Getinge 400LS, 500LS Operator Manual

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

NOTE

NOTES

CAUTION

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

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

• 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.

• 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.

ii

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

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

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

p. 3-14 POSSIBILITY OF INJURY: Observe the following loading

p. 3-1 HOT SURFACES: The chamber and the gasket area could be HOT. Turn

p. 4-12, 4-14, 5-15 BURN HAZARD: Before removing the load, manually lower the door

p. 4-12 HOT SURFACES: The loading car or rack and shelves may be hot enough

p. 4-5, 4-12, 4-15 POSSIBILITY OF INJURY: Do not operate the door while loading or

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

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).

OFF the controls and make sure the sterilizer is cool before cleaning the gasket or removing the sediment screen for cleaning.

approximately one inch to allow residual steam to escape. Stand back to avoid possible burns when lowering the door

to cause burns. Wear protective gloves and eyewear when removing the load from the chamber.

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, 4-15, 5-2, 5-6, 5-9, 5-13, 5-16

p. 3-11 HOT SURFACES: The loading car may be hot enough to cause burns. Wear

p. 6-8 RISK OF CONTAMINATION: If the cycle is advanced or aborted, it must be

p. 3-5 BURN HAZARD: The liquid RTD may be HOT. Wear protective gloves and

POSSIBILITY OF INJURY: Only use 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

protective gloves and eyewear when loading and unloading the chamber.

considered incomplete and the load must be repackaged and reprocessed.

glasses when placing the liquid RTD in the load or removing it from the load.3–8

61301608206 xi

WARNING

p. 3-8, 10-2 POSSIBILITY OF INJURY: Always keep the liquid RTD in the storage

p. 6-18, 6-5 RISK OF CONTAMINATION: If the cycle is cancelled, advanced or aborted,

p. 4-7 Before pressing START, verify that the appropriate cycle is selected for the

p. 5-16, 5-22 If a condition exists OTHER THAN an electrical outage, call Getinge USA

p. 4-12 POSSIBILITY OF INJURY: After completion of a liquids cycle, carefully

p. 4-5, 4-12 POSSIBILITY OF INJURY: Wear protective eyewear and gloves when

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

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.

it must be considered incomplete and the load must be reprocessed (unwrapped goods or liquids) or repacked and reprocessed (wrapped goods).

load being processed.

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

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.

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, 4-10, 4-12, 5-2, 5-9, 5-13, 5-15, 6-2, 6-8,

p. 4-7, 4-10, 4-12, 4-15, 5-9, 5-13, 5-15, 6-8

p. 4-7, 4-10, 4-12, 4-14, 5-9, 5-13, 5-15, 6-8

p. 5-6 RISK OF CONTAMINATION: If the cycle advance feature is used, the cycle

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

RISK OF CONTAMINATION: If the Process Failure indicator is flashing, the cycle must be considered incomplete and the load must be repackaged and reprocessed.

RISK OF CONTAMINATION: If the sterilizer canceled the cycle due to a power interruption, the load must be repackaged and reprocessed.

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

DESCRIPTION OF SYMBOLS ON THE EQUIPMENT

Switches

Open Door

Close Door

Clear Alarm

!

Start

Directional Arrows (for navigating display screens)

400LS/500LS Series Steam Sterilizers

Indicators

Enter

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

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 (

Contact Getinge USA Customer Support (800)950-9912

MGA

Load Processing Warning

WARNING

Processing a type

of load other

than defined in

Operator's Manual

could be hazardous.

61301609118 Rev. A

WS-0011

see Operator Manual)

61301602908 REV A

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

MANUAL CONVENTIONS

400LS/500LS Series Steam Sterilizers

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

ACCESS REQUIRED

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

61301608206 xvii

xviii

MODELS

Section 1 Getting Started

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 522LS

433LS 533LS

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

Gravity Gravity, Liquids

Vacuum Prevacuum, Gravity, Liquids,

Vacuum Leak Test

61301608206 1–1

Getting Started

S

CONTROLS AND INDICATORS

Figure 1–2. STERILIZER FRONT PANEL

8

6

5

7

!

4

!

CONTROLS

ON / / OFF

2

1

WS-0047

CONTROLS OFF ON

9

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

3

sterilizer controls OFF and ON.

WS-0091

NOTES

WARNING

• 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.

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

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

e

g

j

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

Figure 1–3. DISPLAY WINDOW

a bc

d

NOTE

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.

• 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

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

400LS/500LS Series Steam Sterilizers

Cycle No. Cycle Type

Cycle Name

(8 Characters Max.)

Comments

61301608206 1–7

Getting Started

Table 1–2. Cycle Assignments

Cycle No. Cycle Type

Cycle Name

(8 Characters Max.)

Comments

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

E

C

P

C

A

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, 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.

Bar Graph 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

Exposure Time

P10 grv GRAVITY1

01 STANDBY

HAMBER TEM

37.3 C

SETUP

SELECT

CYCLE

121.1 C

Exposure Temp

0

REMAINING TIM

PARA -

METER

00:30:00

Drying Time

HAMBER PSI

14.68 PSI

Time in Cycle

00:00:00 00:24:15

Time in Current Phase

Estimated Total Time Remaining in the Cycle

UNSEAL

WS-0014

2–2

400LS/500LS Series Steam Sterilizers

P

p

C

G

p

A

C

A

x

C

UNSEAL

S

CT

CYCLE

Details Screen The Details screen displays a list of real-time process critical values,

including: chamber temperature, chamber pressure, jacket temperature, atmosphere PSIA, chamber PSIA, exposure temperature maximum, exposure temperature minimum, steam table differential, overall temperature time, machine 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 bar appears to the right of the list. Use the UP/DOWN arrows to view any additional items.

Figure 2–2. DETAILS SCREEN

00:30:00

Exposure Time

P10 grv GRAVITY 1 02 CYCL COMPLETE

Chamber Tem

hamb Press/PSI Jacket Tem Atmosphere PSI

hamber PSI Exp. Temp Ma Exp. Temp Min 121.4

SETU

ELE

121.1 C

Exposure Temp

61.2

0.00 PSI

122.3 C

14.37 PSI

14.35 PSI

121.7 C

00:30:00

Drying Time

01:36:36 00:04:34

WS-0012

61301608206 2–3

Control Panel Navigation

1

02 CYCL CO

E

UNSEAL

SETUP

01:36:36

00:03:42

p

C

A

8

35

e

0

C

SI

S

CT

CYCLE

E

C

P

C

A

The Plot Graph Screen The Plot Graph screen displays the chamber temperature and pressure as a

trend curve using a graphic display.

Figure 2–3. PLOT GRAPH SCREEN

00:30:00

Exposure Time

121.1 C

Exposure Temp

00:30:00

Drying Time

P10 grv GRAVITY

MPLET

14.

1.2 P

1:4

Tim

WS-0013 700H

ChamberTem

hamber PSI

ELE

Selecting a Process Screen The Bar Graph screen displays when the sterilizer control panel is turned

on. See Turning ON the Controls on page 2-7.

Figure 2–4. BAR GRAPH SCREEN

00:30:00

Exposure Time

P10 grv GRAVITY1

01 STANDBY

HAMBER TEM

37.3 C

SETUP

SELECT

CYCLE

121.1 C

Exposure Temp

REMAINING TIM

1. Press [SETUP]. The SETUP menu appears.

0

PARA -

METER

00:30:00

Drying Time

HAMBER PSI

14.68 PSI

00:00:00 00:24:15

UNSEAL

WS-0014

2–4

400LS/500LS Series Steam Sterilizers

2. Use the UP/DOWN ARROWS to select the process screen:

• Bar Graph

• Details

• Plot Graph

3. Press ENTER. The process screen selected appears.

61301608206 2–5

Control Panel Navigation

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 main window and/or the cycle phase. The following illustration shows the labels assigned to each softkey.

NOTE

Access levels assigned determine the screens that are viewed.

