Medtronic 6056 Technical Manual

6056

Rotation tool kit

Technical Manual

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

The following list includes trademarks or registered trademarks of
Medtronic in the United States and possibly in other countries. All other
trademarks are the property of their respective owners.

Medtronic, Quick Twist

Description/intended use

The contents of the Model 6056 rotation tool kit are
used to extend or retract the helix electrode of the
Medtronic endocardial extendable/retractable
screw-in leads via rotation of the connector pin on the
lead.

Package contents

Dispose of all single-use accessories according to
local environmental requirements.

Each package contains the following items:

• 1 Quick Twist tool

• 1 white fixation tool

• Product documentation

Accessory descriptions

Quick Twist tool – The Quick Twist tool facilitates

both connector pin rotation and stylet insertion into
the lead.

White fixation tool – The white fixation tool
facilitates connector pin rotation.

Contraindications

There are no known contraindications for the
Model 6056 Rotation tool kit.

Warnings and precautions

Note: Medical procedure warnings and precautions

that pertain to the Medtronic implanted system are
provided in the manual that is packaged with the

3

device or on the Medtronic Manual Library website
(www.Medtronic.com/manuals).

For single use only – The accessories are intended
for single use only.

Inspecting the sterile package – Carefully inspect
the sterile package prior to opening.

• If the seal or package is damaged, contact your
local Medtronic representative.

• Do not use the product after its expiration date.

• Do not store this product above 40°C (104°F).

Sterilization – Do not resterilize the contents of the
Model 6056 rotation tool kit. The contents have been
sterilized with ethylene oxide prior to shipment.

Chronic repositioning or removal – Chronic
withdrawal of the helix via rotation of the connector
pin may not be possible because of blood penetration
or fibrotic tissue intrusion in the helix mechanism.

Following lead fixation, remove the selected fixation
tool gently to avoid dislodging the lead tip.

Instructions for use

Note: Refer to the technical manual packaged with

the lead for further instructions on verifying the
mechanical functioning of the helix electrode and
securing the helix electrode into the endocardium.

Note: Either tool may be used to verify the
mechanical functioning of the helix electrode or to
secure the helix electrode into the endocardium. The
choice of tool is left to the discretion of the physician.

Use the following steps to verify the mechanical
functioning of the helix electrode or to secure the
helix electrode into the endocardium:

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1. Attach either the Quick Twist tool or the white
fixation tool to the lead. Ensure that the stylet is
inserted into the lead and proceed as indicated,
according to the tool being used.

Quick Twist tool: Push the Quick Twist tool
onto the IS-11 connector pin (Figure 1).

Figure 1.

White fixation tool: Press both legs of the white

fixation tool together and place the most distal
hole on the IS-1 connector pin (Figure 2).

Figure 2.

1

IS-1 refers to an International Connector Standard (ISO
5841-3) whereby devices and leads so designated are
assured of a basic mechanical fit.

5

2. Using either tool, hold the IS-1 connector leg of
the lead with the thumb on one side and 4
fingers on the other side. Keep the lead body
and the IS-1 connector leg as straight as
possible (Figure 2).

3. Ensure that the stylet is fully inserted, then rotate
the selected fixation tool clockwise until the helix
electrode is fully extended (Figure 3 or Figure 4).

Figure 3.

Figure 4.

Note: The maximum number of rotations of the

selected fixation tool needed to extend or retract
the helix is stated in the technical specifications
supplied with each lead.

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Medtronic disclaimer of warranty

For complete disclaimer of warranty information, see
the accompanying disclaimer of warranty document.

Service

Medtronic employs highly trained representatives
and engineers located throughout the world to serve
you and, upon request, to provide training to qualified
hospital personnel in the use of Medtronic products.
Medtronic also maintains a professional staff to
provide technical consultation to product users. For
more information, contact your local Medtronic
representative, or call or write Medtronic at the
appropriate telephone number or address listed on
the back cover.

CE mark of conformity

The following CE mark of conformity applies to the
Model 6056 rotation tool kit.

1994

Explanation of symbols

Table 1. Explanation of symbols on package

labeling
Refer to the package labels to see which symbols

apply to this product.

Conformité Européenne (European
Conformity). This symbol means
that the device fully complies with
applicable European Union acts.

7

Table 1. Explanation of symbols on package
labeling (continued)

For U.S. audiences only

Authorized representative in the
European community

Date of manufacture

Manufacturer

Use by

Lot number

Reorder number

Serial number

Sterilized using ethylene oxide

Do not reuse

Do not use if package is damaged

Upper limit of temperature

Open here

Consult instructions for use at this
website

Package contents

8

Table 1. Explanation of symbols on package
labeling (continued)

Product documentation

For use with Medtronic transvenous
leads

For use with Medtronic leads

Retractable screw-in

Fixation tool

Quick twist tool

9

Medtronic, Inc.

*M971367A001*

710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
[phone]

Authorized Representative
in the European Community

Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
[phone]

Europe/Middle East/Africa

Medtronic International
Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
[phone]

Australia

Medtronic Australasia Pty Ltd
5 Alma Road
Macquarie Park, NSW 2113
Australia
1800 668 670

Canada

Medtronic of Canada Ltd
99 Hereford Street
Brampton, Ontario L6Y 0R3
Canada
[phone]

Technical manuals

www.medtronic.com/manuals

© 2017 Medtronic
M971367A001 A
2017-08-02