Use Instructions
3UV Smart D60 | Instructions for Use | Revision 1 US
1. Introduction
The UV Smart D60 is intended to reduce micro-organism count by at least log-4 on outer surfaces of channel- less
invasive medical devices
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within 60 seconds by using UV-C light.
The D60 has a disinfection area with 8 lamps, in which medical equipment can be placed. The lamps switch on for 60
seconds during each cycle, in which the micro-organism count on inserted equipment reduces with at least log-4. When
applicable, data about the user, equipment and disinfection cycles is stored on the D60 memory.
The emitted light used is UV-C, ranging from 100-280nm (peak at 253.7nm). The lamps each have an intensity of 75W.
The light is diusely distributed.
The D60 disinfection area is completely sealed o, preventing UV-C light from reaching the user, guaranteeing safe use.
UV-C light cannot penetrate the window in the door; only visible light gets through, enabling the user to see inserted
equipment and to verify if all the lamps are on during a cycle. When opening the D60 during a disinfection cycle, the UV-C
lights switch o automatically.
The germicidal eect of UV-C light will not penetrate dirt, debris and grime. To allow the D60 to perform optimally it is
required that all medical equipment is cleaned before use, according to the corresponding instructions for use provided by
the equipment manufacturer.
The UV Smart D60 should be used by trained personnel only. In addition, the Instructions for Use should be read prior to
operation.
In case they might occur, serious incidents should be reported to UV Smart or your local distributor and competent
authority of the member state.
The UV Smart D60 is a Risk Group 2 device. This device complies with part 15 of the FCC Rules. Operation is subject to
the condition that this device does not cause harmful interference.
FCC Regulatory Notices:
This device complies with Part 15 of FCC Rules, Operation is Subject to following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received including interference that cause undesired operation.
Caution: Any changes or modications to the equipment not expressly approved by the party responsible for compliance
could void user s authority to operate the equipment. This equipment has been tested and found to comply within the
limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation.
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Channel-less invasive devices
A device without working channel(s) which, in whole or in part, penetrates inside the body through a body orice.