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1.    4  5    HELIODENT LUS    Maintenance Instructions                    a sironal Op   aa  O  HON oos    EOR      t     d           NUE         NNT        Maintenance Instructions Sirona Dental Systems GmbH       ATTENTION     Adequate lead proofing of room and operator position is  essential    Since these requirements vary from state to state it is the  assembler s   installer s responsibility that all local radiation  safety requirements are met        2 62 15 144 D 3507 101 01 02 02    Sirona Dental Systems GmbH Maintenance Instructions       General    In order to ensure in compliance with the DHHS requirements the HELIODENT YS must be maintained  annually following date of installation  It is the responsibility of the user to ensure that the equipment is main   tained in accordance with the manufacturer s recommended Maintenance Instructions to ensure compli   ance with the Federal Performance Standard    The manufacturer and the assembler installer are not responsible for disturbances in operation when the  equipment is not used in accordance with the operating instructions    The maintenance inspection and consequent service must be accomplished by a skilled technician   Neither the inspection nor service is part of the equipment warranty     Technical instructions required  Operating Instructions and Service Manual    Instruments required  1  Digital multimeter model FLUKE 87 V  or equivalent  Accuracy  AC voltage   0 5  of reading plus 1 digit  DC voltage   0 1  of 
2.  at the Display  Audible Sound at the Wall Adapter     62 15 144 D 3507 101 01 02 02    Switch unit ON with master power switch  The stored exposure data must light up on the display   see Operating Instructions under    Preparing the exposure        Make an exposure         Set the exposure time to 1 00 s for conventional radiography technique        CAUTION RADIATION  Depress the exposure button and hold until the exposure terminates auto   matically  The radiation indication X ray must light up during the exposure period   Also the backlight colour of the display must change into yellow  Simultaneously an audible beep  must sound at the wall adapter  In operation with remote control  the wall adapter and the remote  control must imitate an audible beep  The display backlight colour will change automatically from  white into blue  when the cooling down time has finished  Also the value of the imitate X ray dose will  vanish from the display    Interrupt an exposure     deadman feature         Set the exposure time to 3 2s        CAUTION RADIATION  Press the exposure button until X ray lights up and subsequently release      the exposure must terminate immediately  The exposure time which had really happen blinks  It can  diversify an depends on the time how long the exposure button was pressed  Press any key on the  front panel to return to the automatic cooling down process on the display    Defective light indicators constitute a safety hazard to the patient as well as to
3.  product complies with DHHS    This product complies with DHHS     Date of manufacture  regulations 21 CFR Subchapter J   regulations 21 CFR Subchapter J      October 2008 Ge    0123 applicable at date of manufacture   ble at date of manufact h    ree or manutan        Sree Done Sonne Date of manufacture     October 2008   N 0 64625 Bensheim   Sorte Domai SHom Cmoki October 2008  Sirona Dental Systoms Sa M   7 Bensheim  Germany Sirona Dental Systems GmbH  z nae 34 E Se MADE IN GERMANY FabrikstraBe 31  ene m D 64625 Bensheim  Germany       Visual Check    e Look for mechanical damage  possibly affecting radiation safety       Inspect cone for possible cracks   e Check the mechanical functions     Test the tubehead in all working positions for possible drift     e Verify that all labels are affixed and legible   Defaced labels must be replaced     To order the above  write to Sirona Dental Systems  address  see rear     giving details on  Customer Name  Customer Address  All Model Numbers with    Serial Numbers still legible on the unit for identification purposes   For serial numbers see also Installation Report   Warranty Passport     62 15 144 D 3507 101 01 02 02    Sirona Dental Systems GmbH Maintenance Instructions       Standby indicator lamp Radiation indication  Ready LED X ray       Remote Timer Remote control                      Exposure button       ATTENTION RADIATION  Observe   Radiation Protection Guidelines   See Operating Instructions           Light Indicators
