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Instructions for use DIAGNOdent display 2191

3 Description of the product | 3.3 Symbols on product, packaging and rating plate

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Follow instructions for use

Follow the electronic instructions for use

HIBC Code

Certification

CE- mark (European Community). A product bearing this mark meets
the requirements of the applicable EC directives.

VDE mark

MET mark

EAC conformity mark (Eurasian Conformity)

Medical device, labelling of medical devices

Product characteristics

Manufacturer

Manufacturing date

Device type

Material number

Serial number

UDI symbol

IP 4X

IP 4X degree of protection against ingress of solid and liquid sub-
stances

+

Battery name

Do not dispose of with household waste

Transportation and storage conditions
(temperature range)

Transportation and storage conditions
(air pressure)

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Содержание DIAGNOdent 2191

Страница 1: ...Instructions for use DIAGNOdent display 2191 ...

Страница 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 ...

Страница 3: ...4 1 Insert batteries 15 5 Operation 18 5 1 Start up 18 5 2 Turn off 19 5 3 Display brightness 21 5 4 Volume 21 5 5 Battery charge display 22 5 6 Reception quality 22 5 7 Bar display of MOMENT and PEAK value 23 6 Maintenance 24 7 Reprocessing steps in accordance with ISO 17664 1 ISO 17664 2 25 7 1 Preparations at the site of use 25 7 2 Manual Reprocessing 25 7 2 1 Manual external cleaning 25 7 2 2 ...

Страница 4: ...y Repair using www kavobox com KaVo Technical Service If you have any technical questions or complaints please contact the KaVo Technical Service 49 0 7351 56 1000 service instrumente kavo com Target group The instructions for use are intended for medical professionals in particular dentists and dental practice personnel Abbreviations LCD Liquid Crystal Display IEC International Electrotechnical C...

Страница 5: ...jury and material damage The warning notes are designated as shown below HAZARD In cases which if not prevented directly lead to death or severe injury WARNING In cases which if not prevented can lead to death or severe injury CAUTION In cases which if not prevented can lead to minor or moderate injury CAUTION In cases which if not prevented can lead to material damage ...

Страница 6: ...epro cessing procedure is effective 4 Reprocess the product and accessories appropriately before disposal 2 2 Explosion hazard Electrical sparks in the product can lead to explosion or fire 4 Do not use the product in explosion hazard areas 2 3 Technical condition If damaged the device or components could injure patients users and third parties 4 Only operate devices or components if they show no ...

Страница 7: ...rised modifications of the device could lead to injury 4 Only use accessories that have been approved for combination with the product by the manufacturer 4 Only use accessories that are equipped with standardised interfaces 4 Do not make any modifications to the device unless these have been ap proved by the manufacturer of the product A damaged or leaking battery could injure patients users and ...

Страница 8: ...tached and injure patients users or third parties This may res ult in aspiration swallowing of parts and possibly even a risk of suffocation 4 Only use spare parts that comply with the specification for repair original KaVo spare parts comply with the specification NOTE If a repair is done with NON KaVo original spare parts this may constitute a product modification that leads to the loss of CE co...

Страница 9: ...play 2191 3 Description of the product 3 1 DIAGNOdent display 2191 9 32 3 Description of the product 3 1 DIAGNOdent display 2191 Infrared receiver Volume button ON OFF button Key to display brightness Table holder for DIAGNOdent pen 2190 ...

Страница 10: ...t ness levels possible temporary display Battery charge display Volume of the signal beep tem porary display Reception quality 3 2 Intended use General The overarching guidelines and or national laws national regulations and the rules of technology applicable to this product for putting into service and use of the KaVo product for the indications for use are to be applied and complied with ...

Страница 11: ...gers and users in Germany are obliged to operate their equipment in compliance with the medical device law MPG The main tenance services encompass all the test tasks required in accordance with 6 of the operator ordinance MPBetreiberV Product specific The DIAGNOdent display 2191 is only intended for dental treatment within the context of dentistry It is to be used in a dentist s office or dental c...

Страница 12: ...quirements of the applicable EC directives VDE mark MET mark EAC conformity mark Eurasian Conformity Medical device labelling of medical devices Product characteristics Manufacturer Manufacturing date Device type Material number Serial number UDI symbol IP 4X IP 4X degree of protection against ingress of solid and liquid sub stances Battery name Do not dispose of with household waste Transportatio...

Страница 13: ...6 AA Power consumption 120 mA Carrier frequency of the infrared re ceiver 38 kHz Protection class covered IP 4X Permissible Ambient temperature 10 C to 30 C Relative Humidity 30 RH to 75 RH 3 5 Transportation and storage conditions CAUTION Startup after refrigerated storage Malfunction 4 Prior to startup strongly refrigerated products must be allowed to warm up to a temperature of 20 C to 25 C 68 ...

Страница 14: ...e above men tioned obligations will mean that the damage will be considered 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 from transportation The shipment must be checked on arrival If the packaging is visibly damaged on delivery please proceed as follows ...

Страница 15: ...ury from electric current Electric shock 4 Do not use power supply units 4 Only supply the product with the prescribed voltage 4 1 Insert batteries CAUTION Risk of injury and material damage due to leaking batteries Risk of injury and material damage 4 Use leak proof batteries only 4 Remove the battery during long downtimes 4 Properly dispose of used batteries 4 Do not use rechargeable batteries 4...