Table 2–1. Softkey Assignments

Softkey Labels Screen or Procedure

SETUP SELECT

CYCLE

SETUP PARA-

ABORT PHS

ADV

SETUP PARA-

CANCEL SETUP Menu CANCEL OK SELECT CYCLE Screen

CANCEL MORE

CANCEL HOME OK EDIT PARAMETERS screen

CANCEL +/- CYCLE PARAMETER dialog box CANCEL EDIT OK VIEW PARAMETERS screen

CANCEL CAPS

CANCEL DELETE OK ENTER PASSWORD screen

CANCEL HOME OK

CANCEL HOME System Menu Options

CANCEL HOME BRIGHT

PARA-

METER

PARAMS

DELETE OK ADD USER, ACCESS AREAS or

LOCK

YES NO Confirmation message box

DEC

BRIGHT

INC

UNSEAL Startup or Default screen

UNSEAL Default Screen CYCLE COMPLETE

MORE Default Screen IN-CYCLE

EXIT Default Screen IN-CYCLE (Timed

Phase) (After MORE is pressed)

ABORT Default Screen IN-CYCLE (Untimed

Phase)

OK

or

SAVE

or

SAVE

OK ABOUT Screen

EDIT PARAMETERS screen

[MORE PARAMS]

MACHINE NAME screen

ALARM CLOCK, LANGUAGE DATE UNITS, or PANEL SETUP screens

(If preference is enabled)

Softkeys

2–6

TURNING ON THE CONTROLS

To turn on the backlit display and the controls:

400LS/500LS Series Steam Sterilizers

CONTROLS OFF ON

WS-0091

NOTES

Press the CONTROLS OFF/ON button.

• The switch illuminates and remains inward.

• The backlit display illuminates.

• The controls turn on.

• If the power is accidentally interrupted by pressing CONTROLS ON/OFF,

turn the controls back ON. The cycle is not cancelled if the controls are turned ON within 2 seconds.

• If primary power is interrupted (e.g., a circuit breaker trips), the cycle is

not cancelled if power is restored within 59 seconds.

61301608206 2–7

Control Panel Navigation

NAVIGATION BASICS

Directional Arrows Each of the Directional Arrows has a specific function:

• Up Arrow ( ↑ )

• scrolls up a list on the process screen

• when the cursor is activated (blinking cursor), increases the digit or value shown in reverse video

• 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 shown in reverse video

• Left Arrow (←)

• moves the cursor on the current screen or window left to highlight a field

ENTER Use the ENTER key 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).

Select an Item from a List Selecting an item from a list is very simple; the UP/DOWN arrow keys are

used to select the item and the ENTER key stores the selection in memory.

For more detailed instructions, see Previewing/Selecting a Cycle on page 4-2.

2–8

400LS/500LS Series Steam Sterilizers

J

\

CE

/

Enter an Alphanumeric Value

When an alphanumeric value needs to be entered, a screen similar to Figure 2–5 displays.

Figure 2–5. KEYBOARD SCREEN

00:30:00

Exposure Time

P10 grv GRAVITY1

01 STANDBY

ENTER PASSWORD PASSWORD:

CANCEL

121.1 C

Exposure Temp

PA

DELETE

00:30:00

Drying Time

00:00:00 00:24:15

OK

WS-0017

When the keyboard screen appears, the blinking cursor is positioned at the location of the first character of the string and the first key on the keyboard is highlighted. The UP/DOWN/LEFT/RIGHT arrows are used to navigate to the appropriate character; ENTER is used to select the character. The selected character or # sign appears in the position of the blinking cursor and the blinking cursor moves to the right of the character. Press [OK] when the password is entered.

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:

• Enter a Password in the 400LS/500LS Series Steam Sterilizers

Supervisor Manual.

• Set Up an Operator Password in the 400LS/500LS Series Steam

Sterilizers Supervisor Manual.

• Change an Operator Password in the 400LS/500LS Series Steam

Sterilizers Supervisor Manual.

• Edit the Cycle Number and Name in the 400LS/500LS Series Steam

Sterilizers Supervisor Manual.

• Assign the Sterilizer Name in the 400LS/500LS Series Steam Sterilizers

Supervisor Manual.

61301608206 2–9

Control Panel Navigation

E

P

A

c

Atomosphere PSIA

PSI

e

)

ss

Communicating With the System

Entering Data in Dialog Boxes

When a dialog box appears over the process screen, it is in read mode. When ENTER is pressed, the screen goes into edit mode allowing parameters to be selected and modified. Once in edit mode:

• LEFT/RIGHT arrows are used to select the parameter to be changed.

• UP/DOWN arrows are used to enter the new value.

• ENTER accepts the changes made and returns the screen to save mode.

• [SAVE] records the new values into memory and returns the screen to read mode.

Figure 2–6. DATA VALUE ENTRY SCREEN

00:30:00

Exposure Time

P10 grv GRAVITY1

01 STANDBY

HAMBER TEM

Ja

Lo

Fo

37.3 C

121.1 C

Exposure Temp

Exposure Tim

00:01:00 - 06:00:00

:30:0 hh:mm:

00:30:00

Drying Time

HAMBER PSI

14.68 PSI

00:00:00 00:24:15

.03

0

Chamber PSIA 12.03 PSI

CANCEL

REMAINING TIM

ws-0212

For more detailed instructions, see Edit Cycle Parameters in the 400LS/ 500LS Series Steam Sterilizers Supervisor Manual.

Responding to Yes/No Message Boxes

Yes/No message boxes appear over process screens and are used to confirm changes made by the user (i.e., 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 Setup the Display Panel in the 400LS/ 500LS Series Steam Sterilizers Supervisor Manual.

2–10

400LS/500LS Series Steam Sterilizers

Exit from a Screen There are three commands used to exit from a screen:

• [CANCEL]—return to the previous screen without saving

changes

• [HOME]—return to the Main window and logs out the current

user.

• [OK]— return to the previous screen.

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

NOTES

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

a. Press [OK] to return to the previous screen. b. 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 appears 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 "Set up the Display Panel" in the 400LS/500LS Series Steam Sterilizers Supervisor Manual)

61301608206 2–11

Control Panel Navigation

2–12

DAILY CHECKLIST

Section 3 Preparation for Use

HS

WARNING

NOTE

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.

Before operating the sterilizer each day:

1. Check the printer paper roll and replace it if necessary. See Replacing the Printer Paper on page 4-21

2. Clean the sediment screens in the chamber drain. See Cleaning the Sediment Screens on page 7-2

3. If the sterilizer is equipped with a steam boiler:

•allow the steam boiler to warm up for 20 to 30 minutes

before running a cycle.

•blow down the steam boiler as required.

See Manual Blow-Down on page 8-4

Some Getinge USA steam boilers are configured for automatic blow-down. If your sterilizer has this feature, see "Automatic Blow-Down Package (Option)" on page 8-7 for setup instructions for the automatic blow-down option.

Operational Readiness 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).

After daily operation, press CONTROLS OFF/ON to turn OFF the sterilizer and allow the chamber time to cool down before cleaning the door gasket and sediment screen.

61301608206 3–1

Preparation for Use

LOAD PREPARATION

WARNING

CAUTION

NOTE

• RISK OF CONTAMINATION: Airborne microbial and particulate contamination is likely to be high in the preparation area. Wear appropriate personal protective equipment when preparing items for cleaning.

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

• POSSIBILITY OF INJURY: Only use 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.

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

RIGID CONTAINER SYSTEM USERS: Contact the Rigid Container System Manufacturer to determine validated cycle parameters and proper loading of contents into the containers.

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

Clean, package, and load items according to established procedures for your workplace.

3–2

400LS/500LS Series Steam Sterilizers

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 OPERATORS 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.

Table 3–1. Load Chart

CYCLE TYPE TYPICAL LOAD

Gravity (grv)

Prevacuum (vac) Porous goods and hard goods

Liquids (liq)

Vacuum Leak Test (lkt) Empty chamber

• Hard goods, such as utensils and glassware

• Porous goods

• Goods that may be damaged if subjected to a vacuum.

• Liquids in open or vented sealed containers only

• Use flasks of Type 1 borosilicate (i.e. Pyrex glass) only

61301608206 3–3

Preparation for Use

TECHNIQUES FOR LOADING

POSSIBILITY OF INJURY: Only use vented or open containers

WARNING

CAUTION

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.

POSSIBILITY OF EQUIPMENT DAMAGE: 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 page 3-9) and to the rack and extendable shelves (see page 3-12):

• 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 will limit 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.

3–4

End of Cycle Routine

WARNINGS

NOTES

400LS/500LS Series Steam Sterilizers

• RISK OF CONTAMINATION: If the cycle is cancelled or

aborted, it must be considered incomplete and the load must be reprocessed or repacked and reprocessed.

