BIOTRONIK ProMRI Protego DF-1 S Technical Manual
Protego DF-1 S ProMRI
Tripolar ICD lead with active fixation
Technical Manual
414086
Revision: E (2015-05-28)
®
© BIOTRONIK SE & Co. KG
All rights reserved.
Specifications subject to modification, revision and improvement.
0123 2015
Index 414086Technical ManualProtego DF-1 S
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel +49 (0) 30 68905-0
Fax +49 (0) 30 6852804
sales@biotronik.com
www.biotronik.com
2 Table of Contents
Table of Contents
Table of Contents
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
About this Technical Manual . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Design and Properties of the Lead . . . . . . . . . . . . . . . . . . . . . 4
Intended Use, Indications and Contraindications . . . . . . . . . 5
Packaging, Sterility, Storage, and Disposal . . . . . . . . . . . . . . 6
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Medical and Technical Complications . . . . . . . . . . . . . . . . . . 7
Risky Therapeutic and Diagnostic Procedures and
Environmental Influences . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Electrical and Electromagnetic Safety . . . . . . . . . . . . . . . . . 10
Handling and Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Implantation: Basic Instructions and Safety Measures . . . 11
Information on the Steroid Collar . . . . . . . . . . . . . . . . . . . . . 12
Opening the Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Checking the Function of the Fixation Screw before
Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Accessing the Vein and Inserting the Lead . . . . . . . . . . . . . 15
Positioning and Fixating the Lead. . . . . . . . . . . . . . . . . . . . . 16
Intraoperative Measurements and Tests . . . . . . . . . . . . . . . 18
Fixating the Lead at the Lead Incision Point . . . . . . . . . . . . 20
Connecting the Lead to the Active Device . . . . . . . . . . . . . . 21
Lead Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Disclaimer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3 Description
1 Description
Description1414086Technical ManualProtego DF-1 S
About this Technical Manual
Target group This technical manual is targeted at medical personnel and cardiologists who are
familiar with the following topics:
• The use of ICDs and the respective leads, tachycardia therapy
• 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 a hard copy of the technical manual.
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 accessories used during implantation.
4 Description
Design and Properties of the Lead
Product name Protego DF-1 S
Model Length
Protego DF-1 S 60 61 cm
Protego DF-1 S 65 65 cm
Protego DF-1 S 75 75 cm
Features at a glance
Lead body The lead body consists of coils and cables that form the electrical connection
Electrical properties The fixation screw is electrically active and forms the distal pole (tip electrode) of
• Fixation: Extendable/retractable fixation screw, electrically active
• Shock coil: 1 x RV
• Bipolar sensing and pacing in the ventricle
• Insulation surface coating improves the lead body's gliding properties
• Steroid collar on the lead tip reduces inflammatory processes and undesired
increases in threshold after implantation
• Connectors:
—1 x DF-1
—1 x IS-1 (bipolar)
between the contact pin on one hand and tip electrode, ring electrodes and shock
coils on the other. Coils and cables are embedded in silicone insulation, which
serves to insulate the conductors from each other and from the outside
environment. The external surface of the silicone insulation is coated to improve the
lead's gliding properties.
Details: Technical Data, p. 24 ff.
the lead.
Sensing and pacing occur between the distal pole and the ventricular ring
electrode.
The energy for cardioversion and defibrillation therapies is provided via the shock
coils.
Fixation The lead tip has an extendable/retractable screw for fixating the lead in the
myocardium.
Extend or retract the fixation screw by rotating the IS-1 connector pin and thereby
the conductor to the tip electrode. For improved handling, a fixation tool is provided
for the connector pin.
Steroid collar The lead tip has a steroid collar in the form of a rubber silicone ring that contains
dexamethasone acetate.
Lead connections The following applies for the connectors:
Connector for Lead connector Standards Label
Sensing, pacing IS-1 • ISO 5841-3
• EN 50077
Shock delivery DF-1 • ISO 11318 DF-1
IS-1 BI
5 Description
Intended Use, Indications and Contraindications
Intended use and indications In combination with a compatible ICD, this lead is designed for the following:
• Permanent sensing and pacing in the right ventricle
• Delivery of defibrillation / cardioversion therapies
With its active fixation screw, this lead is especially suitable for patients with
degenerated trabeculae in the ventricle for whom passive fixation with silicone or
polyurethane tines is not possible.
Contraindications Implantation of this lead is contraindicated in the following cases:
• Patients with mechanical tricuspid valve prostheses or severe tricuspid valve
diseases
• Patients with a dexamethasone acetate intolerance
Guidelines For indications and contraindications of an ICD or pacemaker therapy, we also
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.
6 Description
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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:
• Name of model
• Technical properties and data
•Serial number
• Use by date
• Details on sterility
• Storage information
Sterility The lead and its accessories are packaged in a double blister and sterilized with
ethylene oxide. As a result, the inner blister is also sterile on the outside.
