Air Techniques ScanX Touch - Phosphor Plate and Barrier Envelope Data

Air Techniques, Inc. Page 16
Classication
Medical Devices Directive (2007/47/EC) Class IIa
Medical Device (FDA) Class I
Ambient conditions during operation
Temperature °F 64 to 113
°C 18 to 45
Relative humidity % < 80
Ambient conditions during storage and transport
Temperature °F < 91
°C < 33
Relative humidity % < 80
Dimensions of intraoral PSPs
Size 0 in 0.87 x 1.4
mm 22 x 35
Size 1 in 0.94 x 1.6
mm 24 x 40
Size 2 in 1.2 x 1.6
mm 31 x 41
Size 3 in 1.1 x 2.1
mm 27 x 54
Size 4 in 2.2 x 3
mm 57 x 76
Classification
Medical Devices Directive (2007/47/EC) Class I
Medical Device (FDA) Class I
4.2 Phosphor storage plate
PRODUCT DESCRIPTION
4.3 Barrier envelope