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NOMAD Handheld X-ray System for Intraoral Radiographic Imaging peratOr anual...
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DO NOT OPERATE THIS DEVICE UNTIL YOU HAVE READ THIS MANUAL AND REVIEWED THE ACCOMPANYING MATERIALS. Disclaimer: NOMAD Pro 2 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 Dental...
Table of Contents 1.0 Getting Started 1.1 Indications for Use 1.2 Warnings and Precautions 1.3 Unpack, Check, Register, and Clean NOMAD Pro 2 System 1.4 Charging the Handsets 2.0 Safety Precautions 2.1 Radiation Safety 2.2 Studies and Data on Leakage and Scatter 2.3 Usage and Duty Cycle...
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The device can be used with three detector types: film, digital imaging intraoral sensors, and phosphor plates. NOMAD Pro 2 has a beneficial effect on the dental health of the patient, and results in the meaningful (relevant to the patient) and measurable positive impacts on outcomes related...
1.0 Getting Started 1.1 Indications for Use The NOMAD Pro 2 Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.
Clean the NOMAD Pro 2. Use a non-acetone based disinfectant wipe or a cloth to wipe the exterior surfaces of the NOMAD Pro 2 and charger. Do not use cleaners intended for hard surfaces, since certain chemical combinations may deteriorate the NOMAD Pro 2 plastic prematurely.
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NOMAD Use only the supplied AC/DC power supply. Unwrap the power cord of the power supply and connect it to the charging cradle, then to an AC electrical outlet (universal voltage accommodated). The charger will flash red lights as it initiates, followed by a single green circle that will illuminate to indicate there is adequate power to the charging cradle.
2.0 Safety Precautions 2.1 Radiation Safety The NOMAD Pro 2 was designed to be used in clinical settings (e.g., dental office), with controlled settings, where transportation or use of other X-ray devices might be prohibitive due to the device’s size and/or mobility.
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NOMAD • Do not enable the NOMAD Pro 2 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 the patient is in the direct beam. If others are assisting, then they should wear protective covering as required by local jurisdictions.
Focal Spot Leakage Backscatter Radiation Unique internal shielding of Shielding NOMAD Pro 2 encases the X-ray tube, practically eliminating leakage radiation. This makes it safe to use Pro 2 as a handheld device during exposures. Primary Protective Shielding FDA regulations specify that leakage radiation from X-ray devices not exceed 0.88mGy/hr, while IEC regulations...
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The NOMAD Pro 2 backscatter shield may contain lead dependent on its date of manufacture to attenuate scatter radiation.
60 cm x 60 cm 2.3 Usage and Duty Cycle As a safety feature, the NOMAD Pro 2 will not emit X-rays with insufficient voltage (low battery). The NOMAD Pro 2 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.
Use a non-acetone based disinfectant wipe or a cloth to wipe the exterior surfaces of the NOMAD Pro 2 and charger. Do not use cleaners intended for hard surfaces, since certain chemical combinations may deteriorate the NOMAD Pro 2 plastic prematurely.
For a further level of security, securely store handsets in a separate location. • Take steps to ensure the NOMAD Pro 2 will not be knocked to the ground when not in use. Lay it on its top, side, or in the accessory tabletop stand. Power will automatically shut off after a period of inactivity (approximately three minutes).
NOMAD 2.6 Product Symbols Caution: U.S. Federal law restricts this device to sale by or on the order of a physician or other licensed practitioner. Type BF Equipment (providing a degree of protection against electric shock, pertaining particularly to allowable leakage currents) complying with IEC 60601-1 Warning of ionizing radiation CAUTION: X-RAYS The positive and negative connections (the polarity) of a d.c.
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Model/Catalogue number Serial number Follow Operating Instructions for Use Refer to Instruction Manual Dangerous Voltage: Electrical Shock Hazard The 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 fragile and the package shall be handled with care Audible signal, indicating audible cues emitted by device during operation...
NOMAD 2.7 Location of Device Labels The Handheld X-ray System and Charger have identification labels that specify the model number and applicable product approval listings. Not for sale in U.S. Complies with FDA radiation performance standards 21 CFR, subchapter J. Location: Bottom surface of the NOMAD handheld device.
With the NOMAD Pro 2 placed bottom up on a secure surface, properly orient and carefully slide the charged handset onto the base of the NOMAD Pro 2. (A properly oriented handset should click into place with firm pressure.) The clicking sound ensures the locking ...
NOMAD If the battery charge is too low, the NOMAD Pro 2 will not emit an X-ray and the Recharge Handset alarm will display. When a battery is depleted to the single bar level , it is recommended the handset be recharged.
