User Manual I Primelase I 8
primelase® excellence requires special precautions
with regards to EMC and must be installed and op-
erated in accordance with the provided information.
Portable and mobile RF communications equipment
can affect the primelase® excellence device during
normal use.
Only the cables and accessories supplied by the
manufacturer should be used. The use of unautho-
rised accessories, transducers and cables may cause
increased emissions or decrease the invulnerability of
primelase® excellence.
Do not use the primelase® excellence device while
it is attached to another piece of equipment. In the
event that the device is used while attached to anoth-
er device, be attentive to any alerts that may appear
on the user interface and notify the SAT immediately.
Dangers of risk to vision
The primelase® excellence device is designed to work
while in direct contact with the skin of the patient.
Any direct exposure of the eyes to laser energy radi-
ation is potentially dangerous and may cause serious
harm to the affected person.
The primelase® excellence device should only be used
by personnel with sufcient knowledge of the appropri-
ate technique. Always work in a completely enclosed
room, with all personnel wearing eye protection. Mea-
sures must be put in place to prevent access to the
room in which the laser emission is taking place, such
as notices and signs at the entrance. There is a con-
nector on the rear of the device which allows for the op-
tional installation of a system that blocks laser emission
in the event that the cabin door is opened.
The minimum eye protection required must be of an
optical density of 7 or higher (OD7 +). The manufacturer
supplies eye protection glasses that cover the wave-
lengths used by the device. Always ensure that the
glasses provide sufcient eye protection for the range
of wavelengths that will be used.
Avoid direct exposure of the eyes to laser energy emis-
sion. Direct emission into the eye can cause harm and
injury even when eye protection is used.
Never look directly at the laser window on the applicator.
A fault or application error could expose the user to dan-
gerous laser radiation. In accordance with the applicable
regulations, the device incorporates signs to indicate the
areas on the device where laser emission occurs.
The patient undergoing laser treatment must always
wear opaque protective glasses to avoid radiation expo-
sure. Glasses that ensure this protection are supplied by
the manufacturer with the device.
Do not use the device on facial areas that are very
close to the eyes. A fault or appli- cation error could
expose the patient to dangerous laser light.
In accordance with IEC standard 60825-1 for laser
safety, the nominal ocular hazard distance (NOHD)
must be dened. This value, measured in metres, is the
minimum distance required where the delivered ener-
gy density corresponds with the maximum permissible
error (maximum permitted energy) for eye exposure. In
the worst case scenario, when using the primelase®
excellence system this distance corresponds to the
diode laser that diverges less or is more focused (50
degrees).
The NOHD for primelase® excellence is 10 m.
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