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15. Appendices

164

vatech A9 (Model name: PHT-30CSS) User Manual

15.2.2 Leakage Dose

X-ray Leakage Dose Test Report for PHT-30CSS maintains dosemetric evaluation of

the Vatech dental diagnostic system to meet requirements in IEC Collateral Standard.

To limit unnecessary exposure to the patient, the operator, and other staff, PHT-30CSS

is designed to fulfill IEC 60601-1 (IEC 60601-1-3, IEC 60601-2-63) and this document

provides a leakage test report with the evaluation condition and procedure.

15.2.2.1 Standard

National Deviation

Terminology

Permissive Range

International Standard

IEC 60601-1-3

Leakage

limits leakage at 1m from the

source to 100 mR in 1 hr

15.2.2.2 Measurement Overview

15.2.2.3 PANO Mode Results

Test Condition

Tested Mode

PANO

Distance from focal point [m]

Applied Tube Voltage Peak [kVp]

Applied Tube Current [mA]

Содержание A9

Страница 1: ......

Страница 2: ...Notice 2 vatech A9 Model name PHT 30CSS User Manual...

Страница 3: ...me PHT 30CSS system It is recommended that you thoroughly familiarize yourself with this manual to make the most effective use of this equipment Observe all cautions safety messages and warnings in th...

Страница 4: ...Notice 4 vatech A9 Model name PHT 30CSS User Manual Left blank intentionally...

Страница 5: ...2 Owner and Operator s Obligations 13 2 3 Conventions in this Manual 14 2 4 Marks and Symbols 15 3 Warnings and Precautions 19 3 1 General Safety Guidelines 19 3 2 Electricity related Safety Precauti...

Страница 6: ...nitiating the Console Software 48 7 Acquiring PANO Images 49 7 1 PANO Imaging Program Overview 49 7 2 Configuring Exposure Parameters 56 7 3 Patient Positioning 60 7 4 X ray Exposure 75 7 5 Finishing...

Страница 7: ...115 9 8 Image Comparison according to Patient Position Incorrect Posture 116 10 Troubleshooting 119 10 1 Troubleshooting 119 10 2 Error Codes 120 11 Cleaning and Disinfection 125 11 1 Cleaning 125 11...

Страница 8: ...15 1 Recommended X ray Exposure Tables 155 15 2 X ray Dose Data 162 15 3 Electromagnetic Compatibility EMC Information 175 15 4 Acquiring Images for Pediatric Dental Patients 178 15 5 Degree of cervic...

Страница 9: ...HT 30CSS is a complete digital X ray system equipped with imaging viewers an X ray generator and a dedicated SSXI detector The digital CBCT system is based on a CMOS digital X ray detector The CMOS CT...

Страница 10: ...teeth third molar teeth and odontomas Diagnosis of third molar teeth is only available in some Asian countries and Mexico Diagnosis of root resorption of teeth Assessment of cleft palate Assessment of...

Страница 11: ...ware of diagnostic medical radiation equipment and recognizing equipment connection installation operating conditions Language understanding Understanding how to use manuals English Korean or Understa...

Страница 12: ...1 Introduction 12 vatech A9 Model name PHT 30CSS User Manual Left blank intentionally...

Страница 13: ...repairs The User Manual has typically used the equipment 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 Obligation...

Страница 14: ...re to comply with a warning may result in severe damage to the equipment or physical injury to the operator and patient CAUTION Indicates a situation that demands prompt and careful action a specific...

Страница 15: ...hock Class 1 equipment Label This indicates radiation hazard Label This indicates the authorized representative in the European Community Label The CE symbol indicates that this product complies with...

Страница 16: ...ackage This indicates that this equipment is classified as a CLASS 1 LASER PRODUCT by IEC 60825 1 ED 2 regulations Label This indicates that the user needs to refer to the User Manual Label This indic...

Страница 17: ...ached on the right side of the equipment and it consists of 5 parts as below No Item 1 Main Label 2 CAUTION Label X ray Attention X ray on when equipment in operation 3 X RAY GENERATOR Label 1 0 kW Ge...

Страница 18: ...2 General Information 18 vatech A9 Model name PHT 30CSS User Manual Left blank intentionally...

Страница 19: ...y precautions Follow the instructions specified in this manual to ensure the safety of both the patient and the operator The operator must always maintain vocal visual contact with the patient during...

Страница 20: ...r equivalent alarm system to show the state of the current Ventilation Do not close the equipment s ventilation slots in any case The obstruction of ventilation could result in the equipment overheati...

Страница 21: ...in Off Ratio 1 9 If the temperature inside the tube head reaches 60 C 140 F X ray exposure will cease and an error message will be displayed Normal X ray capabilities will resume after the generator r...

Страница 22: ...sure that equipment movement is not obstructed by the patient s clothing a medical device such as a wheelchair or the patient Do not leave the patient unattended around the equipment Remove all radio...

Страница 23: ...t with other devices Do not connect this equipment to devices that are not designated as a part of the system Do not connect this equipment to a Multiple Portable Socket Outlet MPSO or extension cord...

Страница 24: ...ithout observing ESD protective measures ESD protective measures include Procedures for preventing electrostatic charge build up e g temperature control humidification conductive floor coverings and n...

