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State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
System Specifications
Table 3. System Electrical and Physical Specifications (continued)
Parameter
Mechanical Specifications - DOC
Weight
Dimensions
Mechanical Specifications - TSC
Weight
Dimensions
Lifetime of Device
Device Life (System)
Table 4. Imaging Specifications
Parameter
Optical Parameters - Measured at System Aperture (DOC Optical Port)
Scanning Laser Source Optical Power
Visible Laser Optical Power
Pullback Parameters
Pullback Range
Pullback Speed Settings
General Scan Parameters
A-Scan Range in Air
A-Scan Range in Contrast
Diameter Measurement Accuracy
Area Measurement Accuracy
Axial Resolution
Optical Sensitivity
A-Scans per Second
Frame Rate
Table 5. Physiology Specifications
Parameter
Aortic Pressure Transducer Pressure (Wi-Box™ AO Transmitter to OPTIS™ Integrated Next)
Operating pressure
Accuracy
PW Pressure
Operating pressure
Accuracy
Aortic Pressure Transducer Pressure (Wi-Box to hemodynamic recording system)
Direct galvanic connection
Max pressure shift
40
OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
Specification
3.5 lbs (1.6 kg)
24 x 9 x 10 cm
1.5 lbs (0.7 kg)
21 x 9 x 14 cm
1000 cases minimum (385 cases / yr., ≥ 2 yrs.)
Imaging Specifications
Specification
22.6 mW maximum @ 1305 nm ± 55 nm
(Class 1M Laser Output per IEC 60825-1)
1.45 mW maximum @ 670 nm ± 30 nm (nominal)
(Class 1M Laser Output per IEC 60825-1)
54 mm, 75 mm
18.0 mm/sec, 36.0 mm/sec
7.0 mm
4.83 mm
7% ± 0.1 mm
10% ± 0.1 mm
2
≤ 20 µm in tissue
100 dB minimum
81 kHz minimum
180 frames/second (Hz)
Physiology Specifications
Specification
-200 to +450 mm Hg
± 1 mm Hg or ± 1% of reading, whichever is greater
-30 to +300 mm Hg
±1 mm Hg plus ±1% of reading (-30 to 50 mm Hg)
±3% of reading (50 to 300 mm Hg)
<2 mm Hg
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