Kavo 3D eXam ® Operators’ Manual
k990400 September 19, 2007
10-24
Interpretation
1. The dose per frame at the detector may be calculated by:
Dose per frame at Detector = Dose at Detector / Number of
Frames
Where Number of Frames = 309 for 9 second scan
= 619 for 27 second scan
The tube output per mAs may be normalized to 1m using the
inverse square law for the purposes of assessing consistency of
tube output:
Tube Output (
μ
Gy/mAs) =Dose at Detector x (Source to detector distance)
2
Displayed mAs
Where Source to detector distance = 0.68m for the KaVo 3D eXam
®
Declaration of Conformity
Manufacturer and Technical File Holder:
European Representative:
Imaging Sciences International
LLC
Guy Long
1910 North Penn Road
Imaging Sciences International
LLC
Hatfield, PA 19440
Western Europe Service Centre,
United States of America
Corinium Industrial Estate,
Raans Road,
Phone: (215) 997-5666
Amersham
Buckinghamshire HP6 6JL
Fax: (215) 997-5665
Phone: +44 (0) 149 473 3000
Mobile: +44 (0) 7917 500 202
Fax:
+44 (0) 149 443 1168
Equipment:
KaVo, Model 3D eXam
In accordance with Annex II, we hereby declare that the equipment identified above
is in conformity with the applicable requirements of the European Union Council
Directive concerning Medical Devices 93/42/EEC and LFS 2003:11. The Technical
Document supporting our Declaration of Conformity is held at the disposal of
National Authorities at the address identified above. The equipment listed above
Содержание 3D eXam
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