Safety Glasses SafeView Fit Over Clear Tint Assorted Color Frames Over Ear One Size Fits Most Features For use in situations which may involve splashing or spraying Designed to be lightweight for added comfort in use Single-use lenses may be easily replaced into reusable frames Designed to be easily worn over most prescription glasses Can be used with SAFEVIEW Eyewear Replacement Lenses (item SV250L sold separately) Manufacturer # SV50A Brand SafeView Manufacturer O&M Halyard Inc Country of Origin Mexico Application Safety Glasses Fastening Type Over Ear Frame Color Assorted Color Frames Frame Material Rubber Frame Lens Tint Clear Tint Size One Size Fits Most Style Fit Over UNSPSC Code 46181802

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Protective fluid-resistant 3-layer SMS fabric 21 X 30 X 49 inch Ultrasonically sealed seams Application Protective Procedure Gown Back Style Full Back Color Blue Cuff Style Knit Cuff Fastening Type Hook and Loop Neck / Waist Tie Material SMS Protection Level Not Rated Sleeve Style Long Sleeve Sterility NonSterile Type Over-the-Head / Isolation

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Tape-tab neck closure Tie waist Lightweight 3-layer SMS fabric Hot melt glued seams Specifications    Brand Halyard Basics Manufacturer O&M Halyard Inc Country of Origin China Application Protective Procedure Gown Back Style Full Back Color Yellow Cuff Style Elastic Wrist Fastening Type Tape Tab Neck / Waist Tie Material SMS Protection Level AAMI Level 2 Sleeve Style Long Sleeve Sterility NonSterile Usage Disposable

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Designed to meet established industry performance standards for lower-fluid, shorter procedures SMS fabric for barrier protection Book fold Manufacturer # 99284 Brand Halyard Basics Manufacturer O&M Halyard Inc Country of Origin Honduras Application Non-Reinforced Surgical Gown with Towel Back Style Full Back Color Blue Cuff Style Knit Cuff Fastening Type Hook and Loop Neck / Waist Tie Material SMS Size Large Sleeve Style Long Raglan Sleeve Sterility Sterile Type Fluid Resistant UNSPSC Code 42131702 Usage Disposable

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Non-reinforced, for low to moderate fluid contact Flame resistance: meets NFPA industry standard for low ignition Lint and abrasion resistance: reduces the risk of lint contamination in the wound and related post-operative complications Yellow neck binding Specifications Brand Ultra Manufacturer O&M Halyard Inc Country of Origin China Application Non-Reinforced Surgical Gown with Towel Back Style Full Back Color Blue Cuff Style Knit Cuff Fastening Type Hook and Loop Neck / Waist Tie Material SMS Protection Level AAMI Level 3 Sleeve Style Long Raglan Sleeve Sterility Sterile Usage Disposable

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Exam Glove Halyard Lavender NonSterile Nitrile Standard Cuff Length Textured Fingertips Lavender Halyard Health LAVENDER* Nitrile Exam Gloves are thinner, lighter and more economical than standard nitrile, yet they retain the protective properties required for excellent performance across a wide range of healthcare tasks They're the ideal replacement for vinyl exam gloves, providing more reliable protection, better performance, and more comfort than vinyl Textured fingertips enhance wet and dry grip Higher count per box saves space and waste 250 eaches per box Brand Halyard™ Lavender™ Manufacturer O&M Halyard Inc Country of Origin Thailand Application Exam Glove Color Lavender Color Family Lavender Cuff Style Beaded Cuff Fingertip Thickness Range 2 mil to 4 mil Range Fingertip Thickness: Typ.Values 0.07 mm (2.8 mil) Glove Exterior Textured Fingertips Glove Interior Without Coating Glove Length Standard Cuff Length Hand Compatibility Ambidextrous Length in Inches 9.5 Inch Material Nitrile Protection Level Not Rated Size X-Small, through X-Large  Sterility NonSterile

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Exam Glove Halyard Lavender Small NonSterile Nitrile Standard Cuff Length Textured Fingertips Lavender Halyard Health LAVENDER* Nitrile Exam Gloves are thinner, lighter and more economical than standard nitrile, yet they retain the protective properties required for excellent performance across a wide range of healthcare tasks They're the ideal replacement for vinyl exam gloves, providing more reliable protection, better performance, and more comfort than vinyl Textured fingertips enhance wet and dry grip Higher count per box saves space and waste 250 eaches per box/ 10boxes per case. Brand Halyard™ Lavender™ Manufacturer O&M Halyard Inc Country of Origin Thailand Application Exam Glove Color Lavender Color Family Lavender Cuff Style Beaded Cuff Fingertip Thickness Range 2 mil to 4 mil Range Fingertip Thickness: Typ.Values 0.07 mm (2.8 mil) Glove Exterior Textured Fingertips Glove Interior Without Coating Glove Length Standard Cuff Length Hand Compatibility Ambidextrous Length in Inches 9.5 Inch Material Nitrile Protection Level Not Rated Size X-Small, through X-Large  Sterility NonSterile

