EPA Reg. No. 84526-A - Safety Net America
Contents
1. located at the bottom of the rear panel of the Sanosil Halo Fogger Ensure that the connector is securely in place Plug the Sanosil Halo Fogger into a standard electrical outlet The green status indicator light will illuminate Filling Instructions 1 Push down on the Sanosil Halo Fogger Reservoir Door in the area labeled Push Here to Open Lift to open i 2 Locate the disinfectant fluid level indicator lights to the left of the funnel One orange light will be illuminated indicating the Sanosil Halo Fogger is empty 3 Use personal protection equipment PPE including wrap around style goggles and gloves when pouring disinfectant fluid into the device 4 Open a gallon 3 8 liters bottle of Sanosil HALOMIST and SLOWLY pour the contents into the funnel area AVOID SPLASHING 5 The fluid level indicator lights will illuminate as you pour to show how much disinfectant is in the device 6 The Sanosil Halo Fogger holds two gallons 7 6 liters of disinfectant when full Stop pouring when the top green light on the fluid level indicator is illuminated Do not overfill 7 Wipe up any spills with a clean paper towel or rag Thoroughly rinse off gloves and hands 8 Close Reservoir Door ensuring it clicks 9 The Sanosil Halo Fogger is now ready to be used Maintenance 9 1 Nozzle Cleaning and Alignment 14 HFD583EN_C December 2013 a Ulu Sanosil Halo Fogger User Manual with Sanosil HALOMIST Before perfo2. delay room re entry and allow treated room to remain unoccupied overnight for safety and maximum efficacy 3 Post Dehumidification When accelerated room re entry is necessary the dehumidifier will speed the reduction of the DMHP concentrationwithin the room to a1 ppm level prior to reentry into the room by trainedapplicators Treated rooms may not be released for general public use until one hour after a 1 ppm level of DMHP is achieved in the room as indicated by appropriate instrumention HFDS83EN_C December 2013 r r lO 244 Sanosil Halo Fogger User Manual with Sanosi1 HALOMIST User Safety Requirements 1 Hazards to Humans and Domestic Animals CAUTION Causes moderate eye irritation Avoid contact with eyes or clothing Wash thoroughly with soap and water after handling and before eating drinking chewing gum or using tobacco 2 Users should remove clothing and PPE immediately if Sanosil HALOMIST gets inside Then wash thoroughly and put on clean clothing 3 PPE Personal Protective Equipment is required for special room re entry procedures See Section 5 6 Disinfection Management Plan 4 1 4 2 GENERAL Employees of the site to be disinfected should develop a site specific Disinfection Management Plan DMP for each room to be fogged with Sanosil HALOMIST The user is responsible for all tasks of the disinfection process unless noted in the DMP and must be on site for the entire disinfection treatment process
3. 1 Gallon 3 8L Refill Bottles S010N0G4 Sanosil Power Module 20PMOD12 110 Cl H202 Test Strips H202STPS 50 Storage and Disposal Sanosil Halo Fogger Storage Store in a safe dry location Do not place anything on top of the device Store in an upright position Keep the refill door closed Do not allow Sanosil HALOMIST to be stored in the Sanosil Halo Fogger for longer than one year Disposal Electrical and electronic devices may not be disposed of with domestic waste This product is in accordance with the law waste electrical and electronic equipment WEEE Please contact your local representative for more information Specifications for Sanosil Halo Fogger Mechanical 17 HFDS amp 3EN_C December 2013 Height Width Depth Weight Electrical Power Requirements Certification Current Rating Fuse Electrical Rating Performance Nozzle Flow Volumes treated HFD583EN_C December 2013 Sanosil Halo Fogger User Manual with Sanosil HALOMIST 40 0 101 5 cm 13 25 33 5 cm 18 5 47 cm Approximately 50 Ibs 22 5 kg North American Version 110V International Version 220V MET UL 969 MET CE 4 amps 10 amps 250 volt slow acting 5 x 20mm 4 amps 115 volt 60 Hz 220 volt 50 Hz for the 220V Fogger 1 0 oz min 20 400 3 660 ft M lon 18
4. 8 Electric shock hazard Do not plug in if electrical plug or parts are wet 9 There are no user serviceable parts inside the Sanosil Halo Fogger other than the nozzle An operator may only perform maintenance procedures specifically described in this manual The manufacturer should make all other repairs 10 While in use the body of the Sanosil Halo Fogger may become warm to the touch Use caution when handling 11 Use personal protection equipment PPE including wrap around style goggles and gloves when pouring disinfectant fluid into the device Avoid splashing or overfilling which could harm the user and or the device 12 Specific warning and caution statements are included for Sanosil HALOMIST see Section 6 3 13 Sanosil International is not responsible for any injury or damage caused by using this device outside of the specific parameters detailed in this manual 11 HFD583EN_C December 2013 a ISl Sanosil Halo Fogger User Manual with Sanosil HALOMIST 6 2 Operation Warnings These warnings pertain to the actual use of the Sanosil Halo Fogger unit 1 To ensure effectiveness and safety use only with Sanosil HALOMIST Using any other manufacturer s disinfecting or cleaning product will result in serious injury exposure and environmental damage 2 Position the device on a secure surface to prevent rolling or moving while in use 3 Use only a Sanosil supplied electrical cord 4 Always unplug the power cord from the outl
5. Areas Central Supply Rooms or Areas Critical Care Units or CCUs Dental operatories Dentist office 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 This product or product name is designed specifically as a healthcare grade ready to use disinfectant disinfecting fogging solution formula product for use in the following settings of 1100 ft up to Sanosil HaloMist EPA Reg No 84526 A EPA Label 12 17 2013 Page 4of5 Healthcare Use Sites continued 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
