KaVo DEXIS CariVu 3-in-1 Instructions For Use Manual
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KaVo DEXIS CariVu 3-in-1 Instructions For Use Manual

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Instructions for use
DEXIS CariVu 3-in-1 by KaVo

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Summary of Contents for KaVo DEXIS CariVu 3-in-1

  • Page 1 Instructions for use DEXIS CariVu 3-in-1 by KaVo...
  • Page 2 Distributed by: Manufacturer: DEXIS LLC KaVo Dental GmbH 1910 North Penn Road Hatfield, Bismarckring 39 PA 19440 USA 88400 Biberach Phone: 1-888-883-3947 Germany www.dexis.com www.kavo.com...

  • Page 3: Table Of Contents

    Instructions for use DEXIS CariVu 3-in-1 by KaVo Table of contents Table of contents 1 User instructions ........................ 5 1.1 Transport and storage....................7 1.1.1 Damage in transit ....................1.2 Product Disposal......................9 1.3 Terms and conditions of warranty ................... 9 2 Safety..........................
  • Page 4 Instructions for use DEXIS CariVu 3-in-1 by KaVo Table of contents 7.2 Preparations at the site of use..................37 7.3 Disassembly........................38 7.4 Manual processing ......................38 7.4.1 Manual external cleaning ..................38 7.4.2 Manual internal cleaning ..................38 7.4.3 Manual external disinfection ................

  • Page 5: User Instructions

    1 User instructions | 1 User instructions Dear User, Congratulations on purchasing this KaVo quality product. By following the in- structions below you will be able to work smoothly, economically and safely. © Copyright by KaVo Dental GmbH KaVo and DEXIS CariVu are either registered trademarks or trademarks of KaVo Dental GmbH.
  • Page 6 Instructions for use DEXIS CariVu 3-in-1 by KaVo 1 User instructions | Explanation brevi- ation Processing instructions Abbreviation Explanation Camera DEXIS CariVu 3-in-1 by KaVo Tip Vision Full HD Fluorescence cover Fluorescence Cover Vision Full HD Sheath Sheath Vision Full HD...

  • Page 7: Transport And Storage

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 1 User instructions | 1.1 Transport and storage Follow the instructions for use VDE mark MET mark Transportation and storage conditions (Temperature range) Transportation and storage conditions (Air pressure) Transportation and storage conditions...
  • Page 8 Freight Forwarders' Terms and Conditions, Art. 28). Outside Germany Note KaVo shall not be held liable for damage arising from transportation. The shipment must be checked on arrival. If the packaging is visibly damaged on delivery, please proceed as follows: 1.

  • Page 9: Product Disposal

    Claims from this warranty can only be asserted when the transfer form (copy) belonging to the product has been sent to KaVo, and the original can be pre- sented by the operator or user. 9 / 50...

  • Page 10: Safety

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 2 Safety | 2.1 Infection hazard 2 Safety Note All serious events occurring in relation to the product must be reported to the manufacturer and the competent authority of the member state, in which the user and/or patient resides.

  • Page 11: Qualification Of Personnel

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 2 Safety | 2.4 Qualification of personnel ▶ Only use consumables that have been approved for combination with the product by the manufacturer. ▶ Do not make any modifications to the device unless these have been ap- proved by the manufacturer of the product.

  • Page 12: Led Light

    KaVo spare parts comply with the specification. Note If a repair is done with NON-KaVo original spare parts, this may constitute a product modification that leads to the loss of CE conformity. In the event of damage, the responsibility is with the service company or the operator.

  • Page 13: Product Description

    The camera enables various applications in health facilities/dental offices, dental clinics, orthodontics and oral and maxillary surgery. Connected to a computer, a monitor and imaging software such as CONEXIO, the DEXIS CariVu 3-in-1 by KaVo can be used to create and save images and videos.
  • Page 14 The DEXIS CariVu 3-in-1 by KaVo is available in two similar models. The differ- ences between the models are a wall mounted version to store the device with a cable length of 2.5 meters (model 1.011.4444) and a table holder version to...

  • Page 15: Intended Use

    3.1 Intended use Indications for use: The DEXIS CariVu 3-in-1 by KaVo acquires patient images as a diagnostic aid for detection of smooth surface caries, occlusal caries, proximal caries, initial caries, secondary caries, and tooth cracks. The DEXIS CariVu 3-in-1 by KaVo is designed for use by a trained professional in the field of dentistry.

  • Page 16: Symbols On Product And Rating Plate

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 3 Product description | 3.2 Symbols on product and rating plate 3.2 Symbols on product and rating plate ① Type plate ④ Date of manufacture ② Serial number ⑤ Catalog number ③ HIBC Code...

