DEXIS ORTHOPANTOMOGRAPH OP 3D EX Instructions For Use Manual

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ORTHOPANTOMOGRAPH

OP 3D EX

™

Instructions for Use

225433-PTU rev. 10

ENGLISH

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Summary of Contents for DEXIS ORTHOPANTOMOGRAPH OP 3D EX

Page 1 ORTHOPANTOMOGRAPH OP 3D EX ™ Instructions for Use 225433-PTU rev. 10 ENGLISH...
Page 3: Table Of Contents
4.1.3.1 3D imaging program settings................28 4.1.3.2 3D scout image..................... 31 4.1.3.3 3D image preview....................33 4.1.4 Dental cast view........................35 4.1.4.1 Dental cast program selection................35 4.1.4.2 Dental cast scout image view................36 4.1.4.3 Dental cast image preview.................37 4.1.5 Device settings........................39 ORTHOPANTOMOGRAPH OP 3D EX...
Page 4 9.3 Patient contacting parts........................88 9.4 Device dimensions..........................88 9.4.1 Main device dimensions....................88 9.5 Symbols that may appear on the device or its parts............... 89 9.6 Electromagnetic Compatibility (EMC) tables................91 9.7 X-ray tube assemblies........................97 9.8 Workstation minimum requirements................... 99 ORTHOPANTOMOGRAPH OP 3D EX...
Page 5: 1 Disclaimer And Legal Notices
Download this manual in digital format or order one in printed format for no additional cost from: http://www.dexis.com NOTICE! Make sure to get the manual that applies to your device. For service, contact your local distributor. ORTHOPANTOMOGRAPH OP 3D EX...
Page 6: 2 Introduction
2.1 ORTHOPANTOMOGRAPH OP 3D The ORTHOPANTOMOGRAPH OP 3D EX (later called device) is a dental X-ray device producing high quality digital images of dentition, TM-joints, head and neck area. To take images, you need a suitable workstation connected to the device and a dental imaging software to capture and manage the images.
Page 7: Intended Use And Intended Purpose
2.2 Intended use and intended purpose ORTHOPANTOMOGRAPH OP 3D EX is an X-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be conﬁgured to take panoramic or 3D images of cranio- maxillofacial complex including the ear, nose and throat (ENT) and airway regions, and cervical spine.
Page 8: Abbreviations
Dose Area Product Low Dose Technology ™ for low resolution 3D imaging Metal Artifact Reduction. Reduces the eect of metal and other dense radiopaque objects, that typically create artifacts which are seen as stripes and shadows. Quality Control ORTHOPANTOMOGRAPH OP 3D EX...
Page 9: Signal Words
• This device complies with the EMC (Electromagnetic Compatibility) according to IEC 60601-1-2. Radio transmitting equipment, cellular phones etc. shall not be used in proximity of the device as they could inﬂuence the performance of the device. ORTHOPANTOMOGRAPH OP 3D EX...
Page 10: Connection Requirements
3D imaging using Cone Beam technology. 2.10.2 Connection requirements 2.10.2.1 Electrical connection requirements NOTICE! Always follow local and national requirements regarding the connection of medical systems. ORTHOPANTOMOGRAPH OP 3D EX...
Page 11: Network Requirements
Failure to maintain cybersecurity can result in compromised imaging device functionality, loss of data (PHI or PII) availability or integrity, or exposure of other connected devices or networks to security threats. NOTICE! Report any cybersecurity incident related to the use of the device to the manufacturer. ORTHOPANTOMOGRAPH OP 3D EX...
Page 12: Operating Environment
Any workstation used with the device must conform the workstation minimum requirements presented in the device documentation as well as the dental imaging software system requirements. Example of system network infrastructure and security ORTHOPANTOMOGRAPH OP 3D EX...
Page 13 Only trained and authorized service personnel may install and service the imaging device and related software. Contact the manufacturer’s representative for software updates. • Decommissioning instructions are provided separately in the device and software documentation. ORTHOPANTOMOGRAPH OP 3D EX...
Page 14: Device Modification
Manual, which is available for authorized service technicians. • Connect only items that have been speciﬁed as part of the ME system or speciﬁed as being compatible with ME system by the manufacturer of the device. ORTHOPANTOMOGRAPH OP 3D EX...
