23
3.
Apply gentle traction to the lead by grasping the labeled area of the lead
body to ensure a secure connection.
CAUTION:
Insert the lead terminal straight into the lead port. Do not bend the
lead near the lead-header interface. Improper insertion can cause insulation or
connector damage.
WARNING:
When connecting the lead to the pulse generator, it is very
important that proper connections are made. The terminal pin must be inserted
beyond the setscrew block to enable a proper connection. Visualization of the
terminal pin insertion indicator beyond the setscrew block may be used to
confirm that the terminal pin is fully inserted into the pulse generator port.
Evaluation of the electrical performance of the lead after connection to the
pulse generator is the final confirmation of full insertion. An improper
connection could result in loss of therapy or inappropriate therapy.
NOTE:
If the lead terminal will not be connected to a pulse generator at the
time of lead implantation, you must cap the connector before closing the pocket
incision. The lead cap is designed specifically for this purpose. Place a suture
around the lead cap to keep it in place.
4.
Giving consideration to patient anatomy and pulse generator size and
motion, gently coil any excess lead and place adjacent to the pulse
generator. It is important to place the lead into the pocket in a manner that
minimizes lead tension, twisting, sharp angles, and/or pressure.
Electrical Performance
1.
Evaluate the lead signals using the pulse generator.
2.
Place the pulse generator into the implant pocket as indicated in the pulse
generator physician's manual. Also refer to the instructions in this manual
("Connection to a Pulse Generator" on page 22).
3.
Evaluate the lead signals by viewing the real-time EGM. Consider the
following:
•
The signal from the implanted lead should be continuous and without
artifact, similar to a body-surface ECG.
•
A discontinuous signal may indicate a lead fracture or an otherwise
damaged lead, or an insulation break that would necessitate lead
replacement.
•
Inadequate signals may result either in a failure of the pulse generator
system to detect an arrhythmia or in an unnecessary delivery of
therapy.
4.
Test for diaphragmatic stimulation by pacing the lead at a high voltage
output, using professional medical judgment to select the output voltage.
Adjust the lead configurations and lead position as necessary. Testing
should be conducted for all lead placements.
Conversion Testing
After obtaining acceptable signals, use the pulse generator to demonstrate
ability to reliably convert ventricular fibrillation (VF) and, when appropriate to
the patient, ventricular tachycardias. This testing involves inducing arrhythmias