• RISK OF CONTAMINATION: Airborne microbial and

particulate contamination is likely to be high in the preparation area. Wear appropriate personal protective equipment when preparing items for cleaning.

• For detailed information regarding failure and fault conditions and

informational messages, refer to Diagnostic Message Types on page 6-2.

• For information regarding troubleshooting, refer to page 6-7.

The status of the completed load should be verified before removing the load from the sterilizer. The following table outlines what to look for to determine if a cycle completed successfully or aborted

61301608206 3–5

Preparation for Use

.

Table 3–2. Cycle Result Determination

Successful Cycle Aborted Cycle

• CYCLE COMPLETE is printed on the printout below the

• CYCLE ABORTED is printed on the printout.

CYCLE RESULTS.

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

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

PROCESS END 14:35:41 CYCLE RESULTS Exp. Temp Max 121.8C Exp. Temp Min 121.5C Overall Time at Temp 00:32:34

DAILY COUNTER 2

01:36:36 14.37 102.9 CYCL COMPLETE 01:36:04 14.31 106.8 CE UNSEALING 01:36:04 14.31 106.9

CYCLE COMPLETE

• CYCLE COMPLETE appears against a green background* in the cycle information portion of the Display window (Figure 1–3, Area d).

• 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 failure message appears against a flashing red back-

• Pulsing alarm tone is activated.

• PROCESS COMPLETE status indicator is flashing red

• 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 cor-

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

CYCLE ABORTED

00:03:11 14.26 88.8 AIR-IN 00:03:00 14.24 89.1 00:02:10 14.22 100.3 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

CYCLE ABORTED

the cycle information portion of the Display window. (Figure 1–3, Area d)

ground* in the critical alarms portion of the Display window. (Figure 1–3, Area f).

indicating an aborted cycle.

rected and CLEAR ALARM is pressed.

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

(NOTE: Doors on unidirectional units do NOT automatically unseal; check the cycle printout to confirm results.)

*panel version 3.07 or later

3–6

• The door remains sealed.

(NOTE: The door remains sealed until the failure condition is acknowledged.)

POSSIBILITY OF INJURY: If a WATER IN DRAIN message

WARNING

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.

Liquid RTD Placement (Option)

400LS/500LS Series Steam Sterilizers

WARNING

WARNINGS

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.

Place the liquid RTD (load probe) into the center of the largest container with the greatest volume of liquid and locate it in the coolest part of the chamber (usually near the chamber drain). If the container is sealed, a selfventing automatic sealing stopper with an opening for the load probe is required.

• POSSIBILITY OF INJURY: Only use 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.

• POSSIBILITY OF INJURY: Always keep the liquid RTD in the storage holster (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.

POSSIBILITY OF EQUIPMENT DAMAGE: Use of sealed, unvented

CAUTION

Self-Venting

Automatic

Sealing Stopper

(bottom drain baffle removed for clarity)

containers to process liquids can be result in permanent damage to the sterilizer.

Figure 3–1. LIQUID RTD PLACEMENT

Drain

Storage Holster

Liquid RTD

(Load Probe)

WS-0226

61301608206 3–7

Preparation for Use

NOTE

For more information about the load probe, see Liquid RTD Package on page 12-1.

3–8

LOADING ACCESSORIES

400LS/500LS Series Steam Sterilizers

CAUTION

Loading Car and Transfer Carriage (533LS only)

WARNING

Do not place items on the floor of the chamber. Always use the loading car or shelf provided.

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.

Figure 3–2. LOADING CAR AND TRANSFER CARRIAGE (533LS only)

Sterilizer

Chamber

Loading Car

(Door Open)

Track

Assembly

NOTES

Transfer

Carriage

Units equipped for racks and shelves

will not accept a loading car

and transfer carriage.

WS-0054

NOTE:

• Loading cars and transfer carriages are not available for 400LS Series Steam Sterilizers.

• On power door units, be careful when aligning the transfer carriage with the sterilizer chamber. Bumping the door control footswitch may accidentally activate the door motor.

61301608206 3–9

Preparation for Use

To transfer the loading car to the chamber:

1. Align the car and carriage directly in front of the open chamber. Make sure the carriage’s locking rod handle is in the down position (see Figure 3–3).

2. Move the transfer carriage forward until the carriage contacts the sterilizer door and the notches in the transfer carriage align with the chamber rails.

3. Turn the locking rod handle approximately 90° to the “Lock to Sterilizer” position.

4. Push the loading car onto the track assembly located in the chamber.

5. Turn the locking rod handle back to the "Unlock and Transport" position, then pull the carriage away from the sterilizer.

Figure 3–3. TRANSFER CARRIAGE OPERATION

Sterilizer

Chamber

Notch

Carriage Locking

Plate

Chamber

Rail

Loading

Car

Lock to

Sterilizer

LOCKING ROD HANDLE DETAIL

Locking Rod

Handle

Unlock and

Transport

Transfer

Carriage

Transfer Carriage

Loading Car Frame

Carriage

Lock

Loading Car Frame

WS-0095

3–10

400LS/500LS Series Steam Sterilizers

HS

WARNING

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

To remove the loading car from the chamber:

1. Follow steps 1 through 3 on page 3-10 for positioning and securing the transfer carriage in front of the open chamber.

2. Pull the loading car out of the chamber until the car’s axle makes contact with the rod support rear block on the carriage.

3. Turn the locking rod handle back to the “Unlock and Transport” position.

4. Pull the carriage away from the sterilizer.

61301608206 3–11

Preparation for Use

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.

WARNINGS

HS

shelf-caution1

20 lbs.

MAX

DO NOT EXCEED 20 POUNDS

ON EXTENDED SHELVES

• 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 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).

Figure 3–4. RACK AND EXTENDABLE SHELVES

Rack

(100 lb. Total Load

All Shelves)

Extendable

Shelves

DO NOT EXTEND SHELVES

CONTAINING BOTTLES

NOTE

• Routine cleaning (see page 7-4) prolongs the useful life of the shelves, as chlorides from the steam or spillage from liquid loads may otherwise corrode 300 series stainless steel.

• For information on positioning shelves and racks, see "Installing/ Removing, & Adjusting Shelf Racks" on page 7-15.

CAUTION

Do not place items on the floor of the chamber. Always use the loading car or shelf.

3–12

SEQUENCE OF OPERATION

Section 4 Operating Instructions

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

• Turning on the Controls—see page 4-2

• Previewing/Selecting a Cycle—see page 4-2.

• Loading the Sterilizer—see page 4-5.

• Editing Cycle Parameters—see page 4-6.

• Starting a Cycle—see page 4-7.

• Canceling a Cycle (Manual Abort)—see page 4-9.

• End of Cycle Routine—see page 4-10

• Unloading the Sterilizer—see page 4-12.

This section also covers:

• Opening and Closing the Sterilizer Door—see page 4-15.

• Operating the Printer—see page 4-19.

• Reading the Cycle Printout—see page 4-25.

• Performance Testing—see page 4-28.

61301608206 4–1

Operating Instructions

E

P

A

OPERATING THE STERILIZER

Turning on the Controls For information regarding controls, see Turning ON the Controls on page 2-

7.

Previewing/Selecting a Cycle When making a cycle selection, pressing ENTER displays the exposure

time and temperature, drying time, and the cycle name for the selected cycle at the top of the Main Display window (see Figure 4–1). This feature permits preview of several different cycle settings before final selection.

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

NOTES

• The information that appears in the main display window depends on the type of display chosen as the default (Details, Plot Graph, or Bar Graph).

• Press CANCEL at any time to return to the main display window without selecting a cycle.

