BIOTRONIK ProMRI Protego DF-1 S User manual

BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel [phone]
Fax [phone]
[e-mail]
www.biotronik.com
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.
Index 414086Technical ManualProtego DF-1 S
0123 2015

2Table 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

3Description
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
Note: Keep this technical manual for later use.
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.
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.

4Description
Design and Properties of the Lead
Product name Protego DF-1 S
Features at a glance • 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:
—1x DF-1
—1x IS-1 (bipolar)
Lead body The lead body consists of coils and cables that form the electrical connection
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.
Electrical properties The fixation screw is electrically active and forms the distal pole (tip electrode) of
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:
Model Length
Protego DF-1 S 60 61 cm
Protego DF-1 S 65 65 cm
Protego DF-1 S 75 75 cm
Connector for Lead connector Standards Label
Sensing, pacing IS-1 • ISO 5841-3
• EN 50077
IS-1 BI
Shock delivery DF-1 • ISO 11318 DF-1

5Description
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.

6Description
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
•Serialnumber
• Use by date
• Details on sterility
• Storage information
!
!
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.
!
!
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.
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.
Storage Maintain the following storage conditions:
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.
Storage temperature Maximum storage duration
5–50°C 2 years

7Safety
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
Improper connection between
lead and the active device
Properly connect the lead to
the active device.
Lead dislodgement Reposition lead.
Lead fracture Replace lead.
Insulation defect Replace lead.
Significant
worsening of the
threshold
Excessive fibrotic tissue
formation
Adjust pulse amplitude and
duration; reposition or replace
the lead.

8Safety
Risky Therapeutic and Diagnostic Procedures and Environmental Influences
Note: Tissue damage due to excessive heating usually causes change or loss of the
sensing and pacing function of the implanted lead.
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).
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.
Procedure Type of danger
Diathermy • Tissue damage due to excessive heating of
the lead
• Induction of ventricular fibrillation
Magnetic resonance imaging
(Please read the explanation at the
end of this section.)
• 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
Hyperbaric oxygen therapy • Penetration of bodily fluids into the lead or
device
Transcutaneous electrical nerve
stimulation (TENS), stimulation
current
• Induction of ventricular fibrillation
• 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.

Note: Tissue damage due to excessive heating usually causes change or loss of the
sensing and pacing function of the implanted lead.
9Safety
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.
Problematic environmental
influences
• Increased ambient pressure:
!
!
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 cham-
bers).
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.
• 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.
Procedure Type of danger Recommendations for risk
mitigation
Therapeutic ultra-
sound
Tissue damage due to
excessive heating of the
lead
Do not direct the energy focus
onto the lead or the device.
Afterwards: perfom a full
follow-up.
External defibrilla-
tion
Tissue damage due to
excessive heating of the
lead
Afterwards: perfom a full
follow-up.
Electrophysiological
ablation
Tissue damage due to
excessive heating of the
lead
Induction of ventricular
fibrillation
Damage to the lead
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.
HF surgery (electro-
cautery)
Tissue damage due to
excessive heating of the
lead,
Induction of ventricular
fibrillation
Do not direct the energy focus
onto the lead or the device.
Afterwards: perfom a full
follow-up.
Lithotripsy Mechanical effect on or
damage to the lead
Keep energy focus from the
lead.
Afterwards: perfom a full
follow-up.

10 Safety
Electrical and Electromagnetic Safety
!
!
WARNING
Risk of death due to induction of ventricular fibrillation
Ensure that the contact surfaces of the lead connectors of implanted leads never
touch any electrically conducting or wet surfaces, including human hands or skin.
Note: For information about therapy or diagnostic procedures that pose a potential
risk, refer to the appropriate section of this manual (see Risky Therapeutic and
Diagnostic Procedures and Environmental Influences, p. 8).
Electrical safety Implanted leads are a direct electrical connection to the myocardium.
Therefore, it is important for the safety of the patient that no electrical energy -
other than the pulses from the active device - is conducted to the lead, neither by
direct contact nor indirectly due to electromagnetic conduction.
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 myocardium.
Additional information For further information about this topic and possibilities of risk mitigation, refer to
the manuals for BIOTRONIK active devices.
Preventing leakage currents Leakage currents to the active device, the lead or directly to the myocardium must
be 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.
Only connect the lead to battery-powered measurement and pacing devices or to
devices that are classified as type CF (Cardiac Floating) applied parts complying
with EN 60601, and follow the instructions in the respective technical manuals.

