633HC Steam Sterilizers Technical Manual Rev B March 2008

633HC STEAM STERILIZER USER MANUAL 61301607026 REV B US

USER MANUAL 61301607026 REV B US MARCH 2008 Getinge®, Biosign®, and EZ-VU® are registered trademarks. Copyright ©2007–2008 Getinge USA, Inc.

PUBLICATION HISTORY Revision

Date

Reason

A

8/2007

Initial release

B

3/2008

Changes due to product maturity

For quality service on the 633HC Steam Sterilizer and information on our Performance Assurance Plan, contact: Getinge USA, Inc. 1777 East Henrietta Road Rochester, NY 14623-3133 Phone: 1-800-950-9912 www.getingeusa.com NOTE This manual contains proprietary information of Getinge USA, Inc. It shall not be reproduced in whole or in part without the written permission of Getinge USA, Inc. This manual is intended for qualified technicians with specialized training. If you require additional help, contact the company service representative.

WARNING POSSIBILITY OF INJURY: Misuse of equipment or bypassing its safety features may result in personal injury. CAUTION POSSIBILITY OF DAMAGE TO EQUIPMENT: Misuse of equipment may result in equipment damage. POSSIBILITY OF DAMAGE TO EQUIPMENT: The 633HC Steam Sterilizer is designed to steam sterilize hospital goods and solutions. This equipment is NOT intended for use other than expressly stated.

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TABLE OF CONTENTS Special Safety Instructions... ix

SECTION 1 PREFACE Summary of Contents...1–1 Environmental Impact Assessment...1–2 Manual Conventions...1–3 Symbols Used in This Manual...1–3 Descriptions of the Symbols on the Equipment...1–4 Switches...1–4 Indicators...1–5 Labels...1–5

SECTION 2 SAFETY General...2–1 Product Liability...2–3 Isolating Device...2–3 Safety Features...2–4 Door Lockout...2–4 Door Obstruction Switch...2–4

SECTION 3 INTRODUCTION Models...3–2 Controls and Indicators...3–3 Control Panel Navigation...3–7 Process Screens...3–7 Selecting a Process Screen...3–9 Softkeys...3–10 Disabling or Enabling the Controls...3–12 Turning the Controls ON or OFF...3–13 Navigation Basics...3–13 Directional Arrows...3–13 Enter...3–14 Selecting an Item from a List...3–14 USR 61301607026 Rev B US

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Entering an Alphanumeric Value... 3–14 Entering Values in Dialog Boxes... 3–15 Responding to Yes/No Message Boxes... 3–16 Exiting from a Screen... 3–16 Operating the Printer... 3–17 Status Indicator... 3–18 Advancing the Paper... 3–18 Using the Lever... 3–18 Saving Printouts... 3–19 Tearing Off Printer Paper... 3–19 Replacing the Printer Paper... 3–19 Storing and Handling Paper Rolls... 3–22 Printing a Duplicate Record... 3–22 Reading the Cycle Printout... 3–23 Cycle Start and Parameters... 3–23 Phases... 3–23 Validating the Exposure Phase... 3–24

SECTION 4 OPERATION Sequence of Operation... 4–1 Operating the Sterilizer... 4–2 Start of Day Checklist... 4–2 Turning the Controls ON... 4–2 Operational Readiness... 4–2 Previewing and Selecting a Cycle... 4–3 Operating the Sterilizer Door... 4–6 Safety Features... 4–7 Opening and Closing the Sterilizer Door... 4–7 Load Preparation... 4–9 Techniques for Loading... 4–11 Flash Sterilization... 4–13 Loading Accessories... 4–14 Operating the Loading Car and the Transfer Carriage... 4–14 Rack and Extendable Shelves... 4–20 Loading the Sterilizer... 4–22 Processing a Cycle... 4–23 End of Cycle Routine... 4–25 Unloading the Sterilizer... 4–27 iv

