Caution: Federal law (USA) restricts this
device to sale by or on the order of a
physician.
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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
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Description/intended use
The 5873W wrench kit can be used to connect any
Medtronic lead system to any Medtronic device. The
larger, white-handled torque wrench is designed to
slip when overtorqued to prevent damage to the
socket or the setscrew(s). Sufficient tightening of the
setscrew is indicated by a clicking sound as the
torque wrench ratchets on itself. The white-handled
hex wrench is designed to twist when overtorqued to
prevent damage to the socket or the setscrew(s).
Note: The wrenches have the same tip dimensions;
so, it is up to the individual’s preference as to which
wrench to use.
The Model 5873W 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:
•1 #2 White-Handled Torque Wrench
•1 #2 White-Handled Hex Wrench
•Product documentation
Contraindications
To date, there are no known contraindications to the
use of the Model 5873W wrench kit.
Warnings and precautions
Note: Medical procedure warnings and precautions
that pertain to the Medtronic implanted system are
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provided in the manual that is packaged with the
device or on the Medtronic Manual Library website
(www.Medtronic.com/manuals).
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
accessory kit is for single use only and is not intended
to be resterilized.
Instructions for use
Perform the following steps for both the larger,
white-handled torque wrench and the smaller,
white-handled hex wrench. (Refer to the device
technical manual for complete details on connecting
the lead(s) to the device.)
1. Insert the torque/hex wrench into the bisected
grommet as shown in Figure 1 and Figure 2. The
torque/ hex wrench should be left inserted in
each distal grommet until the lead is secure.
This eliminates the “piston effect” (difficulty in
inserting the lead due to compression of
trapped air in the connector port) by allowing a
pathway for venting trapped air when the lead is
inserted. The rubber connector seal maintains
the torque/hex wrench in position.
a. Check that the setscrew(s) are retracted
from the connector port by visual inspection
of the opening. If a setscrew(s) is
obstructing the pathway, rotate the
setscrew(s) counterclockwise one or two
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revolutions until the opening is no longer
obstructed.
Caution: Counterclockwise rotation
beyond this point may disengage the
setscrew from the connector port.
b. Eliminate the “piston effect” when the lead
is inserted by leaving the torque/hex
wrench in the distal grommet.
Figure 1.
Figure 2. Connector port setscrew(s)
preparation using the torque wrench
2. To insert the lead, push the lead into the
connector port until the lead pin is clearly visible
in the pin viewing area.
Note: Lubricate the lead connector end, to ease
lead insertion, with sterile water only.
3. To secure the lead, tighten the setscrew(s) by
turning clockwise as indicated in Figure 3 and
Figure 4. When using the larger, white-handled
torque wrench, complete tightening will be
indicated by a clicking sound. When using the
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smaller, white-handled hex wrench, tighten the
setscrew(s) clockwise, until you feel resistance.
You should be able to turn the setscrews 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 setscrew(s) must be engaged for
pacing to begin. Do not pull on the lead until all
setscrews have been tightened.
Figure 3.
Figure 4. Tightening the setscrew(s) using the
torque wrench
Special notice
Medtronic Wrench Kits (the “Wrench Kits”) consist of
Tools (the “Tools”) to connect a Medtronic lead
system to a Medtronic pulse generator. The Tools
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may easily be damaged by improper handling or use.
Consequently, no representation or warranty is made
that 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.
CE mark of conformity
The following CE mark of conformity applies to the
Model 5873W wrench kit.
1994
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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
Serial number
Sterilized using ethylene oxide
Do not reuse
Do not use if package is damaged
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Table 1. Explanation of symbols on package
labeling (continued)