  • Page 17: Product Configurations

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 3 Product description | 3.3 Product configurations Disposal instructions, see user instructions 3.3 Product configurations The camera is available with two different lengths of cable: Standard Configuration Cable length 2.5 m (1.011.4444) Used in combination with treatment Cable length 1.30 m...
  • Page 18 Instructions for use DEXIS CariVu 3-in-1 by KaVo 3 Product description | 3.4 Technical Specifications Operating conditions Ambient temperature +10 to + 30 Air pressure 800 to 1060 hPa Rel. humidity 5 to 95 % non-condensing Operating altitude max. 2000 m...

  • Page 19: Delivery Content

    The USB cable is used to connect the camera to the computer and to send the captured image/video to the imaging software. The DEXIS CariVu 3-in-1 by KaVo needs an imaging software that is released for connection to the camera. The function of the camera depends on the selected mode, which can be se- lected using the control panel.

  • Page 20: System Components

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 3 Product description | 3.6 System components 3.6 System components Camera ① Window with 2 LEDs each for Intraoral mode and Fluorescence mode ② Tip holder ③ Control panel See also: 2 6 Operation, Page 25 Camera with tip attached ①...

  • Page 21: Control Panel

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 3 Product description | 3.7 Control panel 3.7 Control panel The control panel is situated on the top and bottom side of the camera. ① Trigger button for capturing an im- ③ Status LED indicating the current...

  • Page 22: Installation Of The Wall Mount

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 4 Installation of the wall mount 4 Installation of the wall mount The wall mount can either be screwed to the wall or glued to the treatment unit or to another surface.
  • Page 23 Instructions for use DEXIS CariVu 3-in-1 by KaVo 4 Installation of the wall mount ▶ Slide the wall mount onto the mounting rail and place the DEXIS CariVu 3- in-1 by KaVo in the wall mount. 23 / 50...

  • Page 24: Startup And Shut-Down

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 5 Startup and shut-down | 5.1 Recommended PC requirements 5 Startup and shut-down WARNING Hazard from non-sterile products. Infection hazard for dentist and patient. ▶ Before first use and after each use, process and sterilize the medical device and accessories accordingly.

  • Page 25: Operation

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 6 Operation | 6.1 Start up of the camera 6 Operation 6.1 Start up of the camera ▶ Use the USB cable to connect the camera to the computer. ▶ Start up the imaging software.
  • Page 26 Instructions for use DEXIS CariVu 3-in-1 by KaVo 6 Operation | 6.2 Use a sheath Note For optimum image quality of the system, there must be no air present be- tween the clear view window of the sheath and the exposure window of the camera.

  • Page 27: Snap-In And Detach The Tip

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 6 Operation | 6.3 Snap-in and detach the tip ▶ Then process the camera and accessories according to recommendations. See also: 2 7 Processing steps in accordance with ISO 17664, Page 37 6.3 Snap-in and detach the tip...

  • Page 28: Recording Images

    Possibly hazardous optical radiation emitted from product. Risk of injury. Do not stare into the active light source. The DEXIS CariVu 3-in-1 by KaVo camera houses an lens system with a perma- nent autofocus, which focuses permanently between the macro range and facial images.
  • Page 29 This mode can be used to record intraoral images. Recording an image in Intraoral mode The DEXIS CariVu 3-in-1 by KaVo can be used to record still images and videos. The possible recording modes depend on the imaging software. ▶ Connect the camera to the computer.

  • Page 30: Fluorescence Mode

    In Fluorescence mode, it is recommended to plug the fluorescence cover onto the camera to be able to record optimally illuminated images. In this mode, the DEXIS CariVu 3-in-1 by KaVo camera records images in the fluorescence range for the detection of occlusal caries.
  • Page 31 Instructions for use DEXIS CariVu 3-in-1 by KaVo 6 Operation | 6.4 Recording images Analysis ▪ The dental hard substance is shown in a greenish colour ▪ Metabolic products of cariogenic bacteria are shown in a reddish colour Recording an image in Florescence mode ▶...

  • Page 32: Transillumination Mode

    Proximal caries Occlusal caries Secondary caries The DEXIS CariVu 3-in-1 by KaVo can detect caries in the enamel, but not in the dentin. Healthy dental enamel is shown bright in the image, whereas cari- ous sites are shown as dark spots.
  • Page 33 Instructions for use DEXIS CariVu 3-in-1 by KaVo 6 Operation | 6.4 Recording images ð The tip is connected automatically to the camera while it is being plugged on, and switches it into Transillumination mode. Note Do not damage the sheath when you attach the tip.

