VNS Therapy LivaNova Tunneler 402 Manual

26-0005-2500/14 (Non-US) — 1 of 4
2005
Rx Only
Note:This “Directions for Use” contains
information on the LivaNova®Model 402
Tunneler. Physicians should refer to the
LivaNova Pulse Generator physician’s
manual for important prescribing and
safety information.
LivaNova®Tunneler
Model 402
Directions for Use
For Healthcare Professionals
June 2017
Non-U.S. Version

LivaNova® Tunneler Model 402
2 of 4 — 26-0005-2500/14 (Non-US)
1. DESCRIPTION
The VNS Therapy®System, used for vagus nerve stimulation
(VNS), consists of an implantable Pulse Generator and Lead, and
an external programming system used to change stimulation
settings.
The LivaNova®Tunneler, Model 402 is designed for use during
implantation of a LivaNova dual-pin or single-pin Lead.1It is
recommended for subcutaneous tunneling of the Lead
connector(s) from the neck to the chest. The Tunneler, supplied
sterile, is a single-use-only device.
The Tunneler consists of four basic components: a stainless steel
shaft, two fluorocarbon polymer sleeves, and a stainless steel
bullet tip.
Figure 1 shows a diagram of the assembled device with the larger
diameter sleeve to be used with a dual-pin Lead.
Figure 1. Assembled Tunneler with Larger Diameter
Sleeve
Figure 2 shows a diagram of the assembled device with the
smaller diameter sleeve to be used with a single-pin Lead.
Figure 2. Assembled Tunneler with Smaller Diameter
Sleeve
Dimensions of the LivaNova Tunneler were optimized to minimize
risk of damage to Lead connector(s) that may occur with the use of
general-purpose tunnelers.
Component dimensions are shown in Table 1.
Table 1. Tunneler Dimensions
Note: No component of the VNS Therapy System is made with natural
rubber latex.
2. INTENDED USE
The Tunneler is intended for use only to aid in routing, or directing,
the Lead from the neck incision to the chest incision.Precautions
The Tunneler is a single-use-only device. Never resterilize
or reuse it.
Replacements for Tunnelers should be available in the event
of compromised sterility or damage induced during surgery.
Care should be taken not to injure any arteries, veins, or
nerves during the tunneling procedure.
Always tunnel from the neck incision to the chest
incision to reduce the risk of damaging one of the major
arteries or veins in the neck.
3. STORAGE AND HANDLING
Store the Tunneler between -20°C(-4°F) and +55°C
(+131°F).
Do not store the Tunneler where it is exposed to water or
other liquids, because moisture can damage the seal
integrity of the package materials.
Before opening the sterile package, examine it carefully for
evidence of damage or compromised sterility. If the outer package
has been opened or damaged, LivaNova cannot guarantee
sterility of the Tunneler and it should not be used. An opened or
damaged product should be returned to LivaNova.
To open the Tunneler package, do the following:
1. All single-pin and dual-pin Leads referred to in this “Directions for Use” are
manufactured by LivaNova, Inc.
ARetainer
BStainless Steel Shaft
CShaft Handle
DSleeve
EBullet Tip
ARetainer
BStainless Steel Shaft
CShaft Handle
DSleeve
EBullet Tip
Component Dimension (Nominal)
Stainless steel shaft length 13.4 in 34 cm
Large-diameter fluorocarbon
polymer sleeve (dual-pin Lead)
length 11 in 28 cm
inside
diameter 0.25 in 6.4 mm
outside
diameter 0.31 in 7.9 mm
Small-diameter fluorocarbon
polymer sleeve (single-pin Lead)
length 10.45 in 26.5 cm
inside
diameter 0.135 in 3.4 mm
outside
diameter 0.185 in 4.7 mm
Stainless steel bullet tip outside
diameter 0.31 in 7.9 mm
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LivaNova® Tunneler Model 402
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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. DIRECTIONS FOR USE
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 (H2O2) sterility symbol or the ethylene oxide
(EO) sterility symbol, as described in Section 2 of these directions.
The Tunneler has been sterilized using H2O2or 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 H2O2)—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 H2O2.
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).
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Figure 3. Position of Sleeve and Lead Connector(s)
3. With the sleeve in place between the two incisions, carefully
insert the Lead connector(s) inside the end of the sleeve at
the neck incision.
For a dual-pin Lead, the second connector will form a slight
compression fit between the first Lead connector tubing and
the inside of the sleeve (see Figure 3).
4. Carefully pull the sleeve, along with the Lead connector(s),
from the chest incision end until the lead connector(s)
completely exit(s) the chest incision.
5. Remove the Lead connector(s) from the sleeve, leaving the
electrode array at the neck incision site.
6. Discard the Tunneler after use.
5. INFORMATION AND SUPPORT
If there are questions regarding use of the VNS Therapy System
or any of its accessories, contact LivaNova:
LivaNova USA, Inc.
100 Cyberonics Boulevard
Houston, Texas 77058 USA
Telephone: [phone]
1 [phone] (US and Canada)
Fax: [phone]
LivaNova Belgium NV
Ikaroslaan 83
1930 Zaventem BELGIUM
Telephone: [phone]
Fax: [phone]
For 24-hour support, call:
Telephone: [phone] (US and Canada)
[phone] (Worldwide)
Internet
www.livanova.com
___________________________________________________________________
© Copyright 1998 - 2017 LivaNova, PLC, London, UK
All rights reserved.
LivaNova is a registered United States trademark of LivaNova, PLC. NCP, Demipulse,
Demipulse Duo, Perennia, VNS Therapy, AspireHC, PerenniaFLEX, PerenniaDURA
and AspireSR are registered trademarks of LivaNova USA, Inc. Pulse and Pulse Duo
are trademarks of LivaNova USA, Inc. Corresponding foreign trademarks may also be
registered or pending.
ASingle-Pin Lead
BTunneler Sleeve
CDual-Pin Lead