DIGORA Optime DXR-50 001 Users Manual rev 2 Sept 2008

Imaging plate unit

DIGORA® Optime DXR-50 001 Digital intraoral imaging plate system

User’s Manual

This unit is marked according to the Medical Device Directive 93/42/EEC (if the unit contains the CE mark)

Document number 204253 rev. 2 (0908) Original approved English language version

Manufactured by SOREDEX P.O. BOX 148 FIN-04301 TUUSULA, FINLAND Tel. +358 (0)10 270 2000 Fax. + 358 9 701 5261

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Soredex endeavours to produce product documentation that is accurate and up to date. However, our policy of continual product development may result in changes to products that are not reflected in the product documentation. Therefore, this document should not be regarded as an infallible guide to current product specifications. Soredex maintains the right to make changes and alterations without prior notice. II

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Contents 1. The DIGORA® Optime... 1 1.1 Introduction ... 1 1.2 System installation ... 2 Positioning the unit ... 2 Positioning the PC ... 3 Other devices ... 3

2. Intraoral imaging plate unit ... 4 2.1 Main parts and controls ... 4 2.2 Accessories ... 5 2.2 Display symbols and what they mean ... 7 2.3 Using the system ... 10 Preparing the system ... 10 Preparing an IP for exposure ...11 Imaging plate holders ... 13 Taking an exposure ... 14 Reading an imaging plate ... 16 Single user configuration ... 16 Multiconnect configuration ... 19

Removing IPs from the plate collector ... 20 Standby mode ... 20 Retrieve last image ... 21 Shutting down the unit ... 22 IP erasing mode (Initial erasing of the IPs) ... 22 Errors ... 23

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3. Setup options ... 24 3.1 Tooth numbering ... 24 Selecting the tooth numbering feature ... 24 Using the tooth numbering feature ... 24 3.2 Resolution ... 25 3.3 Image Processing ... 25

4. Handling and care of imaging plates... 26 4.1 General ... 26 4.2 Handling ... 26 4.3 Cleaning ... 27 4.4 Storage ... 28 4.5 Replacement ... 28 4.5 Disposal ... 28

5. Unit care and maintenance... 29 5.1 Cleaning the unit ... 29 5.2 Disinfecting unit ... 29 5.3 Maintenance... 30 5.4 Repair ... 30 5.5 Disposal ... 30

6. Symbols that appear on or in the unit... 31 7. Warnings and precations ... 32 Appendix A. Technical Specifications ... A - 1 Appendix B. Installation and setup ... B -1

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Introduction

Imaging plate unit

1. The DIGORA® Optime 1.1 Introduction This manual describes how to use the DIGORA® Optime digital imaging plate unit (the unit) which is part of the digital intraoral imaging plate system (the system). The complete system comprises the following: -

the DIGORA® Optime digital imaging plate unit (the unit).

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SOREDEX dental Imaging Plates (IPs), protective covers, hygiene bags and other related imaging plate accessories.

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A PC (not supplied) in which suitable dental imaging software.

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A local area network (LAN) cable (not supplied) will be required if the system is to be used in a network.

The unit is a laser scanning device designed to automatically read reusable SOREDEX dental intraoral imaging plate sizes 0, 1, 2, and 3. After reading the images can be viewed on the PC using the dental imaging sofware. The unit can either be connection directly to the PC or to network via the LAN cable. The unit can be set up to work with a single PC, the single user configuration, or with several PCs, the multiconnect (multiple user) configuration. With the multiconnect configuration up to eight PCs can be used, one at a time, with the unit. This manual describes how to use both configurations.

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Introduction NOTES: Only personnel trained and authorized by the manufacturer of the unit are allowed to install and configure the unit. Only use the imaging plates, protective covers and hygiene bags supplied by the manufacturer of the unit. Please read the section 7. Warnings and precations before using the unit.

