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STERRAD® 100S Sterilization System
User’s Guide A99900
© ASP 2021. All rights reserved.
A99900-50 July 2021.
STERRAD® 100S Sterilization System
User’s Guide A99900
ADVANCED STERILIZATION PRODUCTS, INC. 33 Technology Drive, Irvine, CA 92618, USA
Contact your local ASP Representative for additional information. For additional copies of this guide, please visit eifu.asp.com
© ASP 2021. All rights reserved. STERRAD® 100S Sterilizer is a registered trademark of ASP Global Manufacturing GmbH. Teflon® and Tyvek®, are a registered trademarks of E.I. du Pont de Nemours and Company. Radel® is a registered trademark of Solvay SA. Other products mentioned in this publication are trademarked by their respective corporations. Reproduction, adaptation or translation of this publication without prior written permission is prohibited. Printed in the USA.
Contents About This Guide
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Overview... 5 Chapter 1. Introduction
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Overview... 7 Operation Information... 7 Overview of STERRAD® 100S Sterilizer Components... 9 Chapter 2. For Your Safety
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Overview... 11 Personal Safety and First Aid... 11 Device Safety... 13 Cassette Handling... 15 Safe Maintenance... 16 Test Regulations... 17 Additional Information... 17 Chapter 3. Preparing Items To Be Sterilized
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Overview... 19 Indications for Use... 19 Determining What Can be Sterilized in the STERRAD® 100S Sterilizer... 22 Items Not To Be Processed... 28 Cleaning, Rinsing, and Drying... 29 Guidelines for Wrapping, Packaging, and Loading... 31 Chapter 4. Day‑To‑Day Operation
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Safe Operation... 33 Sterilizer Operation... 33 Preparing the Load... 34 Biological Indicators... 36 Biological Monitoring Results... 38 Chemical Indicators ... 40 Loading the Sterilization Chamber... 41 Inserting Cassettes... 42 Sterilization Cycle... 44 Starting a Cycle... 44 Watching a Cycle... 45 Completing a Cycle... 46 Cycle Completion Flow Chart... 47 Canceling A Cycle... 48 Unloading and Handling... 49 STERRAD® 100S User’s Guide
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Chapter 5. Routine Maintenance
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Overview... 51 Changing the Cassette Collection Box... 53 Replacing the Vaporizer Plate... 56 Removing the Vaporizer Plate... 56 Installing a New Vaporizer Plate... 57 Replacing the Printer Ribbon Rolls or Cartridge... 59 Replacing the Printer Paper... 62 Resetting the Date and Time... 67 Clock Mode... 69 Setting Pressure Units... 69 Using the History Menu... 70 Cleaning the Sterilizer... 71 Sterilizer Disposal... 71 Master Reset... 72 Chapter 6. Troubleshooting
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Overview... 73 Using System Messages To Troubleshoot The Sterilizer... 74 Appendix A. Specifications
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Installation... 85 Environmental Conditions... 86 Protection and Warning Symbols... 87
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STERRAD® 100S User’s Guide
About This Guide About This Guide
Overview This guide is designed to provide useful information on the day‑to‑day operation and routine maintenance of the STERRAD® 100S Sterilizer. The guide is divided into 6 chapters and 1 appendix. These chapters provide information on using the sterilizer, load preparation, routine maintenance, and troubleshooting the STERRAD® 100S Sterilizer should problems arise. The features of this guide are: •
About This Guide–this section gives you important information on how to get the maximum use out of this guide.
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Chapter 1. Introduction–the first chapter of the guide contains important details about the STERRAD® 100S System, including the major parts of the sterilizer and STERRAD® Process information.
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Chapter 2. For Your Safety–this may be the most important chapter in the guide. You must read it thoroughly, understand the information, and follow all the safety procedures in this chapter. These safety procedures include safe handling of cassettes, safe handling of the load, and first aid information in case of possible hydrogen peroxide exposure.
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Chapter 3. Preparing Items To Be Sterilized–this chapter provides descriptions on preparing items to be sterilized, how to effectively package the load, and information detailing, “How to Determine What Can be Sterilized in the STERRAD® 100S Sterilizer.”
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About This Guide
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Chapter 4. Day‑To‑Day Operation–this chapter gives you detailed information on how to use the sterilizer, how to load the chamber, how to use the control panel, how to run cycles, and how to interpret biological indicator test results.
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Chapter 5. Routine Maintenance–the routine maintenance of your STERRAD® 100S Sterilizer is very minimal. This chapter shows you how to change the vaporizer plate, printer paper, printer ribbon, and the steps to follow to keep your sterilizer clean.
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Chapter 6. Troubleshooting–the STERRAD® 100S Sterilizer displays a number of messages to tell you what the sterilizer status is at any given moment. Many of these messages do not require any action from you. Others require that you call your ASP Service Representative for maintenance. The messages are listed in alphabetical order.
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Appendix A. Specifications–details the technical specification information for your sterilizer.
