Handheld X-ray System for Medical Radiographic Imaging. Operator Manual. Manufactured by

Transcription

1 Handheld X-ray System for Medical Radiographic Imaging Operator Manual Manufactured by

2 DO NOT OPERATE THIS DEVICE UNTIL YOU HAVE READ THIS MANUAL and reviewed the accompanying materials. 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 and its agents or representatives do not accept responsibility for the following: a) injury or danger to personnel from X-ray exposure, b) image over/under exposure 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 damaged, modified, or tampered with in any way. Aribex and NOMAD are registered trademarks within the United States and other countries. NOMAD MD, NOMAD 75kV, NOMAD Dental, NOMAD Pro, NOMAD Pro 2, PORTA-X, and the ARIBEX and NOMAD logos are trademarks of Aribex worldwide. Product protected in other countries by one or more issued patents. U.S. patents issued: 7,224,769 and 7,496,178. Other United States and international patents pending. All other brand and product names are trademarks or registered trademarks of their respective companies. Further information about Aribex intellectual property available: aribex.com

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 Cd Recycling/instructions for handling product at end of life Dangerous Voltage, Electrical Shock Hazard Manufacturer of the device Date of device manufacture REF SN Model number or corresponding name Unique serial number for the device Reference to a radiation filter or a value of filtration Type B Equipment (providing a degree of protection against electric shock, pertaining particularly to allowable leakage currents) Conformity marking indicating that product meets requirements to be sold in the European Union (EU) Marking indicating that product is compliant with certain North American safety standards Power button, used to power on/off device EC REP Audible signal, indicating audible cues emitted by device during operation Indicates manufacturer s authorized representative in the EU

4 Table of Contents 1.0 Getting Started Intended Use/Indications for Use Unpack, Check, and Register NOMAD MD System Charging the Batteries Safety Precautions Radiation Safety Studies and Data on Leakage and Scatter Usage and Duty Cycle Cleaning Security, Storage, and Transportation Setup and Check Attaching a Charged Battery Checking for Power and Adequate Charge Optional Checks Operation Powering Up Ensuring the Right Exposure Time Is Set Preparing to Enable the Device Situating the Patient and Enabling the Device Initiating and Completing an X-ray Exposure Powering Down Exposure Techniques Adult Technique Chart Adult Dose Value Chart Adult Dose Area Product Chart Pediatric Technique Chart Pediatric Dose Value Chart Pediatric Dose Area Product Chart Battery Replacement and Care Battery Replacement Battery Care NOMAD MD Care and Upkeep Alarms and Alerts Troubleshooting Maintenance and Repair Maintenance Schedule Optional Calibration Checks Maintenance Log Sheets Repair Technical Description Basic Technical Specifications Functional Diagram X-ray Tube Specifications and Characteristics EMC Data Limited Warranty 45

5 Thank you for choosing the NOMAD MD TM 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 ing or calling NOMAD MD TM Features: Performance Battery power source delivers dependable high voltage (75kV, true DC) and direct current (2.0mA). Consistent Emission Radiation High-frequency, constant-potential X-ray generator provides high quality images, with a lower radiation dose to the patient than standard AC X-ray systems. (See Compendium Report, May 1993, Vol. XIV, No. 5, X-Radiation: Potential Risks and Dose Reduction Mechanisms. ) Radiation Protection Operator shielded from source radiation. Simple Operation Operator custom-selects exposure time, shutter width, and shooting distance, all to ensure precise X-rays; exposure time digitally displayed on the user-friendly control panel along with indicators for machine and battery status. Exposure Thickness Range Validated to capture diagnostic quality images of body part extremities such as fingers (from 1.5cm) and thighs (up to 21cm). Lightweight and Ergonomic Design provides complete flexibility and convenience, allowing operator to perform exposures without moving patients. Exposure Safety Feature Cannot emit X-rays with insufficient voltage (low battery). Engineered for Compatibility Works with film, phosphor plate (CR), and digital (DR) radiography systems. Security Lock-out Feature Enables the safe training, demonstration, and storage of the device without undue concern related to unintended or unauthorized radiation emission. Inclinometer Inclinometer attached to side of device provides method for measuring angles during exposure process. Authorized Service Complete support and maintenance from Aribex and through our authorized distributors.

6 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. It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. It is not intended to replace a radiographic system with variable tube current and voltage (kvp) which may be required for full optimization of image quality and radiation exposure for different exam types. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician or other licensed practitioner. 1.2 Unpack, Check, and Register NOMAD MD System Unwrap individual components from the protective plastic and check for any noticeable signs of damage. The standard package system includes the following items: NOMAD MD Device with SSD (Source to Skin Distance) cage and integrated inclinometer attached Two Rechargeable Batteries Battery Charger (the charger should be appropriate for local AC line voltage; actual color/style/model may differ) Certificate of Conformance, Getting Started Guide, Battery Charger Manual, Warranty/Registration Card, and NOMAD MD Operator Training DVD SSD Cage Getting Started Guide Inclinometer Certificate of Conformance Battery Charger Manual Warranty/Registration Card Operator Training DVD Batteries: Charge Before Use Battery Charger 6

