Johnson & Johnson ASP STERRAD 200 User manual

STERRAD®200 Sterilization System
User’s Guide
REF 99712
99712_01
May 2008

STERRAD®200 Sterilization System
User’s Guide
REF 99712
33 Technology Drive
Irvine, California 92618 USA
1-888-STERRAD
(1-888-783-7723)
949-581-5799
www.sterrad.com
For warranty information, please visit our website or
contact our Customer Care Center.
For additional copies of this guide, please visit www.e-ifu.com
©2008 Advanced Sterilization Products. All rights reserved. STERRAD®is a registered trademark of Advanced Sterilization
Products. Teflon®, Tyvek®and Nylon®are registered trademarks of E.I. du Pont de Nemours and Company. Other products
mentioned in this publication are trademarked by their respective corporations. Reproduction, adaptation or translation of this
publication without prior written permission is prohibited. Printed in the USA.

STERRAD®200 User’s Guide 3
Contents
About This Guide 5
Overview ....................................................................................................................5
Chapter 1. Introduction 7
Overview ....................................................................................................................7
System Details............................................................................................................8
Chapter 2. For Your Safety 11
Overview ....................................................................................................................11
Personal Safety and First Aid.....................................................................................11
Device Safety..............................................................................................................13
Cassette Handling.......................................................................................................14
Safe Maintenance .......................................................................................................15
Additional Information...............................................................................................15
Chapter 3. Preparing Items To Be Sterilized 17
Overview ....................................................................................................................17
Indications for Use ................................................................................................17
How to Determine What Can be Sterilized in the STERRAD®200 System..............19
Items Not Recommended ...........................................................................................20
Cleaning, Rinsing, and Drying...................................................................................21
Guidelines for Wrapping, Packaging, and Loading....................................................23
Chapter 4. Day-to-Day Operation 27
Safe Operation............................................................................................................27
Sterilizer Operation.....................................................................................................27
Display Sequence..................................................................................................29
Using the Displays.................................................................................................30
Preparing the Load......................................................................................................32
Biological Indicators .............................................................................................34
Chemical Indicators...............................................................................................36
Preparing the Two-Tier Shelf................................................................................37
Creating the Load Item Data List..........................................................................38
Transferring the Load into the Sterilizer...............................................................40
Inserting a Cassette................................................................................................42
Starting a Cycle ..........................................................................................................45
Entering a Password..............................................................................................46
Cycle Notes ...........................................................................................................50
Watching a Cycle ..................................................................................................51
Completing a Cycle...............................................................................................53

4 STERRAD®200 User’s Guide
Additional System Information.............................................................................58
Unloading and Handling .......................................................................................58
Cycle Completion Flow Chart...............................................................................61
Cassette Control..........................................................................................................62
Obtaining a Cycle History..........................................................................................63
Administrative Functions............................................................................................66
System Setup.........................................................................................................66
System Configuration Screen................................................................................67
User/Password Administration Screen..................................................................68
Resetting the Date and Time .................................................................................69
Network Settings Screen .......................................................................................71
Chapter 5. Routine Maintenance 73
Overview ....................................................................................................................73
Maintaining the Printer...............................................................................................74
Replacing the Printer Ribbon Cartridge................................................................74
Replacing the Printer Paper...................................................................................75
Cleaning the Sterilizer ................................................................................................76
Chapter 6. Troubleshooting 77
Overview ....................................................................................................................77
Rebooting the System.................................................................................................77
Using the Message Table............................................................................................78
Appendix A. Specifications 81

STERRAD®200 User’s Guide 5
About This Guide
Overview
This guide is designed to provide useful and complete information on the day-to-
day operation and routine maintenance of the STERRAD®200 Sterilizer.
The guide is divided into 6 chapters and 1 appendix. These chapters provide
information on using the sterilizer, load preparation, routine maintenance, and
troubleshooting the system should problems arise. The appendix contains the
system specification.
The chapters and the appendix are:
• About This Guide-this section gives you important information on how to
get the most use out of this guide.
• Chapter 1. Introduction-the first chapter of the guide has important details
about the STERRAD 200 System including the major parts of the sterilizer
and STERRAD Process information.

