STERRAD 100 Sterilization System Service Guide Rev D

 1997 Advanced Sterilization Products Services, Inc. All rights reserved ALLIANCESM Service Program is a registered service mark of Advanced Sterilization Products Services, Inc. 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.

CONTENTS CHAPTER 1. About the Service Guide Introduction... 1-2 What's New in this Guide?... 1-2 New for REV D!... 1-2 Revision C Information... 1-3 REV A/B Information... 1-3 What's New Table?... 1-4

CHAPTER 2. System Operation Introduction... 2-2 Theory of Operation-Overview... 2-2 Routine Maintenance

... 2-3

Canceled Cycles... 2-10 Alarm Limits By Parameter... 2-11 Software Overview... 2-13 User Interface and Operator Controls... 2-16 Functional Subsystems... 2-16 Additional Documentation... 2-17

STERRAD 100 S Theory of Operation... 2-18 Introduction... 2-18 Phase 1 - Vacuum Preconditioning... 2-18 Phase 2 - Sterilization A... 2-19 Phase 3 - Sterilization B... 2-20 Phase 4 - Venting... 2-21 STERRAD 100 S Process Times... 2-21

CHAPTER 3. System Messages Introduction... 3-2 Using System Messages... 3-2

CHAPTER 4. Vacuum Subsystem Introduction... 4-2 Different Subsystem Configurations... 4-2 Theory of Operation... 4-3 Vacuum Pump... 4-3 Exhaust Filter... 4-4 Oil Return Valve... 4-4

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Throttle Valve... 4-4 Pump Intake Filter... 4-4 HEPA Filter... 4-4 Vent Valve... 4-5 Pressure Switch... 4-5 Capacitance Manometer... 4-5

Vacuum Subsystem Calibration... 4-5 Adjusting The Vacuum Switch... 4-6 Vacuum Switch Test- Block 2... 4-6 Adjustments and Settings... 4-7 Vacuum Pump Ballast Valve Adjustments... 4-7

Removal/Replacement Procedures... 4-8 Pre-Removal Procedures... 4-8 Remove the Bellows

... 4-8

Remove the Throttle Valve... 4-8 Remove the Vacuum Switch

... 4-8

Remove the Vent Valve... 4-10 Remove the HEPA Filter... 4-10 Remove the Intake Filter... 4-10 Remove the Exhaust Filter... 4-10 Remove the AC Connection

... 4-10

Remove the Drain Valve... 4-10 Remove the Oil Return Valve... 4-11 Remove the Pump... 4-11 Replacement Set-Up... 4-11 Attaching the Pump... 4-13 Replace the HEPA filter... 4-13 Replace the Intake Filter... 4-13 Replace the Throttle Valve... 4-13 Replace the Bellows... 4-14 Replace the Vacuum Switch

... 4-14

Replace the Vent Valve... 4-14 Replace the Exhaust Filter... 4-14 Replace the Oil Return Valve... 4-14 Attaching the Power Cables... 4-14

CHAPTER 5. Injection Subsystem Introduction... 5-2 Different Injection Subsystem Configurations... 5-2 Theory of Operation-Injection Subsystem... 5-2 Cassettes... 5-3 Error Handling... 5-4

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Power Failure... 5-4

Injection Subsystem Calibration... 5-4 Injector Valve Height... 5-4 Injector Valve Height-Block 2

... 5-5

Injector Pump Valve Adjustment

... 5-5

Cassette Optics... 5-6 Injector Pump Floating Guide Adjustment... 5-7 Injector Pump Pneumatics... 5-8

Injection Subsystem Removal/Replacement... 5-9 Pre-Removal Procedures... 5-9 Remove the Injector Pump... 5-9 Replace the Injector Pump

... 5-9

Remove the Injector Valve... 5-11 Block 2 Injector Valve/Vaporizer Removal... 5-12 Replace the Injector Valve

