STERRAD 100NX software upgrade Users Guide

STERRAD® 100NX Sterilization System with ALLClear™ Technology Software Upgrade

User’s Guide ADVANCED STERILIZATION PRODUCTS, INC. 33 Technology Drive, Irvine, CA 92618, USA

ASP, The Netherlands BV BIC 1, 5657 BX, Eindhoven, The Netherlands

ASP Customer Support (Call your local ASP Customer Support Representative) www.asp.com For warranty information, please visit our website or contact ASP Professional Services.

©ASP 2021. All rights reserved. STERRAD®, CYCLESURE®, SEALSURE®, APTIMAX®, STERRAD® 100NX and ALLClear™ are trademarks of ASP Global Manufacturing GmbH. Teflon®, Delrin® and Tyvek® are registered trademarks of E.I. du Pont de Nemours and Company. Radel® is a registered trademark of Solvay SA. Kraton® is a registered trademark of Kraton Polymers LLC. Santoprene™ is a trademark of Exxon Mobil Corporation. Ultem® is a registered trademark of SABIC Innovative Plastics IP BV. da Vinci® is a registered trademark of Intuitive Surgical, Inc. The other third trademarks mentioned in this publication are the trademarks of their respective owners. Please note: the screen displays shown in this guide are for reference only. The actual displays on your system may be slightly different depending on your system’s configuration and software revision. Reproduction, adaptation, or translation of this publication without prior written permission is prohibited. Printed in the U.S.

Contents Chapter 1. Introduction... 7 How to Use This Guide...7 Intended Use...7 The STERRAD® Sterilization Process...8 If You Have Questions...8 Chapter 2. Safety Information... 9 Warnings, Cautions, and Notes...9 Symbols Used on the Sterilizer and in This Guide...10 Personal Safety and First Aid...12 Personal Protective Equipment...14 Cassette Handling...14 Device Safety...14 Chapter 3. Load Preparation... 19 Load Weight Requirements...19 Cycles and Materials Processing...22 Recommended Materials...26 Thermoplastics...26 Thermoplastic Elastomers...26 Thermosetting Elastomers...27 Glass...27 Metal...27 Items Not To Be Processed...27 Do Not Process in the EXPRESS Cycle...28 Do Not Process in the DUO Cycle...28 Guidelines for Preparing Items to Be Sterilized...29 Cleaning, Rinsing, and Drying...29 Packaging and Loading...31 Instrument Trays...31 Tray Mats...31 Packaging...31 Loading...32 Chemical Indicators...33 Special Considerations for Flexible Endoscopes...33

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Chapter 4. Operation... 35 Before You Start...35 Start and Warm-up...35 Login...36 Entering Load Information...37 Enter Load Item Data...37 Inserting a Cassette...40 Loading the Chamber...41 Selecting a Cycle...45 Cycle Information...46 Functions...48 Biological Indicators...49 STERRAD® CYCLESURE® 24 Biological Indicator...49 STERRAD VELOCITY™ Biological Indicator...50 Starting a Cycle...51 ALLClear™ Technology...53 Canceling ALLClear™ Technology...54 Cycle in Progress...55 Canceling a Cycle...57 Cycle Completed...59 Processing a Sterilized Load...60 Inspecting Chemical Indicators...60 Processing Biological Indicators...60 Interpretation of Biological Indicator Results...61 STERRAD® CYCLESURE® 24 Biological Indicator...61 STERRAD VELOCITY™ Biological Indicator...62 Chapter 5. Troubleshooting... 65 Running Diagnostics...65 System Message Table...66 Temperature Messages...66 Call Your ASP Representative...70 Chapter 6. Sterilizer Overview... 71 Sterilizer Cycles...71 Sterilizer Features...72 Cassette...73 Cassette Disposal Box...74 Touch Screen and Speaker...75 Chamber...76 Printer...77 Touch Screen Data Entry...78

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Chapter 7. Maintenance... 79 Automatic Maintenance...79 Automatic Lamp Adjustment...79 Manual Maintenance...80 Disposing of Cassettes...80 Removing a Cassette Disposal Box...81 Replacing the Printer Paper...82 Cleaning the Sterilizer Exterior...85 Cleaning the Hydrogen Peroxide Monitor Detector Lens...86 PCMCIA Card Handling and Replacement...87 Data Transfer Using a Memory Stick...88 Sterilizer Disposal...89 Chapter 8. Reports and Files... 91 Displayed Reports...91 Cycle History...91 Printed Reports...93 Short Report...93 Parametric Report...93 Long Report...93 Chapter 9. Access Levels and Supervisor Tasks... 95 Overview...95 Access Levels...95 Additional Utilities Menu...96 Date and Time Settings...98 Set Date...98 Set Time...98 Time Zone...98 Date Format...99 Time Format...99 Cancel/Done...99 System Configuration...99 Access Control Option...100 IMS...100 Vacuum Units...100 Load Data Entry Option...100 Load Removal Option...100 Notepad Option...100 Auto Send Network Files...100 BI Notification...101

