Getinge 633 User manual

633HC STEAM STERILIZER

USER MANUAL 61301607026 REV B US

633HC STEAM STERILIZER

USER MANUAL 61301607026 REV B US

USER MANUAL

61301607026 REV B US

MARCH 2008

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.

ii USR 61301607026 Rev B US

SECTION 1 PREFACE

633HC Steam Sterilizer

TABLE OF CONTENTS

Special Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

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

SECTION 3 INTRODUCTION

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2–1

Product Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2–3

Isolating Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2–3

Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2–4

Door Lockout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2–4

Door Obstruction Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2–4

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 iii

Table of Contents

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 USR 61301607026 Rev B US

633HC Steam Sterilizer

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 v

Table of Contents

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

vi USR 61301607026 Rev B US

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

633HC Steam Sterilizer

APPENDIX D MENU TREE

GLOSSARY

INDEX

USR 61301607026 Rev B US vii

Table of Contents

viii USR 61301607026 Rev B US

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:

633HC Steam Sterilizer

• [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

USR 61301607026 Rev B US ix

Special Safety Instructions

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

x USR 61301607026 Rev B US

633HC Steam Sterilizer

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

USR 61301607026 Rev B US xi

Special Safety Instructions

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

xii USR 61301607026 Rev B US

633HC Steam Sterilizer

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

USR 61301607026 Rev B US xiii

Special Safety Instructions

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

xiv USR 61301607026 Rev B US

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)

SUMMARY OF CONTENTS

• 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.

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

USR 61301607026 Rev B US 1–1

Preface

• 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.

1–2 USR 61301607026 Rev B US

MANUAL CONVENTIONS

633HC Steam Sterilizer

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]

ALL UPPERCASE WITHOUT BRACKETS

> Leads you through nested menu items and

Italics Alarm and informational messages in the

PARAMETER SETTINGS

ACCESS REQUIRED

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

Switches and indicators on the control panel, such as ENTER

dialog box options to a final action, for example:

Select SYSTEM MENU > enter password > TIME SETTINGS.

display window, such as the AIR IN SLOW fault condition

Cross reference to another manual or guide, for example: See AAMI Standard ST79.

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

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.

USR 61301607026 Rev B US 1–3

Preface

!

WS-0091

CONTROLS OFF ON

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

1–4 USR 61301607026 Rev B US

633HC Steam Sterilizer

HS

Contact Getinge USA Customer Support (800) 950-9912

If water leaks from the front of the sterilizer,

DO NOT open the door (see User Manual)

Steam released from the sterilizer chamber can cause serious burns

Stand away while opening the door

WARNING — BURN HAZARD

MGA

61301607429 REV A

INDICATORS

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

DOOR(S) CLOSED

DOOR(S) SEALED

IN PROCESS

PROCESS COMPLETE

!

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

PROCESSING A TYPE OF LOAD OTHER

THAN DEFINED IN USER

MANUAL COULD BE HAZARDOUS

PROCESS FAILURE

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

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.

USR 61301607026 Rev B US 1–5

Preface

OBSERVE PRECAUTIONS

FOR HANDLING

SENSITIVE

DEVICES

The following labels on the control box and power box alert service personnel to possible hazards.

HIGH VOLTAGE CAUTION: To reduce the risk of electrical

shock, do not remove the cover. Refer servicing to qualified service personnel.

ATTENTION: See the accompanying documents for further information.

ATTENTION: Observe precautions for handling electrostatic sensitive devices.

1–6 USR 61301607026 Rev B US

GENERAL

SECTION 2 SAFETY

The 633HC Steam Sterilizer is designed to sterilize and dry (where applicable) typical health care goods. The sterilizer includes pressure pulse gravity steam, pressure vacuum pulsing, and liquids cycles. This sterilizer is NOT intended for use other than expressly stated.

This sterilizer is designed with a number of built-in safety devices. To avoid injury, it is very important that these safety devices are not bypassed or disabled.

CAUTION

POSSIBILITY OF DAMAGE TO EQUIPMENT: Follow the instructions in this manual to ensure the safe and efficient performance of the sterilizer. Failure to comply with these instructions or to provide specific services could void the warranty.

READ THE MANUAL

• Read all instructions thoroughly before use.

• Before repair or service work is performed, service personnel must study the manuals and documentation.

AUTHORIZED PERSONNEL ONLY

• Read all instructions thoroughly before operating the sterilizer.

• Service work must be performed by qualified personnel trained on this equipment.

• The sterilizer must be operated by personnel who know about it and are trained on its use. Personnel must also receive periodic training on this equipment.

• Personnel must receive periodic training on the operation and maintenance of this equipment in accordance with established procedures for the workplace.

USR 61301607026 Rev B US 2–1

Safety

CHEMICAL SAFETY

• Take care when handling any chemical agent used in and around the sterilizer. Read all details on the container or contact the manufacturer:

– if any agent comes into contact with the operator’s eyes or skin, or

if the vapors are breathed in

– about storing the agent and disposing of empty containers

• Take care when using corrosive detergents, such as Getinge Stainless Steel Chamber Cleaner or Getinge Schedule 7 Chamber Cleaner.

ELECTRICAL SAFETY

• The front panels and electrical enclosures may be opened only by authorized and trained personnel. Be sure to switch OFF the electric power before opening front panels and any electrical enclosures. The electrical enclosures may contain 24 V, 115 V, 230 V, and three-phase voltage electrical components.

• Do not touch cables or electrical equipment in the service area.

• The sterilizer must be connected in accordance with the installation instructions and local safety codes.

• Before welding begins on or close to the sterilizer, all wiring connected by plugs and sockets must be disconnected from all circuit boards of the control system.

LOCKOUT

• Always keep the door to the service area locked.

• No personnel should be in the service area while the sterilizer is running.

• Never bypass the door limit switches of the sterilizer.

• When servicing the unit, CONTROLS DISABLE/ENABLE should be set to DISABLE. Remove the key and keep it with you.

HOT SURFACES

• There are hot surfaces in the service area. Never touch any piping that could contain steam.

• The sterilizer uses hot water and steam, which have the potential of causing burns or serious injuries. Wear personal protective equipment suitable for hot water and steam.

OTHER CONSIDERATIONS

• Leakage in the system, due to a worn door seal for example, must be repaired without delay.

• The sterilizer must be kept clean to ensure optimum performance.

• Do not hose down the outside of the sterilizer with water.

2–2 USR 61301607026 Rev B US

PRODUCT LIABILITY

ISOLATING DEVICE

633HC Steam Sterilizer

Modifications to the equipment without the express approval of the manufacturer, or incorrect use of the unit invalidates the manufacturer’s product liability.

The sterilizer is fitted with a main switch on the power box. The box is located on the right side of the sterilizer.

FIGURE 2–1. CIRCUIT BREAKER LOCATION

Power Box Main Switch

Steam Boiler

(option)

Heater Voltage

(208/240/480/600 Vac

Three-Phase)

NOTE

Units with boilers are powered by a three-phase circuit that requires a separate mains disconnect. The boiler has its own circuit breaker.

Mains

Disconnect

Breaker

A07027-K

USR 61301607026 Rev B US 2–3

Safety

WS-0421

Top of Door Light Beam

Door Obstruction Switch

SAFETY FEATURES

WARNING

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.

DOOR LOCKOUT The door can be locked in the open position for maintenance inside the

chamber. Turn the key to DISABLE and remove it. To prevent someone from closing the door during maintenance, keep the keys with you.

FIGURE 2–2. LOCKING THE DOOR IN THE OPEN POSITION

WS-0420

DOOR OBSTRUCTION SWITCH The sterilizer uses a light beam switch at the top of the door to sense when

an object is in the path of the movement of the door. When the light beam is broken as the door is closing, the door stops then reverses direction for 2seconds.

FIGURE 2–3. DOOR OBSTRUCTION SWITCH

2–4 USR 61301607026 Rev B US

SECTION 3 INTRODUCTION

The 633HC Steam Sterilizer is designed to steam-sterilize hospital goods that are heat and moisture stable. Typical load types include:

• non-porous hard goods, including instruments, basins, cups, tools, test tubes, and glassware

• wrapped/unwrapped porous goods, including cloth, towels, gowns, and sheets

• wrapped porous goods, including instruments, basins, and tools

• non-flammable/non-volatile liquids in self-venting or open containers

The liquids cycle is not intended for sterilization of liquids intended for patient contact.

The following information is covered in this section:

Top ic P ag e

Models 3–2

Controls and Indicators 3–3

Control Panel Navigation 3–7

Softkeys 3–10

Disabling or Enabling the Controls 3–12

Turning the Controls ON or OFF 3–13

Navigation Basics 3–13

Operating the Printer 3–17

Reading the Cycle Printout 3–23

USR 61301607026 Rev B US 3–1

Introduction

MODELS

The 633HC Steam Sterilizer models and cycle types are listed in Table 3–1 and the vessel dimensions are listed in Table 3–2. See Figure 3–1 for a picture of the unit.

TABLE 3–1. STEAM STERILIZER MODELS AND CYCLE TYPES

Model Sterilizer Type Cycle Types Available

633HC vacuum/gravity prevacuum, gravity, flash,

liquids, Bowie and Dick test, and vacuum leak test

TABLE 3–2. VESSEL DIMENSIONS

Height Width Chamber Length

26 in. (672 mm) 26 in. (672 mm) 26 in. (660 mm)

39 in. (1000 mm)

51 in. (1300 mm)

FIGURE 3–1. 633HC STEAM STERILIZER

A07026-A

3–2 USR 61301607026 Rev B US

CONTROLS AND INDICATORS

!

CONTROLS

OFF

ON

CONTROLS

DISABLE ENABLE

WS-0241 633HC

1

3 2 4

5

67

8 9

CONTROLS

DISABLE ENABLE

WS-0243

WS-0091

CONTROLS OFF ON

633HC Steam Sterilizer

For operational convenience, the sterilizer has an angled primary control panel on the control end (CE) of the unit. This panel contains a color graphic display; status indicators; and cycle, door control, and programming switches. Figure 3–2 is an illustration of the primary control panel.

FIGURE 3–2. STERILIZER CONTROL PANEL

!

1. Controls:

• CONTROLS DISABLE/ENABLE disables the control panel (preventing door movement during maintenance procedures).

– Sterilizer controls are functional when the key is turned to

ENABLE (key is in the lock).

– Sterilizer controls are not functional when the key is turned to

DISABLE and removed.

NOTE

When servicing the unit, set CONTROLS DISABLE/ENABLE to DISABLE; remove the key and keep it with you.

• CONTROLS OFF/ON turns the sterilizer controls OFF and ON.

– Sterilizer controls are ON when the push button is pressed in

and illuminated.

– Sterilizer controls are OFF when the push button is released

and the button is not illuminated.

USR 61301607026 Rev B US 3–3

Introduction

!

NOTE

If the CONTROLS OFF/ON button is illuminated and the backlight display is blank (the display is in screen saver mode), press any button (e.g., up arrow or ENTER) on the control panel to turn ON the display backlight. To adjust the screen saver delay value, see “Screen Saver” on page B–50.

If the CONTROLS OFF/ON button is pressed during a cycle, the cycle aborts. This is not the recommended method to abort a cycle manually. To abort a cycle manually, see “Canceling a Cycle (Manual Abort)” on page 4–30.

