Advanced Sterilization 100NXRFID Low temperature sterilizer with RFID User Manual

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1. Sterilization system user guide
2. RFID module user guide

Sterilization system user guide

STERRAD® 100NX® Sterilization SystemUser’s GuideRef 99994M-99994_02 April 2012DRAFT

STERRAD® 100NX® Sterilization SystemUser’s Guide1-888-STERRAD ASP U.S.A. Professional ServicesASP Insternational 949-581-5799Please visit www.aspjj.comFor warranty information, please visit our website or contact ASP Professional Services.ASP International Customer Support; call your local ASP Representative)©. 2008-2012 Division of Ethicon. All rights reserved. STERRAD® is a registered trademark of Advanced Sterilization Products (ASP). Teflon®, Delrin®, and Tyvek® are registered trademarks of E.I. du Pont de Nemours and Company. Radel® is a registered trademark of Solvay SA. Kraton® is a registered trademark of Kraton Polymers LLC. Santoprene™ is a trademark of ExxonMobil Corporation. Ultem® is a registered trademark of SABIC. da Vinci® is a registered trademark of Intuitive Surgical, Inc. Other products mentioned in this publication are trademarked by their respective owners. Please note: the screen displays shown in this guide are for reference only. The actual displays on your system may be slightly different depending on your system’s configuration and software revision. Reproduction, adaptation, or translation of this publication without prior written permission is prohibited. Printed in the U.S.A. DRAFT

ContentsChapter 1. Introduction 5How to Use This Guide 5Intended Use 5The STERRAD® Sterilization Process 6If You Have Questions 6Chapter 2. Load Preparation 7Load Weight Requirements 7Cycles and Materials Processing 10Recommended Materials 14Thermoplastics 14Thermoplastic Elastomers 14Thermosetting Elastomers 15Glass 15Metal 15Items Not To Be Processed 15Do Not Process in the EXPRESS Cycle 16Do Not Process in the DUO Cycle 16Guidelines for Preparing Items to Be Sterilized 17Cleaning, Rinsing, and Drying 17Packaging and Loading 19Instrument Trays 19Tray Mats 19Packaging 19Loading 20Chemical Indicators 21Special Considerations for Flexible Endoscopes 21Chapter 3. Operation 23Before You Start 23Start and Warm-up 23Biological Indicators 23Login 24Entering Load Information 25Enter Load Item Data 25Cycle Notes 26Loading the Chamber 28DRAFT

Selecting and Starting a Cycle 32System Ready Screen 33Inserting a Cassette 33Cycle in Progress 34Canceling a Cycle 35Cycle Completed 37Processing a Sterilized Load 38Inspecting Chemical Indicators 38Processing Biological Indicators 38Chapter 4. Troubleshooting 41Running Diagnostics 41System Message Table 42Temperature Messages 42Messages Not In This Table 42Call Your ASP Representative 46Chapter 5. Sterilizer Overview 47Sterilizer Cycles 47Sterilizer Features 48Cassette 49Cassette Disposal Box 50Touch Screen and Speaker 50Chamber 51Printer 52Touch Screen Data Entry 53Chapter 6. Maintenance 55Automatic Maintenance 55Automatic Lamp Adjustment 55Manual Maintenance 56Disposing of Cassettes 56Removing a Cassette Disposal Box 57Replacing the Printer Paper 58Cleaning the Sterilizer Exterior 61Cleaning the Hydrogen Peroxide Monitor Detector Lens 62PCMCIA Card Handling and Replacement 63Data Transfer Using a Memory Stick 64Rebooting the System 65Sterilizer Disposal 65DRAFT

Chapter 7. Reports and Files 67Displayed Reports 67Cycle History 67Printed Reports 69Short Report 69Parametric Report 69Long Report 69Chapter 8. Access Levels and Supervisor Tasks 71Overview 71Access Levels 71Additional Utilities Menu 72Date and Time Settings 73Set Date 74Set Time 74Time Zone 74Date Format 74Time Format 74Cancel/Done 74System Configuration 75Access Control Option 75IMS 75Vacuum Units 75Load Data Entry Option 76Load Removal Option 76Notepad Option 76Network Option 76Alarm Volume 76Backlight Conservation (Minutes) 76Language Selection 76Sterilizer Settings 77Printer Settings 78Transfer Settings 79Cancel/Done 79User Administration 80Add User 81Modify User 82Upload User Data 83Steps to Upload a User Database 84Cassette Functions 85Dispose Cassette 86Peroxide Clearance 87Network 88Diagnostics 88Diagnostic Tests 89Service Functions 89DRAFT

File Management 90Calibration Files 90Diagnostic Files 90Upload File 91Input/Output Doors 92Product Options 92Appendix A. Safety Information 95Personal Safety and First Aid 95Personal Protective Equipment 97Device Safety 97Warnings, Cautions, and Notes 100Symbols 101Appendix B. Consumables, Accessories, and Additional Parts 103Appendix C. Sterilizer Specifications 105DRAFT

Introduction 1STERRAD® 100NX® User’s Guide 5Chapter 1.Introduction How to Use This GuideIf you are a STERRAD® 100NX® Sterilizer operator, you must read the “Safety Information” appendix and the “Introduction,” “Load Preparation,” and “Operation” chapters prior to operating the sterilizer. This “Introduction” explains the features and parts of the sterilizer. “Load Preparation” explains how to prepare and package instruments for processing. “Operation” explains how to operate the sterilizer and obtain optimal results. If you are a supervisor overseeing the STERRAD® 100NX® Sterilizer, you should read the entire user’s guide and pay particular attention to the chapter featuring “Access Levels and Supervisor Level Tasks.” This chapter describes tasks and options that are only available through “Supervisor Level” access.Intended UseThe STERRAD® 100NX® Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD® 100NX® Process to inactivate microorganisms on a broad range of medical devices and surgical instruments.When used as directed by the instructions in this user’s guide, the STERRAD® 100NX® Sterilization System will sterilize both metal and nonmetal medical devices at low temperatures. Please review “How to Determine What Can Be Sterilized in the STERRAD® 100NX® Sterilizer” in the “Load Preparation” chapter along with the cycle information to make sure you follow the directions for processing items in each type of cycle.DRAFT

1 Introduction6STERRAD® 100NX® User’s GuideThe STERRAD® Sterilization ProcessThe STERRAD® 100NX® Sterilizer sterilizes medical devices by diffusing hydrogen peroxide vapor into the chamber and then electromagnetically exciting the hydrogen peroxide molecules into a low-temperature plasma state. The combined use of hydrogen peroxide vapor and plasma safely and rapidly sterilizes medical instruments and materials without leaving toxic residues. All stages of the sterilization cycle operate within a dry environment at a low temperature, and thus the cycle is not damaging to compatible instruments that are sensitive to heat and moisture. The STERRAD® 100NX® Sterilizer can be used for both metal and nonmetal devices, and can also sterilize instruments that have difficult-to-reach (diffusion-restricted) spaces, such as hinges on forceps. Refer to the “Safety Information” appendix for more information on device safety.The sterilizer consistently provides a Sterility Assurance Level (SAL) of 10-6, as defined by U.S. Food and Drug Administration (FDA) and international standards, for clinical use on all allowed substrates within the limits of the claims for materials and geometries when used in accordance with the directions in this user’s guide.If You Have QuestionsIf you are located in the United States and have questions about the STERRAD® 100NX® Sterilizer or questions about which items may be safely sterilized by the STERRAD Process, please call ASP Professional Services at 1-888-STERRAD (1-888-783-7723) or visit our website at www.aspjj.com. Internationally, call your local Advanced Sterilization Products (ASP) Customer Support Representative.DRAFT

Load Preparation 2STERRAD® 100NX® User’s Guide 7Chapter 2.Load PreparationThe STERRAD® 100NX® Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD® sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. Because the cycle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture. CAUTION: KNOW WHAT YOU CAN PROCESSBefore processing items in the sterilizer, make sure you know how the STERRAD® Sterilization Process will affect the item. When constructing your load, the total weight of the load to be sterilized should not exceed the load requirements for the specific cycle. If you have questions, or if you are in doubt about the materials in your devices, contact the medical device manufacturer or your ASP Customer Representative for more information. CAUTION: RISK OF VIOLATION OF WARRANTYImproper processing may limit our liability for damage to processed instruments. Improper processing may also void your instrument warranty.Load Weight RequirementsThe weight of the items to be sterilized must conform to the weights used for validating the sterilizer processes. These weights are listed in the following table. The weight of the load depends on the cycle selected and whether one or both shelves are used. Cycle Type Weight ShelvesSTANDARD Cycle 9.7 kg (21.4 lbs) total weight 1 or 2 shelvesDUO Cycle 6.0 kg (13.2 lbs) total weight 1 or 2 shelvesEXPRESS Cycle 4.9 kg (10.7 lbs) total weight Bottom shelf onlyFLEX Cycle 9.7 kg (21.4 lbs) total weight 1 or 2 shelvesDRAFT

2 Load Preparation8STERRAD® 100NX® User’s GuideSTANDARD Cycle ProcessingThe STERRAD® 100NX® Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.Medical devices with the following materials and dimensions can be processed in the STERRAD® 100NX® Sterilizer STANDARD cycle:◆Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter.† Processing TubingASP has validated the processing of non-reusable polyethylene and Teflon® (polytetrafluoroethylene) medical grade tubing with the dimension and cycles listed below. (These tubing claims have not been reviewed by the Food and Drug Administration (FDA) as the FDA does not classify tubing as medical devices.):◆An inside diameter of 1 mm or larger and a length of 1000 mm or shorter can be processed in the STERRAD® 100NX® Sterilizer STANDARD cycle.*DUO Cycle ProcessingMedical devices, including many flexible endoscopes with accessory devices such as light cords and cameras with the following material and dimensions can be processed in the STERRAD® 100NX® DUO Cycle. ◆Single channel polyethylene and Teflon® (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter.◆Cameras.◆Accessory light cords.◆Flexible endoscopes without lumens.✔Note: Do not include more than 2 flexible endoscopes per load. †The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not exceed the maximum number of lumens validated by this testing.*Sterilize without any additional load. Up to 20 pieces of tubing may be sterilized at one time.DRAFT

Load Preparation 2STERRAD® 100NX® User’s Guide 9EXPRESS Cycle ProcessingThe following types of medical devices can be sterilized in the EXPRESS Cycle:◆General medical devices requiring surface sterilization, or sterilization of mated titanium and stainless steel surfaces.◆Rigid or semi-rigid endoscopes without lumens; for example da Vinci® endoscopes.FLEX Cycle ProcessingMedical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD® 100NX® Sterilizer FLEX cycle:◆Single channel polyethylene and Teflon® (polytetrafluoroethylene) flexible endoscope with an inside diameter of 1 mm or larger and length of 850 mm or shorter.** ◆Non-lumened flexible endoscopes.✔Note: Do Not process more than 2 flexible endoscope per load.Check the medical device manufacturer’s instructions before loading any item into the STERRAD® 100NX® Sterilizer.**One or two flexible endoscopes can be processed per sterilization cycle. No additional load.DRAFT

2 Load Preparation10 STERRAD® 100NX® User’s GuideCycles and Materials ProcessingCAUTION: RISK OF DAMAGE TO LOAD OR STERILIZER.Do not attempt to sterilize items or materials that do not comply with the guidelines specified in this user’s guide. Consult the medical device manufacturer’s instructions or call ASP Customer Support to determine if an item can be sterilized by the STERRAD® 100NX® Sterilization System. This chapter includes cycle information regarding recommended items, materials, and some typical devices that can be sterilized in each of the cycles on the STERRAD® 100NX® Sterilizer. Please refer to these pages whenever you need materials information. Check the medical device manufacturer’s instructions before loading any item into the STERRAD® 100NX® Sterilizer. There is a wide variety of materials and devices that can be sterilized in the STERRAD® 100NX® Sterilizer. Please contact ASP Professonal Services for more information. Information may also be obtained from the device manufacturer. In the U.S.A., call 1-888-783-7723 or contact us through our website at www.aspjj.com. Internationally, call your local ASP Customer Support Representative.DRAFT

