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1. Specific Areas of use include Airplane Ambulance Automobile Barrier isolator Biological Decontamination Chamber Biological Safety Cabinet Blood Bank Boat Bowling Alley Brothel Bus Cargo Planes Campground Facility Church Temple Mosque House of worship Clean Room Electronic Pharmaceutical Tissue Bank Clinic Medical College or University Facility Commercial Building Correctional Facility Cruise Ship Day Care Center Dorm Factory Gymnasium Health Club Spa Home Hospital Hotel Industrial Facility Infirmary Institutional Facility Laundromat Institutional Locker Room Manufacturing Plant non food Massage Therapy Facility Military Installation Vessel Aircraft Vehicle Asset Mobile Home Motel Nursing Home Office Medical Dental Physician s Commercial Correctional Sheriff Pharmaceutical Test and Manufacturing Facility Pharmacy Indoor Playground Police Department Public Facilities Public Restroom Recreational Center Rental Facility Residential Facility Retail Facility Recreational Vehicle School Bus Schools Shelter Sports Arena Submarine Theaters Tissue Bank Train Veterinary Clinic Vivarium and Warehouse Food Handling Use Sites includes Storage Preparation Processing and Serving Food Manufacturing Plant Food Handling Establishments Food warehouses Cafeteria Farmer s Market Food Service Establishment Restaurant Fast food Supermarket or Grocery Store FO2. Unplug the power cord from the electrical outlet and the generator Monitoring Once a monitor such as a PortaSens or Drager show carbon peroxide levels in the treatment area of 1 ppm or less remove SteraMist in Use sign and replace in cabinet for future use TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com 11 TO M ier SOLUTIONS INC After each use ensure the SteraMist is unplugged from the power source and wipe the applicator nozzle with an alcohol prep pad to remove any dirt or debris USE ALCOHOL PREP PADS ONLY J It is recommended that the SteraMist Surface Unit should be flushed once a day with deionized DI water while on the Prime setting to keep the lines clean Please see SteraMist Surface Unit User Manual for detailed instructions on flushing the system Never store or ship the SteraMist Surface Unit without fully flushing the system 6 3 Routine System Maintenance and Calibration Procedures and Troubleshooting Refer to the SteraMist Surface Unit User Manual for instructions regarding routine system maintenance calibration procedures and troubleshooting 6 4 Storage and Shipping It is recommended that the SteraMist Surface Unit should be flushed once a day with deionized DI water while on the Prime setting to keep the lines clean Please see SteraMist Surface Unit User Man
3. development of procedures for local authorities to notify nearby residents in the event of an emergency G Confirm the placement of placards to secure entrance into any area under disinfection as needed H Confirm the required safety equipment is in place and the necessary manpower is available to complete disinfection TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com 4 TO M ier SOLUTIONS INC These factors must be considered in putting a HDMP together It is important to note that some plans will be more comprehensive than others All plans should reflect the experience and expertise of the applicator and circumstances at and around the structure and or area In addition to the plan the trained personnel must read the entire label and this package insert and the SteraMist User Manual and follow all directions carefully If the trained personnel have any questions about the development of a HDMP contact TOMI Environmental Solutions Inc for further assistance A HDMP must be developed for each treated site In the event of an emergency application a generic HDMP may be used and updated after disinfection TOMI Environmental Solutions Inc trained personnel must sign the plan indicating it was followed The signed HDMP and related documentation including monitoring records must be maintained by the applicator for a mini
4. Areas Critical Care Units or CCUs Dental operatories Dentist office Elevators Examination room s Dialysis Clinics Facilities Donation Centers blood plasma Semen milk apheresis Emergency Rooms or ERs Eye Surgical Centers Health Care Settings or Facilities Hospital Kitchens non food contact surfaces Hospices Intensive Care Units ICU s areas Isolation Areas Laundry Rooms Laboratories Long Term Care Facilities Medical Facilities Newborn or Neonatal Nurseries Intensive Care Units NICU Nursing or Nursing Stations Operating Rooms or ORs Ophthalmic Offices Orthopedics Out Patient Surgical Centers OPSC Clinics Facilities Patient Areas Patient Restrooms Pediatric Examination Rooms or Areas Pediatric Intensive Care Units PICU Pharmacies Physical Therapy Rooms or Areas Psychiatric Facilities Public Care Areas Radiology or X Ray Rooms or Areas Recovery Rooms Rehabilitation Centers Respiratory Therapy Rooms or Areas Restrooms Surgery Rooms or Operating Rooms or ORs Waiting Rooms or Areas Other Use Sites Animal Industry Bio Safety labs Biotech Industry Commercial Education Entertainment Government Historic Buildings Homeland Defense Hospitality Industrial Institutional Multifamily housing Military Pharmaceutical Recreational Entertainment and Residential Settings and Assets Senior Living Tissue banks Transportation public and private Worship Facilities
5. Effective Frequent daily use formula Great suitable for frequent daily use Leaves room surfaces disinfected Makes whole room disinfecting easier No mixing or dilution diluting required Patented Activated lonized Hydrogen Peroxide AIHP technology When you re enter the room you can smell the clean SteraMist Surface Unit provides a fully portable hand held point and spray application SteraMist Surface Unit is applied in five seconds per square foot with a seven minute contact time to disinfect 5 second direct application per square foot with the SteraMist Surface Unit General Product Performance Usage Claims Room fogger works to disinfect microorganisms in even the most hard to reach areas Disinfection efficacy against bacteria Effectively eliminates pathogens bacteria from hard nonporous surfaces Effective broad spectrum surface disinfectant Intended for use in all medical healthcare clinical semi critical care and long term care facilities Gets everywhere disinfects pre cleaned hard non porous room surfaces Reaches surfaces that regular disinfectants can t Reduce s risk of cross contamination associated with contaminated surfaces Reduce s labor costs Disinfectant Disinfects Daily Multi purpose Multi room Multi surface Kills pathogenic bacteria Controls odor causing bacteria Deodorizes by killing odor causing bacteria Eliminates Removes odor causing bacte