The NOMAD Pro 2 has an X-ray disable feature that allows the X-rays to be disabled for training purposes. Test firing this X-ray unit may otherwise be dangerous to the testing technician or bystanders.
NOMAD Pro 2. Press and release the Power button to turn on the NOMAD Pro 2. An audible double tone and an active display panel indicate the device has power. Technique factors are redisplayed according to what was...
Section 4.9 Technique Factors Settings and Adjustments). 4.4 Ready the Device Properly position patient and operator before readying the NOMAD Pro 2. Press and release the trigger once to ready the device. A green trefoil will briefly appear on screen above the X-ray tubehead, which is the Enabling X-rays alert.
Press and release the Power button to turn the NOMAD Pro 2 off. The NOMAD Pro 2 also automatically shuts off after approximately three minutes of inactivity. The NOMAD Pro 2 display darkens, accompanied by a tone to indicate shut-down.
4.7 Exposure Techniques As an intra-oral dental X-ray system, the NOMAD Pro 2 can be easily positioned. This high degree of flexibility makes it easy to take exposures while the patient is reclined, lying completely on their back, or sitting upright. Ensure the patient is protected by using an apron.
• DC voltage X-ray generation is efficient in delivering energy at the level optimised for diagnostics, with shorter exposure times required. • The smaller the focal spot, the better the resolution. The NOMAD Pro 2 has a small 0.4mm focal spot.
(i.e., the cancer risk per unit dose of ionising radiation is higher), and so unnecessary radiation exposure is of particular concern for paediatric patients. Please use caution when configuring the NOMAD Pro 2 by considering the patient’s age, size, body habitus, and clinical indication when verifying exposure time settings.
factory defaults are restored through the Reset Defaults menu item. 4.10 Settings Menu The NOMAD Pro 2 Settings Menu allows the operator to customise settings according to individual preferences. To access the Settings Menu, press the Select button. When the...
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Menu Item Icon Options Can be activated to prevent unauthorised use when the NOMAD Pro 2 is idle or stored. This functionality may also be used for training purposes. The red “x” indicates that the X-ray is unlocked. In order to lock the X-ray, the operator presses the...
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NOMAD Menu Item Icon Options May be used to track the number of X-rays taken during a given period of time. In order to reset the trip counter, press the Select button to toggle between the current X-ray count (which will be displayed in red) and the reset count (zero, which will be displayed in green).
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Menu Item Icon Options Allows the operator to save customised timer settings and technique factors. In order to ensure that settings are saved, press the Select button, replacing the red “x” with a green check . The operator may return to Save Settings and determine to not save at any time during the current Settings Menu session.
• Battery life is expected to be at least 2 years with proper care and maintenance. • Batteries and Handsets may only be replaced with NOMAD Pro 2 Handsets. • Battery charge will diminish during extended inactivity. Fully recharge handsets every three months during inactivity.
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• Do not attempt to charge a handset with damaged batteries. Damage can occur if handset experiences liquid ingress, if it has been dropped or punctured , or exposed to heat or fire. Replace battery immediately if there are any signs of deterioration or if batteries do not retain a charge during normal operation.
6.1 Alarms and Alerts The visual and audible alarms signal a programmed action designed to prevent harm to operators, patients, and/or the NOMAD Pro 2. The visual/audible alerts confirm normal conditions or draw the operator’s attention to a required action.
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& A lerts lArms isuAl And udible ndicAtors unction esolution isuAl udible X-rays On Alert At the end of the successful Single tone for exposure the yellow LED turns off, duration of exposure and the panel briefly displays X-ray (X-rays On alert) Complete alert and the screen returns to the at-rest state.
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Failure Alarm 5 audible tones (6.2.12) or a manufacturer (Flashing authorised service centre. Display) The NOMAD Pro 2 should not be operated if it has been dropped or if performance degrades; it should be returned to the manufacturer for an evaluation.
6.2 Troubleshooting If you encounter results and/or errors in the operation of the NOMAD Pro 2 that are not explained in the previous sections, check the following table on user troubleshooting to determine the need for authorised service. If you have additional questions or require help, contact the manufacturer: NOMADsupport@.com...
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This warning alarm can be cleared Self-diagnostics, which 6.2.8 System Failure by powering off, then on. If the alarm automatically run during alarm displayed redisplays, the NOMAD Pro 2 will require X-ray firing, detects a on-screen. authorized service; see Section 7.0 potential issue.
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Section 7.0 Maintenance and when the trigger was device. Repair. pulled. NOMAD Pro 2 times out Manually turn on NOMAD Pro 2 when you after about three minutes are ready to use the device. of inactivity. 6.2.11 NOMAD Pro 2 automatically shuts down.
