MP-0074, Rev E
Contents
1. and d the operator remains within the significant zone of occupancy immediately behind the device shield Do not enable NOMAD Pro until patient and operator are positioned and ready for the exposure preventing interruption and inadvertent exposure of anyone to X rays Do not attempt an exposure if anyone other than patient is in the direct beam If others are assisting then they should wear protective covering When selecting and using Position Indicating Devices PIDs preference should be given to models that allow the backscatter shield to remain at the outer end of the collimator cone for maximum operator protection NOMAD Pro s An exposure can be terminated for any reason by abruptly releasing the depressed trigger for more information see Section 4 0 Operation s As shown in graphic representations maximum protection green area from backscatter radiation red area exists when the NOMAD Pro is positioned near the patient is perpendicular to the operator with the patient s head tilted if needed and the backscatter shield is fully extended toward the patient and parallel to the operator Operation outside the protection zone or with a diminished protective zone requires proper precautions such as the use of lead aprons Proper postionin R Device held back Shield slid back Non perpendicular per postonng aa Do not operate if the backscatter sal MAXIMUM PROTECTION shield or collimator cone ar2. and the device is returned to the counters display with no change When BACK is selected and the Select button is pressed the device returns to the Main Menu NOTE RESET DEFAULTS also resets the TRIP COUNTER to O Allows the user to leave the Main Menu and return to normal operation Powering EXIT off and then on also exits the menu 15 NOMAD Pro 4 10 Technique Factor Settings and Adjustments The factory settings in this chart are intended as a reference starting point only and are based upon average preferences and use with the cone perpendicular to the image receptor Individual results may vary based upon a number of factors including image density preferences the various imaging sensors or available film speeds and brands patient size practitioner techniques and preferences ead Anterior Posterior Bitewings 0 12 0 17 Ch Digital U Sensor i 0 09 0 14 Preset Technique Factors Chart 2 5mA 60kV Phosphor Plate Technique Factor time setting can be adjusted by the operator This is done from the main display screen following these steps Press the Increase or Decrease lt 7 button until the desired time setting is selected NOTE When the Increase or Decrease lt 7 buttons are pressed AND held the rate at which the displayed time setting changes on screen suddenly accelerates Press and release the Select button to activate the Save menu Sele
3. A E EE EE E A EAE EE 24 7 3 X ray Tube Specifications and Characteristics cc ccccsssssccessesccsususecersursesseuususecersas 25 TA EMC Data cc cccccccccccccceccseeeeeeeeeeeceeeeeeneeeeeeseeeeeeeeenseseeesueneeeeeeseeteeeeseeeeseeneeteeeseeeeeaneres 28 o PUN al Canora GS Cr Sc cseatnsaetatinicoscboint niini ani 30 Thank you for choosing the Aribex NOMAD Pro as your X ray solution At Aribex we value your business and we would like to hear from you because your feedback or suggestions are important to us If you have comments please email us NOMAD aribex com NOMAD Pro Dental Features gt Performance battery power source delivers dependable high voltage 60kV true DC and direct current 2 5mA Consistent Emission Radiation high frequency constant potential X ray generator provides high quality images with a lower radiation dosage to the patient than standard AC X ray systems Radiation Protection operator shielded from source and backscatter radiation Simple Operation by selecting patient size receptor type and tooth type the factory preset exposure time is digitally displayed on the user friendly control panel along with indicators for machine and battery status Lightweight and Ergonomic design provides complete flexibility and convenience enabling exposures without moving the patients to the X ray source Exposure Safety Feature cannot emit X rays with insufficient voltage
4. handset in order to continue Use the charging cradle to determine the handset status If the indicator lights illuminate solid or flash red the handset will require authorized service see Section 6 3 Repair and Maintenance 21 NOMAD Pro 6 3 Repair and Maintenance NOMAD Pro is a maintenance free product However a routine wipe down with a disinfectant cloth or wipe is recommended between patients along with a quarterly visual inspection for damage Make sure the power is off while cleaning It is recommended for the handset to be attached during cleaning of the device so that the electrical contacts are not exposed Use a non acetone based disinfectant wipe or a cloth to wipe the exterior surfaces of the NOMAD Pro and charging cradle See also Section 5 0 Handset Replacement and Care for more information related to battery maintenance Repairs can only be undertaken by trained service personnel Direct all questions to an authorized distributor The following are user replaceable components Optional Rectangular Collimator Cone Adapter AP 0036 Handsets AP 0025 Charging Cradle AP 0035 AC to DC Power Supply CP 0062 Optional Hard Shell Carrying Case plastic AC 0004 VV VV V Damaged or faulty NOMAD Pro materials and components must be properly disposed of according to local requirements or returned to an authorized distributor or Aribex Inc Please protect the environment and do not improperly disp
5. illuminated green LED the message READY on the display panel and a double tone lt lt alert confirm that NOMAD Pro is prepared to fire X rays The READY state continues until either an exposure is initiated or timeout occurs after 15 seconds of inactivity accompanied by a double tone 4 lt and the return to the Settings mode green While the device is in the READY state any changes to the settings pressing any user interface panel button will end the state 60 kV 2 5 mA 11 NOMAD Pro 4 6 Initiating and Completing an X ray Exposure X RAY ON To begin the exposure press and hold the trigger The READY message is replaced with X RAY ON the green LED is replaced with a yellow LED and there is an alert tone lt lt for the duration of the exposure To ensure complete exposure keep the trigger depressed until the audible tone 4 lt is complete the yellow LED is off and X RAY COMPLETE briefly displays NOTE An exposure can be prematurely terminated for any reason by abruptly releasing the depressed trigger 4 Power Off Press and release the Power button to turn NOMAD Pro off i NOMAD Pro also automatically shuts off after approximately 3 minutes of inactivity The NOMAD Pro display darkens accompanied by a tone lt to indicate shutdown 12 OPERATOR MANUAL 4 8 Exposure Techniques As an intraoral dental X ray system the NOMAD Pro can be easily positioned This high degree
