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Soredex CRANEX 3D User Manual

Digital panoramic x-ray system
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ENGLISH
CRANEX™ 3D
Digital Panoramic X-Ray System
User Manual
206718 rev. 9

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Summary of Contents for Soredex CRANEX 3D

  • Page 1 ENGLISH CRANEX™ 3D Digital Panoramic X-Ray System User Manual 206718 rev. 9...
  • Page 3 SOREDEX, PaloDEx Group The original language of this manual is English. SOREDEX, PaloDEx Group Oy reserves the right to make changes in specification and features shown herein, or discontinue the product described at any time without notice or obligation.
  • Page 4 CRANEX™ 3D...

  • Page 5: Table Of Contents

    3.1 Panoramic programs................... 19 3.2 Sectional imaging....................22 Default exposure settings................... 22 3.4 User Configurable Default Program ..............22 3.4.1 SMAR™, SOREDEX™ Metal Artifact Reduction........23 3.5 Cephalometric programs..................24 3.6 3D programs ....................... 26 3.7 Exposure settings for 3D imaging ............... 27 3.8.1 AES values for Panoramic imaging............
  • Page 6 5.3.1 Positioning devices .................. 37 5.3.2 General instructions ................. 38 5.3.3 Patient positioning..................39 5.3.3.1 Panoramic exposure..............39 5.3.3.2 TMJ exposure ................43 5.3.3.3 Maxillary Sinus exposure............45 5.3.3.4 Taking a panoramic exposure ........... 47 5.4 Cephalometric exposures ................... 48 5.4.1 General instructions .................
  • Page 7 8.5 Cephalometric calibration..................91 8.5.1 Ceph pixel calibration................91 8.5.2 This calibration should always be a pass.Ceph Quality check program (Optional) ....................92 Technical data......................95 9.1 Technical specifications ..................95 9.2 Unit dimensions....................105 9.3 Symbols that may appear in the unit..............106 9.4 Labels on the unit....................

  • Page 9: Introduction

    Introduction 1.1 CRANEX™ 3D CRANEX 3D is a dental X-ray system for producing high quality digital images of dentition, TM-joints and skull. In order to take images with CRANEX 3D, you need a suitable PC hardware connected to the CRANEX 3D unit and SCANORA™...

  • Page 10: Intended Use

    Only for professionally qualified dental / medical personnel. Typical user is a dental assistant with specific training for using dental x-ray units. 1.4 Associated documentation • CRANEX 3D user manual • CRANEX 3D installation manual • SCANORA software user manual •...

  • Page 11: Abbreviations Used In This Manual

    AES = Automatic Exposure Setting FH = Frankfort-Horizontal SMAR™ = SOREDEX™ Metal Artifact Reduction reduces the effect of metal and other dense radiopaque objects, which typically create artifacts that are seen as stripes and shadows.

  • Page 12: Warnings And Precautions

    Avoid taking x-ray exposures of pregnant women. When taking an x-ray exposure of a child always use the lowest possible x-ray dose, the smallest possible image area and the lowest possible resolution that allows you to perform the required diagnostic task. 206718 rev 9 SOREDEX...

  • Page 13: Warnings For Cross Infection

    1.7.2 Warnings for cross infection Always use available disposable protective covers with the patient positioning accessories: • Bite block cover • Chin plane cover • TMJ support cover • Lip holder cover • Chin cup cover 206718 rev 9 SOREDEX...

  • Page 14: General Warnings

    The installer and the user of the system shall confirm that at least one of the above requirements is fulfilled. A PC is a medical one if it complies IEC 60601-1 standard and that is indicated in the accompanying documents of the PC. 206718 rev 9 SOREDEX...
  • Page 15 Ensure to fulfill or exceed the requirements of your local regulations. The unit or its parts must not be changed or modified in any way without approval and instructions from the manufacturer. 206718 rev 9 SOREDEX...

  • Page 16: Disclaimer

    Unit has at least the following parts that should be regarded as non-environmental friendly waste products: ■ Tubehead (Pb, oil) ■ Collimator (Pb) ■ All electronic circuits, electronic boards inside ■ Sensor covers (EMC painted) 206718 rev 9 SOREDEX...