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Alarm Volume...101 Backlight Conservation (Minutes)...101 Language Selection...101 Sterilizer Settings...101 Printer Settings...102 Transfer Settings...103 Cancel/Done...103 User Administration...104 Add User...105 Modify User...106 Upload User Data...107 Cassette Functions...109 Dispose Cassette...110 Peroxide Clearance...111 Network...112 Diagnostics...112 Diagnostic Tests...113 Service Functions...113 File Management...114 Calibration Files...114 Diagnostic Files...114 Upload File...115 Input/Output Doors...116 Product Options...116 Appendix A. Sterilizer Specifications... 119

Appendix B. Consumables, Accessories, and Additional Parts... 123

Appendix C. User’s Network Connection Information Guide... 125 Section 1. Digital Transfer Interface...126 Network Connection Specifications...126 Security Reminders...127 For Hospital or Healthcare Facilities:...128 If You Have Questions...128

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Section 2. Setting Up the Network...129 Network Settings Display...129 Configuration Mode...130 Hostname...130 IP Address...131 Subnet Mask...131 Gateway...131 Primary DNS...131 Secondary DNS...132 Domain Name...132 User Name...132 Password...133 Shared Folder Name...133 PC/Server Name...133 System Network Setup...134 Section 3. Manual Network File Transfer...139 Section 4. Troubleshooting Utilities...141 Section 5. Network Message Table...143 Section 6. Testing the Network Connection...146

Appendix D. Buttons used in this Guide... 159

Appendix E. Cycle and Biological Indicator Flowcharts... 165

Appendix F. Software License Agreement... 169

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STERRAD® 100NX with ALLClear™ Technology Software Upgrade User’s Guide

Introduction

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Chapter 1. Introduction

Introduction How to Use This Guide If you are a STERRAD® 100NX Sterilizer operator, you must read the “Introduction” (chapter 1), “Safety Information” (chapter 2), “Load Preparation” (chapter 3), and “Operation” (chapter 4) chapters prior to operating the sterilizer. This “Introduction” explains the features and parts of the sterilizer. “Safety Information” explains Personal Safety and First Aid information as well as Device Safety information. “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 Tasks”. This chapter describes tasks and options that are only available through “Supervisor Level” access.

Intended Use The 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 (chapter 3) along with the cycle information to make sure you follow the directions for processing items in each type of cycle.

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Introduction

The STERRAD® Sterilization Process The STERRAD® 100NX Sterilizer sterilizes medical devices by diffusing hydrogen peroxide vapor into the chamber and then electromagnetically exciting the hydrogen peroxide molecules into a low-temperature plasma state. The combined use of hydrogen peroxide vapor and plasma safely and rapidly sterilizes medical instruments and materials without leaving toxic 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 difficult-to-reach (diffusion-restricted) spaces, such as hinges on forceps. Refer to the “Safety Information” chapter (chapter 2) for more information on device safety. The sterilizer consistently provides a Sterility Assurance Level (SAL) of 10-6, as defined by U.S. Food and Drug Administration (FDA) and international standards, for clinical use on all allowed substrates within the limits of the claims for materials and geometries when used in accordance with the directions in this user’s guide.

If You Have Questions If 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.asp.com​.

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Safety Information

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Chapter 2. Safety Information

Safety Information Your safety is of primary concern to Advanced Sterilization Products (ASP). This chapter provides information on safely using the STERRAD® 100NX Sterilizer. You must read and understand the safety information in this chapter before operating the sterilizer. Always pay attention to the warnings, cautions and notes throughout this user’s guide. This information is for your safety and to ensure that you receive the most benefit from the safe operation of your STERRAD® 100NX Sterilization System.

Warnings, Cautions, and Notes Warnings and cautions are accompanied by symbols surrounded by a triangle or circle and are printed in the text in bold. Warnings indicate events or conditions that can result in serious injury or death. Cautions indicate events or conditions that can result in severe damage to the equipment.

 

Notes are printed in italics and have a checkmark in front of the word “Note”. Notes highlight specific information about the proper use and maintenance of the sterilizer.

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Safety Information

Symbols Used on the Sterilizer and in This Guide Hot surfaces present. Do not touch without protection.

Use personal protective equipment.

Corrosive chemical present. Use personal protective equipment. Oxidizing chemical present. Avoid exposure, contact, or ingestion. Use personal protective equipment. Toxic 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.

WEEE Symbol.

Catalogue number. The device specific catalogue number. Serial number. The device specific serial number.

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Safety Information

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RCM. Indicates compliance with applicable ACMA regulatory arrangements. Manufacturer. Followed by the name and address of the manufacturer. Date of Manufacture. Indicates the date when the medical device was manufactured. Authorized representative in the European Community. This symbol is accompanied by the name and address of the authorized representative in the European Community. Use-by-date. Indicates the date after which the device is not to be used. Batch Code. Indicates the manufacturer’s batch code so that the batch or lot can be identified. Consult Instructions for Use. Indicates the user should consult the instructions for use before using this product. Fragile, Handle with Care. Indicates a device which can be broken or damaged if not handled carefully. This Side Up. Indicates the orientation the package should remain in during shipping and storage. CE mark. Indicates the product meets the standards to be sold within the European Economic Area (EEA). The Nationally Recognized Testing Laboratory (NRTL) program of the Occupational Safety & Health Administration (OSHA) acknowledges and confirms private organizations qualification to test technical products for workplace safety according to US OSHA requirements. “US” stands for compliance with US requirements and, “C” stands for compliance with Canadian requirements. USB. Universal serial bus connector port.