6. initiated by a single pull and release Enabling of the trigger within 1 second If no further ENABLING action is taken the device will shift into the X RAYS READY state If the trigger is pulled again before Alert the READY state is indicated the 1 second counter will restart At the conclusion of the ENABLING X RAYS message the READY message will display on screen The READY state will last for 15 seconds or until one of the buttons on the user interface tone Alert O2Deec panel is pressed or until the exposure is initiated by a second pull of the trigger Ready for exposure Double ascending X ray X RAYS ON At the end of the successful exposure the yellow Exposure Single tone for duration of exposure LED turns off and display panel briefly indicates X RAY COMPLETE and the screen returns to the Alert normal mode PTT When the trigger is activated while the device is the trigger is activated while the device is in the X rays locked mode and operation is X ray Lock Tones will be attempted various alert messages will be the sameas displayed For example X RAYS LOCKED the actual SIMULATION ONLY SIMULATION COMPLETE Alert ee Toggle between LOCKED and UNLOCKED by pressing and holding down hold down the Select button and then press the Patient ss EDE button and then press the Patient button button 18 OPERATOR MANUAL Census wie apa eae Condition Indicator Signal 4 Resolut
7. low battery Engineered for Compatibility works with both film and digital imaging systems Authorized Service complete support and maintenance from Aribex and through our authorized distributors X ray Locking Feature enables the safe training demonstration and storage of the device without undue concern related to unintended or unauthorized radiation emission OPERATOR MANUAL 1 0 Getting Started 1 1 Intended Use The NOMAD Pro X ray System is designed to be used for both adult and pediatric patients by trained dentists and dental professionals for producing diagnostic dental X ray images 1 2 Unpack Check and Register NOMAD Pro System Oo Unwrap individual components from the protective plastic and check for any noticeable signs of damage The standard package system includes the following items NOMAD Pro Device AP 0015 2 Handsets AP 0025 Charging Cradle AP 0035 and the AC DC Power Supply CP 0062 Certificate of Conformance Getting Started guide MP 0075 Warranty Registration Card and NOMAD Pro Operator Training CD MP 0073 Device Labels Verify that the serialized Device label is in place located on lower side of unit Verify that the serial number on the Warranty Registration card matches the device serial rer tabes number and the device serial number on the carrying case Verify that the Handsets label located on the top of each Handset and the Charging Cradle label located
8. of flexibility easily makes possible exposures while the patient is reclined lying completely on their back or sitting upright Ensure the patient is protected by using a radiation shielding drape O When taking images operators may hold the NOMAD Pro by having both hands on the handset grip or for increased stability and patient safety by placing one on the grip and the other on the underside of the housing but not on the collimator cone 2 Position the NOMAD Pro relative to the imaging system to minimize cone cutting If your practice uses film holding kits or aiming devices check compatibility in advance Exposure times increase proportionally when the imaging angles vary away from 90 or perpendicular to the film or sensor To maintain low patient X ray doses and keep the operator within the protection zone have the head of the patient slightly tilted and or raise or lower the chin as needed See Section 2 1 Radiation Safety O When the device must be angled and the operator cannot be completely within the protection zone ensure operator protection through the use of proper safety measures such as the use of a lead apron See Section 2 1 Radiation Safety Avoid touching the patient with the cone or backscatter shield disposable plastic coverings can be used to prevent cross contamination O Determine what NOMAD Pro exposure time settings deliver optimal results for the type of imaging digital o
9. NOMAD Eol Handheld X ray System for Intraoral Radiographic Imaging OPERATOR MANUAL MANUFACTURED BY ARIBEX DO NOT OPERATE THIS DEVICE UNTIL YOU HAVE READ THIS MANUAL and reviewed the accompanying materials Disclaimer NOMAD Pro is sold with the understanding that the user assumes sole responsibility for radiation safety as well as any state provincial or local regulatory compliance and that Aribex Inc its agents or representatives do not accept responsibility for a injury or danger to personnel from X ray exposure b image over under exposure due to poor operating techniques or procedures c equipment not properly serviced or maintained in accordance with instructions contained in this publication and d equipment which has been damaged modified or tampered with in any way Aribex and NOMAD are registered trademarks within the United States and other countries NOMAD Dental NOMAD Pro PORTA X and the ARIBEX and NOMAD logos are trademarks of Aribex Inc worldwide U S patents issued 7 224 769 and 7 496 178 United States and international patents pending All other brand and product names are trademarks or registered trademarks of their respective companies The symbols used in this publication or used to mark the equipment have the following meanings AA lonizing Radiation Type BF Equipment providing a degree of protection against electric shock iW pertaining particularly to allowable leakage curren
10. actors such as placing the Test Detector in a lead lined box or the use of a protective lead apron are observed Enable the NOMAD Pro and with the cone perpendicular to the Test Detector make exposures into the Test Detector and capture the resulting data Compare the result with the factory release parameters indicated in the chart below For results outside these parameters discontinue use and contact your dealer distributor or Aribex Test Acceptance Timer Settings and Corresponding Acceptable Ranges Description Limits 0 02sec_ 0 04sec 0 40sec 0 60sec 1 00sec _ kVp ef Goxv 10 54to66 54to66 54to66 54to66 54to66 Accuracy Timer Setpoint 10 1ms 17 to 23 35 to 45 359 to 441 539 to 661 899 to 1101 LIMITED WARRANTY COVERAGE Aribex Inc warrants its medical and dental x ray equipment to be free from any defects in material or workmanship for a period of one 1 year from the date of purchase Aribex Inc also warrants any accessories purchased from Aribex to be free from any defects in material or workmanship for the period of one 1 year from the date of purchase The liability of Aribex Inc is limited to repair or replacement of any parts that Aribex or its authorized resellers determine to be defective Contact Aribex for a Return Material Authorization RMA number and shipping instructions Parts proving defective shall be repaired or replaced free of charge labor and domestic shipping include