... 5-12

CHAPTER 6. User Interface and Control Subsystems Introduction... 6-2 Different User Subsystem Configurations... 6-2 Different Controller Configurations... 6-2 Theory of Operation... 6-3 User Interface Subsystem... 6-4 Controller Operation... 6-7

User Interface Calibration... 6-10 Setting the Printer DIP Switches

... 6-11

Setting the Audible Alarm... 6-12 Setting the LCD Contrast... 6-12 Setting System Parameters... 6-12 Setting the System Clock... 6-16 Setting the System Serial Number and Total Machine Cycles . 6-17 Master Reset... 6-18

Controller Calibration... 6-19 Power Supply Adjustment... 6-19 Analog To Digital (Set Point)... 6-21 High/Low Pressure Range Divider Voltage... 6-22

User Subsystem Replacement Procedures... 6-22 Remove/Replace the Printer... 6-22 Remove/Replace the Printer (Block 2)... 6-23 Remove/Replace the Membrane Switch... 6-23

Control Subsystem Replacement... 6-24

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Remove the Control Enclosure

... 6-24

Replace the Control Enclosure

... 6-25

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Remove the Power Supplies... 6-25 Replace the Power Supplies... 6-25 Remove/Replace the Firmware... 6-26

CHAPTER 7. Door and Chamber Subsystem Contents... 7-1

Introduction... 7-2 Different Door and Chamber Configurations... 7-2 Door and Chamber Subsystem Descriptions... 7-2

Door and Chamber Theory of Operation... 7-3 Chamber Subsystem... 7-3 Door Subsystem... 7-3

Calibration... 7-4 Door and Chamber Temperature... 7-4 Door Top, Bottom, And Over Center Sensors... 7-6 Door Open Close Speed... 7-6 Door and Chamber Alignment... 7-7

Removal/Replacement... 7-13 Open The Door For Servicing... 7-13 Remove the Electrode and Spacers... 7-13 Replace the Electrode and Spacers... 7-14 Remove/Replace the Door... 7-15 Chamber Heaters Removal/Replacement... 7-18 Remove/Replace the Feedthrough... 7-23 Remove the Sight Glass

... 7-27

Replace the Sight Glass

... 7-27

CHAPTER 8. Pneumatic Subsystem Introduction... 8-2 Different Pneumatic Configurations... 8-2 Pneumatic Subsystem Description... 8-2

Pneumatic Theory of Operation... 8-2 Pneumatics Calibration... 8-3 Pneumatics Pressure Switch... 8-3

Pneumatics Removal/Replacement Procedures

... 8-5

CHAPTER 9. AC Subsystem Introduction... 9-2 Different AC Configurations... 9-2

AC Subsystem Theory of Operation... 9-2 AC Calibration... 9-2 AC Removal/Replacement... 9-3

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Remove the AC Enclosure... 9-4 Replace the AC Enclosure... 9-5 Remove the Solid State Relay Board... 9-5 Replace the Solid State Relay Board... 9-5

CHAPTER 10. Radio Frequency (RF) Subsystem Introduction... 10-2 Different RF Configurations... 10-2 RF Theory of Operation... 10-2 RF Calibration... 10-4 RF Removal/Replacement... 10-4 Remove the RF Enclosure

... 10-4

Remove the RF Match... 10-4

CHAPTER 11. System Installation Introduction... 11-2 Pre-Installation... 11-2 Uncrating the System... 11-3 Power Connection... 11-8

Installing the Seismic Restraints... 11-9 Pre-Installation Procedure-To Be Done by the Customer . . . 11-9 Installing the Subframe... 11-10 Installing the Brackets... 11-11

Preparing The System For Use... 11-12 Phase Rotation... 11-12 Initialization... 11-13 Master Resets... 11-13 Cassette Collector Box... 11-14 Date and Time

