ASP sterrad NX User manual

STERRAO® NXTM Sterilization
System
User's Guide
fi'.-fiI ADVANCED STERIUZATION PRODUCTS ®
a ~~ company
Division of Ethicon, Inc .

STERRAD® NXTM Sterilization System
User's Guide
REF 99920
.11.1.1 ADVANCED STERIUZATION PRODUcrS®
a~~company
Division of Ethicon, Inc.
33 Technology Drive, Irvine, CA 92618-9824
Authorized EC Representative
((
Ethicon GmbH
OststraBe 1•D-22844 Norderstedt
0123
CD
~ Irvine, CA 92618
CD 00040 Pomezia, Roma
28042 Campo de las Naciones,
~ 92787 Issy-Ies-Moulineaux Madrid
~ 22844 Norderstedt
~ Ascot, SL5 9EY
~ Johnson &Johnson Mecical Products
@:) 8957 Spreitenbach
~ Markham, ON, L3R OT5
~ 3800 AD Amersfoort
~ ;,;;9:..·":..·.1::..t"·;,;;3:..·":.. t-UtgU
~ '1'101-0065 iltHi:llllfrtB3IRi!§lll'EEl3TI3 5l!\2-s
~ 15125 Maroussi, Athens
CD 1190Wien
~ Rodovia Presidente Dutra, Km 154
G=:> 19184 Sollentuna
~ S.J. Campos-S.P 12240-908
G=:> 1700 Dilbeek
~ 2745-555 Barcarena
~ Na Radosti 399
~ Johnson & Johnson Poland Sp. z 0.0.
~ 155 25 Praha 5 - Zllc[n
~ Szyszkowa 20, 20-285 Warszawa
~ Jakubovo nam. 13
~ Johnson & Johnson Kit.
~ 811 09 Bratislava
~ H-2045 Tbr6kbalint, T6 Park
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.
08-52293-0-00I
LC-I 0033-60I Rev C

Contents
Personal Safety and First Aid ............................................................................................................9
Personal Protective Equipment..........................................................................................................10
Device Cautions, and Notes..........................................................................................................
11
~vlmh"h: Used on the Sterilizer and in This Guide ............................................................................ 11
Intended Use ...................................................................................................................................... 13
The STERRAD@ NX™ Sterilization Process ..................................................................................... 14
Overview of the STERRAD@ Sterilization Cycle..................................................................... 15
The STERRAD® NX"" Sterilizer and Features..................................................................................17
Cassette ........................................................................................................................................17
Cassette Drawer ...........................................................................................................................
18
Cassette Disposal Box..................................................................................................................18
Touch Screen and 18
Chamber.......................................................................................................................................19
Printer...........................................................................................................................................20
Rear Panel....................................................................................................................................
21
Touch Screen Data Entry .............................................................................................................22
Sterilizer Cart.....................................................................................................................................23
Indications for Use.............................................................................................................................25
Items
Not To Be Processed
Cleaning, Rinsing, and
Determilrling What
Can be Sterilized in the NXTM Sterilizer........................................26
Recommended Materials and Lumen Chart.......................................................................................26
Guidelines for Preparing Items to Be Sterilized.................................................................................28
Pa(~k:agil1lg and LU<lUll.'1-S
Instrument Trays
Mats
Loading
Chemical Indicators .....................................................................................................................
31
NXTM User's Guide 3

42
Contents
Loading the Chamber........................................................................................................................ 39
"''''''',C11I15 and .......................................................................................................... 41
rrclce!;sm:g a Sterilized Load ............................................................................................................. 45
Inspecting Chemical Indicators ................................................................................................... 45
t'rclce~;slrlg jJ"VIVt<I""'. Indicators ................................................................................................. 46
Overview........................................................................................................................................... 49
Access Levels.................................................................................................................................... 49
Additional Utilities Menu.................................................................................................................. 50
Date and Time Settings.....................................................................................................................
51
Set Date ....................................................................................................................................... 51
SetTime ...................................................................................................................................... 52
Time Zone................................................................................................................................... 52
Date Format................................................................................................................................. 52
Time Format................................................................................................................................ 52
CancellDone................................................................................................................................ 52
U'1~.VV"'" Cassette................................................................................................................................ 52
Service Functions.............................................................................................................................. 52
System
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
CancellDone................................................................................................................................ 55
A~ ~
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
62
Diagnostic Tests .......................................................................................................................... 62
"'Plr\C1rt<: ............................................................................................................................. 63
63
67
Printed Reports.................................................................................................................................. 68
Short Report ................................................................................................................................ 68
69
STERRADil!> NXTM User's Guide4