11. acture Exposure time is measured during the entire exposure referenced to 75 rise fall using the NERO mAx 8000 x ray meter Collimator Cone Minimum source to skin distance 20cm from focal spot to cone tip Nominal dose output at cone tip 20cm 3 41mGy sec X ray field size and configuration 6cm diameter circle 7 2 Wiring Diagram al i Membrane Switch Panel i a Tare aM Flex Cable 3 Fag ma Ml alli ELA FILAMENT Voll 1a the ELA TUBS VOLTS maa GML TURE ON W BATT HOH a EGE SV REF MONITOR S 4 aaa Say EV MOM 7A Y ON T ppm m EWS LECI we DAAG os aula Aer Scan I ire a HAWG 2058 Det IMMA ame e AMG HDO a eee e HOTE Charger Adaptor can not commect io Norni Pro X Ray wmit OPERATOR MANUAL 7 3 X ray Tube Specifications and Characteristics The VDT70 0 4 12CP is designed for intraoral dental imaging by an X ray unit and is available for nominal tube voltage with self rectified or constant potential circuit manufactured by Kailong distributed in the U S A by Vista Technology Nominal tube voltage 60kV Nominal focal spot IEC 60336 1993 0 4mm Maximum anode heat content 4500J Maximum current continuous service 1 5mA x 70kV Maximum anode cooling rate 100W Nominal anode input power 430W Target material Tungsten Target angle 12 Filament characteristics 2 2 3 0A 2 0 3 5V Minimum inherent filtration IEC 60522 1999 0 8mm Al 50kV M4De
12. amaged can also happen to NOMAD Pro device connectors indicator lights illuminated orange 6 2 11 The handset did not seem to be The trigger is not communicating working when the with the device trigger was pulled The handset in general is not communicating with the device 6 2 12 HANDSET FAILURE displayed The protective fuse in the on screen handset is blown the batteries are otherwise impaired or at the end of their life cycle This warning message can be cleared by powering off then on If device self diagnostics detects the system failure again after clearance the message will redisplay and NOMAD Pro will require authorized service see Section 6 3 Repair and Maintenance Ensure handset is securely attached Replace with a newly charged handset in order to continue Use the charging cradle to determine if the first handset battery can be recharged or is spent and must be taken out of service NOMAD Pro will require authorized service see Section 6 3 Repair and Maintenance NOMAD Pro will require authorized service see Section 6 3 Repair and Maintenance Ensure handset is securely attached Place handset on the charging cradle and pull the trigger If the indicator lights illuminate orange the handset trigger communications are functional NOMAD Pro may require authorized service see Section 6 3 Repair and Maintenance Ensure handset is securely attached Replace with a newly charged
13. arge Immunity IEC 61000 4 3 2006 RF Radiation field strength of 3V m from Radiation field strength of 3V m from PASS Radiated Fields Immunity 80 6000MHz 80 AM 1kHz 80 6000MHz 80 AM 1kHz IEC 61000 4 4 2004 Corrigendum 1 2006 Electrical Fast Transient Immunity Air discharge up to 8kV contact Air discharge up to 8kV contact PASS discharge up to 6kV discharge up to 6kV Power line pulses of 2kV direct I O Power line pulses of 2kV direct I O N A for a battery line pulses of 1kV line pulses of 1kV powered device IEC 61000 4 5 2005 Lightning Power line surges of 2kV common Power line surges of 2kV common N A for a battery Surge Immunity 1kV differential mode 1kV differential mode powered device IEG 61000 4 6 2003 A1 2004 150kHz 80MHz at 3 Vrms 1kHz 150kHz 80MHz at 3 Vrms 1kHz N A for a battery A2 2006 RF Common Mode Immunity IEC 61000 4 8 1993 A1 2000 Power Frequency Magnetic Field Immunity IEC 61000 4 11 2004 Voltage Voltage Dips of gt 95 30 and Voltage Dips of gt 95 30 and N A for a battery Dips and Short Interruptions 60 Interruptions of gt 95 60 Interruptions of gt 95 powered device 80 amplitude modulated 80 amplitude modulated powered device Helmholtz coil at 50Hz and 60Hz to Helmholtz coil at 50Hz and 60Hz to PASS 3 amps rms per meter 3 amps rms per meter 29 NOMAD Pro 7 5 Optional Calibration Check
14. ce center Alarm 19 NOMAD Pro 6 2 Troubleshooting If you encounter results and or errors in the operation of NOMAD Pro that are not explained in the previous sections check the following table on user troubleshooting to determine the need for authorized service If you have additional questions or require help contact Aribex support aribex com Device Symptom Potential Problem Corrective Action Increase the exposure time setting or splat aaa re lee see Incomplete Exposure below Decrease the exposure time setting also check film expiration date old film can produce dark grainy foggy images 6 2 1 Image from X ray exposure did not Overexposure too dark have sufficient contrast Chemical developer for film Ensure chemical freshness and proper based imaging temperature 6 2 2 Image from Combined movements of patient Check the exposure time setting and X ray exposure is and operator during exposure re enable when operator and patient blurred produced too much distortion are again properly situated 6 2 3 ENABLING X RAYS a Release the trigger and wait for the message stays on ggering READY indicator 6 2 4 Device does not THettiaaerouuledtaclanaar Pull and release the trigger within 1 shift into the ENABLING gt ee T g second and wait for the READY X RAYS or READY states indicator NOMAD Pro READY condition 6 2 5 READY indicator expires because the X ray Double check the exposure tim
15. ct YES by pressing the Increase button 6 O Press the Select button to select OK Once saved this change will be maintained in memory until overwritten or until the factory defaults are restored through the RESET DEFAULTS Menu item 16 OPERATOR MANUAL 5 0 Handset Replacement and Care A RECHARGE HANDSET alarm on the display panel indicates either the need to fully engage the handset or the need for a replacement handset NOMAD Pro cannot emit X rays with a low depleted battery insufficient voltage Follow these steps to clear the RECHARGE HANDSET alarm Verify that the handset is locked in place If so and the alarm is still present press and release the Power button on the control panel to turn off NOMAD Pro Place the NOMAD Pro bottom up on a stable surface and depress the release button on the housing just behind the handset to release it from the housing E Slide the Handset forward toward the backscatter shield and the collimator cone O Carefully align a newly charged handset and while avoiding possible pinch points between the housing and the handset slide it into place a properly oriented handset should snap into place without force A clicking sound ensures that the handset is fastened Make sure the handset is secure by pushing it toward the cone When a handset is detached for more than 60 seconds the last exposure setting is erased and would have to be reset when the unit is turned on aga