6. If on Skin For general information on product use etc call the National Pesticides Information Center at 1 800 858 7378 For emergencies call the poison control center 1 800 222 1222 NOTE TO PHYSICIAN Probable mucosal damage may contraindicate the use of gastric lavage See back side right left panel for additional precautionary statements Net Contents as indicated on container EPA Reg No 90150 E EPA Est No 72038 DE 001 See bottom side for Lot No Data Code Product No Expiration Date Questions Comments symbol of telephone Call 1 800 525 1698 Proudly Made in the USA Distributed by TOMI Environmental Solutions Inc 5111 Pegasus Court Suite A Frederick MD 21704 or an authorized TOMI Environmental Solutions Inc distributor insert name Page 1 of 21 Ver 2 04222015 OR Manufactured for TOMI Environmental Solutions Inc 5111 Pegasus Court Suite A Frederick MD 21704 Available via Authorized TOMI Environmental Solutions Inc Distributor insert name Binary lonization Technology BIT V is a licensed trademark of TOMI Environmental Solutions Inc USA PRECAUTIONARY STATEMENTS Hazards to Humans and Domestic Animals DANGER Causes irreversible eye damage Harmful if absorbed through skin Do not get in eyes or on clothing Avoid contact with skin Wear appropriate protective eyewear such as goggles face shield or safety glasses Wash thoroughly wi
7. of 7 minutes Refer to the attached Binary lonization Technology BIT Solution Package Insert label for complete application instructions SteraMist Environment System Room Fogging Misting Directions Use the SteraMist Environment System exclusively with Binary lonization Technology BIT Solution For use in pre cleaned enclosures and on pre cleaned equipment Remove any visible gross filth from surfaces and equipment before application The product must be used as packaged and not diluted in any way To be used only on hard non porous surfaces For use in sealed rooms in industrial commercial and institutional settings Option to include sites from the Optional list of specific Healthcare Use Sites or Other Use Sites lists The use rate to achieve a minimum airborne concentration of 150 ppm parts per million hydrogen peroxide is approximately 0 5 milliliters ml of product per cubic foot fte of enclosure room volume The application time needed to achieve the required concentration will vary depending upon the room size Once the 150 ppm dose concentration is achieved contact time must be maintained for a minimum of 15 minutes before initiating aeration of the room Treatment area should remain unoccupied until PortaSens or other monitoring device registers hydrogen peroxide levels at 1 ppm Refer to the attached Binary lonization Technology BIT V Solution Package Insert label for complete application instructio
8. unit to work properly Binary lonization Technology BIT Solution is to be used exclusively with SteraMist Environment System or the SteraMist Surface Unit equipment Use of any TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com 10 TO M ier SOLUTIONS INC D E G H other solutions or liquids may damage the equipment void the warranty or cause operator injury Setting up the SteraMist Surface Unit a Plug the power cord into a standard 120V electrical outlet To turn on the SteraMist Surface Unit switch the power located on the side of the body to the ON position b Thehandheld applicator comes fully connected to the generator Please refer to the SteraMist Surface Unit User Manual for applicator connection instructions Operating the SteraMist Surface Unit a Prime the handheld applicator by setting the rocker switch to the Prime position and engaging the trigger on the handheld applicator until a steady stream of Binary lonization Technology BIT Solution is consistent Then disengage the trigger b Setrocker switch to Spray c Inorderto close the generator door in preparation for application align and insert the multi conductor cable strain relief in the cabinet slot and close and latch the cabinet door d When activating the handheld applicator in spray mode the device wi
9. use multiple pods in each room The system will always assign the first room as Room A the second room as Room B and the third room as Room C Always assign the largest room as room A to ensure correct initiation of dwell count down and subsequent scrubber initiation d The Setup Scrubber screen will appear i Enter Contact time in minutes The minimum contact time is 15 min ii Enter Scrub time in minutes Dependent on room size environmental conditions and scrubbers iii Press Next e The Startup Options screen will appear Select Remote or Manual as appropriate i If remote start was selected it will start immediately Start the fogger by pressing the button on the remote ii If you select Manual the Setup Delay screen will prompt the operator to enter a delay time in seconds The minimum manual start time is 10 seconds Once a delay time is entered press Start The Warning Screen will appear and begin countdown to startup f While wearing proper PPE in either Remote Mode or Manual Mode wait to assure that all the programmed pods are functioning fog and high energy electrical arc have started If not then press stop on the screen and check pod connections You must repeat the program sequence from step 4 7 If pods still do not function properly check that the dip tube is reaching the bottom of the cartridge and that you have enough solution in the cartridge Also check that you have created
10. with TOMI Environmental Solutions Inc in accordance with Federal Regulations for the specific uses described on the product label in this package insert and the SteraMist User Manuals Uses other than what is specified and described in these materials are not permitted The instructions that follow explain how to define appropriate use conditions for use in dry pre cleaned spaces Using the SteraMist Environment System this includes sealed enclosures in industrial commercial and institutional settings including production operations in pharmaceutical manufacturing manufacturing clean rooms laboratories animal research facilities hotel rooms offices cruise ships and recreational facilities and all other use sites as detailed in the SteraMist Environment System User Manual Using the SteraMist Surface Unit all use site surfaces may be treated without isolation sealed enclosures Effective application of Binary lonization Technology BIT Solution requires adequate Activated lonized Hydrogen Peroxide AIHP concentration and exposure time The process parameters are controlled through the use of appropriate monitoring instruments See the SteraMist User Manual prior to initiating the application process to determine the appropriate steps to take in development and application of the process For additional guidance in service and training on how to develop and monitor custom cycles contact TOMI Environmental Sol
