KaVo DEXIS CariVu 3-in-1 Скачать руководство пользователя | Manualshive

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

3 Product description | 3.2 Symbols on product and rating plate

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3.2 Symbols on product and rating plate

①

Type plate

④

Date of manufacture

②

Serial number

⑤

Catalog number

③

HIBC Code

Accompanying documents

Please note the electronic instructions for use

Please note the instructions for use

Please note the instructions for use

HIBC Code

Certification

CE mark according to Medical Devices Directive EC 93/42

VDE mark

MET mark

Medical device, labeling of medical devices

Product characteristics

Legal Manufacturer

Date of manufacture (YYYY-MM-DD)

SN

Serial number (XXXXXXX)

REF

Catalog number (X.XXX.XXXX)

Type B applied part

Direct current

Operating mode: continuous operation with intermittent load

IP 44

Degree of protection against ingress of solid and liquid substances

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Содержание DEXIS CariVu 3-in-1

Страница 1: ...Instructions for use DEXIS CariVu 3 in 1 by KaVo...

Страница 2: ...Distributed by DEXIS LLC 1910 North Penn Road Hatfield PA 19440 USA Phone 1 888 883 3947 www dexis com Manufacturer KaVo Dental GmbH Bismarckring 39 88400 Biberach Germany www kavo com...

Страница 3: ...17 3 4 Technical Specifications 17 3 5 Delivery content 19 3 6 System components 20 3 7 Control panel 21 4 Installation of the wall mount 22 5 Startup and shut down 24 5 1 Recommended PC requirements...

Страница 4: ...disinfection 40 7 5 3 Automated drying 41 7 6 Care products and systems Servicing 41 7 7 Sterilization 41 7 8 Storage 42 8 Tools and consumables 43 9 Information concerning the electromagnetic compat...

Страница 5: ...umber of the product in all inquiries For repairs please contact KaVo Repair Service For scheduling or if you have any questions please contact KaVo Repair Service KaVo Dental Technologies LLC 11727 F...

Страница 6: ...neral marks and symbols See Chapter on User Instructions Hazard Levels Important information for users and service technicians Action request CE mark European Community A product bearing this mark mee...

Страница 7: ...safety notes in this document must be observed to prevent personal injury and property damage The warning notes are designated as shown below DANGER In cases which if not prevented directly lead to de...

Страница 8: ...have arisen only after the time of delivery in accordance with the General German Freight Forwarders Terms and Conditions Art 28 Outside Germany Note KaVo shall not be held liable for damage arising...

Страница 9: ...th respect to compensation are excluded In the event of default and gross negli gence or intent this shall only apply in the absence of mandatory legal regula tions to the contrary KaVo shall not be h...

Страница 10: ...g is effective Process the product and accessories appropriately before disposal 2 2 Technical condition A damaged device or components can injure patients users and third parties Visually inspect the...

Страница 11: ...ds the national and re gional regulations Only employ the device if the user has the appropriate medical training 2 5 Electrical shock Damage or connection to external devices can lead to electrical s...

Страница 12: ...itute 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 The introduction into the market of a modifie...

Страница 13: ...equipped with an autofocus mechanism which will provide a sharp representation of the tooth which is placed in the center of the image The autofocus provides the ability to have sharp images from clo...

Страница 14: ...le 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 store the d...

Страница 15: ...restricts this device to sale by or on the order of a healthcare professional dentist For dental use only Proper Use According to these regulations this product may only be used for the described appl...

Страница 16: ...note the instructions for use Please note the instructions for use HIBC Code Certification CE mark according to Medical Devices Directive EC 93 42 VDE mark MET mark Medical device labeling of medical...

Страница 17: ...013 1700 Cable length 1 30 m 3 4 Technical Specifications Complete system Power consumption max 0 5 A Supply voltage 5 V Cable length standard 2 5 m Weight 190 g Length standard 255 mm Diameters appro...

Страница 18: ...re 10 to 30 o C Air pressure 800 to 1060 hPa Rel humidity 5 to 95 non condensing Operating altitude max 2000 m Operating environment Permissible installation sites Indoor premises portable Pollution d...

Страница 19: ...le holder Camera Wall mount Control panel Sheath 100 pieces 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...

Страница 20: ...er Fluorescence Cover is used in Fluorescence mode See also 2 6 4 2 Fluorescence mode Page 30 Sheaths The sheaths are used for infection prevention Table holder The table holder is to be placed on the...

Страница 21: ...cording Status LED indicating the current status of the camera Blue Standby mode White Camera is active Red Error Buttons for navigation in the imag ing software e g numbered tooth chart if available...

Страница 22: ...osition using the wall mount Drill holes with a diameter of 6 mm insert the dowels and screw the wall mount tight with screws Gluing the wall mount to a wall NOTICE No secure hold of camera and wall m...

Страница 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...

