Preva Dental X-Ray System
Contents
1. cccccccee cence ence eeeeeeeeeeeeeneeeaes 13 Regular Maintenance ccc ccc e een e cence eee eee eeeeeeeeeeneeeeenaeeeeeganeeeeanees 13 Cleaning and Disinfecting cece cece eee eee eee kk kk mmn 13 Checking System Functions sss 14 System Function Checklist 15 New Tube Seasoning Procedure esses ener 16 Solving Performance ISSUCG ccccc cece cece cece eee eeeeee seat nenne 17 Performance Issues sauna sent ernennen erregen 17 Obtaining Technical SUPPO ars 17 Pre programmed Exposure Times esseeeeeeeeeeeeee 18 Changing Language ccc cece cece cece cece cease eee seat ene nnns 20 System Configuration eee e e e e e ee 21 System Configuration Mode rrarrnannannnanavnnnnnrnnnennnnnnnennnnennnennnnnsnnen 21 Adjusting the Display cce eee 22 Changing Pre programmed Exposure Seriin gS e e eee 23 Showing Current System Configuration cc ccc cece e eeeeeeeeeeeeaeeeanees 29 Changing the GONG SE Jarre 30 Diagnostic Mode PNE RR RR 31 SPECIFICATIONS er ner 32 Preva Dental X Ray System s ceecscsssesesessessee ese agen kane aar aac vene 32 p progeny General Information Preva General Information Indications for Use The Preva Intraoral Dental X Ray System is to be used as an extraoral source of x rays in Dental radiography Con2. 2 Verify the kilovoltage and tube current during an exposure using the diagnostic mode as explained in the System Configuration section of this manual Alternatively you may employ a non invasive meter to evaluate kilovoltage and exposure time 3 Inspect the condition of the remaining imaging chain components such as the film chemistry and processor or the condition of the x ray sensor and computer No X Ray If no x ray is produced check the following 1 Verify that the line cord if one is in use is properly connected 2 Verify that the power switch is in the ON position Pre termination Early release of the exposure switch will cause a pre termination error to Error occur After five seconds the system will return to the normal operating condition Be advised that this will result in an underexposed image Obtaining Technical Support Contact Progeny A Midmark Company 675 Heathrow Dr Lincolnshire Illinois 60069 U S A Phone 888 924 3800 Fax 847 415 9801 7 progenv System Configuration Preva Pre programmed Exposure Times The tables below show the factory default exposure settings for each combination of Tooth Image Receptor Type and Patient Size on the Operator Panel These exposure settings can be modified using the System Configuration mode See the System Configuration section for details 8 inch Cone 20 cm Progeny Schick Dexis Kodak Sirona PSP DSpeed E F Speed Adult Child Adult Child Adult C
3. arrow button and retain current presets To retain the presets select YES p Progeny System Configuration Preva Record Your Pre programmed Exposure Settings If the pre programmed exposure settings do not produce the density desired adjust the settings using System Configuration mode Record your settings in the table below 8 inch 20 cm Cone Digital Receptor D speed Film B E F Speed Film H Tooth Selection po CU Bicuspid k k Bitewing 7 g progeny System Configuration Preva 12 inch 20 cm Cone Digital Receptor D speed Film u E F Speed Film bi m m seconds m pum Bitewing m seconds ma seconds m seconds 05 f progeny System Configuration Preva Showing Current System Configuration The Preva Dental X Ray System displays the current system configuration This display is informational only From the Main System Configuration menu shown in Figure 3 select CONFIGURE UNIT You will see the Configuration menu shown in Figure 6 2 Select SHOW CONFIG The display will show e Current software version e Cone size e Diagnostic mode on or off 3 Press any button on the Operator Panel to return to the Configuration menu CONFIGURE UNIT SET CONFIG SHOW MAINT Figure 6 b EXIT Configuration Menu g progeny 26 A Micimark Company System Configuration Preva Changing the Cone Size Selecting SET CONFIG from the Configuration menu shown in Figure 6