11 Handling and Implantation
3 Handling and Implantation
Handling and Implantation3414086Technical ManualProtego DF-1 S
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.
• Move active fixation leads intracorporally only when the screw is fully retracted
because an extended screw could tear the vascular wall or perforate the
myocardium.
• Coagulated blood can affect the maneuverability of the stylet in the lead and
inhibit or block the screw mechanism.
— Ensure that no blood reaches the interior of the lead on, or with, the stylet.
— As far as possible, prevent blood from entering the lead from other
pathways.
— If needed, use a spare stylet or, when the screw mechanism is affected,
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.
They can also be ordered individually as accessories.
The use of active fixation leads is associated with an increased risk of perforation
and rupture.
• The lead should be implanted in such a way that the fixation screw is not tensed
during contraction and relaxation movements of the heart or other movements
made by the patient.
• Fixate the lead at the incision point of the vein so that there is no tension and so
that the action of the tricuspid valve is not impeded.

12 Handling and Implantation
Information on the Steroid Collar
!
!
CAUTION
Premature elution of the steroid
Do not wipe the lead or immerse the lead in liquids any more than absolutely
necessary.
Intended medical use The lead tip has a steroid collar in the form of a silicone rubber ring that contains
dexamethasone acetate.
The intended effect is the reduction of the inflammatory processes after
implantation and the inflammation-related post-operative threshold increase (lead
maturation behavior).
Long-term performance of
the steroid eluant
The greater the elapsed time since the implantation, the more the original amount
of steroid is eluted.
Over time, the maturation behavior of the lead begins to resemble that of the same
type of lead without steroid-eluting properties. This aspect must be considered if a
lead is to be repositioned.

13 Handling and Implantation
Opening the Package
!
!
CAUTION
Risk to sterility
The inner blister must not come into contact with non-sterile instruments or be
touched by persons who are not wearing sterile gloves.
Step Figure Action
2In the sterile area:
Packaging composition The lead and its accessories are sealed in two blisters, one within the other, and
sterilized with ethylene oxide. 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 the non-sterile area:
open the outer blister by peeling
off the paper seal in the direction
of the arrow.
• Remove the sterile inner
blister by using the gripping
tab.
• Open the inner blister by
peeling off the paper seal in
the direction of the arrow.

14 Handling and Implantation
Checking the Function of the Fixation Screw before Implantation
Function Use the enclosed fixation tool to extend the fixation screw (turn right, clockwise) and
retract it (turn left, counterclockwise).
When fully extended, the fixation screw protrudes a maximum of 1.8 mm from the
lead body.
Number of rotations The maximum number of rotations permissible for the complete extension of the
fixation screw and the maximum number of rotations required to do so are listed in
the "Technical Data" section of this technical manual.
The exact number of rotations required depends on several factors:
•Leadlength
• Precise position and curves of the lead
• Residual torque in either direction resulting from previous rotational
movements
• Increased static friction with first use of the screw mechanism after long
storage
!
!
CAUTION
Damage to the lead caused by turning the screw mechanism too far
Do not exceed the maximum number of rotations to extend or retract the fixation
screw as specified in "Technical Data".
!
!
CAUTION
Damage to the lead when using the screw mechanism
Please take the following precautions into account to prevent damage to the lead:
!
!
CAUTION
Leads with a defective screw mechanism are not suitable for implantation
Do not implant the lead if it fails the function test. Instead, use a replacement lead
that has passed the same test.
Step Action
1Remove the stylet guide from the lead connector.
It will remain on the part of the stylet that is protruding from the lead. The
stylet remains entirely in the lead.
2Clamp the enclosed fixation tool on to the connector pin of the lead
connector.
Alternative: Clamp the connector's contact pin into the groove of the fixation
tool.
3Turn the fixation tool in a clockwise direction until the fixation screw is fully
extended.
4Turn the fixation tool in a counterclockwise direction until the fixation screw
is fully retracted.
5Remove the fixation tool from the connector pin and place the stylet guide
back on the lead connector.
6Do not implant the lead if it fails the function test. Instead, use a replace-
ment lead that has passed the same test.
Checking the screw
mechanism before
implantation
Before starting the implantation process, test proper functionality of the screw
mechanism by fully extending and retracting the fixation screw.
• Only use the lead with a stylet inserted, even if you only want to check the screw
mechanism.
• The stylet must not be kinked or overbent.
• Only use the provided fixation tool clamped to the connector's contact pin to
extend or retract the fixation screw. Do not use any other tools or accessories.

