Symmetry Surgical Quad-Lock Manual Del Usuario página 2

QUAD-LOCK Container System Instructions for Use
®
IMPORTANT INFORMATION
Please Read Before Use
SYMMETRY SURGICAL QUAD-LOCK
Indications
The Symmetry Surgical Quad-Lock® Container System is indicated for use
by hospitals and by health care facilities to:
• organize and protect stainless steel, aluminum, titanium, plastic* and
silicone surgical instruments during sterilization
• allow sterilization of the contained instruments by prevacuum steam,
ethylene oxide, and low temperature hydrogen peroxide sterilization cycles
(validated modalities and parameters are shown in Table 1)
• maintain sterility of the instruments and accessories after sterilization by
prevacuum, ethylene oxide or low temperature hydrogen peroxide for up to
180 days during storage and transport within the healthcare facility as long
as the container has not been opened and the integrity of the filters and
container have not been compromised.
Note: The system has not been tested for maintenance of sterility after
transportation outside the health care facility.
The Quad-Lock system is intended for use with surgical instruments and
accessories made with stainless steel, aluminum, titanium, plastic* and
silicone. However not all medical device/instrument materials are compatible
with each sterilization modality and some restrictions are noted below. Refer
to the instrument/sterilizer manufacturer's instructions for sterilization
recommendations and limitations.
*The sterilization of plastic instruments was confirmed by Symmetry Surgical
for steam sterilization due to the high temperature exposure. Please
reference the sterilization equipment manufacturer's information regarding
material compatibility for each sterilizer/cycle type.
For effective sterilization and drying of any size Symmetry Surgical Quad-
Lock® Sterilization Container, the recommended maximum combined weight
of the single container and its contents is defined in Table 1.
For each sterilization cycle type the qualified lumen quantity and size
(minimum diameter and maximum length) that has been validated for that
cycle is shown in Table 1.
Container system component compatibility by sterilization cycle type is
detailed in Table 2.
Product Description
The Symmetry Surgical Quad-Lock
organize and protect stainless steel, aluminum, titanium, plastic*, and silicone
general surgical instruments and accessories during sterilization and storage.
The filter lids, security lids, and container bottoms are made from anodized
aluminum (see Figure 1). The security lids help ensure sterility during storage
and protect the filters when the containers are stacked. Testing of assembled,
loaded containers up to the weights specified in Table 1 has shown that the
contents can be effectively sterilized when the validated sterilization
parameters are followed. Hospitals should refer to AAMI/AORN guidelines on
weights and weight limit. Please refer to the Indications section for specific
information regarding the sterilization of lumen instruments.
Precautions
1. Use only the filters available from Symmetry Surgical that are designed for
use with the Symmetry Surgical Quad-Lock
other filters might compromise the sterilization process. The disposable filters,
paper indicator cards, and security seals are for single use only.
2. Personnel should wear all appropriate personal protective equipment
(PPE) as defined in hospital operating procedures or as recommended by the
sterilizer manufacturer.
3. Colored filter lids may be used with steam sterilization ONLY. The grey
filter lids can be used with all sterilization modalities. See Table 1 for
complete compatibility information.
LCN 206296-001-L
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4. Container stacking can only be done when using steam sterilization. Do
not stack more than three containers within the steam sterilizer.
5. Process Indicators and Tamper Evident Seals: Per AAMI ST79, process
indicators are used to indicate that the container has been exposed to the
sterilization process and to distinguish between processed and unprocessed
containers. Use of indicators should be in accordance with the facility's
policies and procedures. Steam, Ethylene Oxide, and Hydrogen Peroxide
sterilization chemical indicators should be used for each sterilization load.
DO NOT REUSE. These products include the following:
Catalog Number Description
50-9008 Security Seal
50-9011 Filter, Disposable, Round
Indicator cards
CAUTION: Symmetry Surgical®
to undergo or withstand any form of alteration, such as disassembly, cleaning
or re-sterilization, after a single patient use. Reuse can potentially
compromise device performance and patient safety.
Inspection
CAUTION: Only appropriately trained personnel must perform the
inspection of the sterilization system components.
Inspect the container parts during cleaning and assembly.
Do not use if there are visible signs of excessive wear (e.g. cracking, peeling,
or flaking) of the internal anodized layer, damaged, or defective parts; replace
these products. Worn or damaged components could compromise the sterile
barrier or the use of the sterile contents. The gaskets cannot be repaired
A. Inspecting the Filter Lid
1. Visually check the lid; warpage is not acceptable. Ensure the rim of the lid
and the gasket area has not been damaged in a manner that will compromise
the ability of the lid to maintain a seal when lid is placed upon container
bottom.
2. Visually inspect all gaskets inside the lid. Cuts or cracks in a gasket are not
acceptable. The gasket in the perimeter of the lid must be seated in the
channel along its entire length.
3. Test the gasket for elasticity by compressing it with a finger. The gasket
must return to its original shape without visible indentation.
4. Do not use if there are visible signs of excessive wear (e.g. cracking,
peeling, or flaking).
B. Inspecting the Security Lid
Visually check the security lid; warpage is not acceptable.
C. Inspecting the Container Bottom
1. Inspect the rolled upper edge of the container bottom. Sharp edges or
other defects that could damage the gasket in the lid when the parts are
assembled are not acceptable.
2. Visually inspect all gaskets inside the perforated bottom. Cuts or cracks in
a gasket are not acceptable.
3. Do not use if there are visible signs of excessive wear (e.g. cracking,
peeling, or flaking).
D. Inspecting the Filter Retainer
These instructions pertain to filter retainers located in both the lid and the
perforated container bottom.
1. Visually check the retainer; warpage is not acceptable.
2. Visually inspect the gasket on the bottom side of the retainer (see Figure
2). Cuts or cracks in a gasket are not acceptable.
3. Test the action of the spring latch of the retainer by pressing the latch.
4. Do not use if there are visible signs of excessive wear (e.g. cracking,
peeling, or flaking).
Observe the latch for smooth movement (see Figure 3).
Replacement filter retainers are available:
Catalog Number Description
50-9044 Filter Retainer
Single Use devices have not been designed