Figure 4–1. MAIN DISPLAY WINDOW (Bar Graph)

00:30:00

Exposure Time

P10 grv GRAVITY1

01 STANDBY

HAMBER TEM

37.3 C

121.1 C

Exposure Temp

00:30:00

Drying Time

HAMBER PSI

14.68 PSI

00:00:00 00:24:15

0

REMAINING TIM

SETUP

SELECT

CYCLE

PARA-

METER

UNSEAL

WS-0014-B

4–2

400LS/500LS Series Steam Sterilizers

E

P

A

E

P

A

To select a cycle:

1. From the main display window, press [SELECT CYCLE]. The SELECT CYCLE screen appears.

Figure 4–2. SELECT CYCLE SCREEN

00:30:00

Exposure Time

P10 grv GRAVITY1

01 STANDBY

SELECT CYCLE

P01

P02

P03

P04

P05

P06

P07

CANCEL

HAMBER TEM

vac PREVAC1

37.3 C

vac PREVAC1

grv GRAVITY1

121.1 C

Exposure Temp

0

REMAINING TIM

00:30:00

Drying Time

HAMBER PSI

14.68 PSI

ws-0156 400_500LS

00:00:00 00:24:15

OK

2. Use the UP/DOWN arrows to scroll the list of cycles. The black bar at the right side of the screen indicates more

cycles exist than will fit on one (1) screen. Continued scrolling refreshes the screen and displays any additional cycles.

Stop scrolling when the desired cycle is highlighted.

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 Main Display screen without selecting a cycle.

3. Press ENTER to preview the cycle parameters. The cycle name and cycle parameters appear at the top of

the display window.

Figure 4–3. SELECTING A CYCLE

00:30:00

Exposure Time

P10 grv GRAVITY1

01 STANDBY

SELECT CYCLE

P01

P02

P03

P04

P05

P06

P07

CANCEL

HAMBER TEM

vac PREVAC1

37.3 C

vac PREVAC1

grv GRAVITY1

121.1 C

Exposure Temp

0

REMAINING TIM

00:30:00

Drying Time

HAMBER PSI

14.68 PSI

00:00:00 00:24:15

OK

-

1

Press [OK} to confirm the selected cycle

61301608206 4–3

Operating Instructions

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

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

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

NOTE

Press CANCEL at any time to return to the main display window without selecting a cycle.

The main display window displays.

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

4–4

Loading the Sterilizer

WARNINGS

CAUTION

400LS/500LS Series Steam Sterilizers

• BURN HAZARD: The door and chamber area could be HOT enough to cause burns. Wear personal protective equipment (PPE) when loading the chamber.

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

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

• POSSIBILITY OF INJURY: Only use 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.

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

NOTE

To load the sterilizer:

1. Open the door (if necessary). See Opening and Closing

the Sterilizer Door on page 4-15.

2. Place the load into the chamber.

See Loading Car and Transfer Carriage (533HC only) on page 3-9 or Rack and Extendable Shelves on page 3-12.

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 4-15.

61301608206 4–5

Operating Instructions

Editing Cycle Parameters

• 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.

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

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 Edit Cycle Parameters in the 400LS/500LS Series Steam Sterilizers Supervisor Manual.

4–6

Starting a Cycle

400LS/500LS Series Steam Sterilizers

WARNINGS

• 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 CONTAMINATION: If the wrong cycle is selected, the desired sterility assurance level (SAL) may not be reached.

• RISK OF CONTAMINATION: If the cycle is cancelled or aborted, it must be considered incomplete and the load must be reprocessed (unwrapped goods or liquids) or repacked and reprocessed (wrapped goods).

• RISK OF CONTAMINATION: If the Process Failure indicator is flashing, the cycle must be considered incomplete and the load must be repackaged and reprocessed.

• RISK OF CONTAMINATION: If the sterilizer canceled the cycle due to a power interruption, the load must be repackaged and reprocessed.

• POSSIBILITY OF INJURY: Only use 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.

POSSIBILITY OF EQUIPMENT DAMAGE: Use of sealed, unvented

CAUTION

NOTE

containers to process liquids can be result in permanent damage to the sterilizer.

If the control panel shows UTILITY SHUTDOWN, see Bypassing Utility Shutdown Mode on page B-53.

61301608206 4–7

Operating Instructions

To begin the sterilization cycle:

1. Press START.

a. The door(s) automatically seal (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 display screen.

c. At the end of the cycle, the PROCESS COMPLETE

LED illuminates and the buzzer sounds (the buzzer silences automatically). 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 stops, and a diagnostic message appears on the printout.

NOTE

!

The failure message appears against a flashing red background* in the critical alarms portion of the Display window. (Figure 1–3, Area f).

• Press CLEAR ALARM to clear the message (if the alarm

has corrected) and silence the alarm.

• Refer to Diagnostic Messages on page 6-8 for corrective

action.

4–8

Canceling a Cycle (Manual Abort)

400LS/500LS Series Steam Sterilizers

WARNING

NOTE

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

A cycle can be cancelled during any phase. 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 (i.e. exposure), [MORE] displays. If the cycle is in an untimed phase (i.e. heat-up), [ABORT] displays.

See Canceling a Cycle (Manual Abort) on page 5-2.

If the CONTROLS OFF/ON button is pressed during a cycle, the cycle will abort (after a 2 second timer expires). Therefore, this is not the recommended method to manually abort a cycle. Use the [ABORT] softkey instead

61301608206 4–9

Operating Instructions

End of Cycle Routine

WARNING

CAUTION

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

• RISK OF CONTAMINATION: If the Process Failure indicator is flashing, the cycle must be considered incomplete and the load must be repackaged and reprocessed.

• RISK OF CONTAMINATION: If the sterilizer canceled the cycle due to a power interruption, the load must be repackaged and reprocessed.

• POSSIBILITY OF INJURY: Only use 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.

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

NOTES

• For detailed information regarding failure and fault conditions, and informational messages, refer to FAILURE CONDITION MESSAGES on page 6-3.

• For information regarding troubleshooting and/or diagnostic messages refer to Section 6, Tables 6–1 through 6–6.

The status of the completed load should be verified before removing the load from the sterilizer. The following table outlines what to look for to determine if a cycle completed successfully or aborted

4–10

.

Table 4–1. Cycle Result Determination

Successful Cycle Aborted Cycle

400LS/500LS Series Steam Sterilizers

• CYCLE COMPLETE is printed on the printout below the

• CYCLE ABORTED is printed on the printout.

CYCLE RESULTS.

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

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

PROCESS END 14:35:41 CYCLE RESULTS Exp. Temp Max 121.8C Exp. Temp Min 121.5C Overall Time at Temp 00:32:34

DAILY COUNTER 2

01:36:36 14.37 102.9 CYCL COMPLETE 01:36:04 14.31 106.8 CE UNSEALING 01:36:04 14.31 106.9

CYCLE COMPLETE

• CYCLE COMPLETE appears against a green background* in the cycle information portion of the Display window (Figure 1–3, Area d).

• 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 failure message appears against a flashing red

• Pulsing alarm tone is activated.

• PROCESS COMPLETE status indicator is flashing red

• 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

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

CYCLE ABORTED

00:03:11 14.26 88.8 AIR-IN 00:03:00 14.24 89.1 00:02:10 14.22 100.3 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

CYCLE ABORTED

the cycle information portion of the Display window. (Figure 1–3, Area d)

background* in the critical alarms portion of the Display window. (Figure 1–3, Area f).

indicating an aborted cycle.

corrected and CLEAR ALARM is pressed.

• The door automatically unseals, remains closed, and

• The door remains sealed.

ready to open.

(NOTE: The door remains sealed until the failure condition is

(NOTE: Doors on unidirectional units do NOT automatically

acknowledged.)

unseal; check the cycle printout to confirm results.)

POSSIBILITY OF INJURY: If a WATER IN DRAIN message

WARNING

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.

*panel version 3.07 or later

.

61301608206 4–11

Operating Instructions

S

Unloading the Sterilizer

WARNING

HS

• 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.

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

• RISK OF CONTAMINATION: If the Process Failure indicator is flashing, the cycle must be considered incomplete and the load must be repackaged and reprocessed.

• RISK OF CONTAMINATION: If the sterilizer canceled the cycle due to a power interruption, the load must be repackaged and reprocessed.

• 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, 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.

• 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, 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.

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

POSSIBILITY OF INJURY: Only use vented or open containers

WARNING

to process liquids in this sterilizer. Use of sealed, unvented containers to process liquids can result in severe personal

4–12

CAUTION

400LS/500LS Series Steam Sterilizers

injury due to container breakage. Getinge USA does NOT recommend or endorse use of such containers.

POSSIBILITY OF EQUIPMENT DAMAGE: 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. Refer to "End of Cycle Routine" on page 4-10.

Unload the sterilizer:

1. Unseal the door.

• Single door and standard double door units: The door(s) automatically unseal at the end of the cycle.