Load Preparation 2STERRAD® 100NX® User’s Guide 11DRAFT

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2 Load Preparation14 STERRAD® 100NX® User’s GuideRecommended MaterialsThere is a wide variety of materials and devices that may be sterilized in the sterilizer. The materials listed below are commonly found in medical devices and represent typical classes of materials used to construct medical devices. The items marked with an asterisk (*) may have limited life after repeated sterilization.Please contact ASP Professional Services for more information. Information may also be obtained from the device manufacturer. In the U.S.A., call 1-888-783-7723 or contact us through our website at www.aspjj.com. Internationally, call your local ASP Customer Support Representative.Thermoplastics◆Ethylvinyl Acetate (EVA)◆Kraton® Polymers◆Liquid Crystal Polymer (LCP)◆Polyacetal (Delrin® acetal resin)*◆Polyamide (Nylon)*◆Polycarbonate◆Polyetheretherketone (PEEK)◆Polyetherimide (ULTEM® Polymers) ◆Polyethylene◆Polymethyl methacrylate (PMMA)*◆Polyphenylene sulfone (Radel®)*◆Polypropylene◆Polystyrene◆Polytetrafluoroethylene (Teflon®)Thermoplastic Elastomers◆Santoprene™DRAFT

Load Preparation 2STERRAD® 100NX® User’s Guide 15Thermosetting Elastomers◆Silicone◆Polyurethane◆PVCGlassGlassMetal◆Aluminum◆Brass◆Gold ◆Stainless steel◆TitaniumItems Not To Be Processed◆Single use items for which the manufacturer does not recommend resterilization.◆Liquids and powders.◆Items or materials that absorb liquids.◆Items made of materials that contain cellulose, such as cotton, paper or cardboard, linens, huck towels, gauze sponges, or any item containing wood pulp◆Paper instrument count sheets or lot stickers.◆Items with hinged/mated nylon surfaces.◆Instruments and devices that cannot withstand a vacuum and are labeled for gravity steam sterilization methods only.◆Items whose design permits the surfaces to collapse onto each other unless some method is used to keep the surfaces separated.◆Devices with dead-end lumens.DRAFT

2 Load Preparation16 STERRAD® 100NX® User’s Guide◆Devices with internal parts, such as sealed bearings, that cannot be immersed, may present difficulties in cleaning and should not be processed in the STERRAD® 100NX® Sterilizer.◆Implants for which the manufacturer has not specifically recommended sterilization in the STERRAD® 100NX® Sterilizer.Do Not Process in the EXPRESS Cycle◆Items made of nylon cannot be processed in the EXPRESS Cycle.◆Items made of Kraton® cannot be processed in the EXPRESS Cycle.◆Items made of Polyurethane cannot be processed in the EXPRESS Cycle.◆Items with mated Delrin® surfaces cannot be processed in the EXPRESS Cycle.◆Items with mated anodized aluminum surfaces cannot be processed in the EXPRESS Cycle.◆Items with mated Radel® surfaces cannot be processed in the EXPRESS Cycle.◆Items with mated Ultem® surfaces cannot be processed in the EXPRESS Cycle.◆Items with lumens cannot be processed in the EXPRESS Cycle.Do Not Process in the DUO Cycle◆Items with mated anodized aluminum surfaces cannot be processed in the DUO Cycle.DRAFT

Load Preparation 2STERRAD® 100NX® User’s Guide 17Guidelines for Preparing Items to Be Sterilized✔Note: All items must be cleaned, rinsed, and thoroughly dried before being placed in the STERRAD® 100NX® Sterilizer. Loads containing moisture may cause cycle cancellations.Cleaning, Rinsing, and DryingCleaning and sterilization are two separate processes. Proper cleaning of instruments and devices is a critical and necessary step prior to sterilization.◆All items including accessories must be thoroughly cleaned, rinsed, and dried before loading into the sterilizer. ◆Carefully inspect all instruments, devices, and accessories for cleanliness and dryness prior to packaging. If visible soil is present, the item must be re-cleaned and dried prior to sterilization. If moisture is present, dry the item thoroughly prior to sterilization.◆Carefully inspect all instruments, devices, and accessories for flaws or damage prior to packaging. Items with flaws or damage should be replaced or repaired before using.✔Note: Periodic careful inspection of items after repeated exposure to disinfectant/cleaner/sterilant is necessary, due to the potential damaging effects of the chemical agents.Cleaning is necessary to remove organic and inorganic soil and debris from equipment. This process also removes many microorganisms from the surface of the items. Sterilization then inactivates all remaining spores and live microorganisms.◆Clean your devices according to the medical device manufacturers' instructions. You must remove all blood, tissue, and soil from items using appropriate detergents, cleansers and/or methods. ◆Rinse items thoroughly to remove detergent or cleanser residue. Use treated water that is of a quality that ensures hard water stains do not occur. Failure to remove all organic materials or detergents may result in the formation of light-colored residue on the devices. If residue is visible, you should clean, rinse, dry, and resterilize the device prior to use.DRAFT

2 Load Preparation18 STERRAD® 100NX® User’s Guide◆Dry all items thoroughly. An acceptable method for drying is to blow compressed gas through the lumen until no moisture exits the distal end of the device. Please ensure that any method used to dry the devices is in accordance with the manufacturers' instructions for use or contact the device manufacturer to obtain appropriate and safe procedures. It is necessary to remove moisture from all parts of the items. Only dry items should be loaded into the sterilization chamber to prevent cycle cancellation. WARNING! POSSIBLE RESIDUAL HYDROGEN PEROXIDE CONTACT!Failure to ensure that instruments are completely dry before they are processed in the STERRAD® sterilizer may result in residual hydrogen peroxide being present on the surface of the load after the cycle is complete. This may cause contact burns when the surface of the load is handled. ◆Some complex reusable medical devices may require disassembly for proper cleaning and sterilization. It is very important that you follow the device manufacturers' recommendations concerning cleaning and sterilization. In the absence of STERRAD® System-specific instructions, please contact the relevant medical device manufacturer.WARNING! POSSIBLE NON-STERILE DEVICE! Loads containing moisture may result in either a non-sterile device or cycle cancellation. Wear chemical resistant gloves when handling items from any load containing moisture.DRAFT

Load Preparation 2STERRAD® 100NX® User’s Guide 19Packaging and LoadingIf you choose to package the instruments (highly recommended), proper use and preparation of trays, pouches, and instruments can minimize or prevent cycle cancellations and positive biological indicator (BI) results due to load-related problems. All instruments must be cleaned, rinsed, and thoroughly dried before loading into the sterilizer.Special considerations for loading and processing flexible endoscopes are presented at the end of this chapter. Instrument Trays◆Only STERRAD® Instrument Accessories and APTIMAX® Instrument Trays, are recommended for use in the STERRAD® 100NX® Sterilizer. These instrument trays are specially designed to allow diffusion of hydrogen peroxide and plasma around every item in the load.Tray Mats◆Instrument trays should only be padded with STERRAD® Instrument Mats or polypropylene sterilization wrap. Never use linen, cellulose, or any materials listed in the “Items Not To Be Processed” section.◆Follow the Instructions for Use included with the STERRAD® Instrument Mats to determine the number of mats that can be used at one time in the chamber. Do not use more than the recommended amount of mat material in the chamber at any time. Cycle Name Square Centimeters Square InchesSTANDARD 2250 349DUO 2774 430FLEX 2250 349EXPRESS 1387 215◆Do not use foam pads in instrument trays as they may absorb the hydrogen peroxide.Packaging◆Use only STERRAD® Sterilizer-compatible polypropylene sterilization wrap and Tyvek® pouches.Tyvek® Pouches and Rolls with STERRAD® Chemical Indicators are the only pouches and rolls available on the market that are validated by ASP. They are the only pouches and rolls validated by ASP for efficacy and stability.DRAFT

2 Load Preparation20 STERRAD® 100NX® User’s Guide◆Do not use paper pouches or sterilization wraps containing cellulose or cotton.◆Do not use any wraps or packaging that are not approved by ASP or materials listed in the “Items Not To Be Processed” section. In the USA, use only FDA-cleared polypropylene wraps.◆Properly arrange the items or the scope in a tray to ensure adequate diffusion of hydrogen peroxide throughout the load. ◆Place peel pouches on edge, if possible. Arrange them so that the transparent side of a pouch faces the opaque side of the next pouch. Do not stack pouches on top of each other.◆Do not stack instruments inside the trays. Do not stack trays. Do not stack trays within trays. Do not wrap instruments within a wrapped tray.◆If you are using rigid containers cleared by the FDA for use in the STERRAD® 100NX® Sterilizer, follow the Instructions for Use provided by the rigid container manufacturer. Verify that the rigid containers are cleared for use in each sterilization cycle. Remember the following: ◆Do not stack instruments inside the containers. ◆Do not stack containers. ◆Do not stack containers within containers. ◆Do not wrap instruments within the containers.◆Place STERRAD® Chemical Indicator Strips inside trays and pouches as needed. Loading◆Do not allow any item to touch the walls of the sterilization chamber, door, or electrode.STANDARD and FLEX Cycles Loading Preparation◆The STERRAD® 100NX® Sterilizer STANDARD and FLEX Cycles were validated using a load weight of 4.9 kg (10.7 lbs) per shelf. When constructing your load, the total weight of the load to be sterilized should not exceed 9.7 kg (21.4 lbs).DUO Cycle Loading Preparation◆The STERRAD® 100NX® Sterilizer DUO Cycle was validated using a total load weight of 6.0 kg (13.2 lbs). When constructing your load, the total weight of the load to be sterilized should not exceed 6.0 kg (13.2 lbs).DRAFT

Load Preparation 2STERRAD® 100NX® User’s Guide 21EXPRESS Cycle Loading Preparation◆The STERRAD® 100NX® Sterilizer EXPRESS Cycle was validated using a load weight of 4.9 kg (10.7 lbs) on the bottom shelf only. When constructing your load, the total weight of the load to be sterilized should not exceed 4.9 kg (10.7 lbs).CAUTION: RISK OF DAMAGE TO LOAD OR STERILIZER.Do not allow metal objects to come into contact with the walls of the chamber, door, or electrode. Contact with the walls, door, or electrode can cause a cycle cancellation, and/or damage the item or the sterilizer. Provide at least 25 mm (1 inch) of space between the load and the electrode.Chemical IndicatorsSTERRAD® Chemical Indicator Strips and STERRAD® SEALSURE® Chemical Indicator Tape offer a method to verify that the load has been exposed to hydrogen peroxide in the sterilizer. Chemical indicators are not a substitute for biological indicators. If you use chemical indicator strips or chemical indicator tape, follow the Instructions for Use that accompany these items as you prepare the load.◆Place STERRAD® Chemical Indicator Strips inside trays and Tyvek®pouches or follow your facility’s procedures.◆Secure all wraps with STERRAD® SEALSURE® Chemical Indicator Tape.◆Do not use chemical indicators or tape designed for other sterilization processes.Special Considerations for Flexible EndoscopesFlexible endoscopes are sensitive and complex medical instruments. Read the flexible endoscope manufacturer’s instructions for each endoscope before preparation and loading into the sterilizer. Take special care to confirm that venting caps are placed according to the manufacturer’s instructions. Venting caps are intended to prevent damage to scopes that are being exposed to a vacuum, regardless of the sterilant used.In addition, if you are processing a flexible endoscope containing a water-resistant “immersion” cap, you must remove the immersion cap prior to processing. If the immersion cap is not removed prior to processing, it will damage the scope due to the inability to properly vent. DRAFT

2 Load Preparation22 STERRAD® 100NX® User’s GuideFLEX Cycle: A maximum of 2 flexible endoscopes can be processed per load, with or without silicone mats. Do not add any additional items to the load.DUO Cycle: A maximum of 2 flexible endoscopes can be processed per load, with or without silicone mats. You can also process 1 flexible endoscope with its light cord and a camera.CAUTION: RISK OF DAMAGE TO LOADPrior to processing flexible endoscopes in the STERRAD® 100NX® Sterilizer, please contact the medical device manufacturer, or ASP Professional Services at 1-888-STERRAD.DRAFT

