User Manual
Contents
1. 10 LISING THE OPERATOR PAN NER ei ee rl 10 TAKING E cage EG iis opi at eat 12 USING THE 30 MM CONE 30 A2200 obe bac hae diues Qe debes d duce a 19 RECOMMENDED MAINTENANCE e ELSE RENEE EEN EN ENE NERE NERE EEN EN ERE 14 REGULAR MAINTENANCE ENERO TRO RUM K m 14 CEHEANINGANDIDISINEEG TING cervis staves wed elimuanwior Dutawbre Uie oe tude we Tiros adeo oco 14 CHECKING SYSTEM FUNCTIONS 1 Lc corre rrr rrr enun nennen rne a arua nra Rr a Rr RENS 15 SYSTEMASBNCTION CHECKS E 35 ld fuse tuere o cs vede pos b Mel d ar ute conten pad 16 NEW TUBE SEASONING PROCEDURE rete Dive tec toe aa aude cic alate e Seen es OUS at aah 17 SOLVING PERFORMANCE ISSUES Lee rere r rere RENEE RENE RENEE RENE RENEE RENE a Rr a REA 18 PERFORMANCE ISSUES ERE RE rer EET EET EET TELE ENE 18 OBTAINING TECHNICAL SUPPORT sccececccceccececcceccceceececuucecuccecucausecueuecsececueaecauaecseauaucaesecsenecsua2. MANSIS Preva Dental X ray System 1 User Manual CC 0120 00 02 1576 Rev W ECN P3447 ALLE MARS Preva Dental X ray System User Manual Midmark Corporation 675 Heathrow Dr Lincolnshire Illinois 60069 USA Phone 800 MIDMARK Fax 847 415 9801 midmark com Midmark Corporation 2014 U S Patents D470237 D469182 D470589 and 6 837 468 Table of Contents Preva Table of Contents TABLE OF CONTENTS 3 idi ED see Sie Sie ete a Manne td GENERAL INFORMATION wicca hee eect Le la 1 TSHR Ore S RN 1 WARNINGS TPRECAB TIONS euis deste a DEGREE 1 KRAN EP ROTE CIN EF MT MEUM MEI SEDIT 2 PRODUCT ES lO ease EE PAE PEE 2 GERTIFIED GOMPONENTS eus cn rine tients testes Med ELNA M E ER EA LIII rne UR ai Le n RET Ert 4 AUTHORIZED REPRESENTATIVES cccccecccceccccecccceccececuccecuececuccucecuececsuaecuuaesueaesecausecausecsuaecseeceeaceucausersuaeeaceas 4 EXPLANATION OF SYMBOLS ON TECHNICAL LABELS cccsceccececcececcececcececcecacuccucucuecueuecuuaeceuaucueacaucaeuecauaecess 5 COMPLIANCE WITH APPLICABLE STANDARDS ccccscocceccccecccecccecccecucceceececuceecucusecuenesseaessuaessuaeeuceceecaees 6 OBTAINING TECHNICAL SUPPORT sccccececcececcececcecsccecsccececucecsucecsucecsecesscauueceuecsucecsucessuausscausecuuaecsuaecsuaesas 9 OPERATING
3. RI eo ul Qo c o co HEAT STORAGE J c e 1000 3000 100 150 200 32 Thermal Characteristics Chart
4. Using the Operator Panel Power On Settings Figure 2 Preva Operator Panel Icons When the Preva Dental X ray System is powered on the Operator Panel selections are those that were in use when the system was last powered off 2 7 3 4 5 8 6 9 Large LED screen displays technique settings It also displays menu selections when the system is in menu mode Up and Down arrows are used to change kV mA and time settings Tooth Icon Pressing this button allows the user to select Incisor Bicuspid Bitewing upper or Lower Molar Receptor Icon Choices are Digital D Speed film Speed Film If using phosphor plates select E F Speed Film Setting Patient Size Icon Press to select Large or Small Ready Indicator Circle lights up to indicate that the system is ready to produce X ray Right Arrow Button Use this button to move between kV mA and time selections This button is also used as an Enter key when the System is in menu mode Radiation Indicator This symbol lights up when an X ray is produced Exposure Button Pressing this button will produce an X ray exposure 10 MIIDNIARI Operating Instructions Preva Exposure Settings Adjusting Exposure Settings Exposure Button and Ready Indicator Ready Indicator Radiation Indicators When the system is powered on the operator panel Figure 2 displays the exposure settings kV m and seconds for the currently selected tooth imag
5. CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Preva Dental X ray System is suitable for use in all establishments CISPR 11 including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for IEC 61000 3 2 domestic purposes Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunit The Preva Dental X ray System is intended for use in the electromagnetic environment specified below The customer or the user of the Preva Dental X ray System should assure that it is used in such an environment Immunity test IEC 60601 test level Companies Electromagnetic level environment guidance Electrostatic discharge 6 kV contact 6 contact Floors should be wood concrete or ESD 8 kV air 8 kV air ceramic tile If the floors are covered IEC 61000 4 2 with synthetic material the relative humidity should be at least 3096 Electrical fast 2 kV for power supply lines 2 kV for Mains power quality should be that of transient burst 1 kV for input output lines power supply a transient burst supply lines typical IEC 61000 4 4 lines commercial or hospital environment 1 kV for input output lines IEC 61000 4 5 2 kV line s to earth Voltage dips lt 5 Ut 29596 dip in Ur for Not Applicable
