STERRAD 100NX software upgrade Users Guide

STERRAD NX® 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 NX®, ALLClear™ and STERRAD VELOCITY™ 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 Warnings, Cautions, and Notes...7 Symbols Used on the Sterilizer and in This Guide...8 If You Have Questions...9 Chapter 2. Safety Information... 11 Personal Safety and First Aid... 11 Personal Protective Equipment...13 Cassette Handling...13 Device Safety...13 Chapter 3. Sterilizer Overview... 17 Intended Use...17 The STERRAD NX® Sterilization Process...17 Overview of the STERRAD NX® Sterilization Cycle...18 The STERRAD NX® Sterilizer and Features...20 Cassette...20 Cassette Drawer...21 Cassette Disposal Box...21 Touch Screen and Speaker...21 Chamber...22 Printer...22 Rear Panel...23 Touch Screen Data Entry...23 Chapter 4. Load Preparation... 25 Indications for Use...25 STANDARD Cycle Processing...25 ADVANCED Cycle Processing...26 Determining What Can be Sterilized in the STERRAD NX® Sterilizer...27 Recommended Materials...27 Items Not To Be Processed...32 Cleaning, Rinsing, and Drying...33 Packaging and Loading...35 Instrument Trays...35 Tray Mats...35 Packaging...35

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Loading...36 Chemical Indicators...37 Special Considerations for Flexible Endoscopes...37 Chapter 5. Operation... 39 Before You Start...39 Start and Warm-up...39 Login...40 Entering Load Information...41 Enter Load Item Data...41 Edit/Remove Item Added...42 Cycle Notes...42 Inserting a Cassette...43 Loading the Chamber...44 Inserting the top shelf ...47 Selecting a Cycle...49 Cycle Information...49 Functions...51 Biological Indicators...51 STERRAD® CYCLESURE® 24 Biological Indicator...51 STERRAD VELOCITY™ Biological Indicator...52 Starting a Cycle...53 ALLClear™ Technology...54 Canceling ALLClear™ Technology...55 Cycle in Progress...56 Canceling a Cycle...57 Cycle Completed...58 Processing a Sterilized Load...59 Inspecting Chemical Indicators...59 Processing Biological Indicators...59 Interpretation of Biological Indicator Results...60 STERRAD® CYCLESURE® 24 Biological Indicator...60 STERRAD VELOCITY™ Biological Indicator...61 Data Transfer...62 Chapter 6. Access Levels and Supervisor Tasks... 63 Overview...63 Access Levels...63 Additional Utilities Menu...64 Date and Time Settings...65 Set Date...66 Set Time...66 Time Zone...66 Date Format...66 Time Format...66 Cancel/Done...66

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

System Configuration...67 Access Control Option...67 IMS...67 Vacuum Units...68 Load Data Entry Option...68 Load Removal Option...68 Notepad Option...68 Auto Send Network Files...68 BI Notification...68 Backlight Conservation...69 Language Selection...69 Sterilizer Settings...69 Printer Settings...70 Transfer Settings...71 Cancel/Done...71 File Management...72 Calibration Files...72 Diagnostic Files...72 User Administration...73 Add User...74 Modify User...75 Upload User Data...76 Steps to Upload a User Database...77 Diagnostics...78 Diagnostic Tests...78 Product Options...79 Chapter 7. Reports and Files... 81 Displayed Reports...81 System Summary...81 Cycle History...84 Printed Reports...87 Short Report...87 Long Report...88 Medium Report...88 Files...90 Cycle History Files...91 Calibration Files...92 Diagnostic Files...96 Chapter 8. Maintenance... 97 Automatic Maintenance...97 Automatic Lamp Adjustment...97 Manual Maintenance...98

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Disposing of Cassettes...98 Removing a Cassette Disposal Box...99 Inserting a New Cassette Disposal Box...100 Replacing Printer Paper...100 Cleaning the Sterilizer Exterior...103 Cleaning the Hydrogen Peroxide Monitor Detector Lens...104 Replacing the Air Filter...105 PCMCIA Card Handling and Replacement...106 Sterilizer Disposal...107 Chapter 9. Troubleshooting... 109 System Messages...109 User Notification Screen... 110 Cycle Cancel Screen... 111 Diagnostic Messages... 112 Diagnostics Cassette System Test Screen... 112 Diagnostics Vacuum Test Screen... 113 Diagnostics Temperature Test Screen... 114 Diagnostics Plasma Test Screen... 116 Other Diagnostics... 116 ASP Professional Services... 117 Appendix A. Consumables, Accessories, and Additional Parts... 119

