEPH 0 5 mA increment CT 0 1 mA increment 10 Cooling Cooling Protect Optional fan cooling 60 Total filtration Min 2 5 mm Al Added filtration 2 0 mm Al...

Page 161: ...15 Technical Specifications PCT 90LH User Manual 155 ENGLISH Maximum Rating Charts Emission Filament Characteristics...

Page 162: ...15 Technical Specifications 156 PaX i3D Green Premium User Manual Anode Thermal Characteristics Tube Housing Assembly Thermal Characteristics...

Page 163: ...PANO 198 m 4X4 Binning CT Dental ENT i CEPH Active area 310 4 mm x 36 4 mm Frame Rate 107 fps 2x2 Binning PANO 308 fps 4x4 Binning CT Dental ENT i CEPH Analogue Digital Conversion 14 bits Operating co...

Page 164: ...Allowable input voltage fluctuation requirement 10 Mode of operation Continuous operation with intermittent loading Exposure time Max 18 s Resting time 10 min Column operation time 1 min Resting time...

Page 165: ...GLISH 15 4 Environmental Specifications Item Description During Operation Temperature 10 35 Relative humidity 30 75 Atmospheric pressure 860 1060 hPa During Transport and Storage Temperature 10 60 Rel...

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Page 167: ...6 0 85 5 5 Scan Time Exposure Time Examina tion Arch Selection Mode Scan Time s Exposure Time s High Resolution Green High Resolution Green Pano Examinat ion Narrow Normal Wide Orthogonal Standard 13...

Page 168: ...16 1 2 i CEPH mode Exposure Condition Examination Gender Age Group Hard kVp mA Normal kVp mA Soft kVp mA Lateral PA Man 102 4 5 100 4 5 98 4 5 Woman 100 4 5 98 4 5 96 4 5 Child 98 4 5 96 4 5 94 4 5 Ca...

Page 169: ...man Hard 108 6 5 95 6 5 Normal 106 6 5 93 6 5 Soft 104 6 5 91 6 5 Child Hard 106 6 5 93 6 5 Normal 104 6 5 91 6 5 Soft 102 6 5 89 6 5 Exposure Condition FOV 17x15 17x11 cm Mode High Resolution Green k...

Page 170: ...d 108 6 5 85 5 5 Normal 106 6 5 83 5 5 Soft 104 6 5 81 5 5 Child Hard 106 5 5 83 5 5 Normal 104 5 5 81 5 5 Soft 102 5 5 79 5 5 Exposure Condition FOV 8x8 cm Mode High Resolution Green kVp mA kVp mA Ma...

Page 171: ...12x9 18 0 18 0 13 9 13 9 8x8 Right 18 0 18 0 11 0 11 0 Left 18 0 18 0 11 0 11 0 Center 18 0 18 0 11 0 11 0 Depending on the circumference of the patient s head X ray intensity may be classified as Ha...

Page 172: ...for patient doses monitoring HPA recommends that any national reference dose that achievable dose DAP value of 250 mGy cm 2 for clinical protocol for a standard male patient Standard National Deviatio...

Page 173: ...0 mA 11 9 sec 50 Dental CT 21 x 19 High Resolution 108 kVp 6 5 mA 18 0 sec 2010 Dental CT 21 x 19 Green 95kVp 6 5 mA 18 0 sec 1610 Dental CT 8 x 8 High Resolution 108 kVp 6 5 mA 11 0 sec 620 Dental CT...

Page 174: ...unt based on following standard defined by IEC regulation and has been performed by covering each collimator region in use Standard National Deviation Terminology Permissive Range International Standa...

Page 175: ...lts Direction PANO Adult mR h Dental CT 21 x 19 mR h ENT CT 21 x 19 mR h i CEPH mR h 0 4 5 12 2 11 4 4 4 45 1 2 2 4 3 8 7 2 90 5 8 20 0 15 4 16 4 135 4 4 7 1 5 8 6 2 180 5 6 4 0 3 7 11 4 225 3 2 1 5 4...

Page 176: ...tive shielding facility around the patient s position This information states the identity and intended position of tested phantom and scattered dosimetric evaluation under defined scope and test circ...

Page 177: ...User Manual 171 ENGLISH Results PANO Adult Direction 1 m mR 1 5 m mR 2 m mR 0 1 00 0 74 0 49 45 0 15 0 11 0 08 90 0 69 0 51 0 34 135 0 51 0 38 0 25 180 0 68 0 50 0 33 225 1 38 1 03 0 68 270 1 00 0 74...

Page 178: ...en Premium User Manual Results Dental CT 21 x 19 Direction 1 m mR 1 5 m mR 2 m mR 0 1 46 1 09 0 72 45 1 94 1 45 0 95 90 0 37 0 28 0 19 135 0 95 0 70 0 47 180 4 01 2 99 1 96 225 4 48 3 33 2 18 270 3 92...

