16010-101 Rev. C
17
General Specifications
The IOPac displays thickness measurements to the nearest 1 µ m, and the expected accuracy of readings is ±5
µ
m over
the measurement range of 300 to 1000 µ m. This assumes that the actual speed of sound in the cornea corresponds with
that used in the measurements. The IOPac uses a speed of 1640 m/s, which is the most commonly accepted value for
corneal tissue. The accuracy of the reported measurements will be correspondingly affected if the actual speed of sound
differs, but one should expect less than 3% variation.
Specifications
Class II medical device per FDA classification
Class IIa medical device per European MDD 93/42EEC
Class II medical device per Canadian MDR SOR/98-282
Measurement range:
300 to 1000 µ m
Accuracy:
±5µ m
Overall size:
170 x 90 x 40 mm
Weight:
200 g
Probe tip diameter:
2 mm
Probe ultrasound frequency:
20 MHz
Probe geometry:
Angled or Straight Tip
The IOPac is type BF, which means that the transducer applied to the patient is isolated from the supply mains by
insulation such that the patient leakage current is less than the requirements of IEC60601-1.
The IOPac does not have or require any potential equalization (grounding) conductor.
Storage Conditions
Temperature
5°C to 45°C
Humidity
10%-90% relative humidity, non condensing
Operating Conditions
Temperature
10°C to 35°C
Humidity
20%-80% relative humidity, non condensing
Summary of Contents for IOPac Standard
Page 1: ...Standard User s Guide ...
Page 26: ...26 16010 101 Rev C Notes ...
Page 27: ...16010 101 Rev C 27 Notes ...