Appendix B. Sterilizer Specifications... 121

Appendix C. User’s Network Connection Information Guide ... 123

Section 1. Digital Transfer Interface... 124 Network Connection Specifications...124 Security Reminders...125 For Healthcare Facilities:...126 If You Have Questions...126 Section 2. Setting Up the Network... 127 Network Settings Display...127 Configuration Mode...128

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

Hostname...128 IP Address...128 Subnet Mask...129 Gateway...129 Primary DNS...129 Secondary DNS...129 Domain Name...129 User Name...130 Password...130 Shared Folder Name...131 PC/Server Name...131 System Network Setup...131 Section 3. Manual Network File Transfer... 137

Section 4. Troubleshooting Utilities... 139

Section 5. Network Message Table... 141

Section 6. Testing the Network Connection... 144 A. Preparing the Remote Host Computer for the Ping Test...144 B. Temporarily Turning Off the Windows Security Feature on the Remote Host Computer...148 C. Running the Ping Test from the Sterilizer...150 D. Reset the LAN Settings on your Laptop...154 E. Reset the Network Settings of the Sterilizer...155 Appendix D. Buttons used in this Guide... 157

Appendix E. Cycle and Biological Indicator Flowcharts... 161

Appendix F. Software License Agreement... 165

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STERRAD NX® 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 NX® Sterilizer operator, you must read the “Introduction” (chapter 1), “Safety Information” (chapter 2), “Load Preparation” (chapter 4), and “Operation” (chapter 5) 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 NX® Sterilizer, you should read the entire user’s guide and pay particular attention the chapter featuring “Access Levels and Supervisor Tasks”. This chapter describes tasks and options that are only available through “Supervisor Level” access.

Warnings, Cautions, and Notes



Warnings and cautions are accompanied by symbols surrounded by a triangle or a circle and are printed in the text in boldface italics. 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 STERRAD NX® Sterilizer. 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 STERRAD NX® Sterilization System. IMPORTANT! The photos and graphics of the sterilizer, screens and printouts are for reference only. Your sterilizer may look different or present different screens and/or printed messages.

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Introduction

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. Manufacturer. Followed by the name and address of the manufacturer.

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Introduction

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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.

If You Have Questions If you have any questions about the STERRAD NX® Sterilizer or questions about which items may be safely sterilized by the STERRAD® Process, please call your local ASP Customer Support Representative. You may also wish to visit our website at www.asp.com.

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Introduction

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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, Inc. (ASP). This chapter provides information on safely using the STERRAD NX® 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 NX® Sterilization System.

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 when 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 a 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! 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

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 RESPIRATORY IRRITATION. Inhalation of hydrogen peroxide mist can cause severe irritation of lungs, throat, and nose. If inhalation occurs, move 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! 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 fire hazard and wash before re-use. 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! 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 well ventilated environment (a minimum of 10 air exchanges per hour).

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Safety Information

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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 manufacturers instruction for use for more information.

Cassette Handling WARNING! HYDROGEN PEROXIDE MAY BE PRESENT. Do not remove the plastic wrapper from the cassette package if the indicator strip is red. Red indicates that the cassette might have been damaged. Call ASP Professional Services (1-888-STERRAD) for credit.

Device Safety WARNING! RISK OF INJURY OR DAMAGE TO STERILIZER. The STERRAD NX® Sterilizer should not be used stacked with other equipment. CAUTION: RISK OF DAMAGE TO STERILIZER. Regularly scheduled, or Planned Maintenance (PM) must be performed at the interval specified on the system. Make sure you schedule a service call in a timely manner when notified that a PM is due. CAUTION: RISK OF DAMAGE TO STERILIZER. The sterilizer must only be mounted on an ASP-approved cart or a countertop that meets all ASP specifications.

