7.1 REGULATORY COMPLIANCE
The Odyssey Navigator Diode Laser has been tested to the latest safety standards applicable to medical lasers in the
US and Canada including IEC 60825, IEC 60601-2-22, IEC 60601-1, CSA/CAN C22.2 No. 601.1 and the Food and
Drug Administration’s Laser Performance Standard (21 CFR 1040.10 and 1040.11). The laser has also been tested
according to the telecommunications regulations for the US (FCC Part 15) and Canada (IC RSS 210). Various labels
are included on the laser and the wireless foot switch as evidence of conformity to these requirements. The labels on
the units are required under these standards for safety purposes and should not be removed. Please review all labels
prior to using the laser.
7.2 LABELS
7.2.1 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 an protective clothing
when the laser is in use.
7.2.2 Class 4 Laser Product
810 nm ± 10 nm 3 W
7.2.3 Aiming Beam laser
650 nm ± 10 nm 2 mW
7.2.4 Interference with wireless signal.
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15
of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when
the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful
interference to radio communications. (Operation of this equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct the interference at his own expense).
7.3 DEVICE CAUTIONS
7.3.1 CAUTION
Changes or modifications not expressly approved by Ivoclar Vivadent, Inc. could void the user’s authority to operate
the equipment.
7.3.2 CAUTION
Laser Radiation - Avoid exposure to the eyes or skin from direct or scattered radiation
7.3.3 CAUTION
This product contains no user serviceable components within the chassis. Visible and invisible radiation may be
present when the cover is removed. Do not open the laser chassis under any circumstances.
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Navigator
3 W AT T D I O D E L A S E R
O D Y S S E Y
TM
®
LABELS, SIGNS, WARNINGS AND MANUFACTURER’S INFORMATION
Section 7
INVISIBLE AND VISIBLE LASER RADIATION.
AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION.
WAVELENGTH: 810nm OUTPUT: 3 WATTS
WAVELENGTH: 650nm OUTPUT: 3 mW
CLASS 4 LASER PRODUCT
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