1.2 System installation Positioning the unit Do not position the unit in direct sunlight or near bright light. Sunlight or bright light must not be allowed to shine directly on the unit door into which the IPs are inserted. Position the unit on a stable flat surface so that vibrations will not degrade the image quality. The unit can also be attached to a wall, under or on a shelf with the optional mounting kit. The unit must not be positioned so that it it touching other equipment. It must not be placed on top of or under other equipment. The unit can be positioned within the environment in which the patient is examined and treated (patient environment).

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Positioning the PC The PC connected to the unit should not be used in the patient environment. The minimum horizontal distance between the patient and the PC is 1.5 m (4.5 ft). The minimum vertical distance between the patient and the PC is 2.5 m (6.5 ft).

Other devices DO NOT connect any other devices to the unit or the PC connected to the unit that are:

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not part of the supplied system

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not supplied by the manufacturer of the unit

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not recommended by the manufacturer of the unit.

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2. Intraoral imaging plate unit

2. Intraoral imaging plate unit 2.1 Main parts and controls

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2.2 Accessories For additional information about the accessories listed below contact your authorized dealer. Not all accessories are available for all units. Imaging plates (IPs). Equivalent to film sizes 0, 1, 2 and 3.

IDOT version. An identification code (IDOT) is printed on the IP and will appear on the intraoral image. The IDOT identification mark allows the IP used for an exposure to be easily identified and removed if it damaged.

Standard (STD) version. The standard version has no identification mark.

Protective covers. For IPs 0, 1, 2 and 3.

Hygiene bags. For IPs 0, 1, 2 and 3.

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2. Intraoral imaging plate unit CAUTION: For optimum performance only use IPs, protective covers and hygiene bags supplied by the manufacturer of the unit or the manufacturer’s authorized distributors. The manufacturer will not be held responsible for problems caused by using accessories from other manufacturers.

IP storage box For storing IPs safely and conveniently

Microfiber cloth For cleaning IPs

IP holders For bitewing, periapical and endodontic exposures (optional, not included) See section Imaging plate holders for more information.

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2.2 Display symbols and what they mean During use symbols and animations will appear on the unit display. These: - indicate the status of the unit - help you to operate the unit correctly - show user mistakes and corrective actions - display error codes - display a preview image The main symbols are: Startup During startup the unit serial number, IP address and other information will appear on the unit display.

Multiconnect wait Multiconnect configuration. The unit is not reserved by any PC in the system.

Multiconnect reservation Multiconnect configuration. The unit has been reserved by a PC (e.g. PC number 2).

Unit door

Protective cover and imaging plate Yellow: remove protective cover

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Imaging plate Yellow: wrong way round, rotate

Protective cover

Remove / disconnect

Insert / connect

Busy Unit in operation.

Unit in erasing mode

Check Something wrong or take alternative action.

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Dental imaging software Software not open, not ready or waiting for user action.

Unit connection Not connected or connection not working.

Rotate

Error state and error number

Check documentation supplied with the unit

Unit in service mode (Service technicians only)

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2.3 Using the system For optimum performance only use IPs, protective covers and hygiene bags designed for this unit and supplied by authorized distributors. The manufacturer of this unit will not be held responsible for any problems caused by using accessories from other manufacturers. Proper handling, cleaning and storage of the IPs ensures the best image quality and maximum service life of the IPs. Refer to section 4. Handling and care of imaging plates.

Preparing the system 1. PC: Switch on the PC connected to the unit. 2. PC: Open the dental imaging software and a new or existing patient card where you wish to store the intraoral images. NOTE: If you are using the system for the first time you may wish to check and / or change the setup options. See section 3. Setup options. 3. Press the on/off key to switch the unit on.

The startup animation will appear on the display and the unit will carry out self test during which the IP carrier will slide out of the unit door.

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Imaging plate unit When the status light turns green and ready animation, indicating IP insertion, appears on the unit display, the unit is ready to use (in the ready state).

NOTE: If the ready animation does not appear, check the system setup described in the installation instructions.

Preparing an IP for exposure IMPORTANT NOTE If the IP is being used for the very first time or if it has not been used within the the last 24 hours, it must be erased before use to remove any fogging caused by background radiation. See section, Erasing an imaging plate.