16. cur in a particular instance If interference occurs the user is encouraged to try the following corrective measures reorient or relocate the receiving device increase the separation between the equipment consult the device manufacturer or field service technician for help NOMAD Pro is intended for use in the electromagnetic environment as specified The following tables describe the tests performed and the status of the testing The NOMAD Pro uses RF energy only for its internal function In addition the housing includes conductive shielding therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The test results show that the NOMAD Pro is suitable for use in all establishments including domestic establishments and those directly connected to public low voltage power supply network that supplies buildings used for domestic purposes Test Specifications Radio Frequency Emissions and Electromagnetic Immunity tests in accordance with requirements of EN 60601 1 2 2001 A1 2006 as follows In Accordance with Test Type Document Document Title Conducted and Radiated EN 55011 2007 Industrial Scientific and Medical ISM Radiofrequency Equipment Radio Emissions Class B Disturbance Characteristics ne i Methods of Measurement Electrostatic Discharge IEC 61000 4 2 1995 Electromagnetic Compatibility Basic Immunity Standard Electrostatic Immunity A1 1998 A2 2000 Disc
17. d if defective equipment is returned freight collect to Aribex Utah USA or the location of the authorized service center Equipment repaired or replaced under warranty shall continue to be warranted for the balance of the original warranty term All warranty claims must be made not later than ten 10 business days following the expiration of the applicable warranty period LIMITATIONS OF COVERAGE This warranty does not apply to equipment that is or has been abused misused or altered including opening enclosure or tampering improperly maintained subjected to use beyond rated conditions or damaged as a result of any carelessness or accidents This warranty does not cover ordinary wear and tear or maintenance LIMITATIONS OF LIABILITY Aribex Inc makes no other warranty either expressed or implied with respect to any equipment purchased from Aribex including without limitation any implied warranties of merchantability or fitness for a particular purpose whether or not Aribex may have been informed of the actual uses to which any of such equipment may be put Aribex Inc shall not under any circumstance be liable for incidental indirect consequential punitive or exemplary damages including without limitation damages for delay or lost profits and in no event shall liability of Aribex arising from the purchase sale or use of the equipment or breach of any warranty made above exceed in the aggregate the purchase price paid therefor
18. e 31 CE 0473 ISO 13485 ISO 9001 CERTIFIED COMPANY Aribex Inc 2005 2010 All Rights Reserved English is the original draft language for this manual Aribex Inc Phone 801 226 5522 744 South 400 East AAA Fax 801 434 7233 Orem Utah 84097 Email NOMAD aribex com USA http www aribex com EC REP MT Promedt Consulting Altenhofstr 80 66386 St Ingbert Germany MP 0074 Rev E
19. e terminated before an exposure is not initiated within 15 setting and re enable when operator exposure started seconds of the start of the READY and patient are again properly situated condition This condition automatically clears within 15 seconds or by pressing any button on the user interface panel Be sure to depress the trigger for the duration of the timed exposure NOMAD Pro times out after about Manually turn on NOMAD Pro when 3 minutes of inactivity you are ready to use the device 6 2 7 NOMAD Pro automatically shut down A different problem exists if If this condition persists NOMAD Pro shutdown occured during regular will require authorized service see activity Section 6 3 Repair and Maintenance 20 Incomplete exposure the 6 2 6 INCOMPLETE depressed trigger is released displayed on screen before the timed exposure is able to complete OPERATOR MANUAL Device Symptom Potential Problem Corrective Action Self diagnostics which 6 2 8 SYSTEM FAILURE automatically run at startup and displayed on screen while the device is on detects a potential issue If pressing Power several times does not cause the display to 6 2 9 There was no illuminate the attached handset power to the NOMAD is the likely problem Pro control panel A different problem exists if all handsets appear fully charged 6 2 10 When first placing handset on charging cradle Male connectors on charging cradle are d
20. e broken MINIMIZED PROTECTION Comparative Data for Whole Body Exposure Annual Occupational Dose Limit 5OmSv sno B 3 o5msv A Occupational Dose Limit Requiring Dosimetry Average Natural Background Radiation 2 19MSv ga Average Occupational Radiation Exposure for Flight Crews 1 00mSv i General Public Dose Limit 0 20 0 70mSv Range of Exposure for Dental Personnel Using Conventional X rays 0 30mSv Average Exposure Using NOMAD with D Speed Film 0 12mSv Average Exposure Using NOMAD with F Speed Film or Digital Sensor 1 Standards for Protection Against Radiation 10 CFR 20 US Federal Standards 1994 see also NCRP Report No 116 2 NCRP Report No 145 National Council on Radiation Protection and Measurements p7 9 3 Estimated Cosmic Radiation Doses for Flight Personnel Feng YJ et al Soace Medicine and Medical Engineering 15 4 2002 p265 9 e 4 Normalized average assumes 7 200 exposures per year and the average length of exposure for D speed 0 50 seconds F speed 0 25 seconds digital sensor 0 20 seconds oaa OPERATOR MANUAL Comparative Data for Hand and Extremity Exposure Annual 500mSv Occupational Dose Limit _ Occupational Dose Limit Requiring Dosimetry 0 43mSv Average Exposure Using NOMAD with D Speed Film 0 22mSv Average Exposure Using NOMAD with F Speed Film or Digital Sensor X ray Source Focal Fixed pea Limiting 1 Standards f
