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/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.
5
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.
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.
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)