6. 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 pivot 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 ON i 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 E
7. interruptions and 0 5 cycle voltage variations on lt 40 Ur 60 dip in Ur for power supply input 5 cycles lines lt 70 Ur 80 dip in Ur for IEC 61000 4 11 25 cycles lt 5 Ut gt 95 dip in Ur for 5 s Power frequency Power frequency magnetic fields 50 60 Hz magnetic should be at levels characteristic of a field typical location in a typical commercial IEC 61000 4 8 or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level 7 MIDMARIX General Information Preva Guidance and manufacturer s declaration electromagnetic immunity The Preva Dental X ray System is intended for use in the electromagnetic environment specified below The customer or the user of the Preva Dental X ray System should assure that it is used in such an environment IEC 60601 Complian Electromagnetic environment guidance test test level ce level g g Portable and mobile RF communications equipment should be used no closer to any part of the Preva Dental X ray System equipment including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted 3V 3V d 1 2 x VP RF 150 kHz to IEC 61000 80 MHz 4 6 Radiated RF 3 V m 3 V m d 1 2 x VP 80 MHz to 800 MHz IEC 61000 80 MHz to d 2 3 x VP 800 MHz to 2 5 GHz 4 3 2 5 GHz Where P is the maximum output power rating of the transm
8. Receptor a D speed Film B E F Speed Film H Tooth Selection Bitewing 26 System Configuration Preva Showing Current System Configuration The Preva Dental X ray System displays the current system configuration This display is informational only 1 From the Main System Configuration menu shown in Figure 4 select CONFIGURE UNIT You will see the Configuration menu shown in Figure 7 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 gt SET CONFIG gt SHOW MAINT Configuration gt EXIT Menu Figure 7 27 MIIIMARI lt System Configuration Preva Changing the Cone Size Using a 12 inch 30 cm Cone Figure 8 Set Configuration Menu Selecting SET CONFIG from the Configuration menu shown in Figure 7 displays the Set Configuration menu Figure 8 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 1 2 From the Main System Configuration menu shown in Figure 4 select CONFIGURE UNIT You will see the Configuration menu shown
9. Recommended separation distances between portable and mobile RF communications equipment and Preva Dental X ray System The Preva Dental X ray System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the sensor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the sensor as recommended below according to the maximum output power of the communications equipment power of transmitter W m Ee ase d 1 2 x VP d 1 2 x VP d 2 3 x VP For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Obtaining Technical Support Contact Midmark Corporation 675 Heathrow Dr Lincolnshire Illinois 60069 U S A Phone 800 MIDMARK Fax 847 415 9801 imagingtechsupport midmark com MIDMARIX Operating Instructions Preva Operating Instructions
10. an X ray follow the Steps on page 12 to take an X ray while in diagnostic mode the display shows feedback values for that exposure Until you exit diagnostic mode the display will continue to show feedback values after each exposure 1 From the Main System Configuration menu shown in Figure 4 select CONFIGURE UNIT You will see the Configuration menu shown in Figure 7 2 Select SET CONFIG You will see the Set Configuration menu shown in Figure 8 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 Take an X ray The display will show the following feedback values e kV 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 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 29 Specifications Preva Specifications Preva Dental X ray System Line Voltage Line Load Tube Potential Tube Current Irradiation Time Minimum Source to Skin Distan