... 11-14

PM Log... 11-15 System Acceptance... 11-15

International System Configurations... 11-16 Attach Machine Label... 11-16 Thermal Overload Relay... 11-17 Power Plug... 11-18 Control Panel Bezel... 11-18 Software Installation

... 11-18

System Reset... 11-19 Verify Voltages... 11-19

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Install Printer Ribbon and Paper... 11-21 Replace the Panels... 11-21 Perform BI Validation... 11-21 Final Procedures... 11-21

CHAPTER 12. Planned Maintenance Introduction... 12-2 Maintenance Schedule... 12-2 Level 1 Planned Maintenance... 12-4 Seismic Restraint Inspection... 12-4 Clean the Vaporizer Plate and Vaporizer... 12-4 Replace Vacuum Pump Oil... 12-4 Drain the Air Storage Tank... 12-5 Drain the Pressure Regulator Moisture Trap... 12-5 Drain the Exhaust Filter... 12-6 Replace the Vacuum Pump Oil Filter... 12-6 Clean Air Filters/Panel Assemblies... 12-6 Vacuum Pump Flush... 12-7 Update the Maintenance Log... 12-8

Level 2 Planned Maintenance... 12-9 Replace Exhaust Filters... 12-9 Replace the Catalytic Converter... 12-10 Replace Pump Intake Filter... 12-11 Replace the HEPA Filter... 12-11 Door and Chamber Procedures... 12-12 Clean Platen Surface... 12-12 Update the Maintenance Log... 12-13

CHAPTER 13. Product Certification Introduction... 13-2 Certification Procedures... 13-4 System Preparation... 13-4 Compressor Pressure Switch Test... 13-5 Power Supplies Test... 13-5 Analog to Digital Set Point Test... 13-6 High-Low Pressure Range Divider Voltage Verification... 13-7 Baratron Zero Test... 13-7 Injector Pump Floating Guide Check... 13-9 Cassette Optics Test

... 13-9

RF Power Test... 13-9 Leak Back Test... 13-10

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Master Reset... 13-10 Heater Voltages and Temperatures... 13-10 Temperature Continuity Check... 13-11 Vaporizer Heater Voltage... 13-11 Door Temperature

... 13-11

Chamber Temperature... 13-11

Appendix A. Technical Data Appendix B. AutoTest Introduction... B-2 Overview... B-2 User Interface Tests... B-3 Sensor Tests

... B-8

Injection and Pneumatics Tests... B-14 Throttle Valve/Heater Menus... B-22 Door Test... B-27 Analog Test... B-29 Vacuum Subsystem Tests... B-33 Cassette Adjustments... B-39 Printer Test... B-42

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Chapter

1

About the Service Guide Contents Introduction... 1-2 What’s New in this Guide?... 1-2 NEW FOR REV D!

... 1-2

Revision C Information... 1-3 REV A/B Information... 1-3 What’s New Table... 1-4

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About the Service Guide

Introduction

Introduction This service guide is designed to provide you with complete information needed to service the STERRAD® 100 Sterilizer and the STERRAD 100 S Sterilizer. The System Messages section may be the most valuable section for you. It contains all the messages generated by the system (more or less in alphabetical order). Also in the system messages section are system problems that do not always generate a message. Be sure to check those out too, when troubleshooting a system. The Subsystem section contains the information about all the identified subsystems within the STERRAD system. Each subsystem section contains the theory of operation for that subsystem, calibration procedures, removal and replacement. The STERRAD icon next to a paragraph, like this one, indicates that the information is related to a configuration other than Block 1.8 (usually Block 2)

What’s New in this Guide? NEW FOR REV D! 4 The on-line version contains VIDEO clips. The service guide can be

run from a CDROM. The video clips are available for viewing by just clicking on the video tape icon. The videos have sound (you need a sound card) and can be replayed as many times as you wish. The video clips are located in the PM section and in the removal/replacement sections for the door and feedthrough.

