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CE labelling

CE labelling with code of the Notified Body

Manufacturer

Dispose of correctly in accordance with EU Directive 2012/19/EU (WEEE)

Electronic instructions for use

Instructions 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 Planmeca ProScanner 2.0

User's manual

Содержание ProScanner 2.0

Страница 1: ...PlanmecaProScanner 2 0 user s manual EN 30019182 30019182...

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...

Страница 3: ...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 Image plate scanner 10 2 2...

Страница 4: ...tching off unit 48 4 3 Cleaning and disinfection 48 4 3 1 Image plate scanner 49 4 3 2 Light protection cover 50 4 3 3 Image plate 50 4 3 4 Storage box with image plate storage tray 50 4 4 Maintenance...

Страница 5: ...number FE004630 Article number FE004631 1 1 1 Warnings cautions and notes The warnings cautions and notes in this manual are structured as follows SIGNAL WORD Description of the type and source of da...

Страница 6: ...tions 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 i...

Страница 7: ...manufacturer has designed and constructed this unit so that when used properly and for the intended purpose it does not pose any danger to people or property Nevertheless the following residual risks...

Страница 8: ...e or usage beyond this scope is deemed to be improper The manufacturer accepts no liability for damages resulting from improper usage In these cases the user operator will bear the sole risk Especiall...

Страница 9: ...ied out by Planmeca or by qualified personnel specifically approved and authorised by Planmeca 1 2 6 Electrical safety Comply with all the relevant electrical safety regulations when working on the un...

Страница 10: ...acturer and the competent authority of the Member State in which the user or patient is located 1 2 8 Only use original parts Only use Planmeca parts or accessories and optional articles specifically...

Страница 11: ...accordance with waste code 090199 Wastes not otherwise specified Disposal as domestic waste is possible 1 2 11 Protection from threats from the Internet The unit is to be connected to a computer that...

Страница 12: ...cope of delivery The following items are included in the scope of delivery possible variations due to country specific requirements and or import regulations ProScanner 2 0 Image Plate Scanner 2x Plan...

Страница 13: ...owing optional articles can be used with the unit Wall mounting Plate for ProScanner 2 0 ProScanner 2 0 Imaging Plate storage box Quart test phantom set for Planmeca ProSensor ProScanner 2 1 4 Consuma...

Страница 14: ...V DC 24 Max current consumption A 0 5 Max power consumption W 12 Protection class II Electrical data power supply unit Nominal input voltage V AC 100 240 Frequency Hz 50 60 Nominal output voltage V D...

Страница 15: ...th nm 635 Power 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 emission...

Страница 16: ...ommunication 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...

Страница 17: ...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 Complia...

Страница 18: ...ices Directive 93 42 EEC Class IIa Ambient conditions during operation Temperature C 18 45 Relative humidity 80 Ambient conditions during storage and transport Temperature C 33 Relative humidity 80 Di...

Страница 19: ...the radio system type Planmeca ProScanner 2 0 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...

Страница 20: ...The transport mechanism guides the image plate through the device The image plate is read using a laser inside the scanner unit The scanned data is converted into a digital image and transferred to th...

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 Image plate currently...

Страница 22: ...d on the rear of the unit underneath the cover 1 Network connection 2 Reset button 3 Connection for power supply unit 2 3 2 Cartridges S0 S2 According to the image plate used the cartridge correspondi...

Страница 23: ...d 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 bac...

Страница 24: ...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 amb...

Страница 25: ...nit so it is not exposed to vibrations Place the unit on a firm horizontal surface 3 2 1 2 Wall mounted installation The unit can be mounted on a wall with the wall mounting bracket optional article W...

Страница 26: ...ing unit on wall bracket NOTE The load rating of the wall and the fastening material must be suitable for a weight of approx 5 kg device wall bracket 1 Place the wall mounting bracket in place horizon...

Страница 27: ...ide cover Remove the cover plugs and the attachment screws under the edge of the rear side cover 4 Pull the lower edge of the rear side cover out 1 and remove it downwards 2 3 Assembly User s manual P...

Страница 28: ...ating the device the rear side cover must be mounted 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...

Страница 29: ...chanical 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 Connectin...

Страница 30: ...e device 2 4 Plug in the connecting plug of the power supply unit into the socket connection of the device 5 Plug the mains plug into the power outlet 6 Refit the cover NOTE The cover on the rear must...

Страница 31: ...the IT network Upgrade of devices that are connected to the IT network The data connection utilises part of the bandwidth of the network Interactions with other medical devices cannot be completely ru...

Страница 32: ...unit until it has warmed up to room temperature and it is dry The unit supports the following imaging programs Planmeca Romexis 3 3 1 Network configuration Various options are available for network c...

Страница 33: ...elected The connected ProScanner 2 0 should become visible in the Proscanner 2 0 devices list 4 The unit name designation can be changed and information queried under the General tab 5 An IP address c...

