NOMAD Operator Training

1. NOMAD Operator Training Press the “F5” key to begin  2007

2. Certificate of Training Each operator who uses NOMAD needs to complete this training prior to operating the NOMAD. A certificate signed by the trainer needs to be maintained in the operator’s personnel file and be available for review as required. PLEASE NOTE: This training material is not intended to replace basic x-ray training but is a supplemental material for NOMAD operators.

3. Overview • Fast facts • Who is using NOMAD • Become acquainted with the User Manual • Radiation Safety, shielding • Proper positioning • Operation of the NOMAD • Techniques, etc. • Frequently asked questions and answers • Video review • Supervised practice with the actual unit (hands-on) • Summary • Operator certification test (100% required)

4. NOMAD Fast Facts • Specifications • 60kV, fixed ● 14.4 V battery • 2.3mA, fixed ● 1.5mm Al filtration • 0.01 – 0.99 sec. ● 20cm SSD • Radiation Safety • High-Z Primary shielding, including Pb-lined cone (lead lined cone) • Backscatter shield of 0.5mm Pb-equivalent • Regulatory Compliance • FDA 510(k) Clearance in July 2005 • CE Mark for Europe • Approved in a growing number of countries • Cleared in most states • Acceptance by Dental Community • Well received by the dentists and dental assisting staff • NOMAD continues to see dramatic sales increases

5. Who is Using NOMAD? • Disasters / Forensics • Mobile Dental Practices • Dental Offices • Universities / Hospitals • Military Dentistry

6. Disaster / Forensics Application Spotlight – Tsunami and Katrina • Units sent to Thailand for disaster victim identification • FEMA acquired 15 NOMADs for Katrina • Glowing reports from forensic dentistry

7. Mobile Dentist Practice Mobile Dental Service– Michelle L.D. Caldier, DDS Golden Age Dentistry, Seattle Washington “Without the system I was often unable to obtain current diagnostic films on most of my patients. The success rate by referring patients to an outside radiography clinic was only approximately 10%. “For the few months that I utilized the NOMAD I was able to achieve approximately an 85% success rate in obtaining films [or an improvement from 10% to 85%]. “I could position the film and expose the radiograph within one second, which is critical for my restless patient population.”

8. Dentist Office Dental Assistant - Eileen Bidstrup Eric Vogel Dental Practice, Provo Utah “Portability: The NOMAD comes to you. With standard systems the patients must be moved to the x-ray. This is hard for older patients, children and patients during root canals and surgery. “Time Saver: No adjusting the chair or the x-ray head. I don’t need to leave the room. The NOMAD literally cuts the x-ray time in half. “Working with Children: It allows you to stay right near the child. Because it is faster, children don’t have to have the film or sensor in their mouth so long, making it easier for them and you.

9. Universities / Hospitals • University of Texas – Dr. Robert Langlais, DDS “Teaching our students to incorporate this new technology into dental practice. We see the benefits of it every day.” • UCLA - David A. Altman, DDS “Used both in the hospital and the dental clinic setting. The acceptance has been high with residents, faculty and our dental assisting staff.” • University of Missouri, KC – Susan Masih, Tim Taylor, DDS “The NOMAD is most useful to check implant position. It decreases both staff and patient time and increases patient comfort.”

10. Military - USAF DENTAL EVALUATION & CONSULTATION SERVICE Radiation safety test results from the Air Force Institute of Occupational Health and DECS demonstrated that NOMAD: “Meets applicable radiation safety standards “Clinical evaluators were impressed with how easy the NOMAD was to set up and operate “…put to immediate use in a forensic identification and in the endodontic, implant, and oral surgery clinics “The Aribex NOMAD Dental x-ray unit is rated Excellentfor use in US Air Force dental facilities.”

11. NOMAD Testing to AssureRadiation Safety Your NOMAD has been thoroughly tested at the factory to ensure your safety, making certain that it meets or exceeds federal requirements.

12. National and International Certifications • FDA Clearance: Meets all of the performance and safety standards for diagnostic x-ray equipment, 21CFR1020. • Section 1020.30 (Diagnostic x-ray systems and their major components) • Section 1020.31 (Radiographic equipment) • UL Certification: Meets radiation standards for: • IEC60601-1-3 (Collateral Standard: General requirements for radiation protection in diagnostic x-ray equipment) • IEC60601-2-7 (Particular requirements for the safety of high-voltage generators of diagnostic x-ray generators) • ISO 9001, ISO 13485 & CE Certification: Authority to sell in Europe and other countries. • Health Canada Medical Device License: Approval to sell NOMAD in Canada. • Australia, New Zealand, Thailand, India and France: Local approvals.