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End of Day Checklist...4–29 Closing the Door...4–29 Turning the Controls OFF...4–29 Blowing Down the Steam Boiler...4–29 Canceling a Cycle (Manual Abort)...4–30 Advancing a Cycle...4–33 Shutting Down the Sterilizer...4–36 Recovering from Electrical Power Failure...4–38 Power Failure during Standby...4–39 Power Failure during a Cycle...4–39 Opening the Door Manually...4–40 Performance Testing...4–53 Biological Monitoring...4–53 Bowie and Dick Test...4–53 Vacuum Leak Test...4–54

SECTION 5 PROCESS DESCRIPTIONS Factory Set Parameters...5–2 Sterilizer Cycles...5–3

SECTION 6 TROUBLESHOOTING GUIDE Display Messages...6–1 Diagnostic Message Types...6–1 Troubleshooting...6–7 Diagnostic Messages...6–8

SECTION 7 ROUTINE MAINTENANCE Maintenance Schedule...7–1 Daily...7–2 Cleaning the Sediment Screen...7–2 Cleaning the Bleed Drain Guards...7–3 Weekly...7–4 Cleaning the Exterior Surfaces...7–4 Cleaning the Chamber Interior...7–4 Cleaning the Accessories...7–4 Cleaning Materials...7–4 Cleaning Agents...7–5 USR 61301607026 Rev B US

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Cleaning Methods... 7–5 Cleaning the Door Gasket(s)... 7–5 When Required... 7–6 Resetting the Clock and Calendar... 7–6 Installing the Shelves... 7–8 Removing the Shelves... 7–9 Blowing Down the Steam Boiler (Optional Equipment)... 7–9

SECTION 8 OPTIONAL EQUIPMENT Steam Boiler... 8–2 Water Quality Information for Steam Boilers... 8–3 Blowing Down a Steam Boiler Manually... 8–4 Steam Boiler Automatic Blow-down Package... 8–8 Setting Up Auto Blow-down... 8–9 Steam Boiler Service Maintenance... 8–10 Uninterruptible Power Supply... 8–11 General Description... 8–11

APPENDIX A

CONSUMABLE STOCK AND SPARE PARTS Consumable Stock... A–1 Spare Parts... A–2

APPENDIX B

SUPERVISOR FUNCTIONS Entering a Password... B–2 Menu Options... B–4 Viewing the System Menu Options... B–5 Time Settings Menu... B–7 Configuration Menu... B–8 Password Access... B–9 Setting Up a User Account... B–10 Changing User Access Areas... B–15 Changing a User Password... B–17 Deleting a User Account... B–19 Procedures... B–20 Editing Cycle Parameters... B–20 Parameter Check... B–30 Setting the Clock and Calendar... B–32

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Setting Up the Auto Blow-down... B–33 Setting Up the Utilities On and Off Times... B–35 Bypassing Utility Shutdown Mode... B–38 Editing the Cycle Number... B–38 Editing the Cycle Name... B–39 Cycle Assignments... B–42 Assigning the Sterilizer Name... B–44 Selecting the Language, Date Format, and Units... B–46 Setting Up the Display Panel... B–49 Viewing the About Screen... B–52

APPENDIX C PARAMETER CHECK FEATURE Estimating Valid Cycle Parameters... C–1

APPENDIX D MENU TREE GLOSSARY

INDEX

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SPECIAL SAFETY INSTRUCTIONS THE FOLLOWING SAFETY INSTRUCTIONS APPEAR WITHIN THIS MANUAL ON THE PAGES LISTED AFTER EACH WARNING. READ THEM CAREFULLY BEFORE OPERATING THE UNIT. NOTE “Warning” notes alert the user to the possibility of personal injury. BURN/PINCH HAZARD: KEEP HANDS AND FINGERS AWAY FROM A MOVING DOOR. To stop the door direction if your hands or fingers are accidently caught in the door: If the door is closing

