Getinge 400LS, 500LS Operator Manual

4.8 (4)

OPERATOR MANUAL

61301608206 Rev. C

400LS/500LS SERIES

STEAM STERILIZERS

OPERATOR MANUAL

400LS/500LS Series

Steam Sterilizers

Getinge USA, Inc.

1777 East Henrietta Road

Rochester, New York 14623-3133 USA

Phone: (800) 950-9912

Facsimile: (800) 950-2570

OPERATOR MANUAL 61301608206

Rev. A (02/2002)

Rev. B (01/2003)

Rev. C (09/2005)

Related Publications:

Manual

400LS/500LS Series

 

 

Installation Instructions

61301608205

 

 

Supervisor Manuall

61301608207

 

 

Service Manual

61301608209

 

 

Parts Catalog

61301608210

 

 

DESCRIPTION OF SYMBOLS & NOTES IN MANUAL

The following symbols with related notes appear in this manual.

“Warning” notes alert the user to the possibility of personal injury.

WARNING

“Caution” notes alert the user to the possibility of damage to the equipment.

CAUTION

NOTE

“Notes” alert the user to pertinent facts and conditions.

 

NOTES

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

CAUTION

POSSIBILITY OF INJURY: Misuse of equipment or bypassing its safety features may result in personal injury.

POSSIBILITY OF EQUIPMENT DAMAGE: Misuse of equipment may result in equipment damage.

The 400LS/500LS Series Steam Sterilizers are designed to steam sterilize laboratory goods and solutions.

This equipment is NOT intended for use other than expressly stated.

Getinge® is a registered trademark.

Copyright ©2005 by Getinge USA, Inc.

