Medtronic 6091-65 Technical Manual

6052, 6091, 6094

J-shaped stylet kits

Technical Manual

Caution:

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

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Medtronic

Description

The Model 6052, 6091, and 6094 stylet kits each consist of 2 J-shaped stylets and 2 stylet guides.

The J-shaped stylet is a stainless steel wire designed to be used with Medtronic transvenous leads. At the proximal end of
each J-shaped stylet is a plastic knob marked with the stylet diameter and the applicable lead length for which the stylet is
designed. For example, 14-45 indicates that the stylet diameter is 0.014 in (0.356 mm) and that the stylet is designed for use
with 45 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. J-stylet models Model Knob color Diameter Distal end

6052 White 0.356 mm (0.014 in) Blunt
6091 Gray 0.356 mm (0.014 in) Extended-taper, ball-tipped
6094 Blue 0.356 mm (0.014 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 J-shaped 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 6052, 6091, and 6094
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.

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

• Avoid overbending or kinking the stylet.

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