7 Preliminary Checks: Item Check Device Labels Other Labels Collimator Cone Control Panel Trigger Switch Device Housing SSD Cage Shutter Rings Inclinometer Verify that the device labels (the serial number label located on the backside of the shutter ring housing and the warning label across the foot of the device) are legible and in place. Verify that the serial number on the warranty/registration card (see number 3 below) matches the device serial number and the device carrying case serial number. Inspect for shipping damage. Check that panel face is smooth and free of nicks, scratches, or other damage. Check that trigger moves freely in and out when depressed and released. Check that housing is free of cracks or fractures. Check that cage is firmly attached to the collimator cone and that it is not cracked or broken. Verify the following: the ring with the larger tabs furthest from the operator moves the outer shutters to adjust the horizontal size; the ring with the smaller tabs closest to the operator moves the inner shutters to adjust the vertical size. Rotating tabs clockwise closes the shutters; rotating tabs counterclockwise opens the shutters. Check that face and casing are smooth and free of nicks, scratches, or other damage. Needle inside of inclinometer should respond to tilting of the device. Complete the product warranty/registration card and mail it with proper postage to Aribex today. This can also be completed on the NOMAD MD website: NOMADMDXray.com/ warranty-registration/. Completing the card fulfills a condition of warranty coverage (see Section 8.5 Limited Warranty) and enables you to receive valuable product news and updates. 1.3 Charging the Batteries NOTE: 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. Fully charge the battery before placing it into long-term storage (over 30 days). After placing the battery into long-term storage, it is recommended that the battery be fully recharged every 3 months. 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). 7

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). The red indicator light 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 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 will stop flashing and remain on continuously. Remove the charged battery and charge the second battery for future use. After the initial 30 to 45 minute recharge, the charger will switch to Tune-Up Mode, which continues for 8 hours while cells in the battery are equalized. The battery is ready for use and can be removed at any time during Tune-Up 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. Also see Section 5.0 Battery Replacement and Care. 8

9 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. This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed. Safety equipment used with this device should be fully tested and certified, and CE marked for compliance with the EU PPE (personal protective equipment) Directive. This X-ray unit must only be operated by trained personnel in a controlled setting. Within such a setting, ensure that only the patient is in the direct beam of the x-ray, and that any ancillary personnel are a minimum of 3 meters (approximately 9 feet) away from the patient. If it is necessary for any ancillary personnel to be closer than 3 meters, these personnel should stay out of the direct beam and wear personal protective equipment (PPE), such as an apron (with 0.5mm lead equivalent) and thyroid collar. However, any structural enclosures (e.g., barriers or walls) in the controlled setting will reduce the zone requiring PPE use (see figure below). Safety equipment used with this device should be fully tested and certified, and CE marked for compliance with the EU PPE Directive. The NOMAD MD provides a high degree of protection from unnecessary radiation. However, no practical design can provide complete protection nor prevent operators from exposing themselves or others to unnecessary radiation. It is important to restrict use and follow all applicable government radiation protection regulations. Pregnant women should not be exposed to X-rays unless necessary. Proper safety precautions should be taken to minimize dose to the fetus. Operator Zone Measureable Scatter Radiation Patient 1.4 meters Encroachment Zone with PPE Use 3 meters Operators must be fully acquainted with industry safety recommendations, established maximum permissible doses, and local jurisdiction requirements for use. Beyond these requirements and the 9

10 instructions provided by Aribex, no additional skills, training, or knowledge are required. Do not enable the NOMAD MD until the patient and operator are positioned and ready for the exposure, preventing interruption and inadvertent exposure of anyone to X-rays. An exposure can be terminated for any reason by prematurely releasing the depressed trigger (for more information, see Section 4.0 Operation). 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. For those operators who take over 5000 exposures a year, radiation protective eyewear is also recommended. Safety equipment used with this device should be fully tested and certified, and CE marked for compliance with the EU PPE Directive. 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. Doing so highly increases radiation exposure risks for the patient and will void the NOMAD MD warranty. In addition, do NOT stick extremities (hands, feet, fingers, toes) inside of the SSD cage in order to bring the X-ray source closer to the patient, since this also increases radiation exposure risks for the patient. In implementing a radiation protection program, consult all applicable regulations governing radiation protection and the use of X-ray equipment, and ensure full compliance with any such regulations. 10

11 2.2 Studies and Data on Leakage and Scatter Besides direct beam, potential exposure from X-ray devices has only two other possibilities: 1) leakage radiation and 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. 1 X-ray Source Focal Spot Primary Protective Shielding Rechargeable Battery SSD Cage Source to Skin Distance (min. 30 cm) Recommended patient buffer plane Scatter In order to fully assess backscatter to the operator, Aribex has conducted an internal study to measure these levels. 2 After positioning the NOMAD MD 28 inches (the recommended operating distance) from a secured phantom, a total of 672 X-ray exposures were fired remotely. A radiation-detecting ion-chamber was rotated to various positions in the room for each exposure. The resulting data were graphed to delineate the Significant Zone of Occupancy (or Operator Zone) for both the vertical (Chart 1) and horizontal (Chart 2) axes: 1 IEC , Part gives a leakage radiation limit of 250 µgy/hr (0.250 mgy/hr), at 1 m from the device enclosure, while Aribex follows a standard of 20 µgy/hr (0.020 mgy/hr), at 5 cm from the device enclosure. 2 TP-0223, Test Case, Scatter Radiation, NOMAD MD (75kV) 11

12 Chart 1: Vertical Axis, 60 cm X 200 cm μgy/hr μgy/hr μgy/hr μgy/hr > 81 μgy/hr 12

13 Chart 2: Horizontal Axis, 60 cm X 60 cm μgy/hr μgy/hr μgy/hr μgy/hr > 81 μgy/hr IEC , Part gives a backscatter radiation limit of 20 µgy/hr with a Significant Zone of Occupancy measuring 200 cm high, 60 cm wide, and 60 cm deep: otherwise, PPE is required. As is demonstrated by Charts 1 and 2, the Significant Zone of 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. For those operators who take over 5000 exposures a year, radiation protective eyewear is also recommended. Safety equipment used with this device should be fully tested and certified, and CE marked for compliance with the EU PPE Directive. 13

