3M™ Steri-Vac™
Sterilizer/Aerator
GS Series
For Health Care Facilities
Product
Profile
3M™ Steri-Vac™ Sterilizer/Aerator GS Series
For Health Care Facilities
Product Profile
Sterilization Cycles
3M™ Steri-Vac™ Sterilizer/Aerator GS Series ethylene
oxide (EO) sterilizer/aerators are designed to be used
with 3M™ Steri-Gas™ EO Gas Cartridges to provide a safe
and effective low temperature sterilization process for
healthcare applications.
The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series has two sterilization
cycles, identified as 38°C and 55°C.
The critical sterilization process set points (temperature, humidity
level, sterilant concentration, exposure time) for the 38°C and 55°C
cycles have been validated per “U.S. FDA Guidance on Premarket
Notification [510(k)] Submissions for Sterilizers Intended for Use in
Health Care Facilities.”
The Steri-Vac GS Series sterilizer, Models GS5 and GS8 can
automatically aerate the processed load in the sterilization
chamber after EO gas sterilization. The GS Series sterilizer
is a self-contained system which requires only power,
compressed air and exhaust vent lines for operation.
No floor drains or bulk tanks of ethylene oxide are used.
In addition, no external steam or water connections are
required, as each GS Series sterilizer has a self-contained
internal distilled water tank filled by the Operator. The
GS Series sterilizer requires minimal floor space and can
be installed free-standing, on a rack, or in-wall. Both the
GS5 and GS8 sterilizers are available in a single door
or double-door configuration, facilitating pass-through
processing for controlled environments. Mounting frames
and finishing fascia panels are also available. The GS5
and GS8 provide 136 L (4.8 cubic feet) and 224 L
(7.9 cubic feet) of usable chamber space, respectively.
The key set points for each cycle are provided in Table 1 on the
following page. The cycle profile of a typical 3M™ Steri-Vac™
Sterilizer/Aerator GS Series is provided in Figure 1. A description
of the GS Series sterilization process stages is provided in Figure 2.
Single or dual channel rigid and flexible scopes can be sterilized with
non-lumened medical instruments in any of the GS sterilizer cycles
provided the cycle parameters match the instrument’s sterilization
instructions. The load per cycle should not exceed 20 lumens.
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3M™ Steri-Vac™ Sterilizer/Aerator GS Series
For Health Care Facilities
Figure 1. GS Series Cycle Profile
Air Admission
10
Atmospheric Pressure
1
9
Pressure
Chamber
Preheating
Aeration
2
Chamber
Test
3
Air Removal
6
EO Exposure
5 EO Injection
EO Removal 7
8
Flushing
Conditioning
4
Time
Table 2. Time Estimates for 38°C and 55°C Cycles
Table 1. Preprogrammed Cycle Set Points
38°C Cycle
55°C Cycle
Cycle Temperature
38°C ± 3ºC
55°C ± 3°C
Relative Humidity
40–80%
40–80%
EO Exposure Time
Aeration Temperature
38°C Cycle
55°C Cycle
Preheat 1 (min.)
20
20
Air Removal 1 (min.)
10
10
Chamber Test (min.)
8
8
Conditioning 1 (min.)
65
65
EO Injection (min.)
1.5
1.5
EO Exposure (min.)
270
60
EO Removal 2 (min.)
12-50
12-50
5 Pulses 1 (min.)
55
55
Locked Aeration (min.)
90
90
1.5
1.5
8:50 • 9:30
5:15 • 6:00
4.5 hours ± 5.4 minutes 1 hour ± 1.2 minutes
38°C ± 3°C
55°C± 3°C
Sterilization Cycles
An EO sterilization cycle is defined as a treatment in a sealed,
temperature-controlled chamber and comprising nine stages: preheat,
air removal, chamber test, conditioning, EO injection, EO exposure, EO
removal, flushing, and air admission. Figure 1 is a graph of a pressure
profile of the cycle stages of a GS Series EO sterilization cycle. Table 2
contains the time estimates for each stage of each cycle type. The nine
stages of the sterilization cycle for the 3M™ Steri-Vac™ Sterilizer/Aerator
GS Series are briefly explained in Figure 2 on the following page.
Flushing 2
Air Admission (min.)
Estimated Total Cycle Time
(hh:mm)
1. A ctual time for the stage will vary based upon ambient conditions and composition
of the load.
2. EO removal rates will be longer if an Abator is connected and will be shorter if an
Abator is not connected.