11. in Figure 7 Select SET CONFIG You will see the Set Configuration menu shown in Figure 8 From the Set Configuration menu use the up and down arrows to highlight 12 CONE SIZE 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 Using the up arrow select YES to install presets for the 12 inch Cone SET CONFIG p12 CONE SIZE PDIAG MODE ON PDIAG MODE OFF gt EXIT 28 MIIIMARI lt System Configuration Preva Diagnostic Mode About Diagnostic Mode Showing the Maintenance Summary Showing Feedback Values After an Exposure The Preva Dental X ray System has a diagnostic mode in which you can display a summary of maintenance data or display feedback values after each exposure 1 From the Main System Configuration menu shown in Figure 4 select CONFIGURE UNIT You will see the Configuration menu shown in Figure 7 2 Select SET CONFIG You will see the Set Configuration menu shown in Figure 8 3 To display a summary of maintenance data highlight select SHOW MAINT from the Configuration menu 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 If you take
12. option When changing presets the right arrow button is also used to select the technique factor After selecting a menu option use the up and down arrows to increase or decrease values MENU OPTIONS gt CHANGE PRESETS gt CONFIGURE UNIT gt EXIT ji MIDMARI lt System Configuration Preva Adjusting the Display Adjusting Contrast Reversing the Image Figure 5 Display Options Menu The Preva Dental X ray System allows the operator to adjust the display image 1 2 From the system configuration main menu shown in Figure 4 select ADJUST DISPLAY You will see the Display Options menu shown in Figure 5 Selecting EXIT returns the display to the Main System Configuration menu shown in Figure 4 Select ADJUST CONTRAST from the menu You will see the Progeny logo Use the up and down arrows to increase or decrease the contrast between the menu text and the display background Press the right arrow to save your settings Select REVERSE IMAGE from the menu The text and display background colors will be swapped Press the right arrow to save your settings DISPLAY OPTIONS REVERSE IMAGE b EXIT 22 MIDMARI lt System Configuration Preva Changing Preprogrammed Exposure Settings Displaying the Preset Options Menu Figure 6 Preset Options Menu Changing All Receptor Settings Globally The Preva Dental X ray System allows the operator to increase or decrease image density fo
13. 1988 Consult written instructions in User Manual 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 0 zr BE PE gt MIINDMARIK General Information Preva Compliance with Applicable Standards The following regulatory documents apply Radiation Protection UL 2601 1 File Number E181750 General Safety EMI EMC Degree of Protection Imaging Performance EMC Statement The certified components of the Preva Dental X ray System comply with Radiation Performance Standards 21 CFR Subchapter J at the time of manufacture The certified components of the Preva Dental X ray System comply with IEC 60601 1 3 Radiation protection X ray equipment Classified by Underwriters Laboratories Inc with respect to electrical shock fire and mechanical hazards only in accordance with UL 2601 1 and CAN CSA C22 2 NO 601 1 M90 and to the following particular standards IEC 60601 2 7 IEC 60601 2 28 IEC 60601 1 1995 Protection against electrical shock Class Degree of protection against electrical shock Type BF Applied Part Degree of protection against ingress of water IP67 Not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide IEC 60601 1 2 2007 IEC 60529 2001 Degree of p
14. Configuration Preva Preprogramming to Digital Sensors Changing Presets Individually Recall Presets 6 Ta 8 Turn the system on Push and hold the Tooth and Patient selection switches a menu screen will appear after about 5 seconds Select CHANGE PRESETS from the Menu Options screen Select SELECT RECEPTOR from the Preset Options menu Figure 6 Press 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 Turn the system on Push and hold the Tooth and Patient selection switches a menu screen will appear after about 5 seconds 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 highlight the technique factor tube voltage in kilovolt kV tube current in milliamp mA or duration in seconds s to change Use the up and down a