6. Clostridium difficile spore form ATCC 43598 Pseudomonas aeruginosa Pseudomonas ATCC 15442 Staphylococcus aureus Staphylococcus Staph ATCC 6538 New this claim will only be used for the first six months after commercial introduction Miscellaneous Claims For use in Sanosil HaloFogger For use in room fogging equipment instrument s device s foggerls system s Healthcare grade Hospital grade disinfectant Ready to use formula No mixing required Go Goes above beyond under and around disinfecting sprays and wipes Advanced Patented Formula No Wipe No rinse Dry Mist Whole complete Room Disinfection Disinfecting System Bleach Chlorine Bleach and Chlorine Alcohol free formula technology disinfection disinfecting disinfectant Easy Effective Frequent use formula Great suitable for frequent use Leaves room surfaces disinfected Makes whole room disinfecting easier No mixing or dilution diluting labor required General Performance Claims Effectively eliminates pathogens bacteria from hard nonporous surfaces Effective alternative broad spectrum surface disinfectant Intended for use in all medical healthcare semi critical care and long term care environments Gets everywhere disinfects all pre cleaned hard non porous room surfaces Reaches into every nook crevice and corner that disinfecting sprays and wipes can t Reaches surfaces that regular di
7. The DMP must address a full characterization of the site and include appropriate monitoring and notification requirements consistent with but not limited to the following 1 Inspect the structure and or area to determine its suitability for disinfection size non porous surfaces pre cleaned Size of room area must be between 1100 ft and 3700 ft 2 Seal the room to be treated adequately to ensure that DMHP levels outside the room are kept at acceptable levels and that there is adequate coverage of product within the room Monitor any occupied adjacent rooms and or buildings to ensure safety 3 Prior to each disinfection review any existing DMP MSDS Equipment Manuals and other relevant safety procedures with company officials and appropriate employees 4 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 5 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 This plan must also demonstrate that nearby residents will not be exposed to concentrations above the allowable limits 6 Confirm the placement of placards to secure entrance into any area under disinfection 7 Confirm the required safety equipment is in place and the necessary manpower is available to
8. a clean towel dampened with water Ensure that the funnel screen is in place 15 HFD583EN_C December 2013 Sanosil Halo Fogger User Manual with Sanosil HALOMIST 10 Troubleshooting The following table of potential indicators provides a quick reference of the descriptions probable causes and most common solutions regarding the operation of the Sanosil Halo Fogger If the information in this table does not describe or solve the problem you are having contact Sanosil Customer Service at 1 877 726 6745 Monday through Friday 9 00AM to 5 00PM EST For International calls dial 1 302 454 8102 Symptom No mist is being produced Green indicator light is blinking No power Knocking noise HFD583EN_C December 2013 Possible Cause The nozzle is clogged or misaligned The disinfectant fluid tank is empty Start button not pressed Not plugged in Reservoir Door is not closed correctly Magnet in Reservoir Door is not in place The power cord is not plugged in or the power source is not on The compressor is not running properly Solution Remove the nozzle and clean according to the instructions in this manual Check the fluid leve indicator lights If the orange light is illuminated follow the fill instructions in this manual to refill the tank Press and hold the Start button for 2 seconds to begin fogging Check to make sure that the power cord is plugged into both the Fogger a
9. apply disinfectant in accordance with the label requirements 2 When entering into the area under disinfection always work with two or more people under the direct supervision of a trained applicator wearing appropriate PPE 3 Provide watchmen when a disinfection site cannot otherwise be made secure from entry by unauthorized persons 4 Follow Sanosil Halo Fogger Use Instructions See Section 5 4 6 POST APPLICATION OPERATIONS 1 Provide watchmen when you cannot secure the disinfection site from entry by unauthorized persons during the aeration process 2 Ventilate and aerate in accordance with structural limitations If possible it is recommended that treated air be vented outside of building 3 Turn on ventilating or aerating fans where appropriate 4 Use a suitable DMHP detector before reentry to determine disinfectant concentration example Drager PAC III or ATS PortaSens II 5 Keep written records of monitoring to document completion of aeration 6 Remove warning placards when aeration is complete 7 Inform business clients that employees or other persons may return to work or otherwise be allowed to re enter the aerated structure after a minimum of one hour once the room concentration reaches 1 ppm 4 7 CRITERIA FOR SUCCESSFUL DISINFECTION 1 All Cls that are properly recovered and evaluated exhibit a visible color change following exposure to DMHP 5 Sanosil Halo Fogger Use Instructions 5 1 Room Preparation CAUTION B