About This Guide
6 STERRAD®200 User’s Guide
• Chapter 2. For Your Safety-this may be the most important chapter in the
guide. You must read it thoroughly, understand the information, and follow
all the safety procedures in this chapter. These safety procedures include safe
handling of cassettes, safe transfer of sterilized materials using the two-tier
shelf and carriage, and first aid information in case of possible hydrogen
peroxide exposure.
• Chapter 3. Preparing Items To Be Sterilized-this chapter provides details
on preparing items to be sterilized, packaging the load, using the two-tier
shelf and carriage to transfer the load to the sterilizer and a brief description
of the items that can be sterilized in the STERRAD 200 System.
• Chapter 4. Day-to-Day Operation-this chapter gives you detailed
information on how to use the sterilizer. It shows you the typical displays
that you will see as you use the sterilizer and the different screens available
to the operator and administrator level passwords. It details how to use the
touch screens and how to run cycles.
• Chapter 5. Routine Maintenance-the routine maintenance of the
STERRAD 200 Sterilizer is very minimal. This chapter shows you how to
change the printer paper and ribbon and what steps to follow to keep the
sterilizer clean.
• Chapter 6. Troubleshooting-the STERRAD 200 Sterilizer displays a
number of messages to tell you what the system status is at any given
moment. Many of these messages do not require any action from you.
Others require that you call your ASP service representative.
• Appendix A. Specifications-this appendix provides tables detailing the
technical data relevant to the STERRAD 200 Sterilizer. Size, electrical
requirements, equipment rating and an explanation of the warning symbols
used on the sterilizer are some of the information found in this appendix.

STERRAD®200 User’s Guide 7
Chapter 1.
Introduction
Overview
The STERRAD®200 Sterilization System is a general purpose, low temperature
sterilizer using the STERRAD Process to inactivate microorganisms on a broad
range of medical devices and surgical instruments. This sterilizer offers an
effective, safe, fast, economical, easy to use, reliable, and flexible sterilization
method.
The length of all cycle phases and the setpoints for all critical process parameters
are controlled by a microprocessor and software. The system reliably sterilizes
various material and load configurations, without leaving toxic residue.
The system consistently provides 10-6 sterility assurance level, as defined by
international standards, for clinical use on all allowed substrates within the limits
of the claims for materials and geometries.

1Introduction
8 STERRAD®200 User’s Guide
Figure 1. STERRAD®200 Sterilizer input side on a two
door unit, or front side on a one door unit.
System Details
Here are details of the important parts of the STERRAD 200 Sterilizer.
• The items to be sterilized are placed on the two-tier shelf. The two-tier shelf
(see the following diagram) has 1 adjustable, removable shelf and a fixed
bottom shelf. The packed two-tier shelf is easily moved, using the carriage,
into or out of the sterilizer.

Introduction 1
STERRAD®200 User’s Guide 9
Figure 2. STERRAD®200 Two-Tier Shelf and Carriage
• The carriage is used to move the two-tier shelf into position. This carriage is
a wheeled unit that locks onto the front of the machine so that you can easily
transfer a large load into or out of the sterilizer.
• Your system may have one or two doors. If you have a two-door unit, a door
is located on each side of the unit. One side, the input side, is used for
moving wrapped items to be sterilized into the sterilizer. The other side, the
output side, is used to remove the sterile items from the sterilizer. These
sterile items are then usually moved into a sterile storage area. On the one
door unit, the door is used for both input and output.

1Introduction
10 STERRAD®200 User’s Guide
Figure 3. STERRAD®200 Sterilizer–output side on
a two door unit. Note the absence of a cassette slot.
• A touch screen computer display, mounted on the upper right front of the
sterilizer, enables you to operate the sterilizer. There is a touch screen on
each side of the double door unit.
• A printer, located on the upper left front panel of the unit, delivers printed
messages, process parameters, and other information for your permanent
records. There is usually only one printer on the unit regardless of the
number of doors, however other printer options are available. Contact the
ASP Customer Care Center for more details.
• There is an optional barcode scanner available for the sterilizer. The barcode
scanner is used to conveniently enter bar-coded data from product tags,
labels or other items.
• The usable chamber capacity is approximately 150 liters.