14 2.3 Usage and Duty Cycle An exposure can be terminated for any reason by abruptly releasing the depressed trigger (for more information, see Section 4.0 Operation). As a safety feature, the NOMAD MD will not emit X-rays with insufficient voltage (low battery). The NOMAD MD 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. The following table shows examples of optimal use: Duration 0.25 sec 0.46 sec 0.50 sec 0.99 sec Cycle Every 15 sec Every 28 sec Every 30 sec Every 60 sec Do not operate the NOMAD MD or the battery charger if either was immersed in liquid or subjected to an undue amount of moisture. Return to Aribex for an evaluation. Do not open the housings. Doing so will void the warranty. There are no user serviceable parts inside the NOMAD MD. The NOMAD MD should not be used in environments where flammable cleaning agents are present. Locate the battery charger away from the normal patient environment. 2.4 Cleaning 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 (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. NOTE: The NOMAD MD and the accompanying battery charger are not designed to be subjected to any kind of heat sterilization procedure. Do not spray disinfectant or cleaners directly on the NOMAD MD or battery charger. The connecting areas are open to ingress and damage to your device may result. 2.5 Security, Storage, and Transportation Do not store the NOMAD MD, battery charger, or batteries in extreme conditions: below 20 C ( 4 F) or above +60 C (+140 F) for the device or above +40 C (+104 F) for the batteries, or beyond 95% relative humidity (non-condensing). The optimal storage location is cool, dry, and away from direct sunlight. For more info about storage and operational temperature limits, see Section 8.1 Basic Technical Specifications. 14

15 Aribex recommends that the NOMAD MD (like all electronic equipment) be allowed to acclimate before use when switching between temperature extremes (i.e., cold storage area to a hot use area or hot storage area to a cold use area). The NOMAD MD must be kept in a secure location (such as a locked cabinet) when not in use in order to prevent unauthorized access. The battery serves as one of the device security keys. When finished with the NOMAD MD for the day, detach the battery and lock it away in a separate location to prevent unauthorized use. Another one of the security keys of the device is the lock-out feature. If the NOMAD MD has automatically shut off after a 2.5 minute period of inactivity or if it has been turned off manually, simply pressing the Power button alone will NOT allow the operator to begin the enable sequence. The operator must first press the Power button and then press the upper left and lower right exposure time buttons simultaneously, holding them down for approximately 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). Do not store or carry batteries so that metal objects can contact exposed battery terminals. LC Disengaging the lock-out feature Some battery charge may be lost during extended inactivity (leading to fewer exposures between charging periods). The batteries may also completely lose charge if they are left in the device for over a week. If the NOMAD MD is not likely to be used for an extended period, the battery should be removed from the device. 75kV - 2.0mA THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS, OPERATING INSTRUCTIONS AND MAINTENANCE SCHEDULES ARE OBSERVED. Enable button Low battery indicator 15

16 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. Fully charge the battery before placing it into long-term storage (over 30 days). After placing the battery into long-term storage, it is recommended that the battery be fully recharged every 3 months. 3.0 Setup and Check 3.1 Attaching a Charged Battery Properly orient and carefully insert the 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.) 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. 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). Read the battery charger instruction manual for complete information on how to achieve the longest life and best performance from your batteries. 3.2 Checking for Power and Adequate Charge After inserting a fully charged battery, press, hold briefly, and then release the Power button on the user interface panel. The numeric (LED) display should illuminate, showing an LC (an indication that the security lock is engaged), accompanied by a single, elongated audible signal. Then, simultaneously press the upper left and lower right exposure time buttons and hold them for 2 seconds. If the security lock has been successfully disengaged, the most recently entered exposure time will show on the numeric display. If the LC remains on the display, try pushing the exposure time buttons again, this time being sure to hold down for a full 2 seconds. In order to check whether or not the NOMAD MD has sufficient battery charge to complete an exposure, enable the device by either pressing and releasing the Enable button or pressing and releasing the trigger. LC Disengaging the lock-out feature If the battery is too low, the red Low Battery indicator at the lower right of the control panel will flash, accompanied by an intermittent audible signal. Once a battery is depleted, indicated by the Low Battery alert, it must be recharged before use. 16

17 For continued use, insert the secondary, replacement battery (which should be charged in advance). 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. 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 an apron (with 0.5mm lead equivalent) and thyroid collar, are observed. Safety equipment used with this device should be fully tested and certified, and CE marked for compliance with the EU PPE Directive. On/Off Switch: To verify the On and Off conditions, install a fully charged battery to the NOMAD MD device. Press the Power button. The device should turn on. To turn off the device, press the Power button. Exposure Time Buttons (Up and Down Arrows): With the device turned On and the security lock disengaged, press each of the increase buttons then each of the decrease buttons and verify that the exposure times shown on the LED display change appropriately. Pressing the hundredths up button will cause the display to go from 00 to 02. Pressing the hundredths down button will cause the display to go from 02 to 00. This is because the value 01 is not a viable exposure time. The exposure time buttons have a scrolling feature press down and hold on either the up or down arrow in order to scroll through the different time settings. Enable Switch: With the device turned On and the LED exposure display set at 50 (500ms), press the Enable button and verify functional conditions. Wait approximately 20 seconds, at which point the enabled condition should expire. Automatic Shutdown: Press the Power button to turn the device On and wait for it to automatically shut off after approximately 2.5 minutes of inactivity. 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. See Section 6.1 Alarms and Alerts, for more information. 17

18 4.0 Operation 4.1 Powering Up NOTE: Manufacturer s recommendation is for the operator to wear nitrile or other gloves during basic operation of the NOMAD MD. The NOMAD MD is designed and tested to be capable of operating inside a transparent and protective bag. Second press here First press here Press, hold briefly, and then release the Power button to turn on the NOMAD MD. The numeric (LED) display should illuminate, showing an LC (an indication that the security lock is engaged), accompanied by a single, elongated audible signal. The illuminated display and audible signal indicate the unit has power. Press the upper left and lower right exposure time buttons simultaneously and hold for 2 seconds in order to disengage the security lock. (After approximately 2.5 minutes of inactivity, the NOMAD MD shuts off automatically and can only be activated by pressing the Power button and disengaging the security lock.) 75kV - 2.0mA THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS, OPERATING INSTRUCTIONS AND MAINTENANCE SCHEDULES ARE OBSERVED. Powering On and Unlocking the NOMAD MD 4.2 Ensuring the Right Exposure Time Is Set When the power is turned off, the most recent setting for exposure time is stored in the memory and redisplays when the power is turned back on and the security lock is disengaged. To change exposure settings, press the increase or decrease buttons. (Exposure time increases and decreases by tenths and hundredths of a second. Following is an example of how to read the display: 08 LED setting = 0.08 seconds; 35 LED setting = 0.35 seconds.) A single, short audible signal confirms input when a button is pressed and released. To scroll through exposure time settings, press and hold on the appropriate increase or decrease button. Increase buttons Decrease buttons 75kV - 2.0mA THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS, OPERATING INSTRUCTIONS AND MAINTENANCE SCHEDULES ARE OBSERVED. 18

