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1.0 Introduction
Thank you for purchasing the Keeler TonoCare™.
These Instructions For Use are addressed to healthcare
professionals using the TonoCare Non-contact Tonometer.
The device should only be used by trained and qualified
personnel.
1.1 Device Classification
CE Regulation 93/42 EEC: Class IIa
FDA: Class II
1.2 Indication for use
The Keeler TonoCare Tonometer is a hand-held, battery operated,
non-contact tonometer intended to be used for measuring
intraocular pressure (IOP) of the human eye with less than 3D in
corneal astigmatism.
1.3 Warnings
The Keeler TonoCare should not used in patients with high
corneal astigmatism (>3D).
1.4 Principle of operation
The Keeler TonoCare Tonometer uses the principle of air impulse
tonometry - this is a variation of general applanation tonometry,
however does not require direct contact with the surface of
the eye.
Applanation tonometry is a technology to accurately measure IOP
as an equivalent of the force required to flatten a defined area
of the cornea by mechanical stimuli, as a direct application of the
Imbert-Fick law.
The air impulse technique requires direction of a packet of air
with restricted pressure and volume towards the central portion
of the cornea, and the detection of the pre-defined flattening
of the cornea via the electrical measurement of a light beam
reflected from the corneal surface.
The device is intended to be used in accordance with
these instructions. Please read them carefully and keep
this document safe for future reference.
Summary of Contents for Tonocare
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