14
5.3.11 Not indicated for patients taking Accutane (Isotretinoin)
currently or within the last 6 months.
5.3.12 Use of this device is not recommended for patients who
suffer from light-induced seizures.
5.3.13 Use of this device on pregnant women has not been
studied. Avoid usage on pregnant women.
5.3.14 Do not use this device for procedures other than those
proscribed in this manual. See Section 9.
5.3.15 make sure the disposable tip is fully seated onto the
handpiece before continuing with the procedure.
5.4 NOMINAL OCULAR HAZARD DISTANCE (NOHD)
The NOHD is the distance beyond which the exposure, during
normal operation, is not to exceed the appropriate Maximum
Permissible Exposure (MPE). The NOHD for persons wearing safety
glasses is shown in Table 1 below. The Nominal Hazard Zone (NHZ)
is the area where, the laser source within, which exposure levels
exceeds the MPE (which is the highest level of laser radiation to
which a person may be exposed without hazardous effects or
adverse biological changes in the eyes or skin). The outer limit of
the NHZ is the NOHD. Eye Protection within the NHZ is mandatory.
(See Table 1 below)
NOTE: 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 their own expense).
NOHD (inches)
SOURCE OF RADIATION MPE (mW/cm
2
) DIVERGENCE ANGLE
(DEGREES)
No Eyewear
(inches/cm)
With Eyewear (OD=4)
(inches/cm)
Fiber Optic Devices 1.66 9 154/392 1.54/3.92
Reection from Tissue 1.66 N/A 0.04/0.12 0.0004/0.0012
Table 1 - Nominal Ocular Hazard Distance (NOHD) for various viewing conditions while wearing eye protection.
PRECISE LTM DIODE LASER
MODEL: 002-00176
POWER INPUT: 12VDC, 5A
WORKING BEAM WAVELENGTH: 810±10 NM
810 NM POWER OUTPUT: 5 WATTS
AIMING BEAM WAVELENGTH: 650±30 NM
650 NM POWER OUTPUT: 2 MILLIWATTS
WIRELESS FREQUENCY: 2.4 GHZ
CAO GROUP, INC., 4628 W. SKYHAWK DR.
WEST JORDAN, UTAH 84084, USA
U.S. AND INTERNATIONAL PATENTS PENDING ASSEMBLED IN USA
MANUF. DATE:
MMM YYYYY
SN XXXXXX
FCCID: OUR-XBEE
IC: 4214A-XBEE
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
COMPLIES WITH:
21 CFR 1040.10 &1040.11,EXCEPT FOR DEVIATIONS PURSUANT
TO LASER NOTICE 50, DATED JUNE 24, 2007.
CONFORMS TO UL STD 60601-1, IEC STD 60601-2-22,
EN STD 60601-2-22; CERTIFIED TO CSA STD C22.2 NO. 601.1
0473
Precise LTM Serial Label
Part# 02265 Revision D
Black ink on silver flood
poly label
CAO Group, Inc.
4628 West Skyhawk Drive
West Jordan, UT 84084
Ph: 801.256.9282 Fax: 801.256.9287
www.caogroup.com
ALL DIMENSIONS IN INCHES
DRAWING NOT TO SCALE
REV.D
3183713
Figure 47 - Do Not Reuse
Figure 44 - CAUTION - Laser Emitting Device; Class 4 Laser Figure 45 - Type B Applied Parts
Figure 43 - Rating label with serial number
Figure 48 - Rated For 12VDC, 5A
12VDC 5A
Figure 49 - Dispose of electronics
waste in a responsible manner
Figure 46 - ATTENTION -- Review Operator’s
Manual Prior To Use
Assumptions: Maximum Laser Power = 5 Watts, Direct Viewing Angle = 0°; Reectance Viewing Angle = 20°;
Reectance Coefcient of Tissue = 0.001
Figure 50 - Class ll Electrical Device
Figure 51 - Class llb Medical Device
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