See “End of Cycle Routine” on page 4–25 any time a cycle is aborted.

WARNING

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).

2. Cycle switches:

• START begins the selected processing cycle.

• CLEAR ALARM clears display messages and silences any alarm. See “Display Messages” on page 6–1.

3. Programming switches:

• Directional (up, down, left, and right arrow) switches

– select a cycle; see “Previewing and Selecting a Cycle” on

page 4–3

– enter a password; see “Entering a Password” on page B–2

– change adjustable cycle parameters; see “Editing Cycle

Parameters” on page B–20

– navigate the menus; see “Menu Options” on page B–4

• ENTER enables or stores selections in memory.

• Up arrow softkeys initiate various actions, depending upon the cycle or cycle phase. The softkey labels appear above the five arrow softkeys. See “Softkeys” on page 3–10.

4. Door control switches:

•CLOSE DOOR

Press the switch to close the door. Press the switch a second time to seal the door.

3–4 USR 61301607026 Rev B US

633HC Steam Sterilizer

!

a bc

d

e

g

j

WS-0104

•OPEN DOOR

Press the switch to unseal the door. Press the switch a second time to open the door. See “Operating the Sterilizer Door” on page 4–6.

5. Status indicators:

• DOOR(S) CLOSED indicates the door is closed, but not sealed (or both doors are closed, but not sealed on a double door unit).

• DOOR(S) SEALED indicates the door is sealed (or both doors are sealed on a double door unit).

• IN PROCESS indicates a cycle is in progress.

• PROCESS COMPLETE indicates the cycle is complete (green light) or the cycle is aborted (flashing red light).

• PROCESS FAILURE indicates (flashing red light) that the controls aborted a cycle automatically due to a process failure, equipment malfunction, or failure while in standby.

6. The display window is the interface between the user and the sterilizer.

FIGURE 3–3. DISPLAY WINDOW

The display window includes:

a. Exposure Time

b. Exposure Temperature (can display °F or °C); see “Selecting the

Language, Date Format, and Units” on page B–46 to set the temperature mode

c. Drying Time (not used for liquids cycles)

USR 61301607026 Rev B US 3–5

Introduction

d. Cycle information including:

• cycle selected—such as GRAVITY1 and LIQUIDS1

• phase name—such as HEAT-UP, EXPOSURE, DRYING, EXHAUST, and CYCLE COMPLETE

• time in the cycle—the cycle timer begins when the cycle starts and continues to increase until the cycle is complete

NOTE

When the phase is STANDBY, the cycle timer does not increase.

• time in current phase—the in-phase timer begins when each phase starts and resets at the end of each phase

• IN PROCESS—light blue background

• CYCLE COMPLETE—green background

• PROCESS FAILURE—flashing red background

e. Process screen includes:

• a user selectable process screen

– bar graph; see Figure 3–4 on page 3–7

– details; see Figure 3–5 on page 3–8

– plot graph; see Figure 3–6 on page 3–8

• dialog boxes

•password window

NOTE

If all the items in the list do not fit on one screen, a black scroll bar displays to the right of the list. Use the up and down arrows to view additional items.

f. Critical alarms

• failure conditions

• fault conditions

g. Non-critical information and system messages (informational

messages)

h. through l.—five softkey labels that display different function names

depending on the current screen or cycle phase; see “Softkeys” on page 3–10

7. The printer provides a record of the cycle. See “Operating the Printer” on page 3–17.

8. The jacket pressure gauge indicates the current jacket pressure.

9. The chamber pressure gauge indicates the current chamber pressure.

3–6 USR 61301607026 Rev B US

633HC Steam Sterilizer

PARA-

METER

SETUP

UNSEAL

SELECT

CYCLE

A07502-C

Time in Cycle

Time in

Current Phase

Estimated Total

Time Remaining

in the Cycle

CONTROL PANEL NAVIGATION

The 633HC Steam Sterilizer has an easy to use interface. This section covers:

• three process screens; see page 3–7

• softkeys label assignments; see page 3–10

• the backlight display and the sterilizer controls; see page 3–13

• basic navigation of the software; see page 3–13

PROCESS SCREENS The user has the option of selecting one of three process screens:

• a screen with an enlarged timer (bar graph)

• a list of real-time, process-critical values including, but not limited to, chamber temperature, chamber pressure, jacket temperature, atmospheric pressure, exposure temperature maximum, exposure temperature minimum (details)

• a screen with a graphical display (plot graph)

A password is not required to select a process screen.

BAR GRAPH SCREEN

The bar graph screen displays the chamber temperature and pressure as bar graphs and a digital time representing the time remaining in the cycle. Each bar graph includes a vertical red line to indicate the following information:

• On the chamber temperature bar graph, the red line marks the exposure temperature.

• On the chamber pressure bar graph, the red line marks atmospheric pressure.

FIGURE 3–4. BAR GRAPH SCREEN

00:30:00

Exposure Time

P10 grv GRAVITY1 01 STA NDBY

Chamber Temp

121.1 C

Exposure Temp

Chamber PSIA

00:30:00

Drying Time

00:00:00

00:24:15

37.3 C

14.68 PSI

0

REMAINING TIME

USR 61301607026 Rev B US 3–7

Introduction

DETAILS SCREEN

The details screen displays a list of real-time, process-critical values, including: chamber temperature, chamber pressure, jacket temperature, atmospheric pressure, drain temperature, exposure temperature maximum, exposure temperature minimum, steam table differential, time at exposure temperature, cycle counter, daily counter, leak test start, leak test differential, and software version.

NOTE

If all the items in the list do not fit on one screen, a black scroll bar displays to the right of the list. Use the up and down arrows to view additional items.

FIGURE 3–5. DETAILS SCREEN

00:30:00

Exposure Time

P10 grv GRAVITY1 02 CYCLE COMPLETE

Chamber Temp Chamb Press/PSIG Jacket Temp Atmosphere PSIA Chamber PSIA Drain Temp

121.1 C

Exposure Temp

61.2 C

0.00 PSI

122.3 C

14.37 PSI

14.35 PSI

98.6 C

00:30:00

Drying Time

01:36:36 00:04:34

Exp. Temp Max 121.7 C

SETUP

CYCLE

PAR A-

METER

UNSEALSELECT

WS-0012 HC

PLOT GRAPH SCREEN

Using a graphic display, the plot graph screen displays the chamber temperature and pressure as trend curves.

FIGURE 3–6. PLOT GRAPH SCREEN

00:30:00

Exposure Time

P10 grv GRAVITY 1 02 CYCLE COMPLETE

Chamber Temp Chamber PSIA

121.1 C

Exposure Temp

81.2

14.35

00:30:00

Drying Time

01:36:36 00:03:42

C

PSI

TIME

01:40

SELECT

CYCLE

PAR A-

METER

UNSEALSETUP

WS-0013 HC

3–8 USR 61301607026 Rev B US

633HC Steam Sterilizer

121.1 C

Exposure Temp

00:30:00

Drying Time

P10 grv GRAVITY1 01 STA NDBY

00:30:00

Exposure Time

00:00:00

00:24:15

0

REMAINING TIME

Chamber Temp

14.68 PSI

Chamber PSIA

37.3 C

WS-0014 HC

PARA-

METER

SETUP

UNSEAL

SELECT

CYCLE

121.1 C

Exposure Temp

00:30:00

Drying Time

P10 grv GRAVITY1 01 STA NDBY

00:30:00

Exposure Time

00:00:00

00:24:15

0

REMAINING TIME

Chamber Temp

14.68 PSI

Chamber PSIA

37.3 C

SETUP

DETAILS

PLOT GRAPH BAR GRAPH SYSTEM MENU ABOUT

WS-0445 HC

SELECT

CYCLE

PAR A-

METER

UNSEAL

SELECTING A PROCESS SCREEN

The process screen displays when you turn ON the sterilizer control panel. See “Turning the Controls ON or OFF” on page 3–13.

FIGURE 3–7. PROCESS (BAR GRAPH) SCREEN

1. Press [SETUP].

The setup menu displays.

FIGURE 3–8. SETUP MENU SCREEN

2. Use the up and down arrows to select the process screen:

•DETAILS

• PLOT GRAPH

USR 61301607026 Rev B US 3–9

• BAR GRAPH

3. Press ENTER.

The selected process screen displays.

Introduction

SOFTKEYS

Navigation of the software interface is controlled using the softkeys ( ) that appear at the bottom of each screen. The softkey labels, located directly above the softkeys, change depending on the current screen or the cycle phase. The following table shows the labels assigned to each softkey.

NOTE

Access levels assigned determine the screens that are viewed.

3–10 USR 61301607026 Rev B US

633HC Steam Sterilizer

TABLE 3–3. SOFTKEY ASSIGNMENTS

Softkey Labels Screen or Procedure

SETUP SELECT

CYCLE

SETUP PARA-

ABORT ADVANCE EXIT Default screen in-cycle (timed phase)

SETUP PARA-

CANCEL Setup menu

CANCEL OK SELECT CYCLE screen

CANCEL MORE

CANCEL HOME OK EDIT PARAMETERS screen [MORE

PARA-

METER

PARAM S

UNSEAL Startup or Default screen

UNSEAL Default screen CYCLE COMPLETE

MORE Default screen in-cycle

(after MORE is pressed)

ABORT Default screen in-cycle (untimed phase)

OK

or

SAVE

Quick Edit Parameters screen

PARAMS]

CANCEL +/- Edit Parameters dialog box

CANCEL EDIT OK VIEW PARAMETERS screen

CANCEL CAPS

LOCK

CANCEL DELETE OK ENTER PASSWORD screen

CANCEL HOME OK

YES NO Confirmation message box (if

CANCEL HOME System Menu options

CANCEL HOME BRIGHT

DEC

DELETE OK ADD USER, ACCESS AREAS or

MACHINE NAME screen

ALARM CLOCK, LANGUAGE DATE UNITS, or PANEL SETUP screens

preference is enabled) See “Setting Up the Display Panel” on

page B–49.

BRIGHT

INC

or

SAVE

OK ABOUT screen

Softkeys

USR 61301607026 Rev B US 3–11

Introduction

WS-0243-633HC

WS-0411-633HC

DISABLING OR ENABLING THE CONTROLS

The key lockout feature should be used during maintenance and any time a person needs to enter the sterilizer chamber.

WARNING

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.

To lockout (disable) the controls:

1. Turn the key located in the CONTROLS DISABLE/ENABLE switch to DISABLE.

If the CONTROLS OFF/ON button is depressed:

• The CONTROLS OFF/ON button darkens.

• The backlight display turns OFF.

• The controls turn OFF.

Otherwise, the controls and the backlight display remain OFF.

2. Remove the key and keep it with you.

To enable the controls:

1. Insert the key into the CONTROLS DISABLE/ENABLE switch.

2. Turn the key to ENABLE.

If the CONTROLS OFF/ON button is depressed:

• The CONTROLS OFF/ON button switch illuminates and remains depressed.

• The backlight display illuminates.

• The controls turn ON.

Otherwise, the controls and the backlight display remain OFF.

NOTE

The key cannot be removed from the CONTROLS DISABLE/ENABLE switch unless set to DISABLE.

