Johnson & Johnson ASP STERRAD NX User manual

STERRAD®NX™Sterilization
System
User’s Guide

STERRAD®NX™Sterilization System
User’s Guide
REF 99920
1-888-STERRAD
ASP U.S.A. Customer Care Center 949.581.5799
ASP International Customer Support
(Call your local ASP Customer Support Representative)
www.sterrad.com
© 2005 Advanced Sterilization Products. All rights reserved. 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.
08-52293-0-001 LC-10033-601 Rev C

Contents
Contents
Chapter 1. Introduction 7
How to Use This Guide......................................................................................................................7
If You Have Questions.......................................................................................................................7
Chapter 2. Safety Information 9
Personal Safety and First Aid ............................................................................................................9
Personal Protective Equipment ..........................................................................................................10
Device Safety.....................................................................................................................................10
Warnings, Cautions, and Notes..........................................................................................................11
Symbols Used on the Sterilizer and in This Guide ............................................................................11
Chapter 3. Sterilizer Overview 13
Intended Use ......................................................................................................................................13
The STERRAD®NX™Sterilization Process .....................................................................................14
Overview of the STERRAD®NX™Sterilization Cycle.....................................................................15
The STERRAD®NX™Sterilizer and Features ..................................................................................17
Cassette ........................................................................................................................................17
Cassette Drawer ...........................................................................................................................18
Cassette Disposal Box..................................................................................................................18
Touch Screen and Speaker ...........................................................................................................18
Chamber .......................................................................................................................................19
Printer...........................................................................................................................................20
Rear Panel ....................................................................................................................................21
Touch Screen Data Entry .............................................................................................................22
Sterilizer Cart.....................................................................................................................................23
Chapter 4. Load Preparation 25
Indications for Use.............................................................................................................................25
Determining What Can be Sterilized in the STERRAD®NX™ Sterilizer ........................................26
Recommended Materials and Lumen Chart.......................................................................................26
Items Not To Be Processed................................................................................................................27
Guidelines for Preparing Items to Be Sterilized.................................................................................28
Cleaning, Rinsing, and Drying...........................................................................................................28
Packaging and Loading......................................................................................................................29
Instrument Trays ..........................................................................................................................29
Tray Mats .....................................................................................................................................29
Packaging .....................................................................................................................................30
Loading ........................................................................................................................................30
Chemical Indicators .....................................................................................................................31
Chapter 5. Operation 33
Before You Start ................................................................................................................................33
Start and Warm-up.............................................................................................................................33
Inserting a Cassette ............................................................................................................................34
Preparing the Load.............................................................................................................................35
Biological Indicators ....................................................................................................................35
Login..................................................................................................................................................35
Entering Load Information ................................................................................................................37
Enter Load Item Data ...................................................................................................................37
Cycle Notes ..................................................................................................................................38
STERRAD®NX™ User’s Guide 3

Contents
Loading the Chamber........................................................................................................................ 39
Selecting and Starting a Cycle .......................................................................................................... 41
Cycle Warm Up................................................................................................................................. 42
System Ready Screen........................................................................................................................ 42
Cycle in Progress............................................................................................................................... 43
Canceling a Cycle........................................................................................................................ 43
Cycle Completed............................................................................................................................... 44
Processing a Sterilized Load ............................................................................................................. 45
Inspecting Chemical Indicators ................................................................................................... 45
Processing Biological Indicators ................................................................................................. 46
Chapter 6. Access Levels and Supervisor Tasks 49
Overview........................................................................................................................................... 49
Access Levels.................................................................................................................................... 49
Additional Utilities Menu.................................................................................................................. 50
Date and Time Settings ..................................................................................................................... 51
Set Date ....................................................................................................................................... 51
Set Time ...................................................................................................................................... 52
Time Zone ................................................................................................................................... 52
Date Format................................................................................................................................. 52
Time Format ................................................................................................................................ 52
Cancel/Done ................................................................................................................................ 52
Dispose Cassette................................................................................................................................ 52
Service Functions.............................................................................................................................. 52
System Configuration........................................................................................................................ 53
Access Control Option ................................................................................................................ 53
Printout Option ............................................................................................................................ 53
Vacuum Units.............................................................................................................................. 54
Load Data Entry Option .............................................................................................................. 54
Load Removal Option ................................................................................................................. 54
Notepad Option ........................................................................................................................... 54
Network Option........................................................................................................................... 54
Alarm Volume............................................................................................................................. 54
Backlight Conservation ............................................................................................................... 55
Language Selection ..................................................................................................................... 55
Cancel/Done ................................................................................................................................ 55
File Management............................................................................................................................... 56
Calibration Files .......................................................................................................................... 56
Diagnostic Files........................................................................................................................... 56
User Administration .......................................................................................................................... 57
Add User ..................................................................................................................................... 58
Modify User ................................................................................................................................ 59
Upload User Data ........................................................................................................................ 60
Steps to Upload a User Database.................................................................................................61
Diagnostics........................................................................................................................................ 62
Diagnostic Tests .......................................................................................................................... 62
Chapter 7. Reports and Files 63
Displayed Reports ............................................................................................................................. 63
System Summary......................................................................................................................... 63
Cycle History............................................................................................................................... 67
Printed Reports.................................................................................................................................. 68
Short Report ................................................................................................................................ 68
Long Report................................................................................................................................. 69
4 STERRAD®NX™ User’s Guide

