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KaVo DIAGNOcam Vision Full HD, Instructions For Use Manual

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KaVo DIAGNOcam Vision Full HD Instructions For Use Manual Download Page 39

Instructions for use DIAGNOcam Vision Full HD

7 Reprocessing steps in accordance with ISO 17664 | 7.4 Manual Reprocessing

▶

Spray the disinfectant on a cloth, then wipe down the medical device and
allow the disinfectant to act according to the instructions of the
disinfectant manufacturer.

▶

Follow the instructions for use of the disinfectant.

▶

Do not bend the silicone legs of the tip apart during manual disinfection.

7.4.4 Manual internal disinfection

This product is not designed for manual internal disinfection.

7.4.5 Manual drying

This product is not designed for manual drying.

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Summary of Contents for DIAGNOcam Vision Full HD

Page 1: ...Instructions for use DIAGNOcam Vision Full HD...

Page 2: ...Distributed by KaVo Dental GmbH Bismarckring 39 88400 Biberach Germany Phone 49 7351 56 0 Fax 49 7351 56 1488 Manufacturer KaVo Dental GmbH Bismarckring 39 88400 Biberach Germany www kavo com...

Page 3: ...ended use 15 3 2 Symbols on product and rating plate 16 3 3 Product configurations 17 3 4 Technical Specifications 17 3 5 Scope of delivery 19 3 6 System components 20 3 7 Control panel 21 4 Installat...

Page 4: ...42 8 1 Foot Control Vision Full HD 42 8 1 1 Indications for use foot control 42 8 1 2 Function description foot control 42 8 1 3 Explanation of symbols foot control 42 8 1 4 Technical Specifications...

Page 5: ...ect all questions regarding the product service and maintenance to the following addresses Please refer to the serial number of the product in all inquiries Service Hotline 49 7351 56 2700 Service Mul...

Page 6: ...Mount Vision Full HD General marks and symbols See Chapter on User Instructions Hazard Levels Important information for users and service technicians Action request CE mark European Community A produc...

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

Page 8: ...nsidered to have arisen following delivery in accordance with the General German Freight For warders Terms and Conditions Art 28 Outside Germany Note KaVo shall not be held liable for damage arising f...

Page 9: ...orementioned Directive and must be subjected to special disposal within Europe For more information please visit www kavo com or contact your specialised dental dealers For final disposal In Germany T...

Page 10: ...ross negli gence or intent this shall only apply in the absence of mandatory legal regula tions to the contrary KaVo cannot be held liable for defects and their consequences due to natural wear improp...

Page 11: ...cess the product and accessories appropriately before disposal 2 2 Technical condition A damaged device or components could injure patients users and third parties Only operate devices or components i...

Page 12: ...ppropriate medical training 2 5 Electrical shock Damage or connection to external devices can lead to electrical shock and in jury to patient user and third parties Make sure that the product is undam...

Page 13: ...s 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 modified product where there is reas onable s...

Page 14: ...mages and videos to support the diagnosis of caries mainly in the occlusal area and plaque by means of fluorescent images 3 Transillumination mode The camera can only be used with a tip This mode is u...

Page 15: ...DIAGNOcam Vision Full HD is designed for use by a trained profes sional in the field of dentistry Proper use According to these regulations this product may only be used for the described application...

Page 16: ...ote 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 labelling of medical...

Page 17: ...13 1500 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 Diameter approx...

Page 18: ...10 to 30 o C Air pressure 800 to 1060 hPa Rel humidity 5 to 95 non condensing Max altitude for operation max 2000 m Operating environment Permissible installation sites Indoor use portable Degree of s...

Page 19: ...iece Table holder Camera Sheath 100 pieces Control panel The USB cable is used to connect the camera to the computer and to send the captured image to the imaging software The DIAGNOcam Vision Full HD...

Page 20: ...e Page 31 Sheaths The sheaths are used for infection prevention Foot control The foot control can be used as an alternative to the trigger button on the control panel of the camera Briefly touching th...

Page 21: ...bottom side of the camera 2 1 2 3 4 Trigger button for capturing an im age and or for starting stopping the video recording Status LED indicating the current status of the camera Blue Standby mode Wh...