  • Page 17: Unit Description

    PC with MDD approved dental imaging software and 3D viewing software (not included). All software must conform to the MDD and the relevant legal requirements in the USA. The PC must conform to all the unit and dental imaging software requirements. 206718 rev 9 SOREDEX...
  • Page 18 2 Unit description 1. Sensor holder (panoramic units without 3D option) 2. Panoramic sensor 1. 3D sensor (units with 3D option) 2. Panoramic sensor 206718 rev 9 SOREDEX...

  • Page 19: Patient Positioning Lights

    2 Unit description 2.2 Patient positioning lights 1. Midsagittal 2. Frankfort-horizontal (FH) light 3. Focal trough 4. Cephalometric FH light 5. Horizontal light, top of FOV (3D option only) 6. Horizontal light, bottom of FOV (3D option only) 206718 rev 9 SOREDEX...
  • Page 20 2 Unit description Panoramic lights 1. Midsagittal light 2. Frankfort-horizontal light 1. Focal through light 206718 rev 9 SOREDEX...
  • Page 21 Cephalometric lights (optional) 1. Frankfort-horizontal plane 3D lights (optional) NOTICE! Appropriate lights are turned automatically on based on selected FOV. 1. Midsagittal light 2. Horizontal light, top of FOV 3. Horizontal (H) light, bottom of FOV 206718 rev 9 SOREDEX...

  • Page 22: Patient Positioning Panel

    1. Carriage UP/DOWN (Z-movement) 2. Focal through adjustment (Y-movement) 3. Positioning lights ON/OFF 4. Return 5. Chin support UP/DOWN 2.3.1 Cephalometric unit patient positioning panel (optional) 1. Carriage down 2. Carriage up 3. Positioning lights ON/OFF 206718 rev 9 SOREDEX...

  • Page 23: Accessories

    Disposable cover for Chin cup Disposable covers for patient positioning devices • Bite guide disposable covers • Chin support disposable covers • Temple support disposable covers • Nasion support disposable covers • Ear holder disposable covers 206718 rev 9 SOREDEX...

  • Page 24: Other Detachable Partsemergency Stop Switch

    2 Unit description 2.5 Other detachable parts Bubble level assembly 3D calibration phantom QC phantom Cone phantom Panoramic quality check tool Panoramic quality check tool (option) adapter for ceph (option) Sensor (Pan & Ceph) Platform for dental model 206718 rev 9 SOREDEX...
  • Page 25 An interrupted exposure cannot be continued later, but has to be retaken from the beginning after the emergency stop switch is released. Press to stop the unit, rotate to release. 206718 rev 9 SOREDEX...

  • Page 26: Patient Contacting Parts

    <5 min Disposable cover for Skin <5 min Chin cup TMJ support Skin <5 min Disposable cover for Skin <5 min TMJ support Head support Skin <5 min Disposable cover for Skin <5 min Head support 206718 rev 9 SOREDEX...

  • Page 27: Imaging Programs

    Child panoramic 24,4 cm width x 11,5 height. Child panoramic has reduced width and height. Children can be imaged with less radiation dosage and shorter exposure time. Patients with jaw more narrow than average jaw can be exposed with this too. 206718 rev 9 SOREDEX...
  • Page 28 3 Imaging programs Bitewing: Magnification 1.3 An orthogonal view of the dentition from the canine and posterior. Lateral TMJ: Magnification 1.23 Lateral TMJ program provides a wide layer axially corrected views patient's left right temporomandibular joints. 206718 rev 9 SOREDEX...
  • Page 29 Maxillary Sinus program produces a pan - tomographic layer through the posterior maxillary sinus. The layer is flatter than the standard panoramic programs and is moved 18 mm backward. These images are helpful in visualizing the mid and posterior maxillary sinus. 206718 rev 9 SOREDEX...

  • Page 30: Sectional Imaging

    2. Press the Settings button on the touch screen. 3. Select Imaging program defaults. 4. Select Set current program as default. The selected program is automatically activated when an exam is started for a new patient and at startup. 206718 rev 9 SOREDEX...

  • Page 31: Smar™, Soredex™ Metal Artifact Reduction

    3.4.1 SMAR™, SOREDEX™ Metal Artifact Reduction SMAR, SOREDEX Metal Artifact Reduction software can be used to reduce the effect of metals and other dense radiopaque objects on the 3D image. These create artifacts that are seen typically as stripes and shadows from the above-mentioned objects.

