Advanced Sterilization 02532481 RFID Module User Manual M 99994 04 100NXUser indb

Advanced Sterilization Products RFID Module M 99994 04 100NXUser indb

UserManual.wiki >

Advanced Sterilization >

02532481 User Manual

User Manual

STERRAD® 100NX® Sterilization SystemUser’s GuideRef 9999499994_05January 2017STERRADSTERRAD®100NX®

STERRAD® 100NX® Sterilization SystemUser’s Guide1-888-STERRAD ASP U.S.A. Professional ServicesASP International 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©. 2008-2016 Division of Ethicon. All rights reserved. STERRAD®, CYCLESURE®, SEALSURE®, APTIMAX® and 100NX® are registered trademarks of Advanced Sterilization Products (ASP). Teﬂ on®, 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 conﬁ guration and software revision. Reproduction, adaptation, or translation of this publication without prior written permission is prohibited. Printed in the U.S.A. BEAT

STERRAD® 100NX® User’s Guide 1ContentsChapter 1. Introduction ..................................................................................... 5How to Use This Guide ............................................................................................5Intended Use ............................................................................................................5The STERRAD® Sterilization Process .....................................................................6If You Have Questions .............................................................................................6Chapter 2. Safety Information ............................................................................7Personal Safety and First Aid ...................................................................................7Personal Protective Equipment ................................................................................9Device Safety ...........................................................................................................9Warnings, Cautions, and Notes ..............................................................................13Symbols..................................................................................................................14Chapter 3. Load Preparation ............................................................................ 15Load Weight Requirements ....................................................................................15Cycles and Materials Processing ...........................................................................18Recommended Materials .......................................................................................22Thermoplastics ..................................................................................................22Thermoplastic Elastomers .................................................................................22Thermosetting Elastomers .................................................................................23Glass ..................................................................................................................23Metal .................................................................................................................23Items Not To Be Processed ....................................................................................23Do Not Process in the EXPRESS Cycle ...........................................................24Do Not Process in the DUO Cycle ....................................................................24Guidelines for Preparing Items to Be Sterilized ....................................................25Cleaning, Rinsing, and Drying ...............................................................................25Packaging and Loading ..........................................................................................27Instrument Trays................................................................................................27Tray Mats ..........................................................................................................27Packaging ..........................................................................................................27Loading .............................................................................................................28Chemical Indicators ..........................................................................................29Special Considerations for Flexible Endoscopes ..............................................29

2 STERRAD® 100NX® User’s GuideChapter 4. Operation ....................................................................................... 31Before You Start .....................................................................................................31Start and Warm-up .................................................................................................31Biological Indicators ..............................................................................................31Login ......................................................................................................................32Entering Load Information ....................................................................................33Enter Load Item Data ........................................................................................33Loading the Chamber .............................................................................................36Selecting and Starting a Cycle ...............................................................................40System Ready Screen ........................................................................................41Inserting a Cassette ...........................................................................................41Cycle in Progress ...................................................................................................43Canceling a Cycle .............................................................................................44Cycle Completed ....................................................................................................45Processing a Sterilized Load ..................................................................................46Inspecting Chemical Indicators .........................................................................46Processing Biological Indicators .......................................................................46Chapter 5. Troubleshooting ............................................................................. 49Running Diagnostics ..............................................................................................49System Message Table ...........................................................................................50Temperature Messages ......................................................................................50Messages Not In This Table ..............................................................................50Call Your ASP Representative ...............................................................................54Chapter 6. Sterilizer Overview ......................................................................... 55Sterilizer Cycles .....................................................................................................55Sterilizer Features ..................................................................................................56Cassette .............................................................................................................57Cassette Disposal Box .......................................................................................58Touch Screen and Speaker ................................................................................58Chamber ............................................................................................................59Printer ................................................................................................................60Touch Screen Data Entry ..................................................................................61Chapter 7. Maintenance ................................................................................... 63Automatic Maintenance ........................................................................................63Automatic Lamp Adjustment ............................................................................63Manual Maintenance ..............................................................................................64

STERRAD® 100NX® User’s Guide 3Disposing of Cassettes ...........................................................................................64Removing a Cassette Disposal Box ..................................................................65Replacing the Printer Paper ...................................................................................66Cleaning the Sterilizer Exterior .............................................................................69Cleaning the Hydrogen Peroxide Monitor Detector Lens .....................................70PCMCIA Card Handling and Replacement ...........................................................71Data Transfer Using a Memory Stick................................................................72Sterilizer Disposal ..................................................................................................73Chapter 8. Reports and Files ........................................................................... 75Displayed Reports .................................................................................................75Cycle History ....................................................................................................75Printed Reports .......................................................................................................77Short Report ......................................................................................................77Parametric Report..............................................................................................77Long Report ......................................................................................................77Chapter 9. Access Levels and Supervisor Tasks .............................................. 79Overview ................................................................................................................79Access Levels .........................................................................................................79Additional Utilities Menu ......................................................................................80Date and Time Settings ..........................................................................................81Set Date .............................................................................................................82Set Time ............................................................................................................82Time Zone .........................................................................................................82Date Format .......................................................................................................82Time Format ......................................................................................................82Cancel/Done ......................................................................................................82System Conﬁ guration.............................................................................................83Access Control Option ......................................................................................83IMS ....................................................................................................................83Vacuum Units ....................................................................................................83Load Data Entry Option ....................................................................................84Load Removal Option .......................................................................................84Notepad Option .................................................................................................84Auto Send Network Files ..................................................................................84Alarm Volume ...................................................................................................84Backlight Conservation (Minutes) ....................................................................84Language Selection ...........................................................................................84Sterilizer Settings ..............................................................................................85Printer Settings ..................................................................................................86Transfer Settings ...............................................................................................87Cancel/Done ......................................................................................................87

4 STERRAD® 100NX® User’s GuideUser Administration ...............................................................................................88Add User ...........................................................................................................89Modify User ......................................................................................................90Upload User Data ..............................................................................................91Cassette Functions .................................................................................................93Dispose Cassette................................................................................................94Peroxide Clearance............................................................................................95Network ..................................................................................................................96Diagnostics .............................................................................................................96Diagnostic Tests ................................................................................................97Service Functions ...................................................................................................97File Management ...................................................................................................98Calibration Files ................................................................................................98Diagnostic Files .................................................................................................98Upload File .............................................................................................................99Input/Output Doors ..............................................................................................100Product Options ...................................................................................................100Appendix A. Sterilizer Speciﬁ cations ............................................................... 103Appendix B. Consumables, Accessories, and Additional Parts ........................ 107Appendix C. User’s Network Connection Information Guide ............................ 109

Introduction 1STERRAD® 100NX® User’s Guide 5Chapter 1. IntroductionIntroduction How to Use This GuideIf you are a STERRAD® 100NX® Sterilizer operator, you must read the “Safety Information, “ 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.

1 Introduction 6 STERRAD® 100NX® User’s GuideThe STERRAD® Sterilization ProcessThe STERRAD® 100NX® Sterilizer sterilizes medical devices by diffusing hydrogen peroxide vapor into the chamber and then electromagnetiy 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 residue. 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 difﬁ cult-to-reach (diffusion-restricted) spaces, such as hinges on forceps. Refer to the “Safety Information” chapter for more information on device safety.The sterilizer consistently provides a Sterility Assurance Level (SAL) of 10-6, as deﬁ ned 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 have questions about the STERRAD® 100NX® Sterilizer or questions about which items may be safely sterilized by the STERRAD® Process, please call your local Advanced Sterilization Products (ASP) Representative or visit our website at www.aspjj.com.