Страница 25: ...tion During 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 d...

Страница 26: ...assessment conventional medical CT or MR should be used instead of dental cone beam imaging vatech A9 Model name PHT 30CSS system like other medical equipment uses high frequency electrical signals th...

Страница 27: ...ironment that is susceptible to explosion Do not place flammable materials near this equipment Do not operate the PC while the equipment is operating Failure to comply with this instruction may result...

Страница 28: ...talled by an authorized technician complying with proper installation procedures For further details on installation refer to the vatech A9 Model name PHT 30CSS Installation Manual Security Capabiliti...

Страница 29: ...e Ez3D i 3D viewer software 4 2 Features FOV 8x8 support Anatomically 9 3 x 8 0 cm The multi imaging solution for Accurate Diagnostics Conventional 2D PANO and CEPH image acquisition Control Panel imp...

Страница 30: ...ective 93 42 EEC MEDICAL APPLIED ELECTROMAGNETIC RADIATION EQUIPMENT AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI AAMI ES60601 1 2005 AMD 1 2012 CAN CSA C22 2 No 606...

Страница 31: ...ging System Overview vatech A9 Model name PHT 30CSS User Manual 31 English 4 6 Imaging System Configuration PC Signal Input Output No Item 1 3D viewer License Key 2 Video output 3 Giga Ethernet Cable...

Страница 32: ...ead during CEPH imaging 4 Column UP DOWN Switch optional Adjust column height to adjust the height of the vertical frame 5 Stationary Column Supports the whole part of the equipment 6 Base Optional Ba...

Страница 33: ...tandby Yellow In operation X ray on 14 X ray Generator The X ray tube where the X ray is produced 15 Vertical Frame Holds the Rotating Unit It can be controlled with the Column UP DOWN switch 16 Rotat...

Страница 34: ...il it pops up The Emergency Stop Switch is located under the bottom of the Handle Frame 4 7 3 Exposure Switch The Exposure Switch allows the operator to control image acquisition from outside of the X...

Страница 35: ...l patients PC Polycarbonate Deep Bite Block Deep Bite Block is only available in some Asian countries PC Polycarbonate Special Bite A For PANO TMJ LAT and Sinus PA modes PC Polycarbonate Special Bite...

Страница 36: ...tion Materials Carpus Plate PC Polycarbonate Sanitary Vinyl Covers disposable for the Bite PP PE Polypropylene Polyethylene Protractor 1 set For positioning the patient s body in CEPH mode PC Polycarb...

Страница 37: ...are some recommendations for choosing which chair to purchase Required chair specifications Chair without a backrest Up Down available chair requires height adjustment handle When the chair is lowered...

Страница 38: ...ild is lower than the height of the backrest use a child cushion to increase the sitting height of the pediatric patient to prevent bump with the chair backrest and the equipment rotator part For pati...

Страница 39: ...patients near the equipment and PC Item Specifications CPU Intel Core i3 9100 3 6 4C RAM 16 GB 2 x 8 GB DDR4 2666 UDIMM NECC Memory APJ HDD 1 TB SATA 7200 rpm 3 5 in WKS Graphics board GEFORCE GTX1050...

Страница 40: ...l for more information Security Capabilities It is recommended to install and operate EzDent i SW within a secure operating environment that allows only authorized users to access and a system network...

Страница 41: ...re consists as follows Each imaging mode will be described later No Item Description 1 Tooth icon Click the tooth icon to view the Open Source Announcement and the Console Software version information...

Страница 42: ...nd align the Phantom Jig and then click the READY button 4 Press and hold down the Exposure Switch 7 Patient Information window Displays information on the selected patient The user can freely control...

Страница 43: ...sure time would be displayed DAP Scan Time and Exposure Time Display window It is activated when you click the CONFIRM button after the patient positioning is completed Click the button when all aspec...

Страница 44: ...meters for each mode PANO CEPH Optional and CBCT Scan Selecting Modality changes the Modality Selection screen to the Imaging Parameters Configuration panel 16 EXIT button Exits the console software A...

Страница 45: ...ury to the patient and damage to the equipment Do not operate the PC while the equipment is in operation Doing so may cause an error in the equipment 1 Press the Main Power Switch that is located unde...

Страница 46: ...nd Console Software are being accessed through 2D viewer EzDent i SW 3D viewer and Console Software do not have an image storage capacity of their own and both programs will not be able to keep patien...

Страница 47: ...ter the Name or Chart Number of the patient to be searched on the Patient Search panel and then click the Search button The information on the patient that fits the search condition appears Double cli...

Страница 48: ...tered first 1 Search and select the patient to be captured 2 Click the ACQUISITION tab and select the imaging mode CT Panorama or Cephalo 3 The Main Screen for the selected mode appears From the Main...

Страница 49: ...mage Acquisition Method It reconstructs 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 Exa...

Страница 50: ...7 Acquiring PANO Images 50 vatech A9 Model name PHT 30CSS User Manual Examination Type Arch Selection ROI Example PANO Examination Child Right Front Left Standard Orthogonal Right Front...