11. No 90150 2 5 Submit one copy of the final printed label for the record before you release the product for shipment Should you wish to add retain a reference to the company s website on your label then please be aware that the website becomes labeling under the Federal Insecticide Fungicide and Rodenticide Act and is subject to review by the Agency If the website is false or misleading the product would be misbranded and unlawful to sell or distribute under FIFRA section 12 a 1 E 40 CFR 156 10 a 5 list examples of statements EPA may consider false or misleading In addition regardless of whether a website is referenced on your product s label claims made on the website may not substantially differ from those claims approved through the registration process Therefore should the Agency find or if it is brought to our attention that a website contains false or misleading statements or claims substantially differing from the EPA approved registration the website will be referred to the EPA s Office of Enforcement and Compliance If you fail to satisfy these data requirements EPA will consider appropriate regulatory action including among other things cancellation under FIFRA section 6 e Your release for shipment of the product constitutes acceptance of these conditions The following alternate brand name is acceptable e SteraMist BIT Solution A stamped copy of the label is enclosed for your records Please also note that the recor
12. OD AREAS In establishments where food and food products are held prepared processed and served application may be made only when the facility is not in operation provided exposed food is covered or removed from the area being treated prior to application Food contact surfaces must be rinsed with potable water after use of the product Food areas include areas for receiving storage packing canning bottling wrapping boxing preparing edible waste storage enclosed processing systems mills dairies edible oils syrups serving areas where prepared foods are served such as dining rooms NON FOOD AREAS This product may be used to treat nonfood areas in food handling use sites Nonfood areas include garbage rooms lavatories entries and vestibules offices locker rooms machine rooms boiler rooms garages mop closets and storage after canning or bottling TO M Festum SOLUTIONS INC Package Insert or Additional Label Language for Binary lonization Technology BIT Solution EPA Reg No 90150 E Binary lonization Technology BIT Solution Alternate Brand Name SteraMist BIT Solution StercilMist Healthcare Hospital Disinfectant TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com TO M Benen SOLUTIONS INC TABLE OF CONTENTS 1 GENERAL INFORMATION Binary lonization Technology BIT Solutio
13. a circular flow in the room You may adjust the pods to achieve correct vortex without stopping while the SteraMist is in operation Exit room and seal door to complete room isolation g When starting operation the device will cycle through three phases 1 air flow 2 liquid flow may take up to 30 seconds before mist is visible and 3 high energy electrical arc n TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com 8 TO M ier SOLUTIONS INC Decontamination activity has begun once a steady fog and the high energy electrical arc are observed h Monitor for hydrogen peroxide with a monitor such as a Drager Monitor or PortaSens Monitor outside the room being treated If hydrogen peroxide concentrations exceed 1 ppm outside the treatment room seal leaks as necessary i Inthe event of poor room isolation pushing the button on the remote control or touching the stop button on the touch screen will shut down the fogger j Scrubbing If applicable the scrubber will turn on automatically after the contact period has ended Scrubbing is typically performed until a concentration of lt 1 ppm H202 is achieved k Cycle end When the decontamination cycle is complete the Process Data touch screen will continue to be displayed This screen displays the actual amount of solution dispersed into each room It will also display the C
14. au Tag U S ENVIRONMENTAL PROTECTION AGENCY EPA Reg Number Date of Issuance Office of Pesticide Programs Antimicrobials Division 7510P 90150 2 6 23 15 1200 Pennsylvania Ave N W Washington D C 20460 NOTICE OF PESTICIDE X Registration n Reregistration Conditional under FIFRA as amended Term of Issuance Name of Pesticide Product Binary Ionization Technology BIT Plus Name and Address of Registrant include ZIP Code TOMI Environmental Solutions Inc 9454 Wilshire Blvd Penthouse Beverly Hills CA 90212 Note Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and accepted by the Antimicrobials Division prior to use of the label in commerce In any correspondence on this product always refer to the above EPA registration number On the basis of information furnished by the registrant the above named pesticide is hereby registered under the Federal Insecticide Fungicide and Rodenticide Act Registration is in no way to be construed as an endorsement or recommendation of this product by the Agency In order to protect health and the environment the Administrator on his motion may at any time suspend or cancel the registration of a pesticide in accordance with the Act The acceptance of any name in connection with the registration of a product under this Act is not to be construed as giving the registrant a right to exclu
15. ay be performed by placing an air scrubber in the room or by placing carbon filters over ventilation returns Dehumidifiers are also effective in removing airborne hydrogen peroxide D Cleaning Remove gross filth and visible soil prior to application All areas must be completely dry and free of visible biofilm before application E Secure the enclosure Remove all plants animals open beverages and food F Place SteraMist in Use placards outside all area entrances to ensure no one enters during treatment without appropriate PPE Placard may be removed once the space being treated has aerated and a monitor such as PortaSens or Drager register the hydrogen peroxide levels at below 1 ppm 6 2 Treatment Protocol One the room has been prepared by exposing and cleaning the surfaces isolating the room and setting up the monitoring the SteraMist Surface Unit can be set up and treatment can be initiated A Puton appropriate PPE as described in the product label B To install the Binary lonization Technology BIT Solution cartridge first remove the screw cap Save it to reuse later in recapping any remaining Binary lonization Technology BIT Solution Place the dip tube into the Binary lonization Technology BIT Solution Cartridge and firmly screw on the cap Insert the Binary lonization Technology BIT Solution Cartridge into the solution compartment The measurement window on the bottle must be facing out in order for the
