KaVo NOMAD PRO 2 Operator's Manual
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KaVo NOMAD PRO 2 Operator's Manual

Handheld x-ray system for intraoral radiographic imaging
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Handheld X-ray System
for Intraoral Radiographic Imaging
O
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Summary of Contents for KaVo NOMAD PRO 2

  • Page 1 Handheld X-ray System for Intraoral Radiographic Imaging peratOr anual...
  • Page 2 Thank you for choosing the KaVo NOMAD PRO 2 At KaVo we value your business and we would like to hear from you because your feedback and suggestions are important to us. If you have comments, please email us: support@aribex.com DO NOT OPERATE THIS DEVICE UNTIL YOU HAVE READ THIS MANUAL and reviewed the accompanying materials.

  • Page 3: Table Of Contents

    Table of Contents 1.0 Getting Started 1.1 Indication for Use 1.2 Warnings and Precautions 1.3 Unpack, Check, and Register KaVo 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...
  • Page 4 The device uses a rechargeable battery to allow for the use of the KaVo NOMAD PRO 2 Handheld X-ray System where transportation or use of other x-ray devices might be prohibitive due to the other device’s size and/or lack of mobility.

  • Page 5: Getting Started

    1.0 Getting Started 1.1 Indication for Use The KaVo 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.

  • Page 6: Charging The Handsets

     or go on-line at kavo.com/portable-x-ray-machine/warranty-registration. Registering your device will activate your KaVo NOMAD PRO 2 Care Plan (the first year is free). For terms and conditions of the KaVo NOMAD PRO 2 Care Plan, visit kavo.com 1.4 Charging the Handsets KaVo NOMAD PRO 2 charging system includes rechargeable handsets, a Charging Cradle and an AC/DC Power Supply.
  • Page 7 If the green circle does not illuminate, the Receiving Adequate Power charging cradle is not receiving adequate power and may need to be sent to an KaVo authorized service center for repairs. Position the charging cradle away from the normal patient environment. A plug adapter may be needed to accommodate the local AC configuration.

  • Page 8: Safety Precautions

    2.0 Safety Precautions 2.1 Radiation Safety The KaVo NOMAD PRO 2 was designed to be used in clinical settings (e.g., a dental office) and controlled settings where transportation or use of other X-ray devices might be prohibitive due to the device’s size and/or mobility.
  • Page 9 • Do not enable the KaVo 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.

  • Page 10: Studies And Data On Leakage And Scatter

    IEC regulations stipulate that devices stay below 0.25mGy/hr, an even tighter 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.
  • Page 11 The significant zone of occupancy for operators has been further verified by internal testing. A KaVo NOMAD PRO 2 device was remotely fired into a water phantom repeatedly, with an ion chamber recording radiation readings at 336 points in the room, first to establish the vertical significant zone of occupancy and then to establish the horizontal significant zone of occupancy.

  • Page 12: Usage And Duty Cycle

    2.3 Usage and Duty Cycle As a safety feature, the KaVo NOMAD PRO 2 will not emit X-rays with insufficient voltage (low battery). The KaVo 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.

  • Page 13: Security, Storage, And Transportation

    For a further level of security, securely store handsets in a separate location. • Take steps to ensure the KaVo NOMAD PRO 2 will not be knocked to the ground when not in use by laying it on its side. Power will automatically shut off after a period of inactivity (approximately three minutes).

  • Page 14: Product Symbols

    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 - ATTENTION: RAYONS X The positive and negative connections (the polarity) of a d.c.
  • Page 15 Date of manufacture Model/Catalog number Serial number Follow Operating Instructions for Use The name and address of the Authorized Representative in the European EC REP Community 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...

  • Page 16: Location Of Device Labels

    2.7 Location of Device Labels The KaVo Handheld X-ray System and Charger have identification labels that specify the model number and applicable product approval listings. Conforms to AAMIES60601-1,IEC STDS. 60601- 1-3, 60601-1-6, 60601-2-65, 62366. Certified to CSA STD. C22.2 No. 60606-1. Complies with FDA radiation performance standards 21 CFR, subchapter J.

