THERALASE TLC-2000 Series, Руководство по эксплуатации

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TLC-
2000
THERAPEUTIC MEDICAL LASER
2
Document: 600-0013
TLC-
2000
Labels and Symbols
Canadian Standards Association Symbol (for Canada and US):
Certifies that the product bearing this mark meets or surpasses CSA guidelines for Medical Electrical Device Standard 60601-2-22/IEC 60825-1:2007 (2
nd
Edition).
ATTENTION Consult ACCOMPANYING DOCUMENTS Symbol:
Documents accompanying EQUIPMENT or an ACCESSORY and containing all important information for the USER, OPERATOR, installer or assembler of
EQUIPMENT, particularly regarding safety.
Class 3B Laser Warning Label Symbol – APERTURE LABEL:
Identifies product as a Class
3
B laser, which permits human access to laser radiation in excess of the accessible emission limits of Class
1
and Class
2
, but which
does not permit human access to laser radiation in excess of the accessible emission limits of Class
3
B for any emission duration and wavelength.
Type BF Equipment:
Class
1
ME EQUIPMENT providing a particular degree of protection against electric shock, particularly regarding allowable LEAKAGE CURRENT and
reliability of the protective earth connection. Includes an F-TYPE APPLIED PART.
Laser Radiation Warning Label:
VISIBLE AND INVISIBLE LASER RADIATION. AVOID EXPOSURE TO BEAM.
905
nm LASER: PULSE DURATION
200
ns; PULSE FREQUENCY
10
kHz; PULSE ENERGY
0.8
µ J; TOTAL AVERAGE POWER:
1000
mW; (
5
x
200
mW) DIVERGING ANGLE
14
o x
23
o
660
nm LASER: PULSE DURATION
85
µ s; PULSE FREQUENCY
10
kHz; PULSE ENERGY
0.04
µ J; TOTAL AVERAGE POWER:
400
mW; (
4
x
100
mW) DIVERGING ANGLE
16
o x
22
o IEC
60825-1: 2014
(
3
rd Ed)
Prescription Only Symbol
Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
25
˚C
0
˚C
Op
eration Temperature Range Symbol
This equipment shall be operated within
0
° to
25
° Celsius ambient temperature and maximum altitude of
2000
m.
European Authorized Representative
Obelis s.a. Corporate Office: Registered address :
Bd. Général Wahis 53 Avenue de Tervuren,
34
, box
44
B-
1030
Brussels, Belgium B-1040 Brussels, Belgium
Phone:
32.2.732.59.54
Fax:
32.2.732.60.03
Fragile Symbol
Do not drop.
Humidity Range Symbol
This equipment shall be operated within 0% to 80% relative humidity.
Keep Dry Symbol
This equipment shall be operated within 0% to 80% relative humidity.
Figure 2. Safety Labels and detailed explanations of the symbols.
C
US
EC
REP