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1 Helios 500 Components 1.1 Parts Identification 1.Reusable tip 2.Scanner 3.Holder of scanner 4.USB flash driver 1.2 Button of scanner 2-1. Start / stop scan button Press once to start scanning Press again to stop scanning 2-2 Jaw/ Bite Switch button 2-3.Mode indicators...
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1.3 Packing list Scanner (1pc) Holder of scanner Reusable tip (1pc) (Size L) (3 pcs) Reusable tip USB flash driver (1pc) (Size S) (1pc) Page 5 / 51...
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2 Symbols General warning sign Caution Serial number Catalogue number Batch code Medical device Authorized representative in the European Community Manufacturer Country of manufacture Washer-disinfector for thermal disinfection Type BF applied part Keep dry CE marking Dispose of in accordance with the WEEE directive Direct current Consult instructions for use Manufacturer’s LOGO...
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The Helios 500 could be used for both adult and children in clinical practice. The Helios 500 is designed to acquire 3D models in the followings ...
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DO NOT remove the cover of any scanner components. The scanner contains no user- serviceable parts. For any repairs, contact a qualified Eighteeth service technician. DO NOT replace the cables provided with the scanner with other cables. Doing so may damage the scanner and adversely affect the safety protection and EMC performance of the scanner.
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4.1 Installation Environment Requirements Since this product is not equipped with a workstation, during the installation of this product, customers need to provide an additional laptop or desktop workstation. 4.2 Connecting the Helios 500 to the workstation Step Graphic Example Description...
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Pull out the USB plug to disconnect the scanner. All IT components electrically connected to the Helios 500 must confirm to IEC 60950-1/ IEC 62368-1. Page 10 / 51...
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4.3 Software Installing Step Graphic Example Description Connect the USB flash driver workstation and open it. Double Click Click Click Page 11 / 51...
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Wait until the software installation complete 4.4 Software Update If there is an update of Helios 500 software, we(Sifary) will notify local distributors (agents) and provide free installation USB Flash Driver, and the distributor(agents) will upgrade the software for everyone.
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The holder can be used as a desktop mount holder. Place the scanner in the holder when you are not using it. Page 13 / 51...
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Option Menu User information and More See 5.2.1 options New patient New patient information See 5.2.2 Jaw/ bite Switch Select the upper jaw, lower jaw, See 5.2.3 or bites Process guide Displays the current step in the See 5.2.4 process Data editing toolbar Select and manage 3D model...
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5.2.1.2.1 Import scan data The Import scan Data option allows users to import local scan data in HIZP format into the software for further scanning or other operations. If you need to continue scanning after importing the previously saved scan data, you must ensure that the scan data is acquired by the same scanner currently connected, otherwise you will not be able to perform subsequent scans on the imported data.
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In Settings option, you can set the Auto save scan history, Save date, Save path 5.2.1.2.4 Settings 1) General Seting Tooth number system: Select the FDI/ISO or Universal as the tooth numbering system. Language: Select the user interface language. Sound: Adjust the volume Show tips: When selected, the screen displays an indication of the correct scanning method When scanning 3D image of the occlusal Page...
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Display patient information dialog on start: When selected, the patient information dialog will pop up when Helios opens. 2) Scan Scan sound: When selected, a sound will be continuously played when you are scanning (if your workstation does not have speakers, this option will not take effect).
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Element size: Select the size of interface icons to adapt to different screen resolutions. Mode color: Select the color when displaying the 3D model in monochrome. 4) Save Save occlusal data: When selected, the occlusal registration relationship is saved Auto save scan history: When selected, scan history files are automatically saved when the scan is completed.
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5.2.1.2.5 About Information about the software version is displayed. 5.2.2 New patient ,New patient page is displayed, you can create, modify or view Click patient information Patient information: Patient NO., name, age, gender and comment Tooth position: Adult and child tooth position information Scan type: Restoration, implant and othodontics Material: Materials are selected according to patient 5.2.3 Jaw/ bite Switch...