21. e used to adjust AUDIBLE SOUND the volume and the system emits a tone as each volume is selected so the operator can determine the choice Once the desired volume is determined pressing the Select button saves the volume setting The operator can use the Increase or Decrease lt 7 buttons to toggle between YES and NO in response to the menu prompt RESET EXPOSURE TIME TO FACTORY SETTINGS Nec aoe If YES is selected the system will confirm the selection by displaying ALL CUSTOM Technique SETTINGS WILL BE ERASED ARE YOU SURE Factors and Trip Counter Selecting YES and then the Select button reverts any any customized exposure settings to the factory defaults and returns the device to the Main Menu If ever NO is selected and then the Select button pressed the customized settings will not be changed and the system returns to the Main Menu Poasa OPERATOR MANUAL The device will display two counters One is the OVERALL HISTORY COUNTER which displays the total lifetime X ray shots for the device The other TRIP COUNTER can at any time be reset to 0 by the operator When Reset is selected and the Select button is pressed the user will be prompted with the message RESET TRIP COUNTER When YES is selected and the Select gt button is pressed the TRIP COUNTER is X RAY COUNTER reset to 0 and the device is returned to the counters display When NO is selected and the Select gt button is pressed
22. ecent setting for the exposure time rn is stored in memory and redisplays when power is turned back on However if the battery is replaced the display is reset to the default 0 09 sec Patient value To change exposure settings press each of the button options to toggle through the choices 1 the Patient Size adult or child Receptor 2 the Image Receptor film phosphor plate or sensor and 0 38 sec 3 the Tooth Group Anterior Posterior or Bitewing Examples from factory default settings Examples Tooth Child Sensor and Incisor 0 09sec OR Adult Film and Molar 0 38sec When necessary use the Increase or Decrease buttons to adjust the time in 0 01 second increments Adjusted exposure settings may be saved replacing factory settings see Section 4 10 Technique Factor Settings and Adjustments D gt O qD jab lt Decrease 4 5 Ready the Device To prevent accidental radiation exposure properly position patient and operator before readying the NOMAD Pro Press and release the trigger once to ready the device The device will ENABLING briefly display an ENABLING X RAYS message before indicating READY XRAYS NOTE As a safety precaution if the trigger is held longer than 1 second or pulled a second time while still in the ENABLING X RAYS state the devise will not transition to the READY state This is to prevent an accidental activation of the device by unintended triggering The
23. ep10 CENTRAL X RAY 100MIN F FILAMENT C CATHODE x axis horizontal y axis vertical OUTLINE DRAWING X ray source assembly maximum heat content 6500J X ray source assembly mfg by VMI PS454 25 NOMAD Pro Cathode Emission Filament Characteristics o Nw Bom a oo wo OF NOTE The X ray source assembly heating and cooling curves are equivalent to the anode heating curves shown here Maximum continuous heat dissipation will be made available upon request from Aribex OPERATOR MANUAL X ray Source Focal X ray Source Focal Spot Reference Axis at 90 to Target Receptor 27 NOMAD Pro 7 4 EMC Data Independent laboratory testing for electromagnetic compatibility for conformity to the Sub clause 5 10 requirements of ISO IEC 17025 General Criteria for the Competence of Testing and Calibration Laboratories was conducted by Nemko USA Inc 11696 Sorrento Valley Rd Suite F San Diego CA 92121 1024 USA The NOMAD Pro Dental X ray System has been tested and found to comply with the limits of electromagnetic compatibility standards for medical devices which provide reasonable protection against harmful interference in a typical medical dental setting The NOMAD Pro may generate and radiate radio frequency energy that causes interference to other devices in the vicinity if not used in accordance with the instructions though there is no guarantee that interference will not oc
24. ets and carefully slide it onto the charging cradle do not force the handset onto the charging cradle or damage may result Expect charge time to be less than 3 hours The handset charging cradle and AC power supply may become warm to the touch while charging The handset may be left on the charging cradle overnight without damaging the batteries While the batteries are charging the bank of LED charge indicators will illuminate green in a pulsed pattern Once charging is complete the bank of indicators will illuminate solid green The handset may be left on the charging cradle without damage to the batteries If the charge indicator lights change to red it is an indication of problems consult Section 6 2 Troubleshooting or an Aribex authorized service center 2 OPERATOR MANUAL 2 0 Safety Precautions 2 1 Radiation Safety re a Operators must follow all applicable regulatory guidelines and in house radiation protection program in regard to patients and operators who are pregnant or expect to become pregnant Operators must be fully acquainted with industry safety recommendations and established maximum permissible doses Optimal operator radiation backscatter protection exists when a the backscatter shield is positioned at the outer end of the collimator cone b the backscatter shield is close to the patient c the patient tilts their head when needed to accommodate exposures see Section 4 7
25. harge Immunity Test Radio Frequency Immunity IEC 61000 4 3 2006 Electromagnetic Compatibility Basic Immunity Standard Radiated Radio Frequency Electromagnetic Field Immunity Test Power Frequency Magnetic IEC 61000 4 8 1993 Electromagnetic Compatibility Testing and Measurement Techniques for Field Immunity A1 2000 Power Frequency Magnetic Field Immunity Test 28 OPERATOR MANUAL NOTE The tests documented in the table above are the only tests required for this product as it is a battery operated device and the AC Adapter CP 0062 is certified IEC 61000 3 2 3 3 4 4 4 5 4 6 4 11 and EN 55014 1 2006 are not applicable Emissions Test Summary Specification Frequency Range Compliance Status EN 55011 2007 Group 1 Class B San 0 15MHz 30 00MHz PASS Conducted Emissions EN 55011 2007 Group 1 Class B ia 30 0MHz 2500MHz PASS Radiated Emissions EN 61000 3 2 2000 A2 2005 Up to the 40th Harmonic N A for a battery powered device Power Line Harmonics EN 61000 3 3 1995 A1 2001 A2 2005 Legs than or equal to 4 Maximum Relative Voltage NAN E NE devi Power Line Flicker Change Value of D T lt 3 for more than 200ms YP EN 55014 1 2006 0 15MHz 30 00MHz N A for a battery powered device Discontinuous Disturbance Click Immunity Test Summary Minimum Test Level Required per Compliance Specification EN 60601 1 2 Test Level Completed Status IEC 61000 4 2 1995 A1 1998 A2 2000 Electrostatic Disch