4. displays the Set Configuration menu Figure 7 with options to change the cone size The Preva Dental X Ray System is factory set for use with the standard supplied 8 inch 20 cm Cone The 12 inch 30 cm Cone 30 A2200 is available Using the longer Cone requires longer exposure times which the Preva automatically selects when you change the Cone size in the Set Configuration menu Using a 12 inch 1 From the Main System Configuration menu shown in Figure 3 select Cone CONFIGURE UNIT You will see the Configuration menu shown in Figure 6 2 Select SET CONFIG You will see the Set Configuration menu shown in Figure 7 3 From the Set Configuration menu use the up and down arrows to highlight 12 CONE SIZE 4 Press the right arrow button to select the 12 CONE The display warns you that selecting the 12 inch Cone will override custom presets with the default factory settings for the 12 inch Cone 5 Using the up arrow select YES to install presets for the 12 inch Cone SET CONFIG p 12 CONE SIZE DIAG MODE ON Figure 7 DIAG MODE OFF Set Configuration AE ada gt EXIT g progeny 2 7 Micimark Company System Configuration Preva Diagnostic Mode About The Preva Dental X Ray System has a diagnostic mode in which you can display Diagnostic Mode 2 Summary of maintenance data or display feedback values after each exposure Showing the 1 From the Main System Configuration menu shown in Figure 3 select M
5. of manufacture The certified components of the Preva Dental X Ray System comply with IEC 60601 1 3 Radiation protection x ray equipment UL 2601 1 File Classified by Underwriters Laboratories Inc with respect to electrical shock fire Number and mechanical hazards only in accordance with UL 2601 1 and CAN CSA E181750 C22 2 NO 601 1 M90 and to the following particular standards IEC60601 2 7 IEC60601 2 28 EMI EMC IEC60601 1 2 Certified Components Component Reference Number Tubehead 30 A1027 Control Unit 30 A0010 Cone 8 in 30 A2195 Cone 12 in 30 A2200 Cone 8 in Rectangular 30 A2198 Cone 12 in Rectangular 30 A2203 Cone 60 mm 30 A2196 eco prx General Information Preva EC Declaration of Conformity Name and Progeny Preva Description of Product Catalog P7018 82 inch reach Model 30 A0010 Control 30 A2164 Extension Arm Extra Long Catalog P7017 76 inch reach Model 30 A0010 Control 30 A2071 Extension Arm Long Catalog P7016 66 inch reach Model 30 A0010 Control 30 A2073 Extension Arm Short Catalog P7015 56 inch reach Model 30 A0010 Control 30 A2074 Extension Arm Compact Catalog P7017 MG Mobile Model 30 A0010 Control Class Ilb Reference The following regulatory documents apply Numbers to vr E IEC 60601 1 3 Conformity IS IEC 60601 2 7 Declared IEC 60601 2 28 IEC 60601 2 32 Medical Device directive ISO 13485 FDA 510K File Number K043092 Declaration Midmark Corporation declares tha
6. the Tooth Selection and Patient Size Selection buttons simultaneously for 5 seconds to display the Main System Configuration menu From the Main System Configuration menu highlight and select CONFIGURE UNIT Then highlight and select SET CONFIG On the Set Configuration menu highlight and select DIAG MODE OFF progeny Specifications Preva Specifications Preva Dental X Ray System The following specifications contain information required to be provided to the user per Federal Regulation 21 CFR Line Voltage Line Load Maximum Rated Tube Potential kVp Accuracy Tube Current Exposure Time Timer Accuracy Source to Skin Distance Minimum Half Value Layer Minimum Inherent Filtration Focal Spot Automatic Cooling Time Leakage Technique Factors Target Angle Operating Temperature Storage Temperature Maximum Altitude Cone Focal Length Diameter of X Ray 29 110 230 VAG 10 50 60 Hz Max current 5 amps 70 KVp 5 selectable 4 7 mA 1 mA 20 ms through 2 00 seconds 5 1 ms 8 inch 20 cm 12 inch 30 cm 1 7 mm Aluminum equivalent at 70 kVp 2 mm Aluminum equivalent 70 kVp 0 4 mm IEC 336 15 times the exposure time wait before the next exposure can begin 0 4 mA at 70 kVp 12 5 degrees 50 F 95 F 10 C 435 C 31F 150 F 35 C 66 C 12 000 ft 8 inch 20 cm for bisecting angle technique 12 inch 30 cm for paralleling technique 2 7 inc
7. to arrange for this service and to assure that the personnel performing this are fully qualified to service Progeny Dental x ray equipment Cleaning and Disinfecting Employ personal protective equipment to prevent the spread of infections Clean the outside of the system using a damp towel or non alcohol based disinfectant Cleaning CAUTION Disinfecting e Do not allow liquids to drip into the system electronics e Do not spray cleaner or disinfectant directly onto the machine e Protect the system from contamination using barriers available from dental distributors e Follow the disinfectant manufacturer s recommendations when using their cleaner or disinfectant Cleaning If not using a barrier between each patient perform the following cleaning and Methods disinfecting steps 1 Remove gross bio burden from the cone handles and structure with a disposable towel moistened with water 2 Dry the cone handles and structure with disposable towels 3 Wipe the cone handles and structure with a germicidal broad spectrum disinfectant product following the disinfectant manufacturer s instructions 4 Clean any remaining disinfectant residue from the system with a disposable towel moistened with water This additional step prevents possible product discoloration or corrosion 5 Dry the cone handles and structure with paper towels Caution The Preva Dental X Ray System is not waterproof Use only moistened not saturated to
