Table Des Matières; Description; About This Technical Manual; Design And Properties Of The Lead - BIOTRONIK Sentus ProMRI OTW BP L Manuel Technique

en • English
Table of Contents
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About this Technical Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Design and Properties of the Lead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Intended Use, Indications and Contraindications . . . . . . . . . . . . . . . . . . . . . . . . .1
Packaging, Sterility, Storage, and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Medical and Technical Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Risky Therapeutic and Diagnostic Procedures and Environmental Influences .2
Electrical and Electromagnetic Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Handling and Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Basic Advice and Precautionary Measures for the Implantation . . . . . . . . . . . . .2
Information on the Steroid Collar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Opening the Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Accessing the Vein and Inserting the Lead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Probing the Ostium of the Coronary Sinus and Venogram . . . . . . . . . . . . . . . . . .3
Positioning the Lead in the Coronary Venous System . . . . . . . . . . . . . . . . . . . . .3
Fixating the Lead in the Target Vein. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Intraoperative Measurements and Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Removing the CS Guiding Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Fixating the Lead at the Lead Incision Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Connecting the Lead to the Active Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Lead Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

1 Description

About this Technical Manual

Target group
This technical manual is targeted at medical personnel, cardiologists, cardiac surgeons
and electrophysiologists who are familiar with the following topics:
• The use of implantable triple-chamber pacemakers or ICDs and the respective
leads
• The implantation methods required for this as well as the associated risks and
possible complications
This technical manual
This technical manual is either included in hard copy form in the product packaging or
can be downloaded as a file from the Internet. In the latter case, the package will
include an insert with the URL instead of the technical manual in hard copy form.
Note: Keep this technical manual for later use.
Observe other manuals
Please also observe the technical manuals and accompanying documents for devices
combined with this lead (ICD, pacemaker, additional leads) and for devices and acces-
sories used during implantation.

Design and Properties of the Lead

Lead body
The lead body consists of a coil made up of several parallel wires.
These wires establish the electrical connections between the contacts of the connector
and the tip electrodes and ring electrodes simultaneously.
The insulation is composed of silicone and has a coating to improve gliding properties.
Pacing and sensing
Bipolar pacing and sensing occurs via a tip electrode and a ring electrode.
The contact surfaces of the tip and ring electrodes are equipped with a fractal iridium
coating.
Lead connection
This lead features a bipolar IS-1 connector.
This connector is designed as a bipolar connector according to the international
standards ISO 5841-3 and EN 50077 and is labeled as "IS-1 BI" and "CS".
Lengths
Three lengths are available: 77 cm, 87 cm, and 97 cm.
Fixation
Atraumatic fixation in a left ventricular coronary vessel is performed as follows:
• Model "QP S" or "BP S":
- With a silicone thread between the tip electrode and the ring electrode, which
wedges itself directly between the vessel walls
- Suitable for coronary vessels with small internal diameters
en • English
• Model "QP J" or "QP L" or "BP L":
- With a pre-shaped two-dimensional J-curve (QP J) or S-curve (QP L or BP L) of
the distal area
- Suitable for coronary vessels with an internal diameter that is larger than the
lead diameter.
Positioning
This LV lead can be guided into the target vein with a stylet or using the over-the-wire
technique.
Seal for the guide wire
A seal at the lead tip prevents blood from penetrating the inner lumen of the lead.
The seal is designed so that the guide wire can be introduced from either the proximal
or distal end of the lead.
Steroid collar
The lead has a steroid collar in the form of a rubber silicone ring that contains
dexamethasone acetate.
Suitable stylets
Do not use any stylets other than those included in the package or that are explicitly
designated as suitable for this lead.
These stylets have the following features:
• Specially shaped distal end that ensures that the stylet reaches the lead tip
• Shaping near the handle to lock the stylet in the lead, which preserves the
prestress between the stylet and the lead
Suitable implantation accessories
BIOTRONIK recommends that a combination of an inner and an outer CS guiding
catheter be used for implantation of Sentus OTW QP or Sentus OTW BP.
The Selectra LV lead delivery system is a combination of implant accessories and
various CS guiding catheters that was specifically designed for LV leads.

Intended Use, Indications and Contraindications

Intended use and indications
In combination with a compatible implantable triple-chamber pacemaker or ICD, this
lead is indicated for the following:
• Permanent, transvenous implantation in the coronary venous system via the
coronary sinus of the left side of the heart
• Permanent sensing and pacing of the left ventricle
Left ventricular pacing is indicated for patients who need ventricular resynchronization.
It can also be an alternative if the use of ventricular endocardial leads is contraindi-
cated due to an artificial tricuspid valve.
The implanting surgeon is responsible for choosing the fixation and length variant.
Contraindications
Implantation of this lead is contraindicated in the following cases:
• Existing epicardial leads for left atrial pacing
• Coronary sinus anomalies
• Damage to tissue in the coronary sinus area resulting from infarction
• Venous anomalies that exclude transvenous implantation of leads
• Intolerance to dexamethasone acetate
Guidelines
For the indications and contraindications of an ICD or pacemaker therapy, we moreover
recommend following the respective current guidelines of the Heart Rhythm Society
(HRS), the American College of Cardiology (ACC), the American Heart Association
(AHA), the European Society of Cardiology (ESC), and the German Cardiac Society
(DGK), as well as those of other national cardiology associations.

Packaging, Sterility, Storage, and Disposal

Box and label
The lead is delivered in a box bearing a quality control seal and a product information
label.
The label contains the following information about the lead:
• Model type
• 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
Risk to sterility due to damaged blister
To ensure sterility, the container should be checked for damage prior to opening.
Do not use a lead if you are unsure of its sterility.
1
W CAUTION
Resterilization and reuse
This lead and the provided accessories are intended for single use exclusively. Reuse
of leads or accessories can result in infections, embolisms and damage to the
product.
Resterilization and reuse are prohibited.
Storage
The following storage conditions must be maintained:
Storage temperature Maximum storage duration
5 - 55°C 2 years
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 must be disposed of as medical waste in an environmentally friendly
and proper manner.
The lead does not contain any materials which require any further provisions.

2 Safety

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 pacing thresholds
• Foreign body rejection phenomena
• Lead erosion
• Pericardial tamponade
• Valvular damage
• Damage of vessels, nerves or the lung during the placement of the venal access by
puncture.
• Muscle and nerve stimulation
• Infection
• Pacemaker-induced arrhythmias (some forms of which can be life-threatening)
Technical complications
The following could result in technical malfunctions of the device system, which
consists of pacemaker or ICD and leads:
• Incorrect lead implantation
• Lead dislodgement
• Lead fracture
• Insulation defect
• Battery depletion or component failure of the active device
Potential adverse events and corrective measures
Some of the 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 connect the lead to
sensing lead and the active device the active device.
Lead dislodgement Reposition lead.
Lead fracture Replace lead.
Insulation defect Replace lead.
Significant Excessive fibrotic tissue Adjust pulse amplitude and
worsening of the formation pulse width; reposition or
threshold replace the lead.
405634--D