4.  the operator    CAUTION  The user is not permitted to use the unit until light indicators have been replaced     Maintenance Instructions Sirona Dental Systems GmbH          lol  ps    R  UW      gt  a       S3 LOSEG 882 94 19                               7 mA  1 4 mA          Tube Current Verification      Turn unit OFF and remove housing  see Service Manual       Connect multimeter to X600  range 10mADC   e Turn unit ON   WARNING  Electrical shock hazard      e Set the exposure time on the control panel to 3 2s  using the   or   button   conventional radiography technique        CAUTION RADIATION  Make an exposure   e The reading should be 7mADC  1 4 mA  Record reading   e If specified value is obtained turn unit OFF     Remove meter leads       If specified value cannot be obtained  see Service Manual  chapter  Tube Current Verification        6 62 15 144 D 3507 101 01 02 02    Sirona Dental Systems GmbH Maintenance Instructions            Focus marking    SSD   Source to  Skin Distance 8               Dose Detector          Exposure Time Verification and kV Verification     conventional radiography technique       For testing the exposure times a Digital Dosimeter is required  PTW Diados      Place the Dose Detector in a distance of 8  in front of the Tube Head     Switch unit ON     CAUTION RADIATION  Make an exposure with   Voltage  60 kV  Exposure time  0 4 sec      The reading should be 0 4 sec  0 04 sec   kV   60kV  6kV  Record reading   e Switch unit OFF   e If th
5.  with  MFG specified tests and safety    Technician  Dealer                                                                                                                                               Measurement        mA  Measurement        sec  Measurement        kV          62 15 144 D 3507 101 01 02 02       HELIODENTPLUS    Yearly Maintenance Checklist          Customer  Address   Dealer  Address   Date of original installation  Date of inspection     Report of Assembly FD 2579      The Dental Company                                                             SCHEDULE Yes No Remarks  All manuals are present  Test instruments as required  Manufacturer Model Accuracy Last calibrated  Voltmeter  mAmeter                Exposure Time             Any mechanical damage noticed   All labels are present and legible   All indicator lights are O K    Radiation indicator X ray lights up  audible buzzer O K   Deadman feature O K    Tube current is within specified limits   Specified exposure time O K    Specified kV Value is O K    Exposure button O K  Resistance within specified limits  All keys O K    Mechanical adjustment of the support arm is O K     The unit is in compliance with  MFG specified tests and safety    Technician  Dealer                                                                                                                                               Measurement        mA  Measurement        sec  Measurement        kV          62 15 144 D 3507 101 01 02 
6. 02       HELIODENTPLUS    Yearly Maintenance Checklist          Customer  Address   Dealer  Address   Date of original installation  Date of inspection     Report of Assembly FD 2579      The Dental Company                                                             SCHEDULE Yes No Remarks  All manuals are present  Test instruments as required  Manufacturer Model Accuracy Last calibrated  Voltmeter  mAmeter                Exposure Time             Any mechanical damage noticed   All labels are present and legible   All indicator lights are O K    Radiation indicator X ray lights up  audible buzzer O K   Deadman feature O K    Tube current is within specified limits   Specified exposure time O K    Specified kV Value is O K    Exposure button O K  Resistance within specified limits  All keys O K    Mechanical adjustment of the support arm is O K     The unit is in compliance with  MFG specified tests and safety    Technician  Dealer                                                                                                                                               Measurement        mA  Measurement        sec  Measurement        kV          62 15 144 D 3507 101 01 02 02       We reserve the right to make any alterations which may be required due to technical improvements        Sirona Dental Systems GmbH 2009 Sprache  englisch Printed in Germany  D 3507 101 01 02 02 07 2010 A  Nr   112570 Imprim   en Allemagne    Sirona Dental Systems GmbH    in the USA   FabrikstraBe 
7. 31 Sirona Dental Systems LLC Order No 62 15 144 D 3507  64625 Bensheim 4835 Sirona Drive  Suite 100  Germany Charlotte  NC 28273    www sirona com USA    