8. Company 675 Heathrow Dr Lincolnshire Illinois 60069 U S A Phone 888 924 3800 Fax 847 415 9801 techsupport progenydental com eco prx Operating Instructions Preva Operating the Preva Dental X Ray System Using the Operator Panel Power On When the Preva Dental X Ray System is powered on the Operator Panel Settings selections are those that were in use when the system was last powered off Figure 2 Preva Operator Panel j progeny Operating Instructions Preva Exposure Settings Adjusting Exposure Settings Exposure Button and Ready Indicator Ready Indicator Radiation Indicators 10 When the system is powered on the Operator Panel Figure 2 displays the exposure settings KV mA and seconds for the currently selected tooth image receptor type and patient size Use the Tooth Selection Image Receptor Type and Patient Size buttons to select other exposure settings e For a table of the factory programmed exposure settings refer to the Pre programmed Exposure Settings tables later in this manual Preset exposure settings can be adjusted prior to making an exposure Use the right arrow to select the exposure setting to adjust Then use the up and down arrow buttons to adjust the value e To save new presets use System Configuration mode described later in this manual The Exposure button is used to initiate an x ray exposure For a complete exposure the button must be pressed and held until the R
9. adiation Indicator no longer illuminates and the audible signal is no longer heard Releasing the Exposure button immediately terminates the x ray exposure CAUTION Releasing the Exposure button prior to the completion of the x ray exposure will result in an incomplete exposure of the image This may require the operator to re take the radiograph When a premature release of the Exposure button occurs the system will notify the operator momentarily then return to operating mode The Ready Indicator illuminates when the system is ready to make an exposure Immediately after an exposure the Ready Indicator flashes until the x ray tube cools down sufficiently to make the next exposure When the Ready Indicator is flashing no exposure can be made The Preva has a visible and an audible Radiation Indicator When an exposure IS in progress the Radiation Indicator on the Operator Panel is illuminated and an audible tone is heard The exposure is complete when the Radiation Indicator is extinguished and the audible tone is no longer heard eco prx Operating Instructions Taking an X Ray po Preva Turn the power switch located at the upper right of the Control Unit to the On position The Ready Indicator on the front of the Operator Panel Figure 2 will light Verify that the unit is set for the correct Image Receptor Type The icon for the currently selected Image Receptor Type is illuminated To change the Image Re
10. aintenance CONFIGURE UNIT You will see the Configuration menu shown in Figure 6 Summary 2 Select SET CONFIG You will see the Set Configuration menu shown in Figure 7 3 To display a summary of maintenance data highlight select SHOW MAINT The following maintenance data are displayed e Total KJ kilojoules total system heat on x ray tube e Exposure Count e Reboots power up cycles e OT Counts over threshold counts 4 Press any button on the Operator Panel to return to the Configuration menu Showing If you take an x ray while in diagnostic mode the display shows feedback values Feedback for that exposure Until you exit diagnostic mode the display will continue to Values After an show feedback values after each exposure 1 From the Main System Configuration menu shown in Figure 3 select Exposure CONFIGURE UNIT You will see the Configuration menu shown in Figure 6 2 Select SET CONFIG You will see the Set Configuration menu shown in Figure 7 3 From the Set Configuration menu use the up and down arrows to highlight DIAG MODE ON Press the right arrow button to turn on diagnostic mode 4 Exit System Configuration mode by highlighting and selecting EXIT in the Configuration and Main menus 5 Make an exposure The display will show the following feedback values e kV e mA e Filament current 6 Press any button on the Operator Panel to clear the feedback values from the display 7 To exit diagnostic mode depress
