LightLas 532 – Operator's Manual Rev. No 01 Page 10 of 115
Section 2 SAFETY
This Laser system has been designed and tested to function in a safe and correct
when used as indicated in this manual.
Do not use this laser before reading and understanding completely this Operators
Manual.
It is important to remember that this laser emits high levels of visible laser radiation
which can cause permanent and irreparable eye and tissue damage. Always observe
precautions for laser safety including using warning signs, safety glasses and only
operating the laser in a treatment room that provides protection to casual observers.
2.1 Product Classifications
The LightLas 532 Photocoagulator Laser is a Class IV laser product as specified in the
standard IEC60825-1 (2007) and the USA 21 CFR’s 1040.10, 1040.11.
The LightLas 532 Photocoagulator Laser is classified as Class I Type B Electromedical
equipment as specified in the IEC60601-1 standard.
The LightLas 532 Photocoagulator Laser is classified as a Class II device according to
the FDA CFR21 regulations.
The LightLas 532 Photocoagulator Laser is classified as a Class II Type B Medical
Device according to the MDD 93/42/EEC (as amended by 2007/47/EC).
The LightLas 532 has been designed to comply with the following standards:
Laser standards
IEC 60825-1 (2007)
USA 21 CFR 1040.10, 1040.11 (1997)
IEC60601-2-22 (1995)
Electrical standards
IEC 60601-1:2005
EN 60601-1:2006
EN 60601-1-2:2007
IEC60601-1-2 :2007
USA UL 2601
JIS T1001 (1992) and T1002 (1992)
Others
MDD 93/42/EEC (as amended by 2007/47/EC)
EN 60601-1-6:2010
IEC 60601-1-6 :2010
To Next Page
Loading...