Use a non-acetone based disinfectant wipe or a cloth to wipe the exterior surfaces of the NOMAD Pro 2 and charging cradle. Do not use cleaners intended for hard surfaces, since certain chemical combinations may deteriorate the NOMAD Pro 2 plastic prematurely.
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10. Ensure that the operator of the system has received a copy of the operator manual. • The NOMAD Pro 2 should not be operated if it has been dropped, if housing is broken, if performance degrades, or if the backscatter shield has been broken or compromised in any way;...
NOMAD 7.2 Calibration Checks The NOMAD Pro 2 is factory calibrated and tested prior to release (see your Certificate of Conformance) and there are no adjustment options. Prior to checking the NOMAD Pro 2 calibration performance, please review the information provided below.
7.4 Repair There are no parts designated as repairable in the field by the owner/user of the device, including fuses. Contact Technical Support at 1-888-88-DEXIS if repairs are needed. Only manufacturer supplied components may be used. Substituting manufacturer parts may cause incorrect operation or failure to the device.
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Imaging Technologies Corporation (DITC), Inc. Please protect the environment, and do not improperly dispose of any part of the NOMAD Pro 2 system, the handsets, the charging cradle, or the AC power supply. At end of life, return these items to DITC for replacement, and proper disposal or recycling.
Temperature –4°F (-20°C) to 50°F (10°C) Relative humidity 5% to 90%, non-condensing Do not use the NOMAD Pro 2 outside of the temperature and relative humidity ranges specified. Classification / Specification Compliance Conforms to AAMI ES60601-1, IEC STDS. 60601-3, 60601-6, 62366,...
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(mA) is sensed across a series connected resistor with an accuracy of ±1% and measured using a digital multimeter, prior to encapsulation; the NOMAD Pro 2 has no provision for external measurement of beam current after final manufacture. Exposure time is measured during the entire exposure, references to 75% rise/fall, using the X-ray meter.
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X-ray Source Focal Spot X-ray Source Focal Spot X-ray Beam Rectangular Axis at 90 to Target Receptor Rectangular Collimator Center Location of X-ray Source Focal Spot Optional Rectangular Collimator Exit Field Size 3 cm x 4 cm NOTE: The Rectangular Collimator Cone Adapter dimensions are contained entirely within the 6 cm circular exit field diameter.
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3cm x 4cm. Therefore, DAP = mGy x 28.27cm Compliance with Applicable Standards Standard Title Edition Complies with X-ray equipment for dental intra-oral IEC 60601-2-65 2012 radiography IEC 60601-2-65:2012, NOMAD Pro 2.
8.2 X-ray Tube Specifications and Characteristics The KL 11-0.4-70 is designed for intra-oral dental imaging by an X-ray unit and is available for nominal tube voltage with self-rectified or constant potential circuit – manufactured by Kailong. Nominal tube voltage 70kV Nominal focal spot (IEC 60336:1993) 0.4mm Maximum anode heat content...
The following tables describe the tests performed and the status of the testing. The NOMAD Pro 2 uses RF energy only for its internal function. Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
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Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The NOMAD Pro 2 Intraoral X-ray System is intended for use in the electromagnetic environment specified below. The customer or user of the NOMAD Pro 2 Intraoral X-ray System should ensure that it is used in such an environment.
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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The NOMAD Pro 2 Intraoral X-ray System is intended for use in the electromagnetic environment specified below. The customer or user of the NOMAD Pro 2 Intraoral X-ray System should ensure that it is used in such an environment.
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Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The NOMAD Pro 2 Intraoral X-ray System is intended for use in the electromagnetic environment specified below. The customer or user of the NOMAD Pro 2 Intraoral X-ray System should ensure that it is used in such an environment.
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Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The NOMAD Pro 2 Intraoral X-ray System is intended for use in the electromagnetic environment specified below. The customer or user of the NOMAD Pro 2 Intraoral X-ray System should ensure that it is used in such an environment.
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Portable and Mobile RF Communications Equipment and the NOMAD Pro 2 device The NOMAD Pro 2 Intraoral X-ray System is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the NOMAD Pro 2 Intraoral X-ray System...
(1) from the date of purchase. The liability of DITC is limited to repair or replacement of any parts that DEXIS or its authorized resellers determine to be defective. Contact DITC for a Return Material Authorization (RMA) number and shipping instructions.
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Questions and answers
Do Nomads have a model number or only a serial number? I only see a serial number (SN) on our Nomad units.
The DEXIS NOMAD Pro 2 has both a model/catalogue number and a serial number.
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