Medtronic H1701A08 Instructions for Use

HOW SUPPLIED

The reusable T rocar handle is provided as a clean but NOT STERILE
assembly consisting of the handle, blade holder, end cap and rod; the
disposable blade and tip sets are provided separately. Each disposable
blade and tip set consists of one (1) clean but NOT STERILE blade and
matching tip in sizes 8 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm,
20 mm, 22 mm, and 26 mm.

HANDLING/STERILIZATION

For initial use, the trocar handle and blade/tip sets should be removed
from their containers, overwrapped, and sterilized. THE TROCAR
SHOULD BE STERILIZED UNASSEMBLED. Steam or Ethylene Oxide
Sterilization may be used. Follow recommendations supplied by
sterilization equipment manufacturers. For Steam Sterilization a cycle of
250°F (121°C) for 20 minutes or 270°F (132°C) for 7 minutes may be
used.

Adequate aeration is required following ETO Sterilization.
After each use, discard the blade and tip. The trocar handle should be

disassembled and scrubbed with a brush and mild detergent. Particular
attention should be given to the threaded and knurled areas of the
instrument.

WARRANTY

Medtronic, Inc. warrants that at the time of manufacture, reasonable care
was used in the manufacture of the trocar. No other warranty, including
any warranty of merchantability or fitness for purpose is either expressed
or implied. This warranty is exclusive and in lieu of all others. No
representative of Medtronic, Inc. may change any of the foregoing and
the purchaser (and/or user) accepts the product subject to all terms
herein stated.

CAUTION

Federal law (USA) restricts this device to sale by or on the order of a
physician.

3

Medtronic, Inc.
710 Medtronic Parkway NE
Minneapolis, MN 55432-56 04
USA

© Medtronic, Inc. 2001
All Rights Reserved
UC199403975aML 1200845-002A
March 2001

HANCOCK TROCAR
HANDLING INSTRUCTIONS

DESCRIPTION OF MATERIALS

The Hancock Trocar employs disposable stainless steel cylindrical
blades which correspond to the size and geometry of the Hancock Apical
Left Ventricle Connectors. The trocar creates a clean, uniform circular
ventriculotomy with minimum trauma to surrounding tissues and retains
the myocardial plug to simplify removal.

INDICATIONS

The Hancock Trocar is recommended for use with Hancock Apical Left
Ventricle Connectors.

WARNINGS

Care should be taken not to damage the chordae tendineae or the
ventricular septum when excising the myocardial plug.

Blades and tips are intended for single use only.
Examine the trocar before use to verify correct assembly and secure

attachment of all components.

PRECAUTIONS

For each procedure, sterilize a single trocar handle, end cap and blade
holder in addition to a matching blade and tip for each size connector
which may be selected for implantation.

Aseptically assemble the appropriate blade and tip on the trocar handle
after

the specific size of connector has been selected.

The opening created by the trocar must correspo nd to the size of
connector to be used in order to aid hemostasis and minimize distortion
of the connector.

DIRECTIONS FOR USE

The trocar must be disassembled before cleaning and sterilization. After
sterilization the trocar handle and the appropriate size blade and tip
should be assembled aseptically as shown in illustrations.

Specific recommendations pertaining to the use of the trocar are
included in the surgical techniques detailed in the Hancock Apical Left
Ventricle Connector handling instructions.

STEP I

HANDLE

END CAP

STEP IV

HANDLE

ROD

BLADE HOLDER

TIP

BLADE

Attach the end cap to the handle by turning the end cap clockwise.

STEP II

Attach the blade to the blade holder by turning the blade clockwise.
CAUTION: Do not hold the blade near the cutting edge.

BLADE

BLADE HOLDER

STEP III

HANDLE

BLADE HOLDER

Slide the blade holder onto the shaft of the handle until the blade holder
is fully seated inside the handle.

BLADE

Attach the tip to the threaded shaft of the handle by turning the tip
clockwise until tight.

STEP V

BLADE

ROD

TIP

HANDLE

END CAP

BLADE HOLDER

Completed trocar assembly.

CLINICAL EXPERIENCE

Devices employing similar principles as the Hancock Trocar have been
used extensively to create uniform openings in the heart and vessels.

ACCESSORIES

Replacement blade and tip sets are available in sizes 8 mm to 26 mm.