Medtronic 5873C Technical Manual

5873C
Service kit
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/intended use

The Model 5873C Service kit can be used to connect any compatible Medtronic lead system to any Medtronic device.
The Model 5873C is intended for single use only.

Package contents

Dispose of all single-use accessories according to local environmental requirements. The accessories are supplied sterile. Each package contains the following items:
Two #2-56 setscrews
Two #2 white-handled hex wrenches
One #4 hex wrench
Two #6 hex wrenches
Product documentation

Contraindications

To date, there are no known contraindications to the use of the Model 5873C Service 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 device or on the Medtronic Manual Library website (www.Medtronic.com/manuals).
External defibrillation equipment – Keep external defibrillation equipment nearby for immediate use during the implant procedure and whenever arrhythmias are possible or intentionally induced.
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Handling the service kit – Take care not to cross-thread or strip the screws.
Inspecting the sterile package – Inspect the sterile package with care before opening it.
Contact a Medtronic representative if the seal or package is damaged.
Do not use the product after its expiration date.
Sterilization – Medtronic has sterilized the package contents with ethylene oxide before shipment. This device is for single use only and is not intended to be resterilized.
Verifying device operation – Before connecting the lead, verify proper device operation with a Medtronic pacing system analyzer or similar testing device.

Instructions for use

Securing the lead into a device with an external device boot that requires suturing (see also the device technical manual):
1. Insert the lead terminals fully into the device boot. The lead pin should be clearly visible at the end of the viewing port. See Figure 1.
Figure 1.
2. Use the white-handled wrench to penetrate the rubber and engage the setscrew in place in the device.
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3. To secure the lead, tighten the setscrew by turning the wrench clockwise until resistance is felt. You should be able to turn the setscrew at least 1/2 turn before resistance is felt. If the setscrew turns more than one complete revolution without resistance, the lead is not properly inserted. If this occurs, back the setscrew out and reinsert the lead. (The white-handled wrench is designed to slip when overtorqued to prevent damage to the socket or the setscrew.) See Figure 2.
Figure 2.
4. Tighten the rubber boot with one non-absorbable ligature (synthetic) placed in the groove provided.
Securing the lead into a device with internal sealing rings that do not require suturing (see also the device technical manual):
Note: Spaced sealing rings are molded into the lead
connector end and are designed to ensure a tight fit; no sealant is required. Should the physician need to lubricate the lead, sterile water may be used.
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1. Push each lead end into its respective connector until the lead pin is clearly visible at the end of the pin viewing area. If inserting the lead is difficult, determine if the setscrew is too far in by looking into the lead port. If the setscrew is too tight, insert the hex wrench and turn the setscrew counterclockwise only until the lead pin hole is unobstructed. See Figure 3.
Figure 3.
Caution: Counterclockwise rotation beyond
this point may disengage the setscrew from the connector block. Lubricating the lead end with sterile water may also facilitate lead insertion.
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Figure 4.
2. To engage the setscrews captured in the connector block, pass the hex wrench tool through the pre-pierced holes in the rubber grommet. See Figure 4.
3. To secure the leads, tighten the setscrews by turning clockwise until resistance is felt. The setscrews must be engaged before pacing will begin. Traction should not be applied to the lead until the setscrews have been tightened; and then only gentle traction should be used.
Caution: Care should be taken not to damage the grommets when inserting the hex wrench.
Do not overtighten the screw. The white hex wrench is designed to slip when overtorqued to prevent damage to the socket or the setscrew. Bending the wrench may break it. Do not use other hex wrenches since they have torque capabilities greater than is intended for this connector.
Two hex wrenches are provided with the device. Wrenches may be left inserted in the device until leads are secured. The rubber connector seal maintains wrench position.
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Securing the device using suture holes
The device has suture holes that may be used to secure the device in the subcutaneous pocket using normally available surgical needles.
See the device technical manual for more information.

Special notice

Medtronic Service Kits (the “Service Kits”) consist of Connector means (the “Connectors”) and Tools (the “Tools) to connect a Medtronic lead system to a Medtronic Pulse Generator. The Connectors are implanted with the lead system and the pulse generator in the extremely hostile environment of the human body. Connectors and Tools may easily be damaged by improper handling or use. Consequently, no representation or warranty is made that the failure or cessation of function will not occur.

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.
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CE mark of conformity

The following CE mark of conformity applies to the Model 5873C service kit.
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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.
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 1. 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
Setscrew
#2 White handled hex wrench
#6 Hex wrench
#4 Hex wrench
Use with
Implantable device
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Medtronic, Inc.
*M971363A001*
710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000
Authorized Representative in the European Community
Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands +31 45 566 8000
Europe/Middle East/Africa
Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland +41 21 802 7000
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 +1 905 460 3800
Technical manuals
www.medtronic.com/manuals
© 2017 Medtronic M971363A001 A 2017-08-02
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