Acteon SOPRO 617 User Manual
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Acteon SOPRO 617 User Manual

Acteon SOPRO 617 User Manual

Dental cameras
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SOPRO
617
SOPRO
717 First
SOPROLIFE
SOPROCARE
C50

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Summary of Contents for Acteon SOPRO 617

  • Page 1 SOPRO SOPRO 717 First SOPROLIFE SOPROCARE...

  • Page 2: Table Of Contents

    DENTAL CAMERAS USER MANUAL CONTENTS FOREWORD .............................3 REQUIRED INFORMATION ..........................5 SAFETY INSTRUCTION..........................11 DEVICE INSTALLATION ..........................13 USE OF THE DEVICE ..........................17 CLEANING, DISINFECTION AND STERILIZATION .................... 36 MAINTENANCE AND AFTER-SALES SERVICE....................38 ELECTROMAGNETIC COMPATIBILITY ......................40 TECHNICAL DESCRIPTION ......................... 43 10 DISPOSAL AND RECYCLING ........................

  • Page 3: Foreword

    This document must be used in association with the following documents: • SOPRO Imaging User Manual • Acteon Imaging Suite User Manual • Quickstart: 011809B The Quick Start document is a simplified summary designed to help you. The only official instructions are the user manuals and the regulatory documents accompanying the medical device.
  • Page 4 DENTAL CAMERAS USER MANUAL Please retain all original documentation relating to the medical device and its accessories for reference at a later date. When loaning out or selling the medical device, the documentation must be provided with it. 4/48 011807A – ENGLISH...

  • Page 5: Required Information

    • 1 handpiece holder • 20 protective sheaths • 1 CD of Acteon Imaging Suite (AIS)* or SOPRO Imaging (SI) software (in basic version) • 1 quick start SOPRO Imaging (SI) and/or Acteon Imaging Suite (AIS) software. • 1 intraoral camera quick start guide •...

  • Page 6: Intended Purpose

    SOPRO 617 and SOPRO 171First cameras, with the essential accessories such as docking station and single- use protective sheath, are intended to visualize anatomical and pathological details that cannot be seen with the naked eye, as well as pathology control and post-treatment. SOPRO 617 and SOPRO 171First do not provide a diagnostic.

  • Page 7: Principle Of Operation

    2.3.2 SOPRO 617 The optics and electronics developed around a CCD sensor in SOPRO 617 pick up the images, enhance them and convert them into a video signal which is sent to the video monitor or to a computer screen.
  • Page 8 2.3.6 Docking stations The mini dock U_USB2 module is built-in docking station for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. The mini dock U_USB2 docking station is to be powered directly by a USB 2.0 compatible port .
  • Page 9 DENTAL CAMERAS USER MANUAL The user must not be prone to any of the following: • Any vision problems must be corrected by glasses or lenses. • Colour perception is mandatory. The user must wear gloves. The user is not the patient. The medical device can be used by any adult practitioner of any weight, age, height, gender and nationality.
  • Page 10 DENTAL CAMERAS USER MANUAL 10/48 011807A – ENGLISH...

  • Page 11: Safety Instruction

    DENTAL CAMERAS USER MANUAL SAFETY INSTRUCTION GENERAL PRECAUTIONS Respect the conditions of use and storage (see §9). Prior to each use, make sure the device does not have any rough surfaces, sharp edges or protuberances which could lead to safety problems. Use only the accessories supplied with the device or recommended as options by SOPRO.
  • Page 12 DENTAL CAMERAS USER MANUAL Ethylene dichloride Methylene chloride Ketones Use of these chemicals subject plastic parts to risk of deterioration. CONTRAINDICATIONS None known. SPECIFICS WARNINGS • Not suitable for use in the presence of a flammable anaesthetic mixture containing air, oxygen or nitrous oxide.