Operation 3STERRAD® 100NX® User’s Guide 23Chapter 3.Operation Before You StartEach time you use the STERRAD® 100NX® Sterilizer, follow the instructions provided in the “Load Preparation” chapter. It is your responsibility to be familiar with the load preparation and safety information provided in this user’s guide.Start and Warm-up1. Turn on the main power switch located on left front side panel (as you face it) of the sterilizer.2. The sterilizer begins by warming up. The warm-up can take up to 1 hour.✔Note: The sterilizer should not be turned off during warm-up.3. “Touch Screen to Start” appears on the display when the sterilizer is ready for use.Biological IndicatorsConfirming that sterilizing conditions were achieved during a cycle is an important part of the sterilization process. Biological indicators are one way to ensure that your sterilizer is operating correctly. ASP recommends using the STERRAD® CYCLESURE® 24 Biological Indicator. Contact your ASP Representative regarding biological indicators specifically designed for use in the STERRAD® 100NX® Sterilizer.Place a STERRAD CYCLESURE® 24 Biological Indicator in the chamber at the back of the bottom shelf. Biological testing should be performed at least once per day or as specified by your facility’s policy. Review the Instructions For Use included with the biological indicator to ensure its proper use.DRAFT

3 Operation24 STERRAD® 100NX® User’s GuideLogin✔Note: If your sterilizer has been configured not to require operator login, the login screen will not appear. Skip to the subsection titled Entering Load Information.When you touch the “Touch Screen to Start” screen, the sterilizer displays the Operator Login screen.Figure 1. Operator Login Screen.1. Touch the Operator field. The cursor appears in the field.✔Note: Operator and Password fields are case-sensitive.2. Use the on-screen keyboard to type your assigned operator identification.3. Touch the ENTER key. The cursor jumps to the Password field.4. Type your password. The screen displays a series of “*” characters in place of the characters you type. This is done to keep others from reading your password.5. When you have finished entering your password, touch the ENTER key.DRAFT

Operation 3STERRAD® 100NX® User’s Guide 25Entering Load Information✔Note: If your sterilizer has been configured not to require load item data, this screen will not appear. Skip to the subsection titled Cycle Notes.Enter Load Item DataThe Load Item Data screen allows you to enter information about the contents of the load. This can be done for tracking and traceability or may be useful for inventory purposes. Items can be typed into the screen or selected from a predefined list of items. This information is stored and printed on a cycle report. It can also be transferred to a host computer over a network connection.Figure 2. Enter Load Item Data.1. To enter items not in the database, type the item information in the “Enter Items Here” field. Touch ENTER to accept the item. Repeat for additional items always touching ENTER after each item. Touch Done when the list is complete.2. An optional barcode scanner can be used to enter load item data. You may use this feature if your sterilizer is equipped with this option.DRAFT

3 Operation26 STERRAD® 100NX® User’s GuideSelect From ListIf a database has been established containing frequently used load information, you can select that information using the following steps:1. Touch Select From List.2. Scroll up or down the load item menu list to the desired item.3. Touch the items you wish to add to your current list and touch Select.4. Touch Done to complete the list.5. Touch Keyboard to return to the keyboard entry fields or to use a barcode scanner.Cycle Notes✔Note: If your sterilizer has been configured not to require cycle notes, this screen will not appear. The Cycle Notes screen allows you to enter information about the cycle. For example; record information about biological indicators used in the cycle or other information that should be stored in the cycle history file. This information is printed on the cycle report, and can be transferred to a host computer over a network connection.Figure 3. Cycle Notes.1. Touch the Enter Notes for Cycle field. The cursor appears in the field.DRAFT

Operation 3STERRAD® 100NX® User’s Guide 272. Use the on-screen keyboard to type your notes.3. When data entry is complete, touch the Done button.4. If conditions exist which prevent a sterilization cycle from starting; e.g., no cassette, hydrogen peroxide monitor is blocked, etc., a message is displayed on the screen.5. The program displays the System Ready screen.6. Touch Back to return to the previous screen.DRAFT

3 Operation28 STERRAD® 100NX® User’s GuideLoading the Chamber✔Note: The door is equipped with a safety mechanism that prevents it from closing if it encounters an obstruction. If this occurs, the door stops immediately. You must use the touch screen to open the door.1. Open the active chamber door by pressing the Open Door foot pad, or by touching Open Door on the display, and place your load on the shelves.Figure 4. Touch the Foot Pad to Open the door.✔Note: If necessary, the top shelf can be removed to accommodate a large load placed on the bottom shelf. Figure 5. Do Not Block the UV Lamp.DRAFT

Operation 3STERRAD® 100NX® User’s Guide 292. When placing the load on the shelves, make certain that you do not block the ultraviolet lamp beam in the front right (your right) side of the chamber. Make sure the load is centered on the shelves and that the shelves are centered in the chamber.Figure 6. The Load Should NOT Touch the Electrode.3. Do not allow any part of the load to touch the electrode, the back wall of the chamber, or the inside of the door.4. Leave at least 1 inch (25 mm) of free space between the load and the electrode to allow hydrogen peroxide to diffuse around the load.Figure 7. Do NOT Stack Trays.DRAFT

3 Operation30 STERRAD® 100NX® User’s GuideFigure 8. Load Correctly Placed for STANDARD Cycle ProcessingFigure 9. Load Correctly Placed for DUO and FLEX Cycle Processing5. When you are finished loading the chamber, close the door by tapping the foot pad or pressing the Close Door button on the touch screen.6. If a message requesting that the door be closed is displayed, the door is not securely closed. Make certain that nothing is caught in the door seal.DRAFT

Operation 3STERRAD® 100NX® User’s Guide 31Loading Requirements for the EXPRESS CycleOnly the bottom shelf of the STERRAD® 100NX® Sterilizer should be used when processing loads in the EXPRESS Cycle. The following figure shows a correctly placed load.Figure 10. Load Correctly Placed for EXPRESS Cycle ProcessingDRAFT

3 Operation32 STERRAD® 100NX® User’s GuideSelecting and Starting a CycleWhen the load has been placed in the chamber, and the door has been closed, use the System Ready screen to start the cycle. The following display shows all the cycles available for the STERRAD® 100NX® Sterilizer. You may have one or more cycles installed and enabled on your system. Make sure you understand the differences in the cycles and what types of materials can be sterilized in each cycleFigure 11. Touch the Screen to Start Your Cycle.The screen displays the message “Please Insert New Cassette” if a new cassette is required, if the cassette in the sterilizer is expired, or if there is no cassette installed in the sterilizer. Follow the instructions in the next section to insert a new cassette.Touch your choice of cycle from those displayed and then touch confirm to start the cycle; the cycle starts.✔Note: When alternating between cycle types, the system needs a few minutes to adjust. This adjustment period does not apply when processing consecutive STANDARD and FLEX, or DUO and EXPRESS Cycles.✔Note: If a cycle installed on your system does not appear on the cycle selection screen, this cycle may have been disabled by the supervisor. See Supervisor Level information to learn how to enable/disable an installed cycle.DRAFT

Operation 3STERRAD® 100NX® User’s Guide 33System Ready ScreenThe System Ready screen displays a number of buttons allowing you to select cycles based on the cycles that are loaded and enabled on your sterilizer.Cycle Types◆STANDARD cycle sterilizes the load in about 47 minutes. This cycle is installed on all systems.◆DUO cycle is for sterilization of flexible endoscopes with their light cords and cameras.It sterilizes the load in about 60 minutes.◆FLEX cycle is specifically designed for flexible endoscopes and sterilizes the load in about 42 minutes. ◆EXPRESS cycle is for surface sterilization of general medical devices, rigid and semi-rigid endoscopes without lumens; and sterilization of mated stainless steel and titanium devices. It sterilizations the load in about 24 minutes. Functions◆Logout is used when the current operator is finished using the sterilizer and the option is enabled. When Logout is selected, you must re-login to use the sterilizer.◆Cycle History displays the Select Cycle History screen. This screen allows you to select a cycle history file and view or print it.◆Utilities are available only to operators with Supervisor-level access. It displays the Additional Utilities Menu. ◆Door Open opens the active door.◆Door Close closes the active door.Inserting a Cassette1. Take a new STERRAD® 100NX® Cassette out of the shipping carton.2. Look at the package carefully before opening it. The indicator strip should be white. If the indicator strip is red, or if you see droplets of moisture, do not open the package – it is possible that hydrogen peroxide has leaked inside the package. Refer to the cassette Instructions for Use for proper handling instructions.3. If the indicator strip is white, open the cassette package.4. Position the cassette so that the arrows are pointing towards the sterilizer.DRAFT

3 Operation34 STERRAD® 100NX® User’s Guide5. Insert the cassette into the cassette slot until it stops moving. Do not use force to push the cassette into the machine.Figure 12. Inserting the Cassette into the Slot.6. After a slight pause, the sterilizer pulls the cassette through the slot and the slot door closes. Cassette loading is now complete.Cycle in ProgressWhen you touch the Start Cycle button (after selecting the cycle type), the sterilizer starts a “countdown clock” and begins the sterilization cycle.Figure 13. Cycle In Progress. The Countdown Clock is Displayed.DRAFT

Operation 3STERRAD® 100NX® User’s Guide 35The clock displays the estimated number of minutes and seconds remaining before the cycle is finished. The “Time Remaining” field updates as the sterilization cycle progresses. As each sterilization cycle stage runs, the screen displays the name of the stage. A moving bar graph also displays the percent of the cycle that is complete. For details about the current stage information, refer to the printouts in the “Reports and Files” chapter.Canceling a CycleThere may be occasions when it is necessary to cancel a cycle before it is completed.To cancel a cycle, do the following:1. Touch the Cancel Cycle button. The screen displays a confirmation message.Figure 14. Cancel Cycle Confirmation. Touch Yes or No.DRAFT

3 Operation36 STERRAD® 100NX® User’s Guide2. Touch No to continue with the cycle. Touch Yes to cancel the cycle. Once the cycle cancellation sequence begins, the screen turns red and the cancellation sequence cannot be interrupted. The cancellation sequence may take up to ten minutes to complete.Figure 15. Cycle Cancellation In Progress. Cancellation Has Been Confirmed.Loads from canceled cycles should be rewrapped using new packaging materials, STERRAD® Chemical Indicator Strips, and STERRAD® SEALSURE® Chemical Indicator Tape. If a biological indicator was used in the canceled load, the previously used biological indicator must be discarded and a new biological indicator must be placed in the chamber before restarting the new cycle.WARNING! HYDROGEN PEROXIDE MAY BE PRESENT.If a cycle cancels and the items in the load appear wet, hydrogen peroxide may be present. Wear chemical resistant latex, PVC (vinyl), or nitrile gloves while removing the items from the chamber, and while wiping off the items with a damp cloth. Discard contaminated cloth according to your facility’s procedures.DRAFT

Operation 3STERRAD® 100NX® User’s Guide 37Cycle CompletedWhen the cycle is complete, the Cycle Completed screen is displayed. The background of the screen is green to indicate a successfully completed cycle. The loudspeaker emits one long beep to indicate successful cycle completion. Figure 16. Successful STANDARD Cycle Completed.1. Touch the View Details button to display the cycle history file for the just-completed cycle.2. Touch the Done button to proceed.DRAFT

3 Operation38 STERRAD® 100NX® User’s GuideProcessing a Sterilized LoadWhen you touch the Done button, how the sterilizer responds depends upon the configuration of your sterilizer.◆If login is required before the door can be opened, the Login screen is displayed. When this occurs, enter your operator identification and password and touch Enter. The door opens and the load can be removed. The operator’s name appears on the printout acknowledging the completion of the cycle.◆If no login is required for load removal, the door opens and the load can be removed. WARNING! HYDROGEN PEROXIDE MAY BE PRESENTIf white residue is visible on the load, this is residue from the hydrogen peroxide stabilizer. Wear chemical resistant latex, PVC (vinyl), or nitrile gloves when removing a load with visible white residue. White residue can be minimized by making sure regular Planned Maintenance procedures are performed on your system. The system will inform you when planned maintenance is due. Please schedule your PM service in a timely manner.◆Refer to the cycle completion flowcharts for additional information.Inspecting Chemical IndicatorsAfter ensuring that the chemical indicators exhibit the correct color change, and the cycle printout shows that all the necessary cycle parameters were met, the sterilized load is ready for immediate use, following your facility’s policy. If the chemical indicators do not exhibit the correct color change, investigate the cause, repackage, and then reprocess the load.Processing Biological IndicatorsRemove the biological indicator from the load and process it per its Instructions for Use. Refer to the flowcharts on the following pages for additional information.DRAFT

