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LBL000097A
LightForce FX User Manual, DCN: O
FX
2.3 Safety Strategy
1. 3 Minutes Unattended Protection
If the laser device is left in Ready Mode and does not receive any input for 3 minutes, the laser
will switch back to Standby Mode.
2. Internal Laser Energy Monitor
This is an internal device that monitors the intensity of laser energy generated during
emission. This monitor aborts laser emission if the laser device is unable to maintain the laser
energy output set by the user.
3. Laser Eye Protection
The protective laser eyewear has an optical density rating > 5.0 for 810 nm and 980 nm (see
specification sheet) laser emission. All personnel present during device operation must wear
this eyewear. Contact LiteCure® at 302.709.0408 or 877.627.3858 (for US and Canada) to
purchase additional sets of protective eyewear.
3.1 Classification
According to the applicable standards, the LightForce FX laser is classified as follows:
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Class I Type B device according to EN/IEC 60601-1
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Class IIa according to Council Directive 93/42/EEC
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Class III according to CMDR SOR/98-282
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Class 4 laser product according to IEC 60825-1
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Degree of protection according to EN/IEC 60601-1, IPX 0 (enclosure not waterproof);
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Ordinary protection against ingress of water
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Continuous operation
3.2 Regulatory Compliance
1. The LightForce FX laser complies with 21 CFR Chapter 1, Sub chapter J, as administered by the
Center for Devices and Radiological Health of the US Food and Drug Administration (FDA).
2. The LightForce FX laser is manufactured in compliance with the provisions of Council Directive
93/42/EEC concerning medical device (MDD, EU) and CMDR SOR/98-282 (CAN).
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Device Description
The LightForce FX is a compact medical laser system. The optical delivery system
consists of a flexible fiber threaded through a lightweight hand piece. Activation
occurs when the operator enables the laser and presses the finger switch. A touch-
screen display allows the operator to adjust or set the laser output level. The laser can
operate in continuous wave mode or controlled pulse mode.