• Interlocking double door units: The door at the unload end automatically unseals at the end of the cycle.

• Unidirectional double door units: The door at the unload end must be manually unsealed at the end of the cycle.

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

2. Open the door. See Opening and Closing the Sterilizer Door on

page 4-15.

3. Remove the load See Loading Car and Transfer Carriage (533LS only) on

page 3-9 or Rack and Extendable Shelves on page 3-12.

4. Close the door.

• On unidirectional double door units, press SEAL DOOR

to seal the door at the unload end prior to unsealing the door at the load end for the next cycle.

61301608206 4–13

Operating Instructions

• On interlocking double door units, press SEAL DOOR to seal the door at the unload end and automatically unseal the door at the load end for the next cycle.

4–14

OPENING AND CLOSING THE STERILIZER DOOR

S

• RISK OF CONTAMINATION: If the cycle is cancelled or

WARNING

HS

aborted, it must be considered incomplete and the load must be repackaged and reprocessed.

• RISK OF CONTAMINATION: If the Process Failure indicator is flashing, the cycle must be considered incomplete and the load must be repackaged and reprocessed.

• RISK OF CONTAMINATION: If the sterilizer canceled the cycle due to a power interruption, the load must be repackaged and reprocessed.

• BURN/PINCH HAZARD: KEEP HANDS AND FINGERS AWAY FROM A MOVING DOOR. If your hands or fingers are accidentally caught in the door:

•Manual Door—gently reverse direction to open the door.

•POWER DOOR—PRESS THE FOOTSWITCH, OR THE DOOR CONTROL SWITCH TO REVERSE THE DOOR DIRECTION—or, manually open the door.

400LS/500LS Series Steam Sterilizers

CAUTION

• 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, 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.

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

• POSSIBILITY OF INJURY: Only use 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.

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

61301608206 4–15

Operating Instructions

Safety Features These safety features apply to all units:

• The operator cannot unseal a door during a processing cycle.

• If a door is not fully closed, it cannot be sealed.

• If a door is not sealed, a cycle cannot be started.

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

Manual Door The sterilizer is equipped with a counterbalanced vertical sliding door.

Gentle upward or downward pressure on the door’s handle raises or lowers the door.

The door is sealed by applying steam pressure behind the door gasket located in the chamber headring. When pressure is applied, the gasket is forced against the inside of the door, creating a door-to-chamber seal.

On single door units, a closed door seals automatically when START is pressed. The door unseals automatically at the end of the cycle.

On standard double door units, both closed doors seal automatically when START is pressed. The doors cannot be sealed individually.

NOTE

On units with the interlocking double door option, both closed doors seal automatically when START is pressed. The doors can be sealed individually; however, when either door is sealed, the other door unseals automatically. Only the door at the unload end unseals automatically at the end of the cycle.

On unidirectional double door units, the door at the unload end must be unsealed manually.

Be sure the doors are unsealed (Door(s) Sealed indicator OFF) before turning OFF power to the controls or the sterilizer.

See Section 11 for information regarding unidirectional double door operation.

To open the door:

1. Verify the Status of the Load. See "End of Cycle Routine"

on page 4-10.

2. If the DOOR(S) SEALED indicator is illuminated, press

OPEN DOOR to unseal the door.

3. Wait approximately 30 seconds to allow any trapped steam

to leave the chamber.

4. Apply gentle downward pressure on the door handle.

4–16

400LS/500LS Series Steam Sterilizers

CAUTION

Do not use excessive force when operating the door. Damage to the door or the door’s latching mechanism could result.

To close the door:

1. Apply gentle upward pressure on the handle. The door

latches when fully closed.

2. The door seals automatically when the cycle starts.

Figure 4–4. DOOR OPERATION

WARNING

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. Manual Door—gently reverse direction to open the door.

61301608206 4–17

Operating Instructions

Power Door (Option)

WARNING

On power door units, a motor raises and lowers the door, but does not seal the door. The door is sealed when START or DOOR(S) SEALED is pressed.

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.

NOTES

• A power door can also be raised and lowered manually.

• Wait for approximately one (1) minute for the steam to vent before

opening the door.

To open or close the door:

Press and release the footswitch at the bottom of the sterilizer.

• It is not necessary to hold the footswitch while the motor is running; once

started, the motor runs until the door is fully open or closed.

• If there is an obstruction in the way of a moving door, the door stops after

several seconds. Press and release the footswitch to reverse the door direction. Once the door is reversed and stops moving, remove the obstruction.

To stop a moving door:

Press and release the footswitch. The door moves in the reverse direction.

Figure 4–5. POWER DOOR SWITCH

4–18

Footswitch

WS-0045

OPERATING THE PRINTER

400LS/500LS Series Steam Sterilizers

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.For liquids cycle that use the liquid RTD, the F

load temperature are also printed out. The program time is reset at the start of each cycle.

value and

0

NOTES

• 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 a qualified Getinge USA service representative.

• The temperature and pressure units (°C or °F; PSI, kPa, or bar) can be

configured by an operator with Configuration password access. See "Select the Language, Date Format, and Units in the 400LS/500LS Series Steam Sterilizers Supervisor Manual.

• The column layout of the printout can be configured by a qualified

Getinge USA service representative.

The printer also records any diagnostic messages that occur during the cycle.

• Occasionally with the introduction of AC power to the sterilizer, the

message "LOW POWER BROWN OUT" may occur on the printout. This message should be disregarded.

• 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 operator opens the cover and tears off the printout.

61301608206 4–19

Operating Instructions

Figure 4–6. PRINTER

CLEAR

COVER

COVER SLOT

ROLL

COVER

LEVER

RETAINER

CORE

SLOT

NOTCH

STATUS

TAB

STATUS

COPY

FEED

SHAFT

00-01A

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

or there is a paper jam.

Figure 4–7. STATUS INDICATOR

OFF = NO POWER

ON = READY

BLINKING = PRINTER NOT READY,

PAPER NOT PROPERLY INSERTED, OR ROLL COVER OPEN

A00866BC

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.

4–20

400LS/500LS Series Steam Sterilizers

Using the Lever The lever helps remove the core. (See Figure 4–8) 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

• 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

00-01f

STATUS

(see Replacing the Printer Paper below).

• Small sections—to collect printouts of shorter periods,

such as daily use: When loading paper, do not insert a new core. Instead,

00-01H

STATUS

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.

00-01G

Before opening the sterilizer door, tear off the printout after each cycle.

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, follow the steps on page 4-23 and see Figure 4–8 on page 4-22. For small section or separate printouts, see Saving Printouts above.

For information on ordering printer paper and cores, see Consumable Stock on page A-1.

61301608206 4–21

Operating Instructions

Figure 4–8. REPLACING THE ROLL

REMOVE THE USED CORE

STATUS

INSERT A NEW CORE

STATUS

ALIGN NOTCHES

WITH TABS

INSERT A NEW ROLL

LOAD THE PAPER

STATUS

• PRESS AND RELEASE

• THEN PRESS AND HOLD FOR 1 REVOLUTION

01-00-D

4–22

400LS/500LS Series Steam Sterilizers

Removing the 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 core.

NOTE

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

Inserting a New Core 1. Still holding the lever, align the notches on the new core

with the tabs on the shaft. (See REPLACING THE ROLL, Figure 4–8 on page 4-22.)

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 (see Figure 4–9).

Figure 4–9. FOLD THE PAPER

FOLD

00-01B

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.

• The core turns.

• Take up the paper at least one full revolution.

6. Release FEED. Close the clear cover.

61301608206 4–23

Operating Instructions

Storing and Handling Paper Rolls

NOTE

Printing a Duplicate Record

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, press and release COPY while the unit is not running a cycle.

The duplicate record prints.

• COPY only functions 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.

4–24

READING THE CYCLE PRINTOUT

A sample cycle printout of a liquids cycle run on a 400LS/500LS Series Steam Sterilizer has been provided in Figure 4–10. The proper interpretation of the information produced during a cycle is provided below.

400LS/500LS Series Steam Sterilizers

NOTES

• 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.

• The sample printout shown in Figure 4–10 is from a liquids cycle. Different

sterilization cycles will produce printouts with slightly different information, but time stamps and pressure and temperature readings are all read in the same way.

• There are two (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 a qualified Getinge USA Service Representative.

Cycle Start and Parameters Callout #1 shows a line of text which indicates that a new cycle has started

(e.g., DATE: 01/07/02).