10. complete disinfection These factors must be considered in putting a DMP 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 user must read the entire label and equipment manuals and follow all directions carefully If the user has any questions about the development of a DMP contact Sanosil International or authorized distributor for further assistance PERSONNEL 1 Training and Certification of Applicators Prior to use applicators must be adequately trained and certified by Sanosil International or its authorized distributor or reseller on the hazards and label directions for Sanosil HALOMIST HFDS83EN_C December 2013 e bau Sanosil Halo Fogger User Manual with Sanosil HALOMIST 4 3 4 4 on the use and operation of the DMHP application equipment Sanosil HALOMIST monitoring procedures and when appropriate validation procedures 2 Confirm in writing that all personnel in and around the area to be fogged have been notified prior to application of the disinfectant Consider using a checklist that each employee initials indicating that they have been notified 3 Instruct all disinfection personnel about the hazards that may be encountered and about the selection of PPE including detection equipment 4 Confirm that all personne
11. detector example Drager PAC III or ATS PortaSens li applicator in appropriate PPE verifies safe hydrogen peroxide concentration level is at or below one ppm If level is not at or below one ppm wait an additional 10 minutes and re check Continue to check until safe health exposure level is at or below one ppm Treated room can be re occupied one hour after hydrogen peroxide concentration level is determined to be at or below 1 ppm 12 When treatment is complete unplug the Sanosil Halo Fogger from the power source 13 Store Sanosil Halo Fogger upright in a safe dry location It is not necessary to drain Sanosil Halo Fogger of disinfectant Disinfecting for High Humidity Environments and Applications Requiring Accelerated Room Re Entry Special Instructions A Prepare the room as outlined in Sections 5 1 Room Preparation and 5 2 Room Set Up then 1 Room humidity level of 30 50 or less is recommended before starting the treatment process Some rooms may have a higher humidity level which can extend the room re entry time Position the dehumidifier next to Sanosil Halo Fogger Verify that the dehumidifier s reservoir is empty or empty reservoir prior to use 2 Plug dehumidifier into the correct location on the Sanosil Power Module and then plug the power module into a standard grounded electrical wall outlet 3 Turn on dehumidifier set fan to highest speed setting Check humidity level with humidity sensor if
12. door to the room after you have exited Post a sign on the door indicating that the room should not be entered during treatment process Note time treatment process was started on room sign 9 After 30 seconds the status indicator light will turn solid red and the Sanosil Halo Fogger will begin to dispense Sanosil HALOMIST into the room It is likely that you will hear the Sanosil Halo Fogger running through the door 10 When the Sanosil Halo Fogger has finished dispensing the room will be full of atomized Sanosil HaloMist disinfectant The status indicator will remain illuminated red DO NOT ENTER ROOM at this time 11 The treated room must remain unoccupied until the minimum room re entry wait time has expired and hydrogen peroxide concentration level ppm has been checked 110 minutes is the minimum wait time for re entry length of wait time increases with room size See chart step 4 above Whenever possible delay re entry and allow treated room to remain unoccupied overnight for safety and maximum efficacy Hydrogen peroxide concentration levels must be at or below one ppm for safe room re entry Once safe levels are determined to be at or below one ppm it is recommended that venting to the outside be started to allow increased ventilation and airflow circulation in the room Uncover smoke detectors Upon expiration of room re entry wait time to assure occupational health levels are not exceeded using a handheld hydrogen peroxide
13. humidity level is above 50 let dehumidifier run until HFD583EN_C December 2013 A Io ay N Sanosil Halo Fogger User Manual with Sanosil HALOMIST 5 4 the humidity level is reduced to recommended level 4 Plug the Sanosil Halo Fogger into the correct location on the Sanosil Power Module When the power connection has been made the green status indicator light on top of the device will illuminate 5 Continue following steps section 5 3 Treatment Procedure Protocol Special Room Re Entry Instructions WARNING During the treatment process Sanosil HALOMIST mist liquid aerosol is dispensed Personal protection equipment including the use of an appropriate air respirator is required for hydrogen peroxide concentration levels exceeding safe re entry levels ppm 5 4 1 Early Room Re Entry In case of an emergency and or unknown levels of Hydrogen peroxide mist that may exceed applicable exposure limits within the treated room requires use of a Self Contained Breathing Apparatus SCBA or an airline respirator When entering into an area with the Sanosil Halo Fogger running always work with two or more people under the direct supervision of a trained applicator with all people wearing appropriate PPE 5 4 2 Re Entry to Sealed Room by Applicator Re entry to a sealed room by a trained applicator is allowed under the following circumstances a Only enter the room to perform a planned task e g to retrieve equi