3–12 USR 61301607026 Rev B US

TURNING THE CONTROLS ON OR OFF

WS-0091

CONTROLS OFF ON

To turn the backlight display and the controls ON:

1. Check that the controls are enabled. If not, enable them; see “Disabling or Enabling the Controls” on page 3–12.

2. Press the CONTROLS OFF/ON button.

• The switch illuminates and remains depressed.

• The backlight display illuminates.

• The controls turn ON.

NOTE

If the power is interrupted by pressing CONTROLS ON/OFF accidentally, turn the controls back ON. The cycle is not canceled if the controls are turned ON within 2 seconds.

633HC Steam Sterilizer

If primary power is interrupted (e.g., a circuit breaker trips), the cycle is not canceled if power is restored within 59 seconds.

To turn the backlight display and the controls OFF:

1. Press the CONTROLS OFF/ON button.

NAVIGATION BASICS

DIRECTIONAL ARROWS Each of the directional arrows has a specific function:

•up arrow ( ↑ )

– scrolls up a list on the current screen or window

– when the cursor is activated (blinking cursor), increases the digit or

value that is highlighted

•right arrow (→)

– moves the cursor on the current screen or window right to highlight

a field

•down arrow ( ↓ )

– scrolls down a list on the current screen or window

– when the cursor is activated (blinking cursor), decreases the digit

or value that is highlighted

•left arrow (←)

– moves the cursor on the current screen or window left to highlight

a field

USR 61301607026 Rev B US 3–13

Introduction

121.1 C

Exposure Temp

00:30:00

Drying Time

P10 grv GRAVITY1

01 STANDBY

00:30:00

Exposure Time

00:00:00 00:24:15

123456789 0

ABCDEFG HI J

KLMNOPQ R S T

UVWXYZ

!"#%&()\,; .:

+

SPACE

ÅÄÖÜ

-/ =

ENTER PASSWORD PASSWORD:

CANCEL

OK

DELETE

WS-0017 HC

ENTER Use the ENTER switch to:

• accept numbers and letters when entering passwords, machine names, or changing a parameter setting

• select an item from a list (such as a cycle from the list of available cycles, a menu option, or a parameter)

• store a cycle selection in memory

SELECTING AN ITEM FROM A LIST

ENTERING AN ALPHANUMERIC VALUE

Selecting an item from a list is very simple. Use the up and down arrows to select the item and press ENTER to store the selection in memory.

For more detailed instructions, see “Previewing and Selecting a Cycle” on page 4–3.

When an alphanumeric value needs to be entered, a screen similar to Figure 3–9 on page 3–14 displays.

FIGURE 3–9. KEYBOARD SCREEN

3–14 USR 61301607026 Rev B US

When the keyboard screen displays, the blinking cursor is positioned at the location of the first character of the string and the first key on the keyboard is highlighted. Use the directional arrows to navigate to the appropriate character; press ENTER to select the character. The selected character or # sign displays in the position of the blinking cursor and the blinking cursor moves to the right of the character. After entering the last character of the string, press [OK].

NOTE

The right/left directional arrows wrap, that is, pressing the right arrow when the last key in a row is highlighted selects the first key in the same row; and vice versa. The up/down directional arrows behave in a corresponding manner. You can use this feature to reduce the number of switch presses needed to enter the alphanumerica value.

633HC Steam Sterilizer

121.1 C

Exposure Temp

00:30:00

Drying Time

P10 grv GRAVITY1 01 STANDBY

00:30:00

Exposure Time

00:00:00

00:24:15

0

REMAINING TIME

Chamber Temp

14.68 PSI

Chamber PSIA

37.3 C

00:30:00

CANCEL

WS -0211 HC

Te

mp

PS

Chamber PSIA

3

C

Exposure Time

(00:01:00 - 06:00:00)

00:30:00 hh:mm:ss

Softkeys:

• [CANCEL] returns to the previous screen without accepting the alphanumeric value.

• [DELETE] deletes the character to the left of the cursor.

• [OK] accepts the alphanumeric value and, in the case of the password, displays the next screen if a valid password is entered.

For more detailed instructions, see:

• “Entering a Password” on page B–2

• “Setting Up a User Account” on page B–10

• “Changing a User Password” on page B–17

• “Editing the Cycle Number” on page B–38

• “Editing the Cycle Name” on page B–39

• “Assigning the Sterilizer Name” on page B–44

ENTERING VALUES IN DIALOG BOXES

You change the values of cycle parameters by entering the new values in dialog boxes. When a dialog box displays over a process screen, the cursor is flashing, ready for you to enter the new value:

• Use the left and right arrows to select the field you want to change.

• Use the up and down arrows to enter the new value.

• Press ENTER to accept the changes, close the dialog box, and return the screen to save mode.

FIGURE 3–10. DIALOG BOX FOR VALUE ENTRY

7

68

After the dialog box closes, press [SAVE] to record the new value into memory and return the screen to read mode. For more detailed instructions, see “Editing Cycle Parameters” on page B–20.

USR 61301607026 Rev B US 3–15

Introduction

NOTE

The dialog box displays the range of allowable values within parentheses. If you enter a value that is outside this range and press ENTER, the dialog box does not close but remains open for you to enter a value that is within the range.

RESPONDING TO YES/NO MESSAGE BOXES

EXITING FROM A SCREEN There are three commands used to exit from a screen:

Yes/No message boxes appear over process screens and are used to confirm changes made by the user (e.g., Confirm Save/Cancel). The user responds to the message box by pressing either the [YES] or [NO] softkey at the bottom of the process screen.

For more detailed instructions, see “Setting Up the Display Panel” on page B–49.

• [CANCEL] returns to the previous screen without saving changes.

• [HOME] returns to the Process screen and logs out the current user.

• [OK] returns to the previous screen.

In the case of the ENTER PASSWORD screen, pressing [OK] displays the screen that corresponds to the function selected (when a valid password is entered).

NOTE

If both [OK] and [CANCEL] softkeys display:

1. Press [OK] to return to the previous screen.

2. When in edit mode (cursor blinking), press [CANCEL] to return to the previous screen without saving any changes.

When not in edit mode, press [CANCEL] to return to the previous screen.

If both [OK] and [CANCEL] (or [SAVE] and [CANCEL]) softkeys display, the CONFIRM CANCEL? YES OR NO prompt displays when [CANCEL] is pressed.

The CONFIRM CANCEL? prompt can be turned off by changing the CONFIRM SAVE/CANCEL setting on the PANEL SETUP screen. See “Setting Up the Display Panel” on page B–49.

3–16 USR 61301607026 Rev B US

OPERATING THE PRINTER

633HC Steam Sterilizer

At the beginning of the cycle, the printer records the date and time the cycle was started, sterilizer name and ID number, cycle count, and cycle parameter settings.

During the cycle, the printer records the chamber temperature and chamber pressure at each transition point (start of a new phase), as well as the time of the transition. During exposure, the temperature and pressure are printed twice per minute. The program time is reset at the start of each cycle.

NOTE

The slow print interval (the time between data recordings) is factory set at 1 minute. The fast print interval (the time between recordings during exposure) is factory set at 30 seconds. The print intervals can be shortened (to record more data) or lengthened (to conserve paper) by qualified service personnel.

The temperature and pressure units (°C or °F; psi, kPa, or bar) can be configured by a user with Configuration password access. See “Selecting the Language, Date Format, and Units” in the Appendix “Supervisor Functions.”

The column layout of the printout can be configured by qualified service personnel.

The printer also records any diagnostic messages that occur during the cycle, and the time they occurred.

NOTE

Occasionally with the initial introduction of AC power to the sterilizer, the message “LOW POWER BROWN OUT” may occur on the printout. This message is normal under power up conditions and no further action is required.

When removing the load from the sterilizer at the end of the cycle, be sure the printer’s plastic cover is closed. This prevents residual steam from condensing on the printout or inside the cover.

If the printer’s plastic cover is open and residual steam condenses on the printout, it causes darkening of the thermosensitive paper.

The printer has a paper take-up core which holds a complete roll of paper. If printouts of separate loads are required, this core can be removed. The printout remains behind the paper cover until the user opens the cover and tears off the printout.

USR 61301607026 Rev B US 3–17

Introduction

STATUS

COPY

FEED

SHAFT

TAB

NOTCH

SLOT

CORE

ROLL

COVER

LEVER

CLEAR

COVER

RETAINER

00-01A

COVER SLOT

A00866BC

OFF = NO POWER

ON = READY

BLINKING = PRINTER NOT READY,

PAPER NOT PROPERLY INSERTED, OR ROLL COVER OPEN

FIGURE 3–11. PRINTER

STATUS INDICATOR The STATUS indicator on the printer blinks when the printer is out of paper

or there is a paper jam.

FIGURE 3–12. STATUS INDICATOR

ADVANCING THE PAPER To advance the paper through the printer, press and hold FEED.

To stop the paper advance, release FEED.

To take up slack paper without advancing more paper:

1. Press and release FEED. Then immediately press and hold FEED.

The core takes up slack paper.

2. Release FEED.

USING THE LEVER

3–18 USR 61301607026 Rev B US

The lever helps remove the core. See Figure 3–11. To remove a full core, press the lever in the direction of the arrow. This opens the retainer.

SAVING PRINTOUTS There are three ways to save printouts:

STATUS

00-01f

STATUS

00-01H

STATU S

00-01G

• full roll—to collect a complete roll on the core

Insert the paper into the slot on the core, and remove the core when it is full. See “Replacing the Printer Paper” on page 3–19.

• small sections—to collect printouts of shorter periods, such as daily use

When loading paper, do not insert a new core. Instead, feed the paper to the area by the shaft. When information is printed, open the clear cover and tear off the printout.

• separate printouts—to collect individual printouts for each cycle

For separate small printouts, feed the paper out through the cover slot. During use, keep the clear cover closed. Before opening the sterilizer door, tear off the printout after each cycle.

633HC Steam Sterilizer

TEARING OFF PRINTER PAPER To tear off the printout for individual cycle records:

1. Press FEED for approximately one second.

This advances the paper beyond the SIGNATURE line of the printout.

2. Open the printer cover.

3. Tear off the printout against the tear blade at the top of the printer.

4. Close the printer cover.

REPLACING THE PRINTER PAPER

To replace the printer paper roll (Figure 3–13 on page 3–20):

1. Remove the used take-up core. See “Removing the Used Take-up Core” on page 3–21.

2. Insert a new take-up core. See “Inserting a New Take-up Core” on page 3–21.

3. Insert a new roll. See “Inserting a New Roll” on page 3–21.

4. Load the paper. See “Loading the Paper” on page 3–21.

For small section or separate printouts, see “Saving Printouts” on page 3–19.

For information on ordering printer paper and cores, see Appendix A, “Consumable Stock and Spare Parts”.

USR 61301607026 Rev B US 3–19

Introduction

00-01-D

STATUS

REMOVE THE USED TAKE-UP CORE

STATUS

ALIGN NOTCHES

WITH TABS

INSERT A NEW TAKE-UP CORE

STATUS

INSERT A NEW ROLL

• PRESS AND RELEASE

• THEN PRESS AND HOLD FOR 1 REVOLUTION

STATUS

LOAD THE PAPER

FIGURE 3–13. REPLACING THE ROLL

3–20 USR 61301607026 Rev B US

633HC Steam Sterilizer

REMOVING THE USED TAKE-UP CORE

The printer has a take-up core which holds a complete roll of paper. The printout remains behind the clear cover until the cover is opened and the printout is torn off or the paper roll removed.