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 (00:30:00). The EXPOSURE TIME is the amount of time the EXPOSURE TEMP shall be maintained.

Callout #3 shows the name of the current cycle. In this example, the cycle is a liquids cycle named P13 liq LIQUIDS1.

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 LIQ (liquid) EXPOSURE phase.

Immediately above the word LIQ EXPOSURE, the time the phase started along with the chamber pressure and temperature are printed. In this example, the printout shows the LIQ EXPOSURE phase started at 00:28:13, and, at that time, the chamber pressure was 30.57 PSIG and the chamber temperature was 121.2°C.

During timed phases, the printer reports the appropriate cycle information including F

temperature readings at regular intervals. LIQ EXPOSURE uses the fast log rate, factory set at 30 seconds. Therefore, after the start of LIQ EXPOSURE at 00:28:13, there are readings at 00:28:43, 00:29:13, and so forth. The sample printout is truncated to fit on the page; normally, there are pressure/ temperature readings every 30 seconds for the entire 30 minute phase.

value, load temperature, along with chamber pressure and

0

61301608206 4–25

Operating Instructions

When the cycle transitions from one phase to the next, the new phase name is printed along with the time the phase begins, F

as well as the chamber pressure and temperature readings. In this example, Callout #5 shows the LIQ EXHAUST phase of the P13 liq LIQUIDS1 cycle starting at 00:58:13. The beginning of the new phase (LIQ EXHAUST) also marks the end of the previous phase (LIQ EXPOSURE).

value, load temperature,

0

Validating the Exposure Phase

NOTES

• Phases do NOT overlap.

• Different cycles will feature different phases and parameters.

Unlike the LIQ EXPOSURE phase where readings are printed at the fast log rate, the LIQ 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 of each phase within a cycle is printed. Therefore, it is possible to determine the total time of any given phase. In Figure 4–10, Callout #6 shows the LIQ EXPOSURE phase starting at 00:28:13 and the LIQ EXHAUST phase starting at 00:58:13, the total exposure time is the difference between the two start times, or 00:30:00. This can be validated by the EXPOSURE TIME parameter in Callout #2 which reads 00:30:00.

Examining the EXPOSURE TEMP parameter appearing above EXPOSURE TIME (Callout #2), reveals the P13 liq LIQUIDS1 cycle requires an exposure temperature of 121.1°C. During the LIQ EXPOSURE phase the temperatures recorded are between 121.2 and 121.9°C which are within acceptable sterilization variances.

This information shows the LIQ EXPOSURE phase is valid because

121.1°C was achieved and maintained for a time of at least 00:30:00.

CYCLE END

Callout #7 shows a line that reads CYCLE COMPLETE followed by a line with a time stamp, pressure and temperature reading. This is the end of the P13 liq LIQUIDS1 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 exposure temperature. (OVERALL TMP TIME)

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

4–26

Figure 4–10. SAMPLE PRINTOUT (Liquids Cycle with Load Probe)

7. Time stamp at end of cycle.

6. Total exposure time

00:58:13 (liq. exposure end)

- 00:28:13 (liq. exposure start) 00:30:00 *Total exposure time

400LS/500LS Series Steam Sterilizers

Top of Printout/End of Cycle

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

PROCESS END 02:30:00

CYCLE RESULTS Exp. Temp Max 122.3C Exp. Temp Min 121.6C Overall Tmp Time 00:42:10

DAILY COUNTER 110

02:15:36 48.9 98.0 14.38 82.6 CYCL COMPLETE 02:15:06 48.9 98.0 14.39 87.1 CE UNSEALING 02:15:05 48.9 98.1 14.39 87.1 AIR-IN 02:15:00 48.9 98.1 14.35 87.1 02:14:00 48.9 98.1 14.37 87.2

5. Time stamp for end of Liquid Exposure cycle and beginning of Liquid Exhaust.

4. Beginning of Liquid Exposure cycle.

3. Cycle name.

2. Set exposure time.

1. Date stamp - denotes start of cycle.

Read tape from bottom to top.

00:59:00 40.8 121.7 30.03 121.4 00:58:13 39.9 121.8 30.43 121.8 LIQ EXHAUST 00:58:00 39.7 121.9 30.37 121.8 00:57:30 39.1 121.8 30.50 121.9 00:57:00 38.5 121.8 30.45 121.8

00:28:13 5.3 121.2 30.57 122.1 LIQ EXPOSURE 00:28:00 5.1 121.1 30.84 122.3 00:27:00 4.1 120.6 30.77 122.2

00:02:01 0.0 28.6 14.95 79.8 LIQ HEAT-UP 00:02:00 0.0 28.5 14.95 79.1

00:00:00 0.0 26.0 14.46 59.0 PURGE 00:00:00 0.0 26.0 14.45 59.0 START PROGTIME F000 A102 A103 A100

PROGRAM: P13 liq LIQUIDS1

A100 CHAMBER TEMP A103 CHAMB PSIA A102 Load Temp F000 Fo Value SIGNALS

BlowDown Durat. 00:00:00 Chamber Cooldown 0.75 /M Fo Value Reached 0.0 Exposure Time 00:30:00 Liq Dwell Time 00:00:00 Exp Overdrive 1.0 C Exposure Temp 121.1 C Purge Time PARAMETERS

CYCLE COUNTER : 236

MACHINE NAME : 544LS PROCESS START : 11:38:12

DATE : 11/12/04

00:02:00

Bottom of Printout/Start of Cycle

WS-0223

61301608206 4–27

Operating Instructions

PERFORMANCE TESTING

Biological Monitoring Biological monitoring is used to document the efficacy of specific steam

sterilization cycle.

• Biological indicator test pack should be used during initial installation of steam sterilizers.

• Biological indicator test pack should be used in steam sterilization loads weekly, preferably daily.

• Each load containing implantable devices must be monitored. Whenever possible, the implantable devices should be quarantined until the results of the biological testing are available.

The Getinge USA Biosign Biological Indicators are self-contained test units for monitoring steam sterilization cycles. Biosign is available as an individual test (Part No. 61301600022) or as a pre-assembled single-use test pack (Part No. 61301603337).

4–28

400LS/500LS Series Steam Sterilizers

Vacuum Leak Test To run a vacuum leak test cycle:

1. Make sure the sterilizer chamber is empty.

2. Close the sterilizer door(s).

3. Select the Vacuum Leak Test cycle.

4. Press START.

a. The vacuum leak test cycle begins. b. The cycle includes a conditioning phase, a 3 minute

exposure phase, a 15 minute drying phase, and a 5 minute dwell phase followed by a 15 minute leak test.

The test takes approximately 40 minutes. c. During the cycle, LEAK TEST displays. d. At the end of the cycle, the buzzer sounds and CYCLE

COMPLETE displays.

5. Check the results: a. If the sterilizer passes the test (LEAK TEST FAIL does

not display), the sterilizer is functioning properly.

• Repeat the air removal test (Bowie-Dick test), carefully following the instructions on the S.M.A.R.T. Pack.

• If the sterilizer fails the Bowie-Dick test a second time, consult the B-D Test Pack manufacturer and/or a qualified Getinge USA service representative.

b. If the sterilizer fails the test (LEAK TEST FAIL), shut

down the sterilizer and check the condition of the gasket. If the gasket requires replacement, either follow the procedure Replacing the Door Gasket(s) on page 7-9 or call service. Do not process any loads in the sterilizer until the problem is identified and corrected.

61301608206 4–29

Operating Instructions

4–30

Section 5 Conditional Instructions

The following procedures provide information and instructions for situations that may develop that are not part of standard sterilizer operation:

• Canceling a Cycle (Manual Abort) — see page 5-2.

• Advancing a Cycle (Manual Phase Advance) — see page 5-6.

• End of Cycle Routine— see page 5-9

• Shutting Down the Sterilizer — see page 5-11.

• Recovering from an Electrical Power Failure — see page 5-13.

• Opening the Door Manually — see page 5-15.

61301608206 5–1

Conditional Instructions

CANCELING A CYCLE (MANUAL ABORT)

WARNINGS

CAUTION

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

• RISK OF CONTAMINATION: Airborne microbial and particulate contamination is likely to be high in the preparation area. 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: Only use 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.