Operation 3STERRAD® 100NX® User’s Guide 39Cycle Completion FlowchartDRAFT

3 Operation40 STERRAD® 100NX® User’s GuideSTERRAD® CYCLESURE® 24 Biological Indicator FlowchartDRAFT

Troubleshooting 4STERRAD® 100NX® User’s Guide 41Chapter 4.Troubleshooting ✔Note: Repairs and adjustments should only be made by ASP trained and authorized personnel.Most sterilizer operating problems are accompanied by a system message. These messages are useful in determining the source of the problem. In many cases you can take remedial actions to return the sterilizer to normal operation. Because load related issues are the most frequent cause of cycle cancellation, the easiest solution is to repackage the load and restart the sterilizer when a cycle cancels. Be sure to replace biological and chemical indicators with new ones. In other cases, the problem may be caused by a component failure that requires adjustment or repair by an ASP Service Representative. Call ASP Professional Services at 1-888-STERRAD (1-888-783-7723). Outside the USA, call your local ASP Customer Support Representative.In the following table are messages that are displayed by the system. The messages are listed in alphabetical order. Some messages do not require action on your part and are merely statements of the system status. Other messages require that you insert a cassette, remove the cassette disposal box, or other such action. The display directs you what steps to take. If the cycle had cancelled, wear chemical resistant latex, PVC (vinyl) or nitrile gloves when removing the load.Running DiagnosticsIf the sterilizer or the information in the following table directs you to run diagnostics, remove the load and touch Other Tests from the Diagnostics menu. If you have received a message containing the word “temperature,” touch Temperature Tests. (See the section on “Access Levels and Supervisor Tasks” for information on how to navigate to the Diagnostics menu.) If you run Diagnostics and the tests show that there are errors, contact your ASP Representative and report the diagnostic results. If the diagnostic tests pass with no errors, you can run cycles with your normal load.DRAFT

4 Troubleshooting42 STERRAD® 100NX® User’s GuideSystem Message TableTemperature MessagesWARNING! HOT SURFACES.When a temperature message is displayed, this may mean that the interior of the sterilizer may be very hot. Do not touch the inside of the chamber, electrode, or doors with your bare or gloved hands. Allow the sterilizer to cool before touching interior surfaces.A number of displayed messages concern the temperature of the system; e.g., doors, vaporizer, electrode, etc. These messages contain the word “temperature” and require that you run the temperature test in diagnostics. If the temperature test fails, or if the message is repeated, call your ASP Representative for further action.Messages Not In This TableIf a displayed message is not found in the following table, there is no remedy available that you may safely perform. Call your ASP Representative for further action.If this message appears. . . Do this . . .Cannot Dispose Cassette, Run Diagnostics The cassette did not drop into the disposal box. Remove the load and run diagnostics.Cannot Eject Cassette, Run Diagnostics The cassette did not eject out the cassette slot. Remove the load and run diagnostics.Cassette Accepted, Positioning No action required.Cassette Detected, Verifying No action required.Cassette Did Not Index A cassette was unable to advance to the next cell. Remove the load and run diagnostics.Cassette Expired, Disposing Cassette Insert a new cassette.Cassette Expiry Found During Start Cycle The cassette was found to be expired when the Start Cycle button was pressed. Dispose of the cassette and insert new cassette.Cassette Out Of Date, Disposing Cassette The cassette has been in the sterilizer for 10 days or the cassette has expired. Insert new cassette.DRAFT

Troubleshooting 4STERRAD® 100NX® User’s Guide 43Cassette System Timeout When Piercing The delivery subsystem is not responding. Remove the load and run diagnostics.Cassette Used, Disposing The inserted cassette does not have any unused cells remaining. Insert a new cassette.Control Available On Other Side Use the other side of the sterilizer to access the touch screen.Cycle Canceled By Operator The operator canceled the cycle. Repackage the load. Restart the cycle after cancellation is complete.Delivery System Not Ready Delivery system not responding. Remove the load and run diagnostics.Disposing Cassette No action required.Door Opened Door open sensor malfunction. Remove the load and run diagnostics.Door Sensor Fault Door malfunction. Reboot the system. If the message persists, call your ASP Representative.Function Available on Other Side Only Control of the sterilizer is on the other side of the unit.H2O2 Adjustment In Progress The intensity of the UV lamp is being adjusted. Wait 5 minutes for adjustment to be completed.H2O2 Bulb Warming Up, Please Wait… No action needed.H2O2 Bulb/Detector Fault H2O2 detector malfunction. Run diagnostics.H2O2 Curve Area Too Low. Verify That The Load Is Not Blocking The UV Light PathLoad is absorbing too much peroxide. Remove absorbing materials from the load, repackage, and restart the cycle. If the problem persists, call your ASP Representative.H2O2 Monitor Failure H2O2 bulb or detector malfunction. Remove the load and run diagnostics.WARNING! HYDROGEN PEROXIDE MAY BE PRESENT.Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation. Hydrogen peroxide liquid may be present on the load or in the chamber.H2O2 Peak Too Low The load is absorbing too much peroxide. Remove the absorbent materials from the load, repackage, and restart the cycle. If the problem persists, call your ASP Representative.H2O2 Rate Constant Too High The load is decomposing the H2O2. Check the load for absorbent materials. Repackage, and restart the cycle. If the problem persists, call your ASP Representative.If this message appears. . . Do this . . .DRAFT

4 Troubleshooting44 STERRAD® 100NX® User’s GuideWARNING! HYDROGEN PEROXIDE MAY BE PRESENT.Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation. Hydrogen peroxide liquid may be present on the load or in the chamber.H2O2 Rate Outside the Calibrated RangeReboot the system. If the problem persists, call your ASP Representative.H2O2 Sensor Fault Reboot the system. If the problem persists, call your ASP Representative.High Plasma Power The plasma power is out of specification. Remove the load and run diagnostics.Invalid Key Code. Please Enter A Valid Code Press the OK button and reenter a valid key code.Invalid Load Items File Press the Back button and reinsert the USB memory stick.Less Number of Cells Available, Please Dispose the Cassette The system will automatically move the cassette to the disposal box.WARNING! HYDROGEN PEROXIDE MAY BE PRESENT.Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation. Hydrogen peroxide liquid may be present on the load or in the chamber.Load May Contain H2O2Residual peroxide may be present on the load or chamber walls due to a cancelled cycle or system malfunction. Wearing chemical resistant latex, PVC (vinyl), or nitrile gloves, repackage the load and restart the cycle. If the problem persists, call your ASP Representative.WARNING! HYDROGEN PEROXIDE MAY BE PRESENT.Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation. Hydrogen peroxide liquid may be present on the load or in the chamber.Low Plasma Power The plasma power is out of specification. Remove the load and run diagnostics.Memory Card Full Initiate backup to the memory card or press OK and the system will delete the oldest file.No File Found Press OK. Reinsert the USB memory stick.Other Door Is Open Close the door on the other side of the sterilizer.Please Close Door Touch the close door display or the door foot pad to close the door.If this message appears. . . Do this . . .DRAFT

Troubleshooting 4STERRAD® 100NX® User’s Guide 45Please Enter Valid User Name and Password After the valid user name and password are entered, press OK.Please Insert New Cassette Insert a new, unused cassette.Please Remove Cassette And Verify Cassette Type Wrong cassette type. Confirm that the cassette is a STERRAD® 100NX® cassette.Please Wait While Graph Loads No action required.WARNING! HYDROGEN PEROXIDE MAY BE PRESENT.Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation. Hydrogen peroxide liquid may be present on the load or in the chamber.Power Fail Cancellation A power failure occurred during a cycle. Repackage the load and restart the cycle. If the problem persists, call your ASP Representative.WARNING! HYDROGEN PEROXIDE MAY BE PRESENT.Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation. Hydrogen peroxide liquid may be present on the load or in the chamber.Pressure Check Failed Load is absorbing too much peroxide. Remove absorbing materials from the load, repackage, and restart the cycle. If the problem persists, call your ASP Representative.Pressure Out Of Range (High) Vacuum system malfunction. Remove the load and run diagnostics.Pressure Out Of Range (Low) Vacuum system malfunction. Remove the load and run diagnostics.Printer Is Out Of Paper. Please Load A New Roll. Load paper into the printer.Printing Is In Progress No action required.RFID Data Error, Ejecting Cassette, Verify Cassette Orientation Cassette will automatically eject. Insert a valid cassetteStage Timeout Remove the load and run diagnostics.WARNING! HYDROGEN PEROXIDE MAY BE PRESENT.Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation. Hydrogen peroxide liquid may be present on the load or in the chamber.If this message appears. . . Do this . . .DRAFT

4 Troubleshooting46 STERRAD® 100NX® User’s GuideCall Your ASP RepresentativeIf you encounter a problem or a system message that is not covered in the this user’s guide, do not attempt to perform repairs or adjustments to the STERRAD® 100NX® Sterilizer.. Call ASP Professional Services for assistance in the USA at 1-888-STERRAD (1-888-783-7723) and outside the USA, call your local ASP Customer Support Representative.Unable to Evacuate Chamber . . . Ensure Load is Dry before Starting CycleRemove the load and run diagnostics. Reboot the system. If the problem persists, call your ASP Representative.Unable to Open One Second Data File Replace the PCMCIA card with a new one.UV Path Is Blocked, Open Door And Clear Pathway Object is blocking the UV path. Verify that the shelves and/or the load are not blocking the path. If the problem persists, call your ASP Representative.Warming Up, Please Wait… No action needed.WARNING! HYDROGEN PEROXIDE MAY BE PRESENT.Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation. Hydrogen peroxide liquid may be present on the load or in the chamber.Would You Like to Troubleshoot? Remove the load and run diagnostics. If the problem persists, call your ASP Representative.If this message appears. . . Do this . . .DRAFT

Sterilizer Overview 5STERRAD® 100NX® User’s Guide 47Chapter 5. Sterilizer OverviewSterilizer Cycles The following display shows all the cycles available for the STERRAD® 100NX® Sterilizer. This guide contains detailed instructions for each cycle. Make sure you understand the differences in the cycles and what types of instruments can be sterilized in each cycle.Figure 17. Select Cycle Display Showing All Cycles. Your displaymay be different depending on the cycles installed and enabledfor use. Supervisor Access is required to enable installed cycles.DRAFT

5 Sterilizer Overview48 STERRAD® 100NX® User’s GuideSterilizer FeaturesThe cassette slot, the cassette drawer, the touch screen, PCMCIA slot (inside the access panel), the chamber door, the printer, and the foot pad are found on the input side of the sterilizer (the front of single-door units). On a two door unit the touch screen, chamber door, foot pad, and printer are found on both the input and output sides. The main power switch is located on the left (your left) front side of the sterilizer. The I/O interface is located on the right (your right) front side of the sterilizer. See the sections on Data Transfer and Rebooting the System for locations of the power switch and USB port.. Figure 18. The STERRAD® 100NX® Sterilizer. Not shown: The power switch is at the lower left and the USB port is at the lower right.◆The sterilizer is operated by using the touch screen to begin a cycle, enter load information, monitor the cycle and perform diagnostics.◆A cassette is inserted into the sterilizer through the cassette slot. AccessPanelCassetteSlot LCD Touch Screen DisplayDoorPrinter AccessFoot PadDRAFT

Sterilizer Overview 5STERRAD® 100NX® User’s Guide 49◆The items to be sterilized are placed on the shelves and the door is closed using either the close door button on the touch screen or by tapping the foot pad with your foot. The foot pad is located on the lower portion of the front panel.Load information and cycle notes are entered if desired, a cycle is selected and the chosen cycle is then started. At the conclusion of the cycle the items are removed and are ready for storage or immediate use.If the system is equipped with 2 doors, the load is inserted from the input side and removed from the output side. On 2 door units, the touch screen and door can be used only from the active side; both doors cannot be opened at the same time.CassetteThe cassette contains sealed capsules of hydrogen peroxide solution. Each cassette has coded information that provides displayed details on the cassette expiration date, manufacturer, and cell status including cycle completion information. The sterilizer pulls the cassette through the slot and moves it into the machine, keeping it there until the cassette has been used.Figure 19. Inserting a Cassette.WARNING! HYDROGEN PEROXIDE IS CORROSIVE.Concentrated hydrogen peroxide is corrosive to skin, eyes, nose, throat, lungs, and the gastrointestinal tract. Always wear chemical resistant latex, PVC (vinyl), or nitrile gloves while removing items from the sterilizer following a cancelled cycle. Following a cancelled cycle, if items in the load show any visible moisture or liquid, hydrogen peroxide may be present.DRAFT