1. Open the clear cover.

2. Press and hold the lever in the direction of the arrow.

3. Remove the used core.

NOTE

If printouts of separate loads are required, the take-up core can be removed.

INSERTING A NEW TAKE-UP CORE

1. Still holding the lever, align the notches on the new core with the tabs on the shaft. See Figure 3–13 on page 3–20.

2. Release the lever. Seat the new core against the retainer.

INSERTING A NEW ROLL

1. Open the roll cover.

2. Remove the old roll.

3. Insert the new roll as shown.

4. Pull out about 6 inches of paper.

Be sure the plain side of the paper faces you.

LOADING THE PAPER

1. Close the roll cover.

2. Fold the paper as shown in Figure 3–14 on page 3–22.

USR 61301607026 Rev B US 3–21

Introduction

00-01B

FOLD

FIGURE 3–14. FOLD THE PAPER

3. Rotate the new core so the slot faces you.

4. Insert the paper into the slot.

5. Press and release FEED. Then immediately press and hold FEED.

STORING AND HANDLING PAPER ROLLS

PRINTING A DUPLICATE RECORD

• The core turns.

• Take up the paper at least one full revolution.

6. Release FEED. Close the clear cover.

NOTE

The printer uses a special heat-sensitive paper. The printer does not print on rolls of plain paper.

The paper should not be exposed to temperatures above 104°F (40°C) for extended periods of time. Exposure to direct sunlight for several weeks or longer may darken the paper, making the printout difficult to read.

Direct contact with steam discolors the paper, making the printout difficult to read. Always close the clear protective cover after replacing the paper roll or removing printouts from the take-up compartment.

To print a duplicate of the previous cycle record:

1. When the sterilizer is not running a cycle, press and release COPY.

The duplicate record prints.

3–22 USR 61301607026 Rev B US

NOTE

COPY functions only from the end of a cycle until the start of the next cycle. Pressing CYCLE START clears the printer memory.

During a cycle, COPY is disabled.

READING THE CYCLE PRINTOUT

A sample cycle printout of a vacuum cycle run on a 633HC Steam Sterilizer is shown in Figure 3–15 on page 3–26. The proper interpretation of the information produced during a cycle is the subject of this section.

NOTE

When a printout of a cycle is produced, the cycle start is near the bottom of the printout and the end of the cycle is near the top. When reading the printout, always read from bottom to top.

633HC Steam Sterilizer

CYCLE START AND PARAMETERS

The sample printout shown in Figure 3–15 is from a vacuum cycle. Different sterilization cycles produce printouts with slightly different information, but time stamps and pressure and temperature readings are all read in the same way.

There are 2 printer rates (fast log and slow log). The factory set parameters are:

• Fast Log prints every 30 seconds during the exposure phase.

• Slow Log prints every 60 seconds during phases other than exposure.

Slow and Fast Log intervals may be adjusted by qualified service personnel.

All times are elapsed time (the amount of time that has elapsed since the start of the cycle) except for PROCESS START and PROCESS END.

Callout 1 shows a line of text that indicates that a new cycle has started (DATE:).

The information between Callout 1 and Callout 3 lists some of the parameters for the cycle. As an example, Callout 2 shows the EXPOSURE TIME for the current cycle (00:03:00). The EXPOSURE TIME is the amount of time the EXPOSURE TEMP is maintained.

Callout 3 shows the name of the current cycle. In this example, the cycle is a vacuum cycle named P1 vac PREVAC1.

PHASES Each time a phase within a cycle starts, the phase name is recorded on the

printout. In the sample printout, Callout 4 shows the beginning of the EXPOSURE phase.

USR 61301607026 Rev B US 3–23

Introduction

Immediately above the word EXPOSURE, the printout displays the time stamp for the start of the phase, along with the chamber pressure and temperature. In this example, the printout shows the EXPOSURE phase started at 00:07:46 into the cycle, and, at that time, the chamber pressure was 45.86 psia and the chamber temperature was 135.5°C.

During timed phases, the printer reports the appropriate cycle information including chamber pressure, and chamber temperature readings at regular intervals. EXPOSURE uses the fast log rate, factory set at 30 seconds. Therefore, after the start of EXPOSURE at 00:07:46, there are readings at 00:08:17, 00:08:47, and so forth. The sample printout is truncated to fit on the page; a complete printout displays the pressure and temperature readings every 30 seconds for the entire 3 minute phase.

When the cycle changes from one phase to the next, the new phase name is printed along with the time stamp at which the phase begins, as well as the chamber pressure and temperature readings. In this example, Callout 5 shows the EXHAUST phase starting at 00:10:47 into the cycle. The beginning of the new phase (EXHAUST) also marks the end of the previous phase (EXPOSURE).

VALIDATING THE EXPOSURE PHASE

NOTE

Phases do NOT overlap.

Different cycles feature different phases and parameters.

Unlike the EXPOSURE phase where readings are printed at the fast log rate, the EXHAUST phase readings are reported at the slow log rate.

The following paragraphs use the cycle parameters and results to validate the EXPOSURE phase.

The start time stamp of each phase within a cycle is printed. Therefore, it is possible to determine the total time of any given phase. In Figure 3–15, Callout 4 shows the EXPOSURE phase starting at 00:07:46 into the cycle and Callout 5 shows the EXHAUST phase starting at 00:10:47 into the cycle. The total exposure time is the difference between the two start times, or 00:03:01. This is validated by the EXPOSURE TIME parameter in Callout 2, which reads 00:03:00.

Examining the EXPOSURE TEMP parameter appearing above Callout 2 reveals the P1 vac PREVAC1 cycle requires an exposure temperature of

135.0°C. During the EXPOSURE phase the temperatures recorded are between 135.4°C and 135.5°C, which are within acceptable sterilization variances.

This information shows the EXPOSURE phase is valid because 135.0°C was achieved and maintained for a time of at least 00:03:00.

3–24 USR 61301607026 Rev B US

633HC Steam Sterilizer

CYCLE END

Callout 7 shows a line that reads CYCLE COMPLETE followed by a line with a time stamp, chamber pressure, and chamber temperature readings. This is the end of the P1 vac PREVAC1 cycle.

CYCLE RESULTS

Pertinent information regarding the cycle is displayed together for ease of use. The information includes:

• the number of cycles completed; this counter resets everyday at midnight (DAILY COUNTER)

• the amount of time the sterilizer was at the exposure temperature (TIME AT EXP TEMP)

• the minimum (EXP TEMP MIN) and maximum (EXP TEMP MAX) exposure temperature that occurred during the cycle

USR 61301607026 Rev B US 3–25

Introduction

WS-0053-633HC

1. DATE (the date the cycle starts) Read the tape from bottom to top.

2. Set Exposure time

3. Cycle name

4. The time that has elapsed from the start of the cycle to the beginning of the Exposure phase (the exposure start time)

5. The time that has elapsed from the start of the cycle to the beginning of the Exhaust phase (the exhaust start time)

7. The time that has elapsed from the start of the cycle to the end of the cycle

DRYING phase

runs/prints for 16 min

EXPOSURE phase

runs/prints for 3 min.

PROCESS START

(the time of day

the cycle starts)

Top of Printout/End of Cycle

Bottom of Printout/Start of Cycle

PROCESS END

(the time of day the cycle ends)

6. Total exposure time

00:10:47 (exhaust start time)

- 00:07:46 (exposure start time) 00:03:01 Tot al exposure time

00:27:59 12.58 101.0 CE UNSEALING 00:27:47 4.50 99.5 AIR-IN 00:26:47 0.61 100.9 00:25:47 0.61 101.0 00:24:47 0.60 102.1 01:06:43 4.26 71.9 00:11:40 4.61 76.0 DRYING 00:10:47 45.87 135.5 EXHAUST 00:10:47 45.88 135.5 00:10:17 45.90 135.5 00:08:47 45.85 135.5 00:08:17 45.83 135.4 00:07:47 45.82 135.5 00:07.46 45.86 135.5 EXPOSURE 00:07:00 44.28 134.3 00:06:00 38.92 129.7 00:05:00 5.66 72.8 00:04:57 4.55 73.5 HEAT-UP

NEG TRANS. PT.

00:02:20 9.58 90.2 00:02:00 19.79 114.0

POS. TRANS. PT. 00:01:47 32.27 122.7 00:01:31 23.81 119.2 CONDITIONING 00:01:00 24.79 116.1 00:00:00 14.37 88.5 PURGE 00:00:00 14.36 88.5 STAR T PROGTIME AI05 AI00

PROGRAM: P1 vac PREVAC1

AI00 Chamber Temp AI05 Chamber Pressure SIGNALS

Exposure Temp 135.0 C BlowDown Durat 00:00:10 Drying Time 00:16:00

Dry 1-=vac 2=grav2 2

Exposure Time 00:03:00 PARAMETERS

CYCLE COUNTER : 355 MACHINE NAME : 633 HC PROCESS START : 10:46:01 DATE : 09/29/2006

SIGNATURE:................

PROCESS END 11:1 5:0 6 CYCLE RESULTS Exp. Temp Max 135.5C Exp. Temp Min 135.3C Time at Exp Temp 00:03:13 DAILY COUNTER 1

00:28:34 14.33 101.4 CYCLE COMPLETE

FIGURE 3–15. SAMPLE PRINTOUT OF A STERILIZER CYCLE

3–26 USR 61301607026 Rev B US

SEQUENCE OF OPERATION

SECTION 4 OPERATION

This section covers the sequence a user may follow when sterilizing a load:

Procedure Page

Start of Day Checklist 4–2

Turning the Controls ON 4–2

Previewing and Selecting a Cycle 4–3

Opening and Closing the Sterilizer Door 4–7

Load Preparation 4–9

Techniques for Loading 4–11

Loading Accessories 4–14

Loading the Sterilizer 4–22

Processing a Cycle 4–23

End of Cycle Routine 4–25

Unloading the Sterilizer 4–27

End of Day Checklist 4–29

This section also covers routine procedures including:

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

Opening the Door Manually 4–40

Performance Testing 4–53

USR 61301607026 Rev B US 4–1

Operation

OPERATING THE STERILIZER

START OF DAY CHECKLIST

WARNING

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.

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.

Before operating the sterilizer each day:

1. Check the printer paper roll and replace it if necessary. See “Replacing the Printer Paper” on page 3–19.

2. Inspect and clean the sediment screen in the chamber drain. See “Cleaning the Sediment Screen” on page 7–2.

TURNING THE CONTROLS ON For information regarding the controls, see “Turning the Controls ON or

OPERATIONAL READINESS

3. Clean the bleed drain guards. See “Cleaning the Bleed Drain Guards” on page 7–3.

OFF” on page 3–13.

NOTE

If the sterilizer is equipped with a steam boiler, allow the boiler to warm up for 20 to 30 minutes before running a cycle.

To ensure that the sterilizer is ready for processing without requiring a warm-up period:

• Leave the sterilizer ON during regular periods of sterilizer inactivity.

• Close but do not seal the sterilizer door(s).

Conduct an air removal performance test (Bowie and Dick Test) if the daily schedule includes a prevacuum wrapped goods cycle. See “Bowie and Dick Test” on page 4–53.