Страница 51: ...NO Images vatech A9 Model name PHT 30CSS User Manual 51 English Examination Type Arch Selection ROI Example PANO Examination Orthogonal Left Bitewing Right Standard Bitewing Left Bitewing Bitewing Inc...

Страница 52: ...HT 30CSS User Manual Examination Type Arch Selection Example N A TMJ LAT Open TMJ LAT Close TMJ PA Open Optional TMJ PA Close Optional Sinus LAT Optional Sinus PA Bitewing imaging mode is activated on...

Страница 53: ...ry Typically for some females Normal Standard A panoramic imaging mode for adult patients with a typical arch trajectory Wide Standard A panoramic imaging mode for the patients with a square shaped ar...

Страница 54: ...some parts of the maxillary sinus cannot be acquired SPECIAL Examination N A TMJ LAT Open Close An imaging mode to acquire a lateral image of the TMJ in which the X ray beam is directed on the lateral...

Страница 55: ...mination Type Arch Selection ROI Description Sample Image Sinus PA A special imaging mode to acquire a Sinus image in which an X ray beam is directed on the frontal region of the maxillary sinus Bitew...

Страница 56: ...s 56 vatech A9 Model name PHT 30CSS User Manual 7 2 Configuring Exposure Parameters To acquire PANO Images 6 Getting Started must be completed first If not you must return to the 6 Getting Started and...

Страница 57: ...ll number of adult females Normal Panoramic image of normal adult palatal arches Wide Panoramic image of square shaped palatal arches some number of adult males Orthogonal The panoramic image where th...

Страница 58: ...t select Orthogonal in the Arch Selection panel When a Special Examination option is clicked the PANO Examination panel is disabled If you want to select a PANO Examination option please conduct Arch...

Страница 59: ...nt s gender age group and X ray intensity Click the UP DOWN arrow to adjust kVp and mA The dose is adjustable by 1 kVp and 1 mA respectively 7 Click the CONFIRM button when the exposure parameter sett...

Страница 60: ...r body when positioning the patient is a necessary motion There is a horizontal beam laser for the guide that points the patient s shoulder in the rotator section This laser allows you to proactively...

Страница 61: ...inrest position is already set to PANO mode there is no need to adjust again The installation angle of the Chinrest attachment part may be distorted by 2 degrees This is intended for calibration purpo...

Страница 62: ...the Chinrest and the Bite with a non alcohol based non corrosive cleaning solution and wipe with a dry towel before the next patient 2 Guide the patient to a chair sold separately in the center of th...

Страница 63: ...ontact patient s chest to the handle frame 8 Maintain the position described below Hold the handle firmly Make sure the patient s chest is in contact with the equipment Keep both shoulders parallel St...

Страница 64: ...to align the laser beam properly 1 Align the Vertical Beam with the center of the face Mid sagittal Line It is to prevent the horizontal expansion of the image 2 Align the Horizontal Beam in a straigh...

Страница 65: ...nd wipe with a dry towel before the next patient 2 Guide the patient to a chair sold separately in the center of the equipment 3 Guide the patient to sit in the center of the equipment If a chair with...

Страница 66: ...ame 7 Maintain the position described below Hold the handle firmly Make sure the patient s chest is in contact with the equipment Keep both shoulders parallel Straighten the patient s cervical spine a...

Страница 67: ...ioning 1 Remove the Normal Chinrest and insert the Special Chinrest into the equipment 2 Insert the Special Bite A into the Special Chinrest Clean the Chinrest and the Bite with a non alcohol based no...

Страница 68: ...hion point against the Chinrest and tilt the head forward about 5 At this point make sure the patient s jaw does not touch the equipment If the jaw touches the equipment it is difficult to maintain th...

Страница 69: ...laser beam properly 1 Align the Vertical Beam with the center of the face Mid sagittal Line It is to prevent the horizontal expansion of the image 2 Align the Horizontal Beam in a straight line to th...

Страница 70: ...to sit in the center of the equipment If a chair with a backrest is used make sure that the patient s back is away from the backrest of the chair for proper positioning 4 Position the patient s back a...

Страница 71: ...osture as follows Close the mouth Place the tongue on the roof of the mouth Close the eyes As shown in the picture the support unit of the integrated Chinrest should touch the patient s acanthion poin...

Страница 72: ...pment If a chair with a backrest is used make sure that the patient s back is away from the backrest of the chair for proper positioning 5 Position the patient s back and cervical spine as straight as...

Страница 73: ...he jaw touches the equipment it is difficult to maintain the proper position to get good images Be careful the patient does not touch the equipment with his her jaw 10 the patient maintains the postur...

Страница 74: ...quality Be sure to align the Laser Beam properly 1 Align the Vertical Beam with the center of the face Mid sagittal Line It is to prevent the horizontal expansion of the image 2 Align the Horizontal B...

Страница 75: ...on To acquire optimized images instruct the patient to hold his her breath and not to swallow Also do not let the patient move 1 Get out of the X ray room and close the door The operator must always k...

Страница 76: ...ges can be reconstructed and converted to DICOM format The exported 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...

Страница 77: ...1 CEPH Imaging Program Overview Result Images It provides conventional 2D cephalometric images Image Acquisition Method It acquires multiple images by scanning the specific oral maxillofacial regions...