Biosign®, EZ-VU™ Test Pack—registration pending

ii

Table of Contents

SPECIAL SAFETY INSTRUCTIONS . . . . . . . . . . . . . . . . . . . ix

DESCRIPTION OF SYMBOLS ON THE EQUIPMENT . . . . xv

Switches. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv

Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv

Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvi

MANUAL CONVENTIONS . . . . . . . . . . . . . . . . . . . . . . . . . xvii

Section 1 Getting Started

MODELS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–1

CONTROLS AND INDICATORS . . . . . . . . . . . . . . . . . . . . 1–2

CYCLE ASSIGNMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . 1–7

Section 2 Control Panel Navigation

PROCESS SCREENS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2–2

Bar Graph Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2–2

Details Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2–3

The Plot Graph Screen . . . . . . . . . . . . . . . . . . . . . . . . 2–4

Selecting a Process Screen. . . . . . . . . . . . . . . . . . . . . 2–4

SOFTKEYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2–6

TURNING ON THE CONTROLS . . . . . . . . . . . . . . . . . . . . 2–7

NAVIGATION BASICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2–8

Directional Arrows . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2–8

ENTER. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2–8

Select an Item from a List . . . . . . . . . . . . . . . . . . . . . . 2–8

Enter an Alphanumeric Value . . . . . . . . . . . . . . . . . . . 2–9

Communicating With the System. . . . . . . . . . . . . . . . 2–10

Entering Data in Dialog Boxes . . . . . . . . . . . . . . 2–10

Responding to Yes/No Message Boxes . . . . . . . 2–10

Exit from a Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 2–11

iii

Section 3 Preparation for Use

DAILY CHECKLIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3–1

Operational Readiness . . . . . . . . . . . . . . . . . . . . . . . . 3–1

LOAD PREPARATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3–2

TECHNIQUES FOR LOADING . . . . . . . . . . . . . . . . . . . . . 3–4

End of Cycle Routine. . . . . . . . . . . . . . . . . . . . . . . . . . 3–5

Liquid RTD Placement (Option). . . . . . . . . . . . . . . . . . 3–7

LOADING ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . 3–9

Loading Car and Transfer Carriage (533LS only) . . . . 3–9

Rack and Extendable Shelves. . . . . . . . . . . . . . . . . . 3–12

Section 4 Operating Instructions

SEQUENCE OF OPERATION. . . . . . . . . . . . . . . . . . . . . . 4–1

OPERATING THE STERILIZER . . . . . . . . . . . . . . . . . . . . 4–2

Turning on the Controls . . . . . . . . . . . . . . . . . . . . . . . . 4–2

Previewing/Selecting a Cycle . . . . . . . . . . . . . . . . . . . 4–2

Loading the Sterilizer. . . . . . . . . . . . . . . . . . . . . . . . . . 4–5

Editing Cycle Parameters . . . . . . . . . . . . . . . . . . . . . . 4–6

Starting a Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4–7

Canceling a Cycle (Manual Abort). . . . . . . . . . . . . . . . 4–9

End of Cycle Routine. . . . . . . . . . . . . . . . . . . . . . . . . 4–10

Unloading the Sterilizer . . . . . . . . . . . . . . . . . . . . . . . 4–12

OPENING AND CLOSING THE STERILIZER DOOR . . . 4–15

Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4–16

Manual Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4–16

Power Door (Option) . . . . . . . . . . . . . . . . . . . . . . . . . 4–18

OPERATING THE PRINTER . . . . . . . . . . . . . . . . . . . . . . 4–19

STATUS Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . 4–20

Advancing the Paper . . . . . . . . . . . . . . . . . . . . . . . . . 4–20

Using the Lever . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4–21

Saving Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4–21

Tearing Off Printer Paper . . . . . . . . . . . . . . . . . . . . . 4–21

Replacing the Printer Paper . . . . . . . . . . . . . . . . . . . 4–21

Removing the Take-up Core . . . . . . . . . . . . . . . . . . . 4–23

Inserting a New Core. . . . . . . . . . . . . . . . . . . . . . . . . 4–23

Inserting a New Roll . . . . . . . . . . . . . . . . . . . . . . . . . 4–23

Loading the Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . 4–23

Storing and Handling Paper Rolls . . . . . . . . . . . . . . . 4–24

Printing a Duplicate Record. . . . . . . . . . . . . . . . . . . . 4–24

iv

READING THE CYCLE PRINTOUT. . . . . . . . . . . . . . . . . 4–25

Cycle Start and Parameters. . . . . . . . . . . . . . . . . . . . 4–25

Phases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4–25

Validating the Exposure Phase . . . . . . . . . . . . . . . . . 4–26

CYCLE END . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4–26

CYCLE RESULTS . . . . . . . . . . . . . . . . . . . . . . . . 4–26

PERFORMANCE TESTING . . . . . . . . . . . . . . . . . . . . . . . 4–28

Biological Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . 4–28

Vacuum Leak Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 4–29

Section 5 Conditional Instructions

CANCELING A CYCLE (MANUAL ABORT) . . . . . . . . . . . 5–2

Timed Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5–3

Untimed Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5–4