Contents
Files.................................................................................................................................................... 73
Files.......................................................................................................................73
Calibration Files...........................................................................................................................74
UI,lgnOS~IC Files.................:..........................................................................................................77
Automatic Maintenance.....................................................................................................................79
Pressure
PCMCIA Card Handling and Kel)la(:errlent
Automatic Adjustment.......................................................................................................80
Manual Maintenance..........................................................................................................................
81
Disposing of Cassettes....................................................................................................................... 81
Removing a Cassette Disposal Box.............................................................................................. 81
Inserting a New Cassette Disposal Box .............................................................................................82
Replacing Printer .....................................................................................................................
83
~,,~ .... .., the Sterilizer Exterior..........................................................................................................86
Cleaning the Hydrogen Peroxide Monitor Detector Lens..................................................................86
n.'-'I' .• a·,-,UJ';<' the Air Filter .....................................................................................................................87
Sterilizer Disposal ..............................................................................................................................90
System ...............................................................................................................................92
Diagnostic Messages
ASP Customer Care Center ...............................................................................................................
101
Advanced Sterilization Products Commercial 103
Advanced Sterilization Products Service Warranty .....................................................................103
Advanced Sterilization Products Software License......................................................................104
STERRAO@NX'" User's Guide 5

1Introduction
Chapter 1.
Introduction
How to Use This Guide
If you are a STERRAD®
""'>1"""", Infonnation" the " "Load Preparation,"
"Operation" chapters prior to operating the This "Introduction"
explains the features and parts
of the sterilizer. "Load Preparation" explains
how to prepare and instruments for "Operation"
explains how to operate and obtain results.
If you are a supervisor 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." chapter
describes 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 you can quickly the infonnation you
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 call our Customer Care Center
at 1-888-STERRAD
(1 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
Chapter 2.
I r
ti
Your is of primary concern to Advanced Products
(ASP). This chapter information on safely using the
STERRAD®
NXTN You must read and understand the safety
information in this
chapter before operating tbe sterilizer. Always pay
attention to the warnings, cautions and notes throughout this User's
This information
is for your safety and to ensure that you receive the most
benefit from the safe
of your STERRAD NX Sterilization
Personal and First id
WARNING! HYDROGEN
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 items from the following a cycle. Following a
"''''''-''''1''U cycle, if 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 Concentrated is a oxidizer
and may react with causing ignition and fire.
WARNING! RISK OF EYE INJURY.
Direct hydrogen contact with eyes can cause irreversible tissue .... '''''''''5.'-'.
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.
Ifskin contact occurs, immediately flush with amounts
of water.
If symptoms are severe or consult a immediately.
STERRAD~ NX'" User's Guide 9

2 Safety Information
WARNING! RISK OF RESPIRATORY IRRITATION.
Inhalation of peroxide mist can cause severe irritation of
inhalation occurs, move to fresh air. Consult a physician
WARNING! CONCENTRATED HYDROGEN PEROXIDE IS TOXIC.
of hydrogen peroxide may be life-threatening. If swallowed, drink
of water immediately to dilute. Do not induce vomiting. Consult a
physician immediately.
WARNING! STERILIZATION SURFACES.
At the end of a the of the may be hot. Do not touch the
of the chamber or door with your bare or gloved Allow
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 source an extended period
Personal Protective Equipment
CAUTION! HYDROGEN PEROXIDE MAY BE PRESENT.
Wear latex, PVC whenever handling a load after a
cancellation. liquid may be present on the load
or in the
chamber.
Device Safety
CAUTION: RISK OF DAMAGE LOAD.
Metal objects must not come into contact with the chamber walls, the door, or the
electrode. Contact with the walls, or electrode the sterilizer
or
the metal objects.
NX"" User's Guide
10

Safety Information 2
Warnings, Cautions, and Notes
6 Warnings and cautions are accompanied
by symbols surrounded by a triangle and
are printed in the text
in boldface italics. Warnings indicate events or conditions
that can result
in serious injury or death. Cautions indicate events or conditions
that can result
in severe damage to the 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.
On/Off.
1/0
Alternating current.
'\;
STERRAO
iIP
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 TIRI2).
STERRAO@ NX'" User's Guide 13

3 Sterilizer Overview
The STERRAD® NXTM 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 defmed
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.
STERRAD® NX'" User's Guide14