13. User Manual From the inside cover . . . “DO NOT OPERATE THIS DEVICE UNTIL YOU HAVE READ THIS MANUAL and reviewed the accompanying materials.”

14. User Manual Coming up, we’ll spend some time in the User Manual. You’ll want to follow along or review after this presentation so that you can get all of the information. When we are in the manual, you’ll see a page reference right here to keep you on track User Manual, p##

15. Operators must follow all guidelines and regulations in regard to patients and operators who are pregnant or expect to become pregnant. Operators must be fully acquainted with safety recommendations. Do not enable NOMAD until ready for the exposure. Do not make an exposure if anyone else is in the same room. Use Position Indicating Devices (PIDs) that allow the backscatter shield to remain at the outer end of the cone. User Manual – 2.1 Radiation Safety User Manual, p4-5

16. What’s the NOMAD Difference? • Safe as a handheld x-ray • No need to leave the room during an exposure WHY??? Let’s find out . . .

17. Primary Shielding PRIMARY PROTECTIVE SHIELDING NOMAD was designed with patient and operator safety in mind. The special internal shielding encases the x-ray tube and effectively eliminates leakage radiation. This makes it safe to use NOMAD as a handheld device during exposures.

18. NOMAD Pro Operator Dosage Perspective Leakage – Hand / Extremity Exposure 500mSv Recommended Occupational Limit1 Occupational Limit Requiring Dosimetry1 50mSv Average Using NOMAD with D-Speed Film2 0.43mSv Using NOMAD F-Speed Film or Digital Sensor2 0.22mSv • Standards for Protection against Radiation, 10 CFR 20 (US Federal Standards), 1994 • 2) "Radiation Exposure with the NOMAD Portable X-ray System", Goren AD et al, Dentomaxillofacial Radiology, 37 (2008), S. 109-12; normalized average (includes leakage and backscatter radiation) assumes 7,200 exposures per year, and the average length of exposure for D-speed = 0.50 seconds, F‑speed = 0.25 seconds, digital sensor = 0.20 seconds Operator Manual, p5

19. Secondary Shielding Secondary shielding on NOMAD acts as a barrier against backscatter radiation eliminating the need for the operator to leave the room. As a result of the primary and secondary shielding, operator x-ray exposure is below federal regulatory limits.

20. NOMAD Pro Operator Dosage Perspective Annual Whole Body Exposure 50mSv Recommended Occupational Limit1 Occupational Limit Requiring Dosimetry1 5mSv Range for Dental Professionals & Wall-Mount2 0.2-0.7mSv Average Using NOMAD with D-Speed Film3 0.30mSv Using NOMAD F-Speed Film or Digital Sensor3 0.12mSv • Standards for Protection against Radiation, 10 CFR 20 (US Federal Standards), 1994 • 2) NCRP Report No. 145, p9 • 3)Normalized average assumes 7,200 exposures per year, and the average length of exposure for D-speed = 0.50 seconds, F-speed = 0.25 seconds, digital sensor = 0.20 seconds Operator Manual, p5

21. Backscatter Shield maximum protection exists when the shield is at the outer edge of the cone, close to the subject, and parallel to the operator. The operator protection zone is linked to the positioning of the backscatter shield . . . User Manual, p4-5

22. Backscatter Shield Note how the protection zone changes in these illustrative representations as these factors change . . . The operator protection zone is linked to the positioning of the backscatter shield . . . User Manual, p4-5

23. Backscatter Shield Protection diminishes when the shield is not at the outer edge of the cone, use positioning kits that do not require the shield to be slid back. The operator protection zone is linked to the positioning of the backscatter shield . . . User Manual, p4-5

24. Backscatter Shield Protection diminishes when the shield is distanced from the subject, hold the cone close to the patient. The operator protection zone is linked to the positioning of the backscatter shield . . . User Manual, p4-5

25. Backscatter Shield Protection diminishes when the shield is not parallel to the operator, avoid this by asking the patient to slightly tilt their head. The operator protection zone is linked to the positioning of the backscatter shield . . . User Manual, p4-5

26. Backscatter Shield Remember, maximum protection exists when the shield is at the outer edge of the cone, close to the subject, and parallel to the operator. The operator protection zone is linked to the positioning of the backscatter shield . . . User Manual, p4-5

27. Backscatter Shield If you must compromise the backscatter protection zone, you should wear appropriate protective clothing and always remember to sight through the backscatter shield, not over or around it, don’t lean out of the zone! User Manual, p4-5

28. Radiation Safety • To maintain radiation safety your office should: • ensure NOMAD operators are aware of applicable guidelines and regulations for x-ray operation, • establish an in-house radiation protection program, and • address protection of patients and operators especially those who are or could become pregnant.