Page 15: 3 Overview
3. Lower shelf 4. Rotator 5. Upper shelf 6. PAN/3D Tubehead 7. X-ray sensor 8. Exposure switch 9. Patient handles 10. Emergency stop switch 11. Control panel 12. Head support 13. Mirror 14. Status indication light ORTHOPANTOMOGRAPH OP 3D EX...
Page 16: Exposure Switch
Device status indicator light, located on the top of the carriage, illuminates according the device status: • GREEN: Device is ready for imaging. • YELLOW: Device is generating X-rays. • BLUE: Device is in error state or pending user action. Check the GUI for details. ORTHOPANTOMOGRAPH OP 3D EX...
Page 17: Patient Positioning Lights
4. Horizontal light; bottom of FOV 3.4.2 Panoramic lights 1 - Tilt light 2 - Midsagittal light 3 - FH (Frankfort-Horizontal) light NOTICE! The position of FH light is automatically adjusted according to the selected imaging program. ORTHOPANTOMOGRAPH OP 3D EX...
Page 18: Lights
3.4.3 3D lights 2 - Midsagittal light 3 - Horizontal light, top of FOV 4 - Horizontal light, bottom of FOV NOTICE! The position of the top of FOV light is automatically adjusted according to the selected FOV. ORTHOPANTOMOGRAPH OP 3D EX...
Page 19: Patient Positioning Accessories
Chin rest Flat chin rest (available separately) Bite block Lip support Head support Disposable covers for patient positioning accessories: • Disposable covers for bite block • Disposable covers for lip support • Disposable covers for chin rest ORTHOPANTOMOGRAPH OP 3D EX...
Page 20: Other Detachable Parts
DENTAL CAST IMAGING TOOLS (AVAILABLE SEPARATELY): Dental cast holder 3D QUALITY CONTROL TOOLS: 3D QC phantom 3D QC phantom holder 2D QUALITY CONTROL TOOLS (AVAILABLE SEPARATELY): 2D QC test phantom Copper ﬁlter - 0.8 mm/1.8 mm PAN QC phantom holder ORTHOPANTOMOGRAPH OP 3D EX...
Page 21: Emergency Stop Switch
NOTICE! An interrupted imaging process cannot be resumed. A new image needs to be taken. NOTICE! Make sure that the emergency stop switch is not pressed down when you start the imaging process. NOTICE! Activating the emergency stop causes the device to restart. ORTHOPANTOMOGRAPH OP 3D EX...
Page 22: Device Label Locations
3. Tubehead label 4. PAN/3D collimator label 5. Filtration label 6. Warning label Example illustrations of the device labels: Device type label Serial number labels NOTICE! These labels are for illustrative purposes only. Texts and images may vary. ORTHOPANTOMOGRAPH OP 3D EX...
Page 23: 4 User Interfaces
BASIC USE OF THE GUI: Press on an icon to activate/inactivate imaging program or setting. Active selections are indicated with GREEN colour. Inactive selections are indicated with GRAY colour. ORTHOPANTOMOGRAPH OP 3D EX...
Page 24 GRAY: Device is not ready for imaging, follow the instructions on the status message bar. • YELLOW: Device is generating X-rays. • BLUE: Device is in error state or pending user action. Details are shown on the status message bar. ORTHOPANTOMOGRAPH OP 3D EX...
Page 25: Panoramic Imaging
TMJ, lateral Panoramic Panoramic A sample image for the selected imaging program is shown on the GUI. If you take a segmented image, the unselected segments are grayed out in the sample image. Standard Panoramic Segmented Panoramic ORTHOPANTOMOGRAPH OP 3D EX...
Page 26 • Press on the patient size icon to activate the preset. Select the patient size preset according to the patient to adjust the kV and mA to preset levels. NOTICE! Patient size presets can be adjusted from device settings. ORTHOPANTOMOGRAPH OP 3D EX...
Page 27: Panoramic Image Preview
You can adjust the brightness of the shown preview image using the brightness slider. Contrast slider You can adjust the contrast of the shown preview image using the contrast slider. OK button Press OK button to close the image preview. ORTHOPANTOMOGRAPH OP 3D EX...