STERRAD® 100S User’s Guide
Chapter 1. Introduction
Introduction Overview This guide provides basic information on how to operate your sterilizer safely and efficiently. The STERRAD® 100S Sterilization System is a general purpose, low temperature sterilizer using the STERRAD® 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. You must read, understand, and follow the safety information presented in Chapter 2 and throughout this guide. The safety information is provided for your benefit and for the benefit of your instruments and equipment.
Operation Information The STERRAD® 100S Sterilizer has been developed by Advanced Sterilization Products, Inc. (ASP), to sterilize medical devices by diffusing hydrogen peroxide into the chamber and then “exciting” the hydrogen peroxide molecules into a 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, including the plasma stage, operate within a dry environment at a low temperature, and thus the cycle is not damaging to compatible instruments sensitive to heat and moisture. The 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.
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Introduction
When selecting reusable medical devices to be processed in the STERRAD® 100S Sterilizer, reprocessing information should be obtained from the manufacturer of the medical device in accordance with international norms (such as ISO 17664 or AAMI TIR12). The STERRAD® 100S Sterilizer consistently provides a sterility assurance level (SAL) of 10‑6, as defined by the Food and Drug Administration 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 guide. The devices have been pre‑validated to a 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.
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STERRAD® 100S User’s Guide
Introduction
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Overview of STERRAD® 100S Sterilizer Components Cassette Slot
Alarm Indicator Light LCD Display Indicator Lights
Chamber Door
Control Buttons Printer Drawer Printer Paper Exit
Figure 1. STERRAD® 100S Sterilizer. Your Sterilizer May Be Slightly Different in Appearance.
The main sterilizer components are shown in the preceding illustration: The sterilizer operates as follows: •
the STERRAD® 100S Sterilizer indicates that sterilization can be started by displaying the “Ready to Use” message on the LCD display.
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the items to be sterilized are placed in the chamber.
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a cassette is inserted (if needed).
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START is pressed.
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the door automatically closes and the sterilization process begins.
The sterilization process is complete in about 54 to 74 minutes depending on your sterilizer/cycle type. The load can then be used immediately or stored according to your facility’s procedures.
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Introduction
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STERRAD® 100S User’s Guide
Chapter 2. For Your Safety
For Your Safety Overview Your safety is of primary concern to ASP. This section provides information on safely using the sterilizer. You must read, understand, and use the information in this chapter before operating the unit. Also, always pay attention to the warnings, cautions, and notes throughout this guide. This information is for your safety and to ensure that you receive the most benefit from the safe operation of your STERRAD® 100S Sterilization System. Only trained, experienced technicians, who are fully acquainted with the unit, should repair or adjust the STERRAD® 100S System.
Personal Safety and First Aid •
STERRAD® 100S User’s Guide
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.
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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.
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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.
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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.
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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.
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For Your Safety
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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.
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WARNING! RISK OF INJURY. Do not insert your hand into the sterilizer when the door is closing.
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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 well‑ventilated environment (a minimum of 10 air exchanges per hour).
Device Safety •
DO NOT ATTEMPT TO STERILIZE ITEMS OR MATERIALS THAT DO NOT COMPLY WITH THE DIRECTIONS SPECIFIED IN THIS GUIDE. In addition, you should read the medical device manufacturer’s instructions, or call your ASP Representative to determine whether an item can be sterilized by the STERRAD® 100S Sterilizer.
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All items must be cleaned and thoroughly dried before loading into the sterilizer. Loads containing moisture may cause cycle cancellation.
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The chapter (Chapter 3) on preparing items to be sterilized contains information about which materials and devices can be processed by the sterilizer.
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For Your Safety
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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 instruments.
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Do not change the power source without checking the electrical phase rotation. Prior to relocating the STERRAD® 100S Sterilizer to a new power source, electrical phase rotation should be checked by a qualified technician. Failure to verify and match phase rotation may cause damage to the sterilizer and voids the warranty.
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Do not leave the sterilizer unplugged or turned off for longer than 24 hours. If the sterilizer must be turned off for longer than 24 hours, call your ASP Service Representative for instructions.
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The STERRAD® 100S Sterilizer should not be used stacked with other equipment.
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Only STERRAD® CYCLESURE® 24 Biological Indicators or STERRAD VELOCITY® Biological Indicator should be used to monitor the sterilization cycle. Should a cancellation occur when one of these biological indicators is in the chamber, it should be discarded and a new biological indicator should be used when re‑starting the cycle. Call your ASP Representative for information on the STERRAD® CYCLESURE® 24 Biological Indicator. Refer to STERRAD VELOCITY® Biological Indicator instructions for use.
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Portable and mobile RF communications equipment can affect medical electrical equipment.
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For Your Safety
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Cassette Handling •
WARNING! HYDROGEN PEROXIDE MAY BE PRESENT. Wear chemical resistant latex, PVC (vinyl), or nitrile gloves at all times when handling cassettes. 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 your local ASP Representative for credit.
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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 face or eyes.
