STERRAD 100NX Sterilization System Users Guide May 2014

STERRAD® 100NX® Sterilization System

User’s Guide

1-888-STERRAD ASP U.S.A. Professional Services ASP International 949-581-5799 Please visit www.aspjj.com For warranty information, please visit our website or contact ASP Professional Services. ASP International Customer Support; call your local ASP Representative

©. 2008-2014 Division of Ethicon. All rights reserved. STERRAD®, CYCLESURE®, SEALSURE®, APTIMAX® and 100NX® are registered trademarks of Advanced Sterilization Products (ASP). 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 ExxonMobil Corporation. Ultem® is a registered trademark of SABIC. da Vinci® is a registered trademark of Intuitive Surgical, Inc. Other products mentioned in this publication are trademarked by 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.A.

State: Released; Released Date: 10/21/2014 5:33:57 PM Eastern Standard Time WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use.

Contents Chapter 1. Introduction... 5 How to Use This Guide... 5 Intended Use... 5 The STERRAD® Sterilization Process... 6 If You Have Questions... 6

Chapter 2. Safety Information... 7 Personal Safety and First Aid... 7 Personal Protective Equipment... 9 Device Safety... 9 Warnings, Cautions, and Notes... 13 Symbols... 14

Chapter 3. Load Preparation... 15 Load Weight Requirements... 15 Cycles and Materials Processing... 18 Recommended Materials... 22 Thermoplastics... 22 Thermoplastic Elastomers... 22 Thermosetting Elastomers... 23 Glass... 23 Metal... 23 Items Not To Be Processed... 23 Do Not Process in the EXPRESS Cycle... 24 Do Not Process in the DUO Cycle... 24 Guidelines for Preparing Items to Be Sterilized... 25 Cleaning, Rinsing, and Drying... 25 Packaging and Loading... 27 Instrument Trays... 27 Tray Mats... 27 Packaging... 27 Loading... 28 Chemical Indicators... 29 Special Considerations for Flexible Endoscopes... 29

State: Released; ® User’s STERRAD® 100NX Guide Released Date: 10/21/2014 5:33:57 PM Eastern Standard Time

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Chapter 4. Operation... 31 Before You Start... 31 Start and Warm-up... 31 Biological Indicators... 31 Login... 32 Entering Load Information... 33 Enter Load Item Data... 33 Cycle Notes... 34 Loading the Chamber... 36 Selecting and Starting a Cycle... 40 System Ready Screen... 41 Inserting a Cassette... 41 Cycle in Progress... 42 Canceling a Cycle... 43 Cycle Completed... 45 Processing a Sterilized Load... 46 Inspecting Chemical Indicators... 46 Processing Biological Indicators... 46

Chapter 5. Troubleshooting... 49 Running Diagnostics... 49 System Message Table... 50 Temperature Messages... 50 Messages Not In This Table... 50 Call Your ASP Representative... 54

Chapter 6. Sterilizer Overview... 55 Sterilizer Cycles... 55 Sterilizer Features... 56 Cassette... 57 Cassette Disposal Box... 58 Touch Screen and Speaker... 58 Chamber... 59 Printer... 60 Touch Screen Data Entry... 61

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Chapter 7. Maintenance... 63 Automatic Maintenance... 63 Automatic Lamp Adjustment... 63 Manual Maintenance... 64 Disposing of Cassettes... 64 Removing a Cassette Disposal Box... 65 Replacing the Printer Paper... 66 Cleaning the Sterilizer Exterior... 69 Cleaning the Hydrogen Peroxide Monitor Detector Lens... 70 PCMCIA Card Handling and Replacement... 71 Data Transfer Using a Memory Stick... 72 Rebooting the System... 73 Sterilizer Disposal... 73

Chapter 8. Reports and Files... 75 Displayed Reports... 75 Cycle History... 75 Printed Reports... 77 Short Report... 77 Parametric Report... 77 Long Report... 77

Chapter 9. Access Levels and Supervisor Tasks... 79 Overview... 79 Access Levels... 79 Additional Utilities Menu... 80 Date and Time Settings... 81 Set Date... 82 Set Time... 82 Time Zone... 82 Date Format... 82 Time Format... 82 Cancel/Done... 82 System Configuration... 83 Access Control Option... 83 IMS... 83 Vacuum Units... 83 Load Data Entry Option... 84 Load Removal Option... 84 Notepad Option... 84 Network Option... 84

