CAO Group Precise LTM - Labels, Signs, Warnings, and Information; Federal Compliance and Standards; Danger Laser In Use Signage; Laser Classifications

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SECTION 5: LABELS, SIGNS, WARNINGS, AND
INFORMATION
5.0 FEDERAL COMPLIANCE
The Precise® LTM has been designed to the latest safety standards
applicable to medical lasers in the U.S. and Canada, including IEC
60825, IEC 60601-2-22, and IEC 60601-1. This laser is also designed to
meet the construction and performance requirements of the Food
and Drug Administration’s Laser Performance Standard (21 CFR
1040.10 and 1040.11). The laser has also been certied and tested
according to the telecommunications regulations for the US (FCC
Part 15). 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 38 through 47). Installation and
operation of this device should be made consistent with CAN/
CSA-Z386-08: Laser safety in health care facilities.
5.1 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 42)
5.2 LASER CLASSIFICATIONS
Class 4 Laser Product (treatment laser): 810 nm, 5 Watt
Aiming Beam Laser: 630 – 660 nm, 2 mW
5.3 CAUTIONS
5.3.1 Changes or modications not expressly approved
by CAO Group could void the user’s authority to operate
the equipment and lead to unexpected laser exposure or
electrical shock.
5.3.2 Laser Radiation – Avoid exposure to the face, eyes, or
skin from direct or scattered radiation.
5.3.3 This product contains no user serviceable components
within the chassis. Visible and invisible radiation may be
present when the cover is removed.
5.3.4 U.S. Federal law restricts the device to sale by or on the
order of a licensed professional.
5.3.5 Eyewear that protects your eyes from wavelengths other
than 810 nm do not provide proper protection for use with this
laser. Damage to the retina or corneal may be irreparable if
exposed to direct, reected or scattered radiation.
5.3.6 Use of controls, adjustments or performance of
procedures other than those specied herein may result
in hazardous radiation exposure. Any misuse is considered
abuse of the product.
5.3.7 Do not use system if there is any visible damage to the
system, including, but not limited to, cracks, wear, or damage.
5.3.8 Keep system away from liquids to prevent electrical
shock and damage. Stop and power off system if exposed
to liquids.
5.3.9 Do not use system in an oxygen rich environment to
avoid risk of re.
5.3.10 Consult local services to learn how to properly
dispose/recycle the system.
Figure 39 - Label required under FDA laser notice 50
Figure 40 - Laser Aperture label
Figure 38 - Label required under FDA laser notice 50
Figure 41 - Fiber Cartridge Caution Label
Figure 42 - Danger - Laser signage
ALL DIMENSIONS IN INCHES
PRECISE LTM REAR WARNING LABEL
CAO Group, Inc.
4628 West Skyhawk Drive
West Jordan, UT 84084
P: 801-256-9282
F: 801-256-9287
www.caogroup.com
1.500
0.720
CAUTION - CLASS 4 VISIBLE AND INVISIBLE
LASER RADIATION WHEN OPEN.
AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION.
ATTENTION – RAYONNEMENT LASER VISIBLE ET
INVISIBLE DE CLASSE 4 – EN CAS
D'OUVERTURE EXPOSITION
DANGEREUSE AU RAYONNEMENT
DIRECT OU DIFFUS DES YEUX OU
DE LA PEAU.
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