Contents
Files....................................................................................................................................................73
Cycle History Files.......................................................................................................................73
Calibration Files...........................................................................................................................74
Diagnostic Files............................................................................................................................77
Chapter 8. Maintenance 79
Automatic Maintenance.....................................................................................................................79
Pressure Zeroing...........................................................................................................................79
Automatic Lamp Adjustment .......................................................................................................80
Manual Maintenance..........................................................................................................................81
Disposing of Cassettes .......................................................................................................................81
Removing a Cassette Disposal Box..............................................................................................81
Inserting a New Cassette Disposal Box .............................................................................................82
Replacing Printer Paper .....................................................................................................................83
Cleaning the Sterilizer Exterior..........................................................................................................86
Cleaning the Hydrogen Peroxide Monitor Detector Lens..................................................................86
Replacing the Air Filter .....................................................................................................................87
PCMCIA Card Handling and Replacement .......................................................................................88
Sterilizer Disposal..............................................................................................................................90
Chapter 9. Troubleshooting 91
System Messages ...............................................................................................................................92
Diagnostic Messages....................................................................................................................94
ASP Customer Care Center ...............................................................................................................101
Appendix A. Warranties and Software License 103
Advanced Sterilization Products Commercial Warranty..............................................................103
Advanced Sterilization Products Service Warranty .....................................................................103
Advanced Sterilization Products Software License......................................................................104
Appendix B. Consumables, Accessories, and Additional Parts 107
Appendix C. STERRAD®NX™Sterilizer Specifications 109
STERRAD®NX™User’s Guide 5

Introduction 1
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.
The chapters on “Maintenance,” “Troubleshooting,” and the Appendices
are designed as references. Keep this user’s guide available so that if a
question arises, you can quickly locate the information you need.
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 our Customer Care Center
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.sterrad.com.
STERRAD®NX™User’s Guide 7

Safety Information 2
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 latex, PVC (vinyl), or nitrile gloves
while removing items from the sterilizer following a cancelled cycle. Following a
cancelled cycle, if items in the load show any visible moisture or liquid,
hydrogen peroxide may be present.
WARNING! HYDROGEN PEROXIDE IS AN OXIDIZER.
Avoid allowing hydrogen peroxide to contact organic materials, including paper,
cotton, wood, or lubricants. Concentrated hydrogen peroxide is a strong oxidizer
and may react with organic materials, causing ignition and fire.
WARNING! RISK OF EYE INJURY.
Direct hydrogen peroxide contact with eyes can cause irreversible tissue damage.
If contact with eyes occurs, immediately flush with large amounts of water.
Consult a physician immediately.
WARNING! RISK OF SKIN INJURY.
Direct hydrogen peroxide 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.
STERRAD®NX™User’s Guide 9

2 Safety Information
WARNING! RISK OF RESPIRATORY IRRITATION.
Inhalation of hydrogen peroxide mist can cause severe irritation of lungs, throat,
and nose. If inhalation occurs, move to fresh air. Consult a physician
immediately.
WARNING! CONCENTRATED HYDROGEN PEROXIDE IS TOXIC.
Ingestion of hydrogen peroxide may be life-threatening. If swallowed, drink
plenty of water immediately to dilute. Do not induce vomiting. Consult a
physician immediately.
WARNING! 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.
CAUTION: 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.
Personal Protective Equipment
CAUTION! HYDROGEN PEROXIDE MAY BE PRESENT.
Wear 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
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.
10 STERRAD®NX™User’s Guide

Safety Information 2
Warnings, Cautions, and Notes
ÌWarnings 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 equipment.
Notes are accompanied a check mark 4and are printed in italics. Notes
highlight specific information about the proper use and maintenance of the
STERRAD®NX Sterilization System.
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.
STERRAD®NX™User’s Guide 11

Sterilizer Overview 3
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 AAMI TIR12).
STERRAD®NX™User’s Guide 13

3 Sterilizer Overview
The STERRAD®NX™Sterilization
Process
As a medical 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.
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.
14 STERRAD®NX™User’s Guide

Sterilizer Overview 3
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
♦ 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: Chapter 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.
STERRAD®NX™User’s Guide 15

3 Sterilizer Overview
Exposure 2
The steps in Exposure 1 are repeated.
The STERRAD®NX Sterilization Cycle
Phase Order Stages
Exposure 1 1
Delivery 1
Vaporization Pumpdown 1
Chamber Pumpdown 1
Transfer 1
Diffusion 1
Plasma Pumpdown 1 / Plasma 1
Vent 1
Exposure 2 2
Delivery 2
Vaporization Pumpdown 2
Chamber Pumpdown 2
Transfer 2
Diffusion 2
Plasma Pumpdown 2 / Plasma 2
Final Vent
16 STERRAD®NX™User’s Guide

Sterilizer Overview 3
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.
Cassette
slot
Cassette
drawer
Touch
screen
Chamber
door
Printer
Main power
switch and
circuit breaker
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.
STERRAD®NX™User’s Guide 17

3 Sterilizer Overview
Figure 2. Inserting a Cassette.
Cassette Drawer
After processing of the cassette, the sterilizer automatically discards it into
the cassette disposal box in the cassette drawer.
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 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
18 STERRAD®NX™User’s Guide

Sterilizer Overview 3
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.
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 Place.
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.
STERRAD®NX™User’s Guide 19

3 Sterilizer Overview
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.
Paper
advance
button
Push to
open the
printer
Printed
report
Main power
switch
Figure 5. STERRAD®NX™Printer, Paper Advance Button and Power Switch Details.
The top button opens the printer for paper replacement. The bottom button
advances the paper when pressed. Note the location of the main power
switch under the printer.
20 STERRAD®NX™User’s Guide