Page 28: Imaging
• To easily select multiple teeth (2) click and drag cursor to select all teeth icons within the area. • To select all parts of the dentition, click Select all under the dental chart. • To clear all selections, click Clear Selection under the dental chart. ORTHOPANTOMOGRAPH OP 3D EX...
Page 29: Image Resolution
Standard High Endo • Press on the listed resolution icon to activate it. For recommendations on resolution selection, see chapter 3D Resolutions on page 52. NOTICE! Endo resolution is available only for 5 x 5 FOV. ORTHOPANTOMOGRAPH OP 3D EX...
Page 30 • Press on the patient size icon to activate the preset. Select the patient size preset according to the patient to adjust the kV and mA to preset levels. NOTICE! Patient size presets can be adjusted from device settings. ORTHOPANTOMOGRAPH OP 3D EX...
Page 31: Scout Image
The range how much FOV height can be adjusted is shown with the white marks on the image. The FOV size indicator shows the updated FOV size. It's recommended to adjust the FOV size so that the ROI is in the middle of the volume. ORTHOPANTOMOGRAPH OP 3D EX...
Page 32 NOTICE! Adjustment is not saved to the image. OK button Press OK button to approve the changes made to the FOV location and size using the Scout image and to proceed to the 3D exposure. ORTHOPANTOMOGRAPH OP 3D EX...
Page 33: Image Preview
Press the preview projection icons to change the projection of the shown preview. Coronal Sagittal Axial Slice preview Shows a preview of 3D slices. You can scroll through the preview using the slider on the right side of the image. ORTHOPANTOMOGRAPH OP 3D EX...
Page 34 NOTICE! Adjustment is not saved to the image. Contrast slider You can adjust the contrast of the shown image preview using the contrast slider. NOTICE! Adjustment is not saved to the image. OK button Press OK button to close the image preview. ORTHOPANTOMOGRAPH OP 3D EX...
Page 35: Dental Cast View
Indicates if the Scout image program is active. A Scout image is taken to verify and perform adjustment to the FOV position and height before initiating a full 3D scan. Press the Scout image icon to deactivate/activate it. ORTHOPANTOMOGRAPH OP 3D EX...
Page 36: Dental Cast Scout Image View
You can adjust the brightness of the shown image preview using the brightness slider. NOTICE! Adjustment is not saved to the image. Contrast slider You can adjust the contrast of the shown image preview using the contrast slider. NOTICE! Adjustment is not saved to the image. ORTHOPANTOMOGRAPH OP 3D EX...
Page 37: Dental Cast Image Preview
Press the preview projection icons to change the projection of the shown preview. Coronal Sagittal Axial Slice preview Shows a preview of 3D slices. You can scroll through the preview using the slider on the right side of the image. ORTHOPANTOMOGRAPH OP 3D EX...
Page 38 NOTICE! Adjustment is not saved to the image. Contrast slider You can adjust the contrast of the shown image preview using the contrast slider. NOTICE! Adjustment is not saved to the image. OK button Press OK button to close the image preview. ORTHOPANTOMOGRAPH OP 3D EX...
Page 39: Device Settings
Quality Control should be performed at regular intervals, preferably at least once a month and always after calibration. See chapter Quality control on page 74 for more information on how to take quality control images. ORTHOPANTOMOGRAPH OP 3D EX...
Page 40 See chapter Calibrations for the user on page 69 for more detailed information on calibration programs and how to perform them. NOTICE! The available calibration programs depend on the device conﬁguration. ORTHOPANTOMOGRAPH OP 3D EX...
Page 41: Friendly Name
• 10x11 for larger area coverage Time zone Set the timezone to match the installation location. To change the time zone, start to write the continent, capitol or state (US) and select the correct selection from the drop down list. ORTHOPANTOMOGRAPH OP 3D EX...
Page 42 Click Reset buttons to reset the patient size settings to their default values. The default values for each program are listed in chapter Patient size setting default values on page 87. NOTICE! The available programs and patient size presets depend on the device conﬁguration. ORTHOPANTOMOGRAPH OP 3D EX...
Page 43: Sound Settings
Press Reset to factory settings to set and upload the default values for the sound theme and volume selections to the remote exposure switch. ORTHOPANTOMOGRAPH OP 3D EX...