ADVANCING A CYCLE . . . . . . . . . . . . . . . . . . . . . . . . . . . 5–6

END OF CYCLE ROUTINE . . . . . . . . . . . . . . . . . . . . . . . . 5–9

SHUTTING DOWN THE STERILIZER. . . . . . . . . . . . . . . 5–11

Turning Off Electrical Power . . . . . . . . . . . . . . . . . . . 5–11

Turning Off the Steam and Water Supplies . . . . . . . . 5–12

RECOVERING FROM ELECTRICAL POWER FAILURE 5–13

Power Failure During Standby . . . . . . . . . . . . . . . . . . 5–14

Power Failure During a Cycle . . . . . . . . . . . . . . . . . . 5–14

OPENING THE DOOR MANUALLY. . . . . . . . . . . . . . . . . 5–15

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5–16

Remove Pressure from the Gasket . . . . . . . . . . . . . . 5–18

Remove the Load. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5–21

Restore Pressure to the Gasket. . . . . . . . . . . . . . . . . 5–21

Section 6 Display Messages

DIAGNOSTIC MESSAGE TYPES. . . . . . . . . . . . . . . . . . . 6–2

Failure Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6–2

Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6–4

Informational Messages. . . . . . . . . . . . . . . . . . . . . . . . 6–5

Visual Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6–6

TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6–7

DIAGNOSTIC MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . 6–8

v

Section 7 Routine Maintenance

MAINTENANCE SCHEDULE . . . . . . . . . . . . . . . . . . . . . . 7–1

DAILY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–2

Cleaning the Sediment Screens . . . . . . . . . . . . . . . . . 7–2

Blowing Down the Steam Boiler (option) . . . . . . . . . . . 7–3

WEEKLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–4

Cleaning the Exterior Surfaces . . . . . . . . . . . . . . . . . . 7–4

Cleaning theChamber Interior . . . . . . . . . . . . . . . . . . . 7–4

Cleaning the Accessories . . . . . . . . . . . . . . . . . . . . . . 7–4

Cleaning Materials . . . . . . . . . . . . . . . . . . . . . . . . 7–5

Cleaning Agents . . . . . . . . . . . . . . . . . . . . . . . . . . 7–5

Cleaning Methods . . . . . . . . . . . . . . . . . . . . . . . . . 7–5

EVERY THREE MONTHS . . . . . . . . . . . . . . . . . . . . . . . . . 7–6

Checking the Pressure Relief Valves . . . . . . . . . . . . . 7–6

Jacket Pressure Relief Valve . . . . . . . . . . . . . . . . 7–6

Chamber Pressure Relief Valve . . . . . . . . . . . . . . 7–7

Cleaning the Steam and Water Strainers . . . . . . . . . . 7–7

WHEN REQUIRED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–8

Cleaning the Door Gasket(s) . . . . . . . . . . . . . . . . . . . . 7–8

Replacing the Door Gasket(s) . . . . . . . . . . . . . . . . . . . 7–9

Replacing the Air Filter . . . . . . . . . . . . . . . . . . . . . . . 7–12

Resetting the Clock . . . . . . . . . . . . . . . . . . . . . . . . . . 7–13

Installing/Removing, & Adjusting Shelf Racks. . . . . . 7–15

Installing the Shelves . . . . . . . . . . . . . . . . . . . . . 7–15

Removing the Shelves . . . . . . . . . . . . . . . . . . . . 7–16

Changing the Rack Height . . . . . . . . . . . . . . . . . 7–17

Section 8 Steam Boiler

GENERAL DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . 8–1

WATER QUALITY INFORMATION . . . . . . . . . . . . . . . . . . 8–2

Required Feedwater Quality . . . . . . . . . . . . . . . . . . . . 8–2

Feedwater Quality Recommendations . . . . . . . . . . . . 8–3

Recommended Limits Within a Boiler . . . . . . . . . . . . . 8–3

MANUAL BLOW-DOWN . . . . . . . . . . . . . . . . . . . . . . . . . . 8–4

AUTOMATIC BLOW-DOWN PACKAGE (OPTION) . . . . . 8–7

Setting Up Auto Blow-Down . . . . . . . . . . . . . . . . . . . . 8–8

SERVICE MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . 8–9

Section 9 Utilities Control Feature

vi

Section 10 Uninterruptible Power Supply

GENERAL DESCRIPTION. . . . . . . . . . . . . . . . . . . . . . . . 10–1

OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10–3

Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10–3

Normal Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10–3

Battery Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10–4

ROUTINE MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . 10–5

Cleaning (Weekly) . . . . . . . . . . . . . . . . . . . . . . . . . . . 10–5

Testing (Weekly) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10–5

Replacing Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . 10–5

Section 11 Unidirectional Double Doors

Door Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11–1

Section 12 Liquid RTD Package

THEORY OF OPERATION . . . . . . . . . . . . . . . . . . . . . . . 12–2

Exposure Timing Based on the Chamber Temperature (F0 set to zero (disabled)) . . . . . . . . . . . . . . . . . . 12–3

Exposure Timing Based on the F0 Value . . . . . . . . . 12–3

Appendix A Consumable Stock and Spare Parts

CONSUMABLE STOCK . . . . . . . . . . . . . . . . . . . . . . . . . . . A–1

SPARE PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A–2

Appendix B Menu Tree

Glossary

Index

vii

viii

400LS/500LS Series Steam Sterilizers

SPECIAL SAFETY INSTRUCTIONS

THE FOLLOWING SAFETY INSTRUCTIONS APPEAR WITHIN THIS

MANUAL. READ THEM CAREFULLY BEFORE OPERATING THE UNIT.

