ARIBEX NOMAD MD Operator's Manual
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ARIBEX NOMAD MD Operator's Manual

Handheld x-ray system for medical radiographic imaging
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Handheld X-ray System
for Medical Radiographic Imaging
O
M
peratOr
anual
M
anufactured by

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Summary of Contents for ARIBEX NOMAD MD

  • Page 1 Handheld X-ray System for Medical Radiographic Imaging peratOr anual anufactured by...
  • Page 2 Disclaimer: The NOMAD MD 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. and its agents or representatives do not accept responsibility for the following: a) injury or danger to personnel from X-ray exposure,...
  • Page 3 The symbols used in this publication or used to mark the equipment have the following meanings: Ionizing Radiation Attention, consult instructions for use Laser Radiation: Class 2 laser product, do not stare into beam Recycling/instructions for handling product at end of life Dangerous Voltage, Electrical Shock Hazard Manufacturer of the device Date of device manufacture...

  • Page 4: Table Of Contents

    Table of Contents 1.0 Getting Started 1.1 Intended Use/Indications for Use 1.2 Unpack, Check, and Register NOMAD MD System 1.3 Charging the Batteries 2.0 Safety Precautions 2.1 Radiation Safety 2.2 Studies and Data on Leakage and Scatter 2.3 Usage and Duty Cycle 2.4 Cleaning...
  • Page 5 Thank you for choosing the Aribex NOMAD MD as your X-ray solution! At Aribex 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 contact us by emailing support@aribex.com or calling 1-801-226-5522.

  • Page 6: Getting Started

    1.0 Getting Started 1.1 Intended Use/Indications for Use The NOMAD MD is a handheld and portable general purpose X-ray system. The device uses a fixed tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities.

  • Page 7: Charging The Batteries

    Batteries are charged at the factory and should be fully recharged before the initial use of the NOMAD MD. If the system has been in long-term storage prior to initial use, batteries will definitely require a proper charge first. Actual color/style/model of batteries may differ from batteries shown in manual pictures.
  • Page 8 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 7.0 Maintenance and Repair.  Invert one of the batteries and carefully plug it into the charger (do not force the battery into the charger or the battery may be damaged as a result).

  • Page 9: Safety Precautions

    2.0 Safety Precautions 2.1 Radiation Safety The NOMAD MD was designed to be used in both clinical settings (e.g., a radiology department) 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 10 The SSD cage is designed to maintain a minimum source to skin distance per FDA requirements. Do NOT remove the SSD cage from the NOMAD MD in order to bring the X-ray source closer to the patient. Do NOT make any other modifications to the device.

  • Page 11: Studies And Data On Leakage And Scatter

    2) scatter radiation from the patient/subject in the direct beam. Leakage The primary protective shielding of the NOMAD MD blocks leakage radiation, allowing safe handheld use of the NOMAD MD. Aribex has set and continually meets an internal standard for leakage well below regulations. X-ray Source...
  • Page 12 Chart 1: Vertical Axis, 60 cm X 200 cm Horizontal Significant Zone of Occupancy: 60 cm x 60 cm 0.0 - 10 μGy/hr 11 - 20 μGy/hr 21 - 40 μGy/hr 41 - 80 μGy/hr Foot Phantom and DR Plate >...
  • Page 13 Occupancy for the NOMAD MD contains radiation measurements from the 0 to 40 µGy/hr range: Operators should always wear PPE while using the NOMAD MD in order to be shielded from backscatter radiation. Both an apron (with 0.5mm lead equivalent) and thyroid collar are recommended.

  • Page 14: Usage And Duty Cycle

    Use a non-acetone based disinfectant wipe (with less than 17% alcohol content) or a cloth to wipe the exterior surfaces of the NOMAD MD and charger. Do not use cleaners intended for hard metal surfaces, since certain chemical combinations may deteriorate the NOMAD MD plastic prematurely.
  • Page 15 2 seconds. • Take steps to ensure the NOMAD MD is in a secure location 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).

  • Page 16: Setup And Check

     Make sure the battery is secure by giving it a tug. The NOMAD MD can be placed into service after the operator has checked for power (see Section 3.2 Checking for Power and Adequate Charge).

