Durr Dental VistaCam iX HD Smart Installation And Operating Instructions Manual
Durr Dental VistaCam iX HD Smart Installation And Operating Instructions Manual

Durr Dental VistaCam iX HD Smart Installation And Operating Instructions Manual

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VistaCam iX HD Smart
EN
Installation and operating instructions
2109100026L02
*2109100026L02*

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Summary of Contents for Durr Dental VistaCam iX HD Smart

  • Page 1 VistaCam iX HD Smart Installation and operating instructions 2109100026L02 *2109100026L02*...
  • Page 3: Table Of Contents

    Contents Contents Type plate ....Evaluation of conformity ..Operation ..... . . Important information Cam interchangeable head .
  • Page 4 Contents Record an image with Proxi interchangeable head ..Switching off the camera ..Appendix Reprocessing of the device ..14 Handover protocol .
  • Page 5: About This Document

    Important information The signal word differentiates between four levels Important information of danger: – DANGER Immediate danger of severe injury or death About this document – WARNING Possible danger of severe injury or death These installation and operating instructions rep- resent part of the unit.
  • Page 6: Copyright Information

    Important information Copyright information Safety All circuits, processes, names, software pro- Dürr Dental has designed and constructed this grams and units mentioned in this document are unit so that when used properly and for the protected by copyright. intended purpose it does not pose any danger to The Installation and Operating Instructions must people or property.
  • Page 7: Important Information

    Important information With the aid of a computer, monitor and imaging Intraoral camera with Proxi interchangeable software, this digital system can be used to cre- head ate and store images and videos. The following The Proxi head is not designed for use on artifi- accessories must always be used: a spacer (not cial teeth, teeth with crowns or teeth with exces- for the Cam interchangeable head) and hygienic...
  • Page 8: Specialist Personnel

    Important information Specialist personnel NOTICE Operation Negative effects on the EMC due to Operating personnel are dentists and dental per- non-authorised accessories sonnel. Use only Dürr Dental parts or acces- ❯ They must ensure safe and appropriate handling sories specifically approved by Dürr on the basis of their training and know-how.
  • Page 9: Disposal

    Important information 2.13 Transport The original packaging provides optimum protec- tion for the unit during transport. If required, original packaging for the unit can be ordered from Dürr Dental. Dürr Dental will not accept any responsi- bility or liability for damage occurring dur- ing transport due to the use of incorrect packaging, even where the unit is still under guarantee.
  • Page 10: Product Description

    The following items are included in the scope of delivery (possible variations due to country-spe- cific requirements and/or import regulations): Overview VistaCam iX HD Smart with Cam, Proof and Proxi package ..2109100001 – Handpiece – Cam interchangeable head –...
  • Page 11: Accessories

    Cam interchangeable head for specialist dealers at: VistaCam iX HD Smart ..2109130050 www.duerrdental.net. Proof interchangeable head for VistaCam iX HD Smart ..2109130051 Proxi interchangeable head for VistaCam iX HD Smart .
  • Page 12: Technical Data

    Product description Technical data Electromagnetic compatibility (EMC) Interference immunity tests Handpiece Emitted HF disturbance Compliant Electrical data variables in accordance with IEC 61000-4-3 Nominal voltage V DC Communication USB 2.0 Camera electronics interfaces Image sensor 1/3" CMOS Type of protection IP20 Number of image MPix...
  • Page 13: Proxi Interchangeable Head

    Product description Proof interchangeable head Electrical data for the power supply unit Dominant wave- Electrical frequency 47 - 63 length Max. nominal cur- Irradiance rent Output voltage V DC Sharpness level 4 - ¥ Max. output volt- ±1 age fluctuations Focus level, preset Output current Opening angle...
  • Page 14: Ambient Conditions

    Product description Electromagnetic compatibility (EMC) Interference immunity tests Emitted HF distur- Compliant bance variables in accordance with IEC 61000-4-3 Connection cable Cable length Ambient conditions Ambient conditions during operation Temperature °C 10 to 40 Relative humidity 20 to max. 75 Air pressure 700 - 1060 Ambient conditions during storage and...
  • Page 15: Operation

    Product description Operation Focus button Trigger button The intraoral camera consists of a handpiece and Contacts for interchangeable head various interchangeable heads. The function of The interchangeable head is plugged onto the the camera depends on the function of the inter- handpiece and connected via the contacts.
  • Page 16: Cam Interchangeable Head