16. d for this product currently contains the following CSF e Basic CSF dated 5 12 2015 e Alternate 1 CSF dated 5 12 2015 If you have any questions please contact Karen Leavy by phone at 703 308 6237 or via email at Leavy Karen epa gov ACCEPTED Language in brackets are notes to reviewer Language in parenthesis are optional and may or may not appear on the final label 06 23 20 1 5 Under the Federal Insecticide Fungicide Binary lonization Technology BIT Solution car redo Wa Ail as ceed pond pesticide registered under Alternate Brand Name SteraMist BIT Solution EPA Reg No 00150 2 Bactericide Staphylococcus aureus Staphylococcus Staph ATCC 6538 Pseudomonas aeruginosa Pseudomonas ATCC 15442 For use as a Healthcare Hospital Disinfectant Active Ingredient Hydrogen peroxide 7 8 Inert Ingredients 92 2 Total 100 0 KEEP OUT OF REACH OF CHILDREN DANGER PELIGRO FIRST AID If in Eyes e Hold eye open and rinse slowly and gently with water for 15 20 minutes Remove contact lenses if present after the first 5 minutes then continue rinsing eye Call a Poison Control Center or doctor for treatment advice Take off contaminated clothing Rinse skin immediately with plenty of water for 15 20 minutes Call a Poison Control Center or doctor for treatment advice Have the product container or label with you when calling a Poison Control Center or doctor or going for treatment
17. d liquid to the respective three point receptor Firmly press the connector plugs into their receptors until they bottom out Slide the locking mechanism of the electrical receptor all the way to the right TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com 6 TO M ier SOLUTIONS INC b Depending on number of pods in the room place the pods in a manner that allows for a vortex to be formed c Environmental variables that should be taken into consideration during application are room air movement or wind and to a lesser extent temperature and humidity 50 relative humidity is optimal B Puton appropriate PPE and respiratory protection as stipulated in your hospital company specific Respirator Protection Program C Connecting the Binary lonization Technology BIT Solution Cartridge Place the 1 gallon Binary lonization Technology BIT Solution Cartridge on the floor next to the generator To install the cartridge first remove the screw cap from the cartridge Save it to reuse later in capping any remaining Binary lonization Technology BIT Solution The rigid tube is inserted into the underside of the application cap and the flexible tube into the topside of the application cap Ensure that both tubes are fully seated into the fittings on either side of the application cap Fully seat the other end of the flexible tube
18. detection and containment verification b A monitor such as a PortaSens can be equipped with a hydrogen peroxide sensor with a dynamic range of 0 200 ppm or 0 2000 ppm i When equipped with the 0 200 ppm sensor this unit can be used in place of the Drager unit for containment verification It is outfitted with a sample tube which can be fitted under the door and used to monitor the treatment room concentrations of hydrogen peroxide It can also be taken into the treatment room by the operator to verify purge is complete ii When equipped with the 0 2000 ppm sensor the PortaSens unit is used to monitor treatment room concentrations during fogging operations where hydrogen peroxide concentrations exceed 150 ppm c Limitations of electrochemical sensors such as Drager and PortaSens i Sensors saturate and have inaccurate readings when the relative humidity exceeds 90 ii Sensors may respond to other chemicals in this case the isopropyl alcohol in the BIT Solution and the ozone produced by the high energy electrical arc may give a false higher reading 5 2 Treatment Protocol Once the room has been prepared by exposing and cleaning the surfaces isolating the room and setting up the monitoring the SteraMist Environment System can be set up and treatment can be initiated A Position applicators a The remote applicator is outfitted with a three point connector on the unit Align the three point connector electrical air an
19. eaning sealing and use of Binary lonization Technology BIT Solution in monitored and non monitored applications See SteraMist Binary lonization Technology BIT User Manual for operating procedures of the SteraMist Environment System or SteraMist Surface Unit application equipment Do not use this product without development of an appropriate fogging disinfectant plan as described in detail in the attached package insert on the label Do not deviate from standard cleaning procedures when using SteraMist Environment System or SteraMist Surface Unit fogging misting equipment Binary lonization Technology BIT Solution fogging misting is designed to be the final step in standard cleaning procedures Not for use as a terminal sterilant or high level disinfectant for reprocessing of critical or semi critical medical devices Microbial Disinfection For use as a microbial disinfectant fogging misting solution for disinfection of all dry pre cleaned hard non porous non food contact surfaces in spaces and rooms Do not deviate from standard cleaning protocols when using Binary lonization Technology BIT Solution Use product only with SteraMist Environment System or SteraMist Surface Unit fogging misting equipment following detailed instructions provided in the SteraMist Binary lonization Technology BIT User Manual Read and follow the directions in the attached package insert on the label on room pre
20. eeeeeeeeaeeeaeecaeecaaecaaecaeeeaeeeaeeeaeeeaes 12 TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com 1 TO M Benen SOLUTIONS INC 1 GENERAL INFORMATION BINARY IONIZATION TECHNOLOGY BIT SOLUTION The Binary lonization Technology BIT Solution is for use exclusively with the SteraMist Environment System and the SteraMist Surface Unit for hospital disinfection of rooms Review the SteraMist User Manuals for proper instructions on how to operate the SteraMist Environment System and SteraMist Surface Unit prior to utilizing the equipment for disinfecting areas SteraMist Binary lonization Technology BIT Solution should be applied by properly trained personnel who are thoroughly trained in the use safety and operation of the SteraMist Environment System and SteraMist Surface Unit and Binary lonization Technology BIT Solution Application Process exclusively using Binary lonization Technology BIT Solution and who have received a Certificate of Completion of the SteraMist Technician Training course from TOMI Environmental Solutions Binary lonization Technology BIT Solution is for use as a hospital disinfectant on hard non porous surfaces and is not intended for use on textiles or hard porous surfaces Binary lonization Technology BIT Solution has been registered
