Chattanooga Intelect HPL15, Руководство пользователя

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EN
The lasers in the Intelect HPL 7 and HPL15 family are therapeutic and
surgical lasers with optical fibre output, designed to function with pumped
semiconductor laser heads, with wavelengths between 600nm and
2000nm, with maximum power up to 7W (Intelect HPL 7), up to 15W
(Intelect HPL 15).
Based on Annex IX of Directive 93/42/EEC this device is classified as
a(n):
-Device intended to be used long term
-Device with non-invasive application
-Active medical device
-Class Ilb medical device
Based on general standards for safety (IEC 60601-1) it is classed as a(n):
-Class I apparatus
-Apparatus with type BF applied parts
-Apparatus with class IP2X case protect against solid object bigger then 12
mm
-Apparatus unsuitable for use in the presence of a mix of flammable
anesthetic and air or oxygen or with nitrogen protoxide
-Apparatus for continuous function
Based upon laser emission characteristics (IEC 60825-1:2014, paragraph
d, table 4) the apparatus is classified as:
Class IV
Intelect HPL 7 and HPL15 conforms with RoHS specifications and uses
recycled materials.
General description
Intelect HPL 7 and HPL15 is produced using a ABS and aluminium structure.
The materials used for the structure which come into contact with the
operator and the patient are those which are usual in normal human
activity:
- AISI 316L stainless steel for the handpiece cylinder
- Anodized aluminium EN AW-2011 for the applicator handpiece (Supplier
declaration attached)
- ABS for the case
Within the case there are no coolant liquids or other substances which may
leak out in the case of impact or accident.
5.3 Classification