Medtronic 6082-52 Technical Manual

6048, 6054, 6057, 6082, 6093

Straight stylet kits

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

Description

The Model 6048, 6054, 6057, 6082, and 6093 stylet kits each consist of 2 straight stylets and 2 stylet guides.

The straight stylet is a stainless steel wire designed for use with Medtronic transvenous leads. At the proximal end of each
straight stylet is a plastic knob marked with the stylet diameter and the applicable lead length for which the stylet is designed.
For example, 14-58 indicates that the stylet diameter is 0.356 mm (0.014 in) and that the stylet is designed for use with 58 cm
leads. When inserted into the lumen of the lead conductor, the stylet provides additional stiffness and controlled flexibility for
maneuvering the lead into position.

The stylet guide facilitates inserting the stylet wire into a transvenous lead. The funnel-shaped opening of the stylet guide
steers the stylet tip directly into the lead connector pin. The large radius of the stylet guide over the connector pin entry is
intended to help prevent the stylet wire from kinking as it is maneuvered through the lead body. A notch in the barrel of the
stylet guide allows attachment of a surgical cable alligator clip for taking threshold measurements.

Table 1. Straight stylet models Model Knob color Diameter Distal end

6048 Green 0.356 mm (0.014 in) Blunt
6054 Rust 0.406 mm (0.016 in) Tapered, ball-tipped
6057 Blue 0.356 mm (0.014 in) Ball-tipped
6082 Gray 0.356 mm (0.014 in) Extended-taper, ball-tipped
6093 Purple 0.406 mm (0.016 in) Extended-taper, ball-tipped

Package contents

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

Each package contains the following items:

• 2 straight stylets (sterile)

• 2 stylet guides (sterile)

• Product documentation

Indications

The stylet is intended to aid in the placement of Medtronic transvenous leads. The stylet guide is used to facilitate insertion
of the stylet into a transvenous lead.

Contraindications

To date, there are no known contraindications to the use of the stylets and stylet guides in the Model 6048, 6054, 6057, 6082,
and 6093 stylet kits.

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

Review the lead documentation – Since the stylet is a functional extension of the lead, it is recommended that the lead
documentation be reviewed for all appropriate warnings, complications, precautions, and instructions.

Single use – The stylet kit is for single use only.

Inspecting the sterile package – Inspect the sterile package with care before opening.

• Contact your local Medtronic representative if the seal or package is damaged.

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

• Do not use the product after its expiration date.

Sterilization – Medtronic has sterilized the package contents with ethylene oxide before shipment. This stylet kit is for single
use only and is not intended to be resterilized.

Line-powered and battery-powered equipment – An implanted lead and the stylet in contact with the lead conductor (with
or without the stylet guide attached to the lead connector pin) constitute a direct lowresistance current path to the
myocardium. During lead implant and testing, use only battery-powered equipment or line-powered equipment specifically
designed for this purpose, to protect against fibrillation that may be caused by alternating currents. Line-powered equipment
used in the vicinity of the patient must be properly grounded. Lead connector pins (with or without the stylet guide and the
stylet attached to the lead connector pin) must be insulated from any leakage currents that may arise from line-powered
equipment.

Stylet insertion and withdrawal – Stylet insertion and withdrawal following lead placement should always be done gently
to avoid dislodging the lead tip.

Handling the stylet – Handle the stylet with care at all times.

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• Do not use excessive force or surgical instruments when inserting the stylet into the lead.

• Avoid overbending or kinking the stylet.

• Use a new stylet when blood or other fluids accumulate on the stylet. Accumulated blood or other fluids may damage the
lead or cause difficulty in passing the stylet into the lead.

Directions for use

For instructions on using straight stylets and, where applicable, stylet guides during the implant of a transvenous lead, refer
to the product documentation packaged with each lead.

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 stylet kits.

CE Mark

1994

1997

Models

6048, 6054, 6057, 6082

6093

Explanation of symbols

Table 2. 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.

For U.S. audiences only

Authorized representative in the European community

Date of manufacture

Manufacturer

Use by

Lot number

Reorder number

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Table 2. Explanation of symbols on package labeling (continued)

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

Product documentation

Straight stylet

J-shaped stylet

Stylet guide

Tip: Blunt

Tip: Ball

Tip: Tapered, ball

Tip: Extended-taper, ball

For use with Medtronic transvenous leads

CD-ROM not included

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Medtronic, Inc.

*M971365A001*

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
M971365A001 A
2017-08-02