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Comes with white and blue colors that are bonded together - inspect trays easier and faster than ever Superior microbial barrier protection with patented Powerguard technology H500 grade is for heavy instrument sets, retractors and applications where frequent handling occurs - for 13 to 17 lbs tray weight Made from recyclable number 5 polypropylene fabric HALYARD* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider using: Pre-vacuum steam at 270°F/132°C for 4 minutes, 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes, Lumen, Non Lumen and Flexible Cycles in the STERIS V-PRO® 1, STERIS V-PRO® 1 Plus and STERIS V-PRO® maX Low Temperature Sterilization Systems, Gravity steam at 250°F/121°C for 30 minutes (25 minute dry time for Models 100, 200 and 300 and 30 minute dry time for Models 400, 500 and 600), and Advanced Sterilization Products STERRAD® Sterilization Systems: STERRAD® 50, 100S and 200, STERRAD® NX [Standard Cycle, Advanced Cycle], STERRAD® 100NX [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle) Do not use wrap in dry heat or radiation sterilization methods Specifications Manufacturer O&M Halyard Inc Country of Origin China Application Sterilization Wrap Color White / Blue Grade H500 Layer Dual Layer Material SMS Polypropylene Sterilization Compatibility Steam / EO Gas / Hydrogen Peroxide Usage Disposable

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Comes with white and blue colors that are bonded together - inspect trays easier and faster than ever Superior microbial barrier protection with patented Powerguard technology Made from recyclable number 5 polypropylene fabric H100 grade is for use with light linen packs, linen gowns, towel packs, single basins and other lighter wrapping needs - for 0 to 3 lbs tray weight HALYARD* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider using: Pre-vacuum steam at 270°F/132°C for 4 minutes, 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes, Lumen, Non Lumen and Flexible Cycles in the STERIS V-PRO® 1, STERIS V-PRO® 1 Plus and STERIS V-PRO® maX Low Temperature Sterilization Systems, Gravity steam at 250°F/121°C for 30 minutes (25 minute dry time for Models 100, 200 and 300 and 30 minute dry time for Models 400, 500 and 600), and Advanced Sterilization Products STERRAD® Sterilization Systems: STERRAD® 50, 100S and 200, STERRAD® NX [Standard Cycle, Advanced Cycle], STERRAD® 100NX [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle) Do not use wrap in dry heat or radiation sterilization methods Manufacturer # 34154 Brand QUICK CHECK* H100 Manufacturer O&M Halyard Inc Country of Origin China Application Sterilization Wrap Color White / Blue Dimensions 12 X 12 Inch Grade H100 Layer Dual Layer Material SMS Polypropylene Sterilization Compatibility Steam / EO Gas / Hydrogen Peroxide UNSPSC Code 42281902 Usage Disposable

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Armboard Covers Absorbent Fabric Reinforcement With tube holders Specifications Country of Origin Mexico Application Abdominal Drape Color Blue Drape Name Laparotomy Drape Extremity Cover Arm Covers / Anesthesia Screen Fluid Collection Type Without Pouch Instrument Holders Without Instrument Holder Material Polypropylene Securing Method Adhesive Sterility Sterile Surgical Area Fenestrated Surgical Area Specifications Rectangle 4 X 12 Inch Fenestration Tube and Cord Holders Cord and Tube Holders

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Manufacturer O&M Halyard Inc Country of Origin Mexico Application EENT Drape Color Blue Dimensions 76 W X 124 L Inch Drape Name EENT Split Drape Extremity Cover Without Covers Fluid Collection Type Without Pouch Instrument Holders Instrument Pad Reinforcement Type Instrument Pad Reinforcement Securing Method Adhesive Split Sterility Sterile Surgical Area Split Surgical Area Specifications Split 3 X 25 Inch Tube and Cord Holders Cord and Tube Holders

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Sequential wrap Low lint SMS Fabric KC400 is the fourth of six strength levels in the KIMGUARD* line and is made of our newest SMS sterilization fabric - for 9 to 13 lbs tray weight It’s medium blue, softer and stronger than ever and still delivers the barrier protection you expect from the leader in sterilization packaging Often used for instrument sets, procedure trays and drills Manufacturer O&M Halyard Inc Country of Origin United States Application Sterilization Wrap Color Medium Blue Grade H400 Layer Single Layer Material SMS Polypropylene Sterilization Compatibility Steam / EO Gas

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Extra-wide fabric reinforcements Adjustable neckline with green neck binding - hook and loop Book fold Manufacturer O&M Halyard Inc Country of Origin Honduras Application Fabric-Reinforced Surgical Gown with Towel Back Style Full Back Color Blue Cuff Style Knit Cuff Fastening Type Hook and Loop Neck / Waist Tie Material SMS Protection Level ASTM D4966 Sleeve Style Long Raglan Sleeve Sterility Sterile Usage Disposable