4–2 USR 61301607026 Rev B US

633HC Steam Sterilizer

121.1 C

Exposure Temp

00:30:00

Drying Time

P10 grv GRAVITY1 01 STA NDBY

00:30:00

Exposure Time

00:00:00

00:24:15

0

REMAINING TIME

Chamber Temp

14.68 PSI

Chamber PSIA

37.3 C

WS-0014 HC

PARA-

METER

SETUP

UNSEAL

SELECT

CYCLE

PREVIEWING AND SELECTING A CYCLE

When making a cycle selection, pressing ENTER displays the exposure time, exposure temperature, drying time, and the name of the selected cycle at the top of the SELECT CYCLE screen. See Figure 4–2 on page 4–4. This feature permits the preview of several different cycle settings before final selection.

After previewing the cycle, press [OK] to select the cycle.

NOTE

The information that appears in the Process screen depends on the type currently selected (Details, Plot Graph, or Bar Graph).

Press [CANCEL] at any time to return to the Process screen without selecting a cycle.

FIGURE 4–1. PROCESS SCREEN (BAR GRAPH)

To select a cycle:

1. From the Process screen, press [SELECT CYCLE].

The SELECT CYCLE screen appears.

USR 61301607026 Rev B US 4–3

Operation

SELECT CYCLE

P01

P02 P03 P04 P05 P06 P07

vac PREVAC1

vac PREVAC1 vac PREVAC1 vac PREVAC1 vac PREVAC1 vac PREVAC1 vac PREVAC2

WS-0156 HC

CANCEL

OK

Press ENTER to view the parameters for the highlighted cycle.

Use the up/down arrows to highlight a cycle.

Press [CANCEL] at any time to return to the Process screen without selecting a cycle.

Press [OK] to conrm the selected cycle.

FIGURE 4–2. SELECT CYCLE SCREEN

00:30:00

Exposure Time

P10 grv GRAVITY1 01 STA NDBY

SELECT CYCLE

Chamber Temp

P01

vac PREVAC1

P02

vac PREVAC1

37.3 C

P03

vac PREVAC1

P04

vac PREVAC1

P05

vac PREVAC1

P06

vac PREVAC1

P07

vac PREVAC2

CANCEL

121.1 C

Exposure Temp

0

REMAINING TIME

Chamber PSIA

00:30:00

Drying Time

14.68 PSI

00:00:00 00:24:15

OK

WS-0446 HC

2. Use the up and down arrows to scroll the list of cycles.

The black scroll bar at the right side of the screen indicates more cycles exist than can fit on one screen. Continued scrolling refreshes the screen and displays any additional cycles.

Stop scrolling when the desired cycle is highlighted.

4–4 USR 61301607026 Rev B US

3. Press ENTER to preview the cycle parameters.

The cycle name and cycle parameters appear at the top of the display.

FIGURE 4–3. SELECTING A CYCLE

00:03:00

Exposure Time

P1 vac PREVAC1 01 STA NDBY

Chamber Temp

37.3 C

135.0 C

Exposure Temp

Chamber PSIA

00:16:00

Drying Time

14.68 PSI

00:00:00

00:24:15

0

REMAINING TIME

633HC Steam Sterilizer

4. Verify the cycle parameters are correct for the load.

• If correct, press [OK] to confirm the cycle.

• If not correct, repeat step 2 and step 3 until the correct cycle is selected.

NOTE

Press [CANCEL] at any time to return to the Process screen without selecting a cycle.

The Process screen displays.

NOTE

If a cycle is highlighted without pressing ENTER, pressing [OK] confirms the last cycle entered instead of the cycle currently highlighted.

USR 61301607026 Rev B US 4–5

Operation

OPERATING THE STERILIZER DOOR

WARNING

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).

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).

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).

BURN/PINCH HAZARD: KEEP HANDS AND FINGERS AWAY FROM A MOVING DOOR. To stop the door direction if your hands or fingers are caught in the door accidently:

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

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.

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.

POSSIBILITY OF INJURY: Do not operate the door while loading or unloading the sterilizer.

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.

4–6 USR 61301607026 Rev B US

633HC Steam Sterilizer

WARNING

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.

CAUTION

POSSIBILITY OF DAMAGE TO EQUIPMENT: Use of sealed, unvented containers to process liquids can result in permanent damage to the sterilizer.

SAFETY FEATURES These safety features apply to all units under normal conditions:

• The user cannot close the chamber door when CONTROLS DISABLE/ ENABLE is set to DISABLE.

• The user cannot unseal a door while a cycle is processing.

• If a door is not fully closed, the user cannot seal it.

• If a door does not seal, the cycle does not start.

OPENING AND CLOSING THE STERILIZER DOOR

• If there is pressure or vacuum in the chamber at the end of the cycle, the user cannot unseal the door.

A motor raises and lowers the door, but does not seal the door. The door is sealed when START is pressed.

NOTE

The door can also be sealed by pressing CLOSE DOOR again when the door is already closed.

WARNING

BURN/PINCH HAZARD: KEEP HANDS AND FINGERS AWAY FROM A MOVING DOOR. To stop the door direction if your hands or fingers are caught in the door accidently:

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

USR 61301607026 Rev B US 4–7

Operation

NOTE

Wait for approximately 1 minute for the steam to vent before opening the door.

To open the door:

1. Press OPEN DOOR once.

Stand away from the door area while the door is in motion.

To close the door:

1. Press CLOSE DOOR once.

Stand away from the door area while the door is in motion.

When the door is closed and START is pressed, the door seals automatically and the selected cycle begins. When a cycle is complete, the door unseals automatically, but remains closed until OPEN DOOR is pressed.

4–8 USR 61301607026 Rev B US

LOAD PREPARATION

633HC Steam Sterilizer

WARNING

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.

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).

POSSIBILITY OF INJURY: The liquids cycle is NOT intended for the sterilization of liquids intended for direct patient contact.

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.

CAUTION

POSSIBILITY OF DAMAGE TO EQUIPMENT: Use of sealed unvented containers to process liquids can result in permanent damage to the sterilizer.

NOTE

RIGID CONTAINER SYSTEM USERS: Contact the Rigid Container System Manufacturer to determine validated cycle parameters and proper loading of contents into the containers. It may be necessary to adjust factory settings of the sterilizer to match the manufacturer’s parameters for the container.

The 633HC Steam Sterilizer is designed to steam-sterilize hospital goods and solutions. Typical load types include:

• non-porous hard goods, including instruments, basins, cups, tools, test tubes, and glassware

• wrapped/unwrapped porous goods, including cloth, towels, gowns, and sheets

• wrapped porous goods, including instruments, basins, and tools

• non-flammable/non-volatile liquids in self-venting or open containers

The liquids cycle is not intended for sterilization of liquids intended for patient contact.

Clean, package, and load items according to established procedures for your workplace. Refer to AAMI Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

USR 61301607026 Rev B US 4–9

Operation

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:

WARNING

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.

CAUTION

POTENTIAL DAMAGE TO THE STERILIZER:

• Processing caustic chemicals inside sterilizers is not recommended.

• NaOH is corrosive to copper and brass and has the potential to damage the chamber and lower piping.

4–10 USR 61301607026 Rev B US

TECHNIQUES FOR LOADING

633HC Steam Sterilizer

WARNING

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).

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.

CAUTION

POSSIBILITY OF DAMAGE TO EQUIPMENT: Use of sealed unvented containers to process liquids can result in permanent damage to the sterilizer.

The following recommendations apply both to the loading car and transfer carriage (see Figure 4–4 on page 4–15) and to the rack and extendable shelves (see Figure 4–10 on page 4–20):

• All packages must be positioned in the chamber to allow free circulation and penetration of steam, enhance air elimination, and prevent entrapment of air or water.

• Do not overload the loading car or shelves. When placing items on the car or shelves, be sure there is enough space for free circulation of steam around each pack and each item. This also ensures adequate air elimination, steam penetration, and drainage of condensate, which are all needed to attain product sterility.

• Items capable of holding water, such as basins and trays, should be oriented in the same direction and arranged so that any condensate drains out. Wicking material such as absorbent towels should be used to absorb condensate.

• Large or heavy metal items should be placed on the lowest shelf to enable the condensate to drain out without wetting other items in the load.

• When using non-woven wrap, ensure there are no low spots that might hold condensation.

• When processing liquids in open containers, fill the containers to only 75% of capacity (e.g., 750 mL for a 1 liter container). This limits the liquid loss to < 6% of the volume.

• Heat penetration of liquid solutions is affected by both liquid volume and container geometry. To ensure effective sterilization processing, liquid loads should be of a uniform volume and container size.

USR 61301607026 Rev B US 4–11

Operation

TABLE 4–1. 633HC STEAM STERILIZER LOAD CHART

Cycle Type

vac PREVAC 1

vac PREVAC 2

vac B & D TEST

grv GRAVITY 1

grv GRAVITY 2

No. of

Avail-

able

Cycles

6 275°F

2 275°F

1 273°F

3 250°F

3 275°F

Factory Settings

Exp.

Te mp .

(135°C)

(134°C)

(121°C)

(135°C)

Maximum Items per

Exp.

Time

3 min 16 min Double-wrapped

3 min 3 min Fabric packs 8 18 24

3 min,

30 sec

30 min 30 min Double-wrapped

10 min 30 min Double-wrapped

Dry

Time

0 min S.M.A.R.T. Pack or

Load Configuration

1

instrument trays, up to 16 lbs (per tray)

Fabric packs 8 18 24

equivalent (1 max.) in an EMPTY chamber

instrument trays, up to 16 lbs (per tray)

Fabric packs 8 18 24

instrument trays, up to 16 lbs (per tray)

2

Chamber Length

26 in.

(0.660 m)

4812

1 Test

Pack

4812

39 in.

(1.0 m)

1 Test

Pack

51 in.

(1.3 m)

1 Test

Pack

f3 FLASH 3+

f10 FLASH 10+

liq LIQUIDS

3

lk LEAK TEST

2 275°F

(135°C)

2 275°F

(135°C)

1 250°F

(121°C)

1 268°F

(131°C)

3 min 30 sec

10 min 30 sec

45 min 0.75

psi/min

3 min 15 min

dry,

5 min

dwell,

15 min

test

Fabric packs 8 18 24

5

Unwrapped, non-porous single instrument

Unwrapped, non-porous instrument trays, up to 16 lbs (per tray)

6

Unwrapped, porous or non-porous single instrument

Unwrapped, porous and non-porous instrument trays, up to 16 lbs (per tray)

Each container 1000 mL

4

or smaller

Empty chamber — — —

5

111

222

111

222

60 80 100

4–12 USR 61301607026 Rev B US

633HC Steam Sterilizer

TABLE NOTES

Load configurations follow AAMI Standard ST8: Hospital steam sterilizers where applicable.

1

Factory set drying time is the recommended minimum drying time. Extended drying time may be required depending on local conditions. Gravity cycle drying time may be reduced by selecting vacuum drying phase.

2

Refer to AAMI Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

3

Vacuum leak test cycle parameters are not adjustable.

4

Cooldown rate

5

Your facility must validate the cycle if the load includes containers larger than 1000 mL.

6

Items may NOT be dry. Dry time may be added if required.

FLASH STERILIZATION

WARNING

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).

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.

