Integra LifeSciences Sterilization Containers, Integra Miltex - Manual

miltex containers
Directions for Use – Gravity steam sterilizer ProcessinG
care & HanDlinG of tHe miltex container
miltex containers
The Miltex Rigid Sterilization Container System is intended for use in hospitals
and health care facilities to contain other medical devices that are to be
sterilized and to allow sterilization of the enclosed medical devices, including
surfaces and lumens, using gravity steam sterilizers. The recommended
gravity steam sterilization cycle parameters are 45 minutes exposure at 121
deg C and a 20 minute dry time. 2 metal lumens 3-mm in diameter and up to
200-mm in length were validated. The container is intended for use with non-
porous materials such as stainless steel surgical instruments.
For effective sterilization and drying, the weight of the single container,
basket and basket contents should not exceed the following: 16 lbs for the
one-half size container, 20 lbs for the three-quarter size container, and 25 lbs
for the full size container.
Sterilized devices may be stored and transported within the container. The
container is intended to maintain sterility for a maximum of 60 days as long as
the integrity of the container has not been compromised.
Containers should not be stacked when used within gravity steam
sterilizers.
The functional containers are manufactured from an anodized aircraft
aluminum alloy to prevent corrosion. This aluminum alloy also has high
thermal conductivity for faster drying and is lighter than other metals to make
the Miltex Container easier to transport.
Pre-cleaninG
• Remove lid and basket with instruments from the Container.
• Remove the lid filter retention plate(s).
• Remove the bottom filter retention plate(s)
• Discard the disposable filter(s).
• Remove all indicators and disposable locks.
cleaninG
Do not use any abrasive products, material or stainless steel brushes to
clean the miltex containers. Abrasives can damage the aluminum surface
of the container and will void all manufacturer warranties. never expose
to bleach or other corrosive chemicals. Exposure to bleach may result in
pitting or damage to surface and will void all manufacturer warranties.
manual cleaning
• Use a soft sponge and a neutral pH (7) phosphate -free detergent such
as Miltex Surgical Instrument Cleaner (3-720, 3-725 and 3-726) to
thoroughly clean Miltex Container. Use distilled (demineralized) water
(room temperature) if possible. Verify that all visible contamination
is removed.
• Rinse with water to remove the cleaning solution. Be sure to rinse
thoroughly to remove all detergent residues.
• Thoroughly dry. Store in clean and dry environment.
mechanical cleaning
• Place the container bottom face down (open side down) in the washer.
• Handles should be folded down.
• Follow manufacturers instructions for proper use
• Thoroughly dry. Store in clean and dry environment.
assemBly for Use
Pre-assembly inspection and Preparation
• All components must be thoroughly dry before assembling
• Select appropriate size container and basket.
• Inspect the inside channel of the lid to ensure the silicone gasket is in good
condition. The gasket condition should be free from defects such as wear,
cracks, cuts, tears, or bubbles, loose fit in the channel, and anything else
that might appear out of the ordinary. A defective gasket could indicate
age and/or deterioration and should not be used.
• Inspect the container top and bottom for any dents or marks. Check the
handles and latches for proper operation. Finally, when placing the
filters, verify that the retaining ring “click’s” into place.
• Please refer to AMSI/AAMI ST 79 Standard for additional
recommendations for inspections and cleaning of sterilization containers
(Sections 5.2.3 and 7.5.9)
• The container systems have been validated to withstand 50 sterilization
cycles with no evidence of deterioration.
• The following container lids can be used for each container base:
If there is any evidence of damage or deformation of the device, or if any of
the moving parts fail to operate as intended, then remove the container from
service and contact your Miltex Representative for further assistance.
filter assembly
• Place one sheet of filter paper over each perforated section on the inside
of the container lid or bottom – making sure it is centered on the protruding
pin. When using filter paper with indicator, be sure the indicator faces
toward the inside of the container when the lid is in place and the indicator
is visible through the retention plate.
• Secure each filter with the retention plate by pressing onto the protruding
pin until you hear it click.
• Perforated bottoms: Place one sheet of the filter paper over the perforated
section in the bottom of container – making sure it is centered on the
protruding pin. Secure the filter with the retention plate by pressing onto
the protruding pin until you hear it click.
note: The filters validated for use with the container are Miltex item number
3-5900-15. The paper filters are 190-mm (7.5-inches) in diameter and intended for
single-use only.
instrument and container assembly
• Place cleaned and dried non-porous materials such as stainless steel
surgical instruments into the instrument basket according to established
hospital procedures. Within gravity steam sterilizers, the containers have
been validated for sterilization of instruments with two (2) stainless steel
lumens 3 mm I.D. by up to 200 mm length.
• All instruments should be assembled to allow for uniform exposure to
sterilization agents.
caUtion: Leave minimum of one inch clearance for effective processing.
• For effective sterilization and drying, the weight of the single container,
basket and basket contents should not exceed the following:
o 16 lbs for 1/2 (small) size containers
o 20 lbs for 3/4 (medium) size containers
o 25 lbs for Full (large) size containers
caUtion: Complex instruments (e.g. air-powered instruments, endoscopes,
and instruments with lumens or channels) should be prepared and sterilized
according to the instrument manufacturer’s instructions.
lid size Perforated Base to be used with lid
½ size Lid (11 ¼ in x 11 in)
PN 3-6100-00 PN 3-5110-10 (4 in height)
PN 3-5110-13 (5 1/3 in height)
PN 3-5110-15 (6 in height)
¾ size lid (18 ¼ in x 11 in)
PN 3-6300-00 PN 3-5310-10 (4 in height)
PN 3-5310-13 (5 1/3 in height)
PN 3-5310-15 (6 in height)
full size lid (23 in x 11 in)
PN 3-6500-00 PN 3-5510-10 (4 in height)
PN 3-5510-13 (5 1/3 in height)
PN 3-5510-15 (6 in height)