UV Smart D25 - Intended Use; Intended Medical Indication; Indications for Use

6UV Smart D25 | Instructions for use | Revision 9 EN
Intended use
Intended use
The UV Smart D25 is intended to reduce micro-organism count by at least log-4
on hard, non-porous outer surfaces (glass, plastic, metal) of non-invasive medical
devices within 30 seconds by using UV-C light.
The UV Smart D25 is intended for disinfection of the outer surfaces of the following
non-invasive medical devices:
▪ Infusion pumps;
▪ Thermometers;
▪ Surveillance monitoring equipment;
▪ Stethoscopes;
▪ Communication systems;
▪ Essential feeding pumps;
▪ Blood pressure pumps;
▪ Reex hammers.
These devices should only have direct contact with intact patient skin, in cases
where direct contact applies.
To be disinfected surfaces cannot be shadowed or covered during the disinfection
process.
The device does not support or sustain life.
Intended medical indication
The UV Smart D25 is intended for disinfection of hard, non-porous outer surfaces
of non-invasive medical devices and physically able to t inside the disinfection
chamber’s designated volume.
Indications for Use
The UV Smart D25 can be used in case of the following needs:
▪ Disinfection of common surfaces;
▪ Disinfection within 30 seconds;
▪ Automated disinfection;
▪ Consistent disinfection;
▪ Disinfection on location.
Previously administered, manual disinfection methods can be applied in case of
device failure.
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