TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 8 of 114
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 TruScan 532 Single-Wavelength Photocoagulator Laser is a Class IV laser product as
specified in the standard IEC60825-1 (2007) and USA 21 CFR’s 1040.10 and 1040.11.
The TruScan 532 Single-Wavelength Photocoagulator Laser is classified as Class I Type B
Electromedical equipment as specified in the IEC60601-1 standard.
The TruScan 532 Single-Wavelength Photocoagulator Laser is classified as a Class II
device according to the FDA CFR21 regulations.
The TruScan 532 Single-Wavelength 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 TruScan 532 Single-Wavelength has been designed to comply with the following
standards:
Laser standards
IEC 60825-1
USA 21 CFR 1040.10 and 1040.11
IEC60601-2-22
EN60601-2-22
Electrical standards
IEC 60601-1
EN 60601-1
EN/IEC 60601-1-2
USA UL 2601
JIS T1001 and T1002
Others
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