Page 44 • Demonstration mode activation for exhibition use • Veriﬁcation programs for radiation related testing To access these functions, a PIN code is required. NOTICE! The functions unlocked by the PIN code are highlighted with coloured indicators. ORTHOPANTOMOGRAPH OP 3D EX...
Page 45: Control Panel
2. Press also the underside of the controller slowly. to move faster. Patient positioning lights button. Turn the patient positioning lights on/o. Test mode button. Disable radiation production of the device. You can also use the GUI to activate the Test mode. ORTHOPANTOMOGRAPH OP 3D EX...
Page 46 Button light is dim but visible. Button/Function is enabled Press the button to activate the function. Button light is on. Button/Function is active The function is active as long as the light is on. ORTHOPANTOMOGRAPH OP 3D EX...
Page 47: 5 Imaging Programs
You can choose which segments of the dentition are imaged if imaging of the whole dentition is not required. Press the segments on the dental chart to deselect and select them. ORTHOPANTOMOGRAPH OP 3D EX...
Page 48 Lateral TMJ program provides a lateral view of the patient's left and right temporomandibular joints. You can choose to image both or only other segment in single scan. Press the segments on the dental chart to deselect and select them. ORTHOPANTOMOGRAPH OP 3D EX...
Page 49: Programs
Optimized for single site implants or localized diagnostics, for example, 3rd molar extractions, impacted teeth, periodontal cases, root fractures, single TMJ analysis, endodontics and for pediatric imaging. Available resolutions: Low (LDT) Standard High Resolution optimized for endodontic imaging: Endo ORTHOPANTOMOGRAPH OP 3D EX...
Page 50 (bilateral analysis) and periodontal cases. Available resolutions: Low (LDT) Standard High FOV 8 x 8 Optimized for imaging the entire dentition, both mandibula and maxilla with portion of maxillary sinuses. Available resolutions: Low (LDT) Standard High ORTHOPANTOMOGRAPH OP 3D EX...
Page 51 Optimized for imaging the entire dentition, both mandibula and maxilla, including airway and upper cervical spine or the sinus, maxillary sinuses, jaws with bilateral joints, jaws with airways, analyses of both TMJs and for maxillofacial surgeries. Available resolutions: Low (LDT) Standard High ORTHOPANTOMOGRAPH OP 3D EX...
Page 52: Resolutions
The dental cast program is initially taken with FOV 10 x 10. The height of the FOV can be adjusted after scout image. Available resolutions: NOTICE! The resolution selection aects the amount of image layers produced. Dose production is not aected. Low resolution Standard resolution High resolution ORTHOPANTOMOGRAPH OP 3D EX...
Page 53: 6 Using The Device
6 Using the device 6 Using the device 6.1 General imaging workﬂow ORTHOPANTOMOGRAPH OP 3D EX...
Page 54: Powering On/O The Device
(under a cover, below the power switch) or cutting o the power supply from an external mains isolation switch (not supplied with the device). NOTICE! Press the yellow locking piece in to release the mains cable plug. ORTHOPANTOMOGRAPH OP 3D EX...
Page 55: Preparing The Device For Imaging
Reasonably Achievable) principle and seek to reduce the radiation dose to the amount necessary to acquire images that are clinically adequate. This can be achieved for example through utilizing the pediatric imaging programs and adjusting the imaging parameters for the patient in question. ORTHOPANTOMOGRAPH OP 3D EX...
Page 56: Patient Positioning
• Chin rest in upper jaw position position position NOTICE! The Chin Rest needs to be attached to the device in the correct orientation for the selected imaging program before the device allows images to be taken. ORTHOPANTOMOGRAPH OP 3D EX...
Page 57 NOTICE! If the patient has wide shoulders that could collide with the rotating unit, ask the patient to cross their arms when holding the handles in order to contract the shoulders. 11. Ask the patient to take a step forward to straighten their spine. ORTHOPANTOMOGRAPH OP 3D EX...
Page 58 NOTICE! In rare cases, typically caused by abnormal anatomy, if the ORTHOfocus ™ feature cannot ﬁnd the optimal image layer, the device provides 5 dierent image layers to use in diagnosis. BITEWING IMAGING: • The patient’s occlusal plane should be horizontal and parallel to the FH light. ORTHOPANTOMOGRAPH OP 3D EX...