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.
CAUTION
Resterilization and reuse
This lead is intended for single use only. Reuse of leads can result in infections,
embolisms and damage to the device.
Resterilization and reuse are prohibited.
Storage Maintain the following storage conditions:
Storage temperature Maximum storage duration
5–50°C 2 years
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
malfunctions - 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.
7 Safety
2 Safety
Safety2414086Technical ManualProtego DF-1 S
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
• 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
sensing
Significant
worsening of the
threshold
Improper connection between
lead and the active device
Lead dislodgement Reposition lead.
Lead fracture Replace lead.
Insulation defect Replace lead.
Excessive fibrotic tissue
formation
Properly connect the lead to
the active device.
Adjust pulse amplitude and
duration; reposition or replace
the lead.
8 Safety
Risky Therapeutic and Diagnostic Procedures and Environmental Influences
Improper procedures The procedures listed in the following table must be avoided for patients with an
implanted lead or a device system (pacemaker or ICD).
Procedure Type of danger
Diathermy
Magnetic resonance imaging
(Please read the explanation at the
end of this section.)
Hyperbaric oxygen therapy • Penetration of bodily fluids into the lead or
Transcutaneous electrical nerve
stimulation (TENS), stimulation
current
• Tissue damage due to excessive heating of
the lead
• Induction of ventricular fibrillation
• Tissue damage due to excessive heating of
the lead
• Change of position of the lead (lead
dislodgement) or the active device
• Pulse inhibition, asynchronous and/or
triggered pulse delivery by the active
device
device
• Induction of ventricular fibrillation
Note: Tissue damage due to excessive heating usually causes change or loss of the
sensing and pacing function of the implanted lead.
Magnetic resonance imaging Magnetic resonance imaging is contraindicated due to the associated high
frequency fields and magnetic flux density.
• Patients with an implanted lead of this type may be examined using magnetic
resonance imaging only when specific measures have been taken to ensure the
safety of the patient and device.
• Please contact the responsible authorities or BIOTRONIK beforehand to
determine whether these products are actually certified "MR conditional" in
your country or region.
• You can find detailed information about the requirements, conditions and
measures for safely conducting an MRI scan in our manual "ProMRI
MR conditional device systems."
You can download this manual as a PDF file from
www.biotronik.com/manuals/manualselection or
https://manuals.biotronik.com or order a printed copy from BIOTRONIK.
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9 Safety
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Risky procedures The table below provides an overview of procedures that present a risk to patients
with an implanted lead or a device system. Take appropriate precautionary
measures and observe the specific instructions listed in the table.
Procedure Type of danger Recommendations for risk
Therapeutic ultrasound
External defibrillation
Electrophysiological
ablation
HF surgery (electrocautery)
Lithotripsy Mechanical effect on or
Tissue damage due to
excessive heating of the
lead
Tissue damage due to
excessive heating of the
lead
Tissue damage due to
excessive heating of the
lead
Induction of ventricular
fibrillation
Damage to the lead
Tissue damage due to
excessive heating of the
lead,
Induction of ventricular
fibrillation
damage to the lead
mitigation
Do not direct the energy focus
onto the lead or the device.
Afterwards: perfom a full
follow-up.
Afterwards: perfom a full
follow-up.
Switch off the active device
beforehand.
Keep as much distance as
possible between the ablator
and the lead.
Following ablation and prior to
restarting the active device:
perfom a full follow-up.
Do not direct the energy focus
onto the lead or the device.
Afterwards: perfom a full
follow-up.
Keep energy focus from the
lead.
Afterwards: perfom a full
follow-up.
Problematic environmental
influences
Note: Tissue damage due to excessive heating usually causes change or loss of the
sensing and pacing function of the implanted lead.
• Increased ambient pressure:
The leads are manufactured under standard atmospheric pressure and are not
designed to withstand increased ambient pressure.
Stress resulting from excess pressure may damage the leads.
CAUTION
Damage and failure of the device system
Patients with device systems must avoid situations or environments in which they
would be exposed to high ambient pressures (such as diving or pressure chambers).
• Electromagnetic interference:
Electromagnetic fields may negatively affect patients with device systems as the
intensity and duration of exposure increase. This can have the following
consequences:
— Temporary or permanent effect on or damage to the device system
— Induction of tachycardias, up to and including ventricular fibrillation (in rare
cases)
— Thermal tissue damage (in severe cases)
The patient should be properly informed and instructed on behaviors to avoid
situations with especially risky electromagnetic effects.
Perform a follow-up for clarification if electromagnetic interference is
suspected to have impaired the function of the device system.
In most cases, the problem can be solved by reprogramming the device.
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