5UV Smart D60 | Instructions for Use | Revision 1 US
2. Intended Use
2.1. Intended use
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 within 60 seconds. This is achieved after the equipment is pre-cleaned and checked according to the
manufacturer’s protocol.
The medical devices that can be disinfected with the D60:
▪ Flexible and rigid Channel-less endoscopes;
▪ Invasive transducers;
▪ TEE-probes.
The device does not support or sustain life. Moreover, the D60 has no patient interaction. It is used on medical devices
which do come in contact with the patient. No substances/tissues (derived) of human and/or animal origin are present in
the D60. After a disinfection cycle the D60 can be reused directly after performing the steps indicated in chapter 9.3.
2.2. Intended medical indication
The UV Smart D60 is intended for disinfection of channel-less invasive medical devices physically able to t inside the
designated disinfection area.
2.3. Indications for Use
The UV Smart D60 can be used in case of the following needs:
▪ Disinfection within 60 seconds;
▪ Automated disinfection;
▪ Consistent disinfection;
▪ Disinfection on location.
Previously administered or manual disinfection methods can be applied in case of device failure.
2.4. Contra-indications for use
The UV Smart D60 cannot be used in case:
▪ The Indications for Use are not met;
▪ The D60 is damaged;
▪ The user comes in direct contact with UV-C light, produced by the device;
▪ The invasive medical device has working channels;
▪ The invasive medical device has visible debris on it;
▪ There is any doubt about how to use the D60.
2.5. Intended users
The UV Smart D60 is suitable for use by trained reprocessing personnel or a trained medical professional. These individuals
are qualied by education, training, licensure or client privileging who perform a professional service within their scope
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