Page 59 13. Check that the patient’s head is straight and not rotated and the patient’s mid-line coincides with the midsagittal light. 14. Close the head support. 15. Adjust the forehead support against the patient's forehead. 16. Ask the patient to close their lips and press their tongue against the palate if possible. ORTHOPANTOMOGRAPH OP 3D EX...
Page 60: Patient Positioning For 3D Imaging
NOTICE! Make sure that the device is set up correctly for the intended examination. The device goes to ready state and the status indicator light turns green. NOTICE! If the status indicator light does not turn green, look for more information on the GUI. ORTHOPANTOMOGRAPH OP 3D EX...
Page 61 • Flat chin rest in upper jaw position position position NOTICE! It is possible to take 3D images with FOV 10 x 15 FOV size without using a chin rest if diagnostic need requires it and reduced patient support is justiﬁed. ORTHOPANTOMOGRAPH OP 3D EX...
Page 62 NOTICE! If the patient has wide shoulders that could collide with the rotating unit, ask the patient to cross their arms when holding the handles in order to contract the shoulders. 11. Ask the patient to take a step forward to straighten their spine. ORTHOPANTOMOGRAPH OP 3D EX...
Page 63 FOV lights. 13. Check that the patient’s head is straight and not rotated and the patient’s mid-line coincides with the midsagittal light. 14. Close the head support. 15. Adjust the forehead support against the patient's forehead. ORTHOPANTOMOGRAPH OP 3D EX...
Page 64: Taking An Image
A preview image appears on the GUI for a quick review (no visible artifacts etc.). Acknowledge the preview by pressing the OK button. Continue to take the next image, if multiple images need to be taken. ORTHOPANTOMOGRAPH OP 3D EX...
Page 65: Taking 3D Images
Scout images produce only a small radiation dose so taking additional scout images won't produce excessive radiation dose to the patient. GUI: Approve the scout image and proceed to the 3D imaging phase by pressing OK button. ORTHOPANTOMOGRAPH OP 3D EX...
Page 66: Taking Dental Cast Images
6.5.3 Taking Dental cast images NOTICE! You can take a Scout image of the dental cast before the actual 3D image by activating the Scout selection from the GUI. Attach Chin rest to the lower shelf of the device. ORTHOPANTOMOGRAPH OP 3D EX...
Page 67 Release the exposure button after all device movements stop and the device plays an audible program end sound. A preview image appears on the GUI for a quick review (no visible artifacts etc.). Acknowledge the preview by pressing the OK button. ORTHOPANTOMOGRAPH OP 3D EX...
Page 68: 7 Maintenance
Wait for the control panel to dry or wipe it dry before use. Moisture can aect the usability of the panel. Allowed cleaning agents for cleaning and decontamination of the device: • Distilled water • Ethanol 96% • Isopropyl alcohol • Soapy water • CaviCide ™ , CaviWipes ™ or Metasys ™ disinfectant ORTHOPANTOMOGRAPH OP 3D EX...
Page 69: Calibrations For The User
Calibration data is stored in the device memory and is used for later calibrations and image processing. NOTICE! Perform the calibrations in the exact order they are listed on the GUI. GUI: Go to device settings. GUI: Select Calibrations menu. ORTHOPANTOMOGRAPH OP 3D EX...
Page 70 All calibrations need to be successfully performed before using the device. NOTICE! If calibration program fails, follow the instructions on the GUI (if any) and run the failed program again. NOTICE! Calibration images are shown on the GUI as viewed from the sensor. ORTHOPANTOMOGRAPH OP 3D EX...
Page 71: Calibration Procedure
NOTICE! Make sure that PAN/3D tubehead front cover and sensor covers are installed. Calibrating without the covers may have an eect on the image quality. Select PAN pixel calibration from the Calibrations menu. Protect yourself from radiation. ORTHOPANTOMOGRAPH OP 3D EX...
Page 72 Press and hold the exposure button down to take the calibration image. When the exposure warning stops and the program end sound is played, the program is complete. The calibration image appears on the GUI. Acknowledge the calibration result by pressing the OK button. ORTHOPANTOMOGRAPH OP 3D EX...
