
8
2.2.2 User Precautions & OEM Responsibilities
The specific user precautions as specified in IEC 60825-1 and FDA CFR Title 21 Part
1040 are:
Requirements
Class 2/ll
Class 3R/3a
Class 3B/3b
Laser safety officer
Not required
Not required
Required
Remote interlock
Not required
Not required
Required
**
Key control
Not required
Not required
Required
**
Cannot remove key
when in use
Beam attenuator
Not required
Not required
Required**
Emission indicator
Not required
Not required
Required**
Warning signs
Not required
Not required
Required**
Beam path
Not required
Terminate beam at
useful length
Terminate beam at
useful length
Specular reflection
Not required
Prevent
unintentional
reflections
Prevent unintentional
reflections
Power-On delays
Not required
Not required
Required
**
Eye protection
Not required
Not required
Required under
special conditions
Training
Not required
Required for
operator and
maintenance
personnel
Required for operator
and maintenance
personnel
LMI Class 3B/lllb laser components do not incorporate the safety items indicated by an
asterisk ** in the table above. These items must be added and completed by the OEM
in the system design.
2.2.3 Class 3B/lllb OEM Responsibilities
LMI Technologies has filed reports with the FDA to assist the OEM in achieving
certification of their laser products. The OEM can reference these reports by an
accession number that will be provided upon request.
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