ASP Sterrad 100NX User manual

STERRAD®100NX®Sterilization System
User’s Guide
Ref 99994
M-99994_03
May 2014
DRAFT

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.
DRAFT

STERRAD®100NX®User’s Guide 1
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
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
DRAFT

2STERRAD®100NX®User’s Guide
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
DRAFT

STERRAD®100NX®User’s Guide 3
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
DRAFT

4STERRAD®100NX®User’s Guide
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
DRAFT

Introduction 1
STERRAD®100NX®User’s Guide 5
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.
DRAFT

1 Introduction
6STERRAD®100NX®User’s Guide
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.
DRAFT

Safety Information 2
STERRAD®100NX®User’s Guide 7
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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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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STERRAD®100NX®User’s Guide 9
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).
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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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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STERRAD®100NX®User’s Guide 11
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.
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
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
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12 STERRAD®100NX®User’s Guide
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.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux
appareils radio exempts de licence. L'exploitation est autorisée aux deux
conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2)
l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi,
même si le brouillage est susceptible d'en compromettre le fonctionnement.
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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STERRAD®100NX®User’s Guide 13
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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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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STERRAD®100NX®User’s Guide 15
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 Weight Shelves
STANDARD Cycle 9.7 kg (21.4 lbs) total weight 1 or 2 shelves
DUO Cycle 6.0 kg (13.2 lbs) total weight 1 or 2 shelves
EXPRESS Cycle 4.9 kg (10.7 lbs) total weight Bottom shelf only
FLEX Cycle 9.7 kg (21.4 lbs) total weight 1 or 2 shelves
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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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STERRAD®100NX®User’s Guide 17
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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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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