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Sequential wrap Low lint SMS Fabric KC600 is the highest of six strength levels in the KIMGUARD* line and is made of our newest SMS sterilization fabric - for 17 to 25 lbs tray weight It’s dark blue, softer and stronger than ever and still delivers the barrier protection you expect from the leader in sterilization packaging Often used for extra heavy instrument sets such as orthopedics and cardiovascular sets Manufacturer O&M Halyard Inc Country of Origin United States Application Sterilization Wrap Color Dark Blue Grade H600 Layer Single Layer Material SMS Polypropylene Sterilization Compatibility Steam / EO Gas Usage Disposable

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PURPLE NITRILE* Exam Gloves are frequently the glove of choice for healthcare workers who need outstanding barrier protection from bacteria, viruses and chemicals during procedures where risk of fluid exposure is moderate to high They have been tested against 29 chemotherapy drugs per the ASTM D6978-05 as well as common chemicals found in the healthcare environment Custom design enhances comfort and fit Textured fingertips enhance wet and dry grip Meets ASTM requirements for testing parameters for specific hazardous drugs-http://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare Manufacturer O&M Halyard Inc Country of Origin Thailand Application Exam Glove Color Purple Color Family Lavender Cuff Style Beaded Cuff Fingertip Thickness Range 4.1 mil to 6.0 mil Range Fingertip Thickness: Typ.Values 0.14 mm (5.5 mil) Glove Exterior Textured Fingertips Glove Interior Without Coating Glove Length Standard Cuff Length HCPCS A4927 Hand Compatibility Ambidextrous Length in Inches 9.5 Inch Material Nitrile Protection Level Chemo Tested Sterility NonSterile Type Unspecified

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No potential fluid contact Manufacturer O&M Halyard Inc Country of Origin China Application Bouffant Cap Color Blue Dimensions 24 Inch Circumference Fastening Type Elastic Closure Material 1-Layer Spunbond Size Large Sterility NonSterile Usage Disposable

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3-Layer SMS fabric These protective shoe covers cover the shoe only and are designed for light fluid contact They have six adhesive traction strips on the bottom for stability and sealed seams to help prevent strike-through Manufacturer O&M Halyard Inc Country of Origin China Application Shoe Cover Color Blue Fastening Type Elastic Closure Material SMS Sole Type Nonskid Sole Sterility NonSterile Style Shoe High Usage Disposable

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Manufacturer O&M Halyard Inc Country of Origin China Application Sterilization Tray Liner For Use With For Pre-vaccum Steam and EO Sterilization Specifications 20 X 25 Inch

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Ice pack is made with Stay-Dry™ construction and delivers up to 2-1/2 hours of consistent, dry cold therapy Features a 3-layer construction, which helps reduce wetness due to condensation, minimizes leaking, and has a soft outer covering Easy to fill opening with a clip closure Has 4 ties for added support and versatility 25 per Box Manufacturer O&M Halyard Inc Country of Origin Mexico Activation Method Add Ice Application Ice Bag Dimensions 6-1/2 X 12 Inch Material Stay-Dry™ Material Securing Method Clamp Closure / Tie Straps Size Large Target Area General Purpose Temperature Duration Up to 2-1/2 Hours Usage Reusable

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Made with lightweight spunbond fabric and are designed to cover hair in no fluid contamination environments Manufacturer O&M Halyard Inc Country of Origin China Application Bouffant Cap Color Blue Dimensions 27 Inch Circumference Fastening Type Elastic Closure Material Spunbond Size X-Large Sterility NonSterile Usage Disposable

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Universal size, best suited for use in situations where there is no fluid contamination anticipated. Manufacturer O&M Halyard Inc Country of Origin China Application Surgeon Cap Color Blue Fastening Type Tie Closure Material 4-Ply Tissue Size One Size Fits Most Sterility NonSterile Usage Disposable

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Manufacturer O&M Halyard Inc Country of Origin Mexico Application General Purpose Drape Color Blue Dimensions 55 W X 76 L Inch Drape Name Large Drape Extremity Cover Without Covers Fluid Collection Type Without Pouch Instrument Holders Without Instrument Holder Material SMS Fabric Securing Method Without Adhesive Sterility Sterile Surgical Area Nonfenestrated Tube and Cord Holders Without Cord and Tube Holders

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Puncture Resistant, reinforces fabric across the entire surface designed for use with light to mid-weight trays and instruments Lower linting - to reduce risk of wound contamination Flexible, drapable fabric in a choice of sizes to make setup quick and easy Manufacturer O&M Halyard Inc Country of Origin Mexico Application Back Table Cover Color Light Blue Dimensions 44 X 90 Inch For Use With Trays and Instruments Material Standard Fabric Reinforcement Type Zone-Reinforced Sterility Sterile

