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

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Durr Dental VistaCam iX HD Smart Installation And Operating Instructions Manual Download Page 14

Electromagnetic compatibility (EMC)
Interference immunity tests

Emitted HF distur-
bance variables in
accordance with
IEC 61000-4-3

Compliant

Connection cable

Cable length

cm

250

4.6

Ambient conditions

Ambient conditions during operation

Temperature

°C

10 to 40

Relative humidity

%

20 to max. 75

Air pressure

hPa

700 - 1060

Ambient conditions during storage and
transport

Temperature

°C

-15 to +60

Relative humidity

%

max. 90

Air pressure

hPa

700 - 1060

4.7

Type plate

The type plate is located on the cable:

4.8

Evaluation of conformity

This device has been subjected to conformity
acceptance testing in accordance with the cur-
rent relevant European Union guidelines. This
equipment conforms to all relevant requirements.

Product description

12

2109100026L02 1907V001

EN

Summary of Contents for VistaCam iX HD Smart

Page 1: ...EN VistaCam iX HD Smart Installation and operating instructions 2109100026L02 2109100026L02 1907V001 ...

Page 2: ......

Page 3: ...ndpiece holder with USB hub optional 11 4 6 Ambient conditions 12 4 7 Type plate 12 4 8 Evaluation of conformity 12 5 Operation 13 5 1 Cam interchangeable head 14 5 2 Proof interchangeable head 14 5 3 Proxi interchangeable head 16 5 4 Handpiece holder 17 5 5 Handpiece holder with USB hub optional 17 5 6 Storage box 17 Assembly 6 Installation 18 6 1 Installing the handpiece holder 18 7 Commissionin...

Page 4: ...t the operating location 33 10 4 Manual cleaning intermediate rinsing disinfection final rinse drying 34 10 5 Automatic cleaning intermediate rinsing disinfection final rinse drying 34 10 6 Check for function 34 10 7 Steam sterilising 35 10 8 Issue clearance for the parts for sterilisation 35 10 9 Storing parts for sterilisation 35 11 Cleaning 36 11 1 Cleaning the optical element 36 11 2 Storage b...

Page 5: ...g symbols are used General warning symbol The warnings are structured as follows SIGNAL WORD Description of the type and source of danger Here you will find the possible conse quences of ignoring the warning Follow these measures to avoid the danger The signal word differentiates between four levels of danger DANGER Immediate danger of severe injury or death WARNING Possible danger of severe injur...

Page 6: ...l camera generates an optical image of the oral cavity or face of the patient Intraoral camera with Cam interchangeable head The intraoral camera with Cam interchangeable head is used in or next to the oral cavity of the patient The images aid with diagnosis provide information for the patient and are used for instruction Intraoral camera with Proof interchangeable head The intraoral camera with P...

Page 7: ...r teeth with exces sively large fillings The device only works together with natural enamel in the mouth of the patient After extraction teeth can no longer be analysed with the Proxi head 2 6 General safety information Always comply with the specifications of all guidelines laws and other rules and regula tions applicable at the site of operation for the operation of this unit Check the function ...

Page 8: ...es Note that cable lengths and cable extensions have effects on electromagnetic compatibility The following accessories can have an effect on the electromagnetic compatibility Handpiece holder with USB hub 2109105051 NOTICE Negative effects on the EMC due to non authorised accessories Use only Dürr Dental parts or acces sories specifically approved by Dürr Dental Using any other accessories may re...

Page 9: ...e Only transport the unit in its original packaging Keep the packing materials out of the reach of children 2 14 Disposal Unit The unit must be disposed of properly Within the European Union the unit must be disposed of in accordance with EU Directive 2012 19 EU WEEE If you have any questions about the correct disposal of parts please contact your dental trade supplier An overview of the waste key...

Page 10: ...g 17 x 1 5 mm 2 pieces Microfibre cloth Quick start instructions VistaSoft imaging software DVD DBSWIN imaging software DVD VistaCam iX HD Smart with Cam and Proof package 2109100002 Handpiece Cam interchangeable head Proof interchangeable head Storage box for interchangeable heads Handpiece holder Hygienic protective covers 20 pieces Spacers 5 pieces O ring 17 x 1 5 mm 2 pieces Microfibre cloth Q...

Page 11: ...05051 3 4 Consumables The following materials are consumed during operation of the device and must be ordered separately Hygienic protective covers for VistaCam iX HD Smart 500x 2109010050 Hygienic protective covers for VistaCam iX HD Smart 100x 2109010052 Spacers for VistaCam iX HD Smart 5x 2109132050 FD multi wipes compact Surface disinfection CDF33FW0150 FD 333 forte wipes Quick acting disinfec...

Page 12: ... accordance with IEC 61000 4 2 Compliant Magnetic field for a supply frequency 50 60 Hz in accordance with IEC 61000 4 8 Compliant Electromagnetic compatibility EMC Interference immunity tests Emitted HF disturbance variables in accordance with IEC 61000 4 3 Compliant Camera electronics Image sensor 1 3 CMOS Number of image points sensor MPix el 1 31 Max pixels effec tive PC 1280 x 1024 Video code...

