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7. Notice to the user of this product
To assure compliance with the Safety Standard 21CFR, Chapter I.
Subchapter J. Part 1040. The U.S. bureau of Radiological Health requires
the following information to be provided to the user:
1) Specifications of Laser Radiation.
A. This laser system is designed and built to have a GaAIAs laser
diode radiating at 635nm ± 15 nm.
B. Radiant power
This laser product is designed and built to radiate a maximum
average radiant power of 920µ W as scanning beam during
functional operation. The user may be subject to this radiation as a
scanned beam while the rotor is rotating until such time that the
instrument is turned off.
•
For a period of less than 10 seconds during the operation the
user may be subjected to this radiation.
2) The following labels are affixed to and must remain attached to
this laser product.
A. Certification Label
‘This laser product conforms to the provisions of 21 CFR 1040.10
and 1040.11. For a class 2 laser product.’
Located on the surface of the base of top-handle.
B. Caurion Label
‘Laser beam, do not look into the laser beam source directly.’
Located near to exit aperture, facing upward.
3) Caution to maintain the safety in compliance with the standard.
•
To maintain the safety standard, refrain from any operation, mainte-
nance or adjustment other than described in this instruction manual.
•
Operation, maintenance or adjustment other than those specified in
this instruction manual may result in hazardous radiation exposure.
•
Maintenance and repair not covered in this manual must be done by
an authorized Pentax dealer.
