1
Container Components
(A) Sterilant Access Holes
(B) Lid Latch
(C ) Carrying Handle
(D) Bottom Latch
(E) Container Identification Tag
(F) Data Block
(G) Sled Groove
(H) Filter Retention Plate
(I) Cam Lever
(J) Alignment Tabs
(K) Filter
() Optional Protective Plate
(M) Gasket & Retaining Groove
(N) Filter Ridge
(O) Sled Feet
Instructions for Use
These instructions provide information on how to set up, use, troubleshoot, and
maintain the Genesis reusable rigid sterilization container system. It does not cover
service and repair procedures. For information about the product that is not covered
in this document, contact your local distributor or send an email request to GMB-
Intended Use
The Genesis reusable rigid sterilization container system is a device intended to be
used to enclose another medical device that is to be sterilized by a healthcare
provider. It allows sterilization of the enclosed medical device and maintains sterility
of the enclosed device until used. Figure 1
Baskets and accessory items are intended to organize and secure enclosed medical
devices during sterilization, transport, and storage of the container.
Note: For detailed information regarding usage of specific containers, accessories,
materials, weight limits, and supported sterilization challenges for indicated
sterilization modalities, refer to the Modality Specific Recommendations for
Accessories and Containers chart.
Initial Receiving
Inspect, thoroughly clean, and rinse all reusable components (container, basket, and
accessories) before placing into service. Not properly preparing your Genesis
sterilization containers may adversely affect the protective anodized finish.
General Precautions
Cleaning
• Use only properly diluted, enzymatic / neutral pH detergent solution
recommended for safe use on anodized aluminum. Use of highly acidic or highly
alkaline detergents could permanently damage the protective finish of the
container.
• Alcohol is not recommended for manual cleaning or wiping down. All cleaning
agents should be thoroughly rinsed off prior to any sterilization process to
remove all residual chemicals which could damage the protective anodized finish.
• Do not use abrasive cleaners, abrasive cleaning pads, or metal brushes on
container surfaces. Use of these abrasive materials will permanently damage the
protective anodized finish of the container.
• Do not clean the anodized container or container components (bottom, lid,
retention plate, optional protective plate) in an ultrasonic washer.
• Ultrasonic cleaning (cavitation) processes may loosen threaded accessories such
as pins, dividers, etc. Routine inspection of threaded accessories may require
tightening to secure them after ultrasonic processing.
Processing
• Do not obstruct the sterilant access holes. These holes allow the exchange of air
and penetration of sterilant into and out of the container. When these access
holes are blocked, it can impede this exchange process. Under pre-vacuum
steam, this blockage can cause the container to collapse.
• Do not use adhesive tape on the container.
• The use of basket liners may cause condensate to pool.
• The DST Series Filter recommended for use with Genesis reusable rigid
sterilization containers is for single use only. One filter sheet, or thickness, should
be used underneath each retention plate per process. Using more than one
thickness of the recommended filter (DST Series) has not been validated for
efficacy. ach sterilant access (perforated) area requires one filter.
• When sterilizing mixed loads, containers must be placed below absorbent,
wrapped items on the autoclave cart to avoid excess condensation dripping onto
wrapped goods below the container.
• Sterilize container and contents using hospital protocol. Since sterilizers vary in
design and performance characteristics, it is strongly recommended that the user
verify the cycle parameters for the specific sterilizer and types of instruments
being sterilized prior to use.
• Always practice safe lifting and handling of heavy objects. Do not stack containers
more than three (3) high in pre-vacuum sterilization cycles, per recommended
dry time parameters. Stacking is only recommended in pre-vacuum steam cycles.
• Be sure to choose the correct data card material for the sterilization process used.
Cellulose materials are compatible with steam and thylene Oxide ( O)
processes. Cellulose materials are not compatible with the ST RRAD 50 or
ST RRAD 100S processes.
Steam and 100% O: MD1-1 cellulose data card.
ST RRAD 50 and 100S: MH1-1 non-cellulose data card.
• It is important that each facility verify the manufacturer's written sterilization
instructions (Instructions for Use) to verify that the conditions in their particular
facility (i.e. steam quality, equipment, protocols) achieve the same results as the
manufacturer. If not, the container manufacturer, as well as the equipment
manufacturer, should be consulted to identify potential causes and remedies.
• Only Genesis filters, arrows, data cards, baskets, accessories, and repair parts are
validated for use with the Genesis reusable rigid sterilization container system. Do
not use unauthorized single use accessories or container components.
• If using pre-vacuum steam immediate use steam sterilization (IUSS), container
contents will be wet upon removal from the sterilizer.
Warnings
• Do not use filter materials in the presence of flammable anesthesia. A safety
hazard may occur.
Cautions
• Complex instruments, such as air powered instruments, endoscopes or
instruments with lumens or channels should be sterilized according to the
instrument manufacturer's instructions.
• Lumen devices have not been validated for use in gravity-displacement steam
sterilization modalities.
• Only the following lumen devices have been validated for use in the pre-vacuum
steam modalities:
• ≥ 2.68 mm in inner diameter and ≤ 450 mm in length
• ≥ 1.37 mm in inner diameter and ≤ 242 mm in length
• Lumen devices exceeding 400 mm in length or less than 3.0 mm in inner
diameter have not been validated for use in the 100% thylene Oxide,
ST RRAD 50, or ST RRAD 100S modalities.
• Devices containing silicone and polymeric materials (including silicone mats and
bars) have not been validated for use in gravity-displacement steam sterilization
modalities.
• The stacking basket configuration has not been validated for use in gravity-
displacement steam or 100% thylene Oxide modalities.
• A basket or lifting platform must always be used when sterilizing in a perforated
bottom container model.
• The optional protective plate has not been validated for use in gravity
displacement steam, 100% thylene Oxide, ST RRAD 50, or ST RRAD 100S
modalities.
• Solid bottom containers have not been validated for use in gravity-displacement
steam or 100% thylene Oxide modalities.
• Containers have not been validated for stacking in gravity-displacement steam,
ST RRAD 50, ST RRAD 100S, or 100% thylene Oxide modalities.
• Silicone mat devices have not been validated for use in 100% thylene Oxide,
ST RRAD 50 or ST RRAD 100S modalities.
• Container models other than the Genesis ST RRAD model containers have not
been validated for use in the ST RRAD 50 or ST RRAD 100S modalities.
• Perforated container model numbers CD2-10BDL and DINCD2-8B are not
validated for use in the 100% thylene Oxide Sterilization modality.
• Filter materials other than the Genesis DST-series filters have not been validated
for use with the Genesis sterilization containers.
• The optional protective plate has not been validated for use in the Genesis
container bottom.
• Devices entailing surfaces that are completely obstructed (air-tight occluded
challenges) have not been validated for use with the Genesis reusable rigid
sterilization container system.
Proofed by: ____________________________ Date: _____________
Dimensions checked: ______________ Copy checked: _____________
CF36-1375D
06-23-16
David Knuth
en