8. ULE Yes No Remarks  All manuals are present  Test instruments as required  Manufacturer Model Accuracy Last calibrated  Voltmeter  mAmeter                Exposure Time             Any mechanical damage noticed   All labels are present and legible   All indicator lights are O K    Radiation indicator X ray lights up  audible buzzer O K   Deadman feature O K    Tube current is within specified limits   Specified exposure time O K    Specified kV Value is O K    Exposure button O K  Resistance within specified limits  All keys O K    Mechanical adjustment of the support arm is O K     The unit is in compliance with  MFG specified tests and safety    Technician  Dealer                                                                                                                                               Measurement        mA  Measurement        sec  Measurement        kV          62 15 144 D 3507 101 01 02 02       HELIODENTPLUS    Yearly Maintenance Checklist          Customer  Address   Dealer  Address   Date of original installation  Date of inspection     Report of Assembly FD 2579      The Dental Company                                                             SCHEDULE Yes No Remarks  All manuals are present  Test instruments as required  Manufacturer Model Accuracy Last calibrated  Voltmeter  mAmeter                Exposure Time             Any mechanical damage noticed   All labels are present and legible   All indicator lights are O K    Radiation indicator X ray 
9. e measured Radiation Time is not within specified tolerance   see Service Manual  chapter  Exposure Time Verification       e If the measured kV Verification is not within specified tolerance   see Service Manual  chapter    KV Verification        62 15 144 D 3507 101 01 02 02 7    Maintenance Instructions Sirona Dental Systems GmbH                      34       See SUIS  na RL      lt    Z                           a e f   7  A e e        Le         e   o  bo     b 4    e  B     Py    2  o m   rT    F   le e bi P                  Verification of the Exposure Button    e   If door contacts are installed  close door  close contacts   do not bridge contacts   e Turn unit OFF  WARNING  Electrical shock hazard        Connect multimeter in range for measuring resistance to   DX1 X401 1 and 4  when door contacts are not used   DX1 X401 1 and 2  when door contacts is used      Measure resistance   Exposure button not depressed  R gt 10kOhm  Exposure button depressed  R  lt  100 Ohm  The values must remain constant  even if the coiled cable is moved during the measurement         If the values are not present  check correct function of the door contacts   e   If the values are still not present  exchange exposure button       Disconnect multimeter   e Reattach housing  see Service Manual  chapter    Removing Housing        8 62 15 144 D 3507 101 01 02 02    Sirona Dental Systems GmbH Maintenance Instructions                                                       Verification of the ke
10. iSt                    c c ccc    appendix    62 15 144 D 3507 101 01 02 02 3    Maintenance Instructions    Sirona Dental Systems GmbH       Model No   6151 836 D 3507 _    Serial No   00110   7OkV 7 mA C       1 5 Al   70 IEC 522 0123  R  hre   Tube Pet  k P470 8 35 12G   Model No   6151 893 D 3607    oa tec 336         ay y    rr    product compliesw th DHHS      bl 21 CFR Subchapter J   Date of mandacture  October 2008  Sirona Dental Systems   Fabrixstr  31  D 64625 Bensheim    Garmanw    S    ea sirona  _  TO    Model No 6233022 Serial No 01001  MADE IN GERMANY    This product complies with DHHS  regulations 21 CFR Subchapter J   applicable at date of manufacture   Date of manufacture  October 2008  Sirona Dental Systems GmbH  FabrikstraBe 31   D 64625 Bensheim  Germany           L    D    strona           U T   wode no 62 14 055 D3507      Seriat No  00109 x    P          WARNING  THIS X RAY UNIT MAY BE DANGEROUS TO PATIENT  AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING  INSTRUCTIONS ARE OBSERVED  UNAUTHORIZED USE IS PROHIBITED     For DHHS Inspection    DHHS label is located on the  underside of the wall adapter       sirona      EAD GOIN soos  27   p34    Model No 6175744 03507  SeriaiNo 00109       _   _   _       2  gt   120VAC   10A 2   200V   230V   6A   5A   A  poe A j 8 EX    K  lt  sirona      This product complies with DHHS      62 14 097 D 3507   regulations 21 CFR Subchapter J     Betino  00109   Appicable at date of manufacture     AN Go 6 CE This