  • Page 13: Device Installation

    DENTAL CAMERAS USER MANUAL DEVICE INSTALLATION No special training is required to install the device. CONNECTING SOPRO 617, SOPRO 717 FIRST, SOPROCARE & SOPROLIFE TO A COMPUTER 4.1.1 Required computer configuration This paragraph is linked to the cameras below: •...
  • Page 14 DENTAL CAMERAS USER MANUAL Installation scheme: The footswitch should be connected to MINI DOCK U_USB2 if you have selected it to freeze the image. 4.1.3 Mini dock USB2 connection with the computer The following section is only applicable for cameras for which a docking station is mandatory. Connect the USB cable to one of the computer USB ports.
  • Page 15 The video acquisition module is installed when SI, AIS or OIS (with SDK) is installed. The video acquisition module is a software that can captures films and images from ACTEON cameras video stream, according to dentist’s needs for patient’s oral heath follow-up.
  • Page 16 4.3.2 Imaging software installation for C50 The C50 can be use with can be used with ACTEON® Imaging Suite (AIS) software or SOPRO Imaging (SI) software or any Other Imaging Software (OIS) supporting the Universal Video Class (UVC). The video acquisition module is installed when SI, AIS or OIS (with SDK) is installed.

  • Page 17: Use Of The Device

    To capture an image, you have just to slightly touch SoproTouch as soon as the desired region of interest appears on the screen. The image is automatically captured on the computer - only when used with Acteon Imaging suite (AIS) or SOPRO-Imaging (SI) (if another imaging software is used please refer to its user manual) - During the capture, the video live stream flashes white, confirming the image capture.
  • Page 18 DENTAL CAMERAS USER MANUAL 5.1.3 Operating protocol for SOPROCARE camera PERIO MODE This fluorescent mode (associated with chromatic amplification) helps provide information about the patient’s dental hygiene and highlights dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing).
  • Page 19 DENTAL CAMERAS USER MANUAL Picture Designation Button 1: Press button to switch between DAYLIGHT and PERIO modes. Button 2: Press button to switch between DAYLIGHT and CARIO modes. 5.1.4 Operating protocol for SOPROLIFE camera DIAGNOSIS AID MODE In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution.
  • Page 20 DENTAL CAMERAS USER MANUAL Diagnosis after using the SOPROLIFE is performed and provided by the dental practitioner. Alert signal is only an indication, the dental practitioner is the only expert to judge and adapt his treatment’s option to the situation and also decide to stop treatment based on his clinical sense.
  • Page 21 On Screen Display (OSD) If you are using the C50 with another imaging software (OIS) different from ACTEON® Imaging Suite (AIS) or SOPRO-Imaging (SI) software, and you do not use neither our TWAIN nor our SDK, you will have access to our camera OSD.
  • Page 22 DENTAL CAMERAS USER MANUAL With the fluorescence option enabled 22/48 011807A – ENGLISH...
  • Page 23 DENTAL CAMERAS USER MANUAL 5.2.3 Icon’s designations Available Available on Function Picture Designation on AIS or SI or TWAIN or SDK Automatic Focus Focus The camera does the focus automatically. Single Focus Focus To make the focus, do a short press on capture button.
  • Page 24 DENTAL CAMERAS USER MANUAL USE OF THE VIDEO ACQUISITION MODULE 5.3.1 C50 Main interface 5.3.1.1 With fluorescence option disabled or enabled Video Stream Video Acquisition Module Settings Access Image Capture Button Focus Function used Movie Capture Button Vision Mode Function used ZOOM Function factor used Self-Timer Function used Camera Mode Function used...
  • Page 25 DENTAL CAMERAS USER MANUAL 5.3.2 C50 Functions 5.3.2.1 FOCUS MODE To access the focus menu, use the camera menu button or your mouse. From that menu two options are possible: Automatic Focus Single Focus The option selected is highlighted in blue. The AF is the option selected when the video acquisition module is used for the first time.