Page 13: ...the power supply unit Electrical frequency Hz 47 63 Max nominal cur rent A 0 5 Output voltage V DC 12 Max output volt age fluctuations 1 Output current A 0 5 Rated power W 6 Electromagnetic compatibility EMC Interference emission measurements High frequency emissions in accor dance with CISPR 11 Group 1 Class B Harmonics in acc with IEC 61000 3 2 Not applicable Voltage fluctua tions flickers in ac...

Page 14: ... 20 to max 75 Air pressure hPa 700 1060 Ambient conditions during storage and transport Temperature C 15 to 60 Relative humidity max 90 Air pressure hPa 700 1060 4 7 Type plate The type plate is located on the cable 4 8 Evaluation of conformity This device has been subjected to conformity acceptance testing in accordance with the cur rent relevant European Union guidelines This equipment conforms ...

Page 15: ...the focus button Still images and video recordings can be created with the camera The function of the trigger but ton is dependent of the recording mode in the imaging software still image or video In the Still Image mode the camera switches between Live mode moving image and Freeze mode still image In Video mode the recording starts or stops Pressing the trigger button causes the camera to vibrat...

Page 16: ...etection of caries plaque and calculus Two LEDs are positioned around the optical ele ment with blue violet light wavelength 405 nm The energy rich light causes the tooth structure enamel dentine and the metabolites cariogenic bacteria porphyrins to fluoresce The sub stances emit different colours This makes it pos sible to analyse caries activity and detect poten tial tooth disease Substance Fluo...

Page 17: ... The images are analysed by the imaging software with the help of a filter The prophylaxis view shows the original image Fig 2 Prophylaxis view The caries view analyses the fluorescence of the substances with the caries filter Fig 3 Caries view The colour scale and the numeric values provide reliable information on carious lesions 1 0 Healthy tooth enamel 1 5 Initial caries early stages of enamel ...

Page 18: ... the VistaSoft imaging software Evaluation 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 It is possible to make out to following structures Healthy enamel appears very dark high translucency Approximal caries appears bright low translu...

Page 19: ...nce between the camera and computer 1 2 3 4 1 USB connection for camera or USB stick 2 USB connection for camera or USB stick 3 Connection for power supply unit 4 Micro USB connection for computer The camera is connected to the handpiece holder An additional USB connection is available e g to connect a USB stick The camera switches off automatically when placed in the handpiece holder The camera s...

Page 20: ...ectly after connec tion The installation of a device driver is not nec essary The unit has no main power switch Ensure that the USB connection on the computer and if necessary the hand piece holder with USB hub are easily accessible and that the unit can be unplugged if necessary Connect the USB connection cable to a com puter USB connection socket If the USB cable is to be extended use an USB rep...

Page 21: ...directly The following unit settings can be made in the configuration of the imaging software Standby settings Standby time Time until automatic switch off if the camera is not moved Preset 2 minutes Acquisition settings Camera trig gering The time at which the focus and the image acquisition are executed when pressing the focus button or the trigger but ton Upon pressing preset Upon releasing Sel...

Page 22: ...he function when pressing pre set Settings Image export Each image is automatically copied to a defined path The path file format and other set tings are set in the Light Table module 7 5 Configure the appliance in VistaConfig for VistaEasy Start VistaConfig via Start All Programs Duerr Dental VistaConfig VistaCamCon fig The camera is detected and activated auto matically The registration card Set...

Page 23: ...lug into the power outlet Connect the handpiece holder with the USB cable with the computer Connect the connection cable of the camera in the USB connection of the handpiece holder 7 7 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 i...

Page 24: ...The following interchangeable heads are available Cam interchangeable head Proof interchangeable head Proxi interchangeable head Remove the interchangeable head Pull the interchangeable head off the hand piece upwards Place on the interchangeable head Requirements ü The handpiece and interchangeable head are completely dry Slide the interchangeable head onto the hand piece rotate if necessary unti...

Page 25: ...ully press the disposable hygienic protec tive cover against the optical window using your fingers Ensure that there are no air bub bles between the optical window and the dis posable hygienic protective cover Hold the disposable hygienic protective cover firmly on the white edge and pull off the trans parent plastic side in the direction of the cam era head Pull off the paper underside from the c...

Page 26: ...rchangeable head When imaging with the Proof interchangeable head two views are possible in the imaging soft ware Prophylaxis view This provides an informative overview of the status of oral hygiene Caries view It evaluates the fluorescence of the sub stances and provides a reliable diagno sis of carious lesions based on the colours The following factors can affect the fluo rescence and hence the ...

Page 27: ...ng software Edit the image in the imaging software and save For further information refer to the soft ware manual Analyse the image see Analyse the image To switch back to Live mode press the trigger button again Analyse the image The prophylaxis view shows the original image Red areas indicate caries causing bacteria The healthy enamel is shown as green areas Fig 6 Prophylaxis view The caries vie...