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Alarm Volume... 84 Backlight Conservation (Minutes)... 84 Language Selection... 84 Sterilizer Settings... 85 Printer Settings... 86 Transfer Settings... 87 Cancel/Done... 87 User Administration... 88 Add User... 89 Modify User... 90 Upload User Data... 91 Steps to Upload a User Database... 92 Cassette Functions... 93 Dispose Cassette... 94 Peroxide Clearance... 95 Network... 96 Diagnostics... 96 Diagnostic Tests... 97 Service Functions... 97 File Management... 98 Calibration Files... 98 Diagnostic Files... 98 Upload File... 99 Input/Output Doors... 100 Product Options... 100

Appendix A. Sterilizer Specifications... 103 Appendix B. Consumables, Accessories, and Additional Parts... 107

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Introduction

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Chapter 1.

Introduction How to Use This Guide If you are a STERRAD® 100NX® Sterilizer operator, you must read the “Safety Information, “ 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® 100NX® Sterilizer, you should read the entire user’s guide and pay particular attention to the chapter featuring “Access Levels and Supervisor Level Tasks.” This chapter describes tasks and options that are only available through “Supervisor Level” access.

Intended Use The STERRAD® 100NX® Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD® 100NX® Process to inactivate microorganisms on a broad range of medical devices and surgical instruments. When used as directed by the instructions in this user’s guide, the STERRAD® 100NX® Sterilization System will sterilize both metal and nonmetal medical devices at low temperatures. Please review “How to Determine What Can Be Sterilized in the STERRAD® 100NX® Sterilizer” in the “Load Preparation” chapter along with the cycle information to make sure you follow the directions for processing items in each type of cycle.

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Introduction

The STERRAD® Sterilization Process The STERRAD® 100NX® Sterilizer sterilizes medical devices by diffusing hydrogen peroxide vapor into the chamber and then electromagnetiy exciting the hydrogen peroxide molecules into a low-temperature plasma state. The combined use of hydrogen peroxide vapor and plasma safely and rapidly sterilizes medical instruments and materials without leaving toxic residue. All stages of the sterilization cycle operate within a dry environment at a low temperature, and thus the cycle is not damaging to compatible instruments that are sensitive to heat and moisture. The STERRAD® 100NX® Sterilizer can be used for both metal and nonmetal devices, and can also sterilize instruments that have difficult-to-reach (diffusion-restricted) spaces, such as hinges on forceps. Refer to the “Safety Information” chapter for more information on device safety. The sterilizer consistently provides a Sterility Assurance Level (SAL) of 10-6, as defined by U.S. Food and Drug Administration (FDA) and international standards, for clinical use on all allowed substrates within the limits of the claims for materials and geometries when used in accordance with the directions in this user’s guide.

If You Have Questions If you have questions about the STERRAD® 100NX® Sterilizer or questions about which items may be safely sterilized by the STERRAD® Process, please call your local Advanced Sterilization Products (ASP) Representative or visit our website at www.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® 100NX® Sterilizer. You must read and understand the safety information in this chapter before operating the sterilizer. Always pay attention to the warnings, cautions and notes throughout this user’s guide. This information is for your safety and to ensure that you receive the most benefit from the safe operation of your STERRAD® 100NX® Sterilization System.

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

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Safety Information

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 was before re-use. WARNING! RISK OF RESPIRATORY IRRITATION Inhalation of hydrogen peroxide mist can cause severe irritation of lungs, throat, and nose. If inhalation occurs, move to the person to fresh air. If the person is not breathing, call for emergency medical attention, or an ambulance, then give artificial respiration, preferably mouth-to-mouth, if possible. Consult a physician immediately. WARNING! CONCENTRATED HYDROGEN PEROXIDE IS TOXIC Ingestion of hydrogen peroxide may be life-threatening. If swallowed, call a “poison control” center or physician immediately for treatment advice. Have the person drink plenty of water if the person is able to swallow. Do not give anything by mouth to an unconscious person. Do not induce vomiting unless instructed to do so by the poison control center or physician. WARNING! HEATED STERILIZATION SURFACES At the end of a cycle, the interior of the sterilizer may be hot. Do not touch the inside of the chamber or door with your bare or gloved hands. Allow the sterilizer to cool before touching interior surfaces. WARNING! AVOID EXPOSURE TO ULTRAVIOLET LIGHT The hydrogen peroxide monitor uses an ultraviolet light source located inside the chamber behind the door. To avoid eye injury, do not stare directly at the ultraviolet light source for an extended period of time. WARNING! HYDROGEN PEROXIDE MAY BE PRESENT If white residue is visible on the load, this is residue from the hydrogen peroxide stabilizer. Wear chemical resistant latex, PVC (vinyl), or nitrile gloves when removing a load with visible white residue. White residue can be minimized by making sure regular Planned Maintenance procedures are performed on your system. The system will inform you when Planned Maintenance is due. Please schedule your PM service in a timely manner.

