LIGHTMED TruScan Pro – Operator’s Manual Rev. No. 01 Page 9 of 109
Section 2 Safety
This laser system has been designed and tested to function in a safe and correct operation when
used as indicated in this manual. Do not use this laser without reading and completely
understanding this Operator’s Manual. It is important to remember that this laser emits high levels
of visible and invisible laser radiation, which can cause permanent and irreparable eye and tissue
damages. 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 Pro Ophthalmic Laser is classified as:
• Class IV laser product as specified in the standards IEC60825-1 (2007) as well as USA
21 CFR 1040.10 and 1040.11.
• Class I type B electromedical equipment as specified in the IEC60601-1 standard.
• Class II device according to the FDA CFR21 regulations.
• Class II type B medical device according to the MDD 93/42/EEC (as amended by
2007/47/EC).
The TruScan Pro Ophthalmic Laser has been designed to comply with the following standards:
• IEC 60601-1 3.1 Edition
• EN 60601-1 3.1 Edition
• IEC 60601-1-2 4th Edition
• EN 60601-1-2 4th Edition
• ANSI/AAMI 60601-1
• MDD 93/42/EEC (as amended by 2007/47/EC)
• IEC 60601-1-6 Edition 3.1
• EN 60601-1-6 Edition 3.1
• IEC62366 Edition 3.1
• EN62366 Edition 3.1
• ISO 15223 :2016
• EN ISO14971:2012
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