26. in IMPORTANT HANDSET CARE NOTES Each handset can go through the full discharge charge cycle approximately 300 times Routinely change discharged handset with fully charged one as needed The handset can be left indefinitely on the charging cradle without damaging batteries unless AC power to charging cradle is completely interrupted or turned off during the charge cycle Battery charge will diminish during extended inactivity fully recharge handsets every 3 months during inactivity Never place a low charge battery into long term storage When the charging cradle senses a bad handset battery the indicator lights will illuminate red rather than green In this case the batteries are inoperable and must be serviced e Handset communications and mechanical integrity are checked by pulling the handset trigger when it is on the charging cradle good communication exists when the indicator lights illuminate orange NOMAD Pro 6 0 NOMAD Pro Care and Upkeep 6 1 Alarms and Alerts The visual audible alarm signals a programmed action designed to prevent harm to operator patients and or NOMAD Pro The visual audible alerts confirm normal conditions or draw the operator s attention to a required action NOTE All audible signals except X ray termination may be turned down or off in the AUDIBLE SOUNDS menu see Section 4 9 Settings Menu emai vie are eae Condition Indicator Signal 4 Resolution This state is
27. ion If the operator presses the trigger to activate the READY state before the duty cycle time the device will display the warning message and a ee eae countdown timer will be displayed showing the count down the cool down duty cycle time remaining This will lock the _ Alarm ende device and the message will be displayed until y the duty cycle is complete The device will then return to the normal operation mode 4 Ensure the Handset is locked in place The RECHARGE HANDSET alert terminates after Low Battery five seconds and goes into auto shutdown RECHARGE 9 audible Replace the current Handset with a freshly HANDSET tones charged Handset NOTE If battery voltage is lower than required for the X ray exposure the device will not allow the exposure Duty Cycle Exceeded Double tone COOLING DOWN at the start Alarm Activates if trigger is released before the timed X ray exposure finishes This condition is cleared by pressing any button A warning PRESS ANY KEY tone on the user interface panel or by tuning the power off then on Depress the trigger for the duration of the exposure time Incomplete Exposure Alarm System SYSTEM Failure FAILURE Descending Consult Section 6 2 Troubleshooting 6 2 8 or CALL tone an Aribex authorized service center Alarm MANUFACTURE Handset Failure HANDSET 5 audible Consult Section 6 2 Troubleshooting 6 2 12 or FAILURE tones an Aribex authorized servi
28. l automatically shut off after a period of inactivity approximately 3 minutes Y Do not store or carry handsets so that metal objects can contact exposed battery contact springs Yy Some battery charge may be lost during extended inactivity leading to fewer exposures between handset charging 3 0 Setup and Power Check 3 1 The Backscatter Shield In addition to the radiation shielded cone the backscatter Eyi shield provides additional protection to the operator and VA features an adjustable position to permit exposures made at various angles i O Ideally the shield should remain fully extended to the outer edge of the cone as close to the patient as possible during each image taken see 2 1 Radiation Safety You may find that the backscatter shield needs to be adjusted to accommodate position indicating devices or angled exposures If adjustments are needed gently glide the shield up or down along the cone using equal pressure to maintain a perpendicular alignment and avoid binding To keep the shield securely on the cone a cap is permanently attached at the outer cone end Do not attempt to remove this cap or to remove the backscatter shield Attempting to do so will result in damage to your device NOMAD Pro 3 2 Attaching a Charged Handset With the NOMAD Pro placed bottom up on a secure surface properly orient and carefully slide the charged handsets onto the base of the NOMAD Pro a pr
29. nd an active display panel indicate the device has power Ch C Settings are redisplayed according to what was last displayed or saved when the device was turned off unless the device was disconnected AAM from a charged handset for more than 1 minute 0 1 22sec 4 2 Ensuring Battery Charge Ils Adequate At the completion of each day or when the battery indicator reaches WH one bar recharge the handset Aribex recommends that you keep one handset fully charged at all times to ensure continuous operation i Charged OWN 4 3 Lock Unlock the X ray The X ray lock and unlock functionality can be toggled to prevent mi o unauthorized use when the NOMAD Pro is idle or stored t LOCK UNLOCK is activated by pressing and holding down the Select Ch O button and then pressing the Patient button the device shifts into a X RAYS LOCKED state and the buttons can be released Repeat the process to unlock X rays 0 12 se For security and training purposes the operator may easily toggle W between these setting as needed by repeating the key selection NOTE If the Select button is held down for longer than 3 seconds before the Patient button is pressed the Menu mode will activate if the Select button is pressed and released before the Patient button can be pressed the Save menu is displayed 10 OPERATOR MANUAL 4 4 Ensuring the Right Exposure Time Is Set O When power is turned off the most r
30. on the bottom of the Charging Cradle are all in place Collimator Cone and N Backscatter Shield These two items provide operator protection and should be inspected for shipping damage Trigger Switch Should freely move in and out when depressed and released Should be free of cracks or fractures Complete the product Warranty Registration card and mail it with proper postage to Aribex today Completing the card fulfills a condition of warranty coverage see the inside back cover of this manual 1 NOMAD Pro 1 3 Charging the Handsets NOTE The handsets batteries are partially charged at the factory and normally need not be charged up prior to initial use of the NOMAD Pro However if the system has been in long term storage prior to iniitial use handsets will first require a proper charge In fact it is recommended to fully recharge handsets every 3 months for long term storage to ensure that no low battery becomes damaged O Use only the supplied AC DC Power Supply CP 0062 unwrap the power cord of the power supply and connect it to the charging cradle then to an AC electrical outlet 110 120V or 220 240V dictated by the country region The single green indicator light on the top of the charging cradle will illuminate when the cradle has power Position the charging cradle away from the normal patient environment A plug adapter may be needed to accommodate the local AC configuration 2 Invert one of the hands
