Removing The Cs Guiding Catheter; Fixating The Lead At The Lead Incision Point; Connecting The Lead To The Active Device - BIOTRONIK Sentus ProMRI OTW BP L Manuel Technique

W CAUTION
Damaging the seal
Ensure that the sealing rings of the lead connector are not damaged by the alligator
clips.
Note: For the models with pre-shaped helix or S-curve, the guide wire or stylet must
be retracted 7 to 10 cm, because the distal lead area does not attain its final position
until the pre-shaped form takes shape.
Safety warnings
Please note the following when conducting intraoperative measurements and tests!
W WARNING
Leakage currents can trigger ventricular fibrillation
Only connect implanted leads to battery-operated measurement and pacing devices
or to devices that are classified as type CF (Cardiac Floating) applied parts complying
with EN 60601, and follow the instructions in the respective technical manuals.
All other line-powered devices connected to the patient must be properly grounded.
W CAUTION
Risk of interrupted pacing
During intracardiac measurements, pacing will be temporarily interrupted.
Suitable measuring devices
BIOTRONIK provides measuring devices calibrated to the properties of the active
devices for measuring pacing threshold, defibrillation threshold and intracardiac
potentials.
The input filter characteristics of the measuring device must be as close as possible to
those of the active device, especially when evaluating the intracardiac signal amplitude.
For further details on performing measurements and tests, please refer to the
technical manuals of the respective testing and measuring devices.
Measuring the threshold
In order to measure the pacing threshold, the pacing rate of the measuring device
should be set slightly higher than the patient's intrinsic rate (if present).
The threshold is the lowest pulse amplitude at which the heart can still be paced.
Measuring intracardiac signal amplitudes
The heart must not be paced externally while measuring the amplitudes of intrinsic
cardiac events.
Target values
Generally, the lead position is considered acceptable if the pacing threshold does not
exceed the maximum values shown below, and the intracardiac signal amplitudes do
not fall below the minimum values shown below:
Parameters for measurement in the coronary vein
Pacing threshold [pulse width max. 0.5 ms]
Amplitude of the intracardiac signal
Note: More details regarding electrophysiological measurements can be found in the
technical manual of the measuring device.
Testing the complete device system
Note: The entire device system must pass a final performance test when the lead has
been connected to the pacemaker or ICD and the active device has been implanted in
a subsequent step.
To do so, communication with the test or programming devices is to be established
via the programming head.

Removing the CS Guiding Catheter

Prerequisite for over-the-wire technique
Perform the following steps if a guide wire is still in the lead:
Step Action
1 Completely remove the guide wire from the lead.
2 Insert a suitable stylet into the lead to stabilize the lead.
The stylet tip should lie 7 to 10 cm from the front of the lead tip so as
not to change the fixation of the lead tip.
Prerequisite for stylet technique
In this case, the stylet is already in the appropriate position inside the lead.
Removing the CS guiding catheter
To remove the CS guiding catheter, proceed as follows:
Step Action
1 First remove the CS guiding catheter with the aid of the slitter tool as
described in the technical manual of the CS guiding catheter.
2 Remove the stylet. While removing the stylet, hold the lead by its
connector to stabilize the lead's position.
3 Now repeat the electrical measurements as described in the
preceding section.
This will help to verify that the lead is still positioned correctly after
removal of the CS guiding catheter.

Fixating the Lead at the Lead Incision Point

Purpose
Fixating the lead at the incision point in the vein or in the muscle minimizes the risk of
dislodgment.
The lead fixation sleeve enables secure and smooth fixation of the lead at its incision
point and decreases the risk of damaging the insulation or coil during fixation.
Prerequisites
Placement of the lead and measurement of the threshold and the intracardiac signals
were successful.
Lead fixation sleeve
On delivery, the lead fixation sleeve with ligature grooves is mounted on the lead.
Instructions for use
Move the lead fixation sleeve back to the puncture or incision site and fixate it with
ligature sutures.
Both ligature grooves must be used in order to securely fixate the sleeve and the lead.
Application example: Fixate the lead at the incision site of the vein using the fixation
sleeve.
Limit values
Max. 3 V

Connecting the Lead to the Active Device

Min. 5 mV
Note
Further information on connecting the lead to the active device's connector may be
found in the technical manual of the designated pacemaker or ICD.
Prerequisites
Placement of the lead and measurement of the pacing threshold and the intracardiac
signals were successful.
Safety warnings
The following precautions are to be observed when connecting the lead to an active
device.
W CAUTION
Damage to the lead connector
Ensure that the set screw(s) in the connector ports of the active device do not impede
the smooth insertion of the connector into the port.
Note: Surgical instruments can cause damage to the lead connector.
Make sure that the lead connector does not come into contact with surgical instru-
ments during implantation.
W CAUTION
Damage to the thread
To avoid cross threading, never fully remove the set screw(s) from their threaded
holes.
W CAUTION
Damage to the thread
Use a screwdriver with torque control!
The screwdriver included with the active device ensures optimal torque for securing
the connector without damaging the thread.
Note: Ensure that connections are clean.
• In case of contamination during implantation: Clean lead connectors with
Allocation for IS-1 connectors
The lead is connected based on the diagram on the housing of the active device.
The labeling is allocated as follows:
Labeling of the lead connector
IS-1, BI, CS
Connecting IS-1 connectors
Proceed as follows to connect the lead to an IS-1 connector:
Step
Note: The IS-1 connector of the CS lead is labeled with "IS-1 BI" and "CS" in order to
avoid confusion with a right ventricular or right atrial lead connector when connecting
the CS lead to a pacemaker or ICD.
Step
Note: For active devices that require a separate silicone plug to be inserted into the
screw hole, proceed as indicated in the technical manual provided with the device.
4
a sterile cloth!
Labeling of the active device's connector port
CS or LV
Action
1 Using the screwdriver (included with the active device), pierce the
center of the silicone plug vertically and insert the tip of the screw-
driver into the set screw located on the header of the active device.
2 Rotate the set screw(s) with the screwdriver counterclockwise until
the connector port of the active device is completely clear.
Further information on connecting the lead to the active device may be
found in the technical manual of the designated pacemaker or ICD.
Action
3 Insert the lead connector into the connector port of the active device.
Please consult the technical manual provided with the device for this
procedure.
4 Tighten the set screw(s) by turning the screwdriver in the clockwise
direction.
5 Check that the connector has been correctly inserted (that it has been
placed deep enough).
The tip of the connector should visibly extrude from the other side of
the header as illustrated in the following figure:
6 Carefully withdraw the screwdriver without retracting the set screw.
When you withdraw the screwdriver, the silicone plug automatically
seals the lead connector port safely.
7 • If the bipolar IS-1 port has only one set screw, then the connection
to the contact ring is established via a spring contact in the
connector port.
• If the bipolar IS-1 port has two set screws, proceed with the
second set screw in the same way as with the first set screw.
8 Do a final visual and mechanical check by pulling on the connection
carefully.