WARNING

“Warning” notes alert the user to the possibility of personal injury.

p. ii

POSSIBILITY OF INJURY: Misuse of equipment or bypassing its safety

 

features may result in personal injury.

p. ii

POSSIBILITY OF EQUIPMENT DAMAGE: Misuse of equipment may result

 

in equipment damage.

p. ii

The 400/500 Series Steam Sterilizers are designed to steam sterilize

 

laboratory goods and solutions. This equipment is NOT intended for use

 

other than expressly stated.

p. 4-12, 4-15

BURN HAZARD: Before removing a load from the chamber, manually lower

 

the door approximately one inch to allow residual steam to escape. (If the

 

sterilizer has a power door, 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

RISK OF CONTAMINATION: This sterilizer allows the user to modify cycle

 

settings, which may result in cycle parameters that will not achieve the

 

desired sterility assurance level (SAL). Users with password access are

 

responsible for validation of any cycles that use other than the factory set

 

parameters.

p. 5-15, 5-19

DO NOT attempt to open the sterilizer chamber door unless the CHAMBER

 

pressure gauge reads zero (0 psig). Hot steam can cause serious injury.

p. 3-2, 3-5, 5-2, 5-6, 5-15

RISK OF CONTAMINATION: Airborne microbial and particulate

 

contamination is likely to be high in the decontamination area of the sterile

processing department. Wear appropriate personal protective equipment when preparing items for cleaning.

61301608206

ix

WARNING

“Warning” notes alert the user to the possibility of personal injury.

p. 3-3

CREUTZFELDT-JAKOB DISEASE (CJD) DECONTAMINATION: It is the

 

responsibility of the laboratory 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 OPERTORS 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.

 

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.

p. 4-5, 4-12, 4-14, 5-2, 5-6

BURN HAZARD: The door and chamber area could be HOT enough to

 

cause burns. Wear personal protective equipment (PPE) when loading the

 

chamber.

p. 5-15, 5-17

HOT SURFACES: The pipes on the outside of the chamber may be hot!

 

Avoid touching the pipes when opening and closing the bleed ball valves.

p. 4-14, 4-16, 4-17

BURN/PINCH HAZARD: KEEP HANDS AND FINGERS AWAY FROM A

 

MOVING DOOR.

 

If your hands or fingers are accidentally caught in the door:

 

POWER DOOR—PRESS THE FOOTSWITCH, OR THE DOOR CONTROL

 

SWITCH TO REVERSE THE DOOR DIRECTION—or, manually open the

 

door.

p. 8-4

BURN HAZARD: The drain valve is HOT. Wear personal protective gloves.

p. 5-15

BURN HAZARD: To avoid injury, DO NOT turn the manual valves with the

 

chamber door open.

p. 3-14, 7-17

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. 5-22

BURN HAZARD: To avoid injury DO NOT turn ON the manual valve labeled

 

STEAM TO DOOR(S) with the chamber door open.

x

400LS/500LS Series Steam Sterilizers

WARNING

“Warning” notes alert the user to the possibility of personal injury.

p. 3-14

POSSIBILITY OF INJURY: Observe the following loading

 

recommendations:

 

• The rack can support a maximum load of 100 lbs. An individual shelf can

 

hold up to 100 lbs., evenly distributed.

