Omron Z300 V3 - SETUP, Setup Manual, Page: 92 / 98

91
FDA (21 CFR1040.10 "Laser Products")
Abbreviations:
R:
Required.
N/A:
Not applicable.
S:
Requirements: Same as for other products of that Class. Also see footnotes.
NP:
Not permitted.
D:
Depends on level of interior radiation.
Requirements Class (see note 1)
I IIa II IIIa IIIb IV
Performance (all laser products)
Protective
housing
R (see note 2) R (see note 2) R (see note 2) R (see note 2) R (see note 2) R (see note 2)
Safety interlock R
(see notes 3,4)
R
(see notes 3,4)
R
(see notes 3,4)
R
(see notes 3,4)
R
(see notes 3,4)
R
(see notes 3,4)
Location of
controls
N/A R R R R
Viewing optics R R R R R R
Scanning
safeguard
R R R R R R
Performance (laser systems)
Remote control
connector
N/A N/A N/A N/A R R
Key control N/A N/A N/A N/A R R
Emission
indicator
N/A N/A R R R (see note 10) R (see note 10)
Beam attenuator N/A N/A R R R R
Reset N/A N/A N/A N/A N/A R (see note 13)
Performance (specific purpose products)
Medical S S S S (see note 8) S (see note 8) S (see note 8)
Surveying, level-
ing, alignment
S S S S NP NP
Demonstration S S S S S (see note 11) (see note 11)
Labeling (all laser products)
Certification &
identification
R R R R R R
Protective
housing
D (see note 5) D (see note 5) D (see note 5) D (see note 5) D (see note 5) D (see note 5)
Aperture N/A N/A R R R R
Class warning N/A R (see note 6) R (see note 7) R (see note 9) R (see note 12) R (see note 12)
Information (all laser products)
User information R R R R R R
Product literature N/A R R R R R
Service
information
R R R R R R
Laser Product Classifications Section 7-2