Symmetry Surgical VersaGrip Instrucciones De Uso página 7

Dry
Recirculation Time
Temperature
Detergent Type
7. Use pressurized air to aid in drying time, if necessary.
8. Inspect each instrument for visual cleanliness, pay
close attention to hard-to-reach areas.
9. If visible soil remains, repeat steps 1-8.
The devices were validated with the Enzymatic Detergent: Enzol® Enzymatic Detergent
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2 The devices were validated with an M16 soft-bristle brush
3 The devices were validated with a 5 mm x 24" bottle brush
4 The devices were validated with reverse osmosis (RO/DI) water
The devices were validated with the Non-Enzymatic Detergent: Prolystica 2x Concentrate Neutral Detergent
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Disinfection (Optional)
Warning: Not to be used in place of sterilization.
Detailed Manual High-Level Disinfection Instructions:
1. Disassemble the
"Disassembly" section included in this manual.
2. Disinfect the instruments by submerging them in
the disinfecting solution listed below. Flush
lumens and crevices using a syringe with the
disinfecting solution that has the following active
ingredient: ≥ 2.4% glutaraldehyde
minimum soak time of 45 minutes at 25°C
3. Thoroughly rinse and flush all parts and lumens
with running, demineralized water to remove the
disinfectant.
4. Dry all parts with a lint-free towel immediately after
rinsing.
The devices were validated with Cidex® Activated Dialdehyde Solution
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Detailed Thermal Low-Level Disinfection Instructions:
1. Disassemble the
"Disassembly" section included in this manual.
2. Place the disassembled instruments into the
washer disinfector.
3. Program the washer disinfector using the
following parameters:
Thermal Rinse
Recirculation Time
Temperature
Sterilization
Warnings – When using a sterilization tray:
 Consult the tray manufacturer's instructions to
confirm compatibility with Symmetry VersaGrip™
IFU‐LCN‐ERG100\Rev C
7 Minutes
115°C
N/A
instruments per the
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with a
instruments per the
1 Minute
90°C
laparoscopic instruments (including but not limited to
the lumen length and diameter).
 ONLY use pre-vacuum steam sterilization cycles.
Symmetry VersaGrip™ laparoscopic instruments are
not validated for other sterilization methods.
1. Inspect all components for cleanliness. If fluid or
tissue buildup is present, repeat the above cleaning
and disinfection procedures.
2. Inspect for burns, cuts, and abrasions
electrical insulation on the insert and/or the handle for
instruments equipped with electrosurgical capabilities
as these defects
electrosurgical
complications.
3. Inspect all jaws and cutting edges for damage.
4. Ensure instrument jaws align properly and open and
close completely.
5. Instrument may be sterilized assembled as long as
the cleaning process prior to sterilization was
completed as a dissembled unit.
6. Instruments may be placed in a specialized tray or
containment device for protection. Follow the
instructions provided by the manufacturer.
7. Perform sterilization per the following specifications.
Failure to do so will compromise sterility.
Steam Sterilization
Warnings: Drying time depends on several variables,
including altitude, humidity, type of wrap, preconditioning,
size of chamber, mass of load, material of load, and
placement in chamber. Users must verify that drying time set
in their autoclave yields dry surgical equipment.
NOTE: Open all flush ports for sterilization or incomplete
sterilization may result.
Pre-Vacuum (US)
Wrapping
Temperature
Sterilization Time
Dry Time
Pre-Vacuum (Europe)
Wrapping
Temperature
Sterilization Time
Dry Time
Sterilization was validated using two layers of 1-ply KimGuard KC600 polypropylene wrap.
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in the
could cause unintended
burns and life-threatening
Double
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132°C (270°F)
4 minutes
30 minutes
Double
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134°C (274°F)
3 minutes
30 minutes
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