Страница 78: ...o the anterior It is used to examine cranial diseases trauma and congenital malformations It is used to assess the growth of the lateral side of the face It is also used to examine the ramus mandibula...

Страница 79: ...rea Description Waters view Used to study the frontal sinus the antrum ethmoidal the optic disc pit the frontozygomatic suture the nasal cavity the coronoid process between the upper jaw and the zygom...

Страница 80: ...SS User Manual 8 2 Configuring Exposure Parameters To acquire CEPH images 6 Getting Started must be completed first It is able to set the imaging parameters on the Console Software running on the PC T...

Страница 81: ...creen The CEPH button exists only when the CEPH imaging program is included in the equipment 2 Select an Image Option 3 Select an examination program in the CEPH Examination panel 4 The Gender Age gro...

Страница 82: ...ent s gender age group and X ray intensity Click the UP DOWN arrow to adjust kVp and mA The dose is adjustable by 1 kVp and 1 mA respectively 7 Click the CONFIRM button when the exposure parameter set...

Страница 83: ...s the shadow cast by the patient s cervical spine and allows clear image acquisition Metal implants or bridges may reduce the quality of the images The manufacturer recommends using a chair that can b...

Страница 84: ...ws clear image acquisition Patient Positioning 1 Turn the Nasal Positioner to the Lateral mode Positioning Marker as shown below 2 Leave enough space between the Ear Rods Use the Porion Position Refer...

Страница 85: ...the Ear Rods and Nasal Positioner to the patient 6 Align the Ear Rods into the patient s ears properly so that the head does not move during the operation Moreover aligning the Nasal Positioner with t...

Страница 86: ...8 Acquiring CEPH Images Optional 86 vatech A9 Model name PHT 30CSS User Manual 9 Click the READY button The x ray exposure has not started yet 10 Now go to 8 4 X ray Exposure to start the exposure...

Страница 87: ...User Manual 87 English 8 3 2 PA Mode Patient Positioning 1 Turn the Nasal Positioner to the PA Waters view Carpus mode Positioning Marker as shown below 2 Fold the Nasal Positioner up The Nasal Positi...

Страница 88: ...tch After adjusting the height of the column align the Ear Rods to the patient 6 During the operation correctly align the Ear Rods to the patient s ears so his her head does not move 7 Align horizonta...

Страница 89: ...8 3 3 SMV Mode Patient Positioning 1 Turn the Nasal Positioner to the SMV mode Positioning Marker as shown below 2 Fold the Nasal Positioner up The Nasal Positioner is not used in SMV mode 3 Guide th...

Страница 90: ...atient 6 During the operation correctly align the Ear Rods to the patient s ears so his her head does not move 7 Carefully tilt the patient s head back and adjust so his her Frankfurt Line is vertical...

Страница 91: ...e sure that the patient s shoulders are level and that his her neck is relaxed 5 Adjust the instrument to the patient s sitting height using the Column UP DOWN on the Handle frame or the optional UP D...

Страница 92: ...8 Acquiring CEPH Images Optional 92 vatech A9 Model name PHT 30CSS User Manual 8 Click the READY button The x ray exposure has not started yet 9 Now go to 8 4 X ray Exposure to start the exposure...

Страница 93: ...ositioning the patient Installing the Carpus Plate 1 Turn the Nasal Positioner to the PA Waters view Carpus mode Positioning Marker as shown below 2 Fold the Nasal Positioner up The Nasal Positioner i...

Страница 94: ...er right hand splayed on the Carpus Plate as shown below Make sure that the patient does not bend his her fingers 2 Ask the patient to close his her eyes and sit still until the image acquisition is c...

Страница 95: ...s instruct the patient to hold his her breath and not to swallow Also do not let the patient move 1 Get out of the X ray room and close the door 2 Press and hold down the Exposure Switch until image a...

Страница 96: ...exported 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 the a...

Страница 97: ...rovides conventional 3D CT sliced images Image Acquisition Method It acquires images with the X ray beam scanning specific oral maxillofacial regions and reconstructs them to 3D sliced images Examinat...

Страница 98: ...User Manual 9 2 Configuring Exposure Parameters To acquire CBCT Images 6 Getting Started must be completed first You can set the imaging parameters on the Console Software running on the PC They are...

Страница 99: ...is included in the equipment Make sure FOV Diameter x Height is 8x8 Available options for each FOV are as below Available FOV cm Vertical option Horizontal option 8x8 Occlusion Center 2 Select an Ima...

Страница 100: ...ption manually 5 Select 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 6 The values of tube voltage and...

Страница 101: ...ter setting is completed When you click CONFIRM button The Rotating Unit will move to its initial scanning position The Vertical Beam will be activated to make patient positioning easier The DAP Dose...

Страница 102: ...ring CBCT Images 102 vatech A9 Model name PHT 30CSS User Manual 9 3 Configuring the third molar teeth exposure parameters optional This feature is the only available option in some Asian countries and...

Страница 103: ...m is included in the equipment Make sure FOV Diameter x Height is 8x8 Available options for each FOV are as below Available FOV cm Vertical option Horizontal option 8x8 Occlusion Center 3 Select an Im...