19 4.3 Preparing to Enable the Device The NOMAD MD has several unique features that you should familiarize yourself with before attempting to enable the device and perform exposures. The shutters located at the end of the collimator determine the size of the X-ray field. The shutters are controlled by the two tabbed rings located on the outside rim of the collimator cone. The ring with the larger tabs furthest from the operator moves the outer shutters to adjust the horizontal size; the ring with the smaller tabs closest to the operator moves the inner shutters to adjust the vertical size. Rotating tabs clockwise closes the shutters; rotating tabs counterclockwise opens the shutters. Adjusts Horizontal Size Adjusts Vertical Size Opens Shutters 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. As much as possible, determine device angle, shutter dimensions, and appropriate distance from the patient prior to enabling the device. More precise adjustments can be made after enabling the device, but preliminary inputs are suggested. Inclinometer 19

20 4.4 Situating the Patient and Enabling the Device To prevent accidental exposure, properly position the patient and yourself before enabling the NOMAD MD. Press to enable There are two ways to ready the device for exposures: either press and release the Enable button, or press and release the trigger. Be sure to re-enable the NOMAD MD if any subsequent changes are made to the timer setting prior to exposure. The flashing, green Enabled indicator and audible signal (an intermittent, double beep) confirm that the NOMAD MD is enabled. This continues for 20 seconds or until an exposure is initiated. If the red Low Battery indicator flashes, Indicates device has low battery accompanied by an intermittent audible signal, see Section 3.2 Checking for Power and Adequate Charge and Section 5.0 Battery Replacement and Care. For other error conditions, see Section 6.1 Alarms and Alerts or Section 6.2 Troubleshooting. NOTE: An exposure can be prematurely terminated for any reason by abruptly releasing the depressed trigger. The X-rays On and Start buttons will repeatedly flash simultaneously, accompanied by an audible signal. This condition will continue for 10 seconds, after which the device may be re-enabled. Upon enabling the device, expect to see two colored projections on the patient: a white rectangular light field with a black reticle and a red laser dot. The light field indicates the area of the patient that will be exposed to X-rays; to reduce patient dose, the field size should be collimated to the minimum possible area required to produce the desired diagnostic image. The red laser dot can be moved either up or down on the reticle: moving the device away from the patient causes the laser to travel vertically up the reticle, while moving the device towards the patient causes the laser to travel vertically down the reticle. Indicates device is enabled 75kV - 2.0mA THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS, OPERATING INSTRUCTIONS AND MAINTENANCE SCHEDULES ARE OBSERVED. 20

21 When the laser is aligned with the center of the reticle, the NOMAD MD X-ray source is 28 inches (71.12 cm) from the patient. (The center of the reticle also marks the center of the light field.) For each tick mark above the middle of the reticle that the laser travels up, the X-ray source becomes 4 inches (10.16 cm) further from the patient. For each tick mark below the reticle that the laser travels down, the X-ray source becomes 4 inches (10.16 cm) closer to the patient. 71 cm 101 cm 91 cm 81 cm 61 cm 51 cm When the X-ray source is 28 inches (71.12 cm) from the patient and the shutters are fully open, the X-ray field size is 10 inches x 12 inches (25.40 cm x cm). Reticle image and measurements Location of laser aperture (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. 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. Doing so highly increases radiation exposure risks for the patient and will void the NOMAD MD warranty. In addition, do NOT stick extremities (hands, feet, fingers, toes) inside of the SSD cage in order to bring the X-ray source closer to the patient, since this also increases radiation exposure risks for the patient. 21

22 4.5 Initiating and Completing an X-ray Exposure After enabling the NOMAD MD, make final adjustments for shutter dimensions and distance from the patient. Line up the red laser dot with the middle point of the reticle, or at another point on the reticle, depending on the desired exposure. To generate the exposure, press and hold the handle trigger (or press and hold Start). The Enabled indicator stops flashing, and the green Start and yellow X-rays On indicators illuminate. To ensure complete exposure, keep the trigger or Start button depressed until the audible, continuous-tone signal ends and both the X-rays On and Start indicators are off. Press and hold to initiate X-ray 75kV - 2.0mA THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS, OPERATING INSTRUCTIONS AND MAINTENANCE SCHEDULES ARE OBSERVED. 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. The operator can also take a variety of positions in relation to the patient as well as orient the NOMAD MD using a variety of angles. When taking images, hold the NOMAD MD using two hands, placing one hand on the handle and the other hand under the device housing for increased stability and patient safety. To minimize cone-cutting, the NOMAD MD must be properly positioned relative to the imaging system. The light field and laser should be used to assist in properly aligning the NOMAD MD and detector. Avoid touching the patient with the cone or SSD cage and/or use disposable plastic coverings. The NOMAD MD is designed and tested to be capable of operating inside a transparent and protective bag. 22

