STERRAD 100NX Users Guide

STERRAD NX™ Sterilization System with ALLClear™ Technology

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...1 How to Use This Guide...1 Warnings, Cautions, and Notes...1 Symbols Used on the Sterilizer and in This Guide...2 If You Have Questions...3

Chapter 2. Safety Information... 5 Personal Safety and First Aid...5 Personal Protective Equipment...8 Cassette Handling...8 Device Safety...8

Chapter 3. Sterilizer Overview...15 Intended Use...15 The STERRAD NX Sterilization Process...15 Overview of the STERRAD NX™ Sterilization Cycle...16 The STERRAD NX Sterilizer and Features...17 Cassette...18 Cassette Drawer...19 Cassette Disposal Box...19 Touch Screen and Speaker...19 Chamber...20 Printer...20 Rear Panel...21 Touch Screen Data Entry...21

Chapter 4. Load Preparation... 23 Indications for Use...23 STANDARD Cycle Processing...23 ADVANCED Cycle Processing...24 Determining What Can be Sterilized in the STERRAD NX Sterilizer...24 Recommended Materials...24 Items Not To Be Processed...29 Cleaning, Rinsing, and Drying...30 Packaging and Loading...32 Instrument Trays...32

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Tray Mats...32 Packaging...32 Loading...33 Chemical Indicators...34 Special Considerations for Flexible Endoscopes...34

Chapter 5. Operation... 35 Before You Start...35 Start and Warm-up...35 Login...36 Entering Load Information...37 Enter Load Item Data...37 Edit/Remove Item Added...38 Cycle Notes...38 Inserting a Cassette...39 Loading the Chamber...40 Inserting the top shelf ...43 Selecting a Cycle...45 Cycle Information...45 Functions...47 Biological Indicators...47 STERRAD™ CYCLESURE™ 24 Biological Indicator...47 STERRAD VELOCITY™ Biological Indicator...48 Starting a Cycle...49 ALLClear™ Technology...50 Canceling ALLClear Technology...51 Cycle in Progress...52 Canceling a Cycle...53 Cycle Completed...54 Processing a Sterilized Load...55 Inspecting Chemical Indicators...55 Processing Biological Indicators...56 Interpretation of Biological Indicator Results...56 STERRAD™ CYCLESURE™ 24 Biological Indicator...56 STERRAD VELOCITY Biological Indicator...57 Data Transfer...58

Chapter 6. Access Levels and Supervisor Tasks...61 Overview...61 Access Levels...61

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Additional Utilities Menu...62 Date and Time Settings...63 Set Date...64 Set Time...64 Time Zone...64 Date Format...64 Time Format...65 Cancel/Done...65 System Configuration...65 Access Control Option...66 IMS...66 Vacuum Units...66 Load Data Entry Option...66 Load Removal Option...66 Notepad Option...67 Auto Send Network Files...67 BI Notification...67 Backlight Conservation...67 Language Selection...67 Sterilizer Settings...68 Printer Settings...69 Transfer Settings...70 Cancel/Done...70 File Management...71 Calibration Files...71 Diagnostic Files...71 User Administration...72 Add User...73 Modify User...74 Upload User Data...75 Steps to Upload a User Database...76 Diagnostics...77 Diagnostic Tests...77 Product Options...78

Chapter 7. Reports and Files... 79 Displayed Reports...79 System Summary...79 System Summary File...80 Cycle History...83

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Data Transfer...84 USB Save...85 Printed Reports...86 Short Report...86 Long Report...87 Medium Report...87 Files...89 Cycle History Files...90 Calibration Files...91 Diagnostic Files...95

Chapter 8. Maintenance... 97 Automatic Maintenance...97 Automatic Lamp Adjustment...97 Manual Maintenance...98 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...112 Diagnostic Messages...113 Diagnostics Cassette System Test Screen...114 Diagnostics Vacuum Test Screen...115 Diagnostics Temperature Test Screen...116 Diagnostics Plasma Test Screen...118 Other Diagnostics...119 ASP Professional Services...121