    Product description Cam interchangeable head Proof interchangeable head Spacer Optical system Interchangeable head Focus button Trigger button The Cam interchangeable head has an optical The Proof interchangeable head is used to create element with autofocus with a focal range for intraoral images for the detection of caries, intraoral recordings.
  • Page 17 Product description Application areas of the Proof interchangeable head: Healthy tooth enamel – Detecting plaque and calculus – Detecting caries at an early stage Initial caries, early stages of enamel caries – Fissure caries that are difficult to detect – Precise location of carious lesions on smooth surfaces Enamel caries up to the enamel/dentine –...
  • Page 18: Proxi Interchangeable Head

    Product description Proxi interchangeable head – Healthy enamel appears very dark, high translucency – Approximal caries appears bright, low translu- cency – Dentine appears bright, low translucency – Several restorations appears bright, no translu- cency Spacer interchangeable head Focus button Trigger button The handpiece with the Proxi interchangeable head creates a black and white image for detect-...
  • Page 19: Handpiece Holder

    Product description The enamel appears brighter in patients with USB connection (for camera or USB stick) highly opaque enamel. The caries diagnosis is Connection for power supply unit complicated here by the low difference in con- Micro USB connection for computer trast.
  • Page 20: Assembly

    Assembly Commissioning Assembly NOTICE Installation Short circuit due to the build up of condensation Installing the handpiece The unit can only be put into operation ❯ once it has warmed up to room tem- holder perature and is dry. The handpiece holder can be glued or screwed. Choose suitable fastening material.
  • Page 21: Configuring The Unit In Vistasoft

    Assembly Proper operation of the Dürr Dental hardware Configuring the unit in and software is coordinated. VistaSoft Based on the system requirements for com- ❯ The camera is preconfigured in the imaging soft- puter systems, check whether the device is ware and can be used directly.
  • Page 22: Configuring The Appliance In Dbswin

    Assembly Configuring the appliance in Configure the appliance in DBSWIN VistaConfig for VistaEasy Start DBSWIN. Start VistaConfig via Start > All Programs > ❯ ❯ Duerr Dental > VistaConfig > VistaCamCon- In the Options menu, select > Display Config- ❯ fig.
  • Page 23: Connect The Handpiece Holder With The Usb Hub (Optional)

    Assembly Connect the handpiece Acceptance tests holder with the USB hub Electrical safety checks (optional) Perform the electrical safety check according ❯ to national law. Document the results. ❯ The interchangeable heads in the various versions (see "5 Operation") are applica- tion parts in accordance with IEC 60601-1.
  • Page 24: Usage

    Usage Place on the interchangeable head Usage Requirements: ü The handpiece and interchangeable head are completely dry. Operation Slide the interchangeable head onto the hand- ❯ piece (rotate if necessary) until it engages. NOTICE A guide on the handpiece ensures that the Damage to the camera from falling interchangeable head is placed on correctly.
  • Page 25: Using The Hygienic Protective Cover

    Usage Using the hygienic protective Hold the disposable hygienic protective cover ❯ firmly on the white edge and pull off the trans- cover parent plastic side in the direction of the cam- era head. WARNING Danger of cross contamination when not using the hygienic protective cover or when using the hygienic pro- tective cover more than once...
  • Page 26: Record An Image With The Cam Interchangeable Head

    Usage Record an image with the Record an image with the Cam interchangeable head Proof interchangeable head Still images and video can be recorded with the When imaging with the Proof interchangeable camera. The possible recording modes are head, two views are possible in the imaging soft- dependent on the imaging software.
  • Page 27 Usage Requirements: To switch back to Live mode, press the trigger ❯ ü Camera connected with the computer button again. ü Imaging software started Analyse the image ü Camera in hygienic protective cover The prophylaxis view shows the original image. ü...
  • Page 28: Record An Image With Proxi

    Usage Record an image with Proxi Dentine junction already exceeded interchangeable head CAUTION Deep dentine caries Health risks for the patient due to contraindications Before taking an X-ray image, check ❯ the present tooth restorations. See "2.5 Contraindication". ❯ Positioning the camera correctly The camera must be positioned correctly to achieve a good picture quality.
  • Page 29 Usage Place the camera with spacer on the row of Analyse the image ❯ teeth above the approximal area. The black and white image shows structures with varying translucency as different levels of bright- ness. The lower the translucency, the higher the reflection of the infra-red light and the brighter the structure.
  • Page 30: Switching Off The Camera

    Usage Switching off the camera If the camera is not moved, it automatically switches itself off after the set stand-by time (pre- set 2 minutes). Placing the camera in the handpiece holder, results in automatic switch-off. Always store the camera with the inter- changeable head plugged into the hand- piece holder.
  • Page 31: Reprocessing Of The Device