23 Determine which time settings, angles, shutter widths, and distances 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 shown in Section 4.8 Adult Technique Chart and Section 4.11 Pediatric Technique Chart. Adjust as needed to meet density preference. The body part being imaged should be unobstructed during the exposure. For an explanation of the relationship between shot duration and rest cycle between exposures (also known as the duty cycle), see Section 2.3 Usage and Duty Cycle. 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. For those operators who take over 5000 exposures a year, radiation protective eyewear is also recommended. Safety equipment used with this device should be fully tested and certified, and 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. In addition, do NOT stick extremities (hands, feet, fingers, toes) inside of the SSD cage in order to bring the X-ray source closer to the patient, since this also increases radiation exposure risks for the patient. 23

24 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). The following theoretical dosage technique chart was developed to assist clinicians in providing the lowest exposure time to non-pediatric patients of all sizes. A technique chart specific to pediatric patients is provided in Section 4.11 Pediatric Technique Chart. Adult Technique Chart 2.0 ma 75 kv Focal-Film Distance: 28 in (71.12 cm) 400 Speed Equivalent Imaging System Thickness of Part in Centimeters Extremity Estimated Exposure Time in Seconds Elbow AP Hand Lat Hand Femur Knee Ankle AP Foot Lat Foot

25 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. Adult Dose Values for NOMAD MD Exposure Time in Seconds Dose Value in Micrograys Exposure Time in Seconds Dose Value in Micrograys Adult Dose Area Product Chart Exposure Time in Seconds Dose value is measured using a Fluke TNT 12000D performance meter with a Dosemate diagnostic ion chamber (100 cm²), with a collimated beam of 5cm x 5cm. Adult Dose Area Product (area of 5 cm x 5 cm) for NOMAD MD Entrance Dose Value in Micrograys Dose Value per cm 2 (5cm x 5cm square/25 cm) Exposure Time in Seconds Entrance Dose Value in Micrograys Dose Value per cm 2 (5cm x 5cm square/25 cm) µgy µgy µgy µgy µgy µgy µgy µgy µgy µgy µgy µgy µgy µgy mgy mgy mgy mgy mgy mgy mgy 25

26 Pediatric Technique Chart Use of equipment and exposure settings designed for an average-sized adult can result in excessive radiation exposure for a smaller patient, especially a pediatric patient. Studies 3 have shown that pediatric patients may be more radio-sensitive than 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. The NOMAD MD will work with current pediatric positioning devices. Normal immobilization is recommended for quality imaging of pediatric patients. Please use caution when configuring the NOMAD MD by considering the patient s age, size, body habitus, and clinical indication when verifying exposure time settings. For pediatric patients, which include neonates, infants, children, and adolescents, special effort should be made to reduce radiation dose, when diagnostically feasible. Please consider the following when preparing to image a pediatric patient: Measure the body part to be imaged using calipers. Position the patient properly. Due to the flexible nature of the NOMAD MD, retakes can be reduced by moving the device instead of the patient to achieve the required image. 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. Shield gonads/breasts/thyroid and other body parts not being imaged when possible. Review exposure indicators and image quality. Make your decisions so that retakes of X-rays are kept to a minimum or are not necessary. Because pediatric patients are generally anxious during any medical procedure, the following guidelines should be followed to ensure the patient is calm and still during an X-ray procedure. Following these important guidelines will also help to avoid retakes. Stay with the patient at all times in order to ensure that the patient remains still during the X-ray procedure. The NOMAD MD is sufficiently shielded internally and has a very low dose output, which allows for the X-ray technologist to remain with the patient during exposures. The technologist should be properly trained and should use protective equipment as recommended. Do not attempt to acquire the image until the patient is sufficiently calm and immobile. Ask a parent or other responsible adult to remain in the examination room during the exposure. Because of the low dose output of the NOMAD MD, adults can safely remain in the same room with the patient during the examination. Show the parent where to 3 NAS National Research Council Committee to Assess Health Risks from Exposure to Low Levels of Ionizing Radiation Health risks from exposure to low levels of ionizing radiation: BEIR VII phase 2. Washington, D.C.: National Academy of Sciences, National Academies Press.

27 stand in the exam room during the exposure. Remember, any ancillary personnel must be at least 9 feet (3 meters) away from the patient during exposures, or wear PPE. Since exposures involve the use of radiation, ask women whether they are pregnant or believe they may be pregnant before proceeding with any exposures. If the answer is yes, request that another adult accompany the child during the exposure. Ask accompanying adults beforehand if they have any questions. Instruct adults who remain in the examination room to refrain from distracting the medical team or interrupting the exposure in any way. The most important role of an adult during the exposure is to help the patient stay calm and relaxed. 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. Proper use of the following pediatric technique chart, based on thickness for child sizes, will help to ensure a quality image, reduce overall dose to the patient, and reduce the potential of retakes. Following ALARA (As Low As Reasonably Achievable) principles, the pediatric time settings have been reduced 40% from adult settings. This reduction is based on a study conducted by the American College of Radiology. 4 Pediatric Technique Chart 2.0 ma 75 kv Focal-Film Distance: 28 in (71.12 cm) 400 Speed Equivalent Imaging System Thickness of Part in Centimeters Extremity Estimated Exposure Time in Seconds Elbow AP Hand Lat Hand Femur Knee Ankle AP Foot Lat Foot ACR-SPR Practice Guideline for General Radiography. ACR Practice Guidelines and Technical Standards for 2013.American College of Radiology. Reston, VA. 27

28 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. Exposure Time in Seconds Pediatric Dose Values for NOMAD MD Dose Value in Micrograys Exposure Time in Seconds Dose Value in Micrograys Pediatric Dose Area Product Chart Dose value is measured using a Fluke TNT 12000D performance meter with a Dosemate diagnostic ion chamber (100 cm²), with a collimated beam of 5cm x 5cm. Pediatric Dose Area Product (area of 5 cm X 5 cm) for NOMAD MD Exposure Time in Seconds Entrance Dose Value in Micrograys Dose Value per cm 2 (5cm x 5cm square/25 cm) Exposure Time in Seconds Entrance Dose Value in Micrograys Dose Value per cm 2 (5cm x 5cm square/25 cm) µgy µgy µgy µgy µgy µgy µgy µgy µgy µgy µgy µgy µgy µgy mgy mgy mgy mgy mgy mgy mgy 28