Review the contents of AAMI Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities and/or CDC Guideline for Handwashing and Hospital Environmental Control to

create health care facilities policies and procedures for flash sterilization and sterilization of implantable devices.

AAMI Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities is available on the Internet at

www.aami.org.

Center for Disease Control (CDC) Guideline for Handwashing and Hospital Environmental Control is available on the Internet at www.cdc.gov.

USR 61301607026 Rev B US 4–13

Operation

LOADING ACCESSORIES

The following loading accessories are available for these specific models:

Model Accessories

OPERATING THE LOADING CAR AND THE TRANSFER CARRIAGE

26 in. (660 mm)

chamber

39 in. (1000 mm)

chamber

51 in. (1300 mm)

chamber

NOTE

Units equipped for racks and shelves do not accept a loading car and transfer carriage.

WARNING

HOT SURFACES: The loading car may be hot enough to cause burns. Wear protective gloves and eyewear when loading and unloading the chamber.

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.

Rack and 2 shelves

Rack and 2 shelves or Loading car and transfer carriage

Loading car and transfer carriage

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.

CAUTION

POSSIBILITY OF DAMAGE TO EQUIPMENT: Do not place items on the floor of the chamber; this can block the drain and result in non-sterile or damaged loads. Always use the loading car or shelf.

4–14 USR 61301607026 Rev B US

633HC Steam Sterilizer

FIGURE 4–4. LOADING CAR AND TRANSFER CARRIAGE

Loading

Car

Transfer

Carriage

A07026-B

To transfer the loading car to the chamber:

1. Align the loading car and transfer carriage directly in front of the open chamber.

2. Move the transfer carriage forward until it stops against the rail.

USR 61301607026 Rev B US 4–15

Operation

WS-0415

Locking Handle

in Locked Position

(down)

Loading Car Shown with

the Four-Shelf Option

Locking Handle

Instruction Label

WS-0419

FIGURE 4–5. LOCKING THE TRANSFER CARRIAGE

NOTE

An instruction label showing the correct locked and unlocked positions of the locking handle is located on the transfer carriage. See Figure 4–5 and Figure 4–6.

FIGURE 4–6. LOCKING HANDLE INSTRUCTION LABEL

3. Turn the locking handle counterclockwise to lock the transfer carriage to the sterilizer rail. See Figure 4–5.

4. Pull the transfer carriage to check that it is locked securely. If it is locked correctly, it cannot be pulled away from the sterilizer.

4–16 USR 61301607026 Rev B US

633HC Steam Sterilizer

WS-0416

Locking Handle

in Locked Position (down)

Turn CW to Unlock

FIGURE 4–7. PUSHING THE LOADING CAR INTO THE STERILIZER

5. Push the loading car onto the rail in the sterilizer until it does not go any

farther.

USR 61301607026 Rev B US 4–17

Operation

WS-0417

Locking Handle

in Unlocked Position (up)

FIGURE 4–8. PULLING THE TRANSFER CARRIAGE AWAY FROM THE STERILIZER

6. Release the transfer carriage from the rail by turning the locking handle clockwise.

7. Pull the carriage away from the sterilizer.

REMOVING A LOADING CAR FROM THE CHAMBER

WARNING

HOT SURFACES: The loading car may be hot enough to cause burns. Wear protective gloves and eyewear when loading and unloading the chamber.

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.

4–18 USR 61301607026 Rev B US

633HC Steam Sterilizer

WS-0418

Locking Handle

in Unlocked Position

(up)

Loading Car Shown with

the Four-Shelf Option

To remove the loading car from the chamber:

1. Align the transfer carriage directly in front of the open chamber and

lock the carriage with the locking handle. See Figure 4–7 on page 4–17.

2. Pull the transfer carriage to check that it is locked securely. If it is locked

correctly, it cannot be pulled away from the sterilizer.

3. Pull the loading car out of the sterilizer until it stops at the end of the

transfer carriage.

FIGURE 4–9. UNLOCKING THE TRANSFER CARRIAGE

4. Turn the locking handle clockwise. This secures the loading car to the

transfer carriage at the same time the carriage is unlocked from the sterilizer.

5. Check that the loading car is secured correctly by pushing it toward the

sterilizer. The loading car cannot be moved if it is secured correctly.

6. Pull the transfer carriage away from the sterilizer.

USR 61301607026 Rev B US 4–19

Operation

DO NOT EXCEED 20 POUNDS

ON EXTENDED SHELVES

20 lb MAX

shelf-caution1

DO NOT EXTEND SHELVES

CONTAINING BOTTLES

Extendable

Shelves

Rack

(100 lb total load

all shelves)

WS-0093 633

RACK AND EXTENDABLE SHELVES

The rack and extendable shelves are constructed of 300 series stainless steel. The shelves are removable to facilitate cleaning. The rack can hold up to four shelves. Two shelves are supplied; additional shelves may be purchased as an option.

WARNING

HOT SURFACES: The rack and shelves may be hot enough to cause burns. Wear protective gloves when loading and unloading the chamber.

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).

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.

FIGURE 4–10. RACK AND EXTENDABLE SHELVES

4–20 USR 61301607026 Rev B US

633HC Steam Sterilizer

CAUTION

POSSIBILITY OF DAMAGE TO EQUIPMENT: Do not place items on the floor of the chamber; this can block the drain and result in non-sterile or damaged loads. Always use the loading car or shelf.

NOTE

Routine cleaning prolongs the useful life of the shelves, because chlorides from the steam or spillage from liquid loads may otherwise corrode 300 series stainless steel. See “Cleaning the Chamber Interior” on page 7–4.

For information on positioning the shelves, see “Installing a Shelf” on page 7–8 and “Removing a Shelf” on page 7–9.

USR 61301607026 Rev B US 4–21

Operation

LOADING THE STERILIZER

WARNING

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.

POSSIBILITY OF INJURY: Do not operate the door while loading or unloading the sterilizer.

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.

POSSIBILITY OF INJURY: Wear protective eyewear, clothing, and gloves when handling liquids in containers.

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.

CAUTION

POSSIBILITY OF DAMAGE TO EQUIPMENT: Use of sealed, unvented containers to process liquids can be result in permanent damage to the sterilizer.

To load the sterilizer:

1. Open the door if necessary. See “Operating the Sterilizer Door” on page 4–6.

2. Place the load into the chamber. See “Operating the Loading Car and the Transfer Carriage” on page 4–14 or “Rack and Extendable Shelves” on page 4–20.

NOTE

Always place the load on a shelf or rack. Do not place the load on the floor of the chamber.

3. Close the door. See “Opening and Closing the Sterilizer Door” on page 4–7.

4–22 USR 61301607026 Rev B US

PROCESSING A CYCLE

633HC Steam Sterilizer

WARNING

RISK OF NON-STERILE DEVICE AND POSSIBILITY OF INJURY: Before pressing START, verify that the appropriate cycle is selected for the load being processed.

POSSIBILITY OF INJURY: If the wrong cycle is selected for a liquid load, the containers may burst or crack during processing.

RISK OF NON-STERILE DEVICE: If the wrong cycle is selected, the desired sterility assurance level (SAL) may not be reached.

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).

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).

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).

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.

CAUTION

POSSIBILITY OF DAMAGE TO EQUIPMENT: Use of sealed, unvented containers to process liquids can be result in permanent damage to the sterilizer.

NOTE

If the control panel shows UTILITY SHUTDOWN, see “Bypassing Utility Shutdown Mode” on page B–38.

To begin the sterilization cycle:

1. After the sterilizer is loaded, close the door.

2. Check that the START button LED is flashing. This indicates it is OK to

start the sterilizer.

3. Verify that the correct cycle for the load type is selected.

USR 61301607026 Rev B US 4–23

Operation

!

4. After the load is placed within the sterilizer chamber, edit the cycle parameters as necessary. A password is required to edit cycle parameters.

NOTE

For information regarding editing a cycle parameter, see “Editing Cycle Parameters” on page B–20.

5. Press START.

a. The door(s) seal automatically (if not previously sealed) and the

DOOR(S) SEALED LED illuminates.

b. During the cycle, the IN PROCESS LED illuminates and the

chamber temperature and the elapsed time in each phase display on the screen.

6. At the end of the cycle, the PROCESS COMPLETE LED illuminates and the buzzer sounds.

• The buzzer silences automatically after 1 min or earlier if the door is opened.

• If the LED appears green, the cycle is complete.

• If the LED appears flashing red, the cycle was aborted.

• If a process failure occurs, the PROCESS FAILURE LED flashes, an alarm sounds, the process aborts, and a diagnostic message appears on the printout.

Press CLEAR ALARM to silence the alarm.

See “Diagnostic Messages” on page 6–8 for corrective action.

NOTE

The failure message appears against a red background in the critical alarms portion of the display window screen (Area f in Figure 3–3 on page 3–5).

See Table 4–2 on page 4–26 for details on status indicators and messages.

If the CONTROLS OFF/ON button is pressed during a cycle, the cycle aborts (after a 2 second timer expires). Therefore, this is not the recommended method to manually abort a cycle. Use the [ABORT] softkey instead. See “Canceling a Cycle (Manual Abort)” on page 4–30.

4–24 USR 61301607026 Rev B US

END OF CYCLE ROUTINE

633HC Steam Sterilizer

WARNING

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).

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).

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).

NOTE

For detailed information regarding failure and fault conditions, and informational messages, see “Failure Conditions” on page 6–3.

For information regarding troubleshooting and diagnostic messages, see Table 6–1 on page 6–4 through Table 6–7 on page 6–8.

The status of the completed load should be verified before removing the load from the sterilizer. On the printout, check:

• The minimum chamber temperature during exposure is equal to or greater than the exposure temperature set point.

• The “Time at Exp Temp” is equal to or greater than the selected exposure time

• The printed record shows “CYCLE COMPLETE.”

• The green PROCESS COMPLETE indicator on the display is lit.

NOTE

Table 4–2 on page 4–26 outlines what to look for to determine if a cycle completed successfully or aborted.

USR 61301607026 Rev B US 4–25

Operation

01:36:04 14.31 106.8 CE UNSEALING

SIGNATURE:................

PROCESS END 14: 35: 41 CYCLE RESULTS Exp. Temp Max 121.8C Exp. Temp Min 121.5C Time at Exp Temp 00:32:3 4 DAILY COUNTER 2

01:36 :3 6 14.37 102.9 CYCLE CO MPLE TE

CYCLE CO MPLE TE 633H C

00:03:11 14.26 88.8 AIR-IN 00:03:00 14.24 89.1 00:02:10 14.22 10 0.3 DRYING 00:02:00 18.69 107.8 00:01:26 37.23 126.9 ABORT -HIGH TEMP 00:01.26 37.23 126.9

SIGNATURE:................

CYCLE ABORTED

TABLE 4–2. CYCLE RESULT DETERMINATION

Successful Cycle Aborted Cycle

• CYCLE COMPLETE is printed on the printout

• CYCLE ABORTED is printed on the printout.

below the CYCLE RESULTS.

SAMPLE PRINTOUT--COMPLETED CYCLE SAMPLE PRINTOUT--ABORTED CYCLE

• CYCLE COMPLETE appears against a green background in the cycle information portion of the display window (Area d in Figure 3–3 on page 3–5).

•PROCESS COMPLETE status indicator is green indicating a successfully completed cycle.