15. ause injury if used improperly The instructions contained in this manual must be read and followed when operating the Preva Your Midmark Sales Corporation 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 Product Description The Preva Dental X ray System is a 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 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 Tubehead The Tubehead contains the X ray tube high voltage circuit and Cone It is shipped already assembled to the Articulating Arm Warning 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 Articulating Arm The Articulating Arm provides the articulati
16. ce Focal Spot Operating Temperature Storage Temperature Maximum Altitude X ray Beam Dimension Humidity Range Operation amp Storage AC 100 V to 250 V 50 Hz or 60 Hz 250 V UL Recognized It is recommended that branch circuit does not exceed 15A 60 kV 65 kV 70 kV 4 mA 5 mA 6 mA 7 mA 7 mA is not available at 70 kV 20 ms through 2 s 8 inch 20 cm 12 inch 30 cm 0 4 mm per IEC 60336 50 F to 95 F 10 C to 35 C 31 F to 150 F 35 C to 66 C 12 000 ft 3 657 m Diameter of 2 72 inches 7 cm at the end of the 7 inch Cone Cones with smaller diameter or rectangular beams are available 10 to 80 non condensing 30 Specifications Preva Statements and Information According to 21 CFR Sub Chapter J 1020 30 h 1 i 1020 30 h 1 ii 1020 30 h 2 i 1020 30 h 2 ii 1020 30 h 2 iii 1020 30 h 3 i 1020 30 h 3 ii and iii 1020 30 h 3 v 1020 30 h 3 vi 1020 30 h 3 viii Instructions for the use of the Preva and precautionary statements are part of this User s Manual As described in the Recommended Maintenance section the Preva should be serviced on an annual basis to ensure proper functionality It is the owner s responsibility to arrange for this service and to assure that the personnel performing this service are fully qualified to service Midmark Corporation X ray equipment Leakage t
17. cond 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 is MIDMARIX Solving Performance Issues Preva Solving Performance Issues Performance Issues Light or Dark 1 Adjust the selected exposure time kilovoltage kV or tube current to X ray Images produce an acceptable image If necessary reprogram the technique factors as explained in the System Configuration section on page 19 of this manual 2 Verify the kilovoltage and tube current during an exposure using the diagnostic mode as explained in the System Configuration section pg 19 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 occur Error After five seconds the system w
18. 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 Drythe cone handles and structure with paper towels Caution The Preva Dental X ray System is not waterproof Use only moistened not saturated towels MIDMARIX 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 the system is not to be used See the Troubleshooting section of the Installation Guide or contact Midmark Corporation s Technical Support MIDMARIX Checking System Functions Preva System Function Checklist Wall Mounting Labels Tubehead Tubehead Rotation
19. e receptor type and patient size Use the Tooth Selection Image Receptor Type and Patient Size buttons to select other exposure settings For a table of the factory programmed exposure settings refer to the Preprogrammed Exposure Settings tables on page 19 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 To save new presets use System Configuration Mode described on page 21 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 Radiation 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 and 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
20. eceuaeseuaeeas 18 SYSTEM CONFIGURATION caisson ermal ee rt enc 19 PREPROGRAMMED EXPOSURE TIMES scsccececcececcececcecuccececececsucecsucecuuaecacausecuucecsusecsutecsucusaeausecausecaunecass 19 CHANGING LANGUA EINER SERIE ERN PE MER 20 SYSTEM CONFIGURATION MODE arcana tates rye da uou o MEME nto ee eae dele E DIM M tU a 21 ADJUSTINGCORHEJADISPEAY s 3 iud edes mena ene 22 CHANGING PREPROGRAMMED EXPOSURE SETTINGS scssceccececcececcccecccceccccecuececeeaeceeaucucueucuesecsuaeeauaeeesaeeas 23 RECORD YOUR EXPOSURE SETTINGS 8 20 CM CONE cccccsssseeeeceecsseeeecescuseeeecesaseeeecssauseeeesesaseeees 25 RECORD YOUR EXPOSURE SETTINGS 12 30 CM CONE ccccccsseeececcceseeeeessceseeeeesecaseeeeessceseeeeessoeseeess 26 SHOWING CURRENT SYSTEM CONFIGURATION ccccececececcececececcccecececuccececueceaesecscaeaunecscecauausecscauaunensceeaeners 27 CHANGING THE GONE SIZE 55 stereo ee ta Eon cene ees M 28 HOMODE aoe 29 SPEGIPIGA TIONS vices hese clum 30 PREVA DENTALSERAY OO a aaa aa ERE ne kel 30 STATEMENTS AND INFORMATION ACCORDING TO 21 CFR SUB CHAPTER J ccceceececececeececeececeececeeaeceeaeees 31 THERMAL CHARACTERISTICS GHAR Is wanes Dicet tot ete D p OD UD ce ergs des beeen pep 32 MIIDNMIARIC General Information Preva General Information Intended Use The intended use of the Preva Dental X Ray System is to act as a dia
