User Manual NUVOLAS
April 2023
File: User Manual_NUVOLAS_rev3.docx 16
4.6 NOHD Safety Distance
The NOHD (Nominal Ocular Hazard Distance) is the distance at which the irradiance is
equal to the exposure limit value of the cornea of the eye. The NOHD identifies the danger
area within which there is a risk of damage to the health of the eye if you look directly into
the laser beam without protection.
The NOHD is calculated according to EN 60825-1 and taking into account the permitted
power fluctuations (+/- 20%) according to EN 60601-2-22 using the following equation:
πππ»π· =
β
4 β π
πππ΅β π
β π·πππππ‘ππ πΏππ ππ ππππ
π΅ππππ πππ£πππππππ
4.7 CE Regulations
The laser system NUVOLAS has been approved by the notified body in accordance with
the European Directive 93/42/EEC for medical devices. Accordingly, the device bears the
CE mark CE 0123.
The device has been checked for electrical and mechanical safety. All parts we use
comply with the CE regulations or have been tested for approval or suitability by the
notified body.
Additional devices that you attach to the device require approval from an official test
center. Changes to the device or interventions on your part will void the approval and
warranty.
The test approval number is included with the device.
4.8 RoHS3 regulations
Our company operates worldwide and regards the protection of the environment and
natural resources as an entrepreneurial obligation. Based on individual tests, A.R.C.
Laser GmbH confirms that, to the best of our knowledge, our products do not contain any
substances in concentrations whose placing on the market is prohibited according to the
applicable requirements of Directive 2015/863/EU (RoHS 3).
4.9 Protective Housing
The NUVOLAS laser system has a protective housing. It prevents radiation from the laser
from escaping and protects users from touching live parts. This housing must not be
removed.
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