Page 73: Geometry Calibrations
Press and hold the exposure button down to take the calibration image. The calibration results appear on the GUI. NOTICE! This will take several minutes. Acknowledge the calibration by pressing the OK button. Repeat the calibration for the remaining FOV sizes. Remove the calibration phantom. ORTHOPANTOMOGRAPH OP 3D EX...
Page 74: Quality Control
NOTICE! The device can select the correct QC program automatically after a QC phantom has been attached to the device. GUI: Go to device settings. GUI: Select PAN QC program from the Quality control menu. Attach the PAN QC phantom holder and 2D QC test phantom to the lower shelf. ORTHOPANTOMOGRAPH OP 3D EX...
Page 75 10. If the image fails on any of the previously listed criteria, redo the QC program. If it fails again, recalibrate the device according to Calibration procedure on page 71 or contact service. 11. Detach the PAN QC phantom holder and 2D QC test phantom from the device. ORTHOPANTOMOGRAPH OP 3D EX...
Page 76 GUI: Select 3D QC program from the Quality control menu. Attach the 3D QC phantom holder and the 3D QC phantom to the lower shelf. Protect yourself from radiation. Press and hold the exposure button down to take the QC image. ORTHOPANTOMOGRAPH OP 3D EX...
Page 77 If the image fails or any visual defects are apparent, redo the QC program. If it fails again, recalibrate the device according to Calibration procedure on page 71 or contact service. 10. Detach the 3D QC phantom and the 3D QC phantom holder from the device. ORTHOPANTOMOGRAPH OP 3D EX...
Page 78: Annual Maintenance
• Check device movements and functionality of exposure button. During the annual maintenance, all calibrations and QC programs must be performed according to the device installation manual. The full maintenance procedure is described in detail in the device service manual. ORTHOPANTOMOGRAPH OP 3D EX...
Page 79: 8 Troubleshooting
Check that the acquisition workstation has UDP port 123 opened in the ﬁrewall and the NetTime service installed and running. ORTHOPANTOMOGRAPH OP 3D EX...
Page 80: 9 Technical Data
The device is in conformity with the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. RoHS directives 2011/65/EU and EU 2015/863 on the restriction of the use of certain hazardous substances in electrical and electronic equipment. ORTHOPANTOMOGRAPH OP 3D EX...
Page 81 US 230V: 15 A / 250 VAC 50/60 Hz SJT 3 x AWG 14 Exposure controller cable Remote exposure switch: DINFLEX–YY 4 x AWG 26, max. 15 m Data communication cable CAT5e or higher UTP Ethernet cable ORTHOPANTOMOGRAPH OP 3D EX...
Page 82 1772 x 1762 px Device physical measures Source–Image distance (SID) 630 mm / 24.8 in Dimensions (H x W x D) 1688–2443 x 770 x 1095 mm 66.5–96.2 x 30.3 x 43.1 in Weight 120 kg / 265 lbs ORTHOPANTOMOGRAPH OP 3D EX...
Page 83 NOTICE! The device package and packaging material weights may vary depending on the device conﬁguration. Ambient temperatures Transportation and storage -25 – +55°C RH 0 – 90% Atmospheric pressure 70 – 108 kPa Operation Temperature +10 – +35°C RH 30 – 80% Atmospheric pressure 70 – 106 kPa ORTHOPANTOMOGRAPH OP 3D EX...
Page 84: Imaging Program Specifications
6.4 s 116.7 mm / 4.6 in 85 - 90 kV 2.0 - 12.5 mA (3.2 + 3.2 s) 1228 px TMJ, Lateral 4.0 s 159.6 mm / 6.3 in (2.0 + 2.0 s) 1680 px ORTHOPANTOMOGRAPH OP 3D EX...
Page 85: Programs
2.0 - 12.5 mA 1.3 s 5 ms 5:50 Standard 350 μm 2.4 s 5 ms 5:25 High 250 μm 4.9 s 9 ms 9:25 Voxel size tolerance: ±2% * Exposure time with Medium size patient. ORTHOPANTOMOGRAPH OP 3D EX...
Page 86 9 Technical data Dental cast program & technical factors Resolution Voxel size Exposure time 10 x 10 320 μm 12.0 s Standard 300 μm High 200 μm NOTICE! Current is ﬁxed to 4 mA ORTHOPANTOMOGRAPH OP 3D EX...
