continuous environmental disinfection for surgical...

Continuous Environmental Disinfection for Surgical Suites

Don’t Just Clean... Indigo-Clean™

Designed and manufactured in the USA

2TM

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 ConfigurationsPage 8 ....................... High Quality, High PerformancePage 9 ....................... Performance Data and SafetyPage 10 ..................... Typical Lighting Layout for the Operating RoomPage 11 ..................... Listings, Certifications, Warranty

3TM

Indigo-Clean is a light fixture that installs easily into the ceiling providing excellent overhead lighting and

continuous disinfection

The Problem: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.

The Solution:Indigo-Clean offers a solution that continuously disinfects the environment and bolsters your current infection prevention efforts.

The healthcare environment is a reservoir for pathogens. Indigo-Clean breaks the chain of infection between the environment and an unsuspecting host.

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.


What Makes Indigo-Clean Unique?

• 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: [email protected] | www.indigo-clean.com

White disinfection mode provides ambient lighting and continuous environmental disinfection while occupied

Indigo disinfection mode can be selected to provide maximum continuous disinfection when room is not in use

What is Indigo-Clean?

Break the Chain of Infection by Raising Your Standard of Clean

4TM

Visible light spectrum showing the active element in Indigo-Clean™

Creates ROS

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.

405 nanometers: Peak germicidal activity via photoexcitation of porphryin molecules

Peroxide

Hydrogen Peroxide Hydroxyl ionHydroxyl radical

Oxygen Superoxide anion

O2 O2- O2

2-

H

OH-O2H2

HHH

OH.

Inactivation of bacteria via visable light absorption

Porphyrin

405nm

Bacteria Cell

Inactivated Bacteria Cell

How Does Indigo-Clean Work?


*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.

VISIBLE LIGHT SAFETY ZONEULTRAVIOLET

WAVELENGTH (NM) TM

Typical UV-C germicidal wavelength

254

Indigo-Clean germicidal wavelength (405nm)

5TM

Non-Exposed

Exposedto Indigo-Clean™

ESKAPE Pathogens:• Enterococcus faecalis • Staphylococcal Aureus (including MRSA)1

• Klebsiella pneumoniae

• Acinetobacter baumannii

• Pseudomonas aeruginosa

• Enterobacter species

As well as a range of other organisms:• Aspergillus niger

• E.coli

• Salmonella enteritidis1Maclean 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)

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

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.

Continuously Reduce Overall Bioburden by 70%+ with Indigo-Clean™

Laboratory bacterial reduction after 24 hours

Whole-room Results

ContinuousIndigo-Clean

EpisodicSystems

Killi

ng A

ctiv

ity

Elapsed TimePre- Visible

Light DisinfectionPost-

Leas

t Squ

are

Mea

ns fo

r CFU

/pla

te

90

80

70

60

50

40

30

20

10

0

82.7

71.2

31.5

70% bacterial reductionBefore After

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

What Does Indigo-Clean Kill?

10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: [email protected] | www.indigo-clean.com10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: [email protected] | www.indigo-clean.com

+

6TM

Indigo Disinfection Solution (foreground), White Disinfection Solution (background); Waiting Room, Froedtert & the Medical

College of Wisconsin at 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.

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:

Indigo-CleanTM Clinical Partnership Results: Proven Technology Featured at The Medical College of Wisconsin, Froedtert Hospital

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.

Kenall Partners with the University of Strathclyde to Create Indigo-Clean

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.”

Is Indigo-Clean Proven?

History of Academic Research and Investment in Visible Light Disinfection


2002 2004 2006 2008 2010 2012 2014

2003 2005 2007 2009 2011 2013

Investment in ROLEST from the Robertson Trust, University of Strathclyde

Scottish Enterprise Proof of Concept Funding

Research Funding for other Decontamination Applications

NHS Research / Medical Charity Funding

Indigo-Clean Commercially Available

Clinical evaluations started at Glasgow Royal Infirmary

7TM

Nominal Size 2'×2' Installation Types Grid, Flange Lamp Types White LED and Indigo LED Standard Listings Wet Locations, IP65, NSF2 MIL STD 461F Est. LED Life 125,000 Hrs.



M4SEDIC14

Switchable - White Disinfection Mode and Indigo Disinfection Mode

M4SEDIC22


M4SEDIC24



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

• 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

Indigo-Clean can be operated in two different modes:

White Disinfection Mode Indigo Disinfection ModeProvides comfort and visual acuity. Use during procedures and cleaning.

Typically used when room is not in use

Ambient white light + indigo for continuous environmental disinfection

Indigo disinfection mode for increased continuous environmental disinfection

Switching: Manual

via wall switch (consult factory for wiring diagram)

or

Automatic via control solution

(consult factory)

Applications and Configurations

8TM

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.

Flexibility with Universal Grid/Flange Installation

High Quality, High Performance


*Patents Pending

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

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

Inset door provides a flush mount to the ceiling

Compact 4" depth housing design allows for reduced plenum intrusion

Indigo-Clean (MedMasterTM M4SEDIC*)

9TM

Size Mode Lamp Code Delivered Lumens (lm)

Input Power

(W)

Color Rendering TM-30 Color Quality Est. L70 LED Life (Hrs)

Ra R9 Rf Rg

2'×4'

White Disinfection Mode

150I/100L- 40K8 12,933 177 85 29 72 102

125,000150I/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

Indigo Disinfection Mode

- - 165 - - - - -

2'×2'


75I/50L- 40K8 6,467 89 85 29 72 102

125,00075I/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 - - - - -

1'×4'


75I/50L- 40K8 6,467 89 84 33 72 102

125,00075I/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 - - - - -

Irrad

ianc

e (W

/m2 )

Wavelength (nm)

360 410 460 510 560 610 660 710 760 0.000

0.002

0.004

0.006

0.008

0.010

0.012

0.014

0.016

0.018

0.020

D65 Daylight Spectrum CCT=6500K

Comparison of Indigo-Clean with Daylight

Source

Safety Testing Indigo-Clean has been evaluated against existing visible light safety standards.