3. Flushing includes 5 vacuum + pressure pulses and locked aeration.
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3M™ Steri-Vac™ Sterilizer/Aerator GS Series
For Health Care Facilities
Figure 2. GS Series Sterilization Process Stages
Heating step, without humidification, to bring the chamber walls up to the target cycle temperature. The product load
1 inPreheat.
the chamber will heat up during the Preheat stage (Figure 3), but the temperature of the load at the end of the stage will depend
on a number of factors, including: load weight and density; material and packaging; the starting temperature of the chamber and
the load; the temperature set point; and the preheat time.
2
Air Removal
Vacuum pump removes air from
the chamber to prepare for the
Chamber Test and Conditioning
stages.
3
Chamber Test
A test of the integrity of the sterilization
chamber by holding the chamber in
vacuum and measuring an increase
in pressure that could indicate a
chamber leak.
7
EO Removal
6
EO Exposure
Single vacuum pump down of the
chamber to remove ethylene oxide (EO)
from the head space of the chamber
and product packaging.
The sterilization hold phase, where
the product load is exposed to EO.
8
9
Flushing
Aeration
A series of vacuum/air wash pulses,
to further remove EO from the
chamber and the load.
Warm air continually moved through the
chamber and over the load, to remove
residual EO from the product.
Figure 3.
Preheat Stage
4
4
Conditioning
Controlled low temperature steam
injections to bring the chamber and
load to the desired humidity level.
Conditioning can also be used to
continue to bring the product load to
the target process temperature.
5
EO Injection
Final check of temperature, % relative
humidity, and pressure level followed
by puncture of the 3M™ Steri-Gas™ EO
Gas Cartridge, releasing the ethylene
oxide gas into the vaporizer, and then the
chamber.
3M™ Steri-Vac™ Sterilizer/Aerator GS Series
For Health Care Facilities
Figure 4. GS Series Sterilizer with
Ethernet Connectivity
Ethernet Connectivity Capability
The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series ethylene oxide
(EO) sterilizers have an Ethernet connectivity option (Figure 4).
The Ethernet connection provides several options for users
and Service.
1. T he Ethernet connection allows for interfacing
with third party instrument tracking systems to
access final cycle data and reports in a read-only
accessible folder.
2. C
onnecting the GS Series sterilizer to the Ethernet
provides Service with a means to access diagnostic
information on the GS Series sterilizer from a
desktop computer located on-site within the clinic
network. Service can access cycle information,
reports (e.g. calibration, site setup) and diagnostic
information directly on the sterilizer.
3. The Ethernet connection provides an efficient
means to access, download, and install software
updates for the sterilizer provided by 3M.
The Ethernet connection is not required for normal operation
of the system and its use is optional.
Access Levels
The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series ethylene
oxide (EO) sterilizers have multiple access levels to the
sterilizer functions that requires a Personal Identification
Number (PIN). Access levels include Service, Supervisor,
and Operator. Partitioning access to the sterilizer functions
into three levels reduces the risk of hazards introduced
by the user.
Figure 5. USB Drive Ports
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3M™ Steri-Vac™ Sterilizer/Aerator GS Series
For Health Care Facilities
Cycle Reports and Data
The user can select from three different cycle report formats (Graph, Table, or Detailed)
depending on preference and record keeping requirements. The 3M™ Steri-Vac™
Sterilizer/Aerator GS Series sterilizer allows users to export cycle reports to a USB drive
(Figure 5). The GS Series sterilizer can export up to 100 of the most recent cycle reports.
In addition, the sterilizer automatically retains the last 100 condensed cycle reports in a
read-only folder accessible via an Ethernet connection for use by third party instrument
tracking systems.
Compliance
Cleared by the U.S. FDA as medical devices for healthcare settings - allowing the user
to meet the requirements of ANSI/AAMI ST41: Ethylene Oxide sterilization in healthcare
facilities: Safety and effectiveness.
• Meets applicable device safety, electrical and EMC standards, including
(but not limited) to UL.
• Meets requirements for the European Union Medical Device Directive CE marking.
• Has independent Monitors and Control Sensors to meet EN1422.
• Complies with RoHS Directive 2011/65/EU and WEEE environmental and
disposal Directive 2012/19/EU.
• 3M™ Steri-Gas™ EO Gas Cartridges are EPA registered (7182-1).
• Complies with U.S. Occupational exposure to ethylene oxide,
final standard (29 CFR 1910.1047).