21. ies select each of the number fields initially defaulted to 0 to the left of the words Length Width and Height in feet Enter the associated room dimension b Dose Concentration i Select the number field initially defaulted to O 00 to the left of the words mL PER CU FT Dose concentration must be calculated at rate of 0 5 mL ft ii Press Calculate TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com 7 TO M ier SOLUTIONS INC iii Alternatively you may directly enter the dose in mL by pressing the button to the right of Calculate This button appears as 0 TOTAL mL by default The minimum dose rate must be 0 5 mL ft C Select pods i From the buttons to the right side of the screen select pod or pods to be used in selected room A Pods can only be selected if they are detected Pods can only be detected if they are connected ii Press Next iii If multiple rooms are selected on the Select Number of Rooms for Treatment screen step 4 7 Room B Injection Volume and Room C Injection Volume screens will appear Repeat the above steps a through e for additional rooms Then press Next Please note that if decontaminating 3 rooms simultaneously a pod must be assigned to each room A pod cannot be assigned to more than one room at a time However if programming one or two rooms you may
22. in the room or by placing activated carbon filters over ventilation returns Dehumidifiers are also effective in removing airborne hydrogen peroxide E Expose all surface areas requiring disinfection Open all drawers cabinet doors and bathroom doors TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com 5 TO M ier SOLUTIONS INC F Cleaning Remove gross filth and visible soil prior to application All areas must be completely dry and free of visible biofilm before application G Secure the enclosure a Remove all plants animals open beverages medications and food b Place SteraMist in Use placards outside all room entrances to ensure no one enters during treatment without wearing appropriate PPE c Placards may be removed once the space being treated has aerated and monitors such as a PortaSens or Drager register the hydrogen peroxide levels at below 1 ppm H Set up hydrogen peroxide monitoring for safety purposes and for process verification This must be done to verify the fogging concentrations have reached the desired level and to indicate when it is safe to re enter Two devices are recommended for measuring airborne hydrogen peroxide a A monitor such as a Drager with H20 sensor has a dynamic range of 0 20 ppm This H2O gt sensor is intended to be used outside the treatment area for low level leak
23. into the tube fitting on the Binary lonization Technology BIT Solution input Binary lonization Technology BIT Solution is to be used exclusively with SteraMist Environment System or the SteraMist Surface Unit equipment Use of any other solutions or liquids may damage the equipment void the warranty or cause operator injury a Insert Tube into Fitting Push the tubing through the collet and dual O rings until it bottoms out against the tube stop The collet holds the tube in place and the dual O rings provide a leak resistant seal b Test and Inspect Push and pull the tubing toward and away from the fitting to ensure that it has been installed properly Test and inspect the installation for any leaks c Tube Removal Push uniformly around the collet flange against the fitting body while pulling the tubing away from the fitting to release it D Plug the scrubber into fogger three prong outlets Use of the scrubber will shorten aeration time E Plug the system into a standard electrical 120V wall outlet using the cord provided Press the switch to the ON position where the power cord connects to the unit F The touch screen will boot up and the RUN screen will appear Press Run The Select Number of Rooms for Treatment screen will appear One to three rooms may be selected Press the appropriate button i e One Two or Three The Room A Injection Volume screen will appear a Room Dimensions In ser
24. ions and treatment volume area C CONTACT PHASE Application time will provide adequate AIHP and hydrogen peroxide levels in the treatment area After application is complete sufficient AIHP will be present to provide disinfection of application area through CONTACT The CONTACT time is specified below for each application method D AERATION PHASE Once the Binary lonization Technology BIT Solution application is complete and contact time has concluded the enclosure is aerated and or scrubbed to reduce the AIHP and hydrogen peroxide levels within the enclosure to less than or equal to a 1 ppm level 1 0 PPM TWA 8 hr prior to reentry into the enclosure by trained personnel 3 USER SAFETY REQUIREMENTS Refer to the product label for user safety requirements and PPE 4 HOSPITAL DISINFECTANT MANAGEMENT PLAN HDMP GENERAL GUIDANCE FOR PREPARATION OF A HOSPITAL DISINFECTION MANAGEMENT PLAN A Hospital Disinfection Management Plan HDMP is an organized written description of the required steps involved to help ensure an effective disinfection It will also assist in complying with pesticide product label requirements The guidance that follows is designed to assist in addressing all the necessary factors involved in preparing for and treating a structure and or area This guidance is intended to assist in the planning of any disinfection that may be performed PRIOR TO ACTUAL TREATMENT It is meant to be somewhat prescriptive yet f
25. lexible enough to allow the experience and expertise of the user to make changes based on circumstances that may exist in the TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com 3 TO M ier SOLUTIONS INC field By following a step by step procedure yet allowing for flexibility an effective disinfection can be performed Before any disinfection begins carefully read and review the label and the SteraMist User Manuals This information must also be given to the appropriate company officials supervisors foreman safety officer etc in charge of the structure and or area Preparation is the key to any successful disinfection Finally before any disinfection begins you must be familiar with and comply with all applicable local and state laws The success of the disinfection is not only dependent on your ability to do your job but also upon carefully following all rules regulations and procedures required by governmental agencies SITE SPECIFIC GUIDANCE FOR PREPARATION OF A HOSPITAL DISINFECTION MANAGEMENT PLAN The TOMI Environmental Solutions Inc trained personnel are responsible for working with the owners and or the responsible employees of the site that is undergoing Binary lonization Technology BIT Solution treatment to develop a site specific Hospital Disinfectant Management Plan HDMP for each site that will be t