29. As a safety feature, NOMAD will not emit x-rays with a low battery charge. To avoid damage from overheating observe the duty cycle (the rest period between exposures). Examples: Exposure Duration Rest Cycle User Manual – 2.2 Usage • In other words, if you use “D” speed film with an exposure time of .50 seconds, you should allow the NOMAD to rest for 30 seconds before taking another exposure. • Or, if you are using “F” speed film with and exposure of .25 seconds, you would only need to wait 15 seconds before taking your next exposure. User Manual, p5

30. Practice good housekeeping and regularly clean your NOMAD.  Detach the battery before cleaning NOMAD and unplugged the battery charger before cleaning it.  Use a non-acetone based disinfectant wipe or cloth to wipe down surfaces. User Manual – 2.3 Cleaning User Manual, p6

31. NOMAD must be kept in a secure location, such as a locked cabinet, when not in use to prevent unauthorized access, normally this responsibility resides with the operator. The battery serves as the device security key. When finished with NOMAD for the day, detach the battery and lock it away in a separate location to prevent unauthorized use. In between exposures, store NOMAD so it will not be knocked to the ground (lay it on its side). Do not store the NOMAD, battery charger, or batteries in extreme temperatures or humidity. User Manual – 2.4 Storage User Manual, p6

32. User Manual – 3.1 The Backscatter Shield The backscatter shield provides additional protection to the operator and is adjustable when proper precautions are taken.  The shield should remain fully extended to the outer edge of the cone, as close to the patient as possible for each image taken.  If adjustments are needed, stand the NOMAD on-end on a stable surface and gently glide the shield up or down along the cone using equal pressure to maintain a perpendicular alignment and avoid binding.  Keep the shield securely on the cone by making sure the retainer o-ring remains seated in the groove on the cone end. Hands on exercise, give it a try, when you’re done ensure the shield is at the outer end. User Manual, p7

33. User Manual – 3.2 Attaching a Battery  Carefully insert the newly charged battery into the base of the NOMAD handle.  Make sure the battery is secure by giving it a tug.  Read the battery charger instruction manual for complete information on how to achieve the longest life and best performance from your batteries. Hands on exercise, give it a try. Before you use the charger (or take the exam), review the charger instruction manual and pay particular attention to the Charging Procedure, Using Automatic Tune-Up™ Mode, and Important Charging Notes sections. User Manual, p8

34. User Manual – 3.3 Checking for Power  After inserting a fully charged battery press the POWER button.  You’ll hear a beep and the number (LED) display will light up Hands on exercise, give it a try. User Manual, p8-10

35. User Manual – 4.0 Operation 4.2 Adequate Battery Charge • The LOW BATTERY indicator ☼ will flash, accompanied by an beeping, if the battery charge is low. • As a safety feature, the NOMAD cannot emit x-rays with low battery. User Manual, p10

36. User Manual – 4.0 Operation 4.3 Exposure Time • When power is turned off, the most recent exposure time is stored in memory and redisplays when power is turned back on. • However, if the battery is replaced, the display is reset to the 00 default value. • To change exposure settings press the increase or decrease buttons (by tenths / hundredths of a second). A beep confirms input when a button is pressed. (For example, 08 LED setting = 0.08 seconds.) Hands on exercise, give it a try. User Manual, p10

37. User Manual – 4.0 Operation 4.4 Enabling NOMAD • Properly position the patient and yourself before you press ENABLE (to prevent accidental exposure). • The flashing, green ENABLED indicator and, double beep confirm that NOMAD is enabled. This continues for 30 seconds or until an exposure is initiated. Hands on exercise, give it a try. User Manual, p11

38. User Manual – 4.0 Operation 4.5 X-Ray Exposure • To begin the exposure, squeeze and hold the trigger or press START • The ENABLED lightstops flashing • The green START and yellow X-RAYS ON lightsblink • You hear beep throughout the duration of the exposure • An exposure can be prematurely terminated by releasing the trigger or START User Manual, p11