STERRAD®200 User’s Guide 11
Chapter 2.
For Your Safety
Overview
Your safety is of primary concern to ASP. This chapter provides information on
safely using the sterilizer. You must read, understand and use the information
in this chapter before operating the unit. Also, always pay attention to the
warnings, cautions and notes throughout this guide. This information is for your
safety and to ensure that you receive the most benefit from the safe operation of
your STERRAD®200 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 when removing items from the sterilizer
following a cancelled cycle or if any moisture is noted on items in the load
following a completed cycle.
♦ WARNING! HYDROGEN PEROXIDE IS AN OXIDIZER
Hydrogen peroxide is a strong oxidizing agent and poses a hazard for fire,
explosion, or container rupture. Avoid allowing hydrogen peroxide to contact
organic materials, including paper, cotton, wood, or lubricants. Do not use or
store near heat or open flame. Shoes, clothing, or other combustible material
that have come into contact with hydrogen peroxide must be immediately
and thoroughly rinsed with water to avoid a potential fire hazard. In case of
fire, use only water to extinguish.

2For Your Safety
12 STERRAD®200 User’s Guide
♦ 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! 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.
♦ WARNING! RISK OF RESPIRATORY IRRITATION
Inhalation of hydrogen peroxide mist can cause severe irritation of lungs,
throat, and nose. If inhalation occurs, move the person to fresh air. If the
person is not breathing, call for emergency medical attention, or an
ambulance, then give artificial respiration, preferably mouth-to-mouth, if
possible. Consult a physician immediately.
♦ 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 wash before re-use.
♦ 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. The
vaporizer may be hot. Do not touch it with your bare or gloved hands. Allow
the sterilizer to cool before touching interior surfaces.

For Your Safety 2
STERRAD®200 User’s Guide 13
♦ WARNING! RISK OF BREATHING DIFFICULTIES
On rare occasions, the outlet filter on the vacuum pump can prematurely fail.
If this occurs, you may see mist or what some users have described as “haze”
or “smoke” in the room where the sterilizer is operating. The chemical
composition of the mist is primarily airborne mineral oil with trace amounts
of other compounds. Oil mist exposure may, theoretically, pose an increased
risk to people with certain respiratory conditions, such as asthma, and they
should take special precautions not to be exposed to the mist. If you observe
these conditions, personnel should leave the room as a precaution and
discontinue use of the STERRAD System until the system is repaired.
Personnel should avoid working in the room until the mist has cleared.
Please note that all STERRAD Sterilizers should be used and installed in a
well-ventilated environment (a minimum of 10 air exchanges per hour).
Device Safety
• DO NOT ATTEMPT TO STERILIZE ITEMS OR MATERIALS THAT
DO NOT COMPLY WITH THE GUIDELINES SPECIFIED IN THIS
GUIDE. In addition, you should read the medical device manufacturer's
instructions, or call the ASP Customer Care Center to determine whether an
item can be sterilized by this unit. Information may also be obtained from the
device manufacturer.
• All items must be cleaned and thoroughly dried before loading into the
sterilizer. Loads containing moisture may cause cycle cancellation.
• The chapter on preparing items to be sterilized contains information about
the materials and devices that can be processed by the STERRAD 200
Sterilizer.
• 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 instruments.
• Do not change the power source without checking the electrical phase
rotation. Prior to relocating the STERRAD 200 Sterilizer to a new power
source, electrical phase rotation should be checked by a qualified technician.
Failure to verify and match phase rotation may cause damage to the sterilizer
and void the warranty.
• If you plan to disconnect and store the sterilizer for any length of time, please
contact your ASP service representative at 1-888-STERRAD (1-888-783-
7723) for instructions.

2For Your Safety
14 STERRAD®200 User’s Guide
• An ASP-approved biological indicator (BI) should be used to monitor the
sterilization cycle. Should a cancellation occur when a biological indicator is
in the chamber, discard the biological indicator and then use a new biological
indicator when re-starting the cycle. Call the ASP Customer Care Center for
information on approved biological indicators.
Cassette Handling
• STERRAD 200 CASSETTES CONTAIN CONCENTRATED
HYDROGEN PEROXIDE, A STRONG OXIDIZER.
CONCENTRATED HYDROGEN PEROXIDE IS CORROSIVE TO
SKIN, EYES, NOSE, THROAT, LUNGS, AND GASTROINTESTINAL
TRACT. Direct contact with the skin can cause severe irritation. If skin
contact occurs, immediately flush with large amounts of water. If symptoms
are severe or persist, consult a physician immediately. Direct contact with
eyes can cause irreversible tissue damage. If eye contact occurs, immediately
flush with large amounts of water and immediately consult a physician.
Inhalation of mist can cause severe irritation of lungs, throat, and nose. If
inhalation occurs, move to fresh air and consult a physician immediately.
Ingestion can produce corrosion that may be life threatening. If swallowed,
drink plenty of water immediately to dilute. Do not induce vomiting. Consult
a physician.
• Do not remove the plastic wrapper from the cassette package if the indicator
strip is red. Red indicates that the cassette might have been damaged. Call the
ASP Customer Care Center for more information.
• Do not remove used cassettes from the protective cardboard sleeve. Dispose
of the cassette inside the protective sleeve according to your facility’s
procedures.
• If it is necessary to handle a used cassette that is not in the cardboard sleeve,
wear chemical resistant latex, PVC (vinyl) or nitrile gloves. Do not touch
your gloved hands to your face or eyes.