CAUTION: When handling IPs, protective covers and hygiene bags take all appropriate measures and precautions to prevent cross contamination.

1. Place the IP you wish to use onto a protective cover. The light blue side (sensitive) of the IP must face and be placed on the half of the protective cover that is the same shape as the IP.

2. Fold the half of the protective cover with the semicircular cutout over onto the IP. The metal disk on the back (black side) of the IP must appear in the semicircular cut out.

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2. Intraoral imaging plate unit 3. Turn the protective cover and IP over so that the black side of the protective cover is uppermost. This makes it easier to slide the protective cover and IP into the hygiene bag.

4. Slide the protective cover and IP into the hygiene bag as far as they will go. Make sure that the black side of the protective cover is on the same side as the black side of the hygiene bag.

5. Peel off the cover paper from the sealing tape and then fold the flap, along the pre-formed line, over and onto the sealing tape.

6. Press and slide your thumb along the tape to ensure that the flap is properly sealed.

7. Turn the sealed hygiene bag over and check that the IP and protective cover are in the correct position. You must be able to see the light side of the protective cover and the metal disk on the IP.

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Imaging plate holders It is recommended that imaging plate holders be used to ensure accurate IP positing and consistently good images quality.

Using imaging plate holders improves image quality because: - the IP is positioned correctly in relation to the tooth - there is no positioning guesswork - the IP is not bent and thus distortion is eliminated - the IP cannot move in relation to the X-ray unit - images are standardized and reproduceable - there is no overlapping nor cone cut off - IP wear and tear is minimized - image quality can be maintained irrespecective of who takes the image - time is saved and profitability increased Problems caused by manually positioning the IP include: - incorrect vertical alignment - distortion - cone cut off - poor projection standardization - inferior image quality For more information on imaging plate holders and systems contact you dealer.

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Taking an exposure 1. Place the IP, in its sealed hygiene bag, into the appropriate imaging plate holder and then insert it into the patient’s mouth in the position for the image you wish to take. Note that the back of the sealed hygiene bag, the black side, must face the X-ray source.

2. Select exposure values appropriate for the exposure you are taking. The system will produce excellent images even if the exposure values differ considerably from the optimum values. In most cases the same exposure values can be used for virtually all imaging purposes. For normal everyday use select the Adult Bitewing exposure time from the following table. If required the exposure time can be increased for very large patients and reduced for children. The optimium exposure values also depends on the performace of the X-ray unit being used and may vary by ±1 step from the values in the following table.

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2. Intraoral imaging plate unit

Imaging plate unit If the exposure time is too short images will be noisy. Such images may still usable for somediagnostic purposes. If the exposure time is too long images will be too dark or will show patient movement. These images will not be good enough for accurate diagnostic examination.

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The exposure values table below should only be used as a guide.

Bitewing

Recommended exposure values (s) for DC x-ray units* 60 kV, 7 mA 70 kV, 7 mA 9” cone 12” cone 9” cone 12” cone Adult Child Adult Child Adult Child Adult Child 0.250 0.160 0.500 0.300 0.125 0.080 0.250 0.160

Maxillary incisor 0.200 0.125 0.400 0.250 0.100 0.063 0.200 0.125 Maxillary cuspid 0.200 0.125 0.400 0.250 0.100 0.063 0.200 0.125 Maxillary molar 0.300 0.200 0.600 0.400 0.160 0.100 0.300 0.200 Occlusal 0.250 0.160 0.500 0.300 0.125 0.080 0.250 0.160 Mandibular incisor 0.200 0.125 0.400 0.250 0.100 0.063 0.200 0.125 Mandibular cuspid 0.250 0.160 0.500 0.300 0.125 0.080 0.250 0.160 Mandibular molar 0.250 0.160 0.500 0.300 0.125 0.080 0.250 0.160 *For AC x-ray units increase the exposure times by about 30%

3. Protect yourself from radiation and take the exposure.

4. After the exposure remove the sealed hygiene bag from the patient’s mouth. CAUTION: If there is a risk of cross contamination, wash, disinfect and dry the hygiene bag before opening it.

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