Safety Information 2STERRAD® 100NX® User’s Guide 7 Chapter 2. Safety InformationSafety 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 beneﬁ t from the safe operation of your STERRAD® 100NX® Sterilization System.Personal Safety and First AidWARNING! 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 or if any moisture is noted on items in the load following a completed cycle.WARNING! HYDROGEN PEROXIDE IS AN OXIDIZER.Hydrogen peroxide is strong oxidizing agent and poses a hazard for ﬁ re, 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 ﬂ ame. 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 ﬁ re hazard. In case of ﬁ re, use only water to extinguish.WARNING! RISK OF EYE INJURY.Direct hydrogen peroxide contact with eyes can cause irreversible tissue damage. If contact with eyes occurs, hold the eyes open and ﬂ ush 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 ﬂ ushing the eyes.

2 Safety Information8 STERRAD® 100NX® User’s GuideWARNING! RISK OF SKIN INJURY.Direct hydrogen peroxide contact with the skin can cause severe irritation. Wear chemical resistant latex, PVC (vinyl), or nitrile gloves when handling new, used, 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 ﬁ re hazard and wash before re-use.WARNING! RISK OF RESPIRATORY IRRITATION.Inhalation 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 artiﬁ cial respiration, preferably mouth-to-mouth, if possible. Consult a physician immediately.WARNING! CONCENTRATED HYDROGEN PEROXIDE IS TOXIC.Ingestion 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 SURFACES.At 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 LIGHT.The 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 PRESENT.If 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.

Safety Information 2STERRAD® 100NX® User’s Guide 9WARNING! RISK OF BREATHING DIFFICULTIES.On rare occasions, the outlet ﬁ lter 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 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.Device SafetyWARNING! RISK OF INJURY OR DAMAGE TO STERILIZER.The STERRAD® 100NX® Sterilizer should not be used stacked with other equipment.CAUTION: RISK OF DAMAGE TO LOAD.Metal 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.

2 Safety Information10 STERRAD® 100NX® User’s GuideCAUTION: KNOW WHAT YOU CAN PROCESS.Before 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 WARRANTY.Improper 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 OBJECTS.Metal 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 CAPS.Take special care to conﬁ rm that venting caps are placed according to the manufacturers’ instructions. Venting caps are intended to prevent damage to ﬂ exible scopes that are being exposed to a vacuum, regardless of the sterilant used.CAUTION: RISK OF DAMAGE TO LOAD – IMMERSION CAPS.You 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 ﬂ exible scope due to the inability to properly vent. CAUTION: KNOW WHAT YOU CAN PROCESS – FLEXIBLE ENDOSCOPES.Prior to processing ﬂ exible 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 EQUIPMENT.Portable and mobile RF communications equipment can affect medical electrical equipment.

Safety Information 2STERRAD® 100NX® User’s Guide 11Guidance And Declaration-Electromagnetic EmissionsThe STERRAD® 100NX® Sterilizer is intended for use in the electromagnetic environment speciﬁ ed 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 ﬂ uctuations/ﬂ icker emissions IEC 61000-3-3CompliesSystem is conﬁ gured with FCC ID: AXJ100NXRFID or FCC ID: AXJ02532480 or contains FCC ID: AXJ02532481System is conﬁ gured with IC Certiﬁ cation Number: 10207A-100NXRFID or IC Certiﬁ cation Number: 10207A-02532480 or contains IC Certiﬁ cation Number 10207A-02532481WARNING! (PART 15.21) RISK OF NON-COMPLIANCE.Changes or modiﬁ cations not expressly approved by Advanced Sterilization Products could void the user’s authority to operate the equipment. Manufacturer is not responsible for any radio or TV interference caused by unauthorized modiﬁ cations to this equipment.

2 Safety Information12 STERRAD® 100NX® User’s GuideFCC Rules and Industry Canada (IC) Regulatory InformationCompliance Statement (Part 15.19)The equipment 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.Compliance Statement (Part 15.105(b))Note: This 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 Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.Class A digital device notice “CAN ICES-3 (A)/NMB-3(A)”RF Radiation Exposure StatementThis equipment complies with the FCC/IC radiation exposure limits set forth for portable transmitting devices operation in a controlled environment. End users must follow the speciﬁ c operating instructions to satisfy RF exposure compliance.The equipment should only be used where there is normally at least 20cm separation between the antenna and all person/user.This transmitter must not be co-located or operation in conjunction with any other antenna or transmitter.Any changes or modiﬁ cations not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment.

Safety Information 2STERRAD® 100NX® User’s Guide 13Warnings, Cautions, and NotesWarnings 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 speciﬁ c information about the proper use and maintenance of the sterilizer.

2 Safety Information14 STERRAD® 100NX® User’s GuideSymbolsHot 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.

Load Preparation 3STERRAD® 100NX® User’s Guide 15 Chapter 3. Load PreparationLoad 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 safely sterilize medical instruments and materials without leaving toxic residue. 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 PROCESS.Before 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 speciﬁ c 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 WARRANTY.Improper 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 shelves

3 Load Preparation16 STERRAD® 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 Teﬂ on® (polytetraﬂ uoroethylene) 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 ﬂ exible 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 Teﬂ on® (polytetraﬂ uoroethylene) ﬂ exible 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 ﬂ exible endoscopes per load. †The validation testing for this lumen size was conducted using a maximum of 10 lumens in the USA; 40 lumens for markets outside the USA. Your loads should not exceed the validated maximum number of lumens.*Sterilize without any additional load. Up to 20 pieces of tubing may be sterilized at one time.

Load Preparation 3STERRAD® 100NX® User’s Guide 17EXPRESS 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 ﬂ exible endoscopes, with the following materials and dimensions can be processed in the STERRAD® 100NX® Sterilizer FLEX cycle: Single channel polyethylene and Teﬂ on® (polytetraﬂ uoroethylene) ﬂ exible endoscope with an inside diameter of 1 mm or larger and length of 850 mm or shorter.**  Flexible endoscopes without lumens. Note: Do Not process more than 2 ﬂ exible endoscope per load.Check the medical device manufacturer’s instructions before loading any item into the STERRAD® 100NX® Sterilizer.**One or two ﬂ exible endoscopes can be processed per sterilization cycle. No additional load.

3 Load Preparation18 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 speciﬁ ed in this user’s guide. Consult the medical device manufacturer’s instructions or call your ASP Representative 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. For more information contact your local ASP Representative or visit our website at www.aspjj.com. Information may also be obtained from the device manufacturer.

Load Preparation 3STERRAD® 100NX® User’s Guide 19

3 Load Preparation20 STERRAD® 100NX® User’s Guide

Load Preparation 3STERRAD® 100NX® User’s Guide 21

3 Load Preparation22 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 your ASP Representative for more information. Information may also be obtained from the device manufacturer.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 Polytetraﬂ uoroethylene (Teﬂ on®)Thermoplastic Elastomers Santoprene™

Load Preparation 3STERRAD® 100NX® User’s Guide 23Thermosetting Elastomers Silicone Polyurethane PVCGlass GlassMetal 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.

3 Load Preparation24 STERRAD® 100NX® User’s Guide Devices with internal parts, such as sealed bearings, that cannot be immersed, may present difﬁ culties in cleaning and should not be processed in the STERRAD® 100NX® Sterilizer. Implants for which the manufacturer has not speciﬁ cally 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.

Load Preparation 3STERRAD® 100NX® User’s Guide 25Guidelines 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 ﬂ aws or damage prior to packaging. Items with ﬂ aws 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.

3 Load Preparation26 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-speciﬁ c 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.