31. ons to disinfect the exterior surfaces of the NOMAD Pro and the handset in between use on each patient Leave the handset connected to the NOMAD Pro and wipe down all surfaces of the device Unplug the charging cradle before cleaning NOTE NOMAD Pro the handsets the charging cradle and the AC power supply are not designed to be subjected to any kind of sterilization procedure 2 4 Security Storage and Transportation gt Do not store the NOMAD Pro handsets charging cradle or AC power supply in extreme conditions below 20 C 4 F or above 60 C 140 F or beyond 95 relative humidity non condensing The optimal storage location is cool dry and away from direct sunlight gt Aribex recommends that the NOMAD Pro like all electronic equipment be allowed to acclimate before use when switching between temperature extremes i e cold storage to a warm area use or hot area storage to a cool area use gt When finished for the day with NOMAD Pro detach the handset 6 OPERATOR MANUAL gt The X RAY LOCK and UNLOCK Section 4 3 serves as the device security key to prevent unauthorized use In addition it is recommended that the device be locked away when not in use For a further level of security securely store handsets in a separate location gt Take steps to ensure the NOMAD Pro will not be knocked to the ground when not in use Lay it on its top side or in the accessory cradle Power wil
32. operly oriented handset should click into place with firm pressure The clicking sound ensures the locking mechanism has secured the NOMAD Pro to the handset To verify this lock apply slight pressure in the release direction 3 3 Checking for Power NOMAD Pro Control Panel O After locking a handset in place press the Power button The operation control display panel will activate with a battery power level icon in the upper right corner Five bars is an indication of a fully charged handset If the battery charge is too low the NOMAD Pro will not W AN emit an X ray and the RECHARGE BATTERY alarm will display O 1 2 sear The RECHARGE BATTERY alarm may also display if the handset is not fully engaged 60 kV 2 5 mA s SNS a When a battery is depleted to the single bar level L Aribex recommends the handset be recharged Replace a low charge handset with the secondary handset which should be charged in advance 8 OPERATOR MANUAL 3 4 Optional Checks The NOMAD Pro is factory calibrated and tested prior to release see your Certificate of Conformance Each time the device power is turned on it automatically runs a self diagnostic to ensure proper function However the optional checks listed below may be performed periodically as desired NOMAD Pro has an X ray disable feature that allows the X rays to be disabled for training purposes Test firing this X ray unit may other
33. or Protection against Radiation Spot oe 10 CFR 20 US Federal Standards 1994 see also NCRP Report No 116 Backscatter Radiation 2 Radiation Exposure with the NOMAD Portable Shielding X ray System Goren AD et al Dentomaxillofacial Radiology 37 2008 p109 12 normalized average includes leakage and backscatter radiation assumes 7 200 exposures per year and the average length of exposure for D speed 0 50 seconds F speed 0 25 seconds digital sensor Primary 0 20 seconds Protective Shielding i In implementing a radiation protection program consult all applicable regulations governing radiation protection and the use of X ray equipment and ensure full compliance with any such regulations 2 2 Usage and Duty Cycle As a Safety feature NOMAD Pro will not emit X rays with insufficient voltage low battery The NOMAD Pro is also designed to avoid damage from overheating The minimum duty cycle rating for maximum exposure the relationship between duration and frequency of exposures taken during a rolling 60 second period is 1 60 This duty cycle is programmed into your NOMAD Pro Examples of optimal use Exposure Duration 0 09 sec 0 20 sec 0 40 sec 1 00 sec py pemetca me 6 seconds 24 seconds 60 seconds Between Exposures Exposures Per Minute gt 10 gt 8 gt 2 1 5 NOMAD Pro 2 3 Cleaning Routinely use a non acetone based disinfectant wipe according to chemical manufacturer s recommendati
34. ose of any part of the NOMAD Pro system the handsets the charging cradle or the AC power supply At end of life return these items to Aribex for replacement and proper disposal or recycling If product return is required contact Aribex for a Return Material Authorization RMA number and shipping instructions to return the product to the proper facility If the product is under warranty you will be required to provide the serial number from the label affixed on the underside of the NOMAD Pro Be sure to include the RMA number on the package you are returning Products without an RMA number cannot be processed Aribex will not assume responsibility for shipping damages however we will help you file a claim with the freight carrier Please see warranty information at the end of this manual 22 OPERATOR MANUAL 7 0 Technical Description 7 1 Basic Technical Specifications Maximum deviation from fixed factors 5 unless otherwise noted Total weight 2 5kg 5 5 Ibs Environmental Operation Temperature 5 to 40 C 23 to 104 F Relative humidity 10 to 80 non condensing Storage and transportation Temperature 20 to 60 C 4 to 140 F Relative humidity 95 non condensing Classification Spec Compliance IEC 60601 1 Amend 1 amp 2 60601 1 3 Internally Powered 60601 2 7 21 CFR 1020 30 amp 1020 31 Type BF MDD 93 42 EEC Annex IX Class IIb IPX specification IPX0 do not operate under wet condi
35. r film based that is used on a regular basis NOTE Both digital imaging sensors and film speeds can vary somewhat in their characteristics and could require different exposure settings to meet density preference See Section 4 9 Settings Menu for more information 13 NOMAD Pro 4 9 Settings Menu NOMAD Pro menus allow the operator to customize settings according to individual preferences To access the Main Menu press and hold down the Select button for 3 seconds When the Main Menu appears the operator can access the desired Menu item s by pressing the Increase and Decrease buttons to scroll up or down When the desired Menu item is highlighted press the Select 4 button to access the Menu item Within the Menu items there are options such as YES and NO which are selected using either the Increase or Decrease X gt buttons Once a selection is made pressing the Select button confirms the choice To exit the Main Menu highlight EXIT at the bottom of the list and then press the Select gt button or power the device off and then on When system information is selected from the settings menu the device software SYSTEM INFO version information will be displayed on screen Pressing the Select button will return the operator to the Settings menu The volume may also be adjusted by the operator The range is from 1 softest up to 5 loudest The Increase or Decrease lt 7 buttons ar
