Radiation Safety Report on Portable X-ray system, ZEN-PX2

Produced by Genoray Quality Control Center and Research Lab

Genoray America Inc., 1073 N. Batavia St., Orange, CA 92867, USA, http://genorayamerica.com Submitted to FDA, State Health Department of California, North Dakota, South Dakota, Florida, Puerto Rico, New York, New Jersey, Arkansas, Washington, and to many other authorities

9 1 2

13.12 ft 5 8

4 7 13.12 ft 1) Device

Equipment : Portable Dental X-ray system , PORT-XII (identical unit as ZEN-PX2) Total Filtration : 1.8mm AI Inherent Filtration : 0.8 mm Al at 50kV Technique : 60kV, 2mA Source to skin distance : 200 mm X-ray field : 60mm

2) Test Setting Test instrument : BARRACUDA of RTI Electronics AB, Sweden Test room : - Size : 400 x 400(cm) [13.12 ft X 13.12 ft] - Material : cement - Thickness of wall : 25cm

Test setting of device : 60kV, 2mA, 0.5sec Normal exposure time for dental images are at or about 0.1~0.12 seconds for digital and 0.5~0.8 for film

Note: The scatter radiation was measured in the cement room of above test points (1~9) 3) Test data We have conducted five set of test to get more accurate data by gaining the average of all collected data. 1st test Test point 1 Test point 2 Test point 3 Test point 4 Test point 5 Test point 6 Test point 7 Test point 8 Test point 9 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 20.4 19.4 17.2 2.6 2.3 2.7 2.5 2.9 3.1 109.1 109.5 112.2 8.2 8.1 6.9 285.2 283.5 223.4 0 0 0 0 0 0 0 0 0 R R R R R R R R R R R R R R R R R R R R R R R R R R R 2nd test Test point 1 Test point 2 Test point 3 Test point 4 Test point 5 Test point 6 Test point 7 Test point 8 Test point 9 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 17.0 17.2 19.2 3.3 2.9 3.1 3.3 3.8 3.7 95.1 90.5 28.4 7.7 7.9 7.5 273.4 288.2 244.3 0 0 0 0 0 0 0 0 0 R R R R R R R R R R R R R R R R R R R R R R R R R R R 3rd test Test point 1 Test point 2 Test point 3 Test point 4 Test point 5 Test point 6 Test point 7 Test point 8 Test point 9 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 15.9 16.8 18.1 2.9 2.6 2.5 3.1 2.9 3.4 101.1 99.8 102.2 8.5 8.4 8.3 236.3 224.4 266.2 0 0 0 0 0 0 0 0 0 R R R R R R R R R R R R R R R R R R R R R R R R R R R

 4th test Test point 1 Test point 2 Test point 3 Test point 4 Test point 5 Test point 6 Test point 7 Test point 8 Test point 9 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 22.4 20.2 23.7 1.9 2.2 2.1 3.5 3.8 3.7 90.1 92.5 94.2 6.8 7.3 7.7 196.6 220.7 213.4 0 0 0 0 0 0 0 0 0 R R R R R R R R R R R R R R R R R R R R R R R R R R R

5th test Test point 1 Test point 2 Test point 3 Test point 4 Test point 5 Test point 6 Test point 7 Test point 8 Test point 9 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 30.0 29.1 32.2 2.3 3.3 2.8 3.2 3.8 3.6 92.1 95.3 97.4 6.9 6.7 7.4 270.2 271.5 276.2 0 0 0 0 0 0 0 0 0 R R R R R R R R R R R R R R R R R R R R R R R R R R R

Average from 5 sets (3 tests each) of test. Test point 1 Test point 2 Test point 3 Test point 4 Test point 5 21.25 R 2.63 R 3.35 R 93.96 R 7.62 R Test point 6 Test point 7 Test point 8 Test point 9 251.56 R 0 R 0 R 0 R

4) Prediction

NCRP (National Council on Radiation Protection) states that a high-volume dental practice usually acquire 300 images per week. per week and 60 images per day basis.
1 day exposure (60 times) Test point 1 Test point 2 Test point 3 Test point 4 Test point 5

This was used in this prediction using 300 images

1.27 mR 0.15 mR 0.20 mR 5.63 mR 0.45 mR

Test point 6 Test point 7 Test point 8 Test point 9

15.09 mR 0 mR 0 mR 0 mR

Note that this data is plain measurement and does not represent prediction based on realistic workflow.

1 week exposure (300 times) Test point 1 Test point 2 Test point 3 Test point 4 Test point 5

6.37 mR 0.78 mR 1.00 mR 28.18 mR 2.28 mR

Test point 6 Test point 7 Test point 8 Test point 9

75.46 mR 0 mR 0 mR 0 mR

Note that this data is plain measurement and does not represent prediction based on realistic workflow.

1 month exposure (1200 times) [300 times per week X 4 weeks] Test point 1 Test point 2 Test point 3 Test point 4 Test point 5

25.50 mR 3.15mR 4.02 mR 112.75 mR 9.14 mR

Test point 6 Test point 7 Test point 8 Test point 9

301.87 mR 0 mR 0 mR 0 mR

Note that this data is plain measurement and does not represent prediction based on realistic workflow.

1 year exposure (14400 times) [1200 times per month X 12 months] Test point 1 Test point 2 Test point 3 Test point 4 Test point 5

306.00 mR 37.87 mR 48.24 mR 1353.02 mR 253.72 mR

Test point 6 Test point 7 Test point 8 Test point 9

3,622.46 mR 0 mR 0 mR 0 mR

Note that this data is plain measurement and does not represent prediction based on realistic workflow.

5) Summery Of presented test points, operator effected points are point 2, 3, and 5. The annual average of those three points is 113.27 mR [(37.87 + 48.24 + 253.72) / 3]. In a typical dental office, this workload would be shared among two to four technicians. Also above data was collected using 0.5 seconds of exposure. But in realistic environment, 0.5 only represents the chemical film environment which most practices no longer use. When using digital sensor, the exposure time is decreased from Below table shows prediction that average of 0.5 seconds per image to average of 0.11 seconds.

can be drawn from data collected and realistic workflow implementation.

Exposure setting Typical ZEN-PX2 used with film

mR 56.63

mSv 0.56

Typical ZEN-PX2 used with digital 12.45 0.12 0.5 seconds measurement was used for firm and 0.11 was used for digital sensors. 1 year exposure was set to 7200 times, calculated based on shared workload of busy dental office (300 images per week) betweentwotechnicians.

6) Conclusion ZEN-PX2s radiation emitting level at operators perspective is fairly minimum amount. The industrys regulation suggests maximum occupational limit as 5,000mR annually. Given presence of PX2s safety features and this report, I can safely conclude that this device is very safe device in terms of radiation hazard as it creates none. The average background radiation in US is about 295mR per year which is approximately 20 times more than a whole year use of ZEN-PX2.

Exposure setting US Occupational Limit Typical ZEN-PX2 used with film Typical ZEN-PX2 used with digital Average background radiation in US

mR 5,000 56.63 12.45 295

mSv 50 0.56 0.12 2.95

This very well concludes that ZEN-PX2 is safe to use machine that only produces 1/20th of the radiation that we already receive in our daily life. (1/349th of US Occupational Limit) And this data shows that there will be no or minimal negative effect from using ZEN-PX2 Portable X-ray system as Handheld X-ray solution.