Load Preparation 3STERRAD® 100NX® User’s Guide 27Packaging 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 ﬂ exible 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 Inches STANDARD 2250 349 DUO 2774 430 FLEX 2250 349 EXPRESS 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 efﬁ cacy and stability.

3 Load Preparation28 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).

Load Preparation 3STERRAD® 100NX® User’s Guide 29EXPRESS 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 health care 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 ﬂ exible endoscope manufacturer’s instructions for each endoscope before preparation and loading into the sterilizer. Take special care to conﬁ rm 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 ﬂ exible 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.

3 Load Preparation30 STERRAD® 100NX® User’s GuideFLEX Cycle: A maximum of 2 ﬂ exible 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 ﬂ exible endoscopes can be processed per load, with or without silicone mats. You can also process 1 ﬂ exible endoscope with its light cord and a camera.CAUTION: RISK OF DAMAGE TO LOAD.Prior to processing ﬂ exible endoscopes in the STERRAD® 100NX® Sterilizer, please contact the medical device manufacturer, or your ASP Customer Representative.

Operation 4STERRAD® 100NX® User’s Guide 31 Chapter 4. OperationOperation 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 IndicatorsBiological indicators are an important method of conﬁ rming that sterilization was achieved during a cycle. The following biological testing methods are recommended:  The STERRAD® CYCLESURE® 24 Biological Indicator (BI), when used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycle, are used as follows:Compare the processed STERRAD® CYCLESURE® 24 vial with the positive control vial.

4 Operation 32 STERRAD® 100NX® User’s Guide1. The absence of a color change and turbidity in the processed STERRAD® CYCLESURE® 24 vial (i.e. the media remains purple as compared directly to a negative control) indicates that the sterilization conditions were achieved in the STERRAD® Sterilizer (sufﬁ cient to kill at least one million of the most resistant identiﬁ ed bacterial spores).2. If the processed STERRAD® CYCLESURE® 24 BI changes color from purple to yellow (as in the positive control vial), and/or exhibits turbidity, this indicates that conditions necessary to achieve sterilization in the STERRAD® Sterilizer have not been met. In addition, inspect the chemical indicator response for the correct color change and verify “Cycle Status: Passed” and “Process Complete” from the cycle completion report. Use of the STERRAD® CYCLESURE® 24 Biological Indicator (BI) in a test pack conﬁ guration for periodic testing (i.e. performance qualiﬁ cation upon installation and revalidation) conﬁ rms that a sterility assurance level (SAL) of 10-6 has been achieved during the cycle. Verify “Cycle Status: Passed” and “Process Complete from the cycle completion report.Note: Instructions for use are provided in the test pack. Place a STERRAD® CYCLESURE® 24 BI in the chamber at the back of the bottom shelf. Biological testing should be performed at least once per day or as speciﬁ ed by your health care facility’s policy. Review the Instructions for Use included with the biological indicator to ensure its proper use.For the STERRAD® 100NX® DUO cycle in the United States, the STERRAD® CYCLESURE® 24 BI should only be used in a test pack conﬁ guration.LoginNote: If your sterilizer has been conﬁ gured 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.

Operation 4STERRAD® 100NX® User’s Guide 33Figure 1. Operator Login Screen.1. Touch the Operator ﬁ eld. The cursor appears in the ﬁ eld.Note: Operator and Password ﬁ elds are case-sensitive.2. Use the on-screen keyboard to type your assigned operator identiﬁ cation.3. Touch the ENTER key. The cursor jumps to the Password ﬁ eld.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 ﬁ nished entering your password, touch the ENTER key.Entering Load InformationNote: If your sterilizer has been conﬁ gured 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.

4 Operation 34 STERRAD® 100NX® User’s GuideItems can be typed into the screen or selected from a predeﬁ ned 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” ﬁ eld. 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.Select 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 ﬁ elds or to use a barcode scanner.

Operation 4STERRAD® 100NX® User’s Guide 35Cycle NotesNote: If your sterilizer has been conﬁ gured 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 ﬁ le. 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 ﬁ eld. The cursor appears in the ﬁ eld.2. 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.

4 Operation 36 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.

Operation 4STERRAD® 100NX® User’s Guide 372. 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.

4 Operation 38 STERRAD® 100NX® User’s GuideFigure 8. Load Correctly Placed for STANDARD Cycle Processing.Figure 9. Load Correctly Placed for DUO and FLEX Cycle Processing.5. When you are ﬁ nished 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.

Operation 4STERRAD® 100NX® User’s Guide 39Loading 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 ﬁ gure shows a correctly placed load.Figure 10. Load Correctly Placed for EXPRESS Cycle Processing.

4 Operation 40 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 conﬁ rm 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.

Operation 4STERRAD® 100NX® User’s Guide 41System 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 ﬂ exible endoscopes with their light cords and cameras.It sterilizes the load in about 60 minutes. FLEX cycle is speciﬁ cally designed for ﬂ exible 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 ﬁ nished 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 ﬁ le 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.Note: Always wear chemical resistant latex, PVC (vinyl), or nitrile gloves when handling a cassette.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 Operation 42 STERRAD® 100NX® User’s Guide4. Position the cassette so that the arrows are pointing straight into the cassette door slot of the sterilizer. Do not insert the cassette at an angle. Figure 12a. Inserting the Cassette into the Slot.5. Completely insert the cassette into the cassette slot until it reaches a stop, the cassette must be ﬂ ushed with the panel.6. After a slight pause, the system will complete the cassette insertion automatically. Do not use excessive force to insert the cassette.Figure 12b. Inserting the Cassette into the Slot.

Operation 4STERRAD® 100NX® User’s Guide 43Cycle 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.The clock displays the estimated number of minutes and seconds remaining before the cycle is ﬁ nished. The “Time Remaining” ﬁ eld 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.

4 Operation 44 STERRAD® 100NX® User’s GuideCanceling 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 conﬁ rmation message.Figure 14. Cancel Cycle Conﬁ rmation. Touch Yes or No.2. 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 Conﬁ rmed.

Operation 4STERRAD® 100NX® User’s Guide 45Loads 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 health care facility’s procedures.Cycle 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 ﬁ le for the just-completed cycle.2. Touch the Done button to proceed.

4 Operation 46 STERRAD® 100NX® User’s GuideProcessing a Sterilized LoadWhen you touch the Done button, how the sterilizer responds depends upon the conﬁ guration of your sterilizer. If login is required before the door can be opened, the Login screen is displayed. When this occurs, enter your operator identiﬁ cation 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 PRESENT.If 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 ﬂ owcharts 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 health care 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 ﬂ owcharts on the following pages for additional information.

Operation 4STERRAD® 100NX® User’s Guide 47Cycle Completion Flowchart

4 Operation 48 STERRAD® 100NX® User’s GuideSTERRAD CYCLESURE® 24 Biological Indicator Flowchart

Troubleshooting 5STERRAD® 100NX® User’s Guide 49 Chapter 5. TroubleshootingTroubleshooting 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 your local ASP Representative for service information.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.

5 Troubleshooting50 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 or in Appendix C5 (for network related messages), 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.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.Cassette System Timeout When Piercing The delivery subsystem is not responding. Remove the load and run diagnostics.

Troubleshooting 5STERRAD® 100NX® User’s Guide 51If this message appears. . . Do this . . .Cassette Used, Disposing The inserted cassette does not have any unused cells remaining. Insert a new cassette.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 Sensor Fault Door malfunction. Reboot the system. If the message persists, call your ASP Representative.Function Available on Other Side Control of the sterilizer is on the other side of the unit.H2O2 Adjustment Failed. Please Call ASP.Call your ASP Customer Support Representative.H2O2 ADJUSTMENT FAILED OPEN DOOR, CLEAR UV PATHWAY, CLEAN UV LENS AND CLOSE DOOR. PRESS OK BUTTON WHEN READY TO RESTART THE STERILIZER.Follow the instruction displayed. Press the OK button on the display message. 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 resist ant 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.