Страница 34: ...ld limitation 3x4 60 kV mGycm2 60 kV mGycm2 60 kV mGycm2 Incisors 0 10 s 18 3 0 10 s 3 8 0 10 s 7 7 Premolars 0 14 s 25 6 0 14 s 5 4 0 14 s 10 8 Molars 0 19 s 34 8 0 19 s 7 3 0 19 s 14 7 Bite wing 0 2...

Страница 35: ...t be carried out in accordance with local rules and regulations Find out which tests are required Carry out testing in accordance with local rules and regulations Acceptance test NOTE The Intra Extra...

Страница 36: ...NOTE A sample template for a handover protocol is included in section Sample handover protocol template on page 61 3 Assembly 32 Planmeca ProScanner 2 0 User s manual...

Страница 37: ...age 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 Image plates are toxic...

Страница 38: ...ates in a light protection cover or cartridge of the correct size Image plates will be pre exposed on exposure to natural radiation and stray X ray radiation Protect erased and exposed image plates fr...

Страница 39: ...ion and clarity Read the image data within 30 minutes of exposure Never handle exposed image plates without the light protection cover Do not subject an exposed image plate to X ray radiation before o...

Страница 40: ...ct 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 36 Planmeca ProScan...

Страница 41: ...3 Remove cartridge The green cartridge display extinguishes When the device is ready to scan the green status LED flashes in addition 4 Usage User s manual Planmeca ProScanner 2 0 37...

Страница 42: ...e as the image 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 image plate without a light pro...

Страница 43: ...e RFID tag peels off replace the image plate 1 If using it for the first time or if it has been stored for over a week erase the image plate see section Erasing image plate on page 48 2 Completely sli...

Страница 44: ...e positioning it inside the patient s mouth see section Light protection cover on page 50 5 Allow the light protection cover to fully dry Taking X ray image CAUTION Damage to the image plate caused by...

Страница 45: ...minutes Preparing for scanning CAUTION Light erases the image data on the image plate Never handle exposed image plates without the light protection cover Wear protective gloves 1 Remove the image pl...

Страница 46: ...e glove powder from your hands before handling the image plate 6 Tear off the light protection cover 4 2 3 Scanning image data Starting image plate scanner and software NOTE The reading out process is...

Страница 47: ...ED lights up Scan the image plate at this point and not before Scanning image plate NOTE To avoid the mix up of X ray images only scan the X ray images from the selected patient 1 Open the cover 4 Usa...

Страница 48: ...faces down the inactive back side of the image plate faces the operator The image plate must not be pulled out of the light protection cover before placement on the input unit There is the risk of im...

Страница 49: ...otection cover downwards into the unit The image plate must be inserted fully into the input unit Make sure that only the image plate and not the light protection cover is inserted into the unit 4 Usa...

Страница 50: ...4 Remove the empty light protection cover 4 Usage 46 Planmeca ProScanner 2 0 User s manual...

Страница 51: ...image data is automatically transmitted to the imaging software The progress of the scanning process is displayed in the preview window on the monitor After it has been scanned the image plate is eras...

Страница 52: ...please introduce the image plate to be erased unexposed by X ray into the scanner as described in Scanning image data on page 42 In this case the use of a light protection cover is not required At ste...

Страница 53: ...id 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 disinfectan...

Страница 54: ...d off with a soft lint free wipe prior to every use Remove resistant or dried on dirt with the image plate cleaning wipe When doing this observe the instructions for use for the cleaning wipe Allow th...

Страница 55: ...als 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 image plates for sig...

Страница 56: ...te not exposed or not sufficiently exposed X ray tubes check unit settings Expose the image plate X ray unit is faulty Inform a Service Technician Incorrect cartridge light protection cover was also p...

Страница 57: ...e Ghosting or double exposure on X ray image Possible cause Remedy Image plate exposed twice Only expose the image plate once Image plate not sufficiently erased Check the erasure unit is working corr...

Страница 58: ...bend the image plate Shadow on X ray image Possible cause Remedy Image plate removed from the light protection cover before scanning Do not handle image plates without a light protection cover Store...

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...

Страница 60: ...the image plate Replace scratched image 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 bei...

Страница 61: ...ng instructions for the image 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...

Страница 62: ...Inform a service technician if the problem persists Connection to scanner lost E2490 The connection to the unit was interrupted while the software was still attempting to communicate with the unit Res...

Страница 63: ...es not fit into the intake slot Incorrect cartridge used Use the correct cartridge for the size of image plate being used Light protection cover slips into intake slot together with image plate Incorr...

Страница 64: ...File sizes uncompressed The actual file size will depend on the image plate format and the pixel size File sizes stated are approximate and have been rounded upwards Suitable compression methods can...

Страница 65: ...A 4 Sample handover protocol template Appendix A Resolution data User s manual Planmeca ProScanner 2 0 61...

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Страница 68: ...Planmeca Oy Asentajankatu 6 00880 Helsinki Finland tel 358 20 7795 500 fax 358 20 7795 555 sales planmeca com www planmeca com 2160200008L02...

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