SterilizerOverview
verview of the E
erilization C Ie
The STERRAD NX Sterilization Cycle consists of two Exposure 1
and Exposure 2. The following information provides a briefdescription for
each
of the steps.
Exposure 1
• Delivery 1: The hydrogen peroxide is transferred from the cassette into
the
• Vaporization Pumpdown
1: The pressure within the chamber and
vaporizer! condenser is reduced. Water
is removed from the hydrogen
solution, leaving behind a concentrated peroxide
solution in the condenser.
• Chamber Pumpdown
1: The is isolated the
The chamber pressure
is reduced to remove air
from the lumens.
• Transfer
1: The concentrated is transferred
to the chamber where it penetrates throughout the load.
• Diffusion
1: Chapter pressure is increased order to drive h."i1"r..rY<,n
is through the load packaging onto the surfaces of the devices
and into the lumens
of the load.
• 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.
STERRAO@ NX'" User's Guide
15

SterilizerOverview
Exposure 2
The steps in Exposure 1 are repeated.
The STERRAO@ NX Sterilization Cycle
Phase Order
Exposure I
Exposure 2 2
Stages
Delivery 1 Pumpdown I
Transfer 1
Diffusion 1
Plasma Pumpdown I / Plasma I
Vent I
Delivery 2
Vaporization Pumpdown 2
Chamber Pumpdown 2
2
Diffusion 2
. Plasma Pumpdown 2 / Plasma 2
Final Vent
NX'" User's Guide
16

Sterilizer Overview 3
The STERRAO® NXTM Sterilizer and
Features
I Cassette
slot .
Cassette
drawer
Cassette
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.
l
----t-, ------11 Touch 1
screen
Chamber
----i door
0 ...
Main power
-a.- ..... .,.....r-----1 switch and
circuit breaker
Figure l. The STERRAD<il NX~ Sterilizer.
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
STERRAD® NX'" User's Guide18

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
often 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.
STE'
u . ........ ,
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<B> NX no User's Guide 19

3 SterilizerOverview
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.
Push to
open the
printer
Paper
advance
button
Printed
report
Main power
switch
Figure 5. STERRAD® NX'" Printer , Paper Advance Button and Power Switcb 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.
STERRAD~ NX no User's Guide
20

SterilizerOverview 3
Rear Panel
Option
connector
Network
connector
Figure 6. Rear Panel.
Power cord
secured in
the inlet by
retainer
RJ-45
,.,.- - ---i socket
Network
cable
Figure 7. Connection Panel Located on the Lower Rear ofthe Sterilizer.
STERRAO@NX'" User's Guide
21

3 Sterilizer Overview
Touch Screen Data Entry
The following figure shows a typical data entry screen. The typewriter
"keys" input the indicated character each time a key is touched. You can
touch the screen with yourfinger or with a stylus to move the cursor from
place to place.
MM/DD/YY
Enter Load Item Data HH:MM:SS
ITEM # TRACKING NUMBER
I .p
0
Enter I Done
ltems I
~ 1 ~ I ~ l ! I ~ I; I*I ~ I ~ I ~ l : I:,
y
Q W E R T U I 0 P
BACKSP
-:
A S D F G H J K L
< >
CAP LOCK
Z X C V B N M ENTER
( ) I ?
..
BACKSP ALT ,
ALT
[ 1 /
Figure 8. Example ofan Information Entry Screen.
Most screens provide function buttons that display other screens or select
sterilizer functions. Common function buttons are shown in the following
table.
Function Buttons
Button Function
Done. Touch this button to indicate that you are finished
using the screen.
Back. Touch this button to return to a prior screen.
View. Touch this button to view the selected report or
file.
Print. Touch this button to print the selected report or
file.
Cancel. Touch this button to cancel the entry you just
made.
STERRAD~ NX'" User's Guide 22

SterilizerOverview 3
Sterilizer Cart
is an optional accessory that may be used to hold the
Sterilizer. The following figure shows the sterilizer
placed upon the cart.
Push sterilizer
on cart here
Push sterilizer
lower rear corner)
on cart here. --~:---..lllo.
Pull cart here
(shelf)
9. Sterilizer Cart
The casters may be locked and unlocked by pressing on caster levers. In
order for the cart to have maximum stability, the casters should be oriented
in the position as shown in the above.
The may be pulledand
pushed as shown in the figure above. DO
NOT push or pull the as this
is the least stable
orientation. DO NOT move the the door open. DO NOT use
the door handle to move the sterilizer.
The next
"Ha~''''l
how to use STERRAD NX Sterilizer to
sterilize your items.
STERRAD<!J) NX'" User's Guide 23