11. ceptor type press the Image Receptor Type button until the correct Image Receptor Type is selected Verify that the system is set for the appropriate Patient Size The icon for the currently selected Patient Size is illuminated The change the Patient Size press the Patient Size button until the correct Patient Size is selected Verify that the unit is set for the Tooth to be imaged The icon for the currently selected Tooth is illuminated To change the Tooth Selection press the Tooth Selection button until the correct Tooth is selected If desired preset exposure settings for the combination of Image Receptor Type Tooth Selection and Patient size selected in steps 2 4 can be adjusted prior to making an exposure Use the right arrow to select the exposure setting to adjust Then use the up and down arrow buttons to adjust the value Skip this step if you are using pre programmed exposure settings Note When exposure settings are being adjusted the Tooth Selection Image Receptor Type and Patient Size buttons are turned off Position the Tubehead to the patient using standard accepted positioning procedures Press and hold the Exposure button until the audible signal is no longer heard and the Radiation Indicator is no longer illuminated Releasing the Exposure button or coil cord hand switch at any time will immediately terminate the exposure Note When using the coil cord hand switch it is recommended that the operator exit the ope
12. enu shown in Figure 3 select ADJUST DISPLAY You will see the Display Options menu shown in Figure 4 2 Selecting EXIT returns the display to the Main System Configuration menu shown in Figure 3 Adjusting 1 Select ADJUST CONTRAST from the menu You will see the Progeny logo C 2 Use the up and down arrows to increase or decrease the contrast between ontrast the menu text and the display background 3 Press the right arrow to save your settings Reversing the 1 Select REVERSE IMAGE from the menu The text and display background Image colors will be swapped 2 Press the right arrow to save your settings DISPLAY OPTIONS gt REVERSE IMAGE b EXIT Figure 4 Display Options Menu g progeny 21 A Micimark Company System Configuration Preva Changing Pre programmed Exposure Settings The Preva Dental X Ray System allows the operator to increase or decrease image density for all presets for a receptor simultaneously or to change each of the technique factors for a preset individually You can also restore factory default settings For charts of the factory default settings refer to Factory Default Exposure Settings later in this manual Note If the 12 inch cone is going to be used configure the Preva for use with the 12 inch cone before changing pre programmed exposure settings Configuring the Preva for use with the 12 inch cone will reset exposure settings to the default settings used with the 12 inch cone Note Bef
13. ess the up or down button to highlight the sensor or phosphor plate to change and press Enter Select YES or NO on the Verification screen Exit the Preset Options menu Exit the Menu Options menu A message of Saving Settings will display briefly and then the system will return to the normal operational mode Note When you are working in service mode the green light next to the exposure button will blink 1 Select EDIT PRESETS from the Preset Options menu The display notifies you that you are entering Edit Preset Mode and Tooth Size Image Receptor Type and Patient Size are illuminated Use the Tooth Selection Image Receptor Type and Patient Size Selection buttons to select the preset to change The display shows the current values for the preset Use the right arrow button to display the technique factor to change Use the up and down arrow buttons to set the value for the selected technique factor and preset Repeat steps 2 4 to change additional presets When you have completed all changes press the Tooth Selection and Patient Size Selection buttons simultaneously for 5 seconds to record the change To return all presets to factory defaults select RECALL PRESETS from the Preset Options menu The menu will ask you to confirm your choice Select YES using the up arrow button and return all presets to factory default settings Selecting YES will erase any custom presets that have been set up Select NO using the down