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Safety Information

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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 wellventilated environment (a minimum of 10 air exchanges per hour).

Personal Protective Equipment WARNING! HYDROGEN PEROXIDE MAY BE PRESENT Wear chemical resistant latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation. Hydrogen peroxide liquid may be present on the load or in the chamber.

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

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Safety Information

CAUTION: KNOW WHAT YOU CAN PROCESS Before processing any item in the STERRAD® 100NX® Sterilizer, make sure you know how the STERRAD Sterilization Process will affect the item. Read, understand, and follow the medical device manufacturers’ instructions for their products. This guide lists certain types of items and materials that can be safely processed in certain cycle choices. Make sure you understand the parameters of each cycle type before processing your items. This guide is not intended to replace any medical device manufacturers’ instructions. If you have questions, or if you are in doubt about the materials in your devices, contact the medical device manufacturer or your ASP Customer Representative for more information. CAUTION: RISK OF VIOLATION OF WARRANTY Improper processing may limit our liability for damage to processed instruments. Improper processing may also violate your instrument warranty. CAUTION: RISK OF DAMAGE TO LOAD – METAL OBJECTS Metal objects must not come into contact with the chamber walls, the doors, or the electrode. Contact with the walls, doors, or electrode could damage the sterilizer or the metal objects. CAUTION: RISK OF DAMAGE TO LOAD – VENTING CAPS Take special care to confirm that venting caps are placed according to the manufacturers’ instructions. Venting caps are intended to prevent damage to flexible scopes that are being exposed to a vacuum, regardless of the sterilant used. CAUTION: RISK OF DAMAGE TO LOAD – IMMERSION CAPS You must remove the water-resistant immersion cap (if present) prior to processing in the sterilizer. If the immersion cap is not removed prior to processing in the STERRAD® 100NX™ Sterilizer, it will damage the flexible scope due to the inability to properly vent. CAUTION: KNOW WHAT YOU CAN PROCESS – FLEXIBLE ENDOSCOPES Prior to processing flexible endoscopes in the STERRAD® 100NX® Sterilizer, you must read, understand, and follow the medical device manufacturer's instructions for use for the particular scope to be processed. Please contact the medical device manufacturer for more information on what can be processed in the STERRAD® 100NX® Sterilizer. CAUTION: RF COMMUNICATIONS EQUIPMENT Portable and mobile RF communications equipment can affect medical electrical equipment.

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Safety Information

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

Emissions Test

Compliance

Electromagnetic Environment - Guidance

RF emissions CISPR 11

Group 1

The STERRAD® 100NX® Sterilizer uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

The STERRAD® 100NX® Sterilizer is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions

Class A

IEC 61000-3-2 Voltage fluctuations/flicker emissions

Complies

IEC 61000-3-3

System is configured with FCC ID: AXJ100NXRFID or FCC ID: AXJ02532480 System is configured with IC Certification Number: 10207A-100NXRFID or IC Certification Number: 10207A-02532480

WARNING! (PART 15.21) RISK OF NON-COMPLIANCE Changes or modifications not expressly approved by Advanced Sterilization Products could void the user’s authority to operate the equipment. Manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment.

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Safety Information

FCC Rules and Industry Canada (IC) Regulatory Information Compliance Statement (Part 15.19) The equipment device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received including interference that may cause undesired operation. Compliance Statement (Part 15.105(b)) Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Class A digital device notice “CAN ICES-3 (A)/NMB-3(A)” RF Radiation Exposure Statement This equipment complies with the FCC/IC radiation exposure limits set forth for portable transmitting devices operation in a controlled environment. End users must follow the specific operating instructions to satisfy RF exposure compliance. The equipment should only be used where there is normally at least 20cm separation between the antenna and all person/user. This transmitter must not be co-located or operation in conjunction with any other antenna or transmitter. Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment.

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Safety Information

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Warnings, Cautions, and Notes Warnings and cautions are accompanied by symbols surrounded by a triangle or a square and are printed in the text in bold. Warnings indicate events or conditions that can result in serious injury or death. Cautions indicate events or conditions that can result in severe damage to the equipment.  Notes are printed in italics and have a checkmark in front of the word “Note.” Notes highlight specific information about the proper use and maintenance of the sterilizer.