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STERRAD® CASSETTES CONTAIN CONCENTRATED HYDROGEN PEROXIDE, A STRONG OXIDIZER. CONCENTRATED HYDROGEN PEROXIDE IS CORROSIVE TO SKIN, EYES, NOSE, THROAT, LUNGS, AND GASTROINTESTINAL TRACT. Wear chemical resistant latex, PVC (vinyl), or nitrile gloves at all times when handling cassettes. Direct contact with the skin can cause severe irritation. If skin contact occurs, immediately flush with large amounts of water. If symptoms are severe or persist, consult a physician immediately. Direct contact with eyes can cause irreversible tissue damage. If eye contact occurs, immediately flush with large amounts of water and immediately consult a physician. Inhalation of vapor or mist can cause severe irritation of lungs, throat, and nose. If inhalation occurs, move to fresh air and consult a physician immediately. Ingestion can produce corrosion that may be life threatening. If swallowed, immediately drink plenty of water to dilute. Do not induce vomiting. Consult a physician.
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Wear chemical resistant latex, PVC (vinyl), or nitrile gloves at all times when handling cassettes. 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 your ASP Representative for credit.
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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 face or eyes.
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Empty or expired cassettes must be replaced prior to starting the cycle as directed by a message on the sterilizer display. Cassettes with unused hydrogen peroxide are hazardous waste as defined by the US Environmental Protection Agency and should be disposed of accordingly.
Safe Maintenance
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Repairs and adjustments should only be attempted by experienced technicians who are fully trained to maintain and repair the STERRAD® Sterilizer.
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Use of unauthorized parts for maintenance or repair could cause personal injury, result in costly damage or unit malfunction, and void the warranty.
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Do not clean the chamber door area with abrasives. The sterilization chamber uses an O‑ring vacuum seal to maintain a vacuum in the chamber. Never use rough cleaning tools, such as a wire brush or steel wool, on the door housing or chamber assembly. This could damage the O‑ring vacuum seal.
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For Your Safety
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Test Regulations The STERRAD® 100S meets the following test regulations: •
IEC 60601‑1‑2:2007
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EN 60601‑1‑2:2007
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CISPR 11:2009, Group 1, Class A
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EN 55011:2007, Amendment A2:2007, Group 1, Class A
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IEC 61000‑4‑2:2008, EN 61000‑4‑2:1995, Amendment 2, 2001
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IEC 61000‑4‑3:2008, EN 61000‑4‑3:2006, Amendment 1, 2008
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EN 61010‑2‑040:2005
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EN 61010‑1:2001
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UL 61010‑1/R:2008‑10
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CAN/CSA C22.2 No. 61010‑1/R:2009
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CAN/CSA C22.2 No. 61010‑2‑40:2007
Additional Information The information in this chapter is repeated where appropriate throughout this guide for your safety and use. This information is subsequently labeled: WARNINGS, Cautions, or Notes as appropriate. •
WARNINGS are shown in the text in all bold, upper case letters. They indicate events or conditions that can result in serious injury or death.
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Cautions are shown in the text in bold letters, and they indicate events or conditions that can result in damage to equipment.
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Notes are shown in italics. They highlight specific information about the proper use and maintenance of the sterilizer.
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STERRAD® 100S User’s Guide
Chapter 3. Preparing Items To Be Sterilized
Preparing Items To Be Sterilized Overview This chapter briefly describes the materials and devices that can be sterilized by the STERRAD® 100S Sterilizer. It also provides information on how to prepare items for sterilization. STERRAD® 100S Sterilizers can process many of the items you commonly sterilize as well as instruments that are sensitive to heat and moisture. However, there are a few important exceptions. Please review “How to Determine What Can be Sterilized in the STERRAD® 100S Sterilizer” contained in this chapter.
Indications for Use The STERRAD® 100S Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. Because the cycle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture. The sterilizer can sterilize instruments that have diffusion‑restricted spaces, such as the hinged portion of forceps and scissors.
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Preparing Items To Be Sterilized
Devices with Metal lumens (use Short Cycle unless Long Cycle is Specified) Medical devices that have a single stainless steel lumen that has: •
an inside diameter of ≥ 1 mm and a length of ≤ 125 mm,
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an inside diameter of ≥ 2 mm and a length of ≤ 250 mm,
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an inside diameter of ≥ 3 mm and a length of ≤ 400 mm,
can be processed in the STERRAD® 100S Sterilizer without a STERRAD® Booster/Adaptor. Medical devices that have a single stainless steel lumen that has: •
an inside diameter of ≥ 1 mm but < 2 mm and a length > 125 mm and ≤ 500 mm,
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an inside diameter of ≥ 2 mm but < 3 mm and a length > 250 mm and ≤ 500 mm,
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an inside diameter of ≥ 3 mm and a length of > 400 mm and ≤ 500 mm,
must be processed with a STERRAD® Booster/Adaptor in the sterilizer. Medical devices with a lumen made of copper containing alloys, such as Monel, having an inside diameter of ≥ 3 mm, and a length of ≤ 500 mm, must be processed with a STERRAD® Booster/Adaptor in the sterilizer.
Devices with Nonmetal Lumens Reprocessable medical devices that have a polyethylene or Teflon® (PTFE) lumen (medical tubing) having the following dimensions can be processed in the STERRAD® 100S Sterilizer:
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STERRAD® 100S User’s Guide