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Impulse Dymanics OPTIMIZER Smart System - Connecting the Implanted Leads to the OPTIMIZER Smart IPG

Impulse Dymanics OPTIMIZER Smart System
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18
7.4 Verifying Lead Placement
Note: The Programmer Wand of the OMNI Smart Programmer is not sterile and cannot
be sterilized. The Programmer Wand needs to be placed in a sterile cover before it can be
brought into the sterile field.
Place the Programmer Wand over the IPG. Ask the person operating the Programmer
(outside the sterile field) to measure the lead impedances and make sure they are
adequate.
Note: Any significant lead impedance deviation at a subsequent check-up may be a sign
of lead displacement or indicative of another problem requiring further investigation.
Once the leads are in place, secure each lead to its respective lead anchor sleeve. Clean
the lead body with sterile saline before you secure the anchoring sleeve to the lead.
Secure the anchoring sleeve with two non-absorbable ligatures and tighten gently -- Do
Not Over-Tighten.
7.5 Connecting the Implanted Leads to the OPTIMIZER Smart IPG
Important considerations:
When tightening or loosening the set screws, always insert the tip of the torque
wrench fully and in line with the set screw. Do not insert the wrench into the set
screw at an angle.
Prior to inserting the IS-1-BI lead connectors, verify visually that none of the set
screws protrude into any of the IPG header cavities (please refer to the diagram on
the IPG). Back off any set screw found protruding beyond the wall into the header
cavity by turning it back with the Allen wrench in a counter-clockwise direction.
Turn the set screw just enough so that its tip is no longer inside the header cavity.
Do not back the set screw completely out of the terminal block.
Under no circumstances may items other than the implantable lead connectors (or
Port Plug) be introduced into the port of the IPG connector terminal.
Note: Provided the connectors are correctly installed, the connector retention force in the
terminals is at least 10 N.
Clean the lead plugs with sterile distilled water (if using saline, wipe the plugs dry with a
surgical sponge afterwards) and fully insert each plug into the respective connector
terminal at the IPG. Observe that the male ends of the lead plugs are inserted beyond the
respective lead tip terminals. Tighten the set screws using the sterile #2 Allen torque
wrench included in the IPG package. Turn the torque wrench clockwise until there is a
distinct clicking sound/feel. This feature prevents over-tightening of the set screw.
Carefully apply traction on the strain relief of each lead to make sure that the leads are
securely anchored in the terminal. Finally, tighten the set screws securing the contact
between the rings of the plugs and the corresponding parts of the terminal block.
Insert the Port Plug provided with the OPTIMIZER Smart IPG package into the “A” port
of the IPG and gently tighten the ring set screw only. The protruding length of the Port
Plug may be shortened, but it is recommended to leave at least 1 cm length protruding
from the IPG to enable future removal of the Port Plug if it becomes necessary to connect
an atrial sensing lead.
Warning: DO NOT tighten the tip set screw or damage to the Port Plug may occur!

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