6
1.0 Introduction
1.3 Intended purpose
Product name:
ATMOS HL 21 LED
Main functions:
Medical LED cold light source with headband for
fixation on the head of examiner
Intended purpose:
Illumination of orifices (e.g. ear/nose/throat) for
visual diagnostics
Intended Users / User profile:
Doctors and medical specialists
Intended Patient population:
All patients without any restrictions
Medical conditions to
be diagnosed, treated or
monitored:
Diagnostic examination of anatomy of all kinds
Application organ:
No restrictions (mainly ear, nose, throat)
Application time:
< 60 min.
Application site:
Outpatient medical facilities, e.g. ENT practices,
hospital outpatient departments, medical care
centers
Patient selection criteria:
None
Indications:
Whenever visual examination is indicated
Medical contra-indications:
None
Other contra-indications:
None
Warnings:
None
The product is:
active
Sterility/specific microbial
status:
Non sterile
Single use product /
reprocessing:
No single use product. Reprocessing according to
instructions for use.