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Higher count per box saves space and reduces waste Their unique nitrile formulation lets AQUASOFT* Gloves offer comfort and tactile sensitivity comparable to latex without the risk of latex skin irritation and allergies Country of Origin Malaysia Application Exam Glove Color Blue Color Family Blue Cuff Style Beaded Cuff Fingertip Thickness Range 2 mil to 4 mil Range Fingertip Thickness: Typ.Values 0.08 mm (3.1 mil) Glove Exterior Textured Fingertips Glove Interior Without Coating Glove Length Standard Cuff Length Hand Compatibility Ambidextrous Length in Inches 9.5 Inch Material Nitrile Protection Level Chemo Tested Sterility NonSterile Type Unspecified

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Shoe and lower leg coverage Plastic film coating over SMS fabric; two 1 inch urethane foam traction strips Heavy fluid contact Manufacturer O&M Halyard Inc Country of Origin China Application Boot Cover Color Blue Fastening Type Elastic Closure Material Plastic Film Coated SMS Size One Size Fits Most Sole Type Nonskid Sole Sterility NonSterile Style Knee High Usage Disposable

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Best suited for those procedures in which little potential fluid contact is anticipated 3-Layer SMS fabric Country of Origin China Application Shoe Cover Fastening Type Elastic Closure Material SMS Size One Size Fits Most Sterility NonSterile Style Shoe High Usage Disposable

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Manufacturer O&M Halyard Inc Country of Origin China Application Sleeve Protector Color Blue Dimensions 6 X 23-1/2 Inch Fastening Type Elastic Closure Material SMS Size One Size Fits Most Sterility Sterile Usage Disposable

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Medium-weight SMS fabric 24 X 30 X 50 inch Hot melt glued seams Hot seams Country of Origin Mexico Application Protective Procedure Gown Back Style Full Back Cuff Style Elastic Wrist Fastening Type Tape Tab Neck / Waist Tie Material SMS Protection Level AAMI Level 2 Sleeve Style Long Sleeve Sterility NonSterile Type Over-the-Head / Isolation Usage Disposable

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Designed to resist moderate fluid strike-through Brand FluidShield Manufacturer O&M Halyard Inc Country of Origin Mexico Application Procedure Mask Bacterial Filtration Efficiency BFE ≥98% Color Blue Fastening Type Earloops Fluid Resistance 120 mmHg Particle Filtration Efficiency PFE ≥98% Protection Level ASTM Level 2 Size One Size Fits Most Sterility NonSterile Style Pleated User Adult

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Chemical Indicator, strips printed with reactive ink for Plasma or Vaporized Hydrogen Peroxide sterilization processes.Internal Control. Metals Free. Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are single-use chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. Innovative highly sensitive red ink was developed to turn to yellow when the indicator is exposed to Plasma or Vaporized Hydrogen Peroxide. Endpoint condition: 50 ºC, 6 minutes, 2.3 mg/l H2O2. Indicators 100% free of toxic heavy metals. Instructions For Use: Place a Chemdye® CD42 Process Indicator within each package, bag or tray that will be sterilized by Plasma or Vaporized Hydrogen Peroxide. In rigid containers, place the indicator in every corner, or at least two diagonally opposite corners, to ensure that the sterilization agent has reached the most inaccessible areas. Perform the sterilization cycle. After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Plasma or Vaporized Hydrogen Peroxide, the ink must turn to the yellow reference color when the sterilization parameters are reached. For reference color, please refer to Result Reference Guide. More Info About This Product: Color Chart

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CD40 / Multi-variable Chemical Indicator, strips printed with reactive ink for Plasma or Vaporized Hydrogen Peroxide sterilization processes. Control of plasma or vaporized H2O2 sterilization processes. Conditions: 6 minutes, 50 °C, 2,3 mg/l H2O2. Characteristics: Type 4 Chemical Indicator (according to ISO 11140-1). Strips printed with indicator ink. Size: 105 x 18 mm (approximate). Initial color: Purple. Final color: Green. 100 % Toxic Heavy Metals free. Instructions For Use: Place a Chemdye® CD40 Multivariable Process Indicator within each package, bag or tray that will be sterilized by Plasma or Vaporized Hydrogen Peroxide. In rigid containers, place the indicator in every corner, or at least two diagonally opposite corners, to ensure that the sterilization agent has reached the most inaccessible areas. Perform the sterilization cycle. After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Plasma or Vaporized Hydrogen Peroxide, the ink must turn to the green or lighter reference color when the sterilization parameters are reached. Specifications: Process: Hydrogen peroxide Initial Color: Purple Final Color: Green Indicator Type: Type 4 chemical indicator Regulations: ISO 11140-1 More Info About This Product: Color Chart