  • Page 17: Setup And Power Check

    The clicking sound ensures the  locking mechanism has secured the KaVo NOMAD PRO 2 to the handset. To verify this lock, apply slight pressure in the release direction. There are electric voltages present at the handset terminals. Protect the handset from damage;...

  • Page 18: Optional Checks

    If the battery charge is too low, the KaVo 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 ...

  • Page 19: Operation

    4.1 Powering Up NOTE: The manufacturer’s recommendation is for the operator to wear nitrile or other gloves during basic operation of the KaVo NOMAD PRO 2. Press and release the Power button to turn on KaVo NOMAD PRO 2. An audible double tone and an active display panel indicate the device has power.

  • Page 20: Ready The Device

    4.4 Ready the Device To prevent accidental radiation exposure, properly position the patient and operator before readying the KaVo NOMAD PRO 2. Press and release the trigger once to ready the device. The device will briefly display an Enabling X-rays message before indicating Ready.

  • Page 21: Initiating And Completing An X-Ray Exposure

    Press and release the Power button to turn KaVo NOMAD PRO 2 off. The KaVo NOMAD PRO 2 also automatically shuts off after approximately three minutes of inactivity. The KaVo NOMAD PRO 2 display darkens, accompanied by a tone to indicate shut-down.

  • Page 22: Exposure Techniques

    When taking images, operators may hold the  KaVo NOMAD PRO 2 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).

  • Page 23: Ensuring Image Quality

    • DC voltage X-ray generation is efficient in delivering energy at the level optimized for diagnostics, with shorter exposure times required. • The smaller the focal spot, the better the resolution. The KaVo NOMAD PRO 2 has a small 0.4mm focal spot.

  • Page 24: Technique Factors Settings And Adjustments

    (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 KaVo NOMAD PRO 2 by considering the patient’s age, size, body habitus, and clinical indication when verifying exposure time settings.

  • Page 25: Settings Menu

    Reset Defaults menu item. 4.10 Settings Menu The KaVo NOMAD PRO 2 menus allow the operator to customize settings according to individual preferences. To access the Main Menu, press and hold down the Select button for three seconds.
  • Page 26 Menu Item Function 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 zero by the operator. When Reset is selected and the Select button is pressed, the user will be prompted with the message Reset Trip Counter?

  • Page 27: Handset Replacement And Care

    • Battery life is expected to be at least 2 years with proper care and maintenance. • Batteries and Handsets may only be replaced with KaVo NOMAD PRO 2 Handsets. • Battery charge will diminish during extended inactivity. Fully recharge handsets every three months during inactivity.
  • Page 28 • Risk of fire or explosion exists if batteries inside the handset are replaced by unauthorized service personnel; do not use batteries from other sources. • Properly dispose of spent or damaged handsets; return to KaVo or an authorized distributor for replacement and recycling. Do not place in municipal waste stream.

  • Page 29: Kavo Nomad Pro 2 Care And Upkeep

    6.1 Alarms and Alerts The visual and audible alarms signal a programmed action designed to prevent harm to operators, patients, and/or the KaVo NOMAD PRO 2. The visual/audible alerts confirm normal conditions or draw the operator’s attention to a required action.
  • Page 30 & A lerts lArms isuAl And udible ndicAtors unction esolution isuAl udible X-ray Exposure 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-ray exposure Complete alert and the screen alert) returns to the at-rest state.
  • Page 31 Section 6.2 Troubleshooting Failure Alarm 5 audible tones (6.2.12) or an KaVo authorized service center. The KaVo NOMAD PRO 2 should not be operated if it has been dropped or if performance degrades; it should be returned to KaVo for an evaluation.

  • Page 32: Troubleshooting

    6.2 Troubleshooting If you encounter results and/or errors in the operation of the KaVo NOMAD PRO 2 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 KaVo: support@aribex.com...
  • Page 33 Device Symptom Potential Problem Corrective Action KaVo NOMAD PRO 2 Manually turn on KaVo NOMAD PRO 2 times out after about when you are ready to use the device. three minutes of inactivity. 6.2.7 KaVo NOMAD PRO 2 automatically shuts down.
  • Page 34 Section 7.0 Maintenance and Repair. A different problem exists KaVo NOMAD PRO 2 will require authorized if all handsets appear service; see Section 7.0 Maintenance and fully charged. Repair. If the green power...

