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UV Smart D45
Certifications
CE Certificate
The UV Smart D45 device received CE certification (MDR Class IIa).
Health Canada
The UV Smart D45 is registered with Health Canada as a Class II medical device.
Standards
The product complies with NEN-EN 61010 (Safety requirements for electrical equipment for measurement, control, and laboratory use- Secondary standard: Electromagnetic disturbances - Requirements and tests).
This certificate means that the D45 complies with the general safety requirements for laboratory electrical equipment.
The EN 14885 standard is used as a reference for the efficacy of the D45 (Chemical disinfectants and antiseptics - Application of European
Standards for chemical disinfectants and antiseptics). Efficacy results are in line with this standard, meaning that the equipment achieves the same (or higher) level of disinfection as chemicals solution such as wipes, sprays, and liquids (as there is currently no guideline for UV-C).
UV Smart Technologies B.V. has held the EN-ISO 13485 certificate since 2020. This certification is the international standard for manufacturers, suppliers and distributors of medical devices to demonstrate that they meet the legal requirements for medical devices.
Patent Protection
Impelux™ is a patented technology that uses UV technology for guaranteed disinfection without damaging equipment and with validated and continuous effectiveness.
Technical Specifications
For disinfection of:
Wired ultrasound probes
Dimensions:
- Width: 390 mm
- Depth: 200 mm
- Height: 525 mm
Disinfection Chamber:
- Width: 140 mm
- Depth: 118 mm
- Height: 380 mm
Power cable:
- Length: 2 m
Disinfection cycle:
- 75 seconds
Effective against:
- Viruses
- Bacteria
- Spores
- Yeast
- Fungi
- Mycobacteria
Clinical Evidence
The disinfection efficiency of the UV Smart D45 has been validated and proven by extensive research conducted in medical center such as Marburg University (Germany). Studies have also been conducted in clinical laboratory Eurofins (Italy).
Eurofins*
Eurofins concluded that D45 meets the European standard for disinfection of medical devices. Conclusion: D45 meets the EN-14885 standards for the full spectrum of microorganisms.
Marburg University*
Following favourable results of disinfection with rigid endoscopes using Impelux™ technology, Marburg University investigated the effectiveness of disinfection of ultrasounds probe with the D45. The study concluded that UV-C light-based reprocessing demonstrated a substantial reduction in bacterial contamination, making it a promising approach for disinfection of ultrasound probes in ORL. The UV-C light system used in this study consistently delivered reproducible results and exhibited compatibility with non-critical medical devices.
*These studies are available upon request from info@biomiq.health
Frequently Asked Questions
What products can I disinfect in the D45?
The D45 is designed for fast and effective disinfection of wired ultrasound probes. For tailor-made advice, please contact us.
On what is the D45 placed?
The D45 can be delivered as stand-alone to be placed on any available cabinet or shelves or with a wall mount or on a trolley. The trolley allows the D45 to be moved easily from patient room to patient room.
Can the data of the D45 be retrieved?
Yes, the data of the D45 can be retrieved. This can be done via a USB port at the back. Each disinfection cycle (success and failure) can be viewed with all data: time and date stamp, which equipment was disinfected, person that started the disinfection process, reached UV-C dose, current threshold, cycle number and person that took out the equipment.
Does the D45 demonstrate the effectiveness of the process?
The D45 contains sensors that check during each disinfection cycle whether sufficient UV-C dose has been released for successful disinfection. Yearly maintenance must be performed in order to keep the claimed performance of the device.
What accessories are available for the D45?
When the trolley is used, holders can be added on it, for storing disinfectants, gloves, printer and/or probe covers. There are validation stickers, a tool to check whether the UV-C emission is sufficient. There is also a transport case (flight case), in which the D45 can be transported safely to its destination. A printer can also be added to ease the traceability of probes disinfection.
Can I test the D45 in my hospital/clinic?
To see if the D45 fits in your workflow, you can request a 2-week trial placement. This will give you an idea of what the product can do for your organization in the fight against healthcare-associated infections.
Downloads
In search of something else? Contact us to request additional resources about this product.
Product Description
Automated. Fast. No Consumables.
The UV Smart D45 is designed to disinfect ultrasonic transducers (ultrasound probes) quickly, efficiently and consistently using the disinfection power of pure UV-C light. In a matter of seconds, the item is disinfected and ready for use again with all necessary reprocessing data automatically recorded.Product Description
Automated. Fast. No Consumables.
The UV Smart D45 is designed to disinfect ultrasonic transducers (ultrasound probes) quickly, efficiently and consistently using the disinfection power of pure UV-C light. In a matter of seconds, the item is disinfected and ready for use again with all necessary reprocessing data automatically recorded.Certifications
CE Certificate
The UV Smart D45 device received CE certification (MDR Class IIa).
Health Canada
The UV Smart D45 is registered with Health Canada as a Class II medical device.