 

• Do not place more than 20 lbs. 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. 3-1

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. 4-12, 4-14, 5-15

BURN HAZARD: Before removing the load, manually lower the door

 

approximately one inch to allow residual steam to escape. Stand back to

 

avoid possible burns when lowering the door

p. 4-12

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. 4-5, 4-12, 4-15

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

 

unloading the sterilizer.

p. 4-12

RISK OF CONTAMINATION: 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. 3-2, 4-11, 5-10, 5-16, 6-3, 6-17

POSSIBILITY OF INJURY: If a WATER IN DRAIN message displays, DO

 

NOT open the chamber door manually. Hot water in the chamber may spill

 

out if the door is opened. Wait until the message clears before attempting to

 

open the door.

p.3-2, 3-7, 4-5, 4-7, 4-10, 4-13, POSSIBILITY OF INJURY: Only use vented or open containers to process 4-15, 5-2, 5-6, 5-9, 5-13, 5-16 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. 3-11

HOT SURFACES: The loading car may be hot enough to cause burns. Wear

 

protective gloves and eyewear when loading and unloading the chamber.

p. 6-8

RISK OF CONTAMINATION: If the cycle is advanced or aborted, it must be

 

considered incomplete and the load must be repackaged and reprocessed.

p. 3-5

BURN HAZARD: The liquid RTD may be HOT. Wear protective gloves and

 

glasses when placing the liquid RTD in the load or removing it from the

 

load.3–8

61301608206

xi

WARNING

“Warning” notes alert the user to the possibility of personal injury.

p. 3-8, 10-2

POSSIBILITY OF INJURY: Always keep the liquid RTD in the storage

 

pocket (see Figure 3–1) when not in use. If the probe is improperly stored,

 

the controls may prematurely determine that the cycle is complete. If the

 

flasks are removed before the cycle is complete, they may burst or crack.

p. 6-18, 6-5

RISK OF CONTAMINATION: If the cycle is cancelled, advanced or aborted,

 

it must be considered incomplete and the load must be reprocessed

 

(unwrapped goods or liquids) or repacked and reprocessed (wrapped

 

goods).

p. 4-7

Before pressing START, verify that the appropriate cycle is selected for the

 

load being processed.

p. 5-16, 5-22

If a condition exists OTHER THAN an electrical outage, call Getinge USA

 

service before operating the sterilizer. Failure to do so may result in

 

personal injury.

p. 4-12

POSSIBILITY OF INJURY: After completion of a liquids cycle, carefully

 

remove the container taking care not to agitate the liquid. If the load is

 

agitated when removed from the chamber, the container may burst or crack.

p. 4-5, 4-12

POSSIBILITY OF INJURY: Wear protective eyewear and gloves when

 

handling liquids in containers.

p. 8-9

POSSIBILITY OF INJURY: Steam boiler maintenance should be performed

 

by qualified personnel only.

p. 4-7

POSSIBILITY OF INJURY: If the wrong cycle is selected for a liquid load,

 

the containers may burst or crack during processing.

p. 4-7

RISK OF CONTAMINATION: If the wrong cycle is selected, the desired

 

sterility assurance level (SAL) may not be reached.

p. 1-3, 3-2, 3-9, 4-6, 4-7, 4-9,

RISK OF CONTAMINATION: If the cycle is cancelled or aborted, it must be

4-10, 4-12, 5-2, 5-9, 5-13, 5-15,

considered incomplete and the load must be repackaged and reprocessed.

6-2, 6-8,

 

p. 4-7, 4-10, 4-12, 4-15, 5-9, 5-13,

RISK OF CONTAMINATION: If the Process Failure indicator is flashing, the

5-15, 6-8

cycle must be considered incomplete and the load must be repackaged and

 

reprocessed.

p. 4-7, 4-10, 4-12, 4-14, 5-9,

RISK OF CONTAMINATION: If the sterilizer canceled the cycle due to a

5-13, 5-15, 6-8

power interruption, the load must be repackaged and reprocessed.

p. 5-6

RISK OF CONTAMINATION: If the cycle advance feature is used, the cycle

 

must be considered incomplete and the load must be repackaged and

 

reprocessed.

xii

 

400LS/500LS Series Steam Sterilizers

p. 5-15, 5-17

View the CHAMBER and JACKET pressure gauge while the steam bleeds

 

from the chamber. Wait until the pressure is at zero (0 psig) before operating

 

the STEAM TO DOOR(S) and VACUUM TO DOOR(S) valves.

p. 5-15, 5-16

Retracting the door gasket manually should be performed by qualified

 

service maintenance personnel only. This procedure requires access to the

 

service side of the equipment.

p. 6-18

POSSIBILITY OF INJURY: Manual mode is intended for use by service

 

technicians 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. 7-2

HOT SURFACE: The chamber and sediment drain screens may be hot.