26. ll cycle through three phases 1 air flow 2 mist flow and 3 atmospheric cold plasma arc Disinfection activity can begin once a steady fog and the atmospheric cold plasma arc are observed Remember always keep the nozzle of the applicator pointed away from you and others at all times and never operate the handheld applicator while pointed upward Application a Apply in broad even strokes ensuring that there is a consistent even mist with no drips runs or missed areas Do not over saturate b For Microbial Disinfection Binary lonization Technology BIT Solution must be administered a maximum of 2 feet from the surface being disinfected remediated at a coverage rate of 1 ml ft for 5 seconds Allow product to contact surface for a minimum of 7 minutes c The application rate is practiced and assessed during training and can be visually confirmed by the technician or a third party outside the area by timing coverage strokes d Environmental variables that should be taken into consideration during application are room air movement or wind and to a lesser extent temperature and humidity e Biological Indicators can be used to confirm coverage To deactivate the handheld applicator release the button The device will cycle off in the following order 1 atmospheric cold plasma arc 2 mist flow and 3 air flow To turn off the SteraMist Surface Unit switch the power located on the side of the generator to the OFF 0 position
27. ls eliminates bacteria Surface Disinfectant Whole Complete Room Surface Disinfectant This product reduces the risk of cross contamination of bacteria on hard pre cleaned non porous surfaces This product helps aids in the reduction of cross contamination of bacteria on hard pre cleaned nonporous surfaces Use this product in places that are difficult to disinfect reach This product kills the bacteria that cause bad odors formula product for use in hospitals healthcare medical facilities formula product for use in hospitals healthcare medical facilities for whole complete room surface disinfection YS OS This product kills bacteria on hard non porous nonfood contact surfaces in public places This product kills bacteria on commonly touched on hard non porous non food contact surfaces in non residential public places in hotel rooms in medical facilities Staphylococcus aureus Staphylococcus Staph ATCC 6538 and Pseudomonas aeruginosa Pseudomonas ATCC 15442 Healthcare Use Sites This product product name is designed specifically as a hospital healthcare ready to use disinfectant disinfecting fogging formula product for use in the following settings Including but not limited to Ambulatory Surgical Centers ASC Anesthesia Rooms or Areas Assisted Living or Full Care Nursing Homes CAT Laboratories Central Service Areas Central Supply Rooms or
28. mum of 2 years and a copy provided to the owner of the treated site Note to Reviewer Use Instructions for the SteraMist Surface Unit may appear before the Use Instructions for the SteraMist Environment System in the Package Insert 5 STERAMIST ENVIRONMENT SYSTEM USE INSTRUCTIONS 5 1 Room Preparation A Review existing product label HDMP hospital company specific PPE protocols and SteraMist Environment User Manual B Survey the room taking note of the following a Dimensions of the room in feet length width and height b Location of supply and return vents and any other air entry or egress paths door jambs windows bathroom vents hoods etc C Position and type of equipment and furniture d Proximity to staff and general public C Room isolation a Determine room isolation approach and perform isolation Isolation is preformed to speed concentration of the AIHP to the required dose level of 150 ppm b The SteraMist Environment System must not be used without disabling HVAC and other ventilation systems If ventilation systems must remain operational controls must be put in place to prevent dilution of the fog through ventilation and unintentional personnel exposures c Isolation may also be achieved by sealing with tape and plastic sheeting or other means D Determine aeration approach Venting to atmosphere is the preferred method Alternatively scrubbing may be performed by using a scrubbing device
29. n seen 2 2 Binary lonization Technology BIT SOLUTION Application Process csccccsscssseceseessseesseesesees 2 3 USER SAFETY REQUIREMENIES issiima CY EN n eea SEU esas tuoi seb Vo Deoa sia dou nsb adea s Ue pa Ree UR repa 3 4 Hospital Disinfectant Management PLAN HDMP ccccscccssceessecssseeceeeeecsaeeessaeeseeeessaeeessaeeseaseeaes 3 5 SteraMist Environment system USE INSTRUCTIONS 2 0 ce eeeeecsseeceeeeeeeeeeaaeeeeeeeeeeeeaaaaeaeeeeeseeeeetaaeeeees 5 5 1 Room Preparatlion i e eae a a a ea a NE NES NSER Sere ENEMY RN S SERES 5 5 2 Treatment P OELOGOL ue erret rete edere exc ventre a neni Fee RN ree RA REN AEREE AE EATE EER 6 5 3 Routine System Maintenance Calibration Procedures and Troubleshooting 9 544 Storage and Shippitig iu iiec ree pete p E REN ROAST anal TUO EE E SE pepe pe EUER RR 9 5 5 Annual Recalibration and Recertification sess 10 6 STERAMIST SURFACE UNIT USE INSTRUCTIONS sseessseseseseeeeeneennne nennen a nennen 10 6 1 PREPAFATION c 10 6 2 Treatment Protocol tres tisse b DE tiro PER NRREE E FER e neto cabe Fin REEF nada 10 6 3 Routine System Maintenance and Calibration Procedures and Troubleshooting 12 6 4 Storage and ShippiDg eset rin ien ocio rese Iv ente retes HE venir oe dee rosse De reve Une Ae 12 6 5 Annual Recalibration and Recertification cccesccesceesceeeeeeeeee
30. n Technology BIT Solution using only deionized DI water Please see SteraMist Environment System User Manual for detailed instructions on flushing the system Never store or ship the SteraMist Environment System without fully flushing the system TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com 9 TO M Benen SOLUTIONS INC 5 5 Annual Recalibration and Recertification The SteraMist Environment System must be recalibrated and recertified by a certified SteraMist Service Technician Contact your certified SteraMist Service Technician at 1 800 525 1698 to schedule onsite calibration or to arrange for shipping of your SteraMist to a TOMI location for calibration 6 STERAMIST SURFACE UNIT USE INSTRUCTIONS 6 1 Preparation A Review the product label existing HDMP for the location to be treated hospital company specific PPE protocols and SteraMist Surface User Manual B Survey the area to be treated taking note of the following a Position of equipment and furniture b Proximity to other room occupants c Application goal i e total room disinfection or only high touch surface disinfection C Venting to the atmosphere is the preferred aeration method However the SteraMist Surface Unit may be used effectively without disabling HVAC and other ventilation systems Alternatively scrubbing m
