LivaNova® Tunneler Model 402
26-0005-2500/14 (
Non-US
) — 3 of 4
1.
Grasp the tray’s tab that has the peel illustration and peel
back the outer cover.
2.
Using sterile technique, lift out the sterile inner tray.
3.
Grasp the inner tray’s tab and carefully peel off the cover to
expose the contents without dropping them.
Make sure to remove all four pieces in the package:
1 Shaft
1 Bullet tip
1 Large-diameter sleeve (for use with a dual-pin Lead)
1 Small-diameter sleeve (for use with a single-pin Lead)
4.
D
IRECTIONS
FOR
U
SE
The following directions cover the use of the Tunneler. Placement
of the Lead electrodes around the nerve is described in the Lead
physician’s manual. Implantation of the Pulse Generator is
described in the Pulse Generator physician’s manual.
4.1.
Sterilization
Reference the exterior package label to ascertain the method of
sterilization. The sterilization method is indicated by the hydrogen
peroxide gas plasma (H
2
O
2
) sterility symbol or the ethylene oxide
(EO) sterility symbol, as described in Section 2 of these directions.
The Tunneler has been sterilized using H
2
O
2
or EO and is
supplied in a sterile package to permit direct introduction into the
operating field. A sterilization process indicator is included in the
package. The Tunneler should be used only if the color of the
indicator is in the range of gold to bronze (in the case of product
sterilized with H
2
O
2
)—or gray to green (in the case of product
sterilized with EO). An expiration (use-before) date is indicated on
the package.
If the package has been exposed to extreme temperatures or
moisture, or if there is any indication of external damage, the
package should be left unopened and returned to LivaNova with a
Returned Product Form.
Call first for a
Return Goods
Authorization (RGA)
number
,
available from Technical Support
(see “Information and Support” on page 4).
Do not use
the Tunneler if the following occurs:
The outer or inner package has been pierced or altered,
because this could have rendered it nonsterile.
The expiration (use-before) date has passed, because
this can adversely affect the device’s sterility.
The color of the process indicator within the inner
package is not in the range of gold to bronze for product
sterilized by H
2
O
2
.
The color of the process indicator within the inner
package is not in the range of gray to green for product
sterilized by EO.
Do not resterilize
the Tunneler because sterility,
functionality, and reliability cannot be ensured, and infections
may occur. Return any opened packages that have not been
used to LivaNova.
The Tunneler is a single-use-only device.
Never resterilize
or reuse it.
4.2.
Assemble the Tunneler
The Tunneler must be assembled at the time of surgery. To do so,
follow these steps:
1.
Using sterile technique, remove the four Tunneler
components from the inner tray, and place them into the
sterile field.
2.
Select the appropriate sleeve.
The
larger
diameter sleeve is used when implanting a
dual-pin Lead (used with a dual-receptacle Pulse
Generator).
The
smaller
diameter sleeve is used when implanting a
single-pin Lead (used with a single-receptacle Pulse
Generator).
3.
Slide the appropriate sleeve over the shaft until it fits up
against the retainer at the handle end of the shaft.
4.
Carefully screw the bullet tip onto the shaft (see Figure 1 and
Figure 2).
Do not over-tighten the bullet tip. Doing so could
damage the bullet tip threads.
4.3.
Pass the Tunneler and Lead
After the chest and neck incisions are made, and before the
electrodes are inserted around the left cervical vagus nerve, the
Tunneler can be inserted and passed from the neck incision to the
chest incision. (If necessary, the Tunneler can be manually shaped
to help direct it through the body.)
Do not manually shape the Tunneler
more than 25
degrees
, because doing so may cause the sleeve to bend or
kink.
To pass the Tunneler, do the following:
1.
Place the bullet-tip end of the Tunneler through the neck
incision and tunnel subcutaneously toward the chest incision,
exerting force on the handle end and directing the Tunneler
as necessary.
2.
After the bullet tip has passed from one incision site to the
other, unscrew the bullet and withdraw the shaft from the
sleeve, leaving the sleeve extended through both incisions
(see Figure 3).
2