Страница 24: ...8 GB memory is recommended Hard Disk 16 GB of free disk space is rec ommended 16 GB of free disk space is rec ommended Display Full HD 1920 1080 or higher Full HD 1920 1080 or higher e g 1920 1200 Gra...

Страница 25: ...the control panel Removal of the camera from the table holder or wall mount 6 2 Use a sheath Apply the sheath WARNING Risk of infection due to soiled or contaminated camera Infection Always use the ca...

Страница 26: ...d exactly over the ex posure window of the camera This enables sharp imaging Tighten the clear view window in front of the exposure window of the cam era Note In event of bad image quality or milky di...

Страница 27: ...p can lead to damage on the camera and the tip Make sure that the contours of the camera align with those of the tip Do not force the tip to snap in Do not slide the tip in axial direction Before the...

Страница 28: ...ress off the tip at the predetermined recess and do not touch it by the soft silicone legs 6 4 Recording images 6 4 1 Intraoral mode CAUTION Possibly hazardous optical radiation emitted from product R...

Страница 29: ...heath first before use the camera See also 2 6 2 Use a sheath Page 25 The recording window of the imaging software shows a live image Select Intraoral mode still image or video in the imaging software...

Страница 30: ...s In this mode the DEXIS CariVu 3 in 1 by KaVo camera records images in the fluorescence range for the detection of occlusal caries For homogeneous illumination LEDs are provided at the lens system wh...

Страница 31: ...e a sheath Page 25 To be able to capture an optimum image the fluorescence cover needs to be fully plugged onto the camera This prevents the ingress of extraneous light and is an additional aid for si...

Страница 32: ...screen In this mode the DEXIS CariVu 3 in 1 by KaVo camera records images in tran sillumination for the detection of occlusal caries proximal caries secondary caries and cracks Proximal caries Occlusa...

Страница 33: ...tip The recording window of the imaging software shows a live image Select an image detail The camera has a fixed focus in this mode Press one of the two trigger buttons The camera switches to Freeze...

Страница 34: ...ove the camera from the camera holder Select Fluorescence mode still image or video in the imaging software or with the menu button Select an image detail The camera automatically focuses the selected...

Страница 35: ...ws the Intraoral mode exclusively Select an image detail The camera automatically focuses the selected image detail permanent autofocus Press one of the two trigger buttons The camera switches to Free...

Страница 36: ...zed by the camera Position the camera to get live video of the selected tooth Look for similar horizontal alignment of the tooth by moving the device hor izontally Adjust the device alternately mesial...

Страница 37: ...es No No No Wall Mount Vision Full HD Multi Person use Yes Yes No No No Sheath Vision Full HD Single Use No No No No No 7 2 Preparations at the site of use WARNING Hazard from contaminated products Co...

Страница 38: ...F or until the part is visually clean Clean gently since excessive force may damage the camera Do not bend the silicone legs of the tip apart during manual cleaning Visually inspect if the part looks...

Страница 39: ...n the medical device and allow the disinfectant to act in accordance with the instructions of the disinfectant manufacturer Comply with the instructions for use of the disinfectant Do not bend the sil...

Страница 40: ...which are operated using alkaline cleaning agents The validations were conducted with the VARIO TD program the cleaning agent neodisher MediClean forte and the neutralisation agent neodisher Z For pro...

Страница 41: ...age must be large enough for the product so that the packaging is not stretched The quality and use of the sterilization packaging must comply with applica ble standards and be suitable for the steril...

Страница 42: ...er 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 7 8 Storage Processed products must be stored protected from bac...

Страница 43: ...hich illuminates the tooth from the sides The Tip Vision Full HD is fully repro cessable The Tip Vision Full HD is provided in a 1 pc package as well as in a 4 pcs package 1 013 5709 Fluorescence Cove...

Страница 44: ...Vision Full HD has a back plate which can be fixed to a surface by using the at tached tape or by using screws The main body is also equipped with a magnet inside This magnet can be detected by the m...

Страница 45: ...mission of the device is very low and interference with adja cent electronic devices is unlikely HF emissions according to CISPR 11 Class B The DEXIS CariVu 3 in 1 by KaVo is suitable for use in all e...

Страница 46: ...ccording to EN 61000 4 2 8 kV contact discharge 15 kV atmospheric discharge 8 kV contact discharge 2 4 8 15 kV atmo spheric discharge Floors should be made of wood or concrete or be fitted with cerami...

Страница 47: ...stationary wireless radio transmitters as measured locallyc should be lower than the conformance level at all frequencies d Interference is possible in the vicinity of devices bearing the following ic...

Страница 48: ...XIS CariVu 3 in 1 by KaVo is intended for use in an electromagnetic en vironment in which the HF interference parameters are controlled The cus tomer or the user of the DEXIS CariVu 3 in 1 by KaVo can...

Страница 49: ......

Страница 50: ...1 013 7129 bd 20220323 06 en US...

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