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

A cycle can be cancelled 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 (i.e. exposure), [MORE] displays. If the cycle is in an untimed phase (i.e. heat-up), [ABORT] displays.

5–2

400LS/500LS Series Steam Sterilizers

E

P

A

E

P

A

Timed Phase During a timed phase (i.e. exposure), the screen appears as follows:

Figure 5–1. IN-CYCLE SCREEN

NOTE

00:30:00

Exposure Time

P10 grv GRAVITY1

04 EXPOSURE

HAMBER TEM

121.3 C

121.1 C

Exposure Temp

00:30:00

Drying Time

HAMBER PSI

30.20 PSI

01:01:53 00:25:48

36

REMAINING TIM

SETUP

If the sterilizer is not in a timed phase (i.e. waiting for the chamber to heat up), ABORT displays in the same position as MORE in the previous figure.

To cancel a cycle during a timed phase:

PAR A-

METER

MORE

WS-0096

1. Press [MORE]. The screen appears as follows:

Figure 5–2. IN-CYCLE SCREEN (ABORT)

00:30:00

Exposure Time

P10 grv GRAVITY1

04 EXPOSURE

HAMBER TEM

121.3 C

121.1 C

Exposure Temp

HAMBER PSI

30.20 PSI

36

REMAINING TIM

ABORT

PHS ADV

00:30:00

Drying Time

01:01:53 00:25:48

EXIT

ws-0157

61301608206 5–3

Conditional Instructions

E

P

A

2. Press [ABORT]. The sterilizer ceases all processing activity and begins an exhaust (or liquid exhaust) phase (including exhaust, dry, air in, and standby phases).

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

4. Press OPEN DOOR to unseal the door(s). Wait approximately one (1) minute for the steam to vent before opening the door.

5. Open the door about an inch for 10 seconds to allow residual steam vapors to escape. On power door units, unseal the door and wait about a 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 5-9.

7. Remove the load from the chamber.

Untimed Phase During an untimed phase (i.e. Heat-up), the screen appears as

follows:

Figure 5–3. IN-CYCLE SCREEN

00:30:00

Exposure Time

P10 grv GRAVITY1

02 HEAT-UP

HAMBER TEM

121.3 C

121.1 C

Exposure Temp

00:30:00

Drying Time

HAMBER PSI

30.20 PSI

00:30:14 00:24:15

66

REMAINING TIM

SETUP

NOTE

If the sterilizer is in a timed phase (i.e. exposure), MORE displays in the same position as ABORT in the previous figure.

5–4

PARA-

METER

ABORT

ws-0111

400LS/500LS Series Steam Sterilizers

To cancel the cycle during an untimed phase:

1. Press [ABORT]. The sterilizer ceases all processing activity and begins an exhaust (or liquid exhaust) phase.

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

3. Press OPEN DOOR switch to unseal the door(s).

4. Open the door about an inch for 10 seconds to allow residual steam vapors to escape. On power door units, unseal the door and wait about a 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.

5. Verify the status of the load. See End of Cycle Routine on page 5-9.

6. Remove the load from the chamber.

61301608206 5–5

Conditional Instructions

ADVANCING A CYCLE

ARNINGS

This feature may be used to terminate a timed phase and advance to the next phase. Timed phases include: PURGE, LIQ DWELL, EXPOSURE, LIQ EXPOSURE, and DRYING.

• RISK OF CONTAMINATION: If the cycle advance feature is used, the cycle must be considered incomplete and the load must be repackaged and reprocessed.

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

• RISK OF CONTAMINATION: Airborne microbial and particulate contamination is likely to be high in the preparation area. 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 the chamber.

NOTE

• POSSIBILITY OF INJURY: Only use 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.

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.

5–6

400LS/500LS Series Steam Sterilizers

E

P

A

E

P

A

To advance a cycle:

From the Main Display screen shown in the following figure:

Figure 5–4. MAIN DISPLAY SCREEN

00:30:00

Exposure Time

P10 grv GRAVITY1

04 EXPOSURE

HAMBER TEM

121.3 C

121.1 C

Exposure Temp

00:30:00

Drying Time

HAMBER PSI

30.20 PSI

01:01:53 00:25:48

36

REMAINING TIM

SETUP

1. Press [MORE]. The softkey labels at the bottom of the screen appear as shown in the following figure.

Figure 5–5. MAIN DISPLAY SCREEN (ADVANCE CYCLE)

00:30:00

Exposure Time

P10 grv GRAVITY1

04 EXPOSURE

PAR A-

METER

121.1 C

Exposure Temp

00:30:00

Drying Time

01:01:53 00:25:48

MORE

WS-0096

HAMBER TEM

121.3 C

HAMBER PSI

30.20 PSI

36

REMAINING TIM

ABORT

61301608206 5–7

PHS ADV

EXIT

ws-0157

Conditional Instructions

2. Press [PHS ADV]. 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 air-in phase 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 5-9.

4. Remove the load from the chamber.

5–8

END OF CYCLE ROUTINE

400LS/500LS Series Steam Sterilizers

WARNING

CAUTION

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

• RISK OF CONTAMINATION: If the Process Failure indicator is flashing, the cycle must be considered incomplete and the load must be repackaged and reprocessed.

• RISK OF CONTAMINATION: If the sterilizer canceled the cycle due to a power interruption, the load must be repackaged and reprocessed.

• POSSIBILITY OF INJURY: Only use 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.

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

NOTES

• For detailed information regarding failure and fault conditions, and informational messages, refer to FAILURE CONDITION MESSAGES on page 6-3.

• For information regarding troubleshooting and/or diagnostic messages refer to Section 6, Tables 6–1 through 6–6.

The status of the completed load should be verified before removing the load from the sterilizer. The following table outlines what to look for to determine if a cycle completed successfully or aborted

61301608206 5–9

Conditional Instructions

.

Table 5–1. Cycle Result Determination

Successful Cycle Aborted Cycle

• CYCLE COMPLETE is printed on the printout below the CYCLE RESULTS.

• CYCLE ABORTED is printed on the printout.

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

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

CYCLE ABORTED

00:03:11 14.26 88.8 AIR-IN 00:03:00 14.24 89.1 00:02:10 14.22 100.3 DRYING 00:02:00 18.69 107.8 00:01:26 37.23 126.9 ABORT -HIGH TEMP

• CYCLE COMPLETE appears against a green background* in the cycle information portion of the Display window (Figure 1–3, Area d).

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

(NOTE: The message/phase clears/changes when the sterilizer door opens.)

00:01.26 37.23 126.9

• STANDBY appears against a flashing red background* in the cycle information portion of the Display window. (Figure 1–3, Area d)

• The failure message appears against a flashing red background* in the critical alarms portion of the Display window. (Figure 1–3, Area f).

• 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.

CYCLE ABORTED

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

(NOTE: Doors on unidirectional units do NOT automatically unseal; check the cycle printout to confirm results.)

*panel version 3.07 or later

5–10

• The door remains sealed.

(NOTE: The door remains sealed until the failure condition is acknowledged.)

POSSIBILITY OF INJURY: If a WATER IN DRAIN message

WARNING

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.

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 operators should know the location of the mains disconnect circuit breaker and the steam and water supply shutoff valves at the sterilizer site.

400LS/500LS Series Steam Sterilizers

NOTE

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

Turning Off Electrical Power 1. Turn OFF power to the sterilizer at the mains disconnect

circuit breaker (see Figure 5–6 on page 5-12).

2. If the sterilizer has an uninterruptible power supply (UPS), press the Off/Standby switch on the UPS (see Figure 10–1 on page 10-1).

3. If the sterilizer has a steam boiler or a vacuum pump, turn off the three-phase voltage at the circuit breaker.

61301608206 5–11

Conditional Instructions

!

/

Turning Off the Steam and Water Supplies

Steam Supply

(units without steam generator)

Cold Water Supply

Cold Water

Shutoff

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

Figure 5–6. CIRCUIT BREAKERS AND SHUTOFF VALVES

Hot Water Supply

(units with steam generator)

Steam Shutoff

115 VAC

!

C O

N T

O

R

N

O L

/

S O F F

Hot Water

Shutoff

UPS

(option)

Three-Phase Voltage

to Vacuum Pump

Three-Phase Voltage

to Steam Boiler

Main

Disconnect

Circuit

Breaker

Circuit

Breaker

Vacuum Pump

- or -

(option)

Steam

Boiler

(option)

WS-0197

5–12

RECOVERING FROM ELECTRICAL POWER FAILURE

S

• RISK OF CONTAMINATION: If the sterilizer canceled the

WARNING

cycle due to a power interruption, the load must be repackaged and reprocessed.