    Usage Reprocessing of the Important information! The reprocessing notes in accordance device with EN ISO 17664 have been indepen- dently tested by Dürr Dental for the Risk analysis and categorisa- preparation of the device and its compo- tion nents for their reuse. A risk analysis and categorisation of medical The person conducing the reprocessing is products often used in dentistry must be per-...
  • Page 32: Preparation At The Operating Location

    Usage Protect the unit from contamination when General information ❯ transporting it from the treatment chair to the Comply with all national directives, standards ❯ reprocessing location. and specifications for the cleaning, disinfection and sterilisation of medical products as well as Manual pre-cleaning, clean- the specific specifications for dental practices and clinics.
  • Page 33: Reprocessing The Spacer

    Usage 10 Reprocessing the spacer Drying Allow the device to air-dry. ❯ 10.1 Risk analysis and categorisa- The device must be completely dry before a new hygienic protective cover is fitted. tion A risk analysis and categorisation of medical products often used in dentistry must be per- formed before their reprocessing by the operator.
  • Page 34 Usage The reprocessing procedure was validated as fol- Important information! lows: The reprocessing notes in accordance – Pre-cleaning with EN ISO 17664 have been indepen- – FD 322 premium wipes for quick-acting dis- dently tested by Dürr Dental for the infection (ready-to-use disinfection wipes, preparation of the device and its compo- Dürr Dental)
  • Page 35: Preparation At The Operating Location

    Usage Comply with the concentration, temperature, Note the action time of the cleaning agent. ❯ ❯ residence time and post-rinsing specifications Protect the unit from contamination when ❯ issued by the manufacturer of the cleaning and transporting it from the treatment chair to the disinfectant agent.
  • Page 36: Manual Cleaning, Intermediate Rinsing, Disinfection, Final Rinse, Drying

    Usage 10.4 Manual cleaning, intermedi- 10.5 Automatic cleaning, interme- ate rinsing, disinfection, final diate rinsing, disinfection, rinse, drying final rinse, drying A disinfectant or combined cleaning and disinfec- Selection of the washer-disinfector tant agent is required for manual disinfection. It Automatic cleaning and disinfection requires a must have the following properties: washer-disinfector with the following properties...
  • Page 37: Steam Sterilising

    Usage 10.7 Steam sterilising Requirements placed on the steam steriliser: – Corresponds to EN 13060 or EN 285 and/or Packing ANSI AAMI ST79 For packaging of the components, use only ster- – Suitable programme for the products listed ile barrier systems made of transparent paper film (e.
  • Page 38: Cleaning

    Usage 11 Cleaning Dry clean the lens in the handpiece with com- ❯ pressed air or with a cotton bud (from the cleaning set). 11.1 Cleaning the optical element The optical element is located partly in the inter- changeable head and partly in the handpiece. NOTICE Damage of the optical element from incorrect cleaning...
  • Page 39: 12 Maintenance

    Usage 12 Maintenance 12.1 Replace the O-ring If the interchangeable head does not engage properly when placed on, the O-ring on the handpiece can be replaced. Replace the O-ring. ❯ 12.2 Firmware update Do not break the connection between the unit and computer while updating the firmware.
  • Page 40: Troubleshooting

    Troubleshooting Troubleshooting 13 Tips for operators and service technicians Any repairs exceeding routine maintenance may only be carried out by qualified personnel or our service. Error Possible cause Remedy Image cloudy, milky Hygienic protective cover not Place the hygienic protective ❯...
  • Page 41: Proof Interchangeable Head

    Troubleshooting Error Possible cause Remedy Moving image judders Insufficient computing power Reduce the image resolution. ❯ Use the computer in accor- ❯ dance with the system requirements (9000-618-148). USB driver not up to date Install the up-to-date USB Camera is not detected by the ❯...
  • Page 42 Troubleshooting Error Possible cause Remedy Image is too light or too dark Incorrect settings in the imaging Alter the brightness of the ❯ software image in the imaging soft- ware. Adapt the brightness in the ❯ configuration of the imaging software to change the bright- ness settings.
  • Page 43 Appendix Appendix 14 Handover protocol This document confirms the qualified handover and provision of instructions for the medical device from Dürr Dental. This must be carried out by a qualified adviser for the medical device, who will instruct you in the proper handling and operation of the medical device. Product name Order number (REF) Serial number (SN)
  • Page 44 Hersteller/Manufacturer: DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com...

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