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Implant: Acquires a 3D model of scanning rod 5.2.4 Process guide Scan: Enables you to scan the upper and lower jaw, and the bites Refine: Refines the acquired 3D model, and enables you to use various tools to check the refined results Report: Complete the case information and save the scan results Next step: Proceed to the next step...
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Front view Back view Right view Left view Top view Bottom view Show occlusion analysis: Check the bite surface penetration results Switch view: Unfold the bite surface penetration results Clipping mode:Selecet a clipping mode Reset:Reset a new section 5.2.7 Scanning assistant Non-highlight surface scanning Highlight surface scanning Selecet it when connecting reusable tip size L...
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6. Clinical Guide 6.1 Restoration process 6.1.1 User login ,fill in Username, Password and verification code,and Startup software click 6.1.2 New patient Click to open the new order process: fill in the information such as Patient NO., name, age, gender and comment, select tooth position and scan type, Restoration( Inlay, Crown, Pontic, Other), and click to enter the scan process.
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For detailed information on cleaning, disinfection and sterilization, please refer to the Helios 500 User Manual: cleaning, disinfection and sterilization. Avoid any liquid from leaking into the air outlet near the tip mount or the air inlet at the rear of the scanner (see the figure below), otherwise the scanner may be damaged.
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3) The recommended scanning method is to start with a molar, since it has greater details for easier identification. Change the scanning angle to less than 60 degrees during scanning to allow the surfaces to overlap, if the overlap is too small, the alignment may be lost.
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will automatically repair the holes in the model and mark the color, you can do the following during or after the scanning Hold down the middle mouse button to zoom in and out of the model Hold down the left mouse button and drag the mouse to rotate the model Click to exchange the upper jaw and lower jaw Click...
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the bite position is correct. 3) Press the button the scanner, slowly move the scanner tip in mesial direction with equal coverage of upper and lower teeth. The example below shows a bites. You can scan one or two bites. It is recommended to scan one on the left side and one on the right side of the patient’s mouth 4) After scanning the bites, rotate the model and zoom the view to ensure that the bite is accurate and that there are no areas where the bite is mismatched.
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6.1.6.1 View orientation ,Select a perspective to view the model Click 6.1.6.2 Occlusion analysis Click to check the bite surface penetration results Click to check the bite surface penetration results from the front Page 29 / 51...
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6.1.6.3 Measurement Click , then create a section, the section outline is displayed on the right. Click display different clipping mode. Click to reseat a new section; The left button of mouse selects the two points to be measured and generates the length dimension.
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6.2 Implant process 6.2.1 User login 6.2.2 New patient Click to open the new order process: fill in the information such as Patient NO., name, age, gender and comment, select tooth position and scan type, Implant(Crown, Post & Core, Pontic, Custom Abutment, Other), and click to enter the scan process.
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6.2.3 Upper Jaw/ Lower Jaw scan Remove the healing abutment, adjust the scanning jaw position to the jaw position from which the healing abutment was removed, press the button on the scanner to activate the scanner, and scan the gum section immediately (before gum collapse), then refer to 6.1.3 to complete the scanning of the healing abutment jaw and the opposite jaw 6.2.4 Scanning of the scanning rod...
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3) Attach the scanning rod to the implant and scan from 1-2 teeth near the scanning rod so that the system can identify the 3D model until completing scanning and then remove the scanning rod. Selecting to help scan accuracy when scanning high-light surfaces such as implants, scanning rod.
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6.2.8 Completing and Saving the case Reference to 6.1.7 Othodontics process 6.3.1 User login 6.3.2 New patient Click to open the new order process: fill in the information such as Patient NO., name, age, gender and comment, select tooth position and scan type, Othodontics, and click to enter the scan process.
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Reference to 6.1.6 6.3.7 Completing and Saving the case Reference to 6.1.7 Page 35 / 51...
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Sterilization should be no more than 60 cycles,After 60 cycles, discard it. Reprocessing Instructions Before cleaning, disconnect the component from the Helios 500. Remove gross contaminations from the components with cold water (<40°C) immediately after use. Don’t use a fixating detergent or hot water (>40°C) as this can cause the fixation of residuals which may...