14. g progeny A Midmark Company Preva Dental X Ray System User Manual 0120 00 02 1576 Rev V ECN P3187 g progeny A Midmark Company More Than Imaging Excellence Midmark Corporation 675 Heathrow Drive Lincolnshire Illinois 60069 U S A Phone 888 924 3800 Fax 847 415 9801 progenydental com g progeny A Midmark Company Preva Dental X Ray System User Manual 00 02 1576 Rev U ECN P2774 Midmark Corporation 675 Heathrow Dr Lincolnshire Illinois 60069 U S A Phone 888 924 3800 Fax 847 415 9801 progenydental com Progeny Dental 2006 U S Patents D470237 D469182 D470589 6 837 468 and 6 664 853 Table of Contents Preva Table of Contents Table o COMEN T TTD TET General Information 0 ee 1 Indications TOR MISC Em 1 COMI AINIGIC ANIONS EE 1 Warnings Precautions csse enn 1 Salet ADL 010 EEE EN 3 Compliance with Applicable Standards cccccceeceeeeeeeeeeeeeeeeeeeaeens 5 Certified Components eee eee e e e e e e e 5 EC Declaration of Conformity esses mene 6 Authorized Representatives eee e ee e e e 7 Explanation of Symbols on Technical Labels eee ee 8 Obtaining Technical Support cnr erret tren een 8 Operating the Preva Dental X Ray System ssssuss 9 Using the Operator Panel ernennen 9 TAI EE a UU UM 11 Using the 12 inch Cone sse 12 Recommended Maintenance
15. h 6 9 cm at the end of the Cone Specifications for optional cones differ eco prx Specifications Preva rm RATEN NE S DU LLL Ll MI IT JET o Ar m d A COOLING t NLT T IST ME Be A ad 0 50 100 150 200 250 300 TIME s Focal spot 0 4mm TT HH I Fe TE FI TT w TITT IT TT HET td Rake HH ze HH HH Figure 8 eS Toshiba Tube 0 1 1 Rating Charts Exposure Time s Tube Current mA O N A D ea progeny 3 0 A Micimark Company Specifications Figure 9 Kailong Tube Rating Charts 31 ei GQ GM bM G B IE LU Ba E GITT Tr I Thermal Characteristics Chart di Preva
16. hild Adult Child Adult Child Adult Child Adult Child Adult Child t tjt tjt tjt tjt t 60 60 65 65 60 60 60 60 60 60 60 60 7 7 7 7 7 7 7 7 7 7 7 7 0 125 0 064 0 080 0 050 0 080 0 064 0 160 0 080 0 320 0 160 0 160 0 080 12 inch Cone 30 cm Progeny Schick Dexis Kodak Sirona PSP D Speed E F Speed Adult Child Adult Child Adult Child Adult Child Adult Child Adult Child Adult Child Adult Child t tjt tjt t d rd tit tjt rid t 60 60 65 65 60 60 65 65 60 60 60 60 60 60 60 60 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 0 250 0 125 0 160 0 100 0 250 0 125 0 160 0 100 0 160 0 125 0 320 0 160 0 640 0 320 0 320 0 160 is f Progeny System Configuration Preva Changing Language Five languages are preprogrammed in the display panel To change follow the steps below Push and hold the Tooth and Patient selection switches a menu screen will appear after about 5 seconds See Figure 34A Using the down arrow highlight Configure Unit and press the right arrow key See Figure 34 Select Languages on the next screen is highlighted press the right arrow key Select the desired language and press the right arrow key If you do not see your desired language listed arrow down to More and press the right arrow key After selection arrow down to Exit and press the right arrow key then repeat this procedure to return to the main screen Figure 34A Preva Operator Panel gi progeny 1 9 M
17. icimark Company System Configuration Preva System Configuration System Configuration Mode About System The Preva Dental X Ray System has a software driven system configuration Configuration mode When the Preva is in system configuration mode you can perform the Mode following procedures e Adjusting the Display Changing Pre programmed Exposure Settings Changing the Cone Size Showing Current System Configuration Displaying Diagnostic Data Using System 1 To enter system configuration mode depress the Tooth Selection and Configuration Patient Size Selection buttons on the Operator Panel simultaneously for 5 Mode seconds The display shows the Main System Configuration menu as shown in Figure 3 and the Ready Indicator blinks 2 To select menu items while in system configuration mode use the up and down arrows to highlight a menu option Then use the right arrow button as an Enter button to select the highlighted option When changing presets the right arrow button is also used to select the technique factor 3 After selecting a menu option use the up and down arrows to increase or decrease values MENU OPTIONS gt CHANGE PRESETS gt CONFIGURE UNIT Figure 3 V Main System b EXIT Configuration Menu g progeny 20 A Micimark Company System Configuration Preva Adjusting the Display The Preva Dental X Ray System allows the operator to adjust the display image 1 From the system configuration main m
