UV Smart D60 User manual

1UV Smart D60 |Instructions for Use |Revision 1 US
Instructions for Use
US United states of America
To avoid the risk of accidents or damage to the D60, it is essential to
read these instructions before it is installed and used.
UV Smart D60

2UV Smart D60 |Instructions for Use |Revision 1 US
Table of contents
1. Introduction .............................................................................................................................................................
2. Intended Use ...........................................................................................................................................................
2.1. Intended Use
2.2. Intended Medical Indication
2.3. Indications for Use
2.4. Contra-indications for Use
2.5. Intended users
2.6. Intended use environment
2.7. Claimed performance
3. Clinical benets .......................................................................................................................................................
4. Residual risks ..........................................................................................................................................................
5. Warnings and precautions ......................................................................................................................................
5.1. Warnings
5.2. Precautions
6. Product overview .....................................................................................................................................................
6.1. Packaging content
6.2. Features and dimensions
7. Interface ....................................................................................................................................................................
8. Sounds and lights ....................................................................................................................................................
9. Use .............................................................................................................................................................................
9.1. Connected and standalone D60
9.2. First time (setup)
9.3. Before every D60 use
9.4. After every D60 use
9.5. Placement of medical equipment guide
9.6. D60 use
9.7. Navigating the D60 menu
9.8. Adding//editing equipment
9.9. Adding/editing users
9.10. Exporting data via USB
10. UV Soft.....................................................................................................................................................................
10.1. First time use
10.2. D60 settings
10.3. Equipment settings
10.4. User settings
10.5. Export
10.6. License
10.7. Server
10.8. Language
10.9. Info
10.10. Exit
11. Maintenance ............................................................................................................................................................
11.1. Maintenance
11.2. Cleaning
11.3. Calibration
11.4. Yearly validation
11.5. Disposal
12. Problem solving ....................................................................................................................................................
12.1. Problem solving
12.2. Out-of-use
12.3. Broken glass
12.4. Overheating
13. Technical specications ........................................................................................................................................
14. Symbols ..................................................................................................................................................................
15. Warranty ..................................................................................................................................................................
16. Contact details .......................................................................................................................................................
17. Index ........................................................................................................................................................................
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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 devices1within 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 di󰀨usely 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 e󰀨ect 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 modications 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.
1Channel-less invasive devices
A device without working channel(s) which, in whole or in part, penetrates inside the body through a body orice.

4UV Smart D60 |Instructions for Use |Revision 1 US
This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference
will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception,
which can be determined by turning the equipment o󰀨 and on, the user is encouraged to try to correct the interference by
one or more of the following measures:
• Re-orient or relocate the receiving antenna • Increase the separation between the equipment and receiver
• Connect the equipment into an outlet on a di󰀨erent circuit from that to which the receiver is connected
• Consult the dealer or an experienced radio/TV technician for help.
ISED Canada Regulatory Notices:
This device is compliant with ISED Canada license-exempt RSS standards. Operation is authorised under the following
two conditions:
1 - the device may not cause harmful interference;
2 - the device must accept any interference received, even if it compromises operation.
Cet appareil est conforme aux normes CNR exemptes de licence d’ISDE Canada. Le fonctionnement est autorisé sous
les deux conditions suivantes :
1 - l’appareil ne doit pas causer d’interférences nuisibles ;
2 - l’appareil doit accepter toute interférence reçue, même si elle compromet son fonctionnement.
RF Exposure information
FCC:
This device complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This device complies
with the safety requirements for RF exposure for mobile (>20 cm) use conditions in accordance with FCC rule part 2.1091.
ISED Canada:
This equipment complies with ISED Canada RSS-102 radiation exposure limits set forth for the general population. This
equipment complies with the safety requirements for RF exposure in accordance with RSS-102 Issue 5 section 2.5.2 for
mobile (>20 cm) use conditions.
Cet équipement est conforme aux limites d’exposition aux radiations CNR-102 de l’ISDE Canada établies pour la population
générale. Cet équipement est conforme aux exigences de sécurité pour l’exposition aux radiofréquences conformément
à la section 2.5.2 de la norme CNR-102 Issue 5 pour les conditions d’utilisation mobile (>20 cm).

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 qualied by education, training, licensure or client privileging who perform a professional service within their scope