NOMAD Dental User Manual
Contents
1. Ideally the shield should remain fully extended to the outer edge of the cone as close to the patient as possible for 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 stand the NOMAD on end on a stable surface and while holding the backscatter shield perpendicular to the collimator cone tube shaped cone 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 retainer o ring is permanently attached in the groove at the outer cone end Do not attempt to remove this o ring or to remove the backscatter shield attempting to do so will result in damage to your device 3 2 Attaching a Charged Battery cD Properly orient and carefully insert the newly charged battery into the base of the NOMAD handle a properly oriented battery should click into place without force forcing the battery into position may damage the battery and or the NOMAD The clicking sound ensures the snaps on both sides of the handle bottom are fastened Make sure the battery is secure by giving it a tug NOMAD can be placed into service after the check for power section 3 3 Read the battery charger instruction manual for complete information on how to achieve the longest li2. ARIBEX moman EEN Portable X ray System for Intraoral Radiographic Imaging USER MANUAL Disclaimer NOMAD Dental 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 overexposure 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 modified or tampered with in any way DO NOT OPERATE THIS DEVICE UNTIL YOU HAVE READ THIS MANUAL and reviewed the accompanying materials see the Certificate of Conformance accompanying your device NOMAD Dental is also cleared by the US Food and Drug Administration FDA as a medical device and complies with DHHS Radiation Performance Standard 21 CFR Subchapter J 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 and used to mark the eq
3. 55014 1993 EN 61000 3 2 2000 EN 61000 3 3 1995 A1 2001 Discontinuous Disturbance Test Power Line Harmonics Power Line Flicker Immunity Test Summary Minimum Test Level Required Compliance Specification per EN 60601 1 2 Test Level Completed Status IEC 61000 4 2 1995 1998 A2 2000 Discharge Immunity IEC 61000 4 3 2000 A1 2002 RF Radiated Fields Immunity IEC 61000 4 4 1995 A1 2000 A2 2001 Electrical Fast Transient Immunity IEC 61000 4 5 2001 Lightning Surge Immunity IEC 61000 4 6 1996 A1 2000 RF Common Mode Immunity IEC 61000 4 8 1993 A1 2000 Power Frequency Magnetic Field Immunity IEC 61000 4 11 2001 Voltage Dips and Short Interruptions Se Criterion B Air discharge up to 8kV contact discharge up to 6kV Criterion A Radiation field strength of 3V m from 80 2500MHz 80 amplitude modulated 1 kHz Criterion B Power line pulses of 2kV direct I O line pulses of 1kV Criterion B Power line surges of 2kV common 1k V differential mode Criterion A 150 kHz 80 MHz at 3 Vrms 80 amplitude modulated 1 kHz Criterion A Helmholtz coil at 50 Hz to 3 amps rms per meter Criterion B and C Voltage Dips of gt 95 30 and gt 60 Interruptions of gt 95 Criterion B Air discharge up to 8kV contact discharge up to 6kV Criterion A Radiation field strength of 3V m from 80 2500MHz 80 amplitude modulated 1
4. D Speed Film 0 22mSv Average Exposure Using NOMAD with F Speed Film or Digital Sensor ee Fixed Beam pred 1 Standards for Protection against Radiation sa Shielding 10 CFR 20 US Federal Standards 1994 see also NCRP Report No 116 2 Radiation Exposure with the NOMAD Portable X ray System Goren AD et al Dentomaxillofacial Device N Geometrical Radiation Field Radiology 37 2008 p109 12 normalized __ cao e average includes leakage and backscatter radiation assumes 7 200 exposures per year and LY the average length of exposure for D speed 0 50 Primary Permanent seconds F speed 0 25 seconds digital sensor Protective Filtration Shielding 0 20 seconds Source to Skin Distance Patient ft Plane 2 2 Usage As a Safety feature NOMAD will not emit X rays with insufficient voltage low battery The NOMAD is also designed to avoid damage from overheating The minimum duty cycle rating the relationship between duration and frequency of exposures is 1 60 Examples of optimal use Duration 0 25s 0 46s 0 50s 0 99s Cycle Every 15 sec Every 28 sec Every 30 sec Every 60 sec 2 3 Cleaning O Turn off the power and detach the battery before cleaning Ensure the battery charger is unplugged before attempting to clean it Use a non acetone based disinfectant wipe or a cloth to wipe the exterior surfaces of the NOMAD and charger NOTE NOMAD and the accompanying battery c
