Guidance And Manufacturer's Declaration - Welch Allyn Spot VS100 Directions For Use Manual

Directions For Use
• Accuracy:
Cylindrical axis:
• Range:
• Accuracy:
Pupil size:
• Range:
• Accuracy:
Pupil distance:
• Range:
• Accuracy:
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:
• Accuracy:

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.
-1.50D to 1.50D,±0.50D
-3.00D to < -1.50D, ±1.00D
>1.50D to 3.00D, ±1.00D
1 to 180 degrees in 1-degree increments
± 10 degrees (for cylinder values > 0.5D)
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
± 0.4 mm
35mm to 80 mm in 1 mm increments
± 1.5 mm
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)
± 1.5 degrees
Specifications 45