5 Sterilizer Overview50 STERRAD® 100NX® User’s GuideCassette Disposal BoxAfter processing of the cassette, the sterilizer automatically discards it into the cassette disposal box. The cassette disposal box holds 2 used cassettes. When the box has the maximum number of cassettes, the sterilizer displays a message indicating that the box must be replaced. The cassette disposal box must be closed to permit safe disposal of cassettes. Refer to the “Maintenance” chapter for additional information.Figure 20. Cassette Disposal Box.Touch Screen and SpeakerThe sterilizer displays information and allows you to enter commands on the color touch screen display. By touching buttons displayed on the screen, you can enter letters and numbers, make selections, and start and stop the sterilizer.DRAFT

Sterilizer Overview 5STERRAD® 100NX® User’s Guide 51Figure 21. Using the Touch Screen.An internal loudspeaker emits “beep” tones to call for user attention or indicate errors. A single long beep indicates a successfully completed cycle. A series of ten short beeps indicates a canceled cycle.ChamberThe load is placed in the chamber for sterilization. The chamber walls and doors contain heaters that keep the chamber interior warm during operation. When the chamber door(s) are closed, a vacuum-tight seal is created, allowing the chamber atmosphere to be evacuated during operation. Figure 22. The STERRAD® 100NX® Chamber Empty and With a Typical Standard Cycle Load Correctly Placed.The chamber contains 2 slide-out shelves to permit efficient loading. Inside the chamber, surrounding the shelves is a metal screen (the electrode) that helps generate plasma during operation.DRAFT

5 Sterilizer Overview52 STERRAD® 100NX® User’s GuidePrinterThe sterilizer has an integrated internal printer located in the front panel. On two door units, a printer is located in the main panel on each side. The printer prints cycle reports and other information on a roll of thermal paper. The printer features easy, drop-in paper loading and requires no ink cartridges. (The system is also designed to interface to a second, external printer that is USB-compliant and supports PCL-3 protocol.)◆The handle is squeezed and the door is pulled toward you to open the printer door for printer paper replacement. ◆The top button advances the paper. Figure 23. STERRAD® 100NX® Printer Paper Advance Button.DRAFT

Sterilizer Overview 5STERRAD® 100NX® User’s Guide 53Touch Screen Data EntryThe following figure shows a typical data entry screen. The typewriter “keys” input the indicated character each time a key is touched. Touch the screen to move the cursor from place-to-place. The load list can be predefined and used repeatedly.Figure 24. Example of a Data Entry Screen.DRAFT

5 Sterilizer Overview54 STERRAD® 100NX® User’s GuideFunction ButtonsMost screens provide function buttons that display other screens or select sterilizer functions. Common function buttons are shown in the following table.Button FunctionDone. Touch this button to indicate that you are finished using the screen.Back. Touch this button to return to a prior screen.View. Touch this button to view the selected report or file.Print. Touch this button to print the selected report or file.Cancel. Touch this button to cancel the entry you just made.DRAFT

Maintenance 6STERRAD® 100NX® User’s Guide 55Chapter 6.Maintenance✔Note:Repairs and adjustments should only be attempted by experienced technicians who are fully trained to maintain and repair the STERRAD® 100NX® Sterilizer. Use of unauthorized parts for maintenance or repair could cause personal injury, result in costly damage, or sterilizer malfunction and voids the warranty.Automatic Maintenance The adjustment of the hydrogen peroxide monitoring lamp is performed automatically by the sterilizer software. The user does not have to perform any task to start this procedure. Automatic Lamp AdjustmentWhen the sterilizer shows the System Ready screen, the message “Auto Adjustment in Progress” will be displayed while the sterilizer adjusts the intensity of the UV lamp. This function can take approximately 5 minutes to complete. The automatic adjustment will take place if the lamp voltage is below a preset limit.DRAFT

6 Maintenance56 STERRAD® 100NX® User’s GuideManual MaintenanceThe following maintenance procedures are performed by the user:◆Disposing of cassettes.◆Inserting a new cassette disposal box.◆Replacing the printer paper roll.◆Cleaning the sterilizer exterior.◆Cleaning the hydrogen peroxide monitor detector lens.◆Replacing the air filter.◆Replacing the PCMCIA card (if desired).◆Disposing of a sterilizer.These tasks are performed when needed. The printer paper is replaced when the roll is empty. The sterilizer exterior should be cleaned only when necessary. This chapter provides step-by-step instructions on how to perform these maintenance tasks. Information on inserting a cassette box follows the disposal section.Disposing of CassettesWhen a cassette is empty the sterilizer automatically moves it to the cassette disposal box. The screen displays a message instructing you which actions to take next. When the cassette disposal box contains 2 cassettes, it is full, and you must dispose of the full cassette disposal box. For safety reasons, you must use the cassette disposal box to dispose of cassettes. Never reuse a cassette disposal box. Once a cassette disposal box has been removed, a new cassette disposal box must be inserted.DRAFT

Maintenance 6STERRAD® 100NX® User’s Guide 57Removing a Cassette Disposal BoxWARNING! HYDROGEN PEROXIDE MAY BE PRESENT.Wear chemical resistant latex, PVC (vinyl), or nitrile gloves. This will protect you from contact with any residual hydrogen peroxide that may be present in the cassettes.1. Open the cassette access door. Pull the tab on the cassette disposal box to more easily slide it completely out.Figure 25. Open the Access Panel and Remove the Used Cassette Box.2. Close the lid by pinching it shut along the edge.Figure 26. Pinch the Edge of the Lid to Close the Box.3. Dispose of the closed cassette box according to your facility’s policy.DRAFT

6 Maintenance58 STERRAD® 100NX® User’s Guide4. Insert a new box making sure the lid is open and not caught in the opening, and the tab is facing you.Figure 27. Insert the New Cassette Box with the Lid Open so the Tab is on the Left.5. Close the access panel.Replacing the Printer PaperWhen the printer paper roll is empty, the sterilizer displays a message “Printer is out of paper. Please load a new roll.” 1. Open the printer by pushing or squeezing up on the handle as shown. The printer door opens toward you.Figure 28. Open the Printer.2. The empty paper roll rests on the bottom of the printer door. Remove the empty roll.DRAFT

Maintenance 6STERRAD® 100NX® User’s Guide 59Figure 29. Remove the Empty Paper Roll.3. Insert a new paper roll as shown in the following figure. The paper should feed from the top of the roll. Figure 30. Insert a New Paper Roll.4. Pull a short length of paper over the top of the printer door.5. Align the paper so that it fits between the two paper guides on the top of the printer door.DRAFT

6 Maintenance60 STERRAD® 100NX® User’s Guide6. Push the door shut making sure the paper stays in place.Figure 31. Make sure the Printer Door Latches Securely and the Paper is in Place.7. Press the paper advance button. Check the alignment of the paper and make certain it does not jam or misfeed.Figure 32. Press the Paper Advance Button.8. When the paper has advanced normally, tear off the used strip in an upward direction. Paper replacement is now complete.DRAFT

Maintenance 6STERRAD® 100NX® User’s Guide 61Cleaning the Sterilizer Exterior✔Note:Do not attempt to clean the chamber, door, interior surfaces, shelves, or electrode. If these items need cleaning, in the U.S.A. call ASP Professional Services. Outside the USA, call your local ASP Customer Support Representative for assistance.The sterilizer exterior can be cleaned with a soft cloth and a mild, nonabrasive detergent solution if necessary. When cleaning the sterilizer exterior, follow these guidelines:1. Turn off the power to the sterilizer before cleaning the exterior.2. Never allow cleaning solution or water to enter the interior or chamber. Moisten a cloth with nonabrasive detergent solution and use the damp cloth to clean the surfaces.3. Do not spray cleaning solution directly on the touch screen. Use a dampened cloth to clean the screen.4. If you have any questions about proper cleaning techniques, in the U.S.A. please call ASP Professional Services. Outside the USA, call your local ASP Customer Support Representative before proceeding. Failure to follow these guidelines may result in damage to the sterilizer and may void the warranty.DRAFT

6 Maintenance62 STERRAD® 100NX® User’s GuideCleaning the Hydrogen Peroxide Monitor Detector LensThe hydrogen peroxide monitor lens is located on the input side of the sterilizer. The lens must be kept clean. Wipe off the lens once every three months or when an accumulation of debris is noted. This is shown in the following figure.Figure 33. Cleaning the Hydrogen Peroxide Monitor Lens.1. Always use a lint-free cloth to clean the lens.2. Moisten the cloth with isopropyl alcohol. Never use an abrasive cleanser.3. Wipe the lens to remove any accumulated debris.DRAFT

Maintenance 6STERRAD® 100NX® User’s Guide 63PCMCIA Card Handling and ReplacementThe PCMCIA card contains the flash memory used to store cycle data. It should not be removed arbitrarily. If you need to remove or replace it, use the following steps:1. Turn off the sterilizer, or go to the “Additional Utilities” menu and press the PCMCIA button. Either method allows you to safely remove the PCMCIA card.2. Open the cassette access door.3. Eject the PCMCIA card by pressing the eject button on the top of the card slot (see the following figure).Figure 34. Press the Button at the Top of the Card Slot to Eject the PCMCIA Card.To reinsert the PCMCIA card, do the following:1. Examine the PCMCIA card and note the location of the label.2. Orient the PCMCIA card so that the side of the card with the label faces left.DRAFT

6 Maintenance64 STERRAD® 100NX® User’s Guide3. Insert the card into the PCMCIA card slot.4. Press the end of the PCMCIA card until the card is firmly seated in the slot (you will feel a “click” as the card is seated in the connector).Figure 35. Insert the PCMCIA Card Correctly.✔Note: The STERRAD® 100NX® Sterilizer will not operate unless the PCMCIA card is properly installed.Data Transfer Using a Memory StickA memory stick can be inserted in to the USB port located on the right (your right) side of the sterilizer. Go to the Cycle History screen and select Data Transfer, then USB Save. Select cycle data to be transferred and data type. Figure 36. Insert the Memory Stick into The USB Port.DRAFT

Maintenance 6STERRAD® 100NX® User’s Guide 65Rebooting the SystemIf it becomes necessary to reboot the system, flip the main switch on the sterilizer to turn off the system and then turn it back on.Figure 37. The Main Power Switch/Circuit Breaker is Located on the Side of the Sterilizer at your Left.Sterilizer DisposalApplicable in the EU: All electrical and electronic equipment (including batteries) must be returned to a waste collection system or treatment and recycling facility. Follow decontamination instructions before returning waste. Contact your ASP Representative if you need assistance.Other Countries: Prior to disposal of the sterilizer, user must follow decontamination instructions. The disposal of infectious waste, electronic circuit boards and other electronic components (including batteries) are regulated in many countries; (e.g., by the US Environmental Protection Agency). Please ensure compliance with all International, Federal, State, and Local regulations before disposal. Contact your ASP Representative for additional information. Main Circuit BreakerDRAFT

6 Maintenance66 STERRAD® 100NX® User’s GuideDRAFT

Reports and Files 7STERRAD® 100NX® User’s Guide 67Chapter 7.Reports and FilesDisplayed Reports Users with Operator-level access can display the Cycle History files. Users with Supervisor-level access can display the Cycle History files, as well as Calibration files and Diagnostic files.All files that are displayed can be printed by touching the Print button on the file display screen.Cycle HistoryCycle history data is stored in the sterilizer’s memory. The memory holds data from the last 200 cycles. After 200 cycles are completed, the oldest cycle history record is overwritten with new data from the 201st cycle. If your sterilizer is configured with the optional network connection, cycle history data can be periodically uploaded to a host computer and preserved permanently if desired.When you touch the View Cycle History button on any screen where the button appears, the program displays the Select Cycle History screen. The list box shows the cycle number, status, completion date and time, and reason for cancellation (if applicable) for all cycle history records currently in the sterilizer’s memory.DRAFT

