Contents Contents Macro Interchangeable head: . . . Proof interchangeable head ..Proxi interchangeable head ..Important information Handpiece holder ... . About this document .
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Contents 10.1 Risk analysis and categorisation . . 27 10.2 Reprocessing procedure in accordance with EN ISO 17664 . . 27 10.3 Preparation at the operating location ....10.4 Manual cleaning, intermediate rinsing, disinfection, final rinse,...
Important information Important information Wear protective gloves. About this document CE labelling These installation and operating instructions rep- resent part of the unit. Application part type B If the instructions and information in these installation and operating instructions are not followed, Dürr Dental will not be able Comply with the Operating Instructions.
Important information Safety Improper use Any other usage or usage beyond this scope is Dürr Dental has designed and constructed this deemed to be improper. The manufacturer unit so that when used properly and for the accepts no liability for damages resulting from intended purpose it does not pose any danger to this.
Important information If you have any questions about the correct ❯ NOTICE disposal of parts, please contact your dental trade supplier. Negative effects on the EMC due to non-authorised accessories Use only Dürr Dental parts or acces- ❯ sories specifically approved by Dürr Dental.
VistaCam iX for USB connection cable Proxi interchangeable heads (100x) . .2108010053 for VistaCam iX (2.5 m) ..2108-150-50 FD multi wipes compact Storage box for Surface disinfection ... CDF33FW0150 interchangeable heads .
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 Voltage 5 - 12 V DC Signal output USB 2.0 Camera electronics Type of protection IP20 Image sensor 1/4"...
Product description Proof interchangeable head Evaluation of conformity This device has been subjected to conformity Technical data acceptance testing in accordance with the cur- Illumination 4 LEDs rent relevant European Union guidelines. This Wavelength equipment conforms to all relevant requirements. Sharpness level Opening angle 68°...
Product description Operation VistaCam iX is an intraoral camera system and consists of a handpiece and various interchange- able heads. The function of the camera depends on the function of the interchangeable head. The interchangeable head is recognisable from the symbol on the rear.
Product description Cam interchangeable head Fig. 3: Mounting with Macro interchangeable head Fixed-focus optical element Proof interchangeable head The Cam interchangeable head has a fixed-focus optical element with a focus range that enables intraoral imaging. Eight LEDs are arranged around the optical ele- ment to ensure uniform illumination.
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Product description Substance Fluorescent colour Tooth structure (enamel, den- Green tine) Metabolites of cariogenic bac- teria (porphyrins) The spacer enables optimum analysable images. The position and the distance of the image are reproducible. In addition, the spacer screens off the image area and minimises the penetration of external light.
Optical system Proxi interchangeable head Capture ring Handpiece The VistaCam iX handpiece with the Proxi inter- changeable head creates a black and white Fig. 6: Case example 1 – Lesions in the mesial image for detecting caries in the approximal area are visible as a wide bright strip up to the region.
Product description The enamel appears brighter in patients with The storage box protects the interchangeable highly opaque enamel. The caries diagnosis is heads not placed on the camera from soiling and complicated here by the low difference in con- scratches. Up to five interchangeable heads can trast.
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.
Assembly Acceptance tests Electrical safety checks 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. 9000-618-176/30 1812V009...
Usage Remove the interchangeable head Usage Pull the interchangeable head off the hand- ❯ piece upwards. Operation NOTICE Damage to the camera from falling down or scratching Always place the camera in the hand- ❯ piece holder. Do not place the camera on a storage ❯...
Usage Start the imaging program, refer to the soft- Hold the disposable hygienic protective cover ❯ ❯ ware instruction (DBSWIN 2100-725-91, firmly on the white edge and pull off the trans- VistaEasy 9000-618-137). parent plastic side in the direction of the cam- era head.
Usage Place the spacer onto the interchangeable Taking an image with Cam ❯ head from above. Ensure that the spacer does and Macro interchangeable not cover the optical element of the inter- heads changeable head. If the camera is taken out of the handpiece holder, the camera shows a moving image (Live mode).
Usage Press on one point of the capture ring. Preparation ❯ The teeth must be prepared differently depending on the required analysis. For prophylaxis view: Do not clean the teeth professionally. ❯ For caries analysis: Carry out professional teeth cleaning. ❯...
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Usage Press on one point of the capture ring. ❯ Fig. 9: Caries view The colour scale and the numeric values provide reliable information on carious lesions: Healthy tooth enamel Alternatively, press the foot switch or the but- ❯ ton in the software. Initial caries, early stages of enamel caries The camera switches to "Freeze"...
Usage Record an image with Proxi Press on one point of the capture ring. The ❯ camera switches to "Freeze" mode. The freeze interchangeable head frame will be displayed in the imaging pro- gram / transmitted to the monitor. Positioning the unit correctly Edit the image using the imaging program and ❯...
Usage Switching off the camera Carefully pull off the hygienic protective cover ❯ and dispose of it. Disinfect the camera (see "9 Reprocessing of ❯ the device"). Place the camera in the handpiece holder. ❯ Result: The camera switches off automatically. Always store the camera with the inter- changeable head plugged on.
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-...
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.
Usage 10 Reprocessing the spacer Important information! The reprocessing notes in accordance 10.1 Risk analysis and categorisa- with EN ISO 17664 have been indepen- tion dently tested by Dürr Dental for the preparation of the device and its compo- A risk analysis and categorisation of medical nents for their reuse.
Usage The reprocessing procedure was validated as fol- Comply with the concentration, temperature, ❯ lows: residence time and post-rinsing specifications – Pre-cleaning issued by the manufacturer of the cleaning and – FD 322 premium wipes for quick-acting dis- disinfectant agent. infection (ready-to-use disinfection wipes, Only use cleaning agents that are non-fixing ❯...
Usage Note the action time of the cleaning agent. 10.4 Manual cleaning, intermedi- ❯ Protect the unit from contamination when ❯ ate rinsing, disinfection, final transporting it from the treatment chair to the rinse, drying reprocessing location. A disinfectant or combined cleaning and disinfec- tant agent is required for manual disinfection.
Usage 10.5 Automatic cleaning, interme- 10.7 Steam sterilising diate rinsing, disinfection, Packing final rinse, drying For packaging of the components, use only ster- ile barrier systems made of transparent paper film Selection of the washer-disinfector that are approved for use in steam sterilisation Automatic cleaning and disinfection requires a according to the manufacturer information.
Usage 11 Cleaning Requirements placed on the steam steriliser: – Corresponds to EN 13060 or EN 285 and/or ANSI AAMI ST79 11.1 Cleaning the optical element – Suitable programme for the products listed (e. g. with hollow bodies, fractionated vacuum NOTICE procedure in three vacuum steps) Damage of the optical element from...
Usage If particles can still be seen on the image, dry 12 Maintenance ❯ clean the interchangeable head from the inside The appliance is maintenance-free. with compressed air or with a foam rod (from the cleaning set). 11.2 Storage box Clean the surface of the storage box and the internal shelf in the event of contamination or visi- ble soiling and disinfect.
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 ❯...
Troubleshooting 13.1 Proof interchangeable head Error Possible cause Remedy Image contains a high amount Penetration of external light Check the position of the ❯ of red; healthy tooth sub- spacer (directly on the tooth). stance is not properly green Turn off or dim source of ❯...
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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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