  • Page 17: Optional Checks

    3.3 Optional Checks The NOMAD MD is factory calibrated and tested prior to release (see your Certificate of Conformance); the only adjustment options are length of exposure and X-ray field size. However, the optional checks listed below may be performed by a qualified technician as desired.

  • Page 18: Operation

    Manufacturer’s recommendation is for First press here the operator to wear nitrile or other gloves during basic operation of the NOMAD MD. The NOMAD MD is designed and tested to be Second press here capable of operating inside a transparent and protective bag.

  • Page 19: Preparing To Enable The Device

    Closes Shutters The inclinometer attached to the left side of the NOMAD MD is used to measure the angle of the device relative to the earth. Even before enabling the NOMAD MD, you can determine which angle will be best suited for the exposure being taken.

  • Page 20: Situating The Patient And Enabling The Device

    The flashing, green Enabled indicator and audible signal (an intermittent, double 75kV - 2.0mA beep) confirm that the NOMAD MD is THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS, OPERATING INSTRUCTIONS AND MAINTENANCE enabled. This continues for 20 seconds or SCHEDULES ARE OBSERVED.
  • Page 21 (top: full view, left: close-up view) The laser used in the NOMAD MD is a Class 2 laser. Operators should take extra precautions to not shine the laser in their own eyes, the eyes of the patient, or anyone else’s eyes.

  • Page 22: Initiating And Completing An X-Ray Exposure

    Indicates exposure is in process 4.6 Powering Down Press and release Power button to turn the NOMAD MD off, or wait for it to automatically shut off after approximately 2.5 minutes of inactivity. 4.7 Exposure Techniques The NOMAD MD provides a high degree of flexibility, making it possible for exposures to be produced while patients are reclined, lying on their backs, or sitting upright.
  • Page 23 CE marked for compliance with the EU PPE Directive. Do NOT remove the SSD cage from the NOMAD MD in order to bring the X-ray source closer to the patient. Do NOT make any other modifications to the device. Doing so highly increases radiation exposure risks for the patient and will void the NOMAD MD warranty.

  • Page 24: Adult Technique Chart

    4.8 Adult Technique Chart The NOMAD MD has been validated to capture diagnostic quality images of body part extremities. For the scope of this device, an extremity is defined as any body part projecting from the torso other than the head. This includes body parts such as fingers (from 1.5cm) and thighs (up to 21cm).

  • Page 25: Adult Dose Value Chart

    4.9 Adult Dose Value Chart Typically, dose value is proportional to the quality of the images obtained. Appropriate considerations should be made for adult patients to assure appropriate dose is maintained based on mAs settings. nOMad Md dult alues fOr Exposure Time in...

  • Page 26: Pediatric Technique Chart

    This is especially important when the patient may be physically compromised due to injury. • Collimate prior to exposure. The NOMAD MD has the ability to collimate down to 1.3 cm by 1.3 cm. X-ray only the indicated area with proper collimation. This will reduce the overall radiation dose as well as prevent excess scatter from degrading image contrast and resolution.
  • Page 27 • Acquire all X-ray exposures in a timely manner. Since the only adjustments needed on the NOMAD MD are collimation and time setting, the device allows for quick acquisition of images. Be sure to collimate before exposure to reduce or eliminate the possibility of retakes.

  • Page 28: Pediatric Dose Value Chart

    4.12 Pediatric Dose Value Chart Typically, dose value is proportional to the quality of the images obtained. Appropriate considerations should be made for pediatric patients to assure appropriate dose is maintained based on mAs settings. nOMad Md ediatric alues fOr Exposure Time in...

  • Page 29: Battery Replacement And Care

     Carefully insert a newly charged battery into the base of the NOMAD MD handle. (A properly oriented battery should click into place without force; forcing the battery into position may damage the battery and/or the device.) A clicking sound ensures that the snaps on both sides of the handle bottom are fastened.
  • Page 30 The following are instructions for handling a product at end of life. Please, protect the environment and do not improperly dispose of any part of the NOMAD MD system, battery, or charger; contact an authorized distributor or Aribex, Inc., regarding assistance in returning the product for proper disposal.

  • Page 31: Nomad Md Care And Upkeep

    6.1 Alarms and Alerts The visual and audible alarms signal a programmed action designed to prevent harm to the operator, patients, and/or the NOMAD MD. The visual/audible alerts confirm normal conditions or draw the operator’s attention to a required action.