7 Reports and Files68 STERRAD® 100NX® User’s GuideTouch the scroll bars to scroll through the list. Touch the line you wish to select.Figure 38. Select Cycle History File.Print List prints a list of all cycle history files stored in the sterilizer.View Cycle displays the selected Cycle History file on the screen.Print Cycle (Short) prints a short-format report of the selected cycle history file.Print Cycle (Long) prints a long-format report of the selected cycle history file.Parametric Print prints a parameter format report of the selected cycle history file (external printer required).Data Transfer – allows you to transfer the cycle information to a USB memory stick or to a networked PC.Back returns you to the previous screen.DRAFT

Reports and Files 7STERRAD® 100NX® User’s Guide 69Printed ReportsEvery time a cycle is completed, a cycle completion report is printed. Depending upon how your sterilizer has been configured, the report will either be a short-format report, a parametric report, or a long-format report. Each report extracts data from the cycle history record created by the cycle. The short-format report indicates the cycle status (Passed or Failed), date, time, operator and load information. The parametric report contains much more detail than the short report, but is less extensive than the long-format report. The long-format report includes all of the data in the short report plus detailed information about each stage of the sterilization cycle.Short ReportThe short-format report lists identifying information about the cycle, shows the cycle status, lists the date and duration of the cycle, and shows operator and load identifying information. The short-format report is useful for record keeping purposes and providing traceability of sterilized loads. Parametric ReportThe parametric format report shows single-point values for a certain number of parameters. It is a more confined report than the long printout and contains a table of all critical parameters and their values. It is only available if an external printer is attached.Long ReportThe long-format report lists detailed information about the cycle, shows the cycle status, lists the date and duration of the cycle, shows operator and load identifying information, and provides detailed data about the operation of the sterilizer, including temperatures, pressures, plasma measurements, and sterilant concentrations throughout the cycle. The long-format report is useful for detailed cycle quality control and contains valuable diagnostics information for ASP Service Representatives.DRAFT

7 Reports and Files70 STERRAD® 100NX® User’s GuideDRAFT

Access Levels and Supervisor Tasks 8STERRAD® 100NX® User’s Guide 71Chapter 8. Access Levels and Supervisor TasksOverviewUsers with Supervisor-level access privileges (see below) are permitted to perform a set of restricted sterilizer functions. These functions are not used in daily sterilizer operation and some of them are designed to control access, manage system records, and perform advanced diagnostic functions.Access LevelsThe STERRAD® 100NX™ Sterilizer can be configured to require that all users enter a valid operator identification and password before operating the sterilizer. This access control is enabled through the System Configuration screen and user identifications, passwords, and access levels are assigned and maintained through the User Administration screens.There are three levels of access available. Each is associated with a different subset of permitted operations.Operator-level access is designed to permit a user to perform tasks associated with the daily operation of the sterilizer. These privileges allow a user to:◆Select, start, and cancel a cycle.◆Enter load item information and cycle notes.◆Print a cycle history report and view cycle history files.◆Run diagnostics when a cycle cancels.Supervisor-level access includes all of the privileges of Operator-level access and additionally provides the ability to:◆Add, delete, and modify user names, passwords, and access levels.DRAFT

8 Access Levels and Supervisor Tasks72 STERRAD® 100NX® User’s Guide◆Select, view, and print all sterilizer files.◆Run diagnostic tests and print reports.◆Set date and time.◆Configure sterilizer features.◆Configure the network connection and upload data to the network.Service-level access is only for use by ASP Service Representatives.Additional Utilities MenuThe Additional Utilities Menu is available only to users with Supervisor- or Service-level access privileges. If a user with Operator-level privileges touches an Additional Utilities button on any screen, the Login screen will be displayed with the message: “Supervisor- or Service-Level Login Required.”The Additional Utilities Menu allows supervisors to configure the sterilizer and the network connection, set the date and time, set up and maintain user privileges, view and print files, perform diagnostic tests, and dispose of cassettes.Figure 39. Additional Utilities Menu.Date & Time allows you to set the date, time, time zone, and formats used for displaying and printing date and time.System Config allows you to set sterilizer features.User Admin allows you to add, delete, or modify operator identifications, passwords, and access levels.DRAFT

Access Levels and Supervisor Tasks 8STERRAD® 100NX® User’s Guide 73Cassette Functions allows you to automatically dispose a cassette into the collection box or perform the peroxide clearance procedure.Network allows you to configure a network connection.Diagnostics starts a sequence of operator-assisted diagnostic tests and prints a diagnostic test report.Service Functions are reserved for use by ASP Service Representatives.File Management allows you to select, display, and print files.Upload file reads the load items database file from a USB memory stick.Input/Output door open opens the door on the input or output side.Input/Output door close closes the door on the input or output side.PCMCIA allows you to safely remove the PCMCIA card. Do not try to remove the PCMCIA card without using this feature.Product Options allows you to enable or disable certain feature upgrades.The Back button returns you to the prior screen from which you originally selected the Additional Utilities Menu screen.Date and Time SettingsUse the Date and Time Settings screen to set the date and time, and select the local time zone and display formats.Figure 40. Date and Time Setting.DRAFT

8 Access Levels and Supervisor Tasks74 STERRAD® 100NX® User’s GuideSet DateUse the MM box to set the month (01-12), the DD box to set the day (01-31), and the YY box to set the year.Set TimeUse the HH box to set the hour (01-12 if 12-hour format is selected, 00-23 if 24-hour format is selected). Use the MM box to set the minute (00-59) and the SS box to set the second (00-59). If 12-hour format is selected, you may only select hours 01-12, and you must touch the AM or PM buttons to indicate the correct time.Time ZoneScroll through the selections until your time zone is displayed.Date FormatSelect the desired format for the date. The formats that include “YYYY” display a four-digit year.Time FormatSelect 12-hour or 24-hour format. If 12-hour format is selected, the AM and PM buttons on the Set Time line are enabled. If 24-hour format is selected, the AM and PM buttons are disabled.Cancel/DoneTo cancel the date or time setting, touch the Cancel button. When the date and time settings are correct, touch the Done button to return to the Additional Utilities menu.DRAFT

Access Levels and Supervisor Tasks 8STERRAD® 100NX® User’s Guide 75System ConfigurationUse the System Configuration screen to set sterilizer features. Selections on this screen allow you to set the volume of the alarm loudspeaker, the language used in displays and reports, and several access, report, and connection features. The sterilizer comes configured with factory-set defaults. If you want to change the default settings, select your preferred settings.Figure 41. System Configuration.Access Control OptionUser Login requires that a user identification and password be entered before the sterilizer can be loaded and run. This is the factory default setting.No User Login allows any person to operate the sterilizer.IMSEnabled causes the system to capture data with an IMS system (optional).Disabled causes the system to not capture data with an IMS system (optional).Vacuum UnitsTorr/mTorr expresses vacuum measurements in torr and mtorr. kPa/Pa expresses vacuum measurements in kilopascals and Pascals. This is the factory default setting.DRAFT

8 Access Levels and Supervisor Tasks76 STERRAD® 100NX® User’s GuideLoad Data Entry OptionEnabled causes the Enter Load Item Data screen to be displayed after login. This is the factory default setting.Disabled skips the Enter Load Item Data screen.Load Removal OptionWith Login requires that a user enter a user identification and password to open the sterilizer door when a cycle is complete. Without Login allows any person to open the sterilizer door when a cycle is complete. This is the factory default setting.Notepad OptionEnabled causes the Cycle Notes screen to be displayed after login. This is the factory default setting.Disabled skips the Cycle Notes screen.Network OptionEnabled allows the sterilizer to transmit data on a network. Disabled disables the network connection. This is the factory default setting.Alarm VolumeTouch the + or - buttons to adjust the volume of the alarm loudspeaker. The factory default setting is in the middle of the scale.Backlight Conservation (Minutes)Touch the number of minutes; 15, 30, or 60, to indicate how long the splash screen remains visible in the idle state before starting screen saver mode.Language SelectionScroll through the list to select the language used in displays and printed reports. The factory default setting is English.DRAFT

Access Levels and Supervisor Tasks 8STERRAD® 100NX® User’s Guide 77Sterilizer SettingsTouch Sterilizer Settings to display the following screen. The information entered here is included in the printout, but its use is optional. Touch Done to save the settings and return to the previous screen.Figure 42. Sterilizer Settings.Facility Name – Enter the name of the hospital or medical facility.Department Name – Enter the name of the department you wish to use as an identifier for the sterilizer.Sterilizer ID – Enter an ID such as an asset tag number or other information used to identify the sterilizer.Sterilizer Serial Number – This is configured by the manufacturer and cannot be altered.DRAFT

8 Access Levels and Supervisor Tasks78 STERRAD® 100NX® User’s GuidePrinter SettingsTouch Printer Settings to display the following screen: Touch Done to save the changes.Figure 43. Printer SettingsInternal Printer Input Side allows you to select the printer on the input side. This is the default.Internal Printer Output Side allows you to select the printer on the output side (2 door configuration).External Printer allows you to select an external printer connected to the USB port.Short Format instructs the sterilizer to print only the short report when a cycle is complete. This is the factory default setting.Long Format instructs the sterilizer to print only the long report when a cycle is complete.Parametric Format instructs the sterilizer to print only the parametric report when the cycle is complete. This format is available only when an external printer is selected.Graphs of various functions are available for printing if an external printer is selected. Touch the graph(s) desired.IMS Printout Enabled prints the IMS information if an external printer is selected.IMS Printout Disabled does not print the IMS information.DRAFT

Access Levels and Supervisor Tasks 8STERRAD® 100NX® User’s Guide 79Transfer SettingsWhen you touch Transfer Settings from the System Configuration menu, the following screen appears. This screen displays selectable report types that automatically transfer via a network to a remote PC upon cycle completion.Touch Done to save the settings. Touch Cancel to return to the previous screen.Figure 44. Transfer SettingsCancel/DoneTo cancel system configuration (on the System Configuration Menu), touch the Cancel button. When the system configuration settings are correct, touch Done. Cancel and Done have the same function on all the other screens you can access through the System Configuration menu.DRAFT

8 Access Levels and Supervisor Tasks80 STERRAD® 100NX® User’s GuideUser AdministrationUse the User Administration screen to add, modify, or delete user names, passwords, and access levels. A button on this screen allows you to upload user information to a USB memory stick. Supervisor-level access allows you to add, edit or delete a User or another Supervisor.✔Note: It is very important that you, as an administrator, keep track of your password. If you forget or lose your password, a service call is necessary for you to regain access to the supervisor area of the system.Figure 45. User Administration.Add User displays the Add User screen. On this screen you can set up a new user’s operator identification, password, and access level.Modify User displays the Modify User screen. On this screen you can modify or delete an existing user’s identification, password, and access level. Touch Edit User on this screen to change information.Upload User Data causes the sterilizer to receive a complete database file of user names, passwords, and access levels from a USB memory stick.Back returns you to the Additional Utilities Menu.DRAFT

Access Levels and Supervisor Tasks 8STERRAD® 100NX® User’s Guide 81Add UserUse the Add User screen to enter a new user’s identification, password, and access level.Figure 46. Add User.1 Enter the user’s operator “identification” in the Operator field. The entry must be alpha-numeric and no more than 10 characters.✔Note: Operator and Password fields are case-sensitive.2. Enter the user’s password in the Password field. The entry must be alpha-numeric, no more than 10 characters.3. Scroll through the Access Level selections and select an appropriate access level. You may only choose “Operator” or “Supervisor.” Only Service Users can select “Service” level access.4. Touch the Cancel button to exit this screen and return to the User Administration screen.5. Touch the Done button when you have finished entering information for a new user.DRAFT

8 Access Levels and Supervisor Tasks82 STERRAD® 100NX® User’s GuideModify UserUse the Modify User screen to modify an existing user’s identification, password, and access level.Figure 47. Modify User.1 Touch the user’s name whose information you wish to edit or delete.2. Touch Delete User to remove the user from the access list and revoke access to sterilizer operation.3. Touch Edit User to change the user’s information including access level.DRAFT