  • Page 35: Maintenance And Repair

    Sheets. On-going Maintenance: Observe the following steps for on-going maintenance of the KaVo NOMAD PRO 2. 1. The KaVo NOMAD PRO 2 may be sent to KaVo for a maintenance and inspections as required by local regulatory authority. 2. Review Section 1.1 Indications for Use...
  • Page 36 10. Ensure that the operator of the system has received a copy of the operator manual. • The KaVo 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;...

  • Page 37: Calibration Checks

    Enable the KaVo NOMAD PRO 2 and, with the cone perpendicular to the test detector, make exposures into the test detector and capture the resulting data.

  • Page 38: Maintenance Log Sheets

    9. X-Rays On LED and Audible Signal 10. Operator Manual 11. Calibration Checks (Optional) *It is recommended to replace handsets after years 2 and 4. Contact KaVo for more information on covering battery replacement through the KaVo NOMAD PRO 2 Care Plan. 7.4 Repair There are no parts designated as repairable in the field by the owner/user of the device, including fuses.
  • Page 39 KaVo, Inc. Please protect the environment, and do not improperly dispose of any part of the KaVo NOMAD PRO 2 system, the handsets, the charging cradle, or the AC power supply. At end of life, return these items to KaVo for replacement, and proper disposal or recycling.

  • Page 40: Technical Description

    Temperature -4°F (-20°C) to 122°F (+50°C) Relative humidity <90%, non-condensing Do not use the KaVo 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,...
  • Page 41 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; the KaVo 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 NERO mAx model 8000 X-ray meter.

  • Page 42: X-Ray Tube Specifications And Characteristics

    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...
  • Page 43 X-ray Source Focal Spot X-ray Source Focal Spot X-ray Beam Rectangular Axis at 90o to Target Receptor Optional Rectangular Collimator Optional Rectangular Collimator Exit Field Size 3 cm x 4 cm NOTE: The optional Rectangular Collimator Cone Adapter dimensions are contained entirely within the 6 cm circular exit field diameter.
  • Page 44 Cathode Emission/Filament Characteristics Chart Rating Chart Thermal Characteristics Chart...

  • Page 45: Manufacturer's Declaration

    The following tables describe the tests performed and the status of the testing. The KaVo 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.
  • Page 46 The KaVo NOMAD PRO 2 Intraoral X-ray System is intended for use in the electromagnetic environment specified below. The customer or user of the KaVo NOMAD PRO 2 Intraoral X-ray System should ensure that it is used in such an environment.
  • Page 47 The KaVo NOMAD PRO 2 Intraoral X-ray System is intended for use in the electromagnetic environment specified below. The customer or user of the KaVo NOMAD PRO 2 Intraoral X-ray System should ensure that it is used in such an environment.
  • Page 48 The KaVo NOMAD PRO 2 Intraoral X-ray System is intended for use in the electromagnetic environment specified below. The customer or user of the KaVo NOMAD PRO 2 Intraoral X-ray System should ensure that it is used in such an environment.
  • Page 49 The KaVo NOMAD PRO 2 Intraoral X-ray System is intended for use in the electromagnetic environment specified below. The customer or user of the KaVo NOMAD PRO 2 Intraoral X-ray System should ensure that it is used in such an environment.
  • Page 50 The KaVo 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 KaVo NOMAD PRO 2 Intraoral X-ray System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the KaVo NOMAD PRO 2 Intraoral X-ray Systems recommended below, according to the maximum output power of the communications equipment.

  • Page 51: Cables

    (1) year from the date of purchase. The liability of KaVo is limited to repair or replacement of any parts that KaVo or its authorized resellers determine to be defective. Contact KaVo for a Return Material Authorization (RMA) number and shipping instructions.
  • Page 52 11727 Fruehauf Dr Altenhofstrasse 80 Charlotte, NC 28273 U.S.A. 66386 St. Ingbert, Germany Phone: +1-866-340-5522 Tel: +49 6894 581020 Email: support@aribex.com Fax: +49 6894 581021 http://www.kavo.com e-mail: info@mt-procons.com Website: www.mt-procons.com 2018 Aribex 1.013.3038 EN Rev A 2018 February 1 ©...

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