21. echnique factors 70 kV 0 4 mA Minimum filtration half value layer in useful beam 1 7 mm Al equivalent at 70 kV The cooling curve charts for the anode can be found on page 32 Please note that due to the integrated design of the Preva there is no meaningful separate cooling curve for the tube housing Since the Preva operates as a complete system in only one mode as a high frequency X ray system there is no need to provide a tube rating chart Rated nominal line voltage 110 V 230 V Line voltage regulation 1096 of the nominal line voltage The maximum momentary line current less than 5 s of the Preva is 10 A when operated on 120 V 1 2 kW Operation at higher input voltage will reduce the maximum current 5 A at 240 V The technique factors producing the maximum momentary line current are 65 kV 7 mA 2S Generator rating at maximum technique factor of 65 kV 7 mA is 455 W Duty cycle is 1 15 Maximum deviation from indicated values a Peak tube potential maximum deviation 5 b Tube current maximum deviation 1 mA c Exposure time min 20 ms max 2 s max deviation 5 1 ms The measurement criteria for all technique factors used in paragraphs h 3 ili and h 3 vi is 90 of the selected peak tube voltage T MIDMARIX Specifications Preva Thermal Characteristics Charts Figure 9 Toshiba Tube Rating Chart Figure 10 Kailong Tube Rating Chart 4500 4000 3500
22. fore 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 could 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 MIDMARIX 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 Installation Guide for the purposes and applications for which it was designed Modifications and or additions to the equipment may only be carried out by Midmark Corporation or by third parties expressly authorized by Midmark Corporation 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 c
23. g the down arrow highlight Configure Unit and press the right arrow key See Figure 3 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 3 Preva Operator Panel 20 MIIIMARI lt System Configuration Preva System Configuration Mode About System Configuration Mode Using System Configuration Mode Figure 4 Main System Configuration Menu The Preva Dental X ray System has a software driven system configuration mode When the Preva is in system configuration mode you can perform the following procedures Adjusting the Display Changing Preprogrammed Exposure Settings Changing the Cone Size Showing Current System Configuration Displaying Diagnostic Data To enter system configuration mode depress the Tooth Selection and Patient Size Selection buttons on the Operator Panel simultaneously for 5 seconds The display shows the Main System Configuration menu as shown in Figure 4 and the Ready Indicator blinks 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
24. gnostic source for radiographic dental imaging Warnings Precautions Radiation Safety Only qualified and authorized personnel may operate this equipment observing all laws and regulations concerning radiation protection The operator at all times must remain at a safe distance 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 Electrical Safety WARNING To avoid the risk of electric shock this equipment must only be connected to supply mains with protective earth Only qualified and authorized service personnel should remove covers on the equipment All maintenance that requires removing of protective covers must be executed by service personnel when the patient is not present The sensor shall only be replaced when the operator and any part of the machine does not touch the patient Caution Operator is not to touch the USB connector on the Articulated Arm 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 Be
25. 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 T MIDMARIX Operating Instructions Preva Taking an X ray en 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 Receptor 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 To 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 se