Access Levels and Supervisor Tasks 8STERRAD® 100NX® User’s Guide 834. Touch Done to return to the previous screen.Figure 48. Edit User.◆To modify the selected user’s information, touch the Edit User button. ◆To change the user’s operator name, make changes in the Operator field.◆To change the user’s password, make changes in the Password field.◆To change the user’s access level, select the desired Access Level. You may only choose “Operator” or “Supervisor.” Only Service Users can select “Service” level access.5. Touch the Cancel button to exit this screen and return to the Modify User screen.6. Touch the Done button when you have finished – the Modify User screen is displayed.Upload User DataYou can also add up to 1000 user identifications by uploading them to the sterilizer from a USB memory stick. The user data must be formatted to be compatible with the STERRAD® 100NX® Database format for user information. It must include the Access Level.When the Upload User Data button is touched, the Upload User Data screen is displayed. DRAFT

8 Access Levels and Supervisor Tasks84 STERRAD® 100NX® User’s GuideFigure 49. Upload User Data.If the user data shown is acceptable, touch Confirm. The following section contains information on uploading user data.Steps to Upload a User DatabaseTo upload a list of user identifications and passwords, perform the following steps:1 Create an ASCII text file called “users.rec” that contains the user identifications, passwords, and access levels. Use Microsoft Notepad to create the entry. Save the file as “users.rec” and in the “Encoding” drop down menu in Notepad Save, select UTF-8. Each entry should be separated by a comma only (no spaces). Example:USERNAME1,PASSWORD1,ACCESS-LEVEL1USERNAME2,PASSWORD2,ACCESS-LEVEL2where:◆USERNAME must be alpha-numeric, no more than 10 characters◆PASSWORD must be alpha-numeric, no more than 10 characters◆ACCESS-LEVEL must be either 1, 2 (1=Operator, 2 = Supervisor)2. Copy users.rec file to a USB memory stick and insert the memory stick into the sterilizer’s port located on the lower right (your right) side of the sterilizer.DRAFT

Access Levels and Supervisor Tasks 8STERRAD® 100NX® User’s Guide 853. On the sterilizer, touch the Upload User Data button. The information in the file will be displayed with the password concealed by “*” characters. You will receive an “INVALID STERRAD® 100NX® DATABASE FILE” message if the password or user name is longer than the permissible length, you have specified an invalid access level, or you have used an invalid format.4. Touch Confirm to accept the displayed data, logout the current user and return to the prior screen.Cassette FunctionsWARNING! HYDROGEN PEROXIDE MAY BE PRESENT.Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation or when disposing of a cassette. Hydrogen peroxide liquid may be present on the cassette, the load or in the chamber.This function has two options: Dispose Cassette which is used to remove the currently loaded cassette from the sterilizer to resolve an error message or to move a cassette that may be stuck in place; and Peroxide Clearance which is used to dispose of peroxide remaining in the sterilizer reservoir when the peroxide has expired. Peroxide in the system expires after 10 days. The system displays a message indicating that either of these functions need to be performed.Figure 50. Touch Cassette Functions to display this screen. Touch Dispose Cassette or Peroxide Clearance.DRAFT

8 Access Levels and Supervisor Tasks86 STERRAD® 100NX® User’s GuideDispose CassetteThe Dispose Cassette function moves the cassette from inside the sterilizer to the cassette box. The remaining volume of hydrogen peroxide is displayed on the screen.Touch Dispose Cassette to move the cassette into the cassette disposal box.Figure 51. Press Dispose Cassette to Move the Cassette Into the Cassette Disposal Box.DRAFT

Access Levels and Supervisor Tasks 8STERRAD® 100NX® User’s Guide 87Peroxide ClearanceThe DUO Cycle requires the sterilizer to hold peroxide in a reservoir to optimize sterilization. If this peroxide expires, you must dispose of the peroxide remaining in the system. “Peroxide Clearance,” must be performed when a message appears or no subsequent DUO cycles can be run.✔Note: Before you start Peroxide Clearance, ensure the chamber is empty. Figure 52. Typical Peroxide Clearance MessageFigure 53. Touch Peroxide Clearance to begin the procedure.DRAFT

8 Access Levels and Supervisor Tasks88 STERRAD® 100NX® User’s GuideNetworkSTERRAD® 100NX™ Sterilizer can be configured to communicate with a remote personal computer over a network. If you need to use this feature, please contact Advanced Sterilization Products for details on performing this setup.DiagnosticsThe diagnostics function prompts you to select one of two types of tests (either Temperature Test or Other Tests). If Other Tests is selected, the sterilizer runs ten operator-assisted tests of the sterilizer subsystems. You may skip one or more tests in the automatic sequence by touching the Cancel button when a test begins. This causes the program to advance to the next test in the sequence.The ten tests and the sterilizer elements that are tested are listed in the order in which they occur in the following table.Touch the Diagnostics button to start automatic diagnostic testing of the sterilizer.✔Note: The duration of the Temperature Test is a minimum of 11 minutes.Figure 54. Touch Either Button to Run Tests Than Can Help You Resolve System Messages.DRAFT

Access Levels and Supervisor Tasks 8STERRAD® 100NX® User’s Guide 89Diagnostic Tests* Times are approximate. If a failure is detected, the time may be extended.The ten tests take approximately 23 minutes and 10 seconds to complete. When the series of tests is complete, the sterilizer creates and stores a diagnostics file and prints a report. When printing is complete, the Additional Utilities menu is displayed.Service FunctionsThe Service Functions button is reserved for use by ASP Service Representatives.Order Test Name What is tested Average Time to Run*1 Power Supply Test DC power supply 30 sec.2 Vacuum Test Vacuum pump, pressure sensors and valves (vacuum control, vent, inlet, transition, delivery, and oil return)12 min.3 Door Test Door Motor and sensors 20 sec.4 Plasma Test Plasma electrical subsystemElectrode integrity 3 min. 20 sec.5 Cassette Test Cassette electro-mechanical subsystem RFID Reader 5 min.6 H2O2 Sensor Test Ultraviolet lamp and detector 20 sec.7 Display Test Touch screen and display function 20 sec8 Printer Test Printer function 10 sec.9 Fan Test Fan function 10 sec.10 Sound Test Loudspeaker function and volume 1 min.DRAFT

8 Access Levels and Supervisor Tasks90 STERRAD® 100NX® User’s GuideFile ManagementUse the File Management screen to select and display calibration files or diagnostic report files.Figure 55. File Management.Calibration FilesTouch the Calibration Files button to display a list of calibration files created during a sterilizer calibration. Scroll through the list and touch the file name you wish to view. Touch the View button to display the selected calibration file. Touch the Back button to return to the Additional Utilities menu.Diagnostic FilesTouch the Diagnostic Files button to display a list of reports created by the Diagnostics function. Scroll through the list and touch the report you wish to view. Touch the View button to display the selected report. Touch the Back button to return to the Additional Utilities menu.DRAFT

Access Levels and Supervisor Tasks 8STERRAD® 100NX® User’s Guide 91Upload FileThis screen allows you to upload item information from a separate database to the sterilizer using the USB memory port.Figure 56. Load Items Files1 Using Microsoft “Notepad,” create a list of load items similar to the example shown in the figure. To obtain the above display; i.e., ENDOSCOPE1, ENDOSCOPE2, etc. Each load item must be entered on the same line separated by a comma with no spaces before or after the comma. Be sure to include a comma after the last load item. Up to 1000 load items can be defined.2. Save the file with the file name “loaditems.txt” and use the “encoding” drop down in Notepad to save the file encoded as UTF-8.3. Insert the USB memory stick with the file loaditems.txt resident on the stick into the sterilizer’s USB port located on the lower right side of the front panel. 4. Select “Upload File” for the Additional Utilities men.5. Review the database displayed on the screen and press Confirm to accept the database into the sterilizer or press Back to cancel.DRAFT

8 Access Levels and Supervisor Tasks92 STERRAD® 100NX® User’s GuideInput/Output DoorsThe doors can be opened or closed via the foot pad that you tap with your foot or by touching the Input or Output Door buttons. If the system has only one door, only the Input Close Door and Input Open Door buttons are available for use. Only one door can be opened at a time. For example, if the Input Door is open, the Output Door cannot be opened at the same time.The Input Open Door and Input Close Door buttons open and close the input side of the sterilizer. That is the side where you load your instruments for processing.The Output Open Door and Output Close Door buttons open and close the output or clean side of the sterilizer. This is the side, on a two door unit, where you would remove your sterilized items. When the door is moving, the door open and close buttons, and the foot pad, are disabled until the door has completed its movement.Product OptionsWhen you select Product Options from the Additional Utilities Menu, and the EXPRESS or DUO cycles are installed, the following is displayed after the installation is complete, and every time you select Product Options after installation. ENABLED is the default option. This feature is only available with Supervisor-Level access.Figure 57. Product OptionsDRAFT

Access Levels and Supervisor Tasks 8STERRAD® 100NX® User’s Guide 93Install guides you to install any newly purchased features.Back returns you to the Additional Utilities Menu.Enabled displays any cycle in your sterilizer which can be selected (enabled). The choices appear on the Start Cycle display. Disabled removes the selected cycle buttons from the Start Cycle Screen. These cycles are still available for future use by selecting Enabled on the Product Options screen.DRAFT

8 Access Levels and Supervisor Tasks94 STERRAD® 100NX® User’s GuideDRAFT

Safety Information ASTERRAD® 100NX® User’s Guide 95Appendix A. Safety InformationYour safety is of primary concern to Advanced Sterilization Products (ASP). This chapter provides information on safely using the STERRAD® 100NX® Sterilizer. You must read and understand the safety information in this chapter before operating the sterilizer. Always pay attention to the warnings, cautions and notes throughout this user’s guide. This information is for your safety and to ensure that you receive the most benefit from the safe operation of your STERRAD® 100NX® Sterilization System.Personal Safety and First AidWARNING! HYDROGEN PEROXIDE IS CORROSIVEConcentrated hydrogen peroxide is corrosive to skin, eyes, nose, throat, lungs, and the gastrointestinal tract. Always wear chemical resistant latex, PVC (vinyl), or nitrile gloves while removing items from the sterilizer following a cancelled cycle or if any moisture is noted on items in the load following a completed cycle.WARNING! HYDROGEN PEROXIDE IS AN OXIDIZERHydrogen peroxide is strong oxidizing agent and poses a hazard for fire, explosion, or container rupture. Avoid allowing hydrogen peroxide to contact organic materials, including paper, cotton, wood, or lubricants. Do not use or store near heat or open flame. Shoes, clothing, or other combustible material that have come into contact with hydrogen peroxide must be immediately and thoroughly rinsed with water to avoid a potential fire hazard. In case of fire, use only water to extinguish.WARNING! RISK OF EYE INJURYDirect hydrogen peroxide contact with eyes can cause irreversible tissue damage. If contact with eyes occurs, hold the eyes open and flush with large amounts of water for at least 15-20 minutes. Remove contact lenses, if present, and then continue rinsing the eyes. Consult a physician immediately after flushing the eyes.DRAFT

A Safety Information96 STERRAD® 100NX® User’s GuideWARNING! RISK OF SKIN INJURYDirect hydrogen peroxide contact with the skin can cause severe irritation. Wear chemical resistant latex, PVC (vinyl) or nitrile gloves when handling used cassettes or ejected cassettes, items from a cancelled cycle, or items that have moisture present after a completed cycle. Immediately take off contaminated clothing and rinse thoroughly with water to avoid potential fire hazard and was before re-use.WARNING! RISK OF RESPIRATORY IRRITATIONInhalation of hydrogen peroxide mist can cause severe irritation of lungs, throat, and nose. If inhalation occurs, move to the person to fresh air. If the person is not breathing, call for emergency medical attention, or an ambulance, then give artificial respiration, preferably mouth-to-mouth, if possible. Consult a physician immediately.WARNING! CONCENTRATED HYDROGEN PEROXIDE IS TOXICIngestion of hydrogen peroxide may be life-threatening. If swallowed, call a “poison control” center or physician immediately for treatment advice. Have the person drink plenty of water if the person is able to swallow. Do not give anything by mouth to an unconscious person. Do not induce vomiting unless instructed to do so by the poison control center or physician.WARNING! HEATED STERILIZATION SURFACESAt the end of a cycle, the interior of the sterilizer may be hot. Do not touch the inside of the chamber or door with your bare or gloved hands. Allow the sterilizer to cool before touching interior surfaces.WARNING! AVOID EXPOSURE TO ULTRAVIOLET LIGHTThe hydrogen peroxide monitor uses an ultraviolet light source located inside the chamber behind the door. To avoid eye injury, do not stare directly at the ultraviolet light source for an extended period of time.WARNING! HYDROGEN PEROXIDE MAY BE PRESENTIf white residue is visible on the load, this is residue from the hydrogen peroxide stabilizer. Wear chemical resistant latex, PVC (vinyl), or nitrile gloves when removing a load with visible white residue. White residue can be minimized by making sure regular Planned Maintenance procedures are performed on your system. The system will inform you when Planned Maintenance is due. Please schedule your PM service in a timely manner.DRAFT