  • Page 26 DENTAL CAMERAS USER MANUAL If long press on the up/Down arrows, the ZOOM factor goes from x1 or x2, or vice versa according to the arrow used, and move fluently. If the ZOOM is defined as a Quick Access into the advanced settings of the module, by a short press on the camera up/Down arrows, the ZOOM factor goes from x1 or x2 or vice versa according to the arrow used and move step by step.
  • Page 27 DENTAL CAMERAS USER MANUAL 5.3.2.5 CAMERA MODE To access the Camera Mode menu, use the camera menu button or your mouse. From that menu two options are possible: Intra-Oral Mode Portrait Mode The option selected is highlighted in blue. The Intra-Oral Mode is the default option applied when the video acquisition module is used. To change the option press on the camera arrows buttons or select it with a mouse click.
  • Page 28 Device Settings If a camera is already connected to the computer, the video source should automatically be configured. NOTE: Only Acteon cameras can be used with the video acquisition module. Video source selection Product serial number...
  • Page 29 DENTAL CAMERAS USER MANUAL Capture Settings Movie Resolution: define the resolution of the movie Movie Quality: define the movie compression quality Capture shortcut: to define a shortcut to capture an image or a movie Camera capture button: Enable or Disable 5.3.2.8.1 Movie Resolution From this setting the users can define the movie resolution:...
  • Page 30 DENTAL CAMERAS USER MANUAL Advanced Settings The user can access the Advanced Settings by using the toggle button “Advanced mode” option below. From that panel the operator can adjust the following parameters: Capture Mode: Define buy the imaging software calling the video acquisition module.
  • Page 31 DENTAL CAMERAS USER MANUAL 5.3.2.8.2 Configuration sharing Password to share the module configuration with all computer’s users: admin 5.3.3 SOPRO Camera Main interface Video Stream Image Capture Button Video Acquisition Module Settings Access Movie Capture Button 5.3.3.1 IMAGE CAPTURE The default option presents into the video acquisition module Advanced Settings is Freeze After Capture. When this option is enabled and an image is captured, from the camera capture button or from the video acquisition module Capture button...
  • Page 32 DENTAL CAMERAS USER MANUAL Image Frozen As soon as an image is captured a white flash appears (see image below) on the video stream in less than a second to inform the user an image had been taken. 5.3.3.2 MOVIE CAPTURE When the user press on records button from the video acquisition module or if the module is run in movie mode from the imaging software, the movie capture performed through the camera capture button...
  • Page 33 DENTAL CAMERAS USER MANUAL Device Settings If a camera is already connected to the computer, the video source should automatically be configured. NOTE: Only Acteon cameras can be used with the video acquisition module. Video source selection Audio source selection...
  • Page 34 DENTAL CAMERAS USER MANUAL 5.3.3.1.4 Reset to default settings If a modification is done, the users can press reset button to come back to the default value. Advanced Settings The user can access the Advanced Settings by using the toggle button “Advanced mode” option below. From that panel the operator can adjust the following parameters: Capture Mode: Define buy the imaging software calling the video acquisition module.
  • Page 35 DENTAL CAMERAS USER MANUAL 5.3.3.1.9 Configuration sharing Password to share the module configuration with all computer’s users: admin 5.3.4 About While the “Advanced Mode” is enabled the user can access the information about the video acquisition module by pressing on the seen on the picture above.

