New World Medical Kahook Dual Blade, Manual

Page: 4 / 20

CAUTION
A. Physician training is required before use of this instrument.
B. Contents are guaranteed sterile provided that the
package including the tray seal are not punctured
or damaged. Do not use if the package is dam-
aged or open, or if the seal appears damaged.
C. Read instructions before use.
D. Do not use if the product is past its expiration date.
E. When removing the instrument from its tray ensure that the
tip does not touch any part of the tray. The blade tip may
dull if it touches the tray surface. Do not touch the tip to any
surfaces other than those of the eye as it may damage or
dull the tip.
F. Do not use an instrument if it contains debris, is dull, bent,
rusted or otherwise damaged.
G. Precautions standard to ophthalmic surgery should be
observed when using the Kahook Dual Blade
® , including
customary aseptic technique.
H. The knife contains stainless steel. Some individuals may be
sensitized or allergic to metals, avoid using the KDB in such
cases.
I. Used sharps are contaminated and can transmit diseases.
Immediately after use, dispose of the instrument in an
appropriately labeled puncture resistant biohazard sharps
container.
J. The Kahook Dual Blade
®
is a single
patient, single use disposable instrument.
Do not reuse or re-sterilize. Re-sterilized or reused
devices pose risks of infection and dull blades that
may result in damage to tissue.
2
STERILIZE
!
DESCRIPTION AND INTENDED USE
The Kahook Dual Blade ® (KDB) is a disposable ophthalmic knife, a manual surgical instrument
used in ophthalmic surgical procedures to manually cut trabecular meshwork (TM) in
pediatric and adult patients. The KDB is sterile and is intended for single patient, single use.
The KDB consists of a surgical grade stainless steel body and a plastic handle. The stainless
steel body is comprised of a long thin neck that allows for access to the TM, a pointed tip
used to pierce TM, a ramp that lifts and stretches tissue as the device is advanced, and
two thin blades that cut TM. An indicator on the plastic handle specifies the direction to
advance the KDB.
CONTRAINDICATIONS
Like most angle surgeries, proper visualization using a gonioprism is key to manually cutting
TM with the KDB. Do not attempt to use the KDB if corneal clarity is poor or if visualization
of angle structures is not possible.
CAUTION: Do not use the KDB if you are not trained for intraoperative gonioscopy or have
poor visualization of angle structures. Improper visualization may result in misuse of the KDB
and damage to eye structures adjacent to the TM.
INSTRUCTIONS
1. Removing the Instrument from the Plastic Tray
1.1. CAUTION: See G.
1.2. Open the box and peel away the sealed Tyvek lid from the plastic container.
1.3. Remove the KDB from the plastic container taking care to lift the tip away from the
tray first by gripping the KDB handle at the finger slots provided in the tray.
1.4. CAUTION: See E.
1.5. Inspect instrument and CAUTION: See F.
English (en)