Press one of the following: • [OPEN DOOR] • [CANCEL] • CONTROLS OFF/ON

If the door is opening

Press one of the following: • [CLOSE DOOR] • [CANCEL] • CONTROLS OFF/ON

p. 4–6, p. 4–7 CREUTZFELDT-JAKOB DISEASE (CJD) DECONTAMINATION: It is the responsibility of the facility to establish internal policies and procedures relative to processing instruments that have or may have been exposed to CJD. If instruments exposed to CJD are processed in accordance with the World Health Organization (WHO) Infection Control Guidelines for Transmissible Spongiform Encephalopathies (TSE), there are: POTENTIAL HAZARDS TO USERS AND REPAIR PERSONNEL: • Be sure to wear personal protective equipment (PPE) when handling NaOH liquids. • Heated NaOH liquids have the potential to injure personnel who handle the containers. • Heated NaOH liquids can emit fumes that can be corrosive to eye tissue and can cause respiratory distress. • Cleaning residual NaOH from the chamber interior could lead to skin burns and the production of NaOH aerosol mist. p. 4–10

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POSSIBILITY OF INJURY: Observe the following loading recommendations: • The rack can support a maximum load of 100 lb. An individual shelf can hold up to 50 lb, evenly distributed. Up to 4 shelves can be placed on the rack as long as the total maximum weight of 100 lb is not exceeded. • Do not place more than 20 lb on the end of an extended shelf. • Liquid loads (hot or cold) should never be placed on an extended shelf. • Do not extend a shelf with liquid loads (hot or cold). p. 4–20 BURN HAZARD/SHOCK HAZARD: Before performing any maintenance on the boiler, allow the boiler to cool down and disconnect the electrical power at the source. p. 8–10 BURN HAZARD: Before removing a load from the chamber, unseal the door and wait about a minute for the steam to vent before opening the door. Stand back to avoid possible burns when lowering the door. p. 4–6, 4–27, 4–40, 4–51 BURN HAZARD: Flash sterilized unwrapped instruments could still be hot at the end of the cycle. These instruments could burn the patient if used immediately in surgical procedures. Use personal protective equipment when removing these items from the sterilizer and allow sufficient time for them to cool before using them in surgical procedures. p. 4–13, 4–18, 4–20, 4–28, 5–12, 5–15 BURN HAZARD: Hot steam can cause serious injury. DO NOT attempt to open the sterilizer chamber door unless the CHAMBER pressure gauge on the front panel reads zero (0 psig) or less (negative). p. 4–40, 4–46 BURN HAZARD: Hot steam can cause serious injury. View the CHAMBER pressure gauge while the steam bleeds from the chamber. Wait until the CHAMBER pressure gauge reads zero (0 psig) or less (negative) before operating manual valves. p. 4–40, 4–42 BURN HAZARD: The door and chamber area could be HOT enough to cause burns. Wear personal protective equipment (PPE) when loading and unloading the chamber. p. 4–6, 4–22, 4–27, 4–30, 4–34 BURN HAZARD: The drain valve is hot. Wear protective gloves. p. 8–4, 8–7 BURN HAZARD: To avoid injury, DO NOT turn ON the manual valve labeled “STEAM TO DOOR(S)” with the chamber door open. p. 4–52 BURN HAZARD: To avoid injury, DO NOT turn the manual valves with the chamber door open. p. 4–40

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FIRE HAZARD: Loose electrical connections may result in an electrical fire. When performing periodic maintenance, check that the heating elements, element flange bolts, contactors, and three-phase supply terminal block are torqued to the values specified in the Technical Manual (61301607028). p. 8–10 HOT SURFACES: The chamber and sediment drain screens may be hot. Allow them to cool before attempting to remove them for cleaning. p. 7–3 HOT SURFACES: The chamber and the gasket area could be HOT. Turn OFF the controls and make sure the sterilizer is cool before cleaning the gasket or removing the sediment screen for cleaning. p. 4–2 HOT SURFACES: The loading car may be hot enough to cause burns. Wear protective gloves and eyewear when loading and unloading the chamber. p. 4–14, 4–18 HOT SURFACES: The loading car or rack and shelves may be hot enough to cause burns. Wear protective gloves and eyewear when removing the load from the chamber. p. 4–27 HOT SURFACES: The pipes on the outside of the chamber may be hot! Avoid touching the pipes when opening and closing the bleed valves. p. 4–40, 4–42 HOT SURFACES: The rack and shelves may be hot enough to cause burns. Wear protective gloves when extending the shelves out of the chamber. p. 7–8, 7–9 HOT SURFACES: The rack and shelves may be hot enough to cause burns. Wear protective gloves when loading and unloading the chamber. p. 4–20 HOT SURFACE: If the sterilizer is ON, the chamber headring, which houses the gasket, could be hot. Allow the headring to cool before cleaning the door gasket. p. 7–5 HOT SURFACE: Make sure the sterilizer chamber is cool before attempting to clean the interior surfaces. p. 7–4 HOT SURFACE: The chamber and sediment drain screens may be hot. Allow them to cool before attempting to remove them for cleaning. p. 7–2 POSSIBILITY OF INJURY: After completion of a liquids cycle, remove the container carefully, taking care not to agitate the liquid. If the load is agitated when removed from the chamber, the container may burst or crack. p. 4–27