 

Allow it to cool before attempting to remove it for cleaning.

p. 7-4

HOT SURFACE: Make sure the sterilizer chamber is cool before attempting

 

to clean the interior surfaces.

p. 7-6

BURN HAZARD: (1) Keep away from outlet (discharge) end of the safety

 

valve when operating the pressure release handle. (2) The handle on the

 

pressure release valve may be hot. Wear protective gloves when operating

 

the valve.

p. 7-7

BURN HAZARD WHEN CLEANING THE STEAM STRAINER: All steam

 

lines are hot! Prevent burns by avoiding contact with the lines until the lines

 

are cool.

p. 7-8, 7-9, 7-15

HOT SURFACE: If the sterilizer is ON, the chamber headring which houses

 

the gasket, could be hot. Allow the headring to cool before replacing the

 

door gasket.

p. 5-15

RISK OF NON-STERILE DEVICE: The following procedure is NOT intended

 

for unidirectional double door units. On unidirectional double door units,

 

attempting to open the door manually may compromise the integrity of the

 

biological seal. The door should be unsealed only by authorized personnel

 

following standard operating procedures at the sterilizer site.

p. 3-9

POSSIBILITY OF INJURY: The loading car can hold a maximum load of 200

 

lbs. with a maximum of 100 lbs. evenly distributed on each shelf. To avoid

 

injury or equipment damage, do not exceed these weight limits

61301608206

xiii

xiv

400LS/500LS Series Steam Sterilizers

DESCRIPTION OF SYMBOLS ON THE EQUIPMENT

Switches

Open Door

Close Door

Clear Alarm

!

Start

Directional Arrows (for navigating display screens)

Enter

Up Arrows (for selecting softkey options (i.e. Save, Cancel, OK, and so forth)

Indicators

Door(s) Closed

Door(s) Sealed

In Process

Process Complete

Process Failure

!

61301608206

xv

Labels

 

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

 

 

BURN HAZARD: Hot surfaces or heat-emitting area. Avoid contact. Risk of

 

 

burns.

 

 

HS

Burn Hazard

WARNING — BURN HAZARD

Steam released from the sterilizer chamber can cause serious burns

Stand away while opening the door

If water leaks from the front of the sterilizer,

DO NOT open the door (see Operator Manual)

Contact Getinge USA Customer Support (800)950-9912

MGA

61301602908 REV A

Load Processing Warning

WARNING

Processing a type of load other than defined in Operator's Manual could be hazardous.

61301609118 Rev. A

WS-0011

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 cover. Refer servicing to qualified service personnel.

ATTENTION: Refer to accompanying documents for further information.

Electrostatic Sensitive Devices

OBSERVE PRECAUTIONS

FOR HANDLING

SENSITIVE

DEVICES

xvi

400LS/500LS Series Steam Sterilizers

MANUAL CONVENTIONS

Before you begin using this manual, it is important to understand the conventions used. These conventions are established for visual ease of use.

ITALIC CAPS

Display text, such as the ENTER PASSWORD

 

prompt.

[ALL CAPS]

Softkeys on the control panel, such as [MORE] or

 

[OK].

ALL CAPS

Switches and indicators on the control panel, such

 

as ENTER.

>

The > symbol leads you through nested menu

 

items and dialog box options to a final action. For

 

example: SYSTEM MENU>enter

 

password>CONFIGURATION>EDIT CYCLES.

Italic Upper/Lower Case Cross reference to another section, manual, or guide; such as: see 400/500 Series Steam Sterilizers Service Manual.

PARAMETER SETTINGS

Parameter Setting Access Required is an alert that a password with appropriate access rights is necessary to proceed.