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IT26-C / Moving front Chemical Integrator to monitor Steam sterilization processes between 118°C and 138°C. Control of Steam sterilization processes between 118 °C and 138 °C. Characteristics: Type 5 Integrating Indicator (according to ISO 11140-1). Size: 52 mm x 21 mm. Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark bar along the paper wick. The migration is visible through a zone marked ACCEPT or REJECT, thus indicating whether sterilization conditions were met. The extent of migration depends on steam quality, time, and temperature. The ACCEPT result is reached when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of 106 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C. Optionally, the readout of the chemical indicator can be done using Trazanto Automatic Quality Control and Traceability System (see instructions for use in device´s manual). Instructions For Use: Carefully open the package and remove only the number of indicators needed. Reseal the package tightly. Place a Integron® IT26-C indicator in each pack, peel pouch, container system or tray to be steam sterilized in the most inaccessible area to sterilizing agent. Perform de sterilization cycle. After the sterilization process has finished, the dark bar should have reached the ACCEPT zone. If the dark bar has not reached the ACCEPT zone, a REJECT result is indicated and the items in the pack, peel pouch, container system, or tray were not exposed to proper steam sterilization conditions. These items should be reprocessed according to established procedures and a new IT26-C has to be used. Despite this, regarding cycle integration parameters, this process can be considered as accepted. In case the IT26-C indicator shows a damp appearance after the sterilization process, Terragene® recommend planning an equipment´s maintenance. Specifications: Process: Steam Indicator Type: Type 5 chemical indicator Regulations: ISO 11140-1 More Info About This Product: User Manual

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IT26-C Extender/ Moving front Chemical Integrator to monitor Steam sterilization processes between 118°C and 138°C. Control of Steam sterilization processes between 118 °C and 138 °C. Characteristics: Type 5 Integrating Indicator (according to ISO 11140-1). Size: 52 mm x 21 mm. Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark bar along the paper wick. The migration is visible through a zone marked ACCEPT or REJECT, thus indicating whether sterilization conditions were met. The extent of migration depends on steam quality, time, and temperature. The ACCEPT result is reached when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of 106 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C. Optionally, the readout of the chemical indicator can be done using Trazanto Automatic Quality Control and Traceability System (see instructions for use in device´s manual). Instructions For Use: Carefully open the package and remove only the number of indicators needed. Reseal the package tightly. Place a Integron® IT26-C indicator in each pack, peel pouch, container system or tray to be steam sterilized in the most inaccessible area to sterilizing agent. Perform de sterilization cycle. 4After the sterilization process has finished, the dark bar should have reached the ACCEPT zone. If the dark bar has not reached the ACCEPT zone, a REJECT result is indicated and the items in the pack, peel pouch, container system, or tray were not exposed to proper steam sterilization conditions. These items should be reprocessed according to established procedures and a new IT26-C has to be used. NOTE: In some extended or wet steam cycles, the dark bar can display discoloration in some zones of the reading window, imposing a difficulty for result´s interpretation (see Result Reference Guide for reference). Despite this, regarding cycle integration parameters, this process can be considered as accepted. In case the IT26-C indicator shows a damp appearance after the sterilization process, Terragene® recommend planning an equipment´s maintenance.

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2 level chemical integrator for Ethylene Oxide sterilization processes. One-side laminated strips. Metals free. Integron® IT12 Chemical Integrators (Type 5 according to ISO 11140-1:2014 standard) are single-use two level chemical indicators that consist of paper strips laminated on the back side and printed with indicator ink. They have been designed for monitoring Ethylene Oxide (EO) sterilization processes. The integration level contains a purple/brown ink which was developed to turn to green when a theoretical spore population reaches its kill time, thus indicating that the SAFE condition has been met. Level 1 – Red: Exposure level. Indicator ink turns yellow to indicate exposition to the process, but does not ensure that the variables required to achieve the integration condition have been achieved (UNSAFE condition). Level 2 – Purple / brown: Integration level. Indicator ink turns green to indicate that the integration condition indicated in the quality certificate has been achieved. This condition consists of the kill time of a theoretical 106 Bacillus atrophaeus spore population, calculated in a BIER (Biological Indicator Evaluator Resistometer), and is called SAFE condition. Indicators 100% free of toxic heavy metals. Instructions For Use: Place a Integron® IT12 Chemical Integrator along with the material to be sterilized in a suitable package according to the recommended sterilization techniques. Place the indicators in those areas of most difficult access to the sterilizing agent. Perform the sterilization cycle. After the sterilization process has finished and evacuation/ventilation process is over, you may:               A. Remove the integrator indicator taking the necessary precaution to avoid                          contact with the remaining sterilizing agent.              B. Ventilate the load together with the integrator indicator and then perform                        the reading. Analyze the results. If the SAFE integration condition has been reached, the        sterilization process has been effective. Specifications: Process: Ethylene Oxide Initial Color: Level 1 Red, Level 2 purple-brown Final Color: Level 1 Yellow, level 2 Green Indicator Type: Type 5 chemical indicator Regulations: ISO 11140-1 More Info About This Product: Color Chart

