Indigo-Clean
Transcription
Indigo-Clean
Continuous Environmental Disinfection for Surgical Suites Don’t Just Clean... Indigo-Clean™ Designed and manufactured in the USA TM A Revolutionary New Technology to Continuously Disinfect the Environment Indigo-Clean, a continuous disinfection technology, is patented and proven to kill harmful bacteria linked to hospital acquired infections (HAIs). Using a combination of 405nm Indigo and White LEDs, Indigo-Clean emits narrow spectrum light that kills bacteria while providing ambient illumination for the space. Unlike UV light, Indigo-Clean uses safe, visible light to automatically and continuously kill harmful bacteria in the air, and on hard and soft surfaces. Page 3 ....................... What is Indigo-Clean? Page 4 ....................... How Does It Work? Page 5 ....................... What Does Indigo-Clean Kill? Page 6 ....................... Is Indigo-Clean Proven? Page 7 ....................... Applications and Configurations Page 8 ....................... High Quality, High Performance Page 9 ....................... Performance Data and Safety Page 10 ..................... Typical Lighting Layout for the Operating Room Page 11 ..................... Listings, Certifications, Warranty 2 What is Indigo-Clean? TM The Problem: The Solution: Current environmental disinfection methods are applied at discrete moments in time (i.e. episodically). The results of achieving a "clean room" are short-lived as harmful bacteria re-populate the space. Indigo-Clean offers a solution that continuously disinfects the environment and bolsters your current infection prevention efforts. Break the Chain of Infection by Raising Your Standard of Clean The healthcare environment is a reservoir for pathogens. Indigo-Clean breaks the chain of infection between the environment and an unsuspecting host. White disinfection mode provides ambient lighting and continuous environmental disinfection while occupied Indigo-Clean, a patented continuous environmental disinfection technology, uses visible light to safely, automatically and continuously kill harmful bacteria, 24/7, in the air and on hard and soft surfaces. Indigo-Clean bolsters current infection prevention methods and is proven to kill a wide range of harmful bacteria. Don’t Just Clean... Indigo-Clean™ Indigo disinfection mode can be selected to provide maximum continuous disinfection when room is not in use What Makes Indigo-Clean Unique? Indigo-Clean is a light fixture that installs easily into the ceiling providing excellent overhead lighting and continuous disinfection • Continuous environmental disinfection kills bacteria missed during routine cleaning • Indigo-Clean is NOT UV light... it uses safe 405nm visible light • Automatically kills bacteria reducing risk of human error • Kills bacteria in the air, and on hard and soft surfaces • No special or additional training required • Light is safe for patients and caregivers • Products can be applied to balance cost effectiveness and visual preference for your application • Different modes are used to increase disinfection 10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: indigo-clean@kenall.com | www.indigo-clean.com 3 How Does Indigo-Clean Work? TM How It Works*: • The 405nm emitted from Indigo-Clean reflects off of walls and surfaces, penetrating harmful micro-organisms • The 405nm light targets and excites naturally occurring molecules within the bacteria called porphyrins, to produce intra-cellular Reactive Oxygen Species (ROS). • Similar to bleach, these ROS create an oxidative environment within the organism, inactivating it and preventing it from re-populating the space. Creates ROS Visible light spectrum showing the active element in Indigo-Clean™ 405nm Oxygen Superoxide anion O2- O2 ULTRAVIOLET VISIBLE LIGHT SAFETY ZONE H Indigo-Clean germicidal wavelength (405nm) Typical UV-C germicidal wavelength H H Hydrogen Peroxide Hydroxyl radical H2O2 .OH Peroxide O2-2 H Hydroxyl ion OH- Bacteria Cell 254 WAVELENGTH (NM) 405 nanometers: Peak germicidal activity via photoexcitation of porphryin molecules TM Porphyrin Inactivated Bacteria Cell Inactivation of bacteria via visable light absorption *Indigo-Clean products and technology covered by U.S. Patent No. US 9,039,966 and US 8,398,264. May also be covered by patents found at www.kenall.com/patents. Other patents pending. 