5 Troubleshooting52 STERRAD® 100NX® User’s GuideIf this message appears. . . Do this . . .H2O2 Peak 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.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 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 speciﬁ cation. 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.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 speciﬁ cation. Remove the load and run diagnostics.No File Found Press OK. Reinsert the USB memory stick.Other Door Is Opened 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.

Troubleshooting 5STERRAD® 100NX® User’s Guide 53If this message appears. . . Do this . . .Please 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.WARNING! HYDROGEN PEROXIDE MAY BE PRESENT.Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling new or used cassettes.Please Remove Cassette And Verify Cassette Type Wrong cassette type. Conﬁ rm 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.

5 Troubleshooting54 STERRAD® 100NX® User’s GuideIf this message appears. . . Do this . . .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.Call 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 your local ASP Representative for more information.

Sterilizer Overview 6STERRAD® 100NX® User’s Guide 55Chapter 6. Sterilizer OverviewSterilizer OverviewSterilizer CyclesThe 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 display may be different depending on the cycles installed and enabled for use. Supervisor Access is required to enable installed cycles.

6 Sterilizer Overview56 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.Cassette SlotAccess PanelLCD Touch Screen DisplayDoorPrinter AccessFoot PadFigure18. 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.

Sterilizer Overview 6STERRAD® 100NX® User’s Guide 57 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 19a. Do not insert the cassette at an angle. Figure 19b. Position the cassette so that the arrows are pointing straight into the cassette door slot of the sterilizer.

6 Sterilizer Overview58 STERRAD® 100NX® User’s GuideWARNING! 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 when handling new or used cassettes and 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.Cassette 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.

Sterilizer Overview 6STERRAD® 100NX® User’s Guide 59Figure 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 efﬁ cient loading. Inside the chamber, surrounding the shelves is a metal screen (the electrode) that helps generate plasma during operation.

6 Sterilizer Overview60 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.

Sterilizer Overview 6STERRAD® 100NX® User’s Guide 61Touch Screen Data EntryThe following ﬁ gure 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 predeﬁ ned and used repeatedly.Figure 24. Example of a Data Entry Screen.

6 Sterilizer Overview62 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 ﬁ nished using the screen.Back. Touch this button to return to a prior screen.View. Touch this button to view the selected report or ﬁ le.Print. Touch this button to print the selected report or ﬁ le.Cancel. Touch this button to cancel the entry you just made.

Maintenance 7STERRAD® 100NX® User’s Guide 63Chapter 7. MaintenanceMaintenance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.

7 Maintenance64 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 ﬁ lter. 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.

Maintenance 7STERRAD® 100NX® User’s Guide 65Removing 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 health care facility’s policy.

7 Maintenance66 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.

Maintenance 7STERRAD® 100NX® User’s Guide 67Figure 29. Remove the Empty Paper Roll.3. Insert a new paper roll as shown in the following ﬁ gure. 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 ﬁ ts between the two paper guides on the top of the printer door.

7 Maintenance68 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.

Maintenance 7STERRAD® 100NX® User’s Guide 69Cleaning the Sterilizer ExteriorNote: Do not attempt to clean the chamber, door, interior surfaces, shelves, or electrode. If these items need cleaning, call your local ASP 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 your local ASP Representative before proceeding. Failure to follow these guidelines may result in damage to the sterilizer and may void the warranty.

7 Maintenance70 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 ﬁ gure.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.

Maintenance 7STERRAD® 100NX® User’s Guide 71PCMCIA Card Handling and ReplacementThe PCMCIA card contains the ﬂ ash 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 ﬁ gure).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.

7 Maintenance72 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 ﬁ rmly 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.

Maintenance 7STERRAD® 100NX® User’s Guide 73Rebooting the SystemIf it becomes necessary to reboot the system, ﬂ ip the main switch on the sterilizer to turn off the system and then turn it back on.Main Circuit BreakerFigure 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.

7 Maintenance74 STERRAD® 100NX® User’s Guide

Reports and Files 8STERRAD® 100NX® User’s Guide 75Chapter 8. Reports and FilesReports and FilesDisplayed Reports Users with Operator-level access can display the Cycle History ﬁ les. Users with Supervisor-level access can display the Cycle History ﬁ les, as well as Calibration ﬁ les and Diagnostic ﬁ les.All ﬁ les that are displayed can be printed by touching the Print button on the ﬁ le 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 conﬁ gured 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.

8 Reports and Files76 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 ﬁ les stored in the sterilizer.View Cycle displays the selected Cycle History ﬁ le on the screen.Print Cycle (Short) prints a short-format report of the selected cycle history ﬁ le.Print Cycle (Long) prints a long-format report of the selected cycle history ﬁ le.Parametric Print prints a parameter format report of the selected cycle history ﬁ le (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.

Reports and Files 8STERRAD® 100NX® User’s Guide 77Printed ReportsEvery time a cycle is completed, a cycle completion report is printed. Depending upon how your sterilizer has been conﬁ gured, 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 conﬁ ned 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.

8 Reports and Files78 STERRAD® 100NX® User’s Guide

Access Levels and Supervisor Tasks 9STERRAD® 100NX® User’s Guide 79 Chapter 9. Access Levels and Supervisor TasksAccess 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 conﬁ gured to require that all users enter a valid operator identiﬁ cation and password before operating the sterilizer. This access control is enabled through the System Conﬁ guration screen and user identiﬁ cations, 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 ﬁ les. Run diagnostics when a cycle cancels.

9 Access Levels and Supervisor Tasks80 STERRAD® 100NX® User’s GuideSupervisor-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. Select, view, and print all sterilizer ﬁ les. Run diagnostic tests and print reports. Set date and time. Conﬁ gure sterilizer features. Conﬁ gure 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 conﬁ gure the sterilizer and the network connection, set the date and time, set up and maintain user privileges, view and print ﬁ les, 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.

Access Levels and Supervisor Tasks 9STERRAD® 100NX® User’s Guide 81System Conﬁ g allows you to set sterilizer features.User Admin allows you to add, delete, or modify operator identiﬁ cations, passwords, and access levels.Cassette Functions allows you to automatically dispose a cassette into the collection box or perform the peroxide clearance procedure.Network allows you to conﬁ gure 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 ﬁ les.Upload ﬁ le reads the load items database ﬁ le 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.

9 Access Levels and Supervisor Tasks82 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.

Access Levels and Supervisor Tasks 9STERRAD® 100NX® User’s Guide 83System Conﬁ gurationUse the System Conﬁ guration 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 conﬁ gured with factory-set defaults. If you want to change the default settings, select your preferred settings.Figure 41. System Conﬁ guration.Access Control OptionUser Login requires that a user identiﬁ cation 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.

9 Access Levels and Supervisor Tasks84 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 identiﬁ cation 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.Auto Send Network FilesEnabled allows the sterilizer to transmit data on a network at the end of a cycle. Disabled suspends the automatic transmission of network data at the end of a cycle. 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.

Access Levels and Supervisor Tasks 9STERRAD® 100NX® User’s Guide 85Sterilizer 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 identiﬁ er 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 conﬁ gured by the manufacturer and cannot be altered.

