zen-px2 radiation safety report

7/27/2019 ZEN-PX2 Radiation Safety Report

1/5

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

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

1 2

34

6

9

8

7

13.12 ft

13.12 ft5


2/5

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 2nd test 3rd test

Test

point

1

1 20.4 R Test

point

1

1 17.0 R Test

point

1

1 15.9 R

2 19.4 R 2 17.2 R 2 16.8 R

3 17.2 R 3 19.2 R 3 18.1 R

Test

point

2

1 2.6 R Test

point

2

1 3.3 R Test

point

2

1 2.9 R

2 2.3 R 2 2.9 R 2 2.6 R

3 2.7 R 3 3.1 R 3 2.5 R

Test

point

3

1 2.5 R Test

point

3

1 3.3 R Test

point

3

1 3.1 R

2 2.9 R 2 3.8 R 2 2.9 R

3 3.1 R 3 3.7 R 3 3.4 R

Test

point

4

1 109.1 R Test

point

4

1 95.1 R Test

point

4

1 101.1 R

2 109.5 R 2 90.5 R 2 99.8 R

3 112.2 R 3 28.4 R 3 102.2 R

Test

point

5

1 8.2 R Test

point

5

1 7.7 R Test

point

5

1 8.5 R

2 8.1 R 2 7.9 R 2 8.4 R

3 6.9 R 3 7.5 R 3 8.3 R

Test

point

6

1 285.2 R Test

point

6

1 273.4 R Test

point

6

1 236.3 R

2 283.5 R 2 288.2 R 2 224.4 R

3 223.4 R 3 244.3 R 3 266.2 R

Test

point

7

1 0 R Test

point

7

1 0 R Test

point

7

1 0 R

2 0 R 2 0 R 2 0 R

3 0 R 3 0 R 3 0 R

Testpoint

8

1 0 R Testpoint

8

1 0 R Testpoint

8

1 0 R2 0 R 2 0 R 2 0 R

3 0 R 3 0 R 3 0 R

Test

point

9

1 0 R Test

point

9

1 0 R Test

point

9

1 0 R

2 0 R 2 0 R 2 0 R

3 0 R 3 0 R 3 0 R


3/5

4th test 5th test

Test

point

1

1 22.4 R Test

point

1

1 30.0 R

2 20.2 R 2 29.1 R

3 23.7 R 3 32.2 R

Test

point

2

1 1.9 R Test

point

2

1 2.3 R

2 2.2 R 2 3.3 R

3 2.1 R 3 2.8 R

Test

point

3

1 3.5 R Test

point

3

1 3.2 R

2 3.8 R 2 3.8 R

3 3.7 R 3 3.6 R

Test

point

4

1 90.1 R Test

point

4

1 92.1 R

2 92.5 R 2 95.3 R

3 94.2 R 3 97.4 R

Test

point

5

1 6.8 R Test

point

5

1 6.9 R

2 7.3 R 2 6.7 R

3 7.7 R 3 7.4 R

Test

point

6

1 196.6 R Test

point

6

1 270.2 R

2 220.7 R 2 271.5 R

3 213.4 R 3 276.2 R

Test

point

7

1 0 R Test

point

7

1 0 R

2 0 R 2 0 R

3 0 R 3 0 RTest

point

8

1 0 R Test

point

8

1 0 R

2 0 R 2 0 R

3 0 R 3 0 R

Test

point

9

1 0 R Test

point

9

1 0 R

2 0 R 2 0 R

3 0 R 3 0 R

Average from 5 sets (3 tests each) of test.

Test point 1 21.25 R Test point 6 251.56 R

Test point 2 2.63 R Test point 7 0 R



Test point 5 7.62 R


4/5

4) Prediction

NCRP (National Council on Radiation Protection) states that a high-volume dental practice

usually acquire 300 images per week. This was used in this prediction using 300 images

per week and 60 images per day basis.

1 day exposure (60 times)

Test point 1 1.27 mR Test point 6 15.09 mRTest point 2 0.15 mR Test point 7 0 mRTest point 3 0.20 mR Test point 8 0 mRTest point 4 5.63 mR Test point 9 0 mRTest point 5 0.45 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 6.37 mR Test point 6 75.46 mRTest point 2 0.78 mR Test point 7 0 mRTest point 3 1.00 mR Test point 8 0 mRTest point 4 28.18 mR Test point 9 0 mRTest point 5 2.28 mR


1 month exposure (1200 times) [300 times per week X 4 weeks]

Test point 1 25.50 mR Test point 6 301.87 mRTest point 2 3.15mR Test point 7 0 mRTest point 3 4.02 mR Test point 8 0 mRTest point 4 112.75 mR Test point 9 0 mRTest point 5 9.14 mR


1 year exposure (14400 times) [1200 times per month X 12 months]

Test point 1 306.00 mR Test point 6 3,622.46 mRTest point 2 37.87 mR Test point 7 0 mRTest point 3 48.24 mR Test point 8 0 mRTest point 4 1353.02 mR Test point 9 0 mRTest point 5 253.72 mR



5/5

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

average of 0.5 seconds per image to average of 0.11 seconds. Below table shows prediction that

can be drawn from data collected and realistic workflow implementation.

Exposure setting mR mSv

Typical ZEN-PX2 used with film 56.63 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 fordigital sensors. 1 year exposure was set to 7200 times, calculatedbasedonsharedworkloadofbusydentaloffice(300imagesperweek)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 mR mSv

US Occupational Limit 5,000 50

Typical ZEN-PX2 used with film 56.63 0.56

Typical ZEN-PX2 used with digital 12.45 0.12

Average background radiation in US 295 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.

zen-px2 radiation safety report

Documents