21 Appendix
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
69 / 80
CE in accordance with EC Directive 93/42/EEC for Medical Devices
The unit is a class IIa product.
Conformity assessment: Directive 93/42 / EEC: Annex II without section 4.
21 Appendix
21.1 Correction Calculation of the Tonometrically calculated IOP
The Corvis® ST program offers the option to save the tonometrically
measured IOP in the data of an examination and to correct it by Central
Corneal Thickness (CCT). Different correction formulae can be applied for
this. The corrected IOP value and the IOP change are also saved.
The correction formulae according to Shah, Ehlers, and the Dresdener
correction formulae approximate the actual IOP related to corneal
thickness from the measured value.
☞
As the table is imported, a linear relationship will be adopted for the va-
riates. It is sufficient to define a start value and an end value with the as-
sociated correction values.
21.2 Electromagnetic Compatibility
Medical electrical equipment is subject to special precautionary
requirements with respect to EMC, and must be installed and operated
according to the EMC-Instructions contained in the accompanying pa-
perwork.
No special measures need be observed in respect of OCULUS devices and
systems.
Portable and mobile RF-communications devices can interfere with
electrically operated medical devices.
Produced in consideration of permissible deterioration during or cau-
sed by the EMC testing without affecting the essential performance
criteria
A short interruption of the USB connection during the examination
is permissible because it will not affect the diagnosis, treatment and
observation.