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Safety Information

Personal Safety and First Aid WARNING! HYDROGEN PEROXIDE IS CORROSIVE. Concentrated hydrogen peroxide is corrosive to skin, eyes, nose, throat, lungs, and the gastrointestinal tract. Always wear chemical resistant latex, PVC (vinyl), or nitrile gloves while removing items from the sterilizer following a canceled 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 fire, explosion, or container rupture. Avoid allowing hydrogen peroxide to contact organic materials, including paper, cotton, wood, or lubricants. Do not use or store near heat or open flame. Shoes, clothing, or other combustible material that have come into contact with hydrogen peroxide must be immediately and thoroughly rinsed with water to avoid a potential fire hazard. In case of fire, use only water to extinguish. WARNING! RISK OF EYE INJURY. Direct hydrogen peroxide contact with eyes can cause irreversible tissue damage. If contact with eyes occurs, hold the eyes open and flush with large amounts of water for at least 15-20 minutes. Remove contact lenses, if present, and then continue rinsing the eyes. Consult a physician immediately after flushing the eyes. WARNING! 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 canceled cycle, or items that have moisture present after a completed cycle. Immediately take off contaminated clothing and rinse thoroughly with water to avoid potential fire hazard and 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 artificial 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.

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Safety Information

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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 may be hydrogen peroxide residue. The load will need to be reprocessed to prevent potential injury to the patient. As a precaution, when handling any part of the system or load items that have been exposed to hydrogen peroxide, please wear the appropriate PPE (chemical resistant latex, PVC/vinyl, or nitrile gloves). Refer to the glove manufacturer’s instructions for use for more information. White residue can be minimized by making sure regular Planned Maintenance (PM) 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. WARNING! RISK OF BREATHING DIFFICULTIES. On rare occasions, the outlet filter on the vacuum pump can prematurely fail. The exhaust filter of vacuum pump could be degraded and decrease its efficiency if planned maintenance is not conducted properly. 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 wellventilated environment (a minimum of 10 air exchanges per hour).

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Safety Information

Personal Protective Equipment WARNING! HYDROGEN PEROXIDE MAY BE PRESENT. As a precaution, when handling any part of the system or load items that have been exposed to hydrogen peroxide, please wear the appropriate PPE (chemical resistant latex, PVC/vinyl, or nitrile gloves). Refer to the glove manufacturer’s instructions for use for more information.

Cassette Handling WARNING! HYDROGEN PEROXIDE MAY BE PRESENT. Do not remove used cassettes from the cassette collection box. Dispose of the sealed cassette collection box according to local waste regulations. Cassettes with unused hydrogen peroxide are hazardous waste as defined by the US Environmental Protection Agency and should be disposed of accordingly. If it is necessary to handle a used cassette, wear chemical resistant latex, PVC (vinyl), or nitrile gloves. Do not touch gloves to your face or eyes.

Device Safety WARNING! RISK OF INJURY OR DAMAGE TO STERILIZER. The STERRAD® 100NX Sterilizer should not be used stacked with other equipment. WARNING! 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.

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Safety Information

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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 confirm that venting caps are placed according to the manufacturers’ instructions. Venting caps are intended to prevent damage to flexible scopes that are being exposed to a vacuum, regardless of the sterilant used. CAUTION: RISK OF DAMAGE TO LOAD – IMMERSION 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 flexible scope due to the inability to properly vent. CAUTION: KNOW WHAT YOU CAN PROCESS – FLEXIBLE ENDOSCOPES. Prior to processing flexible endoscopes in the STERRAD® 100NX Sterilizer, you must read, understand, and follow the medical device manufacturer’s instructions for use for the particular scope to be processed. Please contact the medical device manufacturer for more information on what can be processed in the STERRAD® 100NX Sterilizer. CAUTION: RF COMMUNICATIONS EQUIPMENT. Portable and mobile RF communications equipment can affect medical electrical equipment.

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Safety Information

Guidance And Declaration-Electromagnetic Emissions The STERRAD® 100NX Sterilizer is intended for use in the electromagnetic environment specified below. Assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment – Guidance

RF 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 61000-3-2

Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

System is configured with FCC ID: AXJ100NXRFID or FCC ID: AXJ02532480 or contains FCC ID: AXJ02532481 System is configured with IC Certification Number: 10207A‑100NXRFID or IC Certification Number: 10207A-02532480 or contains IC Certification Number: 10207A‑02532481 WARNING! (PART 15.21) RISK OF NON-COMPLIANCE. Changes or modifications 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 modifications to this equipment.

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Safety Information

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FCC Rules and Industry Canada (IC) Regulatory Information Compliance 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 Statement This 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 specific operating instructions to satisfy RF exposure compliance. The equipment should only be used where there is normally at least 20 cm 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 modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment.

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