29 5.0 Battery Replacement and Care 5.1 Battery Replacement A flashing, red Low Battery indicator located on the control panel and intermittent audible signal indicate the need for a freshly charged battery. The NOMAD MD cannot emit X-rays with a low, depleted battery with insufficient voltage. Follow these steps to clear the Low Battery alert: Press and release the Power button on the control panel in order to turn the device 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 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. Make sure the battery is secure by giving it a tug. When a battery is detached and then reattached or when a new battery is attached, the most recently entered exposure time is shown on the numeric display, after first disengaging the security lock. After the initial 30 to 45 minute recharge, the charger will switch to Tune-Up Mode, which continues for 8 hours while cells in the battery are equalized. The battery is ready for use and can be removed at any time during Tune-Up 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. 5.2 Battery Care Battery life is expected to be between 1-2 years or charge/discharge cycles, whichever occurs first. When the battery charger senses a bad battery, the battery is spent and must be taken out of service. Batteries should also be taken out of service once only 10 to 20 exposures can be taken per charging cycle. Do not attempt to charge damaged or spent batteries. An authorized distributor, Aribex, or your local recycling center will accept spent or damaged batteries. Please fully discharge and properly package batteries before returning to Aribex for disposal (see the accompanying instruction manual about the batteries for proper packaging guidelines). Order new 14.4V batteries from Aribex or your authorized distributor. Do not use batteries from other sources; doing so will invalidate the warranty. Check the battery periodically (at least weekly) and ensure proper functionality. 29

30 Replace the battery immediately if it does not retain a charge during normal operation or if there are any signs of deterioration. Do not drop the batteries since mechanical shock can damage the batteries and can initiate battery failure. The batteries contain no user serviceable parts. Opening the battery enclosure will void the warranty. Do not pierce the plastic enclosure (no nails, screws, or other sharp metal objects). Risk of Shock: There is high electrical current present at the battery charger terminals. Do not probe with fingers or conductive objects. Cd 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, regarding assistance in returning the product for proper disposal. Please fully discharge and properly package batteries before returning to Aribex for disposal (see the accompanying instruction manual about the batteries for proper packaging guidelines). 30

31 6.0 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. Condition Visual Indicator Audible Signal Function/ Resolution Overheating Alarm LED display begins alternately flashing OH and a countdown sequence O H None Operation suspends if the device overheats; after waiting for the countdown sequence to complete, power on and continue with exposures (see Section 2.3 Usage and Duty Cycle). Low Battery Alert Red Low Battery indicator flashes Slow series of short beeps Replace the battery and reset exposure time (for information see Section 5.0 Battery Replacement and Care). X-ray Exposure Alert Green Start and yellow X-rays On indicators illuminate Continuous tone (for the duration of the timed exposure) At the end of the successful exposure, audible signal and indicators stop. Incomplete Exposure Alert Green Start and yellow X-rays On indicators flash Series of long beeps Activates if trigger is released before the timed X-ray exposure finishes and ends automatically after 12 seconds or if power is manually turned off and then on. System Readiness Alert Green Enabled indicator flashes Slow series of short, double beeps Activates when Enable is pressed/ released; ends automatically after 20 seconds or when an exposure starts (trigger or Start is pressed). 31

32 Condition Visual Indicator Audible Signal Function/ Resolution Invalid Input Error Alert N/A Two short beeps Invalid input (for example, triggering prior to enabling) activates alert, which then ends automatically. Valid Input Alert For numeric LED display, time setting increments or decrements Single short beep Valid when panel button is pressed or released. System Alert Alert LED display turns off Two short beeps X-ray emissions are not detected during timed exposure because there has been a failure in the internal Followed by a system shutdown circuitry. The battery may be OK. Power OFF Alert LED display turns off Two short beeps Followed by a system shutdown Power button is pressed and released (while power is on). Power ON Alert LED display lights up Single long beep Power button is pressed and released (while power is off). 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 ing support@aribex.com or calling Device Symptom Potential Problem Corrective Action Image from X-ray exposure does not have sufficient contrast. Underexposure (too light). Overexposure (too dark). Chemical developer (for filmbased imaging). Increase the exposure time setting; or see Incomplete Exposure below (6.2.4). Decrease the exposure time setting. Also check film expiration date (old film can produce dark, grainy/foggy images). Ensure chemical freshness and proper temperature. 32

33 Device Symptom Potential Problem Corrective Action Image from X-ray exposure is blurred Green Enabled indicator stops flashing (and corresponding, short double beeps end) before an exposure is started Green Start and yellow X-rays On indicators flash (with corresponding series of long beeps) Yellow X-rays On indicator does not illuminate The NOMAD MD automatically shuts down. Combined movements of operator and patient during exposure produced too much distortion. The NOMAD MD is no longer enabled. If an X-ray exposure is not initiated within 20 seconds of enabling, the system ready condition will terminate. Incomplete exposure the depressed trigger was released before the timed exposure was able to complete. 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. After about 2.5 minutes of inactivity, the NOMAD MD 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 and shutdown occurred, a different problem exists. Check the exposure time setting and re-enable when operator and patient are again properly situated. Check the exposure time setting and re-enable when operator and patient are again properly situated. This condition is cleared automatically within 10 seconds or by manually turning the NOMAD MD off and back on. Follow proper procedures for replacing the battery; see Section 5.0 Battery Replacement and Care. The NOMAD MD will require authorized service; see Section 7.0 Maintenance and Repair. Manually turn on the NOMAD MD when you are ready to use the device. The NOMAD MD will require authorized service; see Section 7.0 Maintenance and Repair. 33

