DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0230-53095, Rev 05
Revision Date 05-Mar-2021
Page
12
of
79
5.
Classifications (DYS403)
The DYSIS Ultra 2.0 Digital Colposcope is a Class-IIa device according to the 93/42/EEC Medical Device Directive
and a Class-II device as per the US FDA classification.
ME Classification
–
class II device as it contains a protectively earther power supply.
DYSIS Ultra 2.0 Digital Colposcope IP rating 00 (no protection against contact and ingress of objects or liquids).
DYSIS Ultra 2.0 Digital Colposcope is a Class-A Software Medical Electrical Equipment product as per IEC 62304
–
no injury or damage to health is possible as a result of using the software.
DYSIS Ultra 2.0 Digital Colposcope is a Risk Group 2 LED product according to IEC 62471
.
The DYSIS reusable metal speculum is a Type BF applied part and the DYSIS disposable speculum is a Type B
applied part per International Electro-technical Commission (IEC 60601-1), according to the type of protection
against electric shock.
The DYSIS Ultra 2.0 Digital Colposcope Optical Head is not an applied part but could accidentally come in
contact with the patient
’s leg
. The optical head and the positioning arm are protected by double insulation
that prevents the patient coming into contact with the electrical system.
The power supply used with DYSIS Ultra 2.0 Digital Colposcope is Class II. Refer to technical documentation for
more information on electrical safety per IEC 60601-1.
Mode of operation; DYSIS Ultra 2.0 Digital Colposcope is classified for continuous operation.