  • Page 36: Cleaning, Disinfection And Sterilization

    DENTAL CAMERAS USER MANUAL CLEANING, DISINFECTION AND STERILIZATION In accordance with EN ISO 17664, this section provides users with instructions for cleaning, disinfection, and sterilization of SOPRO reusable medical devices. Instructions related to cleaning, disinfection and sterilization protocols for each medical device and accessory supplied by SOPRO have been validated. This section is applicable only for devices manufactured by SOPRO.
  • Page 37 DENTAL CAMERAS USER MANUAL Caution: Any deviation from the recommended sterilisation settings must be approved by the user. 6.4.2 Instruction for steam sterilization SOPROTIPS & C50TIPS must be cleaned and packaged before sterilization. Package should be double-pouched, with as an example SPS Medical Self-Seal Sterility assurance pouches; part #SSP-380 (inner pouch) and part # SSP-382 (outer pouch).

  • Page 38: Maintenance And After-Sales Service

    (blurry). The camera should be sent to ACTEON in its totality (docking station, handpiece, cables). Please enclose your packing list with a brief explanatory note relative to the noticed defect. If some parts constituting the camera happen to break, it is imperative to send in everything so all defective parts can be replaced.
  • Page 39 DENTAL CAMERAS USER MANUAL product, check its condition, and note any discrepancies on the delivery slip, if necessary. You will then have 48 hours to confirm by registered letter sent to the carrier. After 48 hours, the carrier will be able to deny these discrepancies.

  • Page 40: Electromagnetic Compatibility

    DENTAL CAMERAS USER MANUAL ELECTROMAGNETIC COMPATIBILITY All the information below is based on the requirements of standards to which the manufacturers of electrical medical devices must adhere (as stated in standard IEC 60601-1-2). The medical device complies with the electromagnetic compatibility standards in force. However, the user must make sure that any electromagnetic interference does not create an additional risk, such as radio-frequency transmitters, or other electronic devices.

  • Page 41: Recommended Separation Distances

    DENTAL CAMERAS USER MANUAL Electrical transient conduction along supply ISO 7637-2 lines RECOMMENDED SEPARATION DISTANCES The medical device is designed to be used in an electromagnetic environment in which disturbances due to RF radiation are controlled. The user or installer of the medical device can help prevent any electromagnetic interference by applying a minimum distance, according to the maximum power of the radio-frequency transmission equipment.
  • Page 42 DENTAL CAMERAS USER MANUAL Power Home and frequency professional magnetic field 30 A/m 30 A/m immunity (IEC healthcare 61000-4-8) environment (NA for C50) Professional healthcare facility environment. 0% UT for 0.5 cycles If the use of the Voltage short 0% UT for 0.5 cycles At 0°, 45°, 90°, 135°, 180°, system requires interruptions...

  • Page 43: Technical Description

    DENTAL CAMERAS USER MANUAL TECHNICAL DESCRIPTION ENVIRONMENTAL CONDITIONS: Storage temperature -20 °C / +45 °C Operating temperature +10 °C / +40 °C Relative humidity 10% to 90% Transport, storage and operating atmospheric 700 hPa to 1060 hPa pressure Electrical classification (IEC 60601-1) Class 2 Applied part Type BF...
  • Page 44 DENTAL CAMERAS USER MANUAL PERIO mode, CARIO mode and DAYLIGHT 3 positions mode Image Non-inverted Image capture SoproTouch or footswitch (optional) Angle of view 70° Cable length: 2.5m Handpiece dimensions L: 200; W: 28; H: 24 mm Usable part dimensions W: 14.4 x D: 8 mm Handpiece weight 78 g...
  • Page 45 Usable part dimensions W : 14.25 x D : 8.75 mm Handpiece weight 78 g Continuous service Not protected against water chutes IPX0 SOPRO 617 CCD 1/4” High sensitivity Resolution (752 x 582) PAL; (768 x 494) NTSC Definition 470 lines...

  • Page 46: Disposal And Recycling

    DENTAL CAMERAS USER MANUAL 10 DISPOSAL AND RECYCLING This device bears a recycling symbol in accordance with European Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE). By correctly disposing of this device, you will help prevent any harm to the environment and to human health. The symbol present on the device or in the accompanying documentation shows that this product cannot under any circumstances be processed as domestic waste.

  • Page 47: Regulatory Information

    DENTAL CAMERAS USER MANUAL 11 REGULATORY INFORMATION 11.1 APPLICABLE STANDARDS AND REGULATIONS This medical device complies with the European requirements of Regulation (EU) 2017/745. It was designed and manufactured in accordance with an EN ISO 13485-certified quality assurance system. The information in this user manual is based on the requirements of standards to which the manufacturers of medical devices must adhere (as stated in standard IEC 62366-1).

  • Page 48: Symbols

    Only Indicates the item is a medical device. Indicates a website where a patient can obtain additional inf ormation on the medical product SOPRO S.A a company of ACTEON Group ZAC Athélia IV Av. Des Genévriers 13705 LA CIOTAT Cedex FRANCE Tel.

This manual is also suitable for:

Sopro 717 firstSoprolifeSoprocareC50

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