  • Page 32: Cephalometric Programs

    Reduced Width Lateral program has an optimized image width that is used e.g. for pediatric patients but also adult patients to reduce the radiation dose. Cephalometric posterior-anterior (PA): Magnification 1.15 PA 22 x 20 cm (height x width) 206718 rev 9 SOREDEX...
  • Page 33 3 Imaging programs Carpus program (optional) (Not available in USA and Canada) Requires separate holder, not part of standard delivery. 206718 rev 9 SOREDEX...

  • Page 34: Programs

    Minidose Scan (290μm voxel size) Program for optimized endodontic imaging: Endo program (85µm voxel size) 61 x 78 mm FOV (optional) High resolution (200μm voxel size) Standard resolution (300μm voxel size) Minidose Scan (330μm voxel size) 206718 rev 9 SOREDEX...

  • Page 35: Exposure Settings For 3D Imaging

    Std Res (optional) High Res Exposure settings for scout imaging (default values) Resolution Scan- (h x w) ning time 61 x 41 mm Scout 12.5 0,02 s 61 x 78 mm Scout 12.5 0,04 s (optional) 206718 rev 9 SOREDEX...

  • Page 36: Aes Values For Panoramic Imaging

    AES suggest exposure values based on patient size. The user can change the value before exposure if needed by pushing A button again and changing the values. NOTICE! Values can be re-scaled by SOREDEX authorized service personnel. 3.8.1 AES values for Panoramic imaging...

  • Page 37: Aes Values For Cephalometric Imaging

    12,65 cm 11,45 cm 12,5 10,55 cm 6,5 cm (Min) Ceph Lat/PA 240 V Head width (min) 17,3 cm (Max) 12,6 14,45 cm 12,6 12,65 cm 12,6 12,5 11,45 cm 12,6 10,55 cm 6,5 cm (Min) 206718 rev 9 SOREDEX...
  • Page 38 3 Imaging programs 206718 rev 9 SOREDEX...

  • Page 39: Controlling The Unit

    Controlling the unit 4.1 ClearTouch™ control panel 1. Modality selection 2. Program selection 3. Imaging values 4. Imaging area 5. Status of the unit 6. Test mode 7. Settings 8. End examination 206718 rev 9 SOREDEX...

  • Page 40: Modality Section

    Automatic Exposure setting (AES) 4.4 Status section Status field shows when the unit is ready for capturing or any trouble occurs. Green or red color indicate the status in question. Green means ready to capture and red means 206718 rev 9 SOREDEX...

  • Page 41: Other Sections

    “Retrieve With SMAR”-button will not be visible. NOTICE! Only the last taken x-ray image is saved in the unit until the power is switched off. This im- age data is used in the retrieve procedure. ■ Languages 206718 rev 9 SOREDEX...
  • Page 42 4 Controlling the unit - Use this to select language on the touch screen ■ Service - Use this to reach the programs for periodical maintenance 206718 rev 9 SOREDEX...

  • Page 43: Using The Unit

    5.1.1 Attaching the sensor 1. Insert the four slots on the rear of the sensor, into the four hooks in the sensor holder. 206718 rev 9 SOREDEX...

  • Page 44: Removing The Sensor

    LOCKING 5.1.2 Removing the sensor 1. Slide the locking knob upwards on the side of the sensor to unlock the sensor. UNLOCKING 2. Slide the sensor up and remove it. 206718 rev 9 SOREDEX...

  • Page 45: Preparing The System

    TMJ, lateral projection (axially corrected) 5.3.1 Positioning devices Bite block Chin plane TMJ support & Disposable cover for Bite block Chin rest holder Lip holder for Chin cup edentulous patients & Disposable cover for Chin cup 206718 rev 9 SOREDEX...

  • Page 46: General Instructions

    If AES is disabled, set the exposure values manually and press Return after patient positioning is done and temple supports are closed. 6. Press the Return button to rotate the unit to ‘patient in’ position. 206718 rev 9 SOREDEX...