ACCESS REQUIRED

61301608206

xvii

xviii

Section 1 Getting Started

MODELS

The 400LS/500LS Series Steam Sterilizers are designed to steam-sterilize laboratory goods and solutions. Typical applications include:

utensils

glassware

porous goods

non-porous hard goods

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

Models and cycle types are listed in Table 1–1.

Table 1–1. 400LS/500LS Series Steam Sterilizers

MODEL

STERILIZER TYPE

CYCLE TYPES AVAILABLE

 

 

 

422LS

Gravity

Gravity, Liquids

522LS

 

 

 

 

 

433LS

Vacuum

Prevacuum, Gravity, Liquids,

533LS

 

Vacuum Leak Test

 

 

 

Figure 1–1. 400LS/500LS SERIES STEAM STERILIZER

61301608206

1–1

Getinge 400LS, 500LS Operator Manual

Getting Started

CONTROLS AND INDICATORS

Figure 1–2. STERILIZER FRONT PANEL

 

 

8

6

 

 

 

 

 

 

 

5

7

 

!

 

 

 

 

4

 

 

!

2

 

 

 

 

 

 

CONTROLS

 

 

 

ON / OFF

 

 

 

1

 

 

 

WS-0047

9

 

3

 

CONTROLS 1. CONTROLS OFF/ON — This green push button turns the

OFF ON

sterilizer controls OFF and ON.

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

and illuminated.

WS-0091

• Sterilizer controls are OFF when the push button is released and the button is not illuminated.

• If the CONTROLS OFF/ON button is illuminated and the backlit display is

NOTES

blank, press any button (Up Arrow, Enter, and so forth) on the control panel to turn ON the display back-light.

If the CONTROLS OFF/ON button is pressed during a cycle, the cycle will abort. This is not the recommended method to manually abort a cycle. To manually abort a cycle, see "Canceling a Cycle (Manual Abort)" on page 5-2.

WARNINGS

RISK OF CONTAMINATION: If the cycle is cancelled or aborted, it must be considered incomplete and the load must be repackaged and reprocessed.

1–2

400LS/500LS Series Steam Sterilizers

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:

 

• UP/DOWN/LEFT/RIGHT arrow keys—Used to:

 

1)select a cycle

 

(see "Previewing/Selecting a Cycle" on page 4-2).

 

2)enter a password

 

(see Enter a Password in the 400LS/500LS Series

 

Steam Sterilizers Supervisor Manual).

 

3)change adjustable cycle parameters

 

(see Edit Cycle Parameters in the 400LS/500LS

 

Series Steam Sterilizers Supervisor Manual).

 

4)navigate the menus

 

(see Menu Options in the 400LS/500LS Series

 

Steam Sterilizers Supervisor Manual).

ENTER—Enables/stores selections in memory.

UP ARROW softkeys—Usage varies depending on the

cycle and/or cycle phase. The softkey labels appear above one of the five (5) arrow softkeys.

See Softkeys on page 2-6.

61301608206

1–3

Getting Started

!

4.DOOR CONTROL Switches:

CLOSE DOOR

Manual Door units—Press the switch to seal the door; however, the door seals automatically at the beginning of the cycle.

Power Door units—Press the switch to close the door or use the foot switch. Press the switch a second time to seal the door.

OPEN DOOR

Manual Door units—Press the switch to unseal the door.

Power Door units—Press the switch to unseal the door.

Press the switch a second time to open the door or use the foot switch.

Unidirectional Double Door units—unseals the unload end (Remote End (RE)) door.

See "Opening and Closing the Sterilizer Door" on page 4-15.

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—Green light indicates a cycle is complete.

Flashing red light indicates an aborted cycle.

PROCESS FAILURE—Flashing red light indicates that the controls automatically aborted a cycle due to a process failure, equipment malfunction, or failure while in STANDBY.

1–4

400LS/500LS Series Steam Sterilizers

6.Display Window—The interface between the operator and the sterilizer

Figure 1–3. DISPLAY WINDOW

 

 

 

a

b

c

 

 

 

 

 

 

d

e

f

 

 

 

g

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

j

h

i

k

l

 

 

 

 

WS-0104

The Display Window includes:

a.Exposure Time

b.Exposure Temperature

c.Drying Time (not used for Liquid cycles)

d.Cycle information including:

Cycle selected—Gravity, Liquids and Prevacuum.