Standard Testing Method Results

IEC 62471/627781,2 Independent 3rd Party Laboratory Pass (Exempt)

ACGIH3 Self-Assessment Pass

ICNIRP4,5 Self-Assessment Pass

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

Performance Data and Safety

10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: [email protected] | www.indigo-clean.com 10200 55th Street | Kenosha, Wisconsin 53144 | P: 1-262-891-9200 | E: [email protected] | www.indigo-clean.com

*Patents Pending

The safe, visible, disinfecting light from Indigo-Clean is similar to daylight.

10TM


IESRecommended FC

Zone 1 200–300Zone 2 100–125Zone 3 40–60


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

Indigo-Clean™ Lighting LayoutCurrent Lighting Layout

M4SEDIC – 100W LED (10 – 2'×4') Catalog No. M4SEDIC-24-150I/100L-40K8-DCC-277V-2F-2H-SYM

M2 – Fluorescent Lamp (6) F32T8 (10-2’×4’) Catalog No. M2SEFI24-632-EB-2-120-PAF-2H-MLP-1

M4 – 100W LED (10 – 2'×4') Catalog No. M4SEDI24-100L40K-DCC-DV-2F-2H-SYM

1:1 Replacement

Average Illuminance

System Power Consumption 1890W

ZONE 1 ZONE 2 ZONE 3

270 fc 209 fc 61 fc

Average Illuminance

System Power Consumption 1150W


317 fc 232 fc 84 fc

Average Illuminance

System Power Consumption:


360 fc 263 fc 96 fc

~or~

- White Disinfection Mode 1750W- Indigo Disinfection Mode 1650W

368 370 367

357 352 357

358 351 357

360 354 360

366 361 365

258 315 339 330 287

306 363 380 374 338

326 371 375 375 353

307 365 382 376 339

254 311 336 327 284

322 349

327 350

324 345

325 346

330 353

137 185 225 246 237 205 157 112

135 181 220 239 232 200 154 110

183

218

233

242

242

243

243

235

218

181

144

170

185

191

193

193

192

186

171

143

48 61 81 109 139 160 165 150 123 93 68 52 41

57 73 105

66 88 134

73 99 155

78 107 167

82 110 172

82 112 172

82 110 172

78 107 168

73 99 155

66 87 133

57 73 103

85 61 49

105 71 55

121 79 61

129 84 64

133 87 67

136 89 68

134 87 67

130 85 65

121 79 61

104 70 55

84 60 49

48 60 80 107 135 155 160 146 120 91 67 51 42

290 286 289

275 266 275

270 260 269

270 264 270

279 273 279

203 252 265 261 229

242 290 286 289 273

254 299 298 298 281

243 296 306 303 275

200 249 262 257 226

252 279

251 273

247 269

250 269

251 274

100 141 174 186 181 159 118 77

97 138 169 181 176 155 116 76

138

166

176

180

178

180

181

178

166

137

102

120

129

133

132

133

132

129

120

101

31 38 53 76 100 112 114 107 87 63 44 33 28

37 47 71

42 57 92

46 64 106

49 68 113

51 69 115

51 70 115

51 70 115

49 68 113

46 64 106

42 56 91

36 46 70

56 38 32

70 44 37

79 48 41

85 52 43

86 53 44

86 53 45

86 53 44

84 52 43

80 49 41

70 44 37

55 38 32

31 38 52 74 96 108 110 104 85 62 43 32 27

324 326 323

315 310 315

315 309 314

317 312 317

322 318 321

227 277 299 291 253

269 320 335 329 298

287 326 331 330 311

270 321 337 331 299

224 274 296 288 250

283 308

288 308

285 303

286 305

291 311

121 163 198 216 209 180 138 98

119 159 194 211 204 176 136 97

161

192

205

213

213

214

214

207

192

160

127

150

163

169

170

170

169

164

150

126

42 53 71 96 122 141 145 132 108 82 60 45 37

51 64 92

58 77 118

65 87 137

69 94 147

72 97 151

73 99 152

72 97 152

69 94 148

64 87 137

58 77 117

50 64 91

75 53 43

92 62 49

106 69 53

114 74 57

117 77 59

120 79 60

118 77 59

114 74 57

106 70 54

92 62 49

74 53 43

42 53 70 94 119 137 141 129 106 81 59 45 37

Typical Operating Room Layout

625 Sq. Ft. 625 Sq. Ft. 625 Sq. Ft.

11TM

461FMIL STD


Calculations Based on: 26'× 25' Area, 9' Ceiling Height, 90/60/20 Room Reflectance, .80 LLF Fluorescent, .90 LLF LED

Listings & CertificationsFixtures 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.

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.

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.

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 EMI-related 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.

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.

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.

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.”

IP65OPTION

C

ISO 5Class 100

ADA

WarrantiesOn 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.

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