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Immunity to interference, line-conducted

disturbances induced by high-frequency fields –

SIP/SOP ports
IEC 61000-4-6:2013
3 V
0.15 - 80 MHz
6 V
ISM frequency bands
0.15 - 80 MHz
80 % AM at 1 kHz

Compliant

2.2.2 Imaging plate

Classification

Medical Device Class (MDR) IIa

Ambient conditions during operation

Temperature °C 18 - 45
Relative humidity % < 80

Ambient conditions during storage and transport

Temperature °C < 45
Relative humidity % < 80

Dimensions of intraoral imaging plates

Size 0: 22 x 35 mm
Size 1: 24 x 40 mm
Size 2: 31 x 41 mm

2.2.3 Light protection cover

Classification

Medical Device Class (MDR) I

2 Product description

14 KaVo ProXam iP

Instructions for use

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Содержание ProXam iP

Страница 1: ...KaVo ProXam iP Instructions for use EN ...

Страница 2: ... to the appropriate requirements such as IEC 60364 equipment is used according to the operating instructions Planmeca pursues a policy of continual product development Although every effort is made to produce up to date product documentation this publication should not be regarded as an infallible guide to current specifications We reserve the right to make changes without prior notice COPYRIGHT P...

Страница 3: ... the Internet 7 2 Product description 8 2 1 Overview 8 2 1 1 Scope of delivery 8 2 1 2 Accessories 9 2 1 3 Optional articles 9 2 1 4 Consumables 9 2 1 5 Wear parts and replacement parts 10 2 2 Technical data 10 2 2 1 Imaging plate scanner 10 2 2 2 Imaging plate 14 2 2 3 Light protection cover 14 2 2 4 Type plate 15 2 2 5 Evaluation of conformity 15 2 2 6 Distributor and manufacturer 15 2 3 Operati...

Страница 4: ...6 4 2 5 Switching off unit 48 4 3 Cleaning and disinfection 48 4 3 1 Imaging plate scanner 49 4 3 2 Light protection cover 50 4 3 3 Imaging plate 50 4 3 4 Storage box with imaging plate storage tray 50 4 4 Maintenance 51 4 4 1 Recommended maintenance schedule 51 5 Troubleshooting 52 5 1 Tips for operators and service technicians 52 5 1 1 Poor X ray image 52 5 1 2 Software errors 58 5 1 3 Unit faul...

Страница 5: ...t an orderable number For the respective order number see KaVo sales catalogue 1 1 1 Warnings cautions and notes The warnings cautions and notes in this Instructions for use are structured as follows SIGNAL WORD Description of the type and source of danger Here you will find the possible consequences of ignoring the warning Follow these measures to avoid the danger The signal word differentiates b...

Страница 6: ...uctions for use Comply with the operating instructions Wear protective gloves Switch off and de energise the unit e g unplug from mains Do not reuse Health Industry Bar Code HIBC Direct current DC Non ionizing electromagnetic radiation This way up store and transport in an upright position Keep dry Stacking limits 1 Important information 2 KaVo ProXam iP Instructions for use ...

Страница 7: ...ructed this unit so that when used properly and for the intended purpose it does not pose any danger to people or property Despite this the following residual risks can remain Personal injury due to incorrect use misuse Personal injury due to mechanical effects Personal injury due to electric shock Personal injury due to radiation Personal injury due to fire Personal injury due to thermal effects ...

Страница 8: ...sage The user bears the sole risk KaVo ProXam iP This unit is not suitable for monitoring patients over longer periods of time This unit must not be operated in operating theatres or similar rooms in which dangers may arise from the combustion of flammable materials Light protection cover Especially The multiple use of this accessory and reprocessing contrary to the instructions of the manufacture...

Страница 9: ... taken into account Do not operate the unit in the vicinity of HF surgical instruments or MRT equipment Maintain a minimum distance of at least 30 cm between the unit and other electronic devices Keep a minimum distance of 30 cm between the unit and mobile radio devices Note that cable lengths and cable extensions have effects on electromagnetic compatibility No maintenance measures are required t...