  • Page 34: Combined Intraoral + Fluorescence Mode

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 6 Operation | 6.4 Recording images 6.4.4 Combined Intraoral + Fluorescence mode CAUTION Possibly hazardous optical radiation emitted from product. Risk of injury. Do not stare into the active light source. ▶ Connect the camera to the computer.

  • Page 35: Combined Mode Intraoral + Fluorescence + Transillumination

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 6 Operation | 6.4 Recording images 6.4.5 Combined mode Intraoral + Fluorescence + Transillumination CAUTION Possibly hazardous optical radiation emitted from product. Risk of injury. Do not stare into the active light source.

  • Page 36: Switching The Camera Off

    By resting the tip on the tooth or neighbor teeth and the friction of the light emission arms, the DEXIS CariVu 3-in-1 by KaVo is stabilized. A very close position to the former acquired image needs to be achieved.

  • Page 37: Processing Steps In Accordance With Iso 17664

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 7 Processing steps in accordance with ISO 17664 | 7.1 Overview of the processing options 7 Processing steps in accordance with ISO 17664 7.1 Overview of the processing options Components Single use...

  • Page 38: Disassembly

    Malfunction and material damage. 7.4.1 Manual external cleaning ▶ Clean the DEXIS CariVu 3-in-1 by KaVo, the tip and the fluorescence cover for at least 1 minute per item under running potable water with an flow rate 2l/min and a temperature of 30 °C ± 5 °C (86 °F ± 9 °F) or until the part is visually clean.

  • Page 39: Manual Internal Disinfection

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 7 Processing steps in accordance with ISO 17664 | 7.4 Manual processing Consumables required: ▪ Cloths for wiping the medical device. ▶ Spray the disinfectant on a cloth, then wipe down the medical device and allow the disinfectant to act in accordance with the instructions of the disinfectant manufacturer.

  • Page 40: Automated Processing

    Malfunction and material damage. 7.5.1 Pre-cleaning ▶ Clean the DEXIS CariVu 3-in-1 by KaVo, the tip and the fluorescence cover for at least 1 minute per item under running potable water with an flow rate 2l/min and a temperature of 30 °C ± 5 °C (86 °F ± 9 °F) or until the part is visually clean.

  • Page 41: Automated Drying

    Please comply with the instructions for use of the washer disinfector. ▶ In order to prevent impairment of the KaVo medical device, make sure that the inside and outside of the device is dry after the end of the cycle.

  • Page 42: Storage

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 7 Processing steps in accordance with ISO 17664 | 7.8 Storage ▪ Sterilizer using the gravity method: - 10 minutes at 135 °C (275 °F) - Drying time: 30 min. ▶ Use in accordance with the manufacturer's Instructions for Use.

  • Page 43: Tools And Consumables

    Instructions for use DEXIS CariVu 3-in-1 by KaVo 8 Tools and consumables 8 Tools and consumables Product Catalog number Tip Vision Full HD (1 pc): 1.013.5708 The Tip Vision Full HD can be attached to the main device to allow the device to enable the device for use in transillumination mode.
  • Page 44 Instructions for use DEXIS CariVu 3-in-1 by KaVo 8 Tools and consumables Product Catalog number Cradle Vision Full HD: 1.013.5713 The Cradle Vision Full HD is a table holder for the main device which can be placed on flat horizontal surfaces.

  • Page 45: Information Concerning The Electromagnetic Compatibility In Accordance With En Iec 60601-1-2

    EN IEC 60601-1-2 9.1 Electromagnetic Transmissions The DEXIS CariVu 3-in-1 by KaVo is designed for use in an environment of the kind specified below. The customer or the user of the DEXIS CariVu 3-in-1 by KaVo should ensure that the device is used in an environment of the specified type.

  • Page 46: Resistance To Electromagnetic Interference

    9.2 Resistance to electromagnetic interference The DEXIS CariVu 3-in-1 by KaVo is designed for use in an environment of the kind specified below. The customer or the user of the DEXIS CariVu 3-in-1 by KaVo should ensure that the device is used in an environment of the specified type.

  • Page 47: Resistance To Electromagnetic Interference

    9.3 Resistance to electromagnetic interference The DEXIS CariVu 3-in-1 by KaVo is designed for use in an environment of the kind specified below. The customer or the user of the DEXIS CariVu 3-in-1 by KaVo should ensure that the device is used in an environment of the specified type.

  • Page 48: Recommended Safe Distance Between Portable And Mobile Hf Telecommunications Equipment And The Treatment Unit

    HF telecommunications equipment and the treatment unit electromagnetic environment in terms of stationary transmitters. If the mea- sured field strength at the site, at which the DEXIS CariVu 3-in-1 by KaVo is used, exceeds the compliance levels shown above, the DEXIS CariVu 3-in-1 by KaVo should be monitored to demonstrate proper function.

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