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the surfaces with a soft bristol brush. Regarding cleaning/disinfection, rinsing and drying, it is to distinguish between manual and automated reprocessing methods. Preference is to be given to automated reprocessing methods, especially due to the better standardizing potential and industrial safety. Automated Cleaning: Carefully put the components into the washer-disinfector on a tray and set the parameters as follows, then start the program:...
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by using sterile compressed air. Function Visual inspect the cleanliness of the components and reassemble them. Conduct functional testing according to instructions of use. If Testing, necessary, perform reprocessing process again until the components Mainten are visibly clean. ance: Before packaging and autoclaving, make sure that the components have been maintained according to the manufacturer’s instruction.
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Sterility cannot be guaranteed if packaging is open, damaged or wet. Check the packaging before using it (packaging integrity, no humidity and validity period). Before sterilization, please remove the reusable tip. The instructions provided above have been validated by the manufacturer of the medical device as being capable of preparing a medical device for use.
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Drying: Use a lint free cloth to wipe the surfaces. Inspection Visual inspection for cleanliness of the components. Functional testing according to the user manual. If necessary, perform maintenance: reprocessing process again until the components are visibly clean. Before packaging, make sure that the components have been maintained according to the manufacturer’s instruction.
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8 Troubleshooting Helios 500 Troubleshooting Instructions Problem Description Action There is mismatching and overlap Remove mismatched data and excessive tissue in the 3D image. using the Cut tool and rescan. After bites, there is a gap or Delete the incorrect bite view, and rescan. Enable bite intersection between the upper jaw optimization option.
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● Portable and mobile RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Helios 500, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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Attachment Guidance and manufacturer’s declaration – electromagnetic emissions The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The equipment uses RF energy only for its...
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Conducted RF 3 Vrms (V1)=3Vrms Portable and mobile communications IEC 61000-4- 150 kHz to 80 equipment should be separated from the equipment by no less than the distances calculated/listed below: D=(3.5/V1)(Sqrt P) 150kHz to 80MHz 6Vrms in ISM (E1)= 6Vrms bands in ISM bands between 0,15...
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Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The equipment is intended for use in the electromagnetic environment specified below. The customer or user of the equipment should ensure that it is used in such an environment. Immunity IEC 60601 Test Compliance Electromagnetic Environment –...
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to medical equipment and/or systems, the medical equipment and/or systems’ basic safety and essential performance may be affected. The equipment has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1- 2:2014.
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10 Technical Specification Manufacturer Changzhou Sifary Medical Technology Co., Ltd. Model Helios 500 Dimensions 48cm x 40cm x 21cm ± 2cm(package) Gross Weight 3Kg±10% Color 3D full color Connectivity USB 3.0 Power source USB 3.0 5V, 900mA Reusable tip(Size L):16mm x 14mm Field of view Reusable tip(Size S):12mm x 12mm...
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Display: FHD1920 x 1080 or more nce edition) Others: USB 3.0 port Graphics card: NVIDIA® GeForce® GTX 1650 or more It is MANDATORY to check that your system configuration is compatible with system requirements for the Helios 500 software. workstation Page 49 / 51...
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The service life of Helios 500 series products is 5 years. Warranty Period The scanner of Helios 500 has a 12-month warranty period starting from the date of delivery to the customer. If the damage is proved to be caused by the user's use error, warranty is voided.
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Changzhou Sifary Medical Technology Co., Ltd. Add: No.99 Qingyang Road, Xuejia County, Xinbei District, 213000 Changzhou, Jiangsu China Tel: +86-0519-85962691 Fax: +86-0519-85962691 Email: Info @sifary.com Web: www.sifary.com Caretechion GmbH Tel: +49 211 2398 900 Add: Niederrheinstr. 71, 40474 Düsseldorf, Germany Email: info@caretechion.de All rights reserved.
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Our dental laboratories are not registered with Helios. How do we set this up please?