Страница 104: ...tage and current are configured automatically according to the patient s gender age group and X ray intensity Click the UP DOWN arrow to adjust kVp and mA The dose is adjustable by 1 kVp and 0 1 mA re...

Страница 105: ...ction This laser allows you to proactively identify the possibility of moving the rotator and touching the patient s shoulder If the laser is pointing at the patient s shoulder it can be lowered furth...

Страница 106: ...inrest position is already set to CBCT mode there is no need to adjust again The installation angle of the Chinrest attachment part may be distorted by 2 degrees This is intended for calibration purpo...

Страница 107: ...ient Be sure to use the approved vinyl cover Clean the Chinrest and the Bite with a non alcohol based non corrosive cleaning solution and wipe with a dry towel before the next patient 2 Guide the pati...

Страница 108: ...optional UP DOWN switch while the patient holds the handle 6 Close contact patient s chest to the handle frame 7 Guide the patient to sit in the center of the equipment and maintain the position descr...

Страница 109: ...Acquiring CBCT Images vatech A9 Model name PHT 30CSS User Manual 109 English 8 Let the patient maintain the posture as follows Close the mouth Place the tongue on the roof of the mouth Close the eyes...

Страница 110: ...on alcohol based non corrosive cleaning solution and wipe with a dry towel before the next patient The Third Molar mode is the same as the Normal mode in the imaging and reconstruction method however...

Страница 111: ...6 Close contact patient s chest to the handle frame 7 Guide the patient to sit in the center of the equipment and maintain the position described below Hold the handle firmly Make sure the patient s...

Страница 112: ...ositioned there may be distortion causing the image to be enlarged or reduced or ghost shadows may occur and lower the image quality Be sure to align Laser Beam properly FOV 8x8 cm Center This is a sa...

Страница 113: ...r ghost shadows may occur and lower the image quality Be sure to align Laser Beam properly This is a sample illustration for reference only Actual FOV may vary from the image as shown above 2 Align th...

Страница 114: ...To acquire optimized images instruct the patient to hold his her breath and not to swallow Also do not let the patient move 1 Get out of the X ray room and close the door The operator must always keep...

Страница 115: ...converted to DICOM format The exported 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 ar...

Страница 116: ...head posture Turtle neck syndrome For patients with forwarding head posture artifacts may occur as shown in the image below Cervical part Ghost image Position the patient s back and cervical spine in...

Страница 117: ...arranged in a flat form image Make sure the patient does not up to their head Normal C shaped neck Head up posture Artifact Occurrence arranged in a flat form image 9 8 3 Head down posture For patien...

Страница 118: ...ed in a V shape 9 8 4 Non central location For patients with non central location posture artifacts may occur as shown in the image below left right asymmetry Guide the patient to be positioned in the...

Страница 119: ...then try again Failure of the Control PC s connection Check the connection status of the Communication Port Optic which connects the PC to the equipment If the Exposure Switch is not functioning Cause...

Страница 120: ...uses of the errors mentioned in the subcode 10 2 1 Main code Hardware 001 10 2 1 1 Subcode Generator related error 001 Tail code Description 001 Appears when the tube is not ready for use 002 Appears...

Страница 121: ...value during X ray irradiation 014 Appears when the mA feedback value is less than 50 compared to setting conditions during X ray irradiation 015 Appears when the mA feedback value is higher than 150...

Страница 122: ...n is less than 1280x1024 002 Appears when the resolution is less than 1200x960 10 2 2 3 Subcode PC Network related error 024 Tail code Description 002 Appears when the port is invalid 003 Appears when...

Страница 123: ...tion 000 Appears when there is a capture error 10 2 3 3 Subcode Reconstruction Failure related error 030 Tail code Description 001 Appears when bugs exist in VXM file or there is insufficient memory 1...

Страница 124: ...10 Troubleshooting 124 vatech A9 Model name PHT 30CSS User Manual Left blank intentionally...

Страница 125: ...s disconnect the equipment from the mains Do not use spray cleaner or disinfectant directly onto the equipment as this could cause a fire Cleaners or disinfectant agents may contain powerful ingredien...

Страница 126: ...ot use cleaning agents in aerosol or spray form directly on the surface of the equipment 11 2 Disinfection Use only disinfectants that comply with the valid requirements of the respective national reg...

Страница 127: ...s that can be replaced by the user are the input fuses which must comply with the manufacturer s specifications As a precaution against fire the replacement should be one in the same type and range Th...

Страница 128: ...he power cord 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 th...

Страница 129: ...ified by the manufacturer or state regulations in which the X ray system is being used 12 3 1 Phantom Kit Contents CT NUMBER CHECK PHANTOM x 1 UNIFORMITY CHECK PHANTOM x1 S C CHECK PHANTOM x1 PHANTOM...

Страница 130: ...heck Phantom Manufacturer VATECH Co Ltd Intended Use Low Contrast Resolution Inspection High Contrast Resolution Inspection Complies with IEC 61223 2 6 IEC 61223 3 5 Phantom Jig Assembly Manufacturer...

Страница 131: ...s and maintain records of the data For technical assistance for QA tests contact your local VATECH service representative If the test criteria are not met contact your local VATECH service representat...