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POSSIBILITY OF INJURY: Before transporting liquid loads, make sure the side rails are installed on the loading cart. If the side rails are not installed, the liquid containers could fall off the loading cart and spill or break. p. 4–14 POSSIBILITY OF INJURY: Do not operate the door while loading or unloading the sterilizer. p. 4–6, 4–22, 4–27 POSSIBILITY OF INJURY: If a condition exists OTHER THAN an electrical outage, call qualified service personnel before operating the sterilizer. Failure to do so may result in personal injury. p. 4–41, 4–52 POSSIBILITY OF INJURY: If a WATER IN DRAIN message displays, DO NOT operate the chamber door. Hot water in the chamber may spill if the door is opened. Wait until the message clears before attempting to open the door. p. 4–26, 4–41, 4–42, 6–3, 6–13 POSSIBILITY OF INJURY: If the wrong cycle is selected for a liquid load, the containers may burst or crack during processing. p. 4–23 POSSIBILITY OF INJURY: Manual mode is intended for use by qualified service personnel to check the function of individual outputs. Attempting to operate the sterilizer when any output is set for manual operation may result in possibly dangerous conditions. p. 6–14 POSSIBILITY OF INJURY: Opening the door manually requires retracting the door gasket, which should be performed by qualified service personnel only. This procedure requires access to the service side of the equipment. p. 4–40 POSSIBILITY OF INJURY: Persons entering the chamber could become trapped. Before entering the chamber, turn the CONTROLS DISABLE/ ENABLE key switch to DISABLE, remove the key, and keep it with you. When the CONTROLS DISABLE/ENABLE key switch is set to DISABLE, the control panel is locked and door motion is disabled. p. 3–12, 4–2, 4–6, 4–22, 4–27, 4–30, 4–34, 4–41, 7–2, 7–3, 7–4, 7–5 POSSIBILITY OF INJURY: Retracting the door gasket manually should be performed by qualified service personnel only. This procedure requires access to the service side of the equipment. p. 4–42 POSSIBILITY OF INJURY: Steam boiler maintenance should be performed only by qualified personnel following the procedures in the 600 Series Technical Manual (61301607028). p. 8–10 POSSIBILITY OF INJURY: The liquids cycle is NOT intended for the sterilization of liquids intended for direct patient contact. p. 4–9