10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: indigo-clean@kenall.com | www.indigo-clean.com 4 What Does Indigo-Clean Kill? Non-Exposed Exposed to Indigo-Clean™ TM ESKAPE Pathogens: As well as a range of other organisms: • Enterococcus faecalis • Staphylococcal Aureus (including MRSA)1 • Klebsiella pneumoniae • Acinetobacter baumannii • Pseudomonas aeruginosa • Enterobacter species • Aspergillus niger •E.coli • Salmonella enteritidis 1 Maclean M., et. al. Environmental decontamination of a hospital isolation room using high-intensity narrow-spectrum light, J. Hosp. Infection Vol. 76, pp. 247-251 (2010) Continuously Reduce Overall Bioburden by 70%+ with Indigo-Clean™ Episodic Systems Continuous Indigo-Clean Elapsed Time Before After Least Square Means for CFU/plate Killing Activity Whole-room Results 90 82.7 80 71.2 70 60 50 40 31.5 30 20 10 + 70% bacterial reduction 0 Laboratory bacterial reduction after 24 hours Clinical testing has shown Indigo-Clean can achieve a continuous 70+ percent reduction of harmful bacteria in the environment. At the same time, recently published studies show that improved cleaning can reduce HAI rates for certain organisms.1 Pre- Visible PostLight Disinfection These results, combined with the additional cost per patient due to HAI, suggest that preventing even a single infection would create a positive ROI and drive down costs for healthcare providers. 1: Alfa MJ et. al. “Use of a daily disinfectant cleaner instead of a daily cleaner reduced hospital-acquired infection rates”, Am J Infect Control 2015;43:141-146 10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: indigo-clean@kenall.com | www.indigo-clean.com 5 Is Indigo-Clean Proven? TM Indigo-CleanTM Clinical Partnership Results: Proven Technology Featured at The Medical College of Wisconsin, Froedtert Hospital Indigo-Clean is currently being evaluated by several institutions across the U.S. including Froedtert & the Medical College of Wisconsin Froedtert Hospital in Milwaukee, WI. Recently completed studies at the Hospital involved a 450 sq.ft. waiting area in the Gastroenterology (GI) Diagnostic clinic. This allowed the team to evaluate the level of disinfection across a large, clinically relevant area that was difficult to keep continuously clean due to the large number of patients entering and exiting over the course of the day. The results from this study showed a 70%+ continuous reduction of S. aureus throughout the area and were consistent with those from the University of Strathclyde conducted at the Glasgow Royal Infirmary (Glasgow, Scotland).2,3,4 “In this phase of the trial where the lighting deployment was optimized across the room, we were able to improve the bioburden reduction to more than 70%,” said Dr. Nathan Ledeboer, Associate Professor of Pathology at the Medical College of Wisconsin. Indigo Disinfection Solution (foreground), White Disinfection Solution (background); Waiting Room, Froedtert & the Medical College of Wisconsin at Froedtert Hospital 2: Maclean M., S.J. MacGregor, J.G. Anderson, G.A. Woolsey, J.E. Coia, K. Hamilton, I. Taggart, S.B. Watson, B. Thakker & G. Gettinby (2010). Environmental Decontamination of a Hospital Isolation Room using High-Intensity Narrow-Spectrum Light. Journal of Hospital Infection, 76(3); 247-251. DOI: 10.1016/j.jhin.2010.07.010 3: Bache S.E., M. Maclean, S.J. MacGregor, J.G. Anderson, G. Gettinby, J.E. Coia & I. Taggart (2012). Clinical studies of the High-Intensity Narrow-Spectrum light Environmental Decontamination System (HINS-light EDS), for