NOTE

The message/phase clears/changes when the

sterilizer door opens.

• STANDBY appears against a flashing red background in the cycle information portion of the display window (Area d in Figure 3–3 on page 3–5).

• The failure message appears against a red background in the critical alarms portion of the display window (Area f in Figure 3–3 on page 3–5).

• Pulsing alarm tone is activated.

• PROCESS COMPLETE status indicator is flashing red indicating an aborted cycle.

• PROCESS FAILURE status indicator is flashing red.

• The sterilizer’s control system remains in STANDBY.

• The alarm silences when CLEAR ALARM is pressed.

• The message clears when the cause of the failure is corrected and CLEAR ALARM is pressed.

• See “Diagnostic Messages” on page 6–8 for corrective action.

• The door unseals automatically and remains closed, ready to open.

• The door remains sealed.

NOTE

The door remains sealed until the failure

condition is acknowledged.

WARNING

4–26 USR 61301607026 Rev B US

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.

POSSIBILITY OF INJURY: If a WATER IN DRAIN message displays, DO NOT operate

UNLOADING THE STERILIZER

633HC Steam Sterilizer

WARNING

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.

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).

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).

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).

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.

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.

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.

POSSIBILITY OF INJURY: Wear protective eyewear, clothing, and gloves when handling liquids in containers.

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.

POSSIBILITY OF INJURY: Do not operate the door while loading or unloading the sterilizer.

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.

USR 61301607026 Rev B US 4–27

Operation

WARNING

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.

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.

CAUTION

POSSIBILITY OF DAMAGE TO EQUIPMENT: Use of sealed, unvented containers to process liquids can be result in permanent damage to the sterilizer.

NOTE

Before removing the load, be sure to check that the cycle was successful as indicated by the green PROCESS COMPLETE indicator. If the PROCESS COMPLETE indicator is flashing red (failure), check the printer tape for messages that indicate the cycle was aborted. See “End of Cycle Routine” on page 4–25.

To unload the sterilizer:

1. Unseal the door.

The door(s) unseal automatically at the end of a successful cycle.

NOTE

Wait approximately 1 minute for the steam to vent before opening the door.

2. Open the door. See “Operating the Sterilizer Door” on page 4–6.

3. Remove the load. See “Operating the Loading Car and the Transfer Carriage” on page 4–14.

4. Close the door.

4–28 USR 61301607026 Rev B US

633HC Steam Sterilizer

END OF DAY CHECKLIST

CLOSING THE DOOR Close but do not seal the sterilizer door(s).

TURNING THE CONTROLS OFF After daily operation, press CONTROLS OFF/ON to turn the sterilizer OFF.

NOTE

If you require operational readiness, leave the sterilizer ON to avoid the 20–30 minute warm-up period.

BLOWING DOWN THE STEAM BOILER

Blow-down frequency varies depending on water conditions. See Table 8–3 on page 8–4 for recommended intervals.

If your sterilizer has an integral steam boiler without automatic blow-down, blow down the boiler manually. See “Blowing Down a Steam Boiler Manually” on page 8–4.

Some Getinge USA steam boilers are configured for automatic blow-down. If your sterilizer has this feature, see “Steam Boiler Automatic Blow-down Package” on page 8–8 for instructions to set up the automatic blow-down option.

Blow-down is required less frequently when your sterilizer is connected to a Getinge RO (reverse osmosis) water treatment system. Contact your Getinge service representative for more details.

NOTE

A short boiler recovery time is necessary after the blow-down is completed.

USR 61301607026 Rev B US 4–29

Operation

CANCELING A CYCLE (MANUAL ABORT)

WARNING

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).

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.

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.

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.

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.

CAUTION

POSSIBILITY OF EQUIPMENT DAMAGE: Use of sealed unvented containers to process liquids can result in permanent damage to the sterilizer.

A cycle can be canceled during any phase of operation; however, the softkeys at the bottom of the display screen show different labels, depending on the phase of the cycle. If the cycle is in a timed phase (e.g., exposure or drying), [MORE] displays. If the cycle is in an untimed phase (e.g., heat-up), [ABORT] displays.

TIMED PHASE

During a timed phase (e.g., exposure), the In-Cycle screen displays (see Figure 4–11 on page 4–31). Depending upon your settings, the In-Cycle screen displays either bar graphs (“Bar Graph Screen” on page 3–7), details (“Details Screen” on page 3–8), or plot graphs (“Plot Graph Screen” on page 3–8).

4–30 USR 61301607026 Rev B US

633HC Steam Sterilizer

WS-0096 HC

121.1 C

Exposure Temp

00:30:00

Drying Time

P10 grv GRAVITY1 04 EXPOSURE

00:30:00

Exposure Time

01:01:53

00:25:48

36

REMAINING TIME

Chamber Temp

30.20 PSI

Chamber PSIA

121.3 C

PARA-

METER

SETUP

MORE

WS-0157 HC

121.1 C

Exposure Temp

00:30:00

Drying Time

P10 grv GRAVITY1 04 EXPOSURE

00:30:00

Exposure Time

01:01:53

00:25:48

36

REMAINING TIME

Chamber Temp

30.20 PSI

Chamber PSIA

121.3 C

ABORT

EXIT

ADVANCE

FIGURE 4–11. IN-CYCLE SCREEN

NOTE

If the sterilizer is not in a timed phase (e.g., waiting for the chamber to heat up), [ABORT] displays in the same position as [MORE] in Figure 4–11.

To cancel a cycle during a timed phase:

1. Press [MORE].

The following screen displays:

FIGURE 4–12. IN-CYCLE SCREEN (ABORT)

2. Press [ABORT].

The sterilizer ceases all processing activity and begins an abort sequence (including exhaust or liquid exhaust, dry, air-in, and standby phases).

USR 61301607026 Rev B US 4–31

Operation

WS-0111 HC

121.1 C

Exposure Temp

00:30:00

Drying Time

P10 grv GRAVITY1 02 HEAT-UP

00:30:00

Exposure Time

00:30:14

00:24:15

66

REMAINING TIME

Chamber Temp

14.37 PSI

Chamber PSIA

48.1 C

PAR A-

METER

SETUP

ABORT

3. Wait for the appropriate exhaust phase to complete and STANDBY is displayed.

4. Press CLEAR ALARM to acknowledge the aborted cycle.

5. Press OPEN DOOR to unseal the door(s).

6. Wait approximately 1 minute for the steam to vent before opening the door.

NOTE

If the load was a liquid load, wait 15 minutes before removing the load from the chamber.

7. Verify the status of the load. See “End of Cycle Routine” on page 4–25.

WARNING

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).

8. Remove the load from the chamber.

UNTIMED PHASE

During an untimed phase (e.g., heat-up), the In-Cycle screen displays (Figure 4–13). Depending upon your settings, the In-Cycle screen displays either bar graphs (“Bar Graph Screen” on page 3–7), details (“Details Screen” on page 3–8), or plot graphs (“Plot Graph Screen” on page 3–8).

FIGURE 4–13. IN-CYCLE SCREEN

4–32 USR 61301607026 Rev B US

633HC Steam Sterilizer

NOTE

If the sterilizer is in a timed phase (e.g., exposure), [MORE] displays in the same position as [ABORT] in Figure 4–13 on page 4–32.

To cancel the cycle during an untimed phase:

1. Press [ABORT].

The sterilizer ceases all processing activity and begins an abort sequence (including exhaust or liquid exhaust, dry, air-in, and standby phases).

2. Wait for the appropriate exhaust phase to complete and STANDBY is

displayed.

3. Press CLEAR ALARM to acknowledge the aborted cycle.

4. Press OPEN DOOR to unseal the door(s).

ADVANCING A CYCLE

5. Wait approximately 1 minute for the steam to vent before opening the

door.

NOTE

If the load was a liquid load, wait 15 minutes before removing the load from the chamber.

6. Verify the status of the load. See “End of Cycle Routine” on page 4–25.

WARNING

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).

7. Remove the load from the chamber.

This feature may be used to terminate a timed phase and advance to the next phase. Timed phases include: purge, liquid dwell, exposure, liquid exposure, drying, equalization, and leak test.

WARNING

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).

USR 61301607026 Rev B US 4–33

Operation

WS-0096 HC

121.1 C

Exposure Temp

00:30:00

Drying Time

P10 grv GRAVITY1 04 EXPOSURE

00:30:00

Exposure Time

01:01:53

00:25:48

36

REMAINING TIME

Chamber Temp

30.20 PSI

Chamber PSIA

121.3 C

PAR A -

METER

SETUP

MORE

WARNING

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.

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.

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.

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.

NOTE

The cycle advance feature is intended for use by qualified service personnel only. Improper use of this feature can compromise the integrity of the processing cycle.

FIGURE 4–14. IN-CYCLE SCREEN

To advance a cycle:

1. From the In-Cycle screen, press [MORE].

The softkey labels at the bottom of the screen change as shown in Figure 4–15 on page 4–35.

4–34 USR 61301607026 Rev B US

633HC Steam Sterilizer

WS-0157 HC

121.1 C

Exposure Temp

00:30:00

Drying Time

P10 grv GRAVITY1 04 EXPOSURE

00:30:00

Exposure Time

01:01:53

00:25:48

36

REMAINING TIME

Chamber Temp

30.20 PSI

Chamber PSIA

121.3 C

ABORT

EXIT

ADVANCE

FIGURE 4–15. IN-CYCLE SCREEN (ADVANCE CYCLE)

2. Press [ADVANCE].

The CYCLE ADVANCED message displays for 5 seconds and is printed on the paper tape.

After a cycle phase is advanced, the cycle continues through the exhaust, drying, and air-in phases but the controls enter STANDBY mode, bypassing the CYCLE COMPLETE phase.

3. Verify the status of the load. See “End of Cycle Routine” on page 4–25.

WARNING

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).

4. Remove the load from the chamber.

USR 61301607026 Rev B US 4–35

Operation

UPS

(option)

Mains

Disconnect

Circuit

Breaker

Three-Phase Voltage

to Steam Boiler

Steam Boiler

(option)

Hot Water

Shutoff

Steam Shutoff

Cold Water

Shutoff

Cold Water Supply

Steam Supply

(units without steam boiler)

Hot Water Supply

(units with steam boiler)

115 VAC

WS-0038-633HC

Three-Phase

Mains

Disconnect

Circuit

Breaker

SHUTTING DOWN THE STERILIZER

In an emergency, it may be necessary to remove electrical power from the sterilizer or to turn off the steam and water supplies. All users should know the location of the mains disconnect circuit breaker and the steam and water supply shutoff valves at the sterilizer site.

NOTE

The CONTROLS OFF/ON switch turns OFF the controls only; it does not remove all power from the sterilizer.

TURNING OFF ELECTRICAL POWER

FIGURE 4–16. CIRCUIT BREAKERS

1. Turn OFF power to the sterilizer at the mains disconnect circuit breaker.

4–36 USR 61301607026 Rev B US

633HC Steam Sterilizer

FIGURE 4–17. UNINTERRUPTIBLE POWER SUPPLY OFF SWITCH

Off Button

Standby Mode Indicator (ashing green)

A08214-A-633HC

2. If the sterilizer has an uninterruptible power supply (UPS), press the Off/

Standby switch on the UPS.