4 The parts lists have been eliminated. The STERRAD Sterilization

Systems Parts Book contains all the parts available for the STERRAD 50, 100 and 100 S Systems. STERRAD 100 SI GMP Sterilizer parts are contained in a separate Parts Book addendum.

4 The PMs are now designated as Level 1 (750 cycles) and Level 2 (1500 cycles).

4 Extensive upgrades and configurations, including the international

system configurations have been added to the manual as a separate section.

4 A separate troubleshooting section has been added. This “tree” steps you through a series of procedures to help you troubleshoot various system problems, particularly with the RF subsystem, before swapping out expensive parts.

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What’s New in this Guide?

About the Service Guide

4 As of this publication, there is a plan to replace the current exhaust filter with a catalytic converter. Replacement procedures for this converter are similar to those now given for the exhaust filter. The PM video clips show a prototype of this converter.

4 The schematics are viewable on-oine using an Adobe Acrobat Reader. This reader is available from ASP and is also downloadable from the ASP Bulletin Board Service and at various locations on the Internet.

Revision C Information STERRAD 100 S Sterilizer information is included. When servicing a STERRAD 100 S Sterilizer you should perform all procedures according to the model type (Block 1.8 or Block 2.) If the servicing procedure is different because of the STERRAD 100 S Software, this is noted in the text and you should be certain you are performing the correct procedure for a STERRAD 100 S System. A number of minor errors in the text have been corrected in this revision. These errors were noted and the correct information previously sent in several service and technical bulletins. The new SMC switch settings are included and the correct test is provided for the Baratron Zero Shift Test All references to the Service Test PCB have been removed. You are now directed to use AutoTest where applicable.

REV A/B Information The STERRAD 100 Sterilization System is constantly being upgraded to provide better operation and to make field maintenance easier. Because of this, a number of new parts and procedures now exist for the STERRAD 100 that are known as Block 2. This guide features those Block 2 changes, as well as other configuration differences. Unless indicated in the notes, the differences are those parts and procedures that have changed from Block 1.8 to Block 2. Some procedures you have performed in the past are eliminated in Block 2. It is important to note that the installation chapter features Block 2 installation information with the exception of the installation of the seismic restraint information.

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About the Service Guide

What’s New in this Guide?

What’s New Table The What’s New Table features brief descriptions of various changes to the STERRAD 100 sterilizer that make up Block 2 and information on STERRAD 100 S differences. Where Block 2 components and procedures changed from Block 1.8 or where information on older components is presented, these are noted in the table and detailed in various sections in the guide. Also, information that has changed or been added after the previous manuals (rev A and B) was published is noted in the table.

Section

Differences

Notes

General Information

Service Test Board is no longer used and all references to it have been removed.

Change from rev B

NEW!

Cycle designation changed from Scope/No Scope to Long Cycle and Short Cycle respectively.

.

STERRAD 100 S Sterilizer information added including theory test parameter changes and parts information. System Messages have been updated to reflect changes in software. “Call Customer Service” has been replaced with “Call Technical Service.” Vacuum Subsystem

Change from rev C

Vacuum pump switch has a new type of setting procedure. Oil return valve is now part of the vacuum system. Ballast valve lever is located on top center of the D16A vacuum pumps.

D16A pumps are no longer supplied. However there are many still in use in older machines.

SMC switch has new settings.

Change from rev B

If a STERRAD 100 System is being upgraded to use the STERRAD 100 S Software and it has a D16A pump, the pump must be upgraded with an oil return system.

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About the Service Guide

Section

Differences

Injection Subsystem

Injector valve height calibration has a new procedure.

Notes

Injector pump valve can now be adjusted. All Block 1.8 systems require an upgraded injection system to support the STERRAD 100 S Software. Some Block 1.8 systems have the upgraded injection system regardless of the type of software used. Door and chamber subsystems

Door and chamber thermocouples are in a different location and are tested in a different manner.

NEW!