31. ns STORAGE AND DISPOSAL Do not contaminate water food or feed by storage and disposal Pesticide Storage Keep out of direct sunlight and away from heat Do not freeze Store in original closed dark plastic container in cool dry area away from small children and pets Pesticide Disposal Wastes resulting from the use of this product must be disposed of on site or at an approved waste disposal facility Container Disposal Non refillable container Do not reuse or refill this container If product is leaking or spills should occur please dilute with water and dry with absorbent material or dilute with water as it is flushed into waste water drain Offer for recycling if available or replace cap and discard in trash Optional Marketing Claims note that these claims may or may not appear on the commercial label in addition the claims may be used as bullet points or in a paragraph format Miscellaneous Claims Room is safe to enter within minutes following aeration once hydrogen peroxide is below 1 ppm Effective whole complete room treatment time of just over 75 minutes including application time contact time and aeration time Efficient whole complete room treatment time of just over 75 minutes including application time contact time and aeration time allows for quick room disinfection and turnover Allows for quick room turnover Easily incorporated into current cleaning procedures Lightweight easy to tran
32. ontact Time and Scrub Time This is the minimum data that should be recorded along with date time and room number l To deactivate the SteraMist Environment System while running a cycle press the remote button or stop button on touch screen The device will cycle off in the following order 1 high energy electrical arc 2 liquid flow and 3 air flow You may now press exit and dissemble the unit until next use m To turn off the SteraMist Environment System switch the power to the OFF 0 position Unplug the power cord from the electrical outlet and the generator n After each use i Ensure the SteraMist equipment is unplugged from the power source and using isopropyl alcohol clean all residues present from the nozzle tip guard electrodes electrode posts spray nozzle air cap and retaining ring ii At the end of each shift prior to storage or shipment flush solution o Remove SteraMist in Use placards PPE and store appropriately Make notes of any HDMP recommendations for future use and complete required paperwork 5 3 Routine System Maintenance Calibration Procedures and Troubleshooting Refer to the SteraMist Environment System User Manual for instructions regarding routine system maintenance calibration procedures and troubleshooting guidance 5 4 Storage and Shipping If the SteraMist Environment System will be unused for more than 2 days the system must be flushed of all Binary lonizatio
33. paration room set up treatment procedures and equipment operating procedures for the specific SteraMist Environment System or SteraMist Surface Unit fogging misting machine Binary lonization Technology BIT Solution should be used as part of a Hospital Disinfectant Plan In general the SteraMist Surface Unit should be used when disinfecting specific objects and or selected surfaces with a directed mist from a distance of no more than two 2 feet The SteraMist Environment System should be used when all room surfaces the whole room need s to be disinfected For complete guidelines on developing Hospital Disinfectant Plans refer to the label insert or equipment User Manual SteraMist Surface Unit Hand Held Fogging Misting Directions Use the SteraMist Surface Unit exclusively in conjunction with the Binary lonization Technology BIT Solution For use in pre cleaned enclosures and on pre cleaned equipment Remove any visible gross filth from surfaces and objects before application The product must be used as packaged and not diluted in any way To be used only on hard non porous surfaces For use on surfaces in industrial commercial and institutional settings Option to include sites from the Optional list of specific Healthcare Use Sites or Other Use Sites lists Apply at a maximum distance of 24 inches 2 feet for a minimum of 5 seconds over a 1 square foot treatment area Allow a minimum contact time
34. reated with Binary lonization Technology BIT Solution Trained personnel are responsible for all tasks of the disinfection processes unless otherwise noted in the HDMP and must be on site for the entire disinfection treatment process The HDMP must address characterization of the site and include appropriate monitoring and notification requirements consistent with but not limited to the following A Inspect the structure and or area to determine its suitability for disinfection B When sealing is required consult previous records for any changes to the structure seal leaks and monitor any occupied adjacent rooms and or buildings to ensure safety C Prior to each disinfection review any existing HDMP MSDS SDS SteraMist User Manual and other relevant safety procedures with company officials and appropriate employees D Consult with company officials in the development of procedures and appropriate safety measures for nearby workers who will be in and around the area during application and aeration E Consult with company officials to develop an appropriate monitoring plan that will confirm that nearby workers and bystanders are not exposed to levels above the allowed limits during application disinfection and aeration This plan must also demonstrate that nearby residents will not be exposed to concentrations above the allowable limits F Consult with owners and or responsible employees at the site who will be responsible for
35. ria Gets rid of odors by killing the bacteria that cause them Helps prevent the build up of odors by killing odor causing bacteria on hard pre cleaned non porous surfaces Disinfects hard pre cleaned non porous non food contact surfaces in use sites For hospital healthcare medical semi critical care long term care facilities as a disinfectant For use on hard pre cleaned non porous surfaces located in use sites Great suitable for whole complete room disinfecting disinfection Use on hard to reach areas Use this product in use sites listed here Specific Disinfecting Claims Effective against Bacteria Disinfection of all hard non porous surfaces in a hospital patient room Disinfectant Disinfecting fogging formula product for whole complete room surface disinfection disinfecting An effective disinfectant formula product for use in healthcare facilities An effective disinfectant formula product for use in healthcare facilities for whole complete room surface disinfection disinfecting An effective disinfectant solution semi critical care long term care An effective disinfectant solution semi critical care long term care disinfecting Effective against bacteria Kills eliminates destroys bacteria on hard non porous surfaces Kills eliminates bacteria odors and deodorizes On hard pre cleaned non porous non food contact surfaces this product kil
