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INSTRUCTIONS FOR USE
EZ-4
CONNECTOR TOOL
TM
ENGLISH
This literature is intended for use by professionals trained or experienced in device implant and/or follow-
up procedures.
WARNINGS AND PRECAUTIONS
WARNING: For single patient/single procedure use only. Do not reuse, reprocess, or resterilize. Reuse,
reprocessing, or resterilization may compromise the structural integrity of the device and/or lead to device
failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization
may also create a risk of contamination of the device and/or cause patient infection or cross-infection,
including, but not limited to, the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness, or death of the patient.
WARNING: Use caution handling the lead terminal when the connector tool is not present on the lead. Do
not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA
(alligator) clips, ECG connections, forceps, hemostats, and clamps. This could damage the lead terminal,
possibly compromising the sealing integrity and result in loss of therapy or inappropriate therapy, such as
an electrical short circuit within the header.
CAUTIONS:
• The accessory is sterilized with ethylene oxide (EO) gas before final packaging. When the accessory
is received, it is sterile provided the container is intact. If the container is wet, punctured, opened, or
otherwise damaged, return the accessory to Boston Scientific.
• Do not rotate the terminal pin clockwise or counterclockwise more than the recommended maximum
number of turns indicated for the lead model. Continuing to rotate the terminal pin once the helix is
fully extended or retracted (as indicated by fluoroscopy) can damage the lead, cause a conductor coil
break during fixation, cause lead dislodgment, tissue trauma, and/or cause acute pacing threshold to
rise.
• The helix can become unintentionally extended if the connector tool fixation knob is engaged on the
terminal pin and the lead body is rotated counterclockwise while the fixation knob is held stationary.
STERILE
Sterilized using ethylene oxide. Non-pyrogenic.
INTENDED USE
Use with Boston Scientific DF4
• Protect the lead terminal during lead implant, lead revision, and pulse generator replacement
procedures;
• Provide a safe and secure connection between pacing system analyzer (PSA) patient cables and the
lead terminal;
• Guide the stylet into the lead through the stylet funnel;
• For leads with an extendable/retractable helix, rotate the terminal pin clockwise or counterclockwise
to extend or retract the helix.
CLINICAL BENEFIT
The overall clinical benefit for this accessory is derived from the DF4 implantable cardioverter defibrillation
lead with which it is intended to be used.
DESCRIPTION
The EZ-4 Connector Tool Model 7001, used with DF4 leads, provides a safe and secure connection between
pacing system analyzer (PSA) patient cables and the lead terminal.
• The stylet funnel guides the stylet into the lead. (Figure 1 A)
• The fixation knob rotates the terminal pin clockwise or counterclockwise to extend or retract the helix
of an active fixation DF4 lead. (Figure 1 B)
• The plus and minus signs (+ / -) identify the anode (+) and cathode (-) spring contacts for PSA patient
cables or similar monitor cables. (Figure 1 C, D)
1 DF4 refers to the international standard ISO 27186:2010.
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