Intended Use - Atmos i View COLPO Operating Instructions Manual

1.0 Introduction

1.2 Intended use

Product name:
Main functions:
Intended purpose:
Intended Users / User profile:
Intended Patient population:
Medical conditions to be diagnosed, treated
or monitored:
Application organ:
Application time:
Application site:
Patient selection criteria:
Indications:
Medical contra-indications:
Other contra-indications:
Warnings:
The product is:
Sterility/specific microbial status:
Single use product / reprocessing:
4
ATMOS i View 21 COLPO
ATMOS i View 31 COLPO
The device is a colposcope intended to give a magnified illuminated spa-
cial view on human tissue for diagnostic and treatment purposes.
Standard gynaecological examinations. Visual examination of the genital
area
Doctors and medical specialists
All patients without any restrictions
Diagnostic examination of anatomy of all kinds
Natural orifices (portio and vulva)
Short-term, under normal conditions for permanent use over a maximum
up to 30 days
Application sites are hospitals, doctor's offices, ORs at gynaecologists.
None
Standard gynaecological examination and / or therapy
None
None
None
active
Not steril
Not a single use product. Reprocessing according to instructions for use.