continuous disinfection in the burn unit inpatient and outpatient settings. Burns, 38: 69-76. DOI:10.1016/j.burns.2011.03.008 4: Maclean M., M. Booth, S.J. MacGregor, J.G. Anderson, G.A. Woolsey, J.E. Coia, K. Hamilton & G. Gettinby (2013). Continuous decontamination of an intensive care isolation room during patient occupancy using 405nm light technology. Journal of Infection Prevention, 14(5); 176-181. DOI: Kenall Partners with the University of Strathclyde to Create Indigo-Clean Kenall proudly partners with the University of Strathclyde’s Robertson Trust Laboratory for Electronic Sterilisation Technologies (ROLEST) to create Indigo-Clean. This technology is a part of the university’s long history of disinfection science dating back to the 1800’s. Kenall has the exclusive North American patent rights to create Narrow Spectrum (HINS) lights proven to kill a wide range of bacteria that are linked to HAI’s. Professor Scott MacGregor, Vice-Principal at Strathclyde, developed the HINS-light technology with fellow Strathclyde researchers Professor John Anderson, Dr. Michelle Maclean and Professor Gerry Woolsey. Professor MacGregor said, “Our partnership with Kenall in the United States is an exciting new chapter which will see this innovative technology become a commercially available product. We chose Kenall because of their extensive experience in providing lighting for the most challenging healthcare environments where infection prevention is a key consideration.” History of Academic Research and Investment in Visible Light Disinfection Investment in ROLEST from the Robertson Trust, University of Strathclyde Scottish Enterprise Proof of Concept Funding 2002 2004 2003 2006 2005 NHS Research / Medical Charity Funding 2008 2007 Research Funding for other Decontamination Applications 2010 2009 2012 2011 2014 Indigo-Clean Commercially Available 2013 Clinical evaluations started at Glasgow Royal Infirmary 10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: indigo-clean@kenall.com | www.indigo-clean.com 6 Applications and Configurations TM Indigo-Clean can be operated in two different modes: White Disinfection Mode Indigo Disinfection Mode Provides comfort and visual acuity. Use during procedures and cleaning. Typically used when room is not in use Switching: Manual via wall switch (consult factory for wiring diagram) or Automatic via control solution (consult factory) Ambient white light + indigo for continuous environmental disinfection Indigo disinfection mode for increased continuous environmental disinfection Indigo-Clean (MedMaster M4SEDIC) supports the surgical team, the patient and the surgical suite’s critical environment: • Continuous environmental disinfection • Sealed for infection prevention • IP65 listed per IEC 60598 ensures ingress protection against dust and water • NSF2 listing supports ease of cleanability • Antimicrobial finish M4SEDIC14 Switchable - White Disinfection Mode and Indigo Disinfection Mode Nominal Size Installation Types Lamp Types Standard Listings Est. LED Life 1'×4' Grid, Flange White LED and Indigo LED Wet Locations, IP65, NSF2 MIL STD 461F 125,000 Hrs. • Certified to MIL STD 461F addresses EMI/RFI issues • High performance LED delivers high visual acuity • Universal grid-flange mounting provides field installation flexibility • Lens uniformity reduces glare • Standard dimming offers flexible light levels M4SEDIC22 Switchable - White Disinfection Mode and Indigo Disinfection Mode Nominal Size Installation Types Lamp Types Standard Listings Est. LED Life 2'×2' Grid, Flange White LED and Indigo LED Wet Locations, IP65, NSF2 MIL STD 461F 125,000 Hrs. M4SEDIC24 Switchable - White Disinfection Mode and Indigo Disinfection Mode Nominal Size Installation Types Lamp Types Standard Listings Est. LED Life 2'×4' Grid, Flange White LED and Indigo LED Wet Locations, IP65, NSF2 MIL STD 461F 125,000 Hrs. 10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: indigo-clean@kenall.com | www.indigo-clean.com 7 High Quality, High Performance TM Indigo-Clean (MedMasterTM M4SEDIC*) The MedMaster M4SEDIC is a top rated luminaire that delivers superior lumen and color maintenance over time and addresses the current demands for infection prevention, functional reliability and sensitivity to surrounding medical equipment. From concept to completion, every element of the MedMaster M4SEDIC LED luminaire has been carefully engineered to present the ideal solution for today’s surgical suite. Sealed Housing • One-piece, seam welded housing construction • Smooth exterior with gasketed doorframe for cleanability • Universal housing for both flange and grid installation • Antimicrobial finish • Grounded wireway reduces radiated emissions Internal Components • Dual Stage Power Factor Correction Driver eliminates flicker • Standard 0-10V Dimming • Proprietary mode controller with low voltage input LED Module Array with Indigo-Clean Technology • Serviceable white LED array • High quality ceramic composite mid-power LEDs and high-power 405nm Indigo LEDs • 80 and 90 CRI Lens Door/Frame • Diffused, high-efficiency lens for reduced glare and uniformity • Smooth exterior doorframe is sealed and gasketed to support infection prevention Flexibility with Universal Grid/Flange Installation Flange mounting applications use four adjustable swing-out brackets for fast installation, and ensures a tight seal to the ceiling surface Fully sealed housing with closed cell gasketing ensures ingress protection against contaminants. The luminaire is ETL Certified IP65 per IEC 60598 Compact 4" depth housing design allows for reduced plenum intrusion Inset door provides a flush mount to the ceiling *Patents Pending 10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: indigo-clean@kenall.com | www.indigo-clean.com 8 Performance Data and Safety Size 2'×4' Mode White Disinfection Mode White Disinfection Mode 1'×4' 102 150I/100L- 40K9 11,211 175 92 90 76 108 150I/100L- 50K8 13,974 199 84 34 69 102 150I/100L- 50K9 11,622 171 92 96 78 107 - - 165 - - - - 75I/50L- 40K8 6,467 89 85 29 72 102 75I/50L- 40K9 5,606 88 92 90 76 108 75I/50L- 50K8 6,987 100 84 34 69 102 75I/50L- 50K9 5,811 86 92 96 78 107 - - 83 - - - - 75I/50L- 40K8 6,467 89 84 33 72 102 75I/50L- 40K9 5,606 88 92 90 76 108 75I/50L- 50K8 6,987 100 84 34 69 102 75I/50L- 50K9 5,811 86 92 96 78 107 - - 83 - - - - 0.008 0.006 0.004 0.002 0.000 660 Source 710 760 Irradiance (W/m 2) 0.014 0.010 610 125,000 - 125,000 - 125,000 - Indigo-Clean has been evaluated against existing visible light safety standards. 0.016 0.012 Wavelength (nm) Est. L70 LED Life (Hrs) Safety Testing The safe, visible, disinfecting light from Indigo-Clean is similar to daylight. 560 Rg 72 0.018 510 Rf 29 0.020 460 R9 85 Comparison of Indigo-Clean with Daylight 410 Ra TM-30 Color Quality 177 Indigo Disinfection Mode 360 Color Rendering 12,933 Indigo Disinfection Mode White Disinfection Mode Input Power (W) 150I/100L- 40K8 Indigo Disinfection Mode 2'×2' Delivered Lumens (lm) Lamp Code TM Standard Testing Method Results IEC 62471/627781,2 Independent 3rd Party Laboratory Pass (Exempt) 3 Self-Assessment Pass 4,5 Self-Assessment Pass ACGIH ICNIRP 1: International Electrotechnical Commission – Photobiological safety of lamps and lamp systems, 2006 2: International Electrotechnical Commission – Application of IEC 62471 for the assessment of blue light hazard to light sources and luminaires, 2014 3: American Conference of Governmental Industrial Hygienists – Threshold Limit Values (TLVs) & Biological Exposure Indicies Signature Publications, Cincinnati, 2007 4: International Commission on Non-Ionizing Radiation Protection – Guidelines on limits of exposure to optical radiation from 0.38 to 3.9 mm. Health Physics 73; 539-555; 1997 5: International Commission on Non-Ionizing Radiation Protection – Guidelines on limits of exposure to ultraviolet radiation of wavelengths between 180 nm and 400 nm (incoherent radiation) Health