  • Page 47: Patient Positioning

    If there is any risk of patient biting too high pressure causing fracture of teeth, use lip holder or the chin cup and cotton roll between the teeth for the patient positioning. 206718 rev 9 SOREDEX...
  • Page 48 Make sure the patient’s head is not turned or tilted. 6. Adjust the height of the Frankfort-Horizontal plane (FH) light to get the light over the orbita porion. Straighten the patient's head if needed. 206718 rev 9 SOREDEX...
  • Page 49 Ask the patient to open their lips so that you can see their teeth. The focal trough light should be positioned in the middle of 3rd tooth (canine). 206718 rev 9 SOREDEX...
  • Page 50 Return button and wait for the movement to finish. Verify that the suggested exposure values are suitable for the patient. If AES is disabled, set the exposure values man- ually and press Return after patient positioning is done and temple supports are closed. 206718 rev 9 SOREDEX...

  • Page 51: Tmj Exposure

    2. Adjust the unit height. 3. Guide the patient to the unit and instruct to stand as straight and tall as possible. Ask the patient to take grip on the handles and set the TMJ support under the nose. 206718 rev 9 SOREDEX...
  • Page 52 Straighten the patient's head if needed. 5. TMJ PA projection: Tilt the patient’s head forward. 6. Check the position of the midsagittal light. If it is not on the midsagittal plane of the patient, adjust the patient’s head. 206718 rev 9 SOREDEX...

  • Page 53: Maxillary Sinus Exposure

    Return after patient positioning is done and temple supports are closed. 5.3.3.3 Maxillary Sinus exposure 1. Insert the lip holder for sinus imaging. Place the disposable covers. NOTICE! Use a new disposable cover for every patient. 2. Adjust the unit height. 206718 rev 9 SOREDEX...
  • Page 54 Return button and wait for the movement to finish. Verify that the suggested exposure values are suitable for the patient. If AES is disabled, set the exposure values man- ually and press Return after patient positioning is done and temple supports are closed. 206718 rev 9 SOREDEX...

  • Page 55: Taking A Panoramic Exposure

    Release temple supports. Guide the patient out. Remove disposable covers and disinfect the unit. 4. PC: The image can be examined using the SCANORA software. See SCANORA software user’s manual. 206718 rev 9 SOREDEX...

  • Page 56: Cephalometric Exposures

    PC: Click Image Capture. Select CEPH. Select the imaging program. If AES is enabled (green light lit around "A"), press the Return button and wait for the movement to finish. Ver- 206718 rev 9 SOREDEX...
  • Page 57 (optional). Press Return to drive the unit to ‘patient in’ position. Ask the patient to remove any spectacles, hearing aids, removable dentures, jewelry and hair clips and pins. Place a protective lead apron on the patient. 206718 rev 9 SOREDEX...

  • Page 58: Patient Positioning

    5 Using the unit 5.4.2 Patient positioning 5.4.2.1 Full width and reduced width projection Unlock the lever and turn the ear rods to the lateral pro- jection position. Lock the position. 206718 rev 9 SOREDEX...
  • Page 59 Tall patients can also sit on a chair. Adjust the patient head so that the Frankfort-Horizontal plane (FH) and positioning light are in same horizontal plane. NOTICE! The shown light line is a horizontal reference line. Slide nasion support against patient’s nasion. 206718 rev 9 SOREDEX...

  • Page 60: Pa Projection

    5 Using the unit 5.4.2.2 PA projection Unlock the lever and turn the ear rods to the PA projec- tion position. Lock the position. Tilt the nasion support aside. 206718 rev 9 SOREDEX...
  • Page 61 Guide the patient to the unit facing the sensor. Instruct the patient to stand as straight and tall as possible un- der the cephalostat head. Slide the ear rods towards patient’s ears. Tall patients can also sit on a chair. 206718 rev 9 SOREDEX...

  • Page 62: Reverse Towne Projection

    Reverse towne projection Unlock the lever and turn the ear rods to the PA projec- tion position. Lock the position. Tilt the nasion support aside. Place the disposable covers. NOTICE! Use a new disposable cover for every patient. 206718 rev 9 SOREDEX...

  • Page 63: Waters View

    Slide the ear rods towards patient’s ears. Ask the patient open mouth maximally. 5.4.2.4 Waters view Unlock the lever and turn the ear rods to the PA projec- tion position. Lock the position. Tilt the nasion support aside. 206718 rev 9 SOREDEX...
  • Page 64 Turn the head torsal as reference to the canthomeatal line about 35-40° above the horizontal plane. Slide the ear rods towards patient’s ears. Ask the patient open or close mouth. 206718 rev 9 SOREDEX...