9 Access Levels and Supervisor Tasks86 STERRAD® 100NX® User’s GuidePrinter SettingsTouch Printer Settings to display the following screen: Touch Done to save the changes.Figure 43. Printer Settings.Internal 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 conﬁ guration).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.

Access Levels and Supervisor Tasks 9STERRAD® 100NX® User’s Guide 87Transfer SettingsWhen you touch Transfer Settings from the System Conﬁ guration 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 Settings.Cancel/DoneTo cancel system conﬁ guration (on the System Conﬁ guration Menu), touch the Cancel button. When the system conﬁ guration settings are correct, touch Done. Cancel and Done have the same function on all the other screens you can access through the System Conﬁ guration menu.

9 Access Levels and Supervisor Tasks88 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 from 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 identiﬁ cation, password, and access level.Modify User displays the Modify User screen. On this screen you can modify or delete an existing user’s identiﬁ cation, password, and access level. Touch Edit User on this screen to change information.Upload User Data causes the sterilizer to receive a complete database ﬁ le of user names, passwords, and access levels from a USB memory stick.Back returns you to the Additional Utilities Menu.

Access Levels and Supervisor Tasks 9STERRAD® 100NX® User’s Guide 89Add UserUse the Add User screen to enter a new user’s identiﬁ cation, password, and access level.Figure 46. Add User.1. Enter the user’s operator “identiﬁ cation” in the Operator ﬁ eld. The entry must be alpha-numeric and no more than 10 characters.Note: Operator and Password ﬁ elds are case-sensitive.2. Enter the user’s password in the Password ﬁ eld. The entry must be alphanumeric, 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 ﬁ nished entering information for a new user.

9 Access Levels and Supervisor Tasks90 STERRAD® 100NX® User’s GuideModify UserUse the Modify User screen to modify an existing user’s identiﬁ cation, 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.4. Touch Done to return to the previous screen.Figure 48. Edit User.

Access Levels and Supervisor Tasks 9STERRAD® 100NX® User’s Guide 91 To modify the selected user’s information, touch the Edit User button.  To change the user’s operator name, make changes in the Operator ﬁ eld. To change the user’s password, make changes in the Password ﬁ eld. 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 ﬁ nished – the Modify User screen is displayed.Upload User DataYou can also add up to 1000 user identiﬁ cations 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. Figure 49. Upload User Data.If the user data shown is acceptable, touch Conﬁ rm. The following section contains information on uploading user data.

9 Access Levels and Supervisor Tasks92 STERRAD® 100NX® User’s GuideSteps to Upload a User DatabaseTo upload a list of user identiﬁ cations and passwords, perform the following steps:1. Create an ASCII text ﬁ le called “users.rec” that contains the user identiﬁ cations, passwords, and access levels. Use Microsoft Notepad to create the entry. Save the ﬁ le 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 ﬁ le 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.3. On the sterilizer, touch the Upload User Data button. The information in the ﬁ le 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 speciﬁ ed an invalid access level, or you have used an invalid format.4. Touch Conﬁ rm to accept the displayed data, logout the current user and return to the prior screen.

Access Levels and Supervisor Tasks 9STERRAD® 100NX® User’s Guide 93Cassette FunctionsWARNING! HYDROGEN PEROXIDE MAY BE PRESENT.Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation or a new or used 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.

9 Access Levels and Supervisor Tasks94 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.

Access Levels and Supervisor Tasks 9STERRAD® 100NX® User’s Guide 95Peroxide 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 Message.Figure 53. Touch Peroxide Clearance to begin the procedure.

9 Access Levels and Supervisor Tasks96 STERRAD® 100NX® User’s GuideNetworkSTERRAD® 100NX® Sterilizer can be conﬁ gured 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. Refer to the User’s Network Connection Information Guide found in Appendix C.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.

Access Levels and Supervisor Tasks 9STERRAD® 100NX® User’s Guide 97Diagnostic TestsOrder 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 integrity3 min. 20 sec.5 Cassette Test Cassette electro-mechanical subsystem RFID Reader5 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.* 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 ﬁ le 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.

9 Access Levels and Supervisor Tasks98 STERRAD® 100NX® User’s GuideFile ManagementUse the File Management screen to select and display calibration ﬁ les or diagnostic report ﬁ les.Figure 55. File Management.Calibration FilesTouch the Calibration Files button to display a list of calibration ﬁ les created during a sterilizer calibration. Scroll through the list and touch the ﬁ le name you wish to view. Touch the View button to display the selected calibration ﬁ le. 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.

Access Levels and Supervisor Tasks 9STERRAD® 100NX® User’s Guide 99Upload FileThis screen allows you to upload item information from a separate database to the sterilizer using the USB memory port.Figure 56. Load Items Files.1. Using Microsoft “Notepad,” create a list of load items similar to the example shown in the ﬁ gure. 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 deﬁ ned.2. Save the ﬁ le with the ﬁ le name “loaditems.txt” and use the “encoding” drop down in Notepad to save the ﬁ le encoded as UTF-8.3. Insert the USB memory stick with the ﬁ le 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 Conﬁ rm to accept the database into the sterilizer or press Back to cancel.

9 Access Levels and Supervisor Tasks100 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 Options.

Access Levels and Supervisor Tasks 9STERRAD® 100NX® User’s Guide 101Install 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.

9 Access Levels and Supervisor Tasks102 STERRAD® 100NX® User’s Guide

Sterilizer Speciﬁ cations ASTERRAD® 100NX® User’s Guide 103Appendix A. Sterilizer Speciﬁ cationsSterilizer Speciﬁ cationsPower 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 ﬁ ve-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 ﬁ ve-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 conﬁ guration 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)

A Sterilizer Speciﬁ cations104 STERRAD® 100NX® User’s GuideHumidity Operating: 10% – 85% up to 30oC. Linearly decreasing from 85% at 30oC to 70% at 40oC non-condensing Storage: 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 minutes FLEX 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 None required RequirementsHeat Generation Idle: 289 BTU/hourIn operation: 8,189 BTU/hour maximumRF Generation Portable and mobile RF communications equipment can affect medical Electrical Equipment.

Sterilizer Speciﬁ cations ASTERRAD® 100NX® User’s Guide 105Medical 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 Notiﬁ ed Body)Japan: MHLW (Ministry of Health, Labor and Welfare)Canada: TPP (Therapeutic Products Programme)Australia: TGA (Therapeutic Goods Administration)

A Sterilizer Speciﬁ cations106 STERRAD® 100NX® User’s Guide

Consumables, Accessories, and Additional Parts BSTERRAD® 100NX® User’s Guide 107Appendix B. Consumables, Accessories, and Additional PartsConsumables, 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® EXPRESS Test Pack20123 Contains the BI and pouch.STERRAD® 100NX® Test Pack for STANDARD, FLEX and DUO Cycles20243 Contains the test vials, pouch, mats, and BI. STERRAD® CYCLESURE® 24 Biological Indicator 14324 Used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles. STERRAD® SEALSURE® Chemical Indicator Tape 14202 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 accessories Contact your ASP Representative for a complete list of pouches, rolls, instrument trays and accessories.

B Consumables, Accessories, and Additional Parts108 STERRAD® 100NX® User’s GuideConsumable Products Product Code DescriptionBarcode Reader 11142 Optional barcode scanner for tracking instruments and other information in the cycle history ﬁ le.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 requaliﬁ cation. All of the sensors are independent from the system sensors and the data collected from the IMS is identiﬁ ed separately from the system’s one-second dataAdditional Parts Part NumberCompact Flash Card and Adapter 04-53004-0-001ASP offers a comprehensive line of 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, contact your local ASP Representative.