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Safety Information

Symbols Hot surfaces present. Do not touch without protection. Hazardous chemical present. Use personal protective equipment. Corrosive chemical present. Use personal protective equipment.

Oxidizing chemical present. Avoid exposure, contact, or ingestion. Use personal protective equipment. WEEE Symbol

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.

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Load Preparation

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Chapter 3.

Load Preparation The STERRAD® 100NX® Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD® sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to safely sterilize medical instruments and materials without leaving toxic residue. Because the cycle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture. CAUTION: KNOW WHAT YOU CAN PROCESS Before processing items in the sterilizer, make sure you know how the STERRAD® Sterilization Process will affect the item. When constructing your load, the total weight of the load to be sterilized should not exceed the load requirements for the specific cycle. 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 void your instrument warranty.

Load Weight Requirements The weight of the items to be sterilized must conform to the weights used for validating the sterilizer processes. These weights are listed in the following table. The weight of the load depends on the cycle selected and whether one or both shelves are used. Cycle Type STANDARD Cycle DUO Cycle EXPRESS Cycle FLEX Cycle

Weight 9.7 kg (21.4 lbs) total weight 6.0 kg (13.2 lbs) total weight 4.9 kg (10.7 lbs) total weight 9.7 kg (21.4 lbs) total weight

Shelves 1 or 2 shelves 1 or 2 shelves Bottom shelf only 1 or 2 shelves

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Load Preparation

STANDARD Cycle Processing The STERRAD® 100NX® Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical devices with the following materials and dimensions can be processed in the STERRAD® 100NX® Sterilizer STANDARD cycle: 

Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter.† Processing Tubing ASP has validated the processing of non-reusable polyethylene and Teflon® (polytetrafluoroethylene) medical grade tubing with the dimension and cycles listed below. (These tubing claims have not been reviewed by the Food and Drug Administration (FDA) as the FDA does not classify tubing as medical devices.): 

An inside diameter of 1 mm or larger and a length of 1000 mm or shorter can be processed in the STERRAD® 100NX® Sterilizer STANDARD cycle.*

DUO Cycle Processing Medical devices, including many flexible endoscopes with accessory devices such as light cords and cameras with the following material and dimensions can be processed in the STERRAD® 100NX® DUO Cycle. 

Single channel polyethylene and Teflon® (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter.



Cameras.



Accessory light cords.



Flexible endoscopes without lumens.

 Note: Do not include more than 2 flexible endoscopes per load.

†The validation testing for this lumen size was conducted using a maximum of 10 lumens in the USA; 40 lumens for markets outside the USA. Your loads should not exceed the validated maximum number of lumens. *Sterilize without any additional load. Up to 20 pieces of tubing may be sterilized at one time.

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Load Preparation

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EXPRESS Cycle Processing The following types of medical devices can be sterilized in the EXPRESS Cycle: 



General medical devices requiring surface sterilization, or sterilization of mated titanium and stainless steel surfaces. Rigid or semi-rigid endoscopes without lumens; for example da Vinci® endoscopes.

FLEX Cycle Processing Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD® 100NX® Sterilizer FLEX cycle: 



Single channel polyethylene and Teflon® (polytetrafluoroethylene) flexible endoscope with an inside diameter of 1 mm or larger and length of 850 mm or shorter.** Flexible endoscopes without lumens.

 Note: Do Not process more than 2 flexible endoscope per load. Check the medical device manufacturer’s instructions before loading any item into the STERRAD® 100NX® Sterilizer.

**One or two flexible endoscopes can be processed per sterilization cycle. No additional load.

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Load Preparation

Cycles and Materials Processing CAUTION: RISK OF DAMAGE TO LOAD OR STERILIZER. Do not attempt to sterilize items or materials that do not comply with the guidelines specified in this user’s guide. Consult the medical device manufacturer’s instructions or call your ASP Representative to determine if an item can be sterilized by the STERRAD® 100NX® Sterilization System. This chapter includes cycle information regarding recommended items, materials, and some typical devices that can be sterilized in each of the cycles on the STERRAD® 100NX® Sterilizer. Please refer to these pages whenever you need materials information. Check the medical device manufacturer’s instructions before loading any item into the STERRAD® 100NX® Sterilizer. There is a wide variety of materials and devices that can be sterilized in the STERRAD® 100NX® Sterilizer. For more information contact your local ASP Representative or visit our website at www.aspjj.com. Information may also be obtained from the device manufacturer.

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