KXL System
Operator’s Manual,
Rev G
5-1
5 Equipment Classification
According to EN60601-1 Medical Device Electrical Standard
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Protection against electrical shock
Class 1 (external electrical power source)
Internally powered equipment (internal battery operation)
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Degree of protection against electric shock
Not classified, equipment not provided with applied part
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Degree of protection against ingress of water
Common Devices IP20 (No protection against ingress of water)
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Method of sterilization or disinfection
Disinfect able device
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Degree of protection for use in the presence of a flammable as aesthetic mixture
No protection
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Use conditions
Continuous service
According to FCC Part 15, EN55011 and EN60601-1-2
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Class B
According to EN60825-1 Safety of laser productions
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Alignment lasers are Class 1 Laser Product (<0.39 microwatts)
According to EN62471 Photobiological safety of lamps and lamp systems
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UVA LED is Risk Group 1
According to Annex II.3 of Directive 93/42/EEC as amended by 2007/47/EC
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Class IIa