User’s Network Connection Information Guide CSTERRAD® 100NX® User’s Guide 109Appendix C. User’s Network Connection Information GuideUser’s Network Connection Information Guide

C User’s Network Connection Information Guide110 STERRAD® 100NX® User’s GuideContentsSection 1. Digital Transfer Interface ............................................................................ 111Network Connection Speciﬁ cations ..........................................................................................111Security Reminders ...................................................................................................................112For Health Care Facilities:.........................................................................................................113If You Have Questions ................................................................................................................113Section 2. Setting Up the Network .............................................................................. 114Network Settings Display ..........................................................................................................114Conﬁ guration Mode ...................................................................................................................114Hostname ..................................................................................................................................115IP Address .................................................................................................................................115Subnet Mask ..............................................................................................................................116Gateway .....................................................................................................................................116Primary DNS .............................................................................................................................116Secondary DNS ..........................................................................................................................116Domain Name ............................................................................................................................116User Name ................................................................................................................................117Password ...................................................................................................................................117Shared Folder Name .................................................................................................................118PC/Server Name .......................................................................................................................118System Network Setup ..............................................................................................................118Section 3. Manual Network File Transfer .................................................................... 124Section 4. Troubleshooting Utilities ............................................................................ 126Section 5. Network Message Table .............................................................................. 128Section 6. Testing the Network Connection ................................................................. 131

Digital Transfer Interface C1STERRAD® 100NX® User’s Guide 111Section 1. Digital Transfer InterfaceDigital Transfer InterfaceThis guide is designed for the individuals who are performing and/or overseeing the connection of the STERRAD® 100NX® Sterilizer to a network. This procedure should be done in collaboration with your facility’s computer network department. Service Level Access and a service call by an ASP technician is required to complete the entire networking setup.Prior to performing any tasks on the sterilizer, you must read the safety information in the STERRAD® 100NX® User’s Guide.Note: The STERRAD® 100NX® Digital Transfer Interface (DTI), if it is available on your STERRAD®, is primarily designed for communication with an Instrument Tracking System (ITS). Your ASP technician can provide a list of ASP-qualiﬁ ed ITS providers.Note: The Health Care Organization should validate the performance of any DTI-ITS system prior to use.Network Connection Speciﬁ cationsThe following items are required for Digital Transfer Interface network connection: Category 5e or better Ethernet cabling should be utilized for the network connection. A Category 5e cable with a male RJ45 connector must be connected to the network port located on the lower right side of the sterilizer. Note: ASP is not responsible for any equipment necessary to support the network connection.  Support for Local Area Network (LAN) port speeds of automatic, 100/10 Mbps Ethernet.

C1 Digital Transfer Interface112 STERRAD® 100NX® User’s Guide Use of DHCP IP Addressing (“Auto” mode) is highly recommended. Static (“Manual” mode) conﬁ guration (IP Address, Subnet Mask, Gateway, Primary Domain Name System (DNS), and Secondary DNS assigned by the Information Technology [IT] department) will also be supported. The default Host Name assigned to the sterilizer is “100NX” followed by the sterilizer’s serial number and can be customized. The sterilizer Host Name must be no more than 20 characters long.  The port speed will be set automatically. Microsoft® Distributed File System (DFS) is not supported. Customer IT must provide a local user account with full administrator rights on the computer server using any of these Windows® operating systems: Windows XP, Windows 7, Windows Server 2003 or Windows Server 2008 R2. For other versions, please contact your local ASP representative. The account should be authenticated with a password.Note: If the password of this local user account expires, the DTI of the sterilizer will not be able to access the shared folders and cycle ﬁ les will not be transferred correctly. To avoid this issue, hospital IT staff can disable password expiration for this account. Provide one shared folder per connected sterilizer. Complete form F-107773 prior to the ASP technician’s installation visit. The completed form contains information needed by the ASP technician for network setup.Security Reminders Your hospital LAN should be isolated (i.e. ﬁ rewalled, using Virtual LANs [VLANs]) from the public internet. Access to your hospital LAN should be controlled physically and logically (e.g., using logins and passwords). ASP medical devices do not run Windows Operating Systems (OS) and do not require regular security updates when operated in the intended use environment (a hospital LAN).

Digital Transfer Interface C1STERRAD® 100NX® User’s Guide 113For Health Care Facilities:*The FDA is recommending that you take steps to evaluate your network security and protect your hospital system. In evaluating network security, hospitals and health care facilities should consider: Restricting unauthorized access to the network and networked medical devices. Keeping appropriate antivirus software and ﬁ rewalls up-to-date. Monitoring network activity for unauthorized use. Protecting individual network components through routine and periodic evaluation, including updating security patches and disabling all unnecessary ports and services. Contacting the speciﬁ c device manufacturer if you think you may have a cybersecurity problem related to a medical device. If you are unable to determine the manufacturer or cannot contact the manufacturer, the FDA and DHS ICS-CERT may be able to assist in vulnerability reporting and resolution. Developing and evaluating strategies to maintain critical functionality during adverse conditions.* “FDA Safety Communication: Cybersecurity for Medical Devices and Hospital Networks.” U.S. Food and Drug Administration. June 13, 2013. Web. May 20, 2014. If You Have QuestionsIf you are located in the United States and have questions about the STERRAD® 100NX® Sterilizer, please call ASP Professional Services at 1-888-STERRAD (1-888-783-7723). Internationally, call your local ASP Representative. You may also wish to visit our website at www.aspjj.com.

C2 Setting Up the Network114 STERRAD® 100NX® User’s GuideSection 2. Setting Up the NetworkSetting Up the NetworkNetwork Settings DisplayUse the Network Settings screen to conﬁ gure the sterilizer’s network connection.Note: Always check with your facility’s Network Administrator before conﬁ guring or changing any of the settings on this screen. For networks that don’t support DHCP, you must select “Manual” (static) conﬁ guration.Figure 58. Network Settings Display.Note: For all Network Setting screens that display a keyboard, the keyboard will be U.S. English characters and format.Conﬁ guration ModeSelect Auto to conﬁ gure the IP address dynamically through Dynamic Host Conﬁ guration Protocol (DHCP). This is the preferred mode.

$Setting Up the Network C2STERRAD® 100NX® User’s Guide 115Or, Select Manual to conﬁ gure the IP address manually. Obtain the static IP settings; (e.g., IP Address, Subnet Mask, Gateway, Primary, and Secondary DNS IP addresses) from your Network Administrator.Refer to the table below for acceptable character use for each parameter.Parameters Acceptable CharactersHostname Alphanumeric and _ (underscore)IP AddressSubnet MaskGatewayPrimary DNSSecondary DNSNumeric and . (period)Domain Name Alphanumeric and - @ < > | ? “ ` _ \ / ‘. , ; : [ ] { } _Username PasswordAlphanumeric and ~ ! @ # $ ^ & ( ) _ { } `- % * = + [ ] ; : “ ‘ . , < > ? / \ |Shared Folder NamePC ServerAlphanumeric and @ _ ; , . ` [ ] { } | : ; “ ‘ < > ? / \ . , -HostnameThis is the DNS name of the sterilizer on a network. A Hostname is created by default. To change the default, edit the Hostname ﬁ eld as needed. The Hostname must be a unique name on your local network. In Manual conﬁ guration mode, enter the Hostname assigned to the sterilizer. Obtain this information from your network administrator.Note: The sterilizer will support up to 20 characters maximum.IP AddressA 32-bit address used to identify a node on a Transmission Control Protocol/ Internet Protocol (TCP/IP) network. Each node on the IP network must be assigned a unique IP address, which is made up of the network ID, plus a unique host ID. This address is typically represented with the decimal value of four octets separated by a period (for example, 192.168.1.127). This ﬁ eld cannot be changed in Auto conﬁ guration mode.In Manual conﬁ guration mode, enter the static IP Address assigned to the sterilizer. Obtain this information from your network administrator.$