Page 179: ...er Manual 173 ENGLISH Results ENT CT 21 x 19 Direction 1 m mR 1 5 m mR 2 m mR 0 1 88 1 40 0 92 45 1 74 1 29 0 84 90 0 84 0 62 0 40 135 0 50 0 37 0 25 180 3 08 2 29 1 49 225 4 98 3 70 2 43 270 3 50 2 6...

Page 180: ...D Green Premium User Manual Results i CEPH Direction 1 m mR 1 5 m mR 2 m mR 0 0 95 0 71 0 47 45 1 26 0 94 0 62 90 0 24 0 18 0 12 135 0 62 0 45 0 31 180 2 60 1 94 1 27 225 2 91 2 16 1 42 270 2 55 1 89...

Page 181: ...ocation The PCT 90LH is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply networ...

Page 182: ...ne s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Main power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and vo...

Page 183: ...uding cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance where P is the maximum output power ra...

Page 184: ...e in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PCT 90LH can help Prevent electromagnetic interference by maintaining a minimum dis...

Page 185: ...ss 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 PCT 90LH is used exceeds...

Page 186: ...2 System of Skeletal Maturation Assessment SMA The System uses only four stages of bone maturation all found at six anatomical sites located on thumb third finger fifth finger and radius as seen Fig 1...

Page 187: ...sites in the hand wrist Fig2 Radiographic identification of skeletal maturity indicators A Width of epiphysis as wide as diaphysis 1 Third finger Proximal phalanx 2 Third finger middle phalanx 3 Fift...

Page 188: ...olescent development are found on these six sites Fig 1 orange circles Fig3 Eleven Skeletal maturity indicators SMIs A systematic observational scheme such as that shown in the figure above can furthe...

Page 189: ...16 Appendices PCT 90LH User Manual 183 ENGLISH...

Page 190: ...on throughout exposure 2 Move the Chinrest into a position that is slightly higher than the patient s chin height before requesting that the patient place chin onto the rest Direct the patient to assu...

Page 191: ...oal of the dental hygienist is to maximize the use of panoramic imagery in the assessment of the pediatric patient while minimizing the occurrence of retakes that result from radiographic error Produc...

Page 192: ...or back the patient should be positioned side positioner guides for determining the correct lateral alignment and a chin rest to correctly locate the superior inferior dimension or how far up or down...

Page 193: ...th Figure 3 When the arches are positioned too far posteriorly the anterior teeth will appear broad or widened If the position is excessively posterior anterior teeth may be completely blurred from th...

Page 194: ...ult from incorrect lateral positioning the midsagittal plane must be positioned perpendicular to the floor Most panoramic x ray machines have a head positioner and or laser light beam guide along with...

Page 195: ...t downward turned appearance to the occlusal plane Figure 5 The condyles flare out and off the edges of the image and the palate appears as a widened thick dense radiopacity This positioning error res...

Page 196: ...he machine Figure 2 The patient should be directed to stand in front of the panoramic x ray machine allowing the operator to place the chin rest into a position that is slightly higher than the patien...

Page 197: ...ioning steps the panoramic x ray machine should be inspected and the focal trough recalibrated The dental hygienist who is skilled in understanding panoramic equipment operation and pediatric patient...

Page 198: ...MEJ RE K WEERHEIJM EAPD guidelines for use of radiographs in children P40 48 European Journal of Pediatric Dentistry 1 2003 Guidelines in dental radiology are designed to avoid unnecessary exposure to...

Page 199: ...to two pediatric tissue equivalent phantoms using thermo luminescent dosimeters for three dental CBCT units and six imaging protocols The doses to the thyroid salivary glands and brain ranged from 0...

Page 200: ...he maximum value of mean organ dose in brain CT was 34 3 mGy for brain Maximum values of mean doses for the radiosensitive lens and thyroid were 32 7 mGy for lens in brain CT and 17 2 mGy for thyroid...

Page 201: ...gnetic Compatibility ENT Ear Nose and Throat ESD Electrostatic Discharge EUT Equipment Under Test FDD Focal spot to Detector Distance FOD Focal spot to Object Distance FOV Field of View FPD Flat Panel...

Page 202: ...16 Appendices 196 PaX i3D Green Premium User Manual SOP Signal Output Part SMV Submento Vertical TMJ Temporomandibular Joint...

Page 203: ...formation contact your VATECH representative Tel 82 1588 9510 Email gcs vatech co kr Website www vatech co kr Headquarters 13 Samsung 1 ro 2 gil Hwaseong si Gyeonggi do 18449 Korea Factory 13 Samsung...

Page 204: ......

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