• RISK OF CONTAMINATION: If the cycle is cancelled or

aborted, it must be considered incomplete and the load must be repackaged and reprocessed.

• RISK OF CONTAMINATION: If the Process Failure indicator

is flashing, the cycle must be considered incomplete and the load must be repackaged and reprocessed.

• POSSIBILITY OF INJURY: Only use 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.

400LS/500LS Series Steam Sterilizers

CAUTION

NOTES

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

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.

• 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 shelf-life.

• If the sterilizer has an uninterruptible power supply, the UPS provides

power to the sterilizer controls. See Section 10 for information on the UPS.

61301608206 5–13

Conditional Instructions

Power Failure During Standby

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

Power Failure During a Cycle If power is interrupted for less than 60 seconds, the sterilizer continues the

cycle, at the same point at which power was interrupted, when power is restored.

If power is interrupted for 60 seconds or more, the sterilizer automatically aborts the cycle and returns to standby mode, when power is restored. If there is pressure or vacuum in the chamber, the controls run the appropriate exhaust or air-in phase.

5–14

OPENING THE DOOR MANUALLY

• Retracting the door gasket manually should be performed by

WARNINGS

qualified service maintenance personnel only. This procedure requires access to the service side of the equipment

• RISK OF CONTAMINATION: 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.

• 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.

• View the CHAMBER and JACKET pressure gauges while the

steam bleeds from the chamber. Wait until the pressure is at zero (0 psig) before operating manual valves. Hot steam can cause serious injury.

• DO NOT attempt to open the sterilizer chamber door unless

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

• 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 (PPE) when preparing items for cleaning.

• RISK OF CONTAMINATION: If the sterilizer canceled the

cycle due to a power interruption, the load must be repackaged and reprocessed.

• RISK OF CONTAMINATION: If the Process Failure indicator

is flashing, the cycle must be considered incomplete and the load must be repackaged and reprocessed.

• RISK OF CONTAMINATION: If the cycle is cancelled or

aborted, it must be considered incomplete and the load must be repackaged and reprocessed.

• 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.

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

valves with the chamber door open.

400LS/500LS Series Steam Sterilizers

61301608206 5–15

Conditional Instructions

CAUTION

• 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.

• POSSIBILITY OF INJURY: If a WATER IN DRAIN message is displayed, 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: Only use 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.

POSSIBILITY OF EQUIPMENT DAMAGE: 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 due to an electrical outage. All other conditions should be reported to Getinge USA.

Preparation

WARNINGS

CAUTION

The following subsections outline the procedure to open the door. While this procedure applies to both manual and power doors, it does not apply to unidirectional doors. For unidirectional doors see Unidirectional Double Doors on page 11-1.

• Remove Pressure from the Gasket see page 5-18

• Remove the Load see page 5-21

• Restore Pressure to the Gasket see page 5-21

Be sure to follow the sequence outlined above when opening the door.

• 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

• POSSIBILITY OF INJURY: If a WATER IN DRAIN message is displayed, 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.

RISK OF ELECTRICAL SHOCK: Disconnect all electrical supply circuits to ensure that the sterilizer components will not be energized prior to the performance of required adjustments and testing.

5–16

400LS/500LS Series Steam Sterilizers

S

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

1. Turn OFF the steam supply.

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

ARNING

NOTE

• 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.

• View the CHAMBER and JACKET pressure gauges while the

steam bleeds from the chamber. Wait until the pressure is at zero (0 psig) before operating manual valves. Hot steam can cause serious injury.

3. Locate the chamber bleed ball valve.

4. Open the valve by rotating the handle COUNTER-CLOCKWISE to release any steam from the chamber.

5. Locate jacket bleed ball valve.

6. Open the valve by rotating the handle COUNTERCLOCKWISE to release any steam from the jacket.

The chamber and jacket bleed ball valves are located in the service area on the right side of the sterilizer behind the midline horizontal frame member. See Figure 5–7.

Figure 5–7. CHAMBER AND JACKET BLEED VALVES

Closed

Position

Open

Position

Jacket Bleed

Ball Valve

Front of Sterilizer

Chamber

Bleed

61301608206 5–17

WS-0297

Conditional Instructions

Remove Pressure from the Gasket

WARNING

HS

NOTE

DO NOT attempt to open the sterilizer chamber door unless the CHAMBER and JACKET pressure gauges on the front panel read zero (0 psig). Hot steam can cause serious injury.

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

2. Locate the water to ejector valve.

3. Turn the water to ejector valve ON by rotating the handle CLOCKWISE (approximately 1/4 turn). The water flow creates a vacuum to retract the gasket.

The water to ejector valve is located in the service area on the left side of the sterilizer, just below the middle horizontal frame member. See Figure 5–8.

Figure 5–8. WATER SOLENOID AND HAND VALVES

Water to Eject Solenoid Valve

5–18

Front of Sterilizer

WS-0118 400_500

Getinge 400LS, 500LS Operator Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

Appendix A Consumable Stock and Spare Parts

Appendix B Menu Tree

SPECIAL SAFETY INSTRUCTIONS

DESCRIPTION OF SYMBOLS ON THE EQUIPMENT

Switches

Indicators

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

MANUAL CONVENTIONS

MODELS

Section 1 Getting Started

CONTROLS AND INDICATORS

CYCLE ASSIGNMENTS

Section 2 Control Panel Navigation

PROCESS SCREENS

Bar Graph Screen The Bar Graph screen displays the chamber temperature and pressure as a

Details Screen The Details screen displays a list of real-time process critical values,

The Plot Graph Screen The Plot Graph screen displays the chamber temperature and pressure as a

Selecting a Process Screen The Bar Graph screen displays when the sterilizer control panel is turned

SOFTKEYS

TURNING ON THE CONTROLS

NAVIGATION BASICS

Directional Arrows Each of the Directional Arrows has a specific function:

ENTER Use the ENTER key to:

Select an Item from a List Selecting an item from a list is very simple; the UP/DOWN arrow keys are

Enter an Alphanumeric Value

Communicating With the System

Exit from a Screen There are three commands used to exit from a screen:

DAILY CHECKLIST

Section 3 Preparation for Use

Operational Readiness To ensure that the sterilizer is ready for processing without requiring a

LOAD PREPARATION

TECHNIQUES FOR LOADING

End of Cycle Routine

Liquid RTD Placement (Option)

LOADING ACCESSORIES

Loading Car and Transfer Carriage (533LS only)

Rack and Extendable Shelves The rack and extendable shelves are constructed of 300 series stainless

SEQUENCE OF OPERATION

Section 4 Operating Instructions

OPERATING THE STERILIZER

Turning on the Controls For information regarding controls, see Turning ON the Controls on page 2-

Previewing/Selecting a Cycle When making a cycle selection, pressing ENTER displays the exposure

Loading the Sterilizer

Editing Cycle Parameters

Starting a Cycle

Canceling a Cycle (Manual Abort)

End of Cycle Routine

Unloading the Sterilizer

OPENING AND CLOSING THE STERILIZER DOOR

Safety Features These safety features apply to all units:

Manual Door The sterilizer is equipped with a counterbalanced vertical sliding door.

Power Door (Option)

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

Using the Lever The lever helps remove the core. (See Figure 4–8) To

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

Removing the Take-up Core The printer has a take-up core which holds a complete roll of paper. The

Inserting a New Core 1. Still holding the lever, align the notches on the new core

Inserting a New Roll 1. Open the roll cover.

Loading the Paper 1. Close the roll cover.

Storing and Handling Paper Rolls

Printing a Duplicate Record

READING THE CYCLE PRINTOUT

Cycle Start and Parameters Callout #1 shows a line of text which indicates that a new cycle has started

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

Validating the Exposure Phase

PERFORMANCE TESTING

Biological Monitoring Biological monitoring is used to document the efficacy of specific steam

Vacuum Leak Test To run a vacuum leak test cycle:

Section 5 Conditional Instructions

CANCELING A CYCLE (MANUAL ABORT)

Timed Phase During a timed phase (i.e. exposure), the screen appears as follows: