UV Smart D60 Instructions for Use To avoid the risk of accidents or damage to the D60, it is essential to read these instructions before it is installed and used.
Table of contents 1. Introduction ............................................................................................................................................................. 3 2. Intended Use ........................................................................................................................................................... 5 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.
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 devices1 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.
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.
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.
of practice. Medical professionals include doctors, nurses, hospice workers, (emergency) medical technicians and other trained caregivers. Reprocessing personnel is personnel specifically 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 office, reprocessing facilities, etc.
3. Clinical Benefits Due to the fast D60 disinfection cycles the positive impact of the D60 on the health of an individual is expressed in a positive impact on patient management. By using the D60, equipment can be disinfected faster resulting in a higher turn-over speed. This means a higher number of patients can be treated in the same time frame and a smaller medical equipment inventory is required. Moreover, reprocessing personnel are less burdened because of the simple and quick use of the D60. 4.
5. Warnings and precautions 5.1. Warnings Upon delivery, check that all items are present, without visible debris and undamaged. Do not use a damaged D60. If you think the D60 is damaged, dirty or items are missing, please contact your local distributor. Do not use the D60 in an oxygen enriched environment or in the vicinity of combustible gases (e.g. anesthetics). Do not use the device outside the pre-scribed conditions as stated in the Intended Use Environment paragraph (2.6).
To be disinfected surfaces should not be shadowed or covered during the disinfection process. Use of the D60 could influence the color of the outer surface of the disinfected equipment. Do not remove the USB flash drive during the data importing and exporting processes. Do not stick anything to the inside or outside of the D60. Do not place any medical equipment on the D60 disinfection area floor. The UV-C lamps in the D60 disinfection area contain mercury. Handle the D60 with care to prevent any damage.
6. Product overview 6.1. Packaging content Items - D60 medical device - D60 Instructions for Use - Power cable 6.2. Features and dimensions Features 1. D60 unit 2. Disinfection area 3. Equipment holder 4. Wire holder 5. UV-C lamps (8x) 6. UV-C lamp protection covers (4x) 7. Door 8. Handle 9. Window 10. Control unit panel 11. Touch screen 12. Barcode scanner 13. RFID reader 14. Door magnets (2x) 15. Feet (6x) 16. Wall attachment 17. Control unit lock 18. Micro-switch 19. Main power supply inlet 20.
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7. Interface The D60 interface consists of a touch screen, RFID reader, barcode scanner, speaker and (color)LEDs. Touch screen The touch screen is located approximately at eye-level on the front of the D60 control unit. With touch input the user can navigate through the interface of the screen and hereby control the D60. Throughout the D60 use the D60 displays a variety of screens and animations. Specific screens are explained throughout this Instructions for Use.
8. Sounds and lights Use the following table to identify the meaning behind the D60 sounds and lights.
9. Use 9.1. Connected and standalone D60 Two configurations of the D60 are available: A connected D60 and a standalone D60. During the first time use (setup), the configuration selection is made by the user, depending on the user’s needs. The difference between the configurations is described below: Connected D60 A connected D60 is connected to the client’s intranet, via ethernet cable. This D60 works together with UV Soft, UV Smart’s data logging software.
9.4. After every D60 use Perform the following steps after every D60 use. 1. Remove equipment from the disinfection area. 2. Make sure all visible debris is removed from the disinfection area. 3. In case you use the D60 for only one disinfection cycle, close the door. In case of running multiple disinfection cycles, repeat the process starting at the Before every D60 use-paragraph (9.3). 9.5.
9.5.1.
9.6. D60 use Follow the steps below to correctly use the D60 for disinfection of channel- less invasive medical devices. Make sure to read the Before every D60 use-paragraph (9.3) first. 1. If applicable to the medical equipment, perform leak testing on the medical equipment according to hospital protocol. 2. Pre-clean your medical equipment according to the instructions for use provided by the manufacturer of the equipment. 3.
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9.7. Navigating the D60 menu The D60 menu is accessed by pressing the three-striped icon in the top-right of the home screen. The D60 menu has a structure as displayed below. The next pages describe the path to each end point in more detail.
9.7.1. Disinfection log Navigate to the disinfection log by pressing Disinfection log. The Disinfection log displays the following information: Disinfection start Time stamp, date Pre-clean performed Yes Disinfection finish Time stamp, date Leak test successful Yes Disinfection result Succesful/Reason Rinse & dry performed Yes of failure Measured UV-C dose UV-C dose User IN User responsible Amperage Amperage User OUT User responsible Equipment Equipment inserted 9.7.2.