For Your Safety 2
STERRAD®200 User’s Guide 15
Safe Maintenance
• WARNING! HYDROGEN PEROXIDE MAY BE PRESENT
If white residue is visible on the load; this may be 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 (PM) procedures
are performed on your sterilizer. The sterilizer will inform you when Planned
Maintenance is due. Please schedule your PM service in a timely manner.
• Repairs and adjustments should only be attempted by experienced
technicians who are fully trained to maintain and repair the STERRAD 200
Sterilizer.
• Use of unauthorized parts for maintenance or repair could cause personal
injury, result in costly damage or unit malfunction, and void the warranty.
• Do not clean the chamber door area with abrasives. The sterilization chamber
uses an O-ring vacuum seal to maintain a vacuum in the chamber. Never use
rough cleaning tools, such as a wire brush or steel wool, on the door housing
or chamber assembly. This could damage the seal.
Additional Information
• The information contained in this chapter is repeated where appropriate
throughout this guide for your safety and use. This information is
subsequently labeled: WARNINGS, Cautions or Notes as appropriate.
• WARNINGS are shown in the text in all bold upper case letters. They
indicate events or conditions that can result in serious injury or death.
• Cautions are shown in the text in bold letters. They indicate events or
conditions that can result in damage to equipment.
• Notes are shown in the text with a check mark . They highlight specific
information about the proper use and maintenance of the STERRAD 200
Sterilizer.

STERRAD®200 User’s Guide 17
Chapter 3.
Preparing Items To Be
Sterilized
Overview
The STERRAD®200 Sterilizer can process many of the items you commonly
sterilize as well as instruments that are sensitive to heat and moisture. However,
there are a few important exceptions. Please review the “How to Determine What
Can be Sterilized in the STERRAD 200 System” foldout page contained in this
chapter. It contains details on recommended materials and lumen sizes.
Indications for Use
The STERRAD 200 Sterilizer is designed for sterilization of both metal and
nonmetal medical devices at low temperatures. Because the cycle operates within
a dry environment and at low temperatures, it is especially suitable for
instruments sensitive to heat and moisture. The sections that follow contain more
information on the types of items and materials that can be sterilized in the
STERRAD 200 Sterilizer.
• The STERRAD 200 Sterilizer can sterilize instruments having diffusion-
restricted spaces, such as the hinged portion of forceps and scissors.
• Teflon®or polyethylene lumened instruments with inside diameters of 6 mm
or larger and lengths of 310 mm or shorter can be processed in the
STERRAD 200 Sterilizer.
• Medical devices with only a single stainless steel lumen with:

3Preparing Items To Be Sterilized
18 STERRAD®200 User’s Guide
» an inside diameter of 1 mm or larger and a length of 125 mm or shorter,*
» an inside diameter of 2 mm or larger and a length of 250 mm or shorter,*
» an inside diameter of 3 mm or larger and a length of 400 mm or shorter.
can be processed in the STERRAD 200 Sterilizer.
*Validation testing for this lumen size was conducted using a maximum of 12
lumens per load. Your loads should not exceed the maximum number of lumens
validated by this testing.
Note: The validation studies for this sterilizer were performed
using the STERRAD cycle consisting of a 6-minute, 45-
second injection phase followed by a 2-minute diffusion
phase, and a 2-minute plasma phase. The validation
studies were performed using a validation load consisting
of four instrument trays, each weighing 9.12 lbs. (the total
weight of the load was 36.48 lbs.).
Note: Determination of true length is based upon actual
instruments identified as intended for reprocessing and
meet all other criteria for processing in the STERRAD 200
Sterilizer.
WARNING! DO NOT ATTEMPT TO STERILIZE ITEMS OR
MATERIALS THAT DO NOT COMPLY WITH THE
GUIDELINES SPECIFIED IN THIS GUIDE. IN
ADDITION, YOU SHOULD READ THE MEDICAL
DEVICE MANUFACTURER’S INSTRUCTIONS, OR
CALL THE ASP CUSTOMER CARE CENTER TO
DETERMINE WHETHER AN ITEM CAN BE
STERILIZED BY THIS UNIT.

