Assembly
1. Open handle completely (1).
2. While holding jaws of insert closed, press button
on handle (2) and feed insert into shaft of handle.
Make sure the two pins on the insert align with the
two grooves on the shaft of the handle. Release the
button. Be sure proximal end of insert is properly
engaged into handle.
3. Firmly close handle (3) until a click is heard locking
the insert into handle.
Reprocessing
Warning: The instructions provided below have been
validated by Stryker as being capable of preparing
3 mm, 5 mm, and 10 mm laparoscopic instruments
and their accessories (i.e. Veress needles, trocars,
cannulae, reducers, etc.) for reuse. These instructions
were developed using the guidance from AAMI TIR 12,
ISO 17665, and AAMI ST79, and Stryker recommends
users observe these standards.
Warnings
•
Wear appropriate protective equipment: gloves,
eye protection, etc.
•
These instruments are supplied non-sterile and
must be cleaned and sterilized prior to the first
and every subsequent use.
•
Sodium Hydroxide (NaOH) is a strong caustic
agent and must be used carefully to avoid
injury. Disposal must be in compliance with local
ordinance.
•
Do not stack trays in the sterilizer as this may
compromise the sterility of the products.
Cautions
•
Do not use brushes or pads with metal
or abrasive tips during manual cleaning,
as permanent scoring or damage could result.
•
Allow the instruments to air cool following
steam sterilization. Rapid cooling or "quenching"
the instruments in a liquid will damage the
instrument and void the warranty.
•
Flash sterilization is not a preferred method.
Repeated Flash sterilization may break down the
instrument insulation, compromising the overall
safety and performance of the instrument.
If time permits, use a wrapped sterilization
method instead.
•
Ensure no holes are blocked and tips are in the
open position.
Limitations on Reprocessing
•
Do not cross-sterilize the instruments. Using
multiple sterilization methods may significantly
reduce the performance of the instruments.
•
Do not leave the instruments in solutions longer
than necessary. This may accelerate normal
product aging.
•
Proper processing has a minimal effect on these
instruments. End of life is normally determined
by wear and damage due to use.
•
Damage incurred by improper processing will
not be covered by the warranty.
Instructions
Point of Use
Wipe excess soil from the instruments using
disposable paper towels.
Containment and Transportation
•
Transport instruments in a tray to avoid damage.
•
The instruments should be reprocessed as soon
as possible following use.
•
If an automated reprocessing method is used,
rinse the channels with 50mL of sterile distilled
water immediately after use.
Preparation for Cleaning
1. Disassemble the instruments according to the
"Disassembly" section included in this manual.
2. Prepare an enzymatic detergent
the manufacturer's recommendations.
3. Wipe the instruments with the detergent, using
a clean cloth.
4. Immerse the instruments in the detergent.
Using a syringe, inject any inside regions of the
instruments with 50 mL of the detergent to
ensure all parts are reached.
5. Soak the instruments in the detergent for a
minimum of 15 minutes.
EN-4
according to
1