11. lights up  audible buzzer O K   Deadman feature O K    Tube current is within specified limits   Specified exposure time O K    Specified kV Value is O K    Exposure button O K  Resistance within specified limits  All keys O K    Mechanical adjustment of the support arm is O K     The unit is in compliance with  MFG specified tests and safety    Technician  Dealer                                                                                                                                               Measurement        mA  Measurement        sec  Measurement        kV          62 15 144 D 3507 101 01 02 02       HELIODENTPLUS    Yearly Maintenance Checklist          Customer  Address   Dealer  Address   Date of original installation  Date of inspection     Report of Assembly FD 2579      The Dental Company                                                             SCHEDULE Yes No Remarks  All manuals are present  Test instruments as required  Manufacturer Model Accuracy Last calibrated  Voltmeter  mAmeter                Exposure Time             Any mechanical damage noticed   All labels are present and legible   All indicator lights are O K    Radiation indicator X ray lights up  audible buzzer O K   Deadman feature O K    Tube current is within specified limits   Specified exposure time O K    Specified kV Value is O K    Exposure button O K  Resistance within specified limits  All keys O K    Mechanical adjustment of the support arm is O K     The unit is in compliance
12. reading plus 2 digits  DC current   0 3  of reading plus 1 digit  2  Digital Dosimeter     Model PTW Diados  Nomex or Unfors mult o meter A     CAUTION RADIATION ALA y    Observe radiation protection guidelines as outlined in the Operating Instructions     ESD  CAUTION Technician     PC boards are fitted with electronic components sensitive to electrostatic discharge  ESD    Electrostatic discharge is unavoidable due to friction of clothing  carpeting etc        ATTENTION    To prevent damage of electronic components do not touch same   Discharge your electrostatic energy by touching a grounded point                 Always handle circuit boards by the edge of same              ATTENTION A  WARNING  Electrical shock hazard           List of Contents    pita ee deep dena aha ue oe ced ey a E whe ete NEE E yan her gt tna aN  Sania as ee N A REM E weds a A D ater Page  General   csdeceetak nag is piwne se deleetee as weed Eee eran eye adder ache eee ee seemed ees  3  Visual Check iaiia and e deta eee Fb re ener bh da ee ee ee howe PL ee ee 4  Light Indicators at the Display  Audible Sound at the Wall Adapter                          0 2    5  Tube Current Verification                          ttt eee 6  Exposure Time Verification and kV Verification                        c c    7  Verification of the Exposure Button                     c c  tees 8  Verification of the keyS       2 0    cee ee 9  Mechanical Adjustments  if required     1 2 0 0    cee 10  Yearly Maintenance ChecKl
13. ys      Press all the keys one after the other  checking whether the LEDs above the keys go on and off and  whether the radiation times change     62 15 144 D 3507 101 01 02 02 9    Maintenance Instructions Sirona Dental Systems GmbH           Adjust in Special screwdriver   vertical Torx TX 30  200 mm  7 7 8       position A  Adjust in  horizontal 2    position       Mechanical Adjustments  if required     Readjustment is necessary  if the tubehead does not remain stationary after being positioned     1     10    Adjust spring on left support arm    Slip bellows on both sides over the half shells A  Pull the half shells off    Pull the scissors arm apart and push bellows over the bearing  Set both support arms vertical    Insert torx screwdriver from above into the bore of the bearing and adjust the spring  turn clockwise  gt   tighter     Complete again in reverse order       Adjust spring on right support arm     Slip bellows over the upper half shell A  Press the bellows down    Bring support arm into horizontal position    Insert torx screwdriver from the front into the bore of the bearing and adjust the spring  turn clockwise  gt   tighter     Complete again in reverse order     62 15 144 D 3507 101 01 02 02    HELIODENTPLUS    Yearly Maintenance Checklist          Customer  Address   Dealer  Address   Date of original installation  Date of inspection     Report of Assembly FD 2579      The Dental Company                                                             SCHED
    
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