Страница 132: ...OP on the PHANTOM JIG ASS Y BOTTOM as shown below 5 Make the PHANTOM JIG ASS Y level by using BUBBLE LEVEL and three ALIGN PINs 6 Put CT NUMBER CHECK PHANTOM on the PHANTOM JIG ASS Y 7 Run the EzDent...

Страница 133: ...Select an item below Item Value FOV Diameter x Height 8 x 8 Image Option High Resolution Voxel Size 0 20 Standard Gender Age group Man X ray Intensity Hard 4 Click the Confirm button 5 Click the READ...

Страница 134: ...on the WATER TEFLON and AIR area as shown below Try to make each box as close to 20 0 mm2 in the area as possible 5 Compare the CT NUMBER average values from the WATER TEFLON AIR areas with the standa...

Страница 135: ...CT Uniformity Check Phantom 1 Remove Bite and Temple Supports from the Unit 2 Insert the PHANTOM JIG BOTTOM into the Chinrest and then put the PHANTOM JIG TOP on the PHANTOM JIG BOTTOM 3 Make the PHAN...

Страница 136: ...mage capturing is completed save the image in EzDent i 12 4 2 2 Analyzing CT Uniformity Check Phantom 1 Double click the saved PHANTOM image in EzDent i to run Ez3D i 2 In the Axial pane double click...

Страница 137: ...High Contrast and Low Contrast Resolution Tests Test Frequency HIGH CONTRAST RESOLUTION Initially and Yearly LOW CONTRAST RESOLUTION Initially and Yearly Follow the High and Low Contrast Resolution T...

Страница 138: ...n item below Item Value FOV Diameter x Height 8 x 8 Image Option High Resolution Voxel Size 0 20 Standard Gender Age group Man X ray Intensity Hard 8 Click the READY button when enabled 9 Capture the...

Страница 139: ...ble click the pane for full screen mode 4 Adjust the contrast by using WINDOWING Icon 5 Adjust the Brightness by using WINDOWING Icon 6 Make sure that you can see the minimum size of the Airhole and t...

Страница 140: ...12 Maintenance 140 vatech A9 Model name PHT 30CSS User Manual Left blank intentionally...

Страница 141: ...s must be disposed of by 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...

Страница 142: ...13 Disposing of the Equipment 142 vatech A9 Model name PHT 30CSS User Manual Left blank intentionally...

Страница 143: ...Model name PHT 30CSS User Manual 143 English 14 Technical Specifications 14 1 Mechanical Specifications 14 1 1 Dimensions unit mm With CEPH Without CEPH Top view with Base Front View with Base Top vie...

Страница 144: ...th CEPH Without CEPH Top view with Base Front View with Base Top view without Base Front View without Base 34 8 51 8 38 8 76 4 46 6 34 8 51 8 38 8 46 6 73 8 35 3 76 4 39 3 66 7 77 4 30 4 38 8 39 3 66...

Страница 145: ...mm 77 4 Dimensions during operation Length x Width x Height Without CEPH unit without Base 882 8 L x 1314 5 W x 1948 0 H mm 34 8 L x 51 8 W x 76 7 H inch with Base 983 3 L x 1314 5 W x 1966 0 H mm 38...

Страница 146: ...1 2 Image Magnification Mode FDD mm FOD mm ODD mm Magnification PANO 584 6 425 6 159 1 374 CBCT 584 6 353 6 231 1 653 CEPH 1745 1524 221 1 145 FDD Focal Spot to Detector Distance FOD Focal Spot to Obj...

Страница 147: ...0 1 mA increment for CBCT 1 mA increment for PANO and CEPH Cooling Thermal protect fan cooling 35 95 F Total filtration Min 2 5 mmAl Default filtration 1 0 mm Al Added filtration 1 5 mm Al Fixed PANO...

Страница 148: ...Current mA Exposure Time s PANO 60 80 4 12 2 7 60 80 4 12 4 4 60 80 4 12 5 7 60 80 4 12 6 4 60 80 4 12 6 7 60 80 4 12 8 5 60 80 4 12 8 8 60 80 4 12 9 2 60 80 4 12 9 4 60 80 4 12 11 2 60 80 4 12 11 4...

Страница 149: ...14 Technical Specifications vatech A9 Model name PHT 30CSS User Manual 149 English Maximum Rating Charts Emission Filament Characteristics...

Страница 150: ...14 Technical Specifications 150 vatech A9 Model name PHT 30CSS User Manual Anode Thermal Characteristics X ray Housing Assembly Tube Characteristics...

Страница 151: ...36 4 mm 259 2 x 15 6 mm Frame Rate 308 fps 4x4 binning 330 fps 2x2 Binning Analogue Digital Conversion 14 bits Operating condition 10 35 Temperature 10 75 Humidity Storage condition 10 60 Temperature...

Страница 152: ...wer rating 1 7 kVA Accuracy Tube Voltage kVp 10 Tube Current mA 20 Exposure Time s 5 50 ms The input line voltage depends on the local electrical distribution system Allowable input voltage fluctuatio...