Page 22: ...sired position using the wall mount Drill holes with a diameter of 6 mm insert the dowels and screw the wall mount tight with screws Glue on the wall mount NOTICE No secure hold of camera and wall mou...

Page 23: ...Instructions for use DIAGNOcam Vision Full HD 4 Installation of the wall mount Slide the wall bracket onto the mounting rail and place the DIAGNOcam Vision Full HD in the wall mount 23 52...

Page 24: ...more information please contact KaVo www kavo com or your special ised dental dealer 5 1 Recommended PC requirements PC Mac Operating system Windows 64 bit Windows 10 macOS High Sierra macOS Sierra O...

Page 25: ...l HD 5 Startup and shut down 5 2 Installation and software start up 5 2 Installation and software start up Note For software installation and start up note the installation instructions and in structi...

Page 26: ...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 c...

Page 27: ...y 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 display th...

Page 28: ...the tip 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 Befor...

Page 29: ...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 by product Risk of...

Page 30: ...e sheath first before use the camera See also 2 6 2 Use a sheath Page 26 The recording window of the imaging software shows a live image Select Intraoral mode still image or video in the imaging softw...

Page 31: ...ence range for the detection of occlusal caries For homogeneous illumination LEDs are provided at the lens system which are blue in this mode This light excites the dental hard substance and the metab...

Page 32: ...ble 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 simple positioning of the ca...

Page 33: ...this mode the DIAGNOcam Vision Full HD camera records images in transil lumination for the detection of occlusal caries proximal caries secondary caries and cracks Proximal caries Occlusal caries Sec...

Page 34: ...h the 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 F...

Page 35: ...the camera holder Select combined Intraoral 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...

Page 36: ...tion mode still image in the imaging software or with the menu button The live image shows the Intraoral mode exclusively Select an image detail The camera automatically focuses the selected image det...

Page 37: ...ull HD Multi Person use Yes Yes No No No Foot Control 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 Hazar...

Page 38: ...ual cleaning 7 4 2 Manual internal cleaning This product is not designed for manual internal cleaning 7 4 3 Manual external disinfection WARNING Incomplete disinfection Infection hazard Only use disin...

Page 39: ...d allow the disinfectant to act according to the instructions of the disinfectant manufacturer Follow the instructions for use of the disinfectant Do not bend the silicone legs of the tip apart during...

Page 40: ...d internal and external disinfection KaVo recommends washer disinfectors according to EN ISO 15883 1 which are operated using alkaline cleaning agents having a maximum pH value of 11 The validation wa...

Page 41: ...ove the product from the steam steriliser after the sterilisation cycle The KaVo medical device has a maximum temperature resistance up to 138 280 4 F Sterilisation parameters Select a suitable proces...

Page 42: ...Vision Full HD 8 1 1 Indications for use foot control The foot control is a foot control with tactile function for the wireless transmis sion of a switching pulse or switching signal The transfer take...

Page 43: ...g ele ment EN 60529 2014 Data receiver Operating voltage Ue 5 V DC Transmission Bluetooth 4 0 Low Energy Switching function Momentary Connector Via USB Port Range Safe contact up to 10 m with direct v...

Page 44: ...insert replace To start up the transmitter or replace the battery remove the 4 screws in the bottom of the foot control Remove bottom cover Insert the AAA batteries paying attention to the correct po...

Page 45: ...lisation proced ures steam gamma or e beam Periodically visually inspect the housing shell for integrity 8 1 8 Terms of Use foot control The foot control may not be altered without the manufacturer s...

Page 46: ...emission of the device is very low and interference with adja cent electronic devices is unlikely HF emissions according to CISPR 11 Class B The DIAGNOcam Vision Full HD is suitable for use in all equ...

Page 47: ...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 ceramic tiles If the...

Page 48: ...reless radio transmitters as measured locallyc should be lower than the conformance level at all frequencies d Interference is possible in the vi cinity of devices bearing the fol lowing icon Note 1 A...

Page 49: ...Full HD is intended for use in an electromagnetic envir onment in which the HF interference parameters are controlled The customer or the user of the DIAGNOcam Vision Full HD can help prevent electro...

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