9.7.3. Set language, time zone, time & date, D60 name, User ID scan & Equipment ID scan necessity. Navigate to the settings by pressing System > Scan master user ID > Settings. From here, choose the applicable sub menu. 9.7.4. User database Navigate to the user database by pressing System > Scan master user ID > User database. Here, an overview of all registered users is given. Checkmark icons indicate that an ID and/or PIN is added to a user. Plus icons indicate that no ID and/or PIN is added to a user.
9.7.5. Equipment database Navigate to the equipment database by pressing System > Scan master user ID > Equipment database. Here, an overview of all registered equipment is given. Checkmark icons indicate that an ID is added to a piece of equipment. Plus icons indicate that no ID is added to a piece of equipment. Depending on the D60 configuration, the ID can be added differently. This is explained in the Adding/Editing equipment-chapter (9.8). 9.7.6.
9.7.7. USB import/export of data Navigate to USB import/export by pressing System > Scan master user ID > USB import/export. Chapters 9.8, 9.9 and 9.10 explain importing and exporting in more detail. 9.7.8. Adjusting brightness and volume Navigate to the interface settings by pressing System > Scan master user ID > Interface. Use the sliders to adjust to the desired brightness and/or volume. Press continue to save to the settings.
9.7.10. System log Navigate to the system log by pressing System > Scan master user ID > System log.
9.8. Adding/editing equipment Adding or editing equipment to the D60 is different for a network-connected and standalone D60. Follow the instructions to add or edit equipment in line with your type of D60. 9.8.1. Connected D60 Adding and/or editing equipment data via UV Soft 1. Open UV Soft on your computer. 2. Navigate to the Equipment tab. 3. Login with master user credentials. 4. Change existing equipment or add new equipment. Click save. 5.
9.8.2. Standalone D60 Adding and/or editing RFID tag / Barcode data via the D60 display 1. Navigate to the menu. 2. Press System. 3. Scan master user ID. 4. Press Equipment database. 5. To edit an RFID tag / Barcode connected with a piece of equipment, press the plus or checkmark of the applicable equipment. 6. Scan the new RFID tag / Barcode that is related to that piece of equipment. 7. The equipment has been updated.
Adding equipment via USB flash drive 1. Open the Equipment database csv file in Microsoft Excel (to obtain this file, please refer to paragraph 9.10). 2. Add new equipment and/or add/edit equipment ID(s) exactly according to the format given in the Excel table. 3. Save the excel-file (as .csv) to a flash drive and return to the D60. 4. Navigate to the menu. 5. Press System. 6. Identify yourself as a master user. 7. Select USB import/export 8. Insert the flash drive into the D60. 9. Press import. 10. Accept.
9.9. Adding/editing users Adding or editing users is different for a network-connected and stand-alone D60. Follow the instructions to add or edit users to/in the D60. 9.9.1. Connected D60 Adding/editing users via UV Soft 1. Open UV Soft on your computer. 2. Navigate to the user database. 3. Login with master user credentials. 4. Add new user(s) and/or add/edit user ID(s) and/or user PIN(s). Click save. 5. Return to the D60, press the green button (to start the disinfection). 6. Scan any ID card.
9.9.2. Standalone D60 Adding users via USB flash drive 1. Open the User database csv file in Microsoft Excel (to obtain this file, please refer to paragraph 9.10). 2. Add new user(s) and/or add/edit user ID(s) and/or user PIN(s) exactly according to the format given in the Excel table. Note: assigning ‘1’ to the ‘Master user’-position in the excel table makes a user a master user. A ‘0’ makes a user a normal user. In the example below, Eve is a master user, Andre is a normal user. 3.
9.10. Exporting data via USB During its lifetime the D60 collects data about its use. The following data can be exported from the D60 via the D60 display, using a USB flash drive. Make sure to yearly backup an export of the D60 data. Export User data Equipment data Access and use log Maintenance report System log Follow the instructions below to export data from the D60: 1. Navigate to the menu. 2. Press System. 3. Scan a master user ID. 4. Press USB import/export. 5.
10. UV Soft Two configurations of the D60 are available: A connected D60 and a standalone D60. During the first time use (setup), the configuration selection is made by the user, depending on the user’s needs. A connected D60 is connected to the client’s intranet, via ethernet cable. A connected D60 works together with UV Soft, UV Smart’s data logging software. This chapter explains the use of UV Soft. 10.1. First time use Use the following steps when UV Soft is used for the very first time. 1.