34 Device Symptom Potential Problem Corrective Action There is no power to the NOMAD MD control panel X-ray image is not centered on target area Even though the NOMAD MD is powered on, control panel buttons are unresponsive The LED display begins to alternately flash OH and a countdown sequence. If pressing Power several times does not cause the numeric (LED) display to illuminate, the attached battery is likely the problem. 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). Either red laser dot was not properly aligned with the reticle, or the area being X-rayed was not aligned on the center of the receptor. The NOMAD MD control panel is locked. The NOMAD MD has overheated. 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. The NOMAD MD will require authorized service; see Section 7.0 Maintenance and Repair. Be sure to align the red laser dot with the middle of the reticle before taking the X-ray exposure; also be sure to align the area being X-rayed on the center of the receptor. To unlock control panel after having powered up the NOMAD MD, press the upper left and lower right exposure time buttons simultaneously and hold for 2 seconds. Wait for the countdown sequence to complete; then power on and continue exposures. If you have additional questions or require help, contact customer support by ing support@aribex.com or calling

35 7.0 Maintenance and Repair 7.1 Maintenance Schedule The following quality checks and maintenance items can be performed by any trained personnel. Use Section 7.3 Maintenance Log Sheets to track results. On-going Maintenance: 1. Schedule the NOMAD MD for a maintenance inspection at Aribex every five years. 2. Periodically review Section 1.1 Intended Use/Indications for Use and product labeling in order to verify understanding of indications for use for the NOMAD MD. 3. Clean the NOMAD MD routinely; it is recommended that the NOMAD MD device be cleaned after any patient contact. Make sure the power is off while cleaning and detach the battery. It is unnecessary to detach anything else in order to clean the unit. 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. 4. Batteries should be replaced every 1 2 years or as needed. If during the normal course of use battery charge depletes after exposures (i.e., 25% of expected exposures for a fully charged battery), replace the battery. 5. Periodically assess operator familiarity with the NOMAD MD to determine whether refresher training/certification (per local, national, and jurisdictional requirements) is needed. 6. Periodically review the technique, dose value, and dose area product charts on page 24 through page 28 for comprehension and to assess whether or not chart information is being incorporated into daily use. 7. Periodically review Section 2.1 Radiation Safety and Section 2.2 Studies and Data on Leakage and Scatter in order to become reacquainted with safety precautions, which include designating a Significant Zone of Occupancy and understanding exposure information near the unit. Annual Maintenance: 1. Power Button Verification: Verify that the Power button is working properly and that the exposure time selection LED is illuminated and that an indicator alarm sounds when the device is powered on. 2. Lock-out Mode Verification: Verify that the device is in lock-out mode when the device is initially powered on. Press the upper left and lower right exposure time buttons simultaneously, holding them down for approximately 2 seconds to unlock the device. Verify that the device is unlocked. 3. Automatic Shut-off Verification: Verify that, when left on for a period of approximately 35

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. 5. Enable and Start Buttons Verification: Verify that the Enable and Start buttons on the user interface panel are functioning properly. Also verify that the Enabled and Start LEDs illuminate when their corresponding buttons are pressed. 6. Trigger Verification: Verify that the trigger moves freely when depressed and released. 7. SSD Cage Verification: Verify that the cage is firmly attached to the collimator cone and that it is not cracked or broken. 8. Shutter Rings Verification: Verify the function of the shutter rings. The ring with the larger tabs furthest from the operator moves the outer shutters to adjust the horizontal size; the ring with the smaller tabs closest to the operator moves the inner shutters to adjust the vertical size. Rotating tabs clockwise closes the shutters; rotating tabs counterclockwise opens the shutters. 9. Inclinometer Verification: Verify that the needle inside of inclinometer responds to tilting of the device. 10. Exposure Termination Verification: Select an exposure of 0.99 seconds using the time exposure buttons. Initiate an exposure, but release the exposure switch before 0.99 seconds have elapsed. Verify that the exposure terminates immediately upon release of the trigger. 11. Laser Range Indicator Verification: Verify that the laser range indicator is properly calibrated by placing the device 28 inches from a flat wall or surface and enabling the device. Verify that a white rectangular light field with a black reticle and a red laser dot appear on the wall. If the device is 28 inches from the wall, the red dot should be positioned approximately in the center of the reticle. 12. Light Field Size Verification: With the device positioned 28 inches from the wall, adjust the shutters until they are fully open. Enable the device and measure the light field that is displayed on the wall. It should measure approximately 10 inches x 12 inches (25.4 cm x cm). 13. Image Size Verification: With the device positioned 28 inches from a panoramic film or digital plate, adjust the shutters until they are fully open. Take an exposure. Verify that the resulting image is approximately 10 inches x 12 inches (25.4 cm x cm). 14. X-Rays On LED and Audible Signal Verification: While taking the exposure to verify the x-ray beam size, verify that the X-Rays On LED illuminates and the audible signal is heard Operator Manual Verification: Ensure that the operator of the system has received a copy of the operator manual.

37 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. Fully charge the battery before placing it into long-term storage (over 30 days). After placing the battery into long-term storage, it is recommended that the battery be fully recharged every 3 months. The NOMAD MD and the battery charger are NOT designed to be user serviceable. Do not open the device housing. Doing so will void the warranty. 7.2 Optional Calibration Checks The NOMAD MD 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. Set up a calibrated Performance Meter (such as the Fluke TNT 12000) according to manufacturer s specifications to detect and report the following: X-ray Tube Voltage (kvp average and kv PPV), Radiation Time (ms Effective Mode), and Dose (mr Average Mode). Measurement Method: Final performance measurements are made using a Fluke TNT Exposure time is measured from the moment X-rays are detected until they are no longer detected (which means 90% crossing setting is selected with no timer delay). Accelerating voltage (kv) is calculated using kvp average and kv practical peak value (kv PPV). Linearity is calculated per IEC , a. 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 an apron (with 0.5mm lead equivalent) and thyroid collar, are observed. Safety equipment used with this device should be fully tested and certified, and CE marked for compliance with the EU PPE Directive. Enable the NOMAD MD and with the collimator 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 Aribex. Test Description kvp (eff) Accuracy Timer Accuracy Acceptance Limits 75kV ±10% Setpoint ±(10%, +1ms) Timer Settings and Corresponding Acceptable Ranges 20ms 40ms 400ms 600ms 990ms 67.5 to to to to to to to to to to 1090 A duty cycle of 1:60 is required after each x ray discharge to prevent over-heating damage to the x ray tube. 37