Страница 153: ...owed deviation of the tube voltage tube current exposure time Tube Voltage kVp 10 Tube Current mA 20 Exposure Time s 5 50 ms according to IEC 60601 2 63 The mains resistance should not exceed 0 045 oh...

Страница 154: ...14 Technical Specifications 154 vatech A9 Model name PHT 30CSS User Manual Left blank intentionally...

Страница 155: ...tion Gender A ge group X ray Intensity Tube Voltage kVp Tube Current mA PANO Examination High Resolution Man Hard 75 12 Normal 74 12 Soft 73 12 Woman Hard 74 12 Normal 73 12 Soft 72 12 Child Hard 68 1...

Страница 156: ...hild Standard 11 9 11 4 Right 11 9 5 7 Front 11 9 9 2 Left 11 9 5 7 Orthogonal Standard 14 1 13 5 Right 14 1 6 7 Front 14 1 11 2 Left 14 1 6 7 Bitewing 14 1 8 8 Bitewing Incisor Optional 14 1 2 7 Bite...

Страница 157: ...olution Man Hard 92 10 Normal 90 10 Soft 88 10 Woman Hard 90 10 Normal 88 10 Soft 86 10 Child Hard 88 10 Normal 86 10 Soft 84 10 Green Man Hard 92 10 Normal 90 10 Soft 88 10 Woman Hard 90 10 Normal 88...

Страница 158: ...on Man Hard 92 10 Normal 90 10 Soft 88 10 Woman Hard 90 10 Normal 88 10 Soft 86 10 Child Hard 88 10 Normal 86 10 Soft 84 10 Green Man Hard 92 10 Normal 90 10 Soft 88 10 Woman Hard 90 10 Normal 88 10 S...

Страница 159: ...xposure Time s Lateral 3 9 3 9 1 9 1 9 Full Lateral Optional 5 4 5 4 3 9 3 9 PA 4 9 4 9 2 4 2 4 SMV 4 9 4 9 2 4 2 4 Waters view 4 9 4 9 2 4 2 4 Carpus 4 9 4 9 2 4 2 4 Scan Time The actual time that th...

Страница 160: ...Condition FOV cm Image Option Gender Age Group X ray Intensity Tube Voltage kVp Tube Current mA 8x8 High Resolution Man Hard 95 7 0 Normal 94 7 0 Soft 93 7 0 Woman Hard 95 6 7 Normal 94 6 7 Soft 93 6...

Страница 161: ...ion and late deceleration stages Exposure Time The actual time that the patient is exposed to the X ray emission Reconstruction Time File Size Measured Object Skull FOV cm Voxel Size mm Reconstruction...

Страница 162: ...t Hardware Brand Name Model vatech A9 Model name PHT 30CSS Sensor Type PANO CBCT Xmaru1404CF Plus CEPH Xmaru2602CF X ray Generator DG 07F23T4 Tube D 054SB DAP Dose Area Product is a quantity used in a...

Страница 163: ...13 5 s 133 PANO Child Normal High Resolution 67 kVp 10 0 mA 11 4 s 82 CEPH Adult Man LAT High Resolution 90 kVp 10 0 mA 3 9 s 24 CEPH Child LAT High Resolution 86 kVp 10 0 mA 3 9 s 22 CEPH Adult Man L...

Страница 164: ...aff PHT 30CSS is designed to fulfill IEC 60601 1 IEC 60601 1 3 IEC 60601 2 63 and this document provides a leakage test report with the evaluation condition and procedure 15 2 2 1 Standard National De...

Страница 165: ...60 12 0 107 70 5 0 046 80 2 0 020 90 1 0 011 100 6 0 051 110 11 0 101 120 11 0 094 130 10 0 091 140 7 0 062 150 5 0 043 160 15 0 136 170 22 0 190 180 8 0 066 190 4 0 034 200 4 0 035 210 8 0 070 220 7...

Страница 166: ...pendices 166 vatech A9 Model name PHT 30CSS User Manual 15 2 2 4 CEPH Mode Results Test Condition Tested Mode CEPH Distance from focal point m 1 Applied Tube Voltage Peak kVp 99 Applied Tube Current m...

Страница 167: ...027 70 3 0 030 80 21 0 185 90 31 0 274 100 29 0 254 110 28 0 246 120 28 0 242 130 26 0 225 140 23 0 199 150 17 0 146 160 17 0 148 170 53 0 467 180 17 0 153 190 11 0 095 200 11 0 101 210 17 0 147 220...

Страница 168: ...pendices 168 vatech A9 Model name PHT 30CSS User Manual 15 2 2 5 CBCT Mode Results Test Condition Tested Mode CBCT Distance from focal point m 1 Applied Tube Voltage Peak kVp 99 Applied Tube Current m...

Страница 169: ...0 196 70 18 0 157 80 5 0 043 90 3 0 023 100 6 0 055 110 25 0 221 120 23 0 200 130 25 0 218 140 18 0 157 150 13 0 118 160 14 0 126 170 42 0 369 180 19 0 171 190 15 0 133 200 10 0 092 210 14 0 125 220...

Страница 170: ...15 Appendices 170 vatech A9 Model name PHT 30CSS User Manual...