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IT26-1YS / Unique point chemical integrator for Steam sterilization processes between 121° C and 134° C. Control of Steam sterilization processes between 121 ºC and 135 ºC. Characteristics: Type 5 Integrator Indicator (according to ISO 11140-1). One-side-laminated strips printed with indicator ink. Size: 70 mm x 23 mm. Initial Color: Yellow. Final Color: Black. 100 % Toxic Heavy Metal free. Instructions For Use: Place a chemical integrator Integron® IT26-1YS within each package, bag or tray that will be sterilized by Steam. In rigid containers place an IT26-1YS in every corner, or at least two diagonally opposite corners, to ensure that steam has reached the most inaccessible areas. Perform the sterilization cycle. After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Steam, the ink must turn to the black reference color when the integration conditions are reached. Specifications: Process: Steam Initial Color: Yellow Final Color: Black Indicator Type: Type 5 chemical indicator Regulations: ISO 11140-1 More Info About This Product: Color Chart

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CDWAH-U / Stainless steel re-usable holder of great resistance and durability. The holder is designed to be fixed on the tray, which allows reproducible location of the cleaning indicator in ultrasonic washing machines. Base: 32,7 mm wide, 72,5 mm long. Designed to hold Chemdye® CDWA cleaning indicators and perform routine control of cleaning processes in ultrasonic washers. Characteristics: Chrome plating SUS304 grade stainless steel re-usable holder of great resistance and durability. Base: 32 mm wide, 72.5 mm long, pin at the back side. The holder is designed to be fixed on the tray, which allows reproducible location of the cleaning indicator in ultrasonic washing machines, without representing a challenge to the washing process. Specifications: Process: Cleaning and thermodisinfection Regulations: ISO/TS 15883-5

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Holder for cleaning and thermodisinfection Indicators. Stainless Steel re-usable holder of great resistance and durability. Base: 32 mm wide, 72 mm long, pin at the back side. ISO/TS 15883-5. Designed to hold Chemdye® CDWA and Integron® IT27W indicators in order to perform routine control of cleaning and thermal disinfection processes in automatic machines. Characteristics: Chrome plating SUS304 grade stainless steel re-usable holder of great resistance and durability. Base: 32 mm wide, 72.5 mm long, pin at the back side. Basket: 32 mm wide, 37 mm long, 0.5 mm thick. The holder is designed to mimic the cleaning challenges posed by a large process load during the washing cycle and can be fixed on the tray, which allows reproducible location of the cleaning indicator in the washer-disinfector. When CDWA4 is placed within the holder, half of the test soil is obscured, thus simulating the joint of a surgical instrument, with water stream hitting it indirectly. The other half of the test soil is covered by a mesh, thus posing a difficulty for water stream to reach it, mimicking shadowed or occluded surfaces. The new design of CDWAH optimizes the control of the washer disinfectors ability to force water and detergent into and onto the test soil. Specifications: Process: Cleaning and thermodisinfection Regulations: ISO 15883

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Instructions For Use: Before The Test: Place the holder around the neck of the capsule. Press the holder down so that the groove of the holder fits securely around the neck of the vial. Insert the L shaped end on either side of the holder into the holes of the Ultrasonic device’s basket to hold the vial in position. The holder can be attached to a wire basket or perforated basket. Vials should be placed in the correct location within a tray / basket according to Ultrasonic Cleaning Indicator´s IFU based on the size of the tank. After the test is complete After the ultrasonic cycle remove the vial holding it with three fingers of one hand and the index finger and thumb of the other hand on the holder and lid of capsule. Place the index finger on the end of the holder, then place the thumb on the lid of the capsule for support, push the holder back off the neck of the capsule and remove the holder with both fingers.

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CDWA4 / Cleaning Indicator for cleaning performance tests. Challenge level: very high. Detects all the factors that affect the result of a washing process. Initial Color: Fuchsia. Result: removal of the fuchsia organic substance. Designed for routine control of cleaning processes and for monitoring automatic washing machines effectiveness as well as monitoring ultrasonic washing machines which operate at frequencies equal to or greater than 35 kHz, and temperatures between 30 ºC and 70 ºC. Characteristics: Challenge Level: Very high. Allows detection of all factors affecting the outcome of cleaning process. Initial Color: Fuchsia. Size: 70 mm x 30 mm (approximate). Synthetic temperature-stable support. Result: Elimination of fuchsia organic substance. To interpret results visually, use the results reference guide on product´s instructions for use. Optionally, the readout of the cleaning indicator can be done using Trazanto Automatic Quality Control and Traceability System (see instructions for use in device´s manual). Instructions For Use: Choose the Chemdye® Splat CDWA indicator according to the desired difficulty. Place the indicator on the Chemdye® Splat CDWAH or Chemdye® Splat CDWAH-U holder. Place the system on the tray along with the material. Once the cleaning cycle is over, remove the indicator. Analyze Chemdye® Splat CDWA indicators using the reference table and record results. If unfavorable results are obtained, perform the appropriate corrective actions and repeat the washing process. Specifications: Process: Cleaning and thermodisinfection Initial Color: Fuchsia Regulations: ISO 13485, ISO/TS 15883-5

