Johnson & Johnson DePuy Mitek 108804, Руководство пользователя

Страница: 4 / 105

4
Button (Figure 1) and load the suture into the
tip of the device being sure the suture is pulled
completely to the proximal end of the slot at
the tip of the device. (Figure 3) Even though
it is not required suture management may be
improved if one of the tails is 1 to 2cm long.
FIGURE 3
G. Slot
CAUTION: Use only 2-0 to #2 braided Surgical
Suture with the ExpresSew ll Flexible Suture
Passer and ExpresSew ll Suture Needle.
If using the device in open surgery wet the
distal end of the forcep with sterile water.
Also, if being used in an open procedure, omit
the following references to the arthroscopic
cannula.
2. With the suture loaded and the jaw of the
Flexible Suture Passer closed and the needle
retracted (not showing), pass the Flexible
Suture Passer through the cannula into the
surgical site under direct visualization. Hold the
suture slightly taut to ensure that the suture
does not become entangled on itself or in the
Flexible Suture Passer as it is passed through
the cannula.
NOTE: The ExpresSew ll Flexible Suture
Passer should be used with a 5mm or larger
cannula.
3. When ready to pass the suture, open the
jaw and position the jaws of the Flexible
Suture Passer at the desired location to pass
the suture. Close the jaw with a secure but
GENTLE GRASP. If too much force is used to
grasp tissue, passage of the needle and suture
will be impeded. Note: If more room is required
to open the jaw pull the cannula proximally
once the device is inside the bursa.
4. To deploy the needle, pull the needle
deployment lever. This will advance the needle/
suture through the tissue. If significant force is
required to pass the needle, loosen the grip on
the tissue and try again. Note: If a false start
occurs and the needle is partially deployed, the
device may need to be removed and the suture
reloaded.
5. After passing the suture, release the needle
deployment lever allowing the needle to fully
retract. Open the Jaw, grasp the loop of suture
that has already passed through tissue with
a hook or grasper from another portal. Then
remove the suture passer from the cannula.
CAUTION: If the needle is not fully retracted,
the passer will be difficult to remove from the
tissue.
6. Immediately remove and discard the
disposable suture needle after completion of
the surgery. “NEEDLE – SINGLE USE ONLY”.
The needle is easier to remove if it is in a
partially deployed position.
STORAGE
Store in a cool, dry area.
INSRUMENT CLEANING AND
STERILIZATION INSTRUCTONS
These cleaning and sterilization instructions have
been validated as being capable of preparing
reusable DePuy Mitek instruments for reuse. It is
the responsibility of the end user to ensure that
the cleaning and sterilization is actually performed
using appropriate equipment, materials, and
personnel to achieve the desired result. This
normally requires validation and routine monitoring
of the process. Any deviation from these
instructions should be evaluated for effectiveness
and potential adverse consequences.