15 Handling and Implantation
Accessing the Vein and Inserting the Lead
Preparing the lead After all implantation preparations have been made, proceed as follows:
Two methods of accessing the
vein
There are two options for inserting the lead into the vein:
Method A Through the cephalic vein:
Method B Through the subclavian vein:
• Use a suitable lead introducer set.
Stop the procedure if the lead cannot be easily inserted into the introducer
sheath and check whether the lead introducer set is appropriate for the lead.
• Please consult the technical manual included with the lead introducer set.
!
!
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.
After having established the access to the vein using the lead introducer set, insert
the lead into the vein through the introducer sheath.
Step Action
1 Ensure that the fixation screw is completely retracted.
2 Move the premounted lead fixation sleeve close to the lead
connector.
3 Ensure that a straight stylet is completely inserted into the lead.
Either Method A Incision of the cephalic vein
Or Method B Puncturing the subclavian vein
Step Action
1 Prepare the cephalic vein.
2 Open the vein.
3 Carefully insert the tip of the vein lifter provided into the lumen of the
vein.
4 Raise the vein lifter carefully.
5 Insert the lead into the vein through the opening.

16 Handling and Implantation
Positioning and Fixating the Lead
Note: The position of the fixation screw can be clearly seen on the X-ray image
when the lead is X-rayed from the lateral view (see figure).
!
!
WARNING
The myocardium can be damaged if the fixation screw is over-rotated!
Only rotate the fixation screw as many times as are necessary for complete exten-
sion.
Observe the position of the fixation screw on the X-ray.
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.
Positioning the lead Proceed as follows to position the lead in the ventricle:
Test measurement to assess
the lead position
The electrically active tip of the fixation screw can also contact the myocardium
when the screw is retracted.
Thus, the position of the lead tip can be assessed prior to fixation using
electrocardiac measurements without injuring the tissue.
Fixating the lead tip Proceed as follows to fixate the lead tip in the myocardium after finding a suitable
position:
Step Action
1 Carefully advance the lead tip through the tricuspid valve into the
right ventricle.
2 Find a suitable position for the lead tip:
• Close to or on the ventricular apex
• If possible, perpendicular to the myocardium
Step Action
1 Remove the stylet guide from the lead connector.
It is now on the end of the stylet that is protruding from the lead. The
stylet remains entirely in the lead.
2 Clamp one of the included fixation tools onto the contact pin of the
lead connector.
3 Anchor the lead tip in the myocardium by keeping the lead in
position while rotating the connector pin to the right using the
fixation tool.
X-ray image of the lead with retracted fixation screw:
X-ray image of the lead with extended fixation screw:

!
!
CAUTION
Damage to the lead in the event of defective screw mechanisms
Do not operate the screw mechanism if one of the following problems arises:
Otherwise, the lead may be damaged to the point of uselessness.
!
!
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 failure, pressure necroses, myocar-
dial perforations, irritation to the tricuspid valve or other unwanted complications.
Step Action
4
5
17 Handling and Implantation
• The screw mechanism has become sticky due to coagulated blood or bodily
fluids.
• The screw mechanism has been substantially overwound during retraction or
extension.
• Apply pressure carefully when fixating the lead tip.
• Consider the following two aspects when elongating between the distal and
proximal fixations 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.
If, due to repeated extension and retraction of the fixation screw
(from repositioning of the lead tip), the mechanism becomes difficult
to handle or if it sticks, the following measures are recommended:
•Do not use the screw mechanism any longer.
• Rotate the entire lead with inserted stylet counterclockwise in
order to unscrew the lead from the myocardium without using
the screw mechanism.
• Replace the lead with a new one.
If the stylet can only be moved in the lead using excessive force, the
following measures are recommended:
•Do not continue to reposition the lead.
• Replace the lead with a new one.