  • Page 65: Carpus Program (Optional) (Not Available In Usa And Canada)

    Place the carpus holder to the nasion support holder. Adjust the unit height if needed. Ask the patient to remove rings and metal objects and to place hand on the carpus holder. NOTICE! Carpus holder is a separate accessory. Order from local distributor. 206718 rev 9 SOREDEX...

  • Page 66: Taking A Cephalometric Exposure

    ClearTouch™ control panel ap- pears. Release the ear rods and guide the patient out. Remove disposable covers and decontaminate the unit. PC: The image can be examined using the SCANORA software. See SCANORA user manual. 206718 rev 9 SOREDEX...
  • Page 67 (6 ft) from the focal spot and the X-ray beam. Operator should maintain visible contact with the patient and technique factors. This allows immediate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance. 206718 rev 9 SOREDEX...

  • Page 68: Exposures

    The EasyScout function helps locate the correct dental location of the Field of view. 3. Select the Field Of View (FOV): - XS FOV 61 x 41 mm - Midi FOV 61 x 78 mm (optional) 206718 rev 9 SOREDEX...
  • Page 69 Ask the patient to take grip on the handles and place chin on the chin cup. 11.Check the position of the midsagittal light. If it is not on the midsagittal plane of the patient, adjust the patient’s head. 206718 rev 9 SOREDEX...
  • Page 70 13.Close the temple supports by sliding the temple support knob to the right (A). Adjust the position of the nasion support (B) and push the forehead support in until it touches the patient’s nasion (C). 206718 rev 9 SOREDEX...

  • Page 71: Taking A Scout Image

    ClearTouch control panel ap- pears. ™ 2. Scout preview image appears to the ClearTouch con- trol panel. 3. Fine adjust scout position using the side arrow keys. Press the left lower corner icon to continue. 206718 rev 9 SOREDEX...
  • Page 72 4. Take a new scout or save current and continue to 3D im- age. 5. Previous FOV position is shown as gray circle and new position is showed as green circle. NOTICE! Gray circles remain in control panel until you change the patient. 206718 rev 9 SOREDEX...

  • Page 73: Taking A 3D Image

    ™ warning symbol on the ClearTouch control panel ap- pears. 4. Select SMAR ON or OFF based on your estimation of the need. See chapter 3.4.1. SMAR™, SOREDEX™ Metal Artifact Reduction. 206718 rev 9 SOREDEX...

  • Page 74: Stone Model And Radiographic Guide Scan

    1. Scan the patient with an open bite by securing the bite with cotton pads. 2. Install positioning plate. Position stone model. NOTICE! It is recommended to use a sponge or a foam under radiographic guide during the scan. 206718 rev 9 SOREDEX...
  • Page 75 3. Take scout image with default values. Correct position if needed. 4. Select same resolution and parameters as in patient scan. NOTICE! More detailed instructions in the CRANEX 3D Quick Guide Stone model and radiographic guide scan protocol. 206718 rev 9...

  • Page 76: Warnings And Error Messages

    If restarting the PC and/or restarting the dental imaging software does not allow you to retrieve the images, contact technical support without restarting the unit. 206718 rev 9 SOREDEX...

  • Page 77: Troubleshooting

    Ramus widths are 2. Patient's head 2. Check that patient's different on opposite sides. center position head is centered, and that the head support side clamps where closed to keep the head straight. 206718 rev 9 SOREDEX...
  • Page 78 Image is "smiling" too much. Problem Possible cause Solution Middle area of the image too Patient's neck was not Stretch patient's neck bright and unsharp. Spine stretched shadow. ANECK 206718 rev 9 SOREDEX...
  • Page 79 2. Check patient posi- tioning and type of bite fork rod. Problem Possible cause Solution Rows of teeth exposed too Chin rest was not used with Install chin rest. low. Mandible not exposed bite fork. completely to the image. 206718 rev 9 SOREDEX...

  • Page 80: Image Appearance

    : Contrast and 1. Adjust contrast SCANORA brightness not optimum. brightness. 2. kV used is too high. 2. Lower the kV setting. 3. Gamma value is not cor- 3. Adjust Gamma value rect for the monitor being used. 206718 rev 9 SOREDEX...