Page 28: ...eth Place the spacer vertically on the tooth surface The spacer must come into contact with the teeth Ensure that the relevant approximal area is located in the centre of the image section If the structure underneath the enamel is not visible change the angle of the camera slightly Record an image Requirements ü Camera connected with the computer ü Imaging software started ü Camera in hygienic pro...

Page 29: ...e image 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 It is possible to make out to following structures Healthy enamel appears very dark high translucency Approximal caries appears bright low translu cency Dentine appears bright low t...

Page 30: ...changeable head plugged into the hand piece holder WARNING Danger due to re use of products intended for single use The disposable item is damaged after use and cannot be reused Dispose of disposable items after use Carefully pull off the hygienic protective cover and discard it Disinfect the camera see 9 Reprocessing of the device Place the camera in the handpiece holder Result The camera switche...

Page 31: ...sible for ensuring the reprocessing performed using the equipment materials and personnel achieves the desired results This requires validation and rou tine monitoring of the reprocessing pro cess Any deviation from the instructions described herein by the staff preparing the equipment could lead to lower effec tiveness and possible negative conse quences these lie solely with the staff responsibl...

Page 32: ...er and dispose of it Clean the device with a disposable wipe soaked in cold tap water until no more dirt or contamination can be seen Protect the unit from contamination when transporting it from the treatment chair to the reprocessing location 9 4 Manual pre cleaning clean ing disinfection and drying NOTICE Damage to the device due to incorrect cleaning and disinfection Only clean the surface of ...

Page 33: ...ection Prevention Accessories of the medical device are also sub ject to reprocessing Classification recommendation given intended use of the product semi critical B Semi critical medical product A medical product which comes into contact with mucous membrane or pathologically affected skin The operator is responsible for correct classifica tion of the medical products defining the repro cessing s...

Page 34: ...r Dental Manual cleaning ID 215 enzymatic instrument cleaner Dürr Dental Cleaning brush Manual disinfection ID 213 Instrument disinfection Dürr Dental Automatic cleaning and disinfection Was performed in accordance with EN ISO 15883 with tested efficacy Cleaning agent Neodisher MediClean Forte RDG G 7836 CD Miele Gütersloh Programs Cleaning without neutralisation and D V MEDFORTE Steam sterilisati...

Page 35: ...teria Use clean dry oil and particle free com pressed air Do not exceed temperatures of 138 C Subject all devices used ultrasonic bath cleaning and disinfection device CD sealing device steam steriliser to regular maintenance and inspections 10 3 Preparation at the operating location Wear protective gloves Wear protective goggles Use a mask Use protective clothing WARNING Risk of infection from co...

Page 36: ...essary re dry at a clean location using a hygienic lint free cloth Blow dry the components with compressed air in a clean location 10 5 Automatic cleaning interme diate rinsing disinfection final rinse drying Selection of the washer disinfector Automatic cleaning and disinfection requires a washer disinfector with the following properties and validated processes Corresponds to and tested in accord...

Page 37: ...ts placed on the steam steriliser Corresponds to EN 13060 or EN 285 and or ANSI AAMI ST79 Suitable programme for the products listed e g with hollow bodies fractionated vacuum procedure in three vacuum steps Sufficient product drying Validated process in accordance with ISO 17665 valid IQ OQ and product specific per formance appraisal PQ Perform the following steps Sterilise the parts for sterilis...

Page 38: ...th a foam rod from the cleaning set Dry clean the lens in the handpiece with com pressed air or with a cotton bud 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 Use the following cleaning materials for the stor age box ü FD 366 sensitive disinfectant for sensitive sur faces Use the f...

Page 39: ...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 Click on Select firmware file Result The firmware is updated The process can take several minutes Usage 2109100026L02 1907V001 37 EN ...

Page 40: ...Image too dark LEDs defective Replace the interchangeable head No image USB connection cable not con nected Connect the USB connection cable USB connection cable incor rectly lengthened Use the USB repeater or handpiece holder with USB hub to lengthen the connec tion cable see 3 3 Optional items Computer not switched on soft ware not started Switch on the computer and start the software Camera dri...

Page 41: ... contains a high amount of red healthy tooth sub stance is not properly green Penetration of external light Check the position of the spacer directly on the tooth Turn off or dim source of external light e g operating light darken the room 13 2 Proxi interchangeable head Error Possible cause Remedy Image is tool light in a specific region The angle of the camera to the tooth is not ideal Change th...

Page 42: ...ation of the imaging software to change the bright ness settings Too many reflections in the image Saliva in the mouth Dry the row of teeth with a cloth or compressed air Change the holding angle of the camera lightly Teeth with large surface fillings and a small surface with intact enamel in the image section This image does not permit exact analysis Troubleshooting 40 2109100026L02 1907V001 EN ...

Page 43: ...ber REF Serial number SN o Visual inspection of the packaging for any damage o Unpacking the medical device and checking for damage o Confirmation of the completeness of the delivery o Instruction in the proper handling and operation of the medical device based on the operating instructions Notes Name of person receiving instruction Signature Name and address of the qualified adviser for the medic...

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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