39. User Manual – 4.0 Operation 4.6 Powering Down • Press and release POWER to turn NOMAD off. • NOMAD automatically shuts off after approximately 2-1/2 minutes of inactivity. Hands on exercise, give it a try. User Manual, p11

40. User Manual – 4.7 Exposure Techniques NOMAD provides flexibility for exposures while the patient is sitting upright or reclined.  Hold the NOMAD using two hands as shown for increased stability and patient safety.  Properly position to minimize cone-cutting.  Exposure times increase when not perpendicular to the film or sensor. User Manual, p12

41. User Manual – 4.7 Exposure Techniques  When the protection zone is compromised, use of proper safety measures such as a lead apron.  Avoid touching the patient with the cone or backscatter shield.  Determine the best time settings for the type of digital or film-based imaging used in your practice and document it.  Maintain the operator backscatter protection zone by requesting that the patient to tip, tilt, or turn their head as shown. User Manual, p12

42. User Manual – Self Study and Review • 5.0 Battery Replacement • This section of the User Manual (page 14) along with the DEWALT Instruction Manual will guide you though how to properly care for your batteries and the charger to ensure maximum life and operator safety. Be sure to review these materials fully. • 6.0 Keeping NOMAD up and Running • 6.1 Alarms and Alerts (page 15-16): This will help you more fully understand what you see and hear as you operate your NOMAD. • The remaining sections cover items such as troubleshooting, maintenance, the warranty, and a technical overview of your NOMAD – these sections can be reviewed as needed. User Manual, p14-18

43. Common Questions and Answers Q. Can you safely hold NOMAD in your hand? A. Yes, you can!  Remember the NOMAD difference. NOMAD contains a specially designed primary shielding system to protect the operator from x-ray exposure. Also keep in mind the comparative data we looked at earlier . . . radiation leakage exposure is far below federal and occupational limits. 

44. Here’s what others are saying about NOMAD… “Meets applicable radiation safety standards.”- United States Air Force Dental Evaluation & Consultation Service “Low radiation exposure to operator” - An independent non-profit dental education and product testing foundation

45. Common Questions and Answers Q. Can the operator safely stay in the room during an exposure? A. Again, remember the NOMAD difference. The secondary radiation shield on NOMAD is designed to absorb backscatter radiation off the patient. Independent, third party studies repeatedly conclude that the backscatter radiation is far below federal and occupational limits. 

46. Here’s what others are saying about NOMAD… “My experiences using the NOMAD after Hurricane Katrina, in which I helped in the process of victim identification…  No scatter radiation was detected.” – Anne Birnbaum DDS “Meets applicable radiation safety standards. Personal dosimetry not required.”- United States Air Force Dental Evaluation & Consultation Service “I have worn x-ray exposure badges for several months and have not had any radiation readings.”- Eileen Bidstrup, Eric Vogel Dental Practice

47. Common Questions and Answers Q. How many x-ray exposures can I take on one battery charge? A. It depends on the length of the exposures, typically, 200 to 300 under normal circumstances. And, because your NOMAD was shipped with two batteries and a rapid charger (which only requires about 30 to 40 minutes for a full charge), you should be able to operate uninterrupted.

48. Here’s what others are saying about NOMAD… “The longevity of the battery was amazing as it would last for twelve hours of fairly continuous use.” – Anne Birnbaum DDS, Hurricane Katrina victim identification and Birnbaum Dental, Boulder Colorado Remember to fully review the DEWALT Instruction Manual shipped with your NOMAD for important tips and information like this: “The Automatic Tune-UpTM Mode equalizes or balances the individual cells in the battery pack allowing it to function at peak capacity. Battery packs should be tuned up weekly or after 10 charge/discharge cycles or whenever the pack no longer delivers the same amount of work.”

49. Common Questions and Answers Q. Can I take clear x-rays holding NOMAD in my hand? A. Yes.  All the experience and data show that NOMAD produces diagnostic quality x-rays. An aiming guide is usually not even necessary. This makes NOMAD very...handy!

50. Here’s what others are saying about NOMAD… “Produces sharp images even with intentional shaking.” - An independent non-profit dental education and product testing foundation “The images were excellent.” – Anne Birnbaum DDS, Hurricane Katrina victim identification and Birnbaum Dental, Boulder Colorado