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Super Rapid Self-contained Biological Indicator for Steam sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^6 spores per vial. Readout: 1 hour. An optional visual pH color change confirmation could be made after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to a greenish color first, and then to yellow during incubation at 60 ºC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain purple after the incubation process. 7-day readout is optional and not intended to be routinely performed; it is an initial validation of the 1 hour-reading. Fluorescence results may be compared to the 7-day visual reading. Note: if 7-day readout is performed, a humidified environment will be required to avoid medium to dry out. D-Value: Not lower than 1.5 minutes at 121 ºC. Another D-value is informed at 132 ºC and at 135 ºC. Z-Value is informed. Instructions For Use: Identify the Terragene® Bionova® BT222 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® BT222 SCBI from the sterilized package. WARNING: Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature. Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBI has been exposed to Steam. IMPORTANT: This color change does not evidence the process effectiveness to achieve sterility. If the Process Indicator color has not changed, check the sterilization process. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader Incubators for a maximum of 1 hour at (60 ± 2) °C for super rapid readout. Specifications: Process: Steam Microorganism: Geobacillus stearothermophilus (ATCC 7953) Population: 10^6 Spores/carrier Read-Out Time: 1 h Regulations: IRAM 37102-1, IRAM 37102-3, ISO 11138-1, ISO 11138-3

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Rapid Self-contained Biological Indicator for Ethylene Oxide sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores per vial. Readout: 4 hours. An optional visual pH color change confirmation could be made after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to a greenish color first, and then to yellow during incubation at 37 ºC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain blue after the incubation process. 7-day readout for visual confirmation by color change is optional and not intended to be routinely performed; it is an initial validation of the 4 hour-reading. Fluorescence results may be compared to the 7-day visual reading. Instructions For Use: Identify the Terragene® Bionova® BT110 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® BT110 SCBI from the sterilized package. Check the Process Indicator on SCBI label. A color change to green indicates that the SCBI has been exposed to Ethylene Oxide. IMPORTANT: This color change does not evidence the process effectiveness to achieve sterility. If the color of the Process Indicator has not changed, check the sterilization process. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader incubators for a maximum of 4 hours at (37 ± 2) °C for rapid readout. Note: Holding time between sterilization and incubation should not exceed a 7-day period. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means failure in the sterilization process. If no fluorescence is detected after 4 hours of incubation, the result is negative. The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for visual color change. If chamber relative humidity is unknown or < 35 %, continue to incubate the Biological Indicator for a pH color change result, since low relative humidity may increase the fluorescent readout time beyond 4 hours. Specifications: Process: Ethylene Oxide Microorganism: Bacillus atrophaeus (ATCC 9372) Population: 10^6 Spores/carrier Read-Out Time: 4 h Regulations: IRAM 37102-1, IRAM 37102-2, ISO 11138-1, ISO 11138-2 Length: 40 mm