18. inserted in the top of the Control Unit The Horizontal Arm contains an access cover to connect the cable from the Horizontal Arm to the Control Unit The Horizontal Arm is available in four lengths providing reaches of 56 66 76 and 82 inches The Cone establishes the distance from the x ray tube to the patient s skin It provides positioning assistance and collimates the x ray beam to within a defined circle at its end The Preva is shipped with the standard 8 inch Cone attached to the Tubehead A 12 inch Cone 30 A2200 can be ordered as an option An optional component the remote control switch is used to make exposures in addition to or replacing the use of the exposure button An optional device the mobile unit supports pre programmed technique selections and x ray acquisition See Appendix A for the installation instructions for the mobile unit The Preva Dental X Ray System should only be installed and serviced by approved Progeny dealer personnel Contact Progeny A Midmark Company at 888 924 3800 if you need assistance locating an approved dealer p Progeny General Information Preva Figure 1 Component Diagram Caution Do not hang lead aprons on the horizontal extension arm Peer General Information Preva Compliance with Applicable Standards Radiation The certified components of the Preva Dental X Ray System comply with Protection Radiation Performance Standards 21 CFR Subchapter J at the time
19. nformation Preva Product Description The Preva Dental X Ray System is a state of the art high frequency intra oral x ray machine The Preva consists of five components as shown in Figure 1 Component Diagram the Control Unit the Tubehead the Articulating Arm the Horizontal Arm the Cone and the Remote Control option Control Unit Tubehead Articulating Arm Horizontal Arm Cone Remote Control Mobile Unit Installation and Service The Control Unit provides for the input power connection and control of the Tubehead and Operator Panel It provides automatic line voltage compensation kVp control and exposure time control The Control Unit consists of the mounting base and Operator Panel The Tubehead contains the x ray tube high voltage circuit and Cone The Tubehead is shipped already assembled to the Articulating Arm Note There is a small hole in the plastic handle covering the back of the Tubehead Under no circumstances should this hole be blocked as it provides an air vent to allow the Tubehead oil to expand and contract as the unit is operated The Articulating Arm provides the articulation support for the Tubehead and the reach and coverage of the Tubehead to the patient The Articulating Arm allows smooth movement for precise positioning and does not drift or vibrate when left in position The Horizontal Arm helps provide the necessary reach for the Preva The Horizontal Arm pivots smoothly around a shaft
20. ore changing presets use the table below to write down the presets you are programming Displaying the 1 From the Main System Configuration menu shown in Figure 3 select Preset Options CHANGE PRESETS You will see the Preset Options menu shown in Figure 5 Menu 2 Selecting EXIT returns the display to the Main System Configuration menu shown in Figure 3 PRESET OPTIONS EDIT PRESETS SELECT RECEPTOR RECALL PRESETS Figure 5 K Preset Options gt EXIT Menu Changing All 1 Select ALTER DENSITIES from the Preset Options menu The first Image Receptor Receptor Type illuminates The display shows the selected Image Receptor Settings Type and current density 2 Using the Image Receptor Type button select the image receptor to adjust Globally 3 Use the up and down arrow buttons to specify a percentage by which densities will be increased or decreased for the selected receptor Densities can be increased or decreased according to values provided on the display 4 Press Enter to save your settings g progeny 22 Micimark Company System Configuration Preprogramming to Digital Sensors Changing Presets Individually Recall Presets 23 1 2 3 4 o 6 r 8 Preva Energize the system Press the Tooth Selection and Patient Size Selection buttons for five full Seconds Select CHANGE PRESETS from the Menu Options screen Select SELECT RECEPTOR from the Preset Options menu Figure 5 Pr