Phase name—Heat up, Exposure, Drying, Exhaust and Cycle Complete to name a few.

Time in the cycle—the cycle timer begins when the cycle starts and continues to increase until the cycle is complete.

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

NOTE

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

CYCLE COMPLETE—Green background

PROCESS FAILURE—Flashing red background

61301608206

1–5

Getting Started

e.Process Screen includes:

A user selectable process screen:

Bar graph (See Figure 2–1 on page 2-2)

Details (See Figure 2–2 on page 2-3)

Plot graph (See Figure 2–3 on page 2-4)

Dialog boxes

Password window

NOTE

If all the items in the list do not fit on one screen, a black bar appears to the right of the list. Use the UP/DOWN arrows to view any additional items.

f.Critical alarms

Failure conditions

Fault conditions

g.Non-critical information and system messages

Informational messages

h.through l. — Five (5) softkey labels that display different function names depending on the current screen and/or cycle phase.

See "Softkeys" on page 2-6.

7.Printer — Provides a record of the cycle.

(see "Operating the Printer" on page 4-19).

8.Jacket Pressure Gauge — Indicates the current jacket pressure.

9.Chamber Pressure Gauge — Indicates the current chamber pressure.

1–6

400LS/500LS Series Steam Sterilizers

COPY THESE 2 PAGES AND SAVE FOR REFERENCE

CYCLE ASSIGNMENTS

The sterilizer comes from the factory with up to 18 pre-assigned cycles as shown in the 400LS/500LS Series Steam Sterilizers Supervisor Manual. The cycle number and name can be changed by a qualified person with configuration access privileges. When changes are made to the cycle assignments write your setup in the form below.

Table 1–2. Cycle Assignments

Cycle No. Cycle Type

Cycle Name

Comments

(8 Characters Max.)

61301608206

1–7

Getting Started

Table 1–2. Cycle Assignments

Cycle No. Cycle Type

Cycle Name

Comments

(8 Characters Max.)

Cycle type abbreviations:

vac – Prevacuum(Models 433LS/533LS only)

grv – Gravity

liq – Liquids

lkt – Vacuum Leak test (Models 433LS/533LS only)

DATE: ___________________

1–8

Section 2 Control Panel Navigation

The 400LS/500LS Series Steam Sterilizers have an easy to use interface. This section covers:

Three process screens—see page 2-2

Softkey label assignments —see page 2-6

Turning on the backlit display and the sterilizer controls—see page 2-7

Basic navigation of the software—see page 2-8

For a description of the controls and indicators located on the control panel, see Controls and Indicators page 1-2.

61301608206

2–1

Control Panel Navigation

PROCESS SCREENS

Bar Graph Screen

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, atmosphere PSIA, chamber PSIA, 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.

The Bar Graph screen displays the chamber temperature and pressure as a bar graph and also shows a digital time representing the time remaining in the cycle.

Figure 2–1. BAR GRAPH SCREEN

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

00:30:00

 

 

121.1 C

 

00:30:00

Time in Cycle

 

 

Exposure Time

 

 

Exposure Temp

 

Drying Time

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

P10

 

grv GRAVITY1

 

 

 

 

 

00:00:00

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

01

 

STANDBY

 

 

 

 

 

 

 

00:24:15

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Time in

 

Current

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CHAMBER TEMP

 

 

 

CHAMBER PSIA

Phase

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

37.3

C

14.68

PSI

 

 

 

 

 

 

 

 

 

 

 

 

 

 

0

 

 

 

 

Estimated Total

 

 

 

 

 

 

 

 

 

 

 

Time Remaining

 

 

 

 

 

 

 

 

 

 

 

in the Cycle

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

REMAINING TIME

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SETUP

SELECT

PARA-

UNSEAL

 

 

 

 

 

 

 

 

 

 

 

 

CYCLE

METER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

WS-0014

 

 

 

 

 

 

 

2–2

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