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OPERATORS MANUAL
SECTION 7 – LABELS, SIGNS, WARNINGS AND MANUFACTURER’S INFORMATION
7.1 Federal Compliance
The Pioneer Pro has been designed to comply with the latest safety standards applicable to medical lasers in the US and Canada including
IEC 60825, IEC 60601-2-22, IEC 60601-1 and the Food and Drug Administration’s Laser Performance Standard (21 CFR 1040.10 and 1040.11)
The laser has also been certified and tested according to the telecommunications regulations for the US (FCC Part 15), Canada (IC RSS
210) and the European Community (EN 300 328, and EN 301 489). Various labels are included on the laser and the wireless footswitch as
evidence of conformity to these requirements. The labels on the unit are required under these standards for safety purposes and should not
be removed. Please review all labels prior to using the laser. (SEE FIGURES 7.0.1, 7.0.2, 7.0.3 and 7.0.4)
INVISIBLE AND VISIBLE LASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION
WAVELENGTH: 810 NM OUTPUT: 5.0 WATT
WAVELENGTH: 650 NM OUTPUT: 3mW
CLASS 4 LASER PRODUCT
CAUTION - CLASS 4 INVISIBLE AND VISIBLE LASER
RADIATION WHEN OPEN.
AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION.
Figure 7.0.2 Label required under FDA laser notice 50
Figure 7.0.1 Label required under FDA laser notice 50
LASER APERTURE
ON THE END
OF THE FIBER
Figure 7.0.3 Laser Aperture Label
Figure 7.0.3 Rating Label with serial number
Figure 7.1
7.2 Danger Laser in Use
Each treatment area should have a “laser in use” warning sign posted at the entrance to the treatment area. This signage serves to warn
people to not enter the treatment area without proper safety eyewear and protective clothing when the laser is in use. (See Figure 7.1)
7.3 Class 4 Laser Product – (treatment laser) 810 nm 5 W
7.4 Aiming Beam Laser – 630 – 660 nm 2 mW
7.5 CAUTION:
7.6 CAUTION:
Changes or modifications not expressly approved by Pioneer Lasers, LLC could void the user’s authority to operate the equipment.
Laser Radiation – Avoid exposure to the eyes or skin from direct or scattered radiation.
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