Standards
The product complies with NEN-EN 61010 (Safety requirements for electrical equipment for measurement, control, and laboratory use- Secondary standard: Electromagnetic disturbances - Requirements and tests).
This certificate means that the D45 complies with the general safety requirements for laboratory electrical equipment.
The EN 14885 standard is used as a reference for the efficacy of the D45 (Chemical disinfectants and antiseptics - Application of European
Standards for chemical disinfectants and antiseptics). Efficacy results are in line with this standard, meaning that the equipment achieves the same (or higher) level of disinfection as chemicals solution such as wipes, sprays, and liquids (as there is currently no guideline for UV-C).
UV Smart Technologies B.V. has held the EN-ISO 13485 certificate since 2020. This certification is the international standard for manufacturers, suppliers and distributors of medical devices to demonstrate that they meet the legal requirements for medical devices.
Patent Protection
Impelux™ is a patented technology that uses UV technology for guaranteed disinfection without damaging equipment and with validated and continuous effectiveness.
Technical Specifications
For disinfection of:
Wired ultrasound probes
Dimensions:
- Width: 390 mm
- Depth: 200 mm
- Height: 525 mm
Disinfection Chamber:
- Width: 140 mm
- Depth: 118 mm
- Height: 380 mm
Power cable:
- Length: 2 m
Disinfection cycle:
- 75 seconds
Effective against:
- Viruses
- Bacteria
- Spores
- Yeast
- Fungi
- Mycobacteria
Clinical Evidence
The disinfection efficiency of the UV Smart D45 has been validated and proven by extensive research conducted in medical center such as Marburg University (Germany). Studies have also been conducted in clinical laboratory Eurofins (Italy).
Eurofins*
Eurofins concluded that D45 meets the European standard for disinfection of medical devices. Conclusion: D45 meets the EN-14885 standards for the full spectrum of microorganisms.
Marburg University*
Following favourable results of disinfection with rigid endoscopes using Impelux™ technology, Marburg University investigated the effectiveness of disinfection of ultrasounds probe with the D45. The study concluded that UV-C light-based reprocessing demonstrated a substantial reduction in bacterial contamination, making it a promising approach for disinfection of ultrasound probes in ORL. The UV-C light system used in this study consistently delivered reproducible results and exhibited compatibility with non-critical medical devices.
*These studies are available upon request from info@biomiq.health
Frequently Asked Questions
What products can I disinfect in the D45?
The D45 is designed for fast and effective disinfection of wired ultrasound probes. For tailor-made advice, please contact us.
On what is the D45 placed?
The D45 can be delivered as stand-alone to be placed on any available cabinet or shelves or with a wall mount or on a trolley. The trolley allows the D45 to be moved easily from patient room to patient room.
Can the data of the D45 be retrieved?
Yes, the data of the D45 can be retrieved. This can be done via a USB port at the back. Each disinfection cycle (success and failure) can be viewed with all data: time and date stamp, which equipment was disinfected, person that started the disinfection process, reached UV-C dose, current threshold, cycle number and person that took out the equipment.
Does the D45 demonstrate the effectiveness of the process?
The D45 contains sensors that check during each disinfection cycle whether sufficient UV-C dose has been released for successful disinfection. Yearly maintenance must be performed in order to keep the claimed performance of the device.
What accessories are available for the D45?
When the trolley is used, holders can be added on it, for storing disinfectants, gloves, printer and/or probe covers. There are validation stickers, a tool to check whether the UV-C emission is sufficient. There is also a transport case (flight case), in which the D45 can be transported safely to its destination. A printer can also be added to ease the traceability of probes disinfection.
Can I test the D45 in my hospital/clinic?
To see if the D45 fits in your workflow, you can request a 2-week trial placement. This will give you an idea of what the product can do for your organization in the fight against healthcare-associated infections.
Downloads
In search of something else? Contact us to request additional resources about this product.
True disinfection starts here.
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Device Compatibility
The D45 is compatible with a wide range of devicesClick below to verify that your ultrasound probe is compatible with the D45 or request the a full statement of compatibility.
7 Easy Steps to Complete Device Disinfection
Here's how to use the UV Smart D45.
Step 1: Start the Process
Pre-clean your ultrasonic transducer.
Step 2: Scan Equipment
Scan your ID and the transducer for traceability.
Step 3: Place the Device
Place the transducer in the D45 and close the door.
Step 4: Disinfection
Wait 75 seconds for the D45 to finish the disinfection cycle.
Step 5: Scan your ID
Using the scanner on the D45, scan your ID badge into the system to unlock the door.
Step 6: Sanitize Your Hands
Hand hygiene is an important component of the D45 process.
Step 7: Disinfection Complete
Remove the disinfected equipment from the D45. It is now ready for use.
The Green Standard
Cleaner. Greener. Leaner.The Green Standard promotes sustainability in healthcare infection prevention by providing a framework for incorporating UV-C disinfection devices efficiently into healthcare processes while prioritizing patient safety, sustainability and workflow efficiency.