Страница 10: ...cement parts e g mains cable can have a negative effect in terms of electrical safety and EMC 1 2 10 Transport The original packaging provides optimum protection for the unit during transport If required original packaging for the unit can be ordered from KaVo KaVo will not accept any responsibility or liability for damage occurring during transport due to the use of incorrect packaging even where...

Страница 11: ...s from the Internet Use antivirus software and update it regularly Look for evidence of possible virus infection and if applicable check with the antivirus software and remove the virus Perform regular data backups Restrict access to units to trustworthy users e g via a user name and password Make sure that only trustworthy content is downloaded Only install software and firmware updates that have...

Страница 12: ...re included in the scope of delivery possible variations due to country specific requirements and or import regulations KaVo ProXam iP Imaging Plate Scanner 2x KaVo imaging plate Size 0 2x KaVo imaging plate Size 1 4x KaVo imaging plate Size 2 100x KaVo light protection covers Size 0 100x KaVo light protection covers Size 1 300x KaVo light protection covers Size 2 Cartridge for imaging plate Size ...

Страница 13: ...ver Size 1 100 pcs KaVo Light Protection Cover Size 2 300 pcs KaVo Light Protection Cover Size 2 1000 pcs 2 1 3 Optional articles The following optional articles can be used with the unit Wall Mounting Plate for KaVo ProXam iP Imaging Plate Storage Box Quart Set for KaVo ProXam iS ProXam iP 2 1 4 Consumables The following materials are consumed during operation of the device and must be reordered ...

Страница 14: ...e V DC 24 Max current consumption A 0 5 Max power consumption W 12 Electrical data power supply unit Nominal input voltage V AC 100 240 Frequency Hz 50 60 Nominal output voltage V DC 24 Max output current A 0 5 General technical data Dimensions W x H x D mm 167 x 231 x 216 Weight kg approx 4 Duty cycle 100 Max theoretical resolution Line pairs mm Lp mm approx 16 7 Noise level during scanning dB A ...

Страница 15: ...r mW 10 Technical data of the RFID Module Frequency MHz 13 56 Modulation ASK Max power mW 400 Electromagnetic compatibility EMC interference emission measurements High frequency emissions in accordance with CISPR 11 Group 1 Group 1 Class B Interference voltage at the power supply connection CISPR 11 2009 A1 2010 Compliant Electromagnetic interference radiation CISPR 11 2009 A1 2010 Compliant Elect...

Страница 16: ... communication devices Compliant Immunity to interference table near fields of wireless HF communication devices Radio service Frequency band MHz Test level V m TETRA 400 380 390 27 GMRS 460 FRS 460 430 470 28 LTE band 13 17 704 787 9 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 800 960 28 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMTS 1700 1990 28 Bluetooth WLAN 802 11 b g n RFID 2...

Страница 17: ... 4 6 2013 3 V 0 15 80 MHz 6 V ISM frequency bands 0 15 80 MHz 80 AM at 1 kHz Compliant Immunity to interference due to voltage dips short interruptions and voltage variations IEC 61000 4 11 2004 Compliant Electromagnetic compatibility EMC Interference immunity measurements SIP SOP Immunity to interference discharge of static electricity IEC 61000 4 2 2008 8 kV contact 2kV 4 kV 8 kV 15 kV air Compl...

Страница 18: ...ication Medical Device Class MDR IIa Ambient conditions during operation Temperature C 18 45 Relative humidity 80 Ambient conditions during storage and transport Temperature C 45 Relative humidity 80 Dimensions of intraoral imaging plates Size 0 22 x 35 mm Size 1 24 x 40 mm Size 2 31 x 41 mm 2 2 3 Light protection cover Classification Medical Device Class MDR I 2 Product description 14 KaVo ProXam...

Страница 19: ...ares that the radio system type KaVo ProXam iP conforms to directive 2014 53 EU The full text of the EU Declaration of Conformity is available at www duerrdental com 2 2 6 Distributor and manufacturer Distributor KaVo Dental GmbH Bismarckring 39 88400 Biberach Germany Phone 49 7351 56 0 Fax 49 7351 56 1488 http www kavo com Manufacturer DÜRR DENTAL SE Höpfigheimer Str 17 74321 Bietigheim Bissingen...

