sorin TILDA JT45 Manuel Technique page 4

383376--C_GA_Tilda-TJT_mul.book Page 3 Monday, August 22, 2011 3:31 PM
Preventing leakage currents
Leakage currents to the active device, the lead or directly to the myocardium must be
absolutely prevented, as they can trigger lethal arrhythmias.
Line-powered devices operated in the patient's vicinity must always be grounded
according to regulations. Otherwise, there is a danger of leakage currents caused by
such devices being conducted to the myocardium via the lead.
The lead must only be connected to safety class CF (Cardiac Floating) devices comply-
ing with EN 60601 or to battery-operated measurement and pacing devices; follow the
instructions in the respective technical manuals.
Handling and Implantation
Implantation: Basic Instructions and Safety Measures
• Always implant the lead using X-ray monitoring.
• Monitor the ECG carefully during implantation and keep external defibrillation
equipment and a pacing system analyzer on standby.
• Handle the lead with care. Any strong application of force, such as bending,
stretching and kinking, can permanently damage the lead.
• Do not perforate or damage the lead's insulation or coils when working with the
stylet, tweezers, or other surgical instruments.
• Ensure that the lead fixation sleeve is close to the connector, so that insertion and
positioning of the lead is not hindered.
• Always use the supplied lead fixation sleeve when implanting the lead. This will
reduce the risk of lead dislodgment and protect the lead body from possible
damage from a ligature.
• Coagulated blood may impair or block maneuverability of the stylet inside the lead.
— Ensure that no blood reaches the interior of the lead on, or with, the stylet.
— To the extent possible, prevent blood from entering the lead in other ways.
— If needed, use a spare stylet or replace the lead with a new one.
• The use of unsuitable stylets or improper handling of the stylet can result in
damage to the lead (such as detachment of the silicone insulation at the ring
electrode or separation of the contact ring from the lead connector).
This would result in a malfunction or failure of the lead.
— Use only a suitable stylet for the respective lead (based on length and
diameter). Additional information can be found in the Appendix.
— Never use extremely curved or bent stylets.
Note: Suitable spare stylets are included in sterile packaging with the lead.
Information about the Steroid Collar
Intended medical use
The lead tip has a steroid collar in the form of a rubber silicone ring that contains
dexamethasone acetate.
The intended effect is to decrease the inflammatory processes after implantation and
the inflammation-related postoperative threshold increase (lead maturation behavior).
W CAUTION
Premature elution of the steroid
Do not wipe or immerse the lead in liquids any more than absolutely necessary.
Long-term performance of the steroid eluant
The greater the elapsed time since the implantation, the greater the eluted amount of
previously present steroid.
Over time, the lead ingrowth approaches that of the same type of lead without steroid,
which must be considered in the case of possible repositioning.
Opening the Package
Packaging composition
The lead and its accessories are packaged in a double blister and sterilized with ethyl-
ene oxide gas. As a result, the inner blister is also sterile on the outside.
You can remove the inner blister by using a standard aseptic technique and place it in
the sterile field.
How to open the package
To open, proceed as follows:
Step Figure Action
1 In a non-sterile area:
Open the outer blister by peeling
the paper seal in the direction of
the arrow.
en • English
W CAUTION
Risk to sterility
The inner blister must not come into contact with non-sterile instruments nor be
touched by persons who are not wearing sterile gloves.
Step Figure Action
2 In the sterile area:
• Remove the inner, sterile
blister by using the gripping
tab.
• Open the inner blister by
peeling the paper seal in the
direction of the arrow.
Obtaining Access to the Vein and Inserting the Lead
Preparing the lead
After all implantation preparations have been made, proceed as follows:
Step Action
1 Push the premounted lead fixation sleeve close to the lead connector.
2 Ensure that a straight stylet is completely inserted into the lead.
Venous access - two methods
There are two options for inserting the lead into the vein:
Either Method A Incision of the cephalic vein
Or Method B Puncturing the subclavian vein
Method A
Through the cephalic vein:
Step Action
1 Prepare the cephalic vein.
2 Open the vein.
3 Carefully insert the tip of the vein pick provided into the lumen of the vein.
4 Raise the vein pick carefully.
5 Insert the lead into the vein through the opening.
Method B
Through the subclavian vein:
• Use a suitable lead introducer set.
Interrupt the procedure if the lead cannot be easily inserted into the lead introducer
set and check whether the lead introducer set is appropriate for the lead.
• Please consult the technical manual included with the lead introducer set.
After you have punctured the vein, advance the lead through the catheter of the intro-
ducer into the vein.
W CAUTION
Risk of pacing and sensing loss due to excessive mechanical stress of the lead
Make sure the lead does not become pinched between the clavicle and the first rib
after implantation.
Positioning and Fixating the Lead
Prerequisite
Access to the vein has been obtained through incision of the cephalic vein or puncture
of the subclavian vein, and the lead tip has been inserted.
3
Atrium or ventricle
The subsequent procedure varies according to where the lead is to be positioned and
fixated:
Either In the atrium J-shaped lead
Or In the ventricle Straight lead
In the atrium
Positioning and fixation of a J-shaped lead in the atrium:
Step Action
1 Advance the lead tip into the right atrium.
2 Retract the straight stylet a bit so that the distal end of the lead takes on
a J shape.
The degree of bending can be controlled by the retracted length of the stylet.
3 Using X-ray monitoring, push the lead until its tip reaches the atrial appendage
or the atrial wall and can be anchored in the trabeculae.
4 After successfully anchoring the lead tip, retract the stylet completely from
the lead.
5 If excessive force is required to remove the stylet from the lead:
• Do not reposition the lead any further.
• The lead must be replaced.
In the ventricle
Positioning and fixation of a straight lead in the ventricle:
Step Action
1 Carefully advance the lead tip through the tricuspid valve into the right
ventricle.
The stylet can be pulled back very slightly for this purpose.
2 Using X-ray monitoring, push the lead in until the lead tip reaches the myocar-
dium and can be anchored in the trabeculae.
3 After successfully anchoring the lead tip, retract the stylet completely from
the lead.
4 If excessive force is required to remove the stylet from the lead:
• Do not reposition the lead any further.
• The lead must be replaced.
Note
W CAUTION
Avoid excessive pressure on the lead
Temporary or sustained excessive pressure exerted by the lead tip on the myocar-
dium can cause short-term or long-term lead flaws, pressure necroses, myocardial
perforations, irritation to the tricuspid valve or other unwanted complications.
• Apply pressure carefully when fixating the lead tip.
• Consider the following two aspects when elongating between distal and proximal
fixation of the lead:
— The patient's own movement and heart contractions should not exert tensile
force on the fixation.
— The constant pressure applied to the myocardium by the lead tip should
remain as low as possible.
Measuring Pacing Threshold and Intracardiac Signals
Temporary contact with the lead
To obtain short-term measurements of pacing thresholds and the intracardiac poten-
tial, clamp an alligator clip to the connector pin through the opening in the stylet guide.
The contact ring of the bipolar lead connector is directly accessible for an additional
alligator clip.
W CAUTION
Damaging the seal
Ensure that the sealing rings of the lead connector are not damaged by alligator clips.
This applies especially when connecting an alligator clip to the contact ring of the
lead connector.
Clamping an alligator clip to the connector pin: