Use Instructions
6UV Smart D60 | Instructions for Use | Revision 1 US
of practice. Medical professionals include doctors, nurses, hospice workers, (emergency) medical technicians and other
trained caregivers. Reprocessing personnel is personnel specically trained or educated for the reprocessing of medical
equipment within reprocessing facilities.
2.6. Intended use environment
The intended use environment of the UV Smart D60 is medical related meaning; hospitals, medical clinics, nursing home,
doctor’s oce, reprocessing facilities, etc.
The UV Smart D60 shall be used in the following environmental conditions:
Temperature: 0
o
C – +40
o
C
Relative Humidity: 5% – 90% (without condensation)
Atmospheric pressure: 700hPa - 1060hPa
2.7. Claimed performance
The required reduction of micro-organisms is based on the EN-14885:2018 to compare it to the state of the art of disinfection
methods. The following reductions are determined and claimed:
Table 1: Specic micro-organism reduction by the UV Smart D60
Claim Micro-organism Sort and type Log reduction
Bactericidal
Staphylococcus aureus Gram-positive bacteria, vegetative ≥ 5,0
Pseudomonas aeruginosa Gram-positive bacteria, vegetative ≥ 5,0
Enterococcus hirae Gram-positive bacteria ≥ 5,0
Escherichia coli Gram-negative bacteria, Enterobacteriaceae ≥ 4,0
Fungicidal
Candida albicans Fungus, vegetative yeast ≥ 4,0
Aspergillus brasiliensis Fungus, spore ≥ 4,0
Yeasticidal
Candida albicans Fungus, vegetative yeast ≥ 4,0
Candida auris Fungus, yeast ≥ 4,0
Sporicidal Bacillus subtilis Gram-positive bacteria, endospore ≥ 4,0
Mycobactericidal
Mycobacterium avium Gram-positive mycobacteria, vegetative ≥ 4,0
Mycobacterium terrae Gram-positive mycobacteria, vegetative ≥ 4,0
Tuberculocidal Mycobacterium terrae Gram-positive mycobacteria, vegetative ≥ 4,0
Viricidal
Poliovirus type 1, LSc-2ab (Picornavirus) Enterovirus ≥ 4,0
Adenovirus type 5, strain Adenoid 75 Adenoviridae ≥ 4,0
Murine Norovirus, strain S99 Berlin Caliciviridae ≥ 4,0
Polyomavirus SV40, strain 777 Incertae sedis ≥ 4,0