5. digital imaging systems Authorized Service complete support and maintenance from Aribex and our authorized distributors USER MANUAL 1 0 Getting Started 1 1 Intended Use The NOMAD Dental X ray System is designed to be used for both adult and pediatric patients by trained dentists and dental technicians for producing diagnostic x ray images 1 2 Unpack Check and Register NOMAD O Unwrap individual components from the protective plastic and check for any noticeable signs of damage The standard package system includes the following items gt NOMAD Device with a Backscatter Shield attached gt 2 Charged Batteries gt Battery Charger the charger should be appropriate for local AC line voltage gt Certificate of Conformance Getting Started guide and Battery Charger manual Warranty Card and NOMAD Operator Training CD Preliminary Checks Verify that the device labels Serial Number Label on lower side of unit in Device Labels front of the handle and Warning Label on the lower side behind the handle are legible and in place Other Labels Verify that the serial number on the Warranty Registration card matches the device serial number and the device carrying case serial number Collimator Cone Inspect for damage The lead lining must cover the entire interior surface Control Panel Should be smooth and free of nicks scratches or damage Trigger Switch Should move freely in when depressed and out
6. has to be reset when the unit is turned on again O After the initial 1 hour recharge the charger will switch to Tune Up Mode which continues 8 hours as cells in the battery are equalized The battery is ready for use and can be removed at any time during this mode Always unplug the charger from the power supply when it is not in service For additional info specifically about the charger see the accompanying instruction manual for the battery charger Battery charge will diminish during extended inactivity fully recharge batteries every 3 months during inactivity Never place a low battery into long term storage O Each battery can go through the discharge charge cycle approximately 200 times When the battery charger senses a bad battery it is spent and must be taken out of service Do not attempt to charge damaged batteries An authorized distributor Aribex and your local recycling center will accept spent or damaged batteries Order new 14 4V batteries from Aribex or your authorized distributor Do not use batteries from other sources which invalidates the warranty 14 USER MANUAL 6 0 Keeping NOMAD Up and Running 6 1 Alarms and Alerts The visual audible alarm signals a programmed action designed to prevent harm to operator patients and or NOMAD The visual audible alerts confirm normal conditions or draw the operator s attention to a required action Visual Indicator xt Audible Signal gt Function Re
7. kHz Criterion B Power line pulses of 2kV direct I O line pulses of 1kV Criterion B Power line surges of 2kV common 1kV differential mode Criterion A 150 kHz 80 MHz at 3 Vrms 80 amplitude modulated 1 kHz Criterion A Helmholtz coil at 50 Hz to 3 amps rms per meter Criterion B and C Voltage Dips of gt 95 30 and gt 60 Interruptions of gt 95 device Up to the 40th Harmonic N A for a Pa powered evice lt 4 Maximum Relative Voltage Change Value of D T 3 for more than 200ms N A for a battery powered device N A for a battery powered device N A for a battery powered device N A for a battery powered device N A for a battery powered device 25 NOMAD 7 5 Optional Calibration Checks The NOMAD is factory calibrated and tested prior to release see your Certificate of Conformance and there are no adjustment options 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 curre
8. 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 as follows In Accordance with Test Type Document Document Title Conducted and Radiated EN 55011 1998 A1 Class Limits and Methods of Measurement of Radio Disturbance Emissions B Characteristics of Information Technology Equipment Electrostatic Discharge IEC 61000 i 1995 Electromagnetic Compatibility for Industrial Process Measurement Immunity 1998 E and Control Equipment Electrostatic Discharge Requirements n E AGnit IEC 61000 4 3 2000 Electromagnetic Compatibility Basic Immunity Standard Radiated eae y ee Radio Frequency Electromagnetic Field Immunity Test Power Frequency Magnetic IEC 61000 4 8 1993 Electromagnetic Compatibility Testing and Measurement Field Immunity mt Techniques for Power Frequency Magnetic Field Immunity Test NOTE The tests documented in the table above are the only tests required for this product as it is a battery operated device and has no I O cables IEC 61000 4 4 4 5 4 6 and 4 11 are not applicable Pa USER MANUAL Emissions Test Summary Specification Frequency Range Compliance Status EN 55011 1991 Group 1 Class B Conducted Emissions 0 15 MHz 30 00 MHz N A for a battery powered device EN 55011 1991 Group 1 Class B Radiated Emissions 30 0 MHz 1000 MHz PASS EN
