Phosphor Storage Plate; Barrier Envelope - Air Techniques ScanX Intraoral View Instrucciones De Uso

4.2

Phosphor storage plate

Classification
Medical Device Class
FDA classification (CFR Title 21)
Ambient conditions during operation
Temperature
Relative humidity
Ambient conditions during storage and transport
Temperature
Relative humidity
Dimensions of intraoral phosphor storage plates
Size 0
Size 1
Size 2
Size 3
Size 4
Dimensions of extraoral PSPs
Panoramic 5" x 12"
Panoramic 15 cm x 30 cm
Ceph 8" x 10"
TMJ 5" x 7"
4.3

Barrier envelope

Classification
Medical Device Class
FDA classification (CFR Title 21) Class
2151100018L40 2012V016
°C
°F
%
°C
°F
%
mm
in
mm
in
mm
in
mm
in
mm
in
mm
in 4,92 x 11,25
mm
in 5,82 x 11,73
mm
in
mm
in
Product description
IIa
I
18 - 45
64 - 113
< 80
< 45
< 113
< 80
22 x 35
0.87 x 1.38
24 x 40
0.94 x 1.57
31 x 41
1.22 x 1.61
27 x 54
1.06 x 2.13
57 x 76
2.24 x 2.99
125 x 286
148 x 298
202 x 241
7,95 x 9,49
127 x 177
5 x 7
I
II
EN-
US
13