Страница 20: ...ransport mechanism guides the imaging plate through the device The imaging plate is read using a laser inside the scanner unit The scanned data is converted into a digital image and transferred to the imaging software After scanning the imaging plate runs through the erasure unit Image data still held on the imaging plate is erased with the aid of bright light The imaging plate is then ejected for...

Страница 21: ...artridge S2 7 Display for cartridge S1 8 Display for cartridge S0 The status LEDs display the following status messages Device starts Communication display Standby Ready to scan Imaging plate currently being processed Cartridge for imaging plate missing Error A message is displayed in the software 2 Product description Instructions for use KaVo ProXam iP 17 ...

Страница 22: ...ice S2 cartridge for S2 imaging plate is in the device Status LED flashing 2 3 1 2 Connections The connections are located on the rear of the unit underneath the cover 1 Network connection 2 Reset button 3 Connection for power supply unit 2 Product description 18 KaVo ProXam iP Instructions for use ...

Страница 23: ...rtridge S2 7 Display for cartridge S1 8 Display for cartridge S0 The status LEDs display the following status messages Device starts Communication display Standby Ready to scan Imaging plate currently being processed Cartridge for imaging plate missing Error A message is displayed in the software 2 Product description Instructions for use KaVo ProXam iP 19 ...

Страница 24: ...ted on the rear of the unit underneath the cover 1 Network connection 2 Reset button 3 Connection for power supply unit 2 3 4 Cartridges S0 S2 According to the imaging plate used the cartridge corresponding to the size of the imaging plate must be inserted in the device The cartridge that is currently in the device is indicated via the LEDs on the device 2 Product description 20 KaVo ProXam iP Ins...

Страница 25: ...laced if there are any signs of damage e g if the protective layer is damaged or there are visible scratches that could interfere with the diagnosis Intraoral Inactive side White printed with the word back and the size and manufacturer s information Active side Light blue with positioning aid The positioning aid is visible on the X ray image and makes it easier to align the image correctly during ...

Страница 26: ...eca com software specifications system requirements 3 1 3 Monitor The monitor must comply with the requirements for digital X ray imaging with a high light intensity and wide contrast range Strong ambient light sunlight falling directly onto the monitor and reflections can make it harder or even impossible to perform a diagnosis based on the X ray images 3 2 Installation 3 2 1 Setting up unit WARN...

Страница 27: ... unit on a firm horizontal surface 3 2 1 2 Wall mounted installation About this task The unit can be mounted on a wall with the wall mounting bracket optional article Wall Mounting Plate for KaVo ProXam iP The following information is supplementary to the device Instructions for use As a general rule the Instructions for use for the device must also be observed These instructions include important...

Страница 28: ...itable for a weight of approx 5 kg device wall bracket Steps 1 Place the wall mounting bracket in place horizontally and secure using appropriate materials 2 Remove rear rubber feet and the screws under them 3 Remove the unit s rear side cover Remove the cover plugs and the attachment screws under the edge of the rear side cover 3 Assembly 24 KaVo ProXam iP Instructions for use ...

Страница 29: ... plug them into the unit 6 Mount cover by slotting the top edge into place 1 then closing the cover 2 and securing with screws Make sure the cables are correctly fed through the bottom edge of the cover NOTE When operating the device the rear side cover must be mounted 3 Assembly Instructions for use KaVo ProXam iP 25 ...

Страница 30: ...6 of IEC 60601 1 EN 60601 1 Do not operate any other systems using the same multiple socket Make sure that none of the electrical cables leading to the unit are under any mechanical tension Before initial start up check that the mains supply voltage and the voltage stated on the type plate match for more information see section Technical data on page 10 3 2 2 2 Connecting to mains supply About thi...

Страница 31: ... of the power supply unit NOTE Only the supplied power supply unit may be used Follow these steps to connect to mains supply Steps 1 Attach the matching country specific adapter to the power supply unit 2 Remove the screw covers and screws from the bottom of the device 3 Pull the cover back 1 and remove downwards from the rear of the device 2 3 Assembly Instructions for use KaVo ProXam iP 27 ...

