STERRAD NX Sterilization System Users Guide May 2011

STERRAD® NX® Sterilization System

User’s Guide REF 99920

1-888-STERRAD ASP U.S.A. Professional Services 949.581.5799 ASP International Customer Support (Call your local ASP Customer Support Representative) www.aspjj.com For warranty information, please visit our website or contact ASP Professional Services. For additional copies of this guide, please visit www.e-ifu.com

© 2008-2011 Division of Ethicon. All rights reserved. STERRAD® NX® is a registered trademark of Advanced Sterilization Products (ASP). Teflon® and Tyvek® are registered trademarks of E.I. du Pont de Nemours and Company. Other products mentioned in this publication are trademarked by their respective owners. Reproduction, adaptation, or translation of this publication without prior written permission is prohibited. Printed in the U.S.A.

Contents Chapter 1.Introduction... 5 How to Use This Guide... 5 Warnings, Cautions, and Notes... 5 Symbols Used on the Sterilizer and in This Guide... 6 If You Have Questions... 6 Chapter 2. Safety Information... 7 Personal Safety and First Aid... 7 Personal Protective Equipment... 9 Cassette Handling... 9 Device Safety... 9 Chapter 3. Sterilizer Overview... 13 Intended Use... 13 The STERRAD® NX® Sterilization Process... 13 Overview of the STERRAD® NX® Sterilization Cycle... 14 The STERRAD® NX® Sterilizer and Features... 15 Cassette... 16 Cassette Drawer... 17 Cassette Disposal Box... 17 Touch Screen and Speaker... 17 Chamber... 18 Printer... 18 Rear Panel... 20 Touch Screen Data Entry... 20 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... 25 Recommended Materials... 25 Items Not To Be Processed... 29 Cleaning, Rinsing, and Drying... 30 Packaging and Loading... 32 Instrument Trays... 32 Tray Mats... 32

Packaging... 32 Loading... 33 Chemical Indicators... 33 Special Considerations for Flexible Endoscopes... 34 Chapter 5. Operation... 35 Before You Start... 35 Start and Warm-up... 35 Inserting a Cassette... 36 Preparing the Load... 37 Biological Indicators... 37 Login... 37 Entering Load Information... 39 Enter Load Item Data... 39 Cycle Notes... 40 Loading the Chamber... 41 Selecting and Starting a Cycle... 43 Cycle Warm Up... 44 System Ready Screen... 44 Cycle in Progress... 45 Canceling a Cycle... 46 Cycle Completed... 47 Processing a Sterilized Load... 47 Inspecting Chemical Indicators... 48 Processing Biological Indicators... 48 Data Transfer... 51 Chapter 6. Access Levels and Supervisor Tasks... 53 Overview... 53 Access Levels... 53 Additional Utilities Menu... 54 Date and Time Settings... 55 Set Date... 56 Set Time... 56 Time Zone... 56 Date Format... 56 Time Format... 56 Cancel/Done... 56

System Configuration... 57 Access Control Option... 57 IMS... 57 Vacuum Units... 58 Load Data Entry Option... 58 Load Removal Option... 58 Notepad Option... 58 Network Option... 58 Alarm Volume... 58 Backlight Conservation... 59 Language Selection... 59 Sterilizer Settings... 59 Printer Settings... 60 Transfer Settings... 61 Cancel/Done... 61 File Management... 62 Calibration Files... 62 Diagnostic Files... 62 User Administration... 63 Add User... 64 Modify User... 65 Upload User Data... 66 Steps to Upload a User Database... 67 Diagnostics... 68 Diagnostic Tests... 69 Chapter 7. Reports and Files... 71 Displayed Reports... 71 System Summary... 71 Cycle History... 74 Printed Reports... 77 Short Report... 77 Long Report... 78 Medium Report... 78 Files... 80 Cycle History Files... 81 Calibration Files... 82 Diagnostic Files... 86 Chapter 8. Maintenance... 87 Automatic Maintenance... 87 Pressure Zeroing... 87 Automatic Lamp Adjustment... 88 Manual Maintenance... 88

Disposing of Cassettes... 89 Removing a Cassette Disposal Box... 89 Inserting a New Cassette Disposal Box... 90 Replacing Printer Paper... 91 Cleaning the Sterilizer Exterior... 94 Cleaning the Hydrogen Peroxide Monitor Detector Lens... 94 Replacing the Air Filter... 95 PCMCIA Card Handling and Replacement... 96 Sterilizer Disposal... 98 Chapter 9. Troubleshooting... 101 System Messages... 101 Diagnostic Messages... 105 ASP Professional Services... 111 Appendix A. Consumables, Accessories, and Additional Parts... 113 Appendix B. Sterilizer Specifications... 115

Introduction

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Chapter 1.