Страница 16: ...ons for use DIAGNOdent display 2191 4 Startup 4 1 Insert batteries 16 32 4 Slide the DIAGNOdent display 2191 into the side of the table holder DIAGNOdent display 2191 push forwards in the direction of the arrow ...

Страница 17: ...Instructions for use DIAGNOdent display 2191 4 Startup 4 1 Insert batteries 17 32 ...

Страница 18: ...s followed by a self test of the DIAGNOdent display 2191 The DIAGNOdent display 2191 is ready to receive ð If data are not received within 0 4 sec appears in the MOMENT and PEAK displays Otherwise the current values appear Prerequisites ü The infrared transmitter in the DIAGNOdent pen 2190 must be switched on 4 When switching on hold the button for approx 6 seconds to run the display test travelli...

Страница 19: ... Operation 5 2 Turn off 19 32 5 2 Turn off 4 Press the ON OFF button for 5 seconds ð If no data is received within 90 seconds the DIAGNOdent display 2191 switches off by itself ð After 30 minutes the unit turns off even when data are being received ...

Страница 20: ...Instructions for use DIAGNOdent display 2191 5 Operation 5 2 Turn off 20 32 ...

Страница 21: ...ter 2 mm ð The display brightness can be set in 3 brightness levels ð If no infrared signals are sent the display goes dark to save energy ð If a button is pressed or signals are received the display returns to the pre viously set brightness 5 4 Volume 4 Press the volume button with a pin diameter 2 mm ð The volume can be turned off or set in three levels ...

Страница 22: ... quality Optimum infrared connection between DIAGNOdent pen 2190 and DIAGNOdent display 2191 Some data packages are missing Possible causes There is a 2 infrared transmitter in the room such as laptop with IrDA DIAGNOdent display 2191 is disturbed by a fluores cent light or a strong light source Distance is too great Further DIAGNOdent pen 2190 with IR data trans mission are switched on There are ...

Страница 23: ...NT and PEAK value 23 32 5 7 Bar display of MOMENT and PEAK value The MOMENT and PEAK values are displayed as a bar in addition to the numeric display The display range is 0 to 99 0 bottom mark 99 top mark The PEAK value is a narrow horizontal dash The MOMENT value is the bar height ...

Страница 24: ... of CE conformity In the event of damage the responsibility is with the service company or the operator The introduction of a modified product in the market in which the reasonable suspicion exists to endanger the safety and health of patients or users is pro hibited by Medical Device Law 4 Abs 1 No 1 and therefore requires its own conformity check The following persons are authorised to repair an...

Страница 25: ...rocess by hand only 7 2 1 Manual external cleaning 4 Clean all outer surfaces of the DIAGNOdent display 2191 with a cloth moistened with water and with one of the specified disinfectants if neces sary 4 Comply with the instructions of the disinfectant manufacturer 7 2 2 Manual internal cleaning This product is not designed for manual internal cleaning 7 2 3 Manual external disinfection CAUTION Nev...

Страница 26: ...e instructions for use of the disinfectant 7 2 4 Manual internal disinfection This product is not designed for manual internal disinfection 7 2 5 Manual drying This product is not designed for manual drying 7 3 Automated reprocessing This product is not suitable for automated reprocessing 7 4 Sterilisation This product is not designed for sterilisation ...

Страница 27: ...t pen 2190 is not in display mode e g a menu item has been selected NOTE Malfunction caused by the infrared data transmission Since the data is transmitted to the DIAGNOdent display 2191 by infrared light external influences can cause malfunctions Fluorescent lights can gen erate a similar signal that reduces the range This greatly depends on the type of fluorescent lamps and also the ballast Obse...

Страница 28: ... and must be subjected to special disposal within Europe For more information please visit www kavo com or contact your specialised dental dealers Final disposal in Germany To return an electrical device you need to proceed as follows 1 On the homepage www enretec de of enretec GmbH you can download a form for a disposal order under the menu item eom Download the disposal order or complete it as a...

Страница 29: ...use of other devices in the immediate vicinity of this product or placed on top of this product should be avoided as this may lead to faulty operation of the unit However if this kind of use were necessary regardless this device and the other devices should be monitored closely in order to make sure that they work properly WARNING Non approved accessories Electromagnetic interferences 4 The use of...

Страница 30: ...charge 2 4 8 15 kV Contact discharge 8 kV DIN EN 61000 4 3 VDE 0847 4 3 04 2011 HF emissions of digital mobile phones and other HF emitting devices 80 MHz 2700 MHz 3 V m High frequency electromagnetic fields in the immediate vicinity of wireless communication devices 385 MHz 27 V m 450 MHz 28 V m 710 745 780 MHz 9 V m 810 870 930 MHz 28 V m 1720 1845 1970 MHz 28 V m 2450 MHz 28 V m 5240 5500 5785 ...

Страница 31: ...liable for defects and consequences thereof that have arisen or may arise from natural wear improper handling cleaning servicing or main tenance non compliance with operating maintenance or connection instruc tions calcination or corrosion contaminated air or water supplies or chemical or electrical factors deemed abnormal or impermissible in accordance with the KaVo instructions for use or other ...

Страница 32: ...1 006 3975 bd 20230804 02 en ...

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