26. iculating Arm E NN Remote Control Caution Do not hang lead aprons on the horizontal extension arm 2 MIDMARI lt General Information Preva Certified Components System Component Reference Number Tubehead 30 A1027 Control Unit Preva 30 A0010 Control Unit Preva Mobile 30 A0013 Modular BLD 20 cm Lg 70 mm Cone Gray 30 A2195 Modular BLD 30 cm Lg 70 mm Cone Gray 30 A2200 Modular BLD 20 cm Lg 60 mm Cone White 30 A2196 Modular BLD 30 cm Lg 60 mm Cone White 30 A2201 Modular BLD 30 cm Lg 60 mm Cone Gray 30 A2229 Modular BLD 20 cm Lg 30x40 mm Cone White 30 A2198 Modular BLD 30 cm Lg 30x40 mm Cone White 30 A2203 Modular BLD 20 cm Lg 20x30 mm Cone White 30 A2199 Modular BLD 20 cm Lg 35x45 mm Cone Gray 30 A2221 Modular BLD 20 cm Lg 35x45 mm Cone White 30 A2222 Modular BLD 30 cm Lg 35x45 mm Cone Gray 30 A2223 Modular BLD 30 cm Lg 35x45 mm Cone White 30 A2224 Modular BLD Base Gray 30 A2205 Modular BLD Spacer Gray 30 A2206 Modular BLD Spacer White 30 A2208 Authorized Representatives North Midmark Corporation America 675 Heathrow Dr Lincolnshire Illinois 60069 U S A Phone 800 MIDMARK Fax 847 415 9801 Europe CE Partner 4U Esdoornlaan 13 3951DB Maarn The Netherlands www cepartner4u eu 4 MIRDMARIK General Information Preva Explanation of Symbols on Technical Labels Type B Protection against electric shock IEC 60601 1
27. ill return to the normal operating condition Be advised that this will result in an underexposed image Obtaining Technical Support If the above steps do not resolve any of the error issues that you are experiencing suspend use of the X ray unit and contact Midmark Technical Support for assistance Contact Midmark Corporation 675 Heathrow Dr Lincolnshire Illinois 60069 U S A Phone 1 800 MIDMARK Fax 847 415 9801 imagingtechsupport midmark com i MIDMARIX System Configuration Preva System Configuration Preprogrammed 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 System Configuration Mode on page 21 for details 8inch Cone 20 cm Progeny Schick Sirona PSP D Speed EF Speed Adult Child Adult Child Adult Child Adult Child Adult Child Adult Child Adult Child f o 60 Kodak D Speed Adult Child Adult Child Adult Child Adult Child Adult Child Adult Child P t5 It NL 65 60 60 ri rj 0 160 0 320 19 System Configuration Preva Changing Lanquage 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 3 Usin
28. itter in watts W according to the transmitter manufacture and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 9 TU NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Preva Dental X ray System is used exceeds the applicable RF compliance level above the Preva Dental X ray System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Preva Dental X ray System Over the frequency range 150 kHz to 80 MHz field strengths should be less than Vi V m MIPMARIC General Information Preva
29. on support for the Tubehead and the reach and coverage of the Tubehead to the patient Horizontal Arm The Horizontal Arm helps provide the necessary reach for the Preva It pivots around a shaft inserted in the top of the Control Unit and contains an access cover to connect the cable from the Horizontal Arm to the Control Unit It is available in four lengths on wall mount units providing reaches of 56 66 76 and 82 inches 142 167 193 208 cm a MIDMARIKX General Information Preva Modular Beam Limiting Device BLD Remote Control Model Configurations Installation and Service Figure 1 Component Diagram 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 20 cm Cone attached to the Tubehead A 12 inch 30 cm Cone 30 A2200 can be ordered as an option An optional remote control switch is available to make exposures in addition to or replacing the use of the exposure button The Preva is available as both a wall mount and mobile unit See the Preva Installation and Service Manual for installation and mounting instructions The Preva Dental X ray System should only be installed and serviced by approved Midmark dealer personnel Contact Midmark Sales Corporation at 800 MIDMARK if you need assistance locating an approved dealer Art
30. perating Instructions Preva Using the 30 mm Cone 30 A2200 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 on page 19 of this manual for instructions to set the system to use the longer cone i5 MIDMARIX 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 to arrange for this service and to assure that the personnel performing this are fully qualified to service Midmark Corporation X ray equipment Cleaning and Disinfecting Cleaning Employ personal protective equipment to prevent the spread of infections Clean the outside of the system using a damp towel or non alcohol based Disinieenng disinfectant CAUTION 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 manufacturers recommendations when using their cleaner or disinfectant Cleaning If not using a barrier between each patient perform the following cleaning and Methods
