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1. 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 cleaning 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 Environm2. 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 5 Under the Federal Insecticide Fungicide Binary lonization Technology BIT Solution shee Wa Ail as ceed tan 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 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 co
3. d 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 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 SteraMis
4. ent 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 preparation 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 shoul
5. ntraindicate 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 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 with 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
6. ool 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
7. t 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 lt 1 ppm Refer to the attached Binary lonization Technology BIT Solution Package Insert label for complete application instructions 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 c
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