  • Page 32: Troubleshooting

    Alert 6.2 Troubleshooting If you encounter results and/or errors in the operation of the NOMAD MD 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 customer support by emailing support@aribex.com or calling 1-801-226-...
  • Page 33 6.2.3 Green Enabled The NOMAD MD is no longer Check the exposure time setting indicator stops flashing (and enabled. If an X-ray exposure is and re-enable when operator corresponding, short double...
  • Page 34 NOMAD MD control panel. if it can be recharged. If while attempting an X-ray exposure two short beeps were The NOMAD MD will require emitted and shutdown authorized service; see Section occurred, a different problem 7.0 Maintenance and Repair.

  • Page 35: Maintenance And Repair

    Use a non-acetone based disinfectant wipe (with less than 17% alcohol content) or a cloth to wipe the exterior surfaces of the NOMAD MD and charger. Do not use cleaners intended for hard surfaces, since certain chemical combinations may deteriorate the NOMAD MD plastic prematurely.
  • Page 36 2.5 minutes without pressing any buttons, the device automatically shuts off. 4. Time Exposure Buttons Verification: With the device powered on and unlocked, verify that a time selection value indicates on the user interface panel. Also check the function of the time exposure buttons. Pressing the time exposure buttons should cause the LED display to adjust accordingly.

  • Page 37: Optional Calibration Checks

    • The NOMAD MD should not be operated if it has been dropped, if performance degrades, if the SSD cage has been broken or compromised in any way, or if the light field fails to function; it should be returned to Aribex for an evaluation.

  • Page 38: Maintenance Log Sheets

    7.3 Maintenance Log Sheets Maintenance Test Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Date/ Date/ Date/ Date/ Date/ Initial Initial Initial Initial Initial 1. Power Button 2. Lock-out Mode 3. Automatic Shut-Off 4. Time Selection Buttons 5.

  • Page 39: Repair

    The following are instructions for handling a product at end of life. Please, protect the environment and do not improperly dispose of any part of the NOMAD MD system, battery, or charger; contact an authorized distributor or Aribex, Inc., regarding assistance in returning the product for proper disposal.

  • Page 40: Technical Description

    Use a non-acetone based disinfectant wipe (with less than 17% alcohol content) or a cloth to wipe the exterior surfaces of the NOMAD MD and charger. Do not use cleaners intended for hard surfaces, since certain chemical combinations may deteriorate the NOMAD MD plastic prematurely.

  • Page 41: Functional Diagram

    X-ray Controls and Generator Maximum output power 150W nominal at 75kV, 2.0mA Generator rating 2.0mA at 75kVp ±10% Leakage technique factors 75kV, 2.0mA, 0.99 sec. Measurement Base of Technique Factors The kV is measured during pre-potting testing using a calibrated high voltage divider with a guaranteed accuracy of ±2%.

  • Page 42: X-Ray Tube Specifications And Characteristics

    8.3 X-ray Tube Specifications and Characteristics The KL 11-0.4-70 is available for nominal tube voltage with self-rectified or constant potential circuit – manufactured by Kailong. Nominal tube voltage 50 - 70kV Nominal focal spot (IEC 60336:1993) 0.4mm Minimum anode heat content 4500J Minimum current continuous service 1.5mA x 70kV...
  • Page 43 Rating Chart NOTE: The X-ray source assembly Thermal Characteristics Chart heating and cooling curves are equivalent to the anode heating curves shown here. Maximum continuous heat dissipation anode heating curves will be made available upon request from Aribex. anode cooling curve...

  • Page 44: Emc Data

    RF communications equipment can affect other medical electrical equipment, the RF emissions of the NOMAD MD are very low and are not likely to cause any interference in nearby electronic equipment.

  • Page 45: 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.
  • Page 46 NOTES...
  • Page 47 NOTES...
  • Page 48 0473 ISO 13485 / ISO 9001 ertified ompany © Aribex, Inc. 2005, 2014 All Rights Reserved English is the original draft language for this manual. Phone: 801-226-5522 Aribex, Inc. Fax: 801-434-7233 744 South 400 East Email: support@aribex.com Orem, Utah 84097 http://www.aribex.com...

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