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DIAMOND C-55 Liquid-Cooled OEM Laser Preinstallation Manual, Rev. AG

DIAMOND C-55 Liquid-Cooled OEM Laser Preinstallation Manual, Rev. AG


product is shipped. The form of this report is covered in a pamphlet
entitled: Compliance Guide for Laser Products, HHS Publication
FDA 86-8260. This pamphlet is available at no cost from:
U.S. Food and Drug Administration
Center for Devices and Radiological Health

COHRHighLightFLARMDS0719.pdf

COHRHighLightFLARMDS0719.pdf

…in strict accordance
with the respective safety regulations. We certify that each laser
manufactured by our company complies with FDA Radiation
Performance Standards, 21 CFR Subchapter J and with IEC 60825.
Warning labels as shown in the figure appear on each Coherent-Rofin…

COHR DIAMOND C-30 DS 0817 1.pdf

COHR DIAMOND C-30 DS 0817 1.pdf

…the manual supplied with the laser.
The Diamond C-20 CO2
laser is a component that does not include all safety features as required by the FDA and the Center for Devices and Radiological Health (CDRH). It is sold solely to qualified manufacturers who in
their end product will supply…

COHR DIAMOND C-40 DS 1117 1.pdf

COHR DIAMOND C-40 DS 1117 1.pdf

…the manual supplied with the laser.
The Diamond C-40 CO2
laser is a component that does not include all safety features as required by the FDA and the Center for Devices and Radiological Health (CDRH). It is sold solely to qualified manufacturers who in
their end product will supply…

COHR DIAMOND E-1000 DS 0817 1.pdf

COHR DIAMOND E-1000 DS 0817 1.pdf

…supplied with the laser.
The Diamond E-1000/E-1000i CO2
laser is a component that does not include all safety features as required by the FDA and the Center for Devices and Radiological Health (CDRH). It is sold solely to qualified manufacturers who in their end product will supply all…

COHR HighLightFL Compact MultiMode DS 0818.pdf

COHR HighLightFL Compact MultiMode DS 0818.pdf

…in strict accordance
with the respective safety regulations. We certify that each laser
manufactured by our company complies with FDA Radiation
Performance Standards, 21 CFR Subchapter J and with IEC 60825.
Warning labels as shown in the figure appear on each Coherent-Rofin…

COHR HighLightFL Standard FFC DS 0818.pdf

COHR HighLightFL Standard FFC DS 0818.pdf

…in strict accordance
with the respective safety regulations. We certify that each laser
manufactured by our company complies with FDA Radiation
Performance Standards, 21 CFR Subchapter J and with IEC 60825.
Warning labels as shown in the figure appear on each Coherent-Rofin…

COHR HighLightFL Standard FFS DS 0818.pdf

COHR HighLightFL Standard FFS DS 0818.pdf

…in strict accordance
with the respective safety regulations. We certify that each laser
manufactured by our company complies with FDA Radiation
Performance Standards, 21 CFR Subchapter J and with IEC 60825.
Warning labels as shown in the figure appear on each Coherent-Rofin…

COHR HighLightDL HPR DS 0818.pdf

COHR HighLightDL HPR DS 0818.pdf

…in strict accordance
with the respective safety regulations. We certify that each laser
manufactured by our company complies with FDA Radiation
Performance Standards, 21 CFR Subchapter J and with IEC 60825.
Warning labels as shown in the figure appear on each Coherent-Rofin…

CohrRofi Whitepaper - Marking Stainless Steel Medical Devices de.pdf

CohrRofi Whitepaper - Marking Stainless Steel Medical Devices de.pdf

…Vermeidung von Rückgabebetrug und verbesserte Distributionssteuerung. Wichtiger noch, auf dem amerikanischen Markt wird im Zuge der Umsetzung der FDA Richtlinien die Markierung medizintechnischer Produkte zunehmend Pflicht. Für wiederverwendbare, nicht-implantierbare Artikel ist der 24. September…

Flyer KLS 2017.pdf

Flyer KLS 2017.pdf

…Cooling power max. 8.5 kW, depending on laser output
Weight
Laser unit 200 kg
Ambient conditions
Ambient temperature max. 10 - 35 °C
Relative humidity max. 80 %
Emissions
Noise at 1m, idle 60 dBA
Compliance with standards
CE compliant, FDA compliant

Flyer NA 2017 en.pdf

Flyer NA 2017 en.pdf

…1500 kg
Ambient conditions
Ambient temperature 10-35 °C (stabilized ± 2°C)
Relative humidity max. 80 %
Emissions
Heat dissipation max. 0.4 kW + laser beam power
Noise at 1 m, idle 65 dBA
Compliance with standards
CE compliant, FDA compliant
NA N