14. precautionary statements Net Contents as indicated on container EPA Reg No 84526 EPA Est No as indicated on container See bottom or side for Lot Data code Questions Comments symbol of telephone Call 1 800 726 6765 or Visit us at www sanosilglobal com Made in USA Distributed by Sanosil International LLC 91 Lukens Drive New Castle Delaware 19720 or an authorized Sanosil Internationa distributor insert name Sanosil is a licensed trademark of Sanosil Ltd Switzerland Directions for Use It is a violation of Federal law to use this product in a manner inconsistent with the label For use as a microbial disinfectant fogging solution in environments minimally 1100 ft up to 3700 ft 104 m in size with a maximum height of 8 feet for disinfection of dry pre cleaned hard non porous non food contact surfaces in sealed spaces and rooms located in healthcare facilities and settings Do not deviate from standard cleaning regimes when using Sanosil HaloMist Use product only with Sanosil HaloFogger dispensing device following detailed instructions provided in the Sanosil HaloFogger User Manual Read and follow directions in user manual on room preparation room set up and treatment protocol and equipment operating procedures for HaloFogger device Sanosil HaloMist EPA Reg No 84526 A EPA Label 12 17 2013 Page 1 of S Product effectively kills the following pathogens Bacteria
15. the ductwork Cover any smoke detectors Sealing techniques can vary but most often includes polyethylene sheeting and adhesive tape Verify effectiveness of the sealing process by conducting an air draft potential analysis using a smoke stick test to ensure there are no leaks where openings have been sealed in the room 3 Open internal doors cupboards and drawers of room furniture unless specifically directed to leave them closed as in the operating room 4 Remove mattresses from beds Mattresses with non porous covers can be tilted up against side of bed Mattresses not protected with a non porous cover must be removed from room during treatment procedure 5 Monitor areas immediately adjacent to the fogged space to ensure levels are below TWA for DMHP l 6 If possible modify ambient conditions in the room to meet the following recommended parameters Temperature 202 C 22 C 682 F 42 F Relative Humidity between 30 50 7 Assure all personnel have vacated the treatment room prior to DMHP application Remove all plants animals beverages and food 8 Close all windows and seal door s from outside of room being treated 9 Applicators must not re enter the treated room until exposure levels of DMHP are at or below one ppm Do not release the treated room to the general public until 1 hour after a level of one ppm DMHP is achieved in the room 10 Placarding of Treatment Room The applicator must placard or po
16. PRECAUTIONARY STATEMENTS Hazards to Humans and Domestic Animals CAUTION Causes moderate eye irritation Avoid contact with eyes or clothing Wash thoroughly with soap and water after handling and before eating drinking chewing gum using tobacco or using the toilet FIRST AID If in Eyes 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 If on Skin Rinse skin immediately with plenty of water for 15 20 minutes The affected skin can turn white and itchy These symptoms will disappear within a few minutes Questions Comments or in case of an emergency call toll free 1 877 SANOSIL or 1 877 726 6745 Have the product container or label with you when calling a Poison Control Center or doctor or going for treatment 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 container in areas inaccessible to 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 Recycle if available or discard in trash If product leaking or spills should occur please dilute w
17. SUSLU W e Weve 2 24 sty U S ENVIRONMENTAL PROTECTION AGENCY FPA Reg Number Date of Issuance Office of Pesticide Programs 84526 6 DEC 18 2013 Sz Antimicrobials Division 7510P My 1200 Pennsylvania Avenue NW Term of Issuance Washington D C 20460 Conditional NOTICE OF PESTICIDE Name of Pesticide Product x Registration Sanosil Halomist Reregistration under FIFRA as amended Name and Address of Registrant include ZIP Code Sanosil International LLC 91 Lukens Drive Suite A New Castle DE 19720 On the basis of information furnished by the registrant the above named pesticide is hereby registered reregistered 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 exclusive use of the name or to its use if it has been covered by others The application referred to above submitted under the Federal Insecticide Fungicide and Rodenticide Act as amended is acceptable under FIFRA sec 3 c 7 A provided that you 1 Submit and or cite all data required for registration reregistrat
18. efore proceeding ensure that personnel who operate the Sanosil Halo Fogger have received appropriate training including e Review Sanosil Halo Fogger User Manual and Sanosil HALOMIST Labeling e Review Sanosil HALOMIST Material Safety Data Sheet 1 Remove porous curtains fabric and associated porous items from room including bed linens waste products and visible dirt 2 Cleaning All hard non porous surfaces with visible or non visible soils must be clean Wash soiled surfaces with a generic cleaning agent i e soap and water a multi purpose cleaner etc using a cloth sponge wipe or appropriate cleaning device to ensure visible soils are removed All the surfaces within the treatment area must be completely dry to the touch prior to initiating DMHP application IMPORTANT The Sanosil Halo Fogger does not replace the requirement for manual room cleaning You must follow facility s cleaning procedure before using the Sanosil Halo Fogger HFD583EN_C December 2013 C Sanosil Halo Fogger User Manual with Sanosil HALOMIST 5 2 Room Set Up 1 It is recommended that all ventilation systems including HVAC be turned off for the duration of the fogging process 2 Seal the room to be treated to ensure that DMHP levels outside the room are kept at acceptable levels and that there is adequate coverage of product within the room Seal any supply or return vents and duct work to prevent distribution of Sanosil HALOMIST through
