UV Smart D60 User Manual

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 specically 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 o󰀩ce, 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: Specic 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

UV Smart D60 Specifications

General

Brand	UV Smart
Model	D60
Category	Medical Equipment
Language	English