21. ot of the Tubehead for easy movement while remaining in position after moving Check that all movements are smooth and quiet Verify that the Tubehead is properly counterbalanced for vertical drift and that the Horizontal and Articulating Arms do not drift horizontally Verify that the switch is working properly and that the Ready Indicator is illuminated when the power switch is in the ON position With the power switch located at the upper right of the Control Unit in the i ON position verify that technique factors appear on the Operator Panel Also check the function of the selection buttons for Tooth Selection Image Receptor Type and Patient Size Pressing a selection button should cause indicator lamps to indicate the selected item Verify that the Exposure button on the Operator Panel is functioning properly To make an exposure press and hold the Exposure button until the Radiation Indicator is extinguished and the audible signal is no longer heard Make several exposures and verify that the Radiation Indicator illuminates and the audible signal is heard Select the longest exposure time possible using the up and down arrows Initiate an exposure but release the Exposure button after a brief period of time before the timer terminates the exposure Verify that the display indicates Pre termination Error and returns to normal operating mode If a coil cord hand switch is used inspect the switch housing and coil cord fo
22. r damage or wear Replace if evidence of damage is present Make certain that the user of the system has received the User Manual eco prx Checking System Functions Preva New Tube Seasoning Procedure 16 X ray tubes that sit dormant for several months can become electrically unstable To remedy this condition it is recommended you perform a new tube seasoning procedure This process establishes stable high voltage operation and will ultimately extend the life of the tube Repeat this procedure before returning to normal operation any time the system has been unused for more than two months 1 Qo N D ole o9 I Verify system operation Energize the system Select 60 kilovolts 7 milliamperes and the exposure time of one second Make five exposures at this level observing the normal cooling time Select 65 kilovolts 7 milliamperes and the exposure time of one second Make five exposures at this level observing the normal cooling time Select 70 kilovolts 6 milliamperes and the exposure time of one second Make five exposures at this level observing the normal cooling time p Progeny Solving Performance Issues Preva Solving Performance Issues Performance Issues Light or Dark X 1 Adjust the selected exposure time kilovoltage or tube current to produce Ray Images an acceptable image If necessary reprogram the techniques factors as explained in the System Configuration section of this manual
23. ratory if possible Note In order to comply with regulations and good safety practices the technique factors must be visible to the operator from the remote location Return the Tubehead to the storage position Note Be careful not to strike the Tubehead on the wall when returning it to the storage position It may be necessary to increase or decrease the kV mA or time from the preset values for one exposure To do so 1 2 3 11 Press the Enter button to highlight the value to change Use the up or down button to increase or decrease the value no lights on the display will be lit to indicate the preset values Press the Exposure button Press any other button Tooth Film Patient Size to return the display to the preset values p Progeny Operating Instructions Preva Using the 12 inch Cone 30 A2200 12 The Preva Dental X Ray System is factory set for use with the standard supplied 8 inch 20 cm Cone The 12 inch 30 cm Cone 30 A2200 is available Using the longer cone requires longer exposure times See the System Configuration section of this manual for instructions to set the system to use the longer cone eco prx Recommended Maintenance Preva Recommended Maintenance Regular Maintenance In the interest of equipment safety a regular maintenance program must be established This maintenance program should consist of annual system function checking It is the owner s responsibility
24. t the products described herein meet all the applicable Essential Requirements of the EC Medical Device Directive 93 42 EEC in Annex I For Class llb products described herein the product is manufactured inspected tested and released in accordance with the approved quality assurance system established in accordance with ISO 13485 and Annex Il of the EC Medical Device Directive under the Supervision of the SGS United Kingdom Ltd a Notified Body Contact Technical Support techsupport progenydental com Authorized Representatives eco px General Information North America Europe Preva Midmark Corporation 675 Heathrow Dr Lincolnshire Illinois 60069 U S A Phone 888 924 3800 Fax 847 415 9801 CE Partner 4U Esdoornlaah 13 3951DB Maarn The Netherlands Phone 31 343 442 524 Fax 31 343 442 162 Explanation of Symbols on Technical Labels gt IP gt pp e r ag Type B Protection against electric shock IEC 60601 1 1988 Consult written instructions in User s Manual ATTENTION RAYONS X OPERATION SEULEMENT PAR DU PERSONNEL AUTORISE VOIR MANUEL DE L OPERATEUR WARNING X RAY THIS X RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED X RAY EMISSION Mains HOT WIRE Mains NEUTRAL WIRE Earth Ground P Progeny General Information Preva Obtaining Technical Support Contact Progeny A Midmark
