New World Medical Kahook Dual Blade, Руководство пользователя

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2. Considerations
2.1. Like other angle surgeries, use of a gonioprism over the patient’s cornea under
surgical microscope magnification is required for visualization of the TM and the
instrument during use.
2.2. Positioning of the patient is essential to obtaining a proper view.
2.3. The KDB can be used stand-alone or combined with other procedures.
2.4. The KDB is inserted into the eye through a previously created clear corneal incision.
Larger incisions allow for greater maneuverability.
CAUTION: The KDB is intended to cut TM and cannot be used to make a clear
corneal incision.
2.5. The clear corneal incision should be approximately 180 degrees away from the TM
you desire to cut.
2.6. The anterior chamber should be inflated with viscoelastic when using the KDB.
CAUTION: Overinflating the chamber may make cutting of the TM difficult as the
Canal of Schlemm may collapse.
3. Using the KDB under Gonioscopic View to cut TM.
3.1. Allowing some blood to reflux into the Canal of Schlemm, by lowering intraocular
pressure, can be used to identify the TM. Insert the tip and neck of the KDB
through the clear corneal incision and advance to the opposite side of the anterior
chamber.
CAUTION: Be careful to avoid touching the corneal endothelium and
iris with the KDB as you are advancing or retracting the instrument in the anterior
chamber. When inserting the tip, ensure that the long edge of the footplate is
parallel to the incision (sharp tip is not perpendicular to incision slit).
(Figure a)
3.2 Engage the TM across from the clear corneal incision with the pointed tip of the
KDB and pierce through the TM and into the Canal of Schlemm while avoiding the
anterior wall.
(Figure b)
3.3 Advance the KDB in the direction of the TM region that you intend to cut by
pivoting and advancing/retracting the thin neck along the clear corneal incision
while keeping the KDB footplate in the Canal of Schlemm.
(Figure c) Avoid cutting
surrounding tissue. Some blood reflux into the anterior chamber from the collector
channels can be expected as the TM is removed. Viscoelastic or BSS can be used to
improve visualization of the area that you want to treat. Blood can be aspirated out
of the anterior chamber.
CAUTION: Ensure that the smooth heel of the tip slides
forward with minimal pressure against the anterior wall of the Canal of Schlemm.
If the heel is angled away from the back wall, the pointed tip may engage the
anterior wall of the Canal of Schlemm and prevent smooth advancement of the
KDB or result in sub-optimal engagement of the targeted TM tissue.
3.4 Detach the TM strip by use of the KDB or microforceps. To detach the TM strip
with the KDB, engage the TM across from the clear corneal incision with the
pointed tip of the KDB and pierce through the TM and into the Canal of Schlemm
while avoiding the anterior wall of the Canal of Schlemm. Advance the KDB in one
direction until the desired endpoint of goniotomy is reached. Reverse the blade
and advance towards the original area of treatment until a connection is made
with the initial area of goniotomy.
3.5 Do not leave the detached TM strip in the anterior chamber. The detached TM
tissue can be removed by using the KDB as the tissue may adhere to the blade,
using ophthalmic forceps, or through aspiration from the clear corneal wound.
Only aspirate fully detached TM strips.
3.6 CAUTION: If the angle of approach of the KDB to the TM is too steep only one of
the dual blades may incise the TM.
3.7 After cutting the TM, retract the KDB through the original clear corneal incision.
4. Disposal
4.1. CAUTION: See I other side
4.2. CAUTION: See J other side
HOW SUPPLIED
One KDB is supplied per box. The KDB is packaged in a plastic tray with a Tyvek lid. The tray
secures and protects the delicate tip of the KDB. The KDB is a disposable, single patient,
single use, sterile surgical instrument.
The KDB is sterilized with gamma radiation.
STORAGE REQUIREMENTS
CAUTION: Do not expose to direct sunlight, water, high temperature, and high humidity.
EXPIRATION DATE
The KDB can be used up to 3 years after the date of manufacture as indicated by the
expiration date on the label. Sterility is guaranteed until the expiration date if the packaging
is not punctured or otherwise damaged.
CAUTION: Do not use the KDB past the indicated
expiration date.