Preparing Items To Be Sterilized 3
STERRAD®200 User’s Guide 19
How to Determine What Can be
Sterilized in the STERRAD®200
System
The following page is a chart that unfolds to show you detailed lists of
recommended items, materials, and some typical devices that can be sterilized in
the STERRAD 200 Sterilizer. You should refer to it whenever you need
materials information. Be sure to check with the medical device manufacturer’s
instruction before loading any item into the STERRAD 200 Sterilizer.
♦ Important! Stainless steel, polyethylene, and Teflon®are the only types of
lumens that can be sterilized in the STERRAD 200 Sterilizer.
Note: There are a wide variety of materials and devices that
can be sterilized in the STERRAD 200 Sterilizer. As more
manufacturers complete testing of their products with the
STERRAD 200 Sterilizer, the range of recommended
and/or compatible items grows. ASP maintains updated
information and we are happy to share it with you. Please
contact the ASP Customer Care Center for an up-to-date
list of recommended materials, devices and/or device
manufacturer information. Call 1-888-STERRAD (1-888-
783-7723).

1
More Information
200 mm 250 mm 310 mm 400 mm0mm 125 mm
Measurements are approximate and are for reference only.
How To Determine What Can Be Sterilized In The STERRAD 200 Sterilizer
®
How To Determine What Can Be Sterilized In The STERRAD 200 Sterilizer
®
Is The Reprocessable Medical Device Made Of The Following Materials?**
Does The Reprocessable Medical Device Have A Lumen?
Lumen Lengths
May have limited life after repeated sterilization.
Contact ASP or the device manufacturer to determine the compatibility of any device manufactured from PMMA.
Delrin , Nylon , and Teflon are registered trademarks of the DuPont Corporation.
®® ® ULTEM Polymers is a registered trademark of the GE Company.
®
KRATON™ Polymers is a trademark of KRATON Polymers U.S. L.L.C.
- Aluminum
- Brass
- Delrin acetal resin (polyacetal)
- Ethylvinyl acetate (EVA)
- Glass
®
- KRATON Polymers
- Neoprene
- Non-mated Nylon (polyamide)
- Polycarbonate
- Polyethylene
TM
®
- Polyetherimide (ULTEM Polymers)
- Polymethyl methacrylate (PMMA)
- Polyphenylene sulfone (Radel )
- Polypropylene
- Polystyrene
®
®
Proceed with
Processing.
Yes
Yes
Proceed With Processing If The Lumen Conforms To The Dimensions Listed Below
Is The Lumen Made Of Stainless Steel, Or Teflon ?
®
- Polyurethane
- Polyvinyl chloride (PVC)
- Silicone elastomers
- Stainless steel
- Teflon (polytetrafluoroethylene)
- Titanium
®
No/Don’t
Know
No
No/Don’t
Know
Yes
2
3
4
If the lumens do not conform to these dimensions, please call the device
manufacturer for information on how to properly sterilize these devices.
Lumens not conforming to these dimensions should not be processed in
the STERRAD 200 Sterilizer.
Please call the device manufacturer for
information on how to properly sterilize
this device.
Please call the device manufacturer for
information on how to properly sterilize
this device.
4 mm (0.157 inches)
5 mm (0.196 inches)
6 mm (0.236 inches)
3 mm (0.118 inches)
2 mm (0.078 inches)
1 mm (0.039 inches)
Inside Lumen
Diameters
More Information
* Validation testing for this lumen size was conducted using a maximum of 12 lumens per load.
Your loads should not exceed the maximum number of lumens validated by this testing.
** This list of materials does not apply to trays and containers or other packaging materials. Please refer to the STERRAD 200 User’s Guide for information on appropriate packaging
materials for use in the STERRAD System.
®
Inside Diameter Length
Stainless Steel Lumen
1 mm or larger
2 mm or larger
3 mm or larger
125 mm or shorter*
250 mm or shorter*
400 mm or shorter
Inside Diameter
6 mm or larger
Length
Teflon /Polyethylene Lumens
®
__
310 mm or shorter