25. traindications None known Warnings Precautions Radiation Safety Only qualified and authorized personnel may operate this equipment observing all laws and regulations concerning radiation protection Electrical Safety The operator at all times must remain 6ft 2m from the focal spot and the X ray beam for operator protection Full use must be made of all radiation safety features on the equipment Full use must be made of all radiation protection devices accessories and procedures available to protect the patient and operator from x ray radiation Only qualified and authorized service personnel should remove covers on the equipment This equipment must only be used in rooms or areas that comply with all applicable laws and recommendations concerning electrical safety in rooms used for medical purposes e g IEC US National Electrical code or VDE standards concerning provisions of an additional protective earth ground terminal for power supply connection Before cleaning or disinfecting this equipment must always be disconnected from the main electrical supply The Preva Dental X Ray System is ordinary type medical equipment without protection against ingress of liquids To protect against short circuit and corrosion no water or any other liquid should be allowed to leak inside the equipment Explosion This equipment must not be used in the presence of flammable or potentially Safety explosive gases or vapors which co
26. uld ignite causing personal injury and or damage to the equipment If such disinfectants are used the vapor must be allowed to disperse before using the equipment p Progeny General Information Preva Attention The equipment must only be installed and operated in accordance with the safety procedures and operating instructions given in this manual and in the User Manual for the purposes and applications for which it was designed Modifications and or additions to the equipment may only be carried out by Progeny A Midmark Company or by third parties expressly authorized by Progeny Dental to do so Such changes must comply with legal requirements as well as with the generally accepted technical rules It is the responsibility of the user to ensure that existing legal regulations regarding installation of the equipment with respect to the building are observed Caution Do not hang lead aprons on the horizontal extension arm X RAY PROTECTION X ray equipment may cause injury if used improperly The instructions contained in this manual must be read and followed when operating the Preva Your Progeny Dental dealer will assist you in placing the Preva in operation The Preva Dental X Ray System provides a high degree of protection from unnecessary X radiation However no practical design can provide complete protection nor prevent operators from exposing themselves or others to unnecessary radiation eco prx General I
27. wels progeny Checking System Functions Preva Checking System Functions The following checks must be performed to complete the installation of the Preva Dental X Ray System and as part of the recommended maintenance as indicated in the User Manual Failure to perform these checks may result in an installation that does not comply with U S Radiation Performance Standards 21 CFR Subchapter J CAUTION If the Preva Dental X Ray System does not perform the functions below advise the owner that the system is not to be used See the Troubleshooting section of this manual or contact Progeny s Technical Support M i progeny Checking System Functions Preva System Function Checklist Wall Mounting Labels Tubehead Tubehead Rotation Operator Panel Controls Exposure Button Exposure Indicators Premature Termination Coil cord Hand Switch Option User Information Ensure that the wall support is adequate and that the system is properly mounted to the wall Ensure that all certified components bear labels that include the model and serial number date of manufacture and a statement of certification as noted elsewhere in this manual Check for oil leaks or other evidence that could indicate internal damage Replace the Tubehead if necessary Ensure that the Tubehead maintains its position around the horizontal axis while remaining easy to rotate and position Also check the vertical piv
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