Physics 87, 171-186; 2004 D65 Daylight Spectrum CCT=6500K 10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: indigo-clean@kenall.com | www.indigo-clean.com 9 Typical Operating Room Layout TM 10 Create High Visual Acuity while Disinfecting the Environment Calculations Based on: 26'× 25' Area, 9' Ceiling Height, 90/60/20 Room Reflectance, .80 LLF Fluorescent, .90 LLF LED IES Recommended FC 200–300 100–125 40–60 Zone 1 Zone 2 Zone 3 Indigo-Clean™ Lighting Layout Current Lighting Layout M2 – Fluorescent Lamp (6) F32T8 (10-2’×4’) ~or~ Catalog No. M2SEFI24-632-EB-2-120-PAF-2H-MLP-1 31 38 53 37 47 71 100 42 57 92 138 203 252 265 261 46 64 106 166 242 290 286 289 49 68 113 176 252 290 286 289 115 180 251 275 266 178 247 270 180 250 181 251 51 51 69 70 115 51 70 115 49 68 113 46 64 106 42 56 91 36 46 70 31 38 52 76 100 112 141 174 178 114 44 33 28 42 53 71 77 56 38 32 51 64 92 121 229 102 70 44 37 58 77 118 161 227 277 299 291 273 120 79 48 41 65 87 137 192 269 320 335 329 279 129 85 52 43 69 94 147 205 283 324 326 323 275 273 133 86 53 44 151 213 288 315 310 260 269 269 132 86 53 45 213 285 315 270 264 270 269 133 214 286 279 273 279 274 132 214 291 186 107 181 87 159 63 118 254 299 298 298 281 243 296 306 303 275 200 249 262 257 226 73 97 99 152 86 53 44 72 97 152 84 52 43 69 94 148 80 49 41 64 87 137 70 44 37 58 77 117 55 38 32 50 64 91 138 169 181 108 110 176 155 104 85 116 76 62 27 42 53 70 122 141 163 198 145 132 60 45 37 48 61 81 75 53 43 57 73 105 137 253 127 92 62 49 66 88 134 183 258 315 339 330 298 150 106 69 53 73 99 155 218 306 363 380 374 308 163 114 74 57 78 107 167 233 322 368 370 367 315 308 169 117 77 59 172 242 327 357 352 309 314 303 170 120 79 60 242 324 358 351 317 312 317 305 170 243 325 360 322 318 321 311 169 243 330 366 235 326 371 375 375 353 307 365 382 376 339 254 311 336 327 284 209 108 180 82 138 287 326 331 330 311 270 321 337 331 299 224 274 296 288 250 32 625 Sq. Ft. 119 94 1:1 Replacement 82 82 110 112 109 172 118 77 59 82 110 172 114 74 57 78 107 168 106 70 54 73 99 155 92 62 49 66 87 133 74 53 43 57 73 103 37 48 60 80 164 150 159 194 211 119 137 141 204 129 176 106 136 97 81 139 160 185 225 150 68 52 41 112 85 61 49 287 144 105 71 55 338 170 121 79 61 349 185 129 84 64 357 350 191 133 87 67 357 345 193 136 89 68 354 360 346 193 134 87 67 361 365 353 192 130 85 65 121 79 61 104 70 55 84 60 237 123 205 93 157 186 171 143 181 59 45 135 107 181 220 239 135 155 160 625 Sq. Ft. Average Illuminance 165 246 218 126 160 43 M4SEDIC – 100W LED (10 – 2'× 4') Catalog No. M4SEDIC-24-150I/100L-40K8-DCC-277V-2F-2H-SYM 98 216 192 101 96 96 207 120 137 97 72 129 166 74 M4 – 100W LED (10 – 2'× 4') Catalog No. M4SEDI24-100L40K-DCC-DV-2F-2H-SYM 232 200 146 120 154 110 91 67 625 Sq. Ft. Average Illuminance Average Illuminance ZONE 1 ZONE 2 ZONE 3 ZONE 1 ZONE 2 ZONE 3 ZONE 1 ZONE 2 ZONE 3 270 fc 209 fc 61 fc 317 fc 232 fc 84 fc 360 fc 263 fc 96 fc System Power Consumption 1890W 51 System Power Consumption 1150W System Power Consumption: - White Disinfection Mode 1750W - Indigo Disinfection Mode 1650W 10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: indigo-clean@kenall.com | www.indigo-clean.com 49 42 TM Listings & Certifications 11 Fixtures designed for use in healthcare applications must satisfy a large number of demanding lighting and environmental requirements. Applicable listings are shown below. For the most up-to-date information, please refer to individual product specification sheets at www.kenall.com. IP65 OPTION MIL STD 461F ISO 5 Class 100 NSF2— An NSF2 Listing denotes that the luminaire has been evaluated for corrosion resistance, cleanability and the ability of exposed material to withstand normal wear. This supports the infection control standards established by healthcare facilities as it indicates that the luminaire is easy to sanitize. UL/CUL Listed—The UL symbol signifies that Underwriter’s Laboratory (UL) has determined that a manufacturer has demonstrated the ability