Страница 32: ...rovide documents concerning the units The unit can be connected to the network with a network cable 3 2 3 2 Combining devices safely The overall safety of the unit and its main performance features are independent of the network Incorrect manual configuration can lead to significant network problems the expert knowledge of a network administrator is required for configuration If for example the fo...

Страница 33: ...bly qualified person e g the manufacturer to verify that the setup is safe Observe the specifications of IEC 60601 1 EN 60601 1 when connecting the appliance with other appliances e g a PC system both in and outside the patient environment Only connect peripheral units such as computers monitors or printers that conform at least to the requirements set out in IEC 60950 1 EN 60950 1 The connected c...

Страница 34: ...he unit using the KaVo Device Tool for ProXam iP Check the firewall and release the ports if applicable 3 3 2 Network protocols and ports Port Purpose Service 45123 UDP 45124 UDP Unit recognition and configuration 2006 TCP Unit data 5141 UDP Event protocol data Syslog 1 The port can vary depending on the configuration NOTE When the unit is first connected to a computer it applies the language and ...

Страница 35: ... enter a fixed IP address Steps 1 Deactivate DHCP when you have selected a device from the list 2 Enter the IP address netmask and gateway 3 Save the configuration by selecting Save 3 3 3 2 Testing device About this task You can scan in an X ray image to check that the unit is properly connected Steps 1 Open Romexis 2 Create a test patient in Romexis for example patient ID DEMO0001 For more inform...

Страница 36: ... kV mGycm2 Incisors 0 15 s 445 13 7 0 15 s 4 9 0 15 s 5 8 Premolars 0 20 s 594 18 2 0 20 s 3 8 0 20 s 7 7 Molars 0 27 s 806 24 6 0 27 s 5 2 0 27 s 10 4 Bite wing 0 28 s 834 25 5 0 28 s 5 6 0 28 s 10 8 Check and adjust the specific X ray unit in accordance with the standard values 3 3 5 Acceptance tests The required tests e g acceptance tests must be carried out in accordance with local rules and r...

Страница 37: ...ctrical safety check according to the national law e g in accordance with IEC 62353 Document the results Instruct and hand over the device and document NOTE A sample template for a handover protocol is included in section Sample handover protocol template on page 63 3 Assembly Instructions for use KaVo ProXam iP 33 ...

Страница 38: ...ng plate to X ray radiation before or after the scanning process Do not operate X ray unit during the scanning process if the unit is in the same room as the X ray tube CAUTION Imaging plates are toxic Imaging plates that are not packed in a light protection cover can lead to poisoning when placed in the mouth or swallowed Only place imaging plates in the patient s mouth in a light protection cove...

Страница 39: ...g plates in a light protection cover or cartridge of the correct size Imaging plates will be pre exposed on exposure to natural radiation and stray X ray radiation Protect erased and exposed imaging plates from X ray interference If the imaging plate has been stored for longer than one week erase the imaging plate prior to use Do not store imaging plates under hot or moist conditions Observe the c...

Страница 40: ...clarity Read the image data within 30 minutes of exposure Never handle exposed imaging plates without the light protection cover Do not subject an exposed imaging plate to X ray radiation before or after the scanning process Do not operate X ray unit during the scanning process if the unit is in the same room as the X ray tube 4 2 1 Changing input unit cartridge About this task The device can be u...

Страница 41: ...correct cartridge has been inserted with the display S0 S1 S2 If the incorrect cartridge has been inserted it must be removed and the correct cartridge inserted 2 Open the cover 4 Usage Instructions for use KaVo ProXam iP 37 ...

Страница 42: ...3 Remove cartridge The green cartridge display extinguishes When the device is ready to scan the green status LED flashes in addition 4 Usage 38 KaVo ProXam iP Instructions for use ...

Страница 43: ... 2 imaging plate as an example 4 2 2 1 Required accessories Imaging plate Light protection cover the same size as the imaging plate WARNING Risk of cross contamination when not using the light protection cover or when using the light protection cover more than once Do not use an imaging plate without a light protection cover Do not use the light protection cover more than once disposable item 4 Us...