C2 Setting Up the Network116 STERRAD® 100NX® User’s GuideSubnet MaskA 32-bit value that enables the recipient of IP packets to distinguish the network ID and host ID portions of the IP address. For example, subnet masks use the format 255.255.255.0.This ﬁ eld cannot be changed in Auto conﬁ guration mode.In Manual conﬁ guration mode, enter the Subnet Mask information. Obtain this information from your network administrator. GatewayA device connected to multiple physical TCP/IP networks capable of routing or delivering IP packets between them. A gateway is also called an IP router.This ﬁ eld cannot be changed in Auto conﬁ guration mode.In Manual conﬁ guration mode, enter the Gateway IP address; (e.g., 192.168.1.1). Obtain this information from your network administrator. Primary DNSThe IP address of the primary computer running a service that maintains information about a portion of the DNS database and responds to and resolves DNS queries. This ﬁ eld cannot be changed in Auto conﬁ guration mode.In Manual conﬁ guration mode, enter the Primary DNS address (e.g. 192.168.1.5). Obtain this information from your network administrator. Secondary DNSThe IP address of the secondary computer running a service that maintains information about a portion of the DNS database and responds to and resolves DNS queries. The secondary DNS IP address is optional.This ﬁ eld cannot be changed in Auto conﬁ guration mode.In Manual conﬁ guration mode, enter the Secondary DNS address (e.g. 192.168.1.6). Obtain this information from your network administrator. Domain NameThis ﬁ eld cannot be changed in Auto conﬁ guration mode.In Manual conﬁ guration mode, no entry is required.

Setting Up the Network C2STERRAD® 100NX® User’s Guide 117Figure 59. Network Settings Display. The data shown in this screen’s ﬁ eld is for context.Note: The sterilizer does not logon to the domain or workgroupUser NameEnter the User Name information to login onto the PC or Server. Obtain this information from your network administrator. Note: The sterilizer will support up to 30 characters maximum.PasswordEnter the Password information to login onto the PC or Server. The password is case sensitive. Obtain this information from the network administrator. If using a facility’s password, have their network administrator enter the password in the ﬁ eld.Note: To remove the password from the sterilizer’s memory, delete all characters in the entry ﬁ eld and touch Done.Note: The sterilizer will support up to 15 characters maximum.

C2 Setting Up the Network118 STERRAD® 100NX® User’s GuideShared Folder NameEnter the name of the shared folder located on the remote PC or Server. The folder must be conﬁ gured with shared and security permissions. Obtain this information from your network administrator. One shared folder for each connected sterilizer is required to avoid overwriting existing data ﬁ les.Note: The sterilizer will support up to 60 characters maximum.PC/Server NameEnter the computer server name. An IP Address may be entered if the remote computer server is assigned a static IP address. Obtain this information from your network administrator. For example, SERVER1.jnj.com. Note: The sterilizer will support up to 20 characters maximum.Note: Fully Qualiﬁ ed Domain Name (FQDN) will not be supported.System Network SetupNote: Supervisor Level Access is required for this procedure.These steps are used to conﬁ gure the network settings on the sterilizer. These steps must be performed before the sterilizer can communicate with a networked PC or server. Have your network administrator complete form F-107773 before proceeding. All the references to information needed in the Network Setting screen are on the form.1. Ensure that the Ethernet cable is plugged into the sterilizer and to the active data port on the wall.2. Navigate to the System Ready screen.

Setting Up the Network C2STERRAD® 100NX® User’s Guide 119Figure 60. Cycle Selection. Your System May Have Other Cycle Options.3. Touch Additional Utilities on the System Ready screen.4. Login with Supervisor Level account.Figure 61. Additional Utilities Menu. Touch Network.5. Touch Network on the Additional Utilities Menu.

C2 Setting Up the Network120 STERRAD® 100NX® User’s GuideFigure 62. Network Settings 1. The data shown in this screen’s ﬁ eld is for context.Use the completed form F-107773 to complete the setup:6. Select Auto if box 3 is checked. Proceed to step 14.7. Select Manual if box 4 is checked.8. Enter the information from line 15 for the Hostname9. Enter the information from line 5 for IP Address.10. Enter the information from line 6 for Subnet Mask.11. Enter the information from line 7 for the Gateway.12. Enter the information from line 8 for the Primary DNS.13. Enter the information from line 9 for the Secondary DNS.Note: If Workgroup/Domain appears on your sterilizer, leave the ﬁ eld blank14. Touch Done.

Setting Up the Network C2STERRAD® 100NX® User’s Guide 121Figure 63. Enter Network Settings 2. The data shown in this screen’s ﬁ eld is for context.15. Enter the information from line 11 for the User Account (Username).16. Have the facility’s network administrator enter the Password.17. Enter the information from line 13 for the Shared Folder Name. Note: Using a single shared folder for multiple sterilizers may overwrite existing data. Use a unique shared folder name for each connected STERRAD® 100NX® Sterilizer.18. Enter the information from lines 14 for the PC (computer) Server Name.Note: Use an IP Address if the computer server has a static IP address assigned. The sterilizer will lose connectivity to the computer server if the IP address of the computer server changes.19. Touch Done.20. Touch System Conﬁ g on the Additional Utilities Menu. The following screen will display.

C2 Setting Up the Network122 STERRAD® 100NX® User’s GuideFigure 64. System Conﬁ guration Screen.21. For Auto Send Network Files option, select Enabled.22. Touch Transfer Settings.Figure 65. Transfer Settings.Note: If your sterilizer is conﬁ gured with an Instrument Tracking Software (ITS), a CSV ﬁ le will be transferred by default. Your screen may be different based on your conﬁ guration23. Select desired printout format to be transferred to the computer server.24. Touch Done.25. Touch Done.26. Touch Back.

Setting Up the Network C2STERRAD® 100NX® User’s Guide 123Figure 66. System Ready Screen Showing Cycles to be Transferred.The number of Cycles Pending Transfer is displayed in the upper right of the screen. Up to 200 cycles will be queued if the network connection is lost. CAUTION! Under this condition, when the 201st cycle is started, the ﬁ rst cycle data ﬁ le will be overwritten. Once the network connection has been established or reestablished, the ﬁ le transmission will resume. When the count of the cycle ﬁ les pending transfer reaches 10 or greater, notify your network administrator of potential network problems.Note: Always use hardcopy cycle printouts if the network connection is lost or down.27. To manually transfer a cycle ﬁ le to test the network connection, see “Manual Network File Transfer”.

C3 Manual Network File Transfer124 STERRAD® 100NX® User’s GuideSection 3. Manual Network File TransferManual Network File TransferWith the network successfully conﬁ gured, cycle ﬁ les can be manually transferred to the computer server.1. Navigate to the System Ready Screen.Figure 67. Cycle Selection.2. Touch Cycle History. The Cycle History screen is displayed.3. Touch Data Transfer on the Cycle History screen.4. Touch Network Transfer and the Network Transfer Screen is displayed.

Manual Network File Transfer C3STERRAD® 100NX® User’s Guide 125Figure 68. Network Transfer Screen.5. Select the cycle(s) from the list of Cycles Available.6. Select desired PDF printout format (Short, Long, Medium, Alarm Limit) and/or One Sec File (.CSV) to transfer.7. Touch Transfer. The ﬁ les should begin transferring to the computer server. “Transfer in Progress” message is displayed.8. On the computer server, the ﬁ les will begin appearing in the shared folder. If no ﬁ les appear in the shared folder on the computer server, see “Troubleshooting Utilities”.