38 7.3 Maintenance Log Sheets Maintenance Test Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 1. Power Button 2. Lock-out Mode 3. Automatic Shut-Off 4. Time Selection Buttons 5. Enable and Start Buttons 6. Trigger 7. SSD Cage 8. Shutter Rings 9. Inclinometer 10. Exposure Termination 11. Laser Range Indicator 12. Light Field Size 13. Exposure Size 14. X-Rays On LED and Audible Signal 15. Operator Manual 16. Calibration Checks (Optional) Date/ Initial Date/ Initial Date/ Initial Date/ Initial Date/ Initial Schedule Five-Year Maintenance Inspection at Aribex Maintenance Test Year 7 Year 8 Year 9 Year 10 Year 11 Year Power Button 2. Lock-out Mode 3. Automatic Shut-Off 4. Time Selection Buttons 5. Enable and Start Buttons 6. Trigger 7. SSD Cage 8. Shutter Rings 9. Inclinometer 10. Exposure Termination 11. Laser Range Indicator 12. Light Field Size 13. Exposure Size 14. X-Rays On LED and Audible Signal 15. Operator Manual 16. Calibration Checks (Optional) Date/ Initial Date/ Initial Date/ Initial Date/ Initial Date/ Initial Schedule Five-Year Maintenance Inspection at Aribex 38

39 7.4 Repair Repairs can only be undertaken by trained service personnel. Direct all questions to Aribex toll free: ; fax The following are factory serviceable parts and components: NOMAD MD, main apparatus assembly item SSD cage item Batteries item /120V AC battery charger w/ manual (DeWalt, model DW9116 or DC9310) item /240V AC battery charger w/ manual (DeWalt, model DE9116 or DE9135) item Hard-shell carrying case item Inclinometer item Laser Assembly item LED Assembly item Cd 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, regarding assistance in returning the product for proper disposal. Please fully discharge and properly package batteries before returning to Aribex for disposal (see the accompanying instruction manual about the batteries for proper packaging guidelines). If product return is required, contact Aribex for a Return Authorization (RA) number and shipping instructions to return the product to the proper facility. You will be required to provide the serial number from the label affixed to the backside of the shutter ring housing of the NOMAD MD device. Serial number location Be sure to include the RA number on the package you are returning. Products without an RA number cannot be serviced or given credit consideration. Aribex will not assume responsibility for shipping damages; however, Aribex will help you file a claim with the freight carrier. Please see warranty information at the end of this manual. 39

40 8.0 Technical Description 8.1 Basic Technical Specifications Maximum deviation from fixed factors: ±10% (unless otherwise noted) Total weight: 5kg (11 lbs) Environmental Operation Temperature Relative humidity Storage and transportation Temperature Relative humidity 5 C to +40 C (+23 F to +104 F) +4 C to +40 C (+39 F to +104 F) charging 10% to 80%, non-condensing 20 C to +60 C ( 4 F to +140 F) NOMAD 20 C to +40 C ( 4 F to +104 F) battery 95%, non-condensing Do not use the NOMAD MD device outside of the temperature and relative humidity ranges specified. Classification / Specification Compliance IEC (Ed. 3), , ; 21 CFR & Class II, Type B MDD (93/42/EEC): Annex IX IPX specification Mode of operation Class IIb IP0; do not operate under wet conditions Intermittent operation For use in environments where no flammable anesthetics and/or flammable cleaning agents are present. 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. Electrical Rechargeable NiCad battery 14.4V, 2A/hr Low battery alert set point 14.4V Battery current at 2.0mA, 75kVp output approx. 26A X-ray Controls and Generator Exposure time range Maximum duty cycle Minimum inherent filtration sec. 1:60 (one 0.25 sec. exposure / 15 sec.) 2.5mm Al 40

41 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%. Final performance measurements are made using a Fluke TNT Exposure time is measured from the moment X-rays are detected until they are no longer detected (which means 90% crossing setting is selected with no timer delay). Collimator Cone Minimum source to skin distance Nominal dose output at SSD tip (30cm) X-ray field size and configuration Shielding 30cm (from focal spot to SSD tip) 3.28mGy/sec. Max: x mm Min: x mm Primarily non-lead heavy metals in molded plastic. Some lead is added as needed to reduce radiation leakage. Laser Safety classification Class 2 Wavelength 655 nm Maximum power <1 mw Beam divergence 2 mrad 8.2 Functional Diagram 41

42 8.3 X-ray Tube Specifications and Characteristics The KL is available for nominal tube voltage with self-rectified or constant potential circuit manufactured by Kailong. Nominal tube voltage Nominal focal spot (IEC 60336:1993) Maximum anode heat content Maximum current continuous service Maximum anode cooling rate Nominal anode input power Target material Minimum target angle 50 70kV 0.4mm 4500J 1.5mA x 70kV 100W 430W Tungsten 12 Filament characteristics A, V Minimum permanent filtration (IEC 60522:1999) 0.8mm Al/50kV y M4Deep10 CENTRAL X-RAY 100MIN F x C F F: FILAMENT C: CATHODE C x axis: horizontal y axis: vertical Ø30MAX 10MAX 70 2MIN OUTLINE DRAWING Ø12 42

43 Cathode Emission/Filament Characteristics Chart Rating Chart Thermal Characteristics Chart anode heating curves NOTE: The X-ray source assembly heating and cooling curves are equivalent to the anode heating curves shown here. Maximum continuous heat dissipation will be made available upon request from Aribex. anode cooling curve 43