19. et before moving the device 5 Clean debris from the device nozzle and funnel on a regular basis according to the instructions in this manual see Section 9 Maintenance 6 Regularly check disinfectant fluid level to ensure sufficient volume is present to treat each particular room size 7 Do not set the timer for longer than the suggested fogging time Excessive fogging can create condensation which may activate fire alarm systems 8 Protect this device from severe impact or shock 9 Take care to prevent water or other fluid from entering the device Should this occur allow to completely dry before use Check the accuracy of all operating functions 10 Do not tip the Sanosil Halo Fogger on its side at any time unless completely empty and dry 11 Store Sanosil Halo Fogger in an upright position in a safe dry location Do not place anything on top of the device 12 Additional warning and caution statements are included for Sanosil HALOMIST 7 Walk Around of Sanosil Halo Fogger 12 HFD583EN_C December 2013 C Sanosil Halo Fogger User Manual with Sanosil HALOMIST Rear Handle High Precision Nozzle lonized mist of disinfectant is dispersed via the nozzle Timer Dial Turn the dial to set time for fogging treatment Fogging Time Chari can be found on page 9 of this manual and on the rear panel of the Hato device Start Button Press and hold for 2 seconds to start room disinfecting Disinfectant Fluid Leve
20. il HALOMIST MSDS prior to fogging The Sanosil HALOMIST disinfectant is continuously fogged for the required dispensing time to maintain the desired concentration of the product mist The Sanosil Halo Fogger will automatically stop fogging at the selected time Sanosil HALOMIST decomposes into water and oxygen The Sanosil HALOMIST process can consist of 1 2 or 3 phases depending upon application 1 Dehumidification The Dehumidification phase is required only if the room to be disinfected is above 50 relative humidity In rooms with higher humidity levels the dispensing of product can be affected by increased condensation levels which can decrease the efficacy of the product Room air is first circulated in the sealed treatment room by the dehumidifier to reduce humidity to a predetermined level in the 30 50 relative humidity RH range This permits the target Dry Mist Hydrogen Peroxide DMHP concentration to be maintained below condensation levels during the disinfection phase The time to reach the targeted dehumidification level increases with the volume of the room and is dependent on environmental conditions 2 Disinfection For all disinfecting applications Sanosil HALOMIST is continuously fogged for a selected time to obtain the target DMHP concentration over a pre established period of time for the volume of the enclosed area It is recommended the room temperature be in the range of 202 C 22 C 682 F 42 F Whenever possible
21. ion registration review of your product when the Agency requires all registrants of similar products to submit such data a The Silver DCI was issued on July 6 2012 and you are responsible for addressing the data requirements outlined in the data call in A copy of the DCI can be located in the Docket for this active ingredient http www regulations gov documentDetail D EPA HQ OPP 2009 0334 0032 If you have specific questions about the DCI contact Rose Kyprianou at 703 305 5354 2 Submit a one year study required to satisfy the storage stability and corrosion characteristics requirements Guidelines 830 6317 and 830 6320 You have 18 months from the date of registration to provide these data A stamped copy of your labeling is enclosed for your records Submit a final printed label before distributing or selling this product The basic CSF dated 1 10 13was found to be acceptable Marshall Swindell Product Manager Team 33 Regulatory Management Branch 1 Antimicrobials Division 7510P EPA Form 8570 6 Sanosil HaloMist Disinfectant Fogging Solution Effective against Clostridium difficile Spores For Use in Healthcare Facilities with a minimum area of 1100 ft and maximum of 3700 ft Active Ingredients Hydrogen Peroxide 5 00 SIV enina 0 01 Other Ingredients 94 99 TOtal donneri 100 00 KEEP OUT OF REACH OF CHILDREN CAUTION See back side right left panel for additional
22. ith water and dry with absorbent material or dilute with water as it is flushed into waste water drain Sanosil HaloMist EPA Reg No 84526 A EPA Label 12 17 2013 Page 5 of 5 1 Sanosil Halo Fogger User Manual with Sanosil HALOMIST Table of Contents Sanosil Halo Fogger User Manual 1 General Information 1 1 Sanosil HALOMIST DEC 18 2013 2 Sanosil HALOMIST Application Process pesticide registered PA Reg No aa l 3 User Safety Requirements 4 Disinfection Management Plan 4 1 General 4 2 Personnel 4 3 Monitoring 4 4 Sealing Procedures 4 5 Application Procedures and Disinfection Period 4 6 Post Application Operation 4 7 Criteria for Successful Disinfection 5 Sanosil Halo Fogger Use Instructions 5 1 Room Preparation 5 2 Room Set Up 5 3 Treatment Procedure Protocol 5 4 Re Entry Instructions 5 5 Releasing Room for Re Occupancy 6 Precautions 6 1 Caution Statements 6 2 Operation Warnings 7 Walk Around of Sanosil Halo Fogger 8 Getting Started with the Sanosil Halo Fogger 8 1 Setup and Filling 9 Maintenance 9 1 Nozzle Cleaning and Alignment 9 2 Funnel Cleaning HFD583EN_C December 2013 j Under the Federal Insecticid ici he e Fi f Rodenticide Act as amended ior the t Sanosil Halo Fogger User Manual with Sanosil HALOMIST 10 11 12 13 14 Troubleshooting Replacement Parts Re Order Number Storage and Disposal Specifications of Sanosil Ha