Страница 44: ...g plate is not damaged The RFID tag is attached to the imaging plate If the RFID tag peels off replace the imaging plate About this task Follow these steps to prepare for taking X ray image Steps 1 If using it for the first time or if it has been stored for over a week erase the imaging plate see section Erasing imaging plates on page 46 2 Completely slide the imaging plate into the light protecti...

Страница 45: ...e the patient s mouth see section Light protection cover on page 50 Allow the light protection cover to fully dry 4 2 2 3 Taking X ray image About this task CAUTION Damage to the imaging plate caused by a sharp edged holding system Only use holding systems that will not damage the light protection cover or the imaging plates in any way Do not use holding systems with sharp edges Wear protective gl...

Страница 46: ...ng for scanning About this task CAUTION Light erases the image data on the imaging plate Never handle exposed imaging plates without the light protection cover Wear protective gloves Steps 1 Remove the imaging plate with the light protection cover from the patient s mouth WARNING Contamination of the unit Clean and disinfect the light protection cover before removing the imaging plate 2 In the eve...

Страница 47: ...ate 6 Tear off the light protection cover 4 2 3 Scanning image data 4 2 3 1 Starting imaging plate scanner and software About this task NOTE The reading out process is described using the Romexis imaging software For further information see the Romexis 6 User s manual section Capturing intraoral images with imaging plate scanner Steps 1 Press the on off switch to switch on the device 2 Switch on t...

Страница 48: ...imaging plate centrally and straight onto the input unit The torn off side of the light protection cover faces down the inactive back side of the imaging plate faces the operator The imaging plate must not be pulled out of the light protection cover before placement on the input unit There is the risk of image information being erased by ambient light see section Correct use of imaging plates on p...

Страница 49: ...he input unit Make sure that only the imaging plate and not the light protection cover is inserted into the unit 4 Remove the empty light protection cover 5 Once the imaging plate has been inserted into the unit close the cover and leave it closed throughout the entire scanning process 4 Usage Instructions for use KaVo ProXam iP 45 ...

Страница 50: ...asing imaging plates About this task The imaging plates are automatically erased after scanning However the plates can be erased using the erasing mode which will not scan the plate before erasure The imaging plates should be erased before use in the following cases The first time the imaging plate is used or if it is stored for longer than a week If due to an error the image data on the imaging p...

Страница 51: ...isplays the message Connecting to the scanner Please wait followed by Preparing the scanner for erasing Please wait When the scanner is ready for erasing Romexis displays the message Ready for erasing Please insert imaging plate into the scanner 5 Open the scanner s cover 6 Insert the imaging plate fully into the input unit 4 Usage Instructions for use KaVo ProXam iP 47 ...

Страница 52: ...ck Done or Close The available option depends on whether images have been scanned after erasing the image plate or not Erasing mode is not available directly after scanning 4 2 5 Switching off unit Steps 1 Press the on off switch for three seconds Results As soon as the unit has shut down it switches off completely The LEDs go out 4 3 Cleaning and disinfection When cleaning and disinfecting the un...

Страница 53: ...iquid does not get inside the unit Remove any soiling with a soft lint free cloth that has been dampened with cold tap water Disinfect the surfaces using a disinfection wipe alternatively use disinfectant on a soft lint free cloth Cartridges S0 S2 The cartridges can be cleaned and disinfected with a wipe disinfection or in an immersion disinfection system NOTE Heat damages the cartridges Do not th...

Страница 54: ...ed off with a soft lint free wipe prior to every use Remove resistant or dried on dirt with the imaging plate cleaning wipe When doing this observe the instructions for use for the cleaning wipe Allow the imaging plate to completely dry before using it 4 3 4 Storage box with imaging plate storage tray Clean and disinfect the surface of the storage box and the internal imaging plate storage tray in...

Страница 55: ...vals are based on using the device for 25 intraoral images per day on 220 working days per year Maintenance interval Maintenance work Annually Visually inspect the device Check the imaging plates for signs of scratches and change if necessary Remove dust and dirt from accessible parts Carry out a system check Every 3 years Exchange the cartridges 4 Usage Instructions for use KaVo ProXam iP 51 ...

