Continuous Environmental Disinfection for Surgical Suites · Continuous Environmental Disinfection for Surgical Suites ... disinfection technology, uses visible light ... Peak germicidal

Continuous Environmental Disinfection for Surgical Suites

Designed and manufactured in the USA

Indigo-Clean Installation, Henderson Hospital, Las Vegas, NV

3 .................................................What is Indigo-Clean? 4 .................................................How Does It Work? 5 .................................................What Does Indigo-Clean Kill? 6-7 .............................................Is Indigo-Clean Proven? 9 .................................................Product Configurations 10-11 .........................................Product Functionality and Performance 12 ...............................................Performance Data and Safety 14 ...............................................Kenall Strathclyde Partnership 15 ...............................................Listings, Certifications, Warranty

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.

Indigo-Clean™2

3Indigo-Clean™

The Kenall product shown on this page is designed and manufactured in the USA with components purchased from US suppliers, and meets the Buy American requirements under the ARRA. Kenall has not determined the origin of its domestically purchased components or the subcomponents thereof.

www. kenall.com P: 800-4-Kenall Email: [email protected] 10200 55th Street Kenosha, WI 53144

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? • Indigo-Clean is an environmental disinfection device that is

integrated into your lighting

• 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

• Does not require consumables

• Can be fully automated when used with recommended Indigo-Clean IC100 Controls

White disinfection mode provides ambient lighting and continuous environmental disinfection while room is 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

4 Indigo-Clean™



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)

5Indigo-Clean™



Non-Exposed

Exposed to Indigo-Clean™

ESKAPE Pathogens:E nterococcus faecalisS taphylococcal Aureus (incl. MRSA)1

K lebsiella pneumoniaeA cinetobacter baumanniiP seudomonas aeruginosaE nterobacter species

As well as a range of other organisms:• C-diff1

• VRE• Aspergillus niger• E.coli• Salmonella enteritidis

Clinical testing has shown Indigo-Clean can achieve a continuous 70%+ reduction of harmful bacteria2 in the environment. At the same time, recently published studies show that improved cleaning can reduce HAI rates for certain organisms.3

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

te90

80

70

60

50

40

30

20

10

0

82.7

71.2

31.5

70% bacterial reductionBefore After

1: Antimicrobial Activity of a Continuous Visable Light Disinfection System by Rutala, et. al, ID Week 2016

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: 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?

+

6 Indigo-Clean™



“Although we knew the Indigo-Clean™ lights would give us substantial results given the thorough research and studies done on the lights at medical centers across the nation, we were thrilled when our results were even greater than we anticipated.”

- Lynnelle Murrell, Director of Infection Prevention, Maury Regional

Indigo-Clean Lights Continually Reduce Bacteria 88% at Maury Regional Medical CenterUnique LED Technology Provides a Safer, Cleaner Operating Room Environment by Continuously Reducing Harmful Bacteria

Project: Maury Regional Medical Center Location: Columbia, Tennessee

Indigo Disinfection Mode can be used when room is not in use

For the full case study, visit www.indigo-clean.com

7Indigo-Clean™



For the full case study, visit www.indigo-clean.com

“Maintaining a safe, clean environment for our patients is our number one priority. Indigo-Clean safely, automatically, and continuously disinfects the environment, which means there is no need for room downtime when it (the operating room) is in use.”

– Sam Kaufman CEO & Managing Director, Henderson Hospital

Henderson Hospital Installs Indigo-Clean Lighting in All of the Operating Rooms Unique Technology Keeps Patients Safe by Continuously Reducing Harmful Bacteria in the Environment

Project: Henderson Hospital, a ground-up new construction hospital Location: Las Vegas, NV

Indigo Disinfection Mode used when room is not in use

8 Indigo-Clean™



9Indigo-Clean™



M4SEDIC14 Switchable - White Disinfection Mode and Indigo Disinfection Mode Nominal Size 1'× 4' 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.

M4SEDIC22 Switchable - White Disinfection Mode and Indigo Disinfection Mode 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.

M4SEDIC24 Switchable - White Disinfection Mode and Indigo Disinfection Mode Nominal Size 2’×4’ 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.

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 to address 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

M4SEDIC14 White Disinfection Mode



M4SEDIC14 Indigo Disinfection Mode



10 Indigo-Clean™



Two Operating Modes and Proprietary Controls Make Indigo-Clean Simple to Use

White Disinfection Mode

Provides comfort and visual acuity. Use

during procedures and cleaning. Ambient

white light + indigo for continuous

environmental disinfection.

Indigo Disinfection Mode

Typically used when room is not in use. Indigo disinfection mode provides

increased continuous environmental disinfection.

During periods of occupancy, this IC100 control system is designed to set the Indigo-Clean fixtures into White Disinfection Mode, which provides comfortable white light, yet maintains a

level of continuous disinfection to harmful bacteria. After the room has been unoccupied for a time, the control system will set the Indigo-Clean luminaires to Indigo Disinfection Mode, which provides maximum disinfection to harmful bacteria.

11Indigo-Clean™



High Quality, High PerformanceIndigo-Clean (MedMaster™ 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

Compact 4" depth housing design allows for reduced plenum intrusion

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

*Patents Pending

12 Indigo-Clean™



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

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

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 SafetyM4SEDIC SERIES – White and Disinfection LED

Size Mode Lamp Code Delivered

Lumens (lm)

Input Power

(W)

Color RenderingTM-30 Color

Quality Est. L70 LED Life (Hrs)

Ra R9 Rf Rg

2'×4' White Disinfection Mode

150I/100L-37K8 11,760 154 84 27 74 102

125,000150I/100L-37K9 9,895 146 95 83 86 105

150I/100L-43K8 12,391 162 84 26 78 100

150I/100L-43K9 10,076 146 95 92 88 104

Indigo Disinfection Mode All - 165 - - - - 50,000

2'×2'White Disinfection Mode

75I/50L-37K8 5,514 77 84 27 74 102

125,00075I/50L-37K9 4,639 73 95 83 86 105

75I/50L-43K8 5,809 81 84 26 78 100

75I/50L-43K9 4,724 73 95 92 88 104


1'×4'White Disinfection Mode

75I/50L-37K8 5,660 77 84 27 74 102

125,00075I/50L-37K9 4,763 73 95 83 86 105

75I/50L-43K8 5,964 81 84 26 78 100

75I/50L-43K9 4,850 73 95 92 88 104


Information subject to change without notice. TM-30 Color Vector Graphic available upon request. Visit www.kenall.com for .ies files and additional information.

13Indigo-Clean™



IESRecommended FC

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

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 LayoutCreate High Visual Acuity while Disinfecting the Environment

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

14 Indigo-Clean™



Kenall Partners with the University of Strathclyde to Create Indigo-CleanKenall 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.

History of Academic Research and Investment in Visible Light Disinfection

2002 2004 2006 2008 2010 2012 2014

2003 2005 2007 2009 2011 2013 2015 2017

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 Clinical evaluations

started at Glasgow Royal Infirmary

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.”

2017 Kenall expands product line

2015 Indigo-Clean Commercially

Available

2016 Kenall’s First Operating Room Installation

15Indigo-Clean™



461FMIL STD

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 power system 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.

LED 5-year Warranty POWER SYSTEM

10200 55th Street Kenosha, WI 53144 Tel: 262-891-9700 www.kenall.com

©2017 Kenall Mfg. ̄̄Co. All rights reserved. L10077-052417

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Continuous Environmental Disinfection for Surgical Suites · Continuous Environmental Disinfection for Surgical Suites ... disinfection technology, uses visible light ... Peak germicidal