Page 87: Patient Size Setting Default Values
Standard 6.3 mA 7.1 mA 10 mA High 8 mA 10 x 15 4 mA 5 mA 8 mA Standard 6.3 mA 7.1 mA 10 mA High 8 mA NOTICE! Voltage is ﬁxed to 95 kV ORTHOPANTOMOGRAPH OP 3D EX...
Page 88: Patient Contacting Parts
16 mm 0.6 in A = 0.05m 188 mm 198 mm 7.4 in 7.8 in 219 mm 229 mm 8.6 in 9 in NOTICE! The maximum height of the device is adjustable during the installation calibration. ORTHOPANTOMOGRAPH OP 3D EX...
Page 89: Symbols That May Appear On The Device Or Its Parts
Unique Device Identiﬁcation Caution General warning Radiation warning Laser Class 1 warning Radiation emitting device Type B Applied part Dangerous voltage On or enabled O or disabled External warning light Exposure switch Remote exposure switch Ethernet ORTHOPANTOMOGRAPH OP 3D EX...
Page 90 NRTL Mark Conforms to U.S. and Canada national safety standards Importer Fragile, Handle with Care (Packaging) This way up (Packaging) Keep dry (Packaging) Maximum number of boxes that can be stacked on the bottom box (Packaging) ORTHOPANTOMOGRAPH OP 3D EX...
Page 91: Electromagnetic Compatibility (Emc) Tables
Voltage ﬂuctuations/ ﬂicker Not to be used or installed near active HF SURGICAL emissions EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity of EM IEC61000-3-3 DISTURBANCES is high. ORTHOPANTOMOGRAPH OP 3D EX...
Page 92 The device shall not be used closer than 15cm to sources of 50/60Hz magnetic ﬁeld. NOTICE! U is the a.c. mains voltage prior to application of the test level. ORTHOPANTOMOGRAPH OP 3D EX...
Page 93 NOTICE! If the network connection is disrupted momentarily because of electromagnetic disturbances, re-establish the local network connection. The latest image is stored in the device and transferred automatically to the workstation. Do not power o the device as the image will be erased. ORTHOPANTOMOGRAPH OP 3D EX...
Page 94 ** The carrier shall be modulated using a 50% duty cycle square wave signal. *** As an alternative to FM modulation, the carrier may be pulse modulated using a 50% duty cycle wave signal at 18 Hz. While it does not represent actual modulation, it would be worst case. ORTHOPANTOMOGRAPH OP 3D EX...
Page 95: Separation Distances
WARNING! Use of accessories, transducers and cables other than those speciﬁed or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation. ORTHOPANTOMOGRAPH OP 3D EX...
Page 96 WARNING! The PCX-1 should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the PCX-1 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: ORTHOPANTOMOGRAPH OP 3D EX...
Page 97: X-Ray Tube Assemblies
9 Technical data 9.7 X-ray tube assemblies ORTHOPANTOMOGRAPH OP 3D EX...
Page 98 9 Technical data ORTHOPANTOMOGRAPH OP 3D EX...
Page 99: Workstation Minimum Requirements
• 3D: 10 - 800 MB • Windows 11 Pro or Enterprise 64-bit Operating • Windows 10 Pro or Enterprise 64-bit system NOTICE! 32-bit Windows installations are not supported. Device Driver DTX Studio Driver 24.2 (latest version is always preferred) ORTHOPANTOMOGRAPH OP 3D EX...
Page 100 • 1 TB or more for image data. • 256 GB SSD for the operating system and the imaging software is recommended. Storage space Image sizes: • PAN: 5 - 10 MB • 3D: 10 - 800 MB ORTHOPANTOMOGRAPH OP 3D EX...
Page 101 Display 1920 x 1080 (Full HD) resolution or higher recommended. 2D/3D Viewing workstation See dental imaging software requirements Database server See dental imaging software requirements ORTHOPANTOMOGRAPH OP 3D EX...
Page 102 Contact your PaloDEx Group Oy representative for the most current information. Copyright © by PaloDEx Group Oy. All rights reserved. DEXIS™ is a registered trademark or a trademark of Dental Imaging Technologies Corporation. Headquarters PaloDEx Group Oy Nahkelantie 160 | FI-04300 Tuusula | FINLAND Tel.

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