  • Page 81: Artefacts

    Retake the image. not exposured. prematurely. Problem Possible cause Solution Right and left image sides TMJ areas in sectional imag- Select all sections in pan- are uncomplete. TMJ's are es where deselected. oramic image. not shown. 206718 rev 9 SOREDEX...
  • Page 82 Solution Horizontal lines on image. Sensor problem. Consult the dealer. Problem Possible cause Solution CEPH: Lateral view has 2 ear 1. Cephalostat lock 1. Lock it holder pins. locked 2. Call service 2. Ear holders misaligned 206718 rev 9 SOREDEX...

  • Page 83: Unit Operation

    Possible cause Solution Patient's shoulders are Patient is too big for the unit. Reverse patient's hands on touching the x-ray tube or Wide and high shoulders. handles: left to right side sensor. handle and vice versa. 206718 rev 9 SOREDEX...
  • Page 84 6 Troubleshooting 206718 rev 9 SOREDEX...

  • Page 85: Maintenance

    Annually during normal mainte- Two (2) times annually nance Cephalometric Annually during normal mainte- Two (2) times annually nance NOTICE! The calibrations mentioned in this manual can be done by the user or qualified service personnel. 206718 rev 9 SOREDEX...

  • Page 86: Changing The Fuses

    Positioning light covers The positioning light covers are made of clear plastic. Use a soft cloth dampened with a mild detergent, e.g. soapy water. NEVER use abrasive cleaning agents or polishes to clean the covers. 206718 rev 9 SOREDEX...
  • Page 87 Autoclave Some removable parts in contact with the patient may be autoclaved. These parts are: bite rods, bite guides and chin supports. If autoclaving is performed for these items, disinfection by alternate methods is not needed.s 206718 rev 9 SOREDEX...
  • Page 88 Exposure time: 3 minutes  Prevacuum steam sterilization "Flash" sterilization: Temperature: 270 F (132°C) Exposure time: 3 minutes  Steam-flush pressure-pulse steam sterilization Temperature: 270 F to 275 F (132°C to 135°C) Exposure time: 3 to 4 minutes 206718 rev 9 SOREDEX...

  • Page 89: Calibration And Adjustment

    The image may give a hint on what the problem is (e.g. no radiation, colli- mator severely tilted, image data corrupted…). Contact service if the problem persists after restart- ing the unit and PC. 206718 rev 9 SOREDEX...

  • Page 90: Preparing For Calibration

    4. PC: Click the image acquisition button to activate image capture. 5. Touch the settings button on the touch screen display. 6. Select the Quality assurance button. The calibration display appears. 206718 rev 9 SOREDEX...

  • Page 91: Panoramic Calibration

    8 Calibration and adjustment 8.3 Panoramic calibration 8.3.1 Panoramic geometry calibration 1. Select the program. 2. Press Return. 3. Install the double cone calibration tool. 4. Take an exposure. 5. Repeat the calibration until calibration result “passed” is achieved. 206718 rev 9 SOREDEX...

  • Page 92: Panoramic Pixel Calibration

    NOTICE! Re-do panoramic pixel calibration, if cephalostat sensor is moved to panoramic side or the sensor is changed. 1. Remove the calibration tools. 2. Select the program. 3. Press Return. 4. Take an exposure. 206718 rev 9 SOREDEX...

  • Page 93: Panoramic Quality Check (Optional)

    Panoramic Quality Check (optional) NOTICE! Use the same tool for cephalostat Quality Check. 1. Attach a panoramic Quality Check Tool (optional) to the chin support. 2. Select the Pan QC program. 3. Press Return. 4. Take an exposure. 206718 rev 9 SOREDEX...
  • Page 94 The unit may be configured to use higher exposure values to compensate for an additional 1 mm copper filter. Ask Technical Support to adjust the copper thickness setting as required. 206718 rev 9 SOREDEX...

  • Page 95: Calibration

    Standard geometry calibration has to be done first. 3. Press Return. 4. Install the 3D calibration phantom. 5. Take an exposure. 6. Repeat the calibration until calibration result “passed” is achieved. This calibration is only needed with 3D units. 206718 rev 9 SOREDEX...