18 Handling and Implantation
Intraoperative Measurements and Tests
!
!
CAUTION
Damage to the seal
Ensure that the sealing rings of the lead connectors are not damaged by the
alligator clips.
This applies especially when connecting an alligator clip to the exposed contacts.
!
!
WARNING
Leakage currents can trigger ventricular fibrillation
Only conduct electrophysiological measurements or temporary pacing through
implanted leads with devices that are classified as type CF (Cardiac Floating)
applied parts complying with EN 60601 or with battery-powered measuring and
pacing devices.
All other line-powered devices connected to the patient must be properly
grounded.
!
!
CAUTION
Risk of intermittent pacing
During intracardiac measurements, pacing will be temporarily interrupted.
Connecting the leads
temporarily
For a qualitative evaluation of the lead position, it is necessary to measure pacing
thresholds, intracardiac potentials and the defibrillation threshold.
For this purpose, temporarily connect the patient cable to the lead connectors using
alligator clips. The pin of the IS-1 connector can be accessed via an opening in the
stylet guide.
The contact ring of the IS-1 connector is directly accessible for alligator clips.
DF-1 connectors can only be connected using a suitable adapter.
The DFT test requires an antipole, such as a test housing.
Clamping an alligator clip to the connector pin:
Use suitable patient cables when temporarily connecting the lead to an
intraoperative test system. The stylet must be removed prior to the measurements.
Safety warnings Please note the following when conducting intraoperative measurements and tests!

Note: Active fixation irritates 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.
Note: More details regarding electrophysiological measurements can be found in
the technical manual of the measuring device.
Note: If the device system fails to terminate VT or VF during the DFT test, the
patient gets into a life-threatening condition. Therefore, it is essential to have an
external defibrillator ready during the DFT test.
19 Handling and Implantation
Suitable measuring devices BIOTRONIK provides measuring devices calibrated to the properties of the active
devices for measuring pacing threshold, defibrillation threshold and intracardiac
potentials.
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.
Please refer to the technical manuals of the respective testing and measuring
devices for further details on performing measurements and tests.
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.
Measuring intracardiac signal
amplitudes
The heart must not be paced externally while measuring the amplitudes of intrinsic
cardiac events.
Target values Generally, the lead position is considered acceptable if the pacing threshold does
not exceed the maximum values shown below and if the intracardiac signal
amplitude is not less than the minimum value shown below:
Determinating the
defibrillation threshold
(DFT test)
Use the DFT test to find out which shock energy level and lead configuration can be
used to conduct a safe defibrillation on the patient.
Testing the complete device
system
When the lead is connected to the ICD and the ICD is implanted, you have to perform
a final function test of the device system using the programmer.
Ventricle Measurement condition
Pacing threshold Max. 1.0 V Pulse width: 0.5 ms
Intracardiac signal Min. 5 mV

20 Handling and Implantation
Fixating the Lead at the Lead Incision Point
!
!
CAUTION
Tensile force on the endocardial fixation or impediment of the heart valve
The distance between the fixations at the lead tip and at the entry site of the lead
has to be dimensioned in such a way that the following conditions are met:
Purpose Fixating the lead at the incision point in the vein or in the muscle minimizes the risk
of dislodgment.
The lead fixation sleeve enables secure and smooth fixation of the lead at its
incision point and decreases the risk of damaging the insulation or coil during
fixation.
Prerequisites Placement of the lead and measurement of the threshold and the intracardiac
signals were successful.
Lead fixation sleeve On delivery, the lead fixation sleeve with ligature grooves made of silicone is
mounted on the lead.
Instructions for use Move the lead fixation sleeve back to the puncture or incision site and fixate it with
ligature sutures.
Application example: Fixate the lead at the incision site of the vein using the fixation
sleeve.
• Contraction of the heart and other movement of the patient should not put
tension on the fixation.
• The tricuspid valve's function must not be hindered by the lead.