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Hyper Rapid Self-contained Biological Indicator for Vaporized Hydrogen Peroxide sterilization processes. Final readout: 5 minutes. Indications For Use: Terragene® Bionova® BT98 fluorescence hyper rapid readout Biological Indicators have been designed for quick and easy monitoring of Plasma or vaporized hydrogen Peroxide sterilization cycles. Device Description: Terragene® Bionova® BT98 fluorescence hyper rapid readout Biological Indicators are single-use Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearotermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT98 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. Precautions: Warning: Do not use Terragene® Bionova® BT98 SCBI to control EO, Dry Heat, Formaldehyde or other sterilization processes different from specified. Do not reuse SCBI. Warning:  Place one or more SCBI in sterilizing hard-to-reach areas to ensure all areas of the chamber are sterilized. Please evaluate all load configurations to ensure ALL hard-to-reach areas have been identified, and place a SCBI in each of those locations. Warning:  Do not reuse the sterilizer until the SCBI test result is negative. Instructions For Use: Identify the Terragene® Bionova® BT98 SCBI by writing the sterilizer number (incase of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. Caution Wear safety glasses and gloves when removing the Terragene® Bionova® BT98 SCBI from the sterilized package. ( Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature.) Check the Process Indicator on SCBI label. A color change to green indicates that the SCBI has been exposed to Hydrogen Peroxide. IMPORTANT: This color change does not evidence the process effectiveness to achieve sterility. If the color of the Process Indicator has not changed, check the sterilization process. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® auto-reader incubators for a maximum of 5 minutes at (60 ± 2) °C for hyper rapid readout. (Holding time between sterilization and incubation should not exceed a 1-hour period.) Important: Use a non-sterilized SCBI as a positive control at least once per day, when a sterilization cycle is run. The positive control ensures that correct incubation conditions were met; the capability of the medium to promote rapid growth; viability of spores has not been altered due to improper storage temperature, humidity or proximity to chemicals and proper functioning of Terragene® Bionova® Auto-Reader Incubators. Both, the positive control indicator and the processed indicator, should belong to the same batch. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means failure in the sterilization process. If no fluorescence is detected after 5 minutes of incubation, the result is negative. The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for visual color change. Record positive results and discard the SCBIs immediately, as it is indicated below. Hyper Rapid Readout: 5 minutes The hyper rapid readout must be carried out in the appropriate Terragene® Bionova® auto-reader incubators. Fluorescence is emitted after the reader stimulates the spore carrier with UV light. Final readout of negative results is readily available after 5 minutes of incubation. Fluorescence readout is an indirect measure of the viability of Geobacillus stearothermophilus spores after the sterilization process (positive results). Furthermore, a failure in the sterilization process can also become evident by culture medium color-change. Due to the high sensitivity of the fluorescence results at 5 minutes, conventional incubation for color change of Terragene® Bionova® SCBI BT98 is not an advantage. Visual Confirmation: 5 days: Optionally, you can perform a visual color-change confirmation after a 5-day incubation. If the sterilization process has not been successful, culture medium will turn to yellow during incubation at (60 ± 2) ºC, indicating the presence of living spores. If sterilization was successful, culture medium will remain purple after incubation. The positive control must show a color change from purple to yellow for results to be valid. ( If 5-day readout is performed, a humidified environment will be required to prevent medium from drying out.) Readout Time: 7 days A 7-day readout is optional and may be routinely performed. This is an initial validation of the 5-minute readout. Fluorescence results are compared to the 7-day visual readouts. Monitoring Frequency: Follow facility policies and procedures which should specify a biological indicator monitoring frequency compliant with professional association recommended practices and/or national guidelines and standards. As the best practice and to provide optimal patient safety, Terragene® recommends that every sterilization load be monitored with an appropriate biological indicator. Storage: Store in a dark place at temperature between 10-30 ºC and 30-80 % relative humidity. Do not freeze. Do not store biological indicators near sterilizing agents or other chemical products. Shelf Life: Biological Indicators have an expiration date of 2 years from the date of manufacture when stored at recommended conditions. Do not use indicators after their expiration date. Chemical Process Indicator on SCBI label have an expiration date of 2 years when used as part of SCBI. Endpoint Stability Reaction: Chemical Process Indicator endpoint shall remain unchanged for a period of 6 months when stored at previously indicated conditions. Disposal: Discard biological indicators after use according to your country’s healthcare and safety regulations. The positive biological indicators can be autoclaved in a gravity air displacement steam sterilizer at 121 ºC for 5 minutes, 132 ºC for 15 minutes or 134 ºC for 10 minutes; or in a dynamic air removal steam sterilizer at 132 °C for 4 minutes or 135 °C for 3 minutes. Specifications: Population: 10^6 Spores/carrier Read-Out Time: 5 min Regulations: IRAM 37102-1:1999, ISO 11138-1:2017, ISO 13485:2016 / NS-EN ISO 13485:2016

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Ultra Rapid Self-contained Biological Indicator for Steam sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^6 spores per vial. Readout: 20 minutes. An optional visual pH color change confirmation could be made after 48 hours of incubation. If the sterilization process has not been successful, the culture medium will change to a greenish color first, and then to yellow during incubation at 60 ºC, thus showing the presence of living spores. If the sterilization process is successful culture medium will remain purple after the incubation process. 7-day readout is optional and not intended to be routinely performed; it is an initial validation of the 20 minute-reading. Fluorescence results may be compared to the 7-day visual reading. Note: If 7-day readout is performed, a humidified environment will be required to avoid medium to dry out. D-Value: Not lower than 1.5 minutes at 121 ºC. Another D-value is informed at 132ºC and at 135ºC. Z-Value is informed. Instructions For Use: Identify the Terragene® Bionova® BT224 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® BT224 SCBI from the sterilized package. (Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature.) 5. Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBI has been exposed to Steam. ( This color change does not evidence the process effectiveness to achieve sterility. If the Process Indicator color has not changed, check the sterilization process.) 6. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. 7. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader Incubators for a maximum of 20 minutes at (60 ± 2) °C for ultra rapid readout. Important: Use a non-sterilized SCBI as a positive control at least once per day, when a sterilization cycle is run. The positive control ensures that correct incubation conditions were met; capability of medium to promote rapid growth; viability of spores has not been altered due to improper storage temperature, humidity or proximity to chemicals and proper functioning of Terragene® Bionova® Auto-Reader Incubators. Both, the positive control indicator and the processed indicator, should belong to the same batch. Note: Holding time between sterilization and incubation should not exceed a 7-day period. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means a failure in the sterilization process. If no fluorescence is detected at 20-minute incubation, the result is negative. The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for a visual color change.

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