  • Page 96: Pixel Calibration

    8 Calibration and adjustment 8.4.2 3D pixel calibration 1. Remove the 3D calibration phantom. 2. Select the program. 3. Press Return. 4. Take an exposure. The result image informs when the calibration is passed. 206718 rev 9 SOREDEX...

  • Page 97: Quality Check Program

    7. Review, with 3D viewing software from the axial view by scrolling the slices the info about calibration result. The resulting image contains information on whether the quality check was passed. Repeat until quality check is passed. 206718 rev 9 SOREDEX...
  • Page 98 8 Calibration and adjustment 206718 rev 9 SOREDEX...

  • Page 99: Cephalometric Calibration

    1. Rotate the ear holders into PA view position and move them completely apart. Turn nasion support up out of the way. 2. Select Ceph Pix program. 3. Press Return. 4. Take an exposure. 206718 rev 9 SOREDEX...

  • Page 100: This Calibration Should Always Be A Pass.ceph Quality Check Program (Optional)

    This calibration should always be a pass. Quality check program (Optional) 1. Attach the QC phantom to the ceph unit and ensure that it’s leveled from the spirit level. 2. Select the Ceph QC program. 3. Press Return. 4. Take an exposure. 206718 rev 9 SOREDEX...
  • Page 101 5. Visually evaluate the result using the installed imaging software. Subjects to be evaluated: 1. Smoothness of the exposed area. Non-exposed area surrounds the whole image. 2. High contrast resolution; minimum 3.1LP/mm must be distinguishable. 3. All four low contrast holes must be visible. 206718 rev 9 SOREDEX...
  • Page 102 8 Calibration and adjustment 206718 rev 9 SOREDEX...

  • Page 103: Technical Data

    Technical data 9.1 Technical specifications Manufacturer SOREDEX, PaloDEx Group Oy, Nahkelantie 160 2064 FIN-04300 Tuusula, FINLAND Quality system In accordance with ISO13485 and ISO9001 standard Environmental In accordance with ISO14001 standard management system Conformity to standards: IEC 60601-1 IEC 60601-1-1...
  • Page 104 Max. anode heat content 35 kJ Max. X-ray tube assembly heat 385 kJ content Max. continuous heat dissipation of 38 W the X-ray tube assembly Total filtration min. 3.2 mm Al, 90kV Leakage Technique Factors 5625 mAs/h @ 90kV/4mA 206718 rev 9 SOREDEX...
  • Page 105 Maximum impedance of main 2D modalities The following charts represent technique factors that can be used with the selected line voltage and continuous radiation. One of the three technique factors is always fixed. Table 1: 100 VAC 12.5 206718 rev 9 SOREDEX...
  • Page 106 9 Technical data Table 2: 120 VAC 12.5 Table 3: 240 VAC 12.5 206718 rev 9 SOREDEX...
  • Page 107 1750 W nominal at 90 kV, 12.5 mA Tube voltage 57 - 90 kV (+/- 5 kV) Tube current 3,2 - 16 mA (+/- 1 mA) Supply frequency 75 - 150 kHz Spine compensation kV / mA compensated Spine compensation Pre-programmed mode 206718 rev 9 SOREDEX...
  • Page 108 Patient positioning Positioning panel, integrated Connection cable CAT6 UTP Ethernet cable (CRANEX 3D - PC) Panoramic programs & Technical factors & magnification: Standard Adult Panoramic 57-90 kV/ 3.2-16 mA/2.5-16.4 s Child Panoramic 57-90 kV/ 3.2-16 mA/2.5-14.4 s TMJ PA 57-90 kV/ 3.2-16 mA/5.6-10.6 s...
  • Page 109 Patient database Standalone workstation Server on local area network (LAN) Panoramic patient positioning Operation Left Motorised carriage movement Positioning aids Chin rest, bite block, 3-point headrest Hinged mirror, 3 positioning laser lights, Y-layer step less adjustment 206718 rev 9 SOREDEX...
  • Page 110 Pan sensor or interchangeable Ceph sensor Technology/Sensor type CMOS 100 x 100 m and 14 bits Image pixel size and depth Active area height 5.8 inches / 148 mm / 1480 pixels Resolution 5 LP/mm (panoramic) max height 146 mm 206718 rev 9 SOREDEX...
  • Page 111 200 m and 13 bits Image pixel size and depth Active sensor surface 100 x 68 mm (H x W) max height 129 mm Unit physical measures: source-image distance (SID) 500 mm (Panoramic) 570 mm (3D) 206718 rev 9 SOREDEX...
  • Page 112 Upgrade CRANEX 3D panoramic with Cephalometric imaging. Field upgrades for model CRANEX 3D Upgrade Description Cephalostat Upgrade Add ceph imaging to CRANEX 3D pan Left / right Change handedness to pan ceph 3D Upgrade Add 3D imaging: - Panoramic unit to 3D unit...

