ii
CLASS 1 LASER COMPLIANCE
This device complies with: “21 CFR 1040.10” and “EN 60825-1”.
CSA COMPLIANCE
This device complies with the following CSA standard for Canada and the USA:
“UL Std No. 60601-1 Second Edition – Medical Electrical Equipment Part 1:
General Requirements for Safety”
FCC COMPLIANCE
This device complies with Part 15 of FCC Rules and its operation is subject to the
following two conditions:
1) This device may not cause harmful interference.
2) This device must accept any interference received, Including interference that
may cause undesired operation.
FCC Warning
Modications to the device that are not expressly approved by the manufacturer may void your
authority to operate the device under FCC Rules.
EMC COMPLIANCE
This device complies with the following EMC standard:
“IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic phenomena - Requirements and tests”.
SAFETY COMPLIANCE
This device complies with the following safety standard:
“IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential
performance.
CE COMPLIANCE
This device complies with Council Directive 93/42/EEC for Medical Devices.
Class 1 Laser Product
C US
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