Preface
20
■ FDA Standard
Requirements
Class
*1
I
IIa
II
IIIa
IIIb
IV
Performance (all laser products)
Protective housing
[1040.10(f)(1)]
Safety interlock
[1040.10(f)(2)]
Location of controls
[1040.10(f)(7)]
Viewing optics
[1040.10(f)(8)]
Scanning safeguard
[1040.10(f)(9)]
R
*2
R
*3,4
N/A
R
R
R
*2
R
*3,4
R
R
R
R
*2
R
*3,4
R
R
R
R
*2
R
*3,4
R
R
R
R
*2
R
*3,4
R
R
R
R
*2
R
*3,4
R
R
R
Performance (laser system)
Remote interlock connector
[1040.10(f)(3)]
Key control
[1040.10(f)(4)]
Emission indicator
[1040.10(f)(5)]
Beam attenuator
[1040.10(f)(6)]
Manual reset mechanism
[1040.10(f)(10)]
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
R
R
N/A
N/A
N/A
R
R
N/A
R
R
R
*10
R
N/A
R
R
R
*10
R
R
*13
Performance (specific-purpose products)
Medical
[1040.11(a)]
Surveying, leveling, alignment
[1040.11(b)]
Demonstration
[1040.11(c)]
S
S
S
S
S
S
S
S
S
S
*8
S
S
S
*8
NP
S
*11
S
*8
NP
S
*11
Labeling (all laser products)
Certification/identification
[1010.2,3]
Protective housings
[1040.10(g)(6),(7)]
Aperture
[1040.10(g)(5)]
Class warning
[1040.10(g)(1),(2),(3)]
R
D
N/A
N/A
R
R
*5
N/A
R
*6
R
R
*5
R
R
*7
R
R
*5
R
R
*9
R
R
*5
R
R
*12
R
R
*5
R
R
*12
Information (all laser products)
User information
[1040.10(h)(1)]
Product literature
[1040.10(h)(2)(i)]
Service information
[1040.10(h)(2)(ii)]
R
N/A
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
: Required
N/A : Not applicable
S
: Requirements : Same as for other products of that Class.
NP : Not permitted
D
: Depends on level of inner radiation
Содержание HL-D3 Series
Страница 9: ...Preface 7 ...
Страница 27: ...Preface 24 MEMO ...
Страница 43: ...Chapter 1 Before Use 1 16 1 MEMO ...
Страница 219: ...Chapter 4 Description of Functions 4 140 4 MEMO ...
Страница 298: ...1 Apx Appendix 1 Index 2 ...
Страница 304: ......