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POSSIBILITY OF INJURY: The loading car can hold a total maximum load of 440 lb. The shelves on the car are able to hold a maximum of 275 lb evenly distributed on each shelf, but the total weight of 440 lb on the car must not be exceeded. To avoid injury or equipment damage, do not exceed these weight limits. p. 4–14 POSSIBILITY OF INJURY: Use only vented or open containers to process liquids in this sterilizer. Use of sealed, unvented containers to process liquids can result in severe personal injury due to container breakage. Getinge USA does NOT recommend or endorse use of such containers. p. 4–7, 4–9, 4–11, 4–22, 4–23, 4–28, 4–30, 4–34, 4–39, 4–41 POSSIBILITY OF INJURY: Wear protective eyewear, clothing, and gloves when handling liquids in containers. p. 4–22, 4–27 RISK OF INFECTION: Airborne microbial and particulate contamination is likely to be high in the decontamination area of the sterile processing department. Wear appropriate personal protective equipment (PPE) when preparing items for cleaning. p. 4–9, 4–30, 4–34, 4–40 RISK OF INFECTION: The liquids cycle is NOT intended for the sterilization of liquids intended for direct patient contact. p. 5–16 RISK OF NON-STERILE DEVICE AND POSSIBILITY OF INJURY: Before pressing START, verify that the appropriate cycle is selected for the load being processed. p. 4–23 RISK OF NON-STERILE DEVICE: After removing wrapped goods from the chamber, inspect for residual moisture (wet packs). Moisture on or within a package can potentially create a pathway for migration of microorganisms from the outside to the inside of a sterilized package. p. 4–27 RISK OF NON-STERILE DEVICE: If the cycle is aborted, advanced, or canceled, it must be considered incomplete and the load must be reprocessed (unwrapped goods or liquids) or repackaged and reprocessed (wrapped goods). p. 3–4, 4–6, 4–9, 4–23, 4–25, 4–27, 4–30, 4–32, 4–33, 4–35, 4–39, 4–40, 6–1, 6–4, 6–8, 6–13, 6–15 RISK OF NON-STERILE DEVICE: If the PROCESS FAILURE indicator is flashing, the cycle must be considered incomplete and the load must be reprocessed (unwrapped goods or liquids) or repackaged and reprocessed (wrapped goods). p. 4–6, 4–23, 4–25, 4–27, 4–39, 4–40, 6–1, 6–5, 6–6, 6–8 RISK OF NON-STERILE DEVICE: If the sterilizer cancels the cycle due to a power interruption, the load must be reprocessed (unwrapped goods or liquids) or repackaged and reprocessed (wrapped goods). p. 4–6, 4–23, 4–25, 4–27, 4–38, 4–40, 6–2, 6–8, 6–12

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RISK OF NON-STERILE DEVICE: If the wrong cycle is selected, the desired sterility assurance level (SAL) may not be reached. p. 4–23 RISK OF NON-STERILE DEVICE: The recommended minimum exposure time and temperature for unwrapped non-porous flash cycle loads (e.g., metal instruments) is 3 minutes at 275°F (135°C). p. 4–11, 4–13, 5–12 RISK OF NON-STERILE DEVICE: The sterilizer controls allow users to modify cycle settings, which may result in cycle parameters that do not achieve the desired sterility assurance level (SAL). Users with password access are responsible for validation of any cycles with settings other than the factory set parameters. p. 5–1, 5–5, 5–9, 5–12, 5–15, 5–18, B–9, B–21, B–22, B–25, B–28, B–30, C–1 SHOCK HAZARD: Disconnect all electrical supply circuits to ensure that the sterilizer components will not be energized prior to the performance of required adjustments and testing. p. 4–42 SHOCK HAZARD: To disconnect all power, turn OFF the sterilizer at the mains circuit breaker. CONTROLS OFF/ON does not remove primary power from the sterilizer. p. 2–4

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SECTION 1

PREFACE

Before operating the sterilizer, please read all the instructions and become familiar with the sterilizer’s design, safety features, and operation. This manual is intended to provide the knowledge to: • ensure safe equipment operation with optimal efficiency • select the appropriate cycle for the load to be sterilized • handle any nonstandard task, such as assigning passwords • assist with routine maintenance This manual is intended for users, supervisors, and qualified maintenance personnel in the operation of the 633HC Steam Sterilizer. If additional help is required, contact a qualified Getinge service representative. The following documentation is supplied with the machine: • User Manual (61301607026) • Installation Manual (61301607027) • Quick Reference Poster (61301607268) The following documentation is available for purchase: • Technical Manual (61301607028) • Parts Catalog (61301607029) Getinge reserves the right to make changes to specifications and equipment without prior notice. The information contained within this manual is current as of the date of issue.