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

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Appendix B. Sterilizer Specifications...125 Appendix C. User’s Network Connection Information Guide ...127 Section 1. Digital Transfer Interface... 128 Network Connection Specifications...128 Security Reminders...129 For Healthcare Facilities:...130 If You Have Questions...130

Section 2. Setting Up the Network... 131 Network Settings Display...131 Configuration Mode...132 Hostname...132 IP Address...133 Subnet Mask...133 Gateway...133 Primary DNS...133 Secondary DNS...134 Domain Name...134 User Name...134 Password...135 Shared Folder Name...135 PC/Server Name...135 System Network Setup...135

Section 3. Manual Network File Transfer... 141 Section 4. Troubleshooting Utilities...143 Section 5. Network Message Table...145 Section 6. Testing the Network Connection... 148 A. Preparing the Remote Host Computer for the Ping Test...148 B. Temporarily Turning Off the Windows Security Feature on the Remote Host Computer...152 C. Running the Ping Test from the Sterilizer...154 D. Reset the LAN Settings on your Laptop...158 E. Reset the Network Settings of the Sterilizer...159

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Appendix D. Buttons used in this Guide... 161 Appendix E. Cycle and Biological Indicator Flowcharts...167 Appendix F. Software License Agreement... 171

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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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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 Personal Protective Equipment when operating the STERRAD System, handling cassettes or loads to avoid skin injury. 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.

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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

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 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 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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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.

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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. 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. WARNING: Use of accessories and cables other than those specified in this User Guide is not warranted and could affect the electromagnetic emissions or immunity of this 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 EN 55011 (CISPR 11)

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Description Radiation Emissions

IEC 60601-1-2 Compliance Level

Electromagnetic Environment – Guidance

Group I, Class A

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.

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Safety Information

Emissions

Description

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IEC 60601-1-2 Compliance Level

Electromagnetic Environment – Guidance

EN 55011 (CISPR 11)

Conducted Emissions

Group I, 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.

EN 61000-3-2

Harmonic Current Emissions

Class A

Harmonic emissions are low from the system and is unlikely to cause interference with other equipment.

EN 61000-3-3

Voltage Fluctuations and Flicker

Pst ≤ 1.0 Plt ≤ 0.65 dc The system’s voltage ≤ 3.3% dmax ≤ 4.0% fluctuations has no effect on flicker in lighting systems. Use of dedicated mains supply is required.

IEC 60601-12 Compliance Level

Electromagnetic Environment – Guidance

2,4,6 and 8kV (±) Contact Discharge 2, 4, 8 and 15kV (±) Air Discharge

Static generating materials should not be used near the system. The system may require power cycling if an electrostatic discharge to the system occurs.

IEC 61000-4-3 Radio Frequency 80MHz to 2.7GHz Electromagnetic 3V/m 80% AM 1kHz Field, Amplitude Modulated

The operation of radio or wireless devices should be limited when within 1 meter (3.3 ft) of the system.

Immunity

Description

IEC 61000-4-2 Electrostatic Discharge

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IEC 60601-12 Compliance Level

Electromagnetic Environment – Guidance

IEC 61000-4-3 Proximity Field from Wireless Transmitters

385MHz: 27V/m @ 18Hz pulse modulation 450MHz: 28V/m @ FM modulation 710MHz, 745MH, 780MHz: 9V/m @ 217Hz pulse modulation 810MHz, 870MHz, 930MHz: 28V/m @ 18Hz Pulse modulation 1720MHz, 1845MHz, 1970MHz: 28V/m @ 217Hz Pulse Modulation 2450MHz: 28V/m @ 217Hz Pulse modulation 5240MHz, 5500MHz, 5785MHz: 9V/m @ 217Hz Pulse modulation

The operation of radio or wireless devices should be limited when within 1 meter (3.3 ft) of the system.

IEC 61000-4-4 Electrical Fast Transients

±2.0kV AC/DC Mains ±1.0kV Signal and Control Lines

Mains power quality should be similar to those found in a typical medical facility or hospital.

Immunity

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Description

STERRAD NX with ALLClear Technology User’s Guide