Welch Allyn Spot VS100, Directions For Use Manual

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• Accuracy: -1.50D to 1.50D,±0.50D
-3.00D to < -1.50D, ±1.00D
>1.50D to 3.00D, ±1.00D
Cylindrical axis:
• Range: 1 to 180 degrees in 1-degree increments
• Accuracy:
± 10 degrees (for cylinder values > 0.5D)
Pupil size:
• Range: Years 0.5 - 19: 4.0 mm to 9.0 mm in 0.1 mm increments
Years 20 - 100: 3.0 mm to 9.0 mm in 0.1 mm increments
• Accuracy: ± 0.4 mm
Pupil distance:
• Range:
35mm to 80 mm in 1 mm increments
• Accuracy: ± 1.5 mm
Screening principle: Eccentric photorefraction (photoretinoscopy) is used to estimate the magnitude of ametropia based
on characteristics of the light reflex in the pupil.
Gaze
Corneal Light Reflex (Gaze):
• Range:
0.0 to 20.0 degrees in increments of 1 degree Nasal(N) or Temporal(T)
0.0 to 20.0 degrees in increments of 1 degree Inferior(I) or Superior(S)
• Accuracy:
± 1.5 degrees
Guidance and manufacturer's declaration
EMC compliance
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all
medical electrical equipment. This device complies with IEC 60601-1-2:2014.
•
All medical electrical equipment must be installed and put into service in accordance
with the EMC information provided in this Directions for use.
• Portable and mobile RF communications equipment can affect the behavior of
medical electrical equipment.
The device complies with all applicable and required standards for electromagnetic
interference.
Directions For Use Specifications 45