Symmetry Surgical Quad-Lock Manual Del Usuario página 4

QUAD-LOCK Container System Instructions for Use
®
B. Inserting Filters
Insert new filter(s) in each lid and perforated container bottom before
each use. The polypropylene filters (catalog no. 50-9011) are for single use
only; DO NOT REUSE.
1. Remove the filter retainer by squeezing the spring latch in the handle (see
Figure 15), and lifting the retainer off.
2.Visually inspect the new filter by holding it up to the light. If there are
pinholes or tears, discard the filter.
3. Place a new filter on the spindle.
4. Inspect the gasket on the bottom side of the retainer and test the
action of the spring latch as outlined in Inspection.
5. Test the action of the spring latch of the retainer by pressing the latch.
Observe the latch for smooth movement. If the latch does not operate
smoothly, replace the product.
6. Reinstall the retainer by centering it over the spindle (ensure that the
printed side of the filter faces up). Squeeze the spring latch and partially seat
the retainer so it engages the spindle. Release the spring latch. With the flat
of the hand, push the retainer fully onto the spindle until a "click" is heard.
7. Inspect the entire edge of the retainer to ensure that the gasket is firmly
compressed against the lid (see Figure 16).
If the gasket is not compressed all around, set that retainer aside and use
another retainer. Repeat Steps 4 and 15 through 17.
C. Loading the Instruments
CAUTION: When using a perforated container bottom
1. Position the instruments in the wire baskets in accordance with hospital
routines. Assemble the instruments to allow uniform exposure to the
sterilization agent. Ensure that the instruments are placed so that water will
not pool inside the instrument, but will drip downward.
CAUTION: Do not wrap the containers or the instrument baskets in any type
of hospital wrap prior to sterilization. No absorbent sheets or cloths are
required in the container bottom for sterilization.
2. When using a perforated container bottom, place a wire base in the
container before adding instruments or baskets.
3. Place the instruments and wire basket(s) into the container bottom.
CAUTION: Adhere to the following instructions for usage and placement
of the Pin Mat within the containers. Inappropriate use of the pin mat
could cause moisture to remain in the container after sterilization.
- Do not use a pin mat in containers that will be stacked in the sterilizer.
- Do not place the pin mat into the container bottom before adding
instruments, baskets, or the wire base.
4. Make sure that there is a minimum of 2 inches (51 mm) of free space
between the instruments and the top edge of the container bottom.
5. Place the container filter lid on top of the container bottom. Snap the locks
down to lock the lid in place. Make sure that the lid securely compresses the
gasket against the container bottom. Make sure that the locks are secure by
testing that they require sufficient force to open.
6. Insert a security seal into the channel of the container lid lock and secure
the seal (see Figure 17). It is recommended to use two seals per container,
located on opposite sides.
7. Use the paper indicator cards to record important information, and insert
the indicator cards into the appropriate holders on the container bottom.
Insert the metal identification plate(s) into the appropriate holders, if desired.
Sterilization
CAUTION: Do not sterilize the container with the security lid on. The
security lid will prevent steam from entering the perforations in the
container lid and could prevent effective sterilization of the contents.
CAUTION: When sterilizing with Ethylene Oxide or Hydrogen
Peroxide do not stack the containers in the sterilizer. The container
has not been validated for stacking with these cycle types.
CAUTION: When sterilizing with STERRAD Low Temperature
Hydrogen Peroxide cycles do not use the silicone mats. These mats
are not compatible with these cycle types and may cause cycle
termination:
LCN 206296-001-L
CAUTION: After sterilization, allow the containers to cool before
handling. If containers are handled while hot, use heat proof gloves. If
the optional silicone handles are available, hold the containers by the
silicone handle covers to prevent burns.
Use a validated, properly maintained and calibrated sterilization equipment.
Effective sterilization can be achieved using the cycle parameters and load
configurations described in Table 1.
General Precautions
Storage
CAUTION: Do not place hot containers in a cold draft, or on a cold floor.
This can cause the container to deform or may cause condensation.
CAUTION: Place the heaviest containers on the bottom of the stack.
Over stacking may damage the container.
CAUTION: Do not stack the containers higher than 60cm for storage.
After sterilization cycle and when the containers are completely cooled, an
optional security lid may be placed atop the container lid to provide additional
protection for the filters. Align the arrow of the security lid with one of the
notches on the lid (See Figure 18). Press the security lid down until it clicks.
Store the sterilized containers in a clean, dry, secure environment. Under
these conditions, the contents of the unopened containers will maintain sterile
for 180 days.
Storage of the Disposable Filters and Indicator Cards
Store the disposable filters and the paper indicator cards in a cool, dry place.
Opening the Container
1. Verify the identification on the outside of the container. Verify that the
sterilization indicator has changed color, when exposed to each cycle type..
2. Cut the security seals and remove them from the container lid locks.
3. Lift all four locks on the container lid and lift the lid, if using a security lid, lift
the lid with the security lid in place away from the container bottom.
4. Remove the contents of the container under aseptic conditions.
Service
For service outside the United States, contact your local Symmetry Surgical
representative.
Inside the United States, call the Symmetry Surgical at 1 800 251 3000.
Summary of Testing
Sterilization performance studies were conducted for the Symmetry Surgical
Quad-Lock
total loaded container weight as listed in Table 2 including baskets,
instruments, and accessories. All met the acceptance criteria for effective
sterilization. Shelf life testing has been conducted to support 180 days for all
cycle types. Reuse testing up to 100 cycles showed no effect on the function
of the container after processing. Further details on container performance
testing can be obtained from Symmetry Surgical. Qualified container
contents and lumen size and quantity noted in Table 1 were qualified by
Symmetry Surgical. Please reference the sterilization equipment
manufacturer's information regarding material compatibility for each
sterilizer/cycle type.
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Protective Silicone Mat
508550 Half
508551 Three-Quarter
508552 Full
® Container Systems for the cycles described in Table 1 with a
Not
Compatible
with
Sterrad
Cycles