3. If the sterilizer has a steam boiler, turn off the three-phase voltage at the

circuit breaker. See Figure 4–16 on page 4–36.

USR 61301607026 Rev B US 4–37

Operation

UPS

(option)

Mains

Disconnect

Circuit

Breaker

Three-Phase Voltage

to Steam Boiler

Steam Boiler

(option)

Hot Water

Shutoff

Steam Shutoff

Cold Water

Shutoff

Cold Water Supply

Steam Supply

(units without steam boiler)

Hot Water Supply

(units with steam boiler)

115 VAC

WS-0038-633HC

Three-Phase

Mains

Disconnect

Circuit

Breaker

TURNING OFF THE STEAM AND WATER SUPPLIES

1. If the sterilizer does not have a steam boiler, turn off the steam and cold water supplies.

FIGURE 4–18. SHUTOFF VALVES

RECOVERING FROM ELECTRICAL POWER FAILURE

WARNING

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).

4–38 USR 61301607026 Rev B US

633HC Steam Sterilizer

WARNING

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).

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).

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.

CAUTION

POSSIBILITY OF DAMAGE TO EQUIPMENT: Use of sealed unvented containers to process liquids can result in permanent damage to the sterilizer.

POWER FAILURE DURING STANDBY

POWER FAILURE DURING A CYCLE

When a power failure occurs, the controls store cycle information in shortterm, non-volatile memory. This information includes whether a cycle was in progress, the current cycle type, the current cycle phase, and elapsed time in the current phase.

NOTE

Cycle assignments and settings are backed up by a lithium battery inside the control box. This battery is not user-replaceable but has a 10-year shelflife.

If the sterilizer has an uninterruptible power supply (UPS), the UPS provides power to the sterilizer controls. See “Uninterruptible Power Supply” on page 8–11 for information on the UPS.

If a power failure occurs while in standby, the sterilizer returns to standby mode, when power is restored.

If power is interrupted for less than 60 seconds and conditions are still within reset parameters when power is restored, the sterilizer continues the cycle from the appropriate phase when power was interrupted. If conditions are not acceptable, the cycle aborts and returns to standby mode.

If power is interrupted for 60 seconds or more, the sterilizer aborts the cycle automatically when power is restored, relieves pressure and vacuum in the chamber, and returns to standby mode.

USR 61301607026 Rev B US 4–39

Operation

OPENING THE DOOR MANUALLY

WARNING

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.

HOT SURFACES: The pipes on the outside of the chamber may be hot! Avoid touching the pipes when opening and closing the bleed valves.

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.

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).

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.

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).

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).

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).

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.

BURN HAZARD: To avoid injury, DO NOT turn the manual valves with the chamber door open.

4–40 USR 61301607026 Rev B US

633HC Steam Sterilizer

WARNING

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.

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.

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.

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.

CAUTION

POSSIBILITY OF DAMAGE TO EQUIPMENT: Use of sealed unvented containers to process liquids can result in permanent damage to the sterilizer.

Manual gasket retraction may be necessary if access to the chamber is required and UNSEAL DOOR is inoperative. All faults and failures unrelated to an electrical outage should be reported to Getinge USA.

The following sequence outlines the procedure to open the door:

1. “Preparation” on page 4–42

2. “Removing Pressure from the Gasket” on page 4–46

3. “Lowering the Door” on page 4–50

4. “Removing the Load and Closing the Door” on page 4–52

5. “Resetting the Manual Valves” on page 4–52

Be sure to follow this sequence when opening the door.

USR 61301607026 Rev B US 4–41

Operation

PREPARATION

WARNING

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.

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.

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.

The chamber pressure gauge on the front panel should read zero (0 psig) before opening the sterilizer chamber door. Follow these instructions to relieve chamber pressure to permit opening the door.

1. Turn OFF the steam supply.

2. Turn OFF power to the sterilizer at the power source (the circuit breakers on the sterilizer power box).

WARNING

HOT SURFACES: The pipes on the outside of the chamber may be hot! Avoid touching the pipes when opening and closing the bleed valves.

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.

NOTE

The locations of the manual valves depend upon the size of the sterilizer’s chamber. For an overview of the valve locations, see either Figure 4–19 on page 4–43 (26-inch units) or Figure 4–20 on page 4–44 (39- and 51-inch units).

4–42 USR 61301607026 Rev B US

FIGURE 4–19. MANUAL VALVES (26-INCH UNIT)

WS-0404-633HC

Vacuum to Door(s)

Valve

Steam to Door(s) Valve

Water to Ejector

Solenoid Valve

Chamber Bleed Valve

CONTROL

END

633HC Steam Sterilizer

USR 61301607026 Rev B US 4–43

Operation

WS-0403-633HC

Vacuum to Door(s)

Valve

Steam to Door(s) Valve

Water to Ejector

Solenoid Valve

Chamber Bleed

Valve

CONTROL

END

FIGURE 4–20. MANUAL VALVES (39- AND 51-INCH UNITS)

4–44 USR 61301607026 Rev B US

633HC Steam Sterilizer

Chamber

Bleed Valve

Handle

WS-0406-633

REMOTE END

BELOW CHAMBER

Chamber

Bleed Valve

Handle

WS-0405-633

REMOTE END

BELOW CHAMBER

FIGURE 4–21. CHAMBER BLEED VALVE (26-INCH UNIT)

FIGURE 4–22. CHAMBER BLEED VALVE (39- AND 51-INCH UNITS)

3. Locate the chamber bleed valve.

NOTE

The chamber bleed valve is located in the service area on the left side of the sterilizer below the chamber.

4. Open the valve by rotating the handle COUNTERCLOCKWISE to

USR 61301607026 Rev B US 4–45

release any steam from the chamber.

Operation

REMOVING PRESSURE FROM THE GASKET

WARNING

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).

1. Verify the chamber pressure gauge reads zero (0 psig) or less (negative).

2. Locate the water to ejector valve.

NOTE

On 26-inch units, the water to ejector valve is located in the service area on the right side of the sterilizer below the chamber. See Figure 4–24 on page 4–47.

On 39- and 51-inch units, the water to ejector valve is located in the service area on the left side of the sterilizer above the chamber. See Figure 4–23 on page 4–47.

4–46 USR 61301607026 Rev B US

633HC Steam Sterilizer

Water to Ejector

Solenoid Valve

WS-0407-633

Handle

REMOTE END

BELOW CHAMBER

Handle

Water to Ejector

Solenoid Valve

WS-0118-633

CONTROL END

ABOVE CHAMBER

FIGURE 4–23. WATER TO EJECTOR SOLENOID VALVE (26-INCH UNIT)

FIGURE 4–24. WATER TO EJECTOR SOLENOID VALVE (39- AND 51INCH UNITS)

3. Turn the water to ejector valve ON by pushing the white handle IN and

rotating it CLOCKWISE approximately 1/4 turn to the open position indicated on the valve housing.

The water flow creates a vacuum to retract the gasket.

USR 61301607026 Rev B US 4–47

Operation

Handle

(open position)

Steam to Door(s) Valve

WS-0408-633

Handle

(closed position)

CONTROL END

ABOVE CHAMBER

Handle

(open position)

Steam to Door(s) Valve

WS-0409-633

Handle

(closed position)

CONTROL END

ABOVE CHAMBER

FIGURE 4–25. STEAM TO DOOR(S) VALVE (26-INCH UNIT)

FIGURE 4–26. STEAM TO DOOR(S) VALVE (39- AND 51-INCH UNITS)

NOTE

The STEAM TO DOOR(S) valve is located in the service area on the left side of the sterilizer above the chamber.

4. Locate the manual valve labeled “STEAM TO DOOR(S).”

5. CLOSE the valve by rotating the handle CLOCKWISE.

This turns OFF the steam supply to the door gasket.

4–48 USR 61301607026 Rev B US

Getinge 633 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

SPECIAL SAFETY INSTRUCTIONS

SECTION 1 PREFACE

SUMMARY OF CONTENTS

ENVIRONMENTAL IMPACT ASSESSMENT

MANUAL CONVENTIONS

SYMBOLS USED IN THIS MANUAL

DESCRIPTIONS OF THE SYMBOLS ON THE EQUIPMENT

SWITCHES

INDICATORS

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

GENERAL

SECTION 2 SAFETY

PRODUCT LIABILITY

ISOLATING DEVICE

Door Obstruction Switch

SAFETY FEATURES

DOOR LOCKOUT The door can be locked in the open position for maintenance inside the

SECTION 3 INTRODUCTION

MODELS

CONTROLS AND INDICATORS

CONTROL PANEL NAVIGATION

PROCESS SCREENS The user has the option of selecting one of three process screens:

SELECTING A PROCESS SCREEN

SOFTKEYS

DISABLING OR ENABLING THE CONTROLS

TURNING THE CONTROLS ON OR OFF

NAVIGATION BASICS

DIRECTIONAL ARROWS Each of the directional arrows has a specific function:

ENTER Use the ENTER switch to:

SELECTING AN ITEM FROM A LIST

ENTERING AN ALPHANUMERIC VALUE

ENTERING VALUES IN DIALOG BOXES

RESPONDING TO YES/NO MESSAGE BOXES

EXITING FROM A SCREEN There are three commands used to exit from a screen:

OPERATING THE PRINTER

STATUS INDICATOR The STATUS indicator on the printer blinks when the printer is out of paper

ADVANCING THE PAPER To advance the paper through the printer, press and hold FEED.

USING THE LEVER

SAVING PRINTOUTS There are three ways to save printouts:

TEARING OFF PRINTER PAPER To tear off the printout for individual cycle records:

REPLACING THE PRINTER PAPER

STORING AND HANDLING PAPER ROLLS

PRINTING A DUPLICATE RECORD

READING THE CYCLE PRINTOUT

CYCLE START AND PARAMETERS

PHASES Each time a phase within a cycle starts, the phase name is recorded on the

VALIDATING THE EXPOSURE PHASE

SEQUENCE OF OPERATION

SECTION 4 OPERATION

OPERATING THE STERILIZER

START OF DAY CHECKLIST

TURNING THE CONTROLS ON For information regarding the controls, see “Turning the Controls ON or

OPERATIONAL READINESS

PREVIEWING AND SELECTING A CYCLE

OPERATING THE STERILIZER DOOR

SAFETY FEATURES These safety features apply to all units under normal conditions:

OPENING AND CLOSING THE STERILIZER DOOR

LOAD PREPARATION

TECHNIQUES FOR LOADING

FLASH STERILIZATION

LOADING ACCESSORIES

OPERATING THE LOADING CAR AND THE TRANSFER CARRIAGE

RACK AND EXTENDABLE SHELVES

LOADING THE STERILIZER

PROCESSING A CYCLE

END OF CYCLE ROUTINE

UNLOADING THE STERILIZER

END OF DAY CHECKLIST

CLOSING THE DOOR Close but do not seal the sterilizer door(s).

TURNING THE CONTROLS OFF After daily operation, press CONTROLS OFF/ON to turn the sterilizer OFF.

BLOWING DOWN THE STEAM BOILER

CANCELING A CYCLE (MANUAL ABORT)

ADVANCING A CYCLE

SHUTTING DOWN THE STERILIZER

RECOVERING FROM ELECTRICAL POWER FAILURE

POWER FAILURE DURING STANDBY