9. setting for exposure time is stored in memory and redisplays when power is turned back on However if the battery is replaced the display is reset to the 00 default value increase To change exposure settings press the increase or decrease buttons by tenths hundredths of a second A single short audible signal gt example confirms input when a button is pressed released For example 08 LED setting 0 08 seconds 35 LED setting 0 35 seconds decrease 10 USER MANUAL 4 4 Situating the Patient and Enabling the Device Properly position the patient and yourself before enabling NOMAD to prevent accidental exposure Press and release ENABLE to ready the device be sure to re enable NOMAD if any subsequent changes are made to the time setting prior to exposure ENABLED The flashing green ENABLED indicator x and audible signal gt intermittent double beep confirm that NOMAD is enabled This continues for 30 seconds or until an exposure is initiated 4 5 Initiating and Completing an X ray Exposure NOTE An exposure can be prematurely terminated for any reason by abruptly releasing the depressed trigger START To begin the exposure squeeze the handle trigger or press and hold START The ENABLED indicator xt stops flashing and the green START and yellow X RAYS ON indicators lt lt illuminate X RAYS ON To ensure complete exposure keep the trigger or START button Ka depre
10. when released Device Housing Should be free of cracks or fractures NOMAD 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 and enables you to receive valuable product news and updates 1 3 Charging the Battery NOTE Batteries are charged at the factory and should be fully recharged before the initial use of the NOMAD If the system has been in long term storage prior to iniitial use batteries will definitely require a proper charge first In fact it is recommended to fully recharge batteries every 3 months for long term storage to avoid damage to any low battery O Unwrap the power cord of the battery charger and connect it to an AC electrical outlet 110 120V or 220 240V dictated by the country region Position the battery charger away from the normal patient environment A plug adapter may be used as needed use only the supplied battery charger for manufacturer and model info see section 6 3 Repair and Maintenance Invert one of the batteries and carefully plug it into the charger do not force the battery into the charger or damage to the battery may result The red indicator light lt 4 on the top of the charger will flash at a steady rate while the battery is charging The required charge time varies normally between 30 to 45 minutes Battery and
11. with the cone or backscatter shield and or use disposable plastic coverings O Determine what NOMAD time settings deliver optimal results for the type of digital or film based imaging that is done on a regular basis Note that digital imaging sensors and film speeds can vary somewhat in their characteristics and could require different exposure settings than the suggested nominal exposure times in the Technique Factor Chart Adjust as needed to meet density preference 7 For an explanation of the relationship between shot duration and rest cycle between exposures duty cycle see section 2 2 Usage 42 USER MANUAL Technique Factor Chart 23ma soxv Recommended exposure settings X 1 100 second with cone perpendicular to film sensor Digital Sensor Phosphor Plate Schick Sensor Air Techniques Accent Sensor Planmeca DIXI 3 Air Techniques ScanX PSP Kodak Insight Kodak Ultraspeed Adult Sensor 1 amp 2 Child Sensor 1 Adult Sensor 1 amp 2 Child Sensor 1 Adult Sensor 1 amp 2 Child Sensor 1 Maxilla upper Mandible lower Maxilla upper Mandible lower Maxilla upper Mandible lower Maxilla upper Mandible lower Maxilla upper Mandible lower Maxilla upper Mandible lower Maxilla upper Mandible lower Maxilla upper Mandible lower Maxilla upper Mandible lower Maxilla upper Mandible lower Maxilla upper Mandible lower Maxi
12. D and charger Repairs can only be undertaken by trained service personnel Direct all questions to an authorized distributor The following are factory serviceable parts and components gt NOMAD Dental main apparatus assembly item AP 0001 gt Retainer o rings item CP 0046 gt Backscatter shield inner o ring assembly item AP 0012 gt Batteries item CP 0001 gt 110 120V AC battery charger w manual DeWalt model DW9116 or DC9310 item CP 0002 gt 220 240V AC battery charger w manual DeWalt model DE9116 or DE9135 item CP 0045 gt Hard shell carrying case accessory item MP 0018 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 Be sure to include the RMA number on the package you are returning Products without a RMA number cannot be serviced or given credit consideration Aribex will not assume responsibility for shipping damages however it will help you file a claim with the freight carrier Please see warranty information at the end of this manual 19 NOMAD 7 0 Technical Description A Basic Technical Specifications Maximum deviation from fixed factors 5 unless otherwise noted Total weight 4kg Environmental Oper
13. NTY 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 included 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 I
14. Press the POWER button and verify the ON and OFF conditions Increase Decrease Switch Up and Down Arrows With the device turned ON press each of the Increase then Decrease buttons and verify that the exposure times as displayed on the LED display change appropriately Enable Switch With the device turned ON and the LED display set at 50 500ms press the ENABLE button and verify functional conditions Wait approximately 30 seconds at which point the enabled condition should expire Automatic Shut Off Press the POWER button to turn the device ON and wait for it to automatically shut off after approximately 2 5 minutes of inactivity See section 6 1 Alarms and Alerts for more information NOMAD 4 0 Operation 4 1 Powering Up Press and release POWER button to turn NOMAD on after approximately a 2 5 half minutes of inactivity NOMAD shuts off automatically When the power is turned on a single long audible signal gt and an illuminated numeric LED display indicate the unit has power 14 2 Ensuring Battery Charge Is Adequate POWER example If the LOW BATTERY indicator xt flashes accompanied by an intermittent audible signal see sections 3 3 Checking for Power and Adequate Charge and 5 0 Battery Replacement LOW BATTERY For other error conditions please see sections 6 1 Alarms and Alerts or 6 2 Troubleshooting 4 3 Ensuring the Right Exposure Time Is Set When power is turned off the most recent
15. and shutdown occurred a different problem exists see section 6 1 Alarms If pressing POWER several times does not cause the numeric LED display to illuminate the attached battery is the likely problem However if while attempting an x ray exposure two short beeps were emitted and shutdown occurred a different problem exists see section 6 1 Alarms and Alerts Follow proper procedures for replacing the battery see section 5 0 Battery Replacement NOMAD will require authorized service see section 6 3 Repair and Maintenance Manually turn on NOMAD when you are ready to use the device If this condition persists NOMAD will require authorized service see section 6 3 Repair and Maintenance Ensure battery is securely attached Replace with a newly charged battery before continuing Use the battery charger to determine if the first battery is spent and must be taken out of service or if it can be recharged NOMAD will require authorized service see section 6 3 Repair and Maintenance If you have additional questions or require help contact support aribex com 48 USER MANUAL 6 3 Repair and Maintenance NOMAD is a maintenance free product except for routine cleaning Make sure the power is off while cleaning detach the battery It is unnecessary to detach anything else in order to clean the unit Use a non acetone based disinfectant wipe or a cloth to wipe the exterior surfaces of the NOMA
16. ation Temperature 5 C to 40 C 23 F to 104 F 4 C to 40 C 39 F to 104 F charging Relative humidity 10 to 80 non condensing Storage and transportation Temperature 20 C to 60 C 4 F to 140 F NOMAD 20 C to 40 C 4 F to 104 F battery Relative humidity 95 non condensing Classification Specification Compliance IEC 60601 1 Amnd 1 amp 2 60601 1 3 60601 2 7 21 CFR 1020 30 amp 1020 31 Class Il Type BF MDD 93 42 EEC Annex IX Class IIb IPX specification IPO do not operate under wet conditions 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 NiCd battery 14 4V 2A hr Low battery alert set point 11 6V Battery current at 2 3mA 60kVp output 16A X ray Controls and Generator Exposure time range 0 01 0 99 sec certified for 0 02 0 99 sec Maximum duty cycle 1 60 one 0 25 sec exposure 15 sec Minimum inherent filtration 1 5mm Al Maximum output power 140W nominal at 60kV 2 3mA Generator rating 2 3mA at 60kVp 10 Leakage technique factors 60kV 2 3mA 0 99 sec l 20 USER MANUAL 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
17. charger may become warm to the touch while charging which is a normal condition When the battery is fully charged and ready to use the indicator light lt lt will stop flashing and remain on continuously Remove the charged battery and charge the second battery for future use O Optimal battery life and performance occurs when the NiCad battery is fully discharged prior to recharging For more information review the accompanying battery charger Instruction Manual also see section 5 0 Battery Replacement 2 USER MANUAL 2 0 Safety Precautions 2 1 Radiation Safety 4 This x ray unit may be dangerous to operator and bystander unless safe exposure factors and operating instructions are observed s Operators must follow all guidelines dictated by applicable regulations 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 safety recommendations and established maximum permissible doses Optimal operator radiation backscatter protection exists when a the operator remains within the cone shaped backscatter protection zone immediately behind the backscatter shield b the backscatter shield is positioned at the outer end of the collimator cone c the patient tilts their head when needed to accommodate exposures see section 4 7 and d the backscatter shield is close to the patient D
18. eesaeeeseeeeaaees 8 3 4 ODUNA OC lt 3 6 lt a nee ne ee eee ee eee ne ee eee eres 9 4 0 9121 42 1 6 9 eee nen eee ee en eee ec ee A A eee eee eee een 10 4 1 FOUTS ereo E EEA ERE EE ete enet os E E 10 4 2 Ensuring Battery Charge Is Adequate ccc cccccccccccceececeeeeeeeeeee esses eeseeesaeeeseeesaeeesaeeees 10 4 3 Ensuring the Right Exposure Time IS Set ccc ccccccececeeeeee cess eeeee esse eeeeeeeseeesseeesseeees 10 4 4 Situating the Patient and Enabling the Device cee ccecccceeceaeeeeceeeeseeeeaeeesaeeesaeeeeaes 11 4 5 Initiating and Completing an X ray Exposure cccccccecccececeeeeceeeeseeeeaeeeseeeesaeeeseeeesaees 11 4 6 Powering DOWN cicero cctecsue te naaa TE EE NTE E EE 11 4 1 Expos re TechNIJUGS siscctccsedocctensncdtivuvedecesel anian a a aaaea a aa 12 5 0 Battery INGDIACEMION meiride i a a a a 14 6 0 Keeping NOMAD Up and Running cccceeccceececeeeeceeeeaeeeeaeeeseeeeeeeeeeseeeseeeseeeeseeeeseeesaneeseeeesaeees 15 6 1 Alamns and AISTIS to eee cee ee e a i a eee ener 15 6 2 Troubleshooting sessrncaranncen i T E E amen sad 17 6 3 Repair and Maintenance cccccsccccsceceececencecueccueeceueeceucecaueecaeeesaeeceueeceueessesssansaeeesaas 19 LO Techical DesciptU N errereen A A A EEA E 20 7 1 Basic Technical Specifications eicscaccsccsecnedncdavcedanndesnecewecce daned Gancancdious dentecesanedaceencd verededaces 20 7 2 Fan ional TIAA serea gst aers pou tose wae sade dean
19. fe and best performance from your batteries 3 3 Checking for Power and Adequate Charge NOMAD Control Panel 1 After inserting a fully charged battery press and release the POWER button The numeric LED display should illuminate accompanied by a single long audible signal p NOMAD measures whether sufficient battery charge exists prior to a timed exposure when ENABLE is pressed to ready the device If the battery is too low the yellow LOW BATTERY indicator 3 at the lower right of the control panel will flash accompanied by an intermittent audible signal USER MANUAL O Once a battery is depleted indicated by the LOW BATTERY alert it must be recharged before use For continued use insert the secondary replacement battery which should be charged in advance NOTE See section 5 0 Battery Replacement for more information 3 4 Optional Checks The NOMAD is factory calibrated and tested prior to release see your Certificate of Conformance there are no adjustment options However the optional checks listed below may be performed by a qualified technician as desired Test firing this x ray unit may be dangerous to the testing technician or bystanders unless safe test exposure techniques are used such as the use a lead lined cap to cover the end of collimator or test firing in a protected area a amp ON OFF Switch Install fully charged battery to NOMAD device
20. harger are not designed to be subjected to any kind of sterilization procedure 2 4 Security Storage and Transportation gt NOMAD must be kept in a secure location such as a locked cabinet when not in use to prevent unauthorized access The battery serves as the device security key When finished with NOMAD for the day detach the battery and lock it away in a separate location to prevent unauthorized use Make sure NOMAD will not be knocked to the ground when not in use Lay it on its side if necessary Power will automatically shut off after a period of inactivity approximately 2 5 minutes Do not store or carry batteries so that metal objects can contact exposed battery terminals Do not store the NOMAD battery charger or batteries in extreme conditions below 20 C 4 F or above 40 C 104 F or beyond 95 relative humidity non condensing This storage location should be cool dry and away from direct sunlight For more info about storage and operational temperature limits see section 7 1 Basic Technical Specifications gt __ lt USER MANUAL gt Some battery charge may be lost during extended inactivity leading to fewer exposures between charging 3 0 Setup and Check 3 1 The Backscatter Shield In addition to the lead lined cone the backscatter shield provides additional protection to you the operator and features an adjustable position to permit exposures made at various angles
21. ith the patient s head tilted if needed and the backscatter shield is fully extended toward the patient Operation outside the protection zone or with a diminished protective zone Comparative Data for Whole Body Exposure Annual 50mSv Occupational Dose Limit m 3 65mSv E Occupational Dose Limit Requiring Dosimetry Average Natural Background Radiation 2 19MSv a Average Occupational Radiation Exposure for Flight Crews 1 00mSv i General Public Dose Limit 0 20 0 70mSv f 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 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 ry USER 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
22. lert automatically Valid Input For numeric LED display time setting increments or Single short beep decrements Valid when panel button is pressed released Alert LED display turns off Two short beeps X ray emissions are not detected during timed exposure but the Followed by a system shutdown battery is OK Power OFF LED display t ff af hort b leased while power is on Alert Followed by a system shutdown released while power is on Power ON l l POWER button is pressed and LED display lights up Single long beep released while S is off Alert 46 USER MANUAL 6 2 Troubleshooting If you encounter results and or errors in the operation of NOMAD that are not explained in the previous sections check the following table on user troubleshooting to determine the need for authorized service Device Symptom Potential Problem Corrective Action Increase the exposure time setting eeo toco or see Incomplete Exposure below Decrease the exposure time setting also check film expiration date old film can produce dark 6 2 1 Image from x ray exposure does not have Overexposure too dark sufficient contrast Chemical developer for film Ensure chemical freshness and based imaging proper temperature Combined movements of 6 2 2 Image from x ray operator and patient during Check the exposure time setting and re enable when operator and patient are again properly situated exposure is blurred exposure produced t
23. lla upper Mandible lower Premolars amp Canines E Aa O 0O incisors O O CoO N The settings in this chart are based upon an independent university study and are intended as a reference point only Individual results may vary based upon a number of factors including the various imaging sensors and film speeds and brands available patient mass and the technician techniques 13 NOMAD 5 0 Battery Replacement A flashing yellow LOW BATTERY indicator xt control panel and intermittent audible signal indicate the need for a freshly charged battery NOMAD cannot emit X rays with a low depleted battery insufficient voltage Follow these steps to clear the LOW BATTERY alert Press and release POWER on the control panel in order to turn NOMAD off Grasp and depress the buttons on both sides of the battery to release it from the handle You may have to put pressure at the very top of the buttons nearest the handle Then pull the battery away from the handle Carefully insert a newly charged battery into the base of the NOMAD handle a properly oriented battery should click into place without force forcing the battery into position may damage the battery and or the NOMAD A clicking sound ensures that the snaps on both sides of the handle bottom are fastened Make sure the battery is secure by giving it a tug When a battery is detached any stored exposure time is erased from memory and
24. nc 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 therefore 27 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 U S A http www aribex com EC REP MT Promedt Consulting Altenhofstr 80 66386 St Ingbert Germany MP 0013 Rev G
25. nt mA is sensed across a series connected resistor with an accuracy of 1 and measured using a digital multimeter prior to encapsulation NOMAD has no provision for external measurement of beam current after final manufacture Exposure time is measured from the moment x rays are detected until they are no longer detected which means zero crossing mode is selected with no timer delay 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 IEC60601 2 7 50 102 2a This x ray unit may be dangerous to testing technician and any bystanders unless safe test exposure factors such as placing the Test Detector in a lead lined box or the use of a protective lead apron are observed aa ry Enable the NOMAD 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 ee A and oe OE Acceptable oe Description Limits lal 60kV 10 54to66 54to66 54to66 54to66 54to66 Accuracy Timer Setpoint 10 1ms 17 to 23 35t045 359 to 441 539 to 661 890 to 1090 LIMITED WARRA
26. o not enable NOMAD until patient and operator are positioned and ready for the exposure diminishing the likelihood of interruption and preventing inadvertent exposure of anyone to x rays Do not attempt an exposure if anyone else is in the same room unless it is necessary that the patient be accompanied by another person That person must then stay out of the direct beam and wear protective clothing 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 s An exposure can be terminated for any reason by abruptly releasing the depressed trigger for more requires proper precautions such as the information see section 4 0 Operation use of lead aprons i Proper postioning Do not operate with the backscatter NOMAD held back Shield slid back Non perpendicular MAXIMUM shield removed PROTECTION MINIMIZED PROTECTION NOTE In implementing a radiation protection program please consult all applicable state provincial and local regulations governing radiation protection and the use of x ray equipment and ensure full compliance with any such regulations s As shown in graphic representations maximum protection green area from backscatter radiation red area exists when the NOMAD is positioned near the patient is perpendicular to the operator w
27. oo much distortion 6 2 3 Green ENABLED NOMAD is no longer enabled If indicator stops flashing and an x ray exposure is not initiated corresponding short double within 30 seconds of enabling beeps end before an the System Ready condition will exposure is started terminate Double check the exposure time setting and re enable when operator and patient are again properly situated This condition is cleared automatically within 15 seconds or by manually turning NOMAD off and back on The exposure will likely need to be repeated 6 2 4 Green START and Incomplete exposure the yellow X RAYS ON indicators depressed trigger was released flash with corresponding before the timed exposure was series of long beeps able to complete 17 NOMAD Device Symptom Potential Problem Corrective Action 6 2 5 Yellow X RAYS ON indicator does not illuminate 6 2 6 NOMAD automatically shuts down 6 2 7 There is no power to the NOMAD control panel No exposure a subsequent Low Battery alert will signal whether a low battery is the source of the problem If within a few seconds two short beeps are emitted and the system automatically shuts down a different problem exists see section 6 1 Alarms and Alerts After about 2 5 minutes of inactivity NOMAD emits two short beeps and shuts off automatically the system has timed out However if while attempting an x ray exposure two short beeps were emitted
28. 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 Dental has no provision for external measurement of beam current after final manufacture Exposure time is measured from the moment x rays are detected until they are no longer detected which means zero crossing mode is selected with no timer delay 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 28mGy sec X ray field size and configuration 6cm diameter circle Shielding Lead lined Backscatter radiation shielding 0 5mm Pb equivalent 7 2 Functional Diagram High Voltage X Ray Module Logie Control Board LED COM X Ray On LED X Ray On LED Low Batt Start LED Enable LED 7 Seg A gt 7Seg8 See 77 a5 5s WID Battery Load Circuit 21 7 3 X ray Tube Specifications and Characteristics The VTD 0 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 50 70kV Nominal focal spot IEC 60336 1993 0 4mm Maximum anode heat conten
29. s E sede eedesecnnedaect 21 7 3 X ray Tube Specifications and Characteristics ccccccccecccseececeeeceeeeeeeeeeeesseeeseeesaees 22 7 4 NC A persed eee cee tase rece aede secs yee ease A A daieee se A E 24 7 9 Op Melal alDrat oN G MOCKS sariaren EE En EET E EE ESETET ERAS 26 HE IMIS N T UNOS E E E E 27 Thank you for choosing the Aribex NOMAD 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 Dental Features gt Performance battery power source delivers dependable high voltage 60kV true DC and direct current 2 3mA 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 exposure time is the only setting requiring operator input 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 Exposure Safety Feature cannot emit x rays with insufficient voltage low battery Engineered for Compatibility works with both film and
30. solution LED display begins Overheating flashing Yellow LOW BATTERY Low Battery indicator flashes LOW BATTERY Alert Green START and yellow X ray X RAYS ON indicators Exposure illuminate STAAT Alert K RAYS ON Green START and yellow X RAYS ON indicators flash STAAT Alert X RAYS ON Incomplete Exposure System Green ENABLED indicator Readiness faches ENABLED Alert Series of long beeps Slow series of short beeps Continuous tone for the duration of the timed exposure Series of long beeps Slow series of short double beeps Operation suspends if the device overheats after cooling for approximately 5 minutes or longer depending upon room temperature power on see Duty Cycle in section 2 2 Usage Replace the battery and reset exposure time for information see section 5 0 Battery Replacement At the end of the successful exposure audible signal and indicators stop Activates if trigger is released before the timed x ray exposure finishes and ends automatically after 15 seconds or if power is manually turned off on Activates when ENABLE is pressed released ends automatically after 30 seconds or when an exposure starts trigger is depressed or START is pressed 15 Visual Indicator lt lt Audible Signal Function Resolution pee input Invalid input for example triggering prior to enabling Mie IN Sino Siete activates alert which then ends A
31. ssed until the audible continuous tone signal ends and both indicators lt lt are off 4 6 Powering Down a Press and release POWER to turn NOMAD off NOMAD automatically shuts off after approximately 2 5 minutes of inactivity POWER 11 14 7 Exposure Techniques NOMAD provides a high degree of flexibility making it possible for exposures to be produced while the patient is reclined lying on their back or sitting upright O When taking images hold the NOMAD using two hands one on the handle and the other under the battery for increased stability and patient safety To minimize cone cutting NOMAD must be properly positioned relative to the imaging system Check compatibility with film holding kits or aiming devices in advance See comments pertaining to PIDs in section 2 1 Radiation Safety Exposure times increase proportionally when the imaging angles vary from 90 or perpendicular to the film or sensor To maintain low patient x ray doses and keep the operator within the protection zone request that the patient slightly tilt their head and or raise or lower their chin as needed Also see section 2 1 Radiation Safety 4 When angled shots are required 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 Also see section 2 1 Radiation Safety Avoid touching the patient
32. t 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 permanent filtration 0 8mm Al 50kV IEC 60522 1999 M4Deep10 CENTRAL X RAY l 100MIN lx F FILAMENT C CATHODE x axis horizontal y axis vertical OUTLINE DRAWING 22 USER MANUAL Cathode Emission Filament Characteristics Zea al 25kH 60kV aa pe 7 a NOMAD 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 Dental X ray System 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 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 is suitable for use in all establishments including domestic establishments and those directly connected to public low voltage power supply
33. uipment have the following meanings 4 0 lonizing Radiation A Electrical Shock Hazard eS Ds Instructions for handling product at end of life Type BF Equipment providing a degree of protection against electric shock pertaining particularly to allowable leakage currents ARIBEX USER NOMAD MANUAL Dental Table of Contents 1 0 Genn aE A ea E TO 1 1 1 AKE CCN E E EE E P E E A E EE A ce emaeeeaden 1 1 2 Unpack Check and Register NOMAD n annannnnnnnnnnnsnnnnnnnnnnnonrnnrrnrrnrnnrsnrsnrsnrrnronronrrnrrrrrnrnne 1 1 3 Charging the Battery sisssssssrisonannn ania ai mes veneouae 2 2 0 Safety Precautions deen we een on ee eee nee eee een 3 2 1 Radiation Safety cepa saieecsr Sve eencincncemiisnnneaisedb sen deibnamexeaiancuaisne saucnidelsacuua Noe nmcitsised danenieneeaeneuelacun 3 2 2 OSS 6 cee ene E ee er ee eee eee 5 2 3 OVS NG serren anen nE EENE EE pecan EOE panes ince enc NEE EEEN E pecan Wee E EEE E E 6 2 4 Security Storage and Transportation ccc ccccceccceececeeeeeeeeeeeeseeeeseeeeseeeeaeeesaeesseeesaeeess 6 3 0 OVE CU OCNOOK sereis iie irae nance aE ncie EA ESE E AEE E E EAA T 3 1 The Backscatter SIMNGIG o isrrnrrosi anene aAa AEAEE TEE AAE RA KENE AA AERDEN OEK E ARKETA KANRA T 3 2 Attaching a Charged Battery cccccccccscccssceceseecsecceecececeueecaueecaeeeeaeeseeessueeseeeeneeeseas 8 3 3 Checking for Power and Adequate Charge ccccccecccseeeceeeeeeeeeceeeeseueeseeeeae
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