C4 Troubleshooting Utilities126 STERRAD® 100NX® User’s GuideSection 4. Troubleshooting UtilitiesTroubleshooting UtilitiesIf the cycle ﬁ les are not appearing on the computer server or if the number of cycle ﬁ les pending transfer from the System Ready screen is 10 or more cycles, contact your IT department to perform the following:1. Check that the Ethernet cable is connected to the sterilizer and to the active data port on the wall.2. Check and verify that the computer server is up and connected to the network.3. Check that the settings for the computer server have not changed.4. Verify the network settings of screens 1 and 2 (see Figures 62 and 63) on the sterilizer match the computer server settings.5. Navigate to the System Ready screen.6. Touch Additional Utilities on the System Ready screen.7. Login with a Supervisor Level account.8. Touch Network. Figure 69. Network Settings 1. The data shown in this screen’s ﬁ eld is for context.9. Touch Diagnostics.

Troubleshooting Utilities C4STERRAD® 100NX® User’s Guide 127Figure 70. Network Diagnostics Screen. The data shown in this screen’s ﬁ eld is for context.The Command pull down menu has the following utilities ping - to test the reachability of a computer server. ipconﬁ g - displays all current TCP/IP network conﬁ guration values. ipconﬁ g /renew - renews as adapters, and displays all current TCP/IP network conﬁ guration values. netstat - displays network connections (both incoming and outgoing), routing tables, and a number of network interface statistics. tracert - displaying the route (path) and measuring transit delays of packets across an Internet Protocol (IP) network. nslookup - for querying the DNS to obtain domain name or IP address mapping or for any other speciﬁ c DNS record.10. Select a command from the menu and enter in the IP Address/URL.11. Touch Run.12. Once the network connection has been conﬁ rmed, test the network connectivity with a manual cycle transfer. See “Manual Network File Transfer”.

C5 Network Message Table128 STERRAD® 100NX® User’s GuideSection 5. Network Message TableNetwork Message TableIf this message appears… Do this…Another Device On The Network Has The Same IP Address. Contact Hospital IT For Assistance. Contact hospital IT for assistance. Conﬁ rm that no other device on the network has the same IP address. Change the IP address.Cannot Connect To The Remote PC/Server. Conﬁ rm That The Network Cable Is Plugged In. Contact Hospital IT For Assistance. Contact the hospital IT for assistance. Check that the network cable is plugged in to the sterilizer and to the active data port on the wall. Check that the network settings on the sterilizer are correct. Check that the computer server information is correct and has not been changed.Cannot Locate DHCP Server. Contact Hospital IT For Assistance. Contact hospital IT for assistance. Check that the DHCP server is operational.Enter A Valid Hostname (alphanumeric and “_”). Hostname Must Be Unique. Contact Hospital IT For Assistance. Contact hospital IT for assistance. Conﬁ rm that the Hostname is the default STERRAD® 100NX® Hostname or uses alphanumeric characters and “_”.Error In File Generation  The sterilizer is unable to create ﬁ les for the selected cycle. Select a different cycle number to transfer.Error In File Transfer  Contact the hospital IT for assistance. Check that the computer server information is correct and has not been changed.Error In Network File Transfer. The Oldest Cycle Record Will Be Deleted. Contact the hospital IT for assistance. Check that the computer server information is correct and has not been changed.

Network Message Table C5STERRAD® 100NX® User’s Guide 129If this message appears… Do this…Feature Is Not Available Or Network Is Not Conﬁ gured Properly. Please Call ASP Representative For More Information Conﬁ rm network settings are conﬁ gured. Contact ASP Representative for more information.Feature is Not Available. Please Call ASP Representative For More Information Contact ASP Representative for more information.Network Cable Is Disconnected. Conﬁ rm That The Network Cable Is Plugged In. Contact Hospital IT For Assistance. Check that the network cable is plugged in to the sterilizer and to the active data port on the wall. Run Ping in Diagnostics to verify connectivity.Please Enter A Valid DNS IP Address. The Format Is Four Numbers Between 0 And 255 Separated By Periods. Contact Hospital IT For Assistance. Contact the hospital IT for assistance. Verify the values entered.Please Enter A Valid domain name. Contact Hospital IT For Assistance. Contact the hospital IT for assistance. Verify the values entered do not exceed 30 characters.Please Enter A Valid Gateway Address. The Format Is Four Numbers Between 0 And 255 Separated By Periods. Contact Hospital IT For Assistance. Contact the hospital IT for assistance. Verify the values entered.Please Enter A Valid IP Address. The Format Is Four Numbers Between 0 And 255 Separated By Periods. Contact Hospital IT For Assistance. Contact the hospital IT for assistance. Verify the values entered.Please Enter A Valid Subnet Mask. The Format Is Four Numbers Between 0 And 255 Separated By Periods. Contact Hospital IT For Assistance. Contact the hospital IT for assistance.  Verify the values entered. Unable To Establish Connection  Contact the hospital IT for assistance.  Check that the network cable is plugged in to the sterilizer and to the active port on the wall. Check that the network settings on the sterilizer are correct. Check that the computer server information is correct and has not been changed.

C5 Network Message Table130 STERRAD® 100NX® User’s GuideIf this message appears… Do this…Unable To Establish Connection. Conﬁ rm Entered Settings Are Correct. Contact Hospital IT For Assistance. Contact the hospital IT for assistance. Check that the network settings on the sterilizer are correct. Check that the computer server information is correct and has not been changed.  Ensure service account name and password have not changed.

Testing the Network Connection C6STERRAD® 100NX® User’s Guide 131Section 6. Testing the Network ConnectionTesting the Network ConnectionTo ensure that the STERRAD® 100NX® can send data to the network, a “ping” test can be performed. A network crossover cable is required for this test. The steps below are using Windows® 7, operating system. If you are using a different version of Windows, your screens may look different.A. Preparing the Remote Host Computer for the Ping TestBefore the test is run a Local Area Network (LAN) connection must be created.1. Connect the crossover cable to the remote host computer and to the STERRAD® 100NX® sterilizer.2. Press the (start icon) on the Windows® 7 taskbar and select Control Panel.

C6 Testing the Network Connection132 STERRAD® 100NX® User’s Guide3. Select Network and Sharing Center. 4. Select Change Adapter Settings.5. a. Select Local Area Connection.b. Press Properties (not shown).

Testing the Network Connection C6STERRAD® 100NX® User’s Guide 1336. a. Select Internet Protocol Version 4 (TCP/IPv4). b. Press Properties. 7. Select Use the following IP address: and then enter the following sample network number information. IP Address (192.168.1.127), Subnet Mask (255.255.255.0), Default gateway (192.168.1.1),Preferred DNS server (192.168.1.5), Alternate DNS server (192.168.1.6). Press OK.

$C6 Testing the Network Connection134 STERRAD® 100NX® User’s Guide8. a. Press Close on the “Local Area Connection Status”.b. Press Close on the next screen.9. a. You can verify that the LAN information is correct. From the taskbar, click on the (start icon). Select Command Prompt from the list of programs.b. As shown in the example, enter ipconﬁ g/all after “(Drive letter):\>”. Press Enter on the computer’s keyboard.$

Advanced Sterilization 02532481 RFID Module User Manual M 99994 04 100NXUser indb

Advanced Sterilization Products RFID Module M 99994 04 100NXUser indb

User Manual

Navigation menu

Namespaces

Views

Navigation