SUMMARY OF CONTENTS This manual is divided into 13 sections as follows: • Section 1, “Preface”-includes information regarding the intended audience and a summary of the contents of the manual • Section 2, “Safety”-includes all information concerning important safety issues when using or servicing the sterilizer • Section 3, “Introduction”-includes information regarding symbols used within this document and on the equipment as well as basic navigation concepts • Section 4, “Operation”-includes information regarding daily checks, load preparation, and basic operating instructions

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• Section 5, “Process Descriptions”-includes factory set parameters and information regarding cycle parameters and functions • Section 6, “Troubleshooting Guide”-includes information regarding error messages and fault analysis • Section 7, “Routine Maintenance”-includes information regarding periodic maintenance performed by the user/technician • Section 8, “Optional Equipment”-includes information regarding options available for the sterilizer • Appendix A, “Consumable Stock and Spare Parts”-includes part numbers of parts and consumables that should be kept on hand • Appendix B, “Supervisor Functions”-provides information and instructions for situations that may develop that are not part of standard sterilizer operation; includes the cycle assignments table • Appendix C, “Parameter Check Feature”-provides a visual means of determining whether a specific cycle setting is above the parameter check limit • Appendix D, “Menu Tree”-provides a graphic representation of the user interface • Glossary-provides written definitions of product or process related terms used in this manual

ENVIRONMENTAL IMPACT ASSESSMENT The 633HC Steam Sterilizer contains stainless steel, copper, electronic, and electrical components, which can be recycled at the end of the unit’s lifecycle. The sterilizer also contains plastic and batteries that are in the electronic boards, as well as cadmium in batteries, which can NOT be recycled and should be disposed of in accordance with local and federal regulations.

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MANUAL CONVENTIONS Before you begin using this manual, it is important to understand the conventions used. These conventions are established for visual ease of use. [ALL UPPERCASE IN BRACKETS]

Softkeys on the control panel, such as [CANCEL] or [OK]

ALL UPPERCASE WITHOUT BRACKETS

Switches and indicators on the control panel, such as ENTER

>

Leads you through nested menu items and dialog box options to a final action, for example: Select SYSTEM MENU > enter password > TIME SETTINGS.

Italics

Alarm and informational messages in the display window, such as the AIR IN SLOW fault condition Cross reference to another manual or guide, for example: See AAMI Standard ST79.

PARAMETER SETTINGS

An alert that a password with appropriate access rights is necessary to proceed

ACCESS REQUIRED

SYMBOLS USED IN THIS MANUAL The following symbols with related notes appear in this manual. “Warning” alerts the user to the possibility of personal injury. “Caution” alerts the user to the possibility of damage to the equipment. “Note” alerts the user to pertinent facts and conditions.

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DESCRIPTIONS OF THE SYMBOLS ON THE EQUIPMENT The following symbols and definitions represent the switches, indicators, and labels found on the unit. SWITCHES

OPEN DOOR (also used to unseal the door)

CLOSE DOOR (also used to seal the door

!

CLEAR ALARM

START

Directional arrows (for navigating display screens)

ENTER

Softkeys (for selecting softkey options, such as Save, Cancel, and OK) CONTROLS OFF ON

CONTROLS OFF/ON

WS-0091

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CONTROLS DISABLE/ENABLE

CONTROLS DISABLE

ENABLE

To enable the controls, insert the key and turn it to ENABLE.

WS-0411-633HC

WS-0243

To disable the controls, turn the key to DISABLE. Remove the key to avoid unauthorized operation. WS-0243-633HC

INDICATORS

DOOR(S) CLOSED

DOOR(S) SEALED

IN PROCESS

PROCESS COMPLETE

PROCESS FAILURE

! LABELS

The following labels on the sterilizer alert personnel to possible hazards.

BURN HAZARD: Hot surfaces or heatemitting area. Avoid contact. Risk of burns. HS

WARNING - BURN HAZARD Steam released from the sterilizer chamber can cause serious burns Stand away while opening the door If water leaks from the front of the sterilizer, DO NOT open the door (see User Manual) Contact Getinge USA Customer Support (800) 950-9912 MGA

61301607429 REV A

PROCESSING A TYPE OF LOAD OTHER THAN DEFINED IN USER MANUAL COULD BE HAZARDOUS

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WARNING-BURN HAZARD: Steam released from the sterilizer chamber can cause serious burns. Stand away while opening the door. WARNING: Do not enter chamber without disabling controls. Processing a type of load other than defined in User Manual could be hazardous.

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