sorin TILDA JT45 Manuel Technique page 5

383376--C_GA_Tilda-TJT_mul.book Page 4 Monday, August 22, 2011 3:31 PM
Note: If the lead is intended for unipolar use, a suitable temporary antipole should be
prepared for measurements and testing prior to connection with the active device and
implantation.
For this purpose, an applicable test housing is usually put in the designated device
pocket and connected to a patient cable.
Safety warnings
Observe the following when measuring the thresholds and the intracardiac potentials!
W WARNING
Leakage currents can trigger ventricular fibrillation.
Only conduct electrophysiological measurements or temporary pacing through
implanted leads with devices of safety class CF (Cardiac Floating) according to
EN 60601 or with battery-operated measuring and pacing devices.
All other line-powered devices connected to the patient must be properly grounded.
Suitable measuring devices
Measuring devices that are adapted to the properties of active implants are provided to
measure the threshold and determine the intracardiac potential.
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.
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.
W CAUTION
Risk of intermittent pacing
During intracardiac measurements, pacing will be temporarily interrupted.
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:
Atrium Ventricle Measurement condition
Pacing threshold Max. 1.5 V Max. 1.0 V Pulse width: 0.5 ms
Intracardiac signal Min. 1.5 mV Min. 5 mV
Note: A recently implanted lead can stimulate the myocardium.
This can result in a temporary change in the measured values.
Wait until the measured values have become sufficiently stabilized. In general, this
occurs 5 to 10 minutes after fixation.
Fixating the Lead at the Entry Site
Purpose
Fixating the lead at the entry site in the vein or in the muscle minimizes the risk of
dislodgment.
Prerequisites
Placement of the lead and measurement of the threshold and the intracardiac signals
was successful.
W CAUTION
Tensile force on the endocardial fixation or impediment of the heart valve
The distance between the fixations at the tip and at the entry site of the lead has to be
dimensioned in such a way that the following conditions are met:
• Contraction of the heart and other movement of the patient should not put tension
on the fixation.
• The tricuspid valve's function may not be hindered by the lead.
Lead fixation sleeve
The lead comes with a lead fixation sleeve which has ligature grooves and ligature tabs.
The lead fixation sleeve enables secure and smooth fixation of the lead at its entry site
and decreases the risk of damaging the insulation or coil during fixation.
Example: Fixate the lead at the incision site of the vein using the fixation sleeve.
Connecting the Lead to the Active Device's IS-1 Connector
Note
Further information on the topic of connecting the lead the IS-1 connector on the active
device may be found in the technical manual of the designated pacemakers or ICDs.
Prerequisites
Placement of the lead and measurement of the threshold and the intracardiac signals
was successful.
Procedure
Proceed as follows to connect the lead to an IS-1 connector:
Step Action
1 Remove the stylet and the stylet guide from the lead.
2 Using the screwdriver (included with the active device), pierce the slit in the
silicone plug vertically in the middle and insert the blade of the screwdriver
into the set screw located on the header of the active device.
3 Rotate the screwdriver counterclockwise until the connector port of the active
device is completely clear, as applicable.
Further information on the topic of connecting the lead to the IS-1 connector
on the active device may be found in the technical manual of the designated
pacemakers or ICDs.
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.
W CAUTION
Damage to the thread
To avoid cross threading, never fully remove the set screw(s) from their threaded
holes.
Step Action
4 Insert the lead connector into the port of the active device.
Please consult the technical manual provided with the device for this proce-
dure.
5 Tighten the set screw(s) by turning the screwdriver in the clockwise direction.
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.
Step Action
6 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:
7 Carefully withdraw the screwdriver without retracting the set screw.
When you withdraw the screwdriver, the silicone plug automatically seals the
lead connection safely.
8 • If the bipolar IS-1 port has only one set screw, the connection to the
contact ring is already established via a spring contact in the port while
introducing the connector.
• 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.
9 Do a final visual and mechanical check by pulling on the connection carefully.
Note: For active devices that require a separate silicone plug, proceed as indicated in
the technical manual provided with the respective device.
4
Lead Placement
Depending on the implantation site and patient's anatomy, the lead may be longer than
required to connect the active device and the lead position in the heart.
In this case, we recommend placing the excess lead length around the active device in
loose loops.
Schematic diagram: Placing the lead around the active device.
W CAUTION
Damage to the lead as a result of mechanical overstress
When positioning the lead, make sure it is not knotted, twisted or bent.
W CAUTION
Damage to the lead as a result of mechanical overstress
If the active device is implanted underneath the pectoral muscle, ensure that no parts
of the lead lie between the housing of the device and the ribs.
Otherwise local pressure and chafing can damage the lead insulation.
Pinching between clavicle and 1st rib
To prevent mechanical overstress causing the failure of pace/sense functions, make
sure that the lead does not become pinched between the clavicle and the first rib after
implantation.
Appendix
Technical Data
Basic data
Model types TILDA T 53, TILDA T 60, TILDA JT 45, TILDA JT 53
Application • Fixation in the right ventricle
(TILDA T 53, TILDA T 60):
Ventricular sensing and pacing
• Fixation in the right atrium
(TILDA JT 45, TILDA JT 53):
Atrial sensing and pacing
Fixation Passive (3 tines)
Connections 1 x IS-1, bipolar
Insulation material Silicone
Lead length TILDA T 53
TILDA T 60
TILDA JT 45
TILDA JT 53
Suitable introducer sheath 7 F
Lead connector
Connecting system IS-1 Suitable for active devices
with an IS-1 connector
Polarity Bipolar
Tip electrode
Shape Lens (flat spherical segment)
Material Pt/Ir
Surface (size) 2
1.3 mm
Surface, structure Iridium, fractal
Steroid
Active agent Dexamethasone acetate
Quantity 0.75 mg
Steroid bonding agent Silicone
53 cm
60 cm
45 cm
53 cm