En • English - sorin TILDA JT45 Manuel Technique

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en • English
Description
Design and Properties of the Lead
Lead body
The lead body of bipolar leads consists of two coaxial coils, each of which is made up of
several parallel wires.
The coils make up the conduction to the tip and ring electrodes and are insulated
against each other as well as on the outside with silicone.
Electrical properties
Pacing and sensing of the bipolar leads occurs between the distal pole and the ring
electrode.
Fixation
The lead tip has a tine made of silicone for passive fixation of the lead in the trabeculae
of the right ventricle or atrium.
Lead connection
The lead connector is produced according to the international standards ISO 5841-3:
2000 and EN 50077:1993 and is labeled 'IS-1 BI'.
Note: Pacemakers and ICDs whose connectors do not correspond to the above-
mentioned standards may only be connected to this lead using a suitable adapter.
For further information about the compatibility of the lead connectors, please contact
the manufacturer of the active device.
Steroid collar
With these leads, the lead tip has a steroid collar in the form of a rubber silicone ring
that contains dexamethasone acetate.
Intended Use and Indications
Intended use
This lead is only intended for the following use:
• The permanent, transvenous implantation in the right ventricle (straight design) or
atrium (J-shaped design)
• As components of an integrated system for long-term heart pacing, together with a
suitable implantable pacemaker or ICD
These leads fulfill all clinical requirements for this.
W CAUTION
Resterilization and reuse
These leads are exclusively intended for single use. Resterilization and reuse are
prohibited.
Indications
Together with an active device (ICD or pacemaker), this lead constitutes a device
system. The indications and contraindications for the lead are similar to those of the
respective ICD or pacemaker.
For the indications of an ICD or pacemaker therapy, we recommend following the
respective current guidelines of the Heart Rhythm Society (HRS), the American College
of Cardiology (ACC), the American Heart Association (AHA), and the German Cardiac
Society (Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung), as well
as those of other national cardiology associations.
Packaging, Sterility, Storage, and Disposal
Box and label
The lead is delivered in an box bearing a quality control seal and a product information
label.
The label contains the following information about the lead:
• Name of model
• Technical properties and data
• Serial number
• Use by date
• Details on sterility
• Storage information
Sterility
The lead and its accessories are sealed in two blisters, one within the other, and steril-
ized with ethylene oxide. As a result, the inner blister is also sterile on the outside.
W CAUTION
Damage to a blister puts the sterility of the lead into question
Before opening, inspect the blister for signs of damage to ensure sterility.
Do not use a lead if you are unsure of its sterility.
Storage
The following storage conditions must be maintained:
Storage temperature Maximum storage duration
Normal conditions 5 - 25°C 2 years
Short-term exception 5 - 50°C 1 month
W CAUTION
Improper storage
If the specified time period and temperature range for storage are exceeded, then the
documented properties of the lead can no longer be guaranteed. Technical malfunc-
tions - as well as decreased effectiveness of the steroid in the case of steroid-eluting
leads - may result.
Disposal
An explanted lead can and/or must be disposed of as contaminated medical waste in
an environmentally friendly and proper manner.
The lead does not contain any materials which require any further provisions.
Safety
Contraindications
Contraindications
Implantation of this lead is contraindicated in the following cases:
• If the lead is to be guided into the ventricle: mechanical tricuspid valve prostheses
or severe tricuspid valve disease
• If the lead is to be guided into the atrium: after intervention in atrial appendage
• Intolerance against dexamethasone acetate
Together with an active device (ICD or pacemaker), this lead constitutes a pacing
system. The indications and contraindications for the lead are similar to those of the
respective ICD or pacemaker.
Medical and Technical Complications
Medical complications
Potential medical complications of using implantable pacemakers or ICDs include the
following:
• Formation of fibrotic tissue
• Thrombosis, embolism
• Elevated thresholds
• Foreign body rejection phenomena
• Lead erosion
• Pericardial tamponade
• Valvular damage
• Muscle and nerve stimulation
• Infection
• Pacemaker-induced arrhythmias (some forms of which can be life-threatening)
Technical complications
The technical function of the device system may be impaired by:
• Incorrect lead implantation
• Lead dislodgment
• Lead fracture
• Insulation defect
• Battery depletion or component failure of the active device
Potential adverse events and corrective measures
Some potential adverse events and corrective measures are listed in the table below.
Problem Possible cause Corrective measure
Loss of pacing or Improper connection between Properly re-connect the lead to
sensing lead and the active device the active device.
Lead dislodgment Reposition lead
Lead fracture Replace lead
Insulation defect Replace lead
Significant Excessive fibrotic tissue Adjust pulse energy;
worsening of the formation reposition or replace the lead
threshold
Risky Therapeutic and Diagnostic Procedures
Overview
The following therapeutic or diagnostic procedures can pose a risk to the health or life
of patients with implanted leads:
• External defibrillation
• Interaction between a pacemaker and an Implantable Cardioverter Defibrillator (ICD)
2
• Ultrasound therapy and diathermy
• Radiation therapy
• Transcutaneous Electrical Nerve Stimulation (TENS)
• Lithotripsy
• Magnetic resonance imaging
• Electrocautery
• Hyperbaric oxygen therapy
• Electrophysiological ablation
• High frequency surgery
Potential risks
The table below provides an overview of procedures that are especially risky in con-
junction with implanted leads.
Procedure Type of danger
Defibrillation (external or with ICD) • From functional disruption to complete
failure of the active device
• Diathermy • Heating of the lead (burning of the
myocardium)
• Electrophysiological ablation
• Induction of ventricular fibrillation
• High frequency surgery
• From functional disruption to complete
• Electrocautery
failure of the active device
Ultrasound diathermy • Heating of the lead
Transcutaneous Electrical Nerve • Heating of the lead (burning of the
Stimulation (TENS) myocardium)
• Induction of ventricular fibrillation
Lithotripsy • Mechanical or electrical effect on the
active device and lead
• Damage to the active device
Magnetic resonance imaging • Heating of the lead
• Damage to the circuitry of the active device
• Change of position of the lead or the
active device
• Pulse inhibition, asynchronous and/or trig-
gered pulse delivery by the active device
• Lead dislodgment
Additional information
In many cases, the dangerous effect is based on the induction of electrical voltages in
the lead through electromagnetic fields of the listed procedure.
Note: For additional information about risky procedures and possibilities of risk
mitigation, refer to the user manuals of the respective pacemakers or ICDs.
Electrophysiological ablation
In case of electrophysiological ablation, we recommend switching off the pacemaker or
ICD beforehand, keeping as much distance as possible between the ablator and the
lead, and performing a full follow-up prior to restarting the device system.
Electrical and Electromagnetic Safety
Electrical safety
Implanted leads are a direct electrical connection to the myocardium.
Therefore, it is important for the safety of the patient that electrical energy is not
conducted to the lead (other than the pulses from the active device), neither by direct
contact nor indirectly by electromagnetic induction.
W WARNING
Risk of death due to induction of ventricular fibrillation
Ensure that the connector pins of the implanted lead never touch any electrically
conducting or wet surfaces, including human hands or skin.
Electromagnetic induction
A lead can receive electromagnetic energy as an antenna would and cause electrical
voltages at the lead tip and connector.
This can induce ventricular fibrillation in some cases, as well as damage or otherwise
affect the active device and, if the energy dose is high enough, even damage the myo-
cardium.
Note: For information about therapy or diagnosis procedures that pose a potential
risk, refer to the appropriate section of this manual (See Risky Therapeutic and
Diagnostic Procedures, p. 2).
Additional information
For further information about this topic and possibilities of risk minimization, refer to
the manuals for the designated ICDs or the pacemakers.