Haag-Streit Eyestar 900, Инструкция по эксплуатации

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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05
6.4.4 Axial length (AL)
Measurement range: 14 - 38 mm
Display resolution: 0.01 mm
In vivo repeatability (1. SD): ± 0.005 mm
6.4.5 Keratometry (K)
Measurement range K: 32.1 - 67.5 dpt
Display resolution K: 0.01 dpt
In vivo repeatability K
mean
(1. SD): ± 0.067 dpt
In vivo repeatability AST (1. SD): ± 0.127 dpt
Measurement range Axis: 0 - 180°
Display resolution Axis: 1°
In vivo repeatability Axis, 0.5 dpt < AST ≤ 1.5 dpt (1. SD): ± 4.5°
In vivo repeatability Axis, AST > 1.5 dpt (1. SD): ± 1.6°
6.4.6 White-to-white distance (WTW)
Measurement range: 7 - 16 mm
Display resolution: 0.01 mm
In vivo repeatability (1. SD): ± 0.079 mm
6.4.7 Pupillometry (PD)
Measurement range: 2 - 13 mm
Display resolution: 0.01 mm
6.5 Topography
In-vivo repeatabilies reported in this chapter are based on a clinical investigation
with N = 29 subjects, including 42 eyes with healthy cornea and 16 eyes with
irregular corneal shape, comprising the following pathologies/treatments:
Keratoconus, DSAEK, corneal crosslinking, Pseudoexfoliation Syndrome, corneal
transplant, susp. Salzmann degeneration, corneal lesion, corneal indentation. Only
one eye per subject per class (healthy cornea, irregular corneal shape) is included in
the analysis.
Covered area (diameter): Standard 7.5 mm / Extended 12 mm
6.5.1 Invivo repeatability standard topography (7.5 mm
diameter)
This repeatability table is based on N=32 eyes (including 9 eyes with irregular
corneal shape), with three measurements per eye.
Area
Center zone Middle zone Outer zone
Measurand Unit
Mean
1)
2 Std.
Dev.
2)
Mean 2 Std.
Dev.
Mean 2 Std.
Dev.
Anterior corneal curvature dpt 0.25 0.44 0.12 0.36 0.092 0.44
Posterior corneal
curvature
dpt 0.027 0.064 0.018 0.050 0.015 0.062
Anterior elevation μm – 2.9 – 3.9 – 5.1
Posterior elevation μm – 2.9 – 4.8 – 5.9
Pachymetry μm – 2.2 – 3.7 – 4.7
Areas indicate the center zone (diameter ≤ 3 mm), middle zone (3 mm < diameter ≤
6 mm) and outer zone (diameter > 6 mm) regions of the cornea.
1) Mean: Standard deviation of the mean difference between paired data sets.
2) 2 Std. Dev.: Twice the mean of the standard deviation of differences between paired data sets.