Removal and replacement of the door and feedthrough are augmented in the on-line guide with video clips.

Change from rev C

Guide rail alignments have changed. Door open/close speed setting have a new procedure. The door solenoid features a safety lock.

Change from rev C

Controller Subsystem Pin connectors on control panel are different and in different locations. Analog to digital set point test points are in a different location. Analog to digital set point test point are in a different location. Microprocessor PCB is different All STERRAD 100 S Systems have a Z180 CPU. AC subsystem

AC circuit breakers are on the exterior of the system in Block 2.

User Interface

The Block 2 membrane switch has different removal procedure.

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About the Service Guide

Section

What’s New in this Guide?

Differences

Notes

User software available in more language choices. STERRAD 100 S software substantially changes system operation due to change in injection and cycle time.

Change from rev C

If a Block 1.8 system is upgraded to use the STERRAD 100 S Software, he membrane switch must be changed to accommodate the software and language differences. Installation

The entire chapter presents procedures for Block 2 devices only.

Contact ASPS if you have occasion to install a Block 1.8 device.

Seismic restraint installation for both Block 1.8 and Block 2 are presented.

Change from rev A Service Guide.

A drilling template is included in the seismic installation kit. This template is provided for the customer to aid in the accurate placement of the restraint hardware. Planned Maintenance

PM procedures are augmented in the on-line guide with video clips.

NEW!

Planned Maintenance is now designated as PM Leve 1 and PM Level 2

NEW!

Two kits are now available for PMs. PM1 (750 cycles) and PM2 (1500 cycles).

Change from rev C

Change from rev C

An air filter is now on the rear panel. D16A pump has a different procedure for draining/replacing the pump oil and filter and a different fill indicator.

D16A pumps are no longer supplied. However there are many still in use in older machines.

Exhaust filter oil is not drained on Block 2 devices NEW!

1-6

A vaporizer plate is now attached to the electrode. It is easily removed for cleaning.

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What’s New in this Guide?

About the Service Guide

Section

Differences

Notes

The paper ribbon and cassette collection box are no longer part of the PM procedures. These are now customer maintenance items only. Product Certification

Analog to digital set point test has new test points and trim pot adjustments. Door and chamber temperature checks have different test points different trim pot adjustments and a different verification procedure. Baratron Zero Shift test added to certify capacitance manometer. Error in text corrected.

Change from rev A Service Guide. Error correction to rev B.

Technical Data

User interface has a multi-language control panel that is interchangeable.

More languages are available for the control panel and software. Change from rev A Service Guide.

Parts List

This section has been eliminated. Parts are now contained in the STERRAD System Parts Book.

AutoTest

Autotest procedures updated and corrected.

Change from rev A Service Guide.

SMC switch settings updated per manufacturer’s recommendation.

Change from rev B Service Guide

A Publication Change Request form is available for your use. Please fax or mail it back with your suggestions, comments and correction. If you wish, using the form as a guide, email your information. The email address is: [email protected]. Be sure to enclose your full name, location phone number and fax number.

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Chapter

2

System Operation Contents Introduction... 2-2 Theory of Operation-Overview... 2-2 Routine Maintenance... 2-3 Canceled Cycles... 2-10 Alarm Limits By Parameter... 2-11 Software Overview... 2-13 User Interface and Operator Controls... 2-16 Functional Subsystems... 2-16 Additional Documentation... 2-17 STERRAD 100 S Theory of Operation... 2-18 Phase 1 - Vacuum Preconditioning... 2-18 Phase 2 - Sterilization A... 2-19 Phase 3 - Sterilization B... 2-20 Phase 4 - Venting... 2-21 STERRAD 100 S Process Times... 2-21

