Avedro KXL System, Руководство оператора

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KXL System
Operator’s Manual,
Rev G
2-1
2 Introduction
2.1 System Overview
The KXL System is an electronic medical device which delivers ultraviolet light (365 nm
wavelength) in a circular pattern onto the cornea after a solution of Riboflavin has been applied.
Irradiating the Riboflavin creates singlet oxygen, which forms intermolecular bonds in corneal
collagen, stiffening the cornea through crosslinking. UV flux and irradiation time (that is,
fluence) at the cornea are controlled by an onboard computer system.
The Optics Head houses the UVA irradiation mechanism. The LED is preset by the manufacturer
to emit UVA radiation at a wavelength of 365 nm at an intensity of 3 mW/cm
2
to 45 mW/cm
2
.
A fixed aperture mounted in the UVA irradiation beam path is used to produce a uniform circular
area of irradiation at the treatment plane with an approximate diameter of 9 mm. Alignment lasers
are used to aid the user in focusing the beam on the patient’s cornea. Fine alignment of the UV
beam through observation of the alignment lasers is controlled through a wireless remote and an
internal drive system. Treatment time is selectable by the user from 1 minute to 30 minutes in
1 second increments and power is selectable from 3 mW/cm
2
to 45 mW/cm
2
in 1 mW/cm
2
increments. Power/time combinations that would result in a surface exposure of more than
10 J/cm
2
or more are prohibited by the software.
The KXL is a portable system with an articulating arm to allow movement of the system for
alignment of the UV Beam to the patient’s cornea. An internal battery powers the system; the
battery is recharged by a system internal charger from any standard AC outlet. The treatment
parameters (induction period, UV exposure time, UV intensity, and beam diameter) are selected
through the user interface touch screen computer.
The KXL System is used in conjunction with a Riboflavin solution and an RFID card.