Страница 56: ...te not exposed or not sufficiently exposed X ray tubes check unit settings Expose the imaging plate X ray unit is faulty Inform a Service Technician Incorrect cartridge light protection cover was also pushed into the unit Use the correct cartridge for the size of imaging plate being used Imaging plate falls out of unit and no image appears on monitor Possible cause Remedy Correct imaging plate not...

Страница 57: ...e Ghosting or double exposure on X ray image Possible cause Remedy Imaging plate exposed twice Only expose the imaging plate once Imaging plate not sufficiently erased Check the erasure unit is working correctly Inform a service technician if the problem persists 5 Troubleshooting Instructions for use KaVo ProXam iP 53 ...

Страница 58: ...bend the imaging plate Shadow on X ray image Possible cause Remedy Imaging plate removed from the light protection cover before scanning Do not handle imaging plates without a light protection cover Store the imaging plate in a light protection cover 5 Troubleshooting 54 KaVo ProXam iP Instructions for use ...

Страница 59: ... taking an X ray image make sure there are no metal parts between the X ray tube and the patient Check X ray tube Software unable to combine the data to make complete image Possible cause Remedy The X ray dose on the imaging plate was insufficient Increase X ray dose 5 Troubleshooting Instructions for use KaVo ProXam iP 55 ...

Страница 60: ...lean the imaging plate Replace scratched imaging plates Unit was shaken by impact or light protection cover closed during scanning process Set up the unit so that it cannot be shaken Prevent the unit from being touched during the scanning process Light strips in CaptureUI Possible cause Remedy Too much incident ambient light during the scanning process Darken the room Turn the unit so that the lig...

Страница 61: ...ating instructions for the imaging plates and film retainer systems X ray image shows pre erasure at one end Possible cause Remedy After the light protection cover has been torn off and before pushing into the input unit the imaging plate is pushed out of the light protection cover Do not push out the imaging plate until the torn off light protection cover has been placed on the input unit 5 Troub...

Страница 62: ...nection to scanner lost The connection to the unit was interrupted while the software was still attempting to communicate with the unit Restore the connection to the unit Repeat the process Error during data transmission between unit and computer Error message CRC error timeout Connecting cable used is incorrect or too long Only use original cables H30000 Image plate might be exposed from wrong si...

Страница 63: ...be connected to or is not responding Automatic restarting has been attempted unsuccessfully Restart the workstation If the problem continues contact your service technician 5 1 3 Unit faults Fault Probable cause Solution Unit not shown in the imaging software Network cable not installed Install the network cable No DHCP server connected It may take some time for the imaging software to detect the ...

Страница 64: ... size of imaging plate being used Cartridge display does not light up Cartridge not inserted correctly Insert the cartridge correctly Network connection has been disconnected Connecting cable between device and computer not correctly connected Check the connecting cable The IP address of the device is being used by another unit Check the network settings IP address and subnet mask and assign a uni...

Страница 65: ...y specifications The warranty does not usually cover bulbs glassware rubber parts software scanner tips batteries tubes screws nuts and other fasteners imaging plates and the colourfastness of plastics Defects or their consequences that can be attributed to interventions on or changes made to the product by the customer or a third party are excluded from the warranty Claims from this warranty can ...

Страница 66: ...0 s A 2 File sizes uncompressed The actual file size will depend on the imaging plate format and the pixel size File sizes stated are approximate and have been rounded upwards Suitable compression methods can considerably reduce the file size without loss of data Max theoretical resolution LP mm 16 7 Pixel size μm 30 Intra Size 0 2 x 3 1 8 MB Intra Size 1 2 x 4 2 3 MB Intra Size 2 3 x 4 3 0 MB A 3...

Страница 67: ...A 4 Sample handover protocol template Appendix A Resolution data Instructions for use KaVo ProXam iP 63 ...

Страница 68: ...ntatives Country Address GB UK Responsible Person Duerr Dental Products UK Ltd 14 Linnell Way Telford Way Industrial Estate Kettering Northants NN 16 8PS Appendix B Country representatives 64 KaVo ProXam iP Instructions for use ...

Страница 69: ......

Страница 70: ...KaVo Dental GmbH Bismarckring 39 88400 Biberach Deutschland www kavo com 1 015 1209 2160400008L02 ...

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