Labelling; Basic User Approach - Dermalux FlexMD User Manual

Aesthetic Technology Limited

27. Labelling

Product Labelling conforms to PL-001 (Rev 8) – Dermalux® Product Labelling Specification.
28.1 Symbols and Product Labelling
Serial Number
Product Code
and Reference
Date of Manufacture
Product is CE marked.
Notified body number: 2797
Upper and Lower
Operating Temperature
2 = Protection against
objects larger than 12.5mm
IP20
X = No protection.
Do not dispose of in
general waste.
Table 12: Labelling Identification.
PL-027 (Rev 7)
Electrical Warning
Keep Dry
Manufacturer
General Warning
Follow instructions for use
Upper and Lower
Operating Humidity
40

28. Basic User Approach

Figure 16: Flex MD on Treatment Couch,
Overhead, Side View.
Figure 17: Flex MD on treatment Couch, Over-
head, End View.
PL-027 (Rev 7)
The diagrams to the left demonstrate how the
device should be set up and positioned around
the users face. This is for illustrative purposes
only.
The minimum distance between the LED Array
and the user should be no less than 25mm.
The positioning of the LED Array mitigates
unintended exposure and the device should
only be used with a user in place.
Note: The distance determines the j/cm2
of the emitted light, the further the user is
from the device the lower the optical power
density.
41