36. ring Battery Charge Is Adequate cccccccccccscccseceeceeeceeecaeecueeeuesaueseesaeeseeeaes 10 Aa Lock Unlock e ATAY ges dace cede ge ents sede E E E EAEri 10 4 4 Ensuring the Right Exposure Time ls SOE occa ceseresenesnencectsemanaiveeaeessransraianmsnaeeuaioom ess 11 2 eaa e DOVO seria EE EE 11 4 6 Initiating and Completing an X ray EXPOSUIE cccccc cece eeeceeece cece eeeeeeaeeseueseeeseeeseeeaes 12 L PON T O a E E E T tent 12 4 8 Exposure Techniques cccccccecceeceeceeceeceeseeteeseeeaeceesaeeseeseeseeseeseeseeseesueseeseeseeseeseetas 13 ye IN MONU ssr arkeen nne sn n AE EEEE EEEO EEEE Si 14 4 10 Technique Factor Settings and Adjustment c cccccccesccceeceeeseseceeeceeecaeeeeeseeeeaes 16 5 0 Handset Replacement and Care s ssss222 1 6 0 NOMAD Pro Care and Upkeep s 2 22 1 8 6 1 Alarms and Alerts areca teccesscrnatcneapcneantnmannasaeawsawls to andadlsencesenieneanctantenmaienest qantas Saxssiaa ts dnainale aedietwites 18 O ge 10 e so a9 10 Cece eee ee er eee ner eer E ee eee eee ee eee eee eee 20 6 3 Repair and Maintenance ccccccceccecceeceeceeceececeeeeeeeeeseeseeseeseeseeeeeseeseeseeeeeseeseeseesaees 22 7 0 Technical Description 2 2 x 29 Tk Basic Weenie Se CHI QI OM isc saraieracasanaeseea nascar eueaiee iD ene 23 De WTI DAA E E E
37. s The NOMAD Pro is factory calibrated and tested prior to release see your Certificate of Conformance and there are no adjustment options A self diagnostics is completed each time the device is powered up However the optional checks listed below may be performed by a qualified technician as desired Setup a calibrated Performance Meter such as the Victoreen NERO mAx model 8000 according to manufacture s specifications to detect and report the following X ray Tube Voltage kV Effective Mode Radiation Time ms Effective Mode and Dose mR Average Mode The filter card for the Test Detector should be in the 50 100kVp position Measurement Method Final performance measurements are made using a NERO mAx model 8000 X ray meter from Victoreen Tube current mA is sensed across a series connected resistor with an accuracy of 1 and measured using a digital multimeter prior to encapsulation NOMAD Pro has no provision for external measurement of beam current after final manufacture Exposure time is measured during the entire exposure referenced to 75 rise fall using the NERO mAx 8000 X ray meter Accelerating voltage kV is measured at both peak kVp conditions and effective conditions kVeff which is the equivalent kV as if the kV were constant through the whole exposure time Linearity is calculated per IEC 60601 2 7 50 102 2a This X ray unit may be dangerous to testing technician and any bystanders unless safe test exposure f
38. tions Mode of operation Intermittent operation Conductive connection to patient No conductivity with the applied part For use in environments where no flammable anesthetics and or flammable cleaning agents are present non acetone based disinfectant wipes or cloths Electrical Rechargeable lithium batteries 22 2V nominal 25 2V maximum 1 25A hr Low battery alert set point Any cell of the 6 lt 3 5V Battery current at 2 5mA 60kKVp output 12 5A Maximum energy input in one hour 150W X ray Controls and Generator Exposure time range 0 02 1 00 sec in 0 01 second increments Minimum duty cycle 1 60 one 1 second exposure every 60 seconds Minimum permanent filtration gt 1 5mm Al 0 8mm glass 0 5mm Al 0 2mm plastic cap Maximum output power 150W nominal at 60kV 2 5mA Generator rating 2 5mA 5 at 6OkVp 10 Leakage technique factors 60kV 2 5mA 1 00 sec Maximum air kerma at handgrips and lt 0 05mGy in 1 hour control panel 23 NOMAD Pro Measurement Base of Technique Factors The kV is measured during pre pot testing using a calibrated high voltage divider with a guaranteed accuracy of 2 Final performance measurements are made using a NERO mAx model 8000 X ray meter from Victoreen Tube current is sensed across a series connected resistor with an accuracy of 1 and measured using a digital multimeter prior to encapsulation NOMAD Pro has no provision for external measurement of beam current after final manuf
39. ts 35 Ea Reference to a radiation filter or a value of filtration NOMAD Ereg Operator MANUAL Table of Contents 1 0 Getting Sa ra Ire Oates atten ae ieee ennai aaa E Meh WANT USO aca tceeatte aeteat ane satsnon E T E E ae E E R 1 1 2 Unpack Check and Register NOMAD Pro System ccccsscceeecseeseeeceeeeeeeceeeaeeeaees 1 t3 Charging he rt US a ap caeecuasetaneieonoeniane scaualasaatenonmeensacauasn anenianea lt aiaiaanau named asiehenaneawaseueeneacauieend 2 2 0 Safety Precautions cccccccenscesnceeeseeennneeneeeeseeennneenneeessennneenmeees A1 Radiaton Salely a oees ean dans secpcact amet teeh cas cn rii ante detec tn Geen EKEK E ra K ariin ir eiei ririri iai 3 Pe U O MDN C E e a E A E E ten rere en rr nee 5 Me ASIC AIMING erar E E PF 6 2 4 Security Storage and Transportation cccccsceuscecesecanececenarecacenanseecentueseqeneenedenmaenedencudtegecdees 6 3 0 Setup and Power CheCkK s 2 21 The Backscatter SnMield irssnrei E ates med wld cok gaaueliiiakiuebaneteauhanabtactiaei T 32 Alachnga charged Manse sonnet ele konii re hoan 8 3 3 Checking fOr POWER cccccccceccceeeeeeceneceeeceeeceeeeceueseuecuecaeeseeesueseueceueseeesaeeaueeaeesenesaas 8 DA QDUGHAl CMEGCKS A 9 4 0 OHEra TON dician a TO At POWT OT i 5tostieseiscstnonlssnleanicsuiaseyncnvesriecheodiecduaadiaxe sued deus sootdesaimaactisabiouninabieseeeaniesbeesnta 10 4 2 Ensu
40. wise be dangerous to the testing technician or bystanders See Section 4 3 for more information Power On Off Attach a fully charged handset to the NOMAD Pro device Press the Power 5 button and verify the Power On and Power Off states Increase Decrease Exposure Time With the device on select the patient size the image receptor type and the tooth type The exposure time corresponding to the selections will display on screen Press Increase and the Decrease lt 7 buttons and verify that the exposure time changes appropriately Triggering With the device on and an exposure time selected press and release the trigger once this will ready the device and the display will indicate the X ray READY state Press any push button on the user interface panel or wait approximately 15 seconds for the timeout the X ray READY state will end Automatic Shutdown With the device on allow approximately 3 minutes of inactivity to pass for the system to automatically turn off or shut down X ray Disable With the device on press and hold down the Select button and in combination then O press the Patient 4 button the device shifts into a X RAYS LOCKED state and the buttons can be released Repeat the process to unlock the X ray See Section 6 1 Alarms and Alerts for more information NOMAD Pro 4 0 Operation 4 1 Power On Press and release Power button to turn on NOMAD Pro An audible double tone a
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