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System Operation

Introduction

Introduction The STERRAD® 100 Sterilizers are intended for use in hospitals and other medical service institutions for the purpose of sterilizing medical instruments and other equipment. The product employs the proprietary STERRAD Hydrogen Peroxide Gas Plasma Sterilization Process to achieve 10-6 Sterility Assurance Level (SAL) in a cycle time of approximately 75 minutes (51-72 minutes for the STERRAD 100 S System). This process does not create toxic by-products nor dangerous heat levels and requires no special venting or piping. Many types of medical instruments and equipment can be safely and completely sterilized with this process. This section presents the general Theory of Operation for the STERRAD 100 Systems. Each subsystem section has more detailed theory about the subsystem. Remember, when you see the STERRAD icon, as with this paragraph, this indicates that the information pertains to a different system configuration other than the standard Block 1.8 system.

Theory of Operation-Overview The STERRAD Sterilization Process occurs in the following manner: F The items to be sterilized are placed in the sterilization chamber, the chamber is closed, and a vacuum is drawn. F An aqueous solution of hydrogen peroxide is injected into the chamber where it vaporizes, surrounding the items to be sterilized. F After a period of hydrogen peroxide diffusion, the pressure is reduced in the chamber. The formation of a low-temperature gas plasma is initiated by applying radio frequency (RF) energy to create an electric field. F In the plasma state, the hydrogen peroxide vapor breaks apart into reactive species that include free radicals. F The combined use of hydrogen peroxide vapor and plasma, safely and rapidly sterilizes most medical instruments and materials without leaving toxic residues. F Following the reaction, the activated components lose their high energy and recombine to form primarily oxygen, water and other non-toxic by-products. F When the process is complete, the RF energy is turned off, the vacuum is released and the chamber is returned to atmospheric pressure by venting through a High Efficiency Particulate Air (HEPA) filter. The items within are sterilized and ready for use.

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Theory of Operation-Overview

System Operation

Routine Maintenance The operator is required to perform maintenance as detailed in the Operator’s Manual. The operator maintenance includes cleaning the injector valve vaporizer bowl, replacing the printer ribbon and replacing the cassette collection box. Printer paper is replaced as needed. In addition to the routine maintenance performed by the operator the service technician performs these activities: F Complete the planned maintenance procedure and product certification at 750 cycles or 6 months using the PM1 kit. F Complete the planned maintenance procedure and product certification at 1500 cycles using the PM2 kit.

Service Philosophy Sterilizer servicing is limited to the service activities described in this guide. All planned and corrective maintenance activities must be performed by ASP or its authorized representative. Unauthorized repairs void the warranty.

The Sterilization Cycle The sterilization cycle is automatically controlled by a programmed microprocessor that monitors operating parameters and controls each of the five stages of the cycle. The operator interacts with the system through the control panel, a status indicator display, and a two-line alphanumeric display. When the operator has loaded the process chamber and pressed the START button, the door automatically closes and the five stage sterilization cycle proceeds. The five stages are as follows: F Vacuum - The atmospheric pressure in the process chamber is reduced to 300 mTorr. F Injection - Hydrogen peroxide is initially vaporized into the process chamber. F Diffusion - Then the hydrogen peroxide vapor is allowed to diffuse to all areas of the load for a fixed time period. F Plasma - RF energy ionizes gases within the process chamber. F Vent - Filtered air is admitted into the chamber, and then returned to atmospheric pressure.

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System Operation

Theory of Operation-Overview

Figure 2-1. The Sterilization Cycle

Electrical energy at high frequency is used to break down hydrogen peroxide (H2O2) molecules into an unstable ionized state called a low temperature plasma. The combination of hydrogen peroxide vapor and plasma safely and rapidly sterilizes most medical instruments and materials without toxic residues. At the end of the process, the active species in the plasma lose their high energy and recombine to form stable compounds such as oxygen, water, and other non-toxic by-products. At the end of the cycle, or following a problem with the cycle at any stage, the system presents an appropriate message on the front panel display and prints a status report. If the cycle was interrupted by an apparent malfunction, the printout indicates the reason for the interruption and suggests appropriate corrective action.

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