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Safety Information

WARNING! IMPORTANT PM PROCEDURE. 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 instruction for use for more information. White residue can be minimized by making sure regular Planned Maintenance (PM) procedures are performed on your sterilizer. The sterilizer will inform you when Planned Maintenance is due. Please schedule your PM service in a timely manner. WARNING! KNOW WHAT YOU CAN PROCESS. Before processing any item in the STERRAD NX® 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. The lumen charts in this guide lists the certain types of items and materials that can be safely processed in the sterilizer. 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 door, or the electrode. Contact with the walls, door, 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 NX® Sterilizer, it will damage the flexible scope due to the inability to properly vent.

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Safety Information

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CAUTION: KNOW WHAT YOU CAN PROCESS – FLEXIBLE ENDOSCOPES. Prior to processing flexible endoscopes in the STERRAD NX® 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 NX® Sterilizer. CAUTION: RF COMMUNICATIONS EQUIPMENT. Portable and mobile RF communications equipment can affect medical electrical equipment.

Guidance And Declaration-Electromagnetic Emissions The STERRAD NX® 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 I

The STERRAD NX® 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 NX® 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

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Sterilizer Overview

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Chapter 3. Sterilizer Overview

Sterilizer Overview Intended Use The STERRAD NX® Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX® Process to inactivate microorganisms on a broad range of medical devices and surgical instruments. This sterilizer offers an effective, safe, fast, economical, easy to use, reliable, and flexible sterilization method. When used as directed by the instructions in this user’s guide, the STERRAD NX® Sterilization System will sterilize both metal and nonmetal medical devices at low temperatures. Please review the “How to Determine What Can Be Sterilized in the STERRAD NX® Sterilizer” chart in the “Load Preparation” chapter (chapter 4). This chart contains details on recommended materials and lumen sizes. When selecting reusable medical devices to be processed in the STERRAD NX® Sterilizer, reprocessing information should be obtained from the manufacturer of the medical device in accordance with international norms (such as ISO 17664 or TAMI TAR).

The STERRAD NX® Sterilization Process As a healthcare professional, you may already be familiar with general sterilization principles. However, the STERRAD NX® Sterilizer represents a new technology, and it requires special attention to the ways in which it differs from other sterilizers. The STERRAD NX® Sterilizer sterilizes medical devices by diffusing hydrogen peroxide vapor into the chamber and then electromagnetically exciting the hydrogen peroxide molecules into a low-temperature plasma state. The combined use of hydrogen peroxide vapor and plasma safely and rapidly sterilizes medical instruments and materials without leaving toxic residues. All stages of the sterilization cycle operate within a dry environment at a low temperature, and thus the cycle is not damaging to compatible instruments sensitive to heat and moisture. (Refer to chapter 4 for more information on compatible instruments.)

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Sterilizer Overview

The STERRAD NX® 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. 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. The devices have been pre-validated to an SAL of 10-6 based upon worst-case conditions, including lumens within the claim lengths and mated surfaces. If additional technical information concerning validation is needed, please contact your ASP Representative.

Overview of the STERRAD NX® Sterilization Cycle The STERRAD NX® Sterilization Cycle consists of two phases: Exposure 1 and Exposure 2. The following information provides a brief description for each of the steps.

Exposure 1

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

Delivery 1: The hydrogen peroxide is transferred from the cassette into the vaporizer.



Vaporization Pumpdown 1: The pressure within the chamber and vaporizer/condenser is reduced. Water is removed from the hydrogen peroxide solution, leaving behind a concentrated hydrogen peroxide solution in the condenser.



Chamber Pumpdown 1: The chamber is isolated from the vaporizer/ condenser. The chamber pressure is reduced to remove air from the lumens.



Transfer 1: The concentrated hydrogen peroxide solution is transferred to the chamber where it penetrates throughout the load.



Diffusion 1: Chamber pressure is increased in order to drive hydrogen peroxide is through the load packaging onto the surfaces of the devices and into the lumens of the load.



Plasma Pumpdown 1 / Plasma 1: Plasma power is applied to the electrode screen and the plasma is lit.



Vent 1: The chamber is vented to atmospheric pressure.

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