Chapter 4 - Technical Specification
4.2 Laser safety designation (IEC 60825-1)
CAUTION
The P200TxE is a Class 1 laser device at the eye, and complies with IEC/EN 60825-
1:2014 and 21 CFR1040.10 and 1040.11 except for deviation pursuant to Laser Notice 50,
dated June 24, 2007.
Based on current scientific knowledge, a Class 1 laser device can be considered as safe
by engineering design, and safe under reasonably foreseeable conditions of operation.
Wavelengths:
SLO: 532 ±5 nm, 635 ±5 nm
SLO fa: 488 ±2 nm
SLO icg: 802 ±2 nm
Swept source OCT wavelength: 1050 ±10 nm
Resolution:
Typical Axial Resolution: <7 micron
Transverse Resolution: 20 micron (in tissue)
optomap plus: 14 micron
4.2.1 External Laser warning information
Location of Laser warning Warning information
Positioned on the rear scan
head cover.
CLASS 1 LASER DEVICE
4.2.2 Internal Laser warning information
Location of Laser warning Warning information
Positioned on the laser module
(BDIO)
VISIBLE AND INVISIBLE LASER RADIATION
AVOID DIRECT EXPOSURE TO BEAM
CLASS 3B LASER PRODUCT
Positioned on the swept
source cover
WARNING - LASER RADIATION
AVOID EXPOSURE TO BEAM
CLASS 3B LASER PRODUCT
Positioned of the fiber network
cover
CAUTION - INVISIBLE LASER RADIATION
PRESENT IF FIBER REMOVED, CLASS 3R
LASER RADIATION
Positioned on the reference
arm cover
WARNING – AVOID EXPOSURE TO BEAM,
INVISIBLE RADIATION PRESENT WHEN COVER IS REMOVED,
CLASS 3B LASER RADIATION
4.3 Electromagnetic compatibility (EMC)
The P200TxE is intended for use in the electromagnetic environment as specified in the following tables. The
customer or the user of the device should assure that it is used in such an environment.
Part Number: G110230/1ENG Page 63 of 72
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