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Z500
Setup Manual
SECTI
ON 4
4-4 La
ser P
ro
d
u
c
t Clas
sification
s
75
SECTION 4
Appendix
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