to produce a product complying with UL’s requirements with respect to specific risk, performance under specific conditions, compliance with regulatory codes and specified standards, or any other conditions as determined by UL. IP65— UL Certified IP65 per IEC 60598 ensures that the enclosure is dust-tight and protected against jet streams of water from any direction without any harmful effects. ETL—A product bearing the ETL Listed Mark is determined to have met the minimum requirements of prescribed product safety standards as certified by a Nationally Recognized Testing Laboratory (NTRL). The mark also indicates that the manufacturer's production site conforms to a range of compliance measures and is subject to periodic follow-up inspections to verify continued conformance. MIL STD 461F— Military Standards testing measurements cover both radiated and conducted electromagnetic emissions in addition to maximum allowable amounts of emitted energy based on both frequency range and field strength. Luminaires meeting MIL STD 461F pose the lowest possible likelihood of causing EMIrelated issues. ISO 5— Suitable for ISO 5, Class 100 Rated Rooms (FED-STD 209E). Measures the number of particles equal to or greater than 0.5 mm in one cubic foot of air. The measurement must not exceed specified particle limits in order for the space to be considered a controlled ‘clean room’ environment. C ADA ADA Compliant—Although ADA is not specific to lighting, it does impact fixture design by creating standards for wall sconce projection space and hanging light clearance. Section 4.4 of the ADA states that ”objects projecting from walls with their leading edges between 27” and 80” above the finished floor shall protrude no more than 4” into walks, halls, corridors, passageways or aisles.” Warranties On behalf of our valued customers, Kenall promises to stand behind our medical-grade luminaires. Our commitment to excellence enables us to offer a variety of product warranties including the Kenall exclusive 5-year LED Warranty. LED 5-year Warranty Kenall’s LED products are warranted by Kenall to be free of defects in workmanship and materials for a period of one (1) year from the date of invoice. Kenall warrants LED lamps and internal power regulation components for a period of five (5) years from the date of invoice against defects in materials and workmanship that result in a fixture depreciation of 30% or greater. Lumen depreciation is compared to the published lumen output of the product on the date of manufacture per IESNA LM-79 reporting procedures. Normal accumulation of particulates on the optical surfaces shall not be factored into the lumen depreciation. Kenall reserves the right to issue credit, repair, or replace the defective merchandise, at its discretion, upon notification and confirmation by its local representative of the defect. Kenall also reserves the right to test and examine the defective product if the defect is questionable, and to deny the warranty herein for any product altered, improperly installed, or installed in applications for which it is not intended. This includes operation in ambient temperatures above stated limits for any length of time. Failure by electrical surge shall not be covered under warranty. Kenall assumes no responsibility for labor or freight costs incurred in connection with the installation, removal, or replacement of products determined to be defective or any other consequential or incidental damages arising from the use of the product. Kenall’s entire liability on any claim of loss or damage resulting from a defective product is limited to the replacement price of the product. 10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: indigo-clean@kenall.com | www.indigo-clean.com Don’t Just Clean... Indigo-Clean™ 10200 55th St. Kenosha, Wisconsin 53144 P: 1-262-891-9200 E: indigo-clean@kenall.com www.indigo-clean.com ©2016 Kenall Mfg. Co. All rights reserved. ¯¯ @GetIndigoClean