36. sive use of the name or to its use if it has been covered by others This product is conditionally registered in accordance with FIFRA section 3 c 7 A You must comply with the following conditions 1 Submit and or cite all data required for registration reregistration registration review of your product under FIFRA when the Agency requires all registrants of similar products to submit such data Signature of Approving Official hor 779 6 23 15 John Hebert Chief Regulatory Management Branch I Antimicrobials Division 7510P EPA Form 8570 6 Page 2 of 2 EPA Reg No 90150 2 Decision No 478883 2 You are required to comply with the data requirements described in the DCI identified below a Hydrogen Peroxcide GDCI 000595 1127 You must comply with all of the data requirements within the established deadlines If you have questions about the Generic DCI listed above you may contact the Reevaluation Team Leader Team 36 http www2 epa gov pesticide contacts contacts office pesticide programs antimicrobial division 3 The data requirements for storage stability and corrosion characteristics Guidelines 830 6317 and 830 6320 are not satisfied A one year study is required to satisfy these data requirements You have 18 months from the date of registration to provide these data 4 Make the following label changes before you release the product for shipment e Revise the EPA Registration Number to read EPA Reg
37. sport and capable of achieving reliable disinfection Self contained allowing for reliable disinfection Easy to transport and can be configured to treat multiple spaces simultaneously Scalable technology able to use multiple units applicators Economical non corrosive and easy to apply Disinfection efficacy against bacteria For use in SteraMist Binary lonization Technology BIT fogging Environment System Surface Unit equipment by a trained technician For use in SteraMist Binary lonization Technology BIT Environment System Surface Unit room handheld fogging equipment instruments device s fogger s system s Healthcare Hospital disinfectant Reagy to use formula no mixing required Go Goes above beyond under and around disinfecting sprays and wipes Disinfects hard to reach hard non porous surfaces in treated room Disinfects high touch hard non porous surfaces in treated room SteraMist Surface Unit disinfects treated hard non porous surfaces on high touch equipment SteraMist Surface Unit disinfects hard non porous high touch surfaces Patented Technology No Wipe No rinse Leaves no residues no wiping necessary Active ingredient exclusively hydrogen peroxide Economical and easy to apply Whole complete Room Disinfection Disinfecting Disinfectant System Bleach Chlorine Bleach and Chlorine free formula disinfection disinfecting disinfectant Easy
38. th soap and water after handling and before eating drinking chewing gum using tobacco or using the toilet Remove and wash contaminated clothing before reuse PERSONAL PROTECTIVE EQUIPMENT PPE For applicators and handlers of the SteraMist Surface Unit Hand Held equipment and for early re entry for the SteraMist Environment System the following PPE must be worn e Protective eyewear such as goggles or face shield or safety glasses e N95 Respirator with Activated Charcoal Filter Powered Air Purifying Respirator or equivalent e Hydrogen peroxide resistant body suit such as a Tyvek protective suit Final selection of additional PPE must be done in accordance with hospital site guidelines and take into consideration the use of the product as well as any infection or exposure hazards related to the environment to be disinfected PHYSICAL AND CHEMICAL HAZARDS This product is incompatible with strong oxidizing and reducing agents Directions for Use It is a violation of Federal law to use this product in a manner inconsistent with its labeling Shade from radiant heat and direct sunlight Stow away from powdered metals and permanganates This product is for use in SteraMist Environment System or SteraMist Surface Unit application equipment only and by personnel trained by TOMI Environmental Solutions Inc Read and follow the Binary lonization Technology BIT Solution package insert label for complete directions on pre cl
39. ual for detailed instructions on flushing the system Never store or ship the SteraMist Surface Unit without fully flushing the system To store the applicator and multi conductor cable open the case remove the cord strain relief and coil the multi conductor cable around the multi conductor retaining hooks in the door The applicator is stored in the mesh pouch 6 5 Annual Recalibration and Recertification The SteraMist Surface Unit must be recalibrated and recertified by a certified SteraMist Service Technician Contact your certified SteraMist Service Technician at 1 800 525 1698 to schedule onsite calibration or to arrange for shipping of your SteraMist to a TOMI location for calibration TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com 12
40. utions Inc 2 BINARY IONIZATION TECHNOLOGY BIT SOLUTION APPLICATION PROCESS The SteraMist Binary lonization Technology BIT Solution is applied through the SteraMist Environment System or the SteraMist Surface Unit SteraMist for the required time to maintain the TOMI Environmental Solutions Inc East Coast Office 5111 Pegasus Court Suite A Frederick Maryland 21704 800 525 1698 www tomiesinc com 2 TO M ier SOLUTIONS INC desired concentration of Activated lonized Hydrogen Peroxide AIHP The Binary lonization Technology BIT Solution fog quickly is broken down into water humidity and oxygen The BIT process consists of four phases A PREPARATION PHASE Develop Hospital Disinfectant Treatment Plan reviewing the user safety requirements and PPE on the label and using guidance in Section 4 Make sure areas to be treated are pre cleaned and are dry and free of visible biofilm When using the SteraMist Environment System sealing the space will allow for a faster concentration of AIHP B APPLICATION PHASE The Binary lonization Technology BIT Solution will flow through the Atmospheric Cold Plasma Arc in the nozzle convert into AIHP and is introduced into the air stream The APPLICATION phase facilitates concentration of AIHP in the treatment area APPLICATION time will be determined by the number of application nozzles used enclosure materials environmental condit
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