23. l indicator Indicates how much disinfectant is in the reservoir and wher it is time to refill Reservoir Door Push and flip open for easy access and refilling Front Handle Reservoir Door Large Wheels For easy maneuvering Funnel Opening Use care to avoid splashing when pouring disinfectant Power Cord Connection Insert the power cord inte the receptacle located on the rear of the Halo Getting Started with the Sanosil Halo Fogger HALO 8 1 Setup and Filling 1a Joy TN Status indicator Light Displays the current status of the Halo device Green indicates one of the following Plugged in and ready for use Treatment process is compiere SENNEN Flashing Green Indicates one of the following Reservoir Door is not closed correctly lt An error has occured Refer lo froubleshooting section of His manual page 1 VEL Flashing Red Indicates 30 second countdown after the Start button has been pushed Red indicates the device is an and dispensing disinfectant The room should be unoccupied THE SANOSIL HALO FOGGER IS DESIGNED FOR USE WITH SANOSIL HALOMIST AND SHOULD NOT BE OPERATED WITH ANY OTHER MANUFACTURER S DISINFECTING OR CLEANING PRODUCT Setup Instructions Locate the connector end of the power cord Insert the connector into the power receptacle HFDS83EN_C December 2013 13 7 3 tolma Sanosil Halo Fogger User Manual with Sanosil HALOMIST 9
24. l are aware of and know how to proceed in case of an emergency situation 5 Instruct all personnel on how to report any accident or incidents related to disinfectant exposure 6 Establish a meeting area for ail personnel in case of emergency 7 Confirm that all applicators have been trained in the use of Sanosil HALOMIST and are in good standing including the required refresher training 8 Develop a Worker Health and Safety Plan as required by OSHA for applicators The owner and operators of the facility being treated should have a Worker Health and Safety Plan as required by OSHA developed for their employees located within close proximity of the application process MONITORING A Perimeter safety 1 Monitoring of Sanosil HALOMIST concentrations must be conducted immediately adjacent to the fogged space to prevent excessive exposure and to determine where exposure may occur Document where monitoring will occur 2 Keep a log or manual of monitoring records for each disinfection site This log must at a minimum contain the timing number of readings taken and level of concentrations found in each location 3 When monitoring for leaks document that there is no DMHP present above the 1 0 ppm level Subsequent leak monitoring is not routinely required However spot checks must be made especially if conditions significantly change 4 Monitoring must be conducted during aeration and corrective action taken if H20 levels exceed
25. lo Fogger HFD583EN_C December 2013 Sanosil Halo Fogger User Manual with Sanosil HALOMIST 1 General Information 1 1 Sanosil HALOMIST Sanosil HALOMIST has been registered by Sanosil International in accordance with Federal Regulations for the specific uses described in this package insert Uses other than as specified and described are not permitted and may not be effective in the disinfection of exposed surfaces in pre cleaned sealed rooms Sanosil HALOMIST Disinfectant Application Process Only Sanosil HALOMIST should be used in the Sanosi Halo Fogger Effective application of Sanosil HALOMIST requires adequate product concentration and exposure time The Sanosil Halo Fogger is designed to achieve the correct concentration and contact time of Sanosil HALOMIST within a defined area Read the Sanosil Halo Fogger User s Manual prior to initiating the application process to determine the appropriate steps to take in development and application of the process Sanosil HALOMIST is applied at a rate of approximately 1 0 oz per minute for a minimum of 10 minutes and maximum of 60 minutes depending upon the room size For use in rooms 1100 ft up to 3700 ft Do not use in rooms smaller than 1100 ft The Sanosil Halo Fogger uses air as a carrier to deliver a dry mist suspension of small liquid droplets in the air of Sanosil HALOMIST to exposed surfaces inside a sealed room for a selected time based on the size of the room Read the Sanos
26. mended run time of the Sanosil Halo Fogger 3 Plug the Sanosil Halo Fogger into a standard grounded electrical wall outlet When the power connection has been made the green status indicator light on top of the device will illuminate 4 Using the chart below also found on the rear of the device or in the Sanosil Halo Fogger User Manual determine the Fogging Time based on the room size cu ft or m3 from Step 2 above Minimum Wait Time Before Room Re Entry by Fogging Checking H202 Applicators 60 3 Minutes Room Size m Time Level ppm and ventilation has been completed 5 Turn the timer dial on the top of the Sanosil Halo Fogger to the number of minutes specified for your room size Do not set the timer for longer than the suggested time Excessive fogging can cause condensation which may reduce effectiveness and may activate fire alarm systems 6 Check the fluid level indicator lights to see level of Sanosil HALOMIST in the Sanosil Halo Fogger It is recommended the unit reservoir be topped off before proceeding with the treatment process Refer to the Setup and Filling Section 8 1 7 Press and hold the Sanosil Halo Fogger Start button for 2 seconds The green status indicator light will begin to flash red indicating that you have 30 seconds to leave the room before the HFD583EN_C December 2013 Sanosil Halo Fogger User Manual with Sanosil HALOMIST Sanosil Halo Fogger device begins to operate 8 Close the
27. nd a wall outlet Then check to see that the wall outlet is working The green status indicator light should be illuminated when properly set up Close Reservoir Door making sure it clicks when closed Call Sanosil Customer Service Check to make sure that the power cord is plugged into both the Fogger and the wall outlet Then check to see that the outlet is working The green status indicator light should be illuminated when properly set up Call Sanosil Customer Service 16 Ta Sanosil Halo Fogger User Manual with Sanosil HALOMIST 11 12 13 14 Disinfecting procedure is Power loss during Confirm power has been restored interrupted treatment process or Re enter room one hour after hydrogen other unforeseen peroxide concentration level is determined circumstances to be at or below 1 ppm and ventilation process has been completed Restart treatment process from beginning Replacement Parts To order replacement parts contact Sanosil Customer Service at 1 877 726 6745 Monday through Friday 9 00AM to 5 00PM EST For International calls dial 1 302 454 8102 Part Part Number 110V Power Cord 8 0750 110VPC 220V Power Cord 8 0750 220VPC International 220V Plug Adapter Kit 0750 220VADPK Nozzle includes nozzle and bolt 0750 000 Re Order Number Part Part Number 110V Sanosil Halo Fogger US and Canada 0750 110 220V Sanosil Halo Fogger 0750 220 Sanosil HALOMIST Case of four
