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:
Manual400LS/500LS Series
Installation Instructions61301608205
Supervisor Manuall61301608207
Service Manual61301608209
Parts Catalog61301608210
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
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.
THE FOLLOWING SAFETY INSTRUCTIONS APPEAR WITHIN THIS
MANUAL. READ THEM CAREFULLY BEFORE OPERATING THE UNIT.
400LS/500LS Series Steam Sterilizers
WARNING
p. iiPOSSIBILITY OF INJURY: Misuse of equipment or bypassing its safety
p. iiPOSSIBILITY OF EQUIPMENT DAMAGE: Misuse of equipment may result
p. iiThe 400/500 Series Steam Sterilizers are designed to steam sterilize
p. 4-12, 4-15BURN HAZARD: Before removing a load from the chamber, manually lower
p. 4-6RISK OF CONTAMINATION: This sterilizer allows the user to modify cycle
“Warning” notes alert the user to the possibility of
personal injury.
features may result in personal injury.
in equipment damage.
laboratory goods and solutions. This equipment is NOT intended for use
other than expressly stated.
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.
settings, which may result in cycle parameters that will not achieve the
desired sterility assurance level (SAL). Users with password access are
responsible for validation of any cycles that use other than the factory set
parameters.
p. 5-15, 5-19DO NOT attempt to open the sterilizer chamber door unless the CHAMBER
pressure gauge reads zero (0 psig). Hot steam can cause serious injury.
p. 3-2, 3-5, 5-2, 5-6, 5-15RISK OF CONTAMINATION: Airborne microbial and particulate
contamination is likely to be high in the decontamination area of the sterile
processing department. Wear appropriate personal protective equipment
when preparing items for cleaning.
61301608206 ix
WARNING
p. 3-3CREUTZFELDT-JAKOB DISEASE (CJD) DECONTAMINATION: It is the
“Warning” notes alert the user to the possibility of
personal injury.
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, 5-6BURN 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, 5-17HOT 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, 4-17BURN/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. 8-4BURN HAZARD: The drain valve is HOT. Wear personal protective gloves.
p. 5-15BURN HAZARD: To avoid injury, DO NOT turn the manual valves with the
chamber door open.
p. 3-14, 7-17HOT SURFACES: The rack and shelves may be hot enough to cause burns.
Wear protective gloves when extending the shelves out of the chamber.
p. 5-22BURN 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. 3-14POSSIBILITY OF INJURY: Observe the following loading
p. 3-1HOT SURFACES: The chamber and the gasket area could be HOT. Turn
p. 4-12, 4-14, 5-15BURN HAZARD: Before removing the load, manually lower the door
p. 4-12HOT SURFACES: The loading car or rack and shelves may be hot enough
p. 4-5, 4-12, 4-15POSSIBILITY 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. 4-12RISK 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, 6-17POSSIBILITY 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. 3-11HOT SURFACES: The loading car may be hot enough to cause burns. Wear
p. 6-8RISK OF CONTAMINATION: If the cycle is advanced or aborted, it must be
p. 3-5BURN 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, 10-2POSSIBILITY OF INJURY: Always keep the liquid RTD in the storage
p. 6-18, 6-5RISK OF CONTAMINATION: If the cycle is cancelled, advanced or aborted,
p. 4-7Before pressing START, verify that the appropriate cycle is selected for the
p. 5-16, 5-22If a condition exists OTHER THAN an electrical outage, call Getinge USA
p. 4-12POSSIBILITY OF INJURY: After completion of a liquids cycle, carefully
p. 4-5, 4-12POSSIBILITY 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. 8-9POSSIBILITY OF INJURY: Steam boiler maintenance should be performed
by qualified personnel only.
p. 4-7POSSIBILITY OF INJURY: If the wrong cycle is selected for a liquid load,
the containers may burst or crack during processing.
p. 4-7RISK OF CONTAMINATION: If the wrong cycle is selected, the desired
sterility assurance level (SAL) may not be reached.
p. 5-6RISK 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, 5-17View 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, 5-16Retracting 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. 6-18POSSIBILITY 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. 7-2HOT SURFACE: The chamber and sediment drain screens may be hot.
Allow it to cool before attempting to remove it for cleaning.
p. 7-4HOT SURFACE: Make sure the sterilizer chamber is cool before attempting
to clean the interior surfaces.
p. 7-6BURN 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. 7-7BURN 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, 7-15HOT 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. 5-15RISK 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. 3-9POSSIBILITY 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
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
LabelsThe 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 CAPSDisplay text, such as the ENTER PASSWORD
prompt.
[ALL CAPS]Softkeys on the control panel, such as [MORE] or
[OK].
ALL CAPSSwitches 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
MODELSTERILIZER TYPE CYCLE TYPES AVAILABLE
422LS
522LS
433LS
533LS
Figure 1–1. 400LS/500LS SERIES STEAM STERILIZER
GravityGravity, Liquids
VacuumPrevacuum, 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
abc
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 ScreenThe 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
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