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3M™ Steri-Vac™ Sterilizer/Aerator GS Series
For Health Care Facilities
Figure 6. Ethylene Oxide Sterilization
Set-up Process
3M Steri-Gas EO Gas Cartridges
™
™
3M™ Steri-Vac™ Sterilizer/Aerator GS Series ethylene oxide (EO) sterilizers are
designed to be used with 3M™ Steri-Gas™ EO Gas Cartridges. Steri-Gas EO Gas
Cartridges are single dose containers of 100% ethylene oxide. Each cartridge has
a unique 2D barcode that is read by the barcode scanner on the GS Series sterilizer.
Scanning the cartridge enables
the sterilizer to verify the
Table 3. 3M Steri-Gas EO
lot code to ensure that the
Gas Cartridge Specifications
cartridge is the correct
Steri-Gas EO Sterilizer/Aerator
Nominal
cartridge for the GS Series
Cartridge
Model
Fill Weight
sterilizer, is unused, and
4-100
GS5
100 grams
is within its shelf life.
8-170
The available 3M Steri-Gas
EO Gas Cartridges and their
respective nominal weights
of EO are listed in Table 3.
The calculated empty chamber
EO gas concentrations for
each GS Series sterilizer are
provided in Table 4.
GS8
170 grams
Project Planning:
site, facility,
equipment, services
Budgeting: facility,
capital equipment,
installation costs,
validations
Hardware Purchase:
sterilizer, abator
& accessories;
monitoring & other
consumable products
Table 4. EO Gas Concentrations
for GS Series sterilizer
Air Emissions
Permitting
Calculated Empty Chamber EO
Concentration (mg/liter)
Steri-Gas EO
Cartridge
Model GS5
4-100
735
N/A
8-170
N/A
759
Model GS8
Additional
Permitting:
site modification and
construction related permit signoff
Physical
Installation
of Equipment
Start-up and
Operational
Training
3M™ Steri-Gas™ EO Gas Cartridges 4-100
Setting up Ethylene Oxide (EO) Sterilization
To establish ethylene oxide (EO) sterilization capability with the 3M™ Steri-Vac™
Sterilizer/Aerator GS Series, a number of actions are required. Figure 6 presents
a high-level overview of this process.
3M will provide a site planning & installation guide and pricing information, as
applicable, for equipment or services in the blue boxes, enabling the customer’s facility
to manage tasks in this overview process. The orange boxes are the responsibility
of the user’s facility, sometimes completed with assistance from external
consulting organizations.
7
IQ, Calibration, OQ
(as applicable)
3M™ Steri-Vac™ Sterilizer/Aerator GS Series
For Health Care Facilities
Product Support
For general product information or to find
your local U.S. 3M representative:
3M offers equipment services to support
installation and on-going maintenance of
3M™ Steri-Vac™ Sterilizer/Aerator GS Series
products and accessory equipment. The following
documents provide additional information related
to accessory equipment, planning, installation,
qualification, calibration and compliance:
3M Health Care Customer Helpline
1 800 228 3957
Outside of the U.S. contact your local 3M
office. Global office locations are available on
our website: visit www.3M.com and select
the specific country for access to your local
3M contacts.
• 3 M™ Steri-Vac™ Sterilizer/Aerator Site
Planning and Installation Guide
Contact
Information
• 3 M™ EO Abator Model 50 System
(brochure)
Product Technical Information
• 3M EO Abator Site Planning and
Installation Guide
1-800-441-1922, option 2
™
• 3M™ Steri-Gas™ EO Gas Cartridge
Product Profile
• SDS 3M™ Steri-Gas™ Cartridge 4-100
• SDS 3M™ Steri-Gas™ Cartridge 8-170
3M Sterilization Tech Line (U.S. only)
Equipment Services Support (U.S.)
3M Health Care Service Center
Suite 200, Building 502
3350 Granada Ave N
Oakdale, MN 55128
1 800 292 6298
• 3 M™ Steri-Vac™ Equipment Services
(brochure)
To obtain these documents, visit
go.3M.com/lowtemp
or contact your local 3M representative.
3
3M Health Care
Infection Prevention Division
3M Center, Building 275-4E-01
St. Paul, MN 55144-1000
USA
1-800 228 3957
www.3M.com/infectionprevention
Please recycle. Printed in USA.
© 3M 2015. All rights reserved.
Issued 7/15. 10686HB
70-2011-5684-4
3M, Steri-Gas and Steri-Vac are trademarks of 3M Company.