3M Health Care Steri-Vac 8XL User manual

3MTM Steri-VacTM
8XL Gas Sterilizer/Aerator
Operator’s Manual
3Health Care

Please read this manual carefully to learn
how to correctly operate and maintain the
3M Steri-Vac 8XL Gas Sterilizer/Aerator.
Incorrect operation may lead to sterilization
failure or serious personal injury.
This manual explains the function of the
sterilizer/aerator, how to correctly sterilize
heat-and/or moisture-sensitive devices, and
how to maintain the sterilizer/aerator.
NOTICE
Before operating the sterilizer / aerator,
read and understand the Health & Safety
Information section of this manual.

Steri-Vac 8XL Gas Sterilizer/Aerator Table of Contents
i
TABLE OF CONTENTS
INTRODUCTION
Intended Use ……………………………………. 1
Features and Benefits ……………………………………. 2
General Information ……………………………………. 3
3M™Steri-Gas™EO Cartridge 8-170 Label ……………………………………. 4
HEALTY & SAFETY INFORMATION
Toxicity ……………………………………. 5
Flammability ……………………………………. 5
Ethylene Oxide Leaks or Spills ……………………………………. 5
Agency Listings ……………………………………. 6
OPERATION
Introduction ……………………………………. 7
Operating Procedure ……………………………………. 8
Sterilizer Controls ……………………………………. 14
Printer ……………………………………. 15
ERROR CODES & TROUBLESHOOTING
Introduction ……………………………………. 17
Caution & Error Codes ……………………………………. 18
PREVENTIVE MAINTENANCE
Cleaning ……………………………………. 23
Compressed Air Line Filters ……………………………………. 23
3M Authorized Service ……………………………………. 24
Preventive Maintenance Agreement ……………………………………. 24

Steri-Vac 8XL Gas Sterilizer/Aerator Introduction
1
INTRODUCTION
Intended Use:
The 3M™ Steri-Vac™ 8XL gas sterilizer/aerator is a compact unit designed to sterilize heat- and/or
moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.
Environmental Operating Conditions
Environmental Condition Condition Range Units
Altitude 2500 (max) meters
Operating Temperature 5 - 35 ºC
Humidity 35-80 (non-condensing) %RH
Voltage Range 220-240 ±10% ~VAC
Transient Over Voltages Category II N/A
Pollution Degree 2 N/A
Note: Follow all applicable governmental, state and local environmental regulations concerning proper installation of
sterilizer/aerator and control of ethylene oxide emissions.
Disposal Information
This product contains lithium batteries on the printed wiring board. Follow all governmental, state and local
required procedures for proper disposal.
Unit Conversion
Pressure: 1 atm = 101.3 kPa = 1.013 bar = 1013 mbar = 76.00 cmHg
Authorized Representatives:
3M Health Care
St. Paul, MN 55144-1000, USA
3M Health Care
D-41453 Neuss, Germany

Introduction Steri-Vac 8XL Gas Sterilizer/Aerator
2
FEATURES & BENEFITS ⎯ETHYLENE OXIDE STERILIZATION
The Steri-Vac 8XL gas sterilizer/aerator is a
compact unit designed to sterilize heat- and/or
moisture-sensitive devices. It utilizes a fully
automatic control system to ensure that proper
sterilization conditions are met, and to minimize
the possibility of operator exposure to ethylene
oxide gas.
Health care facilities throughout the world have
found ethylene oxide gas sterilization to be a
dependable and effective method of sterilizing
heat- and/or moisture-sensitive devices. There
are many benefits to gas sterilization:
• All microorganisms, including resistant
spores, are killed by the chemical reaction
with ethylene oxide.
• Materials can be pre-packaged, then
sterilized and maintained sterile until use.
• Ethylene oxide is relatively non-corrosive to
plastic, metal, or rubber materials.
• Ethylene oxide can penetrate and sterilize
irregular-shaped items.
• Biological monitoring systems (such as
3M™Attest™Biological Indicators) or
chemical monitoring systems (such as
3M™Comply™EO Monitor Tape or 3M™
Comply™EO Indicators) should be used to
ensure that sterilization parameters are met.
These monitoring systems can also be used
to distinguish processed materials from
unprocessed materials.
• Ethylene oxide can be used to sterilize those
materials that cannot be immersed in liquid
disinfectants or processed in dry heat, steam,
or other chemical vapor sterilization
systems.
Ethylene oxide should not be used to sterilize
liquids or devices that may be a potential source
of ignition. Contact the device manufacturer with
questions regarding the proper sterilization
method for a particular device.
Major Features and Benefits
Following are the major features and benefits of
the sterilizer/aerator:
Accurate and Dependable
The solid state electronic design provides
accuracy and dependability. The electronic
controller automatically stops the cycle and
displays the error code if errors are detected.
Continuous Temperature Monitoring
Under normal conditions, the temperature will be
maintained to within ±3°C of the selected cycle
temperature; if the temperature sensor detects a
temperature 4°C beyond the setpoint the
sterilization cycle will automatically stop.
Humidification
Multiple pulses of low-temperature steam help
assure proper humidification.
100% Ethylene Oxide Unit-Dose Cartridge
A unit-dose cartridge of ethylene oxide is
punctured inside the chamber only when proper
chamber conditions are achieved.
Negative Pressure
Throughout the cycle, the chamber remains at
negative pressure relative to the room so gas can
not escape into the sterilization work area. If a
leak failure does occur in the chamber, room air
will migrate into the chamber and the controller
will automatically detect the leak and interrupt
the sterilization cycle until service is performed.
Vacuum Controlled Puncture
The vacuum in the chamber provides the force to
puncture the cartridge; this cannot occur unless
the door is closed and a vacuum below 160
mbars exists in the chamber.
Cycle Status Display
The display on the front panel of the sterilizer
shows cycle status.

Steri-Vac 8XL Gas Sterilizer/Aerator Introduction
3
FEATURES & BENEFITS⎯ETHYLENE OXIDE STERILIZATION
Manual Cycle Interrupt
The operator can manually interrupt a cycle at
any time. If the cartridge of gas was punctured,
the final vacuum and air purge automatically
clears the chamber before the door is unlocked.
Automatic Aeration
Aeration begins automatically after the
sterilization cycle. The sterilization/aeration
process can be accomplished in one chamber,
reducing potential gas exposure that can occur
during load transfer to an aerator.
General Information
Sterilization Cycles
Temperature Gas Exposure Time Cycle Time
approx.
37°C (99°F) 3 hours 5 hours 30 min
55°C (131°F) 1 hour 3 hours 45 min
Sterilant
3M™Steri-Gas™EO Cartridge 8-170
100% ethylene oxide (EO).
Weight of gas....................................170 grams
Minimum gross weight..................... 185 grams
Sterilant Specifications
Refer to the 3M Steri-Gas Consumer Product
Profile.
Shelf Life and Gas Weight
Refer to the 3M Steri-Gas Consumer Product
Profile.
Chamber Dimensions
Width.......................................... 51 cm (20 in)
Depth.......................................... 97 cm (38 in)
Height......................................... 46 cm (18 in)
Diagonal……………………….. 117 cm (46in)
Basket Dimensions
Width........................................... 46 cm (18 in)
Depth.......................................… 91 cm (36 in)
Height......................................... 20 cm (8 in)
Water Requirements
Distilled water is added by the operator to a
reservoir with 7.5 liter (2 gal.) capacity.
NOTICE
A
dditional time is required after the sterilization
cycle time to allow for aeration of the load. It is
necessary to obtain recommended aeration times
and temperatures from device manufacturers.

Introduction Steri-Vac 8XL Gas Sterilizer/Aerator
4
FEATURES & BENEFITS⎯ETHYLENE OXIDE STERILIZATION
3M
™ Steri-Gas ™ EO Cartridge 8-170 Label

Steri-Vac 8XL Gas Sterilizer/Aerator Health and Safety Information
5
HEALTY & SAFETY INFORMATION ⎯ETHYLENE OXIDE STERILIZATION
Please read and understand all instructions before using the Steri-Vac sterilizer/aerator.
DANGER The Steri-Vac sterilizer/aerator uses ethylene oxide gas to sterilize heat-and/or
moisture-sensitive devices. Ethylene oxide is flammable and toxic. Follow all
instructions and precautions carefully.
Toxicity First Aid Toxicity First Aid
Acute Inhalation
May be fatal if
inhaled in high
concentrations.
May cause
irritation of
respiratory tract,
chest tightness,
headache, nausea, vomiting, diarrhea,
light-headed feeling, dizziness,
weakness, drowsiness, cyanosis, loss
of coordination, convulsions, coma,
delay lung injury (fluid in the lungs),
immediate or delayed skin irritation or
blisters, allergic skin reaction.
Chronic Inhalation
The Occupational Safety and Health
Administration (OSHA) classifies
ethylene oxide (EO) as a probable
human carcinogen and reproductive
hazard.
If Inhaled
Move exposed person to
fresh air. Keep warm. If
person is not breathing,
call 911 or an
ambulance, then give
artificial respiration,
preferably mouth-to-
mouth if possible. If
breathing is difficult, give
oxygen. Call a poison
control center or doctor
immediately for further
treatment advice. Call a
physician even if no
symptoms are present.
Keep under medical
observation. Symptoms
may be delayed.
Skin
Contact
Liquid
ethylene
oxide may
cause skin
irritation,
dermatitis,
and blistering.
If On Skin Or Clothing
Immediately flush skin with
plenty of water for 15 – 20
minutes while removing
contaminated clothing and
shoes. Call a poison control
center or doctor immediately for
treatment advice. Aerate, wash,
or clean contaminated clothing,
and discard leather goods.
Toxicity First Aid Toxicity First Aid
Eye Contact
Splashes of
ethylene oxide
may cause
severe eye injury.
High gas
concentrations
may cause
severe eye irritation and injury.
If In Eyes
Hold eye open and rinse
slowly and gently with
water for 15 – 20
minutes. Remove contact
lenses, if present, after
the first 5 minutes, then
continue rinsing eye. Call
a poison control center or
doctor for treatment
advice.
Ingestion
A highly
unlikely
route of
exposure.
Liquid
ethylene
oxide,
upon ingestion, is caustic and
may cause severe irritation and
burns to the gastrointestinal
mucosa.
If Swallowed
Call a poison control center or
doctor immediately for
treatment advice. Have person
sip a glass of water if able to
swallow. Do not induce vomiting
unless told to do so by a poison
control center or doctor. Do not
give anything by mouth to an
unconscious person.
Flammability
Ethylene oxide is flammable in concentrations
from 3% (30,000 ppm) to 100%. Keep all
sources of ignition such as matches, lighted
cigarettes, sparks, and static discharge away
from the sterilizer and cartridges.
Ethylene Oxide Leaks Or Spills
The following indicate Steri-Gas cartridge leakage:
• Liquid ethylene oxide spurting or rapidly dripping from a
cartridge
• A cartridge that feels very cold to the touch
• Cartridge weight loss

Health and Safety Information Steri-Vac 8XL Gas Sterilizer/Aerator
6
HEALTY & SAFETY INFORMATION ⎯ETHYLENE OXIDE STERILIZATION
Agency Listings
The Steri-Vac gas sterilizer/aerator is listed with
Underwriters Laboratories, Inc. (UL).
This internationally recognized laboratory has
inspected and evaluated the Steri-Vac 8XL gas
sterilizer/aerator. UL performs on-going
inspections at the manufacturing facilities.
EPA Registration
Manufacturers of chemical pesticides, such as
ethylene oxide, are required to register their
product label claims with the Environmental
Protection Agency (EPA). Based on these
claims, the EPA requires the manufacturer to
demonstrate that the product meets certain
performance standards prior to issuing a
registration number. The EPA registration
number, which appears on all Steri-Gas
cartridges, is 7182-1.

Steri-Vac 8XL Gas Sterilizer/Aerator Operation
7
OPERATION
Introduction
This section of the manual describes how to
correctly operate the sterilizer/aerator. Included
are procedures for turning on the sterilizer,
preparing items for sterilization, and correctly
performing the sterilization procedure.
A detailed description of the controls and
indicators are also provided. Before operating
the sterilizer/aerator, read and understand the
descriptions for each of the controls and
indicators.
NOTICE
User Responsibility: Only health care professionals or
other appropriately trained personnel in health care and
industrial use areas should use this equipment. It is a
violation of Federal Law (USA) to use this product in a
manner inconsistent with its labeling. Injury to person or
p
roperty can result unless the operating instructions are
followed carefully.

Operation Steri-Vac 8XL Gas Sterilizer/Aerator
8
OPERATING PROCEDURE
Step 1
Step 2
Step 3
Power on the sterilizer.
Turn on the power switch (located on the
left side of the sterilizer). Leave the power
switch on at all times to simplify operation
and allow the sterilizer electronics to
continually monitor sterilizer functions.
Prepare items for sterilization.
Thoroughly clean and rinse all items to
be sterilized to remove mucous, dried
blood, or other organic matter. Dry the
items to remove water droplets.
Package items for storage.
Before sterilizing, package items that
will be stored before they are used. Use
only packaging materials that are
intended for ethylene oxide sterilization.
NOTICE
The packaging area should have a minimum
room humidity of 35% RH.

Steri-Vac 8XL Gas Sterilizer/Aerator Operation
9
OPERATING PROCEDURE
Step 4
Step 5
Step 6
Load the sterilizer baskets.
When loading items in the baskets, leave
some space between each item. Place
packages on edge. When arranging
paper-plastic pouches, place the plastic
side of one pouch against the paper side
of another pouch.
Place biological indicator (BI) in the
sterilizer basket with load.
A BI should be included with each load
to monitor the sterilization process.
The BI or BI test pack should be
representative of the materials being
sterilized and placed in the center of the
load.
Open the sterilizer door.
Turn the handle counter-clockwise to
open the door.
DANGER
To minimize exposure to EO when
retrieving the biological indicator, ensure
that it is easily identifiable when unloading.

Operation Steri-Vac 8XL Gas Sterilizer/Aerator
10
OPERATING PROCEDURE
Step 7
Step 8
Insert gas cartridge.
Insert a Steri-Gas 8-170 cartridge into
the retainer ring on the cartridge holder
inside the chamber. Push the cartridge
down and slightly inward until the
cartridge “snaps” into position.
Place baskets in chamber.
Place the loaded baskets in the sterilizer
chamber. Close the door and turn the
door handle clockwise until it is vertical.
DANGER
DO NOT force the cartridge. Use of
excessive force could result in
p
remature puncture of the cartridge
and subsequent exposure to ethylene
oxide. Remove the cartridge from the
holder and check for obstruction.

Steri-Vac 8XL Gas Sterilizer/Aerator Operation
11
OPERATING PROCEDURE
Step 9
Step 10
Step 11
Select temperature.
Press the temperature select switch until the
desired sterilization/aeration temperature is
displayed. Select the temperature according
to manufacturer’s recommendations for the
devices in the load.
NOTICE
If no switches are pressed within 5 minutes,
the display will go into screensaver mode.
Set the aeration time.
Press the aeration time preset control arrows
to change the time in one hour increments
until the desired aeration time is displayed.
Obtain recommended aeration times and
temperatures from the device manufacturers.
NOTICE
If the sterilizer aeration time is increased
to 12 hours or more, the sterilizer will
retain this setting for the next cycle. Once
aeration is complete, the operator has
the option to either add more aeration
time or end the cycle. If the aeration time
is not increased from its default value,
the sterilizer automatically continues to
aerate the load until the operator stops
the cycle.
Turn on printer.
Press the printer “on” switch (located
behind printer/water door) before
starting the cycle if a cycle printout is
desired.

Operation Steri-Vac 8XL Gas Sterilizer/Aerator
12
OPERATING PROCEDURE
Step 12
Front panel displays cycle sequence
Start the sterilization cycle.
Press the START switch to begin the
sterilization/aeration cycle. The cycle
continues automatically until completion.
Precondition Phase Gas Expose Phase
A
eration Phase
• Preheat
• Chamber vacuum
• Humidification
•
Cartridge punctured
• Gas exposure
•
Gas removal
•
Sterilization cycle
complete
• Aeration
Interrupting the sterilization cycle.
Press the STOP switch at any time to
interrupt the cycle.
NOTICE
If the cycle is interrupted before gas
exposure, the door will unlock immediately.
If the cycle is interrupted after the gas
cartridge is punctured, the machine must go
through final pump down and purge before the
door will unlock.

Steri-Vac 8XL Gas Sterilizer/Aerator Operation
13
OPERATION PROCEDURE
Step 13
Step 14
Step 15
Open sterilizer door.
During aeration cycle, appearance of the
“door unlocked” symbol will indicate
when the door can be opened.
To open the door, turn the handle
counter clockwise, allow approximately
30-60 seconds for the chamber pressure
to equalize with the room pressure.
Unload the sterilizer.
Once the cycle is complete, remove the
baskets from the chamber.
Remove and aerate the empty gas
cartridge with the load. After aeration,
the cartridge can be discarded with non-
incinerated waste.
Return to standby.
To end the cycle after the load has been
removed, press the STOP switch while
the door is open. This places the
sterilizer in the standby mode, ready for
the next cycle.
DANGER
To minimize exposure to EO when
transferring an unaerated load:
• Transfer load quickly.
• Minimize handling or sorting.
• Air flow from baskets should be
directed away from operator.

Operation Steri-Vac 8XL Gas Sterilizer/Aerator
14
STERILIZER CONTROLS
The control panel display shows status during sterilization. The following switches are used to control
sterilizing operations:
Power Switch.
Turns the power to the sterilizer on and off. This
switch should be left on at all times to simplify
operation.
Temperature Select Switch.
Press to select the desired cycle temperature.
Aeration Preset Time Increase Arrow.
Press to increase the aeration time by one hour.
Aeration Preset Time Decrease Arrow.
Press to decrease the aeration time by one hour.
Start Switch.
Press to start the automatic sterilization cycle.
Stop Switch.
Press at any time to interrupt the cycle.
Power-On Indicator.
Shows that power has been turned on to the
sterilizer.