Introduction How to Use This Guide If you are a STERRAD® NX® Sterilizer operator, you must read the “Safety Information” and the “Introduction,” “Load Preparation,” and “Operation” chapters prior to operating the sterilizer. This “Introduction” explains the features and parts of the sterilizer. “Load Preparation” explains how to prepare and package instruments for processing. “Operation” explains how to operate the sterilizer and obtain optimal results. If you are a supervisor overseeing the STERRAD® NX® Sterilizer, you should read the entire user’s guide and pay particular attention the chapter featuring “Access Levels and Supervisor Level Tasks.” This chapter describes tasks and options that are only available through “Supervisor Level” access.

Warnings, Cautions, and Notes

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Warnings and cautions are accompanied by symbols surrounded by a triangle 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. 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. Hazardous chemical present. 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.

If You Have Questions If you are located in the United States and have questions about the STERRAD® NX® Sterilizer or questions about which items may be safely sterilized by the STERRAD Process, please call ASP Professional Services at 1-888-STERRAD (1-888-783-7723). Internationally, call your local ASP Customer Support. Representative. You may also wish to visit our website at www.aspjj.com.

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Safety Information

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Chapter 2.

Safety Information Your safety is of primary concern to Advanced Sterilization Products (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 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 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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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 used cassettes or ejected cassettes, items from a cancelled cycle, or items that have moisture present after a completed cycle. Immediately take off contaminated clothing and rinse thoroughly with water to avoid potential fire hazard and 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. 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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Personal Protective Equipment WARNING! HYDROGEN PEROXIDE MAY BE PRESENT. Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling, a used cassette, an ejected cassette, a load after a cycle cancellation, or if any moisture is noted on a load following a completed cycle. Hydrogen peroxide liquid may be present on the load or in the chamber.

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. 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.

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IMPORTANT! IMPORTANT PM PROCEDURE. If white residue is visible on the load; this may be residue from the hydrogen peroxide stabilizer. Wear chemical resistant latex, PV (vinyl), or nitrile gloves when removing a load with visible white residue. 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. 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. 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.

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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 Group 1 The STERRAD® NX® Sterilizer uses RF energy 11 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 Class A The STERRAD® NX® Sterilizer is suitable for use 11 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 Class A IEC 61000-3-2 Voltage fluctuations/ Complies flicker emissions IEC 61000-3-3

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Sterilizer Overview

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Chapter 3.

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. 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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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 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.

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Sterilizer Overview

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Exposure 2 The steps in Exposure 1 are repeated.

The STERRAD® NX® Sterilization Cycle Phase

Exposure 1

Order

Stages Delivery 1 Vaporization Pumpdown 1

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Chamber Pumpdown 1 Transfer 1 Diffusion 1 Plasma Pumpdown 1 / Plasma 1 Vent 1 Delivery 2 Vaporization Pumpdown 2

Exposure 2

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Chamber Pumpdown 2 Transfer 2 Diffusion 2 Plasma Pumpdown 2 / Plasma 2 Final Vent

The STERRAD® NX® Sterilizer and Features The cassette slot, the cassette drawer, the touch screen, the chamber door, the printer, and the main power switch are found on the front of the sterilizer.

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Figure 1. The STERRAD® NX® Sterilizer.

Cassette The cassette contains sealed capsules of precisely measured amounts of hydrogen peroxide solution. Each cassette contains enough sterilant for five cycles. Cassettes are inserted into the sterilizer through the cassette slot. The sterilizer pulls the cassette through the slot and moves it into the machine, keeping it there until the cassette has been processed.

Figure 2. Inserting a Cassette.

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Cassette Drawer After processing of the cassette, the sterilizer automatically discards it into the cassette disposal box in the cassette drawer. Wear chemical resistant latex, PVC (vinyl), or nitrile gloves when handling used or ejected cassettes.

Cassette Disposal Box The cassette drawer contains a cassette disposal box for used cassettes. The box holds three cassettes. When the box is full, the sterilizer displays a message indicating that the drawer must be emptied. The cassette disposal box must be closed to permit safe disposal of cassettes. Refer to the “Maintenance” chapter for additional information.

Touch Screen and Speaker The sterilizer displays information and accepts commands through a color touch screen. By touching buttons displayed on the screen, you can enter letters and numbers, make selections, and start and stop the sterilizer.

Figure 3. 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.

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Chamber The chamber is where the load is sterilized. The chamber walls and door contain heaters that keep the chamber interior warm during operation. When the chamber door is closed, a vacuum-tight seal is created, allowing the chamber to be evacuated during operation. A locking mechanism prevents the door from being opened when a sterilization cycle is in progress.

Figure 4. The STERRAD® NX® Chamber Empty and With the Load Correctly Placed.

The chamber contains two slide-out shelves to permit efficient loading; the top shelf is removable. Inside the chamber, surrounding the shelves, is a metal screen (the electrode) that helps generate plasma during operation.

Printer 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. When the sterilizer power is on, the printer interior is illuminated with a blue light.

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