28. pment open windows augment aeration process etc and leave the room in the shortest time possible b Always wear wrap around style goggles to protect against irritation of eyes c Determine Hydrogen peroxide levels prior to room entry using a handheld hydrogen peroxide detector example Drager PAC III or ATS PortaSens II d Hydrogen Peroxide levels between 1 and 10 ppm requires at least half face piece respirator and appropriate eye protection with either 3M 6003 or 6006 organic vapor acid gas or multi gas cartridge in combination with particulate filter i e 5N11 or 5P71 e Using a full face piece respirator when quantitatively fit tested with either cartridge mentioned in 5 4 2 c gives an Assigned Protection factor of 50 for use up to SOppm of Hydrogen Peroxide 3M Technical Bulletin 185 and Solvay Chemicals Technical Communication TDS No HOOH PAA RESP Otherwise do not re enter the treated room until one hour after exposure levels are at or below one ppm and the ventilation process has been completed 10 HFD583EN_C December 2013 C IF a4 Sanosil Halo Fogger User Manual with Sanosil HALOMIST 5 5 Releasing Treated Sealed Room for Return to Service and the General Public 1 The treated room can be released for general public use one hour after OMHP levels are determined to be at or below one ppm and the ventilation process has been completed If possible it is recommended that treated air be vented to
29. reas like nooks and crannies Use this product in use sites Kills eliminates 99 9999 of Clostridium difficile C diff spores Kills eliminates 99 99 of Pseudomonas aeruginosa Pseudomonas bacteria Kills eliminates 99 99 of Staphylococcus aureus Staphylococcus Staph bacteria Multiple Multi faceted killing mechanism s Multiple Multi faceted mechanisms of killing action Multiple modes of killing action Specific Disinfecting Claims Kills eliminates bacteria Clostridium difficile C diff spores Kills eliminates 99 9999 of Clostridium difficile C diff spores Kills eliminates Pseudomonas aeruginosa Pseudomonas bacteria Kills eliminates 99 99 Pseudomonas aeruginosa Pseudomonas bacteria Kills eliminates Staphylococcus aureus Staphylococcus Staph bacteria Kills eliminates 99 99 of Staphylococcus aureus Staphylococcus Staph bacteria First disinfectant disinfecting fogging solution formula product proven to kill eliminate bacteria Clostridium difficile C diff spores EPA registered disinfectant disinfecting fogging solution formula product for whole complete room surface disinfection disinfecting An effective disinfectant solution formula product for use in healthcare facilities An effective disinfectant solution formula product for use in healthcare facilities for whole complete room surface disinfection disinfecting An effec
30. rming any maintenance to the Halo disconnect the power cord from the electrical outlet Nozzle Cleaning and Alignment To avoid build up of deposits in the nozzle it is recommended that you clean the nozzle on the Halo on a regular basis Correct alignment of the nozzle is critical for optimal performance Step 1 Unplug Halo from power source Step 2 Remove Nozzle Using adjustable pliers Step 3 Separate Parts Remove Main Bolt from carefully turn nozzle counter clockwise 90 Nozzle Insert Soak both parts in a conventional and remove household de liming agent for two hours Rinse parts thoroughly with water Step 4 Reassemble Nozzle Carefully insert the Main IMPORTANT Posit Bolt back into the Nozzle Insert Make sure the gap surrounds the nozzle tip wings on the Main Bolt nest into the slots down inside the Nozzle insert Funnel Cleaning The fluid funnel inside the Halo device should be checked for debris on a regular basis Visually inspect the funnel If any debris is present wipe with a clean towel dampened with water AD ae Ensure that the funnel screen is in place Step 5 Carefully reinstall the nozzle into the Halo turning nozzle clockwise 90 to lock into place Test Halo for straightness of nozzle stream 9 2 Funnel Cleaning The fluid funnel inside the Sanosil Halo Fogger should be checked for debris on a regular basis Visually inspect the funnel If any debris is present wipe with
31. sinfecting can t Reduce s the risk of cross contamination associated with using a rag wipe or sponge Reduce s labor costs Disinfectant Disinfects Daily Multi action Multi purpose Multi room Multi surface Disinfectant Kills pathogenic bacteria Sanosil HaloMist meets EPA standards for healthcare hospital grade disinfectant Controls odors caused by bacteria Deodorizes by killing bacteria that causes odor s Deodorizing by killing odor causing bacteria at their source Eliminates removes odors caused by bacteria Gets rid of odors by killing the bacteria that cause them Sanosil HaloMist EPA Reg No 84526 A EPA Label 12 17 2013 Page 2 of S 2124 J i u ri N General Performance Claims continued Helps prevent the build up of odors by killing odor causing bacteria on hard pre cleaned non porous non food contact surfaces l Disinfects hard pre cleaned non porous non food contact surfaces in use sites For hospital healthcare medical semi critical care long term care environments For use in hospital s healthcare medical semi critical alcatel long term care environments as a disinfectant For use on hard pre cleaned non porous surfaces located in use sites Great suitable for whole complete room disinfecting disinfection Treats does not cover up no residue no need to rinse after use as a disinfectant Use on hard to reach a
32. st all entrances to the designated buffer zones with signs in English bearing 1 The signal word CAUTION PRECAUTION in red 2 Area under treatment DO NOT ENTER NO ENTRY 3 The statement This sign may only be removed after the treatment of enclosed area one hour after DMHP levels are less than or equal to one ppm 4 Identification of Sanosil HALOMIST disinfectant as a hazard associated with the treatment process 5 Contact information for the applicator All entrances to the treatment room must be placarded Placards must be placed in advance of the treatment in order to keep unauthorized persons from entering the treated room Placards can be removed one hour after the treatment room contains concentrations of DMHP are at or below 1 ppm and the ventilation process has been completed HFD583EN_C December 2013 Sanosil Halo Fogger User Manual with Sanosil HALOMIST 5 3 Fogging Time Treatment Procedure Protocol 1 Position the Sanosil Halo Fogger in a corner of the room approximately one foot away from the wall pointing the nozzle towards the center of the room Choose a corner farthest away from vents ductwork and door IMPORTANT Dispensing airflow path from the Sanosil Halo Fogger must remain unobstructed during entire treatment procedure 2 Measure the length width and height of the room Round up to the nearest cubic foot or cubic meter These measurements will determine the final room size and recom
33. the allowed levels in an area where bystanders or nearby residents may be exposed Ensure that the adjacent areas where levels have exceeded 1 ppm are evacuated by general personnel and that proper respiratory protection is utilized by applicators that enter the area Continue monitoring the area until levels are below 1 ppm DMHP The treated room and adjacent areas must remain unoccupied until one hour after DMHP levels are at or below 1ppm B Efficacy 1 Proper placement of Chemical Indicators Cis in all areas of the room to assure consistent delivery 2 Document Sanosil Halo Fogger run times temperature room humidity and Cl color change SEALING PROCEDURES 1 Sealing must be adequate to prevent any leaks Care should be taken to ensure that sealing materials remain intact until the disinfection is complete Verify effectiveness of the sealing process by conducting a smoke stick test to ensure there are no leaks where openings have been sealed in the room 2 if the structure and or area has been fogged before review the previous DMP information 3 Make sure that construction or remodeling has not changed the building in a manner that will affect the disinfection process HFOS83EN_C December 2013 P IZI Sanosil Halo Fogger User Manual with Sanosi HALOMIST 4 Warning placards must be placed on every possible entrance to the disinfection site 4 5 APPLICATION PROCEDURES AND DISINFECTION PERIOD 1 Plan carefully and
34. the outside of the building 2 Once DMHP levels are determined to be at or below one ppm applicators may re enter the treated room and remove any sealing materials including any covered fire alarms and disconnect or remove the Sanosil Halo Fogger from the treated sealed room 3 Turn on ventilation systems to the outside if available 4 Remove placards and release the treated room for normal operation and use one hour after the levels of DMHP are determined to be at or below one ppm 6 Precautions 6 1 Caution Statements A caution statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to serious injury or death 1 KEEP OUT OF REACH OF CHILDREN 2 Carefully read all instructions warnings cautions and first aid statements prior to use 3 Do not enter room while the Sanosil Halo Fogger is in use Keep door and windows closed 4 Use only as directed 5 Allow Room Re entry Wait Time to expire before re occupying the room Re entry before wait time has expired could result in sensory irritation and should only be done while using proper personal protection equipment PPE including at a minimum wrap around style goggles N 95 respirator mask and gloves 6 Avoid inhalation of vapors or skin and eye contact with Sanosil HALOMIST fog 7 The Sanosil Halo Fogger is designed for ease of use However only properly trained individuals should use this device
35. tive disinfectant solution formula product for use in hospitalis healthcare medical semi critical care long term care environments An effective disinfectant solution formula product for use in hospital s healthcare medical semi critical care long term care environments for whole complete room surface disinfection disinfecting Effective against bacteria Sanosil HaloMist EPA Reg No 84526 A EPA Label 12 17 2013 Page 3 of 5 Specific Disinfecting Claims continued Kills eliminates bacteria odors and deodorizes Surface Disinfectant Whole Complete Room Surface Disinfectant surfaces This product heips aids in the reduction of cross contamination of bacteria on hard pre cleaned non porous surfaces This product helps fight the spread of bacteria on hard pre cleaned non porous surfaces You can Use this product in places that are difficult to disinfect sanitize reach such as nooks and crannies Kills eliminates destroys bacteria on hard non porous surfaces On hard pre cleaned non porous non food contact surfaces this product kills eliminates bacteria This product reduces the risk of cross contamination of bacteria on hard pre cleaned non porous Healthcare Use Sites 3700 ft Ambulatory Surgical Centers ASC Anesthesia Rooms or Areas Assisted Living or Full Care Nursing Homes CAT Laboratories Central Service
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