  • Page 113: Unit Dimensions

    9 Technical data 9.2 Unit dimensions NOTICE! The cephalostat arm and the touchscreen can be on either side (L/R). 206718 rev 9 SOREDEX...

  • Page 114: Symbols That May Appear In The Unit

    The operating instructions can be supplied electronically or in paper format. Collision warning Unit can collide with a seated patient when driving the carriage downwards. Pay attention on the unit movement. Laser radiation (yellow label) Attention,consult accompanying documents Ground (Functional) 206718 rev 9 SOREDEX...

  • Page 115: Labels On The Unit

    Certified to CSA. 9.4 Labels on the unit The main label of the unit is located on the vertical carriage next to the on/off power switch. The unit is Class I, type B and with IP20 protection. 206718 rev 9 SOREDEX...

  • Page 116: Electromagnetic Compatibility (Emc) Tables

    Table 1.1 Electromagnetic emissions IEC 60601-1-2 Ed3 CRANEX 3D is suitable for use in the specified electromagnetic environment. The purchas- er or user of CRANEX 3D should assure that it is used in an electromagnetic environment as described below: Emissions Test...
  • Page 117 Table 1.2 Electromagnetic immunity IEC 60601-1-2 Ed3 CRANEX 3D is suitable for use in the specified electromagnetic environment. The purchas- er or user of CRANEX 3D should assure that it is used in an electromagnetic environment as described below: Immunity Test...
  • Page 118 RF immunity of non-life-support equipment or system IEC 60601-1-2 CRANEX 3D is suitable for use in the specified electromagnetic environment. The purchas- er or user of CRANEX 3D should assure that it is used in an electromagnetic environment as described below: Immunity...
  • Page 119 If not installed and used in accordance with this manual, it may cause harmful interference to radio communications. Portable and mobile RF communications equipment can also affect the performance of CRANEX 3D Table 1.4 Table 4 Recommended Separation Distances...
  • Page 120 Interference may occur in the vicinity of equipment marked with the following symbol: No portable or mobile RF communications equipment may be used closer to any part of the CRANEX 3D including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter.

  • Page 121: X-Ray Tube Assemblies

    (Absolute maximum rating charts) DC (Center-Grounded) DC (Center-Grounded) Focal Spot : 0.5 mm Focal Spot : 0.5 mm 70kV 70kV 80kV 80kV 60kV 60kV 90kV 90kV 50kV 50kV 100kV 100kV EXPOSURE TIME [s] EXPOSURE TIME [s] 206718 rev 9 SOREDEX...
  • Page 122 9 Technical data Figure 1.4 206718 rev 9 SOREDEX...

  • Page 123: Pc Requirements

    2 GB dedicated display memory is required. PCI board connection Full-length PCIe x16 slot (for GPU board) USB ports (for HASP Dongle keys) • 1 for reconstruction system • 1 for 3D viewing SW (if needed) Mouse Mouse with scroll wheel 206718 rev 9 SOREDEX...
  • Page 124 Mouse with scroll wheel OpenCL support OpenCL 1.1 supported by either processor or graphics adapter NOTICE! This is an abbreviated list of requirements. Please refer to the software installation manual or contact your local dealer for detailed installation requirements. 206718 rev 9 SOREDEX...
  • Page 125 The PC and any other external devices shall not be connected to an extension cable. Multiple extension cables shall not be used. Do not position the PC where it could be splashed 206718 rev 9 SOREDEX...

  • Page 126: The Dental Imaging Software

    601-1 and/or IEC 601-1-1 harmonized national standard. 10.2 The dental imaging software The dental imaging software installed in the PC that is used with the unit must have CE-mark according to Medical Device Directive, for example SCANORA software. 206718 rev 9 SOREDEX...

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