4. Setting up the master user The master user has the most accessibility in UV Soft and the D60. The default master user is set to ‘Administrator’. For security reasons is it important to change the admin details to the details of the person responsible appointed by the client where the D60 is placed.
5. Connect to the server Upon D60 implementation at the client, UV Smart qualified personnel shall connect UV Soft to the client’s network. 6. Add a D60 Navigate to the D60-tab. Click “Add” and enter the following credentials: Unit code A 6-digit code identical to a D60. This code is used to establish the connection between UV Soft and the D60. A user can pick a unit code according to their own preference Description The description briefly describes the D60.
10.2. D60 settings Within UV Soft, one or more D60s can be added, edited and its use log can be viewed. Add a D60 Navigate to the D60-tab. Click “Add” and enter the following credentials: Unit code A 6-digit code identical to a D60. This code is used to establish the connection between UV Soft and the D60. A user can pick a unit code according to their own preference Description The brief description of the D60. For example: “D60 - Amsterdam Hospital - Wing X’ Click “Save”.
10.3. Equipment settings Within UV Soft, different equipment can be added, edited and the use log can be viewed. Add equipment Navigate to the Equipment-table. Click “Add” and enter the following credentials: ID number The barcode/RFID number of the piece of equipment Equipment name The RFID ID of the piece of equipment Equipment description The name of the piece of equipment. For example: “Endoscope 001 - Wing Y” The description of the piece of equipment.
10.4. User settings Within UV Soft, different users can be added, edited and its use log can be viewed. Add a user Navigate to the User-tab.
10.5. Export Logged data can be exported. Navigate to the Export-tab and click “Export”. A new window pops up. Select the desired export directory and click “Save”. Open the exported file to see the logged data. 10.6. License Navigate to the Licensing-tab to see the current license key. When applicable, a new key can be entered here. 10.7. Server Upon D60 implementation at the client, UV Smart qualified personnel shall connect UV Soft with the client’s network.
10.8. Language Navigate to the Languages-tab. Select your preferred language. 10.9. Info Navigate to the Info-tab, click “Info”. The following data is displayed. Press OK to exit. UV Soft Version Copyright www.uvsmart.nl Info@uvsmart.nl 10.10. Exit Navigate to the Exit-tab. Click “Exit”.
11. Maintenance 11.1. Maintenance Maintenance on the D60 shall be periodically performed (every 12-18 months) based on the service agreement and should be documented. Maintenance should exclusively be performed by qualified personnel. Do not attempt to open the D60 and/or perform maintenance on the D60. When maintenance is due, the D60 will remind the user with the following screen: If maintenance has not been performed for an extensive amount of time (18 months) the D60 will go out-of-use.
11.5 Disposal Dispose the D60 at your local community waste collection / recycling center for electrical and electronic appliances. UV-C lamps in the D60 contain mercury, manage in accord with disposal laws, see: www.lamprecycle.org. Please contact your local distributor for further information. 12. Problem solving 12.1. Problem solving In case of an occurring problem/error, please refer to the ‘Sounds and lights’-chapter (8) to identify the meaning behind interface feedback and take corresponding action.
13. Technical specifications Type of unit D60 UV-C Medical Disinfection Device Classification (acc. to IEC/EN 61010-1) Medical Disinfection Device Risk Group 2 Ingress Protection IP 20 Voltage rating 120V-230V Frequency 50/60Hz Amperage rating 10A Max. power rating 650W UV-C range 100-280nm (peak at 253.
14. Symbols Keep dry Protect the medical equipment from moisture. GS1 Data Matrix Data Matrix containing the unique Device Identification. Ingress Protection Classification Degree of protection of electrical appliances: Protection against touch by fingers and objects greater than 12 millimeters and no protection against ingress of water. Temperature limits Indicates the lower and upper temperature limits.
15. Warranty UV Smart provides 24 months manufacturing failure warranty. This covers repair or replacement of parts damaged as a result of design/manufacturing errors or material defects. It is not allowed to perform any modifications or repairs per customer’s decision. Modifications or repairs to the unit undertaken by the user/operator or by third parties invalidate the warranty.
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Manufactured by: DOC-2109 UV Smart D60 - Instructions for Use (US) Revision 1 UV Smart Issue date: JUL2022 Technologies B.V. Copyright © 2022 UV Smart Technologies B.V. Patrijsweg 74 All rights reserved. 2289EX +31 8501609 800 UV Rijswijk Smart D60 | Instructions for UseTel. | Revision The Netherlands www.uvsmart.
