Use Instructions

PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 33 of 101
3.2.4. Radiation Output
The Handheld Fluorescence Camera uses a miniature pulsed laser-based range finder to determine the
correct distance between the device and wound for superior image quality. The laser module in the range
finder emits light at 850 nm which is invisible to the human eye. The laser’s individual pulse duration is
3.33 ns and the pulse train is 52.3 ms at a 200 ms repetition rate. The laser complies with 21 CFR 1040.10
and 1040.11 except for deviations pursuant to Laser Notice No.50.
The laser is a Class 1 certified laser
Caution Do not point the laser (from the Range Finder sensor) into eyes
3.3. Warning, Cautions, and Notes
Warnings, cautions, and notes are used to describe serious and non-serious safety conditions of the
device. The symbols used to describe these safety conditions are:
Warnings
Warning
Messages with this heading provide information and actions to take in order to
prevent Eagle V1.2 Imaging System safety hazards.
Cautions
Caution
Messages with this heading provide information and actions to take in order to
operate Eagle V1.2 Imaging System correctly and prevent misuse.
Notes
Note
Messages with this heading provide information and actions to take in order to
increase the user’s understanding of Eagle V1.2 Imaging System correctly.
3.3.1. General Warnings
Warning Description
Always observe device labelling which includes this document and device labels. Refer to
section 4 for information on all device labels.
Do not use accessories or cables other than those specified in this Instructions for Use. Using
unspecified accessories or cables may result in increased emissions or decreased immunity of
the Handheld Fluorescence Camera.