Safety Information ASTERRAD® 100NX® User’s Guide 97WARNING! RISK OF BREATHING DIFFICULTIESOn rare occasions, the outlet filter on the vacuum pump can prematurely fail. If this occurs, you may see mist or what some users have described as “haze” or “smoke” in the room where the sterilizer is operating. The chemical composition of the mist is primarily airborne mineral oil with trace amounts of other compounds. Oil mist exposure may, theoretically, pose an increased risk to people with certain respiratory conditions, such as asthma, and they should take special precautions not to be exposed to the mist. If you observe these conditions, personnel should leave the room as a precaution and discontinue use of the STERRAD® System until the system is repaired. Personnel should avoid working in the room until the mist has cleared.Please note that all STERRAD® Sterilizers should be used and installed in a well-ventilated environment (a minimum of 10 air exchanges per hour).Personal Protective EquipmentWARNING! HYDROGEN PEROXIDE MAY BE PRESENTWear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation. Hydrogen peroxide liquid may be present on the load or in the chamber.Device SafetyWARNING! RISK OF INJURY OR DAMAGE TO STERILIZERThe STERRAD® 100NX® Sterilizer should not be used stacked with other equipment.CAUTION: RISK OF DAMAGE TO LOADMetal objects must not come into contact with the chamber walls, the door, or the electrode. Contact with the walls, door, or electrode could damage the sterilizer or the metal objects.DRAFT

A Safety Information98 STERRAD® 100NX® User’s GuideCAUTION: KNOW WHAT YOU CAN PROCESSBefore processing any item in the STERRAD® 100NX® Sterilizer, make sure you know how the STERRAD Sterilization Process will affect the item. Read, understand, and follow the medical device manufacturers’ instructions for their products. This guide lists certain types of items and materials that can be safely processed in certain cycle choices. Make sure you understand the parameters of each cycle type before processing your items. This guide is not intended to replace any medical device manufacturers’ instructions. If you have questions, or if you are in doubt about the materials in your devices, contact the medical device manufacturer or your ASP Customer Representative for more information.CAUTION: RISK OF VIOLATION OF WARRANTYImproper processing may limit our liability for damage to processed instruments. Improper processing may also violate your instrument warranty.CAUTION: RISK OF DAMAGE TO LOAD – METAL OBJECTSMetal objects must not come into contact with the chamber walls, the doors, or the electrode. Contact with the walls, doors, or electrode could damage the sterilizer or the metal objects.CAUTION: RISK OF DAMAGE TO LOAD – VENTING CAPSTake special care to confirm that venting caps are placed according to the manufacturers’ instructions. Venting caps are intended to prevent damage to flexible scopes that are being exposed to a vacuum, regardless of the sterilant used.CAUTION: RISK OF DAMAGE TO LOAD – IMMERSION CAPSYou must remove the water-resistant immersion cap (if present) prior to processing in the sterilizer. If the immersion cap is not removed prior to processing in the STERRAD® 100NX™ Sterilizer, it will damage the flexible scope due to the inability to properly vent. CAUTION: KNOW WHAT YOU CAN PROCESS – FLEXIBLE ENDOSCOPESPrior to processing flexible endoscopes in the STERRAD® 100NX® Sterilizer, you must read, understand, and follow the medical device manufacturer's instructions for use for the particular scope to be processed. Please contact the medical device manufacturer for more information on what can be processed in the STERRAD® 100NX® Sterilizer.CAUTION: RF COMMUNICATIONS EQUIPMENTPortable and mobile RF communications equipment can affect medical electrical equipment.DRAFT

Safety Information ASTERRAD® 100NX® User’s Guide 99FCC ID: AXJ100NXRFIDThis equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.Guidance And Declaration-Electromagnetic EmissionsThe STERRAD® 100NX® Sterilizer is intended for use in the electromagnetic environment specified below. Assure that it is used in such an environment.Emissions Test Compliance Electromagnetic Environment - GuidanceRF emissions CISPR 11 Group 1 The STERRAD® 100NX® Sterilizer uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.RF emissions CISPR 11 Class A The STERRAD® 100NX® Sterilizer is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissions IEC 61000-3-2Class AVoltage fluctuations/flicker emissionsIEC 61000-3-3CompliesDRAFT

A Safety Information100 STERRAD® 100NX® User’s GuideIC Certification Number: 10207A-100NXRFIDThis Class A digital apparatus has been tested and found to comply with Canadian ICES-003. CAUTION: RISK OF NON-COMPLIANCEChanges or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Warnings, Cautions, and Notes Warnings and cautions are accompanied by symbols surrounded by a triangle or a square and are printed in the text in bold. Warnings indicate events or conditions that can result in serious injury or death. Cautions indicate events or conditions that can result in severe damage to the equipment.✔Notes are printed in italics and have a checkmark in front of the word “Note.” Notes highlight specific information about the proper use and maintenance of the sterilizer.DRAFT

Safety Information ASTERRAD® 100NX® User’s Guide 101SymbolsHot surfaces present.Do not touch without protection.Hazardous chemical present.Use personal protective equipment.Corrosive chemical present.Use personal protective equipment.Oxidizing chemical present.Avoid exposure, contact, or ingestion. Use personal protective equipment.WEEE SymbolToxic chemical present.Avoid exposure, contact, or ingestion.Ultraviolet (UV) light hazard.Do not look at the light without UV eye protection.High voltage hazard.I/O On/Off.Alternating current.DRAFT

A Safety Information102 STERRAD® 100NX® User’s GuideDRAFT

Consumables, Accessories and Additional Parts BSTERRAD® 100NX® User’s Guide 103Appendix B.Consumables, Accessories, and Additional PartsConsumable Products Product Code DescriptionSTERRAD® 100NX® Cassette 10144 2 cassettes per case.Thermal Printer Paper Roll-Case 10305 Used with the thermal printer to record sterilizer information. 12 rolls/caseCassette Disposal Box - Case 20227 This box is used to collect cassettes for disposal. 10 boxes/case.STERRAD® 100NX® Validation Kit 20228, 20229 Contains the trays, mats, and BI validation supplies. (20228 international, 20229 US domestic.)STERRAD® CYCLESURE® 24 Biological Indicator14324 Used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles. STERRAD® SEALSURE® Chemical Indicator Tape14202 Used to seal packaged instruments, the tape changes color when exposed to hydrogen peroxide.STERRAD® Chemical Indicator Strips 14100 Placed inside instrument packages, the chemical indicator strips change color when exposed to hydrogen peroxide. Tyvek® Pouches and Rolls with STERRAD® Chemical IndicatorContact your ASP Representative for a complete list of pouches, rolls, instrument trays and accessories.APTIMAX® Instrument Trays and accessoriesContact your ASP Representative for a complete list of pouches, rolls, instrument trays and accessories.DRAFT

B Consumables, Accessories and Additional Parts104 STERRAD® 100NX® User’s GuideASP also offers a comprehensive line of other consumables and accessories which have been fully tested and validated for use with the STERRAD® 100NX® Sterilizer. For more information on any of these products, in the U.S.A. contact ASP Professional Services at 1-888-STERRAD. Outside the USA contact your local ASP Customer Support Representative.Accessories Product Code DescriptionBarcode Reader 11142 Optional barcode scanner for tracking instruments and other information in the cycle history file.Independent Monitoring System (IMS) 10140 For compliance with ISO 14937. The Independent Monitoring System (IMS) is an optional feature that may be purchased and installed on the sterilizer. It is an independent data collection system that can be used for system validation or requalification. All of the sensors are independent from the system sensors and the data collected from the IMS is identified separately from the system’s one-second data.Additional Parts Part NumberCompact Flash Card and Adapter 04-53004-0-001DRAFT

Specifications CSTERRAD® 100NX® User’s Guide 105Appendix C.Sterilizer SpecificationsPower The phase rotation is adjusted to match the system requirements at installation.208V 60 Hz Power: For versions employing 208V, 60 Hz power, the sterilizer requires a NEMA L21-30 five-wire grounding twist lock outlet attached to a dedicated 30 Amp 3 phase 208 Volt circuit with separate neutral and ground conductors.380 - 415V 50/60 Hz Power: The sterilizer requires a five-wire grounding outlet attached to a dedicated 30 AMP, 3 phase, (200-240VAC, 380-415V) ±10%, 50/60 Hz ±5% circuit with separate neutral and ground conductors. 200V 50/60 Hz Power (Japan): The sterilizer requires a four-wire Delta configuration to a dedicated 30 AMP circuit.Dimensions H: 70.5 in. (179.1 cm), W: 30.5 in. (77.5 cm), D: 40 in. (102 cm).Service clearances Front: 39.5 in. (100 cm); Back: 39.5 in (100 cm); Top: 39.5 in. (100 cm)Left side: 39.5 in. (100 cm); Right side: 39.5 in. (100 cm).Weight 425 kg, 938 lbs 1-Door system457 kg, 1,006 lbs 2-Door systemChamber volume 152 liters.W20.7 in. (51 cm), H16.1 in. (41 cm), D28.93 in. (73.5 cm). Usable volume: 93.4 liters (3.3 cubic feet)Chamber shelves Two shelves, W 17 in. (42.5 cm), D 28 in. (70 cm).Shelf capacity: 55 lb. (25 kg) uniformly distributed.Both shelves are removable.Temperature Operating: 18°C - 35 °C (64° - 95°F).Storage: -29°C - 70°C (-20°F - 158°F)DRAFT

C Specifications106 STERRAD® 100NX® User’s GuideHumidity Operating: 10% – 85% up to 30oC.linearly decreasing from 85% at 30oC to 70% at 40oC non-condensingStorage: 10% – 100% (rainfall will be permitted).Altitude/Pressure Operating altitude up to 3095 m (10,152 ft.).Atmospheric pressure 520-775 torrCycle temperature 47°C – 56°C (116.6°F – 132.8°F)Cycle time STANDARD Cycle - 47 minutesDUO Cycle - 60 minutesEXPRESS Cycle - 24 minutesFLEX Cycle - 42 minutesConnectors Network: RJ45; Barcode reader: USB. Printer: USBMain Power Cable 12 AWG (4 mm2), 3 m (9.84 feet) long, 5 conductorsNEMA L21 - 30P (USA and Canada.)Each country is responsible for installing an appropriate 3 phase plug according to their facility’s power requirements. The plug must match the phase rotation.Mobility On wheelsVenting Requirements None requiredGas Tank Requirements None requiredHeat Generation Idle: 289 BTU/hourIn operation: 8,189 BTU/hour maximumRF Generation Portable and mobile RF communications equipment can affect medical Electrical Equipment.DRAFT

Specifications CSTERRAD® 100NX® User’s Guide 107Medical Device Requirements and GuidelinesMedical Device Directive 2007/47/ECIEC/EN 61010-1: Safety Requirements For Electrical Equipment For Measurement, Control, And Laboratory Use – Part 1: General RequirementsEN 61010-2-040: Safety Requirements for Electrical Equipment, Control and laboratory Use. Particular requirements for sterilizer and washer-disinfectors used to treat medical devices.IEC 60601-1: Medical Electrical Equipment – Part 1: General Requirements For Safety (Japan Requirement)EN 60601-1-2: Medical Electrical Equipment - electromagnetic Compatibility - Requirements and Tests.ANSI/AAMI/ISO 14937: Sterilization Of Health Care Products – General Criteria For Characterization Of A Sterilizing Agent And Development, Validation, And Routine Control Of A Sterilization Process CAN/CSA C22.2 No. 61010-1.UL 61010-1.Medical Device Agencies US: FDA (Food and Drug Administration)EU: TUV Product Service (ASP’s Notified Body)Japan: MHLW (Ministry of Health, Labor and Welfare)Canada: TPP (Therapeutic Products Programme)Australia: TGA (Therapeutic Goods Administration)DRAFT

C Specifications108 STERRAD® 100NX® User’s GuideDRAFT

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