User’s Manual eVA 500 / 500D COLPOSCOPE
8
Issue
1.0
6169000
‐
795
eVO
500/500D
Printed
on
May,
2013
Directives and standards
The instrument described in this manual has been designed in compliance with the
following standards:
−
EN
−
IEC
−
UL
−
CSA
In accordance with Directives 93/42/EEC, Annex II, Article 3, the quality management
system of LABOMED has been approved by UL which is notified body.
•
As per Directive 93/42/EEC, the unit is a Class I instrument
-
For USA: FDA classification Class II
−
IEC 60601-1:2005 (3
rd
edition) Compliance
•
Please observe all applicable accidental prevention regulations.
•
Intended use
LABOMED colposcope eVA 500 and eVA 500D is a device designed to permit
direct viewing of the tissues of the vagina and cervix by a telescopic system
located outside the vagina. It is used to diagnose abnormalities and select areas
for biopsy. It helps the user an excellent level of comfort and improves visual
acuity during use
.
•
NOTE:
The use of eVA500/500D Colposcope is purely for intended Operative and
Diagnostic medical use. No contact is to be made between the patient and the device.