31. r 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 Preprogrammed Exposure Settings on page 19 in this manual Note If the 12 inch 30 cm cone is going to be used configure the Preva for use with the 12 inch cone before changing preprogrammed 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 Before changing presets use the tables on pages 25 and 26 to write down the presets you are programming 1 From the Main System Configuration menu shown in Figure 4 select CHANGE PRESETS You will see the Preset Options menu shown in Figure 6 2 Selecting EXIT returns the display to the Main System Configuration menu shown in Figure 4 1 Select ALTER DENSITIES from the Preset Options menu The first Image Receptor Type illuminates The display shows the selected Image Receptor Type and current density Using the Image Receptor Type button select the image receptor to adjust 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 oo N 23 System
32. rotection against ingress of water IP67 IEC 61223 3 4 200 Line pair resolution better than 8 lp mm Low contrast resolution all holes visible Information regarding potential EMC interference and advice for avoidance The Preva Dental X ray System is considered as non life supporting equipment While using Preva Dental X ray System adjacent to other equipment configuration should be carefully adjusted to ensure that electromagnetic interference EMI does not degrade performance Specifically mobile RF communications equipment can effect medical electrical equipment Please refer to the EMC table below Usage limitation Preva Dental X ray System when integrated with ClearVision Sensors shall be used with IEC 60950 or IEC 60601 compliant computers Also any device between the integrated Preva Dental X ray System and the computer USB Hub shall be compliant with IEC 60950 or IEC 60601 If not this may result in degraded electromagnetic compatibility r MIDMARIX General Information Preva Guidance and manufacturer s declaration electromagnetic emissions The Preva Dental X ray System is intended for use in the electromagnetic environment specified below The customer or the user of the Preva Dental X ray System should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emission Group 1 The Preva Dental X ray System uses RF energy only for its internal
33. rrow 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 Turn the system on Push and hold the Tooth and Patient selection switches a menu screen will appear after about 5 seconds 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 arrow buiton and retain current presets 24 System Configuration Preva Record Your Exposure Settings 8 20 cm Cone If the preprogrammed exposure settings do not produce the density desired adjust the settings using oystem Configuration mode Record your settings in the table below 8 inch 20 cm Cone Digital Receptor D speed Film l E F Speed Film H Tooth Selection Bitewing n 25 System Configuration Preva Record Your Exposure Settings 12 30 cm Cone If the preprogrammed exposure settings do not produce the density desired adjust the settings using oystem Configuration mode Record your settings in the table below 12 inch 30 cm Cone Digital
34. tting to adjust Then use the up and down arrow buttons to adjust the value Skip this step if you are using preprogrammed 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 operatory 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 anything 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 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 or Patient Size to return the display to the preset values re MIDMARIX O
35. xposure 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 for damage or wear Replace if evidence of damage is present Make certain that the user of the system has received the User Manual 1 MIDMARIX Checking System Functions Preva New Tube Seasoning Procedure 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 2 3 POS AL por Ole Verify system operation Energize the system Select 60 kilovolts kV 7 milliamperes mA and the exposure time of one se
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