Страница 171: ...ion This information states the identity and intended position of the tested phantom and scattered dosimetric evaluation under the defined scope and test circumstances to ensure the magnitude of risks...

Страница 172: ...ied Tube Voltage Peak kVp 99 Applied Tube Current mA 12 Applied Exposure time sec 15 5 Mode Direction CBCT FOV 8x8 mR 1 m 3 3 ft 1 5 m 4 9 ft 2 m 6 6 ft 0 Occiput 0 517 0 307 0 166 45 0 502 0 229 0 13...

Страница 173: ...lied Tube Voltage Peak kVp 80 Applied Tube Current mA 12 Applied Exposure time sec 13 5 Mode Direction PANO Adult Normal mR 1 m 3 3 ft 1 5 m 4 9 ft 2 m 6 6 ft 0 Occiput 0 122 0 066 0 034 45 0 105 0 04...

Страница 174: ...0 Applied Exposure time sec 5 4 Since the Ion chamber is located between the generator and the object Data of 1 m and 1 5 m at 270 are not measured Mode Direction Ceph Full Lateral mR 1 m 3 3 ft 1 5 m...

Страница 175: ...unit 230 V 50 Hz Class A Voltage change Voltage fluctuations and Flicker Emission EN 61000 3 3 2013 IEC 61000 3 3 2013 IDLE mode CT mode PANO mode CEPH mode AC Mains of the power supply unit 230 V 50...

Страница 176: ...Line to Ground 0 5 kV 1 kV 2 kV Immunity to Conducted Disturbances Induced by RF fields EN 61000 4 6 2014 IEC 61000 4 6 2013 EN 61000 4 8 2010 IEC 61000 4 8 2009 IDLE mode CT mode PANO mode CEPH mode...

Страница 177: ...Port tested Test Voltage Test level requirem ent 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 Voltage interruptions EN 61000 4 11 2004 IEC 61000 4 11 2004 IDLE mode CT mode PANO mode CEPH mod...

Страница 178: ...g the correct position throughout the exposure 2 Move the Chinrest into a position that is slightly higher than the patient s chin height before requesting that the weak place chin onto the rest Direc...

Страница 179: ...sitioning errors may occur at an even higher rate in pediatric panoramic radiographs 7 The goal of the dental hygienist is to maximize the use of panoramic imagery in the assessment of the pediatric p...

Страница 180: ...a bite block to indicate the correct anterior posterior position or how far forward or back the patient should be positioned side positioner guides for determining the correct lateral alignment and c...

Страница 181: ...osterior teeth 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 blurred entire...

Страница 182: ...sult from incorrect lateral positioning the midsagittal plane must be positioned perpendicular to the floor Most panoramic x ray machines have a head positioner and laser light beam guide along with a...

Страница 183: ...diopacity This positioning error results in a widened appearance of the palate and obliterates the apical regions of the maxillary teeth compromising the images of the unerupted developing dentition A...

Страница 184: ...e chin on the chin rest while maintaining an erect posture the pediatric patient can be directed to stand like a soldier Most children are familiar with the straight back chest forward tucked chin pos...

Страница 185: ...DJ Nowak AJ Pediatric Dentistry Infancy Through Adolescence 4th ed St Louis Elsevier Saunders 2005 677 3 Thomson EM Panoramic radiographs and the pediatric patient Dimensions of Dental Hygiene 2008 6...

Страница 186: ...hen at 12 14 which is 1 2 years after the eruption of premolars and second molars Additional bitewing controls should be based on an overall assessment of the caries activity risk The high risk patien...

Страница 187: ...ons with a 6 year old child anthropomorphic phantom Pediatr Radiol 2010 40 1206 1214 DOI 10 1007 s00247 009 1495 z Background CT examinations of the head and neck are the most commonly performed CT st...

Страница 188: ...0CSS User Manual For additional information on pediatric X ray imaging please refer to the websites below http www fda gov radiation emittingproducts radiationemittingproductsandprocedures medicalimag...

Страница 189: ...atech A9 Model name PHT 30CSS User Manual 189 English 15 5 Degree of cervical ghost occurrence according to Forwarding head posture Normal C shaped neck posture Forward head posture soft Forward head...

Страница 190: ...ildren the head is balanced above the shoulders In this position the load on each vertebra of the cervical spine is spread evenly between the two facets apophyseal joints at the back and the intervert...

Страница 191: ...asses is short orange arrow so attenuation is small but when the patient is in the Forward head posture the distance of the cervical region through which the X ray passes is relatively long Because of...

Страница 192: ...S Complementary Metal Oxide Semiconductor CRS Chronic rhinosinusitis CT Computed Tomography DAP Dose Area Product DC Direct Current DICOM Digital Imaging and Communications in Medicine EMC Electromagn...

Страница 193: ...D Object to Detector Distance PA Posterior Anterior PANO Panoramic PC Personal computer a general purpose computer for individuals RF Radio Frequency ROI Region of Interest SID Source to Image Recepto...

Страница 194: ......

Страница 195: ...nt For the most current information contact your VATECH representative Tel 82 1588 9510 Email gcs vatech com Website www vatech com Headquarters 13 Samsung 1 ro 2 gil Hwaseong si Gyeonggi do 18449 Kor...

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