KaVo NOMAD PRO 2 Operator'S Manual Download Page 52

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Aribex

11727 Fruehauf Dr
Charlotte, NC 28273 U.S.A.
Phone: +1-866-340-5522
Email: [email protected]
http://www.kavo.com

2018 Aribex 1.013.30

EN Rev A 2018 February 1

REP

MT Promedt Consulting

Altenhofstrasse 80
66386 St. Ingbert, Germany
Tel: +49 6894 581020
Fax: +49 6894 581021
e-mail: [email protected]
Website: www.mt-procons.com

0413

DEVICE HAS BEEN CERTIFIED TO MEET THE REQUIREMENTS OF COUNCIL DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES.

Summary of Contents for NOMAD PRO 2

Page 1: ...Handheld X ray System for Intraoral Radiographic Imaging Operator Manual TM...

Page 2: ...nologies LLC 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 procedur...

Page 3: ...18 4 0 Operation 19 4 1 Powering Up 19 4 2 Lock Unlock the X ray 19 4 3 Ensuring the Right Exposure Time is Set 19 4 4 Ready the Device 20 4 5 Initiating and Completing an X ray Exposure 21 4 6 Poweri...

Page 4: ...Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient To make the system as simple as possible for the operator KaV...

Page 5: ...xposure considering the maturity of the child s physical development If use of the device is considered justified the practitioner must take the appropriate precautions such as use of radiation safety...

Page 6: ...e product registration card and mail it with proper postage to KaVo today or go on line at kavo com portable x ray machine warranty registration Registering your device will activate your KaVo NOMAD P...

Page 7: ...he handset charging cradle and AC power supply may become warm to the touch while charging When the handset is first slid onto the charging cradle the first bar will illuminate green for approximately...

Page 8: ...The KaVo NOMAD PRO 2 provides a high degree of protection from unnecessary radiation However no practical design can provide complete protection nor prevent operators from exposing themselves or othe...

Page 9: ...imum protection green area from backscatter radiation red area exists when the KaVo NOMAD PRO 2 is positioned near the patient is perpendicular to the operator with the patient s head tilted if needed...

Page 10: ...limit In response to these regulations KaVo will only ship product that tests below 0 88mGy hr at 1 meter 0 25mGy hr at 1 meter 0 02mGy hr at 5 cm for leakage In order to verify compliance with this l...

Page 11: ...ints in the room first to establish the vertical significant zone of occupancy and then to establish the horizontal significant zone of occupancy Each exposure was taken at 1 00 seconds in order to si...

Page 12: ...Connect only items that are specified as part of the system or that are specified as being compatible with the system 2 4 Cleaning Use a non acetone based disinfectant wipe or a cloth to wipe the exte...

Page 13: ...thorized 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 Take steps to ensure the KaVo N...

Page 14: ...n CAUTION X RAYS ATTENTION RAYONS X The positive and negative connections the polarity of a d c power supply Filtration value X ray source assembly Focal Spot Marking indicating that product is compli...

Page 15: ...he maximum and minimum temperature limits at which the item shall be stored transported or used Kept away from rain and in dry conditions To indicate that the content of the transport package are frag...

Page 16: ...SA STD C22 2 No 60606 1 Complies with FDA radiation performance standards 21 CFR subchapter J Location Top surface of the NOMAD handheld device Use only with 1 013 2001 1 013 2002 or 1 013 4299 chargi...

Page 17: ...t 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 3 2 Attaching a Charged Handset With the KaVo NOMAD...

Page 18: ...for more information Power On Off Attach a fully charged handset to the KaVo NOMAD PRO 2 device Press the Power button and verify that the device correctly powers on and off Increase Decrease Exposure...

Page 19: ...t button while pressing the Patient button The device shifts into an X rays Locked state and the buttons can be released Repeat the process to unlock the X ray device NOTE If the Select button is held...

Page 20: ...age before indicating Ready NOTE As a safety precaution if the trigger is held longer than one second or pulled a second time while still in the Enabling X rays state the device will not transition to...

Page 21: ...ible tone is complete the yellow LED is off and the X ray Complete alert briefly displays The device then returns to the at rest state NOTE An exposure can be terminated for any reason by prematurely...

Page 22: ...m 90 or perpendicular to the film or sensor To maintain low patient X ray doses and to keep the operator within the protection zone have the head of the patient slightly tilted and or raise or lower t...

Page 23: ...ray source Time Settings Sensors and Complete Exposures To ensure image quality use correct time settings The KaVo NOMAD PRO 2 comes with pre sets to give you a starting point However these time sett...

Page 24: ...adults i e the cancer risk per unit dose of ionizing radiation is higher and so unnecessary radiation exposure is of particular concern for pediatric patients Please use caution when configuring the...

Page 25: ...s 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 button to access the menu item Within the menu i...

Page 26: ...r to restore the factory default settings with which the device was shipped These defaults are X rays will be unlocked Audible sound will be set at full volume Trip counter will be reset to zero All f...

Page 27: ...he collimator cone 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...

Page 28: ...there are any signs of deterioration or if batteries do not retain a charge during normal operation Risk of fire or explosion exists if batteries inside the handset are replaced by unauthorized servic...

Page 29: ...rts Alarms Visual and Audible Indicators Function Resolution Visual Audible Enabling Alert None This alert is initiated by a single pull and release of the trigger within one second If no further acti...

Page 30: ...d operation is attempted various alert messages will be displayed For example X rays Locked Simulation Only Simulation Complete Toggle between Locked and Unlocked by pressing and holding down the Sele...

Page 31: ...vates if the trigger is released before the timed X ray exposure finishes This condition is cleared by pressing any button on the user interface panel by turning the power off then on To avoid this er...

Page 32: ...d re enable when operator and patient are again properly situated 6 2 3 Enabling X rays alert stays on Double triggering Release the trigger and wait for the Ready alert 6 2 4 Device does not shift to...

Page 33: ...handset battery can be recharged or is impaired and must be taken out of service A different problem exists if all handsets appear fully charged KaVo NOMAD PRO 2 will require authorized service see S...

Page 34: ...does not completely charge after 5 hours If the green power indicator is illuminated but the handset fails to charge there may be an issue with compatibility of components Ensure that compatible comp...

Page 35: ...d by local regulatory authority 2 Review Section 1 1 Indications for Use and product labeling periodically in order to verify understanding of indications for use for the KaVo NOMAD PRO 2 3 A routine...

Page 36: ...that the trigger moves freely in and out when depressed and released 6 Verify that a single pull and release of the trigger enables the X rays and the device moves into the Ready state 7 Verify that t...

Page 37: ...constant through the whole exposure time Linearity is calculated per IEC 60601 2 7 50 102 2a Keep the Box This X ray unit may be dangerous to testing technician and any bystanders unless safe test ex...

Page 38: ...Initial 1 Power Button Schedule Five Year Maintenance Inspection at KaVo 2 Lock out Mode 3 Automatic Shut Off 4 Time Selection Buttons 5 Trigger 6 Enable Ready State 7 Backscatter Shield 8 Exposure Te...

Page 39: ...Vo or an authorized distributor for replacement and recycling Do not place in municipal waste stream If product return is required contact KaVo for a Return Material Authorization RMA number and shipp...

Page 40: ...60601 6 62366 60601 2 65 Complies with FDA radiation performance standards 21CFR Subchapter J Internally Powered Type BF MDD 93 42 EEC Annex IX Class IIb IPX specification IPX0 do not operate under w...

Page 41: ...Exposure time is measured during the entire exposure references to 75 rise fall using the NERO mAx model 8000 X ray meter Collimator Cone Minimum source to skin distance 21cm from focal spot to cone...

Page 42: ...l 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 Min...

Page 43: ...dimensions are contained entirely within the 6 cm circular exit field diameter This collimator can rotate freely 360 degrees Optional Rectangular Collimator Exit Field Size 3 cm x 4 cm X ray Beam X r...

Page 44: ...44 Cathode Emission Filament Characteristics Chart Rating Chart Thermal Characteristics Chart...

Page 45: ...including domestic establishments and those directly connected to public low voltage power supply networks that supply buildings used for domestic purposes The KaVo NOMAD PRO 2 classified as Medical E...

Page 46: ...PR 11 Group 1 The KaVo NOMAD PRO 2 Intraoral X ray System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby e...

Page 47: ...l or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 0 5 1 kV differential mode 0 5 1 2 kV Mains power quality should be that of a typical commercial or hospital envir...

Page 48: ...in ISM bands E1 3V m Portable and mobile communications equipment should be separated from the KaVo NOMAD PRO 2 Intraoral X ray System by no less than the distances calculated listed below D 3 5 V1 Sq...

Page 49: ...llular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due...

Page 50: ...Output Power Watts Separation Distance According to Frequency of Transmitter m Separation m 150kHz to 80MHz D 3 5 V1 Sqrt P Separation m 80 to 800MHz D 3 5 E1 Sqrt P Separation m 800MHz to 2 5GHz D 7...

Page 51: ...tinue 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 LIMI...

Page 52: ...ribex 1 013 3038 EN Rev A 2018 February 1 